[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]

[TruScreen联合高危型人乳头瘤病毒检测与Thinprep细胞学检测联合高危型人乳头瘤病毒检测在宫颈癌筛查中的比较临床研究]

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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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