Abstract: Provided herein are compositions comprising native and denatured human leukocyte antigens (HLA) and methods of making said compositions. Also provided herein are methods and kits for the detection of antibodies to native HLAs.

Abstract: A filter vial and piston are provided where the vial has a cylindrical wall with a closed bottom and open top and with the hollow, tubular piston therein. The piston has a distal end covered by a cup having a proximal cup seal extending outward to engage the walls of the vial to form a fluid tight seal with the vial during use. The distal end of the piston has a piston flange extending outwardly and located adjacent a recess in the piston so the cup forms a snap fit over the piston flange and extends into the recess. The piston flange causes the cup to bulge sufficiently outward to form a fluid tight seal with the vial during use. A filter is placed in the bottom of the cup and abuts an inwardly extending lip on the cup. The filter is held against the lip by a piston support at the distal end of the piston. A cup support at a distal end of the cup also helps support the filter.

Abstract: This analysis package comprises: a cartridge (3) for reactive products comprising several recipients (4) for reactive products arranged one above the other, wherein each recipient comprises a neck (6), wherein the neck of each recipient is provided with a closing device (7) and a plate (13) for receiving the cartridge (3), wherein the plate comprises a receptacle (22) which is open to the top for receiving the bases of the recipients (4) for reactive products which bases form the cartridge; and means for keeping the recipients for reactive products in position situated in distance from the receptacle, wherein the position keeping means are organized such that they cooperate with the necks of the recipients for reactive products when the bases of said recipients are received in the receptacle (22).

Abstract: The present invention relates to devices and systems for detecting the existence of oral conditions.

Abstract: A buffer kit includes a first eluent and second eluent. The first eluent solution includes at least four buffer salts where at least three of the four buffer salts are a monovalent buffer salt, have a net negative charge or a net neutral zwitterionic charge, and include a sulfonate group and an amine. The second eluent solution includes at least four buffer salts where at least three of the four buffer salts are a monovalent buffer salt, have a net negative charge or a net neutral zwitterionic charge, and include a sulfonate group and an amine. The first eluent solution has a first pH and the second eluent solution has a second pH where the first pH and second pH are different values. The buffer kit provides a linear pH gradient that forms an approximately straight line from at least the first pH to the second pH.

Abstract: A system and method for a beverage container configured to test for a contaminated beverage in the beverage container comprises a base of the beverage container, an upper portion of the beverage container, and a sidewall with an inner surface and an outer surface that extends from the base to the upper portion, and a testing material. A portion of the beverage container is the testing material configured to visibly react when the portion of the beverage container is contacted with the contaminated beverage.

Abstract: The invention relates to a system for collecting a biological sample comprising a container having at least one open end, a closure fitting on or in said at least one open end, a holding element connected to said closure and a solid matrix on which said biological sample is deposited, and optionally at least one processing agent, wherein said solid matrix is at least partially transferable into a liquid or dissolved state by changing at least one physico-chemical property of the environment of said matrix without disintegration of the biomolecules comprised in said biological sample deposited on said matrix.

Abstract: A biological material test strip and adjacently-located reference color chart are affixed to a lid portion of an all-in-one specimen cup to perform color-based reaction testing of collected biological specimens in an uncalibrated environment. After specimen collection, the lid portion is secured to a container portion of the specimen cup. The cup may then be rotated into an upside down position causing the specimen, under the force of gravity, to pass from the container portion and into a volume of the lid portion, such that the test strip is exposed to the specimen as it is received into the volume of the lid portion. An image of the exposed test strip and adjacently-located reference color chart may then be captured and processed to identify any color matches between the individual test pads on the test strip and the corresponding sequences of reference color blocks on the reference chart.

Abstract: A testing device uses a selectively deformable substrate to capture and retain spherical beads for genetic experimentation. A method of fabricating the device is described in which a silicon substrate can be coated with a photosensitive, bio-compatible polymer for photolithographic patterning using a single mask exposure. The polymer is patterned with a matrix of wells, each well capable of expansion to accept placement of a bead in the well, and contraction to secure the bead in the well. The polymer can exhibit piezoelectric properties that cause it to respond mechanically to a selected electrical excitation.

Abstract: A reagent kit comprising: a reagent container assembly with at least one reagent container, wherein the reagent container has at least one container body and at least one closure which can be mounted or provided on the container body. The closure comprises a closure base member and a lid which is mounted movably on the base member for movement at least between a closed lid position and another lid position, and an in-transit securing means mountable in a locking position on the reagent container and which is movable relative to the reagent container from the locking position into a release position. The in-transit securing means, when in the locking position, secures the lid in the closed lid position. By moving the in-transit securing means from the locking position into the release position, the lid is moved from the closed lid position into the other lid position.

Abstract: The invention provides reagents and methods for lateral flow assays and quantitative capture or determination of components, including cells, in a sample. In one aspect, reagents and methods for diagnostic assay are provided. In one embodiment an assay for determining T cell numbers, particularly a CD2+ CD4+ T cell assay is provided. A manufacturing method for producing rapid diagnostic assays in a decentralized manner is also described. The method generates net economic advantages over conventional diagnostic manufacturing practices.

Abstract: A method for assessing a corrosion inhibitor in a coolant, comprises providing a test kit comprising a first chamber containing an acid buffer and a solvent immiscible therein and a second chamber containing an indicator, the second chamber being in fluid communication with the first chamber and being configured such that retraction of the second chamber draws fluid into the first chamber and advancement forces fluid into the second chamber; drawing a coolant sample into the first chamber; contacting the coolant sample with the acid buffer and solvent in the first chamber and extracting the corrosion inhibitor into the solvent; allowing the solvent and buffer to separate in the first chamber; forcing a portion of the separated solvent into the second chamber; contacting the separated solvent with the indicator in the second chamber, and obtaining a visual indication of the presence of corrosion inhibitor in the coolant sample.

Abstract: Provided are a method and a kit for detecting 5-hydroxymethylcytosine in a nucleic acid. The method is a method for detecting 5-hydroxymethylcytosine in a nucleic acid, comprising the steps of: (1) oxidizing 5-hydroxymethylcytosine in a nucleic acid sample by treating the nucleic acid sample with a tungstic acid-based oxidizing agent comprising peroxotungstic acid, tungstic acid, a salt thereof, or a combination thereof with a reoxidizing agent; and (2) determining the position of the oxidized 5-hydroxymethylcytosine in the nucleic acid sample.

Abstract: Subject of the present invention is a biomarker for graft failure and/or mortality after organ transplantation. Procalcitonin was found to be a useful marker for the prediction or risk stratification for graft failure and/or mortality of a subject who has received an organ transplant and monitoring and therapy guidance of such subject.

Abstract: The present invention relates generally to a kit and method for the colorimetric detection of precursors used in the assembly of homemade explosives (HMEs). More specifically, the present invention relates to a bulk HME precursor detection kit and methods of using a kit that is capable of bulk detection of HME precursors, such as urea nitrate, ammonium nitrate and potassium chlorate.

Abstract: The present invention relates to targeted conversion of alpha-hydroxyalkylated residues in biomolecules in the presence of a directing methyltransferase, namely to targeted removal of the alpha-hydroxyalkyl moieties to give unmodified residues, or targeted derivatization of the alpha-hydroxyalkyl groups by covalent coupling of non-cofactor compounds represented by formula HQ-LX1 wherein X represents a functional group or a reporter group attached via a linker moiety L, and QH is selected from HS—, HSe—, HO—H2N—, HN3 or HCN in the presence of a directing methyltransferase. Further development of the method of targeted conversion comprises methods for targeted labeling a biomolecule and method for detecting hydroxymethylated target sites in a biomolecule according to the present invention.

Abstract: The present invention provides methods and compositions for asymmetrically tagging a nucleic acid fragment using asymmetric adapters.

Abstract: It is an object of the present invention to provide a measurement kit for developing a first developing solution and a second developing solution from different directions to suppress background noise, and an immunochromatography kit. The present invention provides a measurement kit, which comprises a first developing member for supplying a first developing solution and a second developing member for supplying a second developing solution, wherein the developing direction of the first developing solution is allowed to intersect with the developing direction of the second developing solution, so that development is carried out by developing the first and second developing solutions in different developing directions, and a water absorbent portion is established on the downstream of each of the developing directions.

Abstract: A biological material test strip and adjacently-located reference color chart are affixed to a lid portion of an all-in-one specimen cup to perform color-based reaction testing of collected biological specimens in an uncalibrated environment. After specimen collection, the lid portion is secured to a container portion of the specimen cup. The cup may then be rotated into an upside down position causing the specimen, under the force of gravity, to pass from the container portion and into a volume of the lid portion, such that the test strip is exposed to the specimen as it is received into the volume of the lid portion. An image of the exposed test strip and adjacently-located reference color chart may then be captured and processed to identify any color matches between the individual test pads on the test strip and the corresponding sequences of reference color blocks on the reference chart.

Abstract: This disclosure relates to compositions that enhance the deposition of detectable moieties on tissue samples, methods utilizing these compositions and kits including these compositions. The compositions include a deposition enhancer having a formula where R1, R2, R3, and R4 are independently selected from aliphatic, aryl, halogen, a heteroatom-containing moiety, and hydrogen; R1 and/or R3 can be bound to R2 to form a fused, aromatic ring system; R5 is selected from a heteroatom-containing moiety; A is selected from, a carbon atom, a heteroatom, other than sulfur, and any combination thereof; n is 1-5, an enzyme, a specific binding moiety and a detectable moiety.

Abstract: Diets high in saturated fat and fructose have been implicated in the development of obesity and nonalcoholic steatohepatitis (NASH) in humans. Provided herein are biomarkers, methods, and animal models useful for the investigation and non-invasive detection of NASH, including a non-invasive biomarker that could be used to establish disease severity, follow progression, and evaluate response to treatment in clinical trials for this increasingly prevalent disease.

Abstract: The present invention provides methods and compositions related to the detection and/or monitoring of the levels of angiogenic factors, specifically VEGF, PlGF and sFlt-1, in urine samples obtained from pregnant women and the effects of such levels on the risk of developing complications of pregnancy, including hypertensive disorders such as preeclampsia, in the first, second, and/or third trimester of pregnancy. The present invention also provides kits for identifying and screening patients at risk of developing a complication of pregnancy, such as preeclampsia.

Abstract: Ketoacidosis is an extreme and uncontrolled form of ketosis, which is a normal response to prolonged fasting. Embodiments of this invention test the ketone level of a patient by measuring the ketone bodies in breath condensation. Some embodiments include a device for medical testing comprising a hollow container, comprising powder mixture of sodium nitroferricyanide, ammonium sulfate and silica and a liquid including an ammonium hydroxide solution.

Abstract: Embodiments of the present disclosure relate generally to reporter compositions which are synthetic nucleotides that comprise nucleotides with a high charge mass moiety attached thereto via a linker molecule. The linker molecules can vary in length in part to enable the high charge mass moiety to extend out from a DNA polymerase complex so that polymerization may not be influenced.

Abstract: Described here are systems, devices, cartridges, methods, and kits for detecting or quantifying at least two different analytes using at least two different techniques, in a single sample. The cartridges typically comprise at least two test sites and the location of at least one test site is not dependent on a corresponding measurement device. The systems generally comprise a device, memory, and a processing module. The device comprises a light source, an array detector, and a port configured to accept at least a portion of a cartridge. The processing module is configured to perform an image analysis of the cartridge. The methods comprise the steps of acquiring calibration information, acquiring an image of the cartridge, performing an image analysis, and cycling through specific detection or quantification techniques corresponding to the techniques required by the test sites. Computer readable media are also described.

Abstract: Sample processing devices that include transmissive layers and control layers to reduce or eliminate cross-talk between process chambers in the processing device are disclosed. The transmissive layers may transmit significant portions of signal light and/or interrogation light while the control layers block significant portions of signal light and/or interrogation light. Methods of manufacturing processing devices that include transmissive layers and control layers are also disclosed. The methods may involve continuous forming processes including co-extrusion of materials to form the transmissive layer and control layer in a processing device, followed by formation of the process chambers in the control layer. Alternatively, the methods may involve extrusion of materials for the control layer, followed by formation of process chambers in the control layer.

Abstract: An immunoanalytical system in which, after a sample such as a patient's serum is subjected to a pretreatment by an immunological pretreatment device, the sample is subjected to light detection by an immunological photometric detection system. Subsequently, the mass spectrometric pretreatment device performs a pretreatment, and the mass spectrometric detection system performs mass spectrometry. The mass spectrometric detection system performs mass spectrometry on components contained in a supernatant. A signal intensity and peak area for each of components are calculated from an obtained chromatograph. A quantitative value measured based on the immunoanalytical method is calculated for each of the components on the basis of the relative ratios of the components.

Abstract: A method and apparatus for minimizing diagnostic errors due to transposition of biological specimens among subjects provides for independent biometric confirmation that a given specimen is from a given donor. In certain embodiments, a biological specimen confirmation kit comprises a portable and openable case housing components of the kit, at least one biological specimen container adapted to receive a biological testing specimen from a donor, and at least one reference sample device adapted to receive a biological reference specimen from the same donor, such that the testing and reference specimens can later be compared for donor match verification by a reference verification entity.

Abstract: The present disclosure encompasses systems, and their methods of use, for detecting a target analyte. The systems include a first and second oligonucleotide probe that associate together to form a complex that binds to a target analyte; a cleavable reporter molecule that binds to the complex; and cleaving agent.

Abstract: The present invention is directed towards methods for measuring and assaying PAS Kinase activity. The methods are useful, for example, for detecting PASK activity in a cell, and for screening for small molecule regulators of PAS kinase activity, as well as characterizing endogenous factors and stimuli that modulate PAS kinase activity, and identifying and optimizing the activity of potential PAS kinase inhibitors.

Abstract: Provided is a method for noninvasive prediction or diagnosis of inflammation and/or infection in amniotic fluid leaked through the cervix into the vagina to predict the concentration of inflammatory markers in the amniotic fluid inside uterus by measuring the concentration of inflammatory markers (various cytokines). Further provided is a method for prediction or diagnosis of inflammation and/or infection in amniotic fluid by measuring the concentration of markers (IL-6, IL-1? IL-8, MCP-1, GRO-?) in the amniotic fluid leaked through the cervix into the vagina in patients with premature rupture of membranes. The method can be performed more stably on pregnant women, as compared to the conventional method for prediction or diagnosis of inflammation and/or infection using invasively collected amniotic fluid.

Abstract: The present invention relates to a fluorescent cell binding assay combining pre-labeling and Western blotting. Intact cells are incubated with pre-labelled binders preferably followed by SDS PAGE (sodium dodecylsulphate polyacrylamide gel) separation and Western blotting. More closely, the invention relates to a cell binding assay in which the degree or amount of binding of one or more cell interacting protein or protein component to the cell surface is measured with the ability to correlate the degree of cell binding to the sample load/total number of cells.

Abstract: The present invention relates in part to a method of stabilizing chloropropenes, such as 1,1,2,3-tetrachloropropene, otherwise known to decompose and degrade, and to the resulting stabilized chloropropene, using a morpholine compound and/or a trialkyl phosphate compound as defined herein. Such stabilized chloropropenes are useful in the manufacture of hydrofluoroolefins such as 2,3,3,3-tetrafluoroprop-1-ene (1234yf).

Abstract: A dilution kit for and a method of diluting concentrated solutions used to treat allergic symptoms are disclosed. The dilution kit may comprise a case comprising: a base; and a cover hingedly coupled to the base. A foam pad may be removably coupled within the base, the foam pad defining a plurality of vial apertures. A plurality of vials may be removably positionable within the plurality of vial apertures. The method may comprise: removably positioning at least one of a plurality of vials in an upwardly facing position within at least one of a plurality of apertures defined in a layer of foam padding in a base of a case of a dilution kit; and placing a predetermined amount of one of a diluent, a concentrated solution, and a combination thereof into at least one empty vial of the plurality of vials.

Abstract: The present invention relates to systems and methods for the rapid in situ determination of the existence of a hook effect and expansion of the dynamic range of a point of care immunoassay. For example, a system for identifying a hook effect and expanding the dynamic range of an immunoassay is provided that may include a primary sensor having first immobilized antibodies that may be configured to generate a first signal based on a presence or absence of a target analyte in a sample. The system may further include an attenuated sensor having second immobilized antibodies at a reduced concentration relative to a concentration of the first immobilized antibodies on the primary sensor and that may be configured to generate a second signal based on the presence or absence of the target analyte in the sample.

Abstract: The problem is to provide a multilayer analysis element for analyzing liquid samples, having improved adhesive force between a transparent support and a detection layer even by handling at the time of processing, while maintaining basic performances such as sensitivity and storage performance. The multilayer analysis element for analyzing liquid samples is characterized in that at least a detection layer containing a substance that generates a detectable change by a gaseous substance, a liquid blocking layer that selectively permeates the gaseous substance, and a spreading layer are integrally adhesion laminated in this order on a transparent support, and the detection layer contains an adhesive polymer and a water-insoluble vinyl polymer.

Abstract: The present invention is an apparatus for detecting the presence, quantity and identity of one or more microorganisms in a sample and a method for using the same. The apparatus is composed of one or more chambers and a sensing element for sensing microorganisms. In particular embodiments, the sensing element is an array of chemoresponsive dyes deposited on a substrate in a predetermined pattern combination, wherein the combination of the dyes have a distinct and direct spectroscopic, transmission, or reflectance response to distinct analytes produced by the microorganism which is indicative of the presence, quantity and identity of the microorganism.

Abstract: A detection kit comprises a plurality of swabs, each of the plurality of swabs having the form of a stick, being bundled together in a single test kit for detection of a plurality of chemical compounds. A user opens a detection kit, swabs a surface or surfaces with the bundled sticks, collecting chemical constituents to be tested on detection surfaces of each of the plurality of sticks. Liquids, mists, vapors and powders may be tested in one method, utilizing one or more dry reagents on the detection surfaces. The sticks may comprise a volume of fluid, releasably contained within the sticks, such that when activated, a fluid, such as a reagent or solvent, is wicked by a wicking tip to the detection surface of the stick. For example, a mechanism is provided that is capable of breaking a vial or ampoule containing the fluid, when activated by a twisting motion or compression. Adhesive may be present on one or more of the detection surfaces.

Abstract: The present invention discloses analyte detection devices for detecting one or more analytes present in test samples, especially biological samples. In particular, the devices of the invention are lateral flow assay devices comprising immobilized metal nanoparticle conjugates as the detection means. Methods of using the devices and kits comprising the devices are also described.

Abstract: The present application provides apparatus (300, 400) and methods for determining the density of a fluid sample. In particular, it provides a sensor device which can be loaded with a fluid sample such as blood, and which further comprises at least one oscillating beam member or resonator (108, 109, 110). Exposure of the blood sample to clotting agents allows a clotting reaction to commence. The device allows the density of the sample fluid to be monitored with reference to the oscillation of the vibrating beam member, thus allowing the monitoring of the clotting of the fluid sample.

Abstract: A method for predicting risk of pre-eclampsia in a pregnant individual includes measuring one or more biochemical markers including an RBP4 biochemical marker in a blood sample obtained from the pregnant individual to determine one or more biomarker levels including an RBP4 biomarker level, identifying, for each of the one or more measured biochemical markers, a difference between the measured biomarker level and a corresponding predetermined control level, and, responsive to the identifying, determining a prediction corresponding to a relative risk of the pregnant individual having or developing pre-eclampsia.

Abstract: The invention relates to a method for automated determination of immunofluorescent foci by means of an immunofluorescence assay using synthetic calibration particles, in addition to a system and kit for carrying out the method. In a preferred embodiment the method is characterized in that the immunofluorescent foci are gamma H2Ax foci.

Abstract: A system and method for a beverage container configured to test for a contaminated beverage in the beverage container comprises a base of the beverage container, an upper portion of the beverage container, and a sidewall with an inner surface and an outer surface that extends from the base to the upper portion, and a testing material. A portion of the beverage container is the testing material configured to visibly react when the portion of the beverage container is contacted with the contaminated beverage.

Abstract: The present invention relates, in general, to methods for detecting and quantitating plasma-derived protein and recombinant protein in a sample based on the difference in protein glycosylation, when the plasma protein and the recombinant protein are essentially the same protein.

Abstract: The present disclosure provides a sensor port configured to receive a plurality of analyte sensors having different sizes, shapes and/or electrode configurations. Also provided are analyte meters, analyte monitoring devices and/or systems and drug delivery devices and/or systems utilizing the disclosed sensor ports.

Abstract: A tape cassette for a medical handheld device is disclosed as comprising a carrier tape, which carries test fields for assaying a sample of a human or animal bodily fluid and/or lancets as functional elements, a supply chamber, in which a supply section of the carrier tape comprising unused functional elements is positioned, a winding unit, in order to wind up the carrier tape and draw it through a tape exit opening of the chamber, so that the functional elements may be brought sequentially into a usage position. The carrier tape in the tape exit opening is oriented transversely to the supply section positioned in the supply chamber.

Abstract: Disclosed are a detection/quantification kit and a detection/quantification method for detecting/quantifying an analyte rapidly at a low cost and in a simple manner. Specifically, disclosed is a kit for detecting an analyte in a sample, comprising a first conjugate and a second conjugate, wherein the first conjugate comprises a first substance comprising a stimuli-responsive polymer and a first affinity substance having affinity for the analyte and bound to the first substance, and the second conjugate comprises a second substance carrying an electrical charge and a second affinity substance having affinity for the analyte and bound to the second substance. The first and second affinity substances can bind to different sites on the analyte simultaneously.

Abstract: The inventors have developed a rapid and sensitive fluorescence-based assay to quantify dNTPs. This assay relies on the principle that incorporation of a limiting dNTP is required for primer-extension and polymerase-mediated 5-3? exonuclease hydrolysis of a quenched fluorophore-labeled probe resulting in fluorescence. The concentration of limiting dNTPs is directly proportional to the fluorescence generated. This assay has important applications in research that investigates the influence of pathological conditions or pharmacological agents on dNTP biosynthesis and regulation.

Abstract: The present disclosure relates to new polymethine compounds and their use as fluorescent labels. The compounds may be used as fluorescent labels for nucleotides in nucleic acid sequencing applications.

Abstract: A point-of-care, screening kit for use by a heath care worker to create custom test strips for screening the bodily fluids of an individual for various, medical conditions includes: (a) a plurality of reagents (12), (b) a substrate (18) configured to: i) receive one of the reagents and react with it so as to cause it to acquire a first characteristic color, and, ii) upon the addition of the individual's bodily fluid to the substrate, acquire, as a result of the formulation of each of the reagents, a second, dichotomous characteristic color when the individual has a specific one of the various, medical conditions.