Abstract: An improved rapid diagnostic device, assay and multifunctional buffer reagent are provided for the detection of a target analyte in a fluid test sample. The 2-step assay utilizes a dual component flow-through device comprising a test unit and a post-filter unit capable of receiving the fluid sample and multifunctional buffer, respectively. The test unit comprises a reaction zone containing immobilized capture reagent that can specifically bind to the target analyte, an absorbent zone supporting the reaction zone, and optionally, a blood separation zone in lateral fluid communication with the reaction zone. The post-filter unit comprises a label zone permeated with a dried indicator reagent which is capable of being placed in transient fluid communication with the reaction zone of the test unit during the assay procedure. The rapid diagnostic assay system reduces the number of assay reagents, method steps and time required for performance compared to other conventional assays.

Abstract: The present invention is directed to a fixative composition, the use of the fixative composition in preparing cytological or histological specimens, and a method of preparing particulate matter, such as cytology, hematology and microbiology specimens, for examination by collecting the particulate matter in a uniform layer, preferably a monolayer, and fixing the particles in a composition according to the present invention. The cytological, hematological, microbiological and histological fixative composition of the present invention contains an aldehyde crosslinker, a polyol and a detergent. The method of the present invention for preserving the particulate or histological specimen uses the fixative composition containing an aldehyde crosslinker, a polyol and a detergent.

Abstract: Improved flow cytometer system particularly adapted to use for sex-selected sperm sorting include enhanced sheath fluid and other strategies which minimize stress on the sperm cells, including a 2.9 percent sodium citrate sheath solution for bovine species and a HEPES bovine gamete media for equine species. Improved collection systems and techniques for the process are described so that commercial applications of sperms samples as well as the resulting animals may be achieved.

Abstract: The invention provides a new single channel, single dilution method and system for identifying, analyzing and quantifying the cellular components of whole blood using a single channel, rather than multiple channels, of an automated hematology analyzer utilizing flow cytometry and the detection of the light scattered and absorbed by each cell. The single channel utilized in the method was previously known and used only for red blood cell and reticulocyte analysis. The method involves the use of an organic dye in the reagent solution for staining the nucleic acid of reticulocytes, including reticulated platelets, and white blood cells in the sample. The single channel method developed and described is particularly useful for determining white blood cell counts and assessing parameters of a whole blood sample, for blood samples from both human and non-human mammals.

Abstract: The present invention relates to a method of carrying out blood tests. The invention is based on the finding that clinico-chemical blood parameters can be determined using not only blood serum but also blood plasma. Therefore, freshly taken blood samples, which are mixed with at least one thrombin inhibitor, can be used for determining both clinico-chemical parameters and hematological parameters. The clinico-chemical parameters can thus be determined using blood plasma, a separation of coagulable components being not required any more.

Abstract: A dual-filled twin bag, a packaging including the twin bag, and a method for forming the packaged twin bags are provided. Each of two bags, a solution bag (10)and a drain bag (12) for a system used for a peritoneal dialysis procedure, are filled, at least partially, with a solution (14). A tubing set (16) connects the two filled bags (10,12) and may also be filled with solution (14) which is added to the bags (10,12) and the tubing set (16) during the manufacturing process. Alternatively, the tubing set (16) may be filled with air. The tubing set (16) is sandwiched between the solution bag (10) and the drain bag (12) and subsequently packaged in an overpouch (24). The method for forming the package including the bags filled with solution is simplified and the overall package size is reduced due to the sandwiched tubing set (16) between the solution bags (10,12) and the provision of solution in both bags (10,12).

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: A non invasive method for determining the blood coagulation status of a human or an animal is described. F1+2, F1, F2, FpA, D-dimers, F1+2 combined with F1, or F1+2 combined with F2 are measured in saliva, sputum and related biological samples. The respective concentrations are inversely correlated to the time it takes blood to coagulate and the probability of bleeding, and directly correlated to the probability of in-vivo formation of a thrombus or emboli. The method can be used in any coagulation disorder study, including congenital, acquired or drug-induced.

Abstract: A blood component deposition-preventing agent and a blood coagulation accelerator are provided, which are substantially indifferent to blood coagulation activity and serum chemistry parameters. Also provided is plastic blood test ware and a blood test matrix which do not confound measured values. A blood component deposition-preventing agent comprising a random copolymer of a monomer component (a) giving a water-soluble homopolymer and a monomer component (b) giving a water-insoluble homopolymer, a blood coagulation accelerator comprising a substantially blood-insoluble antimicrobial composition comprising a carrier and, as supported thereon, an antimicrobial metal, and a blood test ware or matrix carrying them on its inside wall or surface are provided.

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: An anticoagulant for blood cell counting containing at least two kinds of the following antiplatelet agents: theophyllines, adenosines and dipyridamoles. The anticoagulant also contains citric acid, an alkali metal salt thereof or a mixture of citric acid and an alkali metal salt thereof.

Abstract: The invention provides a bicarbonate-containing, crosslinker-free reagent composition which reverses and/or reduces sample handling effects, such as aeration-induced shrinkage and storage-induced swelling of cells in a whole blood sample, particularly for a blood sample requiring repeated sampling and/or subjected to long-term storage. The reagent composition serves as a diluent medium for a blood sample, or an aliquot or portion thereof. The pH of the reagent is in the range of about 7.2 to about 7.5, preferably 7.3. The stability of the pH 7.2-7.5 bicarbonate-containing reagent over time is maintained by storing the reagent in a flexible collapsible container which is impermeable to carbon dioxide and is comprised of a multilayered flexible material, preferably plastic, and attachable to a hematology analyzer.

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: What is shown is an animal blood anticoagulant compound useful in the meat packing industry generally, and in slaughterhouse operations, particularly. The anticoagulant is effective when diluted with water at higher dilution ratios than earlier anticoagulants. In some field trials, this anticoagulant was at least as effective as previously known commercial anticoagulants when diluted by an additional 30%. The present anticoagulant preparation concentrate is an aqueous mixture of soft water (55.0%-65.0/%, w/w); tetrasodium ethylene diamine tetraacetate (Na4EDTA) (0.5%-3.0%, w/w); sodium hexametaphosphate (17.0%-24.0%, w/w); citric acid (5.0%-9.0%, w/w); and sodium hydroxide (4.0%-7.0%, w/w) to obtain a balanced pH that provides optimal chelating and anticoagulant activity. Optimal anticoagulant performance has been found to occur in the range of between pH 6.6 and pH 7.2.

Abstract: The present invention is directed to a fixative composition, the use of the fixative composition in preparing cytological or histological specimens, and a method of preparing particulate matter, such as cytology, hematology and microbiology specimens, for examination by collecting the particulate matter in a uniform layer, preferably a monolayer, and fixing the particles in a composition according to the present invention. The cytological, hematological, microbiological and histological fixative composition of the present invention contains an aldehyde crosslinker, a polyol and a detergent. The method of the present invention for preserving the particulate or histological specimen uses the fixative composition containing an aldehyde crosslinker, a polyol and a detergent.

Abstract: Histamine may be quantitatively measured by performing the following steps. First, an oocyte that expresses histamine receptors is held in a recess formed at the bottom of a vessel. Then, first and second electrodes are inserted into the oocyte. Subsequently, the membrane potential of the oocyte is measured by using the first electrode to stabilize this membrane potential at a predetermined level by driving a current through the second electrode using circuitry for clamping the membrane potential of the oocyte. A sample is then infused into a fine reacting tube having an antigen immobilized on its inner surface together with some buffer solution to promote a histamine releasing reaction. The solution containing histamines that is released in the fine reacting tube is transferred to the vessel to make contact with the oocyte in the vessel.

Abstract: A system, composition and method for the stabilization of biological specimens, which employs a chemical fixative.

Abstract: Hematology control compositions and systems used to measure a plurality of parameters in a blood sample are provided. The hematology control compositions are particularly useful as a control for multi-parameter, automated instrument systems. The control compositions comprise a reticulocyte component, a white blood cell component, a red blood cell component, a nucleated red blood cell component, a platelet component and a reticulated platelet component. Methods of making and using the control compositions are also provided.

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 provides solutions and methods for preserving living biological materials that enable organs, tissues and cells to be stored for extended periods of time with minimal loss of biological activity. The inventive solutions are substantially isotonic with the biological material to be preserved and are substantially free of dihydrogen phosphate, bicarbonate, nitrate, bisulfate and iodide. In one embodiment, preferred for the preservation of platelets, the solutions comprise betaine, sodium chloride and sodium citrate. For the preservation of many living biological materials, the inventive solutions preferably contain a calcium salt selected from the group consisting of calcium sulfate and calcium chloride.

Abstract: Human papillomavirus (HPV) antigen formulations are disclosed which prevent protein aggregation and show prolonged stability as aqueous solutions. These formulations comprise a salt (such as sodium chloride) and a non-ionic surfactant (Polysorbate 80 such as Tween 80®) in physiologically acceptable concentrations.

Abstract: Disclosed is a stabilized enzyme composition for use in clinical examination, comprising: (a) an enzyme component comprising at least two enzymes selected from the group consisting of alkaline phosphatase, creatine kinase and alanine aminotransferase; (b) a stabilizer component comprising effective stabilizing amounts of an albumin, and at least one saccharide selected from the group consisting of trehalose and sorbitol; and (c) an aqueous medium having dissolved therein the components (a) and (b). The enzyme composition of the present invention is stable for a prolonged period of time not only under non-freeze refrigeration conditions, but also under freezing conditions or under conditions for non-freeze refrigeration after thawing of the frozen composition, as compared to the conventional enzymatic compositions.

Abstract: Histamine may be quantitatively measured by performing the following steps. First, an oocyte that expresses histamine receptors is held in a recess formed at the bottom of a vessel. Then, first and second electrodes are inserted into the oocyte. Subsequently, the membrane potential of the oocyte is measured by using the first electrode to stabilize this membrane potential at a predetermined level by driving a current through the second electrode using circuitry for clamping the membrane potential of the oocyte. A sample is then infused into a fine reacting tube having an antigen immobilized on its inner surface together with some buffer solution to promote a histamine releasing reaction. The solution containing histamines that is released in the fine reacting tube is transferred to the vessel to make contact with the oocyte in the vessel.

Abstract: Histamine may be quantitatively measured by performing the following steps. First, an oocyte that expresses histamine receptors is held in a recess formed at the bottom of a vessel. Then, first and second electrodes are inserted into the oocyte. Subsequently, the membrane potential of the oocyte is measured by using the first electrode to stabilize this membrane potential at a predetermined level by driving a current through the second electrode using circuitry for clamping the membrane potential of the oocyte. A sample is then infused into a fine reacting tube having an antigen immobilized on its inner surface together with some buffer solution to promote a histamine releasing reaction. The solution containing histamines that is released in the fine reacting tube is transferred to the vessel to make contact with the oocyte in the vessel.

Abstract: A system, composition and method for the stabilization of biological specimens, which employs a chemical fixative.

Abstract: Histamine may be quantitatively measured by performing the following steps. First, an oocyte that expresses histamine receptors is held in a recess formed at the bottom of a vessel. Then, first and second electrodes are inserted into the oocyte. Subsequently, the membrane potential of the oocyte is measured by using the first electrode to stabilize this membrane potential at a predetermined level by driving a current through the second electrode using circuitry for clamping the membrane potential of the oocyte. A sample is then infused into a fine reacting tube having an antigen immobilized on its inner surface together with some buffer solution to promote a histamine releasing reaction. The solution containing histamines that is released in the fine reacting tube is transferred to the vessel to make contact with the oocyte in the vessel.

Abstract: Histamine may be quantitatively measured by performing the following steps. First, an oocyte that expresses histamine receptors is held in a recess formed at the bottom of a vessel. Then, first and second electrodes are inserted into the oocyte. Subsequently, the membrane potential of the oocyte is measured by using the first electrode to stabilize this membrane potential at a predetermined level by driving a current through the second electrode using circuitry for clamping the membrane potential of the oocyte. A sample is then infused into a fine reacting tube having an antigen immobilized on its inner surface together with some buffer solution to promote a histamine releasing reaction. The solution containing histamines that is released in the fine reacting tube is transferred to the vessel to make contact with the oocyte in the vessel.

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: The present invention provides an improved solution for staining proteins in and/or on a solid matrix or support. Typically, a protein-containing gel or membrane may be washed in a hot solution of water for about five minutes, stained in a hot solution of COOMASSIE brilliant blue dye in dilute aqueous mineral acid for about five minutes, and then rinsed in water. The washing and/or staining steps may be performed by placing the gel in a wash and/or staining solution, respectively, heating the solution in which the gel is placed to boiling in a microwave oven, and incubating the gel in the solution for about five minutes. The entire procedure can be performed in a little over ten minutes, which represents an enormous time savings over existing methods.

Abstract: The present invention is directed to an antigen diluent or buffer for antigens, in particular HCV recombinant antigens, comprising a reducing agent. The antigen diluent or buffer serves as a stabilizing buffer for the antigens. The present invention is also directed to antigen diluents or buffers for use in an automated immunoassay.

Abstract: The present invention encompasses methods of increasing stability of biological substances during drying and the dried compositions derived therefrom. The compositions have improved storage stability.

Abstract: This invention has for its object to provide a blood component deposition-preventing agent and a blood coagulation accelerator, which are substantially indifferent to blood coagulation activity and serum chemistry parameters and a plastic blood test ware and a blood test matrix which do not confound measured values. The invention relates to a blood component deposition-preventing agent comprising a random copolymer of a monomer component (a) giving a water-soluble homopolymer and a monomer component (b) giving a water-insoluble homopolymer, a blood coagulation accelerator comprising a substantially blood-insoluble antimicrobial composition comprising a carrier and, as supported thereon, an antimicrobial metal, and a blood test ware or matrix carrying them on its inside wall or surface.

Abstract: An assembly for collection of a blood sample includes a hydrophobic plastic tube and a non-exudable block or graft copolymer having a hydrophobic domain compatible with and interpenetrated in the matrix of the tube plastic and a hydrophilic domain which provides a hydrophilic interior wall surface to the container. The invention includes a method to make the container.

Abstract: A sample handling system comprising: a transportation line including a combination of plural partitive line units; and a plurality of handling units, wherein each of the plural partitive line units and each of the plurality of handling units form a pair, and each handling unit is installed removably from its corresponding partitive line unit. Each handling unit transmits inoperative information to the transportation line when it becomes inoperative. The transportation line transmits this inoperative information to the central controller. The central controller monitors handling units at which the sample rack can stop over. The sample rack avoids stopover at the inoperative handling unit, but is allowed to advance to the subsequent handling unit passing through the partitive line unit which makes a pair with the inoperative handling unit.

Abstract: A composition including polyethylene glycol (PEG) and glutathione (GSH), is used to treat vascular grafts prior to cryopreservation. The PEG and GSH containing composition is use to treat vascular tissue grafts prior to their cryopreservation to ameliorate the onset of intimal hyperplasia. The composition can also be used to treat vascular tissue grafts prior to cryopreservation by incorporation into solutions used for vascular tissue graft transport and/or in other vascular tissue graft processing steps.

Abstract: An infusible-grade storage medium that is capable of preserving the viability and function of stem cells, nucleated cells and other hematopoietic cells is provided.

Abstract: Histamine may be quantitatively measured by performing the following steps. First, an oocyte that expresses histamine receptors is held in a recess formed at the bottom of a vessel. Then, first and second electrodes are inserted into the oocyte. Subsequently, the membrane potential of the oocyte is measured by using the first electrode to stabilize this membrane potential at a predetermined level by driving a current through the second electrode using circuitry for clamping the membrane potential of the oocyte. A sample is then infused into a fine reacting tube having an antigen immobilized on its inner surface together with some buffer solution to promote a histamine releasing reaction. The solution containing histamines that is released in the fine reacting tube is transferred to the vessel to make contact with the oocyte in the vessel.

Abstract: The present invention is directed to an antigen diluent or buffer for antigens, in particular HCV recombinant antigens, comprising a reducing agent. The antigen diluent or buffer serves as a stabilizing buffer for the antigens. The present invention is also directed to antigen diluents or buffers for use in an automated immunoassay.

Abstract: Disclosed is CPG, a combination of a chlorhexidine salt (such as chlorhexidine digluconate, chlorhexidine diacetate, or chlorhexidine dichloride) and n-propyl gallate that can be used at ambient temperatures as a urine preservative.

Abstract: New human papilloma virus (HPV) vaccine formulations exhibit enhanced long-term stability. Formulation components can include: virus-like particles (VLPs) absorbed onto aluminum, a salt, non-ionic surfactant, and a buffer. Additional formulations also contain a polymeric polyanionic stabilizer and a salt either in the presence or absence buffering agents and nonionic detergent.

Abstract: The invention relates to compounds inhibiting the activation of FX to FXa by TF/FVIIa. The compounds are anticoagulants. The invention also relates to a method of identifying a drug candidate.

Abstract: An improved apparatus and method for evaluating platelet functionality of a blood sample. The apparatus includes a plurality of test cells. Each of the cells includes a platelet function restoration agent, an anticoagulant agent, and a clotting reagent. At least one of the cells also includes a platelet activating agent. The clotting time is determined for each of the aliquot portions, and the relative clotting times of the aliquot portions in the cells are determinative of the platelet functionality of the sample. The method includes the steps of combining a platelet function restoration agent, an anticoagulant agent, a platelet activating agent, and the sample of blood to be tested to form a test mixture. The platelets of the sample are activated by adding a clotting reagent to the test mixture at the start of the activated clotting time test, and the activated clotting time test is terminated upon detecting a predetermined change in a property of the test mixture.

Abstract: A blood analyzing instrument includes a single transducer for simultaneously measuring the DC volume, RF conductivity, light scattering and fluorescence characteristics of blood cells passing through a cell-interrogation zone. Preferably, the transducer includes an electro-optical flow cell which defines a cell-interrogation zone having a square transverse cross-section measuring approximately 50×50 microns, and having a length, measured in the direction of cell flow, of approximately 65 microns.

Abstract: The present invention is an additive preparation for use in bodily fluid collection devices. The additive preparation has an additive, an organic acid and a metal carbonate compound. The preparation effervesces when in contact with a body fluid sample, thereby efficiently dispersing in a body fluid sample. The formulation is desirably tabulated to provide an effective, easily stored, and handled preparation. However, a binding or bulking agent may be added to the additive preparation formulation to provide binding and lubricating properties to the formulation. A binding agent enables granulating of the formulation without the forming of a pellet.

Abstract: Aqueous blood-sample diluting reagent and method of its use for compelling a morphological change in a blood sample to yield an MCV value assayed at elapsed time after the sample is drawn to be consistent within a diagnostically acceptable range with the original, immediate post-drawing MCV value. Selection of a small amount of a predetermined surfactant added within a limited range of concentration, and of a salt for adjusting osmotic pressure of the sample is thereby determined. The blood sample is treated with an anti-coagulant agent immediately post-drawing, and for assay in a particle analyzer at post-drawing elapsed time is diluted with the reagent solution. The reagent has an osmotic pressure (&pgr;) of approximately 150-400 mOsm/kg and a pH of 6.0-8.5. The surfactant is present in a 0.0005% to 0.5% concentration and has a hydrophile-lipophile balance (HLB) of 10-20.

Abstract: This invention provides a method for prolonging the preservation of human blood platelets at reduced temperatures. The method uses an inhibitor system that enables blood platelets to retain their functional integrity during storage. In addition, the inhibitor system prevents the generation of cytokines in the platelet preparation during storage at both 22° C. and 4° C. This is accomplished by interrupting normal platelet function during storage, so as to help keep platelets from activating and losing their shape. Before using the platelets in a transfusion, they are returned to their normal functional level by washing the inhibitor system away from the platelets.

Abstract: Hematology control compositions and systems used to measure a plurality of parameters in a blood sample are provided. The hematology control compositions are particularly useful as a control for multi-parameter, automated instrument systems. The control compositions comprise a reticulocyte component, a white blood cell component, a red blood cell component, a nucleated red blood cell component, a platelet component and a reticulated platelet component. Methods of making and using the control compositions are also provided.

Abstract: The invention provides methods for drying platelets to obtain compositions which are storage stable over a wide range of temperatures and for an extended period of time. The invention also provides compositions obtained thereby and devices for use therein.

Abstract: A method for testing a cell suspension comprises the steps of: (1) diluting a portion of the cell suspension such that the liquid of the diluted suspension has the same osmolality as the extra cellular liquid of the cell suspension (plasma), and (2) subjecting the cells in the diluted suspension formed in step (1) to a cell size measurement while suspended in said diluted suspension. The method involves the testing of cells at their in vivo osmolality, thereby minimizing the possibility of swelling over time and mimicking the cells in vivo condition in respect of its osmotic environment.

Abstract: Blood samples are stabilized for methemoglobin determination with a buffer composition containing (a) carbon monoxide-containing water; (b) sodium tetraborate or potassium tetraborate; and (c) KCN or NaCN. The buffer composition preferably may also have an erythrocytolysis agent. The buffer fixes the valence state of heme iron at a concentration representative of the blood at the time of collection, and maintains that fixed state for an extended period of time preventing further methemoglobin formation. The buffer also prevents reduction of existing target analyte, i.e., methemoglobin (ferric hemoglobin, Fe3+ hemoglobin) to normal reduced hemoglobin (ferrous hemoglobin, Fe2+ hemoglobin).