Description
Introduction:
PEG is generally considered biologically inert and safe. However, studies of clinical safety are generally based on adults, not children. The FDA has been asked to investigate the possible effects of PEG in laxatives for children. Also, a minority of people are allergic to it. Allergy to PEG is usually discovered after a person has been diagnosed with an allergy to an increasing number of seemingly unrelated products, including processed foods, cosmetics, drugs, and other substances that contain PEG or were manufactured with PEG. When PEG is chemically attached to therapeutic molecules (such as protein drugs or nanoparticles), it can be antigenic sometimes, stimulating an anti-PEG antibody response in some patients. This effect has only been shown for a few of the many available PEGylated therapeutics, but it has significant effects on clinical outcomes of affected patients. Other than these few instances where patients have anti-PEG immune responses, it is generally considered to be a safe component of drug formulations.
Intended Use:
The KRIBIOLISA PEG ELISA is used as an analytical tool for quantitative determination of PEG in serum, plasma and cell culture supernatant.
Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Anti- PEG antibody is pre-coated onto microwells. In the first step, samples and standards are pipetted into microwells. If PEG i s present in samples or standards, it will form complex with Anti- PEG antibody, which is precoated onto microwells. In the second step, Anti- PEG Biotin conjugate is pipetted and incubated. In the third step, HRP Conjugate is pipetted and incubated. Free HRP conjugate will be removed by a washing step. In the fourth step , T M B substrate is added to microwells and color develops proportionally to the amount of PEG present in samples or standards. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.
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