KRIBIOLISA™ Anti-Etarnacept (ENBREL) ELISA

0 ng/ml - 640 ng/ml

Colorimetric, 450nm

Enzyme Immunoassay for the quantitative determination of AntiEtanercept in human serum and plasma. Etanercept is a biopharmaceutical that treats autoimmune diseases by interfering with tumor necrosis factor (TNF, a soluble inflammatory cytokine) by acting as a TNF inhibitor. It has U.S. F.D.A. approval to treat rheumatoid arthritis, juvenile rheumatoid arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. TNF-alpha is the "master regulator" of the inflammatory (immune) response in many organ systems.Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential to treat these diseases by inhibiting TNF-alpha. 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 Etanercept and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects antibodies for Anti-Etanercept and may be used for monitoring immunogenicity. Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year The method employs the quantitative sandwich enzyme immunoassay technique. Etanercept is pre-coated onto microwells. Samples and standards are pipetted into microwells and antibodies to Etanercept present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Etanercept is pipetted and incubated. 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-Etanercept in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

Serum and Plasma

30 ng/ml