Enzyme-linked immunosorbent assay for the qualitative determination of antibodies to adalimumab in serum and plasma with confirmation. Adalimumab (Humira®) was associated to the development of anti-Adalimumab antibodies, with some reported to be neutralizing in patients. The Assay Genie Antibody to Adalimumab ELISA Kit can be efficiently used for monitoring Adalimumab anti-drug antibodies (ADA) in biological samples and is for research use only.

The Assay Genie Antibody to Adalimumab (Humira®) ELISA is a sandwich assay for the determination of antibodies against adalimumab in serum and plasma samples. During the first incubation period, the drug adalimumab coated on the wall of the microtiter wells captures the antibodies to adalimumab in patient serum and plasma samples. After washing away the unbound components from samples, a Peroxidase-labelled conjugate is added to each well and then incubated. After a second washing step, the bound enzymatic activity is detected by addition of tetramethylbenzidine (TMB) chromogen-substrate. Finally, the reaction is terminated with an acidic stop solution. The intensity of the reaction colour is directly proportional to the concentration of antibodies to Adlimumab in sample.

Adalimumab (Humira®) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor alpha (TNF-a). Adalimumab (Humira®) was created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab (Humira®) is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps.

Adalimumab (Humira®) binds specifically to (TNF-a) and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab (Humira®) also lyses surface TNF expressing cells in vitro in the presence of complement. Adalimumab (Humira®) does not bind or inactivate lymphotoxin (TNF-beta). TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of rheumatoid arthritis, including juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis patients and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in psoriasis (Ps) plaques.

Adalimumab is to treat various autoimmune diseases and works to treat inflammation. Adalimumab is administered to minimize pain and swelling due to various types of arthritis, including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis and ankylosing spondylitis. Adalimumab also treats various skin conditions including plaque psoriasis and hidradenitis suppurativa.

When administered to patients, all therapeutic proteins have the potential to induce an unwanted immune response for example, to stimulate the formation of antidrug antibodies (ADAs). The impact of immune responses can range from no apparent effect to changes in pharmacokinetics, loss of effect and serious adverse events.

According to the manufacturer's product insert, the use of Adalimumab (Humira®) was associated to the development of anti-adalimumab antibodies, even some were reported to be neutralizing in various percentages of patients, during therapy with the drug Humira®. This has the possibility to lead to severe complications. The Assay Genie Antibody to Adalimumab ELISA Kit can be efficiently used for monitoring Adalimumab anti-drug antibodies (ADAs) in biological samples and is for research use only.

Humira® is a registered trademark of AbbVie Biotechnology, Inc.