TruScreen联合高危HPV检测与液基细胞学联合HPV检测在宫颈癌筛查中的对比研究

杨益; 李春梅; 贾蜀云; 王以锋; 王登攀; 张力尹

doi:10.12182/20250560609

TruScreen联合高危HPV检测与液基细胞学联合HPV检测在宫颈癌筛查中的对比研究

TruScreen Combined With High-Risk Human Papillomavirus Testing vs Thinprep Cytology Test Combined With High-Risk Human Papillomavirus Testing for Cervical Cancer Screening: A Comparative Clinical Study

摘要

摘要:
目的对比人工智能宫颈癌实时筛查技术（TruScreen）联合高危人乳头瘤病毒（high-risk human papillomavirus, hr-HPV）检测与液基薄层细胞学检测（Thinprep cytologic test, TCT）联合hr-HPV在宫颈癌筛查中的临床价值。

方法研究对象为2020年6月–2023年12月期间在攀枝花市中心医院接受宫颈癌筛查的297例女性，筛查项目包括HPV检测、TCT检测以及TruScreen检测。以病理结果为标准，评估TruScreen联合hr-HPV与TCT联合hr-HPV对宫颈低度鳞状上皮内病变（low-grade squamous intraepithelial lesion positive, LSIL⁺）及高度鳞状上皮内病变（high-grade squamous intraepithelial lesion positive, HSIL⁺）的诊断效果。

结果在297例受试者中，病理确诊LSIL⁺ 128例（43.10%），HSIL⁺ 67例（22.56%）。HPV16/18阳性110例（37.04%），TCT检测≥未明确诊断意义的非典型鳞状细胞（atypical squamous cells of undetermined significance, ASC-US）177例（59.60%），176例（59.26%）TruScreen检测异常；TruScreen联合hr-HPV诊断LSIL⁺及HSIL⁺宫颈病变的曲线下面积（area under the curve, AUC）高于TCT联合hr-HPV（P<0.05）。

结论 TruScreen联合hr-HPV在宫颈癌筛查中的效果优于TCT联合hr-HPV，可作为传统细胞学检查的潜在替代方案，具有较高的临床应用价值。

Abstract:
Objective To compare the clinical value of TruScreen, an artificial intelligence-based real-time cervical cancer screening system, combined with high-risk human papillomavirus (hr-HPV) test and Thinprep cytology test (TCT) combined with hr-HPV test in cervical cancer screening.
Methods A total of 297 women undergoing cervical cancer screening at Panzhihua Central Hospital between June 2020 and December 2023 were enrolled. All participants underwent hr-HPV testing, TCT, and TruScreen test. The diagnostic performance of TruScreen combined with hr-HPV test and TCT combined with hr-HPV test for low-grade squamous intraepithelial lesion positive (LSIL⁺) and high-grade squamous intraepithelial lesion positive (HSIL⁺) cervical lesions was evaluated.
Results Among the 297 enrolled women, pathology analysis identified 128 (43.10%) LSI⁺ cases and 67 (22.56%) HSIL⁺ cases. Additionally, there were 110 (37.04%) HPV16/18 positive cases, 177 (59.60%) cases with TCT results ≥ atypical squamous cells of undetermined significance (ASCUS), and 176 (59.26%) cases with abnormal TruScreen results. The area under the curve (AUC) of TruScreen combined with hr-HPV test in diagnosing LSIL⁺ and HSIL⁺ cervical lesions was higher than that of TCT combined with hr-HPV test (P < 0.05).
Conclusion TruScreen combined with hr-HPV test demonstrates superior performance in cervical cancer screening compared with TCT combined with hr-HPV test. TruScreen combined with hr-HPV test may serve as an alternative to conventional cytology-based methods for cervical cancer screening in China.

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