The 15th meeting of the WHO Strategic and Technical Advisory Group (STAG) for neglected tropical diseases (NTDs) was held virtually on 7–8 February 2022.
Conclusions and recommendations to the Director-General
The Strategic and Technical Advisory Group for Neglected Tropical Diseases (STAG-NTD):
(1) Thanks the Secretariat and meeting participants for their contributions to the discussions on development, oversight and regulation of in vitro diagnostics (IVDs) for neglected tropical diseases (NTDs) and on visceral leishmaniasis in Africa and the Americas.
On diagnostics
(1) Commends the quantity and quality of work undertaken by the Diagnostic Technical Advisory Group (DTAG);
(2) Encourages work planned by DTAG on the state of the art of evaluating IVDs in the absence of a gold standard test;
(3) Highlights the need for IVDs that are robust, affordable and appropriately sensitive and specific for their intended purpose and settings for future use, which are characterized, inter alia, by marked resource limitations and extremes of environmental temperature.
(4) Recommmends that:
- WHO establishes an Expert Review Group, to report to the STAG Working Group on Access to Health Products, to assess the risk, quality, safety and performance of diagnostics for possible NTD programme use; the assessment process should be as cost-, time- and effort-efficient as possible while appropriately safeguarding individuals and communities affected by NTDs;
- the IVD assessment process be conducted independently of test developers and require data generated both in the laboratory and in the field in different geographical contexts, with the geographical diversity and extent of separation being dictated by the epidemiology of the disease or infection in question as well as the intended purpose of the IVD (e.g. individual patient diagnosis, treatment response, surveillance);
- when selecting IVDs, the potential cost-savings for NTD programmes be taken into account (e.g. whether treating only confirmed cases vs syndromic/empiric treatment);
- WHO requests the NTD Modelling Consortium to help explore the economic case for increased investment in IVD development for NTDs;
- as soon as feasible, and without waiting for the Expert Review Group to be established, WHO commences work to develop external quality assurance systems for NTD diagnostics, in line with existing WHO guidance and recommended processes, and establishes external proficiency testing for field diagnostics, as in the Buruli ulcer diagnosis model;
- with support from WHO, DTAG establishes a Laboratory Capacity and Networking Subgroup, which should include in its scope of work consideration of how best to ensure that adequate specimen biobanks are made available for routine quality assurance/quality control processes; and
- work on cross-cutting “platforms”, such as for soil-transmitted helminthiases and skin diseases, is considered where appropriate.
On visceral leishmaniasis
(5) Commends the progress of the elimination initiative in the South-East Asia Region and of WHO’s support to endemic countries globally, and notes the challenges to control in other geographies of East Africa and the Americas;
(6) Commends WHO, Member States and stakeholders’ cross-border efforts to address the control and elimination of visceral leishmaniasis, and urges continued coordination between governments to ensure seamless provision of care to affected persons, diligent surveillance and implementation of vector control where applicable according to WHO recommendations;
(7) Commends WHO’s work with manufacturers, donors, academics, health ministries and other stakeholders to replace and improve rapid diagnostic tests following proper IVD evaluation criteria;
(8) Notes that improved rapid tests are urgently needed for East Africa and the Americas, and urges WHO and donors to support evaluations in accordance with the criteria established by DTAG;.
- WHO requests all appropriate stakeholders to take steps to expand the manufacturing capacity and diversity of the manufacturing base for IVDs, including within countries endemic for visceral leishmaniasis; DTAG to request the subgroup on visceral leishmaniasis to draft an evaluation protocol for visceral leishmaniasis IVD;
- WHO urges donors to continue and increase their funding for the global leishmaniasis programme, particularly to support procurement of medicines and diagnostic tests;
- WHO leads advocacy efforts to attract new donors to the programme;
- WHO works with health ministries and appropriate experts to facilitate early investigation of endemicity particularly in populations in which elimination as a public health problem is the programmatic target;;
- WHO engages partners with appropriate expertise to initiate a search for antileishmanial treatments and treatment regimens that are less toxic, easier to administer and have a shorter treatment course, in order to make them more appropriate for resource-limited and remote settings; and;
- WHO, in collaboration with Member States and other stakeholders, develops a bi-regional proposal for elimination of visceral leishmaniasis in East Africa.
(9) Urges WHO to explore funding opportunities for evaluation of rapid diagnostic tests through donor proposals;
(10) Recommends that:
The full report will be published soon