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KRISHGEN BIOSYSTEMS Immunoassay for the quantitative Determination of Anti-Trastuzumab antibodies in human serum and plasma. Assay Range: 40 - 640 ng/ml; Sensitivity: 36 ng/ml.
Supplier: KRISHGEN BIOSYSTEMS KBI2017
Pack Size: 1 x 96 wells. Introduction: Trastuzumab is a humanized monoclonal antibody which targets Her-2/neu receptor. It binds to an extracellular domain of this receptor and inhibits HER2 homodimerization, thereby preventing HER2-mediated signaling. 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 Trastuzumab and can be responsible for allergic reaction, or even anaphylactic shock. This Anti-Trastuzumab ELISA kit detects Anti-Trastuzumab antibodies and may be used for monitoring immunogenicity. Validated against ICH M10 guidelines for bioassays. ELISA Features include a pre-coated plate with break-apart wells, standardisation and Precision CV <10%.
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