Abstract: Disclosed herein are devices and methods that use aqueous two phase systems and lateral flow assays to detect target analytes in a sample. These devices and methods may be used to diagnose a disease or condition in a biological sample, such as blood or serum. In addition, these devices and methods may be used to detect allergens in a food samples or contaminants, such as environmental toxins, in water samples. Device and kit components may be conveniently assembled in a portable container and are amenable to actuation in most settings. The devices are simple to use, requiring a non-trained operator to simply add the sample to the device. Conveniently, the time it takes to detect the target analyte is very short. Thus, the devices and methods disclosed herein provide novel and useful means for point-of-care.

Abstract: Disclosed are a kit for testing myocardial infarction rapidly and a preparation method and use thereof. The kit comprises a strip capable of detecting three markers, namely, human myeloperoxidase (MPO), heart-fatty acid binding protein (FABP3) and cardiac troponin I (cTnI) simultaneously. The strip comprises a sample pad, a conjugate pad, a chromatographic membrane coated with three test lines and a quality control line, and a sample absorption pad. Antibodies of the three markers are all marked on the conjugate pad. The chromatographic membrane has three test lines formed by coating paired antibodies of the three markers respectively, the paired antibodies of the three markers being able to specifically combine with the three markers, respectively. The kit has advantages such as convenient operation, rapid response, high sensitivity and high specificity, point of care test, and economical and practical etc.

Abstract: Disclosed are embodiments of a lateral flow test strip (LFTS) platform which measure osteocalcin (OC) and deoxypyridinoline (Dpd) in saliva to identify early indications of bone loss and minimize bone fracture risk associated with osteoporosis. The OC assay embodiments are based on the experimentally identified optimal markers which exhibit selectivity with very low false positives, and sensitivity relevant to clinical requirements. A prospective clinical study sampling of 20 patients demonstrated excellent correlation of OC in saliva with bone mineral density (BMD). Salivary OC and Dpd levels were validated with a standard commercial ELISA kit against serum (OC) and urine (Dpd).

Abstract: The invention generally relates to methods for quantifying an amount of enzyme molecules. Systems and methods of the invention are provided for measuring an amount of target by forming a plurality of fluid partitions, a subset of which include the target, performing an enzyme-catalyzed reaction in the subset, and detecting the number of partitions in the subset. The amount of target can be determined based on the detected number.

Abstract: A method for retrieving magnetic components from a sample solution includes obtaining an array plate with a sample surface that includes a plurality of sample regions and a surrounding region. A first solution is located on a sample region of the plurality of sample regions. The first solution includes a plurality of magnetic components. A separation layer that includes one or more protrusions is placed so that at least a respective protrusion of the one or more protrusions is at least partially immersed in the first solution. A first magnetic device is placed within the respective protrusion. At least a portion of the plurality of magnetic components is retrieved from the first solution by concurrently moving the separation layer and the magnetic device so that the respective protrusion ceases to be at least partially immersed in the first solution on the sample region.

Abstract: Methods, devices, and reagents are described for performing assays for hemoglobin Ale, glycated albumin, and other glycated proteins. The methods involve a ratio determination between glycated protein and non-glycated protein. In some applications, the assay utilizes LOCI for signal generation. This invention is directed to assays and corresponding devices and reagents for detection of glycated protein, particularly including glycated hemoglobin. As is generally understood, such detection is useful in the management of blood glucose levels in diabetic patients and for monitoring the status of pre-diabetic individuals.

Abstract: Improved capillary zone electrophoresis (CZE), affinity capillary electrophoresis (ACE), and partially filled-ACE (PF-ACE) systems and methods for the detection and quantification of specific molecular entities in a mixture thereof are provided. During manufacturing, heterodimeric bispecific antibodies are often produced along with homodimer species, which can confound quantification of the bispecific antibody. Disclosed are capillary electrophoretic systems and methods of detecting a specific homodimer in the mixture of bispecific heterodimer and homodimers. A ligand capable of binding one of the subunits of the bispecific antibody is contacted with the mixture to form a complex having a reduced electrophoretic mobility, thereby enabling detection of the unbound homodimer.

Abstract: A housing case that includes an inspection strip, a first pot in which a first amplification liquid is sealed, and a second pot in which a second amplification liquid is sealed, includes a lower case, an upper case, and an intermediate member disposed therebetween, in which the upper case includes, on a part facing the first pot, a first protrusive deforming portion that deforms towards a side of the first pot when applied with pressing force from outside, whereby a tearing portion of the intermediate member tears a sheet member of the first pot, and includes, at a part facing the second pot, a second protrusive deforming portion that deforms towards a side of the second pot when applied with pressing force from outside, whereby a sheet member of the second pot is torn.

Abstract: Provided herein is a biological detection system and method of use wherein the biological detection system comprises at least one mixer or liquid bridge for combining at least two liquid droplets and an error correction system for detecting whether or not proper mixing or combining of the two component droplets have occurred.

Abstract: A method for providing quality control on a lateral flow assay device or for triggering a process-related step, the device including a substrate having at least one sample receiving area, at least one reagent zone downstream and in fluid communication with the at least one sample receiving area, at least one detection zone downstream and in fluid communication with the at least one reagent zone and at least one wicking zone downstream of the at least one detection zone, each fluidly interconnected therewith along at least one fluid flow path. The detection material provided in the at least one reagent zone produces a detectable signal that can be tracked and monitored prior to the completion of at least one test being performed on the lateral flow assay device.

Abstract: Disclosed herein are an artificial cell membrane including a supported lipid bilayer (SLB) including a substrate and mobility-decreased metal particles bonded onto the substrate; an analysis device or kit including the artificial cell membrane and examining the interactions between molecules, in which one molecule is bonded to the surface of a mobility-decreased metal particle bonded to the artificial cell membrane and the other molecule is bonded to the surface of a mobility-increased metal particle bonded to a lipid at a low valency; a method of examining the interactions between molecules using the analysis device; a kit for quantitative or qualitative analysis of a target material including the artificial cell membrane by plasmonic scattering measurements; and a multiple analysis kit capable of detecting a plurality of target materials using a plurality of metal particles having different plasmonic scattering wavelengths and/or having mobility on a supported lipid bilayer.

Abstract: The disclosure provides for compositions and methods of making and using a foam composition and its utility in clinical applications.

Abstract: The present invention relates to analyte detection devices and methods of using such devices to detect minute quantities of a target analyte in a sample. In particular, the invention provides an analyte detection device comprising a plurality of composite metallic nanostructures conjugated to analyte binding partners and a surface containing a metallic nanolayer on which a plurality of capture molecules is immobilized. Methods of preparing composite nanostructures are also described.

Abstract: An implantable diagnostic device in accordance with the present disclosure provides various benefits such as a compact size thereby allowing implanting of the device inside animate objects; low cost due to incorporation of inexpensive detection circuitry and the use of conventional IC fabrication techniques; re-usability by heating thereby allowing multiple diagnostic tests to be performed without discarding the device; and a configuration that allows performing of simultaneous and/or sequential diagnostic tests for detecting one or more similar or dissimilar target molecules concurrently or at different times.

Abstract: A referencing method for an optical biosensor system using a single sensing region is provided. The method involves limiting the ligand immobilized in a single sensing region to only a portion thereof. In one embodiment, this is accomplished by selectively deactivating a portion of the sensing surface to prevent immobilization of ligand to that portion. As a result, a reference response can be recorded in the same sensing region as a molecular interaction response. Thus, the bulk refractive index can be accurately accounted for in measuring the kinetics of a molecular interaction.

Abstract: The present invention relates to methods and systems for detecting one or more analytes in a sample and/or for classifying a sample. In particular, the present invention relates to methods and systems which can be used to detect the analytes in real time and which rely on flowing through a microfluidic device one or more types of sensor molecule each comprising a domain that binds one or more analytes, a chemiluminescent donor domain and an acceptor domain, wherein the separation and relative orientation of the chemiluminescent donor domain and the acceptor domain, in the presence and/or the absence of analyte, is within +50% of the Forster distance.

Abstract: There are provided methods, and devices for assaying for a binding interaction between a protein, such as a monoclonal antibody, produced by a cell, and a biomolecule. The method may include retaining the cell within a chamber having an aperture; exposing the protein produced by the cell to a capture substrate, wherein the capture substrate is in fluid communication with the protein produced by the cell and wherein the capture substrate is operable to bind the protein produced by the cell; flowing a fluid volume comprising the biomolecule through the chamber via said aperture, wherein the fluid volume is in fluid communication with the capture substrate; and determining a binding interaction between the protein produced by the cell and the biomolecule.

Abstract: An object is to provide an immunochromatography detection method and an immunochromatography kit in which a prozone phenomenon occurring in a sandwich method when using an analyte in which an antigen is present in a large excess amount is suppressed/excluded. The object was achieved by retaining a nonionic and hydrophilic surfactant having an HLB value of 13 to 18 in a sample addition part of an immunochromatography device, and also using a membrane having a fast flow speed as a membrane to be used for a chromatograph medium.

Abstract: The present invention relates to a method of analysis comprising the preparation and the analysis of a sample in a flexible container without direct handling of the sample and without reopening the flexible container at the end of the preparation of the sample, and also to a container and a kit that enable the implementation of this method.

Abstract: A resonator sensor module is disclosed. The resonator sensor module includes one or more sensing resonators that includes binding sites for an analyte material; one or more reference resonators that lacks any binding sites for the analyte material; a module interface; and one or more switches each including a first position that operatively couples at least one of the one or more sensing resonators and the module interface and a second position that operatively couples at least one of the one or more reference resonators and the module interface.