Objectives. To evaluate the diagnostic performance of the new noninvasive urinary bladder cancer (UBC) rapid test in selected urine voided samples for the detection of transitional cell carcinoma (TCC) of the bladder, and to assess the differential sensitivity of the biomarker regarding the most relevant histologic and clinical parameters of bladder cancer.

Methods. Two hundred sixty-seven subjects were entered into the study and classified into five groups: 111 patients with active TCC of the bladder (group 1); 76 follow-up patients with TCC free from disease as confirmed by cystoscopy (group 2); 25 patients with other benign urologic diseases (group 3); 25 patients with other malignant pathologic conditions (group 4); and 30 healthy subjects (group 5). The UBC rapid test was measured by an immunochromatographic method that qualitatively detects the presence of fragments of cytokeratins 8 and 18 in the urine. UBC rapid test differences regarding stage, grade, tumor size, pattern of growth, focality, and recurrence were also evaluated.

Results. The sensitivity in group 1 was 78.4% and the specificity in group 2 was 97.4%. Positive and negative predictive values in groups 1 and 2 were 97.4% and 79.0%, respectively, with a global accuracy of 86.1%. False-positive rates were 20.0% and 44.0% for groups 3 and 4, respectively. The sensitivities of the UBC rapid test were associated with the histologic and clinical characteristics of bladder cancer, but not enough to reach statistical significance.

Conclusions. The UBC rapid test appears to be a promising noninvasive adjunct that might guide the urologist in the decision to perform cytoscopy for the detection of TCC of the bladder. Further studies appear to be merited to assess its potential diagnostic role.