Analysis of the role of the human papillomavirus 16/18 E7 protein assay in screening for cervical intraepithelial neoplasia: a case control study

• Published in: BMC Cancer
• Main Authors: 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, Zhu, Lan
• Format: Web Resource
• Language: English
• Published: Durham Research Square 18.09.2020
• Subjects: Cervical cancer; Gynecology; Human papillomavirus; Medical screening; Proteins
• DOI: 10.21203/rs.3.rs-39820/v2

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.