Primary standard and method of making secondary standards for ca

Chemistry: analytical and immunological testing – Composition for standardization – calibration – simulation,... – Protein or peptide standard or control

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436 8, 436 14, 436 87, 436 88, 436 95, 436904, G01N 3366, G01N 3368

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051322307

ABSTRACT:
This invention provides a primary standard and/or secondary standards for assay for glycated proteins in samples such as blood. The primary standard is composed of a polymer or copolymer of an amino acid, such as lysine, serine or those listed on table 37 (pages 100-110 of the second edition of Organic Chemistry by Robert Morris and Robert Nielson-Boyd) glycated with a known amount of glucose, preferably .sup.14 C glucose or .sup.3 H glucose, and free of unbound glucose. The preferred secondary standards are composed of glycated native protein per se, or a mixture of a glycated native protein and native protein that has been standardized against a primary standard to give the actual glycated protein value. These primary standards and secondary standards may be packaged and sold as a kit that contains a primary standard and/or a secondary standard and the reagents needed to perform the glycated protein assay. These glycated proteins or glycated polyamino acids can be dyed to give colored products for use as standards for the so-called affinity or ion exchange column assays, used to measure glycated protein percentage.

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Kennedy et al, Diebetes, vol. 29, pp. 413-415, 1980.
Day et al, J. Bio. Chem., vol. 254, No. 3, pp. 595-597, 1979.

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