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

被引:24
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
[11]  
Massad LS, 2013, J LOW GENIT TRACT DI, V17, pS1, DOI [10.1097/LGT.0b013e318287d329, 10.1097/AOG.0b013e3182883a34]
[12]   Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older [J].
Meijer, Chris J. L. M. ;
Berkhof, Johannes ;
Castle, Philip E. ;
Hesselink, Albertus T. ;
Franco, Eduardo L. ;
Ronco, Guglielmo ;
Arbyn, Marc ;
Bosch, F. Xavier ;
Cuzick, Jack ;
Dillner, Joakim ;
Heideman, Danielle A. M. ;
Snijders, Peter J. F. .
INTERNATIONAL JOURNAL OF CANCER, 2009, 124 (03) :516-520
[13]   Rate of detection of high-risk HPV with two assays in women ≥ 30 years of age [J].
Quigley, Neil B. ;
Potter, Nicholas T. ;
Chivukula, Mamatha ;
Knight, Mirna Z. ;
Welche, James R. ;
Olson, Marilyn C. .
JOURNAL OF CLINICAL VIROLOGY, 2011, 52 (01) :23-27
[14]  
Rossi PG, 2013, CURR PHARM DESIGN, V19, P1490
[15]   Liquid-Based Cytology and Human Papillomavirus Testing to Screen for Cervical Cancer: A Systematic Review for the US Preventive Services Task Force [J].
Whitlock, Evelyn P. ;
Vesco, Kimberly K. ;
Eder, Michelle ;
Lin, Jennifer S. ;
Senger, Caitlyn A. ;
Burda, Brittany U. .
ANNALS OF INTERNAL MEDICINE, 2011, 155 (10) :687-+
[16]   Clinical Experience with the Cervista HPV HR Assay Correlation of Cytology and HPV Status from 56,501 Specimens [J].
Youens, Kenneth E. ;
Hosler, Gregory A. ;
Washington, Paula J. ;
Jenevein, E. Patrick ;
Murphy, Kathleen M. .
JOURNAL OF MOLECULAR DIAGNOSTICS, 2011, 13 (02) :160-166
[17]   Clinical Performance Characteristics of the Cervista HPV HR Test Kit in Cervical Cancer Screening in China [J].
Zhao, Jian ;
Zhang, Xiaoguang ;
Ma, Jing ;
Liu, Guiwen ;
Yao, Dianxin ;
Zhang, Weiyuan ;
Wang, Jiandong ;
Wei, Lihui ;
Zhao, Yun ;
Zeng, Yi ;
Liao, Qinping .
JOURNAL OF LOWER GENITAL TRACT DISEASE, 2012, 16 (04) :358-363