Abstract: The current disclosure provides methods for detecting and analyzing K17 expression in a bladder sample obtained from a subject. The current disclosure also pertains to methods and kits for identifying a mammalian subject with bladder cancer by detecting the expression of K17 in a sample. The present methods include both cell-based and cell-free methods for determining the level of keratin 17 in a sample obtained from the bladder of a subject.

Abstract: Described is a method for identifying pathogenic platelet-activating antibodies in a subject's blood and particularly antibodies implicated in heparin-induced thrombocytopenia (HIT) which comprises the preparation of a platelet releasate from a normal subject's platelets, the combination of the platelet release with a normal subject's platelets, a test subject's blood sample, and analyzing the sample for platelet activation.

Abstract: Provided herein are methods, systems, and compositions for detecting one or more HDL-associated proteins (e.g., ApoC3; ApoC3 and ApoA1; ApoC3 and SAA1/2; or proteins in Biomarker Panels 1-30) in a sample from a subject with, or suspected of having, cardiovascular disease (CVD) or other HDL related disease. In certain embodiments, such methods, systems, and compositions are used to determine the approximate risk of CVD (or other disease) for a subject, and/or the approximate cholesterol efflux capacity (CEC) of a sample.

Abstract: An immunochromatographic test strip that enables a specimen to sufficiently and quickly permeate into a sample application region within a test time, reducing variations in detection values of a test line. The test strip maintains consistent detection values even with whole blood specimens. The immunochromatographic test strip includes at least a sample application region, a development region, and a detection region, wherein the sample application region contains polyethylene glycol having a molecular weight of 15,000 to 700,000.

Abstract: A method for evaluating a biological material for unassociated virus-size particles having a particular epitope uses a fluorescent antibody stain specific for binding with the epitope and a fluid sample with the virus-size particles and fluorescent antibody stain is subjected to flow cytometry with identification of fluorescent emission detection events indicative of passage through a flow cell of a flow cytometer of unassociated labeled particles of virus size including such a virus-size particle and fluorescent antibody stain.

Abstract: A card is provided for detecting the existence and/or identity of microbial presence, having a base for receiving thereon a fluidic sample, a transparent cover to overlay the base, formed with a top layer, a bottom layer, and an adhesive layer therebetween, wherein a portion of the bottom layer is formed such that a portion of the adhesive layer is not covered by the bottom layer, and a media applied is to and retained by that portion of the adhesive layer which is not covered by the bottom layer, that media serving to gel the fluidic sample and/or support growth of a micro-organism whose existence and/or identity is being tested by the card. To facilitate manual and/or automated counting of visual indications of micro-organisms, a black ink grid system can be applied which does not diffuse in the presence of the fluidic sample and/or the media, but at the same time which readily is removable from the base when removal is desired.

Abstract: A method for detecting an immune cellular response including the steps of: (a) suctioning a defined amount of the sample by an automated suction/discharge device, (b) discharging this amount, using the device, into container R, containing, beforehand, at least one stimulant for secretion of the molecule by the at least one cell, or else not containing such a stimulant, (c) when the container does not contain the stimulant beforehand, introducing into container R the at least one secretion stimulant contained in container E, using the device, and (d) allowing the sample and stimulant to incubate, forming a mixture, by the at least one cell (i) in container R or (ii) in another container S after suctioning and discharge of the mixture using the device, and (e) detecting the immune cellular response, the detection of the immune cellular response indicates the presence of an immune cellular response specific for the stimulant.

Abstract: In one embodiment, the invention provides a method of diagnosing sepsis or a virus-related infection (often a viral hemorrhagic fever infection) in a subject by detecting and measuring the level of a set of sepsis and virus infection-associated-GTPase biomarkers in a sample obtained from the subject using multiplexed flow cytometry. Related kits are also provided. In a preferred embodiment, the invention provides point of care diagnostic methods for determining an early stage sepsis or the severity of a virus infection, especially in a hospital or other setting.

Abstract: Disclosed are methods and systems for analyte detection in a sample and more particularly, a biological sample. Methods and systems particularly relate to differentiating and/or identifying cell types in biological samples, such as blood samples, by adding antibodies specific to predetermined CD antigens. Other methods and systems relate to controlling the dynamic range of an assay for analyte detection.

Abstract: Compositions comprising multiple hydrogel particles having substantially the same diameter, but with each subgrouping of particles from the multiple hydrogel particles having different associated values for one or more passive optical properties that can be deconvoluted using cytometric instrumentation. Each hydrogel particle from the multiple hydrogel particles can be functionalized with a different biochemical or chemical target from a set of targets. A method of preparing hydrogel particles includes forming droplets and polymerizing the droplets, with optional functionalization.

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: Methods of detecting and flagging and/or suppressing aberrant results caused by incomplete dispersion of an immunoassay reagent used in a turbidimetric immunoassay are disclosed.

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 a method for measuring a cellular uptake amount of a molecule, comprising (i) adding the molecule to an organ-derived cell population to perform incubation, (ii) sorting the organ-derived cell population based on the expression levels of CD31 and CD45, and (iii) after steps (i) and (ii), measuring the amount of the molecule incorporated into the cell population sorted in the step (ii), wherein the molecule is incorporated into cells via a cell surface receptor.

Abstract: Disclosed is a measurement apparatus that includes: a measurement unit configured to measure a control sample for quality control; a display unit; and a processing unit configured to cause the display unit to display an input screen for setting an evaluation criterion used in the quality control, and, in the measurement apparatus, the processing unit causes the display unit to display a quality control result of a test item, based on the evaluation criterion and a measurement result of the control sample.

Abstract: The disclosure relates to methods of preparation of fetal nucleated red blood cells (NRBCs) from biological samples for diagnostic testing.

Abstract: The present disclosure relates to antibodies and antibody fragments useful for detecting, enriching and isolating fetal cells and methods of their use.

Abstract: Related to is the technical field of light initiated chemiluminescence technology, and in particular, to a method for determining HD-Hook-effect sample, a system, a reagent kit, and a device for determining HD-Hook effect in immunoassay, an immunoassay method, a system, a reagent kit, and a device for determining immunoassay.

Abstract: Disclosed herein are methods, biomarkers, systems, compositions and kits for determining the phase or metabolic state (e.g. First Phase, Second Phase, or Third Phase) of a red blood cell (RBC) sample or for determining the phase or metabolic state (e.g., First Phase or Second Phase) of a platelet (PLT) cell sample. The methods disclosed herein are related to the use of isolated RBC sample or isolated PLT sample and analytical tools for providing information that is relevant to the phase or metabolic state of the RBC sample or the PLT sample. The system disclosed herein utilizes isolated RBC sample or isolated PLT sample and at least one analytical tool or an output from the at least one analytical tool. The compositions and kits described herein utilize RBC samples or PLT samples, including compositions in a form that allows for analysis of the RBC sample or the PLT sample.

Abstract: A system for buoyant-particle-assisted cell therapy includes and/or interfaces with a set of buoyant particles. Additionally or alternatively, the system can include and/or interface with a processing container, a set of processing materials (e.g., buffers, factors, solutions, etc.), and/or any other components. A method for buoyant-particle-assisted cell therapy includes processing the set of cells of interest. Additionally or alternatively, the method can include any or all of: preparing a set of buoyant particles; receiving a sample; and isolating a set of cells of interest from the sample.