Korean J Urol.  2001 Jan;42(1):47-50.

Clinical Evaluation of the BTA TRAK assay and Comparison with Voided urine Cytology in Patients with Bladder Cancer

• Lee KH

Abstract

PURPOSE: The purpose of this study was to evaluate the clinical performance of the BTA TRAK assay and to compare it with that of voided urine cytology in the detection of bladder cancer.
MATERIALS AND METHODS
TRAK was evaluated two groups of patients. Bladder cancer group was comprised of patients wit histologically confirmed active bladder cancer. The second group of patients had a history of bladder cancers but were considered to have no evidence of disease on basis of cystoscopic evaluation of bladder and/or biopsy. Sensitivity was determined in urine samples from patients with histologically confirmed bladder cancer. Specificity was determined in samples from patients who had a history of bladder cancer but no current evidence of disease.
RESULTS
BTA TRAK assay was positive in 21 of 24 samples from patients with diagnosed bladder cancer. The sensitivity of BTA TRAK assay (87.5%) was significantly higher than that of voided urine cytology (45.8%). According to grade, the sensitivity of BTA TRAK assay was significantly higher than that of voided urine cytology in urine samples from patients with grade 1 bladder cancer. The specificity of BTA TRAK assay was 80% in patients who had a history of bladder cancer but no current evidence of disease.
CONCLUSIONS
The BTA TRAK assay is superior to voided urine cytology in the detection of bladder cancer. The difference of the sensitivity was statistically significant(p<0.05). The results of this study indicate that BTA TRAK assay is a useful adjunct to cystoscopy in the detection of bladder cancer and useful monitoring tool of bladder cancer.

Keyword

Bladder cancer; Tumor marker; BTA TRAK assay; Cytology

MeSH Terms

Biopsy
Cystoscopy
Humans
Sensitivity and Specificity
Urinary Bladder Neoplasms*
Urinary Bladder*