A Population-Based Clinical Trial Comparing Endocervical High-Risk HPV Testing Using Hybrid Capture 2 and Cervista From the SHENCCAST II Study

作者：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.

来源：American Journal of Clinical Pathology, 2011, 135(5): 790-795.

DOI：10.1309/AJCPKA6ATAPBZ6JQ

• Hybrid Capture 2
• Cervista
• Cervical cancer screening
• Human papillomavirus
• HPV

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 HP V 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.

• 出版日期2011-5
• 单位北京大学