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
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.
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