CancerCheck UBC rapid VISUAL as urinary marker for bladder cancer: Final results of a German multicenter study

Introduction and objective: BTA stat (R) , NMP22 (R) BladderChek (R) , UBC (R) Rapid Test, and CancerCheck (R) UBC (R) rapid VISUAL are uri-nary-based rapid tests. This multicenter study is the first study comparing all available rapid tests on a large cohort of bladder cancer patients and healthy controls in one setting. Methods: In total 732 urine samples (second morning urine) in a real-world assessment have been analyzed. We evaluated clinical sam-ples from 464 patients with histologically confirmed urothelial tumors of the urinary bladder (17 solitary CIS, 189 low-grade, 187 high-grade nonmuscle invasive, 71 high-grade muscle invasive), 77 patients with No Evidence of Disease (NED), and from 191 healthy controls. Urine samples were analyzed by the BTA stat (R), NMP22 (R) BladderChek (R), UBC (R) Rapid Test point-of-care (POC) system using the concile Omega 100 POC reader, and CancerCheck (R) UBC (R) rapid VISUAL. Sensitivities and specificities were calculated by contingency analyses. Results: All investigated urinary markers detected more pathological concentrations in urine of bladder cancer patients compared to tumor-free patients. The calculated diagnostic sensitivities for BTA stat (R), NMP22 (R) BladderChek (R), UBC (R) Rapid Test, CancerCheck (R) UBC (R) rapid VISUAL, and cytology were 62.4%, 13.4%, 58.2%, 28.6%, 36.2% for low-grade, 83.4%, 49.5%, 84.5%, 63.1%, 71.2% for high-grade nonmuscle invasive, and 95.8%, 35.2%, 76.1%, 50.7%, 67.7% for high-grade muscle-invasive bladder cancer. The specificity was 67.9%, 95.5%, 79.4%, 94.4%, and 83.7%, respectively. The area under the curve (AUC) after receiver operating characteristics (ROC) analysis for high-grade non-muscle-invasive tumors was 0.757, 0.725, 0.819, 0.787, and 0.774, respectively. Conclusions: The analysis of more than 700 urine samples offers an objective view on urine-based rapid diagnostics. Elevated patholog-ical concentrations of markers in urine of bladder cancer patients were detected in all investigated tests. The highest sensitivities for high-grade non-muscle-invasive tumors were calculated for BTA stat (R) and UBC (R) Rapid Test, whereas NMP22 (R) BladderChek (R), and cytology showed the highest specificities. BTA stat (R) and UBC (R) Rapid Test have the potential to be used as a clinical valuable urinary protein bio-marker for the detection of high-grade non-muscle-invasive bladder cancer patients and could be included in the management of these tumors. (c) 2023 Elsevier Inc. All rights reserved.