article · PLoS ONE
A diagnostic study conducted in the Democratic Republic of the Congo evaluated the performance of the SD BIOLINE HAT rapid diagnostic test compared with the traditional card agglutination test for trypanosomiasis (CATT) for detecting human African trypanosomiasis. Over five months, mobile teams and health facilities evaluated 131 confirmed cases and 13,527 controls across active and passive screening contexts. The rapid diagnostic test demonstrated a sensitivity of 92.0 percent, which proved significantly higher than the 69.1 percent sensitivity observed for whole-blood CATT and the 59.0 percent sensitivity for plasma dilution CATT. The specificity of the rapid diagnostic test was 97.1 percent, compared to 98.0 percent for standard CATT and 99.6 percent for algorithms incorporating plasma dilution. Incorporating the rapid test into screening programmes offers optimal case detection across both field and clinic environments, though its slightly lower specificity necessitates confirmatory testing for more false positives.
Human African trypanosomiasis requires accurate screening tools to identify infections early and stop transmission. Evaluating rapid diagnostic tests in real-world conditions helps public health authorities choose effective screening tools. Demonstrating that a rapid test achieves higher sensitivity than older methods supports improved case detection in both mobile field units and fixed clinics in endemic regions.
The findings evaluate a commercially named, field-ready rapid diagnostic test (SD BIOLINE HAT) that is already applied and tested in mobile field screening and local clinics. The primary users are national health programmes, mobile screening teams, and healthcare facilities operating in endemic regions. By demonstrating high screening sensitivity, the evidence supports adopting this test within clinical algorithms, balanced against the diagnostic resources needed to confirm additional false positives.
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We carried out a study to compare the performance, in terms of sensitivity and specificity, of the new SD BIOLINE® HAT rapid diagnostic test (RDT) with the card agglutination test for trypanosomiasis (CATT) for diagnosis of human African trypanosomiasis (HAT) in the Democratic Republic of the Congo (DRC). Participants were enrolled actively by four mobile teams, and passively at four health facilities in three provinces. Consenting participants were tested concurrently with the RDT and CATT on whole blood. Those found positive by either test were tested with CATT on serial dilutions of plasma, and with a parasitological composite reference standard (CRS). Cases were only the individuals found positive by the CRS, while controls were negative by both CATT and RDT, as well as those that were positive by CATT or RDT, but were negative by the CRS, and had no history of HAT. Over five months, 131 cases and 13,527 controls were enrolled. The sensitivity of the RDT was 92.0% (95% confidence interval (CI) = 86.1-95.5), which was significantly higher than CATT (sensitivity 69.1%; 95% CI = 60.7-76.4). The sensitivity of CATT on plasma at a dilution of 1:8 was 59.0% (95% CI = 50.2-67.2). The specificity of the RDT was 97.1% (95% CIs = 96.8-97.4) while that of CATT was 98.0% (95% CIs = 97.8, 98.2) and specificities of algorithms involving CATT at 1:8 dilution were 99.6% (95% CI = 99.5-99.7). Reproducibility of results was excellent. We concluded that an algorithm in which the SD BIOLINE® HAT RDT is used for screening is optimal for case detection in both passive and active screening settings. However, the lower specificity of the RDT compared to that of CATT would result in a larger number of false positive individuals undergoing confirmatory testing.
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DOI: 10.1371/journal.pone.0180555
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