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The ImmuSTRIP® HAMA IgG ELISA Test System is a direct enzyme-linked immunosorbent assay for the detection and semi-quantitation of human antibodies to mouse IgG1. Significant titers of human anti-mouse antibody (HAMA) have been associated with patients receiving injections of murine monoclonal antibody for diagnostic and/or therapeutic purposes2 .

The ImmuSTRIP" HAMA IgG ELISA Test System is a direct enzyme linked immunosorbent assay for the semi-quantitative detection of human antibodies to mouse IgG (HAMA). The HAMA assay is a two-stage test carried out in plastic microwell strips which have been coated with mouse IgG, whole molecule. In the first stage, mouse IgG conjugated to horseradish peroxidase (conjugate) is added to the microwell. Diluted test sample is then added and incubated for a specified length of time. If antibody to the mouse IgG is present in the test sample, bridging will occur with the solid phase mouse IgG, the test sample antibody, and the conjugate. If antibody is not present in the test sample, the unbound conjugate will be removed in the subsequent washing step. In the second stage, enzyme substrate is added to the microwell. If bound conjugate is present, the substrate will be reduced; the reduced end product of the catalytic reaction oxidizes the colorless chromogen resulting in a colored end product. Acid is added to stop the reaction and fix the color. The color intensity is proportional to the amount of bound conjugate and, therefore, to the amount of precipitable antibody present in the sample. The color intensity is measured with a microwell strip reader. The ImmuSTRIP" HAMA ELISA Test System may be performed manually or with existing microtiter equipment. Results, which are determined by optical density at 488-492 nm, are available in less than one hour. The test has been standardized against primate anti-mouse IgG serum and has a sensitivity of approximately 40 ng/ml. Final values are reported as nanograms of precipitable antibody equivalents per ml. The assay system is a rapid, efficient, and semi-quantitative method. Specific reagent formulation has eliminated the problem of background interference currently existing in this type of assay.