M. Sanchez-carbayo et al., Initial evaluation of the new urinary bladder cancer rapid test in the detection of transitional cell carcinoma of the bladder, UROLOGY, 54(4), 1999, pp. 656-661
Objectives. To evaluate the diagnostic performance of the new noninvasive u
rinary 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 rel
evant histologic and clinical parameters of bladder cancer.
Methods. Two hundred sixty-seven subjects were entered into the study and c
lassified into five groups: 111 patients with active TCC of the bladder (gr
oup 1); 76 follow-up patients with TCC free from disease as confirmed by cy
stoscopy (group 2); 25 patients with other benign urologic diseases (group
3); 25 patients with other malignant pathologic conditions (group 4); and 3
0 healthy subjects (group 5). The UBC rapid test was measured by an immunoc
hromatographic 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-posi
tive rates were 20.0% and 44.0% for groups 3 and 4, respectively. The sensi
tivities of the UBC rapid test were associated with the histologic and clin
ical characteristics of bladder cancer, but not enough to reach statistical
significance.
Conclusions. The UBC rapid test appears to be a promising noninvasive adjun
ct: 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. UROLOGY 54: 656-661, 1999. (C) 199
9, Elsevier Science Inc.