Abstract: This invention is a method for measuring the ability of a human to absorb cholesterol. The method uses two different cholesterol tracers, the first injected into the blood stream and the second ingested by the human subject. After a waiting period a blood sample is taken from the human subject and analyzed to determine percent cholesterol absorption based on the actual amounts of the two naturally occurring, metabolically stable cholesterol tracers in the blood. The method of this invention is useful in identifying human subjects as high cholesterol absorbers and thereafter administering therapeutic agents to the subject that inhibit the absorption of cholesterol.

Abstract: The present invention relates to a biosynthetic cerebrospinal fluid control and method of use. Additionally, this invention relates to the isolation and purification of stable liquid human prealbumin, a component in the biosynthetic cerebrospinal fluid control.

Abstract: Aqueous solutions containing buffers and electrolytes are adjusted to levels required for calibration of both blood gas analyzers and ion selective electrolyte analyzers. A control material, composed of similar matrix, is adjusted to three levels of blood gas and electrolyte conditions. These quality control materials are used to monitor blood gas/electrolyte laboratory instrumentation.

Abstract: A reagent blood coagulation that causes an increase in turbidity changes when added to a plasma sample containing a substance activating coagulation factor activating such as tissue thromboplastin, phospholipid and thrombin, calcium ion, and molecular substance such as high molecular vinyl and a high molecular polysaccharide. By adding a molecular substance to the reagent, the turbidity change due to blood coagulation is increased, and hence the changing quantity of transmitted light or scattered light increases, thereby making it possible to achieve a more accurate detection. Besides, by adjusting the electric conductivity, pH and osmotic pressure to proper values, the turbidity change due to blood coagulation may be further amplified.

Abstract: Described are control reagents useful in analyte determination. The reagents contain a known concentration or amount of the analyte to be assayed, and a polymer. The polymer is made up of monomers of either water soluble acrylic monomers, water soluble quaternary amines, or mixtures of these two types of molecules. Various control reagent formulations, as well as new polymers useful in control reagents, are disclosed.

Abstract: This invention primarily is directed to a hematology reference control solution, the three separate white cell control portions thereof consisting of three types of fixed red cells of determined size distribution for checking the operation of a particle analyzing instrument, including its predetermined lower and upper threshold settings for each class or subclass of leukocytes.For preparing a human granulocyte analogue, nurse shark erythrocytes are altered and fixed in a chilled solution to simulate in number, size and distribution the granulocytes in human whole blood.

Abstract: A multiple coagulation test device has a plurality of tubes, each tube having associated coagulation detection means, and containing a treatment dosage of a coagulation enhancing agent. Whole blood samples are placed in the tubes which are mixed and warmed to 37.degree. C., with the time to coagulation determined. The agent giving the lowest clotting time is selected as the most effective treatment for reducing hemorrhaging within a few minutes and the selected treatment begun. Utilizing the inventive device eliminates the need to use a multiple agent approach, by identifying the most effective course of action.

Abstract: The present invention provides a method for preparing and storing biological samples prior to measuring ionized Mg.sup.2+ concentrations in order to obtain accurate and reproducible readings. A novel method for accurately reading ionized magnesium ion concentrations in biological samples is provided. A method for monitoring ionized Mg.sup.2+ concentrations and ionized Ca.sup.2+ :Mg.sup.2+ ratios in a patient, useful in diagnosing and prognosing disease states including cardiopulmonary bypass surgery, hypertension, abnormal pregnancy, head trauma, and fetal abnormalities is provided as well as a composition and a method of treating a patient with ionized Mg.sup.2+ or ionized Ca.sup.2+ and Mg.sup.2+.

Abstract: Compositions, such as liquid therapeutic or diagnostic compositions, and methods for their preparation and involving their use. The compositions comprise an effective amount of gelatin from cold water fish skin as a protein base. The indicated gelatin provides many significant advantages and improvements, including for instance its high stabilizing effect on labile organic substrates included in the compositions, and its low temperature gelling properties which provide improved compositions which do not substantially gel during refrigeration. Further representative advantages relate to its behavior as a zwitterion thus reducing or eliminating needs for buffers, and its surprising behavior similar to human serum protein in protein analyses such as the biuret procedure.

Abstract: A standard solution containing thyroxine-binding globulin (TBG) and thyroxine or triiodothyronine dissolved in a buffer solution is used for calibration in a method for the determination of thyroxine (T.sub.4) or triiodothyronine (T.sub.3) in serum, wherein both human and bovine TBG can be used.

Abstract: The present invention provides an aqueous buffer solution and method and solution for hydrating and calibrating a sensor membrane of a fiber-optic catheter useful for measuring an analyte other than chloride in a physiological milieu. The temperature, gaseous atmosphere, and aqueous buffer solution of the sensor component are controlled throughout the calibration process in order to ensure that the device is calibrated in accordance with its intended use. The solution is chemically compatible with the intended use of the device and provides compensation for evaporative loss, contaminants, or changes in the solution occurring during storage especially in plastic containers.

Abstract: A hematology control product comprising leukocyte analogs is described. The analogs comprise red blood cells which simulate at least two physical properties of human leukocytes. A method for making leukocyte analogs from blood cells having desired physical properties is also described. The process comprises expanding the cell volume, changing the hemoglobin content of the cell and fixing the cell. Generally, the monocyte and lymphocyte analogs leak hemoglobin from the cell while the eosinophil analog has the hemoglobin precipitated in the cell. A further method is described to use the control product to determine whether an automatic instrument is operating within manufacturer's specification.

Abstract: A stable reference solution for calibrating and monitoring blood gas instrumentation is disclosed. The solution comprises an aqueous mixture containing a hemoglobin solution derived from a mammalian source which comprises at least about 95% reduced hemoglobin. The solution additionally contains a bicarbonate buffer and a metal catalyzed methemoglobin reducing system and an organic buffer. To provide a control element having a variety of properties similar to fresh, whole, human blood, the reference solution is stored in a sealed ampule under an inert atmosphere containing CO.sub.2 until just prior to use. The ampule is subsequently opened and the solution is equilibrated with a gas mixture having components which provide gasses in a physiological range to the solution. The solution is characterized by exhibiting properties similar to fresh blood subsequent to equilibration and an extended storage life prior to equilibration.

Abstract: A method for purifying human antithrombin III in an alcoholic solution at low temperature using bound heparin is provided.

Abstract: A blood serum sample useful as a calibration baseline comprising a natural blood matrix is disclosed. This serum sample contains less than an HPLC-detectable amount of cortisol. Also disclosed is a serum sample containing less than HPLC-detectable amounts of cortisone and corticosterone and less than RIA-detectable amounts of testosterone, androstenedione, progesterone, DHEA sulfate and 17-OH progesterone. A method of preparing such a serum sample is also disclosed.

Abstract: A method for control or calibration in a chemical analytical determination using a dry analysis element comprising at least one color-producing reagent and a porous layer, wherein the method comprises applying an aqueous dispersion onto the porous layer and measuring the optical density of the color produced, wherein the aqueous dispersion comprises a substance which is the same as or similar to an analyte to be determined and water-insoluble particles dispersed therein, wherein the particles are particles of a homopolymer, a copolymer, phthalates, trimellitates, phosphates, benzoates, amides, phenols, aliphatic esters, hydrocarbons, halogenated hydrocarbons, adipates, sebacates and natural polymers.

Abstract: A stable reference solution for calibrating and monitoring blood gas instrumentation is disclosed. The solution comprises an aqueous mixture containing a hemoglobin solution derived from a mammalian source which comprises at least about 95% reduced hemoglobin. The solution additionally contains a metal catalyzed methemoglobin reducing system, reference concentrations of selected electrolytes and an organic buffer. To provide a control element having a variety of properties similar to fresh, whole, human blood, the reference solution is stored in a sealed ampule under an inert atmosphere containing CO.sub.2 until just prior to use. The ampule is subsequently opened and the solution is equilibrated with a gas mixture having components which provide gasses in a physiological range to the solution. The solution is characterized by exhibiting properties similar to fresh blood subsequent to equilibration and an extended storage life prior to equilibration.

Abstract: Control reagents an oxidant or a hydroxylamine compound together with other ingredients, the most important of which is a known amount of the analyte for which the reagent acts as a control.

Abstract: A stable liquid control and/or calibration serum for use in clinical diagnostics containing a liquid-stable bilirubin derivative and a known concentration of at least one analyte. The invention further addresses a process for the preparation of the stable liquid serum.

Abstract: A method for determining the sensitivity and/or specificity of assays that detect the presence or absence of antibodies to viral and/or other microbial infective agents using porcine seroconversion panels, and production of the seroconversion panels is provided.

Abstract: Reference controls comprised of aldehyde-fixed white blood cells exhibiting a white blood cell histogram profile that is substantially that of whole blood are obtained by the additions of a lipoprotein to the control.

Abstract: A method for producing a liquid phase substance having a pre-established concentration of CO.sub.2 suitable for calibrating analytical instruments such as hemogasanalyzers consists in:preparing an aqueous solution of precisely known strength of a water-soluble salt of carbonic acid,then transferring said solution to a flow reactor containing a cation exchange resin in hydrogenionic form,passing the aforesaid solution of carbonic acid salt through the aforesaid cation resin,thereby achieving the reaction of producing a pre-established quantity of CO.sub.2, andtransferring the eluate thus obtained directly to the analytical instrument for calibration.

Abstract: A multi-phase control and/or calibration system consists of a liquid phase containing an amount of dissolved oxygen (O.sub.2) in which the O.sub.2 partial pressure is made relatively temperature insensitive over an ambient temperature range of interest, and an amount of dissolved carbon dioxide (CO.sub.2) and one or more solute species that provide temperature stability with respect to the partial pressure of CO.sub.2 over the ambient temperature range of interest. The liquid phase is in equilibrium with a vapor phase and the system sealed with a storage atmosphere.

Abstract: A method and system for controlling the concentration of one or more gaseous species of interest in a sample medium throughout a range of temperatures in which a temperature related, time variable dominant independent source of the gaseous species of interest is used to control the partial pressure of one or more gaseous species of interest contained in the sample medium in a manner such that the concentration of the gaseous species of interest in the sample medium remains essentially the same over the temperature range. The source of the gaseous species of interest comprises a reservoir containing an amount of a temperature sensitive source of the gaseous species of interest. The sample and the reservoir are contained in separate fluid-tight, gas-permeable enclosures further confined by a common substantially gas-tight enclosure.

Abstract: A colorimetric, particularly spectrophotometric, method and compositions for determining calcium levels in blood serum in the presence of magnesium and other serum ions is described. The method uses an aqueous composition with a pH between about 7.5 and 10 with arsenazo III to complex calcium and a hydroxyquinoline selected from the group consisting of 8-hydroxyquinoline and 8-hydroxyquinoline-5-sulfonate to complex magnesium. Lipase and a cyclodextrin can be used as reagents to clear triglycerides in the serum which can provide turbidity and false results in some instances. The method is particularly useful for human serum.

Abstract: A control solution for use with a porous reagent strip comprises a flexible semisolid polymer dispersed in water, such as polyvinyl acetate in distilled water, with appropriate control glucose concentration levels. This solution is useful in mimicking whole blood in conjunction with porous reagent strips to determine compliance of the strips and meters to established measurement and performance criteria.

Abstract: The treatment of blood or body fluid and body fluid samples to inactivate or destroy infective viruses, such as the cytomegalovirus, by mixing the sample with an effective amount of glycyrrhizic triterpenoid-detergent, glycyrrhizic triterpenoid-glycerol or glycyrrhizic triterpenoid-EDTA, combination followed by analysis or testing for diagnostic or other purposes is disclosed.

Abstract: Hydrogen peroxide stabilized in the presence of blood components by the addition of a metal oxide oxidant, an anionic chelating agent, particularly hydroxylic carboxylate and nitroprusside, and a catalase inhibitor. The composition finds particular application for stabilizing hydrogen peroxide in a diagnostic assay on a bibulous support.

Abstract: Blood coagulation factors are stabilized by addition of glycylglycine and/or glycylglycylglycine to blood or plasma in such an amount that they have no effect on a blood coagulation time.

Abstract: New internal standards for use in gas chromatography/mass spectrometry test methods, comprising deuterated cannabinoids, have been developed for the analysis of tetrahydrocannabinol and its metabolites in biological fluids.

Abstract: The present invention relates to a novel method for stabilizing aqueous solutions of serum complement for extended periods of time and the resultant stabilized complement solutions. More particularly, morphilino buffering compounds and tris-hydroxymethyl buffering compounds have been used to make aqueous buffers with a pH between about 6.5 and 8.5 and a concentration of greater than 0.01M. These buffers have been found to extend the normal life of complement solutions to unexpectedly longer periods.

Abstract: A method for the detection of a predetermined substance in a fluid is described. The method uses a test strip that is stable to storage and accelerated keeping test conditions. A sample of a fluid containing an unknown quantity of a predetermined substance is contacted with a support having thereon a reagent layer wherein the reagent layer contains a dialyzed latex polymer and a reagent detection system which reacts with the substance to provide a detectable change. The detectable change can be determined qualitatively or quantitatively to determine the presence or the amount of the predetermined substance.

Abstract: Isoenzyme control reagents and methods for making same stabilized by means of plexiform stabilizing means. The preferred plexiform stabilizing means is selected from the group consisting of monosaccharide and disaccharide reducing sugars. The most preferred isoenzyme control reagent comprises the isoenzyme of interest obtained from selected tissue, preclarified human sera, stabilizing cofactor, a chelating agent means, a weak nonphospate buffer and lactose as the most preferred plexiform stabilizing means.

Abstract: A method, device and kit for the quantitative determination of lipoprotein components, especially cholesterol and triglycerides, in body fluids, especially human serum, plasma or whole blood utilizing the selective adsorption of lipoproteins on particulate silica. This selective adsorption is also useful for the quantitative separation of lipoproteins from samples of whole blood for diagnostic purposes.

Abstract: Inclusion in a blood sample of an isomer of glucose which is capable of replacing glucose in blood cell metabolism ensures accuracy of glucose assay.

Abstract: A whole blood control sample and a method of preparing the sample are disclosed. The method comprises collecting a whole blood sample from one or more donor, separating each sample into red blood cells and plasma, fixing the red blood cells, mixing the fixed red blood cells with plasma from the same or a different donor to produce a suspension, quick-freezing the suspension before the red blood cells can settle, and lyophilizing the frozen suspension. The control sample therefore comprises a lyophilized mixture of fixed red blood cells and plasma solids.

Abstract: Control serum containing (1) at least one compound of the formula: ##STR1## in which T is hydrogen or methyl, hydroxymethyl or methoxymethylX is hydrogen hydroxymethyl or methyl when Y is hydroxyl, hydroxymethyl or NR.sub.2 ;Y is hydrogen, hydroxyl, hydroxylmethyl or NR.sub.2 andZ is hydroxyl or an --O--CH.sub.2 --CH.sub.2 OH group when Y is hydrogen or hydroxymethyl, or Z is hydroxymethyl or a carboxyl derivative orT is ethyl or isopropyl,X is hydrogen, or methyl, hydroxymethyl or methoxy,Y is hydroxy, hydroxymethyl or NR.sub.2 andZ is a carboxyl derivative;each R independently is hydrogen or an alkyl group with 1 to 2 carbon atoms optionally containing a hydroxy group and/or (2) at least one compound of the formulaHO(CH.sub.2 --CH.sub.2 --O).sub.n H, (II)in which n is an integer from 2 to 8,in an amount sufficient to reduce turbidities in reconstituted serum after previous lyophilization.

Abstract: A blood gas-hemoglobin analysis control which simulates whole human blood characteristics comprising a buffered suspension medium containing erythrocytes which have been stabilized with an imidoester protein cross-linking agent while being contacted with a gas consisting of pure oxygen or pure carbon monoxide.

Abstract: A device for sampling blood and measuring erythrocyte sedimentation rate. The device comprises a tube with one end closed, a blood sampling portion on an opened end of the tube and an erythrocyte sedimentation rate measuring portion extending from the blood sampling portion. A stopper is located on the open end of said tube, and may be pierced with a blood drawing needle. Finally a partition member is located within said tube and extends substantially over the entire length of said tube. Blood is directly sampled into the device and the device mixes the sampled blood with a solution of an anticoagulant with a high efficiency in the device. Accordingly, measurement of erythrocyte sedimentation rate can be performed quickly and easily.

Abstract: The present invention provides a control or calibration serum for lipid diagnosis, wherein it contains the parameters relevant for lipid diagnosis in the normal or pathological concentration range in a single storage-stable form.The present invention also provides processes for the preparation of this control or calibration serum.

Abstract: A device is described for preparing a standardized concentration of washed particles suspended in a fluid. The preferred method is directed to the preparation from whole blood specimens of a standardized concentration of washed red cells in isotonic solution using a device comprising a test tube formed at the bottom end with a nipple-like receptacle having a predetermined volumetric capacity. Whole blood is mixed with isotonic solution in the device which is then centrifuged causing the red cells to be first washed and then packed into the receptacle. The liquid contents of the device are then decanted without disturbing the packed red cells. Thereafter, the red cells are reconstituted to the desired concentration by adding isotonic solution to a predetermined level in the tube and mixing the cells into the isotonic solution.

Abstract: Blood cells such as erythrocytes of animal origin are treated with a solution containing water, an organic cosolvent (such as dimethylsulfoxide, alone or admixed with a polyol), an aromatic polyaldehyde (such as phthaldialdehyde) and optionally salts and buffers. In an illustrative case, the treating solution is hypertonic and shrinks goat erythrocytes to the size of human platelets.

Abstract: Isoenzyme control reagents and methods for making same stabilized by means of plexiform stabilizing means. The preferred plexiform stabilizing means is selected from the group consisting of monosaccharide and disaccharide reducing sugars. The most preferred isoenzyme control reagent comprises the isoenzyme of interest obtained from selected tissue, preclarified human sera, stabilizing cofactor, a chelating agent means, a weak nonphosphate buffer and lactose as the most preferred plexiform stabilizing means.

Abstract: A superattenuated low calorie beer is prepared from a wort containing as a liquid adjunct a starch-derived syrup which contains dextrins by adding to the wort during fermentation a glucoamylase type debranching enzyme obtained from Schwanniomyces castellii.

Abstract: A process for reducing turbidity in a dried and redissolved control serum and a dried and reconstituted control serum with reduced turbidity are described. The process can also be applied to control sera for lipid determination, and in particular also to those with an increased lipid content.

Abstract: A preservative solution for fixed avian erythrocytes for the viral hemagglutination test of this invention comprises purified water which may contain serum albumin, glycerol or dimethyl sulfoxide and, additionally, a preventive against the growth of bacteria as occasion demands. Fixed avian erythrocytes can stably be preserved in this solution. HA and HI test can precisely be performed by employing fixed avian erythrocytes suspended in this invention.

Abstract: A reagent for determination of human blood coagulation factor XIII for reversed passive hemagglutination reaction which comprises sensitized erythrocytes prepared by sensitizing animal erythrocytes with specific anti-human factor XIII antibody, and a kit using the reagent are disclosed.

Abstract: A binder for low density lipoproteins (LDL) consisting of sulphated polyvinyl alcohol which is cross-linked by the chemical or the physical route to a waterinsoluble product. The binder may be in the form of a hydrogel which is applied or not to a carrier or it may be present on the surface of a polyvinyl alcohol fibre which is preferably in the form of tape having a thickness of 0.1 to 2 .mu.m and a width of 0.5 to 6 .mu.m. The fibre shaped binder is prepared by successively cross-linking with an acidified aqueous solution of glutardialdehyde and sulphating with chlorosulphonic acid.

Abstract: A method is disclosed for determining calcium ion content of serum which comprises calibrating a potentiometric analytical system with calcium standards having a solution containing both TRIS and BisTRIS at a pH of 7.5. The serum sample is diluted with a silicone oil/water emulsion which may further contain a protein complexing agent such as iron, zinc, cadmium, nickel or copper. Measurement is then carried out on the diluted serum sample.

Abstract: A process for the preparation of a glucose-free glycosylated hemoglobin standard in which hemoglobin with a known content of glycosylated hemoglobin HbA.sub.Ia+b+c is converted to cyanmethemoglobin by means of a K.sub.3 (FeCN).sub.6 /KCN solution, stabilized with a sodium phosphate-cyanide buffer and preserved by lyophilizing at -40.degree. C. with a subsequent increase in temperature to -20.degree. C. under a high vacuum and stored at this temperature with the exclusion of light, whereupon the glucose-free glycosylated hemoglobin standard may be reconstituted by the addition of an aqueous medium.