A method for determining the amount of glycated haemoglobin (HbA1c), in whichif requiredthe erythrocytes in a sample are haemolysed, the haemoglobin that is then releasedif requiredis contacted with a proteolytic agent and the glycated haemoglobin degradation products obtained in this way or otherwise are quantified is disclosed. In order to provide such a process and reagents employable therein that has/have the property of sufficient stability of the chemical compounds that are essential to the reaction, for the stabilization of the haemoglobin which is unfolded at a very low pH in the range from 1 to 3, at least one suitable stabilizer is present in the haemolysis solution. Where a leuco dye is used in connection with the determination of the amount of HbA1c, it is proposed that the latter be stabilized with particular phosphine compounds and/or thio compounds, and, in particular embodiments, the requisite proteolytic agent is to be provided in the form of an inactivated protease which is then only reactivated in situ.

Hemoglobin, its variants, and glycated forms of each are determined individually in a multiplex assay that permits correction of the measured level of HbA1c to account for glycated variants and other factors related to the inclusion of the variants in the sample. New antibodies that are particularly well adapted to the multiplex assay are also provided.

A sensor for the detection of HbA1c in a sample includes a substrate, a working electrode and counter electrode formed on a surface of the substrate, and an anti-HbA1c antibody functionalized or chemically functionalized to a surface of an exposed portion of the working electrode.

The present disclosure relates to systems and methods for measuring glycated A1c hemoglobin. A glycated hemoglobin level measuring system includes a sample testing apparatus having a microchannel that compresses a blood sample traveling through, a first pair of electrodes coupled to the microchannel, and a second pair of electrodes coupled to the microchannel. The glycated hemoglobin level measuring system further includes an analysis apparatus having sensors coupled to the first and second pairs of electrodes and configured to calculate a travel time taken by a red blood cell to pass through the first and second pairs of electrodes. The glycated hemoglobin level measuring system can use the travel time to measure a rigidity of the red blood cells and the corresponding glycated hemoglobin level.

Disclosed are methods and kits for analyzing a sample comprising 1,5-anhydroglucitol and a possible first analyte via one or more chemiluminescent reactions. Certain embodiments include measuring a first light response resulting from a first chemiluminescent reaction and measuring a second light response resulting from a second chemiluminescent reaction. Certain embodiments also include comparing the first light response to the second light response to determine a ratio of 1,5-anhydroglucitol and the first analyte. Also provided are kits including reagents for practicing the claimed methods.

Provided is a glycated protein sensor provided with: immobilized protease; immobilized ketoamine oxidase; and a hydrogen peroxide detection section.

The invention relates to a method for the diagnosis of non-alcoholic steatohepatitis (NASH), for determining the activity, the stage, or the severity of NASH or for classifying a subject as a potential receiver or non receiver of a treatment of NASH using circulating miRNAs and other blood circulating markers of liver damage, e.g. alpha 2 macroglobulin, HbA1c, N-terminal pro-peptide of collagen type III, miR-34 and miR-200. It also relates to a kit for implementing the method of the invention, and the compounds for use in a method for the treatment of NASH, wherein the subject to be treated is identified, evaluated or classified according to the method of the invention.

Methods of determining the risk of an adverse cardiovascular event or death in a mammal are provided which include determining in a biological sample obtained from the mammal the level of a combination of biomarkers selected from a glucose metabolism biomarker, a heart function biomarker, a renal function biomarker and at least one biomarker of cardiac injury. A score is allotted based on the level of each biomarker, and the cumulative score is indicative of the risk of an adverse cardiovascular event.

A system for preparing a sample containing hemoglobin HbA1c for measurement by an electrochemical sensor includes a lysing formulary, the lysing formulary including a zwitterionic surfactant. The system further includes a oxidizing formulary, the oxidizing formulary including a cationic surfactant and a isothiazoline derivative and a protease formulary, the protease formulary including a molecule including an azole.

Methods, devices, and systems may use a kinetic model to determine physiological parameters related to the kinetics of red blood cell glycation, elimination, and generation. Such physiological parameters can be used, for example, to determine a more reliable calculated HbA1c. In another example, a method may comprise: receiving a plurality of glucose levels over a time period; receiving a glycated hemoglobin (HbA1c) level corresponding to an end of the time period; determining at least one physiological parameter selected from the group consisting of: a red blood cell glycation rate constant (k.sub.gly), a red blood cell generation rate constant (k.sub.gen), a red blood cell elimination constant (k.sub.age), and an apparent glycation constant (K), based on (1) the plurality of glucose levels and (2) the HbA1c level; and adjusting a glucose level target based on the at least one physiological parameter.