Abstract: Analytical reagent reaction vessel and method for performing sequential analytical assay procedures to determine an analyte in a liquid test sample. The reaction vessel is in the form of a closed container having a substantially horizontal axis of rotation and incorporated with one or more analytical reagents for performing a desired analytical assay procedure. The reaction vessel is designed to provide free gravitational movement of a liquid test sample disposed therein. The analytical reagents are incorporated into the reaction vessel such that they are contacted with a liquid test sample in a desired order or sequence. A liquid test sample disposed in the reaction vessel is capable of being manipulated therein by rotating the reaction vessel about the horizontal axis wherein the liquid test sample is transported by gravity.

Abstract: An analytical method for determining the relative amount of a particular hemoglobin derivative, e.g., glycated hemoglobin, in a blood sample wherein the amounts of both total hemoglobin and the hemoglobin derivative are measured and related mathematically, e.g., as a percentage. The blood sample is treated with the combination of a thiocyanate salt and an oxidant to denature the hemoglobin in the sample and to convert hemoglobin to met-hemoglobin. Met-hemoglobin is measured spectrophotometrically to give the amount of total hemoglobin present, and the denatured hemoglobin derivative can be distinguished and measured by immunoassay. The presence of the oxidant in the denaturant solution has been found to increase the rate of enaturation of hemoglobin thereby reducing the overall assay time and improving the reliability of the determination.

Abstract: The invention relates to a device for sampling and analyzing blood. It comprises an auto-pricker (1), a magazine (2) for strips, these strips comprising a reactive zone, and a reflectometer (6). Moreover, the magazine (2) is integral with the auto-pricker (1) and the device comprises means (7, 8) enabling the reflectometer (6) and the auto-pricker (1) to be made integral at rest.

Abstract: An article of manufacture comprising a blood-collection tube containing an acid such as citric acid in an amount effective to adjust the pH of the blood to be collected in the tube to a level between 5.0 to 7.0. The blood-collection tube may also contain NaF in an amount to produce a concentration thereof between 0.1 to 0.5 mg/ml of the blood.

Abstract: A semiconductor device and a method of making a semiconductor device including a semiconductor substrate of p-type conductivity, a first semiconductor region of n.sup.+ -type conductivity selectively formed on the semiconductor substrate, a second semiconductor region of n-type conductivity formed insularly contacting on the first semiconductor region, a groove extending from a surface of the second semiconductor region spaced from the first semiconductor region to the vicinity of a surface of the first semiconductor region abutting the second semiconductor region, a conductive material charged into the groove, and a third semiconductor region of high impurity n-type conductivity disposed so as to connect a bottom of the groove with the surface of the first semiconductor region, whereby the conductive material in the groove and the third semiconductor region are used as low resistance current paths reaching from the surface of the second semiconductor region to the first semiconductor region.

Abstract: A method and apparatus for adsorption and detection of adsorbents or analytes. The method and apparatus can be employed in the field for rapid adsorption of analytes and is particularly useful for detection of mycotoxins. A sample to be analyzed is prepared in solution and placed in a test tube. A tube-like adsorption column having a seal and a valve member is forcefully fed into the test tube to force solutions through the valve member into the column and through a filter and adsorbent to trap interference. The semi-purified solution may then be analyzed for the presence of analytes. The column with the purified solution may be further employed with a second smaller adsorption column similarly equipped with a seal and valve member fitting within the first column. In similar fashion the second column may be forced into the first column to expel the solution therein into the second column and through one or more selective adsorbents for different analytes such as one or more mycotixins.

Abstract: A process for measuring the amount of stable-type glycated hemoglobin in a sample using high performance liquid chromatography, comprising heating a sample diluted with a hemolysis agent containing a reagent for the removal of unstable-type glycated hemoglobin to achieve the removal of the unstable-type glycated hemoglobin, and analyzing the sample by high performance liquid chromatography.

Abstract: Methods of preparing glucitollysinehemoglobin from a sample of glucohemoglobin containing stable and labile glucohemoglobins and for assaying for the presence of stable glucohemoglobin are disclosed, as is a diagnostic assay system useful for carrying out the methods.

Abstract: A method for determining the percentage of glycosylated hemoglobin in the total hemoglobin of a blood sample includes binding of both glycosylated and nonglycosylated hemoglobin competitively to a nonspecific binder for hemoglobin affixed to a dipstick and reacting the glycosylated hemoglobin with a dihydroxyboryl reagent conjugated to a fluorescent dye. When the binding and reacting steps are complete, the dipstick is washed and its color is measured by absorption of incident light having a wavelength within the absorption range of hemoglobin as an indication of total hemoglobin in the sample. Incident light having a wavelength within the absorption range of the dye is then applied to the dipstick and fluorescence from the dipstick is measured as an indication of glycosylated hemoglobin. The measurements may be made with a reflectometer capable of computing the percentage of glycosylated hemoglobin in the sample from the color and fluorescence measurements.

Abstract: A latex agglutination immunoassay method for determining an analyte in a blood sample in which the pH of the reaction mixture is maintained at about 8.5 or greater in order to overcome nonspecific agglutination of latex particles by hemoglobin present in the sample. The method is particularly applicable to the determination of glycated hemoglobin, e.g., Hb Alc. In another embodiment, native hemoglobin (Ao) can be determined based on its ability to cause agglutination of latex particles suspended in an aqueous solution having a pH of about 8 or below.

Abstract: For the diagnosis of diabetes, a glucosylated protein in a sample is measured by subjecting the sample to a reducing treatment and then detecting a compound, which contains one or more reduced glucosylated lysine residual groups, in accordance with an immunoassay technique in which the reduced glucosylated lysine residual groups are used as an epitope.

Abstract: A historical time series analysis is obtained from a single sample of blood by measurement of hemoglobin and an altered hemoglobin, for example, glycohemoglobin, on a cell-by-cell basis. The results are compared by ratio of glycohemoglobin to hemoglobin on a cell-by-cell basis. Since the alteration of hemoglobin is continuous and irreversible, the ordered set of ratios represents a time-series of the cells, and any deviation from normal will be readily apparent A time-series can also be derived for other constituents, the time-series representing historical data of the other constituents in the person from whom the blood sample was taken.

Abstract: The invention disclosed relates to an electrochemical assay which is particularly concerned with an assay for the presence of, or amount of, glycosylated haemoglobin in a blood sample, but which extends to a general assay for detecting the presence of, monitoring the level of or determining the concentration of compounds containing cis-diol groups, such as glycols, nucleic acid components, sugars, polyols, catechols and glycosylated proteins.When ferrocene boronic acid or a derivative thereof is present free in solution, it can act as a mediator for a wide range of oxido-reductases. However in the presence of, for example, sugars containing the cis-diol structure, the metallocene (such as ferrocene boronic acid) covalently binds to the sugar. When the ferrocene boronic acid is thus bound, it is essentially immobilized and its properties as a mediator and ability to diffuse will be markedly affected.

Abstract: An optical waveguide with one or more coatings of reactants specific to species to be analyzed in a liquid analyte immersed therein. A light signal carried by the waveguide undergoes interaction either with the bulk analyte whereby a first signal in connection with the bulk analyte is obtained and, simultaneously, with a layer of complex resulting from the reaction of one of said specific reactant with one of said species or with two or more complex layers corresponding to two or more of said species, this generating a second (or more) signal to provide the required analytical information on said species.

Abstract: A method for determining glycosylated hemoglobin in a diluted blood sample includes binding of glycosylated hemoglobin to a specific monoclonal antibody and binding of nonglycosylated hemoglobin to a polyclonal antibody. The polyclonal antibody binds to all hemoglobin fractions and blocks the peroxidase activity thereof, except glycosylated hemoglobin bound to the monoclonal antibody which retains peroxidase activity. A beam of light having a wavelength of about 416 nm is passed through the assay medium and is absorbed by all hemoglobin fractions, bound or unbound, and this absorbance thereby provides a measure of total hemoglobin. Hydrogen peroxide and a peroxidase substrate are added. The substrate is oxidized by the peroxide to a product having an absorbance at a wavelength different from 416 nm, the oxidation being catalyzed by the retained peroxidase activity of the bound glycosylated hemoglobin. This absorbance provides a measure of glycosylated hemoglobin.

Abstract: Epitope-specific reagents in the form of receptors that bind to hapten-modified proteins and do not bind to unmodified proteins, methods of their preparation and use, along with diagnostic systems for measuring the presence and amount of hapten-modified protein in an assayed sample are disclosed. In particular, monoclonal antibodies that bind reduced glycosylated proteins (for example, reductively glucosylated proteins including human plasma lipoproteins), but do not react with non-reduced glycosylated proteins, reduced non-glycosylated proteins or non-reduced non-glycosylated proteins are produced and utilized.

Abstract: The unit consists of a cuvette and light guiding means comporting more than one waveguide element in contact with the solution to be analyzed. During operation, signals issuing from said waveguide elements provide data on two or more parameters in the solution substantially simultaneously.

Abstract: A device and method for determining characteristics of a fluid sample using optical measurements and changing the optical density range of a sample, e.g., for the second of two required measurements.

Abstract: The present invention provides a process for the determination of the hemoglobin-haptoglobin complex in the presence of free hemoglobin by utilization of the different peroxidate properties of free and of bound hemoglobin, wherein, for the selective inhibition of the peroxidase activity of the free hemoglobin, a detergent is added and the residual peroxidate activity of the reaction mixture is measured.The present invention also provides a reagent for carrying out this process wherein, besides the substances required for the determination of the peroxidase activity, it contains a detergent for the inhibition of the peroxidase activity of free hemoglobin.Furthermore, the present invention provides a process for determining the haptoglobin content of a sample, as well as a process for determining glycosilated hemoglobin in a sample.

Abstract: A method is provided for determining the percentage of glycohemoglobin in patient whole blood. The method comprises subjecting total hemoglobin comprising non-carbohydrate fixed hemoglobin and glycohemoglobin of samples of (1) patient whole blood lysate P and (2) whole blood lysates K.sub.1 and K.sub.2 of known glycohemoglobin percentages %.sub.1 and %.sub.2, to batchwise selective adsorption on an adsorbent which is specific either for the hemoglobin or for the glycohemoglobin, thereby adsorbing each sample under the same conditions and leaving in solution the corresponding non-adsorbed total hemoglobin fractions P.sub.f, K.sub.1f and K.sub.2f. The ratios R.sub.p, R.sub.k1 and R.sub.k2 of the optical density of the total hemoglobin fractions P.sub.f, K.sub.1f and K.sub.2f to the respective optical density of total hemoglobin aliquot samples of lysates P, K.sub.1 and K.sub.2 are measured, and the percentage of glycohemoglobin relative to total hemoglobin for each patient blood sample is calculated.

Abstract: An immunoassay method and reagent system for determining nonenzymatically glucosylated proteins and protein fragments in a biological fluid based on the specific binding of such proteins and fragments with anti(Amadori-rearranged glucose), e.g., antibodies which selectively recognize the rearranged deoxyfructose form of glucose resulting when proteins are nonenzymatically glucosylated. The antibodies are raised against an immunogen comprising an immunogenic carrier material bearing 1-deoxy-1-fructosyl residues or conformers of such residues. Measurement of nonenzymatically glucosylated proteins and fragments thereof provides a useful index of blood glucose levels.

Abstract: A reagent and improved process for the determination of D-glucose in body fluids by reaction with ATP in the presence of hexokinase, glucose-6-phosphate dehydrogenase, NADP, Mg.sup.++ ions and buffer and measurement of the NADPH formed. The improved process requires, before reaction with ATP, the mixing of the whole blood with a reagent which is composed of 0.01 to 0.5% weight/volume of an alkyl sulphate or sulphonate or of an alkyl-aryl sulphonate wherein the alkyl moiety is C.sub.8 to C.sub.32 and optionally contains one or more hydroxylalkylamino radicals as substituents and/or is interrupted by one or more ether oxygen atoms and the alkyl-aryl radicals having C.sub.8 to C.sub.18 alkyls and optionally a preserving agent.

Abstract: A control material for use in the determination of glycosylated and total hemoglobin, and a method of preparing the same, are disclosed. The control is prepared by the steps of hemolyzing red blood cells, preferably in the presence of a detergent, followed by removal of stroma and lipids from the hemoglobin with an organic solvent such as toluene in the presence of a polyhydroxy compound such as sucrose. A hemoglobin-rich fraction is separated from the resulting mixture and dialyzed against a solution of a polyhydroxy compound. The dialysate may be lyophilized to provide a stable, dry product suitable for reconstitution.

Abstract: An in vitro method for identifying alcoholism and alcohol abuse in humans is disclosed which comprises the isolation and measurement of a unique and stable form of glycosylated hemoglobin.

Abstract: Artificially constituted storage-stable hemoglobin compositions for use in the temperature correction of a cation exchange column chromatographic assay for hemoglobin A.sub.1 or A.sub.1c in a sample of human blood. The relative amounts of hemoglobin components in the composition conform approximately to the following formula:______________________________________ y = mx + b where y = weight percent A.sub.1c with respect to A.sub.1 x = weight percent A.sub.1 with respect to total hemoglobin m = -1.7 and b = 85 when x < 10, and m = -1.2 and b = 80 when x > 10. ______________________________________The compositions when analyzed in a cation exchange assay produce a result which varies with temperature in substantially the same manner as that from a true sample of human blood.

Abstract: A process for the determination of glycosilated hemoglobin in a blood sample comprises liberating glycosilated and non-glycosilated hemoglobin from the erythrocytes by chemical or physical treatment; converting, if desired, the hemoglobin into methemoglobin, and thereafter differentiating the glycosilated and non-glycosilated hemoglobin portion using its reaction with haptoglobin, and determining the glycosilated and/or the non-glycosilated hemoglobin portion.The present invention also provides a reagent for the determination of glycosilated hemoglobin in a blood sample, as well as a reagent for the differentiation of glycosilated and non-glycosilated hemoglobin, comprising haptoglobin.

Abstract: Method and apparatus for separating and measuring the amount of the glycosylated hemoglobin fractions in a blood sample. The method and apparatus provide a means for lysing sample red blood cells and, in the same container, separating the glycosylated hemoglobin fractions from the other residual hemoglobin fractions through the utilization of a polymeric material.

Abstract: An ion exchange method for the separation of hemoglobin A.sub.1 from its Schiff base precursors and from nonglycosylated hemoglobin in a sample of human blood. The known method of lysing the sample, using it to impregnate a weak cation exchange resin, eluting out the glycosylated components with a buffer solution containing from about 0.6 M to about 0.11 M alkali metal ion dissolved therein, and recovering the eluate, is modified by the inclusion of a dihydroxyboryl compound in either the hemolysate, the elution buffer, or both.

Abstract: An ion-exchange system and method is provided for isolating glycosylated hemoglobin (Hb A1) from other hemoglobins in human blood together with a quantitative determination of glycosylated hemoglobin. Separation of the glycosylated hemoglobin is accomplished by the ion-exchange system with little temperature dependence in the range of from about 15.degree.-37.degree. C. and without rigid control of pH and ionic strength. The ion-exchange system lowers the pH of the human blood to about pH=6.9 through the use of a zwitterionic buffer. The ion-exchange system also contains a cation-exchange resin. The preferred composition of the ion-exchange system contains about 0.05 molar 3-(N-morpholino)propanesulfonic acid as the buffer and carboxymethyl dextran as the ion-exchange resin present in an amount of from about 30 milliequivalents to about 50 milliequivalents of binding capacity per liter thereof.

Abstract: An improved process for determining glycosylated hemoglobin wherein the contribution of unstable glucose-aldimine-hemoglobin compounds to the HbA.sub.1 value is substantially eliminated by reacting the hemolysate with a primary amine and a hydrazine compound and thereafter subjecting the hemolysate to chromatography. The process enables reliable evaluation of the HbA.sub.1 value as a long-term parameter in diabetic metabolism control.

Abstract: An ion exchange method and kit for the separation of hemoglobin A.sub.1c from other hemoglobin components in a sample of human blood. The sample is lysed, then used to impregnate a weak cation exchanger. Two buffer solutions are then passed through the column in succession, the first having an alkali metal ion concentration of from about 0.02M to about 0.05M and the second having an alkali metal ion concentration of from about 0.06M to about 0.11M. The second eluate contains substantially all of the hemoglobin A.sub.1c and substantially none of the other hemoglobin components in the original sample. Analysis of the second eluate thus provides a reliable indication of the long-term glucose level in the blood of a patient, and hence the patient's ability to regulate the quantity of glucose ingested. The hemolysate with the Schiff base precursor is introduced directly to the chromatographic column.

Abstract: A method of measuring glycosylated hemoglobin featuring, in one aspect, providing a sample containing hemoglobin, including an unknown amount of glycosylated hemoglobin, contacting the sample with an oxidizing agent to generate formaldehyde, and measuring the formaldehyde as a measure of glycosylated hemoglobin, the measuring being carried out by reacting the formaldehyde with a water-soluble amine or an ammonium salt and a .beta.-diketone to generate a fluorescent compound whose fluorescence is measured as a measure of glycosylated hemoglobin.