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The CardioMPO™ Test is comprised of the CardioMPO Reagent Kit, the CardioMPO Calibrator Kit, and the CardioMPO Control Kit. The CardioMPO Reagent Kit is an enzyme immunoassay intended for the quantitative determination of myeloperoxidase in human plasma, to be used in conjunction with clinical history, ECG and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death. The PrognostiX CardioMPO Calibrator Kit is intended for use with the CardioMPO Reagent Kit to establish a calibration curve that is used to determine MPO concentration. The PrognostiX CardioMPO Control Kit is intended for use with the CardioMPO Reagent Kit as an assayed quality control sample to monitor and evaluate the precision and accuracy of the CardioMPO Test.

The CardioMPO Test is a sandwich enzyme immunoassay that uses two highly specific antibodies, one monoclonal and one polyclonal, and an enzyme labeled anti-rabbit IgG antibody for the measurement of MPO concentration in human plasma. The CardioMPO Test is comprised of the CardioMPO Reagent Kit, the CardioMPO Calibrator Kit, and the CardioMPO Control Kit. The CardioMPO Reagent Kit contains the following: a microtiter plate coated with a monoclonal anti-MPO antibody; a solution of primary polyclonal rabbit anti-MPO antibody; a solution of secondary goat anti-rabbit IgG antibody labeled with horseradish peroxidase solution; TMB substrate solution; Stop Solution; Wash Buffer Concentrate; Assay Buffer; and plate sealers. The CardioMPO Calibrator Kit contains six Calibrators comprised of human MPO in a phosphatebuffered matrix containing proteins, detergents, and stabilizers. Calibrators are intended to establish a calibration curve that is used to determine MPO concentration. Calibrator values are provided on individual Calibrator labels. Calibrators are provided ready-to-use. The CardioMPO Control Kit contains three Controls comprised of human MPO in a human plasma matrix. Controls are intended to monitor and evaluate the precision and accuracy of the CardioMPO Test. Ranges are provided on individual Control labels. Controls are freated in the same manner as patient samples. Calibrators are added directly to the appropriate wells of the Microtiter Plate. Assay Buffer is added to all wells that are intended for Control or sample analysis. Aliquots of Controls or samples are added to the appropriate wells and the plate is incubated for 60 minutes at 20-26°C. The wells are then washed with Wash Buffer to remove antigens not specifically bound to the immobilized antibody. A yellow primary polyclonal rabbit anti-MPO antibody is added to each well and incubated for 60 minutes at 20-26°C. This antibody binds to the MPO captured on the plate. The plate is again washed with Wash Buffer to remove unbound primary antibody. A blue secondary goat anti-rabbit IgG antibody, labeled with the enzyme horseradish peroxidase (HRP), is then added to each well and incubated for 30 minutes at 20-26°C. This antibody binds to the primary antibody, and the MPO in the sample is "sandwiched" between the monoclonal antibody on the solid phase and a complex of the rabbit anti-MPO and the HRP-goat anti-rabbit IgG antibody. The wells are washed with Wash Buffer to remove unbound HRP-labeled antibody. The substrate, tetramethylbenzidine (TMB), is then added to each well and incubated for 10 minutes at 20-26°C resulting in the development of a blue color. Color development is stopped with the addition of Stop Solution, changing the color to yellow. The enzymatic turnover of the substrate is determined spectrophotometrically at 450 nm, preferably with correction at 630 nm, and is directly proportional to the concentration of MPO. The absorbances of the Calibrators are used to plot a standard curve of absorbance versus MPO concentration from which the MPO concentration in the Controls or samples can be determined.