Retrospective clinical performance evaluation of the Abbott Bioline HAT 2.0, a rapid diagnostic test for human African trypanosomiasis based on recombinant antigens.

Background: Rapid diagnostic tests for the serological detection of gambiense human African trypanosomiasis (gHAT) have been developed to overcome the limitations of the traditional screening method, CATT/T. b. gambiense. The Abbott Bioline human African trypanosomiasis (HAT) 2.0 rapid diagnostic test has recently been developed by Abbott using only recombinant antigens. The objective of this study was to evaluate its clinical sensitivity and specificity, in comparison with the other available rapid diagnostic tests and CATT.

Methodology/principal findings: For this study, archived plasma samples from 150 gHAT cases and 150 endemic controls originating from Chad, Guinea, the Democratic Republic of the Congo and Uganda were analysed on the following tests: CATT/T. b. gambiense, the HAT Sero K-SeT, SD BIOLINE HAT and Abbott Bioline HAT 2.0 rapid diagnostic tests, and the immune trypanolysis test. The sensitivity and specificity of Abbott Bioline HAT 2.0 were 96.7% and 78.4%, respectively, and the sensitivity and specificity of SD BIOLINE HAT were 99.3% and 74.1%. The sensitivity and specificity of CATT were 98.7% and 89.2%. The sensitivity and specificity of HAT Sero K-SeT were 99.3% and 81.3%.

Conclusions/significance: The sensitivity and specificity of the Abbott Bioline HAT 2.0 are comparable to those of its predecessors HAT Sero K-SeT and SD BIOLINE HAT. However, considering the decreasing prevalence of gHAT, a higher specificity of the tests used for screening is desirable to improve their positive predictive value.