Comparison of the Bard BTA test with voided urine and bladder wash cytology in the diagnosis and management of cancer of the bladder

Objectives. To compare the Bard BTA test, a simple latex-agglutination test for cancer of the bladder (BC) that can be performed in less than 3 minutes in the urologist's office, with voided urine or bladder wash cytology in the diagnosis of subjects suspected of having BC on the basis of symptoms or recent abnormal cystoscopy or intravenous urography. Methods. The study was performed at three medical centers in 414 subjects (147 female and 267 male; mean age 60 years), 345 of whom (83%) had no prior history of BC. The cytologic examinations were performed by pathologists unaware of the results of the BTA test. Results. Cystoscopy or cystoscopy and biopsy revealed BC in 71 subjects (17%). The overall sensitivities of the BTA test and cytology were 70% and 25%, respectively. The specificities of the BTA test and cytology in the 337 subjects without BC were 90% and 100%, respectively. The sensitivities of the BTA test by tumor grade were 17%, 64%, and 92% for grades 1, 2, and 3, respectively; those of cytology were 17%, 14%, and 44%. Regression analysis suggests that tumor grade but no other study variable explains the sensitivity of the BTA test. Conclusions. The BTA test is considerably more sensitive than cytology in the detection of BC. For urologists who use cytology in the diagnosis and follow-up of patients with BC, the BTA test may replace cytology. (C) 1997, Elsevier Science Inc. All rights reserved.