KRIBIOLISA™ Emicizumab (HEMLIBRA™) ELISA
Enzyme Immunoassay for the Quantitative Determination of Emicizumab in human Serum and Plasma
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Introduction:
Emicizumab (trade name Hemlibra) is a humanized bispecific antibody for the treatment of haemophilia A. Emicizumab binds to both the activated coagulation factor IX and to factor X, mediating the activation of the latter. This is normally the function of coagulation factor VIII, which is missing in haemophilia A patients.
Intended Use:
The KRIBIOLISA™ Emicizumab (HEMLIBRA) ELISA is used as an analytical tool for quantitative determination of Emicizumab (HEMLIBRA) in human serum and plasma.
Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Factor IX and Factor X protein are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Emicizumab present in the sample are bound by the capture antibody. Then, a goat Anti-Human IgG HRP (horseradish peroxidase) is pipetted and incubated. After washing microwells in order to remove any nonspecific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Emicizumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.
