Abstract
Background
Herpes 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.
Methods
Blood 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).
Results
The 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.
Conclusion
These 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.
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