Target product profile for a gambiense human African trypanosomiasis test to identify individuals to receive widened treatment
Target product profile: diagnostic test for Trypanosoma brucei gambiense to identify individuals to receive widened treatment
22 March 2022
Indication
Trypanosoma brucei gambiense diagnosis
Intended use
A diagnostic tool for detecting T. b. gambiense infection should at a minimum be capable of detecting infection by any species of the subgenus Trypanozoon or, preferably, by T. b. gambiense itself.
Target population
Individuals at risk of gambiense human African trypanosomiasis.
Sample type and volume
Ideally, blood would be collected by finger prick or capillary tube, with a maximum volume of 0.07 mL. Alternatively, blood, serum or plasma collection would require a maximum volume of 5 mL.
Use setting
The tool could be applied by any minimally trained individual in an unsophisticated peripheral health facility, or a mobile team in a village with little infrastructure.
Performance
The test should be able to function under hot and humid conditions.
Efficacy
Minimal: clinical sensitivity and specificity of >95% to Trypanozooan corresponding to <100parasites/mL in blood. Optimal (or desirable): clinical sensitivity and specificity of >99% to T b gambiense corresponding to <10 parasites/mL in blood.
Safety
Standard biosafety precautions for handling potentially infectious materials should be taken.
Disease
Human African Trypanosomiasis
Product type
Diagnostic
Author
WHO
Status
Active