Comparison of mRNA-based and next-generation sequencing HPV assays in a population-based cervical cancer…

Cohort studyJournal of gynecologic oncology· May 2026

Comparison of mRNA-based and next-generation sequencing HPV assays in a population-based cervical cancer screening program in China.

Hua Zhang, Hang Zhou, Mengting Li … Wen Chen

CytopathologyCohort studyQ1IF 3.8

APTIMA showed slightly higher specificity than Mygene HPV-STI Assay for cervical intraepithelial neoplasia grade 2 or worse

Comparison of mRNA-based and next-generation sequencing HPV assays in a population-based cervical cancer screening program in China.

Hua Zhang … Wen Chen

Journal of gynecologic oncology · May 2026 · Q1 in General Medicine

Purpose

To evaluate and compare the diagnostic performance of the Food and Drug Administration-approved APTIMA® human papillomavirus (human papillomavirus) assay (E6/E7 mRNA-based) and the Mygene human papillomavirus-STI Assay (Mygene HPV-STI Assay) in detecting cervical intraepithelial neoplasia (cervical intraepithelial neoplasia) 2+ and CIN3+ lesions among Chinese women in a screening setting.

Methods

A total of 3,166 women were enrolled from Wuxiang County, Shanxi Province, China, and followed for 3 years.

n = 3,166 women

Results

APTIMA plus cytology ruled out CIN2+ slightly more accurately than Mygene HPV-STI Assay plus cytology

88.42%

APTIMA CIN2+ specifici

87.96%

MHSA CIN2+ specificity

More results

Among 2,683 women with complete follow-up, the prevalence of high-risk-human papillomavirus was 17.22% by APTIMA and 20.16% by Mygene HPV-STI Assay.

Substantial concordance was observed (κ=0.798).

More results

The Mygene human papillomavirus-STI Assay demonstrated broader human papillomavirus genotyping, while APTIMA yielded slightly superior performance in post-test probability for CIN3+ over 3 years.

ROC analysis confirmed comparable diagnostic discrimination.

“

Conclusion

Both assays offer high clinical accuracy within 3 years. While APTIMA remains the validated standard, the Mygene HPV-STI Assay may serve as a promising next-generation sequencing-based alternative, particularly in expanded genotyping.

Comparison of mRNA-based and next-generation sequencing HPV assays in a population-based cervical cancer screening program in China.

Comparison of mRNA-based and next-generation sequencing HPV assays in a population-based cervical cancer screening program in China.

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