Premarket Evaluation of the POCkit HSV‐2 Type‐Specific Serologic Test in Culture‐Documented Cases of Genital Herpes Simplex Virus Type 2

Background and Objectives: The genital herpes epidemic continues, in part, because patients with subclinical or atypical presentations cannot be identified by most herpes simplex virus (HSV) antibody tests. A new product, POCkit HSV‐2, has been developed to rapidly and accurately detect antibodies to HSV type 2 (HSV‐2) in capillary blood or serum. Goal: Sera from patients with culture‐documented genital or oral herpes were tested to determine the sensitivity and specificity of the POCkit HSV‐2 rapid point‐of‐care antibody test (Diagnology, Belfast, Northern Ireland). Study Design: Sera from 50 patients with culture‐documented HSV type 1 (9 oral, 41 genital) and from 253 patients with genital HSV‐2 were tested by POCkit HSV‐2 for HSV‐2 antibodies. Each subject had a positive culture for HSV within 6 months of serum collection. Sera were preselected to include only those that were seropositive to the respective virus subtype by University of Washington Western blot. Results: Compared with viral culture and Western blot analysis, sensitivity of the POCkit HSV‐2 test for HSV‐2 antibody was 96%; specificity was 98%. Conclusion: This test provides rapid, accurate identification of HSV‐2 antibody in subjects with established HSV infections.