Your new experience awaits. Try the new design now and help us make it even better

ORIGINAL RESEARCH article

Front. Oncol.

Sec. Cancer Epidemiology and Prevention

Volume 15 - 2025 | doi: 10.3389/fonc.2025.1627935

This article is part of the Research TopicCancer Burden and Cancer Screening Strategies in AsiaView all articles

Comparison of the SureX ® HPV genotyping test with the Digene Hybrid Capture ® 2 (HC2) test in cervical cancer screening

Provisionally accepted
Hehao  SunHehao SunHong  WangHong WangYin  LiuYin LiuHuifang  XuHuifang XuPeipei  ChenPeipei ChenXingai  SunXingai SunMengjie  LiMengjie LiPeiyao  LiPeiyao LiKunyao  LiKunyao LiLiyang  ZhengLiyang ZhengShaokai  ZhangShaokai Zhang*
  • Henan Cancer Hospital, Henan Engineering Research Center of Cancer Prevention and Control, Henan International Joint Laboratory of Cancer Prevention, Department of Cancer Epidemiology and Prevention, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China

The final, formatted version of the article will be published soon.

Background Cervical cancer, predominantly caused by high-risk human papillomavirus (HR-HPV) infections, is a critical public health issue. Effective screening is essential. This study compares the SureX ® HPV genotyping test, which detects 25 HPV types, with the widely used Digene Hybrid Capture ® 2 (HC2) test, which targets 13 HR-HPV types, to determine their effectiveness in cervical cancer screening among Chinese women. Methods From September to December 2016, women aged 21-64 years in Shanxi Province were screened for cervical cancer using both SureX ® HPV and HC2 tests. Women with abnormal cytology test would be referred for colposcopy and biopsied if necessary. Concordance rates and kappa coefficients were calculated to analyze the concordance between the two tests. Sensitivity and specificity for detecting CIN2+ cases of the two tests were calculated. Results Among 3028 subjects analyzed in this study, the positive rate of the common set of 13 HR-HPV types for the SureX ® HPV test was 15.0%, slightly higher than HC2 test's 13.5%. The overall concordance rate was 93.9% (95% CI: 92.95%-94.66%), with a kappa coefficient of 0.749 (0.715-0.783). Both tests demonstrated a sensitivity of 80.00% (54.81%-92.95%) for detecting CIN2+, with specificities of 85.30% (83.99%-86.52%) for SureX ® HPV and 86.82% (85.57%-87.98%) for HC2. For CIN3+ detection, both tests had 100% (67.56%-100%) sensitivity, with specificities of 85.20% (83.89%-86.42%) for SureX ® HPV and 86.72% (85.46%-87.89%) for HC2. Conclusions The SureX ® HPV test exhibited excellent concordance with HC2 in detecting the common 13 HR-HPV types and similar sensitivity for identifying CIN2+ cases. Its broader capability to detect 25 HPV genotypes positions it as a promising option for cervical cancer screening.

Keywords: Human papillomavirus, SureX ® HPV test, HC2 test, genotypes, cervical cancer screening

Received: 13 May 2025; Accepted: 10 Jul 2025.

Copyright: © 2025 Sun, Wang, Liu, Xu, Chen, Sun, Li, Li, Li, Zheng and Zhang. 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: Shaokai Zhang, Henan Cancer Hospital, Henan Engineering Research Center of Cancer Prevention and Control, Henan International Joint Laboratory of Cancer Prevention, Department of Cancer Epidemiology and Prevention, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.