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Human Anti-Murine Antibodies (HAMA)

Better manage therapy and patient care with ZEUS ImmuSTRIP® ELISA kits: the only FDA-cleared HAMA IgG ELISA test system.

Antibodies are proteins which are naturally formed by the body in response to antigens. Antibodies can also be created in the lab and administered to help a patient's immune system in fighting disease, foreign bodies, infections, and more. Monoclonal antibodies (MAbs) are a sub-class of antibodies produced by a single clone of an antibody-producing cell. MAbs have many uses, including diagnostic applications (ex. biochemical analyses), therapeutic applications (cancer treatment), autoantibody fingerprinting, protein purification, and more.

Until recently, mice were used substantially in MAb production. However, with the use of mouse antibodies, treatment effectiveness has not been consistent and cross-reactivity has been documented in certain laboratory tests. In addition, many patients may have a reaction in which the body’s immune system creates a new set of antibodies to the counter foreign mouse antibodies. Researchers have termed this the “HAMA response,” referring to the development of human anti-murine (mouse) antibodies (HAMA). Anywhere from one-third to more than half of patients receiving mouse MAbs will develop some form of HAMA response, and at least 10% of the general population has been observed to carry some form of antibody to animal-derived antigens.1-6

The presence of HAMA in a human can be problematic for a number of reasons.7-11 Upon therapeutic treatment with mouse MAbs, the body may have an anaphylactic reaction as mild as a rash or as life-threatening as renal failure. HAMA may also decrease the treatment's efficacy or diminish its potency over time, due to the body countering treatment with its own antibodies. Finally, HAMA may lead to falsely elevated levels of certain assays (such as TSH and PTH) and false negatives in others, making it difficult to make an accurate diagnosis.1-6, 12-13

To download an infographic with more information on the HAMA response, click here.

To improve diagnostic and therapeutic accuracy and facilitate personalized patient care, ZEUS Scientific offers the ZEUS HAMA IgG ELISA Test System.

  • Quantitatively measure levels of HAMA IgG antibody
  • The only FDA-cleared ELISA immunoassay test kit for the detection of HAMA (510K #: K972873)
  • Fast results in as little as one hour
  • Enable clinicians to apply appropriate therapeutic regimes based on HAMA exposure
  • Improve clinical trial participant selection
  • Determine potential cross-reactivity or interference issues in new assay development
  • Validate test results such as PSA, troponin I, hCG, TSH, and multiple tumor markers
  • Save money by avoiding repeat testing
  • Increase efficiency of patient treatment

REFERENCES

  1. Bock JL, Forgiuele J, Wenz B. False positive immunometric assays caused by anti-immunoglobulin antibodies: a case report. Clin Chim Acta. 1985;147:241-246.
  2. Boscato LM, Egan G, Stuart MC. Covert cross reactants in a two-site immunoassay studied with monoclonal antibodies. Anal Biochem. 1985;146:393-401.
  3. Boscato LM, Stuart MC. Incidence and specificity of interference in two-site immunoassays. Clin Chem. 1986;32:1491-1495.
  4. Boscato LM, Stuart MC. Heterophilic antibodies: a problem for all immunoassays. Clin Chem. 1988;34(1):27-33.
  5. Courtenay-Luck NS, Epenetos AA, Winearls CG, et al. Pre-existing human anti-murine immunoglobulin reactivity due to polyclonal rheumatoid factors. Cancer Res. 1987;47:4520-4525.
  6. Cusick CF, Mistry K, Addison GM. Interference in a two-site immunoradiometric assay for thyrotropin in a child. Clin Chem. 1985;31:348-349.
  7. Courtenay-Luck NS, Epenetos AA, Moore R, et al. Development of primary and secondary immune responses to mouse monoclonal antibodies used in the diagnosis and therapy of malignant neoplasms. Cancer Res. 1986;46:6489-6493.
  8. Davies AG, Bourne SP, Richardson RB, et al. Pre-existing anti-mouse immunoglobulin in a patient receiving 131I-murine monoclonal antibody for radioimmunolocalization. Br J Cancer. 1986;53:289-292.
  9. Klein JL, Sandoz JW, Kopher MS, et al. Detection of specific anti-antibodies in patients treated with radiolabeled antibody. Int J Radiat Oncol Biol Phys. 1986;12:939-943.
  10. Pimm MV, Perkins AC, Armitage NC, et al. The characteristics of blood-borne radiolabels and the effect of anti-mouse IgG antibodies on localization of radiolabeled monoclonal antibody in cancer patients. J Nucl Med. 1985;26:1011-1023.
  11. Schroff RW, Foon KA, Beatty SM, et al. Human anti-murine immunoglobulin responses in patients receiving monoclonal antibody therapy. Cancer Res. 1985;45:879-885.
  12. Tjandra JJ, Ramadi L, McKenzie IF. Immunol. Cell Bio. (1990) 68, 367-376.
  13. Goto M, Kuribayashi K, Umemor Y, Ohe Y, Asanuma K, Tanaka M, Kobayashi D, Watanabe N. Anticancer Research (2010) 30; 4354-4356.