Utility of UroVysion and Cytology in Detecting Bladder Cancers: A Study of 1,835 Paired Urine Samples with Clinical and Histological Correlation.
Jack Yang, Timothy M Smith, Daynna J Wolff, Ana Maria Medina, Maria Gallego-Attis, Patricia M Houser, Rosemary A Recavarren. Medical University of South Carolina, Charleston
Background: Urine cytology has been widely used for screening of bladder cancer but is limited by its low sensitivity. UroVysion is an FDA approved molecular test that uses fluorescence in situ hybridization to detect four chromosomal abnormalities commonly occurring in bladder cancers. The present study evaluates the utility of UroVysion in detecting urothelial cell carcinoma (UCC) by correlating it with concurrent urine cytology, histological and cystoscopic findings, and clinical follow up information.
Design: 1,835 cases with the following criteria were identified using a retrospective computerized search of clinical test results from studies performed from 2003 – 2006: 1) valid results of both UroVysion and cytology from the concurrent urine samples, and 2) histological and/or cystoscopic follow up within 4 months of the original tests, or 3) at least 3 years of clinical follow up information. The sensitivity, specificity, positive and negative predictive values of UroVysion and urine cytology in detecting UCC were obtained by comparison with the “gold standard” that is derived from the combination of histological, cystoscopic and clinical follow up information. A clinical positive was defined as UCC confirmed by the concurrent or follow up histology and cystoscopy, or clinically known UCC. A clinical negative was defined as negative histological and cystoscopic findings, or without evidence of UCC during at least a 3 year clinical follow up period.
Results: The correlation of UroVysion and cytology results with clinical findings is shown in Table 1. The overall sensitivity, specificity, positive and negative predictive values for UroVysion in detecting UCC were 61.2%, 89.5%, 42.6% and 92.4%, respectively, for cytology 43.6%, 96.5%, 63.8% and 92.0%, respectively; and for combination of the two tests 73.4%, 86.7%, 50.4% and 94.6%, respectively. The sensitivity of both tests was better for detection of high grade UCC (UroVysion 75.0% and cytology 55.7%) and it was much lower for low grade UCC (UroVysion 46.8% and cytology 20.7%).
|No. of Cases||UroVysion +||UroVysion -||Cytology +||Cytology Atypical||Cytology -|