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 invention provides printing systems and methods for depositing small volumes of liquid on solid substrates. These systems and methods are useful with a wide variety of liquids and substrates and offer a wide variety of applications, including the deposition of arrays of analytes. In particular embodiments, the systems comprise a preservation device, a detachable ganged plurality of printing devices, and/or a wire bonding capillary.

Abstract: This invention provides for a rapid and convenient method of simultaneous collection of both genomic and diagnostic information from a single sample on a bibulous pad by differential extraction of the diagnostic information from the genomic information. It is a surprising discovery of this invention that a PCR assay on the contents of the bibulous pad provides results comparable in reliability, specificity, and sensitivity to the best available serum (blood) based assays. The assays of this invention can be used to confirm each other, either by detecting the genomic information leading to the diagnostic information, or by detecting in the genomic information, a predisposition to a disease and confirming the presence of the disease through diagnostic testing.

Abstract: The invention relates to a method for preparing blood samples for detecting homocysteine and/or total folate and is characterized in that the blood sample is brought into contact with (a) at least one reagent for lysis of the blood cells, (b) at lease one inhibitor of the enzymes which produce and break down homocysteine, and optionally (c) at least one acid.

Abstract: The invention relates to surfaces coated with streptavidin and avidin for use in immunoassays, wherein the surfaces comprise a layer of streptavidin and avidin which are bonded on a surface of a solid supporting material through a biotinylated adhering agent.

Abstract: For blood or other physiological fluid sample collection kits that use filter paper to collect the sample the performance of the kit and associated analytical method can be improved by using a material having properties which are superior to those of standard filter paper or modified filter paper routinely used in standard biological assays. Certain materials currently available for uses other than blood collection, storage, or transport have properties that are advantageous as employed in assays of biological fluids, including the use of specific glass fiber blotting materials for collecting blood samples for hemoglobin or hemoglobin A1c monitoring.

Abstract: The present invention relates to methods in which ion exchange resins are used to reduce the amount of substances which interfere with nucleic acid hybridization in samples. The methods also stabilize the samples. Kits containing the ion exchange resins render the methods convenient to use.

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 herein is an assay of a denatured lipoprotein, in which the denatured site of the denatured lipoprotein contained in a vital sample is exposed to the surface of its lipoprotein particle upon the reaction of an antibody, which recognizes the denatured lipoprotein, with the vital sample containing the denatured lipoprotein.

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: 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: 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).

Abstract: For blood or other physiological fluid sample collection kits that use filter paper to collect the sample, the performance of the kit and associated analytical method can be improved by using a material having properties which are superior to those of standard filter paper or modified filter paper routinely used in standard biological assays. Certain materials currently available for uses other than blood collection, storage, or transport have properties that are advantageous as employed in assays of biological fluids, including the use of specific cellulose blotting materials for collecting blood samples for hemoglobin or hemoglobin A1c monitoring.

Abstract: A sample is prepared from blood in a manner which makes it possible to further analyze proteins in the sample, e.g. to detect prions in the sample. Blood is extracted, allowed to clot and subjected to separation processing (e.g. centrifugation) to obtain serum. The serum is treated with a complexing agent which agent binds prions in the sample forming an agent/protein complex which makes it possible to concentrate the complex. Concentration of the complex results in a sample which can be successfully analyzed, e.g. assayed using a range of different types of assay methodologies for detecting prions.

Abstract: Undesirable metal cation contaminants, including cadmium, can be removed from a solution containing Indium-111, on a bed of an anion exchange resin. The thus purified solution can be stored and transported in a polypropylene vial, to prevent the possibility of cadmium entering the solution from a glassware wall and of Indium from being lost from the solution by chemically reacting with a glassware wall. The vial can be sealed with a rubber stopper which has a polytetrafluroethylene coating facing the solution to prevent the possibility of contaminants which could interfere with later uses of the Indium-111 from leaching into the solution from the rubber stopper. Recipients of the Indium-111-containing vial can be provided with a prepackaged column of the anion exchange resin to enable such recipients to remove the cadmium which accumulated in the solution as a product of radioactive decay during shipment.

Abstract: A composition and a method for using the composition for manipulating the electronic and optical properties of biological particles are disclosed. The composition generally has a hypotonic buffering solution, a polyhydroxy alcohol, a stabilizing agent, and, in some applications, a non-ionic surfactant. By varying the relative concentrations of these components and by adjusting the timing of their combination and interaction, the composition and method allow for the alteration of the electronic and optical properties of the particles to achieve target values for the properties. In one particularly advantageous application, the composition and method of the invention allow for the creation of selected analogs for the subpopulations of human leukocytes from a single biological particle for use as a control product in differentiating particle analyzers.

Abstract: A method for stabilizing analyses 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 a method of preserving a liquid biological sample, comprising the step of: contacting said liquid biological sample with a preservative comprising: sodium benzoate in an amount of at least about 0.15% of the sample (weight/volume); and citric acid in an amount of at least about 0.025% of the sample (weight/volume).

Abstract: Disclosed herein is a method for the detection of a target substance by a colloidal gold immunoassay, which comprises dissolving in an immunoreaction system a metal salt selected from the group consisting of sodium, potassium and lithium fluorides, sodium, potassium, lithium and magnesium iodides, sodium, potassium, lithium and magnesium bromides, lithium and magnesium chlorides, sodium, potassium, lithium and magnesium nitrates, sodium, potassium, lithium and magnesium sulfates, sodium, potassium, lithium and magnesium formates, sodium, potassium, lithium and magnesium acetates, and mixtures of at least two of these metal salts, whereby the metal salt is allowed to exist in a reaction mixture.

Abstract: Disclosed are methods for measuring non-contractile oxidative metabolism in smooth muscle cells comprising providing a medium suitable for the support of oxidative metabolism, incubating a cell or tissue sample with a specimen from a patient, measuring a marker of oxidative metabolism in the incubate, and detecting an increase in oxidative metabolism which is not attributable to a contractile demand for ATP. Such an increase in oxidative metabolism will be indicative of the existence of an agent or combination of agents able to cause an increase in oxidative metabolism in smooth muscle cells, and thus provides means for diagnosing and monitoring various pathologies associated therewith.

Abstract: A method and device for detecting airborne, infectious microorganisms in indoor air and collecting them for rapid identification. Diseased air is drawn into an enclosed chamber where it is percolated through a liquid such that many of the microorganisms become encapsulated in the liquid. The liquid is then atomized to ensure encapsulation of microorganisms which may have escaped encapsulation in the percolation step, and then separated from the air. The relatively slow drawing rate and delicate percolation through the liquid preserves the integrity of the microorganisms. The air is released into the room, while the microorganism-containing liquid is directed to a reservoir. A magnetic substance is added to the reservoir. The microorganism-containing liquid is passed through an electromagnetic field whereupon the microorganisms are attracted to the magnetic surface. These microorganisms are thereafter removed for analysis. The remaining liquid is recycled.

Abstract: A preservative mixture in particular for preserving diagnostic test liquids, contains the sodium salt of mercaptopyridine-N-oxide together with a further preserving substance. A diagnostic test kit according to the invention contains mercaptopyridine-N-oxide sodium salt, a compound from the isothiazolone group and in particular 2-alkyl-3-(2H)isothiazolone hydrochloride with 1 to 8 C atoms in the 2-alkyl group or a preservative mixture according to the invention as the preservative for one or several test liquids of the test kit.

Abstract: The present invention provides stabilizing formulations for maintaining and preserving the integrity of proteins and polypeptides present in a body fluid sample obtained ex-vivo and to be evaluated as a test specimen for either clinical, therapeutic, or research purposes. The stabilizing formulations may be prepared alternatively either as a dry, anhydrous mixture of powders or as an aqueous based liquid containing the dissolved ingredients in admixture. The invention also provides minimalist stabilizing formulations as well as fortified stabilizing formulations which meet specific uses and applications and may be advantageously employed over a wide variety of different time, temperature, and severity of conditions.

Abstract: The present invention relates to a hematology control product for automated hematology instruments containing an aqueous solution of at least one blood cell analog, an absorbance agent in an amount sufficient to simulate a hemoglobin concentration, and a stabilizing agent in an amount sufficient to stabilize the size of the blood cell analog when the control product is subjected to temperature ranging from -15.degree. C. to 45.degree. C. The control product does not require controlled temperature storage for product stability. In addition, a novel method of using a hematology control product is provided wherein the control product contains a single blood cell analog and is used to simulate both red blood cells and white blood cells on an automated hematology instrument.

Abstract: A fluid collection, filtration, and storage device is described. The device has a first tube with a closed first end, an open second end, inner tube-wall surfaces, and an internal diameter; a second tube with a first end porously closed by a filter and an open second end and having an external diameter smaller than the internal diameter of the first tube, the second tube slidably contacting the inner tube-wall surfaces of the first tube at the first end of the second tube when the second tube is inserted in the first tube; and a cap adapted to seal the open second end of the first tube and the open second end of the second tube in a single closing operation while the second tube is inserted into the first tube. The kit is particularly adapted for collecting and storing viscous biologic samples, such as saliva, in the inner tube after the sample has been mixed with a preservative or other substance initially located in the filter.

Abstract: A method of detecting heparin-induced antibodies to complete a diagnosis of heparin-induced thrombocytopenia (HITP) is disclosed. This method comprises the first step of attaching a glycosaminoglycan to a solid support, wherein the glycosaminoglycan is attached to the solid support only at the reducing end of the molecule (unidirectionally). Platelet factor 4 is then bound to the glycosaminoglycan forming a complex having an epitope recognizable by antibodies generated in an HITP immune response. Human blood plasma or serum from a patient suspected of having HITP is exposed to the complex and the complex is analyzed to determine if HITP-related antibodies are present. A device and kit used in performing the diagnostic assay are also disclosed.

Abstract: A reagent for measurement of leukocytes and hemoglobin concentration in the blood includes a cationic surfactant in an amount sufficient to lyse erythrocytes and denature hemoglobin, at least one of the following hemoglobin stabilizers:(a) sulfosalicylic acid, or its salt, in an amount effective for promoting the conversion of hemoglobin into methemoglobin,(b) 0.2 to 10.0 g/L of a water-soluble chelating agent having a nitrogen atom and a carboxyl group, and(c) piperazine, or its salt, in an amount effective for promoting the conversion of hemoglobin into methemoglobin, anda buffer for maintaining pH at 4 to 6.

Abstract: An improved method for detecting even low titer HLA antibodies in proposed organ transplant recipients employs flow cytometry crossmatching (FCXM) on pronase-treated B-cells and T-cells of the donor. Two-color FCXM is preferably employed. The peripheral blood lymphocytes, after pronase digestion, are maintained under conditions to suppress Fcy R receptor regeneration, combined with sera of the proposed transplant recipient, and tested against control sera, using fluorescent reporting complexing agents. Use of pronase digested lymphocytes permits the assay to distinguish between normal or irrelevant IgG B cell binding and immunologically important HLA antibody binding.

Abstract: The object of the present invention is to claim a composition which when added to a patient sample containing a target antigen in an acidic or formalin-containing transport medium neutralizes the acid and formalin while preserving immunoreactivity of the antigen allowing its detection. The composition comprises an amino glycol buffer, an amino acid, a salt, and a non-ionic detergent. A further object of the present invention is to claim a method of processing a sample by adding a composition comprising an amino glycol buffer, an amino acid, a salt, and a non-ionic detergent.

Abstract: A blood collection device comprising formed additive particles. The additive particles are an improvement over available additive formulations that are powder blended in that the components of the additive particles of the present invention are in each formed particle. The formed additive particles comprise a fluoride salt and an ethylenediaminetetraacetate salt or a heparin salt to consistently minimize glycolysis and coagulation of a blood specimen with low hemolysis.

Abstract: A diagnostic method is provided for inflammatory bowel disorders (IBD), based on the relative levels of eosinophil granule proteins in physiological samples obtained from the GI tract of mammals suspected of having an IBD.

Abstract: A method is provided for differentiating leukocyte subpopulations, immunophenotyping of lymphocytes and counting white blood cells. The method preserves leukocyte morphology and surface markers without using fixatives. In addition, the method finds utility in determination of hemoglobin concentration without using cyanide. The stable hemoglobin chromogen formed is measured at approximately 540 nm.

Abstract: Disclosed are improvements for enzyme-catalyzed reactions involving DNA or RNA, including restriction digests, which are based on conducting such reactions in the presence of lipids.

Abstract: A method for staining fecal specimens to diagnose stool parasites preserved with a non-mercury fixative wherein the preserved specimen is stained with a composition of iron hematoxylin stain and trichrome stain.

Abstract: A kit of two liquid reagent components for determining the fructosamine content of a blood sample measured by color change, and methods of determining fructosamine content of a blood sample using these two liquid reagents are disclosed.

Abstract: A pre-determined concentration of stabilized, maturation-arrested porcine reticulocytes in a red blood cell base, useful as a reticulocyte control composition. The composition can be provided in the form of a concentrated reticulocyte composition, to be diluted to a desired final reticulocyte concentration at the time of use. The composition can also be provided in the form of a diluted, ready-to-use control composition. Also included is a method of preparing such a composition, the method involving sequential steps of forming and sedimenting Rouleaux bodies.

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: 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: The cytogenetic chamber includes a chamber enclosure, a drying cavity in the enclosure, a door and a hand-insertion port through the door. A slide-supported, fixative-treated cell (prepared outside the chamber or in situ in the chamber) is in the drying area and air flows through the entirety of the drying area at a substantially uniform (and relatively low) flow rate. The fixative dries at substantially the same drying rate, irrespective of the location of the slide in the drying area. A related method is also disclosed. The invention is particularly useful for chromosome spreading and results in a significantly-increased percentage of metaphases having metaphase areas in the optimal range of 2,500 to 4,500 squared microns.

Abstract: A fluid collection, filtration, and storage device is described. The device has a first tube with a closed first end, an open second end, inner tube-wall surfaces, and an internal diameter; a second tube with a first end porously closed by a filter and an open second end and having an external diameter smaller than the internal diameter of the first tube, the second tube slidably contacting the inner tube-wall surfaces of the first tube at the first end of the second tube when the second tube is inserted in the first tube; and a cap adapted to seal the open second end of the first tube and the open second end of the second tube in a single closing operation while the second tube is inserted into the first tube. The kit is particularly adapted for collecting and storing viscous biologic samples, such as saliva, in the inner tube after the sample has been mixed with a preservative or other substance initially located in the filter.

Abstract: A lytic reagent composition is provided which selectively stromatolyses red blood cells in a blood sample. In addition, a lytic reagent system is provided which enables the differentiation of at least three subpopulations of leukocytes. A method for using the lytic reagent system is also provided. Still further, the lytic reagent system finds use in the determination of the hemoglobin in the blood. The lytic reagent system utilizes an alkyl sulfate, polyoxyethylene based surfactant and acid with a hypertonic, alkaline, stabilizing reagent. The system and analysis method maintains the cellular morphology of the leukocytes and can be used to analyze normal and abnormal blood samples, fresh and aged blood, human and non-human animal blood samples.

Abstract: A fluid collection, filtration, and storage device is described. The device has a first tube with a closed first end, an open second end, inner tube-wall surfaces, and an internal diameter; a second tube with a first end porously closed by a filter and an open second end and having an external diameter smaller than the internal diameter of the first tube, the second tube slidably contacting the inner tube-wall surfaces of the first tube at the first end of the second tube when the second tube is inserted in the first tube; and a cap adapted to seal the open second end of the first tube and the open second end of the second tube in a single closing operation while the second tube is inserted into the first tube. The kit is particularly adapted for collecting and storing viscous biologic samples, such as saliva, in the inner tube after the sample has been mixed with a preservative or other substance initially located in the filter.

Abstract: A lateral flow assay device for detecting the presence of Chlamydia antigen in patient's samples comprises a flow matrix including a labelling zone and a capture zone. Labelling complex comprising antibodies specific for an epitope on the lipopolysaccharide antigen of Chlamydia is present within the labelling zone. Immobilized antibody specific for the same or another epitope of the lipopolysaccharide antigen of Chlamydia is located in the capture zone. The sample containing the Chlamydia antigen will flow first through the labelling zone, where it complexes with the labelling complex, and then to the capture zone, where it is captured by the immobilized antibody. Chlamydia antigen may be extracted from a patient sample, such as a endocervical swab, by first extracting the antigen in a strong base followed by neutralization with a zwitterionic detergent and a blocking protein present in a zwitterionic buffer.

Abstract: A method and device for detecting airborne, infectious microorganisms in indoor air and collecting them for rapid identification. Diseased air is drawn into an enclosed chamber where it is percolated through a liquid such that many of the microorganisms become encapsulated in the liquid. The liquid is then atomized to ensure encapsulation of microorganisms which may have escaped encapsulation in the percolation step, and then separated from the air. The relatively slow drawing rate and delicate percolation through the liquid preserves the integrity of the microorganisms. The air is released into the room, while the microorganism-containing liquid is directed to a reservoir from which samples may be extracted for analysis. The liquid is recycled.

Abstract: Method of detecting urobilinogen in urine using a chemical detection means with an indicator that will produce a detectable quantitative response in the presence of, or lack of urobilinogen in urine on an automated analyzer.

Abstract: Disclosed herein is a cell containing a modified peptide. More specifically, the N-terminal amino acid residue of the peptide is modified by the addition of an aryl ketone group which, when contacted with an appropriate substrate, and exposed to light having a wavelength of about 330 nm or greater, results in the covalent bonding of the peptide to the substrate by a C--H insertion dominant mechanism. In preferred, embodiments, the aryl ketone is a benzophenone moiety. The peptide can be designed to specifically bind to a protein of interest in the cell. The cell is then contacted with light having a wavelength of greater than about 330 nm to bind the peptide covalently to the binding site on the intracellular protein of interest. In this way, the modified peptide can be used to specifically and irreversibly block a binding site on an intracellular protein of interest.

Abstract: Method for the incubation of specimens (7) in fluids (5) for subsequent embedding in capsules by polymerization, the specimens (7) being put into hole capsules (2') which are open at the top and, in the lower third of their cylindrical wall, have at least a circle of passage orifices (6) which are smaller than the diameter of the specimens (7). These specimens (7) are incubated in a fluid (5) extending above these passage orifices (6). The hole capsules (2') are then introduced into enveloping capsules (3) of a larger diameter and with a likewise preferably cylindrical wall, a fluid (5) (a polymerizable monomer batch) present in the enveloping capsules (3) filling at least the gap (S) between the hole capsule (2') and the enveloping capsule (3), and this fluid (5) being finally polymerized under UV radiation or action of heat. The hole capsules (2') and the enveloping capsules (3) can be successively slipped over rams (4') which are located on a carrier (1).

Abstract: A particle separator is provided for collection and manipulation of target particles, e.g., target cells, in a closed sterile field condition. In one embodiment, closed sterile field conditions are maintained from separation through concentration and/or cryo treatment steps and/or transfusion. Preservation of closed sterile field condition are accommodated by using the same integrally coupled rigid-walled vessel for collection and concentration and transfer via integrally coupled conduits to a vessel for cryopreservation and/or transfusion.In one embodiment, a plurality of valves are responsive to a data processor for controlling the path of fluid flow through the particle separator. A plurality of sensors are provided for providing sensor signals indicative of fluid flowing through the cell separator. A peristaltic pump is responsive to the microprocessor assembly for controlling the speed and direction of fluid flow through the system.

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 invention features a method of labeling a cell containing an intracytoplasmic target molecule involving (1) permeabilizing the plasma membrane of the cell so that (a) a reagent capable of detectably labeling the intracytoplasmic target molecule can traverse the plasma membrane into the cytoplasm of the cell; and (b) substantially all of the intracytoplasmic target molecule and the DNA of the cell remain in the cell; and (2) contacting the cell with the reagent to label the intracytoplasmic target molecule. The method may further involve detecting the label in the cell, and isolating the cell on the basis of detecting the label in the cell. The invention also includes cells permeabilized using the method of the invention.