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Evaluation of RealStar® Alpha Herpesvirus PCR Kit for Detection of HSV-1, HSV-2, and VZV in Clinical Specimens
Joint Authors
Yip, Cyril C. Y.
Sridhar, Siddharth
Leung, Kit-Hang
Cheng, Andrew K. W.
Chan, Kwok-Hung
Chan, Jasper F. W.
Cheng, Vincent C. C.
Yuen, K. Y.
Source
Issue
Vol. 2019, Issue 2019 (31 Dec. 2019), pp.1-6, 6 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2019-10-09
Country of Publication
Egypt
No. of Pages
6
Main Subjects
Abstract EN
Several commercial PCR kits are available for detection of herpes simplex virus (HSV) and varicella zoster virus (VZV), but the test performance of one CE-marked in vitro diagnostic kit—RealStar® alpha Herpesvirus PCR Kit—has not been well studied.
This study evaluated the performance of RealStar® alpha Herpesvirus PCR Kit 1.0 on the LightCycler® 480 Instrument II for detection and differentiation of HSV-1, HSV-2, and VZV in human clinical specimens.
We evaluated the analytical sensitivity of the RealStar® and in-house multiplex real-time PCR assays using serial dilutions of nucleic acids extracted from clinical specimens.
The analytical sensitivity of the RealStar® assay was 10, 32, and 100 copies/reaction for HSV-1, HSV-2, and VZV, respectively, which was slightly higher than that of the in-house multiplex real-time PCR assay.
Reproducibility of the cycle threshold (Cp) values for each viral target was satisfactory with the intra- and interassay coefficient of variation values below 5% for both assays.
One-hundred and fifty-three clinical specimens and 15 proficiency testing samples were used to evaluate the diagnostic performance of RealStar® alpha Herpesvirus PCR Kit against the in-house multiplex real-time PCR assay.
The RealStar® assay showed 100% sensitivity and specificity when compared to the in-house assay.
Cp values of the RealStar® and in-house assays showed excellent correlation.
RealStar® alpha Herpesvirus PCR is a sensitive, specific, and reliable assay for the detection of HSV-1, HSV-2, and VZV, with less extensive verification requirements compared to a laboratory developed assay.
American Psychological Association (APA)
Yip, Cyril C. Y.& Sridhar, Siddharth& Leung, Kit-Hang& Cheng, Andrew K. W.& Chan, Kwok-Hung& Chan, Jasper F. W.…[et al.]. 2019. Evaluation of RealStar® Alpha Herpesvirus PCR Kit for Detection of HSV-1, HSV-2, and VZV in Clinical Specimens. BioMed Research International،Vol. 2019, no. 2019, pp.1-6.
https://search.emarefa.net/detail/BIM-1126193
Modern Language Association (MLA)
Yip, Cyril C. Y.…[et al.]. Evaluation of RealStar® Alpha Herpesvirus PCR Kit for Detection of HSV-1, HSV-2, and VZV in Clinical Specimens. BioMed Research International No. 2019 (2019), pp.1-6.
https://search.emarefa.net/detail/BIM-1126193
American Medical Association (AMA)
Yip, Cyril C. Y.& Sridhar, Siddharth& Leung, Kit-Hang& Cheng, Andrew K. W.& Chan, Kwok-Hung& Chan, Jasper F. W.…[et al.]. Evaluation of RealStar® Alpha Herpesvirus PCR Kit for Detection of HSV-1, HSV-2, and VZV in Clinical Specimens. BioMed Research International. 2019. Vol. 2019, no. 2019, pp.1-6.
https://search.emarefa.net/detail/BIM-1126193
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1126193