CLINICAL-EVALUATION OF THE BTA TRAK ASSAY AND COMPARISON TO VOIDED URINE CYTOLOGY AND THE BARD BTA TEST IN PATIENTS WITH RECURRENT BLADDER-TUMORS

Objectives. To assess the clinical performance of the BTA TRAK assay a nd to compare it with that of voided urine cytology (VUC) and the Bard BTA test (BTA) in the detection of recurrent bladder cancer (BC). Met hods, The study was performed on randomly selected archival voided uri ne samples for many of which VUC and/or BTA information was available. Sensitivity was determined in samples from patients with histological ly confirmed recurrent BC. Specificity was determined in samples from healthy volunteers, patients with three categories of current medical conditions, and patients with a history of BC but no current evidence of disease. Results, The TRAK assay was positive in 156 of 216 samples for patients diagnosed with BC, for an overall sensitivity of 72%. Me an values increased with progressing grade and stage of disease, In th e comparison between TRAK and VUC, the overall sensitivities were 68% and 25%, respectively (P<0.001). For Stages Ta and T1 and for all tumo r grades, the sensitivity of the TRAK assay was significantly greater than that of VUC (P<0.001). TRAK sensitivity was also significantly be tter than that of BTA (73% versus 58%, P = 0.005). The specificity of the TRAK assay ranged from 75% in samples from patients with genitouri nary disease to 97% in healthy volunteers. Conclusions, The TRAK assay is superior to VUC and the original BTA test in the detection of BC, The results of the study indicate that the TRAK assay may be a useful adjunct to cystoscopy in the management of patients with recurrent BC. (C) 1997, Elsevier Science Inc. All rights reserved.