Urinary NMP22 BladderChek test in the diagnosis of superficial bladder cancer.

Objective: To study the diagnostic efficacy of the NMP22 BladderChek test and to compare it to cytology in the detection of bladder cancer.

Methods: We evaluated 106 voided urinary specimens of patients with suspicion of bladder cancer. All voided urine samples were evaluated by the NMP22 BladderChek test, cytology, sediment and culture. The diagnostic value of the NMP22 BladderChek test was evaluated according to correlation with cystoscopic findings and, in case of tumour, histological findings. A negative test result in a pTaG1 tumour was not considered false-negative in this study. The results were compared to the diagnostic value of cytology. Moreover, the value of the combination of cytology and the NMP22 BladderChek test was determined.

Results: In total, 29 patients had histologically proven transitional cell carcinoma of the bladder. The NMP22 BladderChek test detected 40% of 15 pTa tumours and 83.3% of the 6 pT1 tumours. Cytology detected pTa in 33.3% and pT1 in 66.6%. The 1 CIS lesion was detected by cytology. In the group of patients in follow-up the sensitivity and specificity were 57.1% (CI 28.8-82.3) and 89.8% (CI 79.2-96.2) for the NMP22 BladderChek test and 42.9% (CI 17.7-71.7) and 93.2% (CI 83.5-98.1) for cytology.

Conclusion: The NMP22 BladderChek test has a slightly higher sensitivity compared to cytology, without a relevant loss in specificity. Furthermore it is an easy test with instant result. However, no extra tumours were detected by adjunction of the NMP22 BladderChek test.