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For In Vitro Diagnostic Use

For the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) using the VITROS 5600 Integrated System.

Cardiac troponin I is used to aid in the diagnosis of myocardial infarction (MI).

The VITROS hs Troponin I assay is performed using the VITROS Immunodiagnostic Products hs Troponin I Reagent Pack and the VITROS Immunodiagnostic Products hs Troponin I Calibrators on the VITROS 5600 Integrated System. An immunometric immunoassay technique is used. Cardiac troponin I present in the sample reacts simultaneously with streptavidin-conjugated antibody (mouse monoclonal anti- cTnI), bound by biotin-BSA on the wells, and a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-cTnI). The antigen-antibody complex is captured by the antibody on the wells. Unbound materials are removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of HRP conjugate bound is directly proportional to the concentration of cardiac troponin I present.

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