Evaluation of an enzyme-linked immunosorbent assay for the detection of herpes simplex virus antigen.

An enzyme-linked immunosorbent assay (ELISA) kit for herpes simplex virus developed by Ortho Diagnostic Systems, Inc., was evaluated. In phase I experiments, 263 clinical specimens from genital lesions were extracted into serum-free medium and then tested by ELISA for herpes simplex virus antigen. The results were compared with those obtained by conventional viral culture. Of 83 specimens, 65 were positive by ELISA (sensitivity, 78.3%). In phase II experiments, 249 clinical specimens were tested for herpes simplex virus antigen in direct specimen and in cell cultures (MRC-5 and rabbit kidney) incubated for 2, 4, and 7 days. Of 63 specimens, 40 were positive by ELISA in the direct specimen (sensitivity, 63.5%), and by 7 days incubation, 100% of the cultures positive by viral cell culture were also positive by ELISA. The ELISA was reproducible, and when both the direct detection and amplification culture were used, the sensitivity of ELISA paralleled the diagnosis of herpes simplex virus infections by viral cytopathic effect.