Expert Panel: Building Capacity for Diagnostics

I will be honored to share with my colleagues my experience.
Prof Mohamed Labib
Head of surgery department
School of medicine
University of Namibia

A very appropriate issue!One major problem,I face in remote areas is that even though primarily I am a clinician,I have to do all the lab work myself with minimal assistance.It is therefore imperative that while developing appropriate technologies,we take care that it should be possible to do lab work with minimal expertise.Bulk purchase or storage of reagants is also not possible.We need to develop easy to do point of care tests which are low cost too.

Violet, I'll be happy to join the discussion.
Sara Friedman C.N.M., M.S.N.

Hello all,
Those are wonderful ideas to discuss. I will be a bit engaged in that week but I will send in my input via mail. Thanks and all the best in the discussion.

Performance of the 2007 WHO Algorithm to Diagnose Smear-Negative Pulmonary Tuberculosis in a HIV Prevalent Setting

Thank you Violet for this opportunity. It would be good to share experiences especially on rapid diagnostics like gene Xpert and LPA.

Dear Violet,
This is such a wonderful opportunity of people who work for TB control.

Naruemol Singha-Dong

It's great to know how we are all getting ready for the discussion on from the 25th February. I am looking forward to it. Many thanks.

Violet

Could Chaka share her experience on the use of rapid diagnostics in the Namibian context vis a vis accessibility of services?

Great job Violet! This discusion comes at just the right time for me. I'm currently attached to the Pulmonology ward in Mulago National Referal Hospital as part of my internship rotation . Investigating patients for TB is at the centre of my daily tasks on the ward; so I really look forward to sharing my experiences. I will link-up with my consultants on the ward where necessary. Let me know if there is anything more I could do. Otherwise thanks for adding me in!

Dear Violet thanks a lot for the invitation. I will be glad to discuss on these issues.
In fact, overall, fluorescence microscopy, procedures related to sputum digestion, growth based methods and Nucleic Acid Amplification Techniques (NAATs) have demonstrated a superior performance compared to the conventional microscopy in experimental settings. However, their implementation under programmes conditions is accompanied by a range of technical and logistical requirements posing obstacles in most HBCs.
It will be interesting to see with all panelists how to manage these challenges!

Thanks for adding me.

Although I am an architect I will comment as good as I can on the items I have observed during my trips for TBCARE/TBCAP.

Hans Mulder
Free Lance Environmental / Architectural Consultant
(TB CAP / TB CARE Infection Control)

Po Box 90777
Windhoek, Namibia
+ 264 61 255446 (office)
+ 264 81 252 4080 (cell)

The laboratory is a very vital link in disease control. The challenges are numerous and I would be happy to contribute to this discussion.

I welcome the opportunity to take part in this discussion but my vantage point is different. Although TB, malaria and AIDs are major problems, I found that there was little awareness of the ways to diagnose and treat patients with rheumatoid disease in Kenya. Diagnostic testing is only part of the equation. Health care professionals and patients need to learn about rheumatic disease. The GBD in Lancet documents this as a major cause of morbidity as well as mortality. I am interested in idease as well as partners.

Thanks to Violet and colleagues for introducing this really important topic. I have worked as a laboratory technical adviser and laboratory capacity builder in several Asian and African countries, where I have noticed that national reference laboratories are often not properly included (or even completely omitted) in national health budgets. As a result, they are over dependent on sporadic sources of external funding for their consumable costs (e.g. from WHO if they have national center status for a given disease(s)). In my view this is very short term and cripples the ability of the lab to truly function as a national reference center and be responsive to emerging and on-going public health issues.

Another issue is the lack of connection of national laboratories with other public health disciplines; for example there may be no one within the laboratory structure that has the training/background/capacity to analyse data trends, surveillance etc and feed this information back into the diagnostic strategies/approach that laboratories may be using for a given disease.

Thirdly, the educational level of those working in national level laboratories in developing countries is often limited with a lack of fully trained scientists. The example I am ...

Thanks to Violet and colleagues for introducing this really important topic. I have worked as a laboratory technical adviser and laboratory capacity builder in several Asian and African countries, where I have noticed that national reference laboratories are often not properly included (or even completely omitted) in national health budgets. As a result, they are over dependent on sporadic sources of external funding for their consumable costs (e.g. from WHO if they have national center status for a given disease(s)). In my view this is very short term and cripples the ability of the lab to truly function as a national reference center and be responsive to emerging and on-going public health issues.

Another issue is the lack of connection of national laboratories with other public health disciplines; for example there may be no one within the laboratory structure that has the training/background/capacity to analyse data trends, surveillance etc and feed this information back into the diagnostic strategies/approach that laboratories may be using for a given disease.

Thirdly, the educational level of those working in national level laboratories in developing countries is often limited with a lack of fully trained scientists. The example I am thinking about in particular is Afghanistan, where external funding and support has been over focused on quick wins and short term programs. There is an urgent need in these situations for complete training programs (from BSc level, to MSc to PhD and then postdoctoral experience). This is difficult to put in place when higher level educational development in the sciences has been neglected (and it often is neglected because inclusion of sufficient practical, hands on training in science degree programs is expensive).

I think in the first instance there needs to be more support for the complete training of public health laboratory scientists. There are some highly successful graduate training programs that have recently been run in Tanzania and Malawi, for example. At present graduates of those programs are being supported while they pursue further post-doctoral studies. These programs have benefited from external long-term financial commitment and also long-term institution-building support (local scientific universities or institutes are twinned with an experienced overseas partner).

I'm curious to know what the panel and other participants think about these issues; in my view, a lack of educated public health laboratory scientists is not only a problem in terms of immediate human resources (and capacity) in this area, but also means there is no one to "fight the public health laboratory corner". Without professional development, there is no leadership in this discipline, which means no vision, no strategy, no sustainable funding and no sustainable resources for public health laboratories.

Amy Mikhail
EUPHEM fellow (European Program for Public Health Microbiology)
Microbiology Reference Services
Health Protection Agency
61 Colindale Avenue
London NW9 5EQ
UK

Phone: +44 (0)208 32 76495
Email:

Hi Violet,

I'm looking forward to this all-important discussion!

This a very important issue and l look forward to sharing learnings and engage in reflections with participants. An important discussion particularly as the world contemplates about how the post mdg era will look like.

I would like to draws your attention to two initiatives that are aimed at improving access to quality diagnostics.

The first is ‘Affordable Access to in-vitro diagnostics through regulatory harmonization approaches’ which is a project led by the London School of Hygiene & Tropical Medicine (Professor Rosanna Peeling and myself) with funding by Grand Challenges Canada.

We are working in partnership with organisations in Africa, Asia and Latin America. In Africa we are working with the East African Community, AU-NEPAD and number of other partners to establish the Pan African Harmonization Working Party (PAHWP) which will complement the work of the Asian Harmonization Working Party (AHWP) and the Latin American IVD Association (ALADDIV). To achieve our goals we shall be working across sectors to include for example National Regulatory Authorities, MoH, manufacturers and organisations such as ASLM and WHO. During Phase I of the project we undertook landscaping to take stock of the current situation and determine priorities. There is general agreement on the principles of harmonization and convergence and, with our partners, we are currently working on a set of white papers that we hope will establish priorities and point to the future. Phase II of the project commences March ...

I would like to draws your attention to two initiatives that are aimed at improving access to quality diagnostics.

The first is ‘Affordable Access to in-vitro diagnostics through regulatory harmonization approaches’ which is a project led by the London School of Hygiene & Tropical Medicine (Professor Rosanna Peeling and myself) with funding by Grand Challenges Canada.

We are working in partnership with organisations in Africa, Asia and Latin America. In Africa we are working with the East African Community, AU-NEPAD and number of other partners to establish the Pan African Harmonization Working Party (PAHWP) which will complement the work of the Asian Harmonization Working Party (AHWP) and the Latin American IVD Association (ALADDIV). To achieve our goals we shall be working across sectors to include for example National Regulatory Authorities, MoH, manufacturers and organisations such as ASLM and WHO. During Phase I of the project we undertook landscaping to take stock of the current situation and determine priorities. There is general agreement on the principles of harmonization and convergence and, with our partners, we are currently working on a set of white papers that we hope will establish priorities and point to the future. Phase II of the project commences March 1st.

The second initiative is the ASLM (African Society for Laboratory Medicine) who are a fairly new organisation dedicated to improving lab services across Africa. I attach two of their strategic goals below – visit their website to join them. http://www.aslm.org/
Goal 1 – African Laboratory Workforce Development: Strengthen the laboratory workforce in Africa to achieve Millennium Development Goals for Health
Strategic Direction: According to the World Health Organization Regional Office for Africa (WHO/AFRO), Africa has fewer than one laboratory professional per 10,000 citizens. Delivery of effective healthcare and expanding health services to new areas requires a viable workforce. Major workforce gaps that ASLM will focus on include development of standards for training and career development in order to increase productivity and retention.
Key Targets: Train and certify 30,000 laboratory professionals and clinicians by 2020, advocate for National
Laboratory Professional Regulatory Councils and develop standardized frameworks for workforce development, retention, and improving and maintaining pre-service training capacity.

Goal 2 – Laboratory Accreditation: Transform the quality of diagnostic services
Strategic Direction: Fewer than 400 laboratories in Africa are accredited to international standards and 90% are in South Africa. Accredited laboratories provide accurate, timely results that will be used to make impactful medical and public health decisions for the patient and community. ASLM will focus on laboratory system strengthening, improved planning and policies and the expansion of the WHO/AFRO Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) programme to increase the number of accredited laboratories.
Key Targets: By 2020, enroll 2,500 laboratories in the WHO SLIPTA quality improvement programme, and enable 250 laboratories to achieve accreditation by international standards.

Thanks Violet for giving me this opportunity to exchange.
Hi Ruth, How are you?
The two initiatives are very important and sound very exiting. Regarding the first initiative I think that a key point (among others) is include all sectors from the begining, identifying and discussing priorities.
How many people are included in this activity? ¿Wich is the mechanism that is used to recover their opinions?
In Latin America, which are the countries participating in this initiative? Who are the partners of Latin America?

Regarding Objective 2: Laboratory Accreditation: Transforming the quality of diagnostic services, also essential
This goal is another great challenge, especially because the large number of laboratories involved
The coordination and monitoring of this activity must be tremendous
how are the main lines used to organize these activities?

Hie Violet,

Thank you for including me as this is a very relevant discussion. My comments will be mainly focused on the private sector and the challenges encountered there.

I look forward to joining the discussion on this very important topic. There are many challenges and opportunities related to enhancing laboratory support for clinical decision making. I will be happy to share my experience with building the laboratory capacities in Africa.
Orhan Morina, MD. Senior Health Systems Advisor, Catholic Relief Services

I am glad that all of you are raising very important issues relating to diagnostics, and many thanks or everyone who has added links for reference in this discussion. I will definitely share my experience from the laboratory point of view when the panel discussion begins next Monday.

Many thanks and best regards,
Violet

Dear Violet i will be glad to brainstorm with all of you and improve the lab capacities in our settings.The Laboratory is at the center of all attention today in Uganda. the recent outbreaks of Ebola/Marburg VHF, the need of lab confirmation of malaria for treatment and the emergence of MDR-TB have emphasized the need of quality lab in this country. your initiative and teh sharing of experience will definitely help us.

To respond to Daniela

Hello Daniela,
Diagnostics have lagged behind other medical products when it comes to regulation and we have found great disparity in regulation between regions and countries. In some countries there are no controls and fake or substandard tests can be openly sold; in other countries we have the other extreme where the population are denied access to good tests for bureaucratic reasons. There are also large differences in capacity to regulate medical devices. A few countries have well established programs, while others have zero personnel with the appropriate training.

We completely agree for the need to be inclusive of all stakeholders. We also think it vital and that the process is led from the regions/countries concerned and not imposed from outside.
We do not intend to reinvent the wheel and we are following guiding principles established some time ago. The WHO, in cooperation with the Pan American Health Organization and the United States Food And Drug Administration have published a set of guiding principles to assist governments in low and middle income countries with deciding what regulatory controls for medical products are best suited for a nation’s health care situation.
A Model Regulatory Program ...

To respond to Daniela

Hello Daniela,
Diagnostics have lagged behind other medical products when it comes to regulation and we have found great disparity in regulation between regions and countries. In some countries there are no controls and fake or substandard tests can be openly sold; in other countries we have the other extreme where the population are denied access to good tests for bureaucratic reasons. There are also large differences in capacity to regulate medical devices. A few countries have well established programs, while others have zero personnel with the appropriate training.

We completely agree for the need to be inclusive of all stakeholders. We also think it vital and that the process is led from the regions/countries concerned and not imposed from outside.
We do not intend to reinvent the wheel and we are following guiding principles established some time ago. The WHO, in cooperation with the Pan American Health Organization and the United States Food And Drug Administration have published a set of guiding principles to assist governments in low and middle income countries with deciding what regulatory controls for medical products are best suited for a nation’s health care situation.
A Model Regulatory Program For Medical Devices: An International Guide. WHO, 2001.
http://new.paho.org/hq/dmdocumen/2009/AmodelRegulatoryProgramforMedicalDevice...

The Global Harmonisation Task Force has also produced a number of useful guidance documents that are now available on the website of the International Medical Device Regulators Forum (IMDRF)

The recently established Latin America IVD Association (ALADDIV) is a regional forum for regulators, researchers and ministries of health representatives to promote the convergence of regulatory standards and procedures. http://www.cbdl.com.br/index.php/noticias/1160-participantes-de-workshop-inte...

The Asian Harmonization Working Group brings together a group of experts from the medical device regulatory authorities and the medical device industry from 23 territories. Its goals are to study and recommend ways to harmonize medical device regulations in the Asian and other regions and to work in coordination with the Global Harmonization Task Force, APEC and other related international organizations aiming at establishing harmonized requirements, procedures and standards. The Working Party has a subgroup that focuses of IVDs.

The Pan African Harmonization Working Group is in the process of being established – so watch this space. It will have an interim secretariat within the East African Community but once established will migrate to AU-NEPAD, where there is already a project on harmonization of regulation of medicines. http://www.amrh.org/

Once the second phase of the project is underway we shall post information on the global diagnostics webpage http://globalhealthdiagnostics.tghn.org/ under the Affordable Access tab.

The ASLM held a conference in Cape Town last December that was attended by well over 1000 people from across Africa. Anyone with an interest in laboratory medicine in Africa can join them.The presentations are available online http://www.aslm2012.org/aslm-2012/aslm2012-speaker-presentations The conference was a great success and ended with a ministerial call to action. Africa http://www.aslm2012.org/docs/ASLM2012%20Ministerial%20Call%20for%20Action.pdf

We held a satelitte session about our project. The presentations will shortly be available on the ASLM website.

Dear all,

I am currently an intern at the non-profit organization Solthis and I am working on a research project on the use of rapid HIV tests and the divergence from proper practices in their use. Solthis is currently working in Mali, Niger, Sierra Leone and Madagascar in several projects, all on HIV and AIDS. The general objective of this study is to qualify and quantify the divergence of practices from the proper procedures when using rapid tests. Furthermore, we would like to develop a set of suggested guidelines to improve quality assurance in the use of theses tests. I stumbled across this community and this discussion and I would really appreciate any insight that any of you might have on this topic. Thank you!

Hi Paul

May I know which divergence are u looking at?

Thanks

Yap

Hi Yap Boum II,

Some of the divergences that have been observed are: reading results before or after the time specified in the manufacturer's instructions, not using the proper diluent (negligence and/or lack of stock), use of expired tests, non-use of capillaries or pipettes for sampling, inconsistency in storage conditions (temperature, humidity, etc). We want to quantify the occurrence of these events, observe if there are other events that could be leading to low quality results and also analyze currently obtained results to see if quality is being upheld.

Hi Ruth
thanks a lot for your very informative reply
all the best

Hi Paula

Thanks for the clarifications. I would be very interesting to correlate the divergence and the performance of the tests. Some tests may remain accurate regardless of the deviation of the used and that will help to define which test is more robust for the "real life" and which deviation is the most critical... I would be very interested on your work and results... if anything we can help with do not hesitate !!!

-----Original Message-----
From: [mailto:]
Sent: Thursday, February 21, 2013 1:27 PM
To: YAP BOUM II
Subject: Re: Building Capacity for Diagnostics


Paula Garcia replied to the "Building Capacity for Diagnostics" expert panel.

Reply contents:
"Hi Yap Boum II,

Some of the divergences that have been observed are: reading results before or after the time specified in the manufacturer's instructions, not using the proper diluent (negligence and/or lack of stock), use of expired tests, non-use of capillaries or pipettes for sampling, inconsistency in storage conditions (temperature, humidity, etc). We want to quantify the occurrence of these events, observe if there are other events that could be leading to low quality results and also analyze currently obtained results to ...

Hi Paula

Thanks for the clarifications. I would be very interesting to correlate the divergence and the performance of the tests. Some tests may remain accurate regardless of the deviation of the used and that will help to define which test is more robust for the "real life" and which deviation is the most critical... I would be very interested on your work and results... if anything we can help with do not hesitate !!!

-----Original Message-----
From: [mailto:]
Sent: Thursday, February 21, 2013 1:27 PM
To: YAP BOUM II
Subject: Re: Building Capacity for Diagnostics


Paula Garcia replied to the "Building Capacity for Diagnostics" expert panel.

Reply contents:
"Hi Yap Boum II,

Some of the divergences that have been observed are: reading results before or after the time specified in the manufacturer's instructions, not using the proper diluent (negligence and/or lack of stock), use of expired tests, non-use of capillaries or pipettes for sampling, inconsistency in storage conditions (temperature, humidity, etc). We want to quantify the occurrence of these events, observe if there are other events that could be leading to low quality results and also analyze currently obtained results to see if quality is being upheld."

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Just a few notes from the February 20th PEPFAR Evaluation:
• Overall message: PEPFAR hasn’t been doing as well on TB-HIV as it has on other clinical HIV services. TB-HIV integration is not where it needs to be.
o “progress in this area has come more slowly than in other clinical services for HIV, and challenges persist in achieving adequate coverage” (pg. 216)
o In 2010, only 49% of PLHA in PEPFAR programs were screened for TB. This fell short of their goal of 68%. (Pg. 240)

• What is preventing better TB-HIV integration? (Pgs. 240-242)
o Separate donor funding streams for TB and HIV prevent integration. One interviewee explained “programs have a positive view of integration until they are competing for funding” (pg. 242)
o Lack of diagnostic capabilities and lab capacity
o Lack of integrated facilities; Loss to follow-up for co-infected patients in areas where programs are poorly linked
o Patient resistance to getting tested for HIV, including a desire among some patients to complete TB treatment before starting ART

• Other notable issues
o TB-HIV collaboration is good at the national and provincial level but variable at the district level’
o Despite listing IPT as ‘cost-saving’ and effective, PEPFAR ...

Just a few notes from the February 20th PEPFAR Evaluation:
• Overall message: PEPFAR hasn’t been doing as well on TB-HIV as it has on other clinical HIV services. TB-HIV integration is not where it needs to be.
o “progress in this area has come more slowly than in other clinical services for HIV, and challenges persist in achieving adequate coverage” (pg. 216)
o In 2010, only 49% of PLHA in PEPFAR programs were screened for TB. This fell short of their goal of 68%. (Pg. 240)

• What is preventing better TB-HIV integration? (Pgs. 240-242)
o Separate donor funding streams for TB and HIV prevent integration. One interviewee explained “programs have a positive view of integration until they are competing for funding” (pg. 242)
o Lack of diagnostic capabilities and lab capacity
o Lack of integrated facilities; Loss to follow-up for co-infected patients in areas where programs are poorly linked
o Patient resistance to getting tested for HIV, including a desire among some patients to complete TB treatment before starting ART

• Other notable issues
o TB-HIV collaboration is good at the national and provincial level but variable at the district level’
o Despite listing IPT as ‘cost-saving’ and effective, PEPFAR has no indicators for IPT. (Pg. 236 and 238)
o Drug stock outs were reported as a major problem in many PEPFAR countries (pg. 412)

• Recommendations
o “The best practices for integrating services, such as HIV and TB, reproductive health, and primary care, need to be identified, evaluated, and scaled up.” (Pg. 367)
o TB and HIV clinics should be co-located to prevent loss to follow-up; it works better than referral systems. (pg. 438)

Hi Violet,
happy to join the group for discussions. the current two topics in my mind are:
1- scope for simplifying HIV test algorithms to better matching with supply chain realities at point of care: i noted some programs (large country) using 3 rapid tests for confirmation of HIV infection whereas other much smaller programs struggle to get Unigold test kits to districts and get these tests used as they should. Theoretic quantification/forecasting of commodities in supply chain management often doesn't take into account how and where these tests are actually used in the field, recurrent stock outs, consumption not reported, emergency supplies, HIV + case sent home to wait for HIV confirmation testing the next month etc.
2 - introducing Xpert TB MDR diagnostic tools as a rapid test: good in a way relieving a lot of LPA lab work. I see there is specific material to read posted by you on GHD online as well. But what is the practice and what are the risks doing this now (quickly) without the necessary back up of culturing/DST to initiate the most effective treatment. We probably all know that for a rnage a reasons setting up the lab infra ...

Hi Violet,
happy to join the group for discussions. the current two topics in my mind are:
1- scope for simplifying HIV test algorithms to better matching with supply chain realities at point of care: i noted some programs (large country) using 3 rapid tests for confirmation of HIV infection whereas other much smaller programs struggle to get Unigold test kits to districts and get these tests used as they should. Theoretic quantification/forecasting of commodities in supply chain management often doesn't take into account how and where these tests are actually used in the field, recurrent stock outs, consumption not reported, emergency supplies, HIV + case sent home to wait for HIV confirmation testing the next month etc.
2 - introducing Xpert TB MDR diagnostic tools as a rapid test: good in a way relieving a lot of LPA lab work. I see there is specific material to read posted by you on GHD online as well. But what is the practice and what are the risks doing this now (quickly) without the necessary back up of culturing/DST to initiate the most effective treatment. We probably all know that for a rnage a reasons setting up the lab infra in public sector will take time and maybe will take forever to get it right down to the level where it counts (villages, districts). Going ahead with Xpert makes it to me seem likely that eventually on the larger scale a significant part of the DR cases detected will be confirmed (ideally?) and then treated without DST results to guide the regimen. What will that mean on the long term?

how does it work the brainstorming next week, is it a flow of emails or a log in etc?
thanks
pascal

Am glad to join you in this very important discussion

Dear all,

I am glad and excited to see the interest this discussion has generated site-wide. I would like to give a brief introduction of myself.
I am a lead medical technologist at a district hospital in Namibia. In our lab we process Clinical chemistry, Hematology including flowcytometry (CD4's), Microbiology & TB direct microscopy, serology and Blood transfusion. Working in a district lab has been a unique and worthwhile opportunity for me. Unlike someone working in one department at a reference lab, I oversee all the lab processes and am responsible for the quality of output we produce as well as managing the inventory system in the lab. I must also ensure that the hospital and the the peripheral clinics that give us samples have enough supplies for sample collection. I will summarize below the challenges from my experience.

Challenges of district laboratories:
1. Skilled staff shortage, one of the obstacles to expanding lab services
2. Infrastructure- most labs were built before independence and now too small for growing populations. Insufficient space also makes many district labs cluttered which compromises safety of lab staff.
3. Supply chain management. The main store where all labs order from bi-monthly is in the ...

Dear all,

I am glad and excited to see the interest this discussion has generated site-wide. I would like to give a brief introduction of myself.
I am a lead medical technologist at a district hospital in Namibia. In our lab we process Clinical chemistry, Hematology including flowcytometry (CD4's), Microbiology & TB direct microscopy, serology and Blood transfusion. Working in a district lab has been a unique and worthwhile opportunity for me. Unlike someone working in one department at a reference lab, I oversee all the lab processes and am responsible for the quality of output we produce as well as managing the inventory system in the lab. I must also ensure that the hospital and the the peripheral clinics that give us samples have enough supplies for sample collection. I will summarize below the challenges from my experience.

Challenges of district laboratories:
1. Skilled staff shortage, one of the obstacles to expanding lab services
2. Infrastructure- most labs were built before independence and now too small for growing populations. Insufficient space also makes many district labs cluttered which compromises safety of lab staff.
3. Supply chain management. The main store where all labs order from bi-monthly is in the capital city. When you run out of reagents you have to refer all your tests affected by that reagent to another lab which still has reagents
4. Machine break-downs. Generally we have two service technicians per type of analyzer for the whole country. For example, hematology machines for the whole organization are supplied by one supplier who assigns 2 technicians for the whole country. So if more than 2 labs have their machines out of order it means the other labs have to wait for those technicians for days, sometimes a week, to get their machine fixed. And again in the meantime you have to send all your samples to another lab.
5. Specialized tests e.g. all molecular diagnostic tests (like HIV viral load), TB culture, are only done in the core reference lab in the capital city. Even the GeneXpert is not yet decentralized.

Potential solutions:
1. For lab machines, labs should probably have their own personnel trained in servicing machines when there is a breakdown instead of waiting for technicians from the companies that supply machines.
2. Establishing regional stores will ease the pressure on one main store. It will also make it easier on forecasting for one region compared to forecasting for the whole country. Uninterrupted inventory system is crucial for the smooth running of laboratories.
3. Skilled staff shortage has been a problem in many developing countries for a long time. Maybe training more lab staff and offering more attractive remuneration and working conditions will help.

Best regards,

Violet

The laboratory plays a very vital role in patients care and treatment services especially in resource limited settings,but the dearth of professional laboratory personnel has adversely hampered the survielance and prevention of diseases in developning countries.More over,the health systems in most developing african countries like nigeria,has placed low regards for the clinical laboratory,hence most lab staff in government hospitals has never been given on the training and refresher cousers since after graduating from the university.there is no capacity building for the laboratory personnels.We do hope that in the nearest future,the laboratory will have a new phase,
thank God for the international donor agencies/NGOs that have come to boast the image of the laboratory.
ACHU ETTA

Its a pleasure to be part of this community. I am a physician working at a district hospital in Namibia. I have also worked in Zimbabwe and Lesotho. Efficient and accessible diagnostic tools results in improved medical care, reduced long term health costs, doctor and patient satisfaction. In developing countries this has been a major challenge. I will not say more on challenges as Violet, whom l work with, has already mentioned them.

I will try to give you more insight on this challenge. The top 5 tests done at our hospital are full blood count, urea and electrolytes, liver function tests, CD4 and sputum microscopy. You will see from the list that the only specific diagnostic test is the sputum microscopy whereas the rest are essential, but mostly evaluate the state of organs as well as for monitoring purposes. In terms of the specific tests the top are sputum microscopy, RPR, malaria rapid tests and urine microscopy. For most of the other diseases the specific tests are either not available or done at central laboratories.

The success of rapid tests especially malaria cannot be over emphasized as we have seen a dramatic decline in cases of patients dying of ...

Its a pleasure to be part of this community. I am a physician working at a district hospital in Namibia. I have also worked in Zimbabwe and Lesotho. Efficient and accessible diagnostic tools results in improved medical care, reduced long term health costs, doctor and patient satisfaction. In developing countries this has been a major challenge. I will not say more on challenges as Violet, whom l work with, has already mentioned them.

I will try to give you more insight on this challenge. The top 5 tests done at our hospital are full blood count, urea and electrolytes, liver function tests, CD4 and sputum microscopy. You will see from the list that the only specific diagnostic test is the sputum microscopy whereas the rest are essential, but mostly evaluate the state of organs as well as for monitoring purposes. In terms of the specific tests the top are sputum microscopy, RPR, malaria rapid tests and urine microscopy. For most of the other diseases the specific tests are either not available or done at central laboratories.

The success of rapid tests especially malaria cannot be over emphasized as we have seen a dramatic decline in cases of patients dying of malaria in Namibia. The rapid tests are available in all health clinics and almost done to all patients suspected of having malaria. In the past 6 months the hospital recorded only 1 death from malaria. This is one of the reason that makes me so optimistic about the GeneXpert test as it will cover some of the short falls of the sputum microscopy tests.

The story goes beyond this however, as its not only infections we have to deal with. Michele Meltzer highlighted this challenge in most resource limited places. HIV has brought other diseases as well which l must admit we are struggling to both diagnose and treat. Examples which quickly come in my mind are HIV nephropathy and HIV related leukemias. Diagnosing these and other diseases is difficult and at times results takes so long to be availed. Histology tests takes about a month to be processed due to limited resources. Lets not forget there is still diabetes, hypertension and their complications all of which need good diagnostic tools.

Eventually what l have noticed is that due to limited diagnostic tools, unfortunately most of the physicians and laboratory staff end up even forgetting about the tests and their importance. I hope together we can share ideas on how to improve on these obstacles.

Dear colleagues,
As probably everywhere effectiveness of our regional TB control program in Vladimir region, Russia, critically depends on laboratories performance. Since resources in terms of staff salaries, equipment and supplies are much more available during last several years, I believe most important issues we face now are laboratory quality assurance, development of optimal laboratory case finding, diagnostic and treatment follow up algorithm which includes sputum fluorescent microscopy, rapid molecular tests (Xpert MTB/Rif), solid and liquid media cultures and F&SL DST. During last 5 - 7 years we introduced several highly sensitive - but quite expensive (and some even very labor intensive) - methods, but to keep laboratory sustainable there is real need to rethink the whole lab process and develop rational and cost effective algorithm to have pathogen confirmation as fast and complete as possible but for affordable cost as well. This collaborative effort of laboratory managers and clinicians requires operational research knowledge and skills, but for most staff in my country such educational background is quite weak.

Grigory Volchenkov, Regional TB Dispensary, Vladimir, Russia

Improving capacities for laboratories to meet the diagnostics needs of different settings is very important and can best be achieved by decentralising a lot of functions that are currently being done at national levels.Procurement and supply chain management from a very centralised level in resource limited nations often has a lot of challenges that result in stock ruptures of requisite vital commodities and over stocking of some commodities and even medicines.
Through a push system of distribution of laboratory commodities from a central level l have witnessed a Provincial hospital overstocked with RDTs that get to expire on shelf, but lack reagents to do renal function tests and liver function tests which would important in managing complicated malaria cases at that level.
My colleague Violet proferred setting up regional stores for distribution as one possible solution to logistical challenges.I also think a serious committment by national level staff to decentralise
the procurement and distribution of laboratory commodities would go a long way in building capacities of laboratories at lower levels.

Entirely agree.

Sandeep
On 26 Feb 2013 13:03, "GHDonline (Fabian Mashingaidze)" <
> wrote:

>
> Fabian Mashingaidze replied to the "Building Capacity for Diagnostics"
> expert panel.
>
> Reply contents:
> "Improving capacities for laboratories to meet the diagnostics needs of
> different settings is very important and can best be achieved by
> decentralising a lot of functions that are currently being done at national
> levels.Procurement and supply chain management from a very centralised
> level in resource limited nations often has a lot of challenges that result
> in stock ruptures of requisite vital commodities and over stocking of some
> commodities and even medicines.
> Through a push system of distribution of laboratory commodities from a
> central level l have witnessed a Provincial hospital overstocked with RDTs
> that get to expire on shelf, but lack reagents to do renal function tests
> and liver function tests which would important in managing complicated
> malaria cases at that level.
> My colleague Violet proferred setting up regional stores for distribution
> as one possible solution to logistical challenges.I also think a serious
> committment by national level staff to decentralise
> the procurement and distribution of laboratory commodities would go a long
> way in building capacities of laboratories at lower ...

Entirely agree.

Sandeep
On 26 Feb 2013 13:03, "GHDonline (Fabian Mashingaidze)" <
> wrote:

>
> Fabian Mashingaidze replied to the "Building Capacity for Diagnostics"
> expert panel.
>
> Reply contents:
> "Improving capacities for laboratories to meet the diagnostics needs of
> different settings is very important and can best be achieved by
> decentralising a lot of functions that are currently being done at national
> levels.Procurement and supply chain management from a very centralised
> level in resource limited nations often has a lot of challenges that result
> in stock ruptures of requisite vital commodities and over stocking of some
> commodities and even medicines.
> Through a push system of distribution of laboratory commodities from a
> central level l have witnessed a Provincial hospital overstocked with RDTs
> that get to expire on shelf, but lack reagents to do renal function tests
> and liver function tests which would important in managing complicated
> malaria cases at that level.
> My colleague Violet proferred setting up regional stores for distribution
> as one possible solution to logistical challenges.I also think a serious
> committment by national level staff to decentralise
> the procurement and distribution of laboratory commodities would go a long
> way in building capacities of laboratories at lower levels."
>
> --
> View this post online:
> <
> http://www.ghdonline.org/diagnostics-panel/discussion/building-capacity-for-d...
> >
>
> Unsubscribe or change your email notification settings:
> <http://www.ghdonline.org/users/sandeep-saluja/edit/>
>
> Contact the GHDonline team:
> <http://www.ghdonline.org/contact/>
>
> You can reply to this discussion by responding directly to this e-mail; it
> will be shared with all community members and posted as is. Files cannot be
> added via email attachment and must be uploaded directly to GHDonline.
>

well yes in principle i agree with moving stock down to where these are
needed
but not entirely:
1- larger stock/buffers okay for sputum containers and basic chemicals/long
shelf lives, but larger overall stocks may have limits
(budgets/disbursement cycles) for more expensive good
2- reporting system on what is in stock, issued, used, expired and
lost.......creating sudden stock outs, emergencies because usage is not
recorded
3- Losses, risks of damage in poor storage conditions

just some of the thoughts i have (at central level)

On Tue, Feb 26, 2013 at 2:40 PM, GHDonline (Sandeep Saluja) <
> wrote:

>
> Sandeep Saluja replied to the "Building Capacity for Diagnostics" expert
> panel.
>
> Reply contents:
> "Entirely agree.
>
> Sandeep
> On 26 Feb 2013 13:03, "GHDonline (Fabian Mashingaidze)" <
> > wrote:
>
> >
> > Fabian Mashingaidze replied to the "Building Capacity for Diagnostics"
> > expert panel.
> >
> > Reply contents:
> > "Improving capacities for laboratories to meet the diagnostics needs of
> > different settings is very important and can best be achieved by
> > decentralising a lot of functions that are currently being done at
> national
> > levels.Procurement and supply chain management from a very centralised
> > level in resource limited nations often has a lot of challenges ...

well yes in principle i agree with moving stock down to where these are
needed
but not entirely:
1- larger stock/buffers okay for sputum containers and basic chemicals/long
shelf lives, but larger overall stocks may have limits
(budgets/disbursement cycles) for more expensive good
2- reporting system on what is in stock, issued, used, expired and
lost.......creating sudden stock outs, emergencies because usage is not
recorded
3- Losses, risks of damage in poor storage conditions

just some of the thoughts i have (at central level)

On Tue, Feb 26, 2013 at 2:40 PM, GHDonline (Sandeep Saluja) <
> wrote:

>
> Sandeep Saluja replied to the "Building Capacity for Diagnostics" expert
> panel.
>
> Reply contents:
> "Entirely agree.
>
> Sandeep
> On 26 Feb 2013 13:03, "GHDonline (Fabian Mashingaidze)" <
> > wrote:
>
> >
> > Fabian Mashingaidze replied to the "Building Capacity for Diagnostics"
> > expert panel.
> >
> > Reply contents:
> > "Improving capacities for laboratories to meet the diagnostics needs of
> > different settings is very important and can best be achieved by
> > decentralising a lot of functions that are currently being done at
> national
> > levels.Procurement and supply chain management from a very centralised
> > level in resource limited nations often has a lot of challenges that
> result
> > in stock ruptures of requisite vital commodities and over stocking of
> some
> > commodities and even medicines.
> > Through a push system of distribution of laboratory commodities from a
> > central level l have witnessed a Provincial hospital overstocked with
> RDTs
> > that get to expire on shelf, but lack reagents to do renal function tests
> > and liver function tests which would important in managing complicated
> > malaria cases at that level.
> > My colleague Violet proferred setting up regional stores for distribution
> > as one possible solution to logistical challenges.I also think a serious
> > committment by national level staff to decentralise
> > the procurement and distribution of laboratory commodities would go a
> long
> > way in building capacities of laboratories at lower levels."
> >
> > --
> > View this post online:
> > <
> >
> http://www.ghdonline.org/diagnostics-panel/discussion/building-capacity-for-d...
> > >
> >
> > Unsubscribe or change your email notification settings:
> > <http://www.ghdonline.org/users/sandeep-saluja/edit/>
> >
> > Contact the GHDonline team:
> > <http://www.ghdonline.org/contact/>
> >
> > You can reply to this discussion by responding directly to this e-mail;
> it
> > will be shared with all community members and posted as is. Files cannot
> be
> > added via email attachment and must be uploaded directly to GHDonline.
> >"
>
> --
> View this post online:
> <
> http://www.ghdonline.org/diagnostics-panel/discussion/building-capacity-for-d...
> >
>
> Unsubscribe or change your email notification settings:
> <http://www.ghdonline.org/users/pascal-verhoeven/edit/>
>
> Contact the GHDonline team:
> <http://www.ghdonline.org/contact/>
>
> You can reply to this discussion by responding directly to this e-mail; it
> will be shared with all community members and posted as is. Files cannot be
> added via email attachment and must be uploaded directly to GHDonline.
>



--

with kind regards
Pascal Verhoeven
MPH/pharmacist
Lao PDR
Mobile
+856(0)2077596717
+856(0)2097141783

Dear all


Looking to the future stock control may soon be aided by new
developments in connectivity. Examples are mobile phones that record
test results, and (after coding for security) send the result and
details of the test device along with the location (GPS) to a cloud –
which is accessed for surveillance (real time tracking of diseases), for
stock control purposes or can be used to monitor performance for QC
purposes.
It may sound fanciful but supermarkets have been controlling their
stock by barcoding for years and companies already monitor the
performance of their instruments (the GeneXpert has this capacity).
Things are moving quickly and there has recently been some debate in
R&D circles about the need to standardise connectivity systems. We
shall need to be aware of the potential of new technology so we can
influence developments to make sure they meet our needs, and to get
timely access.
Kind regards
Ruth
>>> "GHDonline (Fabian Mashingaidze)" <>
26/02/2013 07:33 >>>

Fabian Mashingaidze replied to the "Building Capacity for Diagnostics"
expert panel.

Reply contents:
"Improving capacities for laboratories to meet the diagnostics needs of
different settings is very important and can best be achieved by
decentralising ...

Dear all


Looking to the future stock control may soon be aided by new
developments in connectivity. Examples are mobile phones that record
test results, and (after coding for security) send the result and
details of the test device along with the location (GPS) to a cloud –
which is accessed for surveillance (real time tracking of diseases), for
stock control purposes or can be used to monitor performance for QC
purposes.
It may sound fanciful but supermarkets have been controlling their
stock by barcoding for years and companies already monitor the
performance of their instruments (the GeneXpert has this capacity).
Things are moving quickly and there has recently been some debate in
R&D circles about the need to standardise connectivity systems. We
shall need to be aware of the potential of new technology so we can
influence developments to make sure they meet our needs, and to get
timely access.
Kind regards
Ruth
>>> "GHDonline (Fabian Mashingaidze)" <>
26/02/2013 07:33 >>>

Fabian Mashingaidze replied to the "Building Capacity for Diagnostics"
expert panel.

Reply contents:
"Improving capacities for laboratories to meet the diagnostics needs of
different settings is very important and can best be achieved by
decentralising a lot of functions that are currently being done at
national levels.Procurement and supply chain management from a very
centralised level in resource limited nations often has a lot of
challenges that result in stock ruptures of requisite vital commodities
and over stocking of some commodities and even medicines.
Through a push system of distribution of laboratory commodities from a
central level l have witnessed a Provincial hospital overstocked with
RDTs that get to expire on shelf, but lack reagents to do renal function
tests and liver function tests which would important in managing
complicated malaria cases at that level.
My colleague Violet proferred setting up regional stores for
distribution as one possible solution to logistical challenges.I also
think a serious committment by national level staff to decentralise
the procurement and distribution of laboratory commodities would go a
long way in building capacities of laboratories at lower levels."

--
View this post online:
<http://www.ghdonline.org/diagnostics-panel/discussion/building-capacity-for-d...>

Unsubscribe or change your email notification settings:
<http://www.ghdonline.org/users/ruth-mcnerney/edit/>

Contact the GHDonline team:
<http://www.ghdonline.org/contact/>

You can reply to this discussion by responding directly to this e-mail;
it will be shared with all community members and posted as is. Files
cannot be added via email attachment and must be uploaded directly to
GHDonline.

Dear Colleagues
Thank you so much for such exciting discussions. I am a Lab Scientist and am working in a TB culture laboratory. I do really think that there is need for us to seriously consider the new molecular methods for TB diagnostics. Given the increase in MDR-TB and the TAT for TB culture and DST, Molecular methods is the way to go. so much as I love to see the TB bacilli grow in culture , I think molecular techniques help us to intervene early and prevent the spread of this drug resistant TB

I completely agree we need to move away from TB culture for reasons of
safety. Unfortunately, with the exception of rifampicin, the molecular
tests are not yet adequate for drug susceptibility testing and so we
cannot do away with culture completely - so don't hang up your lab coats
just yet!
There are many mutations that can cause resistance to the other drugs
and low cost, easy to use technology to screen for them all is not yet
available. In addition we do not yet fully understand all the mutations
that predict resistance – this problem is on the way to be solved by
large scale sequencing projects that are being undertaken by ourselves
and others. A more difficult problem is deciding the clinical
significance of the various mutations in terms of treatment
success/failure.
For diagnosis the GeneXpert is very good, but is not affordable in some
settings (minimum price USD10 per cassette). It also requires a reliable
source of power, a safe place to store the cassettes, which are quite
bulky and in some settings air conditioning is needed. Results are
available in under 2 hours so same day testing/treatment registration is
feasible for people tested in the ...

I completely agree we need to move away from TB culture for reasons of
safety. Unfortunately, with the exception of rifampicin, the molecular
tests are not yet adequate for drug susceptibility testing and so we
cannot do away with culture completely - so don't hang up your lab coats
just yet!
There are many mutations that can cause resistance to the other drugs
and low cost, easy to use technology to screen for them all is not yet
available. In addition we do not yet fully understand all the mutations
that predict resistance – this problem is on the way to be solved by
large scale sequencing projects that are being undertaken by ourselves
and others. A more difficult problem is deciding the clinical
significance of the various mutations in terms of treatment
success/failure.
For diagnosis the GeneXpert is very good, but is not affordable in some
settings (minimum price USD10 per cassette). It also requires a reliable
source of power, a safe place to store the cassettes, which are quite
bulky and in some settings air conditioning is needed. Results are
available in under 2 hours so same day testing/treatment registration is
feasible for people tested in the morning that don’t mind waiting
around. It is more sensitive than smear microscopy but not quite as good
as high quality culture.
There are two alternative molecular tests ready for the market that may
be cheaper, from China (Ustar) and India (Bigtec Labs) – but they have
not yet been evaluated and we don’t know how well they work.
The Achilles’ heel of molecular tests for TB is sample preparation as
sputum is difficult to work with and often doesn’t contain very many
bacteria. GeneXpert solves this problem by using a sophisticated
(expensive) cassette and instrumentation with microfluidics and
sonication.
There are some very promising tests in development using alternative
technology, including tests to differentiate active TB from latent
infection but we shall need to be patient for a few more years for
these. I am sure you are already aware that the current crop of
serological tests for TB are not reliable and should not be used.
One of the barriers we face is that diagnostics research is under
funded, and receives far less than money than drugs or vaccines
research. Yet it could make such a difference for a disease such as TB.

best wishes
Ruth

>>> "GHDonline (Ellen Munemo)" <>
26/02/2013 22:07 >>>

Ellen Munemo replied to the "Building Capacity for Diagnostics" expert
panel.

Reply contents:
"Dear Colleagues
Thank you so much for such exciting discussions. I am a Lab Scientist
and am working in a TB culture laboratory. I do really think that there
is need for us to seriously consider the new molecular methods for TB
diagnostics. Given the increase in MDR-TB and the TAT for TB culture and
DST, Molecular methods is the way to go. so much as I love to see the TB
bacilli grow in culture , I think molecular techniques help us to
intervene early and prevent the spread of this drug resistant TB"

--
View this post online:
<http://www.ghdonline.org/diagnostics-panel/discussion/building-capacity-for-d...>

Unsubscribe or change your email notification settings:
<http://www.ghdonline.org/users/ruth-mcnerney/edit/>

Contact the GHDonline team:
<http://www.ghdonline.org/contact/>

You can reply to this discussion by responding directly to this e-mail;
it will be shared with all community members and posted as is. Files
cannot be added via email attachment and must be uploaded directly to
GHDonline.

Thanks Ruth

I fully agree with your accurate description of challenges in TB diagnosis. We also have to think about patients unable to produce a sample but are suspected of having TB (30% of TB suspect in our population of southwestern Uganda) which include children and HIV positive patients. For them the string test is quite promising and has a recovery yield comparable to sputum induction. In the other hand what to do with Xpert negative in setting without culture facilities? Has anyone has experience with LAM?

Nice day

Sent from my iPad

On Feb 27, 2013, at 13:38, "GHDonline (Ruth MCNERNEY)" <> wrote:

>
> Ruth MCNERNEY replied to the "Building Capacity for Diagnostics" expert panel.
>
> Reply contents:
> "I completely agree we need to move away from TB culture for reasons of
> safety. Unfortunately, with the exception of rifampicin, the molecular
> tests are not yet adequate for drug susceptibility testing and so we
> cannot do away with culture completely - so don't hang up your lab coats
> just yet!
> There are many mutations that can cause resistance to the other drugs
> and low cost, easy to use technology to screen for them all is not yet
> available. In ...

Thanks Ruth

I fully agree with your accurate description of challenges in TB diagnosis. We also have to think about patients unable to produce a sample but are suspected of having TB (30% of TB suspect in our population of southwestern Uganda) which include children and HIV positive patients. For them the string test is quite promising and has a recovery yield comparable to sputum induction. In the other hand what to do with Xpert negative in setting without culture facilities? Has anyone has experience with LAM?

Nice day

Sent from my iPad

On Feb 27, 2013, at 13:38, "GHDonline (Ruth MCNERNEY)" <> wrote:

>
> Ruth MCNERNEY replied to the "Building Capacity for Diagnostics" expert panel.
>
> Reply contents:
> "I completely agree we need to move away from TB culture for reasons of
> safety. Unfortunately, with the exception of rifampicin, the molecular
> tests are not yet adequate for drug susceptibility testing and so we
> cannot do away with culture completely - so don't hang up your lab coats
> just yet!
> There are many mutations that can cause resistance to the other drugs
> and low cost, easy to use technology to screen for them all is not yet
> available. In addition we do not yet fully understand all the mutations
> that predict resistance – this problem is on the way to be solved by
> large scale sequencing projects that are being undertaken by ourselves
> and others. A more difficult problem is deciding the clinical
> significance of the various mutations in terms of treatment
> success/failure.
> For diagnosis the GeneXpert is very good, but is not affordable in some
> settings (minimum price USD10 per cassette). It also requires a reliable
> source of power, a safe place to store the cassettes, which are quite
> bulky and in some settings air conditioning is needed. Results are
> available in under 2 hours so same day testing/treatment registration is
> feasible for people tested in the morning that don’t mind waiting
> around. It is more sensitive than smear microscopy but not quite as good
> as high quality culture.
> There are two alternative molecular tests ready for the market that may
> be cheaper, from China (Ustar) and India (Bigtec Labs) – but they have
> not yet been evaluated and we don’t know how well they work.
> The Achilles’ heel of molecular tests for TB is sample preparation as
> sputum is difficult to work with and often doesn’t contain very many
> bacteria. GeneXpert solves this problem by using a sophisticated
> (expensive) cassette and instrumentation with microfluidics and
> sonication.
> There are some very promising tests in development using alternative
> technology, including tests to differentiate active TB from latent
> infection but we shall need to be patient for a few more years for
> these. I am sure you are already aware that the current crop of
> serological tests for TB are not reliable and should not be used.
> One of the barriers we face is that diagnostics research is under
> funded, and receives far less than money than drugs or vaccines
> research. Yet it could make such a difference for a disease such as TB.
>
> best wishes
> Ruth
>
>>>> "GHDonline (Ellen Munemo)" <>
> 26/02/2013 22:07 >>>
>
> Ellen Munemo replied to the "Building Capacity for Diagnostics" expert
> panel.
>
> Reply contents:
> "Dear Colleagues
> Thank you so much for such exciting discussions. I am a Lab Scientist
> and am working in a TB culture laboratory. I do really think that there
> is need for us to seriously consider the new molecular methods for TB
> diagnostics. Given the increase in MDR-TB and the TAT for TB culture and
> DST, Molecular methods is the way to go. so much as I love to see the TB
> bacilli grow in culture , I think molecular techniques help us to
> intervene early and prevent the spread of this drug resistant TB"
>
> --
> View this post online:
> <http://www.ghdonline.org/diagnostics-panel/discussion/building-capacity-for-d...>
>
> Unsubscribe or change your email notification settings:
> <http://www.ghdonline.org/users/ruth-mcnerney/edit/>
>
> Contact the GHDonline team:
> <http://www.ghdonline.org/contact/>
>
> You can reply to this discussion by responding directly to this e-mail;
> it will be shared with all community members and posted as is. Files
> cannot be added via email attachment and must be uploaded directly to
> GHDonline."
>
> --
> View this post online:
> <http://www.ghdonline.org/diagnostics-panel/discussion/building-capacity-for-d...>
>
> Unsubscribe or change your email notification settings:
> <http://www.ghdonline.org/users/yap-boum-ii/edit/>
>
> Contact the GHDonline team:
> <http://www.ghdonline.org/contact/>
>
> You can reply to this discussion by responding directly to this e-mail; it will be shared with all community members and posted as is. Files cannot be added via email attachment and must be uploaded directly to GHDonline.

Many thanks for your invitation to join the Building Capacity for Diagnostics community at GHDonline. This is indeed an excellent initiative that will provide a forum for Lab experts to discuss professional issues.
I think, one of the major factor that has largely contributed to weak Laboratory practices in Africa, is lack of legislation to guide practices, by African governments. This was the same trend in USA until they embedded Clinical Lab practices into their legislation. They often referred to this legislation as CLIA 1988.
In Kenya, the practice is gaining edge and the sooner we enact the Clinical Laboratory practices into our legislation the faster the profession will grow.
Many thanks
Ken

Determine TB-LAM Ag from ALERE is a simple test for lipoarabinomannan
in urine, it is cheaper than expert (I think around 3 to 4 USD per test)
it does not need a fancy instrument, take a few minutes and is easy to
use. It is for use in people with very low CD4 counts, it is not useful
for people who do not have low CD4 counts.
Steve Lawn and colleagues found it effective in an HIV clinic in Cape
Town and discussed its performance the context of smear, culture,
GeneXpert etc.
http://www.sciencedirect.com/science/article/pii/S1473309911702511
but there have been some concerns expressed about specificity in other
settings.

The quality of a sputum sample is crucial for TB diagnosis. A few
years ago we produced some materials (posters, leaflets and videos) to
help patients. Should anyone wish to use the artwork to make their own
posters or leaflets then these are freely available (send me a mail).
They have been used in various African countries and I believe someone
is currently translating into Swahili and Xhosa. We were going to do a
small study in of their effectiveness in Uganda but we ran out of funds ...

Determine TB-LAM Ag from ALERE is a simple test for lipoarabinomannan
in urine, it is cheaper than expert (I think around 3 to 4 USD per test)
it does not need a fancy instrument, take a few minutes and is easy to
use. It is for use in people with very low CD4 counts, it is not useful
for people who do not have low CD4 counts.
Steve Lawn and colleagues found it effective in an HIV clinic in Cape
Town and discussed its performance the context of smear, culture,
GeneXpert etc.
http://www.sciencedirect.com/science/article/pii/S1473309911702511
but there have been some concerns expressed about specificity in other
settings.

The quality of a sputum sample is crucial for TB diagnosis. A few
years ago we produced some materials (posters, leaflets and videos) to
help patients. Should anyone wish to use the artwork to make their own
posters or leaflets then these are freely available (send me a mail).
They have been used in various African countries and I believe someone
is currently translating into Swahili and Xhosa. We were going to do a
small study in of their effectiveness in Uganda but we ran out of funds.
If you would like to see the artwork then we have a cartoon on youtube
http://www.youtube.com/watch?v=HhW85reE0Ug
We also have a version and video appropriate to parts of Latin America
(Spanish and indigenous languages) done in collaboration with a Spanish
NGO and people in Bolivia and we are currently drafting an article for
publication http://www.youtube.com/watch?v=pOAoBM0xH8A
best wishes
Ruth

>>> "GHDonline (YAP BOUM II)" <>
27/02/2013 12:03 >>>

YAP BOUM II replied to the "Building Capacity for Diagnostics" expert
panel.

Reply contents:
"Thanks Ruth

I fully agree with your accurate description of challenges in TB
diagnosis. We also have to think about patients unable to produce a
sample but are suspected of having TB (30% of TB suspect in our
population of southwestern Uganda) which include children and HIV
positive patients. For them the string test is quite promising and has a
recovery yield comparable to sputum induction. In the other hand what to
do with Xpert negative in setting without culture facilities? Has anyone
has experience with LAM?

Nice day

Sent from my iPad

On Feb 27, 2013, at 13:38, "GHDonline (Ruth MCNERNEY)"
<> wrote:

>
> Ruth MCNERNEY replied to the "Building Capacity for Diagnostics"
expert panel.
>
> Reply contents:
> "I completely agree we need to move away from TB culture for reasons
of
> safety. Unfortunately, with the exception of rifampicin, the
molecular
> tests are not yet adequate for drug susceptibility testing and so we
> cannot do away with culture completely - so don't hang up your lab
coats
> just yet!
> There are many mutations that can cause resistance to the other
drugs
> and low cost, easy to use technology to screen for them all is not
yet
> available. In addition we do not yet fully understand all the
mutations
> that predict resistance – this problem is on the way to be solved by
> large scale sequencing projects that are being undertaken by
ourselves
> and others. A more difficult problem is deciding the clinical
> significance of the various mutations in terms of treatment
> success/failure.
> For diagnosis the GeneXpert is very good, but is not affordable in
some
> settings (minimum price USD10 per cassette). It also requires a
reliable
> source of power, a safe place to store the cassettes, which are
quite
> bulky and in some settings air conditioning is needed. Results are
> available in under 2 hours so same day testing/treatment registration
is
> feasible for people tested in the morning that don’t mind waiting
> around. It is more sensitive than smear microscopy but not quite as
good
> as high quality culture.
> There are two alternative molecular tests ready for the market that
may
> be cheaper, from China (Ustar) and India (Bigtec Labs) – but they
have
> not yet been evaluated and we don’t know how well they work.
> The Achilles’ heel of molecular tests for TB is sample preparation
as
> sputum is difficult to work with and often doesn’t contain very many
> bacteria. GeneXpert solves this problem by using a sophisticated
> (expensive) cassette and instrumentation with microfluidics and
> sonication.
> There are some very promising tests in development using alternative
> technology, including tests to differentiate active TB from latent
> infection but we shall need to be patient for a few more years for
> these. I am sure you are already aware that the current crop of
> serological tests for TB are not reliable and should not be used.
> One of the barriers we face is that diagnostics research is under
> funded, and receives far less than money than drugs or vaccines
> research. Yet it could make such a difference for a disease such as
TB.
>
> best wishes
> Ruth
>
>>>> "GHDonline (Ellen Munemo)" <>
> 26/02/2013 22:07 >>>
>
> Ellen Munemo replied to the "Building Capacity for Diagnostics"
expert
> panel.
>
> Reply contents:
> "Dear Colleagues
> Thank you so much for such exciting discussions. I am a Lab
Scientist
> and am working in a TB culture laboratory. I do really think that
there
> is need for us to seriously consider the new molecular methods for
TB
> diagnostics. Given the increase in MDR-TB and the TAT for TB culture
and
> DST, Molecular methods is the way to go. so much as I love to see the
TB
> bacilli grow in culture , I think molecular techniques help us to
> intervene early and prevent the spread of this drug resistant TB"
>
> --
> View this post online:
>
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Thank you to everyone for the very informative discussion so far.

I am a graduate student in the U.S. working on the development of rapid, point-of-care hematology tests as well as other rapid diagnostic tests.

From your experience with current rapid tests for things like HIV and malaria, what are some considerations you think are important to consider when designing new tests?

For example, how could rapid tests be better designed to complement the workflow of a local clinic or a regional lab?

What are the main obstacles in the adoption of rapid tests (mistrust of new technology, poor training on proper use, lack of knowledge about new tests, etc.)?

What kinds of laboratory tests would be most beneficial (in terms of clinical action, improved capacity at local levels) to develop into rapid, point-of-care tests?

Thanks in advance for any insights and responses.

Best,
A.J.

This is a great topic and one of much import. I'm a nurse currently in Guatemala participating in a cervical cancer screening/treatment project. I know that GAVI has been trying to get rapidHPV testing available to LMICs, but I wanted to ask if anyone was able to provide details. Also, a sorely needed rapid diagnostic test needed here is for gonorrhea and chlamydia. We are limited to the syndromic approach as outlined by the WHO, but this leads to a considerable amount of over treatment. Any information on the future of/potential for GC/CT rapid testing would be greatly appreciated. Thank you! - Maggie Sullivan

Dear A.J.

I am sure you will get very useful insight from individuals working in the field but there is also a large body of literature around this topic that is freely available on the internet.

A couple of reviews to get you going



Towards a point-of-care test for active tuberculosis. http://www.nature.com/nrmicro/journal/v9/n3/full/nrmicro2521.html


Point-of-Care Tests to Strengthen Health Systems and Save Newborn Lives: The Case of Syphilis http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001233


Rapid tests for sexually transmitted infections http://sti.bmj.com/content/82/suppl_5/v1.full


There is access to more articles on the Global Health Diagnostics pages http://globalhealthdiagnostics.tghn.org/articles/?page=2

An easy way to keep up to date with published literature is by registering with http://pubcrawler.gen.tcd.ie/


best wishes
Ruth

>>> "GHDonline (Ashok Kumar)" <> 27/02/2013 16:00 >>>

Ashok Kumar replied to the "Building Capacity for Diagnostics" expert panel.

Reply contents:
"Thank you to everyone for the very informative discussion so far.

I am a graduate student in the U.S. working on the development of rapid, point-of-care hematology tests as ...

Dear A.J.

I am sure you will get very useful insight from individuals working in the field but there is also a large body of literature around this topic that is freely available on the internet.

A couple of reviews to get you going



Towards a point-of-care test for active tuberculosis. http://www.nature.com/nrmicro/journal/v9/n3/full/nrmicro2521.html


Point-of-Care Tests to Strengthen Health Systems and Save Newborn Lives: The Case of Syphilis http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001233


Rapid tests for sexually transmitted infections http://sti.bmj.com/content/82/suppl_5/v1.full


There is access to more articles on the Global Health Diagnostics pages http://globalhealthdiagnostics.tghn.org/articles/?page=2

An easy way to keep up to date with published literature is by registering with http://pubcrawler.gen.tcd.ie/


best wishes
Ruth

>>> "GHDonline (Ashok Kumar)" <> 27/02/2013 16:00 >>>

Ashok Kumar replied to the "Building Capacity for Diagnostics" expert panel.

Reply contents:
"Thank you to everyone for the very informative discussion so far.

I am a graduate student in the U.S. working on the development of rapid, point-of-care hematology tests as well as other rapid diagnostic tests.

>From your experience with current rapid tests for things like HIV and malaria, what are some considerations you think are important to consider when designing new tests?

For example, how could rapid tests be better designed to complement the workflow of a local clinic or a regional lab?

What are the main obstacles in the adoption of rapid tests (mistrust of new technology, poor training on proper use, lack of knowledge about new tests, etc.)?

What kinds of laboratory tests would be most beneficial (in terms of clinical action, improved capacity at local levels) to develop into rapid, point-of-care tests?

Thanks in advance for any insights and responses.

Best,
A.J."

--
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<http://www.ghdonline.org/diagnostics-panel/discussion/building-capacity-for-d...>

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Dear Victor,
Here in Namibia, HIV and malaria RDTs are used widely by trained healthcare workers, usually nurses, at HIV counseling and testing centers and public health clinics. We have a training program for HIV rapid testing coordinated by the International Training and Education Center on Health (I-TECH). I have trained nurses for the Ministries of Health and Defense with I-TECH. The training lasts 5 working days; successful participants are issued with certificates which are renewed annually based on performance. The External Quality Assurance (EQA) has 3 aspects:
1- Proficiency testing where they are given "blind" samples every quarter from the National reference lab
2- Sample re-testing; they collect a venous blood sample for every 1 in 20th patient for re-testing with ELISA in the lab
3- On-site assessment by the Quality supervisors. These visits are mostly for quality improvement.
HIV rapid testing is a success story here because quality processes have been in place for a long time. However, we do not have an EQA system in place for malaria RDT's but these have vastly improved access of malaria testing and early treatment intervention especially in remote communities here.

Amy,
I totally agree with you on the need ...

Dear Victor,
Here in Namibia, HIV and malaria RDTs are used widely by trained healthcare workers, usually nurses, at HIV counseling and testing centers and public health clinics. We have a training program for HIV rapid testing coordinated by the International Training and Education Center on Health (I-TECH). I have trained nurses for the Ministries of Health and Defense with I-TECH. The training lasts 5 working days; successful participants are issued with certificates which are renewed annually based on performance. The External Quality Assurance (EQA) has 3 aspects:
1- Proficiency testing where they are given "blind" samples every quarter from the National reference lab
2- Sample re-testing; they collect a venous blood sample for every 1 in 20th patient for re-testing with ELISA in the lab
3- On-site assessment by the Quality supervisors. These visits are mostly for quality improvement.
HIV rapid testing is a success story here because quality processes have been in place for a long time. However, we do not have an EQA system in place for malaria RDT's but these have vastly improved access of malaria testing and early treatment intervention especially in remote communities here.

Amy,
I totally agree with you on the need for professional development of lab staff. We definitely and desperately need graduate training programs not only for capacity building but I also think that this would motivate a good number of laboratorians to stay in this field and provide much needed leadership to younger and less experienced staff.

Dear Ruth,

How are you? I see you have been very busy, brilliant initiatives! The issue of regulation is still weak in manyAfrican countries. I'm glad you have set the ball rolling to bring about improvement in this regard.
The second goal of initiative 2 is also equally important: Accreditation. We need to meet and maintain international standards in our laboratories. There are certain aspects of quality that seem to be downplayed or ignored in the labs: documentation of records and safety issues. We definitely need to train "mentors" who will have a sound command of standards e.g. CLSI accreditation guidelines and the overall Quality Management System for laboratories. We are trying to implement ISO 15189 standards and we realize that we also need to incorporate these guidelines in our university training programs. It's a lot of work which will take a great deal of commitment on the part of lab management and Ministries of Health to accomplish these noble goals.

Best,
Violet

Dear Ruth,

Thank you for the suggestions! I have read some of these and some of the
others look very helpful.

To clarify, I think my main question is about design/user interface with
diagnostic devices, which is generally not covered in the literature or
many of these evaluations. Besides the WHO's ASSURED criteria, I have
found some useful reviews on design of POC tests, such as this one:
http://www.annualreviews.org/doi/full/10.1146/annurev.bioeng.10.061807.160524.
I have, however, often learned the most valuable lessons from people using
tests in the field.

For example, home pregnancy tests should be read at a certain time after
use to guarantee accurate results. Assays that rely on silver
amplification or enzymatic amplification sometimes convert to positive at
some point in time even if a sample is negative. If read at the proper
time however, these tests are fairly accurate and are in common use.

I've heard from colleagues that nurses in a busy clinic did not like tests
similar to this because they were multitasking and had a hard time getting
back to each test after a specific time. They told my colleagues that they ...

Dear Ruth,

Thank you for the suggestions! I have read some of these and some of the
others look very helpful.

To clarify, I think my main question is about design/user interface with
diagnostic devices, which is generally not covered in the literature or
many of these evaluations. Besides the WHO's ASSURED criteria, I have
found some useful reviews on design of POC tests, such as this one:
http://www.annualreviews.org/doi/full/10.1146/annurev.bioeng.10.061807.160524.
I have, however, often learned the most valuable lessons from people using
tests in the field.

For example, home pregnancy tests should be read at a certain time after
use to guarantee accurate results. Assays that rely on silver
amplification or enzymatic amplification sometimes convert to positive at
some point in time even if a sample is negative. If read at the proper
time however, these tests are fairly accurate and are in common use.

I've heard from colleagues that nurses in a busy clinic did not like tests
similar to this because they were multitasking and had a hard time getting
back to each test after a specific time. They told my colleagues that they
would prefer a time insensitive test. Although somewhat obvious in
retrospect, we would not have known this because of the common use of
pregnancy tests. Changing the chemistry to be time-insensitive while
remaining clinically sensitive is a difficult task but may be worth working
on if this is a common problem.

Based on the user experience, are there other areas, such as timing, that
we in the R&D side should pay more attention to?

Best,
A.J.


On Wed, Feb 27, 2013 at 3:47 PM, GHDonline (Ruth MCNERNEY) <
> wrote:

>
> Ruth MCNERNEY replied to the "Building Capacity for Diagnostics" expert
> panel.
>
> Reply contents:
> "Dear A.J.
>
> I am sure you will get very useful insight from individuals working in the
> field but there is also a large body of literature around this topic that
> is freely available on the internet.
>
> A couple of reviews to get you going
>
>
>
> Towards a point-of-care test for active tuberculosis.
> http://www.nature.com/nrmicro/journal/v9/n3/full/nrmicro2521.html
>
>
> Point-of-Care Tests to Strengthen Health Systems and Save Newborn Lives:
> The Case of Syphilis
> http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001233
>
>
> Rapid tests for sexually transmitted infections
> http://sti.bmj.com/content/82/suppl_5/v1.full
>
>
> There is access to more articles on the Global Health Diagnostics pages
> http://globalhealthdiagnostics.tghn.org/articles/?page=2
>
> An easy way to keep up to date with published literature is by registering
> with http://pubcrawler.gen.tcd.ie/
>
>
> best wishes
> Ruth
>
> >>> "GHDonline (Ashok Kumar)" <>
> 27/02/2013 16:00 >>>
>
> Ashok Kumar replied to the "Building Capacity for Diagnostics" expert
> panel.
>
> Reply contents:
> "Thank you to everyone for the very informative discussion so far.
>
> I am a graduate student in the U.S. working on the development of rapid,
> point-of-care hematology tests as well as other rapid diagnostic tests.
>
> >From your experience with current rapid tests for things like HIV and
> malaria, what are some considerations you think are important to consider
> when designing new tests?
>
> For example, how could rapid tests be better designed to complement the
> workflow of a local clinic or a regional lab?
>
> What are the main obstacles in the adoption of rapid tests (mistrust of
> new technology, poor training on proper use, lack of knowledge about new
> tests, etc.)?
>
> What kinds of laboratory tests would be most beneficial (in terms of
> clinical action, improved capacity at local levels) to develop into rapid,
> point-of-care tests?
>
> Thanks in advance for any insights and responses.
>
> Best,
> A.J."
>
> --
> View this post online:
> <
> http://www.ghdonline.org/diagnostics-panel/discussion/building-capacity-for-d...
> >
>
> Unsubscribe or change your email notification settings:
> <http://www.ghdonline.org/users/ruth-mcnerney/edit/>
>
> Contact the GHDonline team:
> <http://www.ghdonline.org/contact/>
>
> You can reply to this discussion by responding directly to this e-mail; it
> will be shared with all community members and posted as is. Files cannot be
> added via email attachment and must be uploaded directly to GHDonline."
>
> --
> View this post online:
> <
> http://www.ghdonline.org/diagnostics-panel/discussion/building-capacity-for-d...
> >
>
> Unsubscribe or change your email notification settings:
> <http://www.ghdonline.org/users/ashok-kumar/edit/>
>
> Contact the GHDonline team:
> <http://www.ghdonline.org/contact/>
>
> You can reply to this discussion by responding directly to this e-mail; it
> will be shared with all community members and posted as is. Files cannot be
> added via email attachment and must be uploaded directly to GHDonline.
>

I nurse in the UK but, having had a little experience of health work in Swaziland, I would be interested to read opinions about diabetes diagnostics for asymptomatic people in developing countries - particularly where HIV &TB are significant problems.

HIV & TB infection, and the long term use of HAART bring large numbers of people in developing countries into contact with medical services. These are also factors contributing to the risk of developing metabolic syndrome and diabetes with resultant health complications. Treatments, such as metformin, which reduce the long term risks of these complications are available in many relatively resource poor settings but appropriate diagnostic facilities are crucial in order to access these therapies. Application of the current WHO diagnostic criteria for diabetes is not without problems when considering the identification of new cases amongst those with HIV or TB infection, or long term HAART use, in resource poor settings; fasting blood glucose measurements will be unobtainable for those who cannot be tested early in the morning due to long travelling times to treatment centres or because morning doses of medication, such as ARVs, must be taken with food; duration of fasting may be difficult to estimate if means of telling ...

I nurse in the UK but, having had a little experience of health work in Swaziland, I would be interested to read opinions about diabetes diagnostics for asymptomatic people in developing countries - particularly where HIV &TB are significant problems.

HIV & TB infection, and the long term use of HAART bring large numbers of people in developing countries into contact with medical services. These are also factors contributing to the risk of developing metabolic syndrome and diabetes with resultant health complications. Treatments, such as metformin, which reduce the long term risks of these complications are available in many relatively resource poor settings but appropriate diagnostic facilities are crucial in order to access these therapies. Application of the current WHO diagnostic criteria for diabetes is not without problems when considering the identification of new cases amongst those with HIV or TB infection, or long term HAART use, in resource poor settings; fasting blood glucose measurements will be unobtainable for those who cannot be tested early in the morning due to long travelling times to treatment centres or because morning doses of medication, such as ARVs, must be taken with food; duration of fasting may be difficult to estimate if means of telling the time are unavailable or the availability of food irregular; HbA1c testing may be unavailable or it may be an inappropriate test to apply (e.g. when there is significant anaemia).

The development and validation of diagnostic tests and procedures for diabetes suitable for use in resource poor settings are likely to be of value by enabling the provision of treatment to reduce diabetes related morbidity. Those with HIV or TB infection, and long term HAART users are a particular risk group who might benefit from such developments.

An extremely important topic. I worked as lab tech in different countries between Middle East and Southern Africa.
One senior colleague used to compare the lab, in endemic areas, to the eyes of physicians.

During my work in south Sudan, with Medecins Sans Frontieres (MSF), we used to have huge challenge in predicting the influx of patients. This was an issue for us and logistics to predict the size of supply. I had to estimate how much reagents we use per test for every disease. I used a simple Excel sheet for it. It was tedious at the beginning, but eventually it went well.

Screening for malaria, was a challenge as well, specially among children.

The toughest challenge was to screen babies and infants for TB.


Best,
Ziad

Without sufficient lab data, it is abig challenge to correctly and
efficiently procure supplies. There is need to strengthen the
laboratories in issues of data collection and use. My experience is
most lab officers do not sufficiently use their data to forecast their
needs. Supply Chain Management should be part of the curriculum during
training so that they may implement when they start working. In
Pharmacy, SCMS is in their curriculum.

--
Ellen Munemo
CMLSc - NMRL TB Lab
+263772891550
Skype - ellen.munemo2012

I'm Hawa Jande Golakai, trained as a medical immunologist/researcher which I worked as for years in South Africa before taking up my current post as program officer for the TB project in Liberia. In my experience working in both the laboratory/research and more corporate sphere, there is a wide gap. Applied science and public health and management need to interact more and learn each others' language, otherwise it is difficult for them to work toward the same deliverables and goals. In Liberia, there is a serious lack of trained professionals expecially in research and lab technology; the system is stretched trying to work with those currently available and sourcing new blood to join the pool. There is a definite need to invest in educating young people in biomedical and healthcare programs in Third world countries. Access and logistics to quality care can also be addressed with better road networks, communication services and quicker turnaround in procurement of basic drugs.

In response to Ruth McNerny's contribution (18) above I would like to comment from a perspective of social anthropology. Improving access to quality diagnostics in developing countries must be much more than increasing their capacity to function in the way that diagnostic services do in developed countries. There is a danger that development can become a business opportunity for industry in developed countries to export its technologies to countries that are less developed. For improved access to quality diagnostics to be sustainable the technological infrastructure to support these services also needs be nurtured in those developing countries and regions so that a degree of self-sufficiency is achieved.

I have suggested above (52) that existing technologies cannot necessarily be applied in uncritically in all settings. As examples the diagnosis of asymptomatic diabetes by fasting blood glucose may be straight forward in an urban context but awkward in rural areas with poor transport links, and anaemia may make the use of HbA1c inappropriate. In the first case there will be inequality of access to diagnostic opportunity based on geography, and in the latter case based on gender since women in developing countries are more commonly affected by anaemia than men. Investment ...

In response to Ruth McNerny's contribution (18) above I would like to comment from a perspective of social anthropology. Improving access to quality diagnostics in developing countries must be much more than increasing their capacity to function in the way that diagnostic services do in developed countries. There is a danger that development can become a business opportunity for industry in developed countries to export its technologies to countries that are less developed. For improved access to quality diagnostics to be sustainable the technological infrastructure to support these services also needs be nurtured in those developing countries and regions so that a degree of self-sufficiency is achieved.

I have suggested above (52) that existing technologies cannot necessarily be applied in uncritically in all settings. As examples the diagnosis of asymptomatic diabetes by fasting blood glucose may be straight forward in an urban context but awkward in rural areas with poor transport links, and anaemia may make the use of HbA1c inappropriate. In the first case there will be inequality of access to diagnostic opportunity based on geography, and in the latter case based on gender since women in developing countries are more commonly affected by anaemia than men. Investment in the research and development of diagnostic technologies which takes account of the contexts of life in developing countries has the potential to reduce such inequalities rather than increase them. I am sure that other contributors can cite better examples to illustrate the need for diagnostic technologies to be devised in developing countries where the particular contexts of their useage can be considered throughout the innovation process.

One of the comments was about rheumatoid arthritis. Diagnostic testing is helpful, but when I was in Kenya, I found the biggest barrier to making the correct diagnosis was the lack of knowledge. Rheumatoid arthritis can be diagnosed clinically. While blood work is helpful, it is not absolutely essential. There is a lack rheumatologists needed to educate both healthcare professionals and the public about rheumatoid arthritis. The answer is not in better diagnostic testing but in more teaching.

Dear A.J,

I am pleased that as a developer you are interested in what the end users experiences are with current rapid diagnostics. I think some of the issues to consider include:
1- Storage conditions especially temperature. For instance the HIV RDTs we use must be stored at temperatures ranging from 2 to 30 deg Celsius. In the summer temperature here in Namibia for example often exceeds 40 deg C. That means refrigeration must always be available and if there are power outages then there is that risk of inaccurate or invalid results. So maybe that should be considered for tests to be used in this part of the world.
2- With immunochromatography RDT's sometimes nurses in the clinics are not 100% sure about their interpretation of results. This is because of the intensity of the line in the TEST region of a device. So they will send a blood sample for lab confirmation before giving the patient a result.
3- How feasible is it to develop multiplex tests for use in busy clinics by healthcare workers who do a lot of multi-tasking?
4- Instead of the qualitative rapid test kits you can also look at developing semi-quantitative ...

Dear A.J,

I am pleased that as a developer you are interested in what the end users experiences are with current rapid diagnostics. I think some of the issues to consider include:
1- Storage conditions especially temperature. For instance the HIV RDTs we use must be stored at temperatures ranging from 2 to 30 deg Celsius. In the summer temperature here in Namibia for example often exceeds 40 deg C. That means refrigeration must always be available and if there are power outages then there is that risk of inaccurate or invalid results. So maybe that should be considered for tests to be used in this part of the world.
2- With immunochromatography RDT's sometimes nurses in the clinics are not 100% sure about their interpretation of results. This is because of the intensity of the line in the TEST region of a device. So they will send a blood sample for lab confirmation before giving the patient a result.
3- How feasible is it to develop multiplex tests for use in busy clinics by healthcare workers who do a lot of multi-tasking?
4- Instead of the qualitative rapid test kits you can also look at developing semi-quantitative tests.

Best,
Violet

Laboratories should create and implement quality policies to ensure that their facilities and staff are competent to carry out their tasks and produce quality results.
In Namibia our Core Reference Laboratory is accredited by SANAS and we use ISO 15189 standards for quality and competence. The organization has a quality policy and each lab should have a quality manual in place which details the standards that the lab must implement. We also have a Quality department which is responsible for annual internal audits of all our labs. After the audit each lab will get a feedback report outlining the non-conformances picked up by the auditors as well as successes. These non-conformances must be "cleared" by a given date. But the challenge of staff shortage and infrastructure is a setback in the implementation of Quality Management System especially in district labs. I will take time and a lot of effort for all the labs to be accredited. The positive thing is that we now have a policy and a system in place.

We use Meditech software for our Laboratory Information Systems in all our labs throughout the country, even at district hospital labs. This makes the flow of work much easier ...

Laboratories should create and implement quality policies to ensure that their facilities and staff are competent to carry out their tasks and produce quality results.
In Namibia our Core Reference Laboratory is accredited by SANAS and we use ISO 15189 standards for quality and competence. The organization has a quality policy and each lab should have a quality manual in place which details the standards that the lab must implement. We also have a Quality department which is responsible for annual internal audits of all our labs. After the audit each lab will get a feedback report outlining the non-conformances picked up by the auditors as well as successes. These non-conformances must be "cleared" by a given date. But the challenge of staff shortage and infrastructure is a setback in the implementation of Quality Management System especially in district labs. I will take time and a lot of effort for all the labs to be accredited. The positive thing is that we now have a policy and a system in place.

We use Meditech software for our Laboratory Information Systems in all our labs throughout the country, even at district hospital labs. This makes the flow of work much easier as it eliminated tedious paperwork. Lab instrument interface is also included and this reduces the chances of error during resulting of tests run on instruments.

Best regards,
Violet

Just to respond to Malcolm Brewster to point out that the market for POC diagnostic tests for infectious diseases is currently flooded with tests manufactured in developing countries/emerging economies (India, China, etc) Some of the tests are excellent, others are completely useless. Most have not been adequately evaluated in the population of intended use which is why we need to strengthen regulation in those countries that currently do not control the sale of diagnostics - to make sure they are safe and effective for the local population.

For those interested in reading about tech transfer for manufacturing diagnostics a landscaping report is available.
Increasing access to diagnostics through technology transfer and local production. 2011 WHO, Geneva. ISBN 978 92 4 150237 5
http://apps.who.int/medicinedocs/en/m/abstract/Js19059en/

It arose from a project managed by the WHO Department of Public Health Innovation and Intellectual Property of the World Health Organization (WHO/PHI) in partnership with the United Nations Conference on Trade and Development (UNCTAD) and the International Centre for Trade and Sustainable Development (ICTSD) with funding from the European Union (EU).

best wishes
Ruth

Dear all,

I would like to sincerely thank everyone; panelists and participants alike, for the fantastic contributions to this discussion. Officially the discussion ended yesterday but you are welcome to keep giving input on this forum. GHDOnline will publish a peer-reviewed discussion brief that will summarize all the important lessons learned on diagnostics. Please note that if you have any resource materials, best practices or guidelines to share you may go ahead and post them here in the future. In this way we will all keep learning from each other.

Many thanks to all,

Violet Chaka

Dear All,
I fully agree with Violet
The discussion was fantastic, congratulations!
all the best
daniela

Well done Violet! I missed out while on fieldwork but that was a great discussion.
Thanks to All.

Thanks Sungano, please feel free to share your thoughts. You are welcome to do so.

Best,
Violet

I am Mary Sekautu, a Laboratory mentor at one of our district lab in Lesotho, we have a challenge of stock outs. I think the reason is that we are still using a push system not a pull system because Laboratories are not used to reporting with their LMIS which helps to reflect our consumption rate, meaning that once we accomplish that we will be able to change this problem. But I belive we are getting there.

An announcement about a course on diagnostics that may be of interest. http://acdx.globe-network.org/

4th Advanced Course on Diagnostics (3-9 November 2013)


Fondation Merieux and the London School of Hygiene & Tropical Medicine have the pleaseure to announce the 4th Advanced Course on Diagnostics (ACDx) to be held at Les Pensieres Conference Centre, Annecy (France) from November 3-9, 2013.
This short intensive course focuses on infectious diseases and is based on transversal approaches of public health and research and development in diagnostics.
It will also include in this edition special sessions from the Moving Forward Forum, that will provide the current state and future potential of diagnostic technologies and the opportunity for networking between decision makers, end users and developers.
The deadline for applications from trainees is the 19th of April, 2013. There is capacity for 50 trainees with 35 potential fellowships.
For more information, contact: or go to acdx.globe-network.org
best wishes
Ruth


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An announcement about a course on diagnostics that may be of interest. http://acdx.globe-network.org/

4th Advanced Course on Diagnostics (3-9 November 2013)


Fondation Merieux and the London School of Hygiene & Tropical Medicine have the pleaseure to announce the 4th Advanced Course on Diagnostics (ACDx) to be held at Les Pensieres Conference Centre, Annecy (France) from November 3-9, 2013.
This short intensive course focuses on infectious diseases and is based on transversal approaches of public health and research and development in diagnostics.
It will also include in this edition special sessions from the Moving Forward Forum, that will provide the current state and future potential of diagnostic technologies and the opportunity for networking between decision makers, end users and developers.
The deadline for applications from trainees is the 19th of April, 2013. There is capacity for 50 trainees with 35 potential fellowships.
For more information, contact: or go to acdx.globe-network.org
best wishes
Ruth


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Dear Colleagues,
You may be interested in a webinar being held tomorrow, March 12, 2013 at 9:00 EDT: An overview of TB laboratory strengthening from the perspective of diagnosing and monitoring treatment of drug-resistant TB in low- and middle-income countries. Culture methods and GeneXpert will be covered.
This webinar is part of the series on Programmatic Management of Drug-Resistant TB being hosted by the DR-TB Training Network, a resource funded by USAID under the TB CARE II project.
Register at www.drtbnetwork.org/webinars.

Dear Panel
i tried to find out a bit more on two rapid tests which are used to confirm Determine(r) positive screened cases in a large control program: Triline and Trispot both from Bhat Biotech India.
In short: Determine HIV 1/2 is test #1 (screening), Triline is test # 2 and Trispot is test #3 for confirmation.

Lao PDR program has much smaller HIV numbers to deal with but the SR would like to explore possibility to apply an scientific valid diagnostic algorithm using the most economical and easy-to-use kits which have been deemed of acceptable quality/performance.

From the inserts it seems that these two tests use a different principle which would of course make sense. Sensitivity/specificity are adequate. But I couldn't trace these 2 Bhat Biotech kits on WHO Diagnostics recommended website ( i have asked them by mail too) nor is the guidance on GF web conclusive for use of these to detect/confirm HIV.
I would appreciate feedback from the panel on this

thank you so much in advance

Dear all,
I am pleased to inform you that a Discussion Brief- a summary of this discussion, is now available. You may access this summary brief online under the "Briefs" tab at the top this page or by visiting the following link: http://www.ghdonline.org/diagnostics-panel/briefs/.
Once again, many thanks for all of your profound and insightful contributions which enriched this discussion. Feel free to add any information or links related to the discussion.