259 results about "Glycated hemoglobin" patented technology

A method of determining the percentage of glycated hemoglobin in a blood sample is disclosed wherein at least one of the assay steps is performed electrochemically. The method includes determining the total amount of hemoglobin in a sample by electrochemically measuring, in an oxygen electroreduction reaction at a cathode, the amount of oxygen in the sample. Because the amount of oxygen dissolved in the sample is known, the total hemoglobin is determined by subtracting the amount of free oxygen from the total oxygen measured, recognizing the fast equilibrium Hb+O2⇄HbO2. This can be followed by determining the amount of glycated hemoglobin in the sample. The cathode reaction is accomplished by contacting the sample with an enzyme, the enzyme being a copper-containing enzyme having four copper ions per active unit. The family of these enzymes includes, for example, laccases and bilirubin oxidases.

Compositions and assay methods for and relating to the detection of glycated hemoglobin are provided. In particular, the presence and level of glycated hemoglobin can be detected in a blood sample. The compositions comprise microparticles which have zinc coating for use in the improved binding of proteins exhibiting a zinc binding domain, in particular glycated hemoglobin.

A system for treating a blood sample (700) having an analyte of interest comprises a strip (200) having a membrane (218), respective portions (216, 220 and 222, or 300) which are provided for receiving the sample, for lysing cells of the sample to liberate hemoglobin, and for capturing glycated hemoglobin. The latter two portions (220 and 222, or 300) of the membrane are treated with lysing and capture agents, respectively. A portion of the strip (214 or 230 or 240) is provided for holding an eluting agent and for releasing the agent upon a release condition. A system for detecting analyte comprises an optical subsystem (550) that is aligned with the strip to provide a signal corresponding to an amount of analyte, and an electronic subsystem (650) for processing the signal (560) to provide a result, such as an amount or percentage of glycated hemoglobin. To use these systems, the user simply applies a small sample (700) to the membrane (218) and closes a door (10) of the detection system over the strip (200) such that the door triggers the release of the eluting agent. No sample pre-treatment is required. The preferably handheld system (100) is a simple and convenient monitoring tool for the user, such as a diabetic patient who must monitor blood glucose on an on-going basis. While the systems are useful in the monitoring of blood glucose, they may be used for treating a sample other than blood and detecting an analyte other than an analyte in blood.

A method of determining the percentage of glycated hemoglobin in a blood sample is disclosed wherein at least one of the assay steps is performed electrochemically. The method includes determining the total amount of hemoglobin in a sample by electrochemically measuring, in an oxygen electroreduction reaction at a cathode, the amount of oxygen in the sample. Because the amount of oxygen dissolved in the sample is known, the total hemoglobin is determined by subtracting the amount of free oxygen from the total oxygen measured, recognizing the fast equilibrium Hb+O2⇄HbO2. This can be followed by determining the amount of glycated hemoglobin in the sample. The cathode reaction is accomplished by contacting the sample with an enzyme, the enzyme being a copper-containing enzyme having four copper ions per active unit. The family of these enzymes includes, for example, laccases and bilirubin oxidases. A device associated with such a process or method is also provided.

Disclosed are a centrifugal micro-fluidic structure for measuring glycated hemoglobin, a centrifugal micro-fluidic device for measuring glycated hemoglobin, and a method for measuring glycated hemoglobin. According to the disclosure, immunosorbent assay and affinity measurements are simultaneously conducted using only a single device in order to detect hemoglobin variants or interfering substances and, therefore, the detected results are applied to analysis of measurement results so as to eliminate and / or compensate for, or calibrate errors in measurement of, glycated hemoglobin, thereby more accurately measuring the glycated hemoglobin.

A method of determining glycated hemoglobin is provided, by which a ratio of the glycated hemoglobin in a sample can be determined accurately and easily. The ratio of glycated hemoglobin can be determined by degrading a glycated hemoglobin in a whole blood sample selectively with a protease to give a glycated hemoglobin degradation product`; causing a redox reaction between a glycation site of the glycated hemoglobin degradation product and a fructosyl amino acid oxidoreductase; and determining this redox reaction. Further, as shown in FIG. 1, in a whole blood sample, there is a correlation between the ratio of the glycated hemoglobin determined by this method and an HbA1c concentration. Thus, without determining the glycated alpha-amino group as a characteristic structure of HbA1c, an amount of HbA1c can be determined accurately and easily from the determined ratio of the glycated hemoglobin.

The invention provides electrochemical biosensors for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The invention provides methods for using the electrochemical biosensors.

The invention provides a micro-fluidic chip for glycosylated hemoglobin immunodetection in serum, comprising a sample introduction pool, a micro-fluid channel, a reaction tank, a detection tank, a waste liquor tank and a pump valve interface, wherein the sample introduction pool, the micro-fluid channel, the water liquor tank and the pump valve interface are serially connected by the micro-liquid channel; antigens or antibodies necessary for protein detection are fixed in the reaction and detection tanks in advance, a serum sample solution to be detected successively flows in the reaction tank by virtue of the sample introduction pool and the micro-fluid channel by an externally connected pump valve system, completes antigen or antibody specific reaction in the reaction tank and agglomerates, and the reaction product is subjected to absorbancy analysis to obtain the immune agglutination reaction and detection of the sample to be detected. The chip is convenient for sample introduction, less in sample consumption, high in reaction efficiency and short in detection time.

The present invention relates to the optical measurement of blood analytes, such as glycated hemoglobin (HbA1c) and serum albumin as a functional metric of mean blood glucose in the diagnosis of diabetic patients. Non-enhanced Raman spectroscopy is employed as the analytical method for quantitative detection of blood analytes. Using processing techniques, non-enzymatic glycosylation (glycation) of the analytes results in measurable and highly reproducible changes in the acquired spectral data, which enable the accurate measurements and classification of glycated and unglycated analytes.

Compositions for accurately assaying a glycated protein by: 1) avoiding effects of globulin and ascorbic acid components, 2) siabilizing proteases and at least enzymes acting on glycated amino acids; 3) accurately assaying albumin; and 4) assaying glycated albumin while avoiding the effects of glycated hemoglobin, and an assay method are provided. Thus, the contents of a glycated protein and glycated albumin can be more accurately determined.

A non-enzymatic electrochemical method of simultaneous measurement of hemoglobin (Hb) and percentage of glycated hemoglobin (% HbA1c) in a blood sample is disclosed. The method includes determining the total amount of hemoglobin in a sample by electrochemically measuring the voltammetric current due to iron (II) and iron (III) redox portions in hemoglobin and determining the percentage of glycated hemoglobin (HbA1c) by potentiometry. Also disclosed is a novel screen-printed electrode (SPE) strip modified for potentiometric measurement of HbA1c.

A compound is represented by Structural Formula (I): or a pharmaceutically acceptable salt thereof. A pharmaceutical composition comprises a compound represented by Structural Formula (I) or a pharmaceutically acceptable salt thereof. A method of treating a subject in need thereof comprises administering to the subject a therapeutically effective amount of a compound represented by Structural Formula (I) or a pharmaceutically acceptable salt thereof. The subject has type 2 diabetes; renal hypertrophy or hyperplasia associated with diabetic nephropathy; Tay-Sachs; Gaucher's; or Fabry's disease. Methods of decreasing plasma TNF-α, lowering blood glucose levels, decreasing glycated hemoglobin levels, inhibiting glucosylceramide synthase, and lowering glycosphingolipid concentrations in a subject in need thereof respectively comprise administering to the subject a therapeutically effective amount of a compound represented by Structural Formula (I) or a pharmaceutically acceptable salt thereof.

A reaction cassette for a glycated hemoglobin meter and a measuring method thereof are provided. The reaction cassette for the glycated hemoglobin meter includes: a first zone receiving a first reagent and a blood sample; a second zone receiving a second reagent; a reaction zone in which the blood sample reacts with the first reagent, or through which the second reagent passes to react with a first blood sample mixture obtained by reacting the blood sample with the first reagent; and a measurement zone measuring an amount of total hemoglobin in the first blood sample mixture, or measuring an amount of glycated hemoglobin in a second blood sample mixture obtained by reacting the first blood sample mixture with the second reagent, wherein the blood sample, the first reagent, and the second reagent move between the reaction zone and the measurement zone according to a rotation angle of the reaction cassette when the reaction cassette is rotated. Therefore, since the reaction cassette reduces the operating time, it is possible to resolve storage and distribution problems of the reaction cassette, which occur when reagents are stored in the reaction cassette.

The invention relates to a four-gradient elution analysis method of a glycated hemoglobin analyzer, which is used for detecting concentration of glycated hemoglobin via ionic exchange chromatography. The method comprises the following steps of: setting four kinds of eluent with fixed concentration; respectively using the four kinds of eluent to elute cation exchange resin having an absorbed sample to be detected; and performing chromatographic analysis on the eluted liquid to determine the content of the eluted ingredients, thereby determining a blood glucose concentration, wherein the four kinds of eluent are respectively as follows: an eluent A for washing and balancing the cation exchange resin, an eluent B for eluting other subfractions including HbA1a and HbA1b of the hemoglobin, an eluent C for eluting HbA1c subfraction of the glycated hemoglobin, and an eluent D for eluting an non-glycated hemoglobin and regenerated cation exchange resin. The method provided by the invention can accurately detect the concentration of the glycated hemoglobin, simplify structures of detection devices and detection programs, improve operational reliability of devices, decrease cost on devices and reduce cross contamination of the eluent.

A reaction cassette for a glycated hemoglobin meter and a measuring method thereof are provided. The reaction cassette for the glycated hemoglobin meter includes: a first zone receiving a first reagent and a blood sample; a second zone receiving a second reagent; a reaction zone in which the blood sample reacts with the first reagent, or through which the second reagent passes to react with a first blood sample mixture obtained by reacting the blood sample with the first reagent; and a measurement zone measuring an amount of total hemoglobin in the first blood sample mixture, or measuring an amount of glycated hemoglobin in a second blood sample mixture obtained by reacting the first blood sample mixture with the second reagent, wherein the blood sample, the first reagent, and the second reagent move between the reaction zone and the measurement zone according to a rotation angle of the reaction cassette when the reaction cassette is rotated. Therefore, since the reaction cassette rotates automatically, it is possible to measure the amount of glycated hemoglobin in a blood sample through simple manipulation and reduce a manufacturing time. Furthermore, since reagents are supplied to the reaction cassette from a separate reagent pack, it is possible to resolve storage and distribution problems of the reaction cassette, which occur when reagents are stored in the reaction cassette.

There is provided a method for specifically determining a glycated β-chain N-terminal of glycated hemoglobin using enzymes without a separation operation, and a determination reagent kit therefor.A protease that cleaves a glycated amino acid and / or a glycated peptide from a glycated β-chain N-terminal without substantially cleaving a glycated amino acid or a glycated peptide from a glycated α-chain N-terminal of glycated hemoglobin or a fragment thereof is screened. The method of specifically determining a glycated β-chain N-terminal of glycated hemoglobin and the determination reagent kit are provided by using the protease obtained by the screening method.According to the present invention, a glycated β-chain N-terminal of glycated hemoglobin can specifically be determined without a separation operation.

Compositions for accurately assaying a glycated protein by: 1) avoiding effects of globulin and ascorbic acid components, 2) siabilizing proteases and at least enzymes acting on glycated amino acids; 3) accurately assaying albumin; and 4) assaying glycated albumin while avoiding the effects of glycated hemoglobin, and an assay method are provided. Thus, the contents of a glycated protein and glycated albumin can be more accurately determined.

The invention relates to a method for measuring glycosylated hemoglobin content, which comprises the following steps of: a, uniformly mixing a whole blood sample and hemolytic liquid; b, adding an appropriate amount of hemolyzed sample into latex suspending in glycine buffer solution; c, respectively adding an antibody B reagent and an antibody A reagent after preset time; d, uniformly mixing andreading a scattering value through a specific protein analyzer under the condition of single-wavelength light irradiation; and e, reading the glycosylated hemoglobin content from a standard curve diagram according to the scattering value. The glycosylated hemoglobin content of the blood sample can be directly determined without separately measuring the total hemoglobin content and the glycosylated hemoglobin content of the blood sample by taking fixed-time nephelometry as a detection principle; and antibody working solution does not need preparing in advance, so that the effective service time of the reagents is prolonged, the operating steps are simplified and the measuring time of the sample is shortened.

A method of treating of glycosylated hemoglobin and in particular the process of hemoglobin isolation and preparation of a stable glycosylated hemoglobin in which the glycosylated hemoglobin remains liquid. The method comprises steps including separating human red blood cells from anti-coagulated blood, washing the human red blood cells with physiological saline and centrifuging the red blood cells and aspirating and discarding a resulting supernatant and white blood cell layer, lysing the packed red blood cells, mixing and freezing the cell / water mixture, defrosting, centrifuging, filtering and saving the supernatant, heating the supernatant, diafiltering the adjusting the hemolysate so that a final hemoglobin concentration is within specified limits. Additives may include potassium cyanide, carbon monoxide, and appropriate preservatives.

The invention discloses a kit for determining glycosylated hemoglobin and a preparation method thereof. The kit comprises three liquid components a reagent R1, reagent R2 and a reagent R3 that are independently to each other. The reagent R1 consists of: a latex glycine buffer solution, polyethylene glycol-2000, Tween-80, glycerin, bovine serum albumin, and sodium azide, the reagent R2 consists of: a glycine buffer solution, an anti-IgG antibody, an anti-HbA1c antibody, sodium chloride, bovine serum albumin and sodium azide, and the reagent R3 consists of: a hemolysin diluent. The preparation method includes: preparing the reagents according to the component content; mixing a to-be-determined sample with the reagent 3, and using the hemolysin diluents to treat the to-be-determined sample; mixing the treated to-be-determined sample with the reagent R1 and reagent R2 and carry out full reaction; employing a fully automatic biochemical analyser to determine the absorbance difference after reaction; and calculating the concentration of glycosylated hemoglobin in the sample according to an absorbance change value. The kit provided by the invention has the advantages of high accuracy, and convenient operation, etc.

The invention provides electrochemical biosensors for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The invention provides methods for using the electrochemical biosensors.

The invention relates to an enzymatic test kit for glycosylated hemoglobin, which is composed of hemolysis buffer solution, reagent R1a, reagent R1b and reagent 2; wherein, the hemolysis buffer solution is 10 to 1000mmol / L N- cycloethyl-2-aminoethanesulfonic acid, 10 to 1000mmol / L MOPS and 1 to 100g / L polyethylene glycol oxide dodecyl ether; the reagent R1a is 100 to 10000 kU / L metalloproteinase, 0.1 to 10mmol / L 2-(iodophenyl)-3-(2, 4- dinitrobenzene)-5-(2, 4-disulfophenyl)-2H tetrazole sodium salt; the reagent R1b is 0.1 to 10mmol / L MES and 0.5 to 50mmol / L CaCl2; the reagent 2 is 1 to 100kU / L fructose valine oxidase with high activity, 30 to 600kU / L POD, 0.01 to 0.5mmol / L DA-64 and 10 to 1000mmol / L Tris-HCl. The test kit coincides with the characteristics of rapidness, large batch size and economy which are required by the glycosylated hemoglobin clinical tests.

The invention provides a one-step type integrated blood glucose meter comprising a blood glucose meter body, a detecting box in an accommodating groove of the blood glucose meter body and a glycosylated hemoglobin detecting unit. The blood glucose meter body is provided with a control circuit. The detecting box is provided with a blood glucose detecting unit corresponding to a blood collecting port and a guide structure allowing the blood glucose detecting unit provided with a blood collecting needle and a blood glucose test strip to collect blood movably. The blood glucose meter body is provided with a drive mechanism connected to the control circuit, and the drive mechanism is used for driving the blood glucose detecting unit to move by sensitive triggering to allow the blood colleting needle to penetrate the blood collecting port to collect blood and return. A glycosylated hemoglobin detecting position is formed on the surface of the blood glucose meter body through the glycosylated hemoglobin detecting unit. The blood glucose meter body further integrally corresponds to a wireless receiving unit, connected to a wireless emitting unit of a blood glucose sensor planted subcutaneously, and a glucose interpreting unit which is connected to the wireless receiving unit and which is used for dynamically converting and displaying blood glucose values. The blood glucose meter integrates functions of blood glucose detection, dynamic blood glucose monitoring and glycosylated hemoglobin detection, and is small in size and convenient to operate.

The present invention provides an electrochemical detection method for content of glycosylated hemoglobin in the blood, and is characterized in that: whole blood specimen is diluted by combined liquid ranging from 30 times to 70 times and passes through a glycosylated protein recognizer, electric activated small molecules are filled into the effluent liquid from the glycosylated protein recognizer, and electrochemical response of the liquid is detected by chemically modified electrodes after the filling, thereby obtaining the concentration of the blood glucose. The glycosylated protein recognizer is eluted by elute solvent, and the electrochemical response of the elute solvent is detected and the concentration of the glycosylated hemoglobin is obtained, thereby obtaining the content of the glycosylated hemoglobin of the sample after calculation. As the electrochemical detection is simple in operation, lower in cost and rapid in the analysis, the present invention is expected to realize the rapid determination of the clinical glycosylated hemoglobin and the rapid determination of the glycosylated hemoglobin after separation and elution.

The present invention is drawn to a method of measuring glycated hemoglobin, which can comprise steps of establishing multiple age-specific groups of red blood cells, and measuring HbA1c levels of at least one of said groups. In another embodiment, a system for measuring glycated hemoglobin can comprise a separating device configured to separate red blood cells into multiple age-specific groups, and a measuring device configured to measure HbA1c levels of at least one of said groups.

A reaction cassette for a glycated hemoglobin meter and a measuring method thereof are provided. The reaction cassette for the glycated hemoglobin meter includes: a first zone receiving a first reagent and a blood sample; a second zone receiving a second reagent; a reaction zone in which the blood sample reacts with the first reagent, or through which the second reagent passes to react with a first blood sample mixture obtained by reacting the blood sample with the first reagent; and a measurement zone measuring an amount of total hemoglobin in the first blood sample mixture, or measuring an amount of glycated hemoglobin in a second blood sample mixture obtained by reacting the first blood sample mixture with the second reagent, wherein the blood sample, the first reagent, and the second reagent move between the reaction zone and the measurement zone according to a rotation angle of the reaction cassette when the reaction cassette is rotated. Therefore, since the reaction cassette rotates automatically, it is possible to measure the amount of glycated hemoglobin in a blood sample through simple manipulation and reduce a manufacturing time. Furthermore, since reagents are supplied to the reaction cassette from a separate reagent pack, it is possible to resolve storage and distribution problems of the reaction cassette, which occur when reagents are stored in the reaction cassette.

The invention provides enzymatic methods for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The methods utilizes one or two different types of oxidizing agents which selectively oxidize low-molecular weight reducing substances and high-molecular weight (mainly hemoglobin) reducing substances in blood samples, coupled with enzymatic reactions catalyzed by proteases, fructosyl amino acid oxidase. The amount of hydrogen peroxide generated in the reaction is measured for determination of percentage of glycated hemoglobin in blood samples. The invention provides kits for performing the methods of the invention.