UroVysion Multi-Target Fluorescence in situ Hybridization Assay for the Detection of Malignant Bile Duct Brushing Specimens: A Comparison with Routine Cytology.

OBJECTIVE: Routine bile duct brushing cytology is an important diagnostic tool in the evaluation of bile duct stricture. The purpose of this study was to evaluate the performance of the UroVysion fluorescence in situ hybridization (FISH) assay for the detection of malignant bile duct brushing specimens.

STUDY DESIGN: Thirty-five bile duct brushing specimens were included in the study. The FISH assay utilized the commercially available UroVysion probes. The indeterminate cytology results were considered as negative for statistical analysis.

RESULTS: Twenty-two of 35 patients were diagnosed as having malignancy based on tissue diagnosis or clinical progression of disease by image assessment. The sensitivity of routine cytology and FISH for the detection of malignancy was 14% (3/22) and 55% (12/22), respectively (p = 0.003). The specificity of routine cytology and FISH was 100% (13/13) and 62% (8/13), respectively (p = 0.025). The false-positive rate for routine cytology and FISH was 0% (0/13) and 38% (5/13), respectively.

CONCLUSIONS: Our study shows that FISH is significantly more sensitive than routine cytology for the detection of malignancy in bile duct brushing specimens. However, in our study, the specificity of FISH was poor compared to the excellent specificity of routine cytology. The compromised specificity of FISH may limit its utility in the detection of malignant bile duct brushing specimens.