Abstract: The invention is directed to the use of weak anion exchange (WAX) materials for trapping of negative and zwitterionic interferences from biological matrices, and then reduction of the biological matrix effect in the quantitative analysis process of basic and neutral compounds present in the matrix. The sample preparation process includes adding the WAX cleanup step before or after or during the conventional extraction procedures like liquid-liquid extraction, protein precipitation, solid phase extraction and others. Such a step greatly enhances the selectivity of the extraction process via the removal of the majority of the contaminants and reduces the matrix effect in the quantitative analysis. In addition, the WAX-enhanced extraction is very simple, versatile, rug and easy to be operated.

Abstract: The present invention provides a reference solution for use in instruments that determine hematocrit levels in biological samples by measuring the resistance and/or conductivity of the biological samples. A reference solution according to the invention achieves conductivities representative of known hematocrit levels in blood, while maintaining tolerable levels of interference with the measurement of other analytes in the reference solution.

Abstract: A reagent for classifying leucocytes, including: a) at least one of surfactant selected from a cationic surfactant, an amphoteric surfactant, and the combination thereof; b) an organic compound having phenyl or heterocyclic group, wherein when the surfactant is a cationic surfactant, the organic compound is an organic compound having an anionic group; when the surfactant is an amphoteric surfactant or a combination of amphotheric and cationic surfactant, the organic compound is an organic compound having an anionic or cationic group; c) a buffer for adjusting pH.

Abstract: The present invention relates to a reagent for classifying leukocytes including (a) at least one surfactant capable of lysing erythrocytes and partly damaging the cell membrane of leukocytes, (b) at least one organic compound bearing an anionic group capable of binding to the cationic component present in the leukocytes to provide morphological differences between the leukocytes, and (c) a buffer for adjusting pH to 2˜8. Also disclosed is a method for classifying leukocytes into four groups.

Abstract: A method for preparing a composition that includes selecting a pH of the composition; selecting a first buffer with a negative temperature coefficient; selecting a second buffer with a positive temperature coefficient; and forming the composition comprising the first buffer and the second buffer. The composition has an average temperature coefficient, ?pH/?T(Ta,Tb)?1×10?3 pH-unit/K and a ?pH(Ta,Tb)?0.31 pH-unit for Ta=4 K and Tb=313 K.

Abstract: The invention provides methods for determining the mid-value titer of a substance in a composition. In some methods the substance comprises at least one anti-hemagglutinin (HA) antibody. The invention also provides systems and computer-readable media for use in association with such methods.

Abstract: The present invention is directed toward a stable calibrator and/or control, kit and process for using in a glucose monitoring instrumentation. Principally, the instant invention teaches a glycolyzed red blood cell component which has been treated with a glycolysis stabilizing effective amount of at least one non-crosslinking aldehyde compound which may be added to fresh plasma along with an amount of glucose to form a simulated whole blood glucose control product, effective for maintaining a particular and essentially stable glucose concentration over a period of time sufficient for accurate measurement and calibration of a glucose measuring instrument.

Abstract: The amount of platelet surface proteins in a sample may be measured by collecting a sample containing platelets into a collection tube containing a platelet stabilizing composition, labeling the platelet surface protein and detecting by cytometry.

Abstract: This invention provides compositions and methods for fixing a biological sample, particularly fecal samples for diagnosis of parasitic infection. The fixative composition of the present invention comprises glyoxal (pyruvate aldehyde) and zinc sulfate and permits staining of biological samples without use of toxic compounds, such as formaldehyde and mercury-containing compounds. The fixative is compatible with many diagnostic assays, including trichrome stains, hematoxlin, ELISA, fluorescent assays, and lateral flow assays.

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

Abstract: In a method for measuring an analyte, which comprises a reaction step of forming a reaction system including a sample containing whole blood, a first substance carried by a solid carrier and specifically binding to an analyte contained in the sample and a second substance specifically binding to the analyte and allowing the analyte to react with the first and second substances and a measurement step of measuring the formed reaction product, (1) the reaction step is performed in a state that blood cells are not disrupted, and (2) at least the reaction step is performed in the presence of a sufficient amount of a detergent that does not cause hemolysis, does not inhibit reactions of the analyte with the first and second substances specifically binding to the analyte and can prevent influence on the reaction system of a component existing in the reaction system.

Abstract: This invention relates to an improved procedure for the multiparameter analysis of leukocyte subpopulations from peripheral blood, bone marrow or any body fluid containing blood nucleated cells, including the quantification of each subpopulation in terms of cells per microliter. The method uses a cocktail of at least four monoclonal antibodies labelled each with a different fluorescent tag, the measurement of at least two light scatter and four fluorescence emissions related parameters and at least one population of fluorescent beads to differentiate and enumerate between and among the different leukocyte subpopulations in the peripheral blood, the bone marrow or other body fluid.

Abstract: A new method of cell fixation using a mild denaturing heat and the fixative PERMIFLOW™ or similar fixative that preserves cell morphology, light scatter profiles, nucleic acid content, cell surface epitopes and unmasks internal epitopes previously not available. The method can be combined with analysis of each of these parameters by flow cytometry and thus has application in drug screening and patient or tumor monitoring protocols.

Abstract: The invention relates to a composition for the stabilization of sulphur-containing amino acids and/or for the inhibition of the continuous formation of sulphur-containing amino acids in withdrawn blood, to the use of suitable substances and compositions therefor as well as optionally for the determination of sulphur-containing amino acids in blood, to a process for these purposes, as well as to a blood collecting device applied appropriately to these processes.

Abstract: Automated staining equipment that can mix reagents is used to spray a Romanowsky stain onto slide mounted specimens which are then briefly centrifuged. The centrifugation step removes excess stain leaving only a thin film. Depending on the time of the centrifugation step, most of the organic solvent and part of the water in the stain are evaporated by airflow through the equipment. This greatly accelerates the staining reaction and preserves water soluble structures such as the granules in basophilic leukocytes. For optimal performance, this staining procedure requires a thiazin-eosin stain with about 90% to about 40% organic solvent, such as methanol, and only about 10% to about 60% water. This is a unique staining reagent in Romanowsky staining.

Abstract: An apparatus is provided for hematology testing, which has a sensing unit defining a counting orifice for the flow of a blood sample through the counting orifice to analyze the blood sample, and a pump unit having three syringes. A first syringe is coupled in fluid communication with the sensing unit on the inlet side of the counting orifice for injecting a stream of blood sample through the counting orifice. A second syringe is coupled in fluid communication with the sensing chamber on the inlet side of the counting orifice for simultaneously injecting a sheath of fluid surrounding the sample stream on the inlet side of the counting orifice. And a third syringe is coupled to the sensing chamber on the outlet side of the counting orifice for aspirating a sheath of fluid from the sensing chamber surrounding the sample stream on the outlet side of the counting orifice.

Abstract: A multi-analyte calibration solution having known amounts of sodium carbonate, ammonium bicarbonate, and ethyl alcohol, with pH adjusted within a range between about 7.8 and 8.4.

Abstract: Compositions, reagents, kits, systems, system components, and methods for performing assays. More particularly, the invention relates to the use of novel combinations of reagents to provide improved assay performance.

Abstract: The invention provides a method for assaying for troponin I in a sample such as serum, the method comprising a determination of the troponin I concentration in a sample using a standard preparation that comprises a complete native troponin complex. One exemplary assay for troponin I concentration according to the invention is an immunoassay. Further contemplated in the method is a step comprising contacting the sample with a Ca2+-binding agent. Another aspect of the invention is the standard preparation comprising a complete native troponin complex. Yet another aspect of the invention is a kit for use in the assay method comprising the standard preparation, a detectable label, and a troponin I binding partner, such as an anti-troponin I antibody. All aspects of the invention are usefully practiced using human materials, such as a human troponin complex, and/or human sources for samples.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. A sample membrane is utilized having a collection region and a detection region, the collection region having a known saturation volume for the intended test sample. A barrier is defined between the collection region and the detection region. The collection region is saturated with the test sample having a volume of less than about 100 microliters so that a known volume of the test sample is contained in the collection region. The barrier is removed from between the collection region and detection region of the membrane and a diluent is supplied to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane.

Abstract: The present invention relates to a method for arresting, protecting and/or preserving an organ which includes administering effective amounts of (i) potassium channel opener or agonist and/or an adenosine receptor agonist and (ii) local anaesthetic to a subject in need thereof. The present invention also relates to a method for arresting, protecting and/or preserving an organ which comprises adding a composition which includes effective amounts of (i) a potassium channel opener or agonist and/or an adenosine receptor agonist and (ii) a local anaesthetic to the organ. The present invention further provides a pharmaceutical or veterinary composition which includes effective amounts of (i) a potassium channel opener or agonist and/or an adenosine receptor agonist and (ii) a local anaesthetic.

Abstract: Use of botulin toxin to obtain a product intended to be administered intramuscular with lissive effect in treating articular pathologies, particularly coxarthrosis, or arthrosis of the hip, epicondylitis of the elbow and rotator muscle cap pathology of the shoulder.

Abstract: To provide a hardness measurement reagent unaffected by an M alkalinity in hardness measurement. A hardness measurement reagent as a one-solution type reagent includes a dye chosen from Eriochrome Black T (EBT) and Calmagite, triethanolamine, a glycol compound, and a pH buffer, in which the pH buffer includes a combination of amines selected from primary amines and secondary amines and a salt of a weak base.

Abstract: A solid heparin tablet composition has a melting point of 25° C. or higher and is a continuous lipid component containing one or more polar lipids, one or more non-polar lipids, optionally one or several of water and mono- to trivalent alcohol in an amount of up to 15% by weight of the composition, and native heparin or fractionated heparin. Also described is a corresponding tablet, processes for production of the composition and the tablet, and a method of preventing or treating conditions amenable to preventive or therapeutic treatment by administration of the tablet.

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

Abstract: A synthetic urine solution and method of its manufacture are disclosed. The solution includes water having a pH between 3 and 10. The solution further includes creatinine and means for removing bacteria from the solution so as to control or eliminate sepsis of the urine solution, preferably through the use of biocide. The solution exhibits a specific gravity of from 1.005 g/cm3 to 1.025 g/cm3. Additional compounds may also be included to further enhance the aesthetics or apparent authenticity of the synthetic urine produced according to this invention.

Abstract: This invention provides compositions and methods for cryoprotection of recombinant live cancer cells. Specifically, an improved cryoprotective medium is provided which includes a hydroxyethyl starch and/or derivative thereof alone or in combination with either DMSO or glycerol.

Abstract: A package assembly comprising a sealed water-impermeable bag enclosing: a spiral wound filtration element comprising a piperazine-based membrane, and an aqueous solution comprises a substantially non-oxidizable buffer having capacity to sequester at least 0.0025 moles per liter of hydrogen ions. The assembly preferably further includes a reducing agent. The assembly provides improved preservation for piperazine-based membranes and elements incorporating such membranes.

Abstract: A thromboplastin reagent includes tissue factor, Factor VIIa, and a net negatively charged phospholipid. The thromboplastin reagent is a synthetic thromboplastin reagent, and is in dried form.

Abstract: A solution for preservation and/or storage of a cell or tissue is described. This simple nonaqueous composition can have 10% polyethylene glycol and 90% methanol. It can be used at room temperature. Special chemicals, equipment, and techniques are not needed. Tissue preserved with and/or stored in the solution can be processed for cytology or histology, including chemical staining and/or antibody binding, by a variety of methods; antigen, DNA, and RNA can be extracted from processed tissue in high yield and with minimal or no degradation. Advantages of the solution include: economy and safety, easy access to archival material, and compatibility with both cellular and genetic analyses. The use and manufacture of the solution are also described.

Abstract: A method of making a reference control containing a nucleated red blood cell component includes providing a blood cell containing a nucleus; treating the blood cell with a treatment solution to alter a nucleus property from a natural value to a target value suitable for simulating nucleated red blood cells on a blood analyzer; and suspending treated blood cell in a suspension medium to form a reference control. The method also includes integrating the nucleated red blood cell component with white blood cell, red blood cell, platelet and reticulocyte components. Further disclosed is a cell treatment composition for altering a nucleus property, which includes a conditioning component, a lytic component for permeating cell membrane, and a fixing component for preserving the cell nucleus. Also disclosed is a method of using the reference control for measurement of nucleated red blood cells on a blood analyzer.

Abstract: A preservation method for biological material having cell membranes includes microinjecting the cells with sugar; preparing the cells for storage; storing the biological material; and recovering the stored biological material from storage. The invention also features a method of culturing a cell in vitro using a hypertonic medium. Carbohydrate sugars such as trehalose, sucrose, fructose, dextran, and raffinose, may be used as bio-protective agents or in the culture medium.

Abstract: An isolated heart preparation in which essentially normal pumping activity of all four chambers of the heart is preserved, allowing for the use of the preparation in conjunction with investigations of electrode leads, catheters, cardiac implants and other medical devices intended to be used in or on a beating heart. The preparation may also be employed to investigate heart functions, in the presence or absence of such medical devices. In order to allow for visualization of heart structures and devices located within the chambers of the heart, a clear perfusate such as a modified Krebs buffer solution with oxygenation is circulated through all four chambers of the heart and the coronary vasculature. The preparation and recordings of the preparation may be used in conjunction with the design, development and evaluation of devices for use in or on the heart, as well as for use as an investigational and teaching aid to assist physicians and students in understanding the operation of the heart.

Abstract: The invention concerns a reagent for determination of leucocytes and measurement of haemoglobin in a sample of blood. This reagent comprises a buffer system that is suited to adjust selectively the pH of the reagent to an acidic value, at least one detergent of cationic type, a nitrogenous compound and, optionally, at least one inorganic salt. This reagent can be used in haematological analyses in human medicine and also permits the identification of a leucocytic subpopulation, in particular the basophil polymorphonuclear leucocytes.

Abstract: Platelet activation is measured by determining Mean Platelet Component (MPC) of suspended blood platelets, using a specific anticoagulant composition. The composition comprises at least one component for effecting platelet sphering (for example EDTA), and at least one platelet antagonist (for example at least one of, and preferably all three of theophylline, adenosine and dipyridamole).

Abstract: An improved reagent system for preparation of cells for flow cytometry having a physiologically compatible salt solution composition including a lysing agent, an agent for minimizing white blood cell lysis, and optionally a preservative.

Abstract: The present invention relates to a method for arresting, protecting and/or preserving an organ which includes administering effective amounts of (I) a potassium channel opener or agonist and/or an adenosine receptor agonist and (II) local anaesthetic to a subject in need thereof. The present invention also relates to a method for arresting, protecting and/or preserving an organ which comprises adding a composition which includes effective amounts of (I) a potassium channel opener or agonist and/or an adenosine receptor agonist and (II) a local anaesthetic to the organ. The present invention further provides a pharmaceutical or veterinary composition which includes effective amounts of (I) a potassium channel opener or agonist and/or an adenosine receptor agonist and (II) a local anaesthetic.

Abstract: A transport/preservation system has been found which provides safe, effective transport for patient specimens and bodily fluids, and functions as a preservative for biological reagents, therapeutics, and personal care products. The transport/preservative formulations can also be used as safe, effective sanitizers on surfaces, equipment, and appliances. The transport preservation formulation includes a biguanide and one or more other antimicrobial agents, which is cidal to microorganisms when present in a sample or on a surface to be sanitized.

Abstract: An artificial mixture which simulates human feces and its method of use for fecal occult blood testing as a control material or for proficiency testing are disclosed.

Abstract: A method for processing blood samples in order to produce DNA complex patterns for diagnostic applications.

Abstract: Controls and standards for assays and method for manufacturing the controls and standards is described. The controls or standards comprise a porous carrier material which has quantitatively reversibly absorbed and dried thereon an analyte for the control or standard wherein the analyte is not degraded over time while it is absorbed to the porous carrier material. Preferably, the controls and standards are provided as a control strip (10) in which the porous carrier material (20) is adhered to the distal end (16) of a support member (12). To quantitatively elute the analyte from the carrier to a solvent for an assay, the carrier is contacted to the same solvent used for the samples in the assay. After the analyte has been eluted, the carrier is discarded and the assay is performed. The controls and standards are useful for assays which detect bacteria, fungi, viruses, and proteins.

Abstract: The amount of platelet surface proteins in a sample may be measured by collecting a sample containing platelets into a collection tube containing a platelet stabilizing composition, labeling the platelet surface protein and detecting by cytometry.

Abstract: A stabilization reagent composition, particularly desirable for stabilizing blood samples containing platelets, contains reactants that generate multiple species of formaldehyde-ammonium complexes; at least one inhibitor of phosphatase enzymatic activity; and at least one inhibitor of protease enzymatic activity. Blood samples and other tissues are stabilized by this composition. Such stabilized samples are produced by methods for stabilizing the tissue by contacting the sample with the composition.

Abstract: A method for discriminating and counting erythroblasts comprises the steps of: (i) staining leukocytes in a hematologic sample by adding a fluorescent labeled antibody capable of binding specifically with leukocytes to the hematologic sample; (ii) raising the permeability only of cell membranes of erythroblasts in the hematologic sample to a nucleotide fluorescent dye which does not permeate a cell membrane usually, the nucleotide fluorescent dye having a fluorescent spectrum capable of being distinguished from that of a fluorescent labeling compound of the fluorescent labeled antibody in step (i); (iii) staining nuclei of the erythroblasts in the hematologic sample with the nucleotide fluorescent dye; (iv) subjecting the hematologic sample to flowcytometry to detect at least two fluorescent signals from each cell; and (v) discriminating and counting the erythroblasts from difference in intensity between the at least two fluorescent signals.

Abstract: This invention relates to preservative solutions for peptides, for example, parathyroid hormone, insulin-like growth factor binding protein 3 (IGFBP3), adrenocorticotropic hormone (ACTH) and mixtures thereof. Preferably, the peptides preserved by the solutions are non-reconstituted. In one embodiment, the preservative solutions comprise a polyvinyl alcohol, EDTA component and molybdic component.

Abstract: An aqueous control solution is disclosed for use with a spectrophotometer or photometric test strip that includes a predetermined amount of an analyte, a hydrophobic reference dye and a surfactant. In one embodiment, the aqueous control solution is applied to a photometric test strip having a chemical that oxidizes glucose and consequently forms hydrogen peroxide which reacts with an indicator dye that is also present on the strip. In this embodiment, the control solution includes a predetermined amount of glucose, an infrared reference dye, sodium dodecyl sulfate, and the indicator dye, such as sulforhodamine B.

Abstract: A lytic reagent composition and the method of use for differential analysis of leukocytes using flow cytometry are disclosed. The lytic reagent composition includes a short chain alkyl oxyethanol, such as 2-methoxyethanol, 2-ethoxyethanol, 2-propoxyethanol, or 2-isopropoxyethanol, in a sufficient amount to preserve leukocytes; a non-lysing nonionic surfactant as a debris solublizer; and an inorganic buffer to maintain pH of the lytic reagent composition in a range from 9.1 to 10.7. The lytic reagent composition is used to lyse red blood cells and preserve leukocytes, as well as used as the sheath reagent for the focus flow measurement. The lytic reagent composition, when used on a flow cytometric analyzer with multiple angle light scatter and light absorbance measurements, enables differentiation of leukocytes into five subpopulations.

Abstract: The present invention provides reagents for use in an automated environment for cell conditioning of biological samples wherein the cells or tissues are predisposed for access by reagent molecules for histochemical and cytochemical staining procedures. The components of the reagents are optimized to facilitate molecular access to cells and cell constituents within the biological sample. The present invention also provides reagents for use in an automated environment for removing or etching embedding media by exposing a biological sample to be stained in histochemical or cytochemical procedures without the dependence on organic solvents. The components of the reagents are optimized to facilitate removal or etching of the embedding media from the biological sample.

Abstract: The present invention provides storage stable, aseptic buffer solutions suitable for gamma sterilization. The buffer solutions include benzethonium chloride as a biocide, and avoid the acidification effects and the formation of precipitates that can be caused by gamma sterilization.

Abstract: A collection container and method for collecting a predetermined volume of a biological sample, and particularly a whole blood sample, includes at least one gene induction blocking agent in an amount effective to stabilize and inhibit gene induction. The gene induction blocking agent is able to stabilize nucleic acids in the biological sample at the point of collection to block ex vivo gene induction in the sample when stored at room temperature. The stabilizing agents include cationic compounds, detergents, particularly cationic detergents, chaotropic salts, ribonuclease inhibitors, chelating agents, organic solvents, organic reducing reagents, and mixtures thereof. The biological sample is collected directly from the animal and immediately mixed with the gene induction blocking agent without any intermediate processing or handling.