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 BioAssay™ ELISA Kit (Human IgM Specific) is for the qualitative determination of anti-PEG IgM antibodies in human serum and plasma.

Test Principle:
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 IgM.

Detection Range:
62.5-1000ng/ml

Precision:
Intra-assay CV: <10%
Inter-assay CV: <10%

Kit Components:
384856A: Microtiter Strips, 1x96 wells
384856B: Standard, 1000ng/ml, 1x250ul
384856C: Standard, 500ng/ml, 1x250ul
384856D: Standard, 250ng/ml, 1x250ul
384856E: Standard, 125ng/ml, 1x250ul
384856F: Standard, 62.5ng/ml, 1x250ul
384856G: Standard, 0ng/ml, 1x250ul
384856H: Wash Buffer, 10X, 1x50ml
384856J: Assay Buffer, 1x50ml
384856K: Detection Reagent, 1000X, 1x17ul
384856L: TMB, 1x12ml
384856M: 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.