TY - JOUR
T1 - Evaluation of RealStar® Alpha Herpesvirus PCR Kit for Detection of HSV-1, HSV-2, and VZV in Clinical Specimens
AU - Yip, Cyril C.Y.
AU - Sridhar, Siddharth
AU - Leung, Kit Hang
AU - Cheng, Andrew K.W.
AU - Chan, Kwok Hung
AU - Chan, Jasper F.W.
AU - Cheng, Vincent C.C.
AU - Yuen, Kwok Yung
N1 - Publisher Copyright:
© 2019 Cyril C. Y. Yip et al.
PY - 2019
Y1 - 2019
N2 - 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.
AB - 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.
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U2 - 10.1155/2019/5715180
DO - 10.1155/2019/5715180
M3 - Article
C2 - 31687393
AN - SCOPUS:85074240118
SN - 2314-6133
VL - 2019
JO - BioMed Research International
JF - BioMed Research International
M1 - 5715180
ER -