Abstract: Methods for assessing a patient's risk of having or developing coronary heart disease based on lipoprotein measurements measure and identify values for lipoprotein subclass constituents and analyze according to predetermined test criteria to identify when there is an increased and/or decreased risk of having and/or developing coronary heart disease associated wit the measured lipoprotein subclass constituent values.

Abstract: The present invention relates to the study and control of atherosclerosis through the modulation of LDL-proteoglycan binding at Site B (amino acids 3359-3369) of the apo-B100 protein in LDL. The invention encompasses methods of identifying compounds which modulate LDL-proteoglycan binding, methods of identifying compounds which modulate atherosclerotic lesion formation, and methods of modulating the formation of atherosclerotic lesions. The invention also encompasses mutant apo-B100 proteins and LDL which exhibit reduced proteoglycan binding while maintaining LDL-receptor binding, polynucleotides which encode these apo-B100 proteins, as well as cells and animals which express the mutant apo-B100 proteins.

Abstract: A method for analyzing a patient's risk of coronary heart disease by determining the presence of NMR-derived or based lipoprotein constituent value abnormalities includes determining the presence of atherogenic dyslipidemia based on the existence of a clustering of lipoprotein constituent abnormalities as defined by predetermined test criteria. Computer program products and automatically produced reports for presenting NMR-derived lipoprotein risk assessment based on patient-specific lipoprotein subclass results present the measurement results adjacent to a segmented reference risk analysis portion. The actual measured results are visually aligned and enhanced within the risk analysis portion to provide easy reference and understanding of the results relative to a risk of developing coronary heart disease.

Abstract: The invention relates to a process for the obtainment of biological components from body fluids, in particular from blood, blood plasma or serum. The biological components are obtained in native and biologically active form and can be employed, for example, for therapeutic purposes and for the preparation of control samples or standards for diagnostic tests.

Abstract: In a printed circuit board manufacturing process, a resist stripping solution blending organic amines with water is used for stripping the photoresist completely from the board. An apparatus for controlling this resist stripping solution comprises a toroidal conductivity controller for measuring the solution conductivity, which correlates to solution concentration. This same apparatus is equipped with a resist stripping solution discharge device for discharging the resist stripping solution and water replenishing device for replenishing water by detecting the liquid level of the resist stripping solution by a liquid level gauge. As the water is replenished, the solution conductivity is lowered; thereby activating the toroidal conductivity controller to add concentrated resist stripping chemistry proportionally to the deviation from the conductivity controller set point. This same apparatus is equipped with a measuring device for measuring the total consumed organic amine reactants.

Abstract: Disclosed is a method for determining alcohol intake or alcohol induced liver damage in a subject by quantifying the content of sialic acid in apolipoprotein J (Apo J). In particular the present invention involves the steps of (a) providing a sample containing Apo J from a subject; (b) purifying the Apo J from the sample; (c) determining sialylation index, i.e., moles of sialic acid peer mole of Apo J in the sample; and (d) evaluating whether the sialylation index is an indication of alcohol intake or alcohol related liver damage recovery from alcohol addiction or alcohol relapse in the subject.

Abstract: This invention relates to a novel protein having a lecithin-cholesterol acyltransferase-like activity, etc. or its salt, a precursor protein of the protein or its salt, a partial peptide of the protein or its salt; a DNA coding for the protein; a recombinant vector; a transformant; a method for producing the protein, a pharmaceutical composition comprising the protein, the partial peptide or its salt; and an antibody to the protein or the partial peptide. The protein, the partial peptide or its salt, and the DNA are useful as an agent for treating or preventing arteriosclerosis, atherosclerosis, hyperlipidemia, hypercalorism, obesity or hypertriglyceridemia. The antibody can be used in assay of the protein, the partial peptide or its salt. The protein, the partial peptide or its salt is useful as a reagent for the screening for candidate medical compounds.

Abstract: The present invention provides a method for directly measuring apolipoprotein B-100 (apoB) or cholesterol associated with very low density lipoprotein (VLDL) in a fluid sample. In one embodiment the method involves the specific capture of intact VLDL particles from a fluid sample with a specific VLDL binding agent. The quantity of VLDL-apoB present in the sample is then measured by detecting the amount of VLDL-apoB bound to the binding agent-VLDL complexes formed in the reaction. In an alternative embodiment of the method, intact VLDL particles from a fluid sample are also captured with a specific VLDL binding agent and thereafter the cholesterol associated with the bound VLDL is determined. The cholesterol contained in the binding-agent-VLDL complexes can be detected by reacting the complexes with labeled cholesterol specific binding agents and measuring the amount of label bound therto, or by releasing the cholesterol in the complexes and measuring the amount of cholesterol released.

Abstract: The present invention relates to methods for the production of a stable troponin preparation and its use as a calibrator and/or control in immunoassays. The formulation is prepared from mammalian, preferably bovine, heart tissue which provides a calibrator/control composition which remains stable over a long period of time.

Abstract: The present invention relates to the use of sterol esters for the long-term stabilization of biological fluids, in particular even those which are obtained by lyophilization and subsequent reconstitution.

Abstract: A method of quality control to diagnose the cause of a malfunction of an instrument. The method uses measurements of the physical property of a sample to diagnose the cause of a malfunction of an instrument. The spatial position of a control product sample is analyzed. Alternatively, the spatial position of a statistically significant number of patient blood samples can be used. The method enables the monitoring of an instrument for problems associated with debris and noise caused by red cell lysis inefficiency; instrument reagents pump volume settings; instrument laser alignments; instrument gain settings; and flow noise caused by partial plugs, residual plugs or other flow problems. The method provides a more specific indication of the type and cause of an instrument malfunctioning than non specific flagging provided by prior art methods.

Abstract: The present invention relates to the use of sterol esters for the long-term stabilization of biological fluids, in particular even those which are obtained by lyophilization and subsequent reconstitution.

Abstract: A method having clinically sufficient degree of diagnostic accuracy for detecting the presence of coronary artery disease in a human patient from the general population and for distinguishing between the stages of the disease in that patient is disclosed. The stages are, first, the non-acute stage, which is either asymptomatic coronary artery disease or stable angina, second, the acute stage known as unstable angina, and, third, the acute stage known as acute myocardial infarction. The diseased state (as opposed to the non-diseased state) is indicated by the clinically significant presence of a first marker in a sample from the patient. The presence of one of the two acute stages, unstable angina or acute myocardial infarction, is indicated by the clinically significant presence of a second marker in a sample from the patient. The presence of the more severe acute stage known as acute myocardial infarction is indicated by the clinically significant presence of a third marker in a sample from the patient.

Abstract: A novel monoclonal antibody which specifically binds to apo-B-48 is disclosed. The monoclonal antibody specifically binds to apo-B-48 but does not bind to apo-B-100.

Abstract: The subject matter of the application is a method for the separation of non-HDL lipoproteins from biological fluids in a carrier through which liquids can flow. The carrier contains a precipitating agent for non-high density lipoproteins (non-HDLs).

Abstract: Novel metal-lipid molecules have the formula M-Or-L. M represents a cluster or colloid of atoms of Au, Ag, Pt, Pd, or combinations thereof. Or is an organic group covalently attached to the metal atoms. L represents a lipid moiety. In a preferred embodiment, M represents a cluster of about 50-70 gold atoms having a diameter of about 1.4 nm in diameter and L represents dipalmitoyl phosphatidyl ethanolamine.

Abstract: The invention provides a new method for antiglobulin testing from serum of a potential blood transfusion recipient in which warm autoantibodies are removed from serum so as to allow identification of alloantibodies present. The method involves contacting serum from a patient with one or more ligands that bind warm autoantibodies but do not bind alloantibodies, separating the non-bound serum components from the bound warm autoantibodies, and using the warm autoantibody-depleted serum in antiglobulin testing. Suitable ligands include phospholipids, the polar head groups of phosphoglycerides, and naturally occurring and synthetic analogues of these molecules.

Abstract: Endotoxin incorporated into liposomes, lipid bilayers or lipid complexes can be detected by combining an aqueous suspension of the liposomes, lipid complexes or lipid bilayers with a suitable detergent. Preferable detergents, e.g., Lubrol-PX.TM. or a polyoxyethylene ether, solubilize the lipid bilayers, liposomes or lipid complexes at acceptable lipid concentrations, forming micelles therefrom which contain lipid bilayer, liposome or lipid complex lipid, detergent and endotoxin, should it be present. The micelles are then assayed for the presence of endotoxin.

Abstract: The present invention relates to the direct quantitative determination of cholesterol and involves the formation of a spectrophotometrically active product of cholesterol obtained by contacting cholesterol with an acyl compound and a perchlorate effective to form the spectrophotometrically active product.

Abstract: The present invention is directed to a method of using a liquid matrix containing a black body light absorbing powder to facilitate the analysis of biomarkers from representative microorganisms by laser desorption mass spectrometry. Both an IR laser (1064 nm) and a UV laser (337 nm) were shown to be compatible and both time-of-flight and Fourier-transform mass analyzer were used. In the present implementation gram negative and gram positive bacteria were suspended in a methanol:chloroform solution and added to a cobalt/glycerol matrix, S/N, sensitivity and sampling time are greatly enhanced for polar lipid biomarkers.

Abstract: Methods are disclosed for producing a substrate surface supporting a continuous planar bilayer lipid membrane by covalently binding a plurality of micellar of vesicle liposomes, optionally comprising a membrane protein or other biologically active membrane-bound component, to a substrate surface supporting a self-assembled monolayer (SAM) of essentially straight long chain molecules. In one embodiment, the micellar or vesicle liposomes covantly bind to hydrophilic spacer molecules attached to the functional groups of the self-assembled monolayer.

Abstract: Cholesterol in low-density lipoprotein (LDL) or very low-density lipoprotein (VLVL) in a sample is determined in the presence of a sugar compound and/or a protein-solubilizing agent.

Abstract: Materials and compositions for making triglyceride controls, calibrators and standards are described. The materials are mono- and di- and tri- glycerides of medium length fatty acids mixed into compositions of human serum or other protein solutions to form stable, miscible solutions suitable for use as controls, calibrators and standards in clinical chemistry for measurement and quality control in assays for triglycerides. The materials described have been used as vehicles for oil-soluble, water-insoluble pharmaceuticals and as facial emollient oils for cosmetics, and as such are safe, functional, stable, rancid-resistant and very inexpensive compared with pure materials synthesized or described previously.

Abstract: Reagent and method are offered for the screening of the functional condition of the body by the person's saliva. Reagent presents itself as an H2O solution, containing ions of Fe3+, chloride ions and multi-atom alcohol .n the concentrations 0.05-3.0M; 0.05-4.0M, and 0.1-5.0M accordingly. Screening is conducted by means of mixing of the persons saliva with the reagent in the following comparison of colour mix with control; during this an orange colour is correlated with the norm; yellow-diabetes SD-1, functional disorders of pancreas; bright-pink and red initial stages of hypertonic disease, diabetes SD-2, pathological influence of smoking; dark-red, developed forms of hypertension, diabetes SD-2, pathogenic-influence of smoking or other toxic substances, leading to the emphasized energetic disorder.

Abstract: The invention relates to a method and reagent for the specific determination of the LDL fraction in the presence of other serum lipoproteins by adding a water soluble polymeric LDL-aggregating agent and a zwitterionic and/or non-ionic detergent. The LDL aggregate is determined in a direct turbidimetric measurement. Preferred LDL-aggregating agents are polyanions having a branched structure with acid groups, particularly branched alkane sulfonic acid groups as side branches. Preferred detergents are those known as "Zwittergent".

Abstract: A method is disclosed for conditioning samples (of e.g. milk or meat) containing fat globules and somatic cells and/or protein particles before they are subjected to fluorescence measurements in order to determine the bacterial content, as well as methods for performing the determination of bacterial content in such samples. The conditioning method involves the treatment of the samples with an ion-chelating agent, a proteolytic enzyme, detergent, and a bacteriologically specific fluorochrome such as ethidium bromide. Detergent is used in a concentration resulting in substantially no dissolution of the fat globules and the conditioned samples thus loses insignificant amounts of fat globules. The assessment of fluorescence is preferably performed in a conventional flow cytometer. As no separation of fat globules is necessary, the methods are simple and fast. The bacterial determinations have proved reliable when compared to standard methods.

Abstract: A process and a reagent for the specific and direct determination of the LDL-fraction in the presence of other serum lipoproteins by adding a polymeric LDL-aggregating agent, followed by direct turbidimetric measurement of the LDL aggregate. Preferred are polymers which have a comb or brush type structure with the side groups having acid character, such as branched alkane sulfonic acids.

Abstract: The invention relates to a method useful in separating non-high density lipoproteins, referred to as "non-HDLs", from biological fluids containing them. A porous carrier is provided which contains a non-HDL precipitating agent. One need only contact the sample of interest to the carrier for one minute or less, after which the precipitated non-HDL-s are no longer present in the sample being tested. The applications of the method include the ability to determine high density lipoproteins in the sample without interference from non-HDLs.

Abstract: A method for screening a compound as a potential anti-obesity agent by determining whether the compound stimulates micro motion of cells in vitro is described

Abstract: A method for quantitatively determining cholesterol in high density lipoproteins, in which, prior to the determination of cholesterol by an enzymatic method, a surfactant and a substance which forms a complex with lipoproteins other than high density lipoproteins are added to a sample containing lipoproteins.The method does not require any pretreatments such as centrifugal separation. With a simple operation, cholesterol in HDLs can be measured effectively. Also, this method can be adopted in a variety of automated analyzers, and thus is very useful in the field of clinical assays.

Abstract: An accurate, stable, liquid lipoprotein control composition is provided. The control composition of the present invention preferably contains lipoprotein, surfactant and a divalent cation. The control may further contain an anti-oxidant agent and a chelating agent. The control composition of the present invention is stable for up to about 12 months at room temperature and up to about 24 months when refrigerated. Methods of making and using the control composition are also provided.

Abstract: Lipid is determined quantitatively by treating a sample with a surfactant in an aqueous medium to obtain a liquid sample dispersion, then reacting the dispersion with a reagent containing cupric ion and bicinchoninic acid, and measuring a colored state developed by complex formation of bicinchoninic acid with cuprous ion formed from cupric ion in the presence of lipid. This method can be effectively applied to determination of amphiphilic lipid having a tendency of gathering in an aqueous medium. Further, two different species interfering with each other in quantitative determination thereof are determined respectively by conducting two different determination methods on the same sample followed by calculation using the values obtained.

Abstract: There is disclosed a non-radioactive method and kit for determining a heart disease risk factor and for determining efficacy of treatment for heart disease.

Abstract: There is disclosed an aqueous dispersed solution as a standard solution for determining lipid levels, having a dispersion form and a particle size, which are similar to those of serum lipids. A lipid-dispersed solution is obtained by evaporating an organic solvent from a mixture prepared by adding cholesterol, a phospholipid, a bile acid or bile acid salt, and a neutral lipid and/or a cholesterol ester in the organic solvent, swelling the resultant thin-film like mixture with water or buffer heated at a temperature higher than a phase transition temperature of the lecithin, and then dispersing the solution by a physical shear force. There can be easily obtained a solution having a cholesterol concentration of about less than 1,000 mg/dl, which is extremely stable and can be stored for a long period of time.

Abstract: Levuglandin (LG) derivatives are used as antigens for raising antibodies useful in diagnostic assays. The antibodies produced by LG-carrier protein adducts can be used to detect adducts of LGE.sub.2 with human low density lipoprotein (LDL). LGE.sub.2 -protein adduct immunoreactivity may be generated during in vitro free-radical oxidation of LDL. An enzyme-linked immunosorbent assay for detecting adducts of LGE.sub.2 with human LDL is also described.

Abstract: In high volume laboratory analysis of patient medical specimens, control materials are inserted at periodical intervals (e.g. once per eight hours) and analyzed. If the results of the analysis deviate from the mean according to statistical rules, the run of analyses prior to the insertion of control materials has in the past been rejected, often causing a substantial loss of results because the control materials were not inserted sufficiently frequently. According to the invention the patient mean of a test is determined, and when the mean deviates from the predetermined mean by more than a selected amount, this determination is used, not to reject the run, but rather to trigger insertion and analysis of control materials. If the analysis of control materials shows that the run is in control, the analyses made prior thereto are reported and the run is resumed. If the control material analysis shows that the run is out of control, then the prior analyses are rejected.

Abstract: An accurate, stable, liquid lipoprotein control composition is provided. The control composition of the present invention preferably comprises lipoprotein, suffactant and a divalent cation. The control may further comprise a chelating agent. It has been surprisingly found that when suffactant and a divalent cation are added to lipoprotein, it performs like native lipoprotein in human serum, i.e. not aggregated or subject to matrix effects. In addition, the control composition of the present invention is stable for up to about 5 months at room temperature (about 22.degree. C.) and up to about 12 months when refrigerated (about 2.degree. C. to about 10.degree. C.). Methods of making and using the control composition are also provided.

Abstract: The invention is a non-invasive diagnostic test which is performed on the surface of the skin. This test indicates skin cholesterol levels which can provide information about the extent of aortic atherosclerosis. The invention also relates to reagents in the form of affino-enzymatic test compounds for use in the diagnostic test.

Abstract: The present invention is directed to the assay and purification of proteins, and particularly to the non-radioactive assay and purification of protein kinases, phosphatases and protease by incubating the enzyme with a substrate modified peptide to form a product modified peptide under conditions where the enzyme is active. The product modified peptide and substrate modified peptide are then separated, and the product modified peptide is measured. The present invention is also directed to kits and bioreagents for performing the assays.

Abstract: There are disclosed a process for detecting and determining an oxidized lipid in a specimen, which is capable of readily and accurately determining a specimen as containing an oxidized lipid, and a process for forming a water-soluble oxidized lipid having a hydroperoxide group which has specific influence on a living body. A specimen is detected and determined to contain an oxidized lipid by adding a lanthanide shift reagent to a specimen, followed by spectroscopic analysis thereof. An oxidized lipid is formed by adding superoxide dismutase (SOD) and CuSO.sub.4 to (1) an emulsion prepared by dissolving linoleic acid or arachidonic acid in deuterated methyl alcohol and adding the solution to a deuterated phosphate buffer under stirring, or to (2) a low density lipoprotein solution sufficiently dialyzed against an undeuterated phosphate buffer; followed by irradiation with long-wave ultraviolet light.

Abstract: The method is directed to assaying for biological components in a sample comprising step (A) generating an oxidase substrate in the presence of an amphoteric surfactant and in the absence of ferrocyanide; (B) initially generating hydrogen peroxide through said oxidase reaction on said substrate of oxidase with subsequent detection of the generated hydrogen peroxide using peroxidase and a color developer capable of being oxidized in the presence of amphoteric surfactant and ferrocyanide; and (C) correlating the amount of color developed to the amount of biological components in the biological sample. Even when the biological component to be detected is present in a very small amount, the interference of bilirubin can be eliminated in assays of biological components in which peroxidase generated from an enzymatic reaction is detected using peroxidase and a color developer capable of being oxidized.

Abstract: A dye is covalently bound to a polymeric film, especially a polyhydric polymer, for assays and other purposes. The dye may be one which, when it comes into contact with hydrogen peroxide, changes color to indicate the presence of hydrogen peroxide. This dyed film may be used in qualitative or quantitative assays. This method chemically immobilizes dyes on support matrices with much higher yields of immobilized dye than has heretofore been possible. The covalently immobilized dye may be immobilized on solid matrix particles and combined with a free-flowing dye component to form a two component dye system. By combining a dyed film-former with a film-opener, the amount of dye available for assay is greatly enhanced. This provides a dye system which can be used to detect and measure quantitatively, accurately and precisely high levels of hydrogen peroxide. These high levels of hydrogen peroxide may result from the enzyme-mediated decomposition of various analytes from undiluted whole blood samples.

Abstract: An aqueous dispersion used for control or calibration of a dry analysis element comprising at least one color producing reagent and a porous layer, which comprises water-insoluble liquid particles having a mean particle size of from about 0.01 to about 10 .mu.m selected from the group consisting of phthalates, trimellitates, phosphates, benzoates, amides, phenols, aliphatic esters, hydrocarbons, halogenated hydrocarbons, adipates, sebacates and natural polymers dispersed therein and a substance which is the same as or similar to the analyte to be determined wherein said substance is selected from the group consisting of glucose, urea, uric acid, creatinine, bilirubin, hemoglobin, triolein, glycerine, cholesterol, triglyceride, (NH.sub.4).sub.2 SO.sub.4, NH.sub.4 Cl, CaCl.sub.2, Ca(NO.sub.3).sub.2, MgCl.sub.2, NaCl, KCl, K.sub.2 HPO.sub.4, (NH.sub.4).sub.2 SO.sub.4, Ca(NO.sub.3).sub.2, and NaNO.sub.3.

Abstract: Disclosed is a serum free control reagent formulation useful for the determination of a pre-selected analyte. The formulation involves an aqueous solution of a predetermined amount of the analyte together with a polymerized quaternary salt of di- or mono- allyl, di- or tri- alkyl ammonium characterized by the formulae: ##STR1## where R is straight or branched chain alkyl of 1 to 4 carbon atoms, n is a number of at least 9 and .theta. represents a counteranion. The formulation typically contains a buffer to maintain its pH at a level of about 7.5 and a preservative.

Abstract: A method is provided for measuring the net HDL cholesterol in the blood. The LDL and VLDL moieties are precipitated out and the remaining cholesterol content of the supernatant is measured. The free cholesterol content of the supernatant is separately measured and substracted from the total to obtain net HDL cholesterol. This value serves as a useful indicator for diagnosing vascular disease. A diet supplement and method for raising serum HDL is provided.

Abstract: An assay device for measuring the concentration of HDL-associated cholesterol in a blood-fluid sample is disclosed. The device includes a glass-fiber sieving matrix capable of separating soluble and precipitated material migrating through the matrix, and a reagent reservoir in the matrix, for releasing a reagent effective to selectively precipitate LDL and VLDL particles, while permitting soluble HDL to migrate through the matrix. The glass fibers are coated with a polymer coating to prevent binding of HDL to the fibers in the presence of the precipitating reagent.

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: Low density lipoproteins are directly determined in fluid samples by selectively precipitating low density lipoproteins from the sample by forming clusters, selectively consuming the high density and very low density lipoproteins, and resolubilizing the low density lipoproteins for direct determination thereof. The clusters are formed by treating the fluid sample with a mixture of a polyanionic compound, a divalent metal, and a nucleating agent. The clusters are redissolved and assayed for low density lipoproteins.

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: .[.There is disclosed an aqueous dispersed solution as a standard solution for determining lipid levels, having a dispersion form and a particle size, which are similar to those of serum lipids. A lipid-dispersed solution is obtained by evaporating an organic solvent from a mixture prepared by adding cholesterol, a phospholipid, a bile acid or bile acid salt, and a neutral lipid and/or a cholesterol ester in the organic solvent, swelling the resultant thin-film like mixture with water or buffer heated at a temperature higher than a phase transition temperature of the lecithin, and then dispersing the solution by a physical shear force. There can be easily obtained a solution having a cholesterol concentration of about less than 1,000 mg/dl, which is extremely stable and can be stored for a long period of time..]. .Iadd.There is disclosed an aqueous dispersed solution as a standard solution for determining lipid levels, having a dispersion form and a particle size, which are similar to those of serum lipids.