The Clinical Efficacy of BTA Stat Test in the Diagnosis for Bladder Cancer

Abstract

Purpose: We evaluated the diagnostic accuracy of BTA(Bladder Tumor Antigen) stat test in the diagnosis for bladder cancer. Materials and Methods: Sensitivity was determined using voided urine samples from patients with histologically proven bladder cancer(n=24), specificity was determined from patients with benign urologic diseases(n=47), healthy volunteers(n=8), patients with a history of bladder cancer but free of disease(n=8), patients with malignant urologic cancer other than bladder cancer(n=6), and patients with non-urologic malignancy(n=1) and the sensitivity of BTA stat test and urine cytology was stratified according to histologic grade and stage. Results: In 24 patients with histologically proven transitional cell carcinoma of the bladder, sensitivity and specificity was 76%, 54% for BTA stat test and 36%, 100% for urine cytology, respectively.For each histologic grade of transitional cell carcinoma(grade 1,2,3), sensitivity was 86%, 55%, 100% for BTA stat test, and 0%, 27%, 86% for urine cytology, respectively. The high false positive rate of BTA stat test was seen in patients with gross hematuria, benign prostatic hyperplasia, and urologic malignancy other than bladder cancer. Conclusions: The BTA stat test is a non-invasive, simple, inexpensive adjunct to cystoscopy, and superior to urine cytology in sensitivity, however its specificity was much inferior to urine cytology, and showed high false positive rate. In our study the BTA stat test was not clinically reliable in the diagnosis for bladder cancer due to high false positive rate.