Abstract: The present invention is in the field of autoimmunity. More specifically, the present invention relates to the detection of autoantibodies to domain 4 of beta 2-glycoprotein I (?2-GPI) as an indicator for atherosclerosis.

Abstract: The invention provides compositions and methods for measuring human serum hepcidin levels. The invention provides methods for the oxidative refolding of a hepcidin polypeptide to a form that is mature, bioactive and folded as in the native configuration and molecular mass; a method for measuring the level of native, bioactive hepcidin in a vertebrate animal.

Abstract: The present invention relates to a method for diagnosing myocardial infarction in a subject who suffers from acute coronary syndrome and has a cardiac troponin level which is detectable but lower than the level that is considered as being indicative for a myocardial infarction. Moreover, the present invention relates to a method for identifying a subject being susceptible to cardiac intervention, wherein the subject suffers from acute coronary syndrome and has a cardiac troponin level which is detectable but lower than a level that is considered as being indicative for a myocardial infarction. The methods of the present invention are based on the determination of H-FABP and, optionally, myoglobin in a sample of the subject and comparing the amount of H-FABP and, optionally, myoglobin to reference amounts.

Abstract: The invention relates to a method for detecting an infection of a mammal with an acid-resistant microorganism, wherein (a) a stool sample of a mammal is incubated with at least two different monoclonal antibodies, fragments or derivatives thereof or aptamers under conditions allowing a complex formation of antigens of the acid-resistant microorganism with antibodies, fragments or derivatives thereof or the aptamers, and wherein (aa) the first monoclonal antibody or the fragment or the derivative thereof or the first aptamer specifically binds an epitope of the first antigen, which shows at least with some mammals a structure after the intestinal passage that corresponds to the native structure or the structure which a mammal produces antibodies against after being infected or immunised with the acid-resistant microorganism or an extract or lysate thereof or a protein therefrom or a fragment thereof or a synthetic peptide; (ab) the second monoclonal antibody or the fragment or the derivative thereof or the sec

Abstract: Compounds of methamphetamine derivatives having a meta-substituted alkyl linker on the benzene ring and a protective group on the nitrogen of the methamphetamine hapten. Such compounds have the structure. wherein R1 is an alkyl linker comprising 2-15 carbon atoms and 0-6 heteroatoms, R2 is a leaving group, and R3 is a protecting group.

Abstract: The invention relates to a method of determining equine NT-proBNP, or fragments thereof, comprising the steps of: providing an equine sample, contacting the sample with at least one antibody which specifically binds to equine NT-proBNP, and determining the presence and/or concentration of the equine NT-proBNP or fragments thereof existing in the sample.

Abstract: A method for improving the diagnostic assessment of cartilage degenerative processes, and to provide means of monitoring the effects of therapeutical measures taken towards arthritic diseases in most mammals utilizes an immunoassay to detect fragments of collagen type II resulting from collagenase activity comprising an antibody directed against an epitope comprised in the amino acid sequence HRGYPGLDG (SEQ ID NO:1), located in the helical region of collagen type II.

Abstract: The present invention concerns a method for the oxidative refolding of a hepcidin polypeptide to a form that is mature, bioactive and folded as in the native configuration and molecular mass; a method for measuring the level of native, bioactive hepcidin in a vertebrate animal; a method for measuring the level of hepcidin gene expression in a vertebrate animal; and a method for regulating the production of native, bioactive hepcidin in a vertebrate animal in vivo. The present invention also concerns an antibody or fragment thereof that specifically binds to a continuous, discontinuous, and/or conformational epitope of a mature and bioactive hepcidin folded as in the native configuration; and a pharmaceutical composition that includes the antibody or a hepcidin polypeptide and that provides antimicrobial, agonistic, or antagonistic activities in vivo in a vertebrate animal.

Abstract: The present invention provides a method of performing a competitive assay for the detection and quantification of an analyte over an extended dynamic range. This is achieved by a multi-step sample addition method whereby different concentrations of sample are added at different times during the assay that produces a dose-response curve with multiple windows of detection. This multi-step sample addition method causes the dose-response curve of the composite assay to broaden, dramatically increasing the assay dynamic range.

Abstract: A method to facilitate recovery troponin I and/or troponin T from a sample comprising addition of troponin C to the sample or to a surface from which the troponin I and/or troponin T are recovered.

Abstract: The present invention provides methods for the identification and use of diagnostic markers for differential diagnosis of diseases. In a various aspects, the invention relates to methods and compositions able to determine the presence or absence of one, and preferably a plurality, of diseases that exhibit one or more similar or identical symptoms. Such methods and compositions can be used to provide assays and assay devices for use in determining the disease underlying one or more non-specific symptoms exhibited in a clinical setting.

Abstract: The present invention provides BoNT/B peptides, BoNT/B peptide compositions, tolerogizing compositions, immune response inducing compositions, as well as methods of determining immunoresistance to botulinum toxin therapy in an individual, methods of treating immunoresistance to botulinum toxin therapy in an individual, methods of reducing anti-botulinum toxin antibodies in an individual and methods of inducing a BoNT/B immune response an individual.

Abstract: The present invention provides BoNT/B peptides, BoNT/B peptide compositions, tolerogizing compositions, immune response inducing compositions, as well as methods of determining immunoresistance to botulinum toxin therapy in an individual, methods of treating immunoresistance to botulinum toxin therapy in an individual, methods of reducing anti-botulinum toxin antibodies in an individual and methods of inducing a BoNT/B immune response an individual.

Abstract: The present invention provides a method for detecting the presence or amount of an analyte in a sample, said method comprising: a porous surface to which particles having attached thereto a binding substance, analyte and binding substance coated label particles are added. If said analyte is present in the sample an immuno- or chemical reaction occurs in the liquid phase. The separation of bound complex from unbound material is achieved by using said surface where the separation occurs mainly two dimensionally on the surface of the porous surface (e.g. grid). Interestingly, the disclosed surface enables a separation where said complexes are distributed two dimensionally on the porous surface (e.g. grid), whereas unbound materials are distributed three dimensionally. Accordingly, said surface enables both a two and a three dimensional separation.

Abstract: Methods for the detection and measurement of tagged (labeled) biologically active materials in a sample are described. The tagged biologically active materials are detected using an atomic mass or optical spectrometer having a source of atoms or atomic ions. Element-labeled biologically active materials, comprising antibodies, antibody Fab? fragments, antigens, aptamers, protein complexes, growth factors, hormones, receptors and other biologically active materials attached to a stable elemental tag, can be used in specific binding assays and measured by elemental spectroscopic detection. Also described are methods for the determination of metals in samples of interest using specific antibodies to isolate the target metals and elemental spectroscopy for detection and quantitation. Kits are provided comprising reagents to detect and measure labeled biologically active materials or labeled competition analytes.

Abstract: A method for analyzing a biological sample by antibody profiling for identifying forensic samples or for detecting the presence of an analyte. In an embodiment of the invention, the analyte is a drug, such as marijuana, Cocaine (crystalline tropane alkaloid), methamphetamine, methyltestosterone, or mesterolone. The method comprises attaching antigens to a surface of a solid support in a preselected pattern to form an array wherein locations of the antigens are known; contacting the array with the biological sample such that a portion of antibodies in the sample reacts with and binds to the antigens in the array to form immune complexes; washing away antibodies that do form immune complexes; and detecting the immune complexes, to form an antibody profile. Forensic samples are identified by comparing a sample from an unknown source with a sample from a known source.

Abstract: The invention relates to a method for diagnosis of a disease, wherein presence or absence of an anti-endothelin-receptor antibody is determined in a sample from a patient to be diagnosed more in particular an anti-endothelin-receptor-A antibody. The disease according to the invention is in particular selected from diabetes, preferably type I diabetes, graft rejection, pre-eclampsia, hypertension, vasculitis, collagenosis, Raynaud-Syndrom (Morbus Raynaud), and inflammatory rheumatic disease and arteriosclerosis. The invention further relates to the use of an inhibitor of an anti-endothelin-receptor antibody or an inhibitor of an endothelin-receptor for the production of a medicament as well as a method for removing anti-endothelin-receptor antibodies from isolated blood by means of plasmapheresis.

Abstract: Generally, the present invention relates to lamotrigine analogs that have substituents at the triazine 3-position and on the benzene 4-position and 5-position. The lamotrigine analogs can include immunogenic moieties that can be used to prepare anti-lamotrigine antibodies, or antigenic moieties that can be used in immunodiagnostic assays for lamotrigine. Also, the lamotrigine analog can include tracer moieties for detecting the presence or amount of the analog during an immunodiagnostic assay. Additionally, the lamotrigine analogs can be used in immunodiagnostic assays to compete with lamotrigine for binding with anti-lamotrigine antibodies.

Abstract: The invention includes an enantioselective indicator-displacement assay useful to determine enantiomeric excess (ee) enantiomeric samples colorimetrically. Determination may be by inspection of color with the naked eye, spectrographic measurement, or mathematical calculation. Concentration may also be determined. The assay may involve two independent absorption measurements. On suitable group of enantiomeric molecules to be assayed include ?-hydroxy acids. The inherent relationship between the absorbance of the indicator-displacement ensemble and the overall concentration and ee of the analyte is established through solution equilibria. The invention also includes use of the assay in drug screening and manufacturing, high throughput screening of catalysts and kits for use in conducting assays of the invention.

Abstract: The present invention provides methods useful for diagnosis of anthrax by detection of capsular polypeptide in serum, urine, or other biological samples.

Abstract: The present invention relates to compounds of formula (I), or pharmaceutically acceptable salts thereof, wherein Z is NR11, NHCO, NHSO2, NHCH2, CH2, CH2CH2, or CH?CH; X is a hydrocarbyl group optionally substituted by one or more R12 groups; R10 and R11 are each independently II or alkyl; R1-R4 are each independently II or (CII2)mR12, where m is O, 1, 2, or 3; each R12 is independently (CH2)aR16, where each R16 is independently selected from O(CH2)bR13, R13, COR13, COOR13, CN, CONR13R14, NR13R14, NR13COR14, SR13, SOR13, SO2R13, NR13SO2R14, SO2OR13, SO2NR13R14, halogen, CF3, and NO2, and wherein each a is 0, 1, 2, or 3 and b is 0, 1, 2, or 3; R13 and R14 are each independently H or (CH2)nR15, where n is 0, 1, 2, or 3; and each R15 is independently selected from alkyl, cycloalkyl, heteroaryl, aralkyl, aryl and heterocycloalkyl, each of which may be optionally substituted by one or more substituents selected from halogen, OH, CN, COO-alkyl, aralkyl, SO2-alkyl, SO2-aryl, COOH, CO— alkyl, CO-aryl, NH2, NH-alkyl, N

Abstract: A solid-phase immunoassay for 6-keto-Prostaglandin F1?, the stable hydrolysis product of prostacyclin (Prostaglandin I2) is disclosed. Prostacyclin, a potent vasodilator with anti-platelet and anti-proliferative properties is an effective treatment for primary pulmonary hypertension and pulmonary arterial hypertension associated with scleroderma and scleroderma-like syndrome. Levels of 6-keto-Prostaglandin F1? can be directly correlated with levels of prostacyclin. Therefore, 6-keto-Prostaglandin F1? has become the indicator of choice to measure prostacyclin levels. The single step immunoassay for 6-keto-Prostaglandin F1? uses the bioluminescent protein, aequorin as a label. Analyte-label conjugates were constructed by linking the carboxyl group of 6-keto-Prostaglandin F1? and lysine residues of aequorin by chemical conjugation methods. The binding properties of 6-keto-Prostaglandin F1? towards its antibody and the bioluminescent properties of aequorin are retained in the conjugate.

Abstract: Topiramate analogs have substituents at the sulfamate group, 9-position, or 10-position. Topiramate analogs may include immunogenic moieties to prepare anti-topiramate antibodies, or antigenic moieties for immunodiagnostic assays. Also, the topiramate analog can include tracer moieties for detecting the presence or amount of the analog during an immunodiagnostic assay. Additionally, the topiramate analogs can be used in immunodiagnostic assays to compete with topiramate for binding with anti-topiramate antibodies. Such an immunodiagnostic assay can be used for detecting the presence of topiramate in a sample obtained from a subject previously administered topiramate by the following: combining an anti-topiramate antibody and a topiramate analog with a sample to form a first composition; allowing any free topiramate from the sample and the topiramate analog to compete for binding with the antibody; detecting binding between the topiramate analog and the antibody.

Abstract: The present invention relates to methods and compositions for measuring latent protein C in test samples, particularly patient samples. The methods and compositions described are sensitive for latent protein C, relative to activated protein C.

Abstract: The present invention relates to novel methods and compositions useful for detecting whole parathyroid hormone at a physiological level and C-terminal parathyroid fragments in a mammalian sample. Such detections may be useful to different parathyroid diseases or disorders in a subject, such as chronic renal failure, hyperparathyroidism and related bone diseases, from normal or non-disease states. One detects whole or non-fragmented (1 to 84) parathyroid hormone in a biological sample and optionally one or more of a selection of C-terminal parathyroid hormone peptide fragments that may or may not function as a parathyroid hormone antagonists. By either comparing values or using independently the value of either the one or more of a selection of C-terminal parathyroid hormone peptide fragments, the whole parathyroid hormone, or the combination of these values, one is able to differentiate chronic renal failure, parathyroid and bone related disease states, as well as differentiate such states from normal states.

Abstract: Methods for detecting analytes in a sample are provided. A plurality of particles, each of which is coated with a capture agent having an affinity for the analyte, is combined with the sample to form a plurality of analyte-particle complexes. The system also includes a transport arrangement for transporting the sample to the sensor surface, and a magnetic field inducing structure constructed and arranged to establish a magnetic field at and adjacent to the sensor surface. The resonant sensor produces a signal corresponding to an amount of analyte-particle complexes that are bound to the sensor surface.

Abstract: The present invention relates to compounds of formula (1), and pharmaceutically acceptable salts thereof, A compound of formula (I), or a pharmaceutically acceptable salt, hydrate, complex or pro-drug thereof (I), wherein: one of R1 and R2 is H, and the other is selected from F and Cl, or R1 and R2 are both F; R3 is selected from cyclopentyl and cyclohexyl; R4 is an optionally substituted 5- or 6-membered monocyclic or an 8- to 10-membered bicyclic aryl or heteroaryl ring which includes up to four heteroatoms. The invention further relates to pharmaceutical compositions comprising compounds of formula (I), and the use of such compounds in the treatment of a disease selected from osteoporosis, Paget's disease, Chagas's disease, malaria, gingival diseases, hypercalaemia, metabolic bone disease, diseases involving matrix or cartilage degradation, and bone cancer disorders such as bone metastases and associated pain.

Abstract: Disclosed are screening processes for identification of compounds that may inhibit complex formation between C-reactive protein and fibronectin. Compounds identified by the disclosed methods may be utilized to inhibit the target analytes that are known to occur during skin aging as well as during the course of several diseases. Accordingly, inhibitory compounds identified by the disclosed methods may be utilized to prevent and treat damaged tissue, inflammatory conditions, cardiovascular conditions, renal conditions, periodontal conditions and obesity, among other conditions. For example, the compounds identified by the disclosed methods may be utilized to treat tissue that has suffered trauma, e.g., burns or wounds, as well as tissue that is inflamed due to any of several causes.

Abstract: Generally, the present invention relates to topiramate analogs that have substituents at the sulfamate group or at the 9-position or 10-position. The topiramate analogs can include immunogenic moieties that can be used to prepare anti-topiramate antibodies, or antigenic moieties that can be used in immunodiagnostic assays for topiramate. Also, the topiramate analog can include tracer moieties for detecting the presence or amount of the analog during an immunodiagnostic assay. Additionally, the topiramate analogs can be used in immunodiagnostic assays to compete with topiramate for binding with anti-topiramate antibodies.

Abstract: The present invention relates to compounds of formula (I), or pharmaceutically acceptable salts thereof. The present invention seeks to provide further substituted heteroaryl-substituted pyrimidine derivatives. More specifically, the invention relates to compounds that have broad therapeutic applications in the treatment of a number of different diseases and/or that are capable of inhibiting one or more protein kinases.

Abstract: A diagnostic test for hepatocellular carcinoma is based on increases in the concentration of two biochemical markers in a biological sample, alpha-1-acid glycoprotein (AAG) or isoforms thereof and alpha-fetoprotein (AFP) or glycoforms thereof. Levels of these markers may be performed using an immunoassay. Also disclosed is a diagnostic kit for use in these assays that comprises reagents for detecting and/or measuring in AAG and AFP in blood, serum or tissue samples. A point-of-care device for the performance of such measurements is also disclosed.

Abstract: The present invention relates to a dry reagent assay device having at least one test zone and at least one reference zone, which provides an internal mechanism for assuring correct and reliable assay procedures and reagent qualities. In one embodiment, the present invention relates to an assay device having at least one test zone for detecting at least one analyte in a sample by reacting the sample with a labeled indicator reagent, and a reference zone for receiving unreacted labeled indicator reagent.

Abstract: A membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes time-resolved fluorescence to detect the signals generated by excited fluorescent labels. Because the labels can have relatively long emission lifetime, short-lived background interference can be practically eliminated through delayed fluorescence detection. In addition, the resulting fluorescent reader can have a simple and inexpensive design. For instance, in one embodiment, the reader can utilize a silicon photodiode and a pulsed light-emitting diode (LED) to accurately excite labels and detect fluorescence on a membrane-based assay device without requiring the use of expensive components, such as monochromators or narrow emission band width optical filters.

Abstract: A test kit for determining the presence of one or more analytes in a fluid sample, including an assay device together with a reading device which engages with the assay device and wherein precisely located engagement of the assay device with the reading device is essential for accurate reading of the assay result, where precisely located engagement of the assay device with the reading device causes a ‘lock-and-key’ interaction between the assay device and reading initiation means of the reading device. Preferably the reading initiation means includes switch actuating means including at least one fixed projecting portion and at least one displaceable projecting portion, and a contact portion of the assay device casing includes a recess shaped to accommodate the fixed projecting portion of the switch actuating means but not the displaceable projecting portion.

Abstract: The invention concerns a micro-muscle designed to be immersed in a biological liquid, comprising a deformable chamber whereof one portion at least consists of a semipermeable membrane, said chamber containing a solution capable of osmotic activity. The solution is preferably activated by a product to be injected into the biological liquid.

Abstract: Methods for therapeutic drug monitoring are provided. A plurality of particles, each of which is coated with a capture agent capable of binding a therapeutic drug of choice is combined with the sample to form a plurality of therapeutic drug-particle complexes. The system also includes a transport arrangement for transporting the sample and/or particles to the sensor surface, and optionally a magnetic field inducing structure constructed and arranged to establish a magnetic field at and adjacent to the sensor surface. The resonant sensor produces a signal corresponding to an amount of therapeutic drug-particle complexes that are bound to the sensor surface.

Abstract: Using two types of antibodies, i.e., a first antibody having a higher affinity for a target substance than for a competitive substance and a second antibody having a higher affinity for the competitive substance than for the target substance, a specimen is treated with these two antibodies. Then, the competitive substance in the specimen first binds to the second antibody and thus the ratio of the target substance to the competitive substance in the specimen is enlarged. As a result, the target substance becomes liable to bind to the first antibody and, in its turn, the reactivity of the target substance is elevated compared with the case of using the first antibody alone. Thus, the target substance in the specimen can be accurately assayed while avoiding the effects of the competitive substance contained in the specimen.

Abstract: A method for the detection or quantitation of unlabeled target analyte in a biological sample, the method comprising labeling a target analyte for a biological sample suspected of containing unlabeled target analyte with an acridinium compound to form a labeled target analyte and providing the labeled target analyte to the biological sample, or providing the labeled target analyte to the biological sample, wherein the acridinium compound comprises an acridinium nucleus having an electron-donating substituent directly attached to the acridinium nucleus, with the electron-donating substituent attached at the C2 position. Chemiluminescent acridinium compounds useful in the method have emission maxima close to or in the near infrared (NIR) region (>590 nm).

Abstract: Malarial parasite Plasmodium falciparum is responsible for the most severe form of malaria in humans, causing about 2 million deaths every year. Lack of effective vaccines and emergence of drug-resistant strains necessitate the need of novel drug targets to treat the disease. The present invention describes a novel assay method of identifying candidate compounds as anti-malarials based on the property of binding to plasmodial parasite 90 kDa heat shock protein.

Abstract: Novel B7-like polypeptides, proteins, and nucleic acid molecules are disclosed. In addition to isolated, full-length B7-like proteins, the invention further provides isolated B7-like fusion proteins, antigenic peptides, and anti-B7-like antibodies. The invention also provides B7-like nucleic acid molecules, recombinant expression vectors containing a nucleic acid molecule of the invention, host cells into which the expression vectors have been introduced, and nonhuman transgenic animals in which a B7-like gene has been introduced or disrupted. Diagnostic, screening, and therapeutic methods utilizing compositions of the invention are also provided.

Abstract: The present invention describes devices and methods for detecting and measuring the amount of acetaminophen-protein adducts in a sample.

Abstract: A method having clinically sufficient degree of diagnostic accuracy for detecting the presence of coronary artery disease in a human patient from the general population and for distinguishing between the stages of the disease in that patient is disclosed. The stages are, first, the non-acute stage, which is either asymptomatic coronary artery disease or stable angina, second, the acute stage known as unstable angina, and, third, the acute stage known as acute myocardial infarction. The diseased state (as opposed to the non-diseased state) is indicated by the clinically significant presence of a first marker in a sample from the patient. The presence of one of the two acute stages, unstable angina or acute myocardial infarction, is indicated by the clinically significant presence of a second marker in a sample from the patient. The presence of the more severe acute stage known as acute myocardial infarction is indicated by the clinically significant presence of a third marker in a sample from the patient.

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. Since troponin I and T exist in various conformations in the blood, the ratios of the monomeric troponin I an 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 is a system to determine the presence of a troponin form or a group of troponin forms in a sample of whole blood, serum or plasma. Disclosed is a stabilized composition of troponin; the stabilized composition can comprise a stabilized composition of troponin I, wherein the troponin I is oxidized, the troponin I can be unbound or the troponin I can be in a complex.

Abstract: A method for food sensitivity panel testing (for sensitivities other than gluten sensitivity) by detecting IgA antibodies in serum is disclosed. A method for testing stool samples for the presence of particular antibodies, which is more sensitive and less invasive than prior art testing methods, is also disclosed for diagnosing immunologic food sensitivities. These methods of diagnosis may be used alone or in combination to further enhance the accuracy of diagnosis.

Abstract: The anti-19P2 ligand monoclonal antibodies of the invention (in particular P2L-1Ca) have very high binding ability and can neutralize the arachidonic acid metabolite releasing activity of the 19P2 ligand. Therefore, they can be used, among others, as diagnostic, prophylactic and/or therapeutic agents for various diseases caused by some or other abnormality in the pituitary function modulating activity (e.g. prolactin secretion promoting activity), central nervous system modulating activity and pancreatic function modulating activity, among others, supposedly possessed by the 19P2 ligand.

Abstract: The MN/CA IX protein is identified herein as a hypoxia marker. The MN/CA9 gene promoter is characterized, and the location of the HIF-1 binding site within the MN/CA9 promoter is identified. Further, the hypoxia inducibility of the MN/CA9 gene and the uses of such inducibility are disclosed. In one aspect, the invention provides diagnostic/prognostic tools for determining the presence of hypoxia in a tissue in a vertebrate, preferably a human, and for measuring the relative degree of hypoxia in said vertebrate. In another aspect, the invention provides methods using tumor biopsies to predict the radioresistance of a preneoplastic/neoplastic tissue in a vertebrate subject, preferably a human patient, for diseases in which MN/CA IX levels can be used to indicate radiobiologically relevant tumor hypoxia. Such predictive methods can be used as an aid in patient therapy selection.

Abstract: The invention provides methods for predicting, diagnosing or monitoring acute cardiac disorders, cardiac transplant rejection, or distinguishing acute cardiac disorders from pulmonary disorders, by measuring BNP signal peptide levels in a sample taken from a subject shortly after onset of, or presentation with the disorder or transplant rejection.

Abstract: Methods and compositions for diagnosing and treating diseases, particularly cancer, associated with differential expression of cancer-associated targets (CAT) in disease cells compared to healthy cells are provided. Also provided are antagonists and agonists of CAT, and methods for screening agents that modulate CAT level or activity in vivo or in vitro.

Abstract: The invention is a procedure for measuring the binding of an entity (ligand) to a surface by using a hapten-conjugated version of the ligand (hapten-ligand). An excess of the hapten-ligand is presented to the binding surface and excess (unbound) hapten-ligand is washed off. Bound hapten-ligand is then solubilized (removed) and applied to a membrane support or separated by electrophoresis and applied to a membrane support. Known amounts of hapten-ligand are similarly applied to the membrane, to provide for hapten-ligand standards. The membrane-bound hapten-ligand is detected by application of an enzyme-conjugated antibody to the hapten; or by application of an antibody to the hapten followed by application of an enzyme-conjugated antibody to the anti-hapten antibody. The resultant membrane-associated enzyme is detected and quantitated by the application of a color or light-producing substrate which reacts with the enzyme.

Abstract: The invention provides compositions and methods for measuring human serum hepcidin levels. The invention provides methods for the oxidative refolding of a hepcidin polypeptide to a form that is mature, bioactive and folded as in the native configuration and molecular mass; a method for measuring the level of native, bioactive hepcidin in a vertebrate animal.