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.
Keywords: human papillomavirus, high-risk, genotyping, atypical squamous cells of undetermined significance, cervical intraepithelial neoplasia