Abstract: Systems and assay methods are disclosed for detecting an autoantibody in a sample. In certain instances, the systems and methods employ a mass tag releasably connected to an antigen. The tag is thereafter released for detection. A tag can be detected by mass spectrometry or in certain instances the tag is fluorescent. Methods for diagnosing a disease or disorder in a subject are also disclosed.

Abstract: The present invention relates to an immunoglobulin G concentrate for therapeutic use, in which the respective contents of anti-A and anti-B antibodies are in accordance with a negative result in the in vitro indirect Coombs test. This IgG concentrate also has a polyreactive IgG content of between 0.01% and 0.1%, in particular between 0.07% and 0.1%, relative to the total content of IgG.

Abstract: Ultrasound-assisted particle agglutination assay methods and apparatuses are described based on first providing a standing wave ultrasound field at a resonance frequency of a test liquid in a resonator cell containing microparticles covered with a binding agent with high affinity to an analyte sought to be detected by the assay test. Formation of the specifically-bound and nonspecifically-bound aggregates of these microparticles is then followed by effective stirring of the liquid with swept-frequency sonication causing disintegration of nonspecifically-bound aggregates and leaving specifically-bound aggregates in place for further detection and measurement. The methods and devices of the invention allow significant improvement in the sensitivity and specificity of agglutination tests and are advantageously applicable to detecting various proteins, DNA, RNA and other biologically active substances. Specific examples are provided.

Abstract: A method of detecting ovarian cancer in a female test subject comprising determining the amount of plasmenyl-PA or a biomarker having a mass charge ratio of approximately 655.3 in a sample of a bodily fluid taken from the female test subject and comparing the amount of plasmenyl-PA (or the biomarker) in the sample of the bodily fluid taken from the female test subject to a range of amounts of plasmenyl-PA (or the biomarker) found in samples of bodily fluids taken from a group of normal female subjects of the same species as the female test subject and lacking ovarian cancer, whereby a lower amount of the plasmenyl-PA (or the biomarker) in the sample of the bodily fluid taken from the female test subject indicates the presence of ovarian cancer.

Abstract: The invention relates to the detection and determination of erythrocytopathies and hemoglobinopathies. The invention provides a method for distinguishing between subsets of red blood cells in a sample involving contacting the sample with at least a first marker reagent reactive with a first component of a red blood cell and with at least a second marker reagent reactive with a second component of a red blood cell and determining the reactivity of the marker reagents with the cells.

Abstract: The invention provides compositions and methods for cell separation. These reagents and techniques specifically agglutinate cells via surface antigen recognition and can be used to recover even rare cell types in high yield.

Abstract: This invention relates to nucleotide polymorphisms in the human Apo(a) gene and to the use of Apo(a) nucleotide polymorphisms in identifying whether a human subject will respond or not to treatment with acetylsalicylic acid.

Abstract: The present invention relates to methods of detecting specific cell surface antigens present in a sample of cells being tested and in particular blood group antigens, which methods do not employ the addition of extrinsic labels to detect said cell surface antigens. Typically detection is carried out using an intrinsic fluorescence capability of the cells being tested.

Abstract: A blood crossmatching apparatus, kit and methods for testing the compatibility of mammals for blood transfusion. Particulate layers in the apparatus allow nonagglutinated red blood cells to permeate through, while agglutinated red blood cells cannot. The apparatus also has a density solution layered above particulate layers. The density solution separates white blood cells from red blood cells in the whole blood when centrifuged, without lysing the red blood cells. Thus, the apparatus can be used to test whole blood.

Abstract: A process for the detection of antibodies in a test sample by carrying out the following steps: (a) preparing a suspension of erythrocytes with a test serum or plasma by mixing a test serum or plasma with erythrocytes; (b)incubating the suspension formed in step (a) at a temperature of from 37° C. to 45° C. for a period of time from sixty seconds to 10 minutes to bind any antibodies in the test serum or plasma to the surface of said erythrocytes (c)combining said suspension with an amount of a solution of a macromolecule which is effective for agglutination of said erythrocytes; (d) packing the resultant red cell agglutinates by centrifugation from the suspension of step (c); and, (f) determining the presence of anti-erythrocyte antibodies by observing if antibody-dependent erythrocyte aggregation has occurred.

Abstract: A process for the detection of antibodies in a test sample by carrying out the following steps: (a) preparing an essentially isotonic and low ionic strength suspension comprising said test sample and erythrocytes; (b) incubating the erythrocytes, test sample and low ionic strength medium at 37-45° C. for various time periods to optimize antibody uptake; (c) combining said suspension with an amount of a solution of hexadimethrine bromide which is effective for agglutination of said erythrocytes and (d) separating the resultant agglutinates of polymer and erythrocytes from said suspension; (e) neutralizing the effect of hexadimethrine bromide by adding an effective amount of a gylcosaminoglycan in combination with other polybrene neutralizing agents; (f) monitoring the resuspended agglutinates for the presence or absence of antibody; (g) stabilizing the antibody dependent aggregate by adding an effective macromolecule as a component of the dispersing solution or separately and optionally.

Abstract: The invention relates to agglutination assays and related kits, reagents and devices. In particular methods of assaying small analytes having few epitopes are disclosed, by means of using hub moieties to which multiple analytes may be bound by a first epitope, together with a further moiety capable of binding a second analyte epitope and which is also capable of binding to a detectable particle. Stable agglutinated complexes may be so formed, which may used as the basis for various assay formats.

Abstract: Polypeptides capable of forming antigen binding structures specific for Rhesus D antigens include the sequences indicated in the FIGS. 1a to 16b. The obtained polypeptides, being Fab fragments, MAY be used directly as an active ingredient in pharmaceutical and diagnostic compositions. The Fab and their DNA sequences can also be used for the preparation of complete recombinant Anti-Rhesus D antibodies. Useful in pharmaceutical and diagnostic compositions.

Abstract: An optical analysis disc includes grooves defining corresponding laser-readable tracks and trigger marks that identify respective target regions on the disc. The trigger marks are implemented as a radial interruption of the grooves to thereby produce an increased reflection of a laser beam. There is also provided an optical analysis disc system including a trigger mechanism having a trigger detector adapted to detect interruptions in grooves of an optical analysis disc. A related method for triggering through interrupted grooves of an optical analysis disc includes detecting interruption in the grooves, generating an electrical reflection signal corresponding to the interruptions detected, and elaborating said reflection signal, so that to generate a trigger signal.

Abstract: A method for the enumeration of micronucleated erythrocyte populations while distinguishing platelet and platelet-associated aggregates involves the use of a first fluorescent labeled antibody having binding specificity for a surface marker for reticulocytes, a second fluorescent labeled antibody having binding specificity for a surface marker for platelets, and a nucleic acid staining dye that stains DNA (micronuclei) in erythrocyte populations. Because the fluorescent emission spectra of the first and second fluorescent labeled antibodies do not substantially overlap with one another or with the emission spectra of the nucleic acid staining dye, upon excitation of the labels and dye it is possible to detect the fluorescent emission and light scatter produced by the erythrocyte populations and platelets, and count the number of cells from one or more erythrocyte populations in said sample.

Abstract: Methods for diagnosing and monitoring systemic lupus erythematosus (SLE) or scleroderma by determining, in a blood sample from the individual being diagnosed or monitored, complement component C4d deposited on surfaces of red blood cells in the sample, and optionally also determining complement receptor CR1 deposited on the red blood cell surfaces. For diagnosis this is compared with the quantity of C4d (and optionally CR1) present on red blood cells of normal individuals. For monitoring it is compared with a value in a sample or samples previously obtained from the individual patient. The comparison may be made with individual values for C4d and CR1 and/or with a ratio of the two found in normal individuals.

Abstract: The present invention discloses an assay for determining the presence of an anti-PEG antibody in a biological sample. Embodiments according to this aspect of the present invention will generally have the steps of: (1) providing an antigen probe capable of forming an antibody-antigen complex with the anti-PEG antibody; (2) contacting the biological sample with the antigen probe under conditions favorable for formation of the antibody-antigen complex; and (3) analyzing the antigen probe, after having performed step (2), to detect for the presence of the antibody-antigen complex, wherein the presence of the anti-PEG antibody is determined if the antibody-antigen complex is detected. Also disclosed are methods for screening patients, methods for monitoring patients using assays of this invention and kits for performing thereof.

Abstract: The present disclosure relates to computational methods and systems associated with nutraceutical related assays.

Abstract: A single measurement can quantify phosphatidyl-inositol glycan complementation class A (PIG-A) associated proteins in red cells, platelets and the major leukocyte subsets present in blood (lymphocytes, monocytes, neutrophils and eosinophils). The single measurement relies on flow cytometry to simultaneously evaluate intensity of fluorochrome emissions and light scattering properties.

Abstract: A method and apparatus for preparing biological cell samples for intracellular analysis. The invention is based upon the recognition that many of the steps of the conventional methods for such sample preparation can be eliminated, leading to a process that readily lends itself to automation and the advantages associated therewith. The method of the invention comprises the steps of (a) cell-fixation, (b) permeabilization and (c) staining (or labeling) of intracellular molecules of interest by probes that are readily detectable by flow cytometric techniques, all without any intervening cell-washing (and re-suspension) steps. Rather, the single cell-washing step is effected after these three steps have been carried out. Preferably, the washing step is carried out by passing the fixed, permeabilized and stained cell sample through a semi-permeable membrane that serves to filter out (by transmission) interferants to waste while retaining the cells of interest.

Abstract: A B-lymphocyte classifying method includes the steps of (1) preparing a measurement sample by mixing a blood sample with a lysing reagent to lyse erythrocytes and to shrink the B-lymphocytes in the blood sample, (2) letting the measurement sample flow through a flow cell of a flow cytometer, (3) radiating a light beam onto a cell in the measurement sample that is flowing through the flow cell, (4) detecting at least two scattered light emitted from the irradiated cell, (5) specifying a region of a B-lymphocyte cluster in accordance with the detected scattered light, and (6) counting the number of B-lymphocytes in the specified region.

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: The present invention provides an immunoassay method in which blood can be measured even without pretreatment by means of a centrifuge etc. In the present invention, antibodies or antigens in a sample are subjected to agglutination reaction with insoluble carriers onto which antigens or antibodies specifically reacting with the antibodies or antigens in the sample have been immobilized and the resulting agglutination mixture is determined for the change in its absorbance or in its scattered light by irradiation with light, wherein said sample is whole blood and the whole blood is forcibly lyzed.

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: An optical analysis disc includes grooves defining corresponding laser-readable tracks and trigger marks that identify respective target regions on the disc. The trigger marks are implemented as a radial interruption of the grooves to thereby produce an increased reflection of a laser beam. There is also provided an optical analysis disc system including a trigger mechanism having a trigger detector adapted to detect interruptions in grooves of an optical analysis disc. A related method for triggering through interrupted grooves of an optical analysis disc includes detecting interruption in the grooves, generating an electrical reflection signal corresponding to the interruptions detected, and elaborating said reflection signal, so that to generate a trigger signal.

Abstract: Rh antibody hybrids for use in testing red blood cells for the presence of one or more Rh factors. The Rh hybrid antibody may also be used in therapeutic procedures which require the use of Rh antisera. The hybrid antibody includes an IgG anti-Rh antibody which has a polymeric tailpiece attached to the carboxy terminal end of each of the IgG antibody heavy chains. A hemagglutinin method is provided for Rh phenotyping in which agglutination of Rh-positive red blood cells is achieved in a one-step process involving addition of the hybrid Rh antisera to the red blood cells being tested.

Abstract: A method for measuring polyamines in erythrocytes in which a polyamine oxidase having a substrate specificity to spermine and spermidine or a polyamine oxidase having a substrate specificity to spermine only is used, an eluate in erythrocytes separated and purified from blood is reacted with these enzymes, and hydrogen peroxide formed is determined with a highly sensitive chromogen1 such as a diphenylamine-based chromogen. A method for measuring amounts of polyamines in erythrocytes easily with high precision. The method is effective for diagnosis of certain disease conditions or physiological conditions or the like.

Abstract: The invention provides compositions and methods for cell separation. These reagents and techniques specifically agglutinate cells via surface antigen recognition and can be used to recover even rare cell types in high yield.

Abstract: Conjugates of nonimmunogenic valency platform molecules and analogs of immunogens that possess the specific B cell binding ability of the immunogen but lack T cell epitopes and which, when introduced into individuals, induce humoral anergy to the immunogen are disclosed. Accordingly, these conjugates are useful for treating antibody-mediated pathologies that are caused by foreign or self immunogens.

Abstract: A tube and float system for use in separation and axial expansion of the buffy coat is provided. The system includes a transparent, or semi-transparent, flexible sample tube and a rigid separator float having a specific gravity intermediate that of red blood cells and plasma. The sample tube has an elongated sidewall having a first cross-sectional inner diameter. The float consists of a main body portion and one or more support members protruding from the main body portion to engage and support the sidewall of the sample tube. The main body portion and the support members of the float have a cross-sectional diameter less than that of the first cross-sectional inner diameter of the tube when the sample tube is expanded, such as by centrifugation. The main body portion of the float together with an axially aligned portion of the sidewall define an annular volume therebetween.

Abstract: Polypeptides capable of forming antigen binding structures specific for Rhesus D antigens include the sequences indicated in the FIGS. 1a to 16b. The obtained polypeptides, being Fab fragments, MAY be used directly as an active ingredient in pharmaceutical and diagnostic compositions. The Fab and their DNA sequences can also be used for the preparation of complete recombinant Anti-Rhesus D antibodies. Useful in pharmaceutical and diagnostic compostions.

Abstract: A method of producing an erythroid cell which is substantially undifferentiated but which is capable of expressing a heterologous protein under the control of a globin promoter thereof, which method comprises maintaining growing uninduced erythroid cells in culture for sufficient period of time that the protein is expressed, and isolating a subclone which expresses said protein. Erythroid cells produced by the method, and methods of detecting the interaction of an insect G-protein coupled receptor with an endogenous signaling cascade of erythroid cells are also described and claimed.

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: An assay for detecting type IV cytosolic phospholipase A2(cPLA2) or a protein immunologically homologous to type IV cPLA2, the assay comprising use of red blood cells, particularly for use in the diagnosis of a disease in which dysfunction of cell signalling systems involving highly unsaturated fatty acids is implicated.

Abstract: This invention provides a method for determining the presence of hemolyzed erythrocytes in blood by detecting erythrocyte adenylate kinase in a serum sample from the blood. This invention also provides a method for diagnosing a hemolytic condition in a subject suspected to be suffering from hemolysis, as well as a method for monitoring hemolysis in a subject undergoing treatment for a hemolytic condition.

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: Simultaneous forward and reverse blood group testing is described using both a visual detection system and a fluorescent based labeling and detection system. Forward and reverse tests could be performed separately, but A and B agglutinates can be detected and discriminated simultaneously.

Abstract: The invention provides compositions and methods for cell separation. These reagents and techniques specifically agglutinate cells via surface antigen recognition and can be used to recover even rare cell types in high yield.

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: The invention relates to a method for detecting specific target-cells in a simple and time saving way, using paramagnetic particles, antibodies recognizing the Fc portions of target-cell associating antibodies and target-cell associating antibodies directed to specific antigen determinants in the target-cell membranes. Incubation of the cell suspension with a mild detergent and/or second set of antibodies or antibody fragments, prelabeled or not with fluorescent agents, metallocolloids, radioisotopes, biotincomplexes or certain enzymes allowing visualization, with dramatically increase the specificity of the method. The method can further be used for isolation of the target-cells by magnetic field application and kit for performing the method according to the invention is described.

Abstract: This invention provides a method of measuring oxidative response of cells without recourse to preparation of cell culture. The process involves: 1) preparing suspensions of cells from a living host in isotonic solutions, 2) preparing samples of test materials in isotonic solution containing tagged choline, 3) adding the cells suspension prepared in step 1 to the samples prepared in step 2, 4) incubating the product of step 3 with shaking for 2-90 minutes, 5) extracting and drying the lipid phase from the product of step 4, and 6) subjecting the product of step 5 to a scintillation counter to measure choline which has been incorporated into phosphatidylcholine (PC). An increase in incorporation of choline into PC in the short term indicates oxidative stress or free radical induced damage. Because the method of the invention using the cell isolates does not require the expense of cell culture with concomitant expense and possibility of cell change, it is particularly useful for clinical evaluation.

Abstract: The present invention provides an immunoassay method in which blood can be measured even without pretreatment by means of a centrifuge etc. In the present invention, antibodies or antigens in a sample are subjected to agglutination reaction with insoluble carriers onto which antigens or antibodies specifically reacting with the antibodies or antigens in the sample have been immobilized and the resulting agglutination mixture is determined for the change in its absorbance or in its scattered light by irradiation with light, wherein said sample is whole blood and the whole blood is forcibly lyzed.

Abstract: The present invention relates to a kit for determining feline blood type, wherein the kit includes a mixture comprised of a first monoclonal antibody and a second monoclonal antibody, wherein both antibodies recognize feline blood group specific A antigens. The present invention also relates to a method for determining feline blood type, wherein the method utilizes two distinct monoclonal antibodies, which recognize feline blood group specific A antigens.

Abstract: The present invention relates to PSGR, a novel prostate specific gene with homology to a G-protein coupled receptor overexpressed in prostate cancer. More specifically, the invention relates to PSGR polynucleotides and the polypeptides encoded by these polynucleotides, and the use of PSGR polynucleotides and polypeptides for detecting disorders of the reproductive system, including disorders of the prostate, particularly the presence of cancer. This invention relates to PSGR polynucleotides and polypeptides as well as vectors, host cells, antibodies directed to PSGR polynucleotides and polypeptides and recombinant and synthetic methods for producing the same. Also provided are methods for diagnosing, treating, preventing, and/or prognosing disorders related to the prostate, including cancer.

Abstract: The differential expression of marker proteins in a targeted population provides a means of identifying and isolating cells. A population of cells associated with the regeneration of pancreatic islets is shown to express certain proteins, including the cell surface proteins ErbB2, ErbB3, and ErbB4; and the nuclear protein Msx-2. Populations of isolated pancreatic islet progenitor cells find use in screening assays, to characterize genes involved in islet development and regulation, and in transplantation to provide a recipient with pancreatic islet functions.

Abstract: The present invention relates to methods for separating cells using immunorosettes. The method involves contacting a sample containing nucleated cells and red blood cells with an antibody composition which allows immunorosettes of the nucleated cells and the red blood cells to form. The antibody composition preferably contains bifunctional antibodies or tetrameric antibody complexes.

Abstract: Cyanide-free reagents for the determination of hemoglobin and leukocytes present in a blood sample comprise an aqueous solutions of at least one quaternary ammonium salt, preferably selected from the group of alkyltrimethylammonium salts, alkyldimethylbenzylammonium salts or alkylpyridium salts consisting of tetradecyltrimethyl ammonium bromide (TTAB), dodecyltrimethyl ammonium chloride, cetyltrimethyl ammonium bromide, hexadecyltrimethyl ammonium bromide and benzalkonium chlorides, and hydroxylamine salts, especially hydrochloride, sulfate and phosphates and other acid salts. The method involves mixing the reagent with a diluent-diluted blood sample, presenting it to an absorbance spectrophotometer and measuring the resulting optical density as an indicator of hemoglobin concentration. This cyanide-free reagent could be used solely for hemoglobin determinations, or, it can also be used in leukocyte counting and sizing using hematology instrumentation.

Abstract: Diagnostic methods comprise measuring specifically the level of at least one iso-eosinophilic cationic protein (iso-ECP) in a sample from an individual to be diagnosed, and comparing the measured level of the iso-ECP with a predetermined level of the iso-ECP. The iso-ECP is cytotoxic and the cytotoxicity of the iso-ECP is not capable of neutralization by the monoclonal antibodies EG1 and EG2. Anti-iso-ECP antibody which may be used in the diagnostic methods specifically binds to a cytotoxic isoform of ECP having an epitope which is unique for the native form of the cytotoxic iso-ECP.

Abstract: The invention provides a method for screening a test compound for the ability of the test compound to induce a response from human naive T-cells. The method comprises admixing human naive T cells, macrophages/monocytes, immortalized B cells lacking class I and class II major histocompatibility antigens, and a test compound; and determining whether the test compound induces a response from the human naive T cells. The invention further provides a method for primary in vitro sensitization of human naive T-cells. The method comprises admixing human naive T cells, macrophages/monocytes, immortalized B cells lacking class I and class II major histocompatibility antigens, and an antigen.

Abstract: A control reference material for the measurement of cells and crystals that are present in synovial fluid at different pathognomic conditions. Several possible suspending buffers for the control, its methods of preparation and a method for using these controls for analyses are provided. These controls are less costly and more readily available in greater quantities than current controls prepared from normal human synovial fluid as the suspending base.