Abstract: Devices and methods for the detection of antigens are disclosed. Devices and methods for detecting food-borne pathogens are disclosed.

Abstract: An ophthalmic device which comprises a holographic element comprising a medium comprising a phenylboronic acid group and, disposed therein, a hologram, wherein an optical characteristic of the element changes as a result of a variation of a physical property of the medium, and wherein the variation arises as a result of interaction between the medium and an analyte present in an ocular fluid.

Abstract: A test strip for immunochromatography comprising a sample receiving member, a label holding member, and a chromatography membrane is described. The chromatography membrane has a first detection zone and a second detection zone. The second detection zone is formed by utilizing a blocking material and the second substance. A method for producing above the test strip is also described.

Abstract: This invention provides an immunochromatography detection apparatus exhibiting excellent convenience, sensitivity, and specificity, a detection method therefore, a kit using the same, and a method for producing such apparatus and kit, by constructing a solid-phase support, on which the conditions for the reaction wherein an analyte specifically binds to a labeled reagent containing a ligand that specifically binds to the analyte and those for the reaction wherein a capture reagent specifically binds to a complex of the analyte and the labeled reagent in the immunochromatography detection method are continuously optimized, and the pretreated specimens are optimized for such reactions.

Abstract: An analytical strip and a detecting method using the analytical strip are provided. The analytical strip includes a substrate having a channel thereon. The channel has a first region, a second region and a third region, which are connected sequentially. A first antibody is localized in the first region. A saccharide and a peroxidase are localized in the first or second region. A second antibody for recognizing a different epitope of an identical antigen with the first antibody is immobilized in the second region. An optical substrate and a substrate reagent including a saccharide oxidase are localized in the third region.

Abstract: The invention provides assay methods for the detection and quantitation of gastrin hormones, including total and free gastrin hormone in a sample. ELISA-type heterogeneous phase assays suitable for use with biological fluid samples such as blood, plasma or other bodily fluids of a mammal, particularly a human subject are provided. The method provides a precise assay for the amounts of free and total G17 and G34 in biological fluid samples, as well as the amounts of free and total Gly-extended G17, and Gly-extended G34. Also provided are methods of determining suitable treatment for patient suffering from a gastrin hormone-mediated disease or condition employing gastrin hormone immunoassays.

Abstract: A test strip and method for detecting an analyte present in a sample.

Abstract: An object of the present invention is to overcome the problem of nonspecific adsorption of a labeled antibody on the detection site and to provide an immunochromatography method by which the false positive signal can be suppressed, and wherein the detection sensitivity is high and the highly reliable measurement can be performed.

Abstract: The invention provides methods for early diagnosis or detection of acute coronary syndrome and prediction of adverse cardiac events on the basis of elevations of catalytic iron in biological fluid of a human subject. An embodiment of the invention provides a method for early detection of acute coronary syndrome (ACS) in a human subject at the time of presentation of the chest pain. The method includes analyzing a test sample of the biological fluid for amount of catalytic iron and detecting acute coronary syndrome in the human subject.

Abstract: An object of the present invention is to provide a hydrophilic cellulose derivative fine particle having a small particle size, a dispersion liquid thereof and a dispersion body thereof; and provide a diagnostic reagent composed of the hydrophilic particle, which is excellent in storage stability and does not require excess components, such as an emulsifier or surfactant. The cellulose derivative fine particle of the present invention is a cellulose derivative fine particle comprising a cellulose derivative with a part of hydroxyl groups of cellulose being substituted with a substituent, wherein the average particle diameter is from 9 to 1,000 nm; and the diagnostic reagent of the present invention is a diagnostic reagent obtained by loading a substance differentially interacting with a test object substance on the above-described cellulose derivative fine particle.

Abstract: Lateral flow assay devices and methods for detecting an analyte in a sample which comprises a plurality of nonspecific binding pair members are adapted for two step determinations.

Abstract: The present invention relates to a chromatography ligand defined by the following formula (I) R1—R2—N(R3)—R4—R5 wherein R1 is a substituted or non-substituted phenyl group; R2 is a hydrocarbon chain comprising 0-4 carbon atoms; R3 is a hydrocarbon chain comprising 1-3 carbon atoms; R4 is a hydrocarbon chain comprising 1-5 carbon atoms; and R5 is OH or H. The invention also comprises a separation matrix, comprising the described ligands coupled to a porous support, such as particles or a membrane. The ligand and matrix according to the invention is useful for purification of biomolecules or organic compounds, such as proteins, polypeptides, DNA etc. An advantageous use according to the invention is the purification of antibodies.

Abstract: A lateral flow test strip for the analysis of a sample featuring numerous capture zones arranged in an array such that each capture zone is substantially equidistant from the sample containing area. The sample does not pass through another capture zone to reach any one of the other capture zones. The capture zones are preferably arranged in a linear array perpendicular to the flow of the sample through the lateral flow test strip. The lateral flow test strip allows for an increased number of simultaneous analyses of numerous analytes from one sample to occur on one lateral flow test strip.

Abstract: The present invention provides methods of quantifying the amount or concentration of one or more peptides and/or proteins in one or more samples using differentially isotopically-labeled peptides and/or proteins. The invention also provides methods of identifying one or more peptides and/or proteins in one or more samples.

Abstract: This invention involves the nano-structured support used for separation or/and analysis, especially the chip substrate, ELISA plate substrate, planar chromatography strip and chromatography gel. Besides, it involves the functionalized nano-structured support of high sensibility for separation or/and analysis, especially the analysis-chip, ELISA plate, planar chromatography reagent strip and chromatography gel. In addition, this invention also involves the nano-structured marking system for analysis. Moreover, it concerns the test kit; especially the chip kit, ELISA kit, and planar chromatography kit. What's more, this invention involves the preparing methods and the applications of all those mentioned above, especially the chip analysis, analyses with ELISA plate, planar chromatography strip and chromatography separation.

Abstract: This invention provides methods and compositions for testing for pregnancy and non-pregnancy in ungulates and non-hoofed ruminates. The tests provided by this invention are useful during a time that coincides with the estrus cycle during which breeding occurs or the first estrus cycle after breeding of a non-pregnant animal. The tests provided by this invention are useful in estrus and ovulation synchronization programs, with pregnancy testing useful at a time allowing for resynchronization of non-pregnant animals within the first estrus cycle. The tests provided by this invention assay for the presence, absence, or level of a selected IFN-?-induced protein in a sample from a female animal. The tests of this invention are useful for testing cells, blood, plasma, serum, cells, milk, nasal secretions, ocular secretions, vaginal secretions, urine, and saliva samples. The tests provided by this invention are immunoassays.

Abstract: To provide a measuring probe excellent in sensitivity and reproducibility, simple operation in the protein immobilization onto a support can prevent peeling or damage. A layer containing a protein is adsorbed onto a support surface to fully encircle the long axis of the support, and the adsorbed layer is treated for cross-linking with a cross-linking agent in a concentration of 1 to 5 moles to 1 mole of the protein.

Abstract: A flow-through assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes a detection zone and compensation zone within which are immobilized capture reagents. The present inventor has discovered that the presence of a compensation zone may enable the detection of an analyte over extended concentration ranges. In particular, the compensation zone facilitates the binding of probes that would otherwise bind within the interior of assay device or that would exhibit “self-quenching”.

Abstract: Disclosed are an immunoassay device which comprises a labeled substance dotting portion and a specimen dotting portion provided thereon, and an immunoassay method using the device.

Abstract: Methods for forming cell arrays of multiple cell samples arranged substantially in a monolayer on a single substrate particularly suited for diagnostic analysis are disclosed. The cell arrays are formed with a high-speed dispensing apparatus capable of dispensing small volumes in precise, complex patterns. Also disclosed are substrates upon which cell arrays may be formed, and methods for conducting diagnostic analyses on the formed cell arrays.

Abstract: Disclosed herein are agents, methods, and kits for determining the presence or concentration of a target, or multiple targets, in a sample, in a uniplexed or multiplexed fashion. In general, the methods enable the analysis of small molecules produced or consumed in liquid-phase that may be analyzed using gas or vapor phase detection methods.

Abstract: Disclosed herein are agents, methods, and kits for determining the presence or concentration of a target, or multiple targets, in a sample, in a uniplexed or multiplexed fashion. In general, the methods enable the analysis of small molecules produced or consumed in liquid-phase that may be analyzed using gas or vapor phase detection methods.

Abstract: The present invention provides a substrate for protein microarrays, whereby compound A and GPTS are mixed for coating onto a solid support to form a layer, wherein said compound A is selected from a group consisting of nitrocellulose, poly(styrene-co-maleic anhydride) and polyvinylidene fluoride. Moreover, the present invention also provides a protein microarray by depositing proteins on said layer of said substrate.

Abstract: A lateral flow immunoassay test device is provided that includes a housing with an elongated slot for holding a test sample collector; an elongated holder member for securing at least one immunoassay test strip therein; a first chamber for storing a first, pre-treatment reagent; and a second chamber for storing a second reagent. Methods of conducting lateral flow immunoassays are also provided. The device and methods of conducting lateral flow immunoassays as provided herein are advantageous in that they allow pre-treatment and pre-incubation of the test sample so that the sample flows onto the test strip more easily and provide for increases in the sensitivity of the assay.

Abstract: The present invention relates to a rapid immunochromatographic test device suitable to detect an antibody and/or antigen in a sample, uses of said device for detecting diseases in a sample, a method for the production of said device as well as a kit comprising the device.

Abstract: The present invention relates to a diagnostic method for the detection of small quantities of amniotic fluid in the vagina. More specifically, the invention relates to the detection of PAMG-1 in the vagina using anti-PAMG-1 antibodies.

Abstract: A rapid test kit may have a genetic probe, and antibody detecting probe or a combination of a genetic probe and an antibody detecting probe disposed within one or more test windows of the test kit. A cellulose filter paper membrane with a flow rate selected in a range of about 0.04 to about 0.4 ml/min/cm2 is used in one example. The test kit provides for rapid screening for DNA, RNA or fragments of DNA or RNA in a bodily fluid or antibodies indicating exposure to such DNA/RNA. The genetic probe may include single stranded DNA or a fragment of single stranded DNA, such as primer, immobilized on the filter paper, and a single stranded DNA, such as the same or a different primer, conjugated with a marker, such as a nanotube or nanoparticle. For example, a gold nanoparticle or a carbon nanotube may be used as a staining agent by conjugating the gold nanoparticle or the carbon nanotube to a genetic probe, such as a DNA primer capable of binding with a complementary DNA or viral RNA or a fragment of one of these.

Abstract: The present invention provides devices, methods and kits for detecting the presence of an analyte in a liquid sample and indicating to the user the presence or absence of the analyte through the formation of a recognizable symbol during the assay. In one embodiment, the present invention provides test strips having a matrix including a sample application zone, a reagent zone, and a detection zone. Within the detection zone are located positive and negative control areas, and an analyte binding area. The positive control area contains one or more components that exhibit a first color when dry and a second color when wetted. When the assay is conducted, the positive control area is wetted by the assay fluids and turns to a second color, thereby functioning as a positive procedural control. When analyte is present in the sample, it binds at the analyte binding area, which interacts with the positive control area to form a second recognizable symbol at the detection zone.

Abstract: The invention relates to analytical methods in which the partition of a labeled substance between a liquid and a solid phase is determined. The assays include solid-phase reagents which can be particulate or monolithic such as, for example, a coated tube. Assays of this type are known per se to the person skilled in the art and include immunoassays and immunometric assays.

Abstract: This invention provides bovine pregnancy test methods and devices. The test is also suitable for other ruminant and/or ungulate animals. Antigens from Group A (early pregnancy antigens), and/or Group B (mid-pregnancy antigens), and Group C (early, mid- and late pregnancy antigens) are detected in a fluid from the animal, and pregnancy is reliably determined. The pregnancy assays of this invention are preferably carried out using immunoassay devices which provide immediate results in the field.

Abstract: A system for treating a blood sample (700) having an analyte of interest comprises a strip (200) having a membrane (218), respective portions (216, 220 and 222, or 300) which are provided for receiving the sample, for lysing cells of the sample to liberate hemoglobin, and for capturing glycated hemoglobin. The latter two portions (220 and 222, or 300) of the membrane are treated with lysing and capture agents, respectively. A portion of the strip (214 or 230 or 240) is provided for holding an eluting agent and for releasing the agent upon a release condition. A system for detecting analyte comprises an optical subsystem (550) that is aligned with the strip to provide a signal corresponding to an amount of analyte, and an electronic subsystem (650) for processing the signal (560) to provide a result, such as an amount or percentage of glycated hemoglobin.

Abstract: The invention relates to devices for performing single step assays for the determination of the presence or absence of an analyte in a liquid sample, and methods of determining the presence or absence of such analytes using such devices. Devices disclosed comprise a labeled analyte-binding reagent reversibly-immobilized on a non-porous solid material, which solid material is in physical contact with a dry porous carrier bearing an immobilized analyte-binding reagent. Also provided are quantitative assay devices.

Abstract: A diagnostic and testing apparatus and related methods for the use of the same are disclosed which derive and use antibodies to equine albumin and equine hemoglobin in testing apparatus, kits, and methods for detecting and localizing gastric and colonic ulcers or bleeding in horses. Fecal droppings from a horse to be tested are placed in a container together with a buffered liquid solution and mixed thoroughly, following which several drops of liquid from the container are placed into a test kit. Visual markers in the test kits signify the detection of the indicators equine hemoglobin and equine albumin, which are respectively indicative of the presence of gastric and/or colonic ulcers or bleeding.

Abstract: This disclosure teaches a method and composition for detecting the presence of class specific antibodies reactive with analytes such as bacteria, allergens, autoimmune antigens, viral proteins, haptens, and carbohydrates by lateral flow techniques. In one embodiment of the disclosure, a test sample is added to the test strip, which then migrates to the site of the immobilized allergens, thereby forming a first antibody IgE-allergen complex. A chase release buffer is added upstream to or from the site of the labeled anti-IgE antibodies, which is itself upstream from the sample site. The anti-IgE antibodies migrate downstream to the site of immobilized first complex, thereby forming a second complex indicating the presence of class specific IgE antibodies in the test specimen. In another embodiment of the disclosure, a liquid form of the labeled anti-IgE antibodies can be added to the test strip after the first complex has been formed.

Abstract: A rapid diagnostic test system includes a lateral-flow strip for performing a binding assay. The lateral-flow strip contains a binding agent having a deposition density that varies periodically along at least a portion of the lateral-flow strip. The test system further includes an imaging system that is used to capture an image of the portion of the lateral-flow strip.

Abstract: The present invention relates to a method of determining the concentration of an analyte in a sample and/or the binding kinetics of an analyte to an analyte sensor molecule. For this purpose the invention relies on detecting the interaction between the analyte and the analyte sensor molecule with the latter being physically adsorbed to a solid, porous support which is in the form of a micro array. In a preferred embodiment, the method may be operated in repeated cycles.

Abstract: This invention relates to methods of testing, diagnosing, monitoring, prognostically stratifying and classifying disease, disorders and other medical conditions and physiological states through the detection and analysis of soluble CD antigens in a body fluid sample.

Abstract: The present invention relates to the qualitative and quantitative validation of marker indices, especially for medical diagnosis and particularly for the determination of the growth fraction in a sample with antibodies against the Ki-67 protein. Diagnostic kit for the quantification of a cell fraction labeled by a marker for in vitro diagnosis, characterized in that a pseudo-tissue is used for the intra- and inter-assay standardization of the marker index.

Abstract: A test device and method for determining the presence or absence of one or more analytes in a fluid sample, the test device including a support or member bearing a mark thereon, and a matrix or member containing a capture zone. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (?) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (?) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Abstract: A test device and method for determining the presence or absence of an analyte in a fluid sample, the test device including a support bearing a mark thereon, and a matrix defining an axial flow path. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (?) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (?) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Abstract: The present disclosure relates to immunoassays for detecting or quantifying at least one analyte of interest in a test sample which exhibits improved sensitivity and specificity compared to the immunoassay formats known in the art.

Abstract: In one aspect, an assay test strip includes a test label that specifically binds a target analyte and a control label that is free of any specific binding affinity for the target analyte and has a different optical characteristic than the test label. In another aspect, an assay test strip includes a test label that specifically binds a target analyte and at least one non-specific-binding label that is free of any specific binding affinity for the target analyte. Systems and methods of reading assay test strips also are described.

Abstract: An assay test strip includes a flow path, a sample receiving zone, a label, a detection zone that includes a region of interest, and at least one position marker. The at least one position marker is aligned with respect to the region of interest such that location of the at least one position marker indicates a position of the region of interest. A diagnostic test system includes a reader that obtains light intensity measurement from exposed regions of the test strip, and a data analyzer that performs at least one of (a) identifying ones of the light intensity measurements obtained from the test region based on at least one measurement obtained from the at least one reference feature, and (b) generating a control signal modifying at least one operational parameter of the reader based on at least one measurement obtained from the at least one reference feature.

Abstract: An object of the present invention is to overcome the problem of nonspecific adsorption of a labeled antibody on the detection site and to provide an immunochromatography method by which the false positive signal can be suppressed, and wherein the detection sensitivity is high and the highly reliable measurement can be performed.

Abstract: Method and device to simultaneously detect different antibodies and antigens via immunoenzimatic tests and ELISA (Enzyme Linked ImmunoSorbent Assay) constituted by small absorbent cylinders, on which the immunocomplexes are formed, blocked at a modular distance on a probe; that carries a label to identify the sample under examination.

Abstract: Arrays of microparticle populations, each population labeled with a single fluorescent dye, are provided for use in multiplex assays. The populations form a virtual multidimensional array wherein each microparticle is identified by fluorescence intensity in two different fluorescence detection channels. The arrays are useful in a variety of assays, including multiplex, multi-analyte assays for the simultaneous detection of two or more analytes by, for example, flow cytometry, and a labeling reagents in, for example, microscopy. The use of singly-dyed microparticles to form multidimensional arrays greatly simplifies the creation of multiplex assays.

Abstract: A method for determining the concentration of factor VIIa-antithrombin complexes is disclosed which has application to estimating the level of intravascular exposure of tissue factor, assessing patient risk for hypercoagulation or other coagulopathies, and monitoring patients for factor VIIa-antithrombin complexes over time which can reveal changes in risk for hypercoagulation or other coagulopathies and/or effectiveness of anticoagulant therapy. Antibodies suitable for use in an in vitro assay for determining the concentration of factor VIIa-antithrombin complexes and methods for making the same are also disclosed.

Abstract: An interactive system is provided with at least one active surface of plastic from monomers containing at least one structural element derived from a carbon dioxide (A), and at least one substance associated to a linker with at least one structural element (B) capable of establishing a hydrogen bond, and involving an interaction between the structural elements (A) and (B). The interactive system is suitable for presenting and eliminating substances in liquids.

Abstract: This invention provides solid phase specific binding lateral flow assay methods, devices and kits for quantitating high and low molecular weight analytes. The methods and devices of the invention employ labelled reagents which are either analyte analogs or complementary specific binding pair members for the analyte and a novel arrangement of capture zones comprising immobilized specific binding substances for either the analyte or the labelled reagent to effect bound from unbound labelled reagent as a function of analyte concentration. The capture zones are disposed on a non-bibulous matrix defining a flow path from a sample receiving zone to the capture zone. The devices of this invention also include multilane flow paths and multiple capture zones to quantitate analyte.

Abstract: The invention provides a method and its kit for quantitatively detecting a specific analyte with a single capturing agent. The quantitative detection of a specific analyte with a single capturing agent comprises: firstly combining the tested analyte with a solid phase capturing agent, then labeling analyte which has been trapped by the capturing agent with a report molecule; secondly eluting the labeled analyte from the complex, recombining the tested analyte with a new solid phase capturing agent, and ascertaining the content of analyte by detecting the report molecule's label signal. The kit of the invention comprises a capturing device, a detecting device, a report molecule for labeling and an analysis substance eluate. The advantages of the invention are the need of one single capturing agent, the capability of detecting for many analytes which can't be tested at present, wide application, high sensibility and low noise.