Abstract: Herein is reported a method for determining bacterial endotoxin at low concentrations in a sample of an antibody (that has been produced using bacterial cells) comprising the following steps in the following order: i) adding magnesium ions to the sample, ii) diluting the sample, iii) dialyzing the sample having a pH-value of 5.7-8.0 against an endotoxin-flee aqueous solution, and iv) determining bacterial endotoxin in the sample using a bacterial endotoxin test, particularly the Limulus amoebocyte lysate assay.

Abstract: The present invention provides a novel sulfated polysaccharide having anticoagulant activity. Specifically, the present invention provides a polysaccharide that includes a repetitive structure of a disaccharide unit composed of a hexuronic acid (HexA) residue and a ?-D-glucosamine (GlcN) residue and having 13% or higher of a 3-O-sulfation rate in GlcN residues.

Abstract: The present invention relates to a method for storage and subsequent lysis of a sample in which the sample is immobilized on a solid support. The solid matrix is embedded with a low concentration of both a chaotropic salt and a surfactant which act synergistically to efficiently store and lyse a biological sample.

Abstract: A chimeric protein is made from the combination of (i) a pathogen recognition module derived from a scavenger receptor and (ii) an anchor domain from a different scavenger receptor. The chimeric protein binds to specific pathogens and is useful in various treatments.

Abstract: The invention features methods for separating cells from a sample (e.g., separating fetal red blood cells from maternal blood). The method begins with the introduction of a sample including cells into one or more microfluidic channels. In one embodiment, the device includes at least two processing steps. For example, a mixture of cells is introduced into a microfluidic channel that selectively allows the passage of a desired type of cell, and the population of cells enriched in the desired type is then introduced into a second microfluidic channel that allows the passage of the desired cell to produce a population of cells further enriched in the desired type. The selection of cells is based on a property of the cells in the mixture, for example, size, shape, deformability, surface characteristics (e.g., cell surface receptors or antigens and membrane permeability), or intracellular properties (e.g., expression of a particular enzyme).

Abstract: The invention concerns a device and a method for concentrating pathogenic germs potentially present in blood products or derivatives and for detecting said germs comprising the following steps: (a) subjecting a sample of said blood product to a blood cell aggregating treatment, (b) eliminating the aggregates formed at step (a) by passing the treated sample over a first filter allowing through the contaminating germs but not the cell aggregates, (c) selectively lyzing the residual cells of the filtrate obtained at step (b), (d) recuperating the contaminating germs by passing the lysate of step (c) over a second filter to detect the contaminating germs possibly trapped.

Abstract: A process for obtaining an IgG composition involves heat treatment. This process obtains an IgG composition from an IgG solution partly purified from human plasma, in which by applying intermediate heat treatment and without using reagents to precipitate high molecular weight aggregates/polymers and/or proteins virtually total elimination of the IgG polymers generated during the process is achieved. Furthermore this process offers high productivity, lower production costs and is easy to implement in comparison with the processes of the know art. In addition to this, by using this process stability is imparted to the final product in liquid.

Abstract: The present invention concerns compositions and methods of extracting infectious pathogens from a volume of blood. In one embodiment, the method includes the steps of creating a fibrin aggregate confining the pathogens and introducing a fibrin lysis reagent to expose the pathogens for analysis. The present invention also concerns materials and methods for removing aurintricarboxylic acid (ATA) from a sample.

Abstract: A method of measuring binding between hemoglobin and a microbe of interest includes: providing hemoglobin from a source of interest; contacting the hemoglobin with a microbe of interest; and measuring the binding affinity between the hemoglobin and the microbe, wherein the binding affinity is indicative of microbe virulence in the presence of the hemoglobin.

Abstract: A method and an apparatus using acridine orange for sorting particles to precisely carry out the measurement of cells in the blood are provided. The cells in the blood is sorted by the steps of staining cells in the blood with acridine orange, irradiating light on the cells in the blood, determining staining behavior using platelets as a staining indicator, and sorting the cells in the blood.

Abstract: The invention features methods for separating cells from a sample (e.g., separating fetal red blood cells from maternal blood). The method begins with the introduction of a sample including cells into one or more microfluidic channels. In one embodiment, the device includes at least two processing steps. For example, a mixture of cells is introduced into a microfluidic channel that selectively allows the passage of a desired type of cell, and the population of cells enriched in the desired type is then introduced into a second microfluidic channel that allows the passage of the desired cell to produce a population of cells further enriched in the desired type. The selection of cells is based on a property of the cells in the mixture, for example, size, shape, deformability, surface characteristics (e.g., cell surface receptors or antigens and membrane permeability), or intracellular properties (e.g., expression of a particular enzyme).

Abstract: The present invention relates to methods and systems for the isolation of DNA on a microfluidic device and the subsequent analysis of the DNA on the microfluidic device.

Abstract: A multifunctional reagent for erythrocytes containing an amount sufficient to produce the lysis of erythrocytes or the sphering of erythrocytes in such a way that they can be detected by a cytometer or an automatic counting device, of a carbamate or of an agent inducing the formation by the erythrocytes, from carbonate and from a nitrogenated heterocycle or ammonium ions, of a carbamate combined with the absorption of CO2 by the erythrocytes, process for lysing or sphering erythrocytes and preparation process for leucocytes.

Abstract: The present invention relates to methods and systems for microfluidic DNA sample preparation. More specifically, embodiments of the present invention relate to methods and systems for the isolation of DNA from patient samples on a microfluidic device and use of the DNA for downstream processing, such as performing amplification reactions and thermal melt analysis on the microfluidic device.

Abstract: A system and method for cleanup of biological samples from contaminants prior to spectroscopy analysis. The system includes a support configured to hold a sample including a liquid having at least one group of biological molecules with a surface of the support binding the molecules at a surface tension angle to the liquid of less than 180 degrees. The system includes an evaporator configured to evaporate liquid from the support, a solvent applicator configured to apply a solvent for dissolution of the contaminants in the sample, and a solvent removal device configured to remove applied solvent from the sample and thereby at least partially remove the contaminants.

Abstract: The present invention relates to fusion proteins and their use in enzymatic treatment of Alzheimer's disease patients. Said fusion protein comprises a component that cleaves the amyloid beta (Ab) peptide e.g. neprilysin, insulin degrading enzyme (IDE), another component that modulates the half-life in plasma e.g. the Fc portion of IgG or PEG; and a third component that connects the first two components.

Abstract: A method for determining the presence and/or amount of an analyte in a sample of whole blood comprises the step of treating the sample with a nonlytic hypertonic salt composition to reduce the hematocrit by reducing the size of the red blood cells. In optical detection systems, the smaller red blood cells create greater scatter, which allows a more accurate correction to be applied in a dual-wavelength detection system. In electrochemical detection systems, as well as in optical detection systems, the smaller red blood cells provide less obstruction to the diffusion of analyte and reagents in the sample, to facilitate the reactions thereof.

Abstract: Carbonyl stress-ameliorating agents have been provided, which contain an enzyme having a glyoxalase I activity and a carbonyl compound-reducing agent as the active ingredients. The carbonyl stress-ameliorating agents of the present invention rapidly eliminate carbonyl compounds, and thus ameliorate carbonyl induced stress conditions.

Abstract: This invention relates to clinical diagnostic assays, related optical bio-discs, and a disc-reading apparatus. The invention is directed to methods and apparatuses for performing immunohematology assays using an optical bio-disc analysis system. The invention is further directed to an optical bio-disc for performing an immunohematologic assay including a substrate having encoded information associated therewith. The encoded information may be readable by a disc drive assembly to control rotation of the disc. The disc may also include at least one target zone or capture zone associated with the substrate. The target zone is disposed at a predetermined location relative to a center of the substrate. The disc further includes a plurality of capture antibodies immobilized within the target zone, a flow channel, fluidic circuit, or analysis chamber associated with the target zone, and an input site in fluid communication with the analysis chamber.

Abstract: The invention relates to an apparatus system and methods for treatment of virus-infected or pathogen-loaded human blood components separated from normal components comprising a separation apparatus and treatment apparatus system that inactivate pathogens in an extracorporeal body fluid system.

Abstract: A novel cell seeded hollow fiber bioreactor is described as a potential bioartificial kidney. Endothelial cells along with pericyte, vascular smooth muscle, and/or mesangial cells or any mesenchymally derived support cells are seeded along a hollow fiber in a perfused bioreactor to reproduce the ultrafiltration function and transport function of the kidney. Maintenance of tissue specific function and ultrastructure suggest that this bioreactor provides an economical device for treating renal failure.

Abstract: An object of the present invention is to provide a method of treatment and a method of storage that are useful in conducting a nucleic acid synthesis procedure capable of directly amplifying an intended nucleic acid in a living body-derived sample without purification steps. The present invention provides a method for synthesis of nucleic acids in which a living body-derived sample itself is mixed with a reaction solution for gene amplification and allowed to react, which method comprises treating the sample with a surfactant before the reaction to destruct solid components such as cells or bacterial bodies containing nucleic acids and uniformly disperse them in the sample liquid.

Abstract: The present invention is directed to a pharmaceutical composition comprising F(ab′)2 antibody fragments that are preferably free from albumin and of whole antibodies and also substantially free of pyrogens, and an effective amount of a pharmaceutically acceptable carrier. It is also directed to a method for the production of a pharmaceutical composition comprising F(ab′)2 antibody fragments using serum or blood plasma of a mammal that has been previously immunized, as a source of antibodies. The serum or blood plasma is digested with pepsin, followed by separation and purification until the pharmaceutical composition of F(ab′)2 fragments is free of albumin and complete antibodies, and substantially free of pyrogens.

Abstract: A method of producing a protein degradation product is provided, by which a protein (including a peptide) in a sample can be degraded quickly and efficiently. A sample containing a protein is treated with a protease in the presence of the tetrazolium compound to give a protein degradation product. Further, by causing a redox reaction between the glycation site of a glycated protein degradation product obtained by this method and a fructosyl amino acid oxidase, and then determining this redox reaction, it is possible to determine the amount of a glycated protein quickly. As the tetrazolium compound, 2-(4-iodophenyl)-3-(2,4-dinitrophenyl)-5-(2,4-disulfophenyl)-2H-tetrazolium salt etc. can be used.

Abstract: Compositions and methods for ameliorating the clinical signs of an avian pneumovirus (APV) infection in a bird are disclosed. The compositions include immunologically effective amounts of an attenuated, cold-adapted APV. Methods for preparing an attenuated, cold-adapted APV composition are also described.

Abstract: An object of the present invention is to provide a novel method for suppressing the action of nucleic acid synthesis inhibitory substances and thereby amplifying a nucleic acid in a sample efficiently. According to the present invention, in a method for synthesis of nucleic acids to amplify an intended nucleic acid in a sample, the sample is brought in advance into contact with an insoluble polymer of a polyanion, a sulfated polymer or a sulfated polysaccharide, to remove nucleic acid synthesis inhibitory substances.

Abstract: There are provided an adsorbent which can effectively adsorb and remove endogenous cannabinoid in fluid, and a process for removing endogenous cannabinoid in fluid by means of the adsorbent. The adsorbent of endogenous cannabinoid is obtained by fixing a compound having a log P value (P indicating distribution coefficient in octanol-water system) of at least 3.50 on a water-insoluble carrier. Endogenous cannabinoid in fluid can be adsorbed and removed in an effective manner by contacting the adsorbent of endogenous cannabinoid with fluid containing endogenous cannabinoid.

Abstract: A process for the isolation and purification of nucleic acids and/or oligonucleotides for use in gene therapy wherein said nucleic acids and/or oligonucleotides are isolated or purified from an essentially biological source, characterized in that said essentially biological sources are lysed, the fractions obtained are optionally freed or depleted from the remainder of said biological sources by per se known mechanical methods, such as centrifugation, filtration; the fractions thus treated are subsequently treated with affinity chromatographic material or with inorganic chromatographic material for the removal of endotoxins; followed by isolation of said nucleic acids and/or oligonucleotides on an anion exchanger which is designed such that DNA begins to desorb from the anion exchanger only at an ionic strength corresponding to a sodium chloride solution of a concentration higher by at least 100 mM than one corresponding to the ionic strength at which RNA begins to desorb from the anion exchanger material.

Abstract: A method to remove cryoprotectants from cryopreserved biological cells and tissues is described. Enzymes are used to convert compounds used as cryoprotectants for cells during cryopreservation to membrane impermeable products. This process effectively removes the cryoprotectant chemicals from the cells prior to their use in transfusion, transplantation, insemination or other applications, without causing osmotic damage due to cell swelling. Methods are described for subsequent removal of the enzymes and enzyme conversion products from the cell and tissue preparations.

Abstract: An additive formulation comprising heparinase and trehalose, a method for using the formulation and a device containing the formulation. The additive formulation is useful in substantially neutralizing residual heparin from a blood sample when used in a blood collection tube without interfering with the clinical analysis of the blood sample.

Abstract: The invention herein provides a method for recovering a polypeptide comprising exposing a composition comprising a polypeptide to a reagent which binds to, or modifies, the polypeptide, wherein the reagent is immobilized on a solid phase; and then passing the composition through a filter bearing a charge which is opposite to the charge of the reagent in the composition, so as to remove leached reagent from the composition.

Abstract: A method for lowering the extractable protein content in a natural rubber latex to below 30 parts per million (ppm) comprises the steps of treating by washing a rubber article, such as a rubber glove, with an aqueous solution containing a soluble silicate and, optionally, a protease. The methods claimed effectively reduce the allergenicity of the articles so treated.

Abstract: The present invention relates to devices and methods for the collection, storage, and purification of nucleic acids, such as DNA or RNA, from fluid samples for subsequent genetic characterization, primarily by conventional amplification methods. The present invention can be used to collect, store, or purify nucleic acids from a treated whole blood source that has naturally occurring nucleic acid amplification inhibitors present, as well as added blood stabilization components that also inhibit nucleic acid amplification. More importantly, these nucleic acids can be released after collection or storage in a manner that enables them to be amplified by conventional techniques such as polymerase chain reaction. In particular, an absorbent material that does not bind nucleic acids irreversibly is impregnated with a chaotropic salt. A biological source sample is contacted with the impregnated absorbent material.

Abstract: A stable, single liquid alpha-amylase assay reagent comprises a polysaccharide or long chain oligosaccharide substrate for alpha-amylase having an optically detectable label bonded to the reducing end glucose, by a bond cleavable by alpha- or beta-glucosidase, and a blocking group bonded to the terminal end glucose. The reagent further comprises beta-amylase and either alpha- or beta-glucosidase. Sorbitol is provided in an amount of about 5% to retard degradation of the enzymes. Zwitterionic buffers are also provided to stabilize the enzymes. In preparing the reagent, the enzymes and substrate are filtered through a 0.2 micron or less filter to remove alpha-amylase producing organisms.

Abstract: The present invention herein provides a method for collecting insect hemolymph which permits the collection of hemolymph, at a time, from a vast number of insect bodies, which does not cause any scattering of the hemolymph during collection thereof, which may widely be used, which permits the collection of the hemolymph free of unnecessary tissues or the like and which can inhibit the melanization of the collected hemolymph. The insect hemolymph can be collected by freezing anesthetized lepidopterous insects, piercing the epidermis of the frozen insects without damaging the alimentary canals thereof and then thawing them in a buffer solution containing a melanization-inhibitory agent to thus discharge the hemolymph of the insects into the buffer solution through the holes while making use of the self-contraction phenomenon caused during the thawing process.

Abstract: A process is disclosed for reducing or removing endotoxins from compositions containing therapeutic active substances extracted from natural sources by genetic engineering and/or biotechnology. For that purpose, the compositions are treated with chromatographic materials. The natural sources are disintegrated, the thus obtained fractions are, if required, centrifuged, filtered or treated using affinity chromatography methods, the fractions are pre-incubated in an aqueous salt solution and detergents, are treated with anion exchange materials, then washed with another salt solution. The active substances are eluted from the anion exchanger then further purified in a manner known per se.

Abstract: The present invention contemplates methods of decontaminating human fluids prior to processing in the clinical laboratory. The techniques handle large volumes of human serum without impairing the testing results. Novel compounds for photodecontaminating biological material are also contemplated which are compatible with clinical testing, in that they do not interfere with serum analytes.

Abstract: A method of increasing efficiency of deantigenation of blood group epitopes on erythrocytes (seroconversion) by exoglycosidases utilizing a step of performing the deantigenation in a zwitterionic buffer. The method provides a buffer system and exoglycosidase that utilizes a twenty to one hundred fold lower total enzyme mass than the prior art methods.

Abstract: The invention relates to an anti-HIV agent comprising, as an active ingredient, at least one porphyrin derivative selected from the following derivatives (A) and (B):(A) porphyrins modified with a compound selected from carbodiimides, alkylenediamines and alcohols; and(B) complexes of a plasma protein or a chemically modified plasma protein and a porphyrin which may have been modified with a compound selected from carbodiimides, alkylenediamines and alcohols.This anti-HIV agent is excellent in killing effect on HIV-infected cells, inhibitory effect on cytopathy due to HIV infection and HIV-replication inhibiting effect, and high in safety.

Abstract: This invention relates to a specimen handling device for collecting, storing, processing and dispensing of samples. The invention provides for the collection of specimens from any solid or semi-solid material, including biological samples, food samples, waste samples or soil samples.

Abstract: This invention relates to a process for the amplification of nucleic acids in the form of DNA or RNA from blood samples by means of an enzymatic amplification method, characterized in that no preparation of the blood sample otherwise necessary to prepurify the nucleic acid to be amplified is performed and the proportion of the sample in the reaction mixture for the amplification process is greater than 5 volume % if a specific amount of salt is present in the reaction mixture. Depending on the proportion of blood sample and its salt contribution of monovalent and/or bivalent ions, the salt concentration in the reaction mixture in which the amplification is performed is, where applicable, adapted to the enzyme requirements by the use of an appropriately concentrated salt solution.

Abstract: In order to avoid the risk of undesired side reactions of blood products, the latter are produced from plasma by using chymotrypsin to inactivate prekallikrein activator. These preparations are obtained by the fractionated enrichment of plasma proteins, with the proviso that a chymotrypsin solution or immobilized chymotrypsin is added to the fractions at any stage of the fractionation process. Before completion of the preparations, the chymotrypsin or the immobilized trypsin is removed from the preparations.

Abstract: A heparinase formulation derived from Flavobacterium heparinum which meets all requirements for a clinical reagent that can eliminate heparin interference of normal blood function has been developed. The heparinase, derived from Flavobacterium heparinum, is free of a component that inhibits coagulation. It is stable under normal manufacturing, shipping and clinical storage conditions for at least one year. The heparinase in useful in vitro to eliminate the interference in hematological assays due to the presence of heparin. The heparinase is also useful for the in vivo neutralization of heparin during surgical procedures. Advantages of this preparation are that it achieves neutralization faster and more completely than previously available compositions and is stable for long periods of time.

Abstract: There is disclosed a method of determining the presence of incompatibility-reaction-causing substances in blood products. There is also disclosed a method of inactivating incompatibility-reaction-causing substances in blood products to be applied therapeutically and prophylactically. For this purpose, a fraction obtained from human or animal blood is treated with pancreas enzymes bound to water insoluble carrier material and, optionally, the fraction is subjected to further fractionation and concentration.

Abstract: This invention provides a rapid and highly effective method for extracting nucleic acids from cells or virions without the use of proteolytic enzymes. Extraction is accomplished within a few minutes using a lysing composition comprising a buffer, a source of a DNA polymerase cofactor, a stabilizer and at least one nonionic surfactant which will release nucleic acids from cytoplasmic and nuclear membranes of cells or virions. The resulting mixture is heated to boiling for up to fifteen minutes, and the nucleic acids are recovered for amplification using polymerase chain reaction. No proteolytic enzyme is used in the extraction process.

Abstract: Process for the specific determination of the serum fructosamine content in blood or in samples obtained from blood by reaction with an appropriate color reagent and measurement of the color change thereby brought about, in which before the color reaction sample components with a non-specific reducing action and/or causing turbidity are removed and subsequently the color reagent is added at a pH value of from 10 to 12. The sample components are removed by treatment at approximately neutral pH value with a reagent composition comprising at least one enzymatic oxidation agent, optionally together with peroxidase and/or catalase and/or lipase, as well as with at least one SH group-blocking substance. A kit for the specific determination of the serum fructosamine content in blood or samples obtained from blood, comprises said reagent composition, a rebuffering reagent with a buffer which has an alkaline pH value and a color reagent for the detection of fructosamine.

Abstract: In order to avoid the risk of undesired side reactions of blood products, the latter are produced from plasma by using chymotrypsin to inactivate prekallikrein activator. These preparations are obtained by the fractionated enrichment of plasma proteins, with the proviso that a chymotrypsin solution or immobilized chymotrypsin is added to the fractions at any stage of the fractionation process. Before completion of the preparations, the chymotrypsin or the immobilized trypsin is removed from the preparations.

Abstract: A cocktail reagent preparation for the rapid production of serum contains thrombin, snake venom, and protamine sulfate. The preparation employs very small quantities of clot promoting substances which behave in a synergistic manner such that rapid clotting of highly heparinized blood is achieved without altering the chemical analysis of the blood enzymes, proteins, sugars, or electrolytes. Thus, clinicians who rely upon the results of such tests can more closely monitor organ and tissue function and adjust patient therapies accordingly.

Abstract: A process for the determination of fructosamine in body fluids by the reaction of a sample solution with a color reagent, wherein the sample liquid is mixed with a buffer solution having a pH value of from 9 to 12, a color-forming reagent and uricase, as well as with at least one detergent, and the chronological change of the extinction is measured kinetically in a temperature range of from 20.degree. to 40.degree. C. at the earliest after 5 minutes.

Abstract: A biochemical procedure for identification and characterization of cells in a biopsy or sample of a body fluid. The method can be used to determine cell type, i.e. epidermal, neuronal; tissue of origin, i.e. breast tissue, liver tissue; and degree of abnormality. The procedure can also be used to make antibodies and hybridization probes to detect cell or tissue specific antigens and nuclear matrix associated nucleic acids in cellular material and body fluids.The procedure is based on the isolation and analysis of the components of a specific subcellular protein fraction referred to here as the "nuclear matrix". The nuclear matrix includes proteins and nuclear matrix associated DNA specific to different cell types. These proteins and nucleic acids are altered or new ones expressed as a result of viral infection, genetic defects or malignancy.