The correct Pap smear result remains challenging for Chinese doctors because of the cytologist experience and quality of the infrastructure.
Aim: To evaluate the efficacy of HPV typing combining with specific PAX1 methylation genes for cervical cancer screening in Xiangya Hospital, China.
Following the GCP guidance, the subjects were recruited in Xiangya Hospital in China. The inclusion criteria were female with age ≥20 and sexual experience. The exclusion criteria included: women had history of cancer related to reproductive tract, had therapy for cervical lesions, had received HPV vaccination or at pregnancy.
The results of Pap and PAX1 methylation biomarkers were determined by using Q-PCR. HPV typing tests were determined by semi-nested PCR and reverse hybridization. Sensitivity, specificity, and accuracy for HPV and the DNA methylated level were analyzed.
Results:Total 432 case control subjects were recruited and 296 HPV-HR subjects were analyzed in the study. The final diagnosis was confirmed by histological reports. The results showed that the PAX1m was significantly higher in HPV-HR patients with CIN3 and worse lesions than those with CIN1, CIN2, and normal cervix (P<0.0001). The sensitivity, specificity and accuracy of PAX1m were >75% , >80% and >78%. As for HPV high risk, the sensitivity and specificity were> 97% and >47%. Compared to the efficacy of HPV-HR for triage of the first screening, PAX1m tests could reduce over 40% of referrals for colposcopy/biopsy.
The current results indicated that the real time PCR-based testing for DNA methylation of PAX1m is promising for cervical cancer detection and screening in Chinese population. Combining with the HPV 16 & 18 typing provide greater sensitivity and specificity for the detection of cervical cancer as first screening.