Aim: To evaluate the clinical performance of PAX1 methylation (PAX1m) and cytology for patients with non-HPV16/18 high-risk HPV (hrHPV) infection. Methods: Cervical exfoliated cells from 387 outpatients with non-HPV16/18 hrHPV - positive were collected for cytology and PAX1m assays. Results: The PAX1m level increased with the severity of cytology and histopathology. For cervical intraepithelial neoplasia (CIN)CIN2+/CIN3+, the areas under the curve were both 0.87. The specificity and positive predictive value (PPV) of PAX1m were greater than abnormal cytology (CIN2+ specificity: 75.5 vs 24.8%; PPV: 38.8 vs 18.7%; CIN3+ specificity: 69.3 vs 22.7%; PPV: 14.0 vs 6.7%). Conclusion: PAX1m increased specificity and PPV for CIN2+/CIN3+ compared with cytology for women with non-HPV16/18 hrHPV (+).
Keywords: CIN; PAX1 methylation; cervical cancer; cervical intraepithelial neoplasia; high-risk human papillomavirus; hrHPV.