Michael F. Sarosdy, M’Liss Hudson, William J. Ellis, Mark S. Soloway, Ralph deVere White, Joel Sheinfeld, Mark V. Jarowenko, Paul F. Schellhammer, Ed W. Schervish, Jay V. Patel, Gerald W. Chodak, Donald L. Lamm, Robert D. Johnson, Mary Henderson, George Adams, Brent A. Blumenstein, Kent R. Thoelke, Randy P. Pfalzgraf, Heather A. Murchison, and Sharon L. Brunelle.

Objectives: To evaluate the BTA stat Test in the detection of recurrent bladder cancer.

Methods: Sensitivity and specificity were determined using frozen voided urine samples from patients with recurrent bladder cancer, volunteers, patients with nonurologic conditions, and patients with a history of bladder cancer but free of disease. Results of cytology and the original BTA Test were compared with the sensitivity of the BTA stat Test in a large subgroup of the patients with cancer.

Results: The BTA stat Test detected 147 (67%) of 220 recurrent cancers. For those urine samples with previous cytologic and BTA Test results available, cytology had a sensitivity of 23%, the BTA Test 44%, and the BTA stat Test 58% for detection of recurrent bladder cancer (P < 0.001, stat versus cytology). The specificity of the BTA stat Test was 72% for benign genitourinary disease and 95% in healthy volunteers.

Conclusions: The BTA stat Test has high sensitivity and is significantly superior to voided urine cytologic analysis in the detection of recurrent bladder cancer.