The BTA stat test is an in vitro immunoassay intended for the qualitative detection of bladder tumor associated antigen in urine of persons diagnosed with bladder cancer. This test is indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy. The BTA stat test is an immunoassay utilizing two different monoclonal antibodies (MAbs) to specifically detect the presence of bladder tumor associated antigen in urine. Each MAb specifically binds to a different epitope on the target antigen (hCFHrp). One MAb serves as the hCFHrp capture agent. The second MAb is conjugated to colloidal gold and serves as the reporter molecule if hCFHrp is present in the specimen. Patient urine is added to the sample well of the device and allowed to react with the colloidal gold-conjugated reporter antibody. If the antigen is present in the sample, it will interact with the conjugate to form an immune complex. The reaction mixture flows through the membrane which contains zones of immobilized antibodies. In the Patient (P) zone, antigen-conjugate complexes are trapped by the capture antibody, forming a visible line. In the absence of the antigen in the patient urine, no visible line will form. The procedural Control (3) zone contains an immobilized goat anti-mouse IgG-specific antibody which will capture the conjugated antibody independently of the presence or absence of the antigen, thereby always producing a line. This procedural control assures the operator that each device is working properly.