Description
Introduction:
Ustekinumab is a human monoclonal antibody. It is directed against interleukin 12and interleukin 23, naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. Ustekinumab is approved in Canada, Europe and the United States to treat moderate to severe plaque psoriasis. 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 preclinical 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 Anti-Ustekinumab antibodies and may be used for monitoring immunogenicity.
Intended Use:
The KRIBIOLISA Anti-Ustekinumab ELISA is used as an analytical tool for quantitative determination of Anti-Ustekinumab antibodies in human serum and plasma.
Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Ustekinumab is pre-coated onto microwells. Samples and standards are pipetted into microwells and antibodies to Ustekinumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Ustekinumab 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-Ustekinumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.
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