title: A population-based clinical trial comparing endocervical high-risk HPV testing using hybrid capture 2 and Cervista from the SHENCCAST II Study.
abstract: Our objective was to directly compare the accuracy of the high-risk human papillomavirus (HPV) assays, Hybrid Capture 2 (hc2; Qiagen, Gaithersburg, MD) and Cervista (Hologic, Bedford, MA), in diagnosing cervical intraepithelial neoplasia (CIN) 3 or worse (cancer). A population-based, cross-sectional study (The Shenzhen Cervical Cancer Screening Trial II) was conducted in Guangdong Province in China. Three high-risk HPV assays, self and direct cervical sampling and cytology, were studied. Abnormal results on any of 6 study tests (33%) resulted in referral to colposcopy. At colposcopy, every patient had at least 5 cervical biopsy specimens obtained. For 8,556 women between the ages of 25 and 59 years (mean, 38.9 years), the rate for CIN 3 or worse was 1.6% (141/8,556). The sensitivity (confidence interval) values for CIN 3 or worse were 97.9% (94.0%-99.6%) and 95.1% (90.0%-98.0%) for hc2 and Cervista, respectively (P > .05). The specificity (confidence interval) values were 87.8% (87.1%-88.5%) and 90.3% (89.6%-90.9%), respectively (P < .05). Differences in accuracy in diagnosing CIN 3 or worse with the hc2 and Cervista tests are minor and result from the decisions made in selecting the cut points.
authors.affiliation: Preventive Oncology International, Cleveland Heights, OH, USA.
authors.forename: Jerome L
authors.initials: JL
authors.lastname: Belinson
authors.forename: Ruifang
authors.initials: R
authors.lastname: Wu
authors.forename: Suzanne E
authors.initials: SE
authors.lastname: Belinson
authors.forename: Xinfeng
authors.initials: X
authors.lastname: Qu
authors.forename: Bin
authors.initials: B
authors.lastname: Yang
authors.forename: Hui
authors.initials: H
authors.lastname: Du
authors.forename: Ruosong
authors.initials: R
authors.lastname: Wu
authors.forename: Chun
authors.initials: C
authors.lastname: Wang
authors.forename: Lijie
authors.initials: L
authors.lastname: Zhang
authors.forename: Yanqiu
authors.initials: Y
authors.lastname: Zhou
authors.forename: Ying
authors.initials: Y
authors.lastname: Liu
authors.forename: Robert G
authors.initials: RG
authors.lastname: Pretorius
mesh_terms: D000328:Adult; D003127:Colposcopy; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000150:complications / Q000821:virology; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000150:complications / Q000175:diagnosis* / Q000821:virology; D014773:Virology / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000150:complications / Q000175:diagnosis* / Q000821:virology