Introduction:
Eculizumab, sold under the trade name Soliris, is a medication used to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It is a humanized monoclonal antibody functioning as a terminal complement inhibitor. In people with PNH, it reduces both the destruction of red blood cells and need for blood transfusion, but does not appear to affect the risk of death. Eculizumab was the first drug approved for each of its uses, and its approval was granted on the basis of small clinical trials. 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 Eculizumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects Anti-Eculizumab antibodies and may be used for monitoring immunogenicity.
Intended Use:
The KRIBIOLISA Anti-Eculizumab (SOLIRIS) ELISA is used as an analytical tool for quantitative determination of Anti-Eculizumab antibodies in serum and plasma.
Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Eculizumab is precoated onto microwells. Samples and standards are pipetted into microwells and antibodies to Eculizumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Eculizumab 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-Eculizumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.
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