[Evaluation of high-risk HPV genotyping detection in cervical cancer screening based on a prospective cohort study]

Objective: To evaluate the clinical performance of high-risk human papillomavirus (HR-HPV) genotyping in cervical cancer screening. Methods: Between June and July 2017, a prospective cervical cancer screening cohort was established in Xiaye Town, Jiyuan City, Henan Province, China by recruiting 3 254 women aged 21 to 64 years. At baseline screening, cervical exfoliated cell specimens were collected for HR-HPV genotyping and liquid-based cytology testing. Follow-ups were conducted over a 3-year period, with cytology testing in the first and second years and both HR-HPV genotyping and cytology testing in the third year. Women meeting the referral criteria were referred for colposcopy, with cervical biopsy and histopathological diagnosis performed as necessary. The endpoint was defined as cervical intraepithelial neoplasia grade 2 (CIN2) or higher confirmed by histopathological diagnosis. The sensitivity and specificity for detecting CIN2 or higher lesions of HR-HPV genotyping were calculated, as well as the cumulative risk of developing CIN2 or higher lesions over the 4-year study period in women with different baseline HR-HPV genotyping results. Results: A total of 2 741 women were included in the statistical analysis. Baseline HR-HPV genotyping detected 453 HR-HPV positive cases (16.53%), including 98 HPV 16/18 positive cases (3.58%) and 355 other HR-HPV positive cases (12.95%). During the 4-year period, 83 cases of CIN2 or higher were diagnosed. The sensitivity and specificity of baseline HR-HPV positivity for CIN2 or higher were 89.16% (95% CI: 80.66%-94.19%) and 85.74% (95% CI: 84.36%-87.02%), respectively. The corresponding rates for HPV 16/18 positivity were 43.37% (95% CI: 33.24%-54.09%) and 97.67% (95% CI: 97.02%-98.18%). The 4-year cumulative absolute risk of CIN2 or higher was highest in the HPV 16/18 positive group (36.73%, 95% CI: 27.85%-46.62%), followed by other HR-HPV positive groups (10.70%, 95% CI: 7.87%-14.38%), and the HR-HPV negative group was the lowest (0.39%, 95% CI: 0.19%-0.76%). Conclusions: HR-HPV genotyping testing exhibits high sensitivity and specificity for detecting CIN2 or higher lesions in cervical cancer screening. It also provides a scientific basis for stratifying the individual risk of developing CIN2 or higher lesions to guide subsequent management. Therefore, the HR-HPV genotyping testing can be considered as an effective method for cervical cancer screening.