Prevalence of HPV-16/18 genotypes and immediate histopathologic correlation results in a Chinese population with negative cytology and positive high-risk HPV testing

Background The objective of this study was to examine the prevalence of human papillomavirus 16/18 (HPV-16/18) genotypes and immediate histopathologic correlations in a Chinese population with negative cytology and positive high-risk human papillomavirus (hrHPV) testing. Methods Patients who had documented negative cytology with immediate follow-up (within the 6 months after negative for intraepithelial lesion or malignancy Papanicolaou [Pap] testing), including a histopathologic examination and/or hrHPV testing, between 2011 and 2018 were included, and the data were analyzed. Results Among 1,424,182 Pap tests, 1,333,453 (93.6%) were interpreted as negative cytology. Although conventional Pap smears had the highest reporting rate, cervical intraepithelial neoplasia 2 and higher (CIN-2+) lesions were detected significantly more with liquid-based cytology preparations (2.1%) than the conventional method (1.4%; P < .01). The overall hrHPV-positive rate was 14.9% (25,507 of 171,273) in the women with negative cytology. Among the 18,423 cytology-negative, HPV-positive cases tested with the Cobas assay, the overall HPV-16/18 prevalence was 24.7%, with 17.9% being HPV-16-positive, 6.2% being HPV-18-positive, and 0.6% being positive for both HPV-16 and HPV-18. The immediate histopathologic examination was documented for 21,796 women with cotesting results, including 8915 HPV-positive cases and 12,881 HPV-negative cases. CIN-2+ lesions were diagnosed in 15.2% of the HPV-16-positive cases; this rate was significantly higher than the rates seen in the HPV-18-positive cases (4.8%) and the cases positive for 1 of the other 12 types of HPV (3.0%). Conclusions This is by far the largest routine clinical practice report of HPV-16/18 genotyping and histopathologic examination in negative-cytology women and the first report of such an investigation in the Chinese population. This study indicates enhanced risk stratification with HPV-16/18 genotype testing in HPV-positive, cytology-negative women in the Chinese population.