A rapid and simple isothermal nucleic acid amplification test for detection of herpes simplex virus types 1 and 2

作者：Kim Hyun Jin; Tong Yanhong; Tang Wen; Quimson Louisito; Cope Vicki A; Pan Xiaojing; Motre Aurelie; Kong Richard; Hong Jian; Kohn Debbie; Miller Nancy S; Poulter Melinda D; Kong Huimin; Tang Yi Wei^*; Yen Lieberman Belinda

来源：Journal of Clinical Virology, 2011, 50(1): 26-30.

DOI：10.1016/j.jcv.2010.09.006

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

Background: A simple and rapid IsoAmp (R) HSV assay has been developed for qualitative detection of herpes simplex virus (HSV) types 1 and 2 from genital lesions. Sample preparation involved a simple dilution step and the diluted specimens were directly added to the device and amplified by isothermal helicase-dependent amplification (HDA). Amplification products were then detected by a DNA strip embedded in a disposable cassette without any instrument. The total test turn-around time is less than 1.5 h from specimen processing to result reporting.
Objectives: To evaluate the analytical and clinical performance of the IsoAmp (R) HSV assay as well as the robustness and reproducibility of the assay.
Study design: The analytical sensitivity of the IsoAmp (R) HSV assay was determined using both HSV-1 and HSV-2. Clinical performance was evaluated using 135 frozen specimens collected from patients with suspected HSV infection in genital area.
Results: The analytical sensitivity of the assays was 5.5 and 34.1 copies/reaction for HSV-1 and HSV-2 respectively with a 95% confidence interval. When the herpes viral culture was used as the reference standard, the clinical sensitivity and specificity of the IsoAmp (R) HSV assay were 100.0% and 96.3% respectively. The inter-laboratory reproducibility achieved an overall 97.5% agreement by testing a total of 80 blinded HSV-1 samples among five laboratories.
Conclusion: Adequate analytical and clinical performance of the IsoAmp (R) HSV assay was demonstrated. This assay is simple to perform and has acceptable inter-laboratory reproducibility.

• 出版日期2011-1