title: Clinical validation of the Cervista HPV HR test according to the international guidelines for human papillomavirus test requirements for cervical cancer screening.
abstract: This study demonstrates that both the clinical sensitivity and specificity of the Cervista HPV HR test for high-risk human papillomavirus (HPV) detection are not inferior to those of the Hybrid Capture 2 (HC2) test. The intra- and interlaboratory reproducibilities of Cervista were 92.0% (kappa, 0.83) and 90.4% (kappa, 0.80), respectively. The Cervista HPV HR test fulfills all the international HPV test requirements for cervical primary screening purposes.
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: Aniek
authors.initials: A
authors.lastname: Boers
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: Rong
authors.initials: R
authors.lastname: Wang
authors.affiliation: Department of Pathology and Medical Biology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: Lorian
authors.initials: L
authors.lastname: Slagter-Menkema
authors.affiliation: Department of Pathology and Medical Biology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: Bettien M
authors.initials: BM
authors.lastname: van Hemel
authors.affiliation: Department of Pathology, AZ St. Jan Brugge-Oostende, Bruges, Belgium.
authors.forename: Hilde
authors.initials: H
authors.lastname: Ghyssaert
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: Ate G J
authors.initials: AG
authors.lastname: van der Zee
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: G Bea A
authors.initials: GB
authors.lastname: Wisman
authors.affiliation: Department of Pathology and Medical Biology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands e.schuuring@umcg.nl.
authors.forename: Ed
authors.initials: E
authors.lastname: Schuuring
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology