The development of this target product profile (TPP) was led by the WHO Department of Control of Ne-
glected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to
identify and prioritize diagnostic needs, a WHO NTD Diagnostics Technical Advisory Group (DTAG)
was... formed, and different subgroups were created to advise on specific NTDs, including a subgroup
working on the human African trypanosomiasis (HAT) diagnostic innovation needs. This group of in-
dependent experts included leading scientists, public health officials and endemic-country end-user rep-
resentatives. Standard WHO Declaration of Interest procedures were followed. A landscape analysis of
the available products and of the development pipeline was conducted, and the salient areas with unmet
needs were identified
more
HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests exist only for Tbg and are based on the detection of specific antibodies, thus they are not confirmatory of infection. With the current low disease prevalence, the positive predicti...ve value of serological tests is particularly low. Field-applicable tools include the card agglutination test for trypanosomiasis (CATT) used mainly in active screening by specialized mobile teams, and the rapid diagnostic tests that are more suitable for individual testing at point-of-care. Confirmation of Tbg infection requires microscopic examination of body fluids necessitating specific training. The best performing methods are laborious and reach 85–95% diagnostic sensitivity when performed by skilled personnel.
more
HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests exist only for Tbg and are based on the detection of specific antibodies, thus they are not confirmatory of infection. With the current low disease prevalence, the positive predicti...ve value of serological tests is particularly low. Field-applicable tools include the card agglutination test for trypanosomiasis (CATT) used mainly in active screening by specialized mobile teams, and the rapid diagnostic tests that are more suitable for individual testing at point-of-care.
more