High performance of human papillomavirus 16/18/58 genotyping combined with cytology in the initial screening of cervical cancer in China

Background: This study evaluated the diagnostic performance of high-risk human papillomavirus (HR-HPV) genotyping combined with cytological triage for detecting histological high-grade squamous intraepithelial lesions or worse (HSIL+) in women without prior screening history. Methods: A total of 1081 women with abnormal HPV test results underwent cytology testing and colposcopy-guided biopsy. The proportion and risk of HSIL+ positivity were analyzed based on HPV genotype and cytological findings. Results: Among the HR-HPV types, HPV16 was the most prevalent, followed by HPV52 and HPV58. HSIL+ was diagnosed in 286 women (26.5%). HPV16-positive women exhibited the highest incidence of HSIL+ (49.9%), followed by those positive for HPV18 and HPV58. In women with normal cytology (negative for intraepithelial lesion and malignancy (NILM), n = 463), 103 cases of HSIL+ were identified, accounting 36.0% of all HSIL-positive cases. The risk ratios and 95% confidence intervals (CIs) for HSIL+ in women positive for HPV16, HPV18 and HPV58 were 5.84 (95% CI: 2.86- 11.92), 2.69 (95% CI: 1.08-6.69), and 3.11(95% CI: 1.12-8.66), respectively, compared to other HR-HPV types. Multivariate analysis indicated that HPV16/18/58 positivity and cytology atypical squamous cells of undetermined significance or worse (cytology >= ASC-US (atypical squamous cells of undetermined significance)) were independent predictors of HSIL or worse. The sensitivity of predicting HSIL or worse was over 90%, and the negative predictive value was 92.0%. Conclusions: The combination of HPV genotyping and cytology demonstrated high diagnostic performance in women without a screening history. In regions with a high prevalence of HPV58, referral for colposcopy or histological examination is warranted for HPV58-positive women to optimize early detection of HSIL.