HerpeSelect® Express Rapid Test Study Protocol Sexually Active Adult Population

The objective of this study is to establish the performance characteristics of the Focus Diagnostics (Focus) HerpeSelect® Express based on comparison to the Focus Diagnostics' HerpeSelect® 2 ELISA IgG (K021486). The Focus HerpeSelect® 2 ELISA IgG device is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-2 in human sera. Positive samples in either the HerpeSelect® 2 ELISA IgG or HerpeSelect® Express will be tested in the HerpeSelect® Immunoblot (K000238).

This external study along with in-house analytical studies will demonstrate the efficacy of the HerpeSelect® Express Rapid Test device as an aid in screening for pregnant women or sexually active adults as in the presumptive diagnosis of HSV-2 infection for point-of-care testing sites as well as hospital/clinics and reference laboratories. Independent sites in the Southeastern, Western, Eastern, and Pacific Northwestern U.S. will test subjects with the HerpeSelect® Express Rapid Test. Sera from those patients will be tested at Focus Diagnostics Reference Laboratory in the HerpeSelect® 2 ELISA IgG. Discrepants between HerpeSelect® Express Rapid Test and HerpeSelect® 2 ELISA IgG may be tested in the HerpeSelect® Immunoblot IgG assay.

Test subjects will be from three patient populations: 375 sexually active adults, 375 pregnant women, and 100 low prevalence adults. Two samples types will be collected from each subject: capillary whole blood and serum. These samples types will be tested with both the HerpeSelect® Express Rapid Test and HerpeSelect® 2 ELISA IgG.