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US 2021/0333290 A1Published application
High speed sample workflow for lc-ms based hba1c measurement
AssigneeRoche Diagnostics Operations, Inc.
InventorsUwe KOBOLD, Andreas LEINENBACH, Indranil MITRA
Life of this patent
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Abstract
The present invention refers to a method for determining peptide fragments of glycated hemoglobin A (HbA1c) molecules by mass spectrometry (MS), a reagent kit, and a clinical 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) subjecting the sample from step (a) to a partial proteolytic digestion step wherein N-terminal fragments of hemoglobin A β-chain molecules are generated,
- (c) optionally enriching the N-terminal fragments of hemoglobin A β-chain molecules generated in step (b), and
- (d) subjecting the sample comprising N-terminal fragments of hemoglobin A β-chain molecules to an analysis by mass-spectrometry (MS) wherein the amount or concentration of HbA1c in the sample is determined.
1 more element
A kit comprising
- (i) an enzyme for the partial proteolytic digestion of HbA β-chain molecules and optionally a digestion buffer for said enzyme,
- (ii) a stopping medium, which is capable of stopping a proteolytic digestion with the enzyme of (i), and
- (iii) optionally enrichment means for enriching the proteolytically digested HbA1c molecules, and
- (iv) optionally an elution medium comprising an organic water-miscible solvent for use in eluting sample components from the enrichment means of (iii).
1 more element
A diagnostic system for determining glycated hemoglobin A (HbAc1) in a sample comprising
- (i) at least one station for the preparation of samples comprising N-terminal fragments of HbA1c molecules, wherein the preparation comprises a partial proteolytic digestion of hemoglobin A (Hb1) molecules,
- (ii) optionally at least one enrichment station adapted for selectively enriching N-terminal fragments of hemoglobin A β-molecules from the sample, and
- (iii) at least one station adapted for the analysis of N-terminal fragments of 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.