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Panelists of Advancing Care Delivery: Driving Demand and Supply of Diagnostics and GHDonline staff

Advancing Care Delivery: Driving Demand and Supply of Diagnostics

Thank you.

Many thanks to all of those who participated in this thoughtful discussion. Although the Expert Panel has ended, please feel free to share any closing remarks. You can also catch up on the discussion summaries for each day of the panel:


Diagnostic Value Chain

Diagnostic technologies go through a chain of events between initial design and eventual implementation around the world. During this discussion, we will touch on each of these key links in the value chain.

Demand and Initial Assessment: Determining demand for diagnostics begins with defining the problem. Researchers should assess clinical, market, and end-user needs through marketing and procurement, and draw on partnerships with local governments and organizations.


Daily Discussion Summaries: Catch up on the discussion summaries for previous days of the panel

  1. What is your country’s approach for using diagnostics for HIV, TB, malaria, and HPV?
  2. What do you see as the biggest barriers to effective use of diagnostics? What would it take to remove these barriers and expand access?

Research and Development: Initial assessments often represent the diagnostic need for a particular point in time. Following assessment, diagnostic assays and devices should be designed and developed for current and future needs with consideration for local constraints.


Daily Discussion Summaries: Catch up on the discussion summaries for previous days of the panel

  1. How have diagnostics for HIV, TB, malaria, and HPV been validated in the country where you work? Was operational or implementation research conducted for these diagnostics? How was it done & what lessons were learned?
  2. Do you see advantages to importing, versus locally manufacturing, diagnostics?

View Demand & Initial Assessment discussion summaries.

Regulation via National and International Bodies: Quality assurance and control processes should be implemented for scaled-up manufacturing and adapted for local distribution. This may include filing for regulatory approval in the global marketplace.


Daily Discussion Summaries: Catch up on the discussion summaries for previous days of the panel

  1. What policies regulate or impact the use of diagnostics in your setting?

View Evaluation & Adaptation discussion summaries.

Production and Delivery Support: On-the-ground efforts are essential for ensuring local uptake of technology by users, clinics, and laboratories. Delivery support can be organized through personnel and user training, technical assistance, and equipment maintenance.


Daily Discussion Summaries: Catch up on the discussion summaries for previous days of the panel

  1. What lessons would you offer regarding production supply, quality, service and support, or other post-launch needs for diagnostics?
  2. To ensure the right patient gets the right diagnostic test and appropriate treatment, what would the ideal delivery system look like for HIV, TB, malaria and HPV in your setting?

View the Regulation discussion summary.

Adapted from “Enabling the Development and Deployment of Next Generation Point-of-Care Diagnostics.”

Panelists

Jane Carter

Jane Carter

Kenya

Nick Day

Nick Day

Thailand

Anthony Emeribe

Anthony Emeribe

Nigeria

Nora Engel

Nora Engel

Netherlands

Ilesh V. Jani

Ilesh V. Jani

Mozambique

Marcel van Kasteel

Marcel van Kasteel

Netherlands

Madhukar Pai

Madhukar Pai

Canada

Advancing Care Delivery: Driving Demand and Supply of Diagnostics

Posted: 03 Sep, 2015   Recommendations: 70   Replies: 219

As we see growing interest in the potential for diagnostics to dramatically improve the health of populations, now is the time to discuss novel approaches for ensuring these technologies are accessible to the world’s poorest and most vulnerable populations.

During this site-wide GHDonline Expert Panel, hosted from September 21 to October 2, we will explore methods for driving innovation and access in global health diagnostics for HIV, TB, malaria, and HPV. Our panelists will share their experiences and expertise, and discuss what must be done to develop delivery systems, business models, new technologies, interoperability standards, and governance mechanisms to ensure each patient will receive the right diagnostic at the right time.

PANELISTS
   • Catharina Boehme, CEO, FIND Diagnostics
   • Jane Carter, MBBS, FRCPC, Technical Director of Clinical and Diagnostics, Amref Health Africa, Kenya
   • Nick Day, FMedSci, FRCP, Director, Mahidol Oxford Tropical Medicine Unit, Thailand
   • Anthony Emeribe, PhD, FMLSCN, Registrar/Chief Executive of the Medical Laboratory Council of Nigeria
   • Nora Engel, PhD, Assistant Professor, Maastricht University Global Health Programs
   • Dana Goldman, PhD, Chair & Director of the Center for Health Policy & Economics, University of Southern California
   • Jeannette Guarner, MD, Professor of Pathology and Laboratory Medicine and the Medical Director of the Clinical Laboratory at Emory University Hospital in Midtown
   • Ilesh V. Jani, MD, PhD, Director of Healthcare Research, Ministry of Health, Mozambique
   • Marcel van Kasteel, MBA, Senior VP of Handheld Diagnostics, Philips
   • Tsehaynesh Messele, MSc, PhD, Former CEO African Society of Laboratory Medicine, Ethiopia
   • Madhukar Pai, MD, PhD, Director, McGill Global Health Programs
   • Rosanna Peeling, Msc, PhD, Professor & Chair of Diagnostics Research Director of the International Diagnostics Centre, London School of Hygiene and Tropical Medicine


DISCUSSION QUESTIONS
1. What is your country’s approach for using diagnostics for HIV, TB, malaria, and HPV? Please explain for each of the following
        • Decentralized point-of-care testing?
        • Decentralized sample collection followed by reference lab centralized testing?
        • Predominant empiric treatment?

2. What do you see as the biggest barriers to effective use of diagnostics? What would it take to remove these barriers and expand access?

3. How have diagnostics for HIV, TB, malaria, and HPV been validated in the country where you work? Was operational or implementation research conducted for these diagnostics? How was it done & what lessons were learned?

4. Do you see advantages to importing, versus locally manufacturing, diagnostics?

5. How are new diagnostics introduced in your country, and who makes decisions about which diagnostics will be covered by insurance schemes (if applicable)?

6. How are guidelines for use disseminated? What challenges have you seen in adapting global guidelines to your setting, and what strategies have you found for training providers on these guidelines?

7. What policies regulate or impact the use of diagnostics in your setting?

8. What lessons would you offer regarding production supply, quality, service and support, or other post-launch needs for diagnostics?

9. To ensure the right patient gets the right diagnostic test and appropriate treatment, what would the ideal delivery system look like for HIV, TB, malaria and HPV in your setting?

To better understand the needs of healthcare professionals around the world, we also hope all our members will share their own experiences with our panelists and the GHDonline community. You know best what diagnostic tools are prevalent in your setting, and what barriers there may be to their usage, so we hope that you will all join us by sharing your thoughts on the questions above and joining the conversation with our exceptional group of panelists from September 21 to October 2.

Replies

 

Madhukar Pai Panelist Replied at 1:48 PM, 14 Sep 2015

Diagnostics are critical for ensuring rapid, quality clinical care and for disease control and surveillance programs. But they get little attention, especially in comparison to drugs and vaccines. Diagnostics development has stalled for several neglected diseases, and even where good tests are available, they are not necessarily accessible or affordable to those who need them the most. For example, of the 9 million TB cases each year, 3 million are either not diagnosed or not notified. Only a third of the estimated MDR-TB patients are diagnosed. Only about half of those infected with HIV are aware of their status. In half of endemic African countries, over 80% of malaria treatments are applied without diagnostic testing.

The global health community should work together to better understand why essential diagnostics are not easily accessible or taken up, and fix the broken value chain that prevents patients in resource-limited settings from getting the diagnostic services that they deserve. This GHDonline Expert Panel on “Advancing Care Delivery: Driving Demand and Supply of Diagnostics” is one step to engage the wider community on this issue. Send in your learnings and suggestions!

Riddhi Doshi Replied at 2:27 PM, 14 Sep 2015

Dear Dr. Pai,

Thanks for the fantastic opening to the Expert panel. MDR-TB is indeed a
very serious Public Health problem for the global population today even
though Africa and Asia bear a large proportion of the burden. The
epidemiological trend of this condition can be pretty much predicted by
availability of diagnostic tools/facilities and medication adherence. Here
I would like to mention two issues or even opportunities for innovation in
diagnostics- Simplified diagnostics and knowledge penetration. For example,
your innovation in the area, GeneXpert/MTB/RIF system is a great example of
simplified diagnostics making it feasible to conduct diagnosis for
Tuberculosis as well as rifampicin resistance using a very simple set up.
Knowledge penetration, on the other hand, while easier to attain at the
policy and health ministry level is quite difficult to attain at the
patient level. For advanced technology like GENEXPERT, it is essential to
make the technology and knowledge about the technology available in rural
and remote as well as urban areas. In the era of patient driven healthcare
and patient reported outcomes, it is as important for the patient to know
and demand the diagnostic as it is to train the physician in newer,
simplified diagnostic technologies.

GIORDANO UCHOFEN Replied at 2:41 PM, 14 Sep 2015

Hi all:

Now in Perú we have a good system for diagnosing TB and treating (this is a government policy and it is standarized). The problem is X-DR like consequence of very bad compliance to the treatment or maybe due to lack of empathy between physician and patient??? Maybe physician's message is not good?? Maybe it is necessary not only to standarize the diagnosis and treatment but also the professional skills to be a TB health provider???

Thank you for this opportunity to express this issue.

Giordano Uchofen, MD.

Obieze Nwanna - Nzewunwa Replied at 2:44 PM, 14 Sep 2015

An odd experience of mine is that international donors or multinational
NGOs come periodically to secondary and primary care facilities with
equipment but not enough reagents and the facilities can not buy these
expensive or inaccessible reagents. With each change in country or state
director, a new initiative is born which brings a new machine with the same
issues. so many facilities have lots of equipment which the can neither
maintain or sustain due to lack of technical skill, access to reagent or
affordability of reagents.

Also there are no processes or management procedures to check and monitor
the availability of the equipment and reagents.


Do you see advantages to importing, versus locally manufacturing,
diagnostics?

Importation is a temporary fix and it hurts the economy. manufacturing
would produce jobs and keep the youth engaged.


How are new diagnostics introduced in your country, and who makes decisions
about which diagnostics will be covered by insurance schemes (if
applicable)?

75% of health expenditures in Nigeria is out of pocket. The private sector
which is the larger sector, is chiefly unregulated thus cost is not
controlled. The decision in private hospitals is dependent on the owner's
experience and financial capacity. Private providers import. Primary and
secondary health facilities receive their diagnostics from the Ministry of
health (when they are being built or commissioned) but subsequently are
sustained by are mainly donor NGOs.

Patrick Hazangwe Replied at 2:49 PM, 14 Sep 2015

I work as a TB specialist supporting the MOH.
In TB work, early dectection leading to early proper treatment in the core for effective TB control and prevention.
Diagnostic tools which facilitates early case dectection are critical if TB is going to be controlled to a non public health disease. The introduction of molecular diagnostic tools like the Gene Xpert is a revolution in TB care. However, the challenge is that the diagnostic tool is not favorable for those regions with the highest TB burden: A good invovation but difficult to implement as most intended health institutions dont have suitable infrastructure: electricty! This becomes a major limiting factor: for both the technology and its consumables as a suitable POC machine.
In the role out of (eg.Gene Xpert in the country, ,lack of electricty for the machines itself, air conditioning ( surprisingly for a machine ment for TB diagnosis in high burden countries), consumables with a short shelf life , requirement for remote management of the machine. All this defeated the basic principles of a POC for community use. Thus access to TB diagnosis remains centralised.
Diagnostic tools should be developed with view of the intended market not the environment where they are manufactured. Diagnostic tools for public health interventions should not complicated health delivery in the already over stretched low income setting.
One good example is the malaria RDT which was easily intergrated into the health systems and now the country.
It would be a good dream for countries with the "problem" to manufacture the diagnostic tool, however, this will remain a dream. But, if the world is putting forward ambitious goals to eradicate global public health conditions, then manufacturers have to stop draining the little resources from the resource limited countries who generate the biggest demand for these diagnostic tools.


On guidelines
Guidlines aim to standardise practise are usually generic. The far guidelines are from the ploblem the less contrete they can be. At global level, it dilutes issues as it tries to be as generic as possible, secondly it also looses specific relevance to regional settings.
I would think guidelines which are regional are much easier for countries to indentify with and adopt to thier context. If guidelines are regional, there would be a reduced need for external technical assistance to intergrate new developmens into national strategies. This is likely to be cost effective for countries will use local or regional experts in adopting and adapting guidelines.
On specific diseases, I would suggest to have more regional specific guidelines, than encompassing global.

Jeannette Guarner Panelist Replied at 3:39 PM, 14 Sep 2015

Totally agree, tests in general whether these are used for diagnostics or for following patients are not given the attention needed. Physicians treating patients need to advocate to have the tests available where they work. The difference in treating someone with fever can be so different if we think about the potential causes: Say you think the patient has salmonellosis you need antibiotics but if you think it is malaria then it is antimalarial medications, then if it is Ebola you quarantine the patient. Drastically different approaches. Why are clinicians not asking for their hospitals, governments and others asking for the tests that will make a difference on how they treat patients?

Sandeep Saluja Replied at 4:59 PM, 14 Sep 2015

Wonderful idea!Truly look forward.
While I am keen to learn more about innovative low cost diagnostics,as a clinician,I would also be happy to be part of clinical trials evaluating new technologies.

Murali Ramachandran Replied at 8:27 PM, 14 Sep 2015

We use the Academic institutions and District Hospitals lab are used for testing.
Periodical training Of staff for quality assurance.
Testing labs are accreted.
Dr.Murali

Urvashi Singh Replied at 2:40 AM, 15 Sep 2015

Dear All,

This is a brilliant discussion.Such brilliant ideas have been shared:

1. There are more equipments but no reagents: One possible answer could be
REAGENT RENTAL.The equipment manufacturer places the equipment and
maintains it and earns from the sale of reagents.This way the onus of
ensuring reagent supply is on the manufacturer and the governments do not
feel the pinch of shelling out big investments at the outset for machines
that may lie unused, awaiting reagents.

2.Locally designed and developed diagnostics:are the best answer ,but these
would need validations, governments need to gear up to support the
endeavour.

3. Regional specific guidelines: brilliant idea.The enlightened minds that
suggest this will have to initiate this and impress upon the national
initiatives of the respective countries, the need for defining guidelines
to best suit the region.

joshua odero Replied at 4:04 AM, 15 Sep 2015

Thank you for bringing in this discussion. Diagnostic plays a key role in patient management however with the current trend in the market, a case in my Country Kenya which I may presume reflects situation in many other African countries show a compromise in patient safety as this kits lack validation to guarantee quality results. The vendors are not prequalified and considering that national testing algorithms exist, few laboraties have standard procedures that respect the testing protocals for malaria and HIV. What would happen when we get a patient with mixed species of malaria and the RDT may only capture one species? My fear is that the clinician will cover the patient with most likely an antibiotic, hence bringing in a new dimension on antibiotic resistance. There is need to improve on capacity of laboratory staff to be able to carry out diagnostics, a case in Microbiology which is neglected as much focus is only on automation and Micro being manual and complex as it requires technical skills, it is abandoned or gabbage is channeled out as results to the patients. It is therefore paramount that national policies are enforced on diagnostics otherwise patient safety will be comprised.

Mohammad Hassan Mashori Replied at 9:05 AM, 15 Sep 2015

Thank you for bringing in this discussion. Diagnostic plays a key role in patient management however with the current trend in the market, a case in my Country pakistan which I may presume reflects situation in many other Asian countries show a compromise in patient safety as this kits lack validation to guarantee quality results.

Isabelle Celentano Replied at 9:18 AM, 15 Sep 2015

In preparation for next week's discussion, I wanted to share a resource that might be of interest. This article (link below) in PLOS Neglected Tropical Diseases outlines the point-of-care diagnostic value chain, a chain of events between initial design, and eventual implementation, of a diagnostic test.

We thank the authors for this model, which has inspired the broader value chain we've used to structure this discussion. During this discussion, we will touch on each of these key links in the value chain. (Please visit this Expert Panel on the web to view the value chain model: www.ghdonline.org/global-diagnostics)

We encourage you to share additional resources on this important topic, as well as any questions you'd like to see our panel address next week. Looking forward to a great discussion!

Attached resource:

Isabelle Celentano Replied at 12:51 PM, 15 Sep 2015

I've included 2 additional resources which may be of interest during this discussion. Please find the links below, and again feel free to share other resources and questions to discuss next week!

Attached resources:

Erwin Sihite Replied at 3:24 AM, 16 Sep 2015

I havent got time to see what others have said in this forum so i'll just answer discussion question according to what i know in indonesia where i live.1. Decentralized point of care testing,where every health provider especially those under goverment wings in remote area can do their own diagnostic for hiv,malaria,tb except hpv that's not available yet unless in hospital.2. The biggest barrier for hiv diagnostic is the supply of hiv kit which limited since it's pricey that sometime we even have to sent patient to hospital just for diagnostic,so lowering the price would be great. Meanwhile for malaria and tb diagnostic,the biggest barier is the available of people that able to do the test using microscope especially in remote area,that's more reason to train every available health worker to do the test.3. I cant answer this question since the publicity of research or validation done in this is controlled by university and goverment.4. Of cource locally manufactured meant lower cost so that's one advantage but so far i dont see local product.5. There's no new diagnostic since hiv-malaria stick (i'd prefer microsope test for malaria) and it's still free for health care under goverment.6. We still use WHO guidelines and health ministry often print these guidelines except the distribution is controlled by them although it's free. The challenge is in diagnostic kit supply and to make sure the patient complaency especially for hiv and tb.7. Local goverment policies influence made health care to use any diagnostic kit and medicine the choose.8. There's this program that once apllied will allow puskesmas (local health care under goverment) to stock up and also to choose which regiment for hiv patient and with that there's no need to sent patient to hospital anymore unless the patient need more advance care.9. Well the diagnostic and treatment is set,beggar cant be choosey but we have special delivery for tb especially hiv since there's still stigma among local community,it will be one of health worker job to deliver the medicine to the patient secretly or they might get desperate,stressed by people around them and it can lower patient complaency

Junior Bazile Replied at 7:00 AM, 16 Sep 2015

I completely agree that this GHDOnline Expert Panel on”Advancing Care Delivery: Driving demand and supply of Diagnostics” is one step to engage the wider community on the issue at hand.
Even in the developed world, sometimes patients go undiagnosed for weeks or months. In resource poor settings the pictures is even darker. The numbers that Madhukar provided below depict a very troubling and worrisome situation. We have seen some insurmountable challenges related to regular supply of diagnostics when supply is controlled by the government. That applies to diagnostics for HIV, TB, and Malaria mainly. The problems are particularly caused by lack of buffer stocks, late arrival of the diagnostics in the country, lack of transportation for distribution at district level, hence, poor management of supply chain.
And when finally the diagnostics make it to the district, there are serious transportation problems preventing distribution within the district. Another aspect of the problem is the turn around time. The reagents might be available in the labs but because of lack of leadership and appropriate management in the labs a result for sputum smear microscopy might take several weeks before being available. And once the result is available the promptness of healthcare professionals to act on it might be another issue.
So, literally there are serious issues that should be addressed at different level in the supply chain and the delivery of care. Those issues might somehow explain why so many TB cases are not diagnosed every year, why so many MDR-TB patients are not diagnosed and why so many HIV positive persons are not even aware of their status.
We still have a lot of work to do as Global Health Professionals but I believe that it’s doable.

Jeannette Guarner Panelist Replied at 8:30 AM, 16 Sep 2015

I would like to comment on my experience with reagent rental when I worked at the Instituto Nacional de Cancerologia in Mexico City. It was fantastic and they are still doing it. Why was it fantastic? The company we rented from at the time included in the package not only the instruments, maintenace and reagents but a laboratory information system (LIS). Thus, we ended being the first public hospital in Mexico with an LIS. Needless to say that our errors in transcription went down dramatically, we did not have to handwrite our labels so we could read the patient identifiers, the instruments read the barcodes and we only needed to enter tests ordered once... It was great. Though, as everyting in life, there is the down side: when Mexico had a monetary devaluation, we were in a pickle! The company we leased (rented) from was American, and although we had fixed for one year our prices the next they went up like crazy...
As pointed out by Urvashi Singh, locally developed tests are good but validations are difficult and take time.

Jose Caballero Replied at 10:33 AM, 16 Sep 2015

Dear colleagues:

The diagnostic tools play an important role in the treatment of patients,
however, in the hospital system in my country Peru, hospitals are run by
the ministry of health, suffer from technology, reagents, limited studies
that have impact negative do not only appropriate treatment for the patient
but has implications to clinical research, which is often not possible
please do it. Different context applies to hospitals in the social
security, these have a suitable implementation.

Timothy Amukele Respondent Replied at 12:22 PM, 16 Sep 2015

Two comments.
First I wanted to echo what Dr Singh and Guarner said about the impact of a reagent rental system. I have seen it transform many hospital laboratories (both in Africa and Asia) from enterprises that were hobbling along and not supporting clinical care, to really robust labs with consistent output. The most dramatic example was a hospital in East Africa that went from about 100 tests per day to over 2000 per day (with much higher quality) once there was a consistent supply of reagents.

I also wanted to comment on POC testing because it is presented as a healthcare solution for low-resource countries. POC testing is most valuable when there is already a functioning diagnostic system over which individual POC tests are overlaid. Attempting to support the full range and variety of clinical (NOT research) needs using POC testing is just not feasible. The reasons it doesn't work in isolation are myriad, but include complex supply chains, high cost, high staffing requirements (they are pulled from central lab to do POC), disease variety, and quality management. I am a supporter of POC testing in the right context but we have to be careful not to pitch it as a panacea.

Madhuri Gandikota Replied at 2:36 PM, 16 Sep 2015

I like the concept of Reagent rentals. However, my concern is the Quality control of the reagents.
How can one monitor that the reagents which will be delivered has quality control? The basic QC is temperature control and are the bottles kept in under appropriate lighted conditions?

As a molecular biologist working in Indian Labs a decade ago, with Indian Vendors supplying Great Brand Name companies too imported from US, Germany , most of our experiments took a really long time to work. The vendor would supply us in -20C or even in dry ice. But we never know where the fault is.

So now a decade later, with smart tracking devices, this is a possibility. Once we ensure the quality of vendors to supply in remote testing areas this is a great idea.

Marcel van Kasteel Panelist Replied at 4:53 AM, 17 Sep 2015

there are some new technologies under development to screen cells automatically which will improve productivity and performance for malaria

Samuel Tesema Replied at 3:15 AM, 19 Sep 2015

Diagnostics remain a challenge specially in health facilities with no regular supply of RDT and other reagents. This is because of poor or unavailable laboratory infrastructure, poorly trained and demotivated staffs. Health posts are supposed to collect sputum for TB diagnosis, but the yield has been persistently low. Until the health system is strengthened I see the benefit of mobile lab service to reach remote areas and make a robust connection to the central labs.

Ferdousi begum Replied at 11:19 AM, 19 Sep 2015

This is definitely a very interesting area for advancing care delivery of
services if all providers only do the needed diagnostic test for each
patient in private sector and also to limit antibiotic resistance. We are
spending more then 60% out of pocket expenditure for health care from
private sectors where all referral doctors are getting the percentage. Even
through in Bangladesh government has been allocating huge amount of money
to upgrade all facility level with high quality diagnostic facility. Goal
is great to offer quality comprehensive services, but in most cases
government still refer patient to private to get quality result. So, what
is happening to that investment? Poor quality of maintenance, lack of
properly trained people, lack of SOPs, proper supervision & monitoring and
in some cases doctors percentage are the key barriers for the people to get
free high quality free diagnostic services. Having proper marketing of
available diagnostic facility is key to demand creation barriers.

ricardo delduque Replied at 6:50 PM, 20 Sep 2015

In my contry there are many cases of tuberculosis yearly, so it´s very important
soon diagnosis so that the disease do not caught more and more people.

Charles Kiyaga Respondent Replied at 7:43 PM, 20 Sep 2015

What is your country’s approach for using diagnostics for HIV, TB, malaria, and HPV? Please explain for each of the following
• Decentralized point-of-care testing?
• Decentralized sample collection followed by reference lab centralized testing?
• Predominant empiric treatment?

In Uganda, POC HIV is used to routine HIV testing for adults by use of RDTs. For TB POCT is done using ZN for microscopy and Gene Expert. For Malaria, POCT is done using RDTs, the same with HPV.

In Uganda we have centralised testing for some HIV diagnostics including EID, VL and also for TB culture.
These centralised testing laboratories are made accessible through a hub based sample transport system. The sample transport system is made up of a network of of hub laboratories at the sub district level. Each hub covers a catchment of 30 to 40km radius around it. Each hub is provided with a motor bike and a rider, who though scheduled visits reaches all health facilities within its catchment. The hub acts as a referral laboratory for the 20 to 30 health facilities within its catchment for most of the routine tests, and only refers high-tech tests that can not be run at the hub laboratory. Samples for tests like EID, VL and MDR TB cultures, which can not be run at the hub laboratory are transported through the courier to the national centralised laboratories. Tests like Gene Expert, CD4 etc are conducted at the hub laboratory. We don't yet have centralised testing for Malaria and HPV. For these, we only use the decentralised system using RDTs or simple microscopy for malaria.

In cases where diagnostic tests are not available especially for Malaria and TB, Clinicians use empirical treatment.

Ujwala Pagedar Replied at 7:45 PM, 20 Sep 2015

So do all high risk people and people who are employed get PPD testing as part of annual physical? To identify early or diagnose latent cases.

Nora Engel Panelist Replied at 2:52 AM, 21 Sep 2015

I work as a social science researcher, mainly doing qualitative research where we conduct interviews, focus group discussions and observations and subsequently analyse those for emerging themes, narratives and the different aspect that can explain a certain phenomenon. For instance, we have conducted research on the diagnostic practices and processes at the point of care (in communities, homes, clinics and hospital wards) in India and South Africa. We wanted to understand what major barriers are to point of care testing. We researched how providers and patients would go about diagnosing the major infectious diseases, how technologies featured in these processes and what their challenges were in ensuring a point of care continuum.

We started to publish this work here:
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0135112
http://www.readcube.com/articles/10.1111%2Ftmi.12450


To answer the first question:
South Africa has a very centralized laboratory system. HIV: initial diagnosis is done with RDTs in clinics, outreach settings, hospital wards and results are discussed with clients within the same visit. Treatment initiation happens only 1week -1month later: follow up tests and CD4 counts to initiate treatment are conducted in centralized labs and often delayed (transportation issues, testing loads, lost/damaged samples, results not filed, lack of human resources, etc); and counseling sessions can take time too.
TB: centralized testing (incl problems of delayed turn around times mentioned above), selected clinic sites have GeneXpert but we found the turn around time to be longer than 24hrs, patients were told to come back in 1-2days (mainly due to backlogs created as they had to test many samples and the machine only has limited slots)

India has a much more peripheral testing infrastructure, with many smaller labs that cooperate with private doctors or are attached to public health clinics. Public clinics do sputum microscopy (in microscopy centres) and some have HIV RDTs (but RDTs in public clinic labs often are too expensive and thus they run out); private labs are varied and unregulated and you will find all sorts of approved and unapproved testing for TB, however we found that smaller labs in poorer neighborhoods do not offer sputum microscopy and cannot afford the reagents for RDTs. they either use older methods or send patients to the public for sputum microscopy. Empirical treatment is rampant for TB, as is delayed diagnosis because sputum testing is avoided and doctors first try to test and treat for other conditions to not shy patients away. We also came across doctors and nurses using the HIV RDT without telling the patient (it is so fast and easy and in case positive you can discuss the result then instead of scaring the patient or shying him/her away.....). This happens in a context of strong social hierarchies between providers and patients and virtual absence of explanation and counseling around testing (why a test is ordered, what a result would meant etc). Additionally, private doctors are nervous to lose patients all the time as they do shop around for other providers and prefer treatment over testing to save cost.

Existing testing infrastructure as well as practices of providers and patients are thus important to be taken into account. The question is to what extent and how this can be done by test developers, regulators, donors and policy-makers, etc.

Anna E. Schmaus Replied at 3:55 AM, 21 Sep 2015

Sputum microscopy could make sense even in rural areas where no experts are for diagnoses. In that case a web-based telemedicine platform could connect doctors, CHW or other medical personnel to a laboratory doctor in the country itself. A light microscopy or even a fluorescence microscopy (both low cost) could be used. This kind of exchange will save money at the long term because patients or sputum does not have to be transported. Doctors in rural areas could think about a collaboration with laboratory doctors and make a small business using the telemedicine software. The software should be able to be used with a smart phone (mobile health). An example you can find here www.case.io

Marcel van Kasteel Panelist Replied at 5:59 AM, 21 Sep 2015

My few cents on this discussion is that we need to improve how we look at diagnostic testing. If we continue to compare costs for diagnostic test and compare them with costs of drugs we will never create a sustainable model. We need to include costs for health costs and other public costs if for instance people get resistant to the drugs. Talking to doctors I have the feeling they don't look broad enough. We need to show data and work all to change the system

Catharina Boehme Panelist Replied at 6:41 AM, 21 Sep 2015

Interesting points being made about perceptions of the value of diagnostics. In supporting increased access to essential diagnostics, we at FIND have observed a few things:
1. Diagnostic results not translating into health impact due to a lack of linkage to care following diagnosis, e.g. One study showed that 30% of Xpert tests for TB did not inform treatment decisions in South Africa;
2. A frequent lack of awareness on the part of clinicians when diagnostics-related policy changes at the national level, which results in low demand (hence the need for roll-out plans to include outreach to clinicians in both public & private sectors, and support for behaviour change) and also sometimes unintended consequences (e.g. malaria RDTs often now guide appropriate malaria treatment, but the introduction of these tests has also led to a dramatic increase in antibiotic prescriptions following a negative malaria test result -- and up to 80% of those with a negative malaria test now receive antibiotics, according to recent yet-to-be-published studies;
3. A low willingness-to-pay threshold by health ministries for diagnostics, e.g. malaria RDTs where recent tenders have resulted in a purchase price of 18 cents per test...and as a result, several manufacturers have left the market, as this is not a sustainable price for a quality diagnostic test.

Jeannette Guarner Panelist Replied at 8:10 AM, 21 Sep 2015

I would like to expand on Catharina Boehme point number 2: Need to involve clinicians.
The customers of diagnostic tests are clinicians. If they do not ask for the test then there is no need to have it!!
In addition to having availability of the test, we need to teach clinicians and other healthcare providers the importance of using tests, how to use them, and the added value they bring.

Jeannette Guarner Panelist Replied at 8:20 AM, 21 Sep 2015

Regarding the comment on telemedicine: It is a good short-term solution. Please make sure to realize this is short-term.
Training a workforce that can do and interpret tests should be the long-term goal.
My experience as people send me emails with photos asking : what is this that I found in my slide (usually regarding fungal elements)? The preparation and photo are crucial to be able to make a reliable diagnosis. Many times I find myself asking them to send me the slide or block to examine the case in more detail as I cannot make heads or tails of the photo sent.

Jeannette Guarner Panelist Replied at 8:25 AM, 21 Sep 2015

Regarding Dana Goldman's comment, a specific diagnosis and treatment go hand in hand. Thus, testing and medication should go hand in hand. Why are these not? Likely a lot of clinicians treat without having a specific diagnosis.

Luis Azpurua Replied at 9:31 AM, 21 Sep 2015

In Venezuela there is a decentralized point of care testing. The private and public networks work this way.

When there is a need of further studying (DNA, genomics, etc.) then we work as a decentralized sample collection followed by refering the sample to the Instituto Nacional de Higiene located in Caracas, our Country´s Capital.

Big problem: discontinuity of interventions. Due to budget constraints, sometimes (more than expected) the public labs run out of reagents, and materials. Right now because of a daunting economical situation, even the private labs are running out of reagents and even sample lab tubes!

Regarding treatment, we used to follow well established protocols. But as explained before, right now we have a medicine shortage. We have to adapt it to what kind of medications we find in the market.

A/Prof. Terry HANNAN Replied at 10:04 AM, 21 Sep 2015

Dear Luiz and others, I am 'remote' from my day-to-day access to GHDonline but I have found this discussion excellent.
There are many important components of this discussion that have been raised but Luiz and Jeanette point out (hint) about resource utilisation and lack of these and associated costs.
From a somewhat 'abstract' perspective we need to address these points by looking at why there is "overuse, underuse and inappropriate use of clinical resources" and the subsequent effects on costs, quality and outcomes.
In the attached document I have tried to address these issues and document some known effective solutions knowing full well we have such a long way to go fro significant improvements in these areas.

Attached resource:

Dana Goldman Panelist Replied at 10:08 AM, 21 Sep 2015

In the United States, we obviously have a fractionated insurance and delivery system. Exposure routes for HIV and TB will be bimodal -- prototypically a poorer, injection drug-using population on public insurance and little social support, contrasted with affluent men who have sex with men with private insurance. In neither group is there any responsibility for long-term outcomes on the part of the insurer or delivery system. The consequence is little incentive to diagnose new cases and treat them with anything but the lowest cost therapy.

Some believe that testing and treating in these diseases saves money. Sadly, it does not. What it does do is provide tremendous health benefits at very reasonable cost. However, public health agencies face difficult decisions when allocating scarce resources to control the spread of HIV/AIDS. Decisions are often made with few local empirical data. We have shown that the prevailing strategy of emphasizing behavioral risk reduction is unlikely to achieve the policy goals of the national HIV/AIDS strategy. We will get a better return from test and treat. http://content.healthaffairs.org/content/33/3/410.abstract?rss=1

Anthony Emeribe Panelist Replied at 10:35 AM, 21 Sep 2015

What is your country’s approach for using diagnostics for HIV, TB, malaria, and HPV? Please explain for each of the following
• Decentralized point-of-care testing?
• Decentralized sample collection followed by reference lab centralized testing?
• Predominant empiric treatment?

In Nigeria, laboratory support to diagnose HIV, TB, malaria and rarely HPV are routinely available to a certain extent and caregivers sometimes neglect the importance of diagnostic testing even though there is awareness that diagnostics are the gateway to HIV, TB, malaria, and HPV care and treatment. There are still substantial barriers to their access. Most diagnostic services are centralized and require trained/certified staff and specialized infrastructures which add to the cost and limit access. Again, HIV, TB, malaria, and less frequently HPV patients are lost due to great distances between testing centers and their abode coupled with delays in returning results (TAT of 24hrs or more).
On the other hand, the lack of multi-departmental and multi-disciplinary cooperation and communication that are key to implementing a cost-effective, user-friendly system that assures quality patient care and operator competence is also a challenge.
Nigeria has also witnessed a greater penetration of rapid diagnostics for HIV, Malaria and TB with the advantage of faster disease management, quick antimicrobial therapy, and less morbidity, mortality, and costs. In contrast to the rapid tests for HIV, TB and malaria, one significant implementation barrier for current POC CD4 cell–based and NAT-based tuberculosis and HIV tests is the requirement of instrumentation for these platforms. The transport, calibration, and maintenance of instrumentation poses additional barriers to implementation of these tests in Nigeria, though these tests provide opportunities for improving care.
Achieving these aims requires the involvement of many stakeholders, as their needs, operational constraints, and priorities are often distinct but by and large, the high cost of diagnostics which hitherto had been a barrier to access by clients will be reduced due to increased competition by manufacturers of diagnostics.
Decentralized point of care testing:
In Nigeria, decentralized testing, ancillary testing or bedside testing which is generally called Point-of Care Testing (POCT) especially as it is applicable to HIV, TB, malaria, and HPV is still sprouting.
HIV, TB and malaria programs have been innovative in developing structures for taking complex treatment algorithms closer to patients, even to areas where healthcare access is barely available. HIV, TB, malaria, and cervical cancer programs have been remarkably successful in providing access to treatment. However, early case detection remains a bottleneck in HIV and tuberculosis control even with the availability of extremely good and inexpensive point-of-care (POC) tests for its diagnosis.
POCT is laboratory testing at any complexity level, that is performed and documented within the hospital organization at sites of immediate patient care (e.g. clinic, nursing unit, etc.), where the results of the test are used for immediate clinical decision making.
Medical Laboratory Science Council of Nigeria in execution of its mandate had set up the Public Health In-Vitro Diagnostics Control Laboratory in Lagos for the regulation of diagnostics importation and use in Nigeria.
Again, the MLSCN charged with regulation of medical laboratory services in Nigeria has broadly assigned all or any form of laboratory testing, including testing that is performed outside of the Clinical Laboratories to qualified medical laboratory practitioners especially when it involves a third party and doing otherwise is illegal. This is to ensure quality, safe and reproducible results that had been the bane of our society. MLSCN as an affiliate member of ILAC has adopted of ISO 15189 Standard for Accreditation and SLITA check list for Lab Certification.

b) Decentralized sample collection followed by reference lab centralized testing:
Majority of testing in Nigeria for HIV, TB, malaria, and HPV diseases is laboratory based, but POC rapid antigen-based tests have been widely used. However, rapid antigen tests are only available for select pathogens (e.g. HIV, Plasmodium species). The performance of such devices ranges from good to poor. Results depend on the analyte, sensitivity of the test, type of sample collected, age of the patient, and time of testing after onset of clinical symptoms.
As a result of reduced sensitivity, specificity, and limited number of analytes detected, the current evolution is to replace rapid antigen POC tests with commercial platforms that perform real-time amplification and detection assays for numerous pathogens. Single-step, cartridge-based molecular test devices target pathogens pertinent to clinical syndromes (e.g. respiratory tract infections, CNS infections, gastroenteritis, and sepsis). These assays can be performed on-demand, require minimal hands-on time (1–2 minutes), require minimal technical skills to operate, and provide rapid results (20 minutes to 5 hours). However, a limitation of some cartridge-based platforms is throughput capability. Some systems only allow 1 test to be performed at a time, often requiring multiple expensive separate platforms or additional modules. This practice is commonly observed in the Early Infant Diagnosis network and Drug resistance testing for HIV and Tuberculosis. Effective laboratory networks have been developed by the HIV control and Tuberculosis control programs. Specimen collection (dry blood spot and sputum respectively) are at peripheral sites and transported to reference laboratories for testing. Over the years conscious efforts have been made to address some of the issues of quality assurance, infection control and turnaround time. In some cases, new technologies have been introduced to mitigate the gap between diagnosis and treatment such as sms printers and Gene experts. However, program managers are still inundated with programmatic gaps in implementation of these technologies and researches are on-going on how these gaps can be filled.

Predominant empiric treatment:
In the past, in recognition of the urgent need to provide antiretroviral treatment (ART) to individuals, the World Health Organization (WHO) produced guidelines on presumptive therapy, where clinical criteria were used to determine the time of ART initiation and to monitor patients during therapy in the absence of immunologic and virologic testing was adopted as standard of practice in Nigeria. Increasing evidence points to the importance of initiating treatment before the development of clinical disease, in both adults and children. A number of cohort studies and randomized clinical trials have shown that early initiation of ART for HIV infection decreases mortality, morbidity, and the incidence of tuberculosis. Emphasis has shifted towards increased use of CD4 cell count testing, to determine treatment eligibility, and increased use of viral load testing, to evaluate treatment failure. Importance of diagnostic testing for HIV management and of the need to strengthen laboratory systems, as expressed in the Maputo Declaration is now the new order.
It appears that HIV, TB, malaria and HPV diagnoses based on clinical symptoms alone, without the support of basic diagnostic tests, is still prevalent rather than the exception (especially outside the control programs) and leads to inappropriate treatment, waste of resources and time, increased morbidity, and unnecessary loss of life.
The weak laboratory support contributes to an over diagnosis of malaria and typhoid that leads to a failure to treat or a delay in treatment of alternative life-threatening infections like HIV, TB and HPV that potentially increase mortality. Clinical overlap between diseases is another common problem that may potentially compromise patient care and that may result in inappropriate antimicrobial therapy. Misdiagnosis occurs with other diseases as well. The accuracy of clinical diagnoses of typhoid fever, when compared with laboratory culture confirmation, was ∼50%.

Jeannette Guarner Panelist Replied at 1:56 PM, 21 Sep 2015

Dana Goldman points out that there are areas in the US where there is also underuse of testing. No doubt about this. But in comparison with certain regions of the world, US physicians tend to overuse laboratory testing.

Mike English Respondent Replied at 2:15 PM, 21 Sep 2015

Interesting that the questions are framed to focus on HIV, TB, malaria and HPV, the first 3 of which are often run as vertical programmes and certainly in Africa typically have specific and often considerable external funding. Even with this the problems alluded to of supply, distribution and access are major - spare a moment to think about the fact that things are so much worse for other diagnositics, try getting a bilirubin measure on a newborn with severe jaundice!

Also interesting to note that while framed as a question about diagnostics the issues are largely health system issues - as is so often the case the technology is often the easy part.

Much has also been learned about changing behaviour of health workers in a large number of other domains than employing diagnostics and utilising them in planning treatment - this wide body of knowledge can inform thinking on how to implement diagnostics into routine care. A significant factor is often clinician / patient belief (and work on mindlines is useful here) and the contrasting way we view risk depending on the frame - our perception of whether it is safe to withhold treatment for example may depend strongly on whether we are in the position of being the clinician with the patient or the programme manager but the risk is the same. Having data on risk and helping people understand them would be useful and interpreting and communicating risk will likely be an increasingly important part of practicing as a clinician.

Nora Engel Panelist Replied at 2:33 PM, 21 Sep 2015

I just wanted to add to a comment by Timothy Amukele on point of care testing:
You mentioned that "POC testing is most valuable when there is already a functioning diagnostic system over which individual POC tests are overlaid. Attempting to support the full range and variety of clinical (NOT research) needs using POC testing is just not feasible. "
As far as I understand most POC tests promise to work where there is no sufficient lab infrastructure, trained human resources or where lab-based testing takes too long. Thus, these devices promise to overcome absence or non-functioning aspects of the diagnostic system in place. Yet, I agree with you that some of the tests intended for use at such settings have faced problems with precisely what you pointed out:; staffing, cost, supply chains, quality management etc. The devices are not enough to overcome absent or non-functioning health system aspects for diagnosing, despite their promise of simplicity, rapidity and low cost! Instead, if POC testing is done at new testing sites, those sites need to be linked to existing labs and embedded into existing supply/distribution/service systems, the particular diagnostic set-ups and practices of diagnosing and seeking/providing care. This is easier said than done, as people at FIND and others can readily attest. The way POC devices are used thus depends to some extent on these more systemic aspects.

Tsehaynesh Messele Giday Panelist Replied at 2:37 PM, 21 Sep 2015

Encouraging progresses have been made in increasing access to diagnostic services in many settings in Africa. However there are still huge challenges and the situation varies in different African countries.

In Ethiopia, testing is mostly decentralized. Malaria RDTs and HIV POCs are available starting the lower level of testing at health posts. TB microscopy is implemented starting health center level which is the next higher level. Referral testing applies for VL, CD4 , EID and molecular tests and culture for TB as well as other specialized tests. HPV testing is rarely available but the National Institute and partners are working to increase accessibility .
The postal service is engaged in referral sample transport. However there are still challenges in the transport mechanism and coverage. The referral system still has a long way to go to operate optimally. Strengthening the laboratory network is critical to ensure adequate transfer of information and specimen between different levels of the health care system.
The comment made on the training of clinicians is important. Clinicians need to be more aware and utilize the tests and minimize empirical treatments when diagnostic services are accessible. The demand for some tests like viral load is still low in many settings. Although a lot of effort has gone to expanding VL testing.
National diagnostic service policies can play a very important role in guiding diagnostic service availability and ensuring quality at different levels of a health care delivery system in the context of each country.

Madhuri Gandikota Replied at 3:00 PM, 21 Sep 2015

The article entitled "Diagnostic Opporutunites in India- a Guide for Finnish companies " developed by Finpro India, in June 2013. is a great source for this discussion.

DISCUSSION QUESTIONS

1. What is your country’s approach for using diagnostics for HIV, TB, malaria, and HPV? Please explain for each of the following

• Decentralized sample collection followed by reference lab centralized testing
• For India, in urban areas, it is basically decentralized point-of-care testing or central lab testing. In rural areas it is more empirical treatment.

2. What do you see as the biggest barriers to effective use of diagnostics?
• Costs of testing.
• Local standards and controls. Extreme temperatures. Having standard established cold chains.
• Storage and transport. Ethics/standards of storage and transport. Diagnostics have the risk of falling into low risk category as opposed to medicines and transporters tend to lenient.
• I personally see that one needs more trained people, more accredited labs, and have a path to encourage new cohort of trained professionals in addition to existing lab technician training.
• These training institutes can also be accredited and have a standardized protocols. This I feel is important given the fact, that many biology students are moving away from biology given the lack of job incentives after Masters. Having a nation wide standard lab training facilities, tapping into university students would not only sensitize these young minds to the relevance of health issues and possible job opportunities. Offering a career path with mile stones would entice a lot of middle class students. Since universities are all over the country it is worthwhile to tab into the local potential, and thus perhaps have an effective supply chain. I
• There are R & D hotspots where all the top Indian Universities and Institutes are located. Having them as Nodal regions and then spreading to local surrounding areas is a worth while option keeping in vew the rural areas.

What would it take to remove these barriers and expand access?
• Govt. of India is offering incentives decreased custom duty for live-saving equipment form 25% to 5%, decreased import duty to 7.5%, hospital >100 beds eligible for 150% tax deduction for capital expenditure.
• But more proactive direct funding/commitment would jump start these issues. I personally feel, develop the skills, trained professionals, accredited labs, ethics, standards, and promote more R and D efforts.

3. How have diagnostics for HIV, TB, malaria, and HPV been validated in the country where you work? Was operational or implementation research conducted for these diagnostics? How was it done & what lessons were learned?

• All tests are validated by accredited laboratories offering testing services, and the hospitals conducting the tests. The major international diagnostic lab service firms are now present in India. I am afraid to say that there are a lot of over the corner diagnostic labs. I have no idea of their standards.

• I personally do not have knowledge of large implementation research for these diagnostics other than Bill and Gates foundation efforts for HIV. National Institute for Research in Tuberculosis (NiRT) Chennai is a WHO Collaborating Centre for TB Research and Training.

4. Do you see advantages to importing, versus locally manufacturing, diagnostics?
• In general, many big international pharma companies are now in India. These companies have both R and D and production efforts in India. So I do not see any advantage of local vs. international in terms of their presence.
• However, in terms of costs, local firm offers economic alternatives. The following site is useful http://dir.indiamart.com/impcat/diagnostic-kits.html.

5. How are new diagnostics introduced in your country, and who makes decisions about which diagnostics will be covered by insurance schemes (if applicable)?

• Central Drug Standard Control Organization (CDSCO) (http://cdsco.nic.in), Directorate General of Health Services is the authority responsible for laying down rules, standards and for approving import and manufacture of drugs, diagnostics, devices, and cosmetics.

• Drug Controller General of India, is responsible for approval of licenses of
• specified categories of drugs and diagnostics products.

• HIV diagnostic kits are defined as “Drugs” under Drugs and Cosmetics Act 1940 and hence is under the control of Drug Controller General of India.

6. How are guidelines for use disseminated? What challenges have you seen in adapting global guidelines to your setting, and what strategies have you found for training providers on these guidelines?

Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India issues guidelines.

7. What policies regulate or impact the use of diagnostics in your setting?

8. What lessons would you offer regarding production supply, quality, service and support, or other post-launch needs for diagnostics?

• More training, R & D efforts, quality accreditations, integrating into local universities/institutes/local hospital chains. Partner-ships with industry (both health and non-health) to leverage the existing supply chains is worth exploring.

• Entice, private/government sector commitment into these areas.

• Involve, urban/rural development/municipal authorities.

9. To ensure the right patient gets the right diagnostic test and appropriate treatment, what would the ideal delivery system look like for HIV, TB, malaria and HPV in your setting?

• An ideal scenario is a reliable, economical, testing service. For people below poverty line,the testing should be free. But testing is not the end. It is the beginning.

• So follow-up and adherence is a huge challenge. Again, private/government /politi cal leaders commitment to ensure the care value delivery chain in accordance to the social/cultural/economic backdrop is important. But this is a huge task and need to be done in a phase wise manner.

Attached resources:

Timothy Amukele Respondent Replied at 3:01 PM, 21 Sep 2015

Mike English, I wish there was a 'retweet' button on here. I love your comment above about our focus on the technology rather than the system.

A/Prof. Terry HANNAN Replied at 3:19 PM, 21 Sep 2015

Nora you make excellent points and Jeanette is also pointing out issues that need addressing. There is numerical evidence for overuse, underuse and inappropriate use in the USA and other nations so these measures would appera "independent" to some extent of the funding models for health care.
SLide 11-14 in the attached PPTX provide measures of these parameters.
One that stands out is the $4.44m CAN spent on unnecessary blood test in 5% of CKD patients in 2005 with each test costing $4.40CAN each!!!
With respect to Timothy's last comment you bring to focus the statement made by Francois Gremy. He stated, "his greatest concern in 1989 was the clinicians and health informaticians will be 'seduced' by the technologies and foreget about the patients".

Attached resource:

Madhukar Pai Panelist Replied at 4:13 PM, 21 Sep 2015

Hi all, thanks for the interesting discussions. I have been thinking a lot about the blind spot that exists in diagnostics: we are focused on tech and policy, but the real world seems to underuse tests and rely heavily on empiric/clinical management of TB and other infectious diseases.

Evidence for this is not hard to find:

1. Xpert trials (SA, Zimbabwe, Brazil) which show limited clinical impact because of empiric therapy
2. Our standardized patient pilot data from India that shows less than 10% of patients with classic TB symptoms were asked to get any test (see Das J et al. Lancet Infect Dis 2015 http://www.thelancet.com/pdfs/journals/laninf/PIIS1473-3099(15)00077-8.pdf)
3. Poor completion of algorithms (even follow-up of Xpert with DST is poor in SA; we also know that smear-negative algorithm has very poor completion rates)
4. Inadequate treatment monitoring (clinicians rely more on their judgement and x-rays than do follow-up smears/cultures)
5. Widespread broad-spectrum antibiotic use in many countries, with no prior testing [e.g. anti-malarials without RDTs]
6. While we have international standards for TB care, studies show many physicians in places like India do not adhere to even the core elements of the standards (see Satyanarayana S et al. IJTLD 2015 http://www.ncbi.nlm.nih.gov/pubmed/26056098).

So, we need a better strategy for how to communicate the value of diagnostics, and create greater demand for diagnostics in resource-limited settings.

Easy available of antimicrobials (many are generics, and often less expensive than diagnostics) and their indiscriminate use is a major issue. Please see the 2015 State of the World's Antibiotics Report: http://cddep.org/publications/state_worlds_antibiotics_2015

Madhuri Gandikota Replied at 5:25 PM, 21 Sep 2015

Great references from Dr. Pai. We missed the point of physicians not adhering to the guidelines.

Jeannette Guarner Panelist Replied at 5:51 PM, 21 Sep 2015

I agree with Mike English. When I saw the questions the panel was supposed to address my first thought was: Why are we focused on HIV, Tb, malaria and HPV? There are are so many other problems such as a high bilirubin in a neonate, or anemia in a patient with an occult cancer ... I told the organizers that we needed to expand. I am very happy that you have done this. Thanks.

I also concur with the fact that we need to address systems, in particular education of use, rather than focusing on whether people have the technology or not. As Mike and Tim have commented.

Dessie Kiber Replied at 5:57 PM, 21 Sep 2015

As part of this, i will be very happy if the recomended diagnostic tests of
diabetes in sub saharan africa are discussed. How many of them are being
used todate?

Kindly

Hugo Flores Navarro Respondent Replied at 8:15 PM, 21 Sep 2015

Hello All

In Mexico, where I work it is like that:

HIV - We have availability of point of care rapid testing. For pregnant women it is actually mandatory (opt out) to get the test. This is agood way to rapidly detect cases, and also to test contacts of possitive cases. To diagnose and start treatment though, all diagnoses must be confirmed trough Western Blot and then viral load and CD4s must be taken. Also TB should be ruled out or treated first. So this management of starting treatment is usually done at special units, some of them located at hospitals. This make it difficult for some patients to be able to follow up with their treatments, since they dont have them available at their first level local clinic. This is something that really needs to be changed.

TB - As others have commented, we need a better test. So far we have been doing smears, that need to be confirmed. Empiric treatment is allowed in case of strong suspicion with negative smears, and cultures are also available to test for difficult cases or suspected drug resistance.
The problem with smears is they have little sensitivity, as you know, and gene xperts are very scarce, because they are expensive. Some rapid tests are being developed, and one of them, being developed in Mexico actually, is being designed to diagnose latent and active TB infection, from a drop of blood. It may be too ambitious but it will be a game changer if it happens, and we need no less than that.

HPV - The standard is to take samples for the -hybrid- test that is very sensitive. The tests are processed centrally, not locally, but the results come back and there are clinics to follow up. It is also not perfect since it depends on many steps, but I know there is no clear gold standard for this. Hybrid is as good as it gets, and then connect to appropriate facility to classify the lesion and treat.

Malaria - Not a big problem in Mexico, and in areas of high prevalence tests are donde centrally.

Have a good day!
Hugo

Catherine (Cathie) Klapperich Respondent Replied at 9:13 PM, 21 Sep 2015

I wanted to post this excellent book on why diagnostics might indeed be "cost effective" in the long term, when a broader perspective is taken.

Attached resource:

Kathryn Roa Respondent Replied at 9:21 PM, 21 Sep 2015

In the Philippines:
TB - decentralized POC testing for DSSM (>3000 nationwide), Xpert testing centers are currently being expanded (>100 nationwide) but for culture and DST, it's decentralized sample collection followed by reference lab centralized testing. With over 7000 islands and numerous Geographically Isolated and Disadvantaged Areas, access is still an issue. For the private sector side, there is still widespread practice of reliance on Chest radiography for diagnosis.

HIV - For the publlic sector, decentralized POC screening tests (in HIV treatment hubs only, not in all community health centers) but for confirmation, it's decentralized sample collection and centralized reference lab in the capital city of Manila which results in delays. There are current efforts to model one-day POC testing.

I agree that it is not enough to have good diagnostic tests. It is important to also address social issues surrounding their use. The drivers of utilization of different diagnostic tests from the sides of the physician and the patient are different and these must be addressed. Currently, the national government enrolls the poorest 2 quintiles of the population in the national health insurance program which has a basic TB DOTS package but this does not cover diagnostics. It only kicks in once a diagnosis of TB is made. In the public sector, DSSM and Xpert are free of charge but there are delays and quality perception issues and a significant part of the population would also rather go to the private sector. There are also policy issues. For example, in HIV, only licensed and trained medical technologists (both technically and in VCT) are allowed to do the screening tests.

Lee Schroeder Respondent Replied at 9:46 PM, 21 Sep 2015

Hi everyone,

Today’s question was about point-of-care vs central lab testing. While testing started at the point of care by, for instance, simply looking at the color of urine, there was a slow centralization of testing to take advantage of economies of scale and to provide the very highest quality results. The drawback has been the inconvenience of waiting for results. As technology advances, highly accurate and inexpensive POC testing may become a reality (and is already a reality some tests like rapid HIV) and will be able to solve some of the problems inadvertently created by lab centralization. However as many have pointed out, empiric treatment has continued regardless of the availability of even very high quality and expensive poc testing.

The paper I added to the resources by di Ruffano offers a language for detailing the different ways that a diagnostic impacts patient outcomes. Loss-to-follow up is part of the story, and poc should theoretically improve that problem. But that is not the only problem. At some point diagnostic confidence becomes important, that is, how much trust do the physician and patient have in the test result? Even with a test like rapid HIV, a mislabeled specimen negates the fantastic accuracy of the test. I think it’s possible that a country with a history of inadequately funded laboratory infrastructures will likely have labs with short testing menus and reputations of questionable accuracy. For physicians in this environment, the very best thing to do might be to ignore a test result and go with empiric treatment (actually, the very best thing in that environment is probably not to order the test at all!). In this sense, if there is a relatively widespread distrust of laboratory results and a culture of empiric treatment, it may not be a surprise that simply adding poc technology does not result in robust benefits.

Healthcare delivery is complicated enough that I think there will likely always be room for both centralized testing and point of care testing. A real hurdle is gaining diagnostic confidence. Diagnostic confidence will come when it is deserved and that will be when laboratory medicine is strengthened at the systems level. At that point, there will be applications for which point-of-care devices absolutely make the most sense, and others that would benefit most from the economies of scale and accuracy of centralized lab testing.

-Lee

Attached resource:

Jeannette Guarner Panelist Replied at 10:22 PM, 21 Sep 2015

The most incredible example of underuse of diagnostics is the 2014-2015 Ebola mega-outbreak . If you do not diagnose the disease it spreads as the patients are not quarantined. Once you recognize you have an outbreak, every one is treated as if they are having Ebola but some had malaria and were not treated. Many even died of malaria... Real problem not having diagnostic tests.
From the Ebola outbreak it is also of interest to remark that a large problem these patients have is electrolyte imbalance. If you cannot measure electrolytes you can end of dying of hyperkalemia, something that could be easily treated with hydration. So again it is not only the diagnosis of the disease that the laboratory is impacting but also the treatment and follow up.

Om G Replied at 10:56 PM, 21 Sep 2015

Something to work with :
Each of these practitioners wants to provide the best care they can.

They will respond to good data.

Most of these choices are about doing what they can, now.

Pierre Bush, PhD Replied at 11:44 PM, 21 Sep 2015

Hi Dr. Lee,
Thank you so much for your contribution, I agree with you and I would like to add the following points:

For a laboratory to provide a good service to clinicians and their patients, there has to be some critical basics:

1. Equipments (called by some machines) that function properly and have the required accuracy and specificity. To achieve this there is a need of:

2. Trained personnel: trained and certified personnel who are able to maintain the equipments, run quality controls and calibration, and properly interpret the results that come from the instruments and communicate the results to clinicians in a timely manner, recognize stat test versus routine tests, recognize critical values, delta checks etc...

3. Good funding of the labs so that the consumables/reagents are always available.

4. Good contract with the vendor so that the repair and preventive (PM) are done on time and promptly.

These criteria applies to the central lab, as well as to the point of care testing. The users of point care equipment (such as IStat) have to be well trained to recognize abnormal results, and instruments'problems.

The first approach to adopt in helping the developing world is to educate the lab professionals. The second approach is to make sure that the equipments are closely monitored by having a good contract with the manufacturer/vendor so that they can provide primary necessary reagent as part of the contracts.
Thank you

Pierre Bush, PhD Replied at 11:56 PM, 21 Sep 2015

On Point 4. I am talking about Preventive Maintenance (done mostly every 3 to 6 months). It is aimed at making sure that old parts are replaced and to make sure that the instrument is measuring what it is supposed to measure. I forgot to mention that Laboratories here in the US participate in proficiency testing program to help educate the lab personnel. The labs are also accredited by several body but the main accrediting agency is the College of American Pathologists. All these conditions make american labs very effective and reliable. In this country (USA) the laboratory is a very important tool in patient'care: treatment/management. It should be the same way in most parts of the world

Thank you.

Jesse Gitaka Replied at 12:25 AM, 22 Sep 2015

The advantages of diagnostics with acceptable specificity and sensitivity in clinical decision making are numerous. Clinicians are made more confident of their decisions and patients are re-assured that what ails them is unveiled. Nonetheless, the approach adopted in providing diagnostics is mainly top down, from tech companies and their agents, to government agencies or hospitals, to labs, then clinicians, and then patients. Perhaps a strategy that stimulates demand from patients or clients for the services may be a game changer, for instance, patients can be empowered to ask for malaria RDT when a clinician suspects the patient to be having malaria. This may call for adverts emphasising need to ask for particular tests in given scenarios. Secondly, since most of the clinician training happens in govenment sponsored hospitals with limited resources, where some diagnostics may be lacking (usually it is the reagents, or broken parts), and mostly with delayed deployment such that a test in use in the private sector will be adopted in these training facilities 2-3 years later, systematically disadvantaging the medical students. Way forward may include specifically targeting to educate the educators to be at the frontline.

YAP BOUM II Replied at 1:12 AM, 22 Sep 2015

Indeed that's it's an interesting comparison. The main difference is also that in western countries physician trust the laboratory while they don't in many African countries. It is critical to (re)educate physician and lab people so that the establish a real relationship.
In many setting all patients with fever and malaria negative rapid test will receive antibiotics !!! Because the lab can't go further than that. Few areas have the lab capacity to make a difference between a viral and bacterial infection. Therefore they treat the most dangerous one which lead to drug resistance which is an upcoming disaster.

The POC should answer the question of fever algorithm is resources limited setting. And I therefore agree with Mike English that focus shouldn't be malaria HIV and TB alone as people died for many other diseases.

Kenneth mworozi Replied at 1:27 AM, 22 Sep 2015

For most part of the discussion, I agree. From Yap Boum II and Dr Lee, PhD, I would like to mention three things:
1. Trust of the lab results by the clinicians.
2. Training of clinicians about the outcomes

Raymond Chimezie Replied at 2:24 AM, 22 Sep 2015

Response to Prof. Emeribe,

Your response to the questions are quite brilliant enough and shows that your leadership is doing something to uplift medical laboratory profession in Nigeria. Believing your response to be true, I still think that the majority of rural residents in Nigeria do not have access to medical laboratory facilities. The problems are due to lack of medical laboratory services at local government health centers, high cost, unnecessary delays, and poor patient relationship. In the rural areas, there are no HIV/AIDS screening and testing centers for the public and even at some state hospitals, it takes for ever to take get medical laboratory results. Given the epidemic of HIV/AIDS, there should be free testing and screening centers. Better still, doctors can order such tests at no cost to the patients if there is any need for that.

As you may know, most local government areas in Nigeria, which is the mainstay of primary health care, have neither a resident doctor nor an equipped medical laboratory facility. How can the greater population of Nigeria have access to professional laboratory service given this absence of doctors at the the local health care system? This may be the reason why many people die from malaria, HIV/AIDS, and TB related diseased because there in no facility to check out the patient before the disease advances. This is what medical laboratory services do to help doctors treat patients adequately. What effort is your organization making to standardized laboratory fees as well as post them at designated places in the healthcare facility. In developed systems like the United States, laboratory fees are predetermined and made available to the public. Nigeria will continue to encounter serious problems in utilizing medical laboratory services in the absence of adequate reagents, water, and power supply. I hope that we should continue this discussion and link it to other aspects of the health care system.

Raymond Chimezie, Ph.D.
Health for Schools and Communities Foundation (www.healthfsc.org)

Florian Sauter Replied at 3:52 AM, 22 Sep 2015

Hello everybody,

I strongly agree with the points Dr. Pay has raised, particularly number 2 - patients with obvious symptoms not receiving a test in the 1st place, and also 3 - poor completion of algorithms.

But contrary to the overuse of clinical diagnosis and empirical treatment, in Northwest Cameroon, where I have been working the last 3 years, we experienced a big reluctance of clinicians and program directors to treat patients empiricaly on a clinical basis without the back up of a positive test result.
Algorithms for the management of HIV positive, but smear negative TB suspects were very poorly completed.

Florian

Alaine Umubyeyi Nyaruhirira Replied at 4:44 AM, 22 Sep 2015

Dear All,



I think,

Driving demand and supply of diagnostic can be done with a more
patient-centered and integrated approach to service delivery as is expected
to increase access to needed health services throughout the life-course;
improve health and clinical outcomes; enhance continuity of care and
satisfaction with services. Laboratory services are a key pillar of health
care services and timely, accurate diagnoses are essential to the provision
of effective treatment. However, the implementation of this approach will
need more effort in strengthening the all health system from central to low
level taking in account the need of each disease but using integration to
minimize the cost. From the lab side these essential elements of laboratory
services must be addressed:

· Laboratory infrastructure, biosafety measures, and maintenance;

· Equipment validation and maintenance;

· Specimen transport and referral mechanisms;

· Management of laboratory commodities and supplies;

· Information and data management systems;

· Quality management systems;

· Strategies and funding for development of laboratory human
resources;

· Integration of diagnostic algorithms into laboratory strengthening
plans.



The illustration can be done with the roll out of Xpert, where the tool is
underused or with limited impact to patient treatment as mention by many of
colleagues. In the time we don’t solve all these points mentioned as ''a
whole'' the ''health system'' will continue to face diagnostic challenges
mentioned during this discussion.

*Alaine Umubyeyi Nyaruhirira, MpH, PHD*
*Senior Laboratory Technical Advisor*
Management Sciences for Health

Deluc Accilus Replied at 6:13 AM, 22 Sep 2015

Hi to every body!
I AM Dr Deluc Accilus family Physician and working in a comunity health hospital in Haiti ..I AM entirely agree with Florian .. The same approche should be followed in the countries with with límited ressources.

Enviado desde mi iPhone

Kenneth mworozi Replied at 6:27 AM, 22 Sep 2015

The diagnostics have been ignore by several policy makers to the extent that even training in some African institutions promotes the syndromic approach which is outdated in the current evidence-based medicine. Like one of the panelist stated, in the USA there is over use of the diagnostics, maybe because of the legal requirements! What about the developing countries where the medical-legal aspects are just growing. From a clinician's point of view, the diagnostics have been ignored by majorly two reasons:
1. The people in the diagnostics are kind of more pro-diagnostics and not pro-patients, just like one discussant states that the diagnostics we need to look bigger than HIV, TB and malaria, and to be specific here, people like radiologists hide in the the labs and either do interpretive work and even if they do interventional diagnostics and interact with the patients, the other physicians do not know what they are actually doing or what they do, so that they can be put to their utmost use and this also goes to the laboratory people, with the automated diagnostics and even before these very important people are rarely seen in the patient management. So, We basically need to change:
a) The training from syndromic to evidence-based approach
b) Involve all teams in patient management, those ward rounds and departmental meeting should involve the diagnostic people, laboratory or radiological and others.
c) The diagnostic people need to put mechanisms whether through workshops and departmental meetings and they show the other clinical team what would have been different if they were involved. More to this, conferences should involve the whole clinical team involved in patient management. Most conference have been highly specialized to the higher sub specialties.
2) The global picture of the diagnostics.
For example during training at all levels, the laboratory people, almost all pay for their tuition fees, where the other clinicians, governments and partners sponsor them for their training. This really shows the importance put on the clinician-the treating person than the diagnostics. Why would we have most scholarships like at the masters or PhD levels in developing countries targeting the physicians/clinicians than the diagnostics? Here I would urge the manufacturers of these equipment who have been active in sponsoring conferences and workshops to also sponsor training in the use of these new equipment and general to improve the human resource in the diagnostics. May be that why the POC diagnostics are becoming popular because we want to use these clincians and nurses to test these patients, because the specialized users are not many.
In general, we can make use of diagnostics when the "Treating guys - The physicians/Clinicians" know there are people to do these tests rightly and also that the (treating guys) know which/what tests - diagnostics exists, they are in the aware of consequences of using syndromic other than evidence-based approach.

A/Prof. Terry HANNAN Replied at 6:49 AM, 22 Sep 2015

These ae immensely educative discussions and I want to thank all for their contributions as I have learnt so much. As I read these informed postings is there not and underlying theme of discordance at the socio-economic level between the Low and Middle Income Nations and those nations with wealth (developed) economies.
The resources these countires are REQUIRING and are ESSENTIAL cost $ and to have them effectively used and maintained requies EDUCATION and community self-reliability and self-sutainability.
So my question is how do we address the growing "digital divide"?

A/Prof. Terry HANNAN Replied at 6:58 AM, 22 Sep 2015

Raymond Chimezie & others, your postings have very powerful messages. As a Specialist Physician I can "understand" the historical arguments for more doctors in many regions (yes they are needed) however because of the time and financial resources to train medical graduates we will never have enough to meet the health care delivery needs of the communities we are sharing knowledge about. We need to train, and are able to, care workers at all levels including the patients themselves and support them with the provision of appropriate technologies (affordable and accessible) to manage the health of the communities.
There are several excellent examples of this but the main one I am aware of is AMPATH in Kenya. Its success can often hide behind an historical cloud of HOW they did it.

Marie Claire GASANGANWA Replied at 7:02 AM, 22 Sep 2015

The professional issues should also be considered in some countries as some may hinder diagnostics like inter- professional collaboration and working together for better patient outcomes not competing for our own image and pride.

Neil Pakenham-Walsh Replied at 8:04 AM, 22 Sep 2015

Dear Mike,

"Much has also been learned about changing behaviour of health
workers in a large number of other domains than employing diagnostics
and utilising them in planning treatment - this wide body of
knowledge can inform thinking on how to implement diagnostics into
routine care. A significant factor is often clinician / patient
belief (and work on mindlines is useful here) and the contrasting way
we view risk depending on the frame - our perception of whether it is
safe to withhold treatment for example may depend strongly on whether
we are in the position of being the clinician with the patient or the
programme manager but the risk is the same. Having data on risk and
helping people understand them would be useful and interpreting and
communicating risk will likely be an increasingly important part of
practicing as a clinician."

I would be very interested to learn more about these issues. Please
would you be able to send a few references of the leading papers on
this topic?

Many thanks, Neil

Elizabeth Shipiki Replied at 8:20 AM, 22 Sep 2015

You are right on spot Kenneth Mworozi


Kind regards


Elizabeth Shipiki | Chief Medical Technologist | Windhoek TB

Namibia Institute of Pathology (NIP)

Marie Teichman Replied at 8:57 AM, 22 Sep 2015

Hi all,

Thank you all for such a rich discussion so far! Due to the volume of responses we have received in the Expert Panel, we will be compiling daily briefs for your use prior to the completion of the full Discussion Brief. Here is Monday's summary.

Best,
Marie T.
Community Coordinator


Monday’s conversation focused on approaches for using HIV, TB, Malaria, and HPV diagnostics in local systems.

A major issue for resource-limited countries is the lack of reliable support systems for using diagnostic tests. Sites that are linked to existing central labs have the most potential for maintaining functioning diagnostic systems. Many participants pointed out the issues with transportation of samples and delays associated with outsourcing the analysis to centralized labs. Various members also described the lack of reagent supplies that has drastic effects. The concept of reagent rentals seemed to draw support from members in Mexico, East Africa, and Asia where this system has created strong, consistent diagnostic outputs.

Panelist Nora Engel outlined her experience with the peripheral testing structure in India:

“Empirical treatment is rampant for TB, as is delayed diagnosis because sputum testing is avoided and doctors first try to test and treat for other conditions to not shy patients away. We also came across doctors and nurses using the HIV RDT without telling the patient (it is so fast and easy and in case positive you can discuss the result then instead of scaring the patient or shying him/her away.....). This happens in a context of strong social hierarchies between providers and patients and virtual absence of explanation and counseling around testing (why a test is ordered, what a result would meant etc). Additionally, private doctors are nervous to lose patients all the time as they do shop around for other providers and prefer treatment over testing to save cost.

Existing testing infrastructure as well as practices of providers and patients are thus important to be taken into account. The question is to what extent and how this can be done by test developers, regulators, donors and policy-makers, etc.”

While we’ll discuss these topics in more detail later, the need for regional guidelines that move beyond generic standards of practices was also raised. Even with national government policies and WHO guidelines, there are many areas where treatment compliance levels drop due inability to apply the guidelines to the local reality, whether that be lack of resources, overall cost, or patient safety compromised due to un-validated diagnostic kits.

Participants also described how policy changes regarding diagnostics at the national level are often not properly disseminated to providers. This leads to low demand for diagnostic tests, leaving diagnoses based on clinical symptoms as a main avenue for treatment. This often leads to many unintended consequences, such as increased antibiotic resistance, inappropriate treatment, and increased morbidity. Panelists and members discussed the importance of health workers championing diagnostic use in their own settings and to pass this knowledge on to patients themselves.

george uchouane Replied at 9:04 AM, 22 Sep 2015

Hi,
I work in a developing coutry and from my expericience the main dificulty is the supply and collection of all diagnostic material, because if the chain of supply has deficits the whole process will be affected. You may find diagnostic material available in the mains deposit but if it doesnt get to the local lab then whole diagnostic work is compromissed.
Regards

Nora Engel Panelist Replied at 9:25 AM, 22 Sep 2015

Some great comments have been already made on what it would take to overcome barriers to efffective use of diagnostics, including overcoming shortages/absence in infrastructure, human resources, skills, training and material to improve lab/testing services, but also building trust into laboratory services so that healthcare providers start demanding tests and acting on results, working interprofessionally (yet requires putting aside professional egos), involving patients more actively into demanding testing and results, and improving medical curricula.
We found many of these to be crucial challenges to diagnosing in public clinics in India where overworked clinicians had often no space, privacy and time to discuss symptoms with patients comprehensively nor order investigations, and many times the lab services available to the clinician were overburdened with target based testing for the Malaria programme for instance.
What about the interfaces between private and public health care sectors? In India, many times patients ended up iterating between the public and private providers during their diagnostic journeys. They were sent from here to there, and at times ended up arguing with lab technicians over divergent results from the private and public sector. This might be a situation particular to the Indian context where the private sector is huge, diverse and unregulated and patients are being asked to go to public and private labs themselves to provide samples and fetch results and carry them back to the providers?

GABRIEL PAUL Replied at 10:34 AM, 22 Sep 2015

In my country we have policy on diagnosing and managing infectious diseases with direct intergration of international health policy.The most challenging issue is lack off enough supply and experts in many areas of Tanzania .Rural areas are mostly affected.
Lack of funds to sustain the established services has been a major thing. Rapid growth of technology and neccessary upgrades of diagnostic tools has challenged the health sector and sometimes caused paralysis of the service.
The better options for low resources countries is to have a regional health agencies which combine efforts in tackling the major issues in specific areas in collaboration with international agencies like WHO etc. Establishing reginal diagnostic centers which will help to diagnose all diseases which needs special expensive machines and rarely available reagents and train local hospitals .Establishing telmedicine centers which will help to meet the need of experties like in area of pathology and radiology few centers like this are working in some other parts of the world but in area like africa telmedicine will be the immediate solutions to gap which exist interms of experts

Elizabeth Glaser Replied at 11:33 AM, 22 Sep 2015

Not to derail from the subject of POC for HIV, TB, and malaria, but my understanding is that there is also POC testing being developed that would help diagnose for certain cancers, such as breast or prostate cancer. Easier access to screening and diagnostic tests for cancer in developing countries is very much needed, as currently malignancies that might respond well to treatment are either not diagnosed at all , or only diagnosed at a very late stage. For example, a person presents with wasting and is negative for TB and/or HIV then a POC test for certain cancers might well be the next logical step when attempting to make a diagnosis. However, using this type of POC test also raises other questions such as does the health system have the capacity to provide follow up confirmatory testing, and then access to cancer treatment?

Can we use some of what we have learned here about POC testing for TB, HIV , and malaria to perhaps mitigate the challenges when POC tests for cancer are eventually brought on the market?

Elizabeth

Catharina Boehme Panelist Replied at 12:22 PM, 22 Sep 2015

Several salient points being made about the health systems issues hindering successful implementation and impact of diagnostics. This points to the need for innovation in delivery mechanisms and models, while always keeping in mind that the clinician/health worker is the critical link between testing and appropriate treatment. On p. 23 of our strategy, we highlight this issue (http://www.finddiagnostics.org/export/sites/default/resource-centre/reports_b...):

It is not enough to develop innovative diagnostics. In order to transform a tool into a solution that has impact, more attention needs to be given to the accompanying “package”. A smart diagnostic solution comprises a diagnostic test that is just right for the need, together with a suite of ingredients that eases the way to improved access and use in a weak health system infrastructure. This package implifi es diagnosis for patients, users, clinicians and countries, and includes tools for implementers, among them those for training, advocacy, installation, quality assurance, support and maintenance, impact measurement and, importantly, an information
technology solution that links results to patient care and surveillance programmes.

Attached resource:
  • FIND Strategy 2015-2020 (external URL)

    Link leads to: http://www.finddiagnostics.org/export/sites/default/resource-centre/reports_brochures/docs/FIND_strategies/FIND_Strategy_1410016_sp.pdf

Madhukar Pai Panelist Replied at 1:26 PM, 22 Sep 2015

Since today’s theme is barriers and potential solutions to overcome them, it is worthwhile to talk about a huge barrier: COST.

In the public sector, we know that most countries spend a tiny fraction of their GDP on health. And, within the health budget, diagnostics get virtually nothing. So, health ministries are reluctant to spend money on tests, even when they know that new technologies (e.g. molecular tests) may be far better than what they have been using for years (e.g. sputum or malaria smears).

In the private sector, patients, labs and doctors have been left to fend for themselves, despite the fact that private sector is often the dominant healthcare provider in many countries. Diagnostic companies charge whatever they think the market will bear. Distributors will add their margins to this already inflated price. Then shipping and import duty costs get added. Private labs and hospitals will add their profit margins (including any incentives that they need to pay the doctors). All of this means that a $10 test can end up becoming a $50 test for the patient who has to pay out of pocket. So, it is not surprising that private doctors skip the entire testing process and manage patients empirically. Antibiotics are far cheaper than tests in these settings.

Potential solutions:

In the public sector, we (civil society, advocacy groups, professional societies etc) need to find ways to advocate with health ministries and convince them of the value of good diagnostics (just as they are convinced of the value of vaccines and essential drugs). South Africa’s scale up of GeneXpert and the engagement of their health minister is a nice story here. Another strategy is to ensure that tests are bundled within treatments, so that test costs are counted as part of treatment. For example, no ART without viral load; no MDR TB treatment without DST, and no ACTs started without malaria testing. This way, the entire treatment, including dx, is costed out and budgeted.

In the private sector, we need an access strategy, and must try and cover both public and private sectors in special pricing agreements. Even if this can be done, we still need some price control strategy, to prevent private labs and hospitals from making huge profits on essential tests. The IPAQT model in India is an example of a strategy that specifically addressed private sector. http://www.ipaqt.org/ Thanks to this model, price of GeneXpert and LPA was reduced by 30 – 50% for the private sector in India, and test volumes have steadily climbed. See: http://archivehealthcare.financialexpress.com/it-healthcare/2738-ipaqt-is-now...

If anyone is aware of other such interventions to make diagnostics more accessible to the private sector, please share.

Asfawesen Gebreyohannes Woldegiorgis Replied at 1:43 PM, 22 Sep 2015

I am an Ethiopian physician practicing internal Medicine in Ethiopia. The diagnostic services for TB, Malaria are available in the primary care units starting from Health Centers in the public health system, and above medium clinics in the private health sector. The barriers to the diagnostic services availability and utilization is multifaceted contributed by all actors in the health system. For example, although the Gov of Ethiopia has constructed thousands of health centers throughout the country many do not have microscopy or those who have microscopy their objectives are nonfunctional. Moreover, the quality of reagents for AFS and Malaria, many a times, are doubtful. HIV RT is widly available in the public and private health facilities, however, the requirement for special certification to run HTC is a barrier for private health facilities to provide HTC. Similarly, Malaria RDTs are allowed to be utilized by the health extension workers in the public health posts. This excludes thousands of primary clinics in the private health sector which are known to provide treatment to over a third of children with fever within 24 hours of onset.
The advanced diagnostic services like Line Prob Assay/Gene x-pert, Viral Load/ EID are highly centralized i.e available only at the Regional Labs in major cities, and more over their existence is not known to many of clinicians practicing in both public and private health facilities, and outside of the TB and HIV programs.
The other barrier is that clinicians and the public also doubt on many of the lab tests because of the variability of test results among laboratories. Labs do not practice IQA and the EQA scheme in the country is so week that transformation in the laboratory management and governance is highly required to establish networking and mentoring system of facilities.
The inter professional communication between lab personnel and clinicians is not well practiced which opens the room for clinicians to make diagnostic decisions based on clinical judgment, to deviate from national guidelines like diagnosing TB based of CXR than relying on Sputum AFS, treating malaria presumptively than demanding for through slide reading etc.

Jeannette Guarner Panelist Replied at 2:32 PM, 22 Sep 2015

I hate to be very simplistic but in my mind the barriers inclued:
1. Money: Those that have $$$ get diagnostic tests. Those that do not have$ may or may not get diagnostic tests. That occurs in the same city whether it is Mexico City or Addis Ababa.... I would even go furhter and say Atlanta.
2. Training: maybe, but I see the same MD in Mexico City asking for X, Y and Z tests for their private patients and mabe only X test in the public hospital for the patient that has little money.

We can delibetate if the government/ public hospital is doing the right thinkg or not, and how the money is allocated (instruments, reagents, maintenance, paying techlonoligst to do the tests...); howerver, in the end it is all about $$$$$.

YAP BOUM II Replied at 3:34 PM, 22 Sep 2015

Dear Cathy

Thank you for bringing up that the most critical part is the end user couple clinician and health worker performing the test as well as the package.
Beyond the production of the best Dx tool and the most efficient training we need to ask the end users what they actually need and not what we think they need. The involvement of the end user in the design of the tool will surely ensure a better implementation. It's possible that the environment and/or the culture affect the use some POC and therefore this need to be included in the process.

In that process the identification of the end user is also critical. We all think about clinician and health worker but in Southwestern Uganda we found that a large majority of patients admitted at the regional hospital first stopped at the traditional healer clinic. We could imagine how to involve those practitioners in design/implementation of POC though we all prefer health worker to perform the test.

http://www.ajtmh.org/content/early/2015/03/19/ajtmh.14-0784.full.pdf

Anthony Emeribe Panelist Replied at 4:03 PM, 22 Sep 2015

What do you see as the biggest barriers to effective use of diagnostics? What would it take to remove these barriers and expand access?

The different barriers to the effective use of diagnostic technologies are:
1) Ambiguous policy on use of diagnostics for clinical management
2) Fragmented, unclear, and complex regulatory and registration processes at both international and national levels
3) Inconsistency between policy recommendations and regulatory standards
4) Absence of robust and standard indicators/metrics to assess the impact of POC diagnostics tests beyond analytical performance
5) Inconsistency in purchasing practices from the donor community and national program
6) Poor definition of market opportunities
7) Undeveloped market environment

What it would take to remove these barriers and expand access are:
1) Clearer policy guidelines with respect to diagnostic testing need to be established
2) Where possible, regional regulatory and registration processes could be harmonized
3) Regulatory standards need to be harmonized with policy guidelines and publicized
4) Investment is needed in fundamental operational research and modeling; local operational research capacity needs to be built
5) Standards for assessment of impact and appropriateness of new POC technologies need to be developed and disseminated to key stakeholders
6) Rigorous market intelligence needs to be collected and appropriately disseminated to key stakeholders.


Elizabeth Glaser Replied at 4:10 PM, 22 Sep 2015

Beliefs and behaviors must be considered when developing and implementing POCs.

Despite the results of the test, treatment decisions may be dependent upon the norms of the provider and the patient or family . Some of these behaviors and belief are relevant around prescribing but also apply to diagnostics.

Practice norms may influence a provider even if microscopy is not clear or the RDT is negative. Beliefs about what constitutes illness or good care can impact what a patient or family may demand. In western Kenya the prevailing belief is that fever =either malaria ( treated with coartem) or typhoid ( treated with antibiotic),
If positive RDT, give coartem;
if negative RDT, give antibiotic for typhoid
OR
if negative RDT, give coartem and if still ill in a few days, come back and get antibiotic for typhoid

In this kind of treatment scenario there is no room to consider false positives or false negatives. There are no false positives and a negative result may be assumed to be a false negative if the provider and patient deem it so.

Anthony Emeribe Panelist Replied at 4:30 PM, 22 Sep 2015

Hi Raymond,
Your comments are well received. Note that most health professionals reject posting to rural areas due to poor facilities and incentives besides budgetary constraints especially at the local government levels. However it is gratifying to note that none of the 774 LGAs in the country lack at least one doctor and a basic lab practitioner who may likely be in private practice. Providing lab services for free may not be feasible as donor funds continue to dry up. Streamlining lab fees across various parts of Nigeria (public and private health facilities) will be an arduous task for obvious reasons. Council advocacy is for Comprehensive Health Centers in all the LGAs to be properly manned by doctors and certified medical laboratory scientists for the supervision of testing sites in all the health posts.
PrE

Sungano Mharakurwa Replied at 4:41 PM, 22 Sep 2015

For some conditions such as malaria, simplicity of the test, in addition to affordability, seems to have been a key barrier to overcome, apart from speed of the test. The detection threshold is also proving a hurdle where programmes are aiming for disease elimination.

Violet Chaka Respondent Replied at 4:58 PM, 22 Sep 2015

Most countries in low resource settings seem to share similar challenges in implementing diagnostics. This has been a very insightful and rich discussion. From my experience, the following challenges are still hampering progress in the effective use of diagnostics:
1) lab diagnostics programmes are inadequately funded especially in the public sector. The greater share of funds is channelled toward treatment, care and prevention strategies. While it's a bit harsh to say lab programmes are "neglected", more can be done to improve the current situation. This also includes implementing strategies and training lab personnel to have a sound command of the Total Quality Management systems and get labs accredited.

2) Supply chain management systems are often not standardized. This leads to poor forecasting by procurement teams hence stockout of reagents and other lab supplies. Consequently, district labs are forced to send samples to referral labs and this lengthens turnaround times of results.

Shortage of skilled personnel especially in "smaller" labs e.g. at district hospitals puts a lot of pressure on the available workers. In some instances it compromises quality systems like proper instrument maintenance and even documentation of quality indicators and incidence reporting.

Solutions:
In general, lab programmes need to be better funded in all aspects if we are care about the quality of results we are producing in the labs. This encompasses the logistics, training, implementation of quality systems.

Best regards,
Violet Chaka

Marie Teichman Replied at 5:37 PM, 22 Sep 2015

Hello everyone,

Here is the brief from today's discussion so far. Please feel free to continue with the current topic on barriers affecting the use of diagnostics!

Best,
Marie T.


Tuesday’s discussion surrounded the barriers that affect the use of diagnostics and strategies to remove them while expanding access to these tools.

A large issue for many resource-limited settings is the lack of available infrastructure to support the proper use of diagnostic tools. Physicians in these settings often lack confidence in the tests due to the widespread distrust of lab results and a strong culture of empiric treatment. Respondent, Lee Schroeder, pointed out that the main hurdle is gaining “diagnostic confidence.” Clinicians and laboratory workers must establish relationships in order to create an environment of trust surrounding the use of diagnostics, while prompting health ministries to strengthen health systems by investing more in lab technology and human resources.

An overwhelming barrier to effective use of diagnostics is cost. While the most important drivers for the use of diagnostics are the patients and providers themselves, without their request for these tools, there is little incentive for health ministries to invest the money and resources required to improve these services.

Panelist Madhukar Pai described the reality in both the private and public sectors regarding the issue of cost of diagnostics. See his post #75 for suggested solutions to these issues:

“In the public sector, we know that most countries spend a tiny fraction of their GDP on health. And, within the health budget, diagnostics get virtually nothing. So, health ministries are reluctant to spend money on tests, even when they know that new technologies (e.g. molecular tests) may be far better than what they have been using for years (e.g. sputum or malaria smears).

In the private sector, patients, labs and doctors have been left to fend for themselves, despite the fact that private sector is often the dominant healthcare provider in many countries. Diagnostic companies charge whatever they think the market will bear. Distributors will add their margins to this already inflated price. Then shipping and import duty costs get added. Private labs and hospitals will add their profit margins (including any incentives that they need to pay the doctors). All of this means that a $10 test can end up becoming a $50 test for the patient who has to pay out of pocket. So, it is not surprising that private doctors skip the entire testing process and manage patients empirically. Antibiotics are far cheaper than tests in these settings.”


There is also a need for straightforward policy regarding clinical management, processes, and standards for diagnostic use on national and international levels. The best option for resource-limited settings is to have regional health agencies combine their efforts to collaborate with international agencies regarding their specific needs. This can help address many of the issues regions face when attempting to improve their health systems.

wilmot Smith Replied at 5:37 PM, 22 Sep 2015

Thanks Marie T. for your great summary of issues arising from day one. While it is factual that there have been some progress made in increasing diagnostics services in many resource limited countries, there are still more to be achieved.
In the West African country of Liberia, diagnostics services for TB, HIV and malaria services has been decentralized to the districts. According to the Essential Packages for Health Services, every health district should have at least a TB diagnostic center. Most health districts have more than one diagnostic center; PMTCT and malaria diagnostic tests, RDTs, are available at almost every point of care beginning from the PHC level one clinics. Microscopy for malaria is present in some PHC clinics, health centers and beyond. In recent times, sample transport from point of care to diagnostic centers and the National Reference laboratory has been strengthened with the introduction of riders transport system by motorbikes even though there have been some delay in getting sample from very remote health facilities.
Posting and maintaining trained laboratory health workers in very remote health facilities and shortages of laboratory reagents at times are some pitfalls in service provision.
At the beginning of 2014, in a very remote district, a sizable number of TB cases treated were confirmed by microscopy, while the rest of the cases excluding the extra pulmonary cases were treated on clinical grounds.
In other to add value to the services, training needs, staff motivation especially those in hard to reached remote districts and health facilities and the regular supplies of laboratory reagents need to be addressed. In addition, community engagement and advocacy also need to be strengthened for the full utilization of these services.

Wilmot L. Smith, MD, Certificate (GHDI)
County Health Officer
National IMAM master trainer
Liberia

Jeannette Guarner Panelist Replied at 6:44 PM, 22 Sep 2015

Agree with Yap Boum. Healers are present in many cultures. They are frequently the first to encounter the patients. They can do a lot of good, they can do a lot of harm. How to engage them is the question. I am not sure there is an answer. Although I suspect we all know stories of successes and of horror.

EMMANUEL ABATTA Replied at 7:00 PM, 22 Sep 2015

In order to enhance quality of care and accuracy of treatment by the Doctor, it is important to increase access to diagnostic services to hospital clients. In the resource constrained countries, there are large gap between the demand and supply of diagnostic services. Many of the clinicians treat most of their patients on assumptions. In the tertiary hospitals where diagnostic equipment are available, certain conditions may affects use of the equipment such as power failure or unavailability of skilled staff. Sometimes the machines are broken down, and the maintenance plan may not have been factored in the hospital workplan. The situation is worst in the rural communities. Many patients at community would love to have access the basic diagnostic infrastructure. There is need for government to ensure that at all levels of care, there are minimum and laboratories with capacity to meet with the basic health needs of the people. Government has a big role to ensure the quality of laboratory services through capacity build the laboratory officers at all levels of care. We should also encourage task shifting because, it is going to be a big challenge reaching out and meeting demand, using only qualified Lab. Scientists. This can be achieved using unified algorithm and SOP

Elizabeth Glaser Replied at 10:33 PM, 22 Sep 2015

Are lab supplies and POC tests restocked on an as needed basis or by looking at associated usage patterns ?
For example if drug X is typically written for every three tests (y) performed , then the two could be restocked in a 1 to 3 ratio.

joshua odero Replied at 11:50 PM, 22 Sep 2015

Hi All,

I entirely agree with Elizabeth Glaser comment, that we indeed need to properly forecast and stock as per our trend in utilization. Erratic procurenent and stock outs is the biggest impediment to laboratory diagnosis and quality service provision.
Thank you.

joshua odero Replied at 12:26 AM, 23 Sep 2015

Well captured Violet Chaka, it is indeed true that laboratory is inadequately funded compared to other sections of the hospital, what could be the challenge? Could it be poor representation at hospital leadership level where decisions are made. There as been deliberate attempt to undermine the profession, from the job adverts where medical doctors or nurses qualifications will be preferred to head programs, it is high time organizations recognise that laboratory personnel have the right credentials to run programmes. This way, neglected professions like Microbiology diagnostics will be uplifted.
Thank you.
Joshua Odero

Sajid Ali, Ph.D Replied at 3:29 AM, 23 Sep 2015

In my province of Khyber Pakhtunkhwa (Pakistan) , TB Culture and Drug susceptibility testing are centralized to Reference laboratory and regional laboratories while the microscopy network for TB diagnostic is decentralized. Smear Microscopy is still the POC at more than 200 centers. While one genepxert serves one million population for MDR detection in a total of 11 genexpert sites in the province.
As laboratory professional I understand the lab results depends on quality of sample and good quality reagents but the less a laboratory professional has influence on these. It is the program managers who can support laboratories to their best but unfortunately that very few laboratory professionals are let to contribute in management. I do agree with Violet Chaka and joshua odero that Laboratory is some what neglected.

Jostas Mwebembezi Replied at 7:24 AM, 23 Sep 2015

Dear All
Thank you for the rich discussion
I hope you all have plans of integrating case based surveillance(CBS) and openMRS in your interventions.
I have done so and have seen exciting results.

Jostas Mwebembezi
Executive Director
Rwenzori Center for Research and Advocacy
Fort portal Uganda

+256774553595

A/Prof. Terry HANNAN Replied at 8:06 AM, 23 Sep 2015

Jostas, do you have some documentation on these projects?

Mulualem Agonafir Replied at 9:12 AM, 23 Sep 2015

In relation to barriers affecting the use of diagnostics, we had a study conducted particularly focusing on Xpert MTB/RIF. We involved health professionals working at DOTs providing health facilities in Addis Ababa. We found an overall low level of knowledge regarding the importance and particular use of Xpert in TB diagnosis. Over half of the study participants had knowledge gaps on the issues of the roles of Xpert on monitoring treatment response and progress, tools to monitor treatment response of cases detected by Xpert. Less than a quarter of the respondents were aware that Xpert is not recommended to monitor treatment outcome. Only half of the respondents replied that presumptive TB cases with drug resistance detected by Xpert should be put on second line anti-TB treatment (according to the national guideline of the country).
Despite the incorporation of Xpert in the national TB and MDR-TB diagnostic algorithm, only half of the respondents knew its presence and use as a tool in detecting TB. Subsequently, majority of the study participants were not aware of patients eligible for diagnosis of TB by Xpert.
I believe that we should equip all the stakeholders with sufficient information before implementing a tool. Otherwise, it results in its inappropriate use/wastage and would not reach to the targeted.

Jostas Mwebembezi Replied at 9:30 AM, 23 Sep 2015

Hi Terry
I have them and we can initiate talks via


HIV case based surveillance (CBS) was recommended by WHO as early as 2006
With CBS: individual level information on all known cases of HIV are reported to a central database.
CBS is a means of uniquely identifying and characterizing persons newly diagnosed with HIV or AIDS and tracking them over time

Ali Elbireer Respondent Replied at 9:44 AM, 23 Sep 2015

Today issue...what are the biggest barriers to effective use of diagnostics? What would it take to remove these barriers and expand access?...
Excellent medical laboratories are vital to ensure accurate diagnoses and to identify pathology at early disease stages. It is essential to embark on solid operational research to identify the cost of poor quality laboratory service and to help us develop practical models for not only building, but also maintaining good quality medical laboratory capacity and services in developing countries. Government officials and health care professionals in these countries should agree on the importance of creating strong medical diagnostic capabilities. Despite sizable investments in laboratory capacity building, SSA is very slowly beginning to utilize some of these resources to build sustainable, accountable government laboratories improving patient outcomes on the basis of quality laboratory results.
Globally, there are many concerns surrounding health care access including laboratories, and there is increasing debate over the appropriate level of quality and value-added cost vs medical necessity in urban and rural areas, especially in RLS.
We always talk about COST as a limiting factor... but IS IT?...We in the laboratory community have to market laboratory/pathology issues and concerns and may need to move the conversation from merely an ETHICAL imperative to COST EFFECTIVENESS imperative for Population Health... because Cost of bad quality in labs will only produce bad healthcare and more wasted resources.

Jeannette Guarner Panelist Replied at 9:47 AM, 23 Sep 2015

I think one of the problems the laboratory associated professions (lab tech, clinical and anatomic pathology, clinincal chemistry, etc.) have is that we are not "seeing" the patients (I always say we see pieces of the patients). Thus, administrators tend to give priority to those health associated professions that have face-time with patients. I must say this problem is not privative of resource constrained settings. I see it in the US as much as I see it around the world.

In previous days some of the discussion has stated that clinicians should advocate for better laboratory services. They are the drivers of us having this or that test available... We definitively need to show our worth to clinicians and hospital administrators.

Jeannette Guarner Panelist Replied at 10:10 AM, 23 Sep 2015

Mulualem Agonafir points again to the issue of educating clinicians: You may implement the test but if clinicians do not ask for it might as well not have it.

Om G Replied at 10:18 AM, 23 Sep 2015

Yap Boum and Jeannette Guarner are hitting on a point that I think is dawning on practitioners. Soon it will be individual patients with the experience of instant communications and banking transactions with their phone expecting to be taken into account.
We know that Western medical training has literally marginalized and even ridiculed natural healing practitioners. This occurred even while big pharma has been investing heavily in plant research, stealing it out from under the noses of traditional healers.
There is room for everyone to grow and it may be a lot easier to do if Western trained persons took a slightly more open minded approach to interactions. We now appreciate the psychological state impacting healing and how ritual can greatly enhance well being.
All true healers perform to the best of their ability with the tools they have. Being marginalized and watching more than a few cynical examples of exploitation would not prepare much fertile ground for working together.
I keep wondering how to provide incentive to the traditional healers, and it occurs that they might be just as interested in knowledge exchange as we are!
It is a gross oversimplification, but I wonder if the data collection tools we can provide for SMS and mobile applications couldn't be tailored to enable traditional healers to share their techniques with one another and with the more 'western' clinics nearby. Symptoms, herbs or methods used, and their efficacy, might be more readily shared between traditional healers in a region before they were shared with the western clinics, but it would also provide much needed respectful interactions and opportunities for learning across the spectrum. Not to mention early warning of trends.
China and India both have embraced herbal remedies within the larger medical structure and I think it bears some consideration.

Om G Replied at 10:28 AM, 23 Sep 2015

Regarding the issues arising from so many different EMR, EHS and other database structures. This is not a barrier! Methods exist to make the information compatible. If we can securely connect each to some means of communication, the glue can be created to connect the dots. It is actually getting easier every day. Most of these systems already have the capacity to export data in more compatible formats, and automated discovery and harmonization is on the horizon. Once it is seen as a priority, development can quickly arrive on the heels of investment.

Timothy Amukele Respondent Replied at 12:31 PM, 23 Sep 2015

I wanted to highlight what Ali said about 'cost effectiveness' and Jeannette said about 'showing our worth'..
Cost is often presented as a roadblock to adopting many of the changes that we have been talking about. But we need a change of perspective.
A house without a roof is cheaper to build than one with a roof, but it's not useful. We have to learn to justify investments in laboratory testing from this vantage point. The costs for a well functioning lab (supplies, controls, equipment) are trivial compared to the impact to the whole healthcare system and larger population.

Anthony Emeribe Panelist Replied at 12:32 PM, 23 Sep 2015

In Nigeria, diagnostics for HIV, TB, malaria, and HPV are validated by Government Agencies in conjunction with implementing partners (NGOs) for specific disease programs.
Pockets of operational research are undertaken on measuring the net effect of technology in the field—in this case, HIV and Tuberculosis POC testing technologies by health system. Regulatory approval process begins and ends with a technical evaluation process based on analytical and clinical accuracy.
The combined technical and operational evaluations would require a multidisciplinary team, which can be challenging and expensive to assemble. As POC technologies become more widely available, however, investments in operations research become increasingly important. It is anticipated that these research activities will inform policies and procurement decisions.

Milka Ogayo Replied at 1:05 PM, 23 Sep 2015

Facilities for basic tests like for malaria may be easy to come by with some incidences of stock outs here and there that can still be handled and an extent of guaranteed quality assurance. challenges arise when advanced tests have to be done mostly because a condition has complicated. Therefore besides the other challenges regarding diagnostic strategies that arise from the supply end I also suggest that the demand end, with poor health seeking behavior may present with complications that are expensive to diagnose especially for those in the LMICs and this also creates a challenge.

Milka

Jeannette Guarner Panelist Replied at 2:29 PM, 23 Sep 2015

Agree with Om G....
We need to work with traditional healers. Going back, many of the medicines we use now came from traditional medicine, example digitalis, tamoxifen... So, we can learn from them, they can learn from us.

Elizabeth Glaser Replied at 2:30 PM, 23 Sep 2015

Re - Funding for laboratories:
The US announced a program to invest more than $1 billion in resources for global health security. The CDC and other US groups will be/ are partnering with the African Union commission and governments in 17 countries ( in East Africa, West Africa and South East Asia) to increase capacity to prevent, detect, and respond to future infectious disease outbreaks. One aspect of this program is to develop the African Centers for Disease Control and Prevention, to develop and increase capacity in existing national public health surveillance, research, and laboratory networks.

Uganda was one of the pilot sites for the program, but the larger program will be rolling out over the next few years.

Has anyone here heard of "The Global Health Security Agenda" or received funding or training through one of the pilot programs? If so , do you think it can assist with some of the issues raised here on capacity, supply, collaboration, and training?


Elizabeth

Attached resource:

Elizabeth Glaser Replied at 2:55 PM, 23 Sep 2015

Please remember that cost effectiveness is just one input of many when making a choice . One has to be careful about when deeming that a project or program is /is not cost effective because the parameters set up in the study may not reflect your situation on the ground. I have found that even the best health economists may leave not understand a typical clinical exchange , so these studies are greatly improved by collaboration with researchers with a clinical background; the same would apply to laboratory costing of laboratory diagnostics. If more lab directors, pharmacists, nurses and other clinicians were trained in this area, we could be better advocates for our programs.
Parameters to consider in cost effectiveness are:
1.What was the effectiveness measure?
2.What costs were considered?
3.What were the outcomes, eg $ per DALY is a summary measure, $ per test performed is more of a process measure
4.What was the time horizon?
5.How generalizable are the results : do they apply to the population at large or only to a limited area or subgroup?
6. Would costs drop over time with scale up ?

Elizabeth

Ann Marie Nelson Respondent Replied at 3:36 PM, 23 Sep 2015

Most of my experience (5 yrs on site in Kinshasa with Projet SIDA and several years as consulting with university hospitals in Uganda, Tanzania, Kenya and other countries) has been in Anatomic Pathology, specifically in HIV/AIDS and infectious diseases.

The challenges to appropriate use of diagnostics are similar to those in clinical labs.

The first is awareness of need.

1. What are the prevalent diseases, conditions in a given population?

2. Are there clinical laboratory tests or cytology/histopathology tests that can impact therapy?

3. Can the existing laboratory accurately provide results in a timely manner? Equipment and trained staff?

4. Are physicians aware of the tests? Do they trust the laboratory? Will they accept the results if they do not support impression?

5. Can the results be used in a meaningful way to improve patient care?

6. Are the tests affordable?

7. Is there a reliable product stream?

Each of these questions identifies complex areas of challenge and must all be addressed in order to have sustainable access to and utilization of appropriate diagnostic tests for the setting.

With this information, a health system can determine which strategies are required.

Ilesh Jani Panelist Replied at 3:52 PM, 23 Sep 2015

How have diagnostics for HIV, TB, malaria, and HPV been validated in the country where you work? Was operational or implementation research conducted for these diagnostics? How was it done & what lessons were learned?

The fact is that validations and/or operational research are not conducted for every diagnostic test in the setting where I work - probably the same is true for many resource-limited settings. Since regulation of diagnostics is a vacuum in our setting, ample space is left for outside pressure (e.g. from interest groups, donors, manufacturers, etc) to influence introduction of diagnostics. Sad but true.

There are examples of good practice (e.g. POC CD4, HIV RDT), where things worked out because the Ministry of Health provided governance and stewardship during the entire process. In these cases, the decisions on what technology to introduce and how to implement were based on evidence generated locally. A formal process of evaluation, with several phases - from an initial product down-selection to a final cost-efficiency and budget impact analysis - was conducted. Since the processes were transparent, there was buying-in from every stakeholder.

In my view, resource-poor countries need to start considering the establishment of formal processes for Health Technology Assessment (HTA). This is not a new concept and is a successful endeavor in many countries, where every health technology considered for incorporation in the public health system is subjected to a formal, transparent and comprehensive evaluation. HTA should be done for diagnostics the same way it is done for other health technologies.

Tsehaynesh Messele Giday Panelist Replied at 5:17 PM, 23 Sep 2015

I agree with Ilesh introduction of new diagnostics needs to be done based on evidence . In many resource limited settings there is no capacity to do this .
It is mostly driven by new initiatives and funding than the need for the tests.
As part of the barrier question I wanted to indicate lack of forecasting capacity at a laboratory level which affects timely purchase of diagnostics. It would be important to strengthen the capacity of laboratory managers on quantification and forecasting to minimize stock outs.

Marie Teichman Replied at 5:47 PM, 23 Sep 2015

Thank you all for such a rich discussion! Here is the summary of today's discussion so far. Please continue to share your experience with panelists and the community.

Marie T.


Wednesday’s discussion continued with barriers to using diagnostics before moving to the validation and research techniques conducted for diagnostic tests.

Multiple participants pointed out the similarities between low resource settings’ challenges in implementing diagnostics, focusing on the lack of attention to laboratory needs by health systems. Despite laboratories’ vital roles to ensuring accurate diagnoses, they are often underfunded compared to other sectors of the health field due to the lack of patient interaction. This leads to an inability to properly stock necessary diagnostics and further delays in clinical operations. As mentioned earlier in the discussion, clinicians and laboratory personnel need to increase interdisciplinary support and advocate for mutually beneficial needs within the system.

The issue of educating all health professionals on how to use diagnostics properly was also raised. There are many apparent knowledge gaps in resource-limited settings, where clinicians have not been trained properly in how to or when to use the tools available to them. In order to improve the use of diagnostics, all collaborators must be supplied with sufficient background information before they can be implemented.

Panelist, Anthony Emeribe, shared his experience with validation and research methods (Reply #102):

“In Nigeria, diagnostics for HIV, TB, malaria, and HPV are validated by Government Agencies in conjunction with implementing partners (NGOs) for specific disease programs.

Pockets of operational research are undertaken on measuring the net effect of technology in the field—in this case, HIV and Tuberculosis POC testing technologies by health system. Regulatory approval process begins and ends with a technical evaluation process based on analytical and clinical accuracy.

The combined technical and operational evaluations would require a multidisciplinary team, which can be challenging and expensive to assemble. As POC technologies become more widely available, however, investments in operations research become increasingly important. It is anticipated that these research activities will inform policies and procurement decisions.”

Also, validations are not necessarily conducted out for all diagnostic tests that are to be implemented in a system. There is a lot of opportunity for outside pressures to influence what new diagnostics are introduced. Participants agree that the introduction of diagnostics should be based on hard evidence, ideally relevant to the local reality. However, this is not often the case.

Charles Kiyaga Respondent Replied at 5:52 PM, 23 Sep 2015

How have diagnostics for HIV, TB, malaria, and HPV been validated in the country where you work? Was operational or implementation research conducted for these diagnostics? How was it done & what lessons were learned?

In Uganda new technologies are validated against conventional technologies before they are allowed to be used for patient care. A validation protocol will have to be developed by the team going to conduct the validation. The protocol is submitted to an institution review board (IRB). The IRB reads the protocol and raises any area of concern that needs to be readdressed. If they are comfortable, they approve the protocol. After IRB approval, the protocol is then submitted to the Uganda National Council of Science and Technology (UNCST), the one body that approves all researches conducted in the country. After UNCST approval, the protocol is finally submitted by UNCST to the President's office, who finally give a go ahead to the researchers to visit the respective districts where the research is going to be conducted.

After the research, results are presented to stakeholders for discussion. If the results are good, then a recommendation is given to pilot the new intervention in a few selected health facilities. Results of the pilot and lessons learnt during the pilot are shared with stakeholders. The stakeholders then recommend for a scale up of the intervention. After the report from the stakeholder's meeting, the Director General of Health Services gives a final approval for the technology to be used for patient in Uganda without restriction.

Lessons learnt;
1- The process of protocol approval is very lengthy and time consuming. After the approval from UNCST, let the approval from president's be removed.
2- For technologies that have been validated in other countries in the region, let the validation not be redone, but rather the pilot implementation.

YAP BOUM II Replied at 12:10 AM, 24 Sep 2015

Thank you Marie for this excellent summary

i am now wondering how we can move from this interesting discussion/platform to actually change what is happening in the field?

what is the way forward?

yap
Yap BOUM II, PhD, MPH, Engr
Regional Representative for Africa
Epicentre / Medecins Sans Frontières
Associate Professor, Faculty of Medicine
Mbarara University of Science and Technology, Uganda
University of Douala, Cameroon

James Korvieh Replied at 9:34 AM, 24 Sep 2015

Dear All


In the developing countries, I think Elizabeth is actually right about the POC, however, in some developing countries, example, Liberia, where I practice, some of the cancer that are diagnosed on clinical ground, there is no chemotherapy available to initiate treatments, therefore in this discussion, I will also appeal to cancer institutions to help developing countries with cancer drugs, especially Liberia.


James

Jostas Mwebembezi Replied at 10:26 AM, 24 Sep 2015

@James
Actually Cancer is becoming more serious than before. Currently in Uganda Cancer is killing every day. Many surface for diagnosis at a time when the cancer has move to a high level.
Ceteris paribus there is a steady rise in the number of Ugandans suffering from various forms of cancer, according to a cancer expert.
Dr Fred Okuku who is based at the Uganda Cancer Institiute in Mulago National Referral Hospital said in the last three years alone, the number of cancer patients shot up from 1200 to 2800 with over 60% of the patients presenting advanced cases of the diseases.

Okuku said infections were the major cause of cancers in the country, adding that cancer of the cervix was the commonest form of cancer among women followed by breast cancer with some cases presenting among patients as young as 18 years.

“Cancer of the cervix is now coming at 18 years and not 35 years (as it used to be) because many young people are starting sex much earlier,” he said.
Okuku said the rise in the number of cases at the Institute is partly as a result of the Ugandans’ poor health seeking culture, adding that as far as Cancer literacy is concerned; Uganda has a long way to go.
“Cancer literacy is very low and it does not matter whether the patient is educated or not. Doctors, teachers, bank managers all turn up late at the Institute,” he said.

He said, of the patients who turn up at the institute with complaints, the majority report having felt discomfort in the last six months (44%). Those who say they have had some form of discomfort in the last three-six months are 34% while those who go for checkup after feeling uncomfortable after less than three months are 22%. He said over 70% of people who turn up at the Institute are normally diagnosed with cancers which are in the fourth stage.
This is stage, Okuku said, is considered very late as far as cancer management is concerned. He noted that when a cancer is discovered early, it can be taken out and cured.

The Uganda Cancer Institute is the only cancer referral centre in Uganda but it also serves patients from Djibouti, Eritrea, Somalia, western Kenya, Rwanda, Burundi, South Sudan and the eastern Democratic Republic of Congo

My organisation( Rwenzori Center for Research and Advocacy) is working had to install an electronic clinic in Fort Portal -a town in western Uganda to help diagnose early cases and refer for treatment. I would move but limited access to financial resources is becoming friction for my organisation to help.

#Someone help

Anthony Emeribe Panelist Replied at 12:12 PM, 24 Sep 2015

Do you see advantages to importing, versus locally manufacturing, diagnostics?
Over 90% of the IVD products used in the country are sourced from foreign manufacturing companies. Many stakeholders believe that locally manufactured IVDs products are sub-standard, due largely to the weak standard and policies for manufacturing IVDs in the country. There is a need to support local manufacturers of quality diagnostics. This will also provide job opportunities as well as technical manpower for after service maintenance of diagnostic equipment, adaptation and minimize waste.
There are also other market forces that determine competitiveness of pricing of diagnostics many of which may not necessarily favour prices of local manufacturers and may even frustrate their efforts.

Menyanga Abu Replied at 12:43 PM, 24 Sep 2015

This is a very usefuland interestingtopic that needs mind-rubbing discussions.

In creating and driving demand andsupply of diagnostics, many factors that may come to play must beconsidered  Many developing and low-income countries do not have access tosome of the latest health technologies due partly to financial constraints andother factors such as-- lack of political commitment onthe side of the government- corruption- cultural attitudes/valued norms- international trades/patentdisputs- problems of using the diagnosticproductsIt is very important to focus andwork on these factors affecting the demand for various health diagnostcs bypoor and low-income countries.We also need to take a look at the actiivitystreams that occur simultaneously in the demand and supply of diagnostics. Thisis the four As: (AAAA) Architecture, Availability, Affordability and Adoption.

Architecture: This involves thedecision making process by the government and non-government organizations asto whether to introduce and put demand for particular diagnostics.This decisionmaking involves the assessment of the safety, efficacy, potential benefits,cost-benfit and cost-utility anlysis of the products. The decision as towhether to demand for the diagnostics or not by poor and low-income countriesis guided by the above factors

Availability: This can be said to bea collective process undergone by the diagnostic products to ensure they get tothe end-users.This includes production, ordering, shiping, storing, distributionand final delivery to the end-users. For manufacturers to meet the demand fortheir products, they do demand forcasting to help them determine how much ofthe diagnostics to produce and if produced how much of the products are likelyto be purchased and utilized and at what price.It is important to note thataccurate demand forcasting is a vital tool that guides the manufacturers toplan and invest in production capacity that will help to make sure there isefficient supply system to meet the demand.

Affordability: Affordability relatesto and involves ensuring that diagnostics can be bought at a reasonable priceby people and organizations that need them. The cost of these products as weall know includes the actual cost price and cost of services-user-fees. Thesecosts includes manufacturers selling price and all add-on cost such as tariffs,VATs and other wholesale mark-ups.In driving demand and supply ofdiagnostics, attention should be paid to the infleuence of cost on the demandfor the products especially for the developing, poor and low-income countries.



Adoption: Adoption relates to thediagnostics gaining acceptance and creating demand at various levels; globalyand nationaly by government, NGOs, service providers, and end-users. Adoptionat national levels means acceptance of the products by the policy makers ofthat gountry. This takes us to the issues of architecture- political commitmentthat is translated into concrete action is the driving force for accepting andintroducing the diagnostics by any government. In creating and driving demandand supply of any diagnostics, there is need to sensitize the policy makers andother stakeholders in the health sector.

One of the determining factors forthe introduction of any diagnostics by any country is the issue ofaffordability. How cost- effective is the product? What are the cost-beffit andcost-utility analysis  like? These factors are guides to decision makingin low and poor resource country. The diagnostics have to be accepted by thecountry policy makers in the ministry of health. Acceptance by the ministry ofhealth will then pave way for the development of treatment protocols andallocation of funding in the budget to purchase the product. It is equallyimportant to note that gaining acceptance and creating demand for diagnosticsamong health care providers and individual is a key component of the adoptionprocess. We should also undrstand that adoption and acceptance of anydiagnostics is influenced by the following:- the perceived purposeof theproduct- the perceived efficacy, risks andbenefits- perceived cost, desiredcharacteristics and delivery logistics.

In the course of driving demand andsupply of diagnostics, those factors mensured in the precceding pages shoul begiven attention as they tend to influence the demand and supply of theseproducts.

Marcel van Kasteel Panelist Replied at 12:54 PM, 24 Sep 2015

I think that there is no opportunity for local IVD manufacturing for local needs. Most IVD companies have manufacturing sites in oversees area's like India. If they perform with the right standards and comply with FDA regulations they can be everywhere. At Philips we have a lot of manufacturing sites around the world for medical products. Interestingly we are shifting some manufacturing sites back to develop countries. Main reason in that labor cost is increasing rapidly in emerging countries but more important is that people in manufacturing sites move very quickly from one place to the other which increases training/hiring costs and make it almost as expensive as in develop markets

Ilesh Jani Panelist Replied at 3:26 PM, 24 Sep 2015

Do you see advantages to importing, versus locally manufacturing, diagnostics?

Few low-income countries have the technological capacity to manufacture diagnostics. Perhaps this question would be more relevant to middle-income countries. If cost is all that matters, then perhaps importing all diagnostics would lead to cost savings for the health system. However, if one thinks broadly and beyond the health system, to have the local capacity to manufacture could bring significant advantages to various sectors such as labour/employment, science & technology, commerce, etc. In the end, it is very unlikely that a country would be able to locally manufacture every diagnostic test needed for its health system. A situation where some diagnostics are imported while others are locally produced would probably constitute the most cost-efficient approach.

Elizabeth Glaser Replied at 4:14 PM, 24 Sep 2015

Why can't there be regional cooperation to develop manufacturing capacity for diagnostics ( and pharmaceuticals, too) ? These regional partnerships would require some kind of specific agreements to allow trade/import/export of devices and work permits pool physical and human resources , but it could decrease reliance on upper income countries for access to devices. Long lag time admittedly to realize this goal.

Catherine (Cathie) Klapperich Respondent Replied at 4:34 PM, 24 Sep 2015

@Ilesh, @Elizabeth and @Marcel,
Thank you for commenting on local manufacturing. This is something we think about a lot (I am a test maker). I'm wondering if there might be value in test makers (companies) enabling the supply chain - getting the diagnostics made elsewhere to the locations they need to be in. The company that makes the IVD cannot get a good price unless they convince the MOH that they have a plan for supply. Maybe we should be providing people with the means to do that more efficiently. The company could have a fleet of trucks/motorcycles that it maintains.. perhaps these ideas are too complicated,

There has to be a way to encourage local business people to want to deliver IVDs to far flung locations on time and keep them useable and in spec. Making the test super cheap can help by allowing local delivery people their markup without making the tests too expensive to use. But getting them there on time and in good condition should be rewarded by the marketplace in some way. It is not enough to get the IVDs into the country, they have to get into the hands of the provider, and in good shape. Local manufacturing gets touted because it seems like a way to shorten the supply chain.

Cathie
www.bu.edu/cftcc

Attached resource:

Tsehaynesh Messele Giday Panelist Replied at 5:29 PM, 24 Sep 2015

I think for countries with a large population size, local IVD manufacturing could be an advantage provided same standard and quality are maintained. It can increase diagnostic availability and access in addition to other benefits. Data on the diagnostic market would be important to determine cost effectiveness. However this information is not available in many countries in Africa and is a gap which may need to be addressed.

In Ethiopia the government encourages and has an incentive provision for local manufacturing in general.

Madhukar Pai Panelist Replied at 5:35 PM, 24 Sep 2015

Hi everyone. I agree with Ilesh - many low-income countries will struggle to manufacture, and importation will remain their main option. However, emerging economies such as India and China can and are making by good contribution by manufacturing generic drugs and vaccines, and there is no reason why they cannot do this for diagnostics. In fact, they are making RDTs and supplying globally. But when it comes to sophisticated/molecular technologies, it has been more challenging. It is only recently that Indian and Chinese companies have launched new molecular dx (e.g. TrueNAT from India; EasyNAT from China). It will be great to see more such products, and it will be wonderful to see some of them get WHO/global endorsement.

Sandeep Saluja Replied at 5:41 PM, 24 Sep 2015

Would not be a good idea to have a couple of international groups who
specifically focus on innovating low cost diagnostics for low resource
areas? They should be monitored for quality by groups like GHD.To encourage
third world participation they should have a policy to specifically engage
scientists and staff from such countries. The governments on their part
should give them duty exemptions and other privileges.

A/Prof. Terry HANNAN Replied at 5:54 PM, 24 Sep 2015

Has anyone heard about or evlauated Theranos which is referred to in Eric Topol's "The Patient Will See You Now". The evolution of this specimen collecting service seems to be way out in front of where we stand now

Marie Teichman Replied at 6:03 PM, 24 Sep 2015

Hi all,

Thank you for another great day of discussion. Here is a summary from the past day. Please continue to add your thoughts and questions for the panelists!

Best,
Marie T.


Thursday’s discussion continued with validation processes and the potential advantages with local manufacturing compared to importing diagnostics.

The validation and acceptance of new diagnostics is often a lengthy process. The idea of regional validation was raised, where approval in one country would allow another in the region to begin with pilot implementation to save time and resources. However, the various governments, NGOs, providers, and end-users must all be willing to adopt these new diagnostics after the process is complete.

A large barrier to local manufacturing of diagnostics is the current status of the industry. Ninety percent of IVD products are not manufactured in local areas for end-users. Many stakeholders see local manufacturing as inadequate due to lower standards and adherence to policies. Panelist Marcel van Kasteel (reply #117) pointed out that local production in many areas may not be an option due to increasing labor costs in many emerging markets. Current competitive pricing models are also unfavorable to possible local manufacturing efforts.

Some advantages to local manufacturing would be the creation of jobs for the community, if cost effective for the manufacturer, and the availability of technological aid for routine equipment maintenance. Manufacturing must also be able to meet the product demand and forecast properly in order to minimize any delays for end-users. However, Panelist Ilesh Jani (reply #118) cited how few resource-limited countries have the technological ability to manufacture diagnostics. It is possible that a combination of local production and importing could be a cost-effective model for health systems. This could be build upon through regional cooperation to develop manufacturing capacity and decrease reliance on importing from other areas of the world.

Featured respondent Cathie Klapperich (reply #120) noted the possibility of test makers enabling the supply chain to support efficient distribution to end-users.

“There has to be a way to encourage local business people to want to deliver IVDs to far flung locations on time and keep them useable and in spec. Making the test super cheap can help by allowing local delivery people their markup without making the tests too expensive to use. But getting them there on time and in good condition should be rewarded by the marketplace in some way. It is not enough to get the IVDs into the country, they have to get into the hands of the provider, and in good shape. Local manufacturing gets touted because it seems like a way to shorten the supply chain. “

Jeannette Guarner Panelist Replied at 6:35 PM, 24 Sep 2015

I have a lot of ambivalence regarding the topic of creating in-country your own diagnositcs.
In some ways why reinvent the wheel... though buying from other countries can end up being expensive but at the same time having reliable validated tests is worth it.
At the same time you may need to creat your own if nothing is available. Say, no company in the US or Europe will create diagnostic tests for cysticercosis, they do not have the demand. Then creating this test in Mexico or another country where the disease is prevalent makes absolute sense.

Judith Thermidor Replied at 7:18 PM, 24 Sep 2015

Great discussion,
I recognize there is improvement in limited resource setting about diagnostic. One of the darkest sides between diagnostic and testing is the inequality of health system in the world, this point can no longer be ignored.
Nowadays, clinical laboratory test is the cornerstone to confirm diagnostic HIV,TB, HVP and malaria. So lack of capacity at laboratory level has bad repercussions and affects those diagnostics.
Absolutely, technologies needs to be readdressed with equipment and training staff. Clinical laboratory test is not only to confirm diagnostic also is the gateway to get a better formal protocol based in evidence and to achieve continuity of any intervention of diagnostic.
Judith,

>

Alphonse Acho Replied at 8:34 PM, 24 Sep 2015

Hi everyone, se can not over emphasize the need for evidence based medicine
which unfortunately is still a problem in most developping countries like
mine, Cameroon. Here, i once heard a medical doctor say he doesn't need a
laboratory in the hospital he was managing because to him, signs and
symptoms were enough for him to make his diagnosis, so he will only need a
nurse to help follow up treatment offered to his patients. No doubt in
most rural areas in my country, laboratory medicine doesn't have a place.
There is misdiagnosis of malaria all the time with antibiotics given most
of the time to treat a presuming typhoid disease, or some times mixed with
anti malarial drugs. This has even led to self medication and now drug
resistance. We have TB diagnostic and treatment centers but they are not
accessible to most patients who have to travel long distances in bad roads
to arrive. We have a central laboratory that does does some specialized
tests and diagnosis of resistance TB. There is no laboratory network in my
country and there is still a problem of standardization of diagnostic
procedures.

jayanth devasundaram Replied at 9:18 PM, 24 Sep 2015

USAID and Gates Foundatiin launched an initiative to find and fund innovations in TB diagnostics. http://gc-tbc.com We are in the middle of identifying and qualifying the pre-finalists for the award. Some very interesting and innovative diagnostics are in the pipeline, including a few resulting from a "wish" from a gathering of Mandate Definition Experts, (that included Dr Pai) for a simplified equivalent of a dipstick test for TB. Watch this space for further news of this effort!

Lee Schroeder Respondent Replied at 9:45 PM, 24 Sep 2015

Re: Theranos, see the attached resource. It more or less reflects the general feeling of most laboratorians I know (i.e., little idea of what the quality of testing will be). Since their technology has been kept more or less hidden, it's hard to say what is true and what isn't at this point...what is probably true is that people will like the ability to get an inexpensive test performed at their own convenience at the local pharmacy.

Attached resource:

Ravi Anupindi Replied at 11:40 PM, 24 Sep 2015

I am just about catching up with the excellent discussions on this very important topic. My comment relates to some of the issues / points made a couple of days ago, so apologies for injecting my thoughts out of sequence. I am not a physician / public health expert but teach in a business school with a focus on supply chain. The last few years I have begun to focus my attention to healthcare delivery. I teach a class on “Innovations in Global Health Delivery”, written a few pedagogical cases (e.g. case study on Operation ASHA – an NGO in India doing some excellent work in TB; link provided below), and discuss TB in my class. I have had the opportunity to host Dr. Pai in my class where he discussed the very innovating IPAQT initiative, he mentioned in one his posts earlier.

Based on my work with organizations in health (as well as non-health) settings, mostly in India, I have come to the conclusion that what is sorely lacking is a “solution-centric” approach to problems. (At least in India) TB is not just a medical problem; it is a social, medical, psychological, behavioral, and a financial problem for the low income patients. To construct a patient-centric solution for TB, one then needs to recognize the clinical, psychosocial, and financial needs of the patient. This basic idea was articulated in a Lancet Global Health piece last year (link provided), co-authored with Dr. Pai and Dr. Yadav. Ddiagnostics is one piece of a solution; it is necessary but not sufficient. So when we consider the issues being discussed here, one needs to look at the entire value chain of care delivery from the perspective of offering a complete solution to a patient; by the way, this point has been articulated by several distinguished contributors in the discussions here in many different forms. Policy makers / decision makers need to be educated on such a solution-centric approach. Only then can we truly understand what role each element of a solution – diagnostics, treatment, counseling, community outreach, etc. – play and how to allocate resources (when the entire chain is managed centrally, e.g., by the government) or how to align incentives of various players (when different pieces are offered by different agencies; e.g., what may happen in the private sector setting that Dr. Pai was alluding to) so that in the end the patient gets a solution, because that is what he/she ultimately cares about. I do not mean to suggest this is an easy task. But only such a holistic approach can get us closer to the goal.

Attached resources:

A/Prof. Terry HANNAN Replied at 7:59 AM, 25 Sep 2015

thanks for this paper. So are my pressions correct? This article is not questioning the "quality" of the testting and mainly focussing on the issues related to seld-testing and results interpretation? Because Theranos is functioning as a commercail enterprise one can presume it meets "certification standards.

Prashant Yadav Respondent Replied at 8:16 AM, 25 Sep 2015

Regarding the discussion on local manufacturing.

We have had long discussions in the last decade or more to understand does "local" mean each country manufacturing IVDs for its own needs? Or is it a loose term used to say manufacturing in developing countries, wherein a manufacturer in one developing country serves many other countries?
If it is local in the strictest sense, then anyone who has looked at the cost of manufacturing, scale economies, labor costs and distribution costs will tell you that it does not make economic sense to do "local" manufacturing, not even for the simplest RDTs. Regional manufacturing closer to demand centers holds promise for some Dx with low to mid range of manufacturing complexity.

Unfortunately, in most places where I have been involved and asked to join the government planning team, this decision is not made based on public health economics but rather by a calculus driven by a complex political economy. The Ministry of Health is usually a passive listener at the table and has limited influence over sourcing restrictions to promote local manufacturers, preferential access clauses etc. Those decisions are driven mostly by the minister in charge of industrial policy and the larger politics around the promise of job creation and self reliance from local manufacturing.

We need to let Dx manufacturers including simple RDT manufacturers and complex molecular Dx evaluate where to manufacturer and how to serve different markets based on a comparison of distribution costs, cost of manufacturing, scale benefits etc. If barriers such as access to capital, access to technical know-how are preventing them from setting up regional production sites, then public policy should create incentives for greater investment or facilitate technology transfer or if regional manufacturers need help with quality improvement.

I worry about the risks of allowing the decision of "where to manufacture" come directly into the realm of public policy. The complex architecture of global health is very good at accomplishing several things such as helping develop new Dx, disseminating information about new Dx approaches and Dx technologies, creating use guidelines, financing unmet resource needs for Dx, market sizing to help Dx manufacturers understand demand, and creating a global quality assurance mechanism, but deciding where to manufacture Dx should not be its role.

Catharina Boehme Panelist Replied at 8:49 AM, 25 Sep 2015

Regarding the past days' discussion on the advantages of local manufacturing, there are clear advantages to be seen in local manufacture of diagnostics, including cost savings to end users (notably shipping, import taxes, adapted customer support, etc.). South Africa's Medical Research Council has a flagship programme, SHIP, to enhance local capacity for R&D of diagnostics and to develop pathways to facilitate the seamless movement of new products and services from the laboratory to the marketplace. Other countries in the region, such as Ethiopia and Kenya, are now thinking of establishing similar initiatives. We like @Elizabeth Glaser's idea for enhanced regional cooperation to maximize national leverage and increase the success rate.

Our experience in working with small and medium enterprises, is that one important bottleneck remains a lack of technical know-how for some complex diagnostics. Other areas that are often under-estimated by smaller enterprises include the complexity of the regulatory and delivery pathways, and the planning often stops after R&D. FIND tries to address some of these gaps through our Support for Success (S4S) programme, which is aimed at smaller companies in BRICS countries and provides free or low-cost technical support and mentorship as needed to support promising diagnostic technologies for poverty-related diseases. Something we are still looking for is greater commitment from large developers to provide in-kind support for this and similar programmes. Volunteers with technical expertise welcome!

Attached resource:

Nora Engel Panelist Replied at 10:25 AM, 25 Sep 2015

I am wondering about how the question related to the site of manufacturing links to the problems of supply, forecasting, distribution, service provision and maintenance that have been mentioned above? Or are these strictly responsibilities of governments?
And what about the number of competing manufacturers? We found that healthcare providers in South Africa were complaining not only about stock outs of HIV RDTs but more so about continuously changing HIV RDT kits that they were being supplied with. These kits from different manufacturers differed only slightly in steps to perform, amount of buffer or drops of blood required but providers were usually only trained on one kit, and not retrained whenever a new kit arrived (room for errors, all had different ways of doing these tests). In addition, the constant changes confused people who came for testing, wondering why each time they were being tested on something different, creating mistrust into the test kits and care offered at the clinics.

Nora Engel Panelist Replied at 10:32 AM, 25 Sep 2015

And on the value of implementation research around diagnostics:
I just came across this careful study that shows how an intervention was designed to improve use of Malaria RDTs, based on prior ethnographic research on the use of Malarai RDTs and the problem that often negative test results are not adhered to by health workers.

Attached resource:

Lee Schroeder Respondent Replied at 10:39 AM, 25 Sep 2015

Re: theranos, my understanding is that they are operating under a CLIA certificate using 'laboratory developed tests' for the most part. Quality requirements for laboratory developed tests are more or less defined by the laboratory. It's with FDA approval that quality gets evaluated to a standardized level. Since that hasn't happened with nearly all of their tests, the question of quality has not been answered...

Jeannette Guarner Panelist Replied at 11:27 AM, 25 Sep 2015

I think that NoraEngel touched on a point that is important for quality. The fact that governments/ hospital administrators change reagent manufactures frequently poses a lot of problems. This is obviously a problem with frequent verification at the laboratory level.
In addition, people form habits and if there is a change in the process very frequently because the diagnostic test has changed errors will occur. Lab techs may be more attuned to the changes with the change in kit/ reagent. Though I really worry when tests are performed by other healthcare providers (nurses, MDs....) as they may not realize the importance of following the steps as the manufacturer states but follow what they have done in the past (say read the test at 10 minutes instead of 20) and errors will occur.

Elizabeth Glaser Replied at 12:15 PM, 25 Sep 2015

There would certainly be potential for a regional manufacturing scheme within the East African Community, where there are many advances toward macroeconomic convergence, a market for diagnostics, and decent transport corridors. I also think there is also a political will to make something like this happen.

Elizabeth

A/Prof. Terry HANNAN Replied at 1:12 PM, 25 Sep 2015

Elizabeth, on this theme a colleague of mine Professor Fred Hollows made eye surgery and cataract replacement self sustaining in Eritrea and now a world wide project-philanthropic- where communities have become resource producing and self sufficient in this activity. The Fred Hollows Foundation

Ilesh Jani Panelist Replied at 3:45 PM, 25 Sep 2015

How are new diagnostics introduced in your country, and who makes decisions about which diagnostics will be covered by insurance schemes (if applicable)?

In the setting where I work there is no formal process to introduce diagnostics in the national health service. In the last decade there have been good practice stories (e.g. HIV RDTs, CD4 point-of-care) but also some that were not so good (e.g. TB GeneXPert). The lack of a formal process for incorporating new technologies opens the door for pressure from a number of entities (interest groups, donors, manufacturers, etc) and for non-transparent practices - not only about what technology is introduced but also where it is placed. The final say on what technology is incorporated in the national health service rests with the Ministry of Health - but without a formal process.

As I have said a few days a go, and I copy and paste here "resource-poor countries need to start considering the establishment of formal processes for Health Technology Assessment (HTA). This is not a new concept and is a successful endeavor in many countries, where every health technology considered for incorporation in the public health system is subjected to a formal, transparent and comprehensive evaluation. HTA should be done for diagnostics the same way it is done for other health technologies."

Some countries, including Mozambique, have an essential drugs list. This list is produced using a transparent and participatory process. While establishing comprehensive HTA processes is certainly a mid- to long-term goal, I believe that an essential diagnostics list is something that could be done relatively fast and then updated periodically.

Marie Teichman Replied at 4:37 PM, 25 Sep 2015

Hi all,

Here is a summary of today's discussion! Please continue to add your thoughts over the weekend and we look forward to picking back up on Monday morning!

Best,
Marie T.


Panelists and community members continued on the topic of in-country manufacturing during Friday’s discussion.

Taking into account the economic factors involved, local manufacturing for a country’s own purpose is not an economically viable option. However, manufacturing near populations who will be the end-users prompts stronger demand for diagnostics that may be neglected if not relevant to the local context. The idea of regional manufacturing efforts was supported by Panelist Catharina Boeheme in its potential to maximize national leverage and increase the overall success rate (reply #134).

The issues surrounding these diseases are not just medical but also include social, psychological, behavioral, and financial effects. There needs to be greater emphasis on “solution centric” approaches to the current issues involving the value chain. The end goal of the value chain is to deliver a complete solution to the patient in terms of diagnosis and treatment. Policy and decision makers must be educated on this holistic approach while creating better incentives for investment and quality improvement projects.

Participants also reiterated the importance of laboratory testing and evidence based protocol in order to maintain continuity of standardized diagnostics. Constant changing of manufacturers often leads to laboratory workers who are untrained regarding new diagnostic kits, leaving room for error and mistrust of test results.

Kathleen England Replied at 4:00 AM, 26 Sep 2015

@Ravi Anupindi

Your statement - "TB is not just a medical problem; it is a social, medical, psychological, behavioral, and a financial problem." is something we all must remember. Diagnosis is just the beginning of a long path to cure. In order to ensure the best outcome for patients, we need to address the systems after diagnosis. We already know from Xpert implementation that even with optimal availability of diagnostic testing, outcomes have not dramatcially changed due to challenges along the treatment journey. Even if we really are able to get tests more readily available in countries and have a higher quality of testing, we are not resolving the other links in the chain to see the desired impact. Holistic, solution centric, patient centered approaches are needed to reach "EndTB" goals.

Thank you Ravi for the re-focus.

Kathleen England

Alaine Umubyeyi Nyaruhirira Replied at 4:15 AM, 26 Sep 2015

Dear All

I agree with Ilesh on the process of began to implement and develop a
process based on the HTA approach to speed up and organize the health
technology sector. But in Many of our country first of all who oversea
health technology at the MOH many time the focal person or team are not
from LAB side but Pharmacist etc... As say again by Iliesh, we have in
many country the essential drug list for the same reason as the supply
chain management is lead by Pharmacist and oversea lab consumables and
reagent etc..

I think we have to redesign the all process from endorsement of a new
technology to implementation and has say previously we can learn from new
technology roll out challenges and change the way countries are managing
this process and help MOH.



*Alaine Umubyeyi Nyaruhirira, MpH, PHD*
*Senior Laboratory Technical Advisor*
Management Sciences for Health

Aamer Ikram Replied at 5:57 AM, 26 Sep 2015

Thanks Marie for the summary. I have been enthusiastically following the discussions. I would support the idea of regional manufacturing, only that way cost effectiveness can be ensured. Changing of manufacturer considering any single lab item/kit is a matter of grave concern for developing countries due to non-availability or lack continuous supply. Regional manufacturing can overcome this hurdle and that will not only ensure supply but the lab errors can be minimized as the staff remains used to that particular item.

Sarder Hossain Replied at 7:31 AM, 26 Sep 2015

Dear All,
This is really a very important discussion! Yes it is true that the world has improved much in diagnosing TB and DR –TB but this is not enough! If we look at the diagnostic landscape of Bangladesh; especially in implementation of rapid diagnostic tools, several issues have popped up in mind. Under National TB Control Program, the rapid diagnostic tools eg. Xpert MTB/RIF was first introduced in 2012 in Bangladesh, and later it expanded to 38 centers in the country. With the concerted efforts of NTP and Partners, a good demand has been created in the community for detection of TB and DR-TB by using Xpert MTB/RIF. As a result, a significant proportion of DR-TB cases has been diagnosed, and many bacteriologically confirmed TB cases have been diagnosed from the suspected pulmonary smear negative TB cases. However, the interrupted and time consuming maintenance process of Xpert MTB/RIF coupled with other operational issues has become the critical problem for ensuring smooth services. As a result, country is facing tremendous challenges to sustain the demand that has already created. It is true that new diagnostic technology brings benefits for the TB Control program but it should be well designed in terms of contextual and operational factors for any real field settings. In implementation of any new product factors such as user friendliness, low cost and higher benefit, minimum maintenance with local availability, minimum operational challenges, minimum infrastructure, appropriate to use at peripheral centers, high sensitivity and specificity, etc. are highly prioritized issues from any consumer point of view.
Another issue, development of country ownership and sustainability plan that are not we portrayed in many settings. Donors have been playing a vital role for implementing the new TB diagnostic tool, and this is mainly project based approach. However, sustainability plan is lacking; when the project is finished, things get complex to continue the services.
So, a well-planned and coordinated approach is highly needed for advancing the TB diagnostic care.
Kind Regards,
Sarder Tanzir Hossain
TB Laboratory Advisor
Challenge TB, MSH
Bangladesh

Deluc Accilus Replied at 8:32 AM, 26 Sep 2015

Hi to every body,
Iam Dr Accilus Deluc , Family Physician . And Iam working in a rural hospital in Haiti patronized by PiH ( partners in Health)

In Haiti, when talking about TB , people often alluded to a bomb that exploted.This is a major public health problem, no one is a safe .
Many efforts were made, a lot of capital invested during the last decades, but it seems that the problem tends to remain around.
Also the are some who think that we should change strategyand approach the problem in different way, and it could be hoped That Haiti can be free TB has a 50% by 2020!!

Dana Goldman Panelist Replied at 9:14 AM, 26 Sep 2015

Ideally, the manufacturing problem here can be solved as it would be in other markets if incentives were set appropriately. That is, we need not assume that planners need to decide the scale and geography. if reimbursement is appropriate. If we paid for health outcomes in the affected regions, then manufacturers and providers would get together to figure out how to deliver the services most cost-effectively. For example, if we rewarded public health services for lower rates of TB deaths -- for example through social impact bonds -- then the relevant agencies would figure out how to do a better job screening and treating. Social health insurance schemes that fund diagnosis and treatment of infectious diseases -- with payments tied to better outcomes -- could be a solution.

Ali Elbireer Respondent Replied at 8:21 PM, 26 Sep 2015

Indeed Theranos sounds like its proprietary technology is poised to transform the lab testing experience for patients and physician worldwides. It says it can perform hundreds of lab tests, using a single finger stick collection with a micro-specimen and return results in four hours. Nevertheless Theranos the lab testing company based in Palo Alto, California remain of the biggest unknowns in the lab testing industry today... No one know what technology they use or if it can be available for resource limited settings... Yet it sounds like what is need to resolve most digsnostic concerns... Anyone has any additional info about it?

A/Prof. Terry HANNAN Replied at 8:28 PM, 26 Sep 2015

Ali, you have just confirmed the value of the GHDonline site as a location for high level intellectula interactions and peer review at all levels. Thank you for this update.

Erwin Sihite Replied at 12:06 AM, 27 Sep 2015

Just manage to open the website and see lot of ideas like reagent rental,a little disagree as it is a monopoly practice for the rental corporation and we never know when monetery crisis will come.
In my opinion,overuse of diagnostic still better than underuse,i know there's 80% chance that diagnostic can be made by anamesa alone but the barier of language,emotional state for both physician and patient,mixed match symptomps even local believe can reduce this chance greatly.
Yes,we're talkin about patients which are human being so not just a medical problem; it is a social, medical, psychological, behavioral, and a financial problem,so local wisdom still needed,we in indonesia still recruit local people to be trained as 'health worker' (unofficially as it is voluntary) to help in certain way,either as our eyes and ear or as educator or should i say motivator?so people didnt go to paranormal practice.
Regarding regional manufcture,isn't it better to have just 1 central national diagnostic manufacture to mass produce as the cost is lower in that way?for distribution will be regional based,on demand and to reach remote area,we use health worker to bring along the kit everytime they go to town (after all no one is trully in remote area whole time,they must have go to town occasionally)
About incentives,it is hard topic as mostly incentives in health sector depend on politic and i dont wanna go there as those people can only talk and rarely go down to see reality underground,the reason why the incentives are fluctuative sometimes raised but mostly erased.

GABRIEL PAUL Replied at 2:59 AM, 27 Sep 2015

I appreciate the fact of local /regional manufacturing which will increase accessibility of both the diagnostic tools.(machine and reagents).In my country we are facing challenges and lab running costs are high and only few tests are customized and the main reason is if you visit each hospital you will find different machines model doing same thing but with different reagent demand.
My wish is to ensure we have a regional manufacturer who will provide a similarly model which fits the purpose hence ensure availability of machine and reagents at low costs.Private and governments hospitals are all suffering the same thing and all the burden go to a patient and outcome is poor care at higher cost.

Ruth MCNERNEY Replied at 5:45 AM, 27 Sep 2015

Dear all

We have reached the point where there is now a choice of laboratory based tests for TB and policy makers/procurers need to take informed choices between the various tests and technologies - which test, and where and when to use it. Their decisions should be based on sound evidence (clinical, economic, logistical). Evaluations of new tests need to be free from the influence of the test developers whether they are commercial organizations or not for profit. For diagnostic tests (IVD) the product development pipeline is long, once a product is ready for selling its clinical performance (sensitivity/specificity) must be assessed in studies at sites typical of intended use (i.e. POC tests should not be evaluated in a reference lab). Once the performance and safety of the test have been determined, and it has been approved for use, clinical trials can be undertaken to assess its impact on patient outcomes, and on the health system. It is only then that cost effectiveness can be assessed.

I attach two documents, one discussing regulation of diagnostic tests, with particular reference to Africa and one discussing the challenges of developing a new test and taking it to market (i.e. making it accessible to patients).

best wishes
Ruth

Attached resources:

Anthony Emeribe Panelist Replied at 7:50 AM, 28 Sep 2015

How are guidelines for use disseminated? What challenges have you seen in adapting global guidelines to your setting, and what strategies have you found for training providers on these guidelines?
• The guidelines for use are disseminated by the relevant Government Agencies that adopt and disseminate the global guidelines in conjunction with the public health department of the Fed Ministry of Health.
• The challenges seen in adopting global guidelines to local settings sometimes is that some provisions may not fit well in the locality hence the need to nationalize/adapt these guidelines within context and conduct training to build requisite capacity to effectively implement the guidelines. Critical issues include affordability, accessibility, technology, etc.

What strategies have you found for training providers on these guidelines?
Advocacy, phased approach starting form National TOT to Regional TOT to State TOT and Local Government Area
• Providers have been advised to use the Med Lab Professionals – Med Lab Scientists, Technicians and Assistants that abound for all forms of diagnostics when it comes to laboratory testing, as these set of practitioners have been trained and all currently empowered by law to conduct testing at all levels of care.

Ameh James Replied at 9:08 AM, 28 Sep 2015

Sir, thanks for sharing this information.
If we specifically consider laboratory testing guidelines in Nigeria, is there any 'universal' guidelines in Nigeria that have been adopted by public or private labs? Who is responsible for monitoring the implementation of these guidelines? Is MLSCN reponsible for certification of assays in Nigeria? What do you think are the impediments or barriers for adopting an assay or test in Nigeria? It seems assays for testing human samples for the purpose of diagnosis are not properly regulated in most low and middle income countries, is that the case with Nigeria as well?? Dont you think, improper regulations could cause misdiagnosis or wrong diagnosis, thereby putting the patients at risk of wrong care and treatment??
Best Regards,
James

Ali Elbireer Respondent Replied at 9:21 AM, 28 Sep 2015

The main challenge I have seen in adapting best laboratory practice guidelines in RLS;
The main challenge is lack of enforcement system and accountability framework in both public and private practices. I have been working with a Collage of American pathology (CAP) Accredited laboratory in Uganda for over a decade, with near perfect audit outcomes & excellent EQA scores with all Ugandan trained lab staff members. Reality is that the training our Lab Technology students get in Uganda, as well as many other SSA countries, is almost identical to any western training for Med Laboratory, what affect our colleagues in Africa is the practical experience they received following graduation. Working without an enforcement system and accountability framework in any industry will lead to disastrous consequences.
Thus before starting any training or process improvements project its critical to create an enforcement system and accountability framework that will help support & sustain adapting all or even gradual/implementation of best laboratory practice guidelines.

Ameh James Replied at 9:42 AM, 28 Sep 2015

Dear Ruth,
I do agree with you, but most of these test developers are from developed countries, either in academia or industry. Most times the developers do not partner or consider the conditions prevalent at the countries where they are shipped to (usually low and middle income countries). So, you see a scenario where developers (probably out of commercial interest) develop a test for developing countries they dont know 'anything' about. Think its of recent I am beginning to witness some commercial companies attempting to evaluate the prototype of their test in labs in developing countries.
I remembered, contacting a diagnostic company to evaluate their diagnostic kit a GCLP accredited lab in Africa, but the response I got was, 'we will send our samples for the evaluation process'. Isnt that a shame??? They want to sell their products in a land where they dont want it evaluated.
Best Regards,
James

Madhukar Pai Panelist Replied at 9:45 AM, 28 Sep 2015

As reviewed in the attached paper, the availability of new tools does not mean that they will be adopted, used correctly, scaled up or have public health impact. Experience to date with new diagnostics suggests that many national tuberculosis programmes (NTPs) in high-burden countries are reluctant to adopt and scale up new tools (e.g. GeneXpert), even when these are backed by evidence and global policy recommendations.

There are several common barriers to effective national adoption and scale-up of new technologies: global policy recommendations that do not provide sufficient information for scale-up, complex decision-making processes and weak political commitment at the country level, limited engagement of and support to NTP managers, high cost of tools and poor fit with user needs, unregulated markets and inadequate business models, limited capacity for laboratory strengthening and implementation research, and insufficient advocacy and donor support. Overcoming these barriers will require enhanced country-level advocacy, resources, technical assistance and political commitment.

Attached resource:

Jeannette Guarner Panelist Replied at 10:31 AM, 28 Sep 2015

As Ali Elbireer points out, the fact is that students (medical students or laboratory technologists) are tought using the same books in the US, Africa, Latin America.... So basic knowledge of the different processes is there. The problem is when they start working as they do what they can with what they have in the location they are working. They learn "bad habits (not following guidelines)" if they are in an environment that fosters "bad habits".
Thus, the problem is access to the policies, procedures, reagents, instrumentation, accountability, etc.

SUMIT MITRA Replied at 10:57 AM, 28 Sep 2015

Hi Ruth - could not agree with you more on the fact that it is high time
that deployment of adequate technologies backed by evidences is a must. Do
check out our website "www.molbiodiagnostics.com". Our platform , a Near
Patient Platform, based on the ASSURED criteria is slowly aiming to at
least ensure that technology reaches , where it must (the hinterlands) to
make a success (even a partial one at that) in the global effort to
minimize the burden of Tuberculosis.

SUMIT MITRA Replied at 11:08 AM, 28 Sep 2015

Just Following up Ruth - Molbio has been selected as the first S4S partner
by FIND & CHAI and the studies / evaluations under this partnership are
currently ongoing in South Africa / Brazil & Uganda.

Anyone interested for more information on our platform may please feel free
to let me know.

SUMIT MITRA Replied at 12:09 PM, 28 Sep 2015

Hi Dr. Pai!

Indeed - getting a new platform in place takes time , from Research to
Commercial Production. But post commercialization, the acceptance of the
product by the market is in itself a lot of work.

In India the private sector has shown willingness to use our platform as
evidenced by our growing list of users( quite a few also have the Xpert) -
However the purpose would be greatly served if the National Program-me
adopts the technology & takes it where it matters. Heres' hoping that it
will happen, sooner than later.

Regards
Sumit.

Luis Azpurua Replied at 12:53 PM, 28 Sep 2015

Jeanette (159)

In Venezuela We see this "bad habits", frequently in small - medium size labs. One of the causes is, again, language barrier. Most of the guidelines / instruction's manuals are in English and there is a scant or no translation at all. (Spanish).

Another cause is poor training / post sale services. Regarding new technologies, sometimes the trainer is a person that have not used the equipment / technology. He / she has taken a theoretical course and both the user and the trainer are facing the equipment for the first time. Sometimes, because of the lack of information, the thecs are using the experience of working with the former technology to use the new one. They start what I call Trial and error cycles until they understand how it works.

Zacarias Mateus Replied at 2:47 PM, 28 Sep 2015

Dear All

In my country ( Mozambique) we use guidelines from the authorities to diagnose HIV, TB and Malaria. We don’t care much more about HPV probably because this not a big public health problem for us.
In the setting of TB now a days we have Gene X pert and Culture for diagnosis, but the really problem is that they are only available in good Laboratories which are few in my country.
For culture it is very difficult to do it because of lack of material and experts, so we only do it when there are suspicion of MDR_TB or XDR-TB.
For HIV test, the government supply all public institutions of health two rapid diagnostic tests ( Determine and UNIGOLD). We only do PCR for HIV in children ≤ 9months born from a HIV+ mothers.
We normally don’t quantify the viral load because we don’t have equipment to do in many of our laboratories.
For Malaria it is easy for us, probably because it’s the leading cause of death in Mozambique. Almost around the country we have the microscopy and rapid diagnostic tests. But there are still places with no capacity to do any of these diagnostics tests.
We normally do those tests according to guides of WHO or CDC. No researches are performed and the Ministry of Health is responsibly for introduce and distribute these diagnostic tests. Some NGO can do it but via ministry of health.
For me one of the solutions for this is to produce locally these diagnostics test, e.g the rapid diagnosis test for HIV and Malaria. We also have to update all health workers about this diagnostic tests and equipping the laboratories.

Best Regards
Zacarias Mateus

A/Prof. Terry HANNAN Replied at 7:11 PM, 28 Sep 2015

Zacarias, while reading your last post here the thought came to me about "Order Sets" to improve Clinical Workflow and attempts to reduce inappropriate variation in care. It is a topic I am looking at here in Santiago, Chile while I am on sabbatical. In my background research I discovered this link to Clinical Workflow 'protocols/guides' from the Children's Hospital of Philadelphia (CHOP acronym!).
The workflow guides are available free from this site and one of the physicians at CHOP has been very helpful in showing how to access and use these pre-defined schemas.
They are not perfect but to me they are a significant step in the right direction. I do not know how much or if these workflow designs lead to direct data capture however I feel they can stimulate innovation in this field.
http://www.chop.edu/pathways

Rebecca Weintraub, MD Replied at 9:27 PM, 28 Sep 2015

We are excited to begin our second week of discussion, thank you all for your contributions to this rich conversation.
In addition today’s summary (below),
I’m pleased to share an important NEJM perspective piece that details the growing economic and health costs of diagnostic errors:
http://www.nejm.org/doi/full/10.1056/NEJMp1508044

____________________________________
Week 2 of the Advancing Care Delivery: Driving Demand and Supply of Diagnostics Expert Panel began with continued discussion on issues regarding global and national guidelines for diagnostic use and strategies for training providers.

The idea of regional manufacturing has been supported by many participants over the past week. This model could minimize the chance for error due to issues of lacking supplies and variation of diagnostic kits. Manufacturers must be conscious of local contexts and operational factors while designing new technologies, taking into account the consumer’s viewpoint (i.e. language barriers, minimum infrastructure/maintenance with local availability, user friendliness in the field).

Panelist Dana Goldman offered a solution with support from national health ministries and policy makers regarding manufacturing issues:

“If we paid for health outcomes in the affected regions, then manufacturers and providers would get together to figure out how to deliver the services most cost-effectively. For example, if we rewarded public health services for lower rates of TB deaths -- for example through social impact bonds -- then the relevant agencies would figure out how to do a better job screening and treating. Social health insurance schemes that fund diagnosis and treatment of infectious diseases -- with payments tied to better outcomes -- could be a solution.”

Funders and procurement organizations play a vital role in the implementation of new diagnostics. However, their work takes a mostly project-based approach, leaving countries with minimal sustainability plans after the project ends. Funders must make informed choices based on clinical, economical, and logistical evidence so as to ensure the cost effectiveness of their diagnostic selections.

Both the private and public sectors often lack accountability frameworks for proper enforcement, creating cycles of poor habits. While professionals in low and high-resource settings often receive some training on the value and how to integrate diagnostics into care, professionals in low-resource settings may encounter limited support for adhering to guidelines once they are in the field. It is critical for proper best practices to be disseminated and adapted to the local context by relevant agencies in conjunction with local ministries. In order to support this, providers must be properly trained and empowered by the government to conduct testing at all levels of care.

Masoud Dara, MD Replied at 2:43 AM, 29 Sep 2015

Dear colleagues,

I would like to add to the excellent comments by Dr Pai that often with introduction of new diagnostics, they remain too long on a "pilot phase". In many settings they are used in parallel to the previous tools. The diagnostic algorithm shall be update based on the yield, disease burden, country context and foreseen resources (human and financial).

The WHO Regional Office for Europe is hosting a platform for key experts on TB laboratory (European TB Laboratory Initiative/ELI) which has been working on new diagnostic algorithm. The ELI members may wish to add.

Ali Elbireer Respondent Replied at 3:36 AM, 29 Sep 2015

Dear Marie & Rebecca... thanks for the summaries and the reminders to keep us informed and connected.

Dear Colleagues,
When we discuss the concept of capacity building, as the primary objective of many laboratory development programs, we do need to avoid the common misconception that capacity building is synonymous with “training”, as the success of a capacity-building program typically measured by the number of people trained in any specific process/method and the training of trainer’s programs.
Based on my experience in developing world class laboratories in RLS, I realized that various interdependent levels of capacity must be strengthened for us to get sustainable results. At the start of any lab development program, we must critically review the laboratory systems “organizational capacity” for improvement, including well-defined laboratory processes and clear roles documented within those structures, to enable laboratory staff to implement what they learn efficiently, with ownership & accountability.

Anthony Emeribe Panelist Replied at 5:27 AM, 29 Sep 2015

What policies regulate or impact the use of
diagnostics in your setting?
Nationally, the policy that regulates in-vitro diagnostics importation, production, stocking and use in Nigeria is covered by Cap M24, LFN 2004
(MLSCN Act No 11 of 2003). However, international guidelines such as that of WHO also play a critical role in programmatic use of diagnostics in Nigeria

Tsehaynesh Messele Giday Panelist Replied at 5:27 AM, 29 Sep 2015

In Ethiopia guidelines are reviewed , adopted and distributed for local use by the National Institute (EPHI) which is also responsible for evaluation of tests and development of testing algorithm. As indicated above ensuring the appropriate use of the guidelines is important and there is a gap of regulation especially for the private sector laboratories. When we talk of strengthening diagnostic services, there needs to be a holistic approach including training and certification of professionals, regulation capacity for diagnostics and testing as well as quality improvement of the laboratories.

Cost and sustainability can be major issues for decision makers when introducing new technologies. I agree with the comment that funders and procurement agencies need to engage the local relevant body when choosing a test to ensure continuity.

SUMIT MITRA Replied at 5:58 AM, 29 Sep 2015

In India the Governmental set ups )hospitals & their laboratories) would be
guided by the RNTCP endorsement, while no such endorsement is required for
private sector laboratories.

Rosalyn Toe-Massaquoi Replied at 5:59 AM, 29 Sep 2015

Hi,
In Liberia, we received or buy lots of diagnostic equipment but can't afford to buy the reagents needed for continuous utilization.
Hence, some hospitals can only do the basic and others who can afford the reagents can do a lot. It is a real problem. Some doctors
from the PURE Non-Governmental organization from the USA came to Liberia to augment the scales of the Post Graduate Medical
Program Residents in Ultrasonography, taught us how to make the ultrasound gel using powder and water. This is a big step forward.
Now we done have to worry about how are we going to get gel for ultrasound. So if some of the manufacturers will like to come to
Africa - West Africa, that will be a good idea. Many more constraints when it comes to diagnostics.

Anthony Emeribe Panelist Replied at 6:04 AM, 29 Sep 2015

Dear Ameh James,
Thank you for your mail. As you know, there is nothing like a Universal guideline. Yes there are guidelines developed for all laboratories in Nigeria. As part of its regulatory function, MLSCN as an arm of the Federal Ministry of Health monitors their implementation (www.mlscn.gov.ng). MLSCN has mandate to regulate only laboratory diagnostics, and part of the process adopted include certification of products. I agree with you that most low and middle income countries do not have optimal regulatory framework for laboratory assays, but the degree varies from Country to Country, with Nigeria being among the first runners in regulation alongside countries like Tanzania and South Africa. It is obvious that improper regulation contributes significantly to wrong diagnosis thereby underscoring the urgent need for strengthening regulatory systems for IVDs. The Federal Ministry of Health with support of implementing partners has guidelines for diagnosis and treatment of HIV/AIDS, Malaria, TB etc. in Nigeria. The impediments or barriers to adopting assays or tests in Nigeria are being addressed. Firstly, the ambiguous regulations establishing the various agencies, conflict of interest, inadequate inter-agency collaboration, inter-professional wrangling, funding and inadequate coordination/control on activities of implementing partners – NGOs, etc.

I cannot agree less with you that assays for testing human samples for the purpose of diagnosis are not properly regulated in most low and middle income countries except those of controlled programs funded by grants and foreign aid and as said, this could cause misdiagnosis thereby putting the patients at risk of wrong care and treatment.

Regards,
PrE

Thomas Shinnick, Ph.D. Respondent Replied at 6:21 AM, 29 Sep 2015

Dear Colleagues,

As mentioned by Dr. Elbireer, capacity building is not just training laboratorians. When implementing a new test, we must take into account the entire diagnostic cascade and ensure that all health care workers in the cascade understand the best uses of the laboratory tests, how to request the test, collect samples, transport to the laboratory, and interpret results. Uptake and impact of a new test suffers if one does not address all steps.
Global guidance documents often address only the laboratory technical details and intended use in general terms. At the country level, these often have to be translated into policies and strategies to have to be translated into concrete action plans. What have been country experiences in translating policies into practice and engaging clinicians, nurses, laboratorians, and program officials during the implementation of a new technology?

Gemeda Abebe Replied at 7:48 AM, 29 Sep 2015

Dear All,
It is such an interesting topic to be discussed as there has been lots of challenges and forthcoming opportunities as far as IVDs are concerned. One thing that is not often clear is that: are IVDs pharmaceuticals? As to me they are not. Pharmaceuticals are the ones that we use for in-vivo purpose weather it is diagnostic or therapeutic. Unless we understand the difference between the two it may have effect on supply chain management and regulatory affairs. In Ethiopia, health related regulatory issues are being addressed by FMHACA (Food, Medicine and Health Care Administration), in fact not by EPHI. Bu there are no clear understanding of IVDs and there is gap in its regulation. Drugs are regulated but that of IVDs is none. What is the experience in other countries?

Madhukar Pai Panelist Replied at 11:22 AM, 29 Sep 2015

Regulatory agencies in LMICs are often underfunded and under-staffed, and lack expertise in IVDs. So, not surprisingly, regulation of diagnostics is very weak in many low and middle income countries. This means that suboptimal tests can be very easily manufactured, distributed and sold. A good case in point was the widespread availability and use of serological, antibody-based tests in India, until the WHO negative recommendation in 2011, and subsequent ban by the Indian government in 2012. Serological tests have also been banned in Cambodia, but they continue to be available in other LMICs (e.g. China). The market is also flooded with all sorts of rapid tests of unknown quality (e.g. if you walked around private labs in India, you will see all of them doing rapid dengue tests, and nobody has any data on their quality!).

In India, IVDs related to blood safety are deemed 'critical' and therefore much better regulated than others. So, HIV tests are better regulated and expected standards are clearly laid out and enforced. Unfortunately, TB is not considered a 'critical' disease, and TB diagnostics are not well regulated. This must change, and the Indian regulatory agency must harness the capacity of large national TB research institutes and NRLs to conduct product validation, before regulatory approval.

Himanshu Vashistha Replied at 12:18 PM, 29 Sep 2015

My concern is very much same as Dr. Pai stated.
In many under facilitated and resource limited settings, these low quality
local made ivd test are flourishing and even after govt. Ban they are still
being used.

Timothy Amukele Respondent Replied at 1:27 PM, 29 Sep 2015

The international standards for IVD regulation and Laboratory quality broadly fall under the ISO umbrella (I'm excluding USA standards here). This conversation illustrates the need for such international standards. While it is necessary for each country to have their own standards and goals that are locally appropriate, it is best if all these are connected to some international standard to allow for transperancy and commutability. Setting up standards that are not connected in some way to international standards ignores the hard-won lessons of countries that have adopted these standards.

To illustrate what I mean by hard-won lessons:- The IVD standards in the US were created after several waves of scandals where people lost their lives, suffered terribly, etc due to poor quality diagnostics. We can avoid many years of additional pain and suffering by looking closely at these standards and adopting best practices from them.

Dana Goldman Panelist Replied at 3:20 PM, 29 Sep 2015

There are ways to encourage the private sector to raise quality. For example, Bennett and Yin conducted a very informative field study in Hyderabad, India. They examined what happened to the rates of counterfeit drugs after entry by chain pharmacies. Quality was higher among established brands than among so-called local brands, which failed 22% of the time. Chain stores sold the higher-quality medications. Poor customers benefited as much as the rich. This suggests that entry of larger firms into the diagnostic market -- combined with efforts to brand them -- could be helpful in raising standards.

Ilesh Jani Panelist Replied at 4:56 PM, 29 Sep 2015

What policies regulate or impact the use of diagnostics in your setting?

As pointed by many of us in the last few days, regulation of diagnostics is generally poor in low-income countries. Many countries have relatively good systems for drugs, vaccines and biologicals and this constitutes an opportunity for diagnostics - a concerted action from global, regional and national actors could potentially have an impact on this.

The use of diagnostics in the setting where I work is significantly impacted by disease-specific clinical guidelines. But national guidelines are not available for the majority of conditions, yet another weakness of our health system. In recent years, as our national reference laboratories become stronger, evaluations performed at national level also start impacting - positively and negatively - the use of certain diagnostics. However, and as already discussed previously, there are no clear policies on the need to conduct evaluations.

Lastly, he use and choice of diagnostics is also impacted by "pre-qualification" and "endorsement" from institutions such as WHO or US-CDC.

Jeannette Guarner Panelist Replied at 5:08 PM, 29 Sep 2015

For developing tests or using the tests there needs to be a minimum standard of quality, pefereably international. If we do not have minimum quality standards there will be errors in diagnoses. Errors in diagnoses will decrease if quality stantards are followed.

Farouk Umaru Replied at 5:13 PM, 29 Sep 2015

Colleagues,

I have been following this great discussion among the great fraternity of laboratory professionals. I want to add my cent:

Development of diagnostic products and technology goes through series of value added chains of activities, processes, and personnel that are critical to the overall usage and benefit of the products. This value added chain is commonly refereed to supply chain. As a result, for a product or technology to realize it value and benefit, at any level of the spectrum, supply chain innovation is needed. We are witnessing the success of the Coca Cola Company because of strong innovation in supply chain activities (I am not affiliated to Coca Cola). The question is, what are we learning from this success to leverage our health systems in developing countries? We talk about weak infrastructure in our countries that are hindrance to the delivery of essential technologies/products to most-in-need in our communities, and yet, that same infrastructure are used by others to deliver alternative products.

As we raised the issue of advancing diagnosis in resource-limited setting, we need to critically give consideration to the entire value chain within which the delivery of products and technologies are inter-related. Thus, the following components of the value chain need our urgent considerations:
1. Clear definition and categorization of products along their value line of usage in order to ensure regulatory compliance. For instance, we have strong or near strong pharmaceutical regulations in most developing countries, yet we have weak or non-existence diagnostics regulations. Other than Nigeria that recently developed regulatory standards for IVD technology/products, little is known in other countries (this was discussed in earlier post).

2. Clear definition of roles and responsibilities. In most developing countries, we often get entangled in inter-agency or inter-department or even inter-professional wrangling that we forget about the real issues on the ground. Forgetting that, as we poke ourselves in the eyes, it blinds us of what is around us! As a result, we continue to point figures on others (such as donors) for our failures, not realizing that we are responsible for our own destiny.

3. Leadership. I am not referring to the head of government here, but the head of laboratory in the rural area, the head of laboratory at the district and the head of laboratory at regional or national level. How many times have we taken up the leadership role of ensuring that laboratory issues are address at the clinic, hospital or regional level? Most often, we rely on "partners" or stakeholders to assume leadership of our program while we seat back and enjoy sunshine! It is time laboratory personnel assume responsibility and leadership of their program at every level of tiered network.

With the current global leadership in laboratory and diagnostic services demonstrated through the Diagnostics Access Initiative (DAI), the African Society of Laboratory Medicine (ASLM), it is time for the entire rank-and-file of laboratory personnel to assume responsibility of delivering quality diagnostics to all in need. When this is done, we are sure to deliver care by driving the demand and ensuring the the supply of quality of diagnosis in developing countries.

Farouk UMARU, PhD, MBA (Supply Chain Epidemiologist)

Peter Cegielski Respondent Replied at 5:20 PM, 29 Sep 2015

Thank you to all of the participants for a very informative and interesting discussion. Let me add another dimension to this topic. There are at least 2 very different types of regulations affecting diagnostic products and diagnostic tests.

First, there are regulations that affect commercially available diagnostic products per se, including the manufacturer and manufacturing process (if it's in the country), registration in a country, licensing and importation, etc. In some countries with federal systems, where provinces or states have some degree of self-determination, these regulations can affect mainly commerce in or movement of these companies and their products across national borders and provincial or state borders.

Second, there are different regulations covering laboratories and laboratory practices. In many countries, laboratories have to be accredited or otherwise approved by the government in order to provide clinical diagnostic services and test results to medical providers or patients. In some countries, this is controlled by policies covering reimbursement for laboratory testing. Laboratories use products and provide diagnostic services and "in-house" diagnostic tests that are not necessarily regulated directly as commercial products. For example, blood smears for malaria or red cell morphology, sputum smears for acid-fast bacilli, examination of body fluids and tissues in pathology or microbiology laboratories, hematocrit, and many other examples that use common reagents are in-house diagnostic procedures. They may use regulated commercial reagents, but are not necessarily regulated in-vitro diagnostic tests.

Some of the comments in today's discussion are concerned mainly with regulation of specific commercially available diagnostic products and devices. Other comments relate more to regulations covering laboratories and laboratory practices. I would be interested to hear participants' perspectives on these 2 distinct regulatory frameworks and how they affect diagnosis and treatment of the diseases we are discussing.

Thank you.

Doris McNeill Replied at 7:38 PM, 29 Sep 2015

Very interesting discussion on the need for international, national, and local regulations regarding the technology concerning diagnostics. This discussion echoes so many other issues with regard to our global health systems, regardless of the income of the region. The disparities are probably most significant in this issue given the barriers that must be overcome in order to provide quality diagnostics in the most remote or poorest regions of the globe.

While I do not share the extensive expertise of this panel, I am aware of the many obstacles of care in regions that do not have access to the best of medical technology (in personnel or infrastructure). So, I did do a bit of searching and found that WHO is trying to address this issue in the recent publication of POST-MARKET SURVEILLANCE OF IN VITRO DIAGNOSTICS 2015 (http://www.who.int/diagnostics_laboratory/150819_pms_guidance_final_version.p...) .

While it does not answer all of your questions or suggestions, it is a pretty good starting point to try to get all stakeholders involved in the process of making this issue something that should concern everyone involved from the inception of a technology (manufacturer) to the delivery (medical personnel) to the reception (patient). If you do not have everyone involved in the surveillance while product is in use, then you cannot know if it works or not, or if there are any problems. It matters not what the product is.

This is a great community to get the word out on many of these health issues. I would be interested to know if any of you participating in this discussion have taken your suggestions to another level. The best suggestions and actions should be coming from the medical community itself. You have the know-how on what is out there and what needs to be out there to make things work effectively and efficiently across many regions of the world. Too often we see that many decisions on health care are being made by it Big Pharma, Major Hospitals, or Insurance Companies. While change is coming, there are many things that may not change until money is not the driving force behind health.

SUMIT MITRA Replied at 8:51 PM, 29 Sep 2015

why not engage the services of bodies like IMA or their affiliates in
tackling such local issues?

Anthony Emeribe Panelist Replied at 6:04 AM, 30 Sep 2015

Q. What lessons would you offer regarding production, supply, quality, service and support, or other post-launch needs for diagnostics?
The lessons are as follows:
- Secure access to the most valuable data by collaborating with payers, providers, academics, and third parties
- Develop unique insights by combining advanced analytics with creativity and investing in visualization technologies
- Create a launch “situation room” that enables launch plans to be rapidly adjusted
- Monitoring feedback and ensuring rapid decision making
- Enabling rapid course correction
- Dynamic short-term adjustments
- Long-term course-correction measures


- Policy endorsement with speed (2 years after design lock / trial start with strong built-in controls)
- Clear procurement system with long time for repair / replacement
- Strong trial data informed rapid policy (w/some impact data)
- Connectivity to lab management information systems

Jean-Francois de Lavison Replied at 6:20 AM, 30 Sep 2015

Please have a look on the initiative launched by WHO on global Consultation on Diagnostics Interoperability Standards, last 11-12 June in Geneva (http://apps.who.int/iris/handle/10665/181059)
As a first step toward the development of multipurpose point-of-care diagnostic platform, a global consultation on diagnostics interoperability standards took place in Geneva in
June 2015, building on earlier work from a number of other stakeholder organizations. The consultation also included a discussion on new business models and financial incentives
for the diagnostic industry to develop and introduce open diagnostic platforms in lowerand middle-income countries based on such standards.

Jane Carter Panelist Replied at 9:28 AM, 30 Sep 2015

One practical way to conduct ongoing post-market surveillance is through External Quality Assessment (EQA) where participants indicate the test kits or RDTs they are using. These EQA schemes are intended to detect mainly poor participant performance but if timely analysis is done one can pick up poor test kit or RDT performance as well. We experienced this when a large number of participants in one country reported wrong results, and one of the RDT batches was found to be faulty. EQA if properly analysed and if timely action is taken can complement regulation and lot testing as an effective ongoing monitoring tool.

Marie Teichman Replied at 10:06 AM, 30 Sep 2015

Hi all,

Here is a summary from yesterday's earlier discussion.

Marie T.
_________
Tuesday’s discussion centered around policies that impact the use of diagnostics around the world.

Global guidelines set by international bodies, such as the WHO, often only address laboratory processes and procedures in general terms. These guidelines should be translated into concrete action plans by national regulatory bodies that take local contexts into account. Health Ministries in resource-limited regions often lack funding for regulatory agencies. This creates a shortage of expertise on IVDs and weak regulations, which lead to the use of poor quality diagnostics. Featured Respondent Timothy Amukele pointed out the need for international standards to provide a framework for transparency and commutability.

With regards to laboratories, Featured Respondents and Ali Elbireer (reply#168) and Thomas Shinnick (reply#174) detailed how capacity building cannot be done by only training laboratorians, but requires all health workers using diagnostics to understand the entire process (i.e. best uses of tests, how to request tests/collect samples, transportation processes to labs, how to interpret results).

Panelist Tsehaynesh Messele (reply#170) also outlined her experience with the regulation of diagnostics:

“In Ethiopia guidelines are reviewed, adopted and distributed for local use by the National Institute (EPHI) which is also responsible for evaluation of tests and development of testing algorithm. As indicated above ensuring the appropriate use of the guidelines is important and there is a gap of regulation especially for the private sector laboratories. When we talk of strengthening diagnostic services, there needs to be a holistic approach including training and certification of professionals, regulation capacity for diagnostics and testing as well as quality improvement of the laboratories.”

Nora Engel Panelist Replied at 10:12 AM, 30 Sep 2015

Dear Sumit Mitra,

Experiences with public-private mix initiatives for TB control in India (e.g. attempts to include the private providers to refer patients to the national TB programme or follow standardized treatment regimens) showed that when engaging bodies like the Indian Medical Association (IMA) they fail to reach practitioners in poor/informal settings/slums as they only address their own members (in this case allopathic doctors, largely practicing in wealthier areas); and they would not be in a position to regulate their members either but focus on sensitizing workshops where they inform practitioners about these initiatives.
This did not work with PPM and I suspect it would also not work with regulating use of diagnostics. Especially, since there are market incentives for using certain diagnostics over others or refrain from testing and treating symptomatically to avoid losing patients and thus income.

best
Nora

Jeannette Guarner Panelist Replied at 2:49 PM, 30 Sep 2015

As Jane Carter points out, external quality control (EQA) or proficiency testing (however you want to call external controls that compare your lab results to others) is very (super) important. Though we need to realize that patient results may have been released while you are waiting for your EQA result. So internal quality controls are also very important.
By January 2016, all US laboratories will have to comply with IQCP (individualized quality control plan). Rapid tests are some of the ones affected by the new regulation as two levels of external controls are not performed every day we test a patient. I think that IQCP will make all laboratorians aware of quality issues that can occur from batch to batch of tests.

Monique Germain Replied at 4:44 PM, 30 Sep 2015

Setting up international standards is a very important step but as the panelists discussed, the process of handling, managing lab materials and lab specimen is as important. Very often, labs are managed by private agencies in LCD countries within an already weak health system. That in itself, is a deterrent in establishing international standards. For example, some labs in LCD countries near the US ship their specimen to be analyzed by US labs due to the lack of infrastructure, i.e. electricity to preserve collected specimen. How would the international standards be useful if the infrastructure does not provide a way to implement them? Who becomes affected?
Monique

Erwin Sihite Replied at 9:40 PM, 30 Sep 2015

We cant turn a blind eye for reality that health sector already became a huge industry and private sector will never allowed their income reduced because they know that they have what people no,i should say countries needed to provide health for their subjects.
Involving private sector except NGO is not an option as they are there merely by profitable prospect unless every citizen already covered by insurance like in usa.
Quality control,internal and external is a must,cant deny it but then again who's in control if not goverment?
And again about cost,we need to treat diagnostic kit and reagent just like drugs,where there's generic brand that's a lot cheaper but with the same quality,a price without brand or patent included. it wouldnt matter whether it's new product or not,as long they are cost effective and efficient with proof (data based analysis),they will be easily accepted.
I was joking once that we should stop people from economic background as ruler and put people that belong to health sector in that seat so policies and regulation didnt choke health sector anymore like high taxes as health is considered as luxury item,imagine that branded bags and shoes like gucci or whatever their name that we consider luxury items isnt considered as one and become tax free.

Lee Schroeder Respondent Replied at 9:53 PM, 30 Sep 2015

I love the idea of using EQA for post-market surveillance of diagnostics, as Jane Carter pointed out. It’s an activity that should be performed everywhere to monitor laboratory practices anyway, with a big ancillary benefit that it can be used in active post-market surveillance. But as Jane also points out, it’s not something that will necessarily come for free.

In the U.S., post-market surveillance of diagnostics is comprised primarily of adverse event passive reporting into a national database. EQA does serve as a form of post-market surveillance, but only if the proficiency testing provider bothers to dig deeply into the data to find patterns (like Jane’s group did). I more or less doubt this happens in any comprehensive manner for most providers because it can take a lot of effort. The College of American Pathologists does put quite a bit of effort and $$ towards this and it pays off occasionally. But there is by no means some centralized analysis of EQA data to monitor diagnostic performance nationally.

There is already quite a bit of EQA in sub-Saharan Africa, but is it being analyzed in a systematic way? While EQA could potentially serve as a substantial component of active post market surveillance, this would be best achieved by weaving into its fabric the collection and analysis of pooled data (likely from many, many providers from multiple countries).

-Lee

Rebecca Weintraub, MD Replied at 7:17 AM, 1 Oct 2015

Thank you for your thoughtful contributions to this global conversation.
Wednesday’s discussion surrounded production supply, quality, service and support, or other post-launch needs for diagnostics.

Participants discussed the need for international bodies, such as the WHO, to apply and enforce minimum standards of quality. This is especially necessary in regions where lack of access to medical technology is an issue, and is a critical starting point for engaging stakeholders.

Panelist Jane Carter outlined her suggestion for improving diagnostic quality (reply #188):

“One practical way to conduct ongoing post-market surveillance is through External Quality Assessment (EQA) where participants indicate the test kits or RDTs they are using. These EQA schemes are intended to detect mainly poor participant performance but if timely analysis is done one can pick up poor test kit or RDT performance as well. We experienced this when a large number of participants in one country reported wrong results, and one of the RDT batches was found to be faulty. EQA if properly analysed and if timely action is taken can complement regulation and lot testing as an effective ongoing monitoring tool.”

Strong leadership from lab management is necessary from all levels of governance (i.e. rural, district, regional, national, international). A concentrated effort will improve regulation issues and innovate the supply chain. In many LMICs plagued by weak health systems, labs are managed by private agencies that deter the implementation of international standards. Laboratories cannot simply rely on stakeholders, as all lab personnel must assume responsibility for delivery of quality diagnostics. There must be clear definition and categorization of products to ensure regulatory compliance and overall success in the use of diagnostics. Proficiency testing in conjunction with quality regulation could serve as an effective monitoring tool for diagnostic quality.

Madhukar Pai Panelist Replied at 4:09 PM, 1 Oct 2015

For infections such as TB, HIV and malaria, ideally, the delivery system will be a point-of-care testing (POCT) program, where the goal is to test and make treatment decisions in the same clinical encounter (or at least by the end of the day, if patients are asked to wait for test results). This requires much more than just RDTs - it requires all parts of the healthcare value chain to contribute.

Please see the attached article entitled "Point-of-care diagnostic testing in global health: what is the point?", where we proposed that:

• In the realm of global health diagnostics, the dominant definition of point-of-care (POC) testing is product-oriented (e.g. instrument-free dipstick), and focuses on characteristics such as simplicity, low cost, and ability to perform outside a laboratory.
• We have argued for a goal-oriented definition of POC testing. We proposed that rapid initiation of correct treatment is the most critical goal of any POC testing, and suggested an alternative definition: POCT is diagnostic testing that will result in a clear and actionable management decision (e.g. start of treatment, referral, initiation of confirmatory test) within the same clinical encounter (e.g. same day).
• POC testing, as such, is not defined by technology but by the diagnostic process. It is important to think in terms of POC testing programs or strategies, rather than POC technologies. The success of a POC testing program must be measured based on the extent to which the rapid completion of the ‘test-and-treat’ cycle in the same clinical encounter is achieved in real-world settings.
• Healthcare systems that choose to implement any test in a POCT program will have to make investments beyond purchasing rapid tests – they need to ensure a system for rapid communication of test results to patients and care providers, and a system to rapidly initiate treatment.

As shown by Nora Engel and others, it is uncommon to find such fully functioning POCT programs in low-resource settings, where 'test and treat' is happening in the same interaction. In many settings, patients are asked to come back another day for test results, and losses to follow-up are a huge issue.

It will be nice to have examples of groups that have overcome the above issues, and successfully implemented POCT programs.

Attached resource:

Ilesh Jani Panelist Replied at 4:27 PM, 1 Oct 2015

To ensure the right patient gets the right diagnostic test and appropriate treatment, what would the ideal delivery system look like for HIV, TB, malaria and HPV in your setting?

This question can't be dealt with using a vertical, disease-focused, approach. In my opinion, current weaknesses are system-wide and an entirely disease-specific approach won't do the job - it may perhaps help reach some short-term goals but eventually even these will reach a bottleneck. Health system strengthening has to be taken seriously if one envisages an efficient health technology delivery system. Most patients in resource-limited settings are seen at the most peripheral level of the health system - health centers. In the near future, community-level services may also become an important "venue". With this in mind, I feel that the only way to reach the right individual with the right health technology is through a reenergized primary health care system.

Hugo Flores Navarro Respondent Replied at 5:44 PM, 1 Oct 2015

Hello,

For today´s discussion,
I think it is really a matter of

Resources - Try to have rapid tests at the points of care when they exist (HIV especially, Hybrids for HPV). In terms of TB, I think it is indispensible to make gene experts available at least at the district levels. This way the samples can be processed way quicker. For example, in our state that would mean having 10 machines, instead of 1 central machine. It is very important to advocate for the reduction in cost of these techonologies if we really want to stop the disease and the surge of drug resistance. In infectious disease, the best prevention is treatment, and to treat, we need to detect very early.

Policy - In terms of policy I would say it is very simple: descentralizing as much as possible. In Mexico, this happens with diagnostic tests (except for Hybrids for HPV), but not really with treatment. And interntionally, reduce the cost for the tests.

Have a good day!

Tsehaynesh Messele Giday Panelist Replied at 1:45 AM, 2 Oct 2015

Weak infrastructures and referral networks, shortages of trained professionals and weak regulatory systems are the major barriers to introducing new technologies and implementing standards in many countries. I agree with system wide approach and strengthening these and other components of health care delivery systems is paramount which needs to be supported by national policies and plans.

Anthony Emeribe Panelist Replied at 6:42 AM, 2 Oct 2015

The ideal delivery system for patients of HIV, TB, Malaria and HPV diagnostics should be system wide approach in such a way that patients’ access quality diagnostics in a timely, cost effective, equitable and accurate manner at all levels of care.
The obstacles or barriers that should be overcome include enhancing the visibility of the laboratory and lab professionals including streamlining/strengthening the training curriculum, harmonization of multiple cadres working in the Lab, the career entry, nomenclature, progression and esteem as for other prime health care providers, job satisfaction and retention, eliminating corruption in the procurement system through dumping of equipment and consumables without due consultation with end users, poor water & power supply, limited coverage of National Health Insurance Scheme and unnecessary acrimony among the health workers. Globally, Health Laboratory Practice should be designed and seen to be a life long career and not a stop gap or transitory cadre.
The ideal delivery system for the provider, depending on his targeted population will vary ranging from conventional test systems to advanced and recent technologies with multiple capacities and capabilities. With the advent of information technology, laboratory information system, e-health, telephone apps, use of drones etc. with new technologies can be exploited to bring state-of-the- art laboratory services closer to the patients and care givers in remote sites.
This GHDOnline discussion over the last two weeks on Lab Diagnostics Demand and Supply has been great and it is expected that with the large community involved it will have a significant impact on the way diagnostics acquisition and use are planned for and applied for optimal benefit of the patients particularly those in remote locations. I commend the organizers and panelists for the good job done.

Rebecca Weintraub, MD Replied at 7:35 AM, 2 Oct 2015

Thank you all for the incredible discussion over the past two weeks

Question of the Day: To ensure the right patient gets the right diagnostic test and appropriate treatment, what would the ideal delivery system look like for HIV, TB, malaria and HPV in your setting?

To probe further:
Do you consider the clinical and financial costs due to misdiagnosis?
How can misdiagnosis be addressed in your setting?

Thank you again for your participation and thoughtful discussion.
We are learning alongside this vibrant GHDOnline community.

Nicholas Day Panelist Replied at 7:57 AM, 2 Oct 2015

What an excellent discussion! Sorry I have come so late to it. The one thing to my mind that comes out again and again is the need for more research on the integrated use of diagnostics in health care delivery. Focussing on issues such as:
1. Health systems research. As Mike English commented this discussion has focussed on diseases addressed by vertical programmes which are often (usually!) poorly integrated into local health systems. In LMIC these are almost always poorly resourced and not well organised, particularly in rural and urban slum areas. What is the most cost effective and clinically efficient way of organising health care delivery, and what role can diagnostics play in improving the outcomes of treatment?
2. Directing empirical treatment. Most patients presenting to health facilities with an acute febrile illness, for example, do not have TB, HIV or malaria, and most will receive treatment that is entirely empirical. The empirical treatment given is usually not evidence-based (few microbiology laboratories and studies to establish the local clinical epidemiology of causes of disease and patterns of resistance in pathogens). So patients are either undertreated or overtreated. An example of the former is scrub typhus, common in rural Asia where I work, but the antibiotics usually dispensed empirically don't cover it (need doxy or azithro). Scrub RDTs are not well validated and certainly not widely available. Overtreatment of acute self-limiting viral infections with antibiotics is a driver of antimicrobial drug resistance, an increasing scourge particularly in the resource poor world. Antimalarials are also often dispensed empirically even when malaria RDTs are negative (doctors know best!), and there is a risk in high transmission areas of incidental parasitaemia causing a positive malaria RDT result in patients with bacterial sepsis who then miss out on antibiotics (maybe a quantitative HRP2 POCT can help with this).
3. Reducing overuse of antibiotics. Lots of noise recently about using CRP or procalcitonin RDTs in treatment algorithms - but very few real life studies to assess the effectiveness (in reducing unnecessary treatment) and risks (not treating a child with sepsis or meningitis because the CRP is low) of this approach.
4. Health economics. Great points have been made already about assessing costs of POC tests in the context of the whole treatment pathway and society as a whole, rather than just in comparison with the cost of drugs. Essential information for policy makers. And what actually are policy makers' decisions based on? Clinical research findings? WHO policy committee recommendations? Pressure from advocacy groups? Other conflicting interests? That itself is a worthy subject for research!

Dana Goldman Panelist Replied at 9:25 AM, 2 Oct 2015

This issue is in part a function of R&D. As we move to 'personalize medicine' to each patient's needs, one would expect progress in developing companion diagnostics. Such is not the case. While scientific obstacles - such as lack of tissue samples - certainly influence the rate of development, I would argue that progress has been stymied by economic incentives. Because reimbursement of diagnostic tests is often cost-based rather than value-based, companies have limited incentive to develop such tests. Reimbursement is typically determined according to a clinical laboratory fee schedule which does not distinguish between personalized medicine tests that may have similar production costs. but provide very different clinical value. In addition, the separation between pharmaceutical companies who make the treatments and the diagnostics companies creates perverse incentives.

More generally, the discordance between reimbursement of diagnostic tests and the value they confer limits incentives for development. Rectifying this deficiency will require a systematic approach to measuring value of the diagnostic, rather than the underlying therapy. This issue is further compliated because the costs of biomarker and/or genetic testing are often substantially greater than the costs of simple laboratory tests (e.g. basic metabolic panels), and the value of information generated by these personalized tests may be far greater if subsequent care involves significant financial cost and adverse risk to patients.

The bottom line is that stakes are higher to develop diagnostics, and some perverse incentives limit their development and ultimately the ability to deliver personalized care.

A/Prof. Terry HANNAN Replied at 9:40 AM, 2 Oct 2015

To Nicholas and all the others who have maintained my “bedtime reading” related to this discussion theme. I accept that I may be responding with a certain or relative degree of ignorance on these matters however Nicholas Day and others have made me think of some underlying ‘foundational’ issues that need to be highlighted when discussing the relevant matters related to this topic.
If we accept that “information management is care” as defined in the WHO Charter [see first three slides in the short attached PPTX file-permission from Prof W. Tierney] then we can grasp the fundamental role of captured “clinical data at the patient care interface(s)" in measuring how we measure and manage health care.
The issues of resources needed, how they are used or inappropriately used comes from the data and information captured in this way. The same data is used to ‘show health funding authorities and support research’ how health care needs to be managed for a particular location(s).
The PPTX slide set shows an excellent rudimentary example of how this is done and the power of the extracted data and information.
The ward graphic, Slide 4, reveals the situation we initially faced in Kenya. Note the text description adjacent to the IV Saline flask.
Slides 5-8 show the evolution of relevant data and information captured in the care processes and then the collated report that reveals many aspects of care. Note the disease categories and incidences (note the dramatic HIV/TB stats) and a rudimentary example of resource utilisation management.
Rather than present my personal perspectives on this graphic and its revelations I will quote Prof William Tierney who stated “we have lit a candle in the darkness of Africa (HIV/AIDS)”.
The governments responses as well as the health care delivery community including patients (see slides 8 &9) dramatically changed health care delivery in Kenya and then many other locations world-wide.
So my message is use what tools we already have and adapt them to capturing direct patient (clinical care) data and then health care delivery should improve.

Marie Teichman Replied at 10:05 AM, 2 Oct 2015

Here is the slide set Terry referred to!

Attached resource:

Rodrigo Cargua Rivadeneira Replied at 12:28 PM, 2 Oct 2015

Health computer need to know and understand the processes Relief and All
around them, to perfect the tools acquired : Besides that there is
potential to generate Automated solutions at all levels para responding to
specific health needs ( management and delivery ) .



Do not forget that the Purpose of the health sector to contribute to the
"good life" of the population, ANY intervention to improve the management
and provision will result in benefits for the health of citizens .

Rodrigo Cargua

Thomas Shinnick, Ph.D. Respondent Replied at 1:13 PM, 2 Oct 2015

Question of the Day: To ensure the right patient gets the right diagnostic test and appropriate treatment, what would the ideal delivery system look like for HIV, TB, malaria and HPV in your setting?
Thanks to all who have added to the discussion of point of care testing.
One of the challenges for a patient is that they may be referred to several independent facilities for diagnostic testing or clinical evaluation.
It would be good to learn of any examples where programs have developed a patient-centered diagnostic approach, such as a faity that has impelementd all the surrently available POCT or near care tests for TB, HIV, malaria, and HPV.

Madhukar Pai Panelist Replied at 1:32 PM, 2 Oct 2015

Do you consider the clinical and financial costs due to misdiagnosis? How can misdiagnosis be addressed in your setting?

Misdiagnosis is clearly a big issue with TB: we know we are missing cases in settings where only direct ZN smear microscopy is available, and where drug-susceptibility testing is rarely done. A large study (Sachdeva et al. PLoS ONE 2015) of 100,000 patients is a good illustration. By doing upfront testing with Xpert MTB/RIF, the Indian TB program could detect far more cases of bacteriologically-confirmed TB and RIF-resistance than their usual approach of microscopy and selective DST. Introduction of Xpert as the initial diagnostic test for TB in public health facilities increased case-notification rates of all bacteriologically confirmed TB by 39% and rifampicin-resistant TB case notification by fivefold. URL: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0126065

Misdiagnosis also occurs because of inappropriate tests, or due to off-label use of tests. The TB field offers two good examples.

Serological, antibody tests are inaccurate and not recommended in any guideline. And yet they were widely used in India (in the private sector) until recently. The economic and social consequences of this is illustrated in the attached study by Dowdy et al. URL: http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001074

IGRAs (e.g. QuantiFERON-TB Gold and T-SPOT.TB) are inappropriately used in some settings (e.g. India, China, again in the non-NTP sectors). While these are acceptable tests for latent TB, their use for active TB in high burden settings is a worrisome practice, given the high prevalence of latent TB in such settings. WHO has strongly recommended against their use of active TB, but healthcare providers use them instead of microbiological tests. The attached study by Little et al. shows that using IGRAs for diagnosis of active TB in a setting like India results in tremendous overtreatment of people without TB, and substantial incremental cost with little gain in health. URL: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0124525

To address misdiagnosis, we need to invest in and scale-up WHO-endorsed tests, and discourage the use of tests which are not validated. This will need countries to improve regulation of diagnostics, and also strategies to promote national and international standards for TB care, so all patients get quality care. In particular, we need to work harder to ensure that the private sector in many countries aligns their practice with NTPs. Poor quality of TB care in the private sector is a huge issue (see: http://www.ncbi.nlm.nih.gov/pubmed/26056098).

Nora Engel Panelist Replied at 2:47 PM, 2 Oct 2015

Dear All,

I agree with the above statements that in order to develop an ideal delivery system, we need to work across diseases with an understanding of how the different elements in a health system work together and with the main goal of ensuring completion of 'test and treat'- cycles (the POC continuum) in one patient encounter, e.g. think of POC testing programs and diagnostic processes rather than just products.
In our research we found how the processes to diagnose/treat different diseases were at times competing with each other (for instance target based Malaria testing as per the national Malaria control programme would draw lab resources away and delay investigations into other diseases in public clinic labs in India).
Calls for health system strengthening are very important and have been made already for many years. What could be fruitful is to think efforts of health system strengthening together with attention to diagnostic processes at POC. Often health system strengthening focuses on specific building blocks that should be strengthened (see the WHO framework for instance, http://www.who.int/healthsystems/strategy/everybodys_business.pdf ) but missing is an understanding of how these things work together, how HR, available technologies, finances, governance, routines and infrastructure interact. These dynamics come to the fore when we examine diagnostic and care processes.

The ideal delivery system is also context dependent, as was pointed out repetitively throughout this discussion. To what extent do countries or regions have the capacities to research their specific diagnostic processes and health system components to adapt technologies and guidelines to their specific settings and then find out what works and does not work. Who can do and fund this work and where can such experiences be shared? And to what extent do we expect test developers and manufacturers to do this work?

Ilesh Jani Panelist Replied at 3:29 PM, 2 Oct 2015

My closing remarks on the discussion

Health technologies are a critical element of a contemporary health system and play a significant role in delivering universal health coverage - leaving no one behind. While good frameworks have been built for some technologies (e.g. drugs), diagnostics have lagged behind. It seems that the time to catch up is now.

A health system-wide approach needs to be taken in order to strengthen diagnostics in resource-poor settings. For point-of-care diagnostics, a rejuvenated primary health care service, that takes into account both health centers and community outreach, should constitute the optimal solution.

Global efforts and regional collaborations are vital to advance the diagnostics field. However, it is even more important that institutions at national level (e.g. regulatory bodies, national public health institutes and laboratories) are strengthened and take leadership roles in the diagnostic value chain.

If diagnostic services are to withstand the challenges of the 21st century then they must be delivered through an overall strong health system. Just like in the Three Little Pigs fable, where the only house that withstands the wolf is the stronger, brick house.

Rosanna Peeling Panelist Replied at 6:40 PM, 2 Oct 2015

I agree with Madhu that we need to support the evaluation of diagnostics by WHO and other public health agencies such as CDC but it is not nearly enough because companies with low quality products would simply change the label and continue to sell these products after the evaluation reports come out. We need every national regulatory authority to share information on products and prevent low quality products from being sold to unsuspecting control programmes, laboratory managers, physicians and citizens.

I agree with Ilesh about the need for health system strengthening if we were to reap the benefit of novel technologies . The implementation of rapid point-of-care (POC) tests has improved access to diagnostics but it has also put tremendous stress into already fragile health systems. We need to put more thought into changing patient pathways with the introduction of POC tests so that we make the health system more efficient and make a bigger impact.

Jeannette Guarner Panelist Replied at 8:50 PM, 2 Oct 2015

Misdiagnosis is a large problem that goes further and cannot be totally fixed with POCT. An example: I am participatingas in a project in the Republic of Georgia on Tb. The project includes resecting Tb lung nodules which apparently is a regular treatment patients receive there. One of the recent cases was diagnosed using GenXpert as having Tb... But guess what, in one of the resected nodules I found an adenocarcinoma in addition to Tb. POCT is targeting diagnosis of only one disease (in this case Tb) what if the patient has something else.

Diagnosing and treating patients is much more complex and requires participation of an entire healthcare system. Yes, we need to start somewhere in many parts of the world... maybe POCT is a strating point, but it will not be the entire solution.

Marc Steben Replied at 8:51 AM, 3 Oct 2015

signs, symptoms and risk factors for TB and lung cancer overlap. as well as risk factors for hep B, hep C and HIV. in this case, it is not a problem of misdiagnosis but a problem having concurrent diagnoses.

Geoffrey Dama Caetano Madeira Replied at 2:17 PM, 4 Oct 2015

I agree with all of you and I would add that we need to built an integrated system. Where clinicians and Lab scientist, and all health staff, are more close to each other. In order to really provide high standard health care services based on evidences. sometimes we forget to look to patients and we place reliance only on the POC.

Rakesh Biswas MD Replied at 10:06 PM, 4 Oct 2015

Thanks Jeannette, Marc and Geoffrey for making this point around the
importance of being 'patient centered' rather than 'testing' centered to
tackle concurrent factors contributing to 'the overall illness' and
developing a pluralistic rather than a traditional 'dyadic' health
information infrastructure.

You may like to read a recent write up about it here:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4587042/

Rebecca Weintraub, MD Replied at 10:20 AM, 5 Oct 2015

Thank you again for your contributions these past two weeks. You have
surpassed all expectations and we are grateful for your willingness to
share so much knowledge surrounding the diagnostic value chain. Below is a
summary from the last days of the panel.

Friday, panelists offered their closing remarks, outlining their ideal
delivery systems for diagnostics.

Global and regional collaboration is vital to advancing diagnostics.
Panelists agreed that a systems-wide approach to strengthening the delivery
system for diagnostics is necessary, and that focusing on disease-specific
approaches will fail to address system issues. Global health laboratory
practice guidelines should also be designed and implemented. Due to the
need for context-appropriate guidelines, national bodies are the key to
strengthening systems and taking leadership roles in the diagnostic value
chain.

Panelists also mentioned the need for greater research on the integrated
use of diagnostics in health care delivery. Progress within the diagnostic
value chain is often hindered by economic incentives during the research
and development phase. The current structure’s reimbursements are
cost-based, versus value-based. This limits incentives to develop
patient-centered tests and companion diagnostics, denying a patient-focused
approach.

Patients must be able to access quality diagnostics in a timely, cost
effective manner. Many panelists mentioned the need for Point-of-Care
programs that can test and make treatment decisions in the same clinical
encounter, or at least the same day. This could promote the rejuvenation of
primary health care services, strengthening the system overall. Simply
improving availability of resources is a key factor in improving care and
supporting a patient-centered diagnostic approach. There is much need for
advocacy surrounding scaling up of health delivery systems and reduced
costs of these vital resources.

Panelist Ilesh Jani summarized the need for improving diagnostic systems:

“If diagnostic services are to withstand the challenges of the 21st century
then they must be delivered through an overall strong health system. Just
like in the Three Little Pigs fable, where the only house that withstands
the wolf is the stronger, brick house.”


--
Rebecca Weintraub, MD
Faculty Director
Global Health Delivery Project at Harvard University
Assistant Professor of Medicine, Harvard Medical School
Associate Physician, Brigham and Women's Hospital

Marie Connelly Replied at 10:40 AM, 5 Oct 2015

I'd like to echo Rebecca's thanks to all of our panelists, respondents, and community members for such an incredible discussion over the last two weeks.

I'm also pleased to share some comments from Francois Venter, who serves as Deputy Executive Director of the Wits Institute for Sexual & Reproductive Health, HIV and Related Diseases, and is an associate professor in the Department of Medicine, University of the Witwatersrand:

“Thank you for a very interesting discussion. Catharina Boehme and Jeannette Guarner made many of my points.

My concern is the “magic bullet” thinking that permeates the diagnostic and monitoring world (and the world of electronic medical records and telemedicine) – often a high tech solution is seen as all that is needed, to address what is usually a very poorly understood and defined problem, with complex cultural and systemic issues. I am all for these solutions, if they can bypass these issues, but they are often based on faulty understandings of clinician, patient and health care system behaviour.

POC CD4 is an excellent example. Many commentators assumed (frankly, with staggering lack of introspection or analysis of external data) that the reason people fall out the system after HIV testing because of the delay in getting a CD4 result, and that this was a simple solution. The fact that they were lost before ART was available, or that HIV testing (and hence CD4 staging) is rarely the major function in any busy clinic, are all one of many reasons I think this technology failed to make major impact. Personally, I think the same goes for the TB XPERT, and the initial disappointing clinical outcomes. Both have been very expensive public health experiments that have yielded very little.

These interventions are exciting, but they need a very calm assessment of the actual problem they are trying to solve. And a more honest assessment of the downside (cost, complexity, maintenance, local and department support).

Francois”

Catherine (Cathie) Klapperich Respondent Replied at 11:31 AM, 7 Oct 2015

I wanted to make everyone aware of a FREE seminar on regulatory and reimbursement issues for devices and diagnostics. CME credits are offered. The seminar will be live streamed and archived. At the website, the archive of last year's version of the event can be watched. http://www.bu.edu/cftcc/events/2015-indide-and-reimbursements/

Attached resource:

William Martinez Replied at 2:03 PM, 19 Oct 2015

Was recalling the company Theranos had come up in the discussion as company with new technology for lab tests, using a single finger stick collection with a micro-specimen and return results in four hours. I came across a article about it the other day challenging some claims and then the CEO response. I thought both were interesting so am attaching hear for anyone interested. It will be interesting to see how Theranos and their technology plays out. Certainly has potential.

Attached resources:

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