Abstract: A method for assigning an antibody standard and determining a minimum detection limit of an antibody detection reagent specifically includes the following steps: S1, determination of a neutralized antigen equivalent of an antibody standard or a sample: an antigen with a known purity and concentration is subjected to a gradient dilution using a matrix, an equal amount of an antibody standard or antibody-containing sample is added to each of the gradient diluents with different concentrations respectively, and after a reaction, each mixture is subjected to an antibody detection using a first antibody detection reagent, to determine the neutralized antigen equivalent of the antibody standard or sample; S2, determination of an antibody titer of the sample; and S3, acquisition of the minimum detection limit of an antibody detection reagent.

Abstract: Applicant discloses an anti-idiotypic antibody to MOR202, which when fused to human albumin, shifted the anti-body in IFE thus mitigating any potential interference of MOR202 with the M-protein clinical assessment.

Abstract: A reservoir and a liquid-cooling radiator are disclosed. The reservoir includes a reservoir body and at least one partition mounted in the reservoir body. The reservoir body has an end panel and a peripheral side panel that is integrally formed and connected with the end panel. The peripheral side plate extends from a peripheral edge of the end panel in a same direction. A liquid chamber is formed and surrounded by the end panel and the peripheral side panel. The peripheral side plate has two side plate portions located on opposing two sides of the end panel. The reservoir body is formed with U-shaped strips extending along inner walls of one side plate portion, the end panel and the other side plate portion in sequence. The U-shaped strips are spaced and arranged in pairs. A groove is formed between the paired U-shaped strips.

Abstract: The application describes methods for determining the concentration and/or particle number of a lipoprotein(a) subform in a biological sample using capillary isotachophoresis laser induced fluorescence (CE-ITP-LIF) and compositional analysis of lipoprotein(a) particles. The ability to measure the concentration and/or particle number of a lipoprotein(a) subform in a biological sample provides a useful diagnostic tool for assessing cardiovascular risk in a subject.

Abstract: Provided herein are compositions useful in detecting degradative enzymes and biomolecules in bodily fluid samples.

Abstract: An assembly, method, system, and apparatus for the assessment of the level of specific lipoprotein particles present in a bodily fluid are disclosed. The levels determined may be used to predict the risk of developing various diseases related to lipoprotein particles.

Abstract: The present invention relates to the discovery of the human survival motor-neuron gene or SMD gene, which is a chromosome 5-SMA (Spinal Muscular Atrophy) determining gene. The present invention further relates to the nucleotide sequence encoding the SMN gene and corresponding amino acid sequence, a vector containing the gene encoding the SMN protein or a DNA sequence corresponding to the gene and transformant strains containing the SMN gene or a DNA sequence corresponding to the gene.

Abstract: The invention provides a method for detection of mutant-type DNA or/and wild-type DNA by contacting at least one of a single-stranded DNA having a substituted nucleotide, a deficient nucleotide region, or an inserted nucleotide region (mutant-type DNA), or/and a wild-type single-stranded DNA corresponding to the mutant-type DNA (wild-type DNA) with a probe hybridizing with both single-stranded DNAs, to form a hybrid with the mutant-type DNA (mutant-type hybrid) or/and a hybrid with the wild-type DNA (wild-type hybrid) (at least one of the obtained mutant-type hybrid and wild-type hybrid has a loop structure), (2) contacting the obtained mutant-type hybrid or/and wild-type hybrid with an intercalator, and (3) detecting the presence or absence of the mutant-type DNA or/and the wild-type DNA by separating the conjugate of mutant-type hybrid and intercalator or/and the conjugate of wild-type hybrid and intercalator.

Abstract: Microfluidic devices and methods for using the same are provided. Aspects of the invention include microfluidic devices that include a separation medium and a pan-capture binding medium. The microfluidic devices are configured to subject a sample to two or more directionally distinct electric fields. Also provided are methods of using the devices as well as systems and kits that include the devices. The devices, systems and methods find use in a variety of different applications, including diagnostic and validation assays.

Abstract: The present invention provides for methods and materials for diagnosing and treating neuromyelitis optica (NMO).

Abstract: The present application discloses variants of Pertuzumab. In particular, it discloses: an unpaired cysteine variant comprising Cys23/Cys88 unpaired cysteines in one or both variable light domains of Pertuzumab, an afucosylated variant of Pertuzumab, a low-molecular-weight-species (LMWS) of Pertuzumab, and a high-molecular-weight-species (HMWS) or Pertuzumab. The application further discloses the isolated variants, compositions, pharmaceutical compositions, and articles of manufacture comprising the variants, as well as methods of making and characterizing the variants and compositions thereof.

Abstract: A method of accurately separating immunoglobulin monomers by subjecting an immunoglobulin solution containing at least immunoglobulin monomers and immunoglobulin aggregates to cross-flow filtration using an ultrafiltration membrane, an ultrafiltration membrane module, and a cross-flow filtration apparatus. The method can separate immunoglobulin monomers by subjecting an immunoglobulin solution containing at least immunoglobulin monomers and immunoglobulin aggregates and having an immunoglobulin concentration of 1 to 150 g/L to cross-flow filtration using an ultrafiltration membrane having a molecular weight cut-off of 100,000 or more and less than 500,000 so that immunoglobulin monomers passes through the ultrafiltration membrane with a permeability of 80% or more while achieving a fractionation performance in which the permeability ratio of immunoglobulin dimers to immunoglobulin monomers that pass through the ultrafiltration membrane is 0.20 or less.

Abstract: A method for capillary electrophoretic analysis of a biological sample, comprising using negatively surcharged modified antibodies so that they migrate to a zone located outside the migration zone for proteins from the biological sample when they are separated during electrophoresis is disclosed. The antibodies have antigenic specificity for a predetermined target protein.

Abstract: Provided herein are microfluidic devices and methods useful for sensitive detection of analytes. The methods and devices described herein are also useful for detecting direct or indirect binding of enzymes or catalysts to a surface, for example a surface having analytes bound thereon. Methods disclosed herein include embodiments utilizing a pre-concentration scheme to improve signal levels of corresponding reporter moieties.

Abstract: Monoclonal antibodies, synthetic and biotechnological derivatives thereof (ScFv or others) are able to recognise the NGF high affinity receptor, TrkA, and act as NGF-antagonist molecules. Pharmacological compositions for therapy, gene therapy, diagnostics of neurological pathologies are also described. Transgenic animal models to study such pathologies are also described.

Abstract: An apparatus includes a porous membrane for retaining antigens from a sample as the sample passes through the membrane. The apparatus also includes a first binding region within the membrane. The first binding region includes antibodies associated with a first antigen of interest. At least some of the antigens retained in the membrane are brought into contact with the first binding region by applying an electrophoresis field across the membrane. The porous membrane could also include an electrophoresis buffer. A presence of the first antigen of interest could be detected by exposing the first binding region to a chemiluminescent reagent, and a quantity of the first antigen of interest could be determined by performing a chemiluminescent assay on the binding region.

Abstract: The invention relates to Factor H gene polymorphisms and haplotypes associated with an elevated or a reduced risk of AMD. The invention provides methods and reagents for diagnosis and treatment of AMD.

Abstract: Measurement of circulating ST2 and/or IL-33 concentrations is useful for the prognostic evaluation of subjects, in particular for the prediction of adverse clinical outcomes, e.g., mortality, and the detection of severe disease.

Abstract: The present invention discloses a bladder cancer biomarker and a test method using the same. The biomarker contains at least one of the mentioned 69 compounds, such as apolipoprotein A1 (APOA1), apolipoprotein A2 (APOA2), peroxiredoxin 2 (PRDX2), heparin cofactor 2 precursor (HCII), and serum amyloid A-4 protein (SAA4), which exist in the urine specimen of a testee. The expression intensity of the biomarker can facilitate diagnosis of bladder cancer and evaluation of aggressiveness and malignancy of bladder cancer. Thereby, the physician can arrange an optimized treatment to achieve the best therapeutic effect.

Abstract: The present invention provides for methods and materials for diagnosing and treating neuromyelitis optica (NMO).

Abstract: The invention relates to genes, gene polymorphisms, and genetic profiles associated with an elevated or a reduced risk of alternative complement cascade deregulation disease such as AMD. The invention provides methods and reagents for determination of risk, diagnosis and treatment of such diseases. In an embodiment, the present invention provides methods and reagents for determining sequence variants in the genome of a patient which facilitate assessment of risk for developing such diseases.

Abstract: Apparatus and method employing gel electrophoresis and optical imaging techniques to measure the amount of biomaterial that attaches to specified locations on a detector slide and to determine the molecular weight of the molecules at those locations.

Abstract: The invention relates to novel neuregulin-? isoforms associated with neuronal processes.

Abstract: The invention provides a diagnostic composition for detecting an affective disorder comprising an antibody selected from the group consisting of an antibody to a beta-arrestin, an antibody to a G-protein coupled receptor kinase and combinations thereof as the active detecting agent therein.

Abstract: A method of detecting proliferative diseases causing sclerosis, comprising measuring the expression of at least one substance selected from the group consisting of STAT3, phosphorylated STAT3, Smad1, phosphorylated Smad1, activin receptor-like kinase 1, activin receptor-like kinase 3 and bone morphogenetic proteins in a biological sample. A kit therefor. A prophylactic and/or therapeutic agent for proliferative diseases causing sclerosis, comprising as an active ingredient a substance having an inhibitory effect on the expression of at least one substance selected from the group consisting of STAT3, phosphorylated STAT3, Smad1 and phosphorylated Smad1. A method of identifying substances effective in preventing and/or treating proliferative diseases causing sclerosis, comprising judging whether or not a test substance inhibits the expression of at least one substance selected from the group consisting of STAT3, phosphorylated STAT3, Smad1 and phosphorylated Smad1. A kit therefor.

Abstract: The present invention relates to novel methods and devices for differentiating in a patient parathyroid diseases, such as 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 also a large non-whole parathyroid hormone peptide fragment that can function as a parathyroid hormone antagonist. By either comparing values or using independently the value of either the large non-whole parathyroid hormone peptide fragment, the whole parathyroid hormone, or the combination of these values one is able to differentiate parathyroid and bone related disease states, as well as differentiate such states from normal states.

Abstract: The present invention provides methods of identifying biomarkers indicative of the presence of a neurodevelopmental disorder, including an autism spectrum disorder, in an individual, using cytometry and mass spectrometry. The invention further provides methods of using the identified biomarkers to diagnose the presence of a neurodevelopmental disorder, including an autism spectrum disorder.

Abstract: The present invention discloses a labeled molecule for prognosing the tumor grade of head neck cancer and a method for the same, wherein a 78-kDA glucose regulated protein (GRP78) is adopted as a labeled molecule of head neck cancer. GRP78 is much more overexpressed in head neck cancer cells than in non-cancer cells. GRP78 also has relation with tumor size, tumor depth and tumor metastasis. Therefore, the present invention uses GRP78 overexpression as a reference for tumor grading of head neck cancer.

Abstract: The present invention relates to the use of milk or a derivative thereof for identifying prion proteins, preferably PrPSc prion proteins, in a mammal. The present invention is also directed to a method for identifying prion proteins, preferably PrPSc prion proteins, in mammals, comprising the step of contacting milk or a derivative thereof with an agent having high affinity and selectivity for prion proteins, preferably for PrPSc prion proteins. In addition, a further aspect the present invention concerns a method for removing PrPC and/or PrPSc prion proteins, preferably PrPSc prion proteins, from milk or a milk derivative wherein milk or a derivative thereof is contacted with sepharose, preferably sepharose comprising divalent immobilized metal ions.

Abstract: The present invention provides isolated monoclonal antibodies that selectively bind albumin from animals. Also provided are methods using such antibodies for the detection of early renal disease in animals. The method includes the steps of (a) obtaining a sample from an animal to be tested; (b) contacting the sample with an antibody having a greater avidity for feline albumin than for other proteins or components in the sample; (c) detecting the complex formed by the antibody and albumin; and (d) determining the amount of albumin in the sample from the amount of antibody-albumin complex detected. An amount of albumin in the range of from 10 ?g/ml to about 300 ?g/ml indicates the presence of early renal disease.

Abstract: Methods are provided for diagnosing and/or characterizing chronic immune disease activity in a subject. In the subject methods, a sample is obtained from a subject suspected of having or known to have a chronic immune disease. The sample is then assayed for the presence of low molecular actin fragments. The assay results are used to diagnose the presence of chronic immune disease activity and/or characterize chronic immune disease activity in the subject, e.g. to confirm an initial chronic immune disease diagnosis, to determine the stage of the disease, to monitor disease progression, to predict disease attacks, and the like. Also provided by the subject invention are kits for practicing the methods.

Abstract: A method for detecting or monitoring the presence of protein fragments, cleaved at novel cleaving sites near the N-terminal part of the collagen IX alpha 1 chain, close to the C-terminal part of the NC4 domain, and at the COL3 domain close to the NC3 domain. Neoepitope antibodies against the neoepitopes were created by the cleavages and an epitope in the cleaved N-terminal part of the NC4 domain unique to collagen IX.

Abstract: This invention provides the first blood test which characterizes asthma severity. More specifically, the present invention provides methods of determining the severity of acute asthma in a patient by determining the levels of C5a or C5a-desArg in the patient's blood, plasma or serum.

Abstract: The use of cortisol agonist for preparing a system for diagnosis of the metabolic syndrome and related conditions as belly fatness, insulin resistancy including increased risk of developing senile diabetes, i.e. diabetes type II, high blood fats and high blood pressure, in which system the dose of cortisol agonist is in an interval where a difference is obtained in the inhibitory effect of the autoproduction of cortisol in individuals suffering from the metabolic syndrome, compared to normal values.

Abstract: Performing high-resolution determination of the relative shift of the spectral properties of a biosensor. The shift in the resonance peak of the biosensor is indicative of the amount of material bound to the surface of the biosensor. A preferred biosensor is a Guided Mode Resonant Filter Biosensor (GMRFB). In one aspect of the invention, curve fitting is used to determine the relative location of the spectrum of the unexposed biosensor with respect to those spectra that are altered (e.g., shifted) by the presence of materials bound to the surface of the biosensor. In an alternative embodiment, the cross correlation function is used to detect spectral peak offsets between a reference spectrum and a spectrum measured from an exposed biosensor. In yet another alternative, maximal likelihood estimation techniques are used to determine the spectral shift or offs.

Abstract: The invention relates to defined peptides and the quantitative determination thereof in body fluids of patients suffering from progredient chronic dementia, in relation to the concentration of said peptides in a control group. The inventive peptides come from a protein precursor having the corresponding gene, are processed in a specific manner, and are optionally post-translationally modified, especially phosphorylized. An increase in the concentrations of these peptides or the corresponding non-processed protein indicates progredient chronic dementia. Progredient chronic dementia is detected by identifying the peptides and/or the protein individually or in combinations. The invention also relates to the use of said peptides for controlling the course of progredient chronic dementia and for the prognosis of progredient chronic dementia, especially for complementing or replacing mini-mental scores, and for developing therapeutic agents to combat progredient chronic dementia such as Alzheimer's disease.

Abstract: This is a self-contained disposable thermal cycler device in which target sequence is amplified as the samples passes over a grid of alternating temperature and then at the completion of the reaction, the amplified material is captured by probes complementary to the targeted sequence. Since the device can be sealed and is disposable, it reduces the occurrence of cross contamination or specimen carry-over.

Abstract: A method for diagnosing a condition of a patient involves the steps of (a) adding one or more reagents to a test sample from a patient, the test samples comprising at least part of a blood sample from the patient, in order to cause formation of a complex comprising at least one acute phase protein and at least one human lipoprotein, while causing substantially no fiber polymerization; (b) measuring the formation of the complex over time so as to derive a time-dependent measurement profile, and (c) determining a slope and/or total change in the time-dependent measurement profile, so as to diagnose a condition of the patient. A greater formation of the complex is correlated to increased probability of death of the patient.

Abstract: The activity of intracellular chemical reactions of molecules is measured by the use of fluorescently labeled substrate molecules that undergo a change in electrophoretic mobility upon chemical reaction such as that catalyzed by an enzyme. Specificity is achieved by using labeled substrate molecules that can be acted upon only by specific enzymes. Thus the activity of a specific enzyme or class of enzymes can be determined. Measurements are made with the intracellular presence of such substrate molecules, at some time of interest, typically after exposure of the cell to a stimulus that activates a particular enzymatic pathway. To ensure accuracy, measurements must be made in a timely manner so as to minimize chemical reactions occurring subsequent to the time of interest. Fast controllable laser lysis is used to obtain the contents of a single cell into which reporter substrate molecules have been introduced.

Abstract: A method for quantitatively detecting an antigen which comprises (1) a first step of providing an Fab? antibody having a uniform isoelectric point, said antibody forming an immune complex with an antigen in an analytical sample and being modified by adding an amino acid sequence comprising a charged amino acid residue and by being labeled with a fluorescent dye, (2) a second step of mixing the Fab? antibody having a uniform isoelectric point with the analytical sample containing the antigen to obtain a mixture comprising the immune complex, (3) a third step of separating the mixture by performing electrophoresis in a carrier, (4) a fourth step of irradiating an excitation light which excites the fluorescent dye to the mixture separated in the third step to cause fluorescence in the immune complex, and (5) a fifth step of detecting the fluorescence.

Abstract: Methods are provided for detecting formation of oligomeric complexes of molecules on the surface of cell membranes. These methods employ pairs of tagged probes and cleaving probes, each of which binds specificly to a cell surface molecule. The tagged probe includes a molecular tag that is linked to a first binding compound through a cleavable linkage, and the cleaving probe includes a second binding agent and a cleavage-inducing moiety that can cleave the linkage when within a defined proximity thereto. Binding of the two probes to cell surface molecules that have formed an oligomeric complex results in release of the molecular tag from the binding compound, providing a measure of formation of the complex.

Abstract: A sample separation apparatus including a porous, or rough, capillary column. The porous capillary column includes a matrix which defines pores, and may be formed rough surface of hemispherical grain silicon. The capillary column is defined in a surface of a substrate, such as silicon. The sample separation apparatus may include a stationary phase or a capture substrate disposed on the surfaces thereof. The sample separation apparatus may also include a detector positioned proximate the capillary column. A variation of the sample separation apparatus includes an electrode proximate each end of the capillary column. The sample separation apparatus may be employed to effect various types of chromatographic separation, electrophoretic separation, and analyte identification.

Abstract: Methods are provided for detecting formation of oligomeric complexes of molecules on the surface of cell membranes. These methods employ pairs of tagged probes and cleaving probes, each of which binds specificly to a cell surface molecule. The tagged probe includes a molecular tag that is linked to a first binding compound through a cleavable linkage, and the cleaving probe includes a second binding agent and a cleavage-inducing moiety that can cleave the linkage when within a defined proximity thereto. Binding of the two probes to cell surface molecules that have formed an oligomeric complex results in release of the molecular tag from the binding compound, providing a measure of formation of the complex.

Abstract: The invention concerns an element for the determination of an analyte in a liquid by means of a specific binding reaction of two bioaffine binding partners containing in or on material which enables liquid transport between the zones. The element comprises a sample application zone; a detection zone located downstream thereof that is devoid of binding reagents and is the last zone on the element that allows liquid transport; a zone containing immobilized analyte or analyte analogue between the sample application zone and the detection zone; and impregnated conjugate that can be detached by liquid located in the sample application zone or upstream or downstream thereof composed of a bioaffine binding partner capable of a specific binding reaction with the analyte to be determined and a detectable label.

Abstract: The invention features a biologically pure culture of a newly identified single-celled organism Spiky Rotating Cells (SPR), methods to diagnose an SPR infection in a human patient, an instrument for collecting and detecting an SPR infection, and methods for treating an SPR infection.

Abstract: The present invention is directed to methods and compositions for determining the presence, absence, and/or amounts of one or more membrane-associated analytes in a sample. In accordance with the invention, binding compounds derivatized with releasable molecular tags specifically bind to selected membrane-associated analytes, after which the molecular tags are released upon activation of cleavage moieties, or sensitizers, anchored in the same membrane as the membrane-associated analytes. The released molecular tags are then identified by their distinct separation and detection characteristics.

Abstract: The invention concerns an artificial antigen specifically identified by the anti-filaggrin autoantibodies present in the serum of patients suffering from rheumatoid polyarthritis, and consisting of one polypeptide comprising all or part of the sequence of one filaggrin unit or of a related molecule, in which an arginine radical has been substituted by a citrulline radical. The invention also concerns the use of this antigen for diagnosing rheumatoid polyarthritis.

Abstract: A microchannel device is provided with a plastic substrate having a microchannel formed therein. Polyelectrolyte multilayers are disposed along selected surfaces of the microchannel. The polyelectrolyte layers comprise alternating net positively charged layers and net negatively charged layers. A microchannel lid has a surface facing the microchannel. In making the microchannel device, selected surfaces of the microchannel are alternatively exposed to solutions comprising positively charged polyelectrolytes and negatively charged polyelectrolytes to form the desired number of polyelectrolyte layers.

Abstract: The invention relates to a capillary electrophoresis-based method of screening complex materials for any unidentified affinity ligand that binds to a target of interest. The method subjects a plug of a mixture of the target and a complex material sample, and a separate plug of a known, tight-binding competitive ligand, to capillary electrophoresis under conditions optimized to allow mingling of the two plugs during the capillary electrophoresis run. Preferably, migration of the competitive ligand is tracked.

Abstract: A method for detecting at least one molecular species in a crude sample is disclosed. The method comprises: acquiring a crude sample containing at least one molecular species; separating from the molecular species sample components that have size and masses greater and/or smaller than the molecular species of interest; pre-focusing molecular species in the crude sample within the capillary electrophoresis apparatus one or more times by applying voltage to the capillary for a period of time sufficient to cause electrophoretic migration of at least one molecular species in the sample up to a boundary between a low-electrolyte plug and a high-electrolyte buffer and applying a negative pressure differential to the capillary for a period of time sufficient to cause the pre-focused molecular species to be pushed substantially to its original position; electrophoretically separating the molecular species in the crude sample; and detecting the separated molecular species.