A guide to aid the selection of diagnostic tests

By Madhukar Pai Moderator | 06 Sep, 2017

Please see this new article by MSF colleagues, where they outline a six-step approach to overcoming the obstacles encountered by Médecins Sans Frontières in selecting and implementing in vitro diagnostic tests. This simple stepwise guide aims to help clinics, organizations and health ministries to make rational decisions about the selection of in vitro diagnostic tests and, over the longer term, will contribute to the development of a practical guide for selecting diagnostics.

URL http://www.who.int/bulletin/volumes/95/9/16-187468/en/



Alaine Umubyeyi Nyaruhirira Replied at 11:06 PM, 6 Sep 2017

Dear Pai

Many thanks for sharing this article which will need broader dissemination
to sensitize MOH and implementer partners who are more proactive in
introduction of new technology to be in the same level. One of challenge
facing by them is the absence of this kind of policy and methodology or
process at all level. The development of practical guide is highly needed.

Best regards,

*Alaine Umubyeyi Nyaruhirira, MpH, PHD*
*Senior Laboratory Technical Advisor*
Management Sciences for Health
Pretoria, Brooklyn Bridge (REGUS)
3rd Floor, Steven House, Brooklyn Bridge Office Park, Pretoria, 0181
Mobile: +27 78 557 0393 or +27 76 4133216
Skype: alaine.umubyeyi.nyaruhirira
Stronger health systems. Greater health impact.

*This message and its attachments are confidential and solely for the
intended recipients. If received in error, please delete them and notify
the sender via reply e-mail immediately.*

Kathleen England Replied at 3:39 PM, 12 Sep 2017

Thanks for sharing. However, I feel there is a step mission, which is very critical for implementing any new technology. The missing element, which must be evaluated prior to rolling out any technology and a lesson learned from GeneXpert implementation, is that countries must assess if appropriate support systems are in place to ensure efficiency, access, and impact. As we have seen over the past several years, support systems are needed for a technology to succeed. To improve access extended and efficient specimen referral systems are critical to get the specimen to the testing site. Laboratory data management systems are critical to expedite treatment of patients confirmed with TB and DRTB. Power support systems are necessary to ensure uninterrupted testing. Routine training (lab and clinical) and quality assurance systems are needed for accurate and reliable diagnosis. And finally, an established and well-managed supply chain must be in place to ensure consistent, reliable, and available testing. Without having strong systems in place, newly implemented technology will provide limited impact.

A second comment relates to country interpretations of WHO and expert recommendations. Many programs view these as “law” and do no understand that recommendations are just that, "recommendations”. Not all countries can implement WHO/expert guidance, policy, or strategies due to various internal limitations and restriction. Programs need to understand the guidance and decide if the guidance or policy is feasible in their setting. If it is not feasible at the current time, the program needs to assess how it can reach this goal overtime and establish an extended longer-term strategy. Too many jump to the directives and fail upon implementation, which leads to discouragement, demotivation, apathy, and disbelief in WHO (and the Experts) as guiding institution.

Finally, the article describes, “number of guidelines, performance evaluations and implementation reports have been produced. However, this wealth of information is unstructured and of uneven quality”. It well known that there is a plethora of guidance documents, evaluations by different expert groups, as well as variable implementation/training platforms, which are mainly donor driven. This brings great confusion to implementers, slows implementation, and builds inconsistencies within the landscape of the national diagnostic network. Unfortunately, there is not enough research done by the individual country to assess what will work best for them and which technologies “should” be implemented. Many resources are wasted due to lack of coordination by national programs, as they typically have a limited or nonexistent national laboratory plan laid out for integrating diagnostic capacity throughout the country. National programs need to take leadership and control of implementing partners to unify the overall agenda according to their national strategy. But first, countries need to establish a sound and complete National Laboratory and Diagnostic Strategy for Integrated Services. One that integrates testing in a more holistic and cost-effective approach. Funds from various partners need to be managed in a way to eliminate redundancy, foster a unified system for patient centered care, build the necessary support systems, and establish a coalition to fight major problematic public health diseases. The current silo-system needs to be revised to manage relevant national health issues and focus on individual care for patients with varying maladies and comorbidities (diabetes, HIV, Hepatitis B/C, TB/DRTB, etc). The paradigm for laboratory diagnostic developments must change and include all relevant stakeholders, both public and private, to close the gaps and restructure systems to work cooperatively.

In the end there remains a great deal of work to be done to establish strong and effective laboratory services in LMICs that will require national leadership, national ownership, and unified collaborations from all stakeholders.

Kathleen England
Sr. TB Diagnostic Advisor

Kenneth Fleming Replied at 3:09 AM, 13 Sep 2017

Very interested in these comments. Totally agree. I am a pathologist recently come to the recognition that pathology and laboratory medicine is lacking in both capacity and standards in many LMICs and that patients are suffering because of lack of accurate diagnosis and of monitoring of response to treatment, with limited resources are being wasted on wrong diagnoses. So seeing the recent surge in interest in improving diagnostics is encouraging. However I am struck that this move appears to be largely aimed at developing technology to provide POCTs seemingly as solutions in themselves. However a test result is not simply a number. It should be part of a system of care. While POCTs are clearly a significant part of a any long term solution, as you say, there need to be mechanisms for QA, selection of the right test, interpretation of the result, training of staff, appropriate further innovation, etc, all the issues you identified. Most importantly, integration into the rest of the lab system so that the patient's care can be properly linked to any past, continuing or future investigations is crucial. Obviously many places do not have a fully functioning lab system at present, but one solution to this is to develop an integrated tiered laboratory system - there may be others depending on local context. Whatever the best approach, the need is to aim to develop a comprehensive coherent lab system, rather than individual components which in isolation will probably be non-sustainable in the long run. It will take many years, but this should be the message of the diagnostics movement.

John Flanigan Replied at 7:44 AM, 13 Sep 2017

Well put. Interesting to see the response.

Ruth MCNERNEY Replied at 5:04 PM, 14 Sep 2017

Here is a possibly controversial suggestion - not novel ideas, but maybe ones that we should be discussing more often.
Are we in danger of using sticking plasters to shore up poorly functioning health systems rather than addressing the root causes of the problem and the lack of investment? Is it now time for a fundamental review and overhaul of the way the global community approaches international health?

We need to recognize that initiatives such as the Global Fund and PEPFAR, for all the good they do, have hindered the evolution of integrated health services in many countries - particularly at the primary care level. The highly vertical nature of TB and HIV programs has meant in many settings it has been a struggle to get even those two health streams to integrate at the community level, despite the obvious advantages for the patients. In the meantime less fashionable diseases (infectious and non-communicable) have fallen by the wayside as the 'big three' have attracted the lion’s share of funding and personnel. While ‘in-country’ program managers compete for resources to combat their particular disease there is little thought (or funding) towards developing quality integrated national health services. Global policy makers (and donors) have also been guilty in the past of imposing a ‘one size fits all’ solutions which can be inappropriate and damaging in some settings.
Perhaps we should ask how decisions are made to introduce new technology? On one side we have donors, WHO etc with targets to meet, who won’t want delays because someone wants to do a local assessment or planning exercise. It takes a brave manager to say no to an international donation! We also have the developers/manufacturers of the new tech, both commercial and not-for-profit who will be judged on the uptake and there may also be activists and politicians pushing for rapid introduction of the latest new tool. The Ministry of Health is often given the task of implementing, but how often are they given the resources needed to do the background work such as preparing local health structures, sensitising local personnel, establishing appropriate QA etc.
Perhaps a proportion of global fund monies should be allocated to organisations assisting with establishing effective health systems that can better cope with changing policies and new tools. The ASLM might be an African example, I’m sure there are others.

Best wishes to all