Abstract: Homogeneous immunoassays that allow for compensation of background signals inherent in samples and reagents. The use of homogeneous immunoassays for the detection of the presence or amount of symmetrical Dimethyl Arginine (SDMA) in biological samples. Reagents and kits for conducting the assays.

Abstract: The present invention is directed to polyclonal antibodies, specific for the capsular polysaccharides of Neisseria meningitidis serogroup X (NmX), wherein said antibodies are suitable for in vitro detection of Neisseria meningitidis serogroup X in biological fluids without culture. The invention also concerns said polyclonal antibodies in different diagnostic tests and methods, in order to detect NmX. The invention discloses also a rapid diagnostic test for detecting NmX in a biological fluid, as well as a method for obtaining polyclonal antibodies useful for detecting NmX in biological fluids such as cerebrospinal fluid, serum and urine.

Abstract: Methods are disclosed of designing antibodies for a sandwich assay for a small molecule having a molecular weight of about 500 to about 2,000. The method comprises preparing a first antibody that binds to the small molecule, and preparing a second antibody that binds to the small molecule at a portion of the small molecule other than a portion to which the first antibody binds. The second antibody is prepared from an immunogen that comprises a predetermined portion of the small molecule. The antibodies may be employed in sandwich assays for the small molecule.

Abstract: Single chain polypeptide fusion protein, comprising: a non-cytotoxic protease capable of cleaving a protein of the exocytic fusion apparatus of a nociceptive sensory afferent; a galanin targeting moiety; a protease cleavage site; a translocation domain; a first spacer located between the non-cytotoxic protease and the protease cleavage site; and a second spacer located between the galanin targeting moiety and the translocation domain.

Abstract: Methods and devices for tissue remodeling and repair of collagenous tissues, including tendons, ligaments, and bone, as well as scalable connective tissue manufacturing, are provided. Collagen fibers are assembled by extensional strain-induced flow crystallization of collagen monomers. Extensional strain also drives the fusion of already formed short collagen fibrils to produce long-range, continuous fibers. Wearable devices for controlled tissue remodeling and wound healing deliver a tissue remodeling solution to a tissue repair site. The remodeling solution, together with appropriate application of strain to the tissue remodeling site, accelerate healing, prevent injury, and reduce scar formation.

Abstract: A method of preparing an immunological substance detection nanowire complex includes preparing a multilayer nanowire in which a first metal and a second metal are alternately stacked, attaching a polymer, having a carboxyl group and an amine group at both ends of the polymer, to the second metal, attaching a first antibody, treated with a thiol's group, to the first metal of the multilayer nanowire, and attaching a second antibody to the second metal through the carboxyl group of the polymer. The second antibody includes a phosphor.

Abstract: The present invention relates to systems and methods that utilize a combination of immunoassay and magnetic immunoassay techniques to detect an analyte within an extended range of specified concentrations. In particular, a device includes a housing, a heterogeneous surface capture immunosensor within the housing and configured to generate a first signal indicative of the concentration of the analyte in an upper concentration range, and a homogeneous magnetic bead capture immunosensor within the housing and configured to generate a second signal indicative of the concentration of the analyte in a lower concentration range.

Abstract: The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using assays that detect one or more of Insulin-like growth factor-binding protein 2, Insulin-like growth factor-binding protein 3, Insulinlike growth factor-binding protein 4, and Insulin like growth factor-binding protein 6 as diagnostic and prognostic biomarker assays in renal injuries.

Abstract: The present invention relates to systems that utilize a combination of immunoassay and magnetic immunoassay techniques to detect an analyte within an extended range of specified concentrations. In particular, a device is provided for detecting an analyte in a biological sample. The device includes a first electrochemical sensor positioned on a substrate. The first electrochemical sensor includes an immobilized layer of antibody configured to bind to the analyte. The device further includes a second electrochemical sensor positioned adjacent to the first electrochemical sensor on the substrate, and a magnetic material that generates a magnetic field aligned with respect to the second electrochemical sensor. The magnetic field captures magnetic beads that have an immobilized layer of antibody configured to bind to the analyte, and concentrates the magnetic beads on or near a surface of the second electrochemical sensor.

Abstract: The present invention relates to systems and methods that utilize a combination of immunoassay and magnetic immunoassay techniques to detect an analyte within an extended range of specified concentrations. In particular, a method includes determining a first concentration of an analyte at a first immunosensor from a reaction of a signal agent with a first complex of signal antibodies, the analyte, and capture antibodies immobilized on a surface of the first immunosensor, determining a second concentration of the analyte at a second immunosensor from a reaction of the signal agent with a second complex of the signal antibodies, the analyte, and capture antibodies immobilized on magnetic beads that are localized on or near a surface of the second immunosensor via a magnetic field, determining a weighted average of the first concentration and the second concentration, and comparing the weighted average to a predetermined crossover concentration point or zone.

Abstract: Arrays of integrated analytical devices and their methods for production are provided. The arrays are useful in the analysis of highly multiplexed optical reactions in large numbers at high densities, including biochemical reactions, such as nucleic acid sequencing reactions. The devices allow the highly sensitive discrimination of optical signals using features such as spectra, amplitude, and time resolution, or combinations thereof. The devices include an integrated diffractive beam shaping element that provides for the spatial separation of light emitted from the optical reactions.

Abstract: Disclosed is an antibody which binds to risperidone, which can be used to detect risperidone in a sample such as in a competitive immunoassay method. The antibody can be used in a lateral flow assay device for point-of-care detection of risperidone, including multiplex detection of aripiprazole, olanzapine, quetiapine, and risperidone in a single lateral flow assay device.

Abstract: Provided herein is a large immuno-sorbent surface area assay (ALISSA) for the rapid and sensitive detection of botulinum neurotoxins (BoNTs) and anthrax toxin. This assay is designed to capture a low number of toxin molecules and to measure their intrinsic protease activity via conversion of a fluorogenic or luminescent substrate. Also provided herein are novel peptides that can be specifically cleaved by BoNT and novel peptides that are resistant to cleavage by BoNT. The combination of these cleavable and control peptides can be used for implementation of an exemplary ALISSA used to specifically detect BoNT enzymatic activity. Furthermore, the ALISSA as described herein may also be used in a column based format for use in a high-throughput system for testing large quantities of samples.

Abstract: Disclosed is a method for preparing a magnetic microsphere for the separation of biological proteins. A magnetic microsphere matrix is treated by formulating and using an appropriate emulsified liquid, and modification of the surface of the magnetic microsphere matrix is realized by emulsion polymerization, thereby obtaining a magnetic microsphere coated with a polyacrylate polymer layer. Said emulsified liquid comprises the following components therein: acyclic acid monoester compounds, acyclic acid glycol compounds, initiators and optionally anionic surface active agents and water. The magnetic microsphere significantly reduces the non-specific adsorption of other proteins, without affecting the joining ability for a specific protein, when used in the separation of biological proteins. A new selection is provided to realize the separation engineering of high protein specificity adsorption.

Abstract: The present invention lies in the field of visualization and quantification of immobilized targets in samples using immunochemical means. In particular, the invention relates to a method and reagents for detection, visualization and quantification of a molecular target in immunostained histological samples using particular compositions of the target specific binding agent. Methods and compositions of the invention are suitable for any assay that uses a target visualization system in histological samples based on detection of the target by the target specific binding agent. The methods and compositions are useful for evaluation of targets that are biomarkers of diseases in medical diagnostic.

Abstract: Methods for detecting colorectal cancer in a subject by detection of a galactose-containing 40 kDa molecule in a serum sample from the subject. Methods for quantifying the amount of a galactose-containing molecule in a serum sample are also provided.

Abstract: The present invention relates to systems and methods that utilize a combination of immunoassay and magnetic immunoassay techniques to detect an analyte within an extended range of specified concentrations. In particular, a device includes a first immunosensor including an immobilized layer of capture antibodies configured to bind to a first complex of signal antibodies and cardiac troponin such that a second complex of the first complex and the immobilized layer of capture antibodies is localized on or near the first immunosensor. The device further includes a second immunosensor having a magnetic field disposed locally around the second immunosensor. The magnetic field is configured to attract magnetic beads such that a third complex of the first complex and capture antibodies immobilized on the magnetic beads is localized on or near the second immunosensor sensor.

Abstract: Provided are biological methods for measuring enzyme activity. The methods include generating reactions, and contacting each reaction generated with a set of internal standards, where each of the internal standards includes a different amount of product. The methods also include generating a standard curve for each of the reactions from the internal standards in each of the reactions.

Abstract: The present invention lies in the field of visualization and quantification of immobilized targets in samples using immunochemical means. The methods of the invention utilize an immunostaining system allowing visualizing single target units in samples as distinct dots. In particular, the invention relates to methods and reagents for visualization and quantification of molecular targets immunostained in histological samples and use of said method and reagents in medical diagnostic. However, the visualization and quantification methods of the invention are applicable to a variety of targets in different samples and allow precise quantifying both relative and absolute amounts thereof.

Abstract: This disclosure pertains to isolated antibodies or antigen binding fragments thereof that specifically bind to the 3ABC non-structural protein of Foot-and-Mouth Disease virus (FMDV), wherein the antibodies or antigen binding fragments thereof recognize the amino acid sequence of SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6 or SEQ ID NO: 12. Accordingly, this disclosure also pertains to polypeptides having an amino acid sequence selected from SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5 or SEQ ID NO: 12. Monoclonal antibody Mab 40C8 is also provided. The current disclosure also pertains to methods of detecting FMDV infection in an animal (including assays differentiating infected animals from vaccinated animals (DIVA)) and kits for performing the detection methods.

Abstract: A sensor comprising an electronic circuit electrically coupled to a type III-V semiconductor material, for example indium arsenide (InAs) and an antibody contacting the type III-V semiconductor material. The sensor produces measurable N changes in the electrical properties of the semiconductor upon antibody-antigen binding events. Electrical properties measurable by the electronic device may include resistivity, capacitance, impedance, and inductance. A method of detecting an antigen using sensors of the invention. A method of detecting a reaction of an analyte to a stimulus using sensors of the invention. Sensor arrays comprising multiple sensors of the invention.

Abstract: A testing module is provided. The testing module includes a carrier, a block member, and a sampling assembly. A flow path connects a storage chamber to a mixing chamber to guide the flow of a fluid. The block member is formed in the flow path to block the fluid from flowing from the storage chamber to the mixing chamber before the connection of the sampling assembly. When the sampling assembly which contains a test sample is connected to the carrier, the fluid mixes with the test sample and flows to the mixing chamber.

Abstract: The invention relates to a method of immobilising at least one RNA molecule onto a surface of a support comprising: i) providing a first support having a surface on which at least one DNA molecule is immobilised, wherein the DNA molecule encodes an RNA molecule and the encoded RNA molecule comprises a binding molecule; ii) providing a second support having a surface on which at least one binding partner for interacting with the binding molecule is immobilised; iii) arranging the first and second supports such that the surfaces displaying the immobilised molecules are in close proximity and substantially face each other, and contacting the DNA molecule immobilised on the surface of the first support with transcription reagents; and iv) carrying out a transcription reaction to generate the encoded RNA molecule, wherein the RNA molecule is directly immobilised onto the surface of the second support via an interaction between the binding molecule of the RNA molecule and the binding partner on the surface of the s

Abstract: The inventive concepts disclosed herein are generally directed to the use of a hand-held mobile computing device, such a smartphone or tablet, to interpret the results of a medical assay device. By controlling conditions like image placement and illumination and correcting for imperfect illumination, accurate results can be obtained with hand-held mobile computing device.

Abstract: Methods include determining in a sample an amount of a first isomeric analyte and a second isomeric analyte. A first measurement value and a second measurement value are determined. The first measurement value represents a total amount of the first isomeric analyte and the second isomeric analyte. The second measurement value represents an amount of the second isomeric analyte only. The second measurement value is subtracted from the first measurement value to obtain a resulting value and the resulting value is equated to an amount of the first isomeric analyte in the sample.

Abstract: Methods for the detection of, or the risk of, bladder cancer in a patient, comprising assaying for the presence of a combination of at least two biomarkers selected from CEA, VEGF, IL-8, NGAL, NSE, IL-2, EGF, TM, d-Dimer, MMP-9, IL-6, IL-4, MMP-9/NGAL, FAS, CRP, TUP and NMP22 in one or more samples isolated from a patient wherein detecting the presence of a combination of at least two biomarkers in the one or more samples indicates the presence or risk of bladder cancer.

Abstract: The CA125 gene has been cloned and multiple repeat sequences as well as the carboxy terminus have been identified. The CA125 molecule comprises three major domains: an extracellular amino terminal domain (Domain 1); a large multiple repeat domain (Domain 2); and a carboxy terminal domain (Domain 3) which includes a transmembrane anchor with a short cytoplasmic domain. The amino terminal domain is dominated by its capacity for O-glycosylation and its resultant richness in serine and threonine residues. An amino terminal extension is presented, which comprises four genomic exons. The molecular structure is dominated by a repeat domain comprising 156 amino acid repeat units, which encompass the epitope binding sites. More than 60 repeat units have been identified, sequenced, and contiguously placed in the CA125 domain structure. More specifically, this invention is directed to a CA125 cDNA sequence which can be introduced into animal or human cells to achieve transcription or expression of the cDNA.

Abstract: The present invention provides a therapeutic agent, a treatment method and an inspection method for diseases caused by activation of neutrophils. More specifically, the invention relates to a neutrophil activation regulator which comprising a histidine-rich glycoprotein (HRG) as an active ingredient, and provides a therapeutic agent for diseases caused by neutrophil activation comprising the neutrophil activation regulator, a treatment method for diseases caused by neutrophil activation, and further an inspection method for diseases caused by neutrophil activation. The present invention is based on the neutrophil activation regulator including the HRG as an active ingredient. The present invention extends to the depressant agent for neutrophil-vascular endothelial cell interaction including the HRG of the present invention as an active ingredient, the treatment method for diseases caused by neutrophil activation and/or inflammatory diseases accompanied by neutrophil activation.

Abstract: A specific and sensitive in vitro ELISA assay and diagnostic test kit is disclosed for determining levels of NT-proBNP protein in a variety of bodily fluids, non-limiting examples of which are blood, serum, plasma, urine and the like.

Abstract: The invention relates to a method for detecting and measuring the presence of mono-nucleosomes and oligo-nucleosomes and the use of such measurements for the detection and diagnosis of disease.

Abstract: An ELISPOT method for in vitro diagnosis and/or in vitro therapy monitoring of infections and/or infectious diseases comprising incubating eukaryotic cells with an antigen, measuring the number of immunocompetent cells which secrete at least two different cytokines as a reaction to the antigen, and in measuring the immunocompetent cells, visualizing the cells with the aid of at least two different dyes and at least two different filter sets, the filter sets comprising narrowband filters.

Abstract: It is intended to identity a protein involved in a molecular mechanism between Akt and cell motility as well as to elucidate its function and find its application. In the present teachings, for achieving the above object, protein or partial peptide thereof containing an amino acid sequence identical or substantially identical to the amino acid sequence represented by SEQ ID: 2 is utilized in the screening of a compound or a salt thereof that activates or inhibits any of cell motility, cell migration and angiogenesis.

Abstract: The invention relates to antibody characteristics used to design a whole blood Point of Care Thyroid Stimulating Hormone (TSH) immunoassay using an ELISA sandwich assay lacking one or more wash steps between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).

Abstract: The invention relates to low wash Thyroid Stimulating Hormone (TSH) immunoassays using an ELISA sandwich assay having limited or no wash step between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).

Abstract: A disease detection system which includes an electrophoresis apparatus and a biomarker detector. The apparatus includes: (a) a transport passage; (b) a plurality of separation passages, each of the separation passages having an overlapping portion that overlaps the transport passage; and (c) a different biomarker concentrator in each of the overlapping portions and which concentrates at least one different biomarker from a specimen from an animal introduced into the transport passage. A plurality of the different biomarkers is associated with at least one predetermined disease, such as diabetes, heart disease or cancer. The detector detects the presence of the different biomarkers which were concentrated by the biomarker concentrators and delivered to the biomarker detector via the separation passages. First and second sets of the biomarker concentrators can be associated with respective first and second predetermined diseases and the user can determine which set will be used in each procedure.

Abstract: Novel phenyl-glyoxal based anti-citrulline probes and methods of synthesis are provided. Methods of use, such as, the development of methods for monitoring substrate citrullination over time; for identifying citrullinated proteins from cells are described.

Abstract: The present invention is directed to methods of identifying and treating a human subject harboring a tumor or other disease comprising assessing HRG gene expression at a protein level in the human subject and administering a treatment comprising an anti-HER3 antibody to the human subject whose HRG gene expression at a protein level is assessed as high. The present invention is also directed to methods of identifying a human subject harboring a tumor or other disease comprising assessing HRG gene expression at a protein level in the human subject and withholding a treatment comprising an anti-HER3 antibody to the human subject whose HRG gene expression at a protein level is assessed as low.

Abstract: The present invention is directed to novel polypeptides having sequence identity with IL-17, IL-17 receptors and to nucleic acid molecules encoding those polypeptides. Also provided herein are vectors and host cells comprising those nucleic acid sequences, chimeric polypeptide molecules comprising the polypeptides of the present invention fused to heterologous polypeptide sequences, antibodies which bind to the polypeptides of the present invention and to methods for producing the polypeptides of the present invention. Further provided herein are methods for treating degenerative cartilaginous disorders and other inflammatory diseases.

Abstract: The invention relates to antibodies directed against human Leukemia Inhibitory Factor (LIF) and to a hybridoma cell line producing said antibodies. The invention also relates to a method for blocking/inhibiting the proliferation of stem cells, and to an in vitro method for the diagnosis of diseases associated with unwanted cell proliferation in a subject or for determining the predisposition of a subject to suffer from said disease associated with unwanted cell proliferation, or for prognosis of average life expectancy of a subject suffering from said disease. The therapeutic potential of said antibodies is based on observing that the inhibition of LIF can be used in therapeutic compositions for the treatment of diseases associated with unwanted proliferation.

Abstract: Methods for managing osteoarthritis, in a human or other mammalian subject, comprising the measurement of certain cytokines and growth factors in a tissue sample of a subject, including one or more of platelet-derived growth factor AB (PDGF-AB), platelet-derived growth factor BB (PDGF-BB), and epidermal growth factor (EGF). Tissue samples may be whole blood, blood fractions, urine, saliva, and synovial fluid. Methods include diagnosing osteoarthritis, and methods for assessing the severity of osteoarthritis, such as in subject that have been diagnosed with osteoarthritis using radiographic or other methods. Methods may also include comparison of measured cytokine levels to a reference level. Methods of managing the clinical progression of osteoarthritis include initiating a clinical action based on the difference between the measured cytokine level and a reference level.

Abstract: The present invention provides a therapeutic agent, a treatment method and an inspection method for diseases caused by activation of neutrophils. More specifically, the invention relates to a neutrophil activation regulator which comprising a histidine-rich glycoprotein (HRG) as an active ingredient, and provides a therapeutic agent for diseases caused by neutrophil activation comprising the neutrophil activation regulator, a treatment method for diseases caused by neutrophil activation, and further an inspection method for diseases caused by neutrophil activation. The present invention is based on the neutrophil activation regulator including the HRG as an active ingredient. The present invention extends to the depressant agent for neutrophil-vascular endothelial cell interaction including the HRG of the present invention as an active ingredient, the treatment method for diseases caused by neutrophil activation and/or inflammatory diseases accompanied by neutrophil activation.

Abstract: The invention concerns a test element for carrying out an immunological sandwich test for determining an analyte from a liquid sample containing a reagent zone or conjugate zone which contains a conjugate of an analyte binding partner and a label which can be detected directly or indirectly by visual, optical or electrochemical means (e.g. an enzyme, fluorescent or direct label etc.) wherein said conjugate can be dissolved by the liquid sample, a detection zone which contains a permanently immobilized (i.e. which cannot be detached by the liquid sample) binding partner for the analyte or for complexes containing the analyte; and a control zone which contains a permanently immobilized binding partner for the conjugate of analyte binding partner and label characterized in that the control zone additionally contains one or more permanently immobilized binding partner(s) for the analyte or for complexes containing the analyte.

Abstract: The present invention relates to an immunoassay for detection of BNP, proBNP and fragments thereof. Essentially the assay comprises: a) contacting the antigen with a first antibody specific to a fragment corresponding to amino acids 11-22 of BNP, or to a part of this peptide comprising at least three amino acids of said sequence, to obtain a first order immune complex. b) contacting the first order immune complex obtained at step (a) with a second antibody recognizing said first order immune complex, to obtain a second order immune complex, wherein said antibody is unable to recognize free BNP, proBNP or free first antibody; c) Detecting the second order immune complex.

Abstract: The present invention relates to an immunoassay for detection of BNP, proBNP and fragments thereof. Essentially the assay comprises: a) contacting the antigen with a first antibody specific to a fragment corresponding to amino acids 11-22 of BNP, or to a part of this peptide comprising at least three amino acids of said sequence, to obtain a first order immune complex. b) contacting the first order immune complex obtained at step (a) with a second antibody recognizing said first order immune complex, to obtain a second order immune complex, wherein said antibody is unable to recognize free BNP, proBNP or free first antibody; c) Detecting the second order immune complex.

Abstract: A method for identifying a kidney transplant recipient at an increased risk of developing interstitial fibrosis or tubular atrophy which comprises obtaining a post-transplant urine sample from the kidney transplant recipient; measuring the level of clusterin in the urine sample; comparing the level of clusterin in the patient sample to the level of clusterin in a control sample from the urine of a non-fibrotic kidney transplant recipient; diagnosing a kidney transplant recipient with a clusterin level that is significantly higher than the clusterin level in the control as being at an increased risk of developing interstitial fibrosis or tubular atrophy.

Abstract: The present invention provides a method of detecting dermatophyte, which does not require a complicated operation such as an enzyme treatment and a heat treatment. The present invention provides a method of detecting dermatophyte, including a step of extracting a dermatophyte component from a sample with a treatment liquid containing a non-ionic surfactant or a zwitterionic surfactant, and a kit for diagnosing dermatophyte infection, containing a treatment liquid comprising the above surfactant, and an antibody specifically recognizing a dermatophyte component, which are housed in separate containers.

Abstract: Provided is a method for diagnosing cancer by detecting a novel cancer marker. Cancer can be diagnosed by detecting soluble glypican 3 in a test sample.

Abstract: Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. In some embodiments, the reader component communicates with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

Abstract: Specific binding members, particularly antibodies and fragments thereof, which bind to transforming growth factor beta 1 (TGF-?1) are provided, particularly recognizing human and mouse TGF-?1 and not recognizing or binding TGF-?2 or TGF-?3. Particular antibodies are provided which specifically recognize and neutralize TGF-?1. These antibodies are useful in the diagnosis and treatment of conditions associated with activated or elevated TGF-?1, including cancer, and for modulating immune cells and immune response, including immune response to cancer or cancer antigens. The anti-TGF-?1 antibodies, variable regions or CDR domain sequences thereof, and fragments thereof may also be used in therapy in combination with chemotherapeutics, immune modulators, or anti-cancer agents and/or with other antibodies or fragments thereof. Antibodies of this type are exemplified by the novel antibodies hereof, including antibody 13A1, whose sequences are provided herein.

Abstract: Thus, herein is reported a method for analyzing/characterizing circulating immune complexes (CICs) formed in vivo comprising a size-exclusion chromatography of a sample obtained from a mammal to which the drug had been administered at least once for determining the weight/size of the immune complexes, optionally a second non-SEC chromatography, and at least one immunoassay, whereby the immune complex is characterized by the correlation of the immune complex size and the immunoassay result/read-out. Also reported herein is the use of a method as reported herein for determining a correlation to altered pharmacokinetics, for determining loss or reduction of efficacy, for determining neutralization of natural counterparts of the drug, for determining immune and hypersensitivity reactions, including serum sickness/type III hypersensitivity reaction/immune complex-mediated disease.