Comparative clinical evaluation of the IsoAmp(®) HSV Assay with ELVIS(®) HSV culture/ID/typing test system for the detection of herpes simplex virus in genital and oral lesions.

The novel IsoAmp(®) HSV Assay employs isothermal helicase-dependent nucleic acid amplification and a user-friendly disposable test device to achieve rapid (<1.5h), on-demand qualitative detection of herpes simplex virus (HSV) types 1 and 2 in oral and genital lesions. To compare performance of the IsoAmp(®) HSV Assay with the ELVIS(®) HSV ID/typing (shell-vial culture and DFA) test system for clinical specimens collected from oral and genital lesions in symptomatic patients. A total of 994 specimens from male and female genital and oral lesions were obtained and evaluated at five study sites in the United States. Results from the IsoAmp(®) HSV Assay were compared to those from the ELVIS(®) system. Separate reproducibility studies were performed at 3 sites using a blinded and randomized study panel. Discrepant specimens were resolved by bidirectional sequencing analysis. After discrepant analysis, overall agreement of IsoAmp(®) with ELVIS(®) was 98.8% with 37.0% overall prevalence (all study sites). Reproducibility rates were well within expectations. The IsoAmp(®) HSV Assay showed excellent performance for clinical use for detection of HSV in genital and oral specimens. In contrast to ELVIS(®), IsoAmp(®) HSV offers excellent sensitivity plus rapid on-demand testing and simpler specimen preparation. Copyright © 2012 Elsevier B.V. All rights reserved.

Citation

Nancy S Miller, Belinda Yen-Lieberman, Melinda D Poulter, Yi-Wei Tang, Paul A Granato. Comparative clinical evaluation of the IsoAmp(®) HSV Assay with ELVIS(®) HSV culture/ID/typing test system for the detection of herpes simplex virus in genital and oral lesions. Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology. 2012 Aug;54(4):355-8

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PMID: 22613012

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