1. Analysis of the role of the human papillomavirus 16/18 E7 protein assay in screening for cervical intraepithelial neoplasia: a case control study.
- Author
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Kong, Linghua, Xiao, Xiaoping, Lou, Huiping, Liu, Pengfei, Song, Shuhui, Liu, Moudu, Xu, Tao, Zhang, Ying, Li, Caijuan, Guan, Ruoli, Li, Yan, Yu, Xin, Liu, Haiyuan, Fan, Qingbo, Shi, Honghui, and Zhu, Lan
- Subjects
CERVICAL intraepithelial neoplasia ,CHEMILUMINESCENCE immunoassay ,ENZYME-linked immunosorbent assay ,CERVICAL cancer ,PROTEINS ,PAPILLOMAVIRUSES ,EARLY detection of cancer ,CASE-control method - Abstract
Background: Cervical cancer is the second-most common gynecological cancer, early screening plays a key role in the diagnosis and treatment of cervical intraepithelial neoplasia (CIN). Sustained E7 protein expression is the pathological basis for CIN and cervical cancer.Methods: We collected the cervical cell samples of women who visited the gynecological clinic of Peking Union Medical College Hospital between September 2018 and September 2019 and submitted them to the high-risk human papillomavirus (Hr-HPV) test. We performed a magnetic particle-based chemiluminescence enzyme immunoassay to analyze the HPV16/18 E7 protein level in CIN of different severities and compared the results with those of cervical pathology (gold standard) and the HPV test.Results: The positive rate of HPV16/18 E7 protein increased with the severity of CIN: 26.6% in normal tissue, 58.3% in CIN1, and 70.6% in CIN2 or higher (CIN2+). For CIN2+, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the E7 protein were 70.6, 67.9, 52.2, and 82.3%, respectively. These values of the HPV test were 86.8, 44.5, 43.7, and 87.1%, respectively. With the combination of the E7 protein assay and HPV test, the specificity for diagnosing CIN2+ was 78.1%, which was significantly higher than that of the HPV test alone.Conclusions: HPV16/18 E7 protein level is correlated with the severity of CIN and has a high concordance rate with the pathological result. For cervical cancer screening, the combination of HPV16/18 E7 protein assay and HPV test improves the CIN diagnostic specificity, detection rate, and detection accuracy. [ABSTRACT FROM AUTHOR]- Published
- 2020
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