Technical comparison of Abbott's UroVysion ® and Biocare's CytoFISH urine fluorescence in situ hybridization (FISH) assays.

BACKGROUND: This study aims to compare the technical performance of Abbott's UroVysion and Biocare's CytoFISH urine cytology probe panel and position the CytoFISH probe panel as an alternative to UroVysion. The CytoFISH probe panel was developed based on clinically sensitive chromosomes found to be amplified in bladder cancers, as well as a locus-specific probe also seen to be amplified in bladder tumors. After extensive testing comparing CytoFISH to UroVysion, we present here our findings for the two assays.

MATERIALS AND METHODS: A total of 216 cases representing a mix of male (ages 36-99) and female (ages 46-91) patients were assayed with both probe sets. The CytoFISH and UroVysion probe panels were tested in accordance with the UroVysion procedure, as outlined in the manufacturer's supplied package insert with the following exception: the probe volume used was 3µL for UroVysion and 5µL for CytoFISH.

RESULTS: The scoring used for the CytoFISH and UroVysion assays revealed a 95% concordance, suggesting that Biocare's CytoFISH Test has at least the same clinical sensitivity and specificity as claimed by the Abbott UroVysion Kit. We found that the CytoFISH 5p15.2 locus-specific probe was easier to score than UroVysion's 9p21 deletion.

CONCLUSION: The high rate of concordance between the two assays suggests that Biocare's CytoFISH assay is a robust alternative to Abbott's UroVysion in the diagnosis and monitoring of bladder carcinoma.