Abstract: Methods are provided for making rapid labeled dextran ladders and other calibrants useful in liquid chromatography. The methodologies include a two-step process comprising a reductive amination step of providing a reducing glycan and reacting it with a compound having a primary amine to produce an intermediate compound. The intermediate compound is then rapidly tagged with a rapid tagging reagent to produce the rapid labeled dextran ladder.

Abstract: Analyzers and methods for making and using analyzers are described such as a method in which multiple absorption readings of a liquid assay are obtained by a photodetector using multiple light sources having at least three separate and independent wavelength ranges and with each of the absorption readings taken at a separate instant of time. Using at least one processor and calibration information of the liquid assay, an amount of at least two analytes within the liquid assay using the multiple absorption readings is determined.

Abstract: 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.

Abstract: Disclosed is a measurement method for a glycated hemoglobin ratio. According to a measurement method for a glycated hemoglobin ratio of the present invention, reagents are easy and convenient to use because of their sequential leakage during the rotation of a cassette, are all discharged by the rotation with no remaining reagent, and are not mixed with each other. Therefore, measurement results are accurate, with fewer errors in the quantities of used reagents and sample blood.

Abstract: Provided is a method for identifying pregnancy failure in a subject, the method comprising determining a concentration of at least one element of fetal or embryonic origin in the vaginal fluid of the subject; and comparing the concentration of the at least one element of fetal or embryonic origin to a reference value, wherein when the concentration of the at least one element of fetal or embryonic origin in the vaginal fluid is higher than the reference value, pregnancy failure is indicated.

Abstract: Described herein are systems and methods for the quantitative analysis of a sample comprising glycated hemoglobin. Also described herein are systems and methods for assaying a sample to quantitatively determine the percentage of glycated hemoglobin in the sample, for example, in a blood sample. The methods and systems described herein may be used in a point-of-care device as well as in other in vitro diagnostic devices.

Abstract: A stimulus-responsive gel material includes: a first polymer having an OH group; a second polymer having a phenylboronic acid structure; fine particles having an average particle diameter of 10 nm or more and 1000 nm or less; and a solvent, wherein the material is capable of being put into a first state in which the OH group of the first polymer and the phenylboronic acid structure of the second polymer are bonded to each other, and a second state in which the bond between the OH group of the first polymer and the phenylboronic acid structure of the second polymer is dissociated, and the wavelength of a reflected light from the material is different between the first state and the second state.

Abstract: 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.

Abstract: Methods and catalyst compositions for formation of furans from carbohydrates. A carbohydrate substrate is heating in the presence of a 2-substituted phenylboronic acid (or salt or hydrate thereof) and optionally a magnesium or calcium halide salt. The reaction is carried out in a polar aprotic solvent other than an ionic liquid, an ionic liquid or a mixture thereof. Additional of a selected amount of water to the reaction can enhance the yield of furans.

Abstract: Methods of conducting an assay for measuring enzymatic modification of a substrate by a glycoprotein having enzymatic activity are provided. The methods include concentrating the glycoprotein having enzymatic activity by capturing the glycoproteins from the input sample on a solid support, washing the glycoproteins captured on a solid support to remove unbound portions of the input sample, adding an enzyme substrate to the output sample comprising glycoproteins having enzymatic activity, and measuring enzymatic modification of the substrate. In some examples, the capturing of the glycoprotein and subsequent washing steps are performed in one or more droplets in oil.

Abstract: Systems and methods are provided for assessing the risk of hemolytic disease of the fetus or neonate, neonatal alloimmune thrombocytopenic purpura, or transfusion-associated lung injury in a patient or transfusion recipient.

Abstract: Provided is a method for assessing cardiovascular risk in Metabolic Syndrome and Type 2 Diabetes patients. The method involves obtaining data from a Type 2 diabetes patient or a Metabolic Syndrome patient and determining a Fayad/Schentag index which includes a Glucose Supply Index (S) to an Insulin Demand Index (D) ratio. The Fayad/Schentag index is used in scoring cardiovascular risks of Metabolic Syndrome patients and for recommending and implementing therapeutic interventions that can be shown to lower cardiovascular risk.

Abstract: A cartridge for measuring a concentration of a glycated protein in a wide measurement range, a system for measuring a glycated protein, and a method of measuring a glycated protein using same.

Abstract: A device adapted to determine an analyte concentration of a fluid sample using a test sensor. The device comprises a display adapted to display information to a user. The device further comprises at least one user-interface mechanism adapted to allow the user to interact with the device. The device further comprises a body portion including at least one opening formed therein, the at least one opening being of sufficient size to receive the test sensor. The device further comprises a memory adapted to store a plurality of stored analyte concentrations. The device further comprises a processing feature adapted to inhibit the stored analyte concentrations from being displayed on the display.

Abstract: Provided is a method and device for identifying glycated protein in a sample using a matrix including a boronic acid moiety that binds glycated proteins.

Abstract: 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.

Abstract: Described herein are systems and methods for assaying a sample to quantitatively determine the percentage of glycated hemoglobin in the sample.

Abstract: A method for analyzing hemoglobin by electrophoresis, capable of analyzing hemoglobin A1c (HbA1c) and modified hemoglobin with improved accuracy in a shortened analysis time is provided. The method for analyzing hemoglobin by electrophoresis includes performing electrophoresis under conditions in which an acidic substance having two or more carboxyl groups is present in an electrophoresis solution. At least two of the carboxyl groups of the acidic substance each have an acid dissociation constant (pKa) lower than the pH of the electrophoresis solution at the time of analysis.

Abstract: 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.

Abstract: Provided is a method and device for identifying glycated protein in a sample using a matrix including a boronic acid moiety that binds glycated proteins.

Abstract: 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.

Abstract: Hemoglobin in a sample solution is quickly and reliably denatured; at the same time, quick and accurate measurement of hemoglobin and a hemoglobin derivative is realized. In a method for measuring hemoglobin and a hemoglobin derivative, and a reagent composition, a measurement kit, an analysis device, and an analysis system used in the method, a sample solution containing a blood component is treated with a nonionic surfactant, an oxidizing agent, and a metal salt to denature hemoglobin in the sample solution to measure the hemoglobin, and thereafter the amount of a hemoglobin derivative in the sample is measured by an immunological method using an antibody specifically binding to a denatured site of the denatured hemoglobin derivative.

Abstract: The present invention provides, as a novel diagnosis marker for type 1 diabetes mellitus, a type 1 diabetes mellitus diagnostic composition comprising alanyl-tRNA synthetase, glycyl-tRNA synthetase, asparaginyl-tRNA synthetase, or tryptophanyl-tRNA synthetase, a diagnostic kit comprising the same, and a diagnostic method using the same. The composition, the kit, and the method, according to the present invention, may be used for early diagnosis and confirmed diagnosis of type 1 diabetes mellitus because type 1 diabetes mellitus can be easily diagnosed from a patient sample.

Abstract: 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.

Abstract: A method for measuring glycated hemoglobin includes hemolyzing a blood sample with a hemolysate; reacting the hemolyzed blood sample with bead conjugates in which beads are conjugated with glycated hemoglobin binding materials; measuring the amount of total hemoglobin in the reacted blood sample; isolating normal hemoglobin from the glycated hemoglobin conjugated with the bead conjugates; measuring the amount of glycated hemoglobin isolated from the normal hemoglobin; and determining the percentage of the glycated hemoglobin in the blood sample on the basis of the measured amounts of total hemoglobin and glycated hemoglobin. The isolation of normal hemoglobin is performed by absorbing the normal hemoglobin using an absorption pad that is a porous pad having pores, each of which has a size greater than the size of the normal hemoglobin and smaller than the size of the bead.

Abstract: A microfluidic device and a method for measurement of biomaterials using the same. The microfluidic device includes a microfluidic structure including: a sample chamber which receives and accommodates blood; a reagent chamber which contains a luminescent reactant; a first detection chamber which contains a first material that is positively charged; a second detection chamber which is connected to the first detection chamber, and contains a second material having a boronate moiety; and at least one channel which connects the sample chamber, the reagent chamber and the first and second detection chambers.

Abstract: Systems and methods for hemoglobin analysis. At least one embodiment of a stabilizing system comprises a stabilizing agent useful to completely or substantially prevent degradation or inactivation of a glycosylated hemoglobin (HbA1c) in a body fluid and a detection agent capable of detecting the HbA1c.

Abstract: A sample analyzer prepares a measurement sample from a blood sample or a body fluid sample which differs from the blood sample; measures the prepared measurement sample; obtains characteristic information representing characteristics of the components in the measurement sample; sets either a blood measurement mode for measuring the blood sample, or a body fluid measurement mode for measuring the body fluid sample as an operating mode; and measures the measurement sample prepared from the blood sample by executing operations in the blood measurement mode when the blood measurement mode has been set, and measuring the measurement sample prepared from the body fluid sample by executing operations in the body fluid measurement mode that differs from the operations in the blood measurement mode when the body fluid measurement mode has been set, is disclosed. A computer program product is also disclosed.

Abstract: Disclosed herein are antibodies, systems and methods for assessing the risk of hemolysis following a blood transfusion with crossmatch incompatible blood. The disclosure provides a method for determining the relative hemolytic index and therefore the risk of post-transfusion hemolysis for said patient.

Abstract: The present invention relates to a liquid chromatography apparatus X, which is provided with a deaerator 4. The liquid chromatography apparatus X is further provided with a dissolved oxygen density adjusting means for maintaining a density of dissolved oxygen in an eluting solution to be supplied to a column 60 constant. Preferably, the dissolved oxygen density adjusting means is configured so as to adjust the density of the dissolved oxygen in the eluting solution by adjusting a degree of decompression in a decompression space of the deaerator 4 based on a measurement result by temperature measurement means 40A, 40B, and 40C for measuring the temperature of the eluting solution.

Abstract: Disclosed relates to an electrochemical determination system of glycated proteins, the system comprising: a filtering means for filtering labeled compounds bound to glycated proteins and non-glycated proteins after adding labeling compounds, capable of selectively binding to the glycated proteins to a solution, in which glycated/non-glycated proteins coexist, to be bound all to the glycated proteins; and a quantifying means for quantifying the filtered labeling compounds, not bound to the glycated proteins. The system of the present invention filters the residual labeled compounds left after binding to glycated proteins to quantify, instead of directly quantifying glycated proteins via the known glycated protein determination methods, thus simplifying the configuration of the system that can provide exact determinations with a low cost.

Abstract: 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.

Abstract: 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, and peroxidase. The invention provides kits for performing the methods of the invention.

Abstract: At least one embodiment of a stabilizing system includes a stabilizing agent present in an amount or concentration sufficient to completely or substantially prevent or reduce degradation or inactivation of a glycosylated hemoglobin (HbA1c) in a body fluid and a detection agent capable of detecting the HbA1c.

Abstract: The present invention is to present a sample analyzer which is capable of respond immediately when a need to perform analysis of multiple items arises. The sample analyzer 1 includes a table 12 capable of holding a first rack 320 and a second rack 330; a reagent dispensing arm 120 which comprises a pipette part 121; a reagent dispensing driving section 120a for moving the reagent dispensing arm 120; a reagent barcode reader 350; and a control section 501 for controlling the reagent dispensing driving section 120a so as to move the pipette part 121 to a predetermined reagent aspirating position according to the identification information obtained by the reagent barcode reader 350.

Abstract: When the concentration of glycated hemoglobin is measured, a plurality of wavelengths are selected as measurement wavelengths from the wavelength range of 400 to 450 nm. Preferably, by use of a liquid chromatography, at least the light of different peak wavelengths in the wavelength range of 415 to 430 nm are continuously or intermittently received to obtain a three dimensional chromatogram having as variables the wavelength, the elution time and the amount of detection. The concentration of glycated hemoglobin is calculated based on this three dimensional chromatogram.

Abstract: A sample analyzer: measures a measurement sample including a sample and a reagent; creates a calibration curve based on first measurement data obtained by measuring a measurement standard sample including a standard sample and the reagent; provides calibration curve specifying information for specifying the calibration curve to the calibration curve; acquires an analysis result by processing second measurement data obtained by measuring the measurement sample based on the calibration curve; and stores the analysis result and the calibration curve specifying information provided to the calibration curve used in the process of the second measurement data in correspondence to each other.

Abstract: A method for storing a tetrazolium compound stably is provided. The tetrazolium compound is stored in the presence of sodium azide. The tetrazolium compound (A) and the sodium azide (B) are present at a ratio (A:B) in the range from 1:0.02 to 1:6.2. Furthermore, when the tetrazolium compound is stored as a solution, the concentration of the sodium azide is in the range from 0.08 to 3.2 mmol/L and the concentration of the tetrazolium compound is in the range from 0.5 to 8 mmol/L. As the tetrazolium compound, it is preferable to use 2-(4-iodophenyl)-3-(2,4-dinitrophenyl)-5-(2,4-disulfophenyl)-2H-tetrazolium salt.

Abstract: The present disclosure provides a device for simultaneously detecting hemoglobin and glycohemoglobin in blood. The device includes a lateral flow assay strip, a laser-induced epifluorescence detection device, and an LED detection device. The present disclosure further provides a method for simultaneously quantifying hemoglobin and glycohemoglobin in blood by an immunological method using the same.

Abstract: Stabilizers for colorants used for detection of enzymatic reactions, having a cyclodextrin and a catalase; reagents including stabilizers; and methods of use of such stabilizers and reagents.

Abstract: This application is directed to methods for improving glucose control by administering metformin in combination with a DPP-IV inhibitor to a patient in need thereof, in an amount sufficient to control the glucose level over an extended period of time.

Abstract: The present invention provides a method of measuring a glycated protein in a sample using a redox reaction, by which the glycated protein can be measured accurately with high sensitivity. In order to remove a glycated amino acid present in the sample other than the glycated protein, the glycated amino acid is degraded in advance by causing a fructosyl amino acid oxidase to act thereon, and thereafter, a fructosyl amino acid oxidase is caused to act on the glycated protein in the presence of a tetrazolium compound and sodium azide to cause a redox reaction. The amount of the glycated protein is determined by measuring the redox reaction. As the glycated protein, glycated hemoglobin is preferable.

Abstract: The present invention relates to a method and an apparatus that measure the concentration of glycated hemoglobin by an optical technique. A wavelength in which the molecular extinction coefficient of oxyhemoglobin agrees or substantially agrees with the molecular extinction coefficient of deoxyhemoglobin is adopted as a measurement wavelength. Preferably, the measurement wavelength is set at from 417 to 421 nm. In the present invention, the concentration of glycated hemoglobin is measured by making use of column chromatography and of using a sample prepared from red blood cells in blood.

Abstract: A method of measuring HbA1c is provided that, even with a whole blood sample after storage, measurement accuracy substantially equal to a whole blood sample right after collection can be maintained. Whole blood is stored in a presence of a glycolytic inhibitor and protease is added to the stored whole blood sample to cleave hemoglobin in the whole blood sample. Then a glycated part of a hemoglobin fragment thereby obtained is treated with fructosyl amine oxidase. Thereafter, a glycation degree of HbA1c is determined by measuring a redox reaction between the glycated part and the fructosyl amine oxidase. Further, instead of storage of the whole blood in a presence of the glycolytic inhibitor, a strong electrolyte substance such as KCl, K2SO4, KNO, NaCl, Na2SO4, NaNO, MgCl2, MgSO4, Mg(NO)2, etc. is added to the whole blood after storage and a protease treatment is performed in a presence of the strong electrolyte substance.

Abstract: A method and apparatus to estimate the concentration of a non-fluorescent substance (e.g. haemoglobin) in a fluorescent assay by separately estimating the non time dependent alteration attributed to inherent filter effects from the time dependent alteration caused by the assay chemistry. Such a method obviates the requirement for a separate photometric or other measurement thereby simplifying the methodology and associated instrumentation.

Abstract: Systems and methods for hemoglobin analysis. At least one embodiment of a stabilizing system comprises a stabilizing agent useful to completely or substantially prevent degradation or inactivation of a glycosylated hemoglobin (HbA1c) in a body fluid and a detection agent capable of detecting the HbA1c.

Abstract: Molecular bioprofiles comprising biologically correlated and relevant analytes that impact the biological state of a human health condition compared to a control population are provided. These molecular bioprofiles are useful in several ways including but not limited to, monitoring a disease or condition's progression, evaluating the impact of an agent or compound on a disease or condition, evaluating the impact of a lifestyle change on a disease or condition and assessing the risk of the disease or condition to a subject. Type II diabetes molecular bioprofiles are of particular interest.

Abstract: 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.

Abstract: The present invention provides a method of pretreating a sample containing a glycated amine as an analyte, thereby enabling highly reliable measurement of a glycated amine. A glycated amino acid in the sample is degraded by causing a fructosyl amino acid oxidase (FAOD) to act thereon, and thereafter, a FAOD further is caused to act on the glycated amine as the analyte in the sample to cause a redox reaction. The amount of the glycated amine is determined by measuring the redox reaction. The substrate specificity of the FAOD caused to act on the glycated amino acid may be either the same as or different from that of the FAOD caused to act on the glycated amine. When using the same FAOD, a FAOD is caused to act on the glycated amino acid to degrade it, and thereafter, the sample is treated with a protease to inactivate the FAOD and also to degrade the glycated amine.

Abstract: The present invention provides a method of pretreating a sample containing a glycated amine as an analyte, thereby enabling highly reliable measurement of a glycated amine. A glycated amino acid in the sample is degraded by causing a fructosyl amino acid oxidase (FAOD) to act thereon, and thereafter, a FAOD further is caused to act on the glycated amine as the analyte in the sample to cause a redox reaction. The amount of the glycated amine is determined by measuring the redox reaction. The substrate specificity of the FAOD caused to act on the glycated amino acid may be either the same as or different from that of the FAOD caused to act on the glycated amine. When using the same FAOD, a FAOD is caused to act on the glycated amino acid to degrade it, and thereafter, the sample is treated with a protease to inactivate the FAOD and also to degrade the glycated amine.