Abstract: An antibody specific for a target analyte is purified by affinity chromatography on a substrate bearing a low-affinity analogue of the target analyte. The antibody is displaced from the substrate by contact with a second analogue of intermediate affinity, which remains complexed with the antibody. This complex can be used in a conventional assay for the target analyte, which displaces the intermediate-affinity analogue. The complexed antibody is rendered more storage-stable because the second analogue protects the antibody binding reagion.

Abstract: Stable coagulation controls containing mammalian blood and at least one non-primate mammalian coagulation factor or non-primate mammalian blood are described. The whole blood coagulation controls have a clotting time in the range of normal human clotting times or abnormal human clotting times.

Abstract: A method for preparing a coagulation control sample which is stable in the absence of buffer and which has a clotting time within the range of normal human clotting times for reproducibly monitoring coagulation capability in a human patient comprising (a) collecting blood from a mammalian animal, (b) removing red blood cells from the blood to produce mammalian plasma, and (c) adding to the plasma an amount of at least one non-primate mammalian plasma that has been adsorbed with a coagulation factors II, VII, IX and X adsorbent prior to addition of the plasma to the mammalian plasma.

Abstract: A three-phase suspension suitable for use as an erythrocyte sedimentation rate (ESR) control having the following three components: (1) a synthetic plasma base, (2) an aggregating agent such as a high molecular weight polymer or combination of high molecular weight polymers, and (3) chemically fixed mammalian red blood cells. The control is designed to allow the user to monitor the accuracy and precision of analytical methods for determining the sedimentation rate of human erythrocytes in whole blood specimens. Chemical fixing of the red blood cells provides the ESR control with the capability of providing useful results in the presence of citrate and/or saline.

Abstract: A reagent for analyzing solid components in urine comprising: (i) a buffer agent for maintaining pH at 5.0 to 9.0, (ii) an osmotic pressure compensating agent for maintaining osmotic pressure at 100 mOsm/kg to 600 mOsm/kg, (iii) a first dye which is a condensed benzene derivative, (iv) a second fluorescent dye capable of staining a damaged cell, and (v) a chelating agent.

Abstract: A three-phase suspension suitable for use as an erythrocyte sedimentation rate control having the following three components: (1) a synthetic plasma base, (2) a high molecular weight polymer, and (3) mammalian red blood cells. The control is designed to allow the user to monitor the accuracy and precision of analytical methods for determining the sedimentation rate of human erythrocytes in whole blood specimens.

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: Methods and compositions for preserving platelets at cryogenic temperatures with retention of hemostatic activity are provided. The compositions include a first agent for inhibiting actin filament severing and a second agent for inhibiting actin polymerization. Contacting the platelets with the first and second agents prior to exposure to cold temperature prevents cold-induced platelet activation.

Abstract: This invention pertains to a PT Assay Calibrator and a method of preparing a PT Assay Calibrator including a coagulation factor such as recombinant FVII or recombinant FVIIa that will allow preparation of PT calibration curves with values about 100% and which will give results analogous to those obtained using fresh normal plasma.

Abstract: Hematology reference control cells and method of manufacture. The invention relates to the methods of preparing stable white blood cell ("WBC") and nucleated red blood cell ("NRBC") fractions and the hematology control reagents containing such stablized cells for primary use on a multi-angle light scatter based hematology instrument.

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 concerns a stable control serum or calibration serum containing bilirubin to analytically examine the methodical accuracy of individual parameters in human sera or patients. The control serum or calibration serum according to the invention is used to stabilize bilirubin in solutions and to generally increase the stability of control sera or calibration sera.

Abstract: A method and composition for fixing and stabilizing tissues, cells, and cell components such that the antigenic sites and nucleic acids are preserved is provided. The fixative employs a formaldehyde donor that is non-toxic, non-flammable, and that stabilizes the cell with minimal damage to and alteration of the cell morphology. The cell antigenic sites are left intact so that studies with monoclonal antibodies may be conducted. Vaccines and related immunotherapeutic methods utilizing antigens stabilized by the fixative of the present invention are also provided. Also disclosed is a method for developing a positive control for test reagents and for test instrumentation.

Abstract: Quantitative buffy coat (QBC) analysis control compositions are provided which sufficiently mimic whole blood and perform consistently in various QBC systems. The control compositions contain a red blood cell component composed of non-human mammalian red blood cells and a granulocyte component composed of fixed human granulocytes. Methods of making and using the control compositions are also provided.

Abstract: A stabilized liquid standard solution for use in calibrating assays of thyroid function containing albumin and known amounts of at least two analytes selected from a group consisting of total thyroxine, free thyroxine, total triiodothyronine, and free triiodothyronine, and optionally, thyroid stimulating hormone.

Abstract: An apparatus and method of equilibrating the dissolved gas composition of an aqueous fluid to reflect the predetermined gas composition contained in a gas equilibration reservoir. The equilibrated aqueous fluid can be used in a method of determining the concentration of a dissolved gas in a fluid sample. In one embodiment, the method is used to control the equilibrated gas composition of a calibrant fluid which, in turn, is used to measure the concentration of a dissolved gas, such as oxygen and carbon dioxide, in a sample fluid, such as whole blood.

Abstract: This invention discloses a population of cells which have been preserved in non-frozen hydrated form, and which have been chemically treated in a manner that renders them metabolically inert and free of proteolytic enzyme activity, but without significantly altering the cell surface proteins that are of interest in flow cytometry. The absence of alteration of the surface proteins is indicated by the ability of the surface proteins to bind to monoclonal antibodies that bind to untreated proteins of the same type, with approximately the same affinity as proteins on untreated cells. The preserved cells and their surface antigens are stable for at least a month when stored at 4.degree. C. in buffered saline solution. These cell preparations are useful as quality control (QC) reagents for processes such as calibrating and standardizing flow cytometry equipment, and for use as "unknown" test samples for QC testing programs, or as patient specimens for archival storage and subsequent retrospective analysis.

Abstract: The invention relates to a composition comprising among others a fibrinopeptide A releasing compound. Furthermore the invention relates to the use of the composition as calibrator in plasma containing fibrinogen. A test kit comprising the said composition and a method to determine soluble fibrin also belong to the invention.

Abstract: The invention relates to a plasma which can be used as a calibrator in coagulation tests which detect the degradation of factor V by activated protein C, to the preparation of such a plasma and to its use.

Abstract: An kit for an assay for measuring activated factor VII (factor VIIa) is disclosed which employs a reagent comprising truncated tissue factor (tTF), a soluble mutant form of tissue factor (TF) that retains the cofactor function of TF toward factor VIIa, but does not support the conversion of factor VII to VIIa. As a result, the tTF assay for factor VIIa is free from interference from factor VII in the plasma and is therefore specific for factor VIIa. The assay is much simpler than existing assays, because it is a single-stage clotting assay performed almost identically to a prothrombin time (PT) assay. It is also considerably more sensitive than current assays for factor VIIa in plasma. Since the tTF assay is calibrated against a factor VIIa standard, it yields an absolute concentration of factor VIIa in ng/ml.

Abstract: A meter is used in conjunction with a hollow, frustum-shaped disposable device to measure the concentration of an analyte in a sample of a biological fluid. The smaller end of the frustum has a porous membrane, to which a sample of the fluid may be applied. Preferably, a reagent in the membrane reacts with the analyte to cause a color change. The meter has a frustum-shaped distal section that mates with the device. The meter measures the color change and computes from the change the analyte concentration in the sample. The meter and disposable device permit remote dosing of the device, which minimizes the likelihood of cross-contamination between the user and the meter. Devices can be mounted on the meter and released from the meter without touching them, to further protect against contamination.

Abstract: The present invention is directed to an in vitro aqueous composition comprising a drug, preferably tacrolimus or rapamycin, having enhanced stability. The invention utilizes a binding protein, preferably FKBP, to stabilize the drug in an aqueous matrix.

Abstract: Reference controls comprised of aldehyde-fixed white blood cells stabilized red blood cells and simulated blood platelets exhibiting a white blood cell histogram profile that is substantially that of whole blood are obtained by the addition of a lipoprotein to the control and an antioxidant to inhibit lysis of stabilized red blood cells by the lipoprotein.

Abstract: A coagulation control sample material for reproducibly monitoring coagulation control capability in a human patient wherein the coagulation control sample material has a predetermined clotting time within the range of from normal to abnormal human clotting times, the control comprising mammalian blood coagulation factors and an amount of at least one non-primate mammalian coagulation factor wherein when the coagulation control sample material has an abnormal human clotting time, the coagulation control comprises an amount of at least one non-primate plasma which has been treated with an adsorbent that adsorbs factors II, VII, IX and X and wherein the coagulation control is stable in the absence of buffer.

Abstract: The present invention relates to therapeutic methods wherein an actin-binding protein, preferably gelsolin or DBP, is administered to a patient with actin-containing clots in order to remove actin from the clots. The invention also relates to diagnostic methods in which actin is removed from an actin-containing clot in vitro and quantitated.

Abstract: The invention is a rapid, continuous test for glycated hemoglobin using a non-equilibrium affinity binding method. Agarose beads derivatized with 3-aminophenylboronic acid specifically bind glycated hemoglobin. This solid phase is incorporated into a sample processor card, modified to mix and to separate the test solution from the solid phase prior to absorbance readings. Two absorbance readings are made on the test solution, one immediately after mixing the reagent/diluent with the specimen, and one after a significant amount of binding has occurred. A linear correlation between total glycated hemoglobin and hemoglobin A.sub.1c permits standardization and reporting of units equivalent to % hemoglobin A.sub.1c. Stable glycated hemoglobin solutions for use as standards in the assay, and a method for preparing the standards are also disclosed.

Abstract: Aqueous solutions of steroid compounds which have biological activity and have a tendency to oxidative degradation at temperatures between 2.degree. and 8.degree. C. on storage in excess of several months are stabilized by the addition of cyclodextrin.

Abstract: Reference controls comprised of aldehyde-fixed white blood cells stabilized red blood cells and simulated blood platelets exhibiting a white blood cell histogram profile that is substantially that of whole blood are obtained by the addition of a lipoprotein to the control and an antioxidant to inhibit lysis of stabilized red blood cells by the lipoprotein.

Abstract: A method for stabilizing analytes with antibodies and antibody fragments comprises dissolving the analyte in a liquid to form a solution, adding analyte-specific antibodies, fragments of such antibodies, or both to the solution, heating the solution, and then cooling and filtering the solution. The filtered solution may be diluted in a suitable matrix.

Abstract: The present invention provides an improved reagent composition and method to perform white blood cell differential counting and subpopulation analysis using both fresh and aged blood samples with accuracy and precision. The invention is particularly applicable for the analysis of aged blood samples that have been stored at room temperature for over a day, thereby allowing accurate and useful information to be obtained from samples that are normally considered to be suboptimal. The improved reagent composition and method are particularly related to the peroxidase method of white blood cell differential determinations. One aspect of the invention includes an improved aqueous reagent composition for carrying out the peroxidase method of differential counting.

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: Disclosed is an apparatus and method of equilibrating the dissolved gas composition of an aqueous fluid to reflect the predetermined gas composition contained in a gas equilibration reservoir. The equilibrated aqueous fluid can be used in a method of determining the concentration of a dissolved gas in a fluid sample. In one embodiment, the disclosed method is used to control the equilibrated gas composition of a calibrant fluid which, in turn, is used to measure the concentration of a dissolved gas, such as oxygen and carbon dioxide, in a sample fluid, such as whole blood.

Abstract: Disclosed is an apparatus and method of equilibrating the dissolved gas composition of an aqueous fluid to reflect the predetermined gas composition contained in a gas equilibration reservoir. The equilibrated aqueous fluid can be used in a method of determining the concentration of a dissolved gas in a fluid sample. In one embodiment, the disclosed method is used to control the equilibrated gas composition of a calibrant fluid which, in turn, is used to measure the concentration of a dissolved gas, such as oxygen and carbon dioxide, in a sample fluid, such as whole blood.

Abstract: A control solution for use with a photometric blood glucose strip contains glucose in an aqueous suspension of carbon black. The control solution mimics blood when applied to a whole blood glucose test strip, which is then inserted into a meter. A meter reading within a predetermined range indicates that meter and strip are operating satisfactorily. Preferably the control solution is buffered to a neutral pH and includes chloride ion to provide a stable end point for the glucose reaction. Depending on the glucose concentration, the solution checks meter and strip operation at high, low, and normal blood glucose levels.

Abstract: The invention is a rapid, continuous test for glycated hemoglobin using a non-equilibrium affinity binding method. Agarose beads derivatized with 3-aminophenylboronic acid specifically bind glycated hemoglobin. This solid phase is incorporated into a sample processor card, modified to mix and to separate the test solution from the solid phase prior to absorbance readings. Two absorbance readings are made on the test solution, one immediately after mixing the reagent/diluent with the specimen, and one after a significant amount of binding has occurred. A linear correlation between total glycated hemoglobin and hemoglobin A.sub.1c permits standardization and reporting of units equivalent to % hemoglobin A.sub.1c. Stable glycated hemoglobin solutions for use as standards in the assay, and a method for preparing the standards are also disclosed.

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: A method of treating a patient having a panic disorder, the patient having an elevated CCK peptide plasma level, by lowering the plasma CCK peptide level of the patient. A further method provides a diagnosis of panic disorder in a patient by detecting if that patient's plasma contains elevated CCK peptide levels. A further method determines the efficacy of the drug for the treatment of panic disorder by detecting the ability of the drug to lower elevated CCK peptide levels in a model for panic disorder. Additionally, a method of dosing a patient having elevated CCK peptide levels with an antipanic disorder drug is characterized by administering the drug to a patient and monitoring the lowering of the elevated plasma CCK peptide levels of the patient.

Abstract: In a method for the determination of coagulation parameters in sample material via a reaction cascade in which a thrombin-catalyzed formation of a fibrin clot from fibrin monomers occurs and the formation of the fibrin clot is measured, an inhibitor of F XIII is added. By this means the reaction vessel can be used several times for coagulation tests.

Abstract: The compound 2,3,5,6-tetrahydroxy-1,4-quinone, its derivatives and structural analogs are used as activators for intrinsic blood coagulation and as diagnostic reagents for the activated partial thromboplastin time test of blood coagulation.

Abstract: The invention relates to a composition for stabilizing proteins for long term dry storage and superior recovery of their native protein structure for extended reconstituted stability at 2.degree.-8.degree. C. The composition comprises: 1) a defibrinated sodium-free blood plasma, 2) a glass-forming sugar, 3) a serum albumin and/or a gelatin, and 4) a potassium salt. In another aspect, the present invention relates to a method for stabilizing a protein for long term dry storage using the above mentioned composition.

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: There is disclosed the use of prothrombin fragments, preferably of human prothrombin fragments, having a thrombin-like activity, in particular of meizothrombin, meizo thrombin (desF1), or mixtures thereof, for diagnostic purposes for assaying thrombin substrates as well as a reagent containing these prothrombin fragments.

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 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: There is described a positive calibrator/control composition for use in assays for the detection of antibodies to infectious disease agents. The composition includes a composite antibody of a nonspecific IgM immunoglobulin moiety covalently linked to a specific, non-IgM antibody moiety. Also described is an assay method which utilizes the positive calibrator or control composition.

Abstract: An assay for activated factor VII (factor VIIa) has been developed using truncated tissue factor (tTF), a soluble mutant form of (tTF) that retains the cofactor function of TF toward factor VIIa. Unlike full-length TF, however, tTF appears not to support the conversion of factor VII to VIIa. As a result, the tTF assay for factor VIIa is free from interference from factor VII in the plasma and is therefore specific for factor VIIa. The assay is much simpler than existing assays, because it is a single-stage clotting assay performed almost identically to a prothrombin time assay. It is also considerably more sensitive than current assays for factor VIIa in plasma. Since the tTF assay is calibrated against a factor VIIa standard, it yields an absolute concentration of factor VIIa in ng/ml.

Abstract: A method and composition for fixing and stabilizing tissues, cells, and cell components such that the antigenic sites are preserved for a useful period of time. The fixative employs a formaldehyde donor that is non-toxic, non-flammable, and that stabilizes the cell with minimal damage to and alteration of the cell morphology. In particular, the cell antigenic sites are left intact so that studies with monoclonal antibodies may be conducted. The invention also discloses a method for developing a positive control for test reagents and for test instrumentation.

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 stable reticulocyte reference control which may be used with both manual and flow cytometric reticulocyte counting devices is provided. The reference control contains erythrocytes loaded with nucleic acids or polyanions capable of binding with a cationic dye. The loaded erythrocytes are suspended in an aqueous preserving medium. Methods of making and using the reticulocyte reference control are also provided.

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.