Noninvasive detection of bladder cancer with the BTA stat test

Purpose: We assess the sensitivity and specificity of the noninvasive BTA s tat* urine test for detection of primary and recurrent bladder cancer with special reference to the size, grade and stage of the tumors, and examine t he effect of intravesical bacillus Calmette-Guerin treatment on the results . Materials and Methods: A total of 250 patients recruited from 3 medical c enters provided voided urine samples for the BTA stat test and cytopatholog ical study. Of these patients 162 were monitored following resection of bla dder tumors and 88 were evaluated for the first time for hematuria or irrit ative voiding symptoms. Each patient underwent cystoscopy. Biopsies were ob tained when a bladder tumor was seen or if carcinoma in situ was suspected. The sensitivity, specificity and accuracy of the BTA stat test were compar ed to standard voided urine cytology. Results: No tumor was found in 122 pa tients, primary transitional cell carcinoma was found in 71 and cystoscopy revealed recurrent tumors in 57. Overall sensitivity of the BTA stat test w as 82.8% and specificity was 68.9%. Sensitivity of urine cytology was 39.8% and specificity was 95.1%. The BTA stat test detected 90.1% of the primary and 73.7% of the recurrent tumors. All patients with carcinoma in situ, hi gh grade tumors, muscle invasive cancer and tumors larger than 2 cm. were d iagnosed by the BTA stat test. Conclusions: The BTA stat test can be used a s a screening test for bladder cancer in patients with hematuria or irritat ive voiding symptoms and for surveillance of those who have not been treate d with intravesical bacillus Calmette-Guerin.