Description
Introduction:
Adalimumab, sold under the trade name Humira among others, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis. In rheumatoid arthritis, adalimumab has a response rate similar to methotrexate, and in combination, it nearly doubles the response rate of methotrexate alone. Adalimumab is a TNF-inhibiting, anti-inflammatory, biologic medication. It binds to tumor necrosis factor-alpha (TNF alpha), which normally binds to TNF alpha receptors, leading to the inflammatory response of autoimmune diseases. By binding to TNF alpha adalimumab reduces this inflammatory response, as it is also part of the immune system, which protects the body from infection, treatment with adalimumab may increase the risk of infections. Anti-Drug Antibodies (ADA) may induce unwanted side effects in biopharmaceuticals. Hence, ADA has been subjected to increase in scrutiny by the regulatory authorities using immunogenicity safety studies. ADA has been observed in pre-clinical and clinical studies, resulting in significant changes in toxicology, pharmacokinetics and efficacy. These effects result from the generation of drug-induced (neutralizing) autoantibodies against Trastuzumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects Anti-Adalimumab antibodies and may be used for monitoring immunogenicity.
Intended Use:
The KRIBIOLISA Anti-Adalimumab ELISA is used as an analytical tool for quantitative determination of Anti-Adalimumab antibodies in human serum and plasma.
Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. A commercially available Adalimumab is pre-coated onto microwells. Samples and Standards are pipetted into microwells and antibodies to Adalimumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Adalimumab is pipette and incubated simultaneously with samples. After washing microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Anti-Adalimumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.
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