(UroToday.com) BTA stat®, Alere NMP22® BladderChek®, and UBC® rapid test are urine based rapid tests for the presence of urinary bladder cancer (BC). uromonitor® is a urine based test measuring FGFR3, KRAS, and TERT mutation. This multicentre study is the first to compare the performance of all available rapid tests with urine cytology.
A total of 499 patients with cystoscopy-verified bladder cancer (BC), 79 patients with no evidence of disease and 221 healthy controls were enrolled in this prospective study. Urine samples were analyzed by voided urine cytology, uromonitor®, BTA stat®, Alere NMP22® BladderChek®, and UBC® Rapid test. UBC® Rapid test was assessed qualitatively and quantitatively using the point-of-care (POC) system concile® Ω100 POC reader using a cutoff of ≥10 ng/ml.
Urine cytology resulted in a sensitivity of 55.9%, and a specificity of 85.7%, while the Uromonitor showed a sensitivity 49.1% and a specificity of 88.7%, respectively. NMP22® showed a sensitivity of 31.1% and a specificity of 96.7%, while BTA stat® showed a sensitivity of 74.0% and a specificity 71.1%. The qualitative and quantitative UBC® Rapid test revealed a sensitivity of 45.5% and 70.7%, with a specificity of 94.0% and 79.0%. BTA stat® and the quantitative UBC® Rapid test proved to be the best dual combination with the highest overall sensitivity (58.7%) and a specificity of 88.6%. Sensitivity increased in cytology, uromonitor®, NMP22®, BTA stat®, and qualitative and quantitative UBC® Rapid test to 70.3%, 55.1%, 44.6%, 84.8%, 57.2%, and 79.7%, with respect.
BTA stat® and the quantitative UBC® rapid test showed higher sensitivity in detecting BC compared to urine cytology, but at the expense of lower specificity. A dual combination of these two tests outperforms urine cytology in terms of higher sensitivity and specificity, making them a potential alternative for the detection of BC.
Presented by: Dr. Christina Meisl, Berlin, Germany
Written by: Stephen B. Williams, MD, MBA, MS @SWilliams_MD on Twitter during the International Bladder Cancer Network Annual Meeting, September 28-October 1, 2022, Barcelona, Spain