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

作者：Miller Nancy S^*; Yen Lieberman Belinda; Poulter Melinda D; Tang Yi Wei; Granato Paul A

来源：Journal of Clinical Virology, 2012, 54(4): 355-358.

DOI：10.1016/j.jcv.2012.04.004

• Herpes simplex virus
• Isothermal helicase-dependent
• amplification
• Disposable detection device

Background: The novel IsoAmp (R) HSV Assay employs isothermal helicase-dependent nucleic acid amplification and a user-friendly disposable test device to achieve rapid (%26lt; 1.5 h), on-demand qualitative detection of herpes simplex virus (HSV) types 1 and 2 in oral and genital lesions. %26lt;br%26gt;Objectives: To compare performance of the IsoAmp (R) HSV Assay with the ELVIS (R) HSV ID/typing (shell-vial culture and DFA) test system for clinical specimens collected from oral and genital lesions in symptomatic patients. %26lt;br%26gt;Study design: 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 (R) HSV Assay were compared to those from the ELVIS (R) system. Separate reproducibility studies were performed at 3 sites using a blinded and randomized study panel. Discrepant specimens were resolved by bidirectional sequencing analysis. %26lt;br%26gt;Results: After discrepant analysis, overall agreement of IsoAmp (R) with ELVIS (R) was 98.8% with 37.0% overall prevalence (all study sites). Reproducibility rates were well within expectations. %26lt;br%26gt;Conclusion: The IsoAmp (R) HSV Assay showed excellent performance for clinical use for detection of HSV in genital and oral specimens. In contrast to ELVIS (R), IsoAmp (R) HSV offers excellent sensitivity plus rapid on-demand testing and simpler specimen preparation.

• 出版日期2012-8