title: A parallel study of careHPV and Hybrid Capture 2 human papillomavirus DNA testing for cervical cancer screening in rural China.
abstract: Hybrid Capture 2 (HC2) has been demonstrated to be a feasible screening method for cervical cancer. Based upon HC2 technology, careHPV is a simple, rapid, accurate, and inexpensive screening test for women in low-resource settings. This study aims to characterize both the careHPV test and HC2 test, and to compare careHPV results of specimens stored in careHPV test collection medium (TCM) to HC2 results from partner specimens stored in Qiagen specimen transport medium and TCM. The positive rates of high-risk HPV in careHPV, HC2, and HC2 (TCM) were 13.2% (108/818), 13.2% (108/818), and 13.6% (111/818), respectively. The agreement rates of pairwise tests were 95.8% (95% CI: 94.5-97.2%), 96.7% (95% CI: 95.5-97.9%), and 97.2% (95% CI: 96.1-98.3%), respectively. The Kappa values of the pairwise tests were 0.82 (95% CI: 0.76-0.88), 0.86 (95% CI: 0.81-0.91), and 0.88 (95% CI: 0.83-0.93), respectively. Based on these findings, although careHPV is demonstrated to be a viable alternative to the HC2 test, improvements on the careHPV test are still required prior to its implementation as a suitable screening method for women in low-resource settings. Further studies on the significance and applicability of the careHPV test must be performed.
authors.affiliation: Department of Cancer Epidemiology, Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, Chaoyang District, Beijing 100021, China.
authors.forename: Chun-Qing
authors.initials: CQ
authors.lastname: Lin
authors.affiliation: Department of Cancer Epidemiology, Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, Chaoyang District, Beijing 100021, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Chen
authors.affiliation: Department of Cancer Epidemiology, Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, Chaoyang District, Beijing 100021, China.
authors.forename: Bin
authors.initials: B
authors.lastname: Liu
authors.affiliation: Department of Epidemiology, Cancer Hospital of Shanxi Province, Taiyuan 030013, Shanxi Province, China.
authors.forename: Yong-Zhen
authors.initials: YZ
authors.lastname: Zhang
authors.affiliation: Department of Gynecologic Oncology, Liaoning Cancer Hospital/Institute, Shenyang 110042, Liaoning Province, China.
authors.forename: Xiao-Li
authors.initials: XL
authors.lastname: Cui
authors.affiliation: Women and Children' Hospital of Qinxian County, No. 185 Shengli Road, Qinxian County, Shanxi Province, China.
authors.forename: Ai-Mei
authors.initials: AM
authors.lastname: Li
authors.affiliation: Department of Gynecologic Oncology, Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, Chaoyang District, Beijing 100021, China.
authors.forename: Wen-Hua
authors.initials: WH
authors.lastname: Zhang
authors.affiliation: Department of Cancer Epidemiology, Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, Chaoyang District, Beijing 100021, China.
authors.forename: Wen
authors.initials: W
authors.lastname: Chen
authors.affiliation: University of Miami Miller School of Medicine, 1150 NW 14th Street, Miami, FL, USA.
authors.forename: Irene
authors.initials: I
authors.lastname: Chang
authors.affiliation: Vanderbilt University School of Medicine, Nashville, TN 37212, USA.
authors.forename: Priya
authors.initials: P
authors.lastname: Sivasubramaniam
authors.affiliation: QIAGEN Gaithersburg, Inc. North America R&D, 1201 Clopper Road, Gaithersburg, MD 20878, USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Zhu
authors.affiliation: Department of Cancer Epidemiology, Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, Chaoyang District, Beijing 100021, China. Electronic address: qiaoy@cicams.ac.cn.
authors.forename: You-Lin
authors.initials: YL
authors.lastname: Qiao
mesh_terms: D000328:Adult; D002681:China; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D012424:Rural Population; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014773:Virology / Q000379:methods
keywords: CareHPV; Cervical cancer; Human papillomavirus (HPV); Hybrid Capture 2 (HC2)