Specificity of human complement factor H-related protein test (Bard BTA stat test)

Objective: The Bard BTA star Test is a new, rapid, non-invasive qualitative test that detects bladder tumour-associated antigen (human Complement Fact or 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. Materia ls and methods: Voided urine samples from 100 healthy volunteers were colle cted 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 perform ed and the BTA stat Test was repeated three months later. Results: Two subj ects tested positive by the BTA star Test, but no bladder cancer was found. The specificity of the BTA stat Test in the studied healthy population was 98%. Conclusions: The BTA smt Test has very high specificity with a true t est-dependent false-positive rate occurring in only 2% of the healthy popul ation. These results justify further studies with the BTA stat Test for bla dder cancer diagnosis, monitoring, and screening.