The influence of haematuria on the utility of the BTA stat test in the diagnosis of bladder cancer: a prospective study

Abstract Background: The urinary bladder tumour antigen (BTA) stat test has already been used for the diagnosis and monitoring of bladder cancer (BC). However, more evidence is needed regarding its efficacy and utility in the clinic. In this study, we investigated the influence of haematuria on the performance of the BTA stat test in a clinical cohort. Methods: Urine samples from 836 subjects, including 50 healthy volunteers, 553 patients with benign urologic disorders, 124 patients with histologically proven BC, and 109 patients with other histologically proven urologic cancers, were analysed by the BTA stat test and urinalysis. We detected the sensitivity and specificity of the BTA stat test in each group, and analysed the effect of haematuria on the specificity. Results: Our data showed that 58.06% of patients had haematuria in the BC group. Haematuria with benign prostatic hyperplasia (BPH), renal hamartoma (RH) and urolithiasis were identified in 39.01%, 42.86% and 66.49% of patients with benign urologic disorders, respectively. Haematuria was identified in 48.72% of prostatic cancer patients and 67.74% of renal cancer patients. The overall sensitivity of the BTA stat test was 90.32%. The sensitivity was 97.22% in BC patients with haematuria and 80.77% in BC patients without haematuria. The overall specificity in healthy individuals, patients with benign urologic disorders and other urologic cancers was 50.84%. In all patients with haematuria, the specificity of the BTA stat test was 15.82%, while it was 72.6% in patients without haematuria. Conclusions: Haematuria has a significant influence on the BTA stat test. Thus, this test should not be used for the diagnosis of bladder cancer in patients with haematuria.