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.
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.
Authors: Matthew L Faron; Nathan A Ledeboer; Anami Patel; Safedin H Beqa; Belinda Yen-Lieberman; Debra Kohn; Amy L Leber; Donna Mayne; William I Northern; Blake W Buchan Journal: J Clin Microbiol Date: 2016-05-18 Impact factor: 5.948
Authors: Chun Kiat Lee; Chean Nee Chai; Sharah Mae Capinpin; Alynn Ang; Sau Yoke Ng; Peak Ling Lee; Christopher Wai Siong Ng; Gabriel Yan; Hong Kai Lee; Lily Lily Chiu; Roland Jureen; Benedict Yan; Tze Ping Loh Journal: Ann Lab Med Date: 2018-09 Impact factor: 3.464
Authors: Akkapol Suea-Ngam; Léonard Bezinge; Bogdan Mateescu; Philip D Howes; Andrew J deMello; Daniel A Richards Journal: ACS Sens Date: 2020-09-11 Impact factor: 7.711