A rapid and simple isothermal nucleic acid amplification test for detection of herpes simplex virus types 1 and 2.
A rapid and simple isothermal nucleic acid amplification test for detection of herpes simplex virus types 1 and 2.
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DOI:
10.1016/j.jcv.2010.09.006
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发表时间:
2011-01
影响因子:
8.8
通讯作者:
Yen-Lieberman, Belinda
中科院分区:
文献类型:
--
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
A simple and rapid IsoAmp® 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 add 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 hours from specimen processing to result reporting. To evaluate the analytical and clinical performance of the IsoAmp® HSV assay as well as the robustness and reproducibility of the assay. The analytical sensitivity of the IsoAmp® HSV assay were 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. 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® 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. Adequate analytical and clinical performance of the IsoAmp® HSV assay was demonstrated. This assay is simple to perform and has acceptable inter-laboratory reproducibility.
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DOI:
10.1016/j.diagmicrobio.2004.03.008
发表时间:
2004-07-01
影响因子:
2.9
作者:
Crist, GA;Langer, JM;Hillyard, DR
通讯作者:
Hillyard, DR
影响因子:
6.4
作者:
Wald, A;Huang, ML;Corey, L
通讯作者:
Corey, L
影响因子:
9.4
作者:
Goldmeyer, James;Li, Haijing;Tang, Yi-Wei
通讯作者:
Tang, Yi-Wei
影响因子:
7.7
作者:
Vincent, M;Xu, Y;Kong, HM
通讯作者:
Kong, HM
影响因子:
8
作者:
Kropp, Rhonda Y.;Wong, Thomas;Steben, Marc
通讯作者:
Steben, Marc