A new amplified enzyme linked immunosorbent assay (amplified ELISA) kit for detecting herpes simplex virus (HSV) antigen was evaluated. Duplicate swabs were taken from 180 patients with clinically suspected herpes lesions. Tests were performed on a direct swab extract and viral transport medium containing a swab. Of the 93 culture positive specimens, 78 of the extracted samples (sensitivity 83.9%) and 72 of the swabs in transport medium (sensitivity 77.4%) were positive by amplified ELISA. A higher sensitivity (49/54, 90.7%) was obtained when the extracted swab was taken first. In early lesions the sensitivity was 93.8% but in late lesions it was 73.3%. This ELISA therefore offers an alternative to culture for early lesions, but culture is the method of choice for differential diagnosis of genital ulceration. As the specificity was 94.3%, this test is acceptable for testing populations with a high prevalence of HSV infection, but culture should be used for screening populations in which the disease is rare.
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