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In Vitro Assay to Evaluate the Impact of Immunoregulatory Pathways on HIV-specific CD4 T Cell Effector Function

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Published on: October 15, 2013

Impact of matrix-associated soluble factors on the specificity of the immunogenicity assessment

Ami C Bautista¹, Danika Wullner, Mike Moxness

¹Clinical Immunology Department, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.

|November 19, 2010

Background:

Specificity and sensitivity are essential in assays for immunogenicity assessment of biotherapeutics. Nonspecific interactions from excess therapeutic or anti-therapeutic antibody, soluble ligands (e.g., target receptor), or serum proteins associated with autoimmune conditions (e.g., rheumatoid factor) in samples can impact the detection of a true anti-therapeutic response.

Results:

Electrochemiluminescence-based bridging assay formats could eliminate the interference due to rheumatoid factor with no pretreatment with Melon Gel™ or aggregated IgG. The interference due to soluble factors was not platform specific for the four therapeutics evaluated in this study.

Conclusion:

Melon Gel pretreatment and avidin high-bind (Meso Scale Discovery) plates can effectively reduce interference due to rheumatoid factor in ELISA- and electrochemiluminescence-based assays, respectively. Excess levels of therapeutic and anti-therapeutic antibodies in bridging assays can impact assay specificity.

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Antigens Involved in Adaptive Immunity

Antigens Involved in Adaptive Immunity

An antigen is any substance the immune system identifies as foreign and potentially harmful to the body, prompting an immune response. Antigens have two functional properties: immunogenicity and reactivity. Immunogenicity is the ability of an antigen to stimulate a specific immune response. At the same time, reactivity describes the antigen's ability to react with the cells and antibodies produced in response to it.
Complete Antigens
Complete antigens possess both immunogenicity and reactivity.

Cross-reactivity

Cross-reactivity

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