Abstract: The present invention relates to combinations of biomarkers and levels thereof that may be used, for example, in the determination of risk associated with the occurrence of a major adverse cardiac event (MACE) in a patient.

Abstract: A device and method for detecting the presence of hemoglobin in a biological sample, more particularly, the presence of blood in a fecal sample as an indicator of upper or lower gastrointestinal tract bleeding.

Abstract: A biochemical sensor includes a substrate with a printing surface, an intermediate layer, and a cover. The printing surface includes a reactive film, two electrode films, a conductive electrode film, and a referential electrode film. The conductive electrode film is arranged between the two electrode films. Each ends of the two electrode films contacts with the reactive film. One end of the conductive electrode film, proximate to the reactive film, contacts with one of the two electrode films. The referential electrode film and one of the two electrode films are arranged on the relative two sides of the printing surface. One end of the referential electrode film extends to contact with the reactive film. The intermediate layer has a notch corresponding to the reactive film, and the cover has an test slot corresponding to the notch. The intermediate layer and the cover are sequentially covered on the substrate.

Abstract: A detection system in a portable assay reader device is enabled or activated after a user applies a manual force to a portion of the reader device, to an object supporting the assay test strip, or to the assay test strip itself. The movement moves a switch from an open state to a closed state. The closed state enables a detection system to monitor one or more test regions in the assay test strip for a reaction. The detection system can include one or more imagers, one or more electrical detectors, one or more magnetic detectors, or one or more optical detectors that monitor the one or more test regions for applicable visible, electrical, magnetic, or optical reactions, respectively. The one or more imagers or detectors transmit data to a processing device to determine the results of a test.

Abstract: A portable, lightweight, rugged, easy-to-operate biosensor useful for rapidly detecting cells, viruses, antibodies, and other proteins. A capillary tube has a capture antibody immobilized on its interior surface. The specific capture antibody is selected based upon a desired target analyte to be detected. A sample potentially containing the target antigen is introduced into the capillary tube. Thereafter, a second antibody labeled with a fluorescent dye is introduced. Upon excitation by electromagnetic energy, typically supplied by a laser, the fluorescence of the sample is captured and analyzed. The apparatus is extremely compact and rugged making it ideal for field use. In addition, accurate results may be obtained by relatively unskilled operators directly from a self-contained readout. Optionally, an external device (e.g., a computer) may be connected to the apparatus via an optional interface.

Abstract: The present invention relates to novel lateral flow devices using two dimensional features, preferably, uniform two dimensional test and control features, and the methods for detecting an analyte using the lateral flow devices, and processes for making the lateral flow devices.

Abstract: Methods and devices for reducing interference from leukocytes in an analyte immunoassay are provided. In one embodiment, a method is provided comprising the steps of amending a biological sample with magnetic sacrificial beads opsonized to leukocytes, binding leukocytes in the sample to the magnetic sacrificial beads, and magnetically retaining the beads out of contact from an immunosensor.

Abstract: Apparatuses and methods for determining whether a test compound solution induces cell activity, an embodiment of the method of the present invention comprising placing a test compound solution in contact with a cell suspension media containing cells, diffusing the test compound solution into the cell suspension from a point source, and detecting activity in the cells with respect to their distance from the point source. Detecting activity in the cells can involve detecting activity in a first group of the cells proximate to the point source, and detecting activity in a second group of the cells farther from the point source than the first group.

Abstract: Devices and methods for the detection of target molecules are disclosed. Devices and methods for detecting food-borne target molecules are also disclosed.

Abstract: The present invention is directed to a device comprising (a) a substrate having a surface and (b) an ordered array of posts over the surface, wherein the posts are capable of binding a protein or small molecule ligand, and wherein the pitch between adjacent posts is less than about 100 nm. The invention is also directed to methods for identifying the presence of an analyte in a fluid and to methods for measuring relative binding specificity or affinity between an analyte in a fluid and the posts, using the device of the present invention.

Abstract: The sensitivity of visually read lateral flow immunoassay tests is enhanced by adding a small quantity of fluorescing dye or fluorescing latex bead conjugates to the initial conjugate material. When the visible spectrum test line is visibly present, the test result is observed and recorded. However, in the case where the result is indeterminate, a light of an appropriate spectrum, such as a UV, visible, or infrared spectrum, is cast on the test line to excite and fluoresce the fluorescing latex beads which are bound in the test line in true positive tests to enhance the visible color at the test line.

Abstract: A cell culture article including a substrate having nanoparticles on the substrate surface, the nanoparticle including: a polymer of formula (I) where (x), (y), (z), R, R?, R?, S, W, and X, are as defined herein. Methods for making the cell culture article or cell culture article and methods for performing an assay of a ligand with the article are also disclosed.

Abstract: A biosensor article including a substrate having polymer modified surface, the polymer comprising the formula (I) where (x), (y), (z), R, R?, R?, S, W, and X, are as defined herein. Methods for making the biosensor article or cell culture article, and methods for performing an assay of, for example, a bioentity, a ligand thereof, or both, with the biosensor article are also disclosed.

Abstract: The present invention relates to an assay device and a method for using such for the quantitative determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains a test site having immobilized thereon a ligand capable of reacting with the analyte and binding such to the test site, and two standard band sites having immobilized thereon known high and low concentrations of a calibrator agent capable of reacting with a label conjugate and binding such to the standard sites, wherein the upstream membrane has a site for the application of a sample to be analyzed, and has a site downstream from the sample application site for depositing label conjugates capable of reacting with the analyte and label conjugates capable of reacting with the

Abstract: A test sensor includes a base, a lid and a channel for receiving a fluid sample. The channel includes a reagent. The test sensor also includes a tip portion extending from at least one of the base and lid. The tip portion prevents or inhibits moisture or contaminants from entering the channel and affecting the reagent. The test sensor further includes a detachable area located adjacent the tip portion. The detachable area is formed so as to assist movement of the tip portion or removal of the tip portion from the remainder of the test sensor. The movement or removal of the tip portion exposes the channel for receiving the fluid sample.

Abstract: The present invention includes methods and devices for preventing interfering substances from affecting the accuracy of a lateral flow immunoassay. In preferred embodiments, a test strip includes a capturing zone that includes at least one mobile capturing reagent that separates at least one interfering substance from the analyte. The capturing zone is preferably located upstream of the sample application zone. In some embodiments, the reagent/conjugate zone is also located upstream of the sample application zone. The capturing zone may be located upstream, downstream, or overlapping with the reagent/conjugate zone in these embodiments. In other preferred embodiments, one or more mobile capturing reagents are included in the elution medium/running buffer. In yet other embodiments, the capturing reagent is incorporated into a sample collection device of a sample collection system, preferably separate from the chromatographic test strip. A lysis zone is also included in some preferred embodiments.

Abstract: The present disclosure relates to a carbon dioxide detector having a borosilicate substrate. It may also have a carbon dioxide responsive indicator solution disposed on the borosilicate substrate. The carbon dioxide detector may be part of a carbon dioxide detector system also including an air intake operably connected to the housing to allow air to reach the carbon dioxide detector. The carbon dioxide detector may include a borosilicate substrate and a carbon dioxide responsive indicator solution disposed on the borosilicate substrate. This detector may be part of a further system, such as a resuscitation system. The detector may be made by wetting a borosilicate substrate with a carbon dioxide responsive indicator solution and drying the indicator solution to immobilize it and form a dried carbon dioxide detector. It may be used to detect the concentration of carbon dioxide in an air sample by exposing the detector to the sample.

Abstract: An apparatus for assaying a tumor drug delivery vehicle and or drug can include an idealized microvascular network (IMN) of one or more interconnected idealized flow channels in fluid communication through a porous wall with a tissue space (e.g., idealized tissue space) containing animal cells and means for quantifying drug delivery through the IMN to the animal cells.

Abstract: Provided herein is an affinity media and the construction and use thereof. The affinity media may be used, for example, for the detection of differential proteins/peptides by depletion of proteins/peptides similar to those in a control sample from a test sample in the search for biologically and pathologically important proteins/peptides. The detected differential proteins/peptides provide vital information for biomarker discovery, drug target discovery, and personalized medicine and treatment.

Abstract: Described and illustrated herein are systems and exemplary methods of operating an analyte measurement system having a meter and a test strip. In one embodiment, the method may be achieved by applying a first test voltage between a reference electrode and a second working electrode and applying a second test voltage between the reference electrode and a first working electrode; measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample containing an analyte is applied to the test strip; measuring a fifth test current at the first working electrode; estimating a hematocrit-corrected analyte concentration from the first, second, third, fourth and fifth test currents; and annunciating the hematocrit-corrected analyte concentration.

Abstract: An analytical test strip (“ATS”) for use with a hand-held test meter (“HHTM”) in the determination of an analyte in a bodily fluid sample (“BFS”) includes a first patterned conductive layer with a working electrode and a reference electrode, as well as a method for determining an analyte in BFS. The ATS also includes an enzymatic reagent layer disposed on the working electrode, a patterned spacer layer disposed over the first patterned conductive layer and configured to define a sample chamber (“SC”) within the ATS, and a second patterned conductive layer disposed above the first patterned conductive layer. The second patterned conductive layer includes a first phase-shift measurement electrode and a second phase-shift measurement electrode, which electrodes are disposed in the SC and are configured to measure, along with the HHTM, a phase shift of an electrical signal forced through a BFS introduced into the SC during the ATS' use.

Abstract: An analytical test strip (“ATS”) for use with a hand-held test meter in the determination of an analyte in a bodily fluid sample includes an electrically insulting substrate, a first patterned conductor layer disposed on the electrically insulating substrate and having a working electrode and a reference electrode. The ATS also includes an enzymatic reagent layer disposed on the working electrode, a first patterned spacer layer disposed over the first patterned conductor layer and defining both a first sample-receiving channel and an analyte determination sample chamber within the ATS, and a second patterned spacer layer disposed over the first patterned spacer layer and defining at least a second sample-receiving channel. The ATS further includes a bodily fluid phase-shift sample chamber in fluidic communication with the second sample-receiving channel.

Abstract: The invention provides kits and methods for detecting or monitoring the number of cells in sample. The cell comprises a cell surface associated protein (CSAP) comprising a cytoplasmic (cytosolic) and an extracellular (ecto) domain. The kit comprises: (i) a chromatographic device; and (ii) a CSAP-binding agent. The method comprises: (i) optionally contacting the sample with an agent capable of lysing or permeabilizing CSAP bearing cells; (ii) contacting the sample with a CSAP-binding agent that binds to the cytoplasmic domain of the CSAP; and (iii) directly or indirectly evaluating the level or presence of bound CSAP in the sample.

Abstract: The disclosure provides for reagent compositions for biosensors comprising release polymers, methods of making such biosensors and films of reagent compositions comprising release polymers. The reagent compositions comprise a release polymer and an effective analyte detecting amount of an enzyme an enzyme cofactor and a redox compound capable of acting in a biosensor as (i) a redox mediator associated with a working electrode (ii) a redox couple associated with a reference electrode or (iii) the redox mediator associated with the working electrode and the redox couple for the reference electrode.

Abstract: Methods for measuring the amount of two or more analytes of interest in a fluid sample, and kits useful in the methods, are disclosed. The methods involve determining a ratio of a detected amount of a single analyte of interest, to the sum of a detected amount of each of the analytes of interest plus a detected amount of a control, wherein the amount of each analyte of interest is directly or inversely related to the ratio for each analyte of interest.

Abstract: A diagnostic test tape for liquid samples is provided comprising a flexible transport tape and a plurality of test fields applied to the transport tape that are distributed in the longitudinal direction of the tape, where said test fields comprise a detection layer and a spreading net spanning the detection layer for a planar uptake of liquid sample, wherein the spreading net is formed from a lattice-like fabric comprising fabric threads that cross at right angles. In order to prevent the fabric from arching up under tape tension it is proposed that the fabric is oriented obliquely to the transport tape such that all fabric threads run obliquely to the longitudinal direction of the tape.

Abstract: A simple membrane assay method for detecting or quantitating an analyte in a specimen sample using an assay device equipped with a membrane bound with a capture-substance to capture the analyte, including the steps of filtering a specimen sample using a filter, dropping the filtrate onto said membrane and detecting the presence of the analyte in said specimen sample, as well as a simple membrane assay kit for detecting the presence of an analyte in a specimen sample, including (1) a filter tube, and (2) an assay device equipped with a membrane bound with a capture-substance to capture the analyte. The method or the kit can decrease the occurrence of false positivity and can provide a highly accurate detection of the analyte such as pathogen and antibody in a specimen collected in a medical scene or by an individual.

Abstract: Disclosed herein are biosensors for the detection of airborne biomolecules. The biosensors include a housing, a sensing component, and optionally a sample capture component. The biosensors may utilize a gel-based detection platform.

Abstract: The present invention includes but is not limited to a specimen collection device that includes a chamber capable of collecting a specimen, a specimen passage slot, a reservoir, a reservoir seal, and a test device. A sample or specimen added to the chamber flows through the specimen passage slot into the reservoir. Flow into the reservoir may be limited by the reservoir seal. The test device positioned within the reservoir detects the presence or concentration of an analyte within the sample or specimen.

Abstract: Compositions, methods and devices for the detection of anti-lipoidal antibodies and the diagnosis of disease, for example, syphilis, are described. In particular, a method for immobilizing a lipoidal antigen, comprising cardiolipin, lecithin, and cholesterol, on a solid support (such as a nitrocellulose membrane) is described. The ability to immobilize a lipoidal antigen on a membrane satisfies a long-felt need for a membrane-based assay for the detection of anti-lipoidal antibodies. Also described are immunoassay devices for concurrently performing treponemal and non-treponemal tests for syphilis.

Abstract: Methods and devices for reducing interference from leukocytes in an analyte immunoassay are provided. In one embodiment, a method is provided comprising the steps of amending a biological sample with magnetic sacrificial beads opsonized to leukocytes, binding leukocytes in the sample to the magnetic sacrificial beads, and magnetically retaining the beads out of contact from an immunosensor.

Abstract: The invention is directed to methods and devices for reducing interference from leukocytes in competitive analyte immunoassays. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with sacrificial beads opsonized for leukocytes; and (b) performing a competitive immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG-coated sacrificial beads.

Abstract: The present invention is directed to the detection of target analytes using electronic techniques, particularly AC techniques.

Abstract: An optic light guide test sensor comprises a light guide, a reagent-coated membrane, and a mesh layer. The reagent-coated membrane and the mesh layer are attached to the light guide at an output end of the light guide. The light guide test sensor is adapted to be used to test the level of an analyte in a biological fluid sample when used with a readhead. A method of manufacturing the light guide test sensor involves providing a plurality of light guides, providing a strip of reagent-coated membrane, and providing a strip of mesh layer. The reagent-coated membrane and mesh layer are attached to the light guides by ultrasonic welding. The reagent-coated membrane and mesh layer may also be attached to the light guides by adhesive.

Abstract: The invention is directed to methods and devices for reducing interference from leukocytes in an analyte immunoassay, and in particular in non-competitive immunoassays. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with sacrificial beads; and (b) performing a non-competitive immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG-coated sacrificial beads.

Abstract: This invention relates to a method and apparatus for detecting a biological molecule associated with enzyme activity in a sample. The invention is applicable to detecting a microorganism associated with an enzyme in a sample such as water, food, soil, or a biological sample. According to a preferred embodiment of the method of the invention, a sample containing an enzyme of interest or a microorganism associated with the enzyme is combined with a suitable substrate, and a fluorescent product of the enzyme-substrate reaction is selectively detected. The fluorescent product is detected with a partitioning element or optical probe/partitioning element of the invention. In one embodiment the partitioning element provides for partitioning of only the fluorescent product molecule into the probe. The invention also provides an automated system for monitoring for biological contamination of water or other samples.

Abstract: An LDL cholesterol measurement method that can be used with a test piece is provided. The LDL cholesterol measurement method for measuring LDL cholesterol in a sample has (A) a step of providing a total-cholesterol measurement portion and a non-LDL cholesterol measurement portion for measuring non-LDL cholesterol, which is cholesterol other than LDL cholesterol; (B) a step of measuring the total cholesterol in the sample in the total-cholesterol measurement portion; (C) a step of measuring the non-LDL cholesterol in the sample in the non-LDL cholesterol measurement portion; and (D) a step of obtaining the LDL cholesterol level in the sample by subtracting the non-LDL cholesterol value measured in the step (C) from the total-cholesterol value measured in the step (B).

Abstract: A device for individually analysing cells of interest, comprising (a) a channel for receiving the contents of a cell of interest, wherein the channel has an input end and an output end, and (b) a cell trapping site in proximity to the input end of the channel, wherein (i) the input end of the channel is adapted such that an intact cell of interest cannot enter the channel; and (ii) the channel contains one or more analytical components for analysing the contents of the cell of interest. In use, a cell is applied to the device, where it is trapped by the cell trapping means. The cell cannot enter the channel intact, but its contents can be released in situ to enter the channel's input end. The contents can then move down the channel, towards the output end, and they encounter the immobilised reagents, thereby permitting analysis of the cell contents.

Abstract: Systems and methods for isolating and characterizing various target materials of a suspension are disclosed. A suspension suspected of containing the target materials is added to a tube. A float with a specific gravity corresponding to that of the target material is inserted into the tube. The tube, float, and suspension are centrifuged together causing the various materials suspended in the suspension to separate into different layers along the axial length of the tube according to their specific gravities. The float and/or tube are configured to drive the various target materials to a region of space between the float and inner wall of the tube.

Abstract: Methods, materials, apparatus and systems are described for performing capillary flow assay. In one aspect, a system includes a sample collection unit to collect a sample liquid and a sample testing and storing unit to interface with the sample collection unit to test and store the collected sample liquid. The sample testing and storing unit includes a sample inlet shaped to receive the collected sample from the sample collection unit, and a sample well positioned below the sample inlet to retain at least a portion of the sample liquid. The sample testing and storing unit includes a sample housing unit to store a remainder of the sample liquid not retained in the sample well, and an analyte testing unit housing shaped to receive an analyte detecting unit to test a presence of a target analyte in the sample liquid.

Abstract: Methods are disclosed for producing a bioweapon-sensitive fibrous-network product, wherein the subject products exhibit a color change in response to exposure to a biological agent (or portion thereof) as used in a biological weapon. Also disclosed are fibrous-network products that contain units of biopolymeric material that impart a color change to the products in response to exposure to a biological agent (or portion thereof) as used in a biological weapon.

Abstract: A method and device for the rapid detection of biomolecules (320) diffusing in a nanometer-confined slit (204) is claimed. In particular, the present invention relates to a novel concept of fluidic side apertures (205) that facilitates the filling of the device, the surface coating with biomolecules and that measures the affinity between fluorescently labeled biomolecules in aqueous solution with other biomolecules immobilized on surfaces.

Abstract: A dynamic and noninvasive method of monitoring the adhesion and proliferation of biological cells through multimode operation (acoustic and optical) using a ZnO nanostructure-modified quartz crystal microbalance (ZnOnano-QCM) biosensor is disclosed.

Abstract: An embodiment of the present invention provides a-method for performing a lateral flow assay. The method includes depositing a sample on a test strip at an application region, detecting a first detection signal arising from the test strip in the first detection zone, and generating a baseline for the first measurement zone by interpolating between values of the detection signal outside of the first measurement zone and inside of the first detection zone. The method may include locating a beginning boundary and an ending boundary for the first measurement zone on the test strip. Additional detection zones having measurement zones may also be incorporated with the embodiment.

Abstract: A biochip including a metal nanoparticle layer on a multilayer substrate can perform qualitative and quantitative analyses simply without a separate tag. A biochip including a metal nanoparticle layer on a multilayer substrate and using a CMOS image sensor can be an economically beneficial biochip reusable and convenient in use by employing a relatively simple detection method without a need of using a separate tag.

Abstract: A high content screening (HCS) assay for rapidly screening one or more compounds to determine functional response or pharmacological properties thereof, comprising: i) priming a cell or cell material with a sensor for a biological response; ii) contacting the compound(s) to be tested with the primed cell or cell material or contacting a cell or cell material which has been contacted with the compound(s) with the primed cell or cell material; iii) simultaneously or subsequently contacting with a fluorescent agonist or a fluorescent neutral antagonist wherein the binding of the fluorescent agonist or antagonist and its associated biological response are detected or monitored in the same cell and are distinct allowing separate readout.

Abstract: The present invention relates to analytical methods, platforms, and devices for the rapid and efficient immunochromatic determination of one or more components in fluid samples.

Abstract: Disclosed are methods for conducting assays of samples, such as whole blood, that may contain cells or other particulate matter. Also disclosed are systems, devices, equipment, kits and reagents for use in such methods. One advantage of certain disclosed methods and systems is the ability to rapidly measure the concentration of an analyte of interest in blood plasma from a whole blood sample without blood separation and hematocrit correction.

Abstract: A cancer cell separating apparatus includes: a flow channel including an antibody fixation area having antibodies which bind specifically to cancer cells fixed thereon, wherein the cancer cells and non-cancer cells are separated using a difference in velocity of movement between the cancer cells and the non-cancer cells in cell slurry introduced into the flow channel.

Abstract: The invention relates to sensors for detecting chemical and biological material and for chemical actuation. In particular, the sensors of the present invention incorporates membranes or beams that are deformable in the presence of chemical adsorption on its surface. The sensor of the present invention contains a polymeric membrane or beam (102) that is clamped at least at two opposing ends (104) and (106).