Evidence map›Paper›PMID 42894019›Full record

ArticleWorld journal of urology2026

Diagnostic performance and pathologic associations of the UroVysion assay in patients with upper tract lesions and negative urinary cytology: a large-scale real-world study of 1,256 patients.

Longtao Zheng, Bao Guan, Zheng Wu, Yi Ding, Bei Zhang, Xuesong Li, Yanqing Gong

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Article in World journal of urology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Longtao Zheng *Department of Urology, Institution of Urology, Beijing Key Laboratory of Precision Medicine, Innovative Translation for Urogenital Diseases, Peking University First Hospital, Peking University, National Urological Cancer Center, Beijing, 100034, China.
Bao Guan *Department of Urology, Institution of Urology, Beijing Key Laboratory of Precision Medicine, Innovative Translation for Urogenital Diseases, Peking University First Hospital, Peking University, National Urological Cancer Center, Beijing, 100034, China.
Zheng Wu *Department of Urology, Institution of Urology, Beijing Key Laboratory of Precision Medicine, Innovative Translation for Urogenital Diseases, Peking University First Hospital, Peking University, National Urological Cancer Center, Beijing, 100034, China.
Yi DingDepartment of Urology, Institution of Urology, Beijing Key Laboratory of Precision Medicine, Innovative Translation for Urogenital Diseases, Peking University First Hospital, Peking University, National Urological Cancer Center, Beijing, 100034, China.
Bei ZhangDepartment of Urology, Institution of Urology, Beijing Key Laboratory of Precision Medicine, Innovative Translation for Urogenital Diseases, Peking University First Hospital, Peking University, National Urological Cancer Center, Beijing, 100034, China.
Xuesong LiDepartment of Urology, Institution of Urology, Beijing Key Laboratory of Precision Medicine, Innovative Translation for Urogenital Diseases, Peking University First Hospital, Peking University, National Urological Cancer Center, Beijing, 100034, China. pineneedle@sina.com.
Yanqing GongDepartment of Urology, Institution of Urology, Beijing Key Laboratory of Precision Medicine, Innovative Translation for Urogenital Diseases, Peking University First Hospital, Peking University, National Urological Cancer Center, Beijing, 100034, China. yqgong@bjmu.edu.cn.

Funding

Beijing Research Ward Excellence Program BRWEP2024W054070107National Natural Science Foundation of China Nos. U23A20460 and 82273350
6 · The paper itself

Abstract

purposeThe UroVysion assay is widely used for diagnosing upper tract urothelial carcinoma (UTUC), but its value in patients with negative urinary cytology remains unclear. This study evaluated its diagnostic performance and pathological associations in this specific population.

methodsThis retrospective study included 1,256 patients with upper tract lesions on imaging, negative urinary cytology, and preoperative UroVysion testing. Pathological diagnosis served as the reference standard. Diagnostic performance was assessed using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy. Logistic regression analysis was used to evaluate the association between UroVysion positivity and high-grade disease, lymphovascular invasion (LVI), and muscle invasion (≥ pT2). Subgroup analyses were performed according to tumor size and location.

resultsAmong the 1,256 patients, 1,007 (80.2%) had UTUC and 249 (19.8%) had benign lesions. The UroVysion assay showed a sensitivity of 66.9%, specificity of 82.7%, PPV of 94.0%, and NPV of 38.2%, and an overall accuracy of 70.1% for UTUC diagnosis. UroVysion positivity was independently associated with high-grade disease (OR = 2.10, p < 0.001), LVI (OR = 1.63, p = 0.023), and muscle invasion (OR = 1.32, p = 0.049). Interaction tests showed no significant heterogeneity by tumor size or tumor location.

conclusionIn patients with upper tract lesions and negative cytology, the UroVysion assay provides complementary diagnostic information and is associated with adverse pathological features. No significant heterogeneity in these associations was observed according to tumor size or location.

Indexed as

Carcinoma, Transitional CellKidney NeoplasmsUreteral NeoplasmsAgedAged, 80 and overFemaleHumansMaleMiddle AgedNeoplasm InvasivenessPredictive Value of TestsRetrospective StudiesSensitivity and SpecificityDiagnostic performancePathologic associationsUpper tract urothelial carcinomaUrinary cytologyUroVysion assay

Identifiers

PMID42894019
PMCPMC13677630

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