ABSTRACT
AIM: To compare nuclear matrix protein 22 expression by BladderChek® and ELISA, as urine-based assays for bladder cancer (BC) detection. PATIENTS AND METHODS: Urine samples of 100 BC patients and 100 controls were analyzed. Comparative statistical evaluations were based on sensitivity and specificity. RESULTS: Seventy-one patients had primary and 29 recurrent BC. The sensitivity of BladderChek® was significantly higher compared to ELISA in the overall cancer cohort and in patients with primary BC (p<0.0001 and p=0.0001, respectively). Both tests demonstrated significant correlation of sensitivities and tumor stage/grade for the overall cancer cohort and for patients with primary BC. Both tests had specificity values of 100% in healthy individuals. Specificity was 93% for BladderChek® and 99% for ELISA in patients with benign diseases (p=0.048). CONCLUSION: BladderChek® may be clinically more useful for BC detection. Due to high specificity, BladderChek® could be used for high-risk screening. However, due to its low sensitivity, BladderChek® cannot replace but only complement cystoscopy for BC detection.
