ELISA/assay

Anti-Infliximab (REMICADE) ELISA

KBI2011

1 x 96 well

Anti-Infliximab (REMICADE) ELISA

Infliximab is a monoclonal antibody which has high specificity for TNFα, and does not neutralize TNF beta. Infliximab causes programmed cell death of TNFα-expressing activated T lymphocytes, an important cell type mediating inflammation; hence it is generally assumed that resolution of activated T cells by Infliximab explains its efficacy in Crohn's disease. 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 infliximab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects antibodies for Anti-Infliximab and may be used for monitoring immunogenicity.

The method employs the quantitative sandwich enzyme immunoassay technique. Infliximab is pre-coated onto microwells. Samples and standards are pipetted into microwells and antibodies to Infliximab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Infliximab 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-Infliximab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

ELISA

Assay Kits

Therapeutic Drug Monitoring

1 x 96 well

Anti-Infliximab

Anti-Infliximab

<10 ng/ml

10-640 ng/ml

100 uL

Serum, Plasma, Cell Culture Supernatants

2.25 hours

RUO

wet

2-8C