Sensitivity of human complement factor H related protein (BTA stat) test and voided urine cytology in the diagnosis of bladder cancer

Purpose: We compared the sensitivity of the BTA stat dagger test, a rapid, noninvasive, qualitative urine test that detects bladder tumor associated a ntigen (human complement factor H related protein) in urine, to that of voi ded urine cytology in patients with primary bladder cancer. We also assesse d the effect of tumor size, number, histological grade and stage on test se nsitivity. Materials and Methods: We evaluated 151 patients with newly diagnosed bladd er cancer in a prospective multicenter study. A voided urine sample obtaine d before transurethral bladder tumor resection was divided for culture, cyt ology and BTA stat testing. Results: Overall sensitivity of the BTA stat test and urine cytology for de tecting primary bladder cancer was 81.5% and 30.3%, respectively (p <0.0001 ). The sensitivity of each test increased as tumor size, number, histologic al grade and stage increased. Conclusions: Sensitivity of the BTA stat test was superior to that of voide d urine cytology in all tumor categories. This noninvasive, easy to perform , point of care test may have the potential to replace cytology for diagnos ing bladder cancer.