The ability to test for prostate specific antigen (PSA) has revolutionized the diagnosis and management of prostate cancer. It is highly recognized that PSA testing plays a fundamental role in the early detection and monitoring of prostate cancer. The FastPack^® IP Total Immunoassay is a chemiluminescent immunoassay for the in-vitro quantitative determination of PSA in human serum and plasma as an aid in the management of patients with prostate cancer. Designed for use with the FastPack^® IP System.