{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T20:02:58Z","timestamp":1767902578760,"version":"3.49.0"},"reference-count":17,"publisher":"Wiley","license":[{"start":{"date-parts":[[2019,10,9]],"date-time":"2019-10-09T00:00:00Z","timestamp":1570579200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases"},{"DOI":"10.13039\/501100002338","name":"Ministry of Education of the People's Republic of China","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002338","id-type":"DOI","asserted-by":"publisher"}]},{"name":"the Providence Foundation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["BioMed Research International"],"published-print":{"date-parts":[[2019,10,9]]},"abstract":"<jats:p>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\u2014RealStar\u00ae <jats:italic>alpha<\/jats:italic> Herpesvirus PCR Kit\u2014has not been well studied. This study evaluated the performance of RealStar\u00ae <jats:italic>alpha<\/jats:italic> Herpesvirus PCR Kit 1.0 on the LightCycler\u00ae 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\u00ae and in-house multiplex real-time PCR assays using serial dilutions of nucleic acids extracted from clinical specimens. The analytical sensitivity of the RealStar\u00ae 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\u00ae <jats:italic>alpha<\/jats:italic> Herpesvirus PCR Kit against the in-house multiplex real-time PCR assay. The RealStar\u00ae assay showed 100% sensitivity and specificity when compared to the in-house assay. Cp values of the RealStar\u00ae and in-house assays showed excellent correlation. RealStar\u00ae <jats:italic>alpha<\/jats:italic> 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.<\/jats:p>","DOI":"10.1155\/2019\/5715180","type":"journal-article","created":{"date-parts":[[2019,10,9]],"date-time":"2019-10-09T19:33:40Z","timestamp":1570649620000},"page":"1-6","source":"Crossref","is-referenced-by-count":9,"title":["Evaluation of RealStar\u00ae <i>Alpha<\/i> Herpesvirus PCR Kit for Detection of HSV-1, HSV-2, and VZV in Clinical Specimens"],"prefix":"10.1155","volume":"2019","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9606-8506","authenticated-orcid":true,"given":"Cyril C. Y.","family":"Yip","sequence":"first","affiliation":[{"name":"Department of Microbiology, Queen Mary Hospital, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Siddharth","family":"Sridhar","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China"},{"name":"State Key Laboratory of Emerging Infectious Diseases, The University of Hong Kong, Hong Kong, China"},{"name":"Research Centre of Infection and Immunology, The University of Hong Kong, Hong Kong, China"},{"name":"Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kit-Hang","family":"Leung","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew K. W.","family":"Cheng","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Queen Mary Hospital, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kwok-Hung","family":"Chan","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jasper F. W.","family":"Chan","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China"},{"name":"State Key Laboratory of Emerging Infectious Diseases, The University of Hong Kong, Hong Kong, China"},{"name":"Research Centre of Infection and Immunology, The University of Hong Kong, Hong Kong, China"},{"name":"Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vincent C. 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