title: A cross-sectional study on HPV testing with type 16/18 genotyping for cervical cancer screening in 11,064 Chinese women.
abstract: Cytology-based cervical cancer screening is restricted because of a lack of cytologists. Thus, HPV-based instead of cytology-based screening may be a more suitable strategy in China. Here, we assessed the effectiveness of HPV testing (Cobas®4800 Test, Roche) and HPV-based programs to detect high-grade cervical intraepithelial neoplasia (CIN) or cancer compared with cytology (Thinprep, Hologic) and cytology-based programs through a cross-sectional study in 11,064 Chinese women aged 21-65 years who were enrolled from Longyou County in Zhejiang Province, China. The rates of HPV positivity and cytology abnormality were 9.8% and 6.1%, respectively. The HPV positivity rate had two age peaks, 21-24 (15.4%) and 60-65 (14.4%) years. According to adjusted data, HPV testing demonstrated significantly higher sensitivity and negative predictive value (NPV) than cytology for detecting CIN2 or worse (90.0% vs. 66.7%, 99.9% vs. 99.5%), and there was an acceptable specificity (91.3%) and positive predictive value (PPV, 12.5%). Furthermore, primary HPV testing with type 16/18 genotyping showed the highest sensitivity (78.6%) and NPV (99.7%) among four screening strategies, and there was similar specificity (96.8%) and PPV (23.9%) compared with co-testing screening to detect CIN2+, while there were fewer colposcopies (4.2) and tests (106.3) performed than with co-testing and primary cytology screening to detect a case of high-grade CIN. The differences in effectiveness were approximately similar when CIN3+ was the identifying target. Our findings suggest that primary HPV testing with type 16/18 genotyping has a higher sensitivity and NPV, possesses optimal cost/effectiveness in the first round of screening and is a feasible strategy of cervical cancer screening for Chinese women.
authors.affiliation: Department of Gynecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.|Key Laboratory of Women's Reproductive Health of Zhejiang Province, Hangzhou, China.
authors.forename: Qiongyan
authors.initials: Q
authors.lastname: Wu
authors.affiliation: Department of Gynecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.|Key Laboratory of Women's Reproductive Health of Zhejiang Province, Hangzhou, China.
authors.forename: Xiumin
authors.initials: X
authors.lastname: Zhao
authors.affiliation: Department of Gynecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
authors.forename: Yunfeng
authors.initials: Y
authors.lastname: Fu
authors.affiliation: Department of Gynecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
authors.forename: Xinyu
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Pathology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
authors.forename: Xiaofei
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Cancer Biology Research Center (Key laboratory of the ministry of education), Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
authors.forename: Xun
authors.initials: X
authors.lastname: Tian
authors.affiliation: Department of Gynecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
authors.forename: Bei
authors.initials: B
authors.lastname: Cheng
authors.affiliation: Department of Pathology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
authors.forename: Bingjian
authors.initials: B
authors.lastname: Lu
authors.affiliation: Department of Gynecology, Women & Children Healthcare Hospital of Quzhou City, Quzhou, Zhejiang, China.
authors.forename: Xiao
authors.initials: X
authors.lastname: Yu
authors.affiliation: Longyou County Maternal and Child Health-Care Center, Quzhou, Zhejiang, China.
authors.forename: Suqiu
authors.initials: S
authors.lastname: Lan
authors.affiliation: Department of Gynecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
authors.forename: Weiguo
authors.initials: W
authors.lastname: Lu
authors.affiliation: Cancer Biology Research Center (Key laboratory of the ministry of education), Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
authors.forename: Ding
authors.initials: D
authors.lastname: Ma
authors.affiliation: Department of Gynecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
authors.forename: Xiaodong
authors.initials: X
authors.lastname: Cheng
authors.affiliation: Department of Gynecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
authors.forename: Xing
authors.identifier: http://orcid.org/0000-0002-1636-4816
authors.initials: X
authors.lastname: Xie
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D003430:Cross-Sectional Studies; D055088:Early Detection of Cancer; D005260:Female; D060005:Genotyping Techniques / Q000379:methods*; D052162:Human papillomavirus 16 / Q000235:genetics*; D052161:Human papillomavirus 18 / Q000235:genetics*; D006801:Humans; D008403:Mass Screening; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000821:virology*; D014626:Vaginal Smears / Q000379:methods*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000821:virology*
keywords: Cervical cancer screening; cervical cytology; cervical intraepithelial neoplasia; genotype; human papillomavirus