Title A Population-Based Clinical Trial Comparing Endocervical High-Risk HPV Testing Using Hybrid Capture 2 and Cervista From the SHENCCAST II Study
Authors 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.
Affiliation Prevent Oncol Int, Cleveland Hts, OH USA.
Peking Univ, Shenzhen Hosp, Shenzhen, Peoples R China.
Royal Ladies Clin, Shenzhen, Peoples R China.
Cleveland Clin, Dept Anat Pathol, Cleveland, OH 44106 USA.
Cleveland Clin, Dept Obstet & Gynecol, Cleveland, OH 44106 USA.
Kaiser Permanente, Dept Obstet & Gynecol, Fontana, CA USA.
2762 Fairmt Blvd, Cleveland Hts, OH 44118 USA.
Keywords Hybrid Capture 2
Cervista
Cervical cancer screening
Human papillomavirus
HPV
GRADE CERVICAL LESIONS
HUMAN-PAPILLOMAVIRUS
CANCER
WOMEN
PERFORMANCE
CYTOLOGY
DETECT
HR
Issue Date 2011
Publisher american journal of clinical pathology
Citation AMERICAN JOURNAL OF CLINICAL PATHOLOGY.2011,135,(5),790-795.
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 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.
URI http://hdl.handle.net/20.500.11897/394830
ISSN 0002-9173
DOI 10.1309/AJCPKA6ATAPBZ6JQ
Indexed SCI(E)
Appears in Collections: 深圳医院

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