Abstract: In spite of significant efforts to identify ?-cell-specific markers for ?-cell imaging and purification, progress has been limited. Herein is disclosed a novel biomarker of human pancreatic ?-cells, CD39L3 (also known as ectonucleoside triphosphate diphosphohydrolase-3 (NTPDase3)). Disclosed are compositions and methods for purifying and imaging ?-cell using anti-CD39L3 antibodies.

Abstract: The object of the present invention is to provide an evaluation method capable of accurately determining a metastasis of cancer, the stage of cancer progression, or the malignancy of cancer.

Abstract: This disclosure relates to devices, assays, and methods related to airway inflammation caused by polymorphonuclear neutrophils (PMNs). In certain embodiments, the disclosure relates to a model device that emulates the changes in airway cell physiology due to transmigration of PMNs from blood to the cells at the air-liquid interface. In certain embodiments, the airway cells are supported on a collagen layer wherein the collagen layer is further supported by a porous polymer from which PMNs can migrate. In certain embodiments, the disclosure contemplates adding bacteria, fungi and/or viruses to the device to emulate disease states. In certain embodiments, the disclosure relates to the use of the model system to test compounds to identify drug candidates and diagnose subjects with airway-related diseases and conditions.

Abstract: The present invention provides compositions, kits, and methods for the detection of host cell proteins (HCPs) in biological samples. In some embodiments, the present invention utilizes immunization of aves hosts with proteins derived from non-aves host cells to produce aves antibodies specific for non-aves HCPs.

Abstract: Hemoglobin, its variants, and glycated forms of each are determined individually in a multiplex assay that permits correction of the measured level of HbA1c to account for glycated variants and other factors related to the inclusion of the variants in the sample. New antibodies that are particularly well adapted to the multiplex assay are also provided.

Abstract: A method includes attaching two or more beads to each unit of one or more units of a chemical component in a sample, to form, for each unit of the chemical component, a multi-bead complex including two or more beads and the unit of the chemical component; placing the sample on a surface of an image sensor; at the image sensor, receiving light originating at a light source, the received light including light reflected by, refracted by, or transmitted through the beads of the multi-bead complexes; at the image sensor, capturing one or more images of the sample from the received light; and identifying, in at least one of the images of the sample, separate multi-bead complexes, the identifying of the separate multi-bead complexes including associating the two or more beads of each of the multi-bead complexes based on proximity to one another.

Abstract: The present invention provides methods, devices, compositions (e.g., capture complexes), and kits useful for enhancing the detection of antibodies in a test sample. The methods, devices, and compositions utilize detectable Fc-binding molecules such as Protein A, Protein G, and/or an Fc-specific antibody to amplify the signal of a detected antibody in immunoassays, such as lateral flow assays.

Abstract: The present disclosure relates to a method for labeling particles with magnetic particles and an apparatus for labeling particles with magnetic particles.

Abstract: Plasma levels of different sub-populations of microvesicles (endothelial, leukocyte, platelet and hepatocyte) were measured by flow cytometry or ELISA/filtration on blood samples from 125 patients with cirrhosis, for which 36 of them were diagnosed with HCC at inclusion. The inventors show that the levels of microvesicles of endothelial origin (CD62E+) could predict the occurrence of HCC in patients with cirrhosis. Therefore the present invention relates to a method for determining whether a patient suffering from cirrhosis is at risk of having or developing hepatocellular carcinoma comprising determining the level of endothelial-derived microvesicles (e.g. by flow cytometry) in a blood sample obtained from the patient.

Abstract: The present invention relates an in vitro method for detecting class II restricted CD4+ T cells in a sample. Herein a sample is contacted with an isolated complex of an MHC class II molecule and a peptide. This peptide comprises an MHC class II restricted T cell epitope of an antigenic protein and immediately adjacent thereof, or separated by a linker of at most 7 amino acids a sequence with a [CST]-xx-C or C-xx-[CST] motif. CD4+ T cells are detected by measuring the binding of the complex with cells in the sample, wherein the binding of the complex to a cell is indicative for the presence of CD4+ T cells in the sample. The present invention further relates to an isolated complex of an MHC Class II molecule and a peptide comprising an MHC class II restricted T cell epitope of an antigenic protein and immediately adjacent thereof, or separated by a linker of at most 7 amino acids a sequence with a [CST]-xx-C or C-xx-[CST] motif.

Abstract: According to some aspects, a method for analyzing a cell is provided. The method includes trapping the cell by binding a first molecule to the cell. The method further includes binding a second molecule to the cell. The second molecule includes a binding portion capable of specific binding to a cell-surface molecule of the cell. The second molecule further includes an identifying portion, a labeling portion coupled to the identifying portion, and a stimulus-degradable linker between the binding portion and the identification portion. The method further includes detaching the identifying portion from the binding portion by stimulating the stimulus-degradable linker where the detached identifying portion is coupled to the labeling portion. The method further includes binding the detached identifying portion through specific binding to an identifying portion recognizing molecule and detecting the labeling portion.

Abstract: The present invention provides a method to quantitatively measure the response of a patient to an immune-modulator drug that will aid clinicians in the determination of the optimal combination/posology of immunosuppressant/immune-modulator drugs. In addition, this method will open the possibility for clinicians to make the necessary adjustments in immunosuppressive therapy, as a way to avoid organ rejection to actually take place. Furthermore, this method will significantly reduce side effects of immunosuppressant drugs, optimizing therapeutic scheme and dosages, enabling the determination of the most effective immunosuppression regimen at the lower dosages for each patient individually and monitoring of treatment efficiency along time, thus opening the door to treatment personalization.

Abstract: Disclosed herein are improved methods of processing, measuring, and detecting levels of ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) in blood samples taken from a human subject at time points within about 8 hours (or about 8 hours or less) after obtaining the sample from the subject. UCH-L1 is an early biomarker for traumatic brain injury (TBI), and there is a need for improved methods for assessing UCH-L1 in blood can aid in the diagnosis and evaluation of a human subject who has sustained or may have sustained a head injury.

Abstract: Methods and kits are provided for determining of immunoglobulin isotypes and subclasses in a subject. In general the subject is a human who is a transplant candidate recipient or recipient, has allergies, or has an autoimmune disease. The method involves analyzing a sample of a body fluid of a transplant candidate or recipient, allergy patient or autoimmune disease sufferer and correlating the relative amounts of each immunoglobulin isotype and subtype, such that the distribution of isotypes and subtypes is an indication of success of the transplant in the candidate and recipient or the prognosis of the autoimmune disease.

Abstract: An analytical process for detecting antibody in human blood serum, which antibody is directed against blood group antigen, wherein the serum contains an additional antibody directed against a surface antigen, by contacting the serum to be analysed with blood cell membranes, which naturally bear surface blood group antigens, followed by detection of agglutination which indicated the presence of antibody directed against at least one surface antigen of the blood cell membranes. The agglutination reaction caused by the additional antibody is prevented, allowing the detection of anti-blood group antibody.

Abstract: The present system and method are useful for the removal of immune inhibitors such as soluble TNF receptors from the body fluid of cancer patients. In some embodiments, soluble TNF-Receptors 1 and 2 are selectively removed from plasma at 80% or more efficiency. In some embodiments, the system includes an immobilized capture ligand of a single chain TNF?. The system and method are useful for the treatment of different cancer types, stages and severity.

Abstract: Disclosed is a method for measuring an immunostimulatory response of an immune cell, including (i) bringing a measurement target immune cell into contact with an immunostimulator, (ii) forming a contact surface with a substance different from the measurement target immune cell on the measurement target immune cell, (iii) bringing the measurement target immune cell into contact with a capturing body that binds to a surface antigen on the contact surface and is capable of generating an optical signal, (iv) detecting the optical signal generated from the capturing body, and (v) determining whether or not the measurement target immune cell from which the contact surface has been eliminated before detecting the optical signal has an immunostimulatory response, based on the detected optical signal.

Abstract: Disclosed are compositions and methods to detect proteins associated with non-coeliac gluten sensitivity (NCGS). Such markers may be useful to allow individuals susceptible to NCGS to manage their food intake to avoid symptoms and further progression of disease.

Abstract: The present invention relates to a device (100) for detecting an analyte (12) in a body fluid sample (14) containing a plurality of cells (16). The device (100) comprises a sample input (18) for receiving a body fluid sample (14) containing a plurality of cells (16), and an immunoassay unit (20) comprising a detection surface (28) for performing an immunoassay of said body fluid sample (14) containing a plurality of cells (16). The immunoassay unit (20) comprises an activating reagent (22) for activating the plurality of cells (16) contained in the body fluid sample (14) to release an analyte (12), an anti-analyte-antibody (24) capable of binding to said analyte (12) to form a complex (26) comprising said anti-analyte-antibody (24) and said analyte (12), wherein the forming of said complex (26) proceeds at least partially simultaneous to the activating of said plurality of cells (16).

Abstract: Test devices to detect pregnancy in a human female subject are provided. In various embodiments, test devices include an assay means to measure the absolute or relative amount of hCG in a sample from the subject; an assay means to measure the absolute or relative amount of FSH in a sample from the subject; and an assay means to measure the absolute or relative amount of one or more progesterone metabolites in a sample from the subject.