Format

Send to

Choose Destination
J Clin Virol. 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.

Author information

1
Boston Medical Center, Boston, MA 02118, United States. nancy.miller@bmc.org

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.

PMID:
22613012
PMCID:
PMC3402216
DOI:
10.1016/j.jcv.2012.04.004
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Elsevier Science Icon for PubMed Central
Loading ...
Support Center