Head-to-head comparison of the MyGene human papillomavirus-sexually transmitted infection assay versus the Cobas 4800 human papillomavirus test for detecting high-grade cervical intraepithelial neoplasia.

OBJECTIVE

Novel human papillomavirus (HPV) tests must undergo thorough validation before implementation in the cervical cancer screening population. The MyGene HPV sexually transmitted infection (STI) assay (MHSA), an emerging test based on emerging next-generation sequencing, presents as a promising tool for enhancing detection capabilities in screening settings. This study aims to conduct a comparative analysis of the clinical performance of two assays (Cobas 4800 vs. MHSA) in detecting 14 high-risk (GR)-HPV genotypes for the identification of high-grade cervical intraepithelial neoplasia (CIN2+/CIN3+) in longitudinal cervical cancer screening among Chinese women.

METHODS

A total of 2985 consecutive specimens from a cervical screening program in Erdos City were examined using both MHSA and Cobas 4800 assays. Follow-up study was also conducted for 3 years.

RESULTS

The overall percent agreement (OPA), percentage of negative agreement (PNA), and Kappa statistics for 14 HR-HPV positivity, type-specific HPV16, HPV18, and 12 other HR-HPV demonstrated strong concordance between the two assays. The clinical performance of MHSA was comparable to the Cobas 4800 assay at both baseline and over the 3-year cumulative follow-up. Moreover, MHSA effectively reduced unnecessary colposcopy referrals and showed better triage efficiency both at baseline and at the 3-year follow-up. When combined with HPV typing and cytology results, MHSA outperforms the Cobas 4800 in terms of clinical performance and triage efficiency.

CONCLUSION

Our study indicated that MHSA could be considered a valuable option for cervical cancer screening in China.