The study was aimed to evaluate the performance of CellDetect® stain in routine clinical use in patients undergoing bladder cancer (BC) assessment in comparison with Papanicolaou stain and FISH.
Voided urine samples were collected from patients with hematuria or under surveillance for BC (with an exclusion of patients with catheters, neobladder and ileal conduit).
Samples were processed into smears using liquid-based cytology (ThinPrep, Hologic). For each sample, one slide was stained with Papanicolaou (standard urine cytology stain), one slide was stained with CellDetect® and, in most of the cases, specimens were prepared for FISH testing. Cystoscopy and biopsies were used as gold standard for diagnosis
A total of 70 urine samples were tested for CellDetect® and standard urine cytology. Samples included 53 negative and 17 positive cases. 51 of the samples were also tested for FISH. Out of those, determined readings were given to: 34 standard cytology cases, 61 CellDetect® cases and 47 FISH.
The performance of the modalities were computed based on the cases with determined readings, CellDetect® was shown to detect BC with 100% sensitivity compared to 67% for standard cytology and 69% for FISH. Specificity was 83% for CellDetect®, 96% for standard cytology and 65% for FISH.
Undetermined readings comprise of 36 (51%) cases of standard cytology, including 28 (40%) atypical and 8 (11%) suspicious cases. With CellDetect® 8 cases (11%) were reported as suspicious and 1 inadequate (1.4%) while none was reported as atypical. With FISH 4 cases were classified as suspicious (8%).
This study highlights the advantages of CellDetect® performance over standard cytology in diagnosing BC. CellDetect® improved the sensitivity of standard cytology by 33%. Furthermore, CellDetect® staining correctly classified 80% of standard cytology atypical readings.