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The FastPack™ PSA Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The FastPack™ PSA Immunoassay is indicated as an aid in the management of patients with prostate cancer. The FastPack™ PSA Immunoassay is designed for use with the FastPack™ Analyzer System.

The FastPack™ PSA Immunoassay is a two-site chemiluminescence assay. The FastPack™ Analyzer System is a compact chemiluminuescent immuoassay system consisting of four components: FastPack™ (Reagent Pack), FastPack™ Sample Filler, FastPack™ Analyzer, and Pressure/Power Supply. The FastPack™ is a small plastic package containing pre-measured reagents. The FastPack™ Sample Filler delivers a quantified sample. The FastPack™ Analyzer performs the assay by automatically mixing and moving the sample and reagents within the pack using pressure pads and a magnet. Temperature control is achieved by heating metal plates.

The Qualisys PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The Qualisys PSA Immunoassay is further indicated for the serial measurement of PSA as an aid in the prognosis and management of patients with prostate cancer.

The Qualisys PSA Immunoassay is a two-site chemiluminescense assay. 1st incubation: 15 minutes at room temperature. Specimen, control or calibrator [100 µL] and PSA Antibody Solution [100 µL] react to form a sandwich complex. 2nd incubation: 2 minutes at room temperature. Streptavidin-coated paramagnetic particle solution [25 µL] is added to the reaction mixture. After the 2-minute incubation, the sandwich complex is bound to the solid-phase via the interaction of biotin and streptavidin. Removal of unbound materials: The paramagnetic particles are washed four times with wash buffer [1.0 mL/wash] to remove unbound materials. Re-suspension of paramagnetic particles: Deionized (DI) water [25 uL] is added to re-suspend the washed paramagnetic particles. Substrate addition and detection: Chemiluminogenic substrate [50 uL] is added to the solid-phase bound complex and results in "glow" chemiluminescence, which is measured using a luminometer (photomultiplier). Emission of light is quantified for 1 second, and is expressed in relative light units (RLU). The amount of bound labeled antibody in RLU's is directly proportional to the concentration of PSA in the sample. Results are determined using cubic spline immunoassay curve fitting.