Objective UroVysion FISH has been used for screening bladder cancer in western countries, but still limited in China. This non-invasive assay is also practical for detecting upper tract urothelial carcinoma. The present study evaluates the effectiveness of UroVysion and urine cytology in detecting upper tract urothelial carcinoma (UTUC) in 216 urine samples from 75 Chinese patients. Methods A total of 75 cases from two centers (Chengde medical college affiliated hospital and Beijing Friendship hospital) were selected with the following criteria: valid results of both UroVysion and cytology from same urine sample; histological and/or cystoscopic follow up within at least one year. The results of the UroVysion and cytology were correlated with clinical outcome that was derived from combination of histological, cystoscopic and clinical follow up information. Results Overall sensitivity, specificity, PPV and NPV in detecting UTUC were 69.3%, 83.3%, 91.2% and 52.1%, respectively for UroVysion, and 50.7%, 86.7%, 86.4% and 41.3%, respectively for cytology. The performance of both UroVysion and cytology was generally better in the surveillance population and in samples with high grade UTUC, but UroVysion manifests more efficiently than cytology in samples with low grade UTUC. In 57 of 216 samples from patients treated by endoscope or partial resection of ureter, the sensitivity of UroVysion and cytology are 70.1% and 61.3%. Conclusions Comparing with urine cytology, UroVysion is an efficient assay for upper tract urothelial carcinoma (UTUC) diagnosis and monitoring, with excellent clinical performance and utility in Chinese patients.
