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KMID : 0352519980350020121
Korea Univercity Medical Journal
1998 Volume.35 No. 2 p.121 ~ p.130
Clinical Trial of the BTA (Bladder Tumor Antigen) Test for Monitoring and Diagnosis of Recurrent Urothelial Transitional Cell Carcinoma
Eun Young Choi
Jun Cheon/Dong Soo Lee/Je Jong Kim/Duck Ki Yoon/Sung Kun Koh
Abstract
Purpose : A single institutional study was done to compare the sensitivity and specificity of the Bard BTA test which was known to be simple, rapid and reproducible in out-patients base with voided urine or bladder washing cytology in diagnosis of recurrent bladder cancer or screening in randomized selected patients.

Materials and Methods : From October 1997 to March 1998, prospective blinded trial was performed in 150 subjects (67 female and 83 male, mean age 57.8¡¾13.2 years). 39 of whom (26%) had prior history of bladder transitional cell carcinoma(TCC) and 12 of whom (8%) was newly diagnosed bladder TCC. Other histologic types of genitourinary malignancy without history of bladder TCC. the benign genitourinary disease and healthy subjects were 25 (16.7%). 39 (26%) and 35 (23.3%), respectively. Each urine was tested for BTA according to a commercial kit. Positive results were indicated by yellow on a test pad. Blinded to all other results, each urine or bladder washing were examined microscopically, and a positive test had malignant/suspicious cells.

Results : Transitional cell carcinoma including recurrent and newly diagnosed cancer was identified in 27 subjects. The BTA test was more sensitive than urine cytology study in detecting recurrent or screening cancer, being overall positivity in 21 cases (77.8%) for BTA test versus 7 cases (25.9%) for cytology. The sensitivity of BTA test increased according to increase of histologic grade(33% for grade l(n=1), 77.8% for grade 2(n=14) and 83.3% for grade 3(n=5)) and stage(33% for Ta, 84.3% for T1, 100% for T2 and 50% for Tis). The specificity of BTA test was 80% in other genitourinary malignancy without history of bladder TCC, 87.2% in benign genitourinary disease and 94.3% in healthy volunteers.

Conclusions : The BTA test demonstrates the definite value in detection and follow-up of urothelial cancer. BTA test could be the first diagnostic test that might predict the presence of urothelial TCC on voided urine specimen. A further advantage of the BTA test is that its result is available essentially at the time of collection of the specimen. Thus, a patient having a positive BTA test but negative cystoscopy result might undergo retrograde pyelography or collection of spilit ureteral specimens for either BTA test or cytology. The ease of performance, the rapid availability of the results, and the low cost will likely contribute to fairly rapid acceptance of this new diagnostic tool.
KEYWORD
Bard BTA Test, voided urine, Urothelial transitional cell carcinoma,
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