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 - Summary - MDSpire
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UroVysion Test Accuracy and Pathologic Correlates in 1,256 Patients With Upper Tract Lesions and Negative Urine Cytology: A Real-World Study

  • By

  • Longtao Zheng

  • Bao Guan

  • Zheng Wu

  • Yi Ding

  • Bei Zhang

  • Xuesong Li

  • Yanqing Gong

  • October 18, 2026

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Objective:

To assess UroVysion diagnostic performance and its association with adverse pathological features in patients with upper tract lesions and negative urinary cytology.

Approach:
  • Design and population: Retrospective cohort at two hospitals, covering January 2012 to June 2025. The analysis included 1,256 patients with imaging-detected upper tract lesions, negative cytology, and preoperative UroVysion testing.
  • Reference diagnosis: UTUC was confirmed in 1,007 patients; 249 were classified as non-cancer based on benign surgical pathology or negative biopsy with no imaging progression for at least six months.
  • Analysis: Diagnostic performance was assessed using sensitivity, specificity, predictive values, and accuracy. Logistic regression evaluated associations between UroVysion positivity and adverse pathological features.
Key Findings:
  • The provided article context reports the cohort composition but does not include diagnostic-performance estimates or results of the pathological association analyses.
Interpretation:

The supplied context describes the study rationale and methods but provides insufficient results to characterize UroVysion accuracy or its relationship with pathological features.

Limitations:
  • The study was retrospective and conducted at two hospitals.
  • Historical cytology results were not retrospectively reclassified under The Paris System.
  • The provided context ends before the study’s diagnostic and pathological results.
Sources:

Original Source(s)

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