Prevention Research
Performance of human papillomavirus typing test in cervical precancer lesions and cervical cancer screening
Shaokai Zhang, Xiping Luo, Zhifang Li, Zheng Su, Jichao Xia, Guiying Hu, Yujing Zhu, Longxu Xie, Xiangxian Feng, Xibin Sun, Wen Chen, Youlin Qiao
Published 2020-03-23
Cite as Chin J Oncol, 2020, 42(3): 252-256. DOI: 10.3760/cma.j.cn112152-20190603-00346
Abstract
ObjectiveTo evaluate the performance of Hybribio human papillomavirus (HPV) typing test kit for high risk HPV-DNA typing detection in screening of cervical precancer lesions.
MethodsA 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.
ResultsThe 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.
ConclusionsThe 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.
Key words:
Human papilloma virus; Cervical intraepithelial neoplasia; Cervical neoplasms; Screening
Contributor Information
Shaokai Zhang
Department of Cancer Prevention and Control, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou 450008, China
Xiping Luo
Department of Gynecology, Guangdong Provincial Women and Child Health Hospital, Guangzhou 510000, China
Zhifang Li
Department of Preventive Medicine, Changzhi Medical College, Changzhi 046000, China
Zheng Su
Department of Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100021, China
Jichao Xia
Guangdong Human Papillomavirus (HPV) Related Disease Molecular Diagnostic Engineering Technology Research and Development Center, Guangzhou 510000, China
Guiying Hu
Department of Gynecology, Guangdong Provincial Women and Child Health Hospital, Guangzhou 510000, China
Yujing Zhu
Department of Gynecology, Jiyuan Women and Children's Health Hospital, Jiyuan 454650, China
Longxu Xie
Guangdong Human Papillomavirus (HPV) Related Disease Molecular Diagnostic Engineering Technology Research and Development Center, Guangzhou 510000, China
Xiangxian Feng
Department of Preventive Medicine, Changzhi Medical College, Changzhi 046000, China
Xibin Sun
Department of Cancer Prevention and Control, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou 450008, China
Wen Chen
Department of Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100021, China
Youlin Qiao
Department of Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100021, China