Validation of rapid point-of-care tests for herpes simplex virus-type 2 in rural Tanzania.

Abstract

BackgroundHerpes simplex virus-type 2 (HSV-2) affects nearly 500 million people worldwide. Up to 70% of women in Tanzania are infected by age 30. Point-of-care (POC) tests to detect HSV-2 antibodies are commercially available. We validated the performance of two HSV-2 POC tests in women in rural Tanzania.MethodsBlood from 56 women was tested for HSV-2 antibodies by Biogate Labs and OnSite Duo rapid tests and Kalon HSV-2 IgG ELISA. Results obtained from the POC tests were compared with those from the ELISA to determine sensitivity, specificity, positive and negative predictive values (PPV and NPV).ResultsThe Biogate had a sensitivity and specificity of 30.3% [15.6%-48.7%] and 100% [85.2%-100%], respectively. The OnSite Duo had a sensitivity and specificity of 69.7% [51.3%-84.4%] and 87.0% [66.4%-97.2%], respectively. The PPV and NPV for the Biogate was 100% [69.2%-100%] and 50% [44.4%-55.6%], respectively. The OnSite Duo had a PPV and NPV of 88.5% [72.3%-95.8%] and 66.7% [53.8%-77.5%], respectively.ConclusionThese tests had different performance characteristics, with the Biogate having a poor sensitivity and excellent specificity, and the OnSite Duo having a slightly better sensitivity though lower specificity. Validation of POC tests is important, as they can be valuable diagnostic tools in low-resource settings.