Glycated protein assay
AssigneeBio-Rad Laboratories, Inc.
InventorsVictor Manneh, Sergei Svarovsky, Anthony Prestigiacomo
Life of this patent
Estimating the term…
Abstract
Methods, devices, and reagents are described for performing assays for hemoglobin Ale, glycated albumin, and other glycated proteins. The methods involve a ratio determination between glycated protein and non-glycated protein. In some applications, the assay utilizes LOCI for signal generation. This invention is directed to assays and corresponding devices and reagents for detection of glycated protein, particularly including glycated hemoglobin. As is generally understood, such detection is useful in the management of blood glucose levels in diabetic patients and for monitoring the status of pre-diabetic individuals.
Claims18
A method for determining the fraction of a glycated protein in a sample, comprising
- contacting (i) a labeled, specific binding member specific for total protein or a peptide corresponding to total protein or un-glycated protein or peptide, and (ii) a labeled, specific binding member specific for glycated protein or peptide with
- a) a sample containing said protein or a peptide of said protein susceptible to glycation;
- and
- b) a non-sample-derived glycated version of said protein or peptide;
- or
- c) a non-sample-derived unglycated version of said protein or peptide;
- detecting a plurality of signals, with at least a first signal indicative of the level of glycated protein, and at least a second signal indicative of the level of total protein or unglycated protein;
- and
- determining a ratio between glycated protein and un-glycated protein, or between glycated protein and total protein, as an indication of the fraction of said protein which is glycated in said sample,
- wherein said contacting is performed under competitive binding conditions, and wherein said first signal and said second signal are distinguishable;
- and
- wherein the sample is contacted with a control labeled binding member that specifically binds a target not in the sample and said control labeled binding member is later detected, wherein the detected amount of control labeled binding member is used to normalize signals for the level of glycated protein or total protein or both.
Dependencies are inferred from the claim text.