SureX PCR HPV检测与杂交捕获法（DH2/careHPV）在原发性宫颈癌筛查中的临床性能比较
Clinical performance of the SureX PCR HPV test versus hybrid capture assays (DH2/careHPV) in primary cervical cancer screening.
作者信息
Ouyang Yumei, Abuduxikuer Guzhanuer, Abulimiti Tangnuer, Abudurexiti Guligeina, Zhuo Qian, Li Wenyun, Muhetaer Kadeliya, Abuduwufu Shaliya, Tuerxun Gulixian, Rezhake Remila, Abulizi Guzhalinuer
机构信息
Gynecological Oncology Center, Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, 830000, China.
Gynecological Oncology Center, Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, 830000, China; Key Laboratory of Medical Innovation Research and Biomedical Transformation, Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, 830000, China.
出版信息
Tumour Virus Res. 2025 Jun;19:200319. doi: 10.1016/j.tvr.2025.200319. Epub 2025 May 14.
BACKGROUND
Evaluating novel human papillomavirus (HPV) tests in well-designed, population-based screening studies is essential for ensuring the benefits of cervical cancer screening.
METHODS
8638 women aged over 25 years from China underwent HPV screening using a PCR-based full genotyping HPV assay (SureX HPV), alongside hybrid-capture HPV tests (DH2/careHPV) and cytology. Any abnormal results triggered colposcopy and biopsy if indicated. Screening performance was evaluated for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and CIN3+.
RESULTS
The high-risk HPV (hrHPV) positive rate by SureX HPV was significantly higher than by careHPV (11.0 % vs. 8.2 %, P <0.01) but similar to DH2 HPV (12.0 % vs. 11.5 %, P =0.34). The overall agreement rates between SureX HPV and careHPV/DH2 HPV were 93.5 % (Kappa=0.63) and 94.0 % (Kappa=0.71). For CIN2+ detection, SureX HPV showed not-significantly higher sensitivity than careHPV (91.2 % vs 82.5 %, P =0.18) but lower specificity (91.2 % vs. 93.1 %, P <0.01). Compared to DH2, SureX HPV demonstrated comparable sensitivity (95.7 % for both, P =1.0) and specificity (89.5 % vs. 90.2 %, P =0.21). Similar patterns were observed for CIN3+ detection. The area under the receiver operating characteristic curve (AUC) for the SureX HPV was similar to hybrid-capture HPV tests (P >0.05 for both) and significantly higher than the cytology (ASC-US+) test for CIN2+/CIN3+ detection (P <0.05 for both).
CONCLUSIONS
The PCR-based SureX HPV test demonstrated good concordance with well-validated hybrid-capture HPV tests in detecting hrHPV and CIN2+/CIN3+. Despite its slightly suboptimal specificity, SureX HPV could be an alternative in primary screening due to its full genotyping capability.
背景
在设计良好的基于人群的筛查研究中评估新型人乳头瘤病毒（HPV）检测对于确保宫颈癌筛查的益处至关重要。
方法
来自中国的8638名25岁以上女性接受了基于PCR的全基因分型HPV检测（SureX HPV）、杂交捕获HPV检测（DH2/careHPV）以及细胞学检查。若有任何异常结果，则在必要时进行阴道镜检查和活检。对检测宫颈上皮内瘤变2级或更严重病变（CIN2+）和CIN3+的筛查性能进行了评估。
结果
SureX HPV检测的高危型HPV（hrHPV）阳性率显著高于careHPV（11.0%对8.2%，P<0.01），但与DH2 HPV相似（12.0%对11.5%，P =0.34）。SureX HPV与careHPV/DH2 HPV之间的总体一致率分别为93.5%（Kappa=0.63）和94.0%（Kappa=0.71）。对于CIN2+检测，SureX HPV的敏感性略高于careHPV但无显著差异（91.2%对82.5%，P =0.18），但特异性较低（91.2%对93.1%，P<0.01）。与DH2相比，SureX HPV的敏感性相当（两者均为95.7%，P =1.0），特异性也相近（89.5%对90.2%，P =0.21）。CIN3+检测也观察到类似模式。SureX HPV的受试者工作特征曲线下面积（AUC）与杂交捕获HPV检测相似（两者P>0.05），且在检测CIN2+/CIN3+时显著高于细胞学（ASC-US+）检测（两者P<0.05）。
结论
基于PCR的SureX HPV检测在检测hrHPV和CIN2+/CIN3+方面与经过充分验证的杂交捕获HPV检测具有良好的一致性。尽管其特异性略逊一筹，但SureX HPV因其全基因分型能力可作为初筛的一种替代方法。
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