Abstract
PURPOSE: To evaluate the performance of different high-risk human papillomavirus (HR-HPV) genotype models in triaging women with cytological diagnosis of atypical squamous cells of undetermined significance (ASCUS). PATIENTS AND METHODS: A total of 36,679 Chinese women who underwent cytology and HR-HPV genotyping assessments during cervical cancer screening were enrolled in this study. Women with cytology-proven ASCUS were referred for further screening by colposcopy and biopsy. The study endpoint was histological detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) at any of the follow-up visits. The sensitivity, specificity, positive predictive values (PPVs), negative predictive values (NPVs), positive likelihood ratio (PLR) and negative likelihood ratio (NLR) of different HR-HPV genotype combination models were estimated. RESULTS: In all, 1675 (4.9%) women were identified as having ASCUS, 1454 women underwent colposcopy and biopsy, and 6.0% (87/1454) women were identified as having CIN2+ lesions. Among those with ASCUS who were identified as having CIN2+, the HR-HPV infection rate was 97.7%, and the prevalence rates of HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 were 48.3%, 8.0%, 6.9%, 4.6%, 1.1%, 2.3%, 3.4%, 3.4%, 26.4%, 1.1%, 17.2%, 2.3%, 0.0% and 0.0%, respectively. Compared to other HR-HPV-type combination models, the HPV16/18/31/33/52/58 model achieved a higher sensitivity [93.1 (87.8-98.4)], specificity [73.0 (70.7-75.4)], PPV [18.0 (14.5-21.5)], NPV [99.4 (98.9-99.9)], PLR [3.7 (3.1-3.8)] and NLR [0.06 (0.03-0.18)] for the triage of ASCUS patients, but the colposcopy referral rate (30.9%) was significantly lower than that of the recommended HR-HPV model (44.0%). CONCLUSION: This study confirms that the specific HR-HPV genotype HPV16/18/31/33/52/58 is an alternative strategy for ASCUS triage and can effectively reduce the high burden of colposcopy referrals in China.