Triage performance of PAX1 m /JAM3 m in opportunistic cervical cancer screening of non‒16/18 human papillomavirus-positive women: a multicenter prospective study in China

In this study, we aimed to validate the performance of the PAX1 and JAM3 methylation (PAX1 /JAM3 ) test as a triage tool for detecting cervical intraepithelial neoplasia grade 3 or worse (CIN3 +) in non-16/18 high-risk human papillomavirus-positive patients (non-16/18 hrHPV +). The triage performance of liquid-based cytology (LBC) and the PAX1 /JAM3 test for detecting CIN3 + were compared. In total, 1851 participants had cervical histological outcomes and were included in the analysis. The sensitivity/specificity of the LBC test results with atypical squamous cells of undetermined significance or worse (LBC ≥ ASCUS) and the PAX1 /JAM3 test were 90.1%/26.7% and 84.8%/88.5%, respectively. PAX1 /JAM3 ( +) had the highest diagnostic AUC (0.866, 95% confidence interval (CI) 0.837-0.896) in the whole cohort. All cancers (n = 20) were detected by PAX1 /JAM3 (+). Compared with LBC ≥ ASCUS, PAX1 /JAM3 (+) reduced the number of patients who needed referral for colposcopy by 57.21% (74.66% vs. 17.45%). The odds ratios for detecting CIN3 + by LBC ≥ ASCUS and PAX1 /JAM3 (+) were 3.3 (95% CI 2.0-5.9) and 42.6 (27.1-69.6), respectively (p