Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria

Prospective Evaluation of a Rapid Diagnostic Test to Screen for Gambiense Human African Trypanosomiasis and Diagnose Plasmodium Falciparum Malaria

A prototype rapid diagnostic test (RDT) to simultaneously screen for gambiense human African trypanosomiasis (HAT) and diagnose P. falciparum malaria (the "HAT/malaria combo") has recently been developed. The performance of this prototype has been evaluated in a retrospective study that showed that its diagnostic performance for HAT and malaria was equivalent to the performance of the SD BIOLINE HAT 2.0 and the SD BIOLINE Malaria Ag P.f tests, respectively.

The purpose of this study is to prospectively evaluate the performance of the test in settings where P. falciparum malaria is endemic, and which are either endemic or non-endemic for HAT. This will enable the assessment of the suitability of the HAT/malaria combo RDT as a diagnostic test for malaria, and a screening test for HAT in pre-elimination and post-elimination contexts, respectively.

Inclusion Criteria:

• Age greater than or equal to 6 years
• Provision of signed informed consent. For children (under the age of 18) provision of signed informed consent by a parent or legal guardian and an age appropriate assent.

Exclusion Criteria:

• Severe anaemia preventing collection of a sample of venous blood
• Severe medical condition preventing informed consent and trial participation (e.g. coma, cognitive impairment, etc.)
• For HAT true negatives only: history of previous HAT infection