RAPID DETECTION AND TYPING OF HERPES-SIMPLEX VIRUS-DNA IN CLINICAL SPECIMENS BY THE HYBRID CAPTURE-II SIGNAL AMPLIFICATION PROBE TEST

A second-generation signal amplification, nucleic acid-based test for the rapid detection and typing of herpes simplex virus (HSV) DNA was d eveloped and evaluated with artificial and clinical specimens, The ana lytical sensitivity of the Hybrid Capture II (HC II) HSV DNA assay was determined by testing either cloned HSV DNA or total genomic HSV DNA titrations and resulted in detection thresholds of between 5 x 10(3) a nd 1 x 10(4) copies per assay, Specificity was assessed by testing a p anel of bacteria and viruses commonly found in the female genital trac t, Sensitivity was assessed by testing 112 ulcerative genital lesions by the HC II assay and comparing the results to those obtained by rout ine cell culture, Discrepant results were resolved by PCR testing, Aft er resolution of the discrepant results, the sensitivity of the HC II assay compared to the consensus result (the results of two of three te sts, the HC II assay, culture, and PCR, were in agreement) was 93.2% ( 41 of 44 specimens), and the specificity was 100% (60 of 60 specimens) , Culture gave a sensitivity of 84.1% (37 of 44 specimens) and a speci ficity of 100% (60 of 60 specimens) compared to the consensus result, The results of HSV typing by the HC II assay and culture agreed in all cases, The HC II assay is a rapid and accurate assay for detecting an d typing HSV types 1 and 2, with a sensitivity comparable to that of c ulture and greater ease of use than culture.