Abstract
OBJECTIVE: Persistent infection with high-risk human papillomavirus (HR-HPV) is the primary cause of cervical cancer (CC). DNA methylation is a promising biomarker for cervical cancer screening. This study aimed to validate the clinical efficacy of a cytological DNA methylation-based ZNF 582 methylation (ZNF582(m) ) test for triage in detecting cervical intraepithelial neoplasia (CIN) grade 3 or higher (CIN3+) among women with HR-HPV infection. METHODS: This case-control study examined 199 women who tested positive for HR-HPV from the colposcopy clinic. The cohort included 15 cases of CC, 37 cases of CIN3, 45 cases of CIN2, 49 cases of CIN1, and 53 normal cases. Using cervical pathology results as a reference, the performance of the ZNF582(m) test for detecting CIN3 + was evaluated and compared with liquid-based cytology (LBC) and P16/Ki67 double stain cytology (DSC). RESULTS: ZNF582(m) test showed statistically significant differences in pathological results between CIN2 and CIN3 (p < 0.001). The area under the receiver operating characteristic curve (AUC) for distinguishing between