Abstract: Compositions, methods and devices for the detection of anti-lipoidal antibodies and the diagnosis of disease, for example, syphilis, are described. In particular, a method for immobilizing a lipoidal antigen, comprising cardiolipin, lecithin, and cholesterol, on a solid support (such as a nitrocellulose membrane) is described. The ability to immobilize a lipoidal antigen on a membrane satisfies a long-felt need for a membrane-based assay for the detection of anti-lipoidal antibodies. Also described are immunoassay devices for concurrently performing treponemal and non-treponemal tests for syphilis.

Abstract: The invention concerns an internal standard used to quantitative analysis of the risk of humoral (i.e. vascular) transplant rejection. The internal standard consists of a stable composition of the C4d complement bound to a carrier consisting of erythrocytes or microparticles. The invention also concerns a method for analyzing in vitro the risk of humoral organ transplant rejection, which consists in determining the amount of component of C4d component fixed on the erythrocytes contained in a blood sample from a patient.

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

Abstract: The invention relates generally to gelsolin binding agents (e.g., antibodies) which can bind to gelsolin polypeptides. Gelsolin binding agents of the invention are useful, alone or in combination, to detect a gelsolin polypeptide (a.k.a., the target polypeptide) in a test sample as well as to purify native gelsolin proteins. Gelsolin binding agents are also useful to diagnose, a gelsolin related medical condition in subjects in need thereof. Kits to detect gelsolin in biological samples are provided by the present invention.

Abstract: The present invention comprises a method for identifying the presence or absence of a pulmonary embolism using a combination of tests and brightline thresholds. The first test is a blood based test measuring D-Dimer concentration and the second test is a respiratory analysis that determines a carboximetry ratio. If the measured D-Dimer value is at or above a threshold indicative of concern and the carboximetry value is equal to or less than a carboximetry ratio threshold, pulmonary embolism is present. If the measured D-Dimer value is at or above a threshold indicative of concern and the respiratory analysis yields a carboximetry ratio greater than the carboximetry ratio threshold, test results are inconclusive and additional testing is required to determine whether a pulmonary embolism is present.

Abstract: The present invention relates to diagnostic means and methods. Specifically, the present invention encompasses a method of diagnosing the cause of cardiac necrosis in a subject comprising determining the amount of a cardiac troponin and the amount of a BNP-type peptide in a sample from a subject suffering from cardiac necrosis and comparing the amount of the cardiac troponin and the amount of the BNP-type peptide to reference amounts, whereby the cause of the cardiac necrosis is to be diagnosed. The present invention further relates to a method of determining whether a subject suffering from cardiac necrosis is susceptible for a therapy against initial heart failure and to a method for determining whether a subject suffering from cardiac necrosis is susceptible for a therapy against coronary heart disease. Also encompassed are diagnostic uses, devices, and kits.

Abstract: The invention concerns anti-clusterin oligoclonal antibodies able to recognize and bind in a selective and specific way antigenic epitopes of clusterin isoforms to be used in tumors diagnosis and in the prediction of their malignancy grade, diagnostic method and related kits.

Abstract: The present invention identifies biomarkers that are diagnostic of nerve cell injury, organ injury, and/or neuronal disorders. Detection of different biomarkers of the invention are also diagnostic of the degree of severity of nerve injury, the cell(s) involved in the injury, and the subcellular localization of the injury.

Abstract: The present invention provides for the in vitro establishing of a prognosis for a subject in severe sepsis with at least two organ failures or in septic shock with at least two organ failures. Embodiments of the invention comprise the steps of measuring the level of the S100A8/A9 complex from a biological sample from a subject, and comparing the measured level to a predetermined threshold in which the measured level of the S100A8/A9 complex above the predetermined threshold is indicative of a bad prognosis and a measured level of the S100A8/A9 complex below the predetermined threshold is indicative of a good prognosis.

Abstract: By detecting an antibody which immunologically reacts with amylase ?2-A in a sample, AIP or FT1DM is examined or the possibility of developing FT1DM is determined. For instance, detection of this antibody is carried out by an immunological method using an antigen which immunologically reacts with this antibody. The antigen is preferably a partial fragment containing the amino acid sequence of amino acid numbers 299 to 511 of human amylase ?2-A (SEQ ID NO: 1).

Abstract: Disclosed is a rapid, non-invasive and highly specific and sensitive diagnostic assay for the identification of individuals with autoimmune chronic urticaria, which makes use of CD203c, and in some embodiments, additional proteins, as a marker for the disease. Test kits for diagnosis of an individual suspected of having autoimmune chronic urticaria are also disclosed. Also disclosed are a method of identifying compounds useful for treating autoimmune chronic urticaria and a method of treating autoimmune chronic urticaria.

Abstract: The invention provides methods for treatment of acute coronary syndrome and prediction of adverse cardiac events on the basis of elevations of catalytic iron in biological fluid of a human subject. An embodiment of the invention provides a method for early detection of acute coronary syndrome (ACS) in a human subject at the time of presentation of the chest pain. The method includes analyzing a test sample of the biological fluid for amount of catalytic iron and detecting acute coronary syndrome in the human subject.

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: The present invention relates to compositions and methods for identifying and quantifying platelet proteins that relate to various bodily states. The present invention further provides methods and compositions for determining whether an individual is using alcohol or other licit or illicit drugs at levels hazardous or harmful to their health. The invention also provides methods for identifying individuals who would benefit from or who may be harmed by specific medications or therapies.

Abstract: Methods of analyzing the electrophoretic mobility distribution of von Willebrand factor (vWF) multimers include providing a sample medium comprising a plurality vWF multimers. The vWF multimers are electrophoretically separated by electrohoretic mobility in the sample medium by subjecting said sample medium to an electric field to provide separated vWF multimers. The separated vWF multimers in the sample medium are exposed to a light source to produce scattered light. The scattered light is detected, and the electrophoretic mobility distribution of the separated vWF multimers is determined from the detected scattered light.

Abstract: Assay systems and specialized antibodies for the detection and quantitation of troponin I and troponin T in body fluids as an indicator of myocardial infarction are disclosed. Troponin I and T exist in various conformations and the ratios of monomeric troponin I and T and the binary and ternary complexes, as well as which form of troponin present in the blood, may be related to the metabolic state of the heart. Disclosed are systems to determine the presence of a troponin form or a group of troponin forms in whole blood, serum or plasma samples. Disclosed is a method for improving the recovery of troponin I or T from a surface used in immunoassays. Also disclosed are antibodies which recognize unbound troponin forms, the forms of troponin in binary complexes, the ternary complex of troponin I, T and C, and the conformations of troponin I having intramolecularly oxidized and reduced cysteines.

Abstract: The present invention relates generally to a method of diagnosing or predicting the development of lung damage and more particularly, to a method of diagnosing or predicting the development of alveolo-capillary membrane damage. The method of the present invention is useful inter alia for detecting lung damage or predicting the development of lung damage such as that caused by noxious agents or as an undesirable side effect resulting from exposure to a therapeutic agent and for monitoring the progress of lung damage.

Abstract: A method of detecting thrombosis or the degree of thrombophilia by measuring a von Willebrand factor cleaving protease, and a kit for detecting thrombosis or the degree of thrombophilia, comprising an antibody or a fragment thereof specifically binding to a von Willebrand factor-cleaving protease, are disclosed. The detection method and the detection kit have an excellent convenience, rapidity, and specificity.

Abstract: Described herein are methods for identifying a subject at risk of progression of heart failure. In some embodiments, the level of galectin-3 in a biological sample from a human subject may be measured and compared to a standard level indicative of risk of progression of heart failure, wherein an elevated level of galectin-3 in the sample indicates a risk of progression of heart failure.

Abstract: This invention relates to the diagnosis and/or monitoring of patients with inflammatory diseases or conditions, e.g., immunologic, hematologic, vascular, or infectious diseases or conditions, by determining levels of complement pathway components on erythrocytes. Methods of diagnosing vascular diseases or conditions by determining levels of complement pathway components on platelets are also disclosed.

Abstract: This invention provides methods for determining metal-induced sensitivity of a subject and kits for affecting the same. Specifically, the invention provides methods for using immune cell proliferation resulting from exposure to test metals as a method for determining metal-induced sensitivity in subjects.

Abstract: This invention generally relates to methods, apparatus, and computer program code for antenatal screening for chromosomal abnormalities, in particular Down's Syndrome. A method of determining a likelihood of a fetus carried by a pregnant mother having a chromosomal abnormality, a first biological, parameter being suitable for screening said fetus for said chromosomal abnormality, the method comprising: receiving first data from a first stage of pregnancy of said mother, said first data comprising data representing a first value of said first biological parameter; receiving second data from a second, later stage of said pregnancy, said second data comprising data representing a second value of said first biological parameter; and determining likelihood data from said first and second data, said likelihood data representing the likelihood of said fetus having a chromosomal abnormality.

Abstract: The invention relates to methods for diagnosing rheumatoid arthritis by assaying for Fibroblast Activation Protein Alpha expression in rheumatoid, myofibroblast like synoviocytes. Therapeutic aspects are also a part of the invention.

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: Methods and apparatus are disclosed for the measurement of lipocalin-2 in body fluids (including but not limited to blood, serum, plasma, urine, saliva, tear, etc.) by an assay such as an immunoassay or an immunotest for (1) the prediction of risk of future cardiovascular diseases; and (2) the determination of the likelihood that certain individuals will benefit to a greater or lesser extent from the use of certain treatments designed to prevent and/or treat cardiovascular diseases.

Abstract: The present invention relates to methods of detecting renal transplant rejection and other forms of renal damage. Protein markers or renal damage are provided, along with assays for detecting said markers. Also provided are methods for identifying markers of renal damage.

Abstract: A method for detecting lysosomal storage diseases including the steps of performing an assay for a single species of glycosaminoglycan contained in a specimen and correlating results of the assay with lysosomal storage diseases. A body fluid such as urine or blood can be employed as a specimen. The assay can be performed by use of a polypeptide that is capable of specifically binding to a glycosaminoglycan-containing molecule. The polypeptide may be an antibody, or a polypeptide having an antigen-binding site of an antibody.

Abstract: The present invention concerns methods and kits for diagnosing a disease condition characterized by non-physiological levels of hepcidin, comprising obtaining a tissue or fluid sample from a subject; contacting the sample with an antibody or fragment thereof that specifically binds to a polypeptide corresponding to the mid-portion or C terminus of a hepcidin protein, and quantifying the hepcidin level using an assay based on binding of the antibody and the polypeptide; wherein the non-physiological level of hepcidin is indicative of the disease condition. The present invention also concerns diagnostic methods and kits for applications in genetic technological approaches, such as for overexpressing or downregulating hepcidin. The present invention further concerns therapeutic treatment of certain diseases by treatment of subjects with hepcidin and agonists or antagonists of hepcidin.

Abstract: The present invention provides a method of diagnosing Crohn's disease in a subject by determining the presence or absence or IgA anti-OmpC antibodies in the subject, where the presence of the IgA anti-OmpC antibodies indicates that the subject has Crohn's disease.

Abstract: The present invention provides a method of diagnosing Crohn's disease in a subject by determining the presence or absence or IgA anti-OmpC antibodies in the subject, where the presence of the IgA anti-OmpC antibodies indicates that the subject has Crohn's disease.

Abstract: The present invention provides a method of diagnosing Crohn's disease in a subject by determining the presence or absence or IgA anti-OmpC antibodies in the subject, where the presence of the IgA anti-OmpC antibodies indicates that the subject has Crohn's disease.

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: The invention is collecting nose sweat and testing the nose sweat for levels of calcium. Testing may be done using standard laboratory procedures for calcium detection, or may be done cow-side using a suitable test for calcium levels, such as a water hardness test kit or a suitable test strip.

Abstract: The invention relates to methods for determining the progression of cartilage degeneration diseases, such as osteoarthritis and rheumatoid arthritis, by quantitating collagen synthesis and degradation markers in patient samples. One can determine whether a cartilage degeneration condition is progressing, regressing, or remaining stable by quantitating collagen synthesis and degradation markers in patient samples and comparing the value obtained to a reference value. When a joint affected by cartilage degeneration in question expresses collagen synthesis and degradation markers, a change in this value is indicative of a change in the progression of the cartilage degeneration condition. The methods and apparatus of the invention allow accurate determination of the therapeutic effects certain cartilage degeneration drug treatments, including osteoarthritis and rheumatoid arthritis drug treatments, so are also useful for pharmaceutical efficacy studies in mammals.

Abstract: A test strip and method for detecting an analyte present in a sample.

Abstract: A method for detecting lysosomal storage diseases including the steps of performing an assay for a single species of glycosaminoglycan contained in a specimen and correlating results of the assay with lysosomal storage diseases. A body fluid such as urine or blood can be employed as a specimen. The assay can be performed by use of a polypeptide that is capable of specifically binding to a glycosaminoglycan-containing molecule. The polypeptide may be an antibody, or a polypeptide having an antigen-binding site of an antibody.

Abstract: Methods and compositions are provided for detecting biomolecular interactions. The use of labels is not required and the methods can be performed in a high-throughput manner. The invention also provides optical devices useful as narrow band filters.

Abstract: The invention provides methods for early diagnosis or detection of acute coronary syndrome and prediction of adverse cardiac events on the basis of elevations of catalytic iron in biological fluid of a human subject. An embodiment of the invention provides a method for early detection of acute coronary syndrome (ACS) in a human subject at the time of presentation of the chest pain. The method includes analyzing a test sample of the biological fluid for amount of catalytic iron and detecting acute coronary syndrome in the human subject.

Abstract: A method of detecting platelet thrombosis or organ failure in a patient suffering from disseminated intravascular coagulation (DIC) or systemic inflammatory response syndrome (SIRS), comprising analyzing a von Willebrand factor-cleaving protease and/or a cleaving factor thereof, is disclosed. A kit for detecting platelet thrombosis or organ failure in a patient suffering from DIC or SIRS, comprising an antibody or a fragment thereof which specifically binds to a von Willebrand factor-cleaving protease, and/or an antibody or a fragment thereof which specifically binds to a cleaving factor of the von Willebrand factor-cleaving protease, is disclosed.

Abstract: Methods for detecting invasive trophoblast antigen (ITA) in biological samples comprise screening the samples for ITA using antibodies that bind to the ITA. The methods are useful to detect pregnancy, trophoblastic diseases, and Down's syndrome in fetuses of pregnant women. Some methods include screening the samples with a plurality of capture antibodies that specifically bind ITA. Chemiluminescent immunoassays are disclosed. The methods may be practiced with the diagnostic kits of the invention.

Abstract: A multi-stage method for diagnosing an immunologic food sensitivity or intolerance in a companion animal. Firstly a saliva or other non-serum bodily fluid sample is collected. The screening the saliva or other non-serum bodily fluid sample detects the presence of at least one of IgA or IgM antibody to a particular food ingredient or composition. An immunologic food sensitivity or intolerance based on the presence of the antibody is diagnosed. Secondly a blood sample is collected and serum from the sample is screened to detect the quantitative presence of at least one of an IgA, IgM or IgG antibody or immune complex to a particular food ingredient or composition. An immunologic food sensitivity or intolerance based on the presence of the antibody or immune complex is diagnosed. Thirdly a biologically active nutrient in relation to the animal from a molecular dietary signature is determined.

Abstract: The present application relates to procedures for the determination of the activity of the protease which activates factor VII, also known as factor VII activating protease or FSAP. The application also relates to a method of detecting whether an individual has increased or lowered activity in the protease which activates factor VII compared to at least one standard sample, wherein the increased or lowered activity indicates an increased risk for disease or cardiovascular complications.

Abstract: The present invention relates to a method for identifying a subject at risk of developing hypertensive end organ damage, such as and in particular heart failure, comprising: a) obtaining a biological sample of said subject; b) determining the level of at least one non-myocytal marker in said sample; c) comparing the level of said marker to a standard level; and d) determining whether the level of the marker is indicative of a risk for developing hypertensive end organ damage. The non-myocytical marker preferably is galectin-3 or thrombospondin-2.

Abstract: A method of detecting liver damage in a subject comprises measuring the level of caspase-3 generated cytokeratin-18 fragments in the bodily sample. The level of measuring the level of caspase-3 generated cytokeratin-18 fragments is then correlated with liver disease progression.

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: Diagnosing an immunologic food sensitivity or intolerance in companion animals comprises collecting a sample; screening the sample to detect the presence of an antibody to a particular food ingredient or composition. The sample can be serum, saliva or other bodily fluid to detect the presence of an IgA, IgM or IgG antibody or immune complex to a particular food ingredient or composition. The food ingredient for which sensitivity or intolerance is tested is contained in at least one of a preprocessed food composition, balanced diet or recipe. Offending ingredient(s) in a preprocessed food composition, balanced diet or recipe is determined. An assessment is made as to whether it is possible to use a different preprocessed food composition, balanced diet or recipe, or whether a special diet needs to be formulated without the offending ingredient(s).

Abstract: There is disclosed a method of diagnosing early stage renal impairment in humans, characterized by the following steps: measuring the amount of apoA-IV in a body liquid or tissue sample of a human, and comparing the measured amount of apoA-IV with a reference value.

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: The present invention relates to antibodies specifically binding to native proBNP, a method for specific detection of native proBNP, a method of correlating the level of native proBNP to the diagnosis of heart failure, a kit for detection of native proBNP and to a hybridoma cell line producing an antibody to native proBNP.

Abstract: The present invention relates to antibodies specifically binding to native proBNP, a method for specific detection of native proBNP, a method of correlating the level of native proBNP to the diagnosis of heart failure, a kit for detection of native proBNP and to a hybridoma cell line producing an antibody to native proBNP.