A Global Comparative Evaluation of Commercial Immunochromatographic Rapid Diagnostic Tests for Visceral Leishmaniasis

Background. Poor access to diagnosis stymies control of visceral leishmaniasis (VL). Antibody-detecting rapid diagnostic tests (RDTs) can be performed in peripheral health settings. However, there are many brands available and published reports of variable accuracy. Methods. Commercial VL RDTs containing bound rK39 or rKE16 antigen were evaluated using archived human sera from confirmed VL cases (n = 750) and endemic non-VL controls (n = 754) in the Indian subcontinent (ISC), Brazil, and East Africa to assess sensitivity and specificity with 95 % confidence intervals. A subset of RDTs were also evaluated after 60 days ’ heat incubation (37°C, 45°C). Interlot and interobserver variability was assessed. Results. All test brands performed well against ISC panels (sensitivity range, 92.8%–100%; specificity range, 96%–100%); however, sensitivity was lower against Brazil and East African panels (61.5%–91 % and 36.8%–87.2%, respectively). Specificity was consistently> 95 % in Brazil and ranged between 90.8 % and 98 % in East Africa. Perfor