The role of E7 oncoprotein self-sampling and self-testing in cervical cancer screening.

OBJECTIVE: To preliminarily explore and validate the role of E7 oncoprotein self-sampling and self-testing in cervical cancer screening. METHODS: Approved by the Ethics Committee of Peking University First Hospital, 461 patients who underwent cervical cancer screening with abnormal screening results in the outpatient clinic from June 13, 2023 to August 29, 2023 were selected and participated in the clinical trial with informed consent. For E7 oncoprotein, the participants use self-sampling brushes to collect samples and perform testing by themselves. Self-sampling and self-testing of E7 oncoprotein detection, and cervical cancer cell cytology combined with high-risk HPV detection, were performed at the same time. The experimental steps were performed according to the instructions of the E7 Protein Test Kit (Colloidal Gold Method) of FAMID Biomedical Technology (Tianjin) Co., Ltd. RESULTS: Among the 461 patients, 452 had valid self-sampling results. Among the 452 patients, 293 needed to be referred for colposcopy, and 34 cervical intraepithelial neoplasia (CIN)1 + patients were identified. The performance of cytology to identify CIN1 + had a sensitivity of 73.53%, specificity of 89.47%, negative predictive value of 97.65%, positive predictive value of 36.23%, and coincidence rate of 88.27%, respectively. The performance of any of the 14 high-risk HPV types to identify CIN1 + had a sensitivity of 82.35%, specificity of 59.33%, negative predictive value of 97.64%, positive predictive value of 14.14%, and coincidence rate of 61.06%. The performance of cytology combined with high-risk HPV to identify CIN1 + had a sensitivity of 77.94%, specificity of 74.40%, negative predictive value of 97.64%, positive predictive value of 25.19%, and coincidence rate of 74.67%. The sensitivity of self-sampling and self-testing of E7 oncoprotein was 76.47%, the specificity was 91.87%, the negative predictive value was 97.96%, the positive predictive value was 43.33%, and the coincidence rate was 90.71%. The coincidence rate of self-sampling and self-testing of E7 oncoprotein combined with cytology and high-risk HPV screening was 82.69%. CONCLUSION: The expression of E7 oncoprotein is closely related to cervical precancerous lesions. The self-sampling and self-testing of E7 oncoprotein had a negative predictive value of 97.96% for identifying CIN1+, and had high sensitivity and specificity. It can be used independently or with combined screening with a compliance rate of 82.69%, which can help increase the cervical cancer screening coverage.