Abstract: The present invention provides a specific binding partner for holoTC having a specificity for holoTC over apoTC of at least 40-fold and an assay method for assaying for holoTC in a sample, the method comprising contacting the sample with a specific binding partner for holoTC and detecting the resultant conjugates.

Abstract: The present invention relates in part to diagnosing the occurrence of heart failure, particularly in subjects who exhibit a normal body fluid level of a natriuretic peptide. The present invention further relates in part to assigning an outcome risk (e.g., worsening cardiac function or a mortality risk, a risk of rehospitalization) to a subject. The methods comprise performing one or more assays that detect one or more biomarkers selected from the group consisting of WAP4C, ESAM, LTBR, Mesothelin, and Syndecan-1 performed on a body fluid sample obtained from a subject, and assigning diagnosis or risk based, at least in part, on the result(s) obtained thereby.

Abstract: Immunostimulatory compositions and methods of use are described to either enhance or diminish the immune stimulation effects of a honey or honey isolate by recognition of the presence of type II arabinogalactan compounds and utilising this knowledge to tailor the concentration of such compounds thereby adjusting the immune stimulation effects.

Abstract: The present invention relates to methods of utilizing pentraxin 3 as a marker for therapeutic efficacy in preclinical models of asthma.

Abstract: A method for enhancing measurement sensitivity or avoiding hemoglobin influence in a latex agglutination or metal agglutination immunoassay method of a target antigen in a biological sample that uses calixarene in the immunoassay.

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

Abstract: Disclosed is a convenient and effective means for quantifying an antigen-specific canine or human IgE.

Abstract: The invention herein is directed to a selective A? oligomer immunoassay capable of reliably and sensitively detecting A? oligomers in a biological sample of a patient. In one embodiment the inventive assay uses a pair of anti-A? oligomer antibodies, 19.3 and 82E1, to detect and quantify A? oligomers in a cerebrospinal fluid (CSF) sample. The inventive assay can be used to differentiate Alzheimer's disease (AD) patients from non-AD patients and/or to stratify AD patients according to the severity of their disease. The inventive assay can also be used as a target engagement assay that can measure bound A? oligomers as a surrogate end-point for the assessment of therapeutic efficacy and/or target engagement.

Abstract: Provided are methods of diagnosing sepsis in a patient by detecting the presence and/or amount of at least two biomarkers of sepsis or severe sepsis/septic shock in a sample from the patient. The methods and biomarkers may be used to develop an accurate prognosis for a patient having sepsis or severe sepsis/septic shock or suspected of having sepsis or severe sepsis/septic shock, or to accurately diagnose a patient having, or suspected of having sepsis or severe sepsis/septic shock. The methods and biomarkers may be used to identify and/or classify a patient as a candidate for a sepsis therapy.

Abstract: An allergy testing system for use with a mobile electronic device having a camera includes a housing that can be attached to the mobile electronic device. First and second light sources within the housing are configured to illuminate, respectively, a test sample and a control sample. A colorimetric assay is performed on the test sample and the control sample. The first light source and the second light source are activated and the camera of the mobile electronic device captures images of transmitted light. The relative intensity of transmitted light is then used by software loaded on the mobile electronic device to determine a relative absorbance value. The relative absorbance value is used, together with a calibration curve, to measure the concentration of a particular allergen within the test sample. Based on the concentration of the allergen the test sample can be labeled as either “positive” or “negative.

Abstract: Disclosed is a diagnostic marker for lung cancer comprising Hp?R as an active ingredient. Because blood, which is relatively easy to sample, is employed as a specimen, the diagnostic kit and marker for lung cancer is very simple and does not subject patients to a load compared to conventional methods that are directed to a biopsy. In addition, the kit and marker of the present invention is useful in the early diagnosis of lung cancer thanks to its high diagnostic sensitivity and selectivity.

Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.

Abstract: The present invention is directed to the detection and quantification of total ras p21 in body fluids, particularly serial changes of total ras p21 levels in a subject's body fluids. Further, the invention is directed to detecting and quantitating total ras p21 in conjunction with one or more other proteins, such as, oncoproteins, angiogenic factors, tumor markers, inhibitors, growth factor receptors, metastasis proteins, and tumor suppressors. The disclosed methods are diagnostic/prognostic for preneoplastic/neoplastic diseases, and useful to select therapies for patients with preneoplastic/neoplastic diseases. The disclosed methods are further useful to monitor the status of a patient's preneoplastic/neoplastic disease, and/or to monitor how a patient is responding to an anticancer therapy.

Abstract: Methods for diagnosing and treating conditions associated with life-threatening neurological complications are provided. The methods involve in some aspects the identification of oxLDL and LOX-1 as critical players in pregnant subjects and in some cases subjects having severe preeclampsia (early onset preeclampsia). Related products and kits are also provided.

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

Abstract: Methods are provided for detecting and optionally quantitating multiple analytes, including nucleic acid and/or polypeptide analytes, in particle-based assays that can be highly multiplexed. Compositions, systems, and kits related to the methods are also featured.

Abstract: The present invention relates to methods for measuring an amount of an analyte using an electrochemical assay in a conduit comprising a sensor, wherein said sensor comprises an electrode having a surface layer of immobilized antibody that binds said analyte, and a counter/reference electrode disposed within said conduit. A solution comprising a substrate for said enzyme and at least one air segment contacts the sensor to remove unbound analyte and labeled antibody from a region of the sensor. The disclosed invention is adaptable to the point-of-care clinical diagnostic field, including use in accident sites, emergency rooms, surgery, nursing homes, intensive care units, and non-medical environments.

Abstract: The present inventors screened peptides having a specific sequence specifically binding to amyloid-beta antibody and accordingly confirmed that A?22(pE)-42 peptide showed higher reactivity to amyloid-beta antibody in serum of Alzheimer's disease patients. Therefore, the said A?22(pE)-42 peptide can be used as an active ingredient for the kit for diagnosing dementia and thus it can be said that the peptide can be effectively used for the diagnosis of dementia whose early diagnosis is hardly possible.

Abstract: To provide a method for assaying soluble LR11 in a biological sample, which method realizes a simple and accurate assay of soluble LR11 present in the sample by immunological means without requiring isolation of soluble LR11 from the biological sample (e.g., a serum sample). The method of the invention for immunologically assaying soluble LR11 present in a biological sample, characterized in that the method includes treating the sample with at least one surfactant selected from among one or more sulfobetaine amphoteric surfactants and one or more amidosulfobetaine amphoteric surfactants.

Abstract: Embodiments herein relate to the field of screening tools for fetal/maternal wellness, and, more specifically, to biomarkers for gestational diabetes. In various embodiments, the methods may provide non-invasive and minimally-invasive screening tools for gestational diabetes that involve detection of changes in a proteomic profile of a test sample relative to a reference sample. In particular embodiments, the method may include determining whether a proteomic profile of a test sample from the subject includes at least one expression signature characteristic of gestational diabetes, wherein the proteomic profile comprises information on the expression of glycosylated fibronectin and glycosylated PSG, for example information on levels of fibronectin-SNA or a fibronectin-antibody complex, and PSG-AAL or a PSG-antibody complex.

Abstract: The present invention relates to a method for detecting the presence and/or concentration of the soluble BAG3 protein in an unknown biological sample and the assay is preferably carried by ELISA assay with antibodies, preferably monoclonal antibodies. The presence of said protein in a soluble form is associated with heart disease or with the presence of pancreatic tumors.

Abstract: Described herein are monoclonal antibodies and methods useful for determining and quantitating the presence of AAD-1 (aryloxyalkanoate dioxygenase) enzyme. These monoclonal antibodies are surprisingly well suited for detecting AAD-1 transgenic event gene products in a variety of plants and plant tissues. The invention further provides quantitative and qualitative immunoassays using the immunoglobulins of the invention.

Abstract: Methods by which specific biomarkers in saliva are used for risk detection, early diagnosis, prognosis and monitoring of Alzheimer's and Parkinson's diseases.

Abstract: Thyroid Stimulating Hormone (TSH) immunoassays are performed using an ELISA sandwich assay that employs scavenging or sacrificial beads for reducing interference caused by cross-reacting endocrine glycoprotein hormone analogues such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).

Abstract: Methods and systems for diagnosing functional and/or structural abnormalities of the heart preceding heart failure, and for predicting the risk of developing heart failure, in a subject comprising measuring a cardiac troponin in a sample and comparing the measurement to a reference value. Other markers, including GDF15 and IGFBP7 are also measured in some embodiments.

Abstract: The invention relates to a method for the diagnosis of dry eye or blepharitis in a subject which is based on the detection of one or more proteins in a sample from said subject. The invention also relates to a method for differentiating dry eyes and blepharitis.

Abstract: The present invention relates to a composition for the diagnosis of mild cognitive impairment, which includes a formulation measuring an mRNA or protein expression level of lipocalin-2 gene, to a kit for the diagnosis of mild cognitive impairment, and to a method for providing information for the diagnosis of mild cognitive impairment using the same. According to the present invention, by using the agent for measuring an mRNA or protein expression level of the lipocalin-2 gene, a patient having mild cognitive impairment can be specifically identified by measuring an expression level of lipocalin-2, which is higher in a group of patients having mild cognitive impairment than in both a normal group and a group of patients having Alzheimer's disease.

Abstract: Numerous diseases have been linked to the production of regulator cells. The present invention relates to the observation that the immune system is cycling in these diseases. Based on these observations, the present invention provides methods for treating diseases such as cancer and a HIV infection. The present invention also relates to methods of determining when a therapy to treat a disease characterized by the production of regulator cells should be administered to a patient.

Abstract: The present invention provides a process and methods for producing asymmetric antibodies in a mammalian expression system. The asymmetric antibodies are transiently or stably expressed and in cells that stably express the asymmetric antibody, following a rapid 2-step process of stable pool to clone, a highly pure asymmetric antibody expressing clone can be identified at a success frequency that permits for screening of tens of clones rather than thousands. The asymmetric antibodies are produced at a high titre and with a high level of purity with no contaminating homodimer antibodies following protein A purification with a step yield of near 100%. Typical downstream purification processes employ standard hydrophobic interaction chromatography (HIC) and/or cation exchange (CEX) resins and the antibody is stable within a wide dynamic range of buffer pH (4-8) and within the requirements for manufacturing antibodies for pre-clinical and clinical applications.

Abstract: The invention relates to thrombospondin fragments found in plasma, their use or use of portions thereof in diagnostic methods, as method calibrators, method indicators, and as immunogens, and as analytes for methods with substantial clinical utility; and their detection in plasma or other bodily fluids for purpose of diagnostic methods, especially for cancer.

Abstract: The present invention relates to the use of antibodies against the S100P protein for the prevention and/or treatment of cancer; and to methods and kits for diagnosing cancer in vitro by means of detecting the levels of S100P in a biofluid, preferably with an antibody. The invention also relates to specific anti-S100P monoclonal antibodies, hybridoma cell lines producing them and method for obtaining them, as well as to pharmaceutical compositions and conjugates containing them.

Abstract: The invention is directed to an apparatus useful in conducting detection of compounds on blotting membranes. The device is comprised of several layers including a porous support layer below the blotting membrane(s), a flow distributor above the blotting membrane(s) and optionally a well on the flow distributor to contain the liquid to the desired area and to allow for lower starting volumes of such liquid. Preferably, the flow distributor is a non-binding or low binding hydrophilic porous membrane such as a 0.22 micron membrane and the support layer is a grid or sintered porous material. The distributor and support are held together to form an envelope around the membrane(s). The use of a hinge, clips and other such devices is preferred in doing so.

Abstract: Fluid analyte sensors include a photoelectrocatalytic element that is configured to be exposed to the fluid, if present, and to respond to photoelectrocatalysis of at least one analyte in the fluid that occurs in response to impingement of optical radiation upon the photoelectrocatalytic element. A semiconductor light emitting source is also provided that is configured to impinge the optical radiation upon the photoelectrocatalytic element. Related solid state devices and sensing methods are also described.

Abstract: The invention is directed to an apparatus useful in conducting detection of compounds on blotting membranes. The device is comprised of several layers including a porous support layer below the blotting membrane(s), a flow distributor above the blotting membrane(s) and optionally a well on the flow distributor to contain the liquid to the desired area and to allow for lower starting volumes of such liquid. Preferably, the flow distributor is a non-binding or low binding hydrophilic porous membrane such as a 0.22 micron membrane and the support layer is a grid or sintered porous material. The distributor and support are held together to form an envelope around the membrane(s). The use of a hinge, clips and other such devices is preferred in doing so.

Abstract: Methods of diagnosing and treating disorders related to TH2 inhibition, including but not limited to asthma, are provided. Also provided are methods of selecting or identifying patients for treatment with certain therapeutic agents that are TH2 pathway inhibitors.

Abstract: The present invention relates to the field of biomarkers. More specifically, the present invention relates to biomarkers useful in diagnosing brain injuries. Brain injury can include overt or traumatic brain injury, as well as subclinical brain injury (SCI). In one embodiment, a method for diagnosing SCI in a patient comprises (a) collecting a sample from the patient; (b) measuring the levels of a panel of biomarkers in the sample collected from the patient, wherein the panel of biomarkers comprises ASTN1, BAI3, CNDP1, ERMIN, GFAP, GRM3, KLH32, MAGE2, NRG3, NRGN, OMG, SLC39A12, RTN1, and MT3; and (c) comparing the levels of the panel of biomarkers with predefined levels of the same panel of biomarkers that correlate to a patient having SCI and predefined levels of the same panel of biomarkers that correlate to a patient not having SCI, wherein a correlation to one of the predefined levels provides the diagnosis.

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 relates to the preparation of a set of depleted polyclonal antibodies, each depleted polyclonal antibody being raised against one specific staphylococcal enterotoxin, and its use for multiplex detection.

Abstract: Methods are provided for the prevention, treatment and diagnosis of Alzheimer's disease, based on the glycosylation pattern of amyloid-beta peptides in body fluids and tissues.

Abstract: The present invention relates to a cascade enzyme-linked immunosorbent assay, more precisely a cascade enzyme-linked immunosorbent assay using magnetic microparticles (MMPs) immobilized with the target antigen specific primary antibody and silica nanoparticles (SPs) immobilized with a cascade reaction initiator and the antigen-specific secondary antibody. When the method of the present invention is applied in the detection of an antigen in biosamples, the detection sensitivity can be significantly increased.

Abstract: Disclosed herein is a method of detecting and identifying antigens that are shed into human bodily fluids during infection. The disclosed method allows circulating antigens associated with a particular infection to be detected within minutes or hours from testing as compared to days required with the current methods. Methods of identifying diagnostic indicators/targets for a given condition or disease are disclosed which include immunizing a veterinary subject with biological fluids obtained from a human infected with particular antigens to identify diagnostic targets for immunoassay. Also disclosed are methods of diagnosing and monitoring a B. pseudomallei-associated condition, such as melioidosis. Point-of-care immunoassays are also provided that can be used to diagnose or monitor the efficacy of a B. pseudomallei-associated condition treatment. These immunoassays can also be used for rapid diagnosis of infection produced by B. pseudomallei, such as meliodosis.

Abstract: The present invention describes a method of diagnosis and/or progression of a disease based on the detection and quantification of the expression levels of biomarkers preferably selected from the group comprising gelsolin isoforms (SEQ. ID 1 and 2) and Vitamin D binding protein isoforms (SEQ. ID 3 and 4). Said method is applied to central nervous system diseases, preferably to Multiple Sclerosis.

Abstract: An assay kit for reacting with an analyte includes a plurality of reaction vessels and a plurality of micro beads. Each of the reaction vessels contains a filter membrane with a plurality of pores, and the diameter of each micro bead is greater than that of each pore. Each of the micro beads is directly or indirectly bound to the analyte, the competitor of the analyte or the identifying molecule. Additionally, an analysis method applied with the assay kit is also disclosed.

Abstract: The invention relates to an immunodiagnostic method for determining the release of neurotensin into the circulation of mammals based on the selective determination of an immunoreactivity of the N-terminal portion of a mammal proneurotensin (PNT immunoreactivity) in a serum or plasma sample of a mammal; this immunoreactivity is not neurotensin or neuromedin immunoreactivity.

Abstract: Provided are methods of detecting cancer or pre-cancerous conditions in patients comprising assaying a patient sample for an elevated level of target molecules representative of expression of nucleosome assembly protein 1-like 1 (NAP1L1), wherein elevated levels of expression of NAP1L1 are indicative of a cancer of the colon, or a precancerous condition of the colon. Also provided are similar methods using panels of biomarkers such as HMGB1; PHB; RPL6; NAP1L1 and CK18. The invention also provides a method for assessing effectiveness of a therapy or putative therapy, methods of staging cancer and assessing progression of a cancer and methods of determining an appropriate cancer treatment regimen.

Abstract: The present invention provides compounds that are surrogates of post-translationally modified proteins and uses thereof. Numerous diseases are associated with post-translationally modified proteins that are difficult to obtain in homogenous form and in quantities needed for immunization and use as convenient standards, calibrators, and/or reference compounds that facilitate the detection and analysis of endogenous post-translationally modified proteins. The surrogate compounds of the invention typically comprise antigenic epitopes (one of which carries a post-translational modification) that are tethered by a flexible and hydrophilic linker. The resulting compound behaves like a surrogate of the post-translationally modified protein because it preserves the character of the included antigens and allows recognition by specific antibodies targeting the individual antigens.

Abstract: Testing systems and methods are disclosed for detecting a pregnancy marker of an animal. A test kit may include a first standard with a first concentration of the marker, a second standard with a second concentration of the marker lower than the first concentration, and at least three test surfaces coated with a biomolecular recognition element selected to bind with the marker. The test may also include a reagent solution with a conjugated biomolecular recognition element that binds with the marker, and a visual indicator that produces a visually detectable change when reacting with the conjugated biomolecular recognition element bound to each test surface. A detectable change generated by the marker from the sample with an intensity greater than the first concentration yields a pregnant result, lower than the second concentration yields a not pregnant result, and between the first and second concentrations yields a retest result.

Abstract: A compound comprising three components A, B, and C, which components are covalently bound forming the compound having the structure A-B-C wherein component A has a specific binding affinity for antigens, component B is covalently linked to component A component C is a compound having an alkylated purine or pyrimidine moiety such as guanine, cytosine or a Coenzyme A moiety and linked thereto a moiety having a physiological effect with the proviso that component B has an catalytical or acceptor activity to couple component C with covalently coupled components A-B.

Abstract: Provided are a method for diagnosing cancer, a diagnosis kit and compositions useful for measurement of NK cell activity. The incidence of cancer may be diagnosed by monitoring changes in the in vivo immune system through measurement of NK cell activity in blood. Thus, the incidence of cancer may be readily predicted as described herein using a blood sample from a subject.

Abstract: A system and method for the detection and quantification of fragile X mental retardation protein (FMRP) in human tissue and blood samples. The system includes several high avidity monoclonal antibodies that may be provided on Xmap microspheres to capture FMRP from a tissue or blood specimen. The resulting complex is reacted with a polyclonal anti-FMRP rabbit antibody and then mixed with an anti-rabbit IgG antibody conjugated to phycoerythrin. Fluorescence emitted from the resulting complex is a function of the amount of FMRP present in the specimen.