Preliminary report of the clinical performance of a new urinary bladder cancer antigen test: comparison to voided urine cytology in the detection of transitional cell carcinoma of the bladder

We compared the ability of a new urinary bladder cancer antigen (UBC) test with conventional cytology for the detection of transitional cell carcinoma of the bladder using voided urine samples. The UBC was measured and correc ted for the creatinine concentration in the urine of 61 patients with trans itional cell carcinoma of the bladder (group 1), 23 patients without recurr ent bladder tumors during follow-up (group 2), 28 patients with benign pros tatic hyperplasia (group 3), nine patients with prostate cancer (group 4), and 90 healthy volunteers free of urological diseases (group 5). The UBC co ncentrations were 308.8+/-578.5, 18.8+/-26.6, 23.9+/-32.7, 17.5+/-18.6 and 4.6+/-6.7 ng mg(-1) creatinine (mean+/-S.D.) for groups 1-5, respectively. The level for group 1 was significantly higher than for any other group. Th e sensitivity and specificity, which were optimized using receiver-operatin g characteristic curves for groups 1 and 2 were 82.0% and 82.6%, respective ly, at a threshold value of 39 ng mg(-1) creatinine. The sensitivity and sp ecificity of cytology for these same groups were 60.7% and 86.9%, respectiv ely. The sensitivity of the UBC was significantly higher than that of cytol ogy, not only for total bladder tumors (82.0% vs. 60.7%, P < 0.02) but also for grade I transitional cell carcinoma of the bladder (76.5% vs. 11.8%, P < 0.001). While offering a similarly high specificity, the UBC test might have an advantage over cytology in terms of superior sensitivity, particula rly for low-grade tumors. (C) 2000 Elsevier Science B.V. Ail rights reserve d.