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Abstract
BackgroundCervical 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.MethodsWe 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.ResultsThe 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.ConclusionsHPV16/18 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.
Highlights
Screening plays a key role in the diagnosis and treatment of cervical intraepithelial neoplasia (CIN)
We analyzed HPV 16/18 E7 protein level in CIN of different severities in order to investigate the relationship between the results of the HPV 16/18 E7 protein assay and the severity of CIN, as well as to investigate the value of the HPV16/18 E7 protein assay in CIN screening and evaluated its role as an auxiliary diagnostic biomarker
The results indicated that the positive rate of E7 protein expression increased with the severity of CIN: it was 32.1% in normal and CIN1 patients and 70.6% in CIN2+ patients (P < 0.001). (Table 1)
Summary
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). Screening plays a key role in the diagnosis and treatment of cervical intraepithelial neoplasia (CIN). To further improve the diagnostic sensitivity and address limitations such as the shortage and varying skill levels of technicians, in 2014 the World Health Organization (WHO) recommended the use of a high-risk human papillomavirus (Hr-HPV) test for cervical cancer screening in developing countries [3, 4]. Different studies have shown great variability in the specificity of HPV testing for high-grade CIN, from 24.8 to 56.1% [5, 6]. Researchers agree that the high sensitivity and low specificity of the HPV test contribute to a high colposcopy referral rate [7]. We analyzed HPV 16/18 E7 protein level in CIN of different severities in order to investigate the relationship between the results of the HPV 16/18 E7 protein assay and the severity of CIN, as well as to investigate the value of the HPV16/18 E7 protein assay in CIN screening and evaluated its role as an auxiliary diagnostic biomarker
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