Evaluation of an enzyme immunoassay for detection of herpes simplex virus antigen in genital lesions.

To evaluate a non-marketed research prototype of a solid-phase enzyme immunoassay for detection of herpes simplex virus in genital lesions, 154 clinical specimens were collected from 127 men and 27 women with symptoms suggestive of herpes simplex virus infection (erythema, vesicles, ulcers and crustae). The samples were tested using the assay and cultures on four monolayers of human embryonic lung fibroblasts and Vero cells. When the culture was used as reference method, sensitivity was 76.9% and specificity 100% (prevalence 42.4%). Comparison of results by patient group showed that sensitivity was highest in material from patients with vesicles and ulcers. The highest sensitivity was obtained in specimens which developed a cytopathological effect within 48 h and in specimens with three or four positive cell cultures. These findings suggest that the assay is more successful in specimens with high virus titres. The enzyme immunoassay was found to be a rapid, moderately sensitive, highly specific test for detection of herpes simplex virus from genital lesions, but the usefulness of the assay is limited and culture methods should be preferred.