Specificity of human complement factor H-related protein test (Bard BTA stat Test).
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 start Test in a healthy population.


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 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.
Raitanen
M P
MP
Clinic of Surgery, Seinäjoki Central Hospital, Tampere, Finland.
Tammela
T L
TL
D000328:Adult; D000951:Antigens, Neoplasm / Q000737:chemistry / Q000652:urine; D014408:Biomarkers, Tumor / Q000652:urine; D017242:Complement Factor H / Q000737:chemistry; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D001749:Urinary Bladder Neoplasms / Q000652:urine*
D000951:Antigens, Neoplasm; D014408:Biomarkers, Tumor; C493495:CFH protein, human; D011933:Reagent Kits, Diagnostic; C112999:bladder tumor-associated antigen; D017242:Complement Factor H