- 作者：Nancy S. Miller ; Belinda Yen-Lieberman ; Melinda D. Poulter ; Yi-Wei Tang ; Paul A. Granato
- 关键词：HSV ; herpes simplex virus ; FDA ; Food and Drug Administration ; HIV ; human immunodeficiency virus ; ELVIS® ; enzyme linked virus inducible system ; ID ; identification ; DFA ; direct fluorescent antibody ; PCR ; polymerase chain reaction ; TCID50 ; 50 % tissue cul
- 刊名：Journal of Clinical Virology
- 出版年：2012
- 出版时间：August, 2012
- 年：2012
- 卷：54
- 期：4
- 页码：355-358
- 全文大小：163 K
class=""h4"">Background
The novel IsoAmp? HSV Assay employs isothermal helicase-dependent nucleic acid amplification and a user-friendly disposable test device to achieve rapid (<1.5 h), on-demand qualitative detection of herpes simplex virus (HSV) types 1 and 2 in oral and genital lesions.class=""h4"">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.
class=""h4"">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.
class=""h4"">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.
class=""h4"">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.