Introduction/Background Effective triage of high-risk human papillomavirus (HR-HPV) women is warranted to avoid unnecessary referral and overtreatment. Therefore, the study aimed to evaluate the performance of the Single-Nucleotide Polymorphisms (SNPs) test in triaging HR-HPV (+) women.

Methodology The study is a multi-center study including 2628 women from Fujian and 1999 women from Shenzhen. All participants underwent PCR-RDB HPV test, and some patients underwent cytology and pathology tests. We designed kompetitive allele-specific PCR (KASPTM) methods to determine the association of single-nucleotide polymorphisms (SNPs) with HPV infections and cervical cancer and evaluated the triage efficacy. The sensitivity, specificity, positive predictive values (PPV), and negative predictive values (NPV) between HPV primary test and HPV & SNP test were calculated.

Results We find that HLA-DP rs4713607 showed a higher risk of HPV infection (OR=2.51, P<0.001) and cervical cancer (OR = 1.61, P = 0.02). HLA-DP rs3117039 showed a lower risk of cervical cancer (OR = 0.48, P = 0.01). Besides, the HPV & SNP (rs4713607 AA or rs3117039 AG/GG ) test achieved comparable sensitivity with the HPV primary test in the detection of CIN2+ (93.06% vs 93.56%) and CIN3+ (93.39% vs 93.39%). Although there was no statistically significant difference, the HPV & SNP test dictated a slightly higher specificity compared to that of the HPV primary test in the detection of CIN2+ (42.98% vs 38.94%) and CIN3+ (37.17% vs 33.63%). More importantly, HPV & SNP tests reduced colposcopy referral rate (34.97% vs 36.59%) and the cost of detecting CIN3+(¥ 6081 vs ¥ 6139).

Conclusion The SNP (rs4713607 AA or rs3117039 AG/GG ) test may serve as a triage test for HR-HPV (+) women, especially in developing countries with large populations because the test had comparable sensitivity, slightly higher specificity and lower cost of the detection of CIN3+.

Disclosures All the authors declared no conflicts of interest.