Description
Principle of the Assay: This immunogenicity assay uses the direct ELISA technique. Test samples are first centrifuged for 15 minutes to clarify and then diluted using assay buffer. Quality control and test samples are pipetted into the appropriate wells. Anti- PEG antibodies bind the immobilized PEG. After washing, detection antibody (anti-human IgM 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