Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection
Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection
The study determines the diagnostic performance and cost of rapid diagnostic tests (RDTs)
 performed on human African trypanosomiasis clinical suspects in peripheral health centres,
 whether or not followed by serological and/or molecular tests on dried blood spots done at
 regional reference centres
In the last decade, the prevalence of Trypanosoma brucei gambiense human African
 trypanosomiasis (HAT) has fallen and HAT has been targeted for elimination. At low disease
 prevalence, integration of case finding into routine activities of peripheral health centres
 becomes crucial. However, HAT case detection by the peripheral health system with limited
 resources requires adapted diagnostic tests and test algorithms.

 The objective of the DiTECT-HAT-WP2 study is to determine the diagnostic performance and cost
 of rapid diagnostic tests (RDTs) performed on clinical suspects in peripheral health centres,
 whether or not followed by serological and/or molecular tests on filter paper done at
 regional reference centres.

 The DiTECT-HAT-WP2 study will be conducted in centres for diagnosis and treatment and in
 sites for serological screening in Guinea, Côte d'Ivoire and DR Congo. In these centres and
 sites, clinical suspects will be tested with several commercially available RDTs for HAT.
 Clinical suspects with at least 1 RDT positive result, will 1° undergo parasitological
 examination and 2° blood collection on filter paper for reference analysis in trypanolysis,
 LAMP, ELISA and real-time PCR in the regional reference laboratory. If the reference
 laboratory tests and parasitological examinations are all negative, the suspect is informed
 and considered free of HAT. If at least 1 reference test is positive, parasitological
 examinations are repeated at least twice at three months interval, unless trypanosomes are
 detected. In order to assess the sensitivity, specificity, Positive Predictive Values and
 Negative Predictive Values of each assay in these multiple populations, the data from the
 multiple assays in the 3 countries will be used in a Bayesian formulation of the Hui-Walter
 latent class model, to estimate the assay performances in the absence of a gold standard. As
 we will collect full cost information for the different algorithms, we will, in addition to
 estimating the diagnostic effectiveness of the assay, be able to estimate the cost of each
 assay in each setting, and rank this jointly with assay performance.

 The results will enable us to propose cost-effective test algorithms to detect HAT, adapted
 to peripheral health centres. Algorithms with high positive predictive values might allow
 test-and-treat scenarios without the need for complicated parasitological confirmations, once
 safe oral easy to use drugs become available to treat HAT.
Inclusion Criteria:

 -  Visit of or residence in a HAT endemic area

 -  Clinical suspicion of HAT based on: Recurrent fever not responding to anti-malarial
 medication; or Headache for a long duration (>14 days); or presence of swollen lymph
 nodes in the neck; or Important weight loss; or Weakness; or Important scratching; or
 Amenorrhea, abortion(s), or sterility; or Coma; or Psychiatric problems
 (aggressiveness, apathy, mental confusion, increasing unusual hilarity, ...); or Sleep
 disruption (nocturnal insomnia and excessive diurnal sleeping); or Motor abnormalities
 (convulsions, abnormal movements, shaking, walking difficulties); or Speech disorders.

 Exclusion Criteria:

 -  Previously treated for HAT (irrespective of time elapsed since treatment)

 -  No informed consent

 -  < 4 years old