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Article: Evaluation of RealStar® Alpha Herpesvirus PCR Kit for Detection of HSV-1, HSV-2, and VZV in Clinical Specimens

TitleEvaluation of RealStar® Alpha Herpesvirus PCR Kit for Detection of HSV-1, HSV-2, and VZV in Clinical Specimens
Authors
Keywordscontrolled study
Herpes simplex virus 2
Herpesviridae
Human alphaherpesvirus 1
multiplex real time polymerase chain reaction
Issue Date2019
PublisherHindawi Publishing Corporation. The Journal's web site is located at http://www.hindawi.com/journals/jbb/index.html
Citation
BioMed Research International, 2019, v. 2019, p. article no. 5715180 How to Cite?
AbstractSeveral 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.
Persistent Identifierhttp://hdl.handle.net/10722/284103
ISSN
2019 Impact Factor: 2.276
2015 SCImago Journal Rankings: 0.725
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorYip, CY-
dc.contributor.authorSridhar, S-
dc.contributor.authorLeung, KH-
dc.contributor.authorCheng, AKW-
dc.contributor.authorChan, KH-
dc.contributor.authorChan, JFW-
dc.contributor.authorCheng, VCC-
dc.contributor.authorYuen, KY-
dc.date.accessioned2020-07-20T05:56:07Z-
dc.date.available2020-07-20T05:56:07Z-
dc.date.issued2019-
dc.identifier.citationBioMed Research International, 2019, v. 2019, p. article no. 5715180-
dc.identifier.issn2314-6133-
dc.identifier.urihttp://hdl.handle.net/10722/284103-
dc.description.abstractSeveral 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.-
dc.languageeng-
dc.publisherHindawi Publishing Corporation. The Journal's web site is located at http://www.hindawi.com/journals/jbb/index.html-
dc.relation.ispartofBioMed Research International-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectcontrolled study-
dc.subjectHerpes simplex virus 2-
dc.subjectHerpesviridae-
dc.subjectHuman alphaherpesvirus 1-
dc.subjectmultiplex real time polymerase chain reaction-
dc.titleEvaluation of RealStar® Alpha Herpesvirus PCR Kit for Detection of HSV-1, HSV-2, and VZV in Clinical Specimens-
dc.typeArticle-
dc.identifier.emailYip, CY: yipcyril@hku.hk-
dc.identifier.emailSridhar, S: sid8998@hku.hk-
dc.identifier.emailLeung, KH: khl17@hku.hk-
dc.identifier.emailChan, KH: chankh2@hkucc.hku.hk-
dc.identifier.emailChan, JFW: jfwchan@hku.hk-
dc.identifier.emailCheng, VCC: vcccheng@hkucc.hku.hk-
dc.identifier.emailYuen, KY: kyyuen@hkucc.hku.hk-
dc.identifier.authorityYip, CY=rp01721-
dc.identifier.authoritySridhar, S=rp02249-
dc.identifier.authorityChan, KH=rp01921-
dc.identifier.authorityChan, JFW=rp01736-
dc.identifier.authorityYuen, KY=rp00366-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1155/2019/5715180-
dc.identifier.pmid31687393-
dc.identifier.pmcidPMC6803750-
dc.identifier.scopuseid_2-s2.0-85074240118-
dc.identifier.hkuros310968-
dc.identifier.volume2019-
dc.identifier.spagearticle no. 5715180-
dc.identifier.epagearticle no. 5715180-
dc.identifier.isiWOS:000492952300005-
dc.publisher.placeUnited States-
dc.identifier.issnl2314-6133-

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