Scand J Urol Nephrol 33: 234-236, 1999

Mika P. Raitanen¹² and Teuvo L. J. Tammela²

From the ¹Clinic of Surgery, Seinäjoki Central Hospital, Tampere, Finland, ²Division of Urology, Tampere University Hospital, Tampere, Finland

(Submitted April 24, 1998. Accepted for publication January 18, 1999)

Objective : The Bard BTA stat Test is a new, rapid non-invasive qualitative test that detects bladder tumour-associated antigen (human Complement Factor H-related protein) in urine. The objective of this study was to evaluate the specificity of the Bard BTA stat Test in a healthy population. Materials and methods: Voided urine samples from 100 healthy volunteers were collected and tested using the BTA stat Test. In the case of a positive BTA stat result, i.v. urography, cystoscopy, ultrasound and re-testing were performed and the BTA stat Test was repeated three months later. Results: Two subjects tested positive by the BTA stat Test, but no bladder cancer was found. The specificity of the BTA stat Test in the studied healthy population was 98%. Conclusions: The BTA stat Test has a very high specificity with a true test-dependent false-positive rate occurring in only 2% of the healthy population. These results justify further studies with the BTA stat Test for bladder cancer diagnosis, monitoring, and screening.

Key words: bladder neoplasms, cytology, tumour marker, screening, diagnosis, monitoring.