Abstract
BackgroundIndividual rapid tests for serodiagnosis (RDT) of human African trypanosomiasis (HAT) are particularly suited for passive screening and surveillance. However, so far, no large scale evaluation of RDTs has been performed for diagnosis of Trypanosoma brucei gambiense HAT in West Africa. The objective of this study was to assess the diagnostic accuracy of 2 commercial HAT-RDTs on stored plasma samples from West Africa.Methodology/Principal findingsSD Bioline HAT and HAT Sero-K-Set were performed on 722 plasma samples originating from Guinea and Côte d’Ivoire, including 231 parasitologically confirmed HAT patients, 257 healthy controls, and 234 unconfirmed individuals whose blood tested antibody positive in the card agglutination test but negative by parasitological tests. Immune trypanolysis was performed as a reference test for trypanosome specific antibody presence. Sensitivities in HAT patients were respectively 99.6% for SD Bioline HAT, and 99.1% for HAT Sero-K-Set, specificities in healthy controls were respectively 87.9% and 88.3%. Considering combined positivity in both RDTs, increased the specificity significantly (p≤0.0003) to 93.4%, while 98.7% sensitivity was maintained. Specificities in controls were 98.7–99.6% for the combination of one or two RDTs with trypanolysis, maintaining a sensitivity of at least 98.1%.Conclusions/SignificanceThe observed specificity of the single RDTs was relatively low. Serial application of SD Bioline HAT and HAT Sero-K-Set might offer superior specificity compared to a single RDT, maintaining high sensitivity. The combination of one or two RDTs with trypanolysis seems promising for HAT surveillance.
Highlights
Human African trypanosomiasis (HAT) or sleeping sickness is a fatal parasitic infection affecting rural populations in sub-Saharan Africa
Screening for gambiense human African trypanosomiasis (HAT) or sleeping sickness is traditionally based on detection of trypanosome specific antibodies in blood
Two rapid tests for serodiagnosis (RDT) have been commercialized recently, and we assessed their diagnostic accuracy on stored plasma samples from West Africa
Summary
Human African trypanosomiasis (HAT) or sleeping sickness is a fatal parasitic infection affecting rural populations in sub-Saharan Africa. Cost-effectiveness of active screening decreases and passive case finding becomes increasingly important [1]. This shift from the mobile team to the fixed health system for HAT detection requires an adapted diagnostic approach. The limited shelf-life of the reconstituted CATT reagent at ambient temperature leads to considerable reagent loss when only few tests are performed per day. Another limitation of the CATT is the need of an agitator and a cold chain and electric power, which are not always available in rural health-care centers. The objective of this study was to assess the diagnostic accuracy of 2 commercial HAT-RDTs on stored plasma samples from West Africa.
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