Wang Mingyang, Ma Ying, Zhang Nina, Li Li, Fu Yurong, Li Li'an, Zhai Qingzhi
Department of Obstetrics and Gynecology, 7th Medical Center, PLA General Hospital, 28 Fuxing Road, Haidian District, Beijing, China.
Department of Obstetrics and Gynecology, 7th Medical Center, PLA General Hospital, 28 Fuxing Road, Haidian District, Beijing, China.
Diagn Microbiol Infect Dis. 2025 Oct;113(2):116917. doi: 10.1016/j.diagmicrobio.2025.116917. Epub 2025 May 23.
In many countries, HPV testing has replaced cervical cytology as the primary screening method for cervical cancer. While HPV testing has high sensitivity, its limited specificity necessitates triage to reduce unnecessary colposcopy referrals. This study evaluates the performance of cervical cytology (TCT) and the GynTect® six-gene methylation test as triage methods for HPV-positive women.
A total of 276 women from China were categorized into four pathological groups: cervical squamous cell carcinoma (CSCC), CIN3, CIN2, and CIN1. The diagnostic performance of TCT and the GynTect test was assessed for detecting CIN3+, with sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) calculated for both methods.
Abnormal cytology (ASC-US+) had a sensitivity of 71.9% and specificity of 75.0% for detecting CIN3+, with a PPV of 57.5% and NPV of 85.0%. In comparison, the GynTect test demonstrated superior diagnostic accuracy, with a sensitivity of 88.5%, specificity of 87.2%, PPV of 78.7%, and NPV of 93.5%. The GynTect test outperformed cytology in identifying CIN3+ while reducing unnecessary colposcopies in women with CIN2- lesions.
The GynTect six-gene methylation test provides higher diagnostic accuracy than cervical cytology in the triage of HPV-positive women. Its superior sensitivity and specificity make it a valuable tool for improving risk stratification in HPV-based cervical cancer screening. These findings support the integration of methylation-based testing into screening programs to enhance diagnostic precision and optimize patient management.
在许多国家，人乳头瘤病毒（HPV）检测已取代宫颈细胞学检查，成为宫颈癌的主要筛查方法。虽然HPV检测具有高敏感性，但其有限的特异性需要进行分流以减少不必要的阴道镜检查转诊。本研究评估宫颈细胞学检查（TCT）和GynTect®六基因甲基化检测作为HPV阳性女性分流方法的性能。
共有276名中国女性被分为四个病理组：宫颈鳞状细胞癌（CSCC）、CIN3、CIN2和CIN1。评估TCT和GynTect检测对检测CIN3+的诊断性能，并计算两种方法的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）。
异常细胞学检查（ASC-US+）检测CIN3+的敏感性为71.9%，特异性为75.0%，PPV为57.5%，NPV为85.0%。相比之下，GynTect检测显示出更高的诊断准确性，敏感性为88.5%，特异性为87.2%，PPV为78.7%，NPV为93.5%。GynTect检测在识别CIN3+方面优于细胞学检查，同时减少了CIN2-病变女性不必要的阴道镜检查。
GynTect六基因甲基化检测在HPV阳性女性的分流中比宫颈细胞学检查具有更高的诊断准确性。其卓越的敏感性和特异性使其成为改善基于HPV的宫颈癌筛查中风险分层的有价值工具。这些发现支持将基于甲基化的检测纳入筛查计划，以提高诊断精度并优化患者管理。
