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.
- 1Department 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.
- 2Department 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. [email protected].
- 3Department 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. [email protected].
Abstract
Purpose
The 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.Methods
This 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.Results
Among 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.Conclusion
In 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.
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BibTeX
@article{zheng2026diagnostic,
title = {{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.}},
author = {Longtao Zheng and Bao Guan and Zheng Wu and Yi Ding and Bei Zhang and Xuesong Li and Yanqing Gong},
journal = {World journal of urology},
year = {2026},
month = oct,
doi = {10.1007/s00345-026-06876-2},
url = {https://europepmc.org/article/MED/42894019},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - 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.
AU - Longtao Zheng
AU - Bao Guan
AU - Zheng Wu
AU - Yi Ding
AU - Bei Zhang
AU - Xuesong Li
AU - Yanqing Gong
PY - 2026
DA - 2026/10/18
JO - World journal of urology
DO - 10.1007/s00345-026-06876-2
UR - https://europepmc.org/article/MED/42894019
AB - Purpose The 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.Methods This 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.Results Among 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.Conclusion In 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.
SN - 0724-4983
SN - 1433-8726
ER -