Abstract: Disclosed are methods for conducting assays of samples, such as whole blood, that may contain cells or other particulate matter. Also disclosed are systems, devices, equipment, kits and reagents for use in such methods. One advantage of certain disclosed methods and systems is the ability to rapidly measure the concentration of an analyte of interest in blood plasma from a whole blood sample without blood separation and hematocrit correction.

Abstract: A testing device for identifying an antigen or antibody within a biofluid sample including: a substrate having a hydrophilic surface thereon; the surface including a collection zone, and at least one detection zone extending therefrom; wherein the biofluid sample can be mixed with a specific antigen or antibody, and deposited on the collection zone and transferred by capillary action to the detection zone; the antigen or antibody in the biofluid sample reacting with an appropriate said antibody or antigen thereby resulting in a visual indication within the detection zone.

Abstract: The present disclosure provides methods and compositions for detecting the presence and activity of creatine transporter proteins (CrT) in biological samples comprising screening the samples for CrT using antibodies that bind to the CrT. The methods are useful to detect the onset of cardiotoxicity in subjects undergoing treatment with anthrocyclines or those susceptible to heart-related conditions. The methods and compositions described herein in can be practiced with diagnostic kits.

Abstract: Disclosed herein are methods for the isolation, identification, and quantification of red blood cells and red blood cell precursors at different developmental stages. Also disclosed are methods for monitoring ex vivo proliferation and differentiation of red blood cells and red blood cell progenitors.

Abstract: The present embodiments relate to compounds with physiological effects, such as the activation of hematopoietic growth factor receptors. The present embodiments also relate to use of the compounds to treat a variety of conditions, diseases and ailments such as hematopoietic conditions and disorders.

Abstract: A dry test strip layer for filtering red blood cells includes a Borosilicate Glass Fiber layer and lectin, impregnated in the borosilicate layer, such that the dry test strip is configured to filter red blood cells from a blood sample.

Abstract: Disclosed are methods for conducting assays of samples, such as whole blood, that may contain cells or other particulate matter. Also disclosed are systems, devices, equipment, kits and reagents for use in such methods. One advantage of certain disclosed methods and systems is the ability to rapidly measure the concentration of an analyte of interest in blood plasma from a whole blood sample without blood separation and hematocrit correction.

Abstract: Methods for detecting the presence or absence of, and for quantifying, one set of cells in a mixed cell population of at least two sets of cells especially Rh positive cells in a mixed population with Rh negative cells, as is found in a fetal maternal hemorrhage (FMH). The magnetic particles coated with anti-D antibodies are reacted with the Rh positive fetal cells in Rh negative maternal blood followed by a specific separation and quantifying technique. Gravitational forces or magnetic forces are used to move reacted magnetic particles to isolate, distinguish and quantify cells differentiated by antigenic composition. Rh positive cell volume is correlated to the volume of the original blood sample as an indication of the number of doses of RhIG needed to be administered to the mother to prevent subsequent Rh immunization.

Abstract: Method for detecting a material of interest, usually an antibody or an antigen on a red blood cell, in a liquid, by observing the potential antigen/antibody reaction products in a novel way. Reaction products are deposited on a magnetic substrate and will exhibit different properties depending upon whether or not the antigen/antibody reaction has taken place. An antigen/antibody reaction product adheres tenaciously to itself and the substrate while the deposit of any unreacted magnetically tagged material is weakly adhering and easily disrupted and dislodged under a disruptive force which would be insufficient to dislodge the reacted deposit. This difference in cohesive property provides the means by which a positive result is distinguished from a negative result.

Abstract: Methods and devices for evaluating a sample from a subject for detecting a target red blood cell protein or antibody are disclosed. In one embodiment, optimized antibody screening methods and devices significantly reduce the level of non-specific binding to a surface (e.g., a test surface bound with a red blood cell preparation), thus allowing for more efficient detection and reduced test time. In other embodiments, the invention provides methods and devices for target capturing that include a substantially planar surface, optionally having an optimized angle, for capture. Alternative solid phase geometries for capture are disclosed. Optimized methods for cell deposition are also disclosed. Thus, optimized methods, devices, kits, assays for evaluating a sample are disclosed.

Abstract: An immunodiagnostic test card includes a plurality of transparent chambers wherein each chamber includes a quantity of testing material that combines with a patient sample, when mixed, to produce an agglutination reaction. A plurality of indicia are disposed to aid in the manufacture and determining the usability of the cards prior to test and also in objectively grading the agglutination reactions that are formed or lack of agglutination.

Abstract: The invention provides methods for determining the differentiation state of cells. The methods include non-invasive, non-perturbing, automatable, and quantitative methods of analysis of cell colonies, individual cells, and/or cellular structures.

Abstract: The invention relates to methods and kits for the quantitative analysis of in vivo mutation frequencies of the Pig-A gene in individuals exposed to a genotoxicant, particularly using peripheral blood samples of vertebrates.

Abstract: Sickle cell anemia is a genetic disease characterized by red blood cells that assume an abnormal, rigid, sickle shape. Acute complications of Sickle cell anemia are treated symptomatically with analgesics and transfusions, and a prophylactic treatment of sickle cell crisis is long term application of hydroxyurea. According to the present invention, an N-methyl D-aspartate receptor (NMDAR) blocker is used for the treatment of sickle cell anemia and for manufacture of a medicament for the treatment of sickle cell anemia. Moreover, a method for screening for a compound effective in the treatment of sickle cell anemia comprises contacting a candidate compound with the NMDAR and selecting said candidate compound as effective if it is found to selectively reduce activity of the NMDAR.

Abstract: Disclosed herein is a method for increasing the efficiency and reducing cost of the blood donation, processing and storage by pre-screening candidate donors for blood type and only collecting blood from donors having a needed blood type. Also disclosed are methods and systems for rapid determination of blood type of a blood donor prior to the initiation of the blood donation process.

Abstract: Fetal blood multi-lineage progenitor cells that are capable of a wide spectrum of transdifferentiation are described.

Abstract: Provided is a panel (3) for analysis having a chamber inside for transferring a sample liquid dispensed as a drop on an injection port (14). The injection port (14) is formed to protrude in a direction away from the chamber, a recessed section (12) is formed around the injection port (14), and the injection port (14) is arranged on the side of a rotating axis center (11) of a holding member (101) for the panel for analysis in an analyzer. Thus, even when a sample liquid is adhered around the injection port, contamination and shortage of the sample liquid can be prevented.

Abstract: Provided is a method for measuring glycated hemoglobin. The method includes a hemolysis step of hemolyzing a blood sample with a hemolysate, a reaction step of reacting the hemolyzed blood sample with bead conjugates in which beads are conjugated with glycated hemoglobin binding materials, a first measuring step of measuring the amount of total hemoglobin in blood, an isolation step of isolating normal hemoglobin from the glycated hemoglobin conjugated with the bead conjugates, a second measuring step of measuring the amount of glycated hemoglobin in blood, and a calculation step of calculating the concentration of glycated hemoglobin in the blood sample based on the measured amounts of total hemoglobin and glycated hemoglobin in the blood sample.

Abstract: A method for assaying by ELISA, carried out on a whole blood sample, of the cellular activation state of a predetermined population of cells of the sample, includes determining the phosphorylation state of an intracellular protein involved in a cell signaling pathway (biomarker). A particular application of the method for assaying the phosphorylation state of an intracellular protein involves monitoring agonist agents or antagonist agents of cellular activation of cellular populations present in a whole blood sample. Such an application may in particular contribute to therapeutic monitoring of patients, or it may be useful in drug screening. In particular, the application pertains to the context of the exploration of hemostasis, in particular blood coagulation, from an observation of the activation of platelets contained in whole blood samples.

Abstract: A method for identifying a platelet population, preferably a population of immature, reticulated platelets, in a biological sample involves incubating the biological sample for less than 5 minutes with at least one labeled, ligand (e.g., monoclonal antibody) that binds to an epitope or antigen on platelets and with a nucleic acid dye. In one embodiment, the dye is Acridine Orange and the label on the ligand is PE-Cy7. The sample is then analyzed and one or more platelet populations is rapidly identified or quantified by passing the incubated sample through a sensing region of a flow cytometer. In one embodiment, this method occurs without a washing or physical cell separation step. The incubated sample is irradiated with a laser light source, and fluorescence of the labeled ligand and the nucleic acid dye are measured along with at least one additional parameter, e.g., light scatter, direct current, axial light loss, opacity, radio frequency, and fluorescence.

Abstract: The present invention provides NB-ARC and CARD-containing proteins (NACs), nucleic acid molecules encoding NACs and antibodies specific for at least one NAC. The invention further provides chimeric NAC proteins. The invention also provides screening assays for identifying an agent that can effectively alter the association of a NAC with a NAC-associated protein. The invention further provides methods of modulating apoptosis in a cell by introducing into the cell a nucleic acid molecule encoding a NAC or an antisense nucleotide sequence. The invention also provides a method of using a reagent that can specifically bind to a NAC to diagnose a pathology that is characterized by an increased or decreased level of apoptosis in a cell.

Abstract: Methods and reagents are disclosed for detecting a false result in an assay for determining a concentration of an analyte in a whole blood sample suspected of containing the analyte. The method comprises determining by means of the assay a concentration of the analyte utilizing a hemolyzed portion of the blood sample to obtain concentration value 1 and determining by means of the assay a concentration of the analyte utilizing a non-hemolyzed portion of the blood sample and multiplying the concentration times a hematocrit factor to obtain concentration value 2. A ratio of concentration value 1 divided by concentration value 2 is determined and is compared to a predetermined ratio of known reliability. If the ratio is less than the predetermined ratio, a false result is indicated.

Abstract: The present invention provides compositions and methods for the detection of red blood cells antigens. The methods and compositions are based on antibodies, serving as primary antibodies or secondary antibodies, that are labeled with a rare-earth based crystal. Methods utilizing antibodies labeled with a rare-earth based crystal enhance the efficiency and accuracy of blood compatability tests and red blood cells phenotyping.

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: The present invention relates a method for the enumeration of in vivo gene mutation. The method utilizes differential staining of GPI-anchor deficient erythrocyte populations to distinguish between wild-type and pig-a gene mutants. Quantitative analyses can be conducted on erythrocytes and/or reticulocytes, and is based upon fluorescent emission and light scatter following exposure to an excitatory light source. Counting of mutant erythrocytes or reticulocytes relative to the number of total erythrocytes or reticulocytes can be used to assess the DNA-damaging potential of an exogenous chemical agent, the DNA-damaging potential of an exogenous physical agent, the effects of an exogenous agent which can modify endogenously-induced DNA damage, and the effects of an exogenous agent which can modify exogenously-induced DNA damage. Kits for practicing the invention are also disclosed.

Abstract: An immunodiagnostic test card includes a plurality of transparent chambers wherein each chamber includes a quantity of testing material that combines with a patient sample, when mixed, to produce an agglutination reaction. A plurality of indicia are disposed to aid in the manufacture and determining the usability of the cards prior to test and also in objectively grading the agglutination reactions that are formed or lack of agglutination.

Abstract: The present invention provides a conjugate which contains a therapeutic moiety linked to a homing molecule that selectively homes to tumor blood vessels and tumor cells and that specifically binds the receptor bound by peptide KDEPQRRSARLSAKPAPPKPEPKPKKAPAKK (SEQ ID NO: 9). Methods of directing a conjugate of the invention to tumor blood vessels and tumor cells and of using a conjugate to treat cancer also are provided.

Abstract: The invention concerns a method for differentiating and counting cellular components present in a biological fluid sample comprising a primary cytological analysis step typically implemented by a flow cytometry equipment (1) to obtain a set of primary results enabling the set of cellular components of the sample to be differentiated and counted in different populations; and a complementary step of cytological analysis of a particular type of cellular components, based on an identified cellular peculiarity, to obtain complementary results enabling at least one cell population or subpopulation of the sample to be differentiated and counted for identification of said cellular peculiarity. The invention is applicable in particular to hematological analyses.

Abstract: The present inventions relates to kits and methods for diagnosing and monitoring breast cancer. An increase in the level or activity of proteins of the ubiquitin/proteasome pathway, and ancillary proteins thereof, as compared to normal control or benign tissue is indicative of breast cancer.

Abstract: The invention relates to a method for phenotyping blood and/or performing an irregular agglutinin test and/or for determination of compatibility of a donor and receiver, using an aqueous solution of ferrofluid, obtained from a mixture of polyoxoanions of Fe(III) and at least one metal M(II) of oxidation state II. The invention further relates to a kit for carrying out said procedure.

Abstract: Chondroitin sulfate proteoglycans (CS-PGs) are axon growth inhibitory molecules present in the glial scar that are responsible (at least in part) for regeneration failure after CNS or spinal cord injury. Removal of chondroitin sulfate glycosamino-glycan chains using the bacterial enzymes chondroitinase-ABC or AC in models of CNS injury promotes both axon regeneration and plasticity. The present invention relates to the use of members of the human hyaluronidase family (endo-beta-acetyl-hexosaminidase enzymes, E.C. 3.2.1.35) for the degradation of chondroitin sulfate (proteoglycans) in the glial scar to promote axonal regrowth in human CNS or spinal cord injury. The present invention also relates to methods for determining endoglycosidase activity, and in particular of the hyaluronidase/chondroitinase type, in a sample, and also relates to methods for detecting compounds that modulate the activity of endoglycosidases and in particular endoglycosidases of the hyaluronidase/chondroitinase type.

Abstract: The present invention relates to a whole-blood culture containing specific immunocompetent killer cells that are activated against tumor cells, viruses, bacteria and/or allergens, whereby the whole-blood culture consists of whole-blood and a culture medium at a ratio of 3:1 to 4:1, whereby the culture medium has an oxygen excess of at least 100% or more and contains a water-soluble emulsification product comprising a mixture of phospholipids, vitamin E, and low-molecular proteoglycans with a molecular weight of 1,200 to 12,000 Dalton, and whereby dead tumor cells or fragments thereof and/or viral and/or bacterial antigens and/or allergens have been added to the whole-blood culture [to serve] as antigen in the specific recognition process for production of the activated killer cells (stimulation). The invention also relates to a method for producing the culture, as well as stimulants for the whole-blood culture and a method for the selection thereof.

Abstract: Peptide-lipid constructs of the structure L-S—F are disclosed, where F is a peptide, S is a spacer covalently linking F to L via an oligomer of ethylene glycol, and L is a diacyl- or dialkyl-glycerolipid (including glycerophospholipids). The spacer ideally has 6 to 14 ethylene glycol repeats, corresponding to PEG with a molecular weight of approximately 250 to 600. Also disclosed is a method of detecting reactive antibodies in serum by contacting serum with cells modified to incorporate a peptide-lipid construct, where the peptide is an epitope of the antibody, and determining the degree of aggluthination of the cells.

Abstract: The present invention generally relates to systems and methods for counting biomolecules or cells. In certain embodiments, the invention provides a cell counting or biomolecule counting system including: a covered chamber having a known height and configured to hold a suspension of biomolecules or cells in a sample; at least one fluorescent light source connected to at least one fluorescent light beam narrowing device; a bright-field light source connected to a bright-field light beam narrowing device; a microscope objective; a detection device; a fluorescent filter assembly to allow only excitation light to illuminate the sample and allow only emission light from the sample to be imaged by the detection device; and a movable light shutter to block bright-field light during fluorescent detection.

Abstract: In vitro diagnosis/prognosis method and kit, for assessment of tolerance in liver transplantation. The present invention refers to the study of peripheral blood transcriptional patterns from 80 liver transplant recipients and 16 non-transplanted healthy individuals employing either oligonucleotide microarrays and/or quantitative real-time PCR to design a clinically applicable molecular test. This has resulted in the discovery and validation of several gene signatures comprising a modest number of genes capable of identifying tolerant and non-tolerant recipients with high accuracy. The marker genes are KLRF1, SLAMF7, NKG7, IL2RB, KLRB1, FANCG, GNPTAB, CLIC3, PSMD14, ALG8, CX3CR1, RGS 3. Multiple peripheral blood lymphocyte subsets contribute to the tolerance-associated transcriptional patterns with NK and ?delta T cells exerting a predominant influence.

Abstract: A biomarker for pancreatic beta-cell mass comprising measuring the levels of CFC1 in the serum of a subject is described. The biomarker provides a noninvasive means for measuring pancreatic beta cell mass that is particularly useful for monitoring the efficacy of treatments for metabolic disorders such as Type I or Type II diabetes, including pancreatic islet cell transplantations.

Abstract: Methods for reducing time to result in blood bank diagnostic testing with an agitation device and a low ionic strength solution are disclosed. Specifically provided are methods for reducing incubation time for antigen-antibody reactions in an immunohematologic assay by subjecting the assay reactants to incubation with agitation and optionally additionally a low ionic strength diluent.

Abstract: The present invention provides methods, diagnostic assays, and diagnostic kits based on said methods, to determine levels of immunosuppressive complexes containing immunosuppressive drugs tacrolimus, sirolimus and cyclosporine A separately and in combination, formed in the blood of a drug-treated patient or in a patient candidate to immunosuppressive drug therapy. These methods, assays and kits are especially useful when using automated systems.

Abstract: A process for the detection of antibodies in a test sample by preparing a suspension of erythrocytes with a test serum or plasma by mixing a test serum or plasma with erythrocytes; incubating the suspension of erythrocytes at a temperature of from 37° C. to 45° C. to bind any antibodies in the test serum or plasma to the surface of said erythrocytes; combining the suspension of erythrocytes with an amount of a solution of a macromolecule which is effective to agglutinate the erythrocytes; packing the resultant red cell agglutinates by centrifuging the suspension of erythrocytes; and, determining the presence of anti-erythrocyte antibodies by observing if antibody-dependent erythrocyte agglutination has occurred.

Abstract: A negative isolation method for separately isolating preparations of Th1 and Th2 helper lymphocytes from peripheral blood mononuclear cells involving the use of novel combinations of monoclonal antibodies to separately sequester specific Th1 and Th2 lymphocytes and contaminating leukocytes and erythrocytes, adding a magnetic colloid to the cells, and using a magnetic column for fractionation of Th1 and Th2 cells. Imbalances in the relative numbers of Th1 and Th2 lymphocytes can be used in the diagnosis and prognosis of human diseases.

Abstract: A method of quickly determining human ABO/Rh/MN blood type and a test kit thereof. A blood sample to be detected is applied onto a test strip pre-coated with anti-A or anti-B or anti-M or anti-N antibody, a rinse solution is dripped onto one end of the test strip, and then the blood group of the blood sample is determined by the presence of agglutinated red cells remained at the reaction sites.

Abstract: Device including migration membrane, conjugate pad on migration membrane, plasma separation membrane on conjugate pad, pre-filter on plasma separation membrane. Migration membrane has test line configured for loading one or plurality of capture antibodies having specific binding affinity for assay target. Migration membrane configured for allowing lateral flow of blood plasma or serum across migration membrane to test line. Conjugate pad configured for loading one or plurality of detection antibodies having specific binding affinity for assay target. Plasma separation membrane configured for allowing passage of blood plasma or serum and trapping erythrocytes. Pre-filter configured for loading assay sample including erythrocytes and either or both blood plasma and blood serum. Pre-filter configured for allowing passage of blood plasma or serum through pre-filter and causing lateral flow of blood plasma or serum within pre-filter. Method includes providing device and carrying out diagnostic assay cycle.

Abstract: An apparatus and a related method for performing particle agglutination reactions in at least one disposable probe tip are disclosed. The at least one probe tip includes a sample cavity for sample acquisition, at least one flanking cavity for the capture of particles by centrifugation or other means, a transition zone for the mixing of the sample with reagents for agglutination and a detection zone for the optical detection of particle agglutination. A mechanism may be attached to the probe tip for the controlled movement of fluids through the internal volume of the probe tip. The probe tip is particularly useful for the automation of high-throughput agglutination-type assays.

Abstract: The invention provides methods for determining the differentiation state of cells. The methods include non-invasive, non-perturbing, automatable, and quantitative methods of analysis of cell colonies, individual cells, and/or cellular structures.

Abstract: The present invention provides compositions and methods for treating or preventing antibody mediated graft rejection and blood typing.

Abstract: Disclosed are methods for detecting antibody in a sample, where the antibody targets an antigen expressed by red blood cells or red blood cell ghosts. Rather than detecting the binding events between a particular antigen antibody pair (as in traditional agglutination based assays) the methods herein allow for multiplexed detection of clinically important allo-immune antibodies to blood group antigens. Specifically the method involves generating fluorescently encoded red blood cells or red blood cell ghosts with known antigen presentation and using them to detect the presence of antibody in serum/plasma with a fluorescent sandwich type immunoassay. The assay results can be read using flow cytometric or fluorescent microscope based imaging techniques.

Abstract: The present invention relates to methods and kits for diagnosing, ascertaining the clinical course a of myelodysplastic syndrome(MDS) and ascertaining response to a therapy regimen of myelodysplastic syndrome. Specifically the invention provides method and kits useful in the diagnosis and determination of clinical parameters associated with MDS based on surface markers unique to MDS.

Abstract: The present invention relates to a method for unspecific enrichment of bacterial cells by means of cationic or anionic polymers and magnetic carriers.

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: The present invention is based on the discovery that hexosamine, and in particular the dynamic O-GlcNAcylation of proteins (modification of proteins by the sugar N-acetylglucosamine) both causes insulin-resistance (a hallmark of type II diabetes) and is responsible for glucose toxicity in the disease. Accordingly, the invention provides methods of diagnosing a subject as having or at risk of having pre-diabetes or diabetes. Also provided are methods of characterizing hyperglycemia in a subject, methods of identifying a protein as being associated with hyperglycemia, and kits for detecting pre-diabetes or diabetes.