Risk Stratification and Performance of Pax1 Methylation and Viral Typing in Women with Hrhpv (+) and Asc-Us

FAN Xing; MAO Saiping; WANG Xiaoli

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Journal of Hunan Normal University(Medical Science) ›› 2025, Vol. 22 ›› Issue (5) : 98-102.

Clinical Medicine

Risk Stratification and Performance of Pax1 Methylation and Viral Typing in Women with Hrhpv (+) and Asc-Us

FAN Xing^1,2, MAO Saiping², WANG Xiaoli¹

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Abstract

Objective To assess the clinical value of paired-box gene 1 methylation (PAX1^m) and viral genotyping for risk stratification of women with high-risk human papillomavirus (hrHPV) -positive and atypical squamous epithelial cell outcome of undetermined significance (ASC-US). Methods In a cross-sectional study, 642 women with hrHPV-positive and cytologic ASC-US were recruited from January 1, 2024, to July 30, 2024, and exfoliated cells from the uterine cervix were collected for methylation testing, and pathological results from colposcopic biopsies were used as a reference. Excluded cases with no pathological and PAX1^m results, 554 cases were included in the statistical analysis, to compare PAX1^m and hrHPV genotyping with different results of absolute cervical intraepithelial neoplasm (CIN) 2 grade or worse (CIN2+) risk, and to explore the performance of PAX1^m, hrHPV genotyping and their combined for detecting CIN2+. Results The absolute CIN2+ risk was 13.5% (95% CI: 8.9%-19.3%) and 1.4% (95% CI: 0.5%-3.1%) for PAX1^m-positive and negative results, respectively (P<0.001). The four results of PAX1^m combined with hrHPV genotyping (HPV16/18 and HPV16/18/31/33/45) were trend-associated with absolute CIN2+ risk (all P<0.001), with the lowest double-negative risk for HPV16/18/31/33/45 and PAX1^m of 0.7% (95% CI: 0.1%-2.5%). The sensitivity and negative predictive value of the combined HPV16/18/31/33/45 or PAX1^m assay were 93.3% (95% CI: 77.9%-99.2%) and 99.3% (95% CI: 97.4%-99.8%), respectively. Conclusion PAX1^m and HPV genotyping stratified the risk of hrHPV-positive women with cytological ASC-US, reduced the colposcopic referral rate while maintaining 90% CIN2+ sensitivity and 99% negative predictive value, and has the clinical value of triage hrHPV-positive women with cytological ASC-US.

Key words

paired-box gene 1 methylation / cervical cancer / cervical intraepithelial neoplasm / hrHPV

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FAN Xing, MAO Saiping, WANG Xiaoli. Risk Stratification and Performance of Pax1 Methylation and Viral Typing in Women with Hrhpv (+) and Asc-Us[J]. Journal of Hunan Normal University(Medical Science). 2025, 22(5): 98-102

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