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

This article focuses on the validation of two point-of-care (POC) rapid diagnostic tests, the Biogate Labs HSV-2 IgG/IgM Rapid Test and the OnSite Duo HSV-1/2 IgG/IgM Rapid Test, for detecting herpes simplex virus-type 2 (HSV-2) antibodies in women from rural Tanzania. Using the Kalon HSV-2 IgG ELISA as the reference standard, the Biogate test demonstrated low sensitivity (30.3%) but perfect specificity (100%), while the OnSite Duo test showed higher sensitivity (69.7%) but lower specificity (87.0%). The study highlights the importance of validating POC tests in local settings due to variability in performance and recommends the OnSite Duo test for field screening with ELISA confirmation. These findings underscore the potential and challenges of using rapid HSV-2 diagnostics to improve care in resource-limited environments.