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Intended Use

The ZEUS HAMA IgG ELISA Test System is a direct enzyme-linked immunosorbent assay for the detection and semi-quantitation of human antibodies to mouse IgG (HAMA). The presence of human anti-mouse antibody (HAMA) has been associated with patients receiving injections of murine monoclonal antibody for diagnostic and/or therapeutic purposes.

Better manage therapy and patient care via the only U.S. FDA-cleared HAMA IgG ELISA Test System

Significance and Background

The presence of human anti-mouse antibodies (HAMA) in humans can be problematic for a number of reasons. Upon therapeutic treatment, the body may respond via anaphylactic complications ranging from mild forms, such as a rash, to life-threatening forms, such as renal failure. HAMA may also decrease the efficacy of the provided treatment or diminish its potency over time. Lastly, HAMA may also lead to falsely elevated levels of certain assays, such as TSH and PTH, and false negatives in others, providing improper diagnoses. It has been observed that anywhere from one-third to more than half of patients receiving mouse-derived antibodies will develop some form of HAMA response and at least 10% of the general population has been observed to carry some form of animal-derived antibodies.

The ZEUS HAMA IgG ELISA Test System may be performed manually or with existing automated microtiter processing platforms. Results, which are read at 450nm, are available in less than 1 hour. The test has been calibrated with baboon anti-mouse IgG serum and has a sensitivity of 37 ng/mL. Final patient values are reported as nanograms of precipitable antibody equivalents per mL.

It is recommended that baseline HAMA levels are determined prior to the initiation of therapy with murine-derived proteins.

Know the efficacy of your diagnoses and treatments while providing better personalized care.

Principle of the Test

The HAMA assay utilizes the ELISA technique for the detection of human anti-mouse antibody (HAMA). Mouse IgG conjugated to horseradish peroxidase enzyme (conjugate) is added to the microwell which has been coated with mouse IgG whole molecule. Diluted test sample is then added and incubated. If antibody to the mouse IgG is present in the test sample, antigen-antibody complexes are formed. If antibody is not present in the test sample, the unbound conjugate will be removed in the subsequent washing step.

Enzyme substrate is then added to the microwell. If bound conjugate is present, the substrate will be reduced; the reduced end-product oxidizes the colorless chromogen resulting in a colored end-product.

Acid is added to stop the reaction and fix the color. The absorbance is measured with an absorbance reader at a wavelength of 450nm.

The absorbance of the solution is directly proportional to the amount of bound conjugate and, therefore, to the concentration of precipitable antibody present in the sample.

Benefits and Features

  • System quantitatively measures levels of human anti-mouse IgG antibody (HAMA)
  • FDA-cleared and CE Marked ELISA test (510K #: K972873)
  • Allows clinicians apply appropriate therapeutic regimes based on HAMA exposure
  • Validate test results such as PSA, Troponin I, hCG, TSH, and multiple tumor markers
  • Save money by avoiding repeat testing
  • Fast results in as little as one hour
  • Improve clinical trial participant selection
  • Determine potential cross-reactivity or interference issues in new assay development
  • Increase efficiency of patient treatment

Product Code: 6401

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