Performance of human papillomavirus typing test in cervical precancer lesions and cervical cancer screening
10.3760/cma.j.cn112152-20190603-00346
- VernacularTitle:人乳头瘤病毒分型检测在宫颈癌前病变和宫颈癌筛查中的应用价值
- Author:
Shaokai ZHANG
1
;
Xiping LUO
;
Zhifang LI
;
Zheng SU
;
Jichao XIA
;
Guiying HU
;
Yujing ZHU
;
Longxu XIE
;
Xiangxian FENG
;
Xibin SUN
;
Wen CHEN
;
Youlin QIAO
Author Information
1. 郑州大学附属肿瘤医院 河南省肿瘤医院癌症中心办公室 450008
- Keywords:
Human papilloma virus;
Cervical intraepithelial neoplasia;
Cervical neoplasms;
Screening
- From:
Chinese Journal of Oncology
2020;42(3):252-256
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the performance of Hybribio human papillomavirus (HPV) typing test kit for high risk HPV-DNA typing detection in screening of cervical precancer lesions.Methods:A total of 9 914 women were recruited in Henan, Shanxi, and Guangdong provinces from June to July 2017. All women underwent HPV DNA test. The women who diagnosed as HPV positive and cytological examination ≥ atypical squamous cells of undetermined significance (ASCUS) or HPV negative and cytological examination≥low-grade squamous intraepithelial lesions (LSIL) underwent colposcopy biopsy and pathological examination. Using the pathological diagnosis as the gold standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and 95% confidence interval ( CI) of high-risk HPV and HPV16/18 tests were calculated. Results:The mean age of 9 914 subjects was (45.0±9.3) years old. Among them, 1 302 subjects were detected as high risk HPV positive, including 211 of HPV16 positive and 64 of HPV18 positive. According to the pathological gold standard of cervical intraepithelial neoplasia grade 2 (CIN2) or worse, the sensitivity and specificity of high risk-HPV and HPV 16/18 for triaging ASCUS women were 90.6% (95% CI: 75.8%-96.8%) and 78.0% (95% CI: 74.5%-81.2%) as well as 56.3% (95% CI: 39.3%-71.8%) and 95.7% (95% CI: 93.8%-97.1%), respectively. The sensitivity and specificity of high risk-HPV and HPV 16/18 for cervical precancer lesions screening were 95.1% (95% CI: 88.1%-98.1%) and 87.6% (95% CI: 86.9%-88.2%) as well as 65.9% (95% CI: 55.1%-75.2%) and 97.8% (95% CI: 97.5%-98.1%), respectively. Conclusions:The Hybribio HPV test kit has a relative high sensitivity and specificity for cervical precancer lesions screening and ASCUS triaging. It is reliable for HPV DNA detection and cervical cancer screening.
