Single center evaluation of sensitivity and specificity of CellDetect assay in early bladder cancer patients.

Until recently, the main diagnostic methods for bladder cancer (BC) are still voided urine cytology and cystoscopy, and many drawbacks persist. In this retrospective study, we evaluated the sensitivity and specificity of the CellDetect assay in the detection of BC with comparison to standard diagnostic methods. Between August 2020 and July 2022, B-ultrasonography or computed tomography (CT) scan was performed for patients with hematuria or irritative voiding symptoms. If no bladder mass was detected, the patient was excluded. A total of 148 patients with bladder mass formed the final study cohort. The patients' urine samples were measured with CellDetect assay, followed by cystoscopy or diagnostic transurethral resection of bladder tumor. The patients were divided into two groups based on previous history of BC: group P and group R. The analysis included descriptive statistics and percentages. Finally, 115 cases had a positive CellDetect result, with 68 cases in group P and 47 in group R, respectively. And 134 cases revealed malignant tumor pathologically. The overall sensitivity and specificity for all patients were 82.1% and 64.2%, respectively. Concerning the subgroups, the respective sensitivity and specificity were: in group P- 81.0% and 50.0%; and in group R- 85.2% and 83.3%, respectively. In conclusion, CellDetect assay demonstrated significant performance for diagnosis of BC: it can identify BC patients at early stage with significant diagnostic performance and good reliability. This assay might develop novel methods and ideas for future clinical practice.