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The cassette COBAS INTEGRA Amikacin MAB contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the quantitative determination of amikacin in human serum or heparinized plasma.

The Roche COBAS INTEGRA Amikacin MAB assay contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA 700 analyzer for the quantitative determination of amikacin in human serum or heparinized plasma. The COBAS INTEGRA Amikacin MAB assay determinations are made on the COBAS INTEGRA 700 analyzer using the principle of fluorescence polarization. When a fluorescent molecule, or fluorophore, is irradiated with light of the proper wavelength (the excitation wavelength) some of the light is absorbed. Within a few nano-seconds the absorbed light is emitted, although at a longer wavelength (the emission wavelength). Whether or not the emitted light is polarized depends on the freedom of the fluorophore to rotate in solution. A small molecule, such as fluorescein, can rotate rapidly before light emission occurs, resulting in depolarization of the emitted light. In contrast, a fluorescent macromolecule, such as a fluorescein-labeled protein, will rotate much more slowly. Thus, in the time frame between excitation and emission, the macromolecule will have rotated only very slightly and the emitted light will be polarized. Fluorescence polarization is a reproducible function of the drug concentration, and is suitable for the quantitative determination of drug concentrations in serum for the purpose of therapeutic drug monitoring. Surface active agents are used to ensure dissociation of the drug from serum proteins and to prevent nonspecific binding of the tracer. After completion of the assay, the COBAS INTEGRA 700 will calculate automatically the millipolarization units (mP) of the tracer. After mP values have been calculated for the 6 calibrators, the system calculates a best-fit curve for the calibrators using a nonlinear lest squares regression analysis. The concentration of drug in each sample is then interpolated from this curve using its measured mP value.