Comparison of the BTA stat (TM) test with voided urine cytology and bladder wash cytology in the diagnosis and monitoring of bladder cancer

Objective: To compare the BTA stat(TM) test (BTA stat), a new one-step immu nochromatographic assay that can be performed in the urologist's office or in the laboratory, to voided urine cytology and bladder wash cytology (cyto logy) in the diagnosis and monitoring of cancer of the bladder (BC). Method s: BTA stat and cytology were performed in a double-blinded, prospective, c linical study on specimens from 240 subjects (68 females; mean age of subje cts: 64 years) suspected of having BC. Results: In 107 subjects with final diagnoses of BC confirmed by cystoscopy or cystoscopy and biopsy, the overa ll sensitivities of BTA stat and cytology were 65 and 33%, respectively. Fa r tumor grades I, II, and III, the sensitivities of BTA stat were 39, 67 an d 83%, respectively. Those of cytology were 4, 20 and 69%. Nine subjects ha d a diagnosis of 'suspicious for bladder cancer'. The specificities of BTA stat and cytology in the 124 subjects without BC were 64 and 99%, respectiv ely. In the subjects with a history of BC (n = 74), the specificities of BT A stat and cytology were 72 and 99%, respectively. The specificity of BTA s tat was lower in subjects with benign or malignant genitourinary disease ot her than BC (46%) than in subjects without genitourinary disease (71%). Con clusions: The BTA stat test is considerably more sensitive than cytology in the detection of BC and can replace cytology as an adjunct to cystoscopy i n the diagnosis and follow-up of patients with BC. However, due to low spec ificity, BTA stat should not be used without first ruling out potential int erferences such as infections, renal disease and cancer, or genitourinary t rauma.