Value of PAX1 Methylation Analysis by MS-HRM in the Triage of Atypical Squamous Cells of Undetermined Significance

Background: Detection of cervical high grade lesions in patients with atypical squamous cells of undeterminedsignificance (ASCUS) is still a challenge. Our study tested the efficacy of the paired boxed gene 1 (PAX1)methylation analysis by methylation-sensitive high-resolution melting (MS-HRM) in the detection of high gradelesions in ASCUS and compared performance with the hybrid capture 2 (HC2) human papillomavirus (HPV)test. Materials and
Methods: A total of 463 consecutive ASCUS women from primary screening were selected.Their cervical scrapings were collected and assessed by PAX1 methylation analysis (MS-HRM) and high-riskHPV-DNA test (HC2). All patients with ASCUS were admitted to colposcopy and cervical biopsies. The Chisquaretest was used to test the differences of PAX1 methylation or HPV infection between groups.
Results: Thespecificity, sensitivity, and accuracy for detecting CIN2 + lesions were: 95.6%, 82.4%, and 94.6%, respectively,for the PAX1 MS-HRM test; and 59.7%, 64.7%, and 60.0% for the HC2 HPV test.
Conclusions: The PAX1methylation analysis by MS-HRM demonstrated a better performance than the high-risk HPV-DNA test for thedetection of high grade lesions (CIN2 +) in ASCUS cases. This approach could screen out the majority of lowgrade cases of ASCUS, and thus reduce the referral rate to colposcopy.