The BTA stat test is available by prescription for home use to detect recurrent bladder cancer as an aid in the management of bladder cancer patients. This is the second clearance for this test; it was previously cleared for laboratory use.
This five-minute single-step rapid immunoassay requires five drops of urine. The appearance of a line in the patient window indicates a positive result. Each foil-wrapped device comes with a plastic dropper, and can be stored at room temperature.
Several studies have reported equal or better sensitivity than cytology in bladder tumor groups. The specificity of the test also has been reported to be high. Overall specificity of the test was found to be less than cytology, 85 percent and 99 percent, respectively.
In two recent studies, the test detected 90 percent and 89 percent of primary, and 74 percent and 66 percent of recurrent tumors. Patients with carcinoma in situ, high grade tumors, muscle invasive cancers and tumors larger than 2cm were diagnosed with this test. However, benign prostatic hyperplasia, kidney stones, or urinary tract infections can produce positive test results. Polymedco