The UroVysion Bladder Cancer Kit detects amplifications of chromosomes 3, 7, and 17, and the deletion of 9p21, by fluorescence in situ hybridization (FISH). Because manual interpretation of UroVysion FISH is time consuming and can be challenged by variable probe signal strengths and background labeling, the authors investigated an automated image analysis system to improve throughput, productivity, quality control, and accuracy.
The authors evaluated the interactive BioView Duet imaging system as an aid to UroVysion FISH interpretation in a 2-armed, blinded comparison with manual screens of the same 135 consecutive cases. Manual and Duet-assisted interpretations were compared with respect to concordance, reproducibility, and timing.
Eighty-one cases were interpreted as positive or negative with 94% concordance and a kappa value of 0.84 between manual and Duet-aided interpretations. Three cases that ultimately were judged positive were detected with the aid of Duet but were missed with a manual screen. A final interpretation could not be given for approximately 25% of Duet-scanned cases. Duet-aided interpretation was highly reproducible for patient and control slides. Pathologist evaluation time per case was 4 minutes compared with 30 minutes for manual interpretation. Cytotechnologist involvement added 18 minutes for a total of 22 minutes, a savings of 8 minutes per case.
Duet-aided interpretations were at least equivalent to manual interpretations. The system permitted interactive review of abnormal cells and had the ability to evaluate the same cells for brightfield cytology followed by FISH. The image processing and analysis tools of the Duet system enhanced the morphology skills of cytology professionals in providing accurate interpretations.