Abstract: The present disclosure relates to methods of detecting manganese in a solution using resacetophenone oxime by spectrophotometric analysis wherein the resacetophenone oxime produces colorimetric responses to indicate the presence of manganese. The resacetophenone oxime is not only stable in solution, but it also may be inserted into a hydrocolloid gel to facilitate a “spot test” for the detection of manganese, resulting in a long shelf life. These manganese testing methods disclosed herein may be used at the pre-disinfection process at water treatment facilities. The disclosed methods of manganese testing may be combined with an ammoniacal buffer reagent that may be used by water processing facilities, prior to final disinfection, to augment existing manganese (II) efforts of removal. A secondary flocculation with this buffer will scavenge additional manganese (II), that can then be removed by sedimentation or filtration.

Abstract: Disclose are methods, compositions and kits for the determination of kidney function that provide an alternative to the standard-of-cure used for eGFR calculations. Described herein are methods for quantitative measurement of ADMA and hydration markers in a urine sample, and process used to transform the input of these methods into a measure of kidney function. The methods allow ADMA and other biomarkers to be detected in urine samples from a subject using a simple and inexpensive assay that can be easily performed noninvasively and only require urine samples for the prediction of kidney function.

Abstract: The present invention relates to a method of identifying a subject being susceptible to a cardiac intervention based on the determination of GDF-15 in a sample of a subject in need of a cardiac intervention. Moreover, the present invention pertains to a method for predicting the risk of mortality or a further acute cardiovascular event for a subject suffering from a cardiovascular complication based on the determination of GDF-15 and a natriuretic peptide and/or a cardiac troponin in a sample the said subject. Also encompassed by the present invention are devices and kits for carrying out the aforementioned methods.

Abstract: Methods for identifying metabolic signatures in blood plasma which are unique to autism are described herein. Samples are analyzed using multiple chromatographic-mass spectrometry-based techniques to orthogonally measure a broad range of small molecular weight metabolites differentially produced in autistic patient samples versus non-autistic control samples. These individual metabolites or a panel of such metabolites serve as metabolic signatures of autism. Such metabolic signatures are used in diagnostic methods to accurately identify individuals with autism spectrum disorder (ASD).

Abstract: Management of the health status of an animal colony using a plurality of blood collection cards and the analysis of dried blood from members of the colony that has been collected on the cards. Members of the colony may be removed from the colony as a result of the analysis.

Abstract: An object of the present invention is to provide an antibody that can be stably supplied and can react with prostasin under non-denaturation and denaturation conditions, and an antigen peptide for preparation of the antibody. The present invention relates to a peptide consisting of the amino acid sequence shown in SEQ ID NO: 1 or a peptide consisting of an amino acid sequence that has a deletion, a substitution, or an addition of one or several amino acids with respect to the amino acid sequence shown in SEQ ID NO: 1 and having antigenicity of prostasin. Furthermore, the present invention relates to an antibody prepared using the peptide as an antigen.

Abstract: The inventors have proposed a novel panel of human serum protein biomarkers for diagnosing hepatic fibrosis and cirrhosis. Presently there is no reliable non-invasive way of assessing liver fibrosis. A 2D-PAGE based proteomics study was used to identify potential fibrosis biomarkers. Serum from patients with varying degrees of hepatic scarring induced by infection with the hepatitis C virus (HCV) was analyzed. Several proteins associated with liver scarring and/or viral infection were identified. These proteins include the inter-?-trypsin inhibitor heavy chain H4 fragments, complement factor H-related protein 1, CD5L, Apo L1, and ?2GPI. Increased and decreased thiolester cleavage of a2M and Complement C3, respectively, was also detected. The concentrations of these novel biomarkers can be determined using an immunoassay where the concentrations would reflect the extent of fibrosis. A fibrosis scoring scale for each of the novel biomarkers is proposed.

Abstract: The present invention relates to methods and kits for the prediction of risk for heart failure using post-translation modified forms of cardiac troponin T as a biomarker.

Abstract: Management of the health status of an animal colony using a plurality of blood collection cards and the analysis of dried blood from members of the colony that has been collected on the cards. Members of the colony may be removed from the colony as a result of the analysis.

Abstract: A protein used as a biomarker for diagnosing IgA nephropathy and TGBM (thin-glomerular-basement-membrane) using urine through a target proteomics method. A diagnosis biomarker protein and a kit for diagnosing IgA nephropathy and TGBM and predicting progress of the nephropathy in advance using the protein are provided. The degree of the progression of the disease can be grasped by detecting IgA nephropathy and TGBM, enabling early diagnosis and confirming progress from the patient's urine. In addition, a monoclonal antibody produced based on the diagnosis biomarker protein can be used for an immunoassay kit (ELISA, antibody coated tube test, lateral-flow test, potable biosensor). The monoclonal antibody is used in early diagnosis and progression detection of IgA nephropathy and development of a novel drug for the purpose of treatment.

Abstract: Management of the health status of an animal colony using a plurality of blood collection cards and the analysis of dried blood from members of the colony that has been collected on the cards. Members of the colony may be removed from the colony as a result of the analysis.

Abstract: In vitro multiparameter method for the diagnosis and early diagnosis, for determination of the severity and for assessing the course and prognosis of neurodegenerative disorders, in which the concentrations of at least two different vasotropic peptides are determined in a biological fluid from a person suffering from subjective or objectively detectable cognitive impairments, the resulting person-specific measurements are combined computationally to give a person-specific complex reference value, and conclusions are drawn concerning the presence of a neurodegenerative disorder in the person on the basis of the person-specific complex reference value found.

Abstract: The present invention relates to a quantitative assay device and a method for the determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains two bands having deposited on there high and low concentrations of different calibrator agents and a test band capable of reacting with conjugated analyte complexes giving rise to a measurable signal.

Abstract: Products and methods for the research, diagnosis, risk assessment, course monitoring, treatment and prophylaxis of various metabolic disorders and their early forms, concomitant diseases and secondary diseases are provided. Metabolic diseases include, for example, metabolic syndrome, non-insulin-dependent diabetes, (type II diabetes), insulin resistance, obesity (adiposis), in addition to diseases that are associated with disorders of the fatty acid metabolism. Methods may include analysis of the concentration of the adipocytic form of the fatty acid binding protein (A-FABP, FABP 4, P2) in various bodily fluids.

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: A method for determining an appropriate treatment option for a patient who has been diagnosed with disseminated intravascular coagulation (DIC) but who may have thrombotic thrombocytopenic purpura (TTP), by analyzing the amount and/or enzyme activity of a von Willebrand factor (vWF)-cleaving protease (ADAMTS13) and the amount of vWF in a patient that has been diagnosed with DIC is disclosed. Using the method of the present invention, a differential diagnosis of patients with thrombotic thrombocytopenic purpura (TTP) can be made from among patients diagnosed with DIC, which could not previously be distinguished on the basis of only clinical findings or known markers. Also disclosed is a kit for determining an appropriate treatment option, the kit comprising an antibody or a fragment thereof which specifically binds to ADAMTS13.

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: Methods and kits for diagnosis and prognosis using biomarkers comprising albumin-bound protein/peptide complex (ABPPC).

Abstract: Embodiments of the present invention provide for novel peptides of use for detection and/or inhibition of anti-?1-adrenergic receptor antibodies. Certain embodiments concern uses of cyclic and/or linear peptides. In other embodiments, the present invention relates to novel peptides of use in diagnostic and/or pharmaceutical compositions. Some embodiments concern diagnosing and/or treating cardiac conditions. Cardiac conditions of the instant invention can concern infectious heart disease, non-infectious heart disease, ischemic heart disease, non-ischemic heart disease, inflammatory heart disease, myocarditis, cardiac dilatation, idiopathic cardiomyopathy, idiopathic dilated cardiomyopathy, immune-cardiomyopathy, heart failure, and any cardiac arrhythmia condition.

Abstract: Disclosed are antibodies that selectively bind to blood coagulation factor FVIII, and highly sensitive immunological assays comprising these antibodies. Preferred assays can detect FVIII at about 3500-fold below the normal physiological levels, and have a wide array of applications including accurate monitoring of FVIII concentration in pharmaceutical products for treatment of blood coagulation disorders, and determination of FVIII levels in plasma of human patients, including those with blood coagulation disorders such as hemophilia.

Abstract: Embodiments of the present invention provide for novel peptides of use for detection and/or inhibition of anti-?1-adrenergic receptor antibodies. Certain embodiments concern uses of cyclic and/or linear peptides. In other embodiments, the present invention relates to novel peptides of use in diagnostic and/or pharmaceutical compositions. Some embodiments concern diagnosing and/or treating cardiac conditions. Cardiac conditions of the instant invention can concern infectious heart disease, non-infectious heart disease, ischemic heart disease, non-ischemic heart disease, inflammatory heart disease, myocarditis, cardiac dilatation, idiopathic cardiomyopathy, idiopathic dilated cardiomyopathy, immune-cardiomyopathy, heart failure, and any cardiac arrhythmia condition.

Abstract: The present invention relates to the use of TFF3 in the diagnosis and detection of Barrett's esophagus using non-invasive, non-endoscopic methods.

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 present invention pertains to a method for in vitro prognosticating and/or diagnosing cerebral cerebral malaria, wherein said method comprises a step of detecting non-erythroid spectrin or fragments thereof, and/or antibodies directed against non-erythroid spectrin, in a biological sample. Reagents and kits for performing this method are also disclosed.

Abstract: According to the method of evaluating stress of the present invention, amino acid concentration data on the concentration value of amino acid in blood collected from a subject to be evaluated is measured, and a stress state including at least depressive illness and major depressive illness in the subject is evaluated based on the concentration value of at least one of Lys, His, ABA, Asn, Phe, Leu, Ile, Val, Trp, Tyr and Met contained in the measured amino acid concentration data of the subject.

Abstract: Aspects of the invention include methods for enhancing blood coagulation in a subject. In practicing methods according to certain embodiments, an amount of a non-anticoagulant sulfated polysaccharide (NASP) is administered to a subject to enhance blood coagulation in the subject. Also provided are methods for preparing a NASP composition having blood coagulation enhancing activity. Compositions and kits for practicing methods of the invention are also described.

Abstract: Methods and systems to collect a sample of bodily fluid from a patient using an integrated needle and test strip assembly are provided. In this novel assembly, the test strip and needle form one unit that captures the sample of blood or interstitial fluid from the patient once the apparatus is pressed to the skin. The hollow aspiration needle includes more than one opening at a distal end, each opening coming into contact with the bodily fluid when disposed within a cutaneous or subcutaneous layer of the patient's skin. The disclosed test strip includes at least one reaction site for testing analyte concentrations and a means for linking to many commercially available test strip meters to provide readout of the analyte concentration. The sample may be captured by capillary flow, by an integrated aspirator, or by a differential vacuum device resident on the test strip meter.

Abstract: Methods, devices, and kits are provided herein for the accurate and rapid detection of disease causing microbes in a sample by the detection of microbial components of which correlate to the presence of the microbe. Kits include a first binding agent operatively coupled to an immobilized support; and a second binding agent operatively coupled to one or more pH indicating moieties wherein the first and second binding agents bind with sufficient specificity to the microbial component to permit detection of that component which correlates to the presence of the microbe in the sample.

Abstract: The invention relates to an in vitro method for detecting pulmonary arterial hypertension (PAHT), or the risk of developing PAHT, which includes determining the presence and/or amount of anti-tenascin C antibodies in a biological sample from a patient.

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: 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: The invention discloses a method of prenatal diagnosis comprising the step of isolating exosomes from an isolated fluid, wherein the exosomes are identified by biomarker detection. Furthermore, the invention discloses the isolation of exosomes from an isolated fluid and the use of a biomarker, particularly CD24 to isolate exosomes from an isolated fluid.

Abstract: The present invention provides, as a novel diagnosis marker for type 1 diabetes mellitus, a type 1 diabetes mellitus diagnostic composition comprising alanyl-tRNA synthetase, glycyl-tRNA synthetase, asparaginyl-tRNA synthetase, or tryptophanyl-tRNA synthetase, a diagnostic kit comprising the same, and a diagnostic method using the same. The composition, the kit, and the method, according to the present invention, may be used for early diagnosis and confirmed diagnosis of type 1 diabetes mellitus because type 1 diabetes mellitus can be easily diagnosed from a patient sample.

Abstract: An embodiment relates to a method of detecting a drug resistance in a patient comprising adding nanoparticles to sample platelets to form activated platelets containing the nanoparticles and comparing a difference in activation of the activated platelets and the sample platelets. Another embodiment relates to a method of monitoring a thrombotic risk factor in a subject in a general population comprising adding nanoparticles to sample platelets to form activated platelets containing the nanoparticles and comparing a difference in activation of the activated platelets and the sample platelets. Yet another embodiment relates to a kit comprising nanoparticles, a fluorescence dye tagged antibody and optionally a buffer, wherein the kit is configured to detect a drug resistance in a patient or a likelihood of the thrombotic risk factor in a subject in general population.

Abstract: The methods of the disclosure provide fluorescence-based assays for calcineurin activity, especially in isolated T cells. The methods include the stimulation of the T cells with agents that specifically target the TCR with or without influencing co-stimulatory pathways. One TCR agonist is monoclonal antibodies specific for CD3, which more precisely distinguish the inducible activity of calcineurin than does an alternative method targeting the T cell receptor (CD3) combined with CD28 costimulation. This method more accurately distinguishes between the measured level of calcineurin activity of T cells from immunosuppressed transplant recipients and normal individuals, and thus has improved diagnostic accuracy with respect to the response of an individual to immunosuppressant therapy following an organ transplant.

Abstract: This disclosure relates to methods of predicting and diagnosing preeclampsia and eclampsia in pregnant subjects. These methods include detecting a decrease of soluble c-kit in a sample obtained from the pregnant subject. A significantly reduced concentration of soluble c-kit in the sample as compared to a gestational age-adjusted control indicates that the pregnant subject will develop or has preeclampsia or eclampsia.

Abstract: The present invention relates to novel uses of the MLN 51 gene or protein. The MLN 51 gene and protein is closely related to the development of rheumatoid arthritis and serve as biomarker and therapeutic target for rheumatoid arthritis, particularly chronic synovitis.

Abstract: The invention relates to antibodies, including monoclonal and polyclonal, or fragments thereof, which discriminate between the histidine and tyrosine isoforms of Complement Factor H and to their use in diagnostic methods and therapeutic treatments relating to Complement Factor H mediated diseases.

Abstract: A method for the detection in a body fluid of perlecan polypeptide fragments that are biomarkers of tumor metastasis, and antibodies for detecting these fragments are described. An immunoassay kit for detecting the presence of these biomarkers in a body fluid, such as serum or urine, is also described.

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 an assay device and a method for using such for the quantitative determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains a test site having immobilized thereon a ligand capable of reacting with the analyte and binding such to the test site, and two standard band sites having immobilized thereon known high and low concentrations of a calibrator agent capable of reacting with a label conjugate and binding such to the standard sites, wherein the upstream membrane has a site for the application of a sample to be analyzed, and has a site downstream from the sample application site for depositing label conjugates capable of reacting with the analyte and label conjugates capable of reacting with the

Abstract: A multi-stage method for diagnosing an immunologic food sensitivity or intolerance in a companion animal. Firstly a saliva or blood spot or other non-serum bodily fluid sample is collected. The screening the saliva or blood spot 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 semi-quantitative or 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 invention in one embodiment uses detection of isoforms of CAP37 as an early detection marker for a chronic inflammatory-associated disease. Chronic inflammatory-related diseases may include, for example, atherosclerosis, psoriasis, and osteoarthritis. The invention is also directed to isoforms of CAP37 protein having apparent molecular weights of about 135 kDa (±15 kDa) and about 100 kDa (±15 kDa) as assessed by SDS PAGE under reducing conditions, and their use as biomarkers for the presence of a chronic inflammatory-associated disease in a subject. The invention is also directed to monoclonal and/or polyclonal antibodies raised against such isoforms of CAP37 protein and kits and diagnostic tests comprising these antibodies.

Abstract: A multi-stage method for diagnosing an immunologic food sensitivity or intolerance in a companion animal. Firstly a saliva or blood spot or other non-serum bodily fluid sample is collected. The screening the saliva or blood spot 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 semi-quantitative or 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 invention includes methods and devices for preventing interfering substances from affecting the accuracy of a lateral flow immunoassay. In preferred embodiments, a test strip includes a capturing zone that includes at least one mobile capturing reagent that separates at least one interfering substance from the analyte. The capturing zone is preferably located upstream of the sample application zone. In some embodiments, the reagent/conjugate zone is also located upstream of the sample application zone. The capturing zone may be located upstream, downstream, or overlapping with the reagent/conjugate zone in these embodiments. In other preferred embodiments, one or more mobile capturing reagents are included in the elution medium/running buffer. In yet other embodiments, the capturing reagent is incorporated into a sample collection device of a sample collection system, preferably separate from the chromatographic test strip. A lysis zone is also included in some preferred embodiments.

Abstract: Disclosed is a method for predicting the risk of developing renal failure or mortality for a subject suffering from diabetes mellitus. More specifically, a method is disclosed for predicting the risk of developing renal failure for a subject suffering from diabetes mellitus, the method including the steps of determining the amounts of PLGF and sFlt-1 in a sample of a subject suffering from diabetes mellitus and comparing the amounts of PLGF and sFlt-1 determined with reference amounts of PLGF and sFlt-1, whereby the risk of developing renal failure is predicted. Also disclosed are diagnostic devices and kits for carrying out the aforementioned methods.

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: A procedure for the identification of a functional disorder of the pancreas by the use of parts of all iso-enzymes of the pancreas elastase and of synthetic amino-acid sequences as antigens for obtaining specific antibodies, as well as their use in immuno-chemical test procedures.

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 provides methods, assays, and kits for predicting or stratifying the risk of celiac disease (CD) based upon HLA-DQ genotype and/or anti-flagellin antibody levels. Such risk prediction or stratification can provide benefits to family members of CD patients, to a subset of patients who are being evaluated clinically for CD, and to researchers, who can utilize this strategy to establish inclusion criteria for participation in research studies investigating potential preventive interventions.