Comparison of the bard Trak (TM) test with voided urine cytology in the diagnosis and follow-up of bladder tumors

Objectives: To compare the results of the BTA Trak(TM) test with voided uri ne cytology (VUC) in the diagnosis and follow-up of bladder tumors. Patients and Methods: Urine samples were obtained from 53 patients with bla dder tumor (77 samples) and 53 patients treated for bladder tumor with no e vidence of disease on the basis of cystoscopic evaluation (88 samples). Uri ne samples were collected prior to cystoscopy. The BTA assay was performed by the BTA Trak(TM) test according to the manufacturer's recommendations. A value >14 U/ml was considered abnormal. Results: There was a statistically significant increase in median BTA value with increasing stage of tumor: 11.9, 57.9 and 391.0 U/ml respectively for stages pTa, pT1 and pT2/3 (p<0.0001, Kruskal-Wallis test). There was also a correlation between increasing grade and median BTA values measured at 6. 9, 13.1 and 235.0 U/ml in grades 1, 2 and 3 tumors respectively (p<0.0001, Kruskall-Wallis test). The overall sensitivity of the BTA Trak(TM) test was 58.4% compared to 46.7% for VUC, a difference of 11.7%, which was statisti cally significant (McNemar test, p<0.005). The sensitivity of both tests co mbined was 63.6%. The specificity of the VUC (94.3%) was significantly high er than that of the BTA Trak(TM) (75.0%) (p<0.005, McNemar test). The accur acy of the Bard Trak(TM) test (67.3%) was similar to that of VUC (66.9%). Conclusion: The BTA Trak(TM) test is more sensitive than urinary cytology i n the detection of bladder tumors but the improvement involved is insuffici ent to consider decreasing the frequency of endoscopic examinations in the follow-up of superficial bladder tumor. Copyright (C) 2000 S. Karger AG, Ba sel.