Abstract: An apparatus, comprising at least separating means (1) for separating blood plasma and red blood cells, which separating means (1) comprise pressure means (20) for pressing at least a part of the blood through a filter (26), wherein at least first collecting means (27) are provided for collecting separated blood plasma and at least one reagent is provided in said first collecting means (27) or can be introduced therein for reaction with substances or organisms present in said blood plasma.

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

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: The present invention provides methods for quantitation of glycated protein in a biological sample using a solid support matrix by making a first bound protein measurement total bound protein under conditions where both glycated and non-glycated protein bind to the support in making a second bound protein measurement under conditions where glycated protein is bound to the support and non-glycated protein is not substantially bound.

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 method for predicting treatment response of a type II diabetes patient to rosiglitazone is provided. The method involves at least one sample from a patient having type II diabetes and analyzing biomarkers predictive of a patient who will respond to treatment with rosiglitazone. The biomarkers include, at least, interleukin-8, histidine, citrate. These biomarkers are identified in at least one classification analyses selected from the group consisting of a majority-vote based classifier and support-vector machine (SVM) classifier. Also provided is a method for predicting treatment response of a type II diabetes patient to glyburide at 8 weeks post-initiation of therapy. The method involves obtaining a sample from a type II diabetes patient who has been treated with glyburide for about 4 weeks and analyzing biomarkers predictive of a patient who will respond to treatment with glyburide at 8 weeks. The biomarkers useful in this method include, at least, sphingomyelin 23:1 and L-phenylalanine.

Abstract: Novel methods for assessing the state of a diabetic condition of a subject are described, comprising determining the amount of a metabolite in a sample from a body fluid or tissue of the subject. The methods may be used, for example, in diagnosing and monitoring insulin resistance, prediabetes, or the response to a drug which alters a diabetic condition.

Abstract: A new method of diagnosing postprandial hyperglycemia by indirectly measuring a blood glucose level is provided. Postprandial hyperglycemia is detected by measuring a glycation degree of lysine in hemoglobin, in which a side chain amino group of lysine is glycated (GHbLys %). Measurement of GHbLys % can be performed by cleaving hemoglobin by protease, treating a glycated part of a lysine residue in the obtained cleavage product of hemoglobin with fructosyl amino acid oxidase, and measuring a redox reaction between the glycated part and fructosyl amino acid oxidase.

Abstract: The present invention provides methods for quantitation of glycated protein in a biological sample using a solid support matrix by making a first bound protein measurement total bound protein under conditions where both glycated and non-glycated protein bind to the support in making a second bound protein measurement under conditions where glycated protein is bound to the support and non-glycated protein is not substantially bound. Diagnostic devices and kits comprising the methods of the present invention are also provided.

Abstract: 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.

Abstract: An analytical test element for blood analyses is provided having an application site and a microfluidic channel structure in fluid communication with the application site. The channel structure includes at least first and second analytical channels for receiving first and second portions of a blood sample applied to the application site. The first analytical channel includes a first analytical site to determine the total haemoglobin value (Hb) of the blood sample. The second analytical channel includes a second analytical site to determine a glycohaemoglobin value (HbA1c) of the blood sample.

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: Disclosed is a method for testing a modified specimen such as a dried blood spot, plasma or serum specimen, for an analyte of interest, such as cholesterol. In accordance with the disclosed subject matter, the level of the analyte of interest in the medium from which the modified specimen was obtained (e.g., from a patient's blood) is determined based on the level of an analyte in a solution formed from the modified specimen and on the level of at least one normalizing analyte. The analyte and normalizing analyte each may be an ion, compound, biochemical entity, or property of the specimen. Also disclosed are a fluid collector and a fluid collection device.

Abstract: 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.

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 fractionating components of a sample are disclosed herein. A method of fractionating components of a sample includes establishing a solution density gradient in a capillary channel, applying the sample to the capillary channel, and centrifuging the sample in the capillary channel, thereby separating the components of the sample by density.

Abstract: Standard reference materials and related methods are described for quality testing and calibration of instruments used for the qualitative and quantitative determination of hemoglobin and glycated hemoglobin as well as other analytes of interest in animal tissue samples. The reference solutions of the disclosure utilize a synthetic cruor in combination with an Hb peptide chain.

Abstract: The presently disclosed subject matter provides methods of diagnosing retinal disorders in subjects by measuring hemoglobin and modified hemoglobin in the subjects. The presently disclosed subject matter further provides methods of treating retinal disorders in subjects by decreasing hypoxia in retinal tissue of the subjects through modulation of hemoglobin levels and activities in the retinal tissue.

Abstract: An object of the present invention is to provide a hydrophilic polymer microparticle which shows reduced swelling in an aqueous medium and has an excellent dispersibility in an aqueous medium, a filler for ion-exchange liquid chromatography which can effectively suppress non-specific adsorption of protein and the like, a method for analyzing glycosylated hemoglobin using the filler for ion-exchange liquid chromatography, a method for production of a filler for ion-exchange liquid chromatography that can maintain suppressive effects on swelling, non-specific adsorption and the like for a long period of time, a filler for ion-exchange liquid chromatography produced by the method for production of a filler for ion-exchange liquid chromatography, and a filler for ion-exchange liquid chromatography for glycosylated hemoglobin analysis. The present is a hydrophilic polymer microparticle, which has a DW/DA ratio of 2.

Abstract: Disclosed is a method for testing a modified specimen such as a dried blood spot, plasma or serum specimen, for an analyte of interest, such as cholesterol. In accordance with the disclosed subject matter, the level of the analyte of interest in the medium from which the modified specimen was obtained (e.g., from a patient's blood) is determined based on the level of an analyte in a solution formed from the modified specimen and on the level of at least one normalizing analyte. The analyte and normalizing analyte each may be an ion, compound, biochemical entity, or property of the specimen. Also disclosed are a fluid collector and a fluid collection device.

Abstract: An analytical test element for blood analyses is provided having at least a substrate body having a channel structure for the flow transport of a blood sample from an application site to at least one analytical site. The channel structure has a dilution channel that can be loaded with the blood sample and is provided with a separation component for retaining corpuscular blood components and has a sample channel which conveys a blood sample aliquot to be diluted and joins the dilution channel at a mixing site.

Abstract: Disclosed are cellular hemoglobin A1c (Hb A1c) normal and abnormal (high) controls for use in detecting Hb A1c levels. The present invention also relates to methods for generating cellular Hb A1c controls using red blood cells and methods for using the cellular controls. The present invention encompasses several methods for the preparation of Hb A1c cellular controls including: (1) a boronate method where the glycation occurs non-specifically; (2) a stabilized diabetic blood method where the glycation occurs specifically on Hb A1c, and (3) the glycation of normal blood method that is achieved by controlling conditions such that glycation occurs predominantly on Hb A1c. These methods produce cellular Hb A1c controls with desirable stability and that can be detected on a variety of instruments.

Abstract: A device is described which provides an automated or manual means to perform chromatographic affinity-based A1c analyses of whole blood or hemolysates in less than 1 minute. Further, such applications are useful for the quantitation of glycated plasma proteins used in analysis of gestational diabetes. The device includes several modules integrated to accomplish processing and analysis of the blood sample. One such module includes a disposable liquid chromatographic column which may be rapidly packed and is easily assembled from readily available materials. Such columns and assemblies may be used in fluid chromatography applications requiring separations of complex materials for purposes of purification and/or quantitation of particular analytes. The columns may be used as stand-alone units or may be integrated into commercially available chromatography systems. The columns have a chemical composition and particle size that allow for low operational pressures.

Abstract: Improved methods and apparatus that make more accurate and reduces risk of filling reaction chambers of cartridge cells with blood samples to conduct blood coagulation tests of the type employing the plunger technique are disclosed. A cartridge holder is provided that secures a test cartridge in a fixed upright position and deflects the plunger flag of each cartridge cell to enable manual insertion of a blood dispenser deeply into the reaction chamber to fill the reaction chamber and avoid contamination of surfaces of the cartridge outside the reaction chamber. Preferably, the cartridge holder provides illumination of the reaction chamber during filling, so that the user can judge when the reaction chamber is properly filled with blood dispensed from the blood dispenser. The cartridge holder may incorporate image magnification to facilitate viewing of the reaction chamber as it is filled.

Abstract: 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 ?-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.

Abstract: A method of measuring an analyte in a sample with excellent sensitivity using a redox reaction is provided. In this method, a reducing substance or an oxidizing substance derived from the analyte is measured in the presence of a tetrazolium compound and sodium azide using the redox reaction, and an amount of the analyte is determined from the amount of the reducing substance or oxidizing substance thus measured. The tetrazolium compound and the sodium azide are present at a ratio in a range from 20:3 to 20:12. Preferably, a solution containing the tetrazolium compound and the sodium azide is aged and then added to the sample.

Abstract: The present invention provides methods for determining a ratio of an amount of a glycated form of a protein to a total amount of the protein in a sample containing the glycated protein, the glycosylated protein, or the glycoprotein. The method incorporates lateral flow test strip or vertical flow test strip devices having negatively charged carboxyl or carboxylate groups and hydroxyboryl groups immobilized and interspersed on a solid support matrix. The solid support matrix may include derivatives of cellulose (e.g., carboxy cellulose) derivatized with carboxylic acid (e.g., carboxylate, carboxyl) groups and hydroxyboryl compounds including phenylboronic acid (e.g., phenylborate), aminophenylboronic acid, boric acid (e.g., borate), or other boronic acid (e.g., boronate) compounds. The present invention is usefi.il for monitoring glycation or glycosylation of hemoglobin or albumin for monitoring glycemic control (e.g., glycemia in diabetes).

Abstract: The invention provides a system for quantitative measurement of percent glycated hemoglobin as hemoglobin A1c in whole blood having extended shelf life at room temperature. The system comprising a blood dilution solution and a device adapted for receiving at least a portion of diluted blood solution, for contacting the blood solution with a dry reagent system, for detecting a change in the reagent system and for providing an indication of the analytical result to the user, and the extended shelf life and the elimination of a requirement for refrigeration for storage is achieved by having the blood dilution solution which comprises a first surfactant for hemolysis and a second surfactant for stability. The system of this invention is useful in other analysis kits and systems as well.

Abstract: Novel bipyridyl-osmium complex conjugates and their use in electrochemical assays are described. The redox reversible-osmium complexes can be prepared to exhibit unique reversible redox potentials and can thus be used in combination with other electroactive redox reversible species having redox potentials differing by at least 50 millivolts in electrochemical assays designed for use of multiple electroactive species in the same cell and in the same sample without interference between the two or more redox coupled conjugate systems.

Abstract: 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.

Abstract: Disclosed is a testing device and methods for the identification of an analyte of interest in a sample. In a preferred embodiment, the testing device includes a front panel having at least one sample application aperture; a rear panel having at least one solvent application aperture; a sample collection matrix disposed between the rear panel and the front panel, the sample collection matrix being in communication with the sample and solvent application apertures of the front and rear panels; and at least one insertable test strip containing a reagent enabling detection of the analyte of interest.

Abstract: A method for determining if blood in a stool sample originated from the upper or lower gastrointestinal tract. This includes a method for purifying and concentrating hemoglobin and its products from a stool sample to allow a simple and sensitive spectrophotometric analysis. A rapid, noninvasive determination of whether the blood originated from an upper gastrointestinal or lower gastrointestinal site is made on the basis of changes in the absorption spectra of hemoglobin that occur when hemoglobin is exposed to a highly acidic environment.

Abstract: A method of measuring an analyte in a sample with excellent sensitivity using a redox reaction is provided. In this method, a reducing substance or an oxidizing substance derived from the analyte is measured in the presence of a tetrazolium compound and sodium azide using the redox reaction, and an amount of the analyte is determined from the amount of the reducing substance or oxidizing substance thus measured. The tetrazolium compound and the sodium azide are present at a ratio in a range from 20:3 to 20:12. Preferably, a solution containing the tetrazolium compound and the sodium azide is aged and then added to the sample.

Abstract: A method of determining Hb is provided, by which an amount of Hb can be determined easily and accurately without fear of damage to the environment. Hemoglobin in a sample is denatured with a tetrazolium compound to give denatured hemoglobin, and an amount of an optical change in the sample is measured at an absorption wavelength specific to the denatured hemoglobin. Using the amount of the optical change thus measured, an amount of the hemoglobin in the sample can be determined. The amount of the optical change preferably is measured at a wavelength in a range from 520 to 670 nm. According to this method, an amount of Hb can be determined with high accuracy as shown in FIG. 1.

Abstract: The object of the present invention is to quantify glycated albumin, by providing means for providing quantification data, which correlate to the data of the quantification of glycated albumin by the HPLC method, without producing any intercept which might complicate use of the means in clinical medicine in a case where a regression curve is plotted by using the corrective quantification method with use of enzymes.

Abstract: The present invention is directed to a novel method for measurement of glycated hemoglobin, as well as assay methods and processes that can be used outside the medical laboratory setting to determine the fraction of total hemoglobin that is glycated.

Abstract: The present invention is directed to a single test system and method for determining the integrated glycemic condition of a subject by measuring the concentration of glucose and the level of protein-bound glucose in a subject's body fluid, such as whole blood. The glucose concentration is indicative of the subject's immediate glycemic condition, whereas the protein-bound glucose concentration is indicative of either intermediate or long-term glycemic condition. Optionally, other analytes indicative of glycemic condition, such as ketone bodies or fatty acid derivatives, can also be measured. The present invention also provides a method of diagnosing diabetes. The invention additionally provides a method for analyzing the concentration of fructosamine in less than or equal to five minutes without the use of a reaction accelerator.

Abstract: A method of determining Hb is provided, by which an amount of Hb can be determined easily and accurately without fear of damage to the environment. Hemoglobin in a sample is denatured with a tetrazolium compound to give denatured hemoglobin, and an amount of an optical change in the sample is measured at an absorption wavelength specific to the denatured hemoglobin. Using the amount of the optical change thus measured, an amount of the hemoglobin in the sample can be determined. The amount of the optical change preferably is measured at a wavelength in a range from 520 to 670 nm. According to this method, an amount of Hb can be determined with high accuracy as shown in FIG. 1.

Abstract: Described is a method and apparatus for determining a diabetic patient's compliance with their insulin dosing regime. The method and apparatus involves taking a blood sample from a patient by a routine finger prick and placing it in a special sample tab which is placed in a spectrophotometer sample housing. The spectrophotometer measures Hb and HbA1c concentrations and allows for calculating a ratio of HbA1c to Hb which is indicative of the degree of patient compliance.

Abstract: A method and a system for separating glycated hemoglobin from non-glycated hemoglobin, and a method for one-read quantitative determination of the glycated hemoglobin and % HbA1c that does not require an additional measurement of total hemoglobin.

Abstract: A method and apparatus for automatically selecting test types for an analytical meter system based on the insertion into the meter of a test element. The test element can be an analytical element, formed by a test strip with a fluid such as blood applied thereto; a control element, formed by a test strip with control fluid applied thereto; or a standard element, or a standard strip exhibiting known optical properties. By inserting the test element into the analytical meter system, optical properties are measured and the existence of relationships between the measurements are ascertained. Based on the existence or nonexistence of certain relationships, the proper test can be automatically selected by the meter without the need for user interaction. Advantageously, the results of the test can be classified and stored according to test type.

Abstract: A method and a system for separating glycated hemoglobin from non-glycated hemoglobin, and a method for one-read quantitative determination of the glycated hemoglobin and %HbA1c that does not require an additional measurement of total hemoglobin.

Abstract: The invention concerns a novel method for the determination of the ratio of glycated to non-glycated haemoglobin in a sample wherein

Abstract: The present invention is directed to a novel method for measurement of glycated hemoglobin, as well as assay methods and processes that can be used outside the medical laboratory setting to determine the fraction of total hemoglobin that is glycated.

Abstract: Disclosed is a method for performing an analytical assay by providing a kit for collecting and storing a test sample, the kit including a sample collection device, a sample storage device, and a printed material having indicated thereon an electronic address for accessing the result of the assay; using the kit to collect a specimen from a test subject at a first location such as the subject's home or a health care provider's office; transporting the collected specimen to an off-site laboratory; analyzing the specimen at the off-site laboratory; and reporting the result of the analysis over a computer communications network such as the Internet.

Abstract: A glycated hemoglobin assay utilizes a simple procedure for the determination of standardized %GHb in whole blood samples correlated to the Diabetes Control and Complications Trial (DCCT). First, a lysed whole blood sample is incubated with a solid phase that is coupled with boronic acid or similar boronate compound through covalent linkage chemistries known in the art. Next, a labeled antibody to human hemoglobin is added and the resulting signal is directly proportional to the %GHb in the sample. The advantages of measuring %GHb using a single determination include high precision and, since the assay is easily automatable, high throughput. With automation, this assay can also be consolidated with other testing on one analyzer. The method according to the various embodiments of the invention thus eliminates the need for two measurements: one for GHb and another for total hemoglobin (THb).

Abstract: Filter paper absorbed with a solution of anticoagulant, e.g., ethylene diamine tetra-acetic acid (EDTA), then dried, useful for collection of a blood sample for analysis of hemoglobin or a hemoglobin fraction in the sample showed higher precision in standard assays than untreated filter paper. Methods of using the anticoagulant-treated filter paper are also described.

Abstract: A apparatus for assaying glycated proteins and other analytes in biological samples such as blood, in which a sample is presented to the apparatus, includes an inlet port between moveable between first and second inlets, such that the inlet can be brought into liquid communication with each inlet in turn. The inlet port accommodates a filter or binder. The apparatus also includes a microprocessor operable via a key pad, at least one light emitter and at least one light detector, a display and driver, and an A to D converter, and is operatively connected to a power source.

Abstract: Disclosed is a testing device and methods for the identification of an analyte of interest in a sample. In a preferred embodiment, the testing device includes a front panel having at least one sample application aperture; a rear panel having at least one solvent application aperture; a sample collection matrix disposed between the rear panel and the front panel, the sample collection matrix being in communication with the sample and solvent application apertures of the front and rear panels; and at least one insertable test strip containing a reagent enabling detection of the analyte of interest.

Abstract: For blood or other physiological fluid sample collection kits that use filter paper to collect the sample, the performance of the kit and associated analytical method can be improved by using a material having properties which are superior to those of standard filter paper or modified filter paper routinely used in standard biological assays. Certain materials currently available for uses other than blood collection, storage, or transport have properties that are advantageous as employed in assays of biological fluids, including the use of specific cellulose blotting materials for collecting blood samples for hemoglobin or hemoglobin A1c monitoring.