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Comparative Study
. 2012 Aug;54(4):355-8.
doi: 10.1016/j.jcv.2012.04.004. Epub 2012 May 20.

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

Nancy S Miller  1 , Belinda Yen-Lieberman, Melinda D Poulter, Yi-Wei Tang, Paul A Granato
Affiliations
Comparative Study

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

Nancy S Miller et al. J Clin Virol. 2012 Aug.

Abstract

Background: 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.

Objectives: 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.

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(®) 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.

Results: 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.

Conclusion: 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.

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Conflict of interest statement

Competing interests: Nancy S. Miller received funding from BioHelix Corporation for this and previous studies; the Boston Medical Center clinical laboratory uses products from Diagnostic Hybrids including the ELVIS® assay. Melinda D. Poulter received funding from BioHelix Corporation for this study. Yi-Wei Tang was a scientific advisory board member of the BioHelix Corporation during this study. None declared for Belinda Yen-Lieberman and Paul A. Granato.

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