Abstract: The purpose of the present invention is to provide a simple and highly accurate method for detecting pancreatic exocrine dysfunction with minimal invasiveness to a subject. The method comprising in vitro measurement of two APOA2 protein variants, mutants thereof and/or fragments thereof in a body fluid sample derived from the subject and detection of the presence or absence of pancreatic exocrine dysfunction on the basis of the measured amounts, and a detection kit for pancreatic exocrine dysfunction including antibodies that can specifically bind to said proteins are provided.

Abstract: A blood-based sample from a cancer patient is subject to mass spectrometry and the resulting mass spectral data is classified with the aid of a computer to see if the patient is a member of a class of patients having a poor prognosis. If so, the mass spectral data is further classified with the aid of the computer by a second classifier which identifies whether the patient is nevertheless likely to obtain durable benefit from immunotherapy drugs, e.g., immune checkpoint inhibitors, anti-CTLA4 drugs, and high dose interleukin-2.

Abstract: The inventors produced substances that neutralize the activity of a bispecific antibody having an activity of functionally substituting for FVIII, and undertook the construction of methods for measuring the reactivity of FVIII that can ensure accuracy even in the presence of this bispecific antibody. As a result, the inventors discovered that in APTT-based one-stage clotting assay, FVIII activity in the plasma of a hemophilia A patient can be evaluated accurately, and also that in APTT-based Bethesda assay, FVIII inhibitor titer in the plasma of a hemophilia A patient carrying a FVIII inhibitor can be evaluated accurately.

Abstract: Bioassays are provided for detecting and analyzing responses from single cells and cell pairs suspended in micro-scale droplets (80-200 ?m diameter) generated in microfluidic devices. Cell responses to various stimuli are analyzed. The stimuli are delivered by homotypic or heterotypic cells, small molecule drugs, and therapeutic agents including immunotherapeutics. The bioassays can be used to describe heterogeneity in any given cell population, and can be used in a clinical setting, such as profiling of patient-derived cells, designing personalized treatment strategies, and optimizing drug combinations for immunotherapy of tumors.

Abstract: A kit of parts and methods for determining the presence and quantity of one or more therapeutic monoclonal antibody drugs and/or therapeutic monoclonal antibody inhibitor drug antibodies in a biological sample, the method including providing a reaction liquid comprising the sample, a first conjugate with the target of the therapeutic monoclonal antibody and a first conjugated moiety and a second conjugate with the target of the therapeutic monoclonal antibody and a second conjugated moiety, followed by detecting the change in spectrophotometric signal when the complex between the therapeutic monoclonal antibody drug, the first conjugate and a the second conjugate forms.

Abstract: The present invention relates to a method for diagnosing an allergy, comprising the steps of bringing into contact of basophils from a whole blood sample of a patient with an allergen in an aqueous solution in the presence of whole blood, with a volume content of whole blood in the aqueous solution of at least 20 percent by volume, under conditions that allow activation of the basophils by the allergen, enrichment of the basophils from step a) and detection of activated basophils, wherein the detection is carried out in that the expression of a marker characteristic of activated basophils is detected by means of chemiluminescence; and a kit comprising a vessel for bringing the basophils into contact with the allergen, wherein the vessel is preferably a microtiter plate, optionally an allergen, an agent for detecting a marker characteristic of activated basophils by means of chemiluminescence, wherein the agent is preferably a ligand against the marker provided with a label capable of chemiluminescence and the

Abstract: This disclosure relates generally to detection and, in particular, to detecting objects within a sample or fraction thereof.

Abstract: Provided herein are methods for simultaneously detecting and quantifying antibodies which bind to the same target and have high sequence identity, such as eculizumab and ALXN1210, present together or alone in a biological sample.

Abstract: Provided is a method for identifying and treating a pregnancy devoid of uterine fetal or embryonic tissue in a subject by determining a concentration of alpha-fetoprotein (AFP) in a specimen evacuated from the uterus of the subject; comparing the concentration of AFP to a reference value; wherein when the AFP concentration in the specimen evacuated from the uterus is below that of a reference value, absence of uterine fetal or embryonic tissue is indicated. Also provided is a method for identifying and treating a presence of fetal or embryonic tissue in a location of a subject other than the uterus by determining a concentration of AFP in a non-uterine specimen obtained from the subject; comparing the concentration of AFP in the specimen to a reference value; wherein when the AFP concentration in the specimen is above that of a reference value, presence of fetal or embryonic tissue is indicated.

Abstract: A manufacturing method of a protein sensor includes the following steps. A hydrophobic material is provided and the hydrophobic material has a surface. An atmospheric pressure plasma process is performed to form a hydrophilic functional group on the surface of the hydrophobic material. A first antibody is immobilized on the surface of the hydrophobic material by the hydrophilic functional group. A mixed solution is prepared. The mixed solution includes a second antibody and an analyte, and the second antibody binds to the analyte. The mixed solution is reacted with the first antibody immobilized on the surface of the hydrophobic material to bind the first antibody to the analyte. Furthermore, a protein sensor manufactured by the above-described manufacturing method of the protein sensor is also provided.

Abstract: The present invention relates to a kit of parts and methods for determining the presence and quantity of one or more TNF-? inhibitor drugs and/or anti-TNF-? inhibitor drug antibodies in one or more biological samples each comprising less than 200 ?l, the method comprising the steps of providing a reaction liquid comprising the sample, a first TNF-? conjugate comprising TNF-? and a first conjugated moiety and a second TNF-? conjugate comprising TNF-? and a second conjugated moiety, said second moiety being capable of generating or ameliorating a detectable signal in the presence of a molecular complex comprising a TNF-? inhibitor, followed by detecting the change in signal when the complex between the TNF-? inhibitor drug, the first TNF-? conjugate and a the second TNF-? conjugate forms.

Abstract: An imaging agent comprises (a) at least one target recognition moiety; (b) at least one observable moiety non-transiently bound to the target recognition moiety, and (c) at least one docking moiety bound to the target recognition moiety, wherein the docking moiety is capable of transiently binding at least one observable moiety. In some embodiments, the at least one target recognition moiety is an antibody or antigen binding fragment thereof.

Abstract: The present invention relates to a method for detecting heart damage in a patient. The invention also relates to methods for treatment of patients identified as having heart damage. The invention further pertains to methods for evaluating the efficacy of an ongoing therapeutic regimen designated to treat a damaged heart in a patient.

Abstract: The methods and compositions described herein relate to the measurement of factor VIII (fVIII) levels and/or activity.

Abstract: The present embodiments relate to antibody binding nanofibrils obtainable by co-fibrillation of carrier proteins and carrier-Z fusion proteins at a molar ratio selected within an interval of from 1:0.20 to 1:0.90. The antibody binding nanofibrils have extremely high antibody binding capacity and can thereby be used in various applications, such as antibody purification, and detection of biomarkers in point of care or laboratory diagnosis applications. (FIG. 6).

Abstract: This document provides methods and materials for detecting PCA-2-specific autoantibodies, which can be associated with paraneoplastic neurological disorders and cancers associated with PCA-2-specific autoantibodies.

Abstract: The invention relates to methods for conducting solid-phase binding assays. One example is an assay method having improved analyte specificity where specificity is limited by the presence of non-specific binding interactions.

Abstract: The disclosure relates generally to methods of detecting and quantifying methotrexate (MTX) in a sample. The methods disclosed herein decrease cross-reactivity and improve sensitivity of the detection.

Abstract: Methods of reducing background noise in signal-generating digital assays, such as fluorescent digital immunoassays, using a colorant are disclosed. The methods utilize a binding member that specifically binds to an analyte in a biological sample. The binding member is conjugated to a signal generating compound, e.g., an enzyme, which is dissociated from the binding member. A colorant is added with a signal generating substrate, e.g., a fluorogenic or chromogenic substrate for the enzyme, or after a signal generating substrate to reduce background noise in a fluorescent digital immunoassay. The signal generated between the signal generating compound and the signal generating substrate is detected and correlated to the presence and/or concentration of the analyte.

Abstract: The present invention is focused on an in vitro method for identifying or screening human subjects at risk of suffering from a pregnancy related disease, in particular from gestational diabetes mellitus or preeclampsia, departing from the level of expression or concentration of a series of biomarkers isolated from a minimally-invasive sample such as gingival crevicular fluid (GCF). Moreover, the method of the invention offers high sensitivity and specificity at an early stage of the pregnancy (see the Examples and figures shown below), which means that it is a strong and cost-effective method for the detection of a pregnancy related disease, in particular gestational diabetes mellitus or preeclampsia, at an early stage of the disease thus procuring effective treatment, avoiding significant long-term adverse effects for both mother and baby.