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

Foundation for Innovative New Diagnostics, Switzerland

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Human African Trypanosomiasis

Interventions

No interventionDIAGNOSTIC_TEST

No intervention

Eligibility

Sex: ALLMin age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

specificity of the HAT/malaria combo test for gambiense HAT in passive screening

Time frame: Enrolment

specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening

Time frame: Enrolment

sensitivity of the HAT/malaria combo test for P. falciparum malaria in passive screening

Time frame: Enrolment

sensitivity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening

Time frame: Enrolment

specificity of the HAT/malaria combo test for P. falciparum malaria in passive screening

Time frame: Enrolment

specificity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening

Time frame: Enrolment

Secondary Outcomes

specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic

Time frame: Enrolment

specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic

Time frame: Enrolment

specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT and animal trypanosomiasis are not endemic

Time frame: Enrolment

specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening in a population living in a setting where HAT and animal trypanosomiasis are not endemic

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.