The Diagnostic Technical Advisory Group (DTAG) for the WHO Global NTD Programme was formed to foster a unified approach for identifying and prioritizing diagnostic needs, and to inform WHO strategies and guidance on NTD diagnostics. The first meeting of the DTAG was held at the Inter Parliamentary Union in Geneva, Switzerland, in October 2019. The second took place virtually in October 2020, the third in June 2021, the fourth in October 2021 and the fifth in November 2022. Several disease-specific and cross-cutting DTAG subgroups have been formed, resulting in the development of target product profiles (TPPs) for new diagnostics, some of which have been published, and some of which are in production. WHO/NTD convened the sixth DTAG meeting on 14 and 15 February 2024, with the following objectives across the end-to-end process of diagnostic development: -consider updates from disease-specific subgroups and TPP production; -discuss progress made by the cross-cutting and resource mobilization subgroups; -discuss the Expert Review Panel for Diagnostics (ERPD) NTD pilot project and lessons learnt; -discuss engagement of manufacturers and developers; -discuss laboratory capacity strengthening and standardization of molecular methods; -deliberate on the priority/focus areas of engagement for the DTAG for the next 2 years.
The purpose of the target product profile for a diagnostic test for confirmation of a cure for visceral leishmaniasis is to communicate the minimum and ideal characteristics desired to meet the need for an in vitro, laboratory-based test for confirming or rejecting a successful cure post-treatment.
"The presence, or absence, of neglected tropical diseases (NTDs) can be seen as a proxy for poverty and for the success of interventions aimed at reducing poverty. Today, coverage of the public-health interventions recommended by the World Health Organization (WHO) against NTDs may be interpreted as a proxy for universal health coverage and shared prosperity - in short, a proxy for coverage against neglect. As the world's focus shifts from development to sustainable development, from poverty eradication to shared prosperity, and from disease-specific goals to universal health coverage, control of NTDs will assume an important role towards the target of achieving universal health coverage, including individual financial risk protection. Success in overcoming NTDs is a "litmus test" for universal health coverage against NTDs in endemic countries. The first WHO report on NTDs (2010) set the scene by presenting the evidence for how these interventions had produced results. The second report (2013) assessed the progress made in deploying them and detailed the obstacles to their implementation. This third report analyses for the first time the investments needed to achieve the scale up of implementation required to achieve the targets of the WHO Roadmap on NTDs and universal coverage against NTDs. INVESTING TO OVERCOME THE GLOBAL IMPACT OF NEGLECTED TROPICAL DISEASES presents an investment strategy for NTDs and analyses the specific investment case for prevention, control, elimination and eradication of 12 of the 17 NTDs. Such an analysis is justified following the adoption by the Sixty-sixth World Health Assembly in 2013 of resolution WHA6612 on neglected tropical diseases, which called for sufficient and predictable funding to achieve the Roadmap's targets and sustain control efforts. The report cautions, however, that it is wise investment and not investment alone that will yield success. The report registers progress and challenges and signals those that lie ahead. Climate change is expected to increase the spread of several vector-borne NTDs, notably dengue, transmission of which is directly influenced by temperature, rainfall, relative humidity and climate variability primarily through their effects on the vector. Investments in vector-borne diseases will avoid the potentially catastrophic expenditures associated with their control. The presence of NTDs will thereby signal an early warning system for climate-sensitive diseases. The ultimate goal is to deliver enhanced and equitable interventions to the most marginalized populations in the context of a changing public-health and investment landscape to ensure that all peoples affected by NTDs have an opportunity to lead healthier and wealthier lives."--Publisher's description.
Dracunculiasis, also known as Guinea-worm disease, is caused by infection with the parasitic nematode Dracunculus medinensis (the Guinea worm). In May 1986, the Thirty-ninth World Health Assembly declared global elimination (i.e. eradication) of dracunculiasis as a goal. The global dracunculiasis eradication campaign, through community-based interventions, has reduced the burden of the disease from an estimated 3.5 million cases per year in 1986 to only 13 human cases and 688 animal infections during 2022. To date, however, there are no validated tests to diagnose pre-patent D. medinensis infection. A critical part of any eradication programme involves reliably identifying infected and exposed definitive hosts. Historically, the diagnosis of Guinea-worm disease was clinical in nature and occurred via visually confirming the emergence of a white worm, roughly 10–14 months after the acquisition of infection. Currently, the definitive diagnosis involves either microscopy or, if necessary, conventional polymerase chain reaction applied to a DNA preparation from emergent worm fragments. A diagnostic tool capable of confirming active infection with D. medinensis many months before the emergence of a Guinea worm would represent a leap forward for the global dracunculiasis eradication campaign. Diagnostic modalities and platforms that can be easily used in locations where Guinea worm is observed or suspected among animal hosts are needed for the early diagnosis of prepatent Guinea worm infection to enhance follow-up and containment of infected hosts. Through the early detection and containment of Guinea worm-infected hosts, these diagnostics would ultimately serve to decrease the amount of parasite available in the environment for onward transmission. Diagnostic tools capable of detecting prepatent infection would enhance disease surveillance and provide national programme staff with additional data to identify transmission hot spots before the emergence of worms in affected areas. Diagnostic tools that can identify hosts with prepatent infection would further inform the targeting and implementation of disease-preventive interventions such as tethering of domesticated animal hosts and treating surface water sources with larvicide. Guinea worm diagnostic tools that could detect prepatent infection would also generate evidence of the absence of Guinea worm infection in definitive hosts, which could help certify countries as free of dracunculiasis transmission and ultimately facilitate the certification of dracunculiasis eradication.
The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.