Performance of Focus ELISA Tests for HSV-1 and HSV-2 Antibodies Among University Students With No History of Genital Herpes

Abstract

Objectives: To define the performance characteristics of the Focus ELISA HSV-1 and HSV-2 assay among 100 university students. Study Design: HSV-1 and HSV-2 Focus ELISA and Western Blot assays were performed on sera from university students who reported no history of genital herpes. Results: HSV-2 and HSV-1 seroprevalence by Western Blot were 3.4% and 48%, respectively. In this population, the positive predictive value of the Focus HSV-2 ELISA was 37.5%, the sensitivity was 100%, and specificity was 94.1%. The PPV of the Focus HSV-1 ELISA was 96.7%, the sensitivity was 69.0%, and the specificity was 97.8%. Conclusions: In this low-prevalence population, the positive predictive value of the Focus HSV-2 ELISA test was low. This finding, together with those reported elsewhere, indicates that caution is warranted when recommending HSV screening in low-prevalence or heterogeneous populations. Consideration should be given to raising the cutoff index value for defining a positive test result.