ORIGINAL RESEARCH article
Front. Public Health
Sec. Infectious Diseases: Epidemiology and Prevention
This article is part of the Research TopicWomen in Infectious Agents and Disease: 2025View all 5 articles
Comparative Evaluation of Two DNA Methylation Assays for Triage of hrHPV E6/E7 mRNA–Positive Women
Provisionally accepted
- Department of Laboratory Medicine, West China Second University Hospital, Sichuan University, Chengdu, China
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This study aimed to evaluate the clinical performance of two commercial methylation-specific PCR assays, GynTect® and CISCER®, as triage tools for detecting high-grade cervical intraepithelial neoplasia (CIN) and cervical cancer in hrHPV E6/E7 mRNA-positive women. A total of 119 women were categorized into five groups based on colposcopy results: cervicitis, CIN1, CIN2, CIN3, and cervical cancer. Both GynTect® and CISCER® showed increasing detection rates with disease severity, reaching 90.91% and 86.36% in cervical cancer cases, respectively. For CIN2+ lesions, GynTect® demonstrated a detection rate of 59.49%, while CISCER® showed 63.29%, with both assays achieving a specificity of 95.00%. For CIN3+ lesions, GynTect® demonstrated a sensitivity of 73.21%, specificity of 87.30%, a positive predictive value (PPV) of 83.7%, and a negative predictive value (NPV) of 78.6%, whereas CISCER® showed a sensitivity of 76.79%, specificity of 85.71%, a PPV of 82.7%, and an NPV of 80.6%. No statistically significant differences in diagnostic performance were observed between the two assays. Both tests also demonstrated comparable performance across different cytological grades and HPV genotypes, with higher detection rates for HPV 16/18–associated lesions compared to non-16/18 types. Overall, although limited by its single-center design and modest sample size, GynTect® and CISCER® demonstrated comparable clinical performance for the identification of high-grade CIN in hrHPV E6/E7 mRNA–positive women, supporting their potential role as effective triage tools in HPV-based cervical cancer screening.
Keywords: Methylation marker, Cervical lesion, HPV E6/E7 mRNA, Triage, assay
Received: 12 Oct 2025; Accepted: 10 Nov 2025.
Copyright: © 2025 Yang, Jiang, Liu, Chang, Che, Lai, Teng, Duan and Jian. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Hui Jian, jianhuihhh@163.com
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