Comparison of the monoclonal UBC-ELISA test and the NMP22 ELISA test for the detection of urothelial cell carcinoma of the bladder

Objectives. To compare the diagnostic value of two enzyme-linked immunosorb ent assay (ELISA) tests, the nuclear matrix protein 22 (NMP22) test and a n ewly developed urinary bladder cancer (UBC) test, in patients having sympto ms suggestive of urothelial cell carcinoma (UCC) and patients under follow- up after transurethral resection (TUR). Methods. Two hundred forty patients with a mean age of 65.8 years (range 22 to 92) were included in this retrospective study. The tests were performed on previously frozen urine samples. Eighty-one patients had symptoms sugge stive of bladder cancer and 159 patients were being followed up after compl ete TUR of UCC. Voided urine was evaluated by the NMP22 test and the monocl onal UBC-ELISA test, which traces cytokeratins 8 and 18. All patients under went subsequent cystoscopy and biopsy evaluation of any suspicious lesion. The cutoff levels for bladder cancer positivity were 10 U/mL for the NMP22 test and 12 mu g/l for the UBC test. Results. In the 54 patients with histologically proved UCC, the NMP22 test had a sensitivity of 55.5% and the UBC test a sensitivity of 64.8%. Accordi ng to the histologic stages, the sensitivity of NMP22 was 51.7% in pTa tumo rs, 46.1% in pT1, and 70% in pT2 or higher tumors; the sensitivity of UBC w as 62.1% in pTa, 55.8% in pT1, and 80% in pT2 or higher tumors. For histolo gic grades 1 to 3, the sensitivity was 50%, 50%, and 68.7% for NMP22 and 66 .6%, 60%, and 68.7% for UBC, respectively. The specificity was 79% and 92% for NMP22 and UBC, respectively. Conclusions. The monoclonal UBC-ELISA test is superior to the NMP22 test in both sensitivity and specificity. Nevertheless, neither test can replace c ystoscopy. (C) 2000, Elsevier Science Inc.