Specificity of Human Complement Factor H-Related Protein Test (Bard BTA stat Test)

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Abstract
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 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.