Clinical Validation of the Cervista HPV HR Test According to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Cancer Screening

被引:23
作者
Boers, Aniek [1 ]
Wang, Rong [1 ]
Slagter-Menkema, Lorian [2 ]
van Hemel, Bettien M. [2 ]
Ghyssaert, Hilde [3 ]
van der Zee, Ate G. J. [1 ]
Wisman, G. Bea A. [1 ]
Schuuring, Ed [2 ]
机构
[1] Univ Groningen, Univ Med Ctr Groningen, Div Gynecol Oncol, Dept Obstet & Gynecol, Groningen, Netherlands
[2] Univ Groningen, Univ Med Ctr Groningen, Dept Pathol & Med Biol, Groningen, Netherlands
[3] AZ St Jan Brugge Oostende, Dept Pathol, Brugge, Belgium
关键词
HIGH-RISK HPV; HYBRID CAPTURE 2; WOMEN; PERFORMANCE; CYTOLOGY; ASSAY; EXPERIENCE;
D O I
10.1128/JCM.02716-14
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
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.
引用
收藏
页码:4391 / 4393
页数:3
相关论文
共 17 条
  • [1] [Anonymous], CERV HPV HR PACK INS
  • [2] A Population-Based Clinical Trial Comparing Endocervical High-Risk HPV Testing Using Hybrid Capture 2 and Cervista From the SHENCCAST II Study
    Belinson, Jerome L.
    Wu, Ruifang
    Belinson, Suzanne E.
    Qu, Xinfeng
    Yang, Bin
    Du, Hui
    Wu, Ruosong
    Wang, Chun
    Zhang, Lijie
    Zhou, Yanqiu
    Liu, Ying
    Pretorius, Robert G.
    [J]. AMERICAN JOURNAL OF CLINICAL PATHOLOGY, 2011, 135 (05) : 790 - 795
  • [3] Comparing the Cervista HPV HR Test and Hybrid Capture 2 Assay in a Dutch Screening Population: Improved Specificity of the Cervista HPV HR Test by Changing the Cut-Off
    Boers, Aniek
    Slagter-Menkema, Lorian
    van Hemel, Bettien M.
    Belinson, Jerome L.
    Ruitenbeek, Teus
    Buikema, Henk J.
    Klip, Harry
    Ghyssaert, Hilde
    van der Zee, Ate G. J.
    de Bock, Geertruida H.
    Wisman, G. Bea A.
    Schuuring, Ed
    [J]. PLOS ONE, 2014, 9 (07):
  • [4] Overview of the European and North American studies on HPV testing in primary cervical cancer screening
    Cuzick, Jack
    Clavel, Christine
    Petry, Karl-Ulrich
    Meijer, Chris J. L. M.
    Hoyer, Heike
    Ratnam, Samuel
    Szarewski, Anne
    Birembaut, Philippe
    Kulasingam, Shalini
    Sasieni, Peter
    Iftner, Thomas
    [J]. INTERNATIONAL JOURNAL OF CANCER, 2006, 119 (05) : 1095 - 1101
  • [5] Analytical performance of the Investigational Use Only Cervista™ HPV HR test as determined by a multi-center study
    Day, Stephen P.
    Hudson, Angela
    Mast, Andrea
    Sander, Tamara
    Curtis, Michelle
    Olson, Sarah
    Chehak, LuAnne
    Quigley, Neil
    Ledford, Joellen
    Yen-Lieberman, Belinda
    Kohn, Debra
    Quigley, Denise I.
    Olson, Marilyn
    [J]. JOURNAL OF CLINICAL VIROLOGY, 2009, 45 : S63 - S72
  • [6] Clinical Laboratory Experience with Cervista HPV HR as a Function of Cytological Classification: Comparison with Retrospective digene HC2 High-Risk HPV DNA Test Data
    Du Chateau, Brian K.
    Schroeder, Elizabeth R.
    Munson, Erik
    [J]. JOURNAL OF CLINICAL MICROBIOLOGY, 2013, 51 (03) : 1057 - 1058
  • [7] Age-Stratified Performance of the Cervista HPV 16/18 Genotyping Test in Women with ASC-US Cytology
    Einstein, Mark H.
    Garcia, Francisco A. R.
    Mitchell, Amy L.
    Day, Stephen P.
    [J]. CANCER EPIDEMIOLOGY BIOMARKERS & PREVENTION, 2011, 20 (06) : 1185 - 1189
  • [8] Comparison of the third wave invader human papillomavirus (HPV) assay and the Digene HPV Hybrid Capture 2 assay for detection of high-risk HPV DNA
    Ginocchio, C. C.
    Barth, D.
    Zhang, F.
    [J]. JOURNAL OF CLINICAL MICROBIOLOGY, 2008, 46 (05) : 1641 - 1646
  • [9] High-Risk Human Papillomavirus Detection in Women With Low-Grade Squamous Intraepithelial Lesions or Higher-Grade Cytology Using the Cervista HPV HR Test
    Gold, Michael A.
    Thomas, Michael A.
    Huh, Warner K.
    Sarto, Gloria E.
    Day, Stephen P.
    [J]. JOURNAL OF LOWER GENITAL TRACT DISEASE, 2013, 17 (01) : 51 - 57
  • [10] Cervista HR and HPV 16/18 Assays vs Hybrid Capture 2 Assay Outcome Comparison in Women With Negative Cervical Cytology
    Kurian, Elizabeth M.
    Caporelli, Mandi-Lee
    Baker, Stephen
    Woda, Bruce
    Cosar, Ediz F.
    Hutchinson, Lloyd
    [J]. AMERICAN JOURNAL OF CLINICAL PATHOLOGY, 2011, 136 (05) : 808 - 816