BTA test and voided urine cytology in the diagnosis and management of cancer of the bladder

The BTA test is a simple latex agglutination test for cancer of the bladder (BC) that can be performed in less than 3 minutes in the doctor's office. In a prospective multicenter study, we compared the BTA test with voided urine cytology in the diagnosis of 414 subjects suspected of having BC on the basis of symptoms, recent abnormal cystoscopy or intravenous urography. All subjects provided a single midstream or catheterized urine specimen for the BTA test and voided cytology the same day as, but before, cystoscopy. The cytologic examinations were performed by pathologists unaware of the results of the BTA test. A total of 345 subjects (83%) had no prior history of BC; 71 subjects (17%) were diagnosed with BC based on cystoscopy or cystoscopy and biopsy. The test sensitivity in all subjects was 70% for BTA test and 25% for cytology (p < 0.001). Test specificity in the 337 subjects without BC was 90% for BTA test and 100% for cytology. The BTA test is significantly more sensitive than cytology for stages T1 and greater than or equal to T2 tumors as well as for grade 2 and 3 tumors. We conclude that the efficacy of the BTA test justifies its possible use in the routine diagnosis and management of persons at risk of having BC. For urologists who use cytology in the diagnosis and follow-up of patients with BC, the BTA test may replace cytology.