Clinical Validation of the Cervista HPV HR Test According to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Cancer Screening |
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| Authors: | Aniek Boers Rong Wang Lorian Slagter-Menkema Bettien M van Hemel Hilde Ghyssaert Ate G J van der Zee G Bea A Wisman Ed Schuuring |
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| Institution: | aDepartment of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands;bDepartment of Pathology and Medical Biology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands;cDepartment of Pathology, AZ St. Jan Brugge-Oostende, Bruges, Belgium |
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| 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. |
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