Evaluation of a commercial enzyme-linked immunosorbent assay for detection of herpes simplex virus antigen.

A commercial enzyme-linked immunosorbent assay (ELISA) for detection of herpes simplex virus (HSV) antigen in clinical specimens and culture lysates was evaluated. A total of 1,155 specimens and an additional 335 cell culture lysates were tested by ELISA, and results were compared to those obtained by cell culture in primary rabbit kidney, human foreskin, and MRC-5. The sensitivity and specificity of the direct test were 52.5 and 96.9% and those of the culture lysate test were 98.7 and 96.9%, respectively. The sensitivity of the direct ELISA correlated with early cytopathic effect in cell culture and varied with specimen source, ranging from 100% with skin lesions to 40.9% with cervical swabs. Of 60 cervical specimens from asymptomatic individuals, 22 (36.6%) yielded false-positives, which may be due to noninfectious HSV. No reproducible cross-reactions were found with other viruses isolated. The Ortho HSV ELISA was found to be rapid, sensitive, and specific for detection of HSV from cell culture lysates, but it needs reevaluation for direct specimen testing, in particular for screening of asymptomatic obstetrical patients.