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学科主题: 临床医学
题名:
Clinical Performance Characteristics of the Cervista HPV HR Test Kit in Cervical Cancer Screening in China
作者: Zhao, Jian1; Zhang, Xiaoguang2; Ma, Jing2; Liu, Guiwen2; Yao, Dianxin2; Zhang, Weiyuan3; Wang, Jiandong3; Wei, Lihui4; Zhao, Yun4; Zeng, Yi2; Liao, Qinping1
关键词: cervical cancer ; CIN 2+ ; HPV detection ; PCR-based sequencing ; Cervista HPV HR
刊名: JOURNAL OF LOWER GENITAL TRACT DISEASE
发表日期: 2012-10-01
卷: 16, 期:4, 页:358-363
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Obstetrics & Gynecology
研究领域[WOS]: Obstetrics & Gynecology
关键词[WOS]: HUMAN-PAPILLOMAVIRUS ; GENERAL PRIMERS ; PGMY PCR ; CYTOLOGY ; POPULATION ; PREVALENCE ; NEOPLASIA
英文摘要:

Objective. A multicenter clinical trial was performed to evaluate and validate the performance of Cervista HPV HR test and to establish its effectiveness in identifying women at risk of having cervical intraepithelial neoplasia 2 (CIN 2) or higher grade (CIN 2+) in the Chinese population.

Materials and Methods. Residual Thin Prep Pap Test samples from women who are negative for intraepithelial lesion or malignancy (NILM) and atypical squamous cells of undetermined significance (ASCUS) or higher grade cytology were tested for high-risk human papillomavirus (HPV). The HPV test results were compared with histology results to determine the clinical sensitivity, specificity, positive predictive value, and negative predictive value of Cervista HPV HR for CIN 2+. The analytical accuracy of Cervista HPV HR compared with consensus HPV L1 polymerase chain reaction (PCR)/sequencing was also determined.

Result. A total of 1,064 subjects were enrolled, including 544 with NILM cytology and 520 with ASCUS or higher grade cytology. Complete data sets including cytology, high-risk HPV test, colposcopy, and histology results for all subjects with ASCUS or higher grade were included in the analysis. The positive rate of Cervista HPV HR was 12.5% in patients with NILM and 69.04% in patients with ASCUS or higher grade. The overall percentage agreement between Cervista HPV HR and PCR with bidirectional sequencing was 86.26%, with positive percentage agreement and negative percentage agreement being 93.4% and 83.3%, respectively. In the overall population, the Cervista HPV HR positivity rate was 38.96% compared with 29.08% for PCR/sequencing. The clinical sensitivity and specificity for CIN 2+ of Cervista HPV HR were 98.50% and 68.21%, respectively. The negative and positive predictive values were 99.69% and 30.68%, respectively.

Conclusions. The Cervista HPV HR test, performed on ThinPrep Pap Test samples, has the clinical performance characteristics required by China for use as part of routine cervical cancer screening.

语种: 英语
WOS记录号: WOS:000309326200005
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/63011
Appears in Collections:北京大学第一临床医学院_期刊论文

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作者单位: 1.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
2.Chinese Ctr Dis Prevent & Control, State Key Lab Infect Dis Prevent & Control, Beijing, Peoples R China
3.Beijing Obstet & Gynecol Hosp, Beijing, Peoples R China
4.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China

Recommended Citation:
Zhao, Jian,Zhang, Xiaoguang,Ma, Jing,et al. Clinical Performance Characteristics of the Cervista HPV HR Test Kit in Cervical Cancer Screening in China[J]. JOURNAL OF LOWER GENITAL TRACT DISEASE,2012,16(4):358-363.
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