Triage accuracy of a six-gene methylation detection for high-risk HPV-positive Chinese women

This study aimed to evaluate the triage accuracy of a six-gene methylation detection test in high-risk human papillomavirus-positive women in China. A total of 369 cervical exfoliated cell samples were collected from high-risk human papillomavirus-positive women undergoing cervical cancer screening at Nanjing Drum Tower Hospital from October 2018 to August 2019. The methylation status of six gene was assessed using real-time methylation-specific polymerase chain reaction. The triage accuracy for cervical intraepithelial neoplasia grade 2 and 3 was compared with that of a commercial methylation kit, cervical cytology, and human papillomavirus types 16/18 tests using receiver operating characteristic curves. Additionally, the effectiveness of the six-gene test for triaging cervical intraepithelial neoplasia grade 2+ and 3+ was validated in 215 samples collected between January and November 2020 and compared with p16/Ki-67 dual-staining cytology. The results demonstrated a significant increase in the positive methylation rate with the severity of cervical intraepithelial neoplasia (P<0.001). This six-gene methylation pattern holds promise for improving triage accuracy in cervical cancer screening for high-risk human papillomavirus-positive women.