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US 2021/0333291 A1Published application
AUTOMATIC SAMPLE WORKFLOW FOR LC-MS BASED HbA1c MEASUREMENT ON INTACT PROTEIN LEVEL
AssigneeRoche Diagnostics Operations, Inc.
InventorsUwe KOBOLD, Andreas LEINENBACH, Indranil MITRA, Holger BUSSKAMP
Life of this patent
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Abstract
The present invention refers to a method for determining intact glycated hemoglobin A (HbA1c) by mass spectrometry (MS), a kit and a diagnostic system adapted for performing the method.
Claims20
A method for determining glycated hemoglobin A (HbA1c) in a sample, comprising:
- (a) providing a sample comprising hemoglobin A (HbA) molecules,
- (b) enriching intact hemoglobin A molecules in said sample, and
- (c) subjecting the sample comprising intact hemoglobin A molecules to an analysis by mass spectrometry (MS), wherein the amount or concentration of HbA1c molecules in the sample is determined.
A kit comprising
- (i) enrichment means for enriching intact glycated HbA1c molecules, in particular comprising a solid phase having a hydrophobic surface for selective binding of intact glycated HbA1c molecules,
- (ii) a substantially neutral solid phase binding medium for use in diluting a hemolysed whole blood sample and binding sample constituents to the solid phase (i) and
- (iii) an elution medium comprising an organic water-miscible solvent such as acetonitrile for use in eluting sample components from the enrichment means (i).
A diagnostic system for determining glycated hemoglobin A (HbAc1) in a sample comprising
- (i) at least one station for the preparation of samples comprising intact HbA1c molecules, wherein the preparation comprises hemolysis of a whole blood sample,
- (ii) optionally at least one enrichment station adapted for selectively enriching intact hemoglobin A molecule from the sample, and
- (iii) at least one station adapted for the analysis of intact hemoglobin A molecules by mass-spectrometry (MS) and determining the amount or concentration of HbAc1 in the sample.
Dependencies are inferred from the claim text.