Abstract: Methods are provided herein for determining antioxidant activity of a test sample in intact cells. The method includes determining the antioxidant capacity of a test sample in intact red blood cells, wherein the test sample is added to intact red blood cells and oxidative damage is measured by alteration of fluorescence intensity of an oxidation-sensitive fluorescent indicator dye.

Abstract: The invention provides methods for isolating cells, particularly antibody-secreting cells that have a high likelihood of secreting antibodies specific for a desired antigen for the purpose of making monoclonal antibodies.

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 provides simple and rapid methods for measuring the function of a desired subset of lymphocytes, for example, T cells, B cells or NK cells. In addition, the present invention provides an all-in-one kit that contains reagents which permit a rapid and reliable analysis of the functions of T cells, B cells and NK cells obtained directly from whole blood or cord blood.

Abstract: Described herein are systems and methods for assaying a sample to quantitatively determine the percentage of glycated hemoglobin in the sample.

Abstract: Hemoglobin, its variants, and glycated forms of each are determined individually in a multiplex assay that permits correction of the measured level of HbA1c to account for glycated variants and other factors related to the inclusion of the variants in the sample. New antibodies that are particularly well adapted to the multiplex assay are also provided.

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 invention relates to a method for detecting a plurality of antigenic molecules carried by erythrocytes and/or a plurality of anti-erythrocyte antibodies of an individual, comprising bringing a sample into contact with distinguishable beads, on which are attached a) antibodies specific for said antigens, or b) erythrocytes, erythrocyte membrane fragments or blood group antigens.

Abstract: The invention relates to a method for detecting a plurality of antigenic molecules carried by erythrocytes and/or a plurality of anti-erythrocyte antibodies, said antigenic molecules carried by the erythrocytes consisting of antigenic molecules carried not only by the erythrocytes, but also by at least one other cell population, other than the blood group antigen molecules, said method comprising bringing a sample into contact with distinguishable beads, on which are attached a) antibodies specific for said antigens, or b) erythrocytes or erythrocyte membrane fragment.

Abstract: Hemoglobin in a sample solution is quickly and reliably denatured; at the same time, quick and accurate measurement of hemoglobin and a hemoglobin derivative is realized. In a method for measuring hemoglobin and a hemoglobin derivative, and a reagent composition, a measurement kit, an analysis device, and an analysis system used in the method, a sample solution containing a blood component is treated with a nonionic surfactant, an oxidizing agent, and a metal salt to denature hemoglobin in the sample solution to measure the hemoglobin, and thereafter the amount of a hemoglobin derivative in the sample is measured by an immunological method using an antibody specifically binding to a denatured site of the denatured hemoglobin derivative.

Abstract: The invention provides a device and method for the rapid identification of patients suspected of having thalassemia. The invention provides a test strip for the aqueous detection of thalassemia related proteins in whole blood. The test strip includes antibodies specific to the gamma 4, (?4) protein and provides easy visual discrimination between a positive result and a negative result. The invention can be used in remote or clinical settings.

Abstract: The invention provides enzymatic methods for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The methods utilizes one or two different types of oxidizing agents which selectively oxidize low-molecular weight reducing substances and high-molecular weight (mainly hemoglobin) reducing substances in blood samples, coupled with enzymatic reactions catalyzed by proteases, fructosyl amino acid oxidase. The amount of hydrogen peroxide generated in the reaction is measured for determination of percentage of glycated hemoglobin in blood samples. The invention provides kits for performing the methods of the invention.

Abstract: A method for measuring glycated hemoglobin includes hemolyzing a blood sample with a hemolysate; reacting the hemolyzed blood sample with bead conjugates in which beads are conjugated with glycated hemoglobin binding materials; measuring the amount of total hemoglobin in the reacted blood sample; isolating normal hemoglobin from the glycated hemoglobin conjugated with the bead conjugates; measuring the amount of glycated hemoglobin isolated from the normal hemoglobin; and determining the percentage of the glycated hemoglobin in the blood sample on the basis of the measured amounts of total hemoglobin and glycated hemoglobin. The isolation of normal hemoglobin is performed by absorbing the normal hemoglobin using an absorption pad that is a porous pad having pores, each of which has a size greater than the size of the normal hemoglobin and smaller than the size of the bead.

Abstract: Methods are provided herein for determining antioxidant activity of a test sample in intact cells. The method includes determining the antioxidant capacity of a test sample in intact red blood cells, wherein the test sample is added to intact red blood cells and oxidative damage is measured by alteration of fluorescence intensity of an oxidation-sensitive fluorescent indicator dye.

Abstract: Disclosed herein are antibodies, systems and methods for assessing the risk of hemolysis following a blood transfusion with crossmatch incompatible blood. The disclosure provides a method for determining the relative hemolytic index and therefore the risk of post-transfusion hemolysis for said patient.

Abstract: The invention provides enzymatic methods for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The methods utilizes one or two different types of oxidizing agents which selectively oxidize low-molecular weight reducing substances and high-molecular weight (mainly hemoglobin) reducing substances in blood samples, coupled with enzymatic reactions catalyzed by proteases, fructosyl amino acid oxidase. The amount of hydrogen peroxide generated in the reaction is measured for determination of percentage of glycated hemoglobin in blood samples. The invention provides kits for performing the methods of the invention.

Abstract: The invention provides enzymatic methods for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The methods utilizes one or two different types of oxidizing agents which selectively oxidize low-molecular weight reducing substances and high-molecular weight (mainly hemoglobin) reducing substances in blood samples, coupled with enzymatic reactions catalyzed by proteases, fructosyl amino acid oxidase, and peroxidase. The invention provides kits for performing the methods of the invention.

Abstract: The present disclosure describes an apparatus for quantifying the quality degradation of individual stored red blood cell (RBC) units, thereby yielding information to improve decisions regarding their respective allocation, patient suitability, and use. The apparatus for quantifying the quality degradation of individual stored (RBC) units comprises: a hemolysis unit; an optical analysis unit; and a computation unit. This apparatus is amenable to clinical implementation as well as indicative of any given unit's relative viability and thus prospective efficacy. This would provide clinicians with actual data on RBC quality when making decisions about which and how many units to use for transfusion of a given patient. Moreover, deploying this testing throughout the supply chain will improve distribution, planning, and inventory control decisions.

Abstract: The present invention relates to use of ?-2-microglobulin (B2M or ?2M) and C-reactive protein (CRP) levels as biomarkers of peripheral artery disease and/or atherosclerosis.

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: Assay methods are disclosed involving specific binding reactions which are simplified compared to known methods. A compound capable of producing chemiluminescence is immobilized on a solid support as is a member of a specific binding pair for capturing an analyte from a sample. An activator compound that activates the chemiluminescent compound and is conjugated to a specific binding pair member is added in excess along with the sample to the solid support. Addition of a trigger solution causes a chemiluminescent reaction at the sites where the activator conjugate has been specifically bound. The assay methods are termed non-separation assays because they do not require removal or separation of excess detection label (activator conjugate) prior to the detection step. The methods are applicable to various types of assays including immunoassays, receptor-ligand assays and nucleic acid hybridization assays.

Abstract: The present invention relates to a diagnostic device for measuring the ratio of similar structural proteins among the proteins secreted in a liquid test sample taken from diagnosis subject. In further detail, the test device according to the present invention comprises detection marker-antibody conjugate recognizing the same site on two or more similar structural proteins and a detection zone in which antibody specifically recognizes each of said proteins via formation of sandwich type complex, wherein said antibodies form a set, and the present Invention relates to a diagnostic device for early diagnosis of polycystic ovary syndrome, abnormal pregnancy, prostatic carcinoma etc. based on determination of the ratio of follicle stimulating hormone and luteinizing hormone in case of polycystic ovary syndrome, the ratio between hCG isomers in case of abnormal pregnancy, and the ratio of prostate-specific antigens (PSA) in case of prostatic carcinoma.

Abstract: The invention provides methods, compositions, and kits for multiplex fractionation of proteins in a sample. Protein-binding molecules, such as small epitope antibodies or small epitope aptamers, are used for multiplex fractionation of proteins in a protein containing sample. Detection of fractionated proteins may be used for characterization of proteins in a sample in applications such as expression profiling, identification and/or quantification of proteins in a sample, and identification or detection of biomarkers.

Abstract: A sample acquiring device for volumetric enumeration of white blood cells in a blood sample comprises a measurement cavity for receiving a blood sample. The measurement cavity has a predetermined fixed thickness. The sample acquiring device further comprises a reagent, which is arranged in a dried form on a surface defining the measurement cavity. The reagent comprises a hemolysing agent for lysing red blood cells in the blood sample, and a staining agent for selectively staining white blood cells in the blood sample. A system comprises the sample acquiring device and a measurement apparatus. The measurement apparatus comprises a sample acquiring device holder, a light source, and an imaging system for acquiring a digital image of a magnification of the sample. The measurement apparatus further comprises an image analyser arranged to analyse the acquired digital image for determining the number of white blood cells in the blood sample.

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: 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 and reagents are disclosed for pretreating a sample suspected of containing a hydrophobic drug for conducting an assay method for detecting the hydrophobic drug. A combination is provided in a medium. The combination comprises (i) the sample, (ii) a releasing agent for releasing the hydrophobic drug and the metabolites from endogenous binding moieties, and (iii) a selective solubility agent that provides for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The selective solubility agent comprises a water miscible, non-volatile organic solvent and is present in the medium in a concentration sufficient to provide for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The medium, which may further comprise a hemolytic agent, is incubated under conditions for releasing the hydrophobic drug and the metabolites from endogenous binding moieties.

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: Assay methods are disclosed involving specific binding reactions which are simplified compared to known methods. A compound capable of producing chemiluminescence is immobilized on a solid support as is a member of a specific binding pair for capturing an analyte from a sample. An activator compound that activates the chemiluminescent compound and is conjugated to a specific binding pair member is added in excess along with the sample to the solid support. Addition of a trigger solution causes a chemiluminescent reaction at the sites where the activator conjugate has been specifically bound. The assay methods are termed non-separation assays because they do not require removal or separation of excess detection label (activator conjugate) prior to the detection step. The methods are applicable to various types of assays including immunoassays, receptor-ligand assays and nucleic acid hybridization assays.

Abstract: The present invention provides a method for determining endoglycosidase activity, and in particular of the heparanase type, in a sample, and also a method for detecting compounds that modulate the activity of endoglycosidases and in particular endoglycosidases of the heparanase type.

Abstract: The present invention provides a new additional identification of a gene related to cancer expression and a diagnostic kit using the same.

Abstract: The present invention relates to methods for detecting a oxidative stress in a biological sample, methods of determining a cumulative record of oxidative injury, and methods of diagnosing diseases of aging, such as cardiovascular diseases, based on the presence or absence of a biomarker or a component thereof. The present invention also relates to a kit for detecting oxidative stress in a biological sample comprising a stabilizing reactant and an antibody. In some embodiments of the invention, the biomarker of oxidative stress is selected from an aldehyde-protein adduct and an aldehyde metabolite-protein adduct, and the proposed method further comprises measuring separately for the same protein biomarkers of oxydative stress formed with different amino acids of the protein.

Abstract: A method of lowering the rate of a specific binding reaction in an assay for the detection and/or measurement of an analyte of interest is provided herein. In particular, the method includes providing a fluorescent conjugate of the analyte; a component capable of specifically binding to the analyte and its fluorescent conjugate; and a sample, which includes or is suspected to include the analyte. The method also includes allowing the specific binding component to interact simultaneously or at different times with the fluorescent conjugate of the analyte and the analyte in the sample, thereby forming a detectable complex due to the reaction between the fluorescent conjugate of the analyte and its specific binding component, wherein the reaction is performed in the presence of non-physiological amounts of at least one additive. The method further includes monitoring for the rate of change of the concentration of the detectable complex as a function of the amount of analyte in the sample.

Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.

Abstract: Quantification of a target analyte is performed using a single sample to which amounts of the target analyte are added. Calibration is performed as part of quantification on the same sample. The target analyte is detectable and quantifiable using label free reagents and requiring no sample preparation. Target analytes include biomarkers such as cancer biomarkers, pathogenic Escherichia coli, single stranded DNA, and staphylococcal enterotoxin. The quantification process includes determining a sensor response of a sensor exposed to the sample and configured to detect the target analyte. Sensor responses are determined after sequential additions of the target analyte to the sample. The amount of target analyte detected by the sensor when first exposed to the sample is determined in accordance with the multiple sensor responses.

Abstract: The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects. In particular, the invention relates to methods and compositions selected to monitor cardiorenal syndrome using assays that detect NGAL, preferably together with assays that detect natriuretic peptides such as BNP. Such methods and compositions can provide early indications of a deterioration in cardiorenal syndrome status, including prognosis regarding mortality and worsening renal function.

Abstract: This invention relates to methods and kits for positive selection of species of interest based on peptide/protein sequence from a biological sample. The species of interest may be proteins and/or peptides of interest which may be placed through a mass spectrometer to obtain a blood peptide/protein signature. The blood peptide/protein signature may be used in proteomic analysis. The techniques include but are not limited to the use of collectors comprising nucleic acid molecules to extract a composition that has a lower concentration of a high abundance species of interest from a sample. This limits the level of influence that any collectors species may have on the results of a mass spectra.

Abstract: A method for determining whether a subject has had a stroke and, if so, the type of stroke which includes analyzing the subject's body fluid for at least four selected markers of stroke, namely, myelin basic protein, S100 protein, neuronal specific enolase and a brain endothelial membrane protein such as thrombomodulin or a similar molecule. The data obtained from the analyses provide information as to the type of stroke, the onset of occurrence and the extent of brain damage and allow a physician to determine quickly the type of treatment required by the subject.

Abstract: The invention provides enzymatic methods for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The methods utilizes one or two different types of oxidizing agents which selectively oxidize low-molecular weight reducing substances and high-molecular weight (mainly hemoglobin) reducing substances in blood samples, coupled with enzymatic reactions catalyzed by proteases, fructosyl amino acid oxidase. The amount of hydrogen peroxide generated in the reaction is measured for determination of percentage of glycated hemoglobin in blood samples. The invention provides kits for performing the methods of the invention.

Abstract: Assay methods are disclosed involving specific binding reactions which are simplified compared to known methods. A compound capable of producing chemiluminescence is immobilized on a solid support as is a member of a specific binding pair for capturing an analyte from a sample. An activator compound that activates the chemiluminescent compound and is conjugated to a specific binding pair member is added in excess along with the sample to the solid support. Addition of a trigger solution causes a chemiluminescent reaction at the sites where the activator conjugate has been specifically bound. The assay methods are termed non-separation assays because they do not require removal or separation of excess detection label (activator conjugate) prior to the detection step. The methods are applicable to various types of assays including immunoassays, receptor-ligand assays and nucleic acid hybridization assays.

Abstract: Assay methods are disclosed involving specific binding reactions which are simplified compared to known methods. A compound capable of producing chemiluminescence is immobilized on a solid support as is a member of a specific binding pair for capturing an analyte from a sample. An activator compound that activates the chemiluminescent compound and is conjugated to a specific binding pair member is added in excess along with the sample to the solid support. Addition of a trigger solution causes a chemiluminescent reaction at the sites where the activator conjugate has been specifically bound. The assay methods are termed non-separation assays because they do not require removal or separation of excess detection label (activator conjugate) prior to the detection step. The methods are applicable to various types of assays including immunoassays, receptor-ligand assays and nucleic acid hybridization assays.

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: Methods and reagents are disclosed for pretreating a sample suspected of containing a hydrophobic drug for conducting an assay method for detecting the hydrophobic drug. A combination is provided in a medium. The combination comprises (i) the sample, (ii) a releasing agent for releasing the hydrophobic drug and the metabolites from endogenous binding moieties, and (iii) a selective solubility agent that provides for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The selective solubility agent comprises a water miscible, non-volatile organic solvent and is present in the medium in a concentration sufficient to provide for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The medium, which may further comprise a hemolytic agent, is incubated under conditions for releasing the hydrophobic drug and the metabolites from endogenous binding moieties.

Abstract: Provided herein is a method for diagnosing and monitoring endometriosis in a subject by measuring levels of the ?-subunit of fibrinogen.

Abstract: The invention provides enzymatic methods for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The methods utilizes one or two different types of oxidizing agents which selectively oxidize low-molecular weight reducing substances and high-molecular weight (mainly hemoglobin) reducing substances in blood samples, coupled with enzymatic reactions catalyzed by proteases, fructosyl amino acid oxidase, and peroxidase. The invention provides kits for performing the methods of the invention.

Abstract: The invention relates to identifying agents which have the ability to preferentially inhibit binding to targets such as heparin of the H384 allotypic variant of human complement Factor H, the allotypic variant associated with age-related macular degeneration (AMD), and the non-disease associated form of the same factor (Y384). The targets of interest show differential binding of the two allotypic variants and antagonists thus identified are of interest in developing treatments for AMD.

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 reticulcoytes 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: This invention is directed to a method for preparation of a biological sample for measurement of protein epitopes that allows for the preservation of intracellular protein epitopes and detection of signal transduction pathways based on the ability to capture transient activation states of the epitopes. The method provided by the invention allows for the rapid fixation of biological samples containing red blood cells, to ensure that epitopes of signal transduction molecules and other intracellular protein epitopes are preserved in the active state. The method of the invention further allows for lysis of red blood cells, thereby making it a useful method for cytometric analysis of biological samples, including, for example, whole blood, bone marrow aspirates, peritoneal fluids, and other red blood cell containing samples. The invention also provides a method to recover or “unmask” epitopes on intracellular antigens that have been made inaccessible by the cross linking fixative necessary to fix the sample.

Abstract: Provided herein is a method for diagnosing and monitoring endometriosis in a subject by measuring levels of the ?-subunit of fibrinogen.

Abstract: Human MAN2A genes are identified as modulators of the IGFR pathway and thus are therapeutic targets for disorders associated with defective IGFR function Methods for identifying modulators of IGFR comprising screening for agents that modulate the activity of MAN2A are provided.