Open AccessClinical Validation of the Cervista HPV HR Test According to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Cancer Screening
Author(s) -
Aniek Boers,
Rong Wang,
Lorian SlagterMenkema,
Bettien M. van Hemel,
Hilde Ghyssaert,
Ate G.J. van der Zee,
G. Bea A. Wisman,
Ed Schuuring
Publication year - 2014
Publication title -
journal of clinical microbiology
Language(s) - English
Resource type - Journals
eISSN - 1070-633X
pISSN - 0095-1137
DOI - 10.1128/jcm.02716-14
Subject(s) - human papillomavirus , cervical cancer , kappa , medicine , test (biology) , hybrid capture , oncology , cancer , cervical intraepithelial neoplasia , biology , paleontology , philosophy , linguistics
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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