Clinical evaluation of a new herpes simplex virus ELISA: a rapid diagnostic test for herpes simplex virus.

A new sensitive and rapid enzyme-linked immunosorbent assay (ELISA) test (Du Pont HERPCHEK) for the detection of herpes simplex virus (HSV) antigen was evaluated. A total of 563 clinical samples collected from patients attending obstetrics and gynecology and sexually transmitted disease clinics in two geographic locations were tested by ELISA, and the results were compared with virus isolation in cell culture. The sensitivity and specificity of the ELISA were 97.5 and 98.6%, respectively. When a confirmatory blocking ELISA was used to demonstrate the presence of HSV antigen in culture-negative but ELISA-positive samples, the specificity of the assay increased to 100%. The assay is easy to perform and may be used to diagnose HSV infection rapidly without the need for culture confirmation.