Serologic herpes testing in the real world: validation of new type-specific serologic herpes simplex virus tests in a public health laboratory.

BACKGROUND Serologic testing for herpes simplex virus type-2 (HSV-2) is being implemented in sexually transmitted disease (STD) clinics. GOAL To determine the performance characteristics of two HSV-2 type-specific serologic assays in a public health laboratory. STUDY DESIGN Sera stored from a cross-sectional study were tested with the Meridian Diagnostics and Focus Technologies HSV-2 ELISA tests and a type-specific strip immunoblot assay (Chiron Corp.) was used as the reference standard. RESULTS Prevalence of HSV-2 infection in this sample was 44%. Compared to the reference standard, the sensitivity of the Meridian Diagnostics HSV-2 test was 95.5% (95% CI 83.3, 99.2) and specificity was 98.2% (95% CI 89.0, 99.9). The Focus Technologies test yielded 97.7% (95% CI 86.5, 99.9) sensitivity and 94.5% (95% CI 83.9, 98.6) specificity. CONCLUSIONS The performance of these HSV-2 type-specific serologic assays was adequate to support their use in high prevalence populations, such as STD clinic patients.