Polyethylene glycol (PEG) chains are often used to modify therapeutic biologic agents in order to prolong the circulating half-life of the modified protein by slowing proteolytic degradation. It has been reported that repeat injections of PEGylated proteins can induce anti-PEG antibodies. Anti-PEG antibodies can result in rapid clearance and decreased drug efficacy (accelerated blood clearance, or ABC, phenomenon).
The Anti-PEG (Polyethylene Glycol) IgG Antibody BioAssay™ ELISA Kit is for the qualitative determination of anti-PEG IgG antibodies in human serum and plasma.
Principle of the Assay
This immunogenicity assay uses the direct ELISA technique. The supplied 96 well microplate is pre-coated with PEG. Quality Control and test samples are pipetted into the appropriate wells. Anti-PEG antibodies bind the immobilized PEG. After washing, detection antibody (anti-human IgG Peroxidase) is added. Any unbound antibody-enzyme reagent is removed with a final wash and a substrate solution is added to the wells for color development. Color development is proportional to the amount of anti-PEG IgG.
Detection Range
62.5-1000ng/ml
Precision
Intra-assay CV: <10% Inter-assay CV: <10%
Kit Components
384855A: Microtiter Strips, 1x96 wells 384855B: Standard, 1000ng/ml, 1x250ul 384855C: Standard, 500ng/ml, 1x250ul 384855D: Standard, 250ng/ml, 1x250ul 384855E: Standard, 125ng/ml, 1x250ul 384855F: Standard, 62.5ng/ml, 1x250ul 384855G: Standard, 0ng/ml, 1x250ul 384855H: Wash Buffer, 10X, 1x50ml 384855J: Assay Buffer, 1x50ml 384855L: Detection Reagent, 1000X, 1x17ul 384855M: TMB, 1x12ml 384855N: Stop Solution, 1x12ml
Storage and Stability
Store all components at -20°C. Stable for 6 months after receipt. For maximum recovery of product, centrifuge the original vial after thawing and prior to removing the cap.
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