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The QMS® Amikacin assay is intended for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.

The QMS® Amikacin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. In particle agglutination assays, the degree of agglutination is inversely proportional to the quantity of free drug in the reaction well. Hence, if no drug is present in the sample, the antibodies in the QMS Amikacin Antibody Reagent (R1) will bind only to the bound drug on the particle which will cause it to agglutinate and will result in higher absorbance. If increased amount of competing drug is present in the sample, this will result in decreased binding of bound drug by the antibody, resulting in a relative decrease in particle agglutination. This in turn results in lower absorbance. The precise relationship between particle agglutination of the unlabeled drug in the sample is established by measuring the absorbance values of calibrators with known concentration of the drug. The absorbance of unknown samples can be interpolated from the absorbance values of the calibration curve and the concentration of the drug present in the sample can be calculated. The assay consists of reagents R1: anti-amikacin monoclonal antibody and R2: amikacin-coated microparticles. A six-level set of QMS® Amikacin Calibrators (A through F) is used to calibroothe assay.

The Randox Laboratories Limited Amikacin Test Kit is an in vitro diagnostic reagent for the quantitative determination of amikacin in serum. Measurements obtained by this device are used in the diagnosis and treatment of patients receiving therapy with amikacin by monitoring levels of amikacin to ensure appropriate therapy.

The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with amikacin, which in the presence of amikacin antibody Solution, agglutinate. When a sample containing amikacin is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is measured in scattered light as a change in absorbance. By monitoring the change in absorbance the concentration of amikacin in the sample can be determined. The change in absorbance is inversely proportional to the concentration of amikacin in the sample.