Abstract: The presently-disclosed subject matter provides methods for diagnosing a cardiovascular disease in a subject by determining an amount of one or more peptide biomarkers disclosed herein in a biological sample from the subject. The presently-disclosed subject matter further provides methods for determining treatment efficacy and/or progression of a cardiovascular disease in a subject by measuring amounts of one or more of the biomarkers in a biological sample from the subject. The presently-disclosed subject matter also provides antibodies and kits for measuring the biomarkers.

Abstract: Various embodiments of methods and kits are disclosed for detection and/or diagnosis of cancer (e.g., active malignancy) in a subject patient by analyzing a first sample of the subject patient's albumin-containing extracellular fluid (e.g., blood serum). Some embodiments comprise analyzing a second sample of the subject patient's albumin-containing extracellular fluid obtained between 2 and 90 days (e.g., between 5 and 30 days) after the first sample.

Abstract: The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using a one or more assays configured to detect a kidney injury marker selected from the group consisting of Heat shock 70 kDa protein 1, Alpha-1-antitrypsin Neutrophil elastase complex, Stromelysin-1:Metalloproteinase inhibitor 2 complex, 72 kDa type IV collagenase:Metalloproteinase inhibitor 2 complex, Insulin-like growth factor 1 receptor, Myeloid differentiation primary response protein MyD88, Neuronal cell adhesion molecule, and Tumor necrosis factor ligand superfamily member 10 as diagnostic and prognostic biomarkers in renal injuries.

Abstract: A disposable cartridge adapted to be used with a sensor-dispensing instrument comprises a housing, test sensors, a mechanical mechanism and moveable seals. The housing forms at least one opening therethrough. The test sensors are stacked in the housing. The test sensors are adapted to assist in testing at least one analyte. The mechanical mechanism is adapted to urge the test sensors in a first direction. One of the test sensors is positioned for ejection from the cartridge. The moveable seals is adapted to be in a closed position that seals the at least one opening so as to provide a substantially moisture-proof and a substantially air-tight cartridge, and one of the moveable seals is adapted to be in an open position that allows one of the test sensors to be moved therethrough.

Abstract: A method comprises: sorbing a sample solution comprising nucleic acids to a sample receiving portion of a quartz fiber filter by contacting the sample solution with the sample receiving portion; and washing the sample receiving portion while keeping most of nucleic acids around the sample receiving portion by flowing a wash solution through the sample receiving portion under a wicking force directed away from the sample receiving portion. An associated apparatus is also provided.

Abstract: An analyte detection system and method for the detection of one or more analytes in a sample, the analytes selected from the group consisting of explosives, narcotics, gunshot residue, organophosphate reagents, and toxic industrial chemicals, based on a capillary action in a sample card. The sample card includes a housing with at least one cavity made of flexible material, a sample substrate for collecting the sample with a portion of the substrate exposed from outside the housing, at least one test capsule in the cavity and an absorbent pad. The test capsule(s), the sample substrate, and the absorbent pad comprise at least one or more reagents. The test capsule(s) is ruptured with a rupture mechanism upon inserting the sample card into a reader device. The absorbent pad absorbs a liquid from the test capsule and delivers the same to the sample substrate.

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: The present invention provides a method of detecting (e.g., by flow cytometry) a target compound, cell or particle, wherein the target is labelled with a detectable luminescent compound. The method comprises utilizing as the detectable luminescent compound a compound comprising a porphyrinic macrocycle such as a porphyrin, chlorin, bacteriochlorin, or isobacteriochlorin. In particular embodiments, the detectable luminescent compound comprises a compound of the formula A-A?-Z—B?—B, wherein: A is a targeting group or member of a specific binding pair that specifically binds the detectable luminescent compound to the target compound, cell or particle; A? is a linker group or covalent bond; B? is a linker group or covalent bond; B is a water-soluble group; and Z is the porphyrinic macrocycle.

Abstract: A method includes providing a container, introducing a substance into the container, and introducing a readily dissolvable film into the container such that the dissolvable film overlies the substance within the container. An alternative method includes providing a container, providing a readily dissolvable film, the film comprising a substance carried by the film, and introducing the film into the container.

Abstract: The invention relates to methods for coating nanoparticles with a limited amount of a binding partner and nanoparticles obtainable by the methods disclosed. In particular, the invention is of interest, when coating with only a limited amount of protein is desirable.

Abstract: The present invention relates to a method for the semi-quantitative determination of cariogenic bacteria in a sample of saliva and/or plaque, in which the microorganisms contained in a sample of plaque or saliva are brought into contact with a carbon source that is fermented to acid by the cariogenic bacteria. The microorganisms are then incubated under conditions which make possible selective acid formation by the cariogenic bacteria. The acid formation is then detected by determining the pH at least once within a period of 12 hours after adding the carbon source, wherein the cariogenic bacteria are determined semi-quantitatively in the sample by comparison of the pH with at least one reference value. In addition, the invention provides kits for carrying out such methods.

Abstract: The present invention concerns the identification of biomarkers and groups or combinations of biomarkers that can be used for non-invasive diagnosis of intra-amniotic infection, and diagnostic assays using such biomarkers.

Abstract: Certain disclosed embodiments of the present invention concern the synthesis, derivatization, conjugation to immunoglobulins and signal amplification based on discrete, relatively short polymers having plural reactive functional groups that react with plural molecules of interest. Reactive functional groups, such as hydrazides, may be derivatized with a variety of detectable labels, particularly haptens. The remaining reactive functional groups may be conjugated directly to a specific binding molecule, such as to the oxidized carbohydrate of the Fc region of the antibody. Disclosed conjugates display large signal amplification as compared to those based on molecules derivatized with single haptens, and are useful for assay methods, particularly multiplexed assays.

Abstract: A bedside apparatus and method designed to collect and monitor liquids output from a catheterized patient including an electronic unit and one of a plurality of defined disposable collecting and measuring rigid vessels that may differ in shape and size. Each defined vessel has at least one inlet to connect to a catheter outputting liquid from a patient in order to collect the liquid in the defined vessel. The defined vessel has at least one outlet valve to control draining of liquid from the vessel. An electronic unit has a configuration to receive the defined vessel and to securely mount and hold the defined vessel in a fixed relationship. The electronic unit further has a liquid level sensing device located in juxtaposition to the defined vessel to sense the level of liquid contained in the vessel.

Abstract: This invention relates, e.g., to a method for determining if a subject has myocardial ischemia, comprising (a) providing a blood sample obtained from a subject suspected of having myocardial ischemia; (b) determining in the sample the amount of one or more of the following proteins: (i) Lumican and/or (ii) Extracellular matrix protein 1 and/or (iii) Carboxypeptidase N; and (c) comparing the amount(s) of the protein(s) to a baseline value that is indicative of the amount of the protein in a subject that does not have myocardial ischemia, wherein a statistically significantly increased amount of the protein(s) compared to the baseline value is indicative of myocardial ischemia. Other proteins indicative of myocardial ischemia are also described, as are methods for treating a subject based on a diagnostic procedure of the invention, and kits for carrying out a method of the invention.

Abstract: The present invention provides molecular biosensors capable of signal amplification, and methods of using the molecular biosensors to detect the presence of a target molecule.

Abstract: Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. In some embodiments, the reader component communicates with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

Abstract: An oestrus detector 100 includes a reservoir portion 135 which contains a colored liquid. The detector 100 further includes a generally planar portion 110 that is attached to and sealed from the reservoir portion 135, except for an open or closed passage 111 in a seal line separating the reservoir portion 135 and the generally planar portion 110. In use the liquid is squeezed from the reservoir portion 135, through the passage 111, and into the generally planar portion 110, when the reservoir portion 135 receives pressure.

Abstract: A two step lateral flow assay method for identifying IgE antibodies in a sample comprises applying a sample to a sample port of a device, wherein the device is adapted to deliver the sample to a lateral flow matrix having a plurality of IgE antigen species immobilized at respective positions at a first location; allowing the sample to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species to a second location downstream of the first location; and, after a predetermined period of time, applying liquid buffer to the lateral flow matrix to mobilize labeled reagent which is adapted to bind anti-IgE antibody and which is dried on the lateral flow matrix at a location upstream of the sample port delivery of the sample to the lateral flow matrix, and allowing labeled reagent mobilized by the liquid buffer to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species and bind with any IgE antibody bound to the immobilized IgE antigen species, a

Abstract: The present application provides apparatus 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. 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: The present invention relates to methods of reversibly staining a target cell. The invention also relates to methods of isolating a target cell or a target cell population that is defined by the presence of at least one common specific receptor molecule. The invention also provides kits that can be used to carry out the methods of the invention.

Abstract: Disclosed is a reagent set, including a boxy body; an internal holding member arranged in the box body to form a container accommodating region in the box body; and a reagent container, arranged in the container accommodating region, and including a main body portion and a mouth portion formed on an upper surface of the main body portion.

Abstract: The invention provides compositions and methods for the detection of targets in a sample; in particular, an in situ hybridization (ISH) sample. Probes and detectable labels may be provided in multiple layers in order to increase the flexibility of a detection system, and to allow for amplification to enhance the signal from a target. The layers may be created by incorporating probes and detectable labels into larger molecular units that interact through nucleic acids base-pairing, including peptide-nucleic acid (PNA) base-pairing. Optional non-natural bases allow for degenerate base pairing schemes. The compositions and methods are also compatible with immunohistochemistry (IHC), immunocytochemistry (ICC), flow cytometry, enzyme immuno-assays (EIA), enzyme linked immuno-assays (ELISA), blotting methods (e.g. Western, Southern, and Northern), labeling inside electrophoresis systems or on surfaces or arrays, and precipitation, among other general detection assay formats.

Abstract: A calibrator, for calibrating a sensor, has a calibration chamber for containing a calibration liquid. The liquid comprises water or an aqueous solution of an analyte to be sensed. A hydrogen peroxide-quenching material is provided exposed to the interior of the calibration chamber. The hydrogen peroxide-quenching material contacts the calibration liquid. After the calibration chamber containing the calibration liquid is sterilized by irradiation with gamma radiation, the hydrogen peroxide-quenching material decomposes any hydrogen peroxide formed in the calibration liquid to avoid adverse effects on a sensor placed in contact with the calibration liquid.

Abstract: The present invention relates to a blood glucose monitoring system, a strip accommodation device, a strip storage device, and an automated blood collection device, wherein the blood glucose monitoring system has the strip accommodation device formed integrally therewith, the strip accommodation device being configured to convert a rotary motion of a cover of an operating member into an upward linear motion and to eject one of a plurality of strips through an ejection hole, thereby easily storing the strips therein, preventing the contamination of the strips from the foreign matters like outside moisture, and accurately and easily measuring the concentration of the glucose in the blood.

Abstract: The present invention relates to methods and kits for evaluating the severity of a burn injury, which are based on the detection in a clinical fluid sample of skin metabolism products, such as collagen peptides which are released upon collagen degradation or synthesis.

Abstract: The present invention relates to a method for selectively enriching and/or isolating microbial and optionally additionally viral nucleic acids from samples that contain a mixture of microbial cells, freely circulating nucleic acids and higher eukaryotic cells, and optionally additionally viruses, in a liquid, and to a kit for selectively enriching and/or isolating intracellular and extracellular microbial nucleic acids, and optionally additionally viral nucleic acids, from samples that contain a mixture of microbial and higher eukaryotic cells, freely circulating nucleic acids, in particular extracellular microbial nucleic acids, and optionally additionally viruses in a liquid.

Abstract: Devices and methods for testing a biological sample for an analyte of interest are provided that make use of a reaction chamber for receiving a reaction mixture, a housing positioned below the reaction chamber for receiving a test cassette, and a door that is positioned in the top portion of the housing. The door includes a ramp that extends downwardly into the housing such that biasing the ramp upwards opens the door into the cavity of the reaction chamber and places the reaction chamber in fluid communication with the insertion area to thereby allow the reaction mixture to flow onto a test cassette and allow for the determination of an amount of an analyte of interest.

Abstract: The invention comprises a device for detecting an analyte in a liquid sample deposited on a first portion of the device for transport to a second portion of the device that is in fluid contact with the first portion. In specific embodiments, the device is a pregnancy test device, which detects human chorionic gonadotropin (hCG) as an indicator of pregnancy. Devices with improved clinical sensitivity are provided which are capable of detecting all clinically relevant hCG isoforms.

Abstract: The present invention relates to a sealing device for closing an introduction aperture, the sealing device comprising a fixed support and a shutter mounted movably in translation relative to the support between an extended position and a final retracted position, wherein the sealing device is in a final retracted configuration and wherein the shutter closes introduction aperture. The device includes locking means for preventing any movement of the shutter when it is in the final retracted position. The sealing device further comprises an intermediate retracted configuration, wherein the shutter is at least partly retracted. The sealing device also comprises motion guiding means for guiding the movement of the shutter and designed so that the extension of the shutter is required to move the shutter from the intermediate retracted position to the final retracted position.

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 device for use in molecular diagnostics testing includes at least one sealed reagent storage container, and at least one opener for unsealing the reagent storage container. The device further includes an actuator coupled to the reagent storage container and opener such that moving the actuator brings the reagent storage container and the opener together so that the opener unseals the reagent storage container.

Abstract: The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using assays that detect one or more markers selected from the group consisting of Clusterin, Heart-type fatty acid binding protein, Hepatocyte growth factor, Interferon gamma, Interleukin-12 subunit beta, Interleukin-16, Interleukin-2, 72 kDa type IV collagenase, Matrix metalloproteinase-9, Midkine, and Serum amyloid P-component as diagnostic and prognostic biomarkers in renal injuries.

Abstract: A package comprising a body comprising a first compartment containing a first substance and a second compartment containing a second substance. The package includes a first state in which the first compartment is isolated from the second compartment such that the first substance is separated from the second substance, and a second state in which the first compartment communicates with the second compartment such that the first substance and the second substance combine.

Abstract: Disclosed is a fluidic assay device for assaying at least one property of a liquid sample, the device comprising: (i) a liquid sample application region; (ii) at least one test flow path in liquid flow communication with the sample application region; (iii) a reference flow path in liquid flow communication with the sample application region; and (iv) a junction region, at which the test flow path and the reference flow path contact one another, the junction region typically comprising an outlet, conduit, chamber or other portion which permits the onward flow of liquid; wherein a liquid flowing along the reference flow path, upon reaching the junction region, has the effect of preventing the flow of liquid along the test flow path. The invention relates to a fluidic device for the passage of a liquid. It also relates to an assay device suitable for measurement of the amount and/or presence of an analyte in, or property of, a fluid sample.

Abstract: A disposable blood analysis cartridge may include a sample collection reservoir, an absorbance measurement channel, and an optical light scattering measurement channel. One or more valves may be disposed between the sample collection reservoir and the absorbance measurement channel and/or the optical light scattering measurement channel. A negative pressure may be applied to the cartridge to pull sample from the sample collection reservoir through the one or more valves and into the absorbance measurement channel and/or the optical light scattering measurement channel. Once the sample is pulled into the absorbance measurement channel and/or the optical light scattering measurement channel, the one or more valves may be closed. With the one or more valves closed, and in some cases, a pusher fluid may be provided to push the fluid sample to other regions of the disposable fluid blood analysis cartridge.

Abstract: The present invention relates to the use of N-linked glycan profiles of blood or blood component proteins as biomarkers for diagnosing diabetes mellitus and for monitoring the efficacy of anti-diabetic therapy. Specifically, the present invention relates to detecting changes in the amounts of N-linked glycans as diagnostic biomarkers for diabetes mellitus and as indicators of the efficacy of anti-diabetic therapy over time.

Abstract: A molecular construct comprises a donor label, an acceptor label, a linker peptide disposed between the donor and the acceptor, the linker having a cleavage site sequence, and a spacer between at least one of (a) the donor and the cleavage site sequence and (b) the acceptor and the cleavage site sequence. Preferably, the construct is selected from the group consisting of CFP-(SGLRSRA)-SNAP-25-(SNS)-YFP, and CFP-(SGLRSRA)-synaptobrevin-(SNS)-YFP. In preferred embodiments, the linker peptide is a substrate of a botulinum neurotoxin selected from the group consisting of synaptobrevin (VAMP), syntaxin and SNAP-25, or a fragment thereof that can be recognized and cleaved by the botulinum neurotoxin. Advantageously, the spacer increases the electronic coupling between the donor label and the acceptor label relative to a corresponding construct without the spacer.

Abstract: Apparatus (1) includes a device (20) for moving at least one compartment (2) in the apparatus, the compartment forming a support for tubes (3), which apparatus further includes elements (50) for taking a specimen of a product contained in the tubes, the movement device (20) including elements (21) for guiding the compartment during movement of the compartment and further including stirring members (27) for the guiding elements, the movement device being mounted on a chassis (4) of the apparatus.

Abstract: Methods and assay for the portable colorimetric detection of an antioxidant in a food sample. The method includes the steps of providing a colorimetric reagent, the reagent including a plurality of ceria nanoparticles immobilized to a support, contacting the colorimetric reagent with the food sample, and detecting an optical property of the colorimetric reagent, where a change in the optical property of the colorimetric reagent is associated with the presence of antioxidant in the food sample. The change in the optical property of the colorimetric reagent is dependent upon the concentration of the antioxidant in the food sample.

Abstract: The present invention relates to combinations of fluorescent dyes used in molecular biology, particularly in multiplex PCR. In particular, the present invention relates to a combination of dyes for amplification reactions, wherein at least four different dyes are used, wherein the first dye is 5-FAM or 6-FAM or a blend thereof, the second dye is selected from the group consisting of DY-530, HEX, CAL Fluor Orange 560 and ATTO 532, the third dye is selected from the group consisting of ATTO 550, DY-555 and DY-556, the fourth dye is selected from the group consisting of ROX, DY-510XL and ATTO 565, and optionally a fifth dye is selected from the group consisting of DY 632 and DY-520XL.

Abstract: The present invention relates to an apparatus for quantifying the binding and dissociation kinetics of molecular interactions of small molecular bio materials with high sensitivity almost without the influence of a change in the reflective index resulting from a buffer solution by making polarized incident light incident on the binding layer of a bio material, formed in a thin dielectric film, so that the polarized incident light satisfies a p-wave non-reflecting condition and a quantifying method using the same.

Abstract: A system for diagnostic testing may include a meter for performing a diagnostic test on a sample applied to a test media, the meter having a housing and an interface for receiving a signal representing coding information, and a container configured to contain test media compatible with the meter, the container having a coding element associated therewith. Additionally, the system may provide a mechanism for removing the meter from an interconnected test container and reattaching it to a new container using on-container coding methods that can recalibrate the meter for the new container of test strips.

Abstract: The present invention provides an apparatus for fluid sample collection and analyte testing, including a sample receiving member and at least one membrane test strip, and optionally a sample retention member, fingerprint acquisition pad, and/or fluid collector. It also provides a fluid collection apparatus having an absorbent material, compression element, and closure element, and optionally a lid that allows the apparatus to be used in conjunction with a fluid container. Also provided are methods of collecting, testing, and retaining a fluid sample and verifying the identity of one or more individuals associated with the sample, such as the test subject, test administrator, and/or witnesses.

Abstract: A kit comprising a carrier and vessels arranged on the carrier, wherein different reagents are contained in different vessels, the vessels are arranged with an openable closing device on top of the carrier, the carrier has a footprint on the bottom side for being placed on a base, and the carrier has bottom positioning means for being positioned on at least one workplace of an automated laboratory system for microtiter plates according to the SBS standard.

Abstract: A portable analyzer A1 includes: hole forming means designed to form a hole 3 for insertion of a specimen sampling implement 6 therein; and analyzing means capable of analyzing a specimen when the sampling implement 6 is inserted into the hole 3, the hole forming means including a first member 1 having a first region R1 corresponding to a portion of an internal surface of the hole 3, and a second member 2 having a second region R2 corresponding to another portion of the internal surface of the hole 3. The first and second members 1 and 2 are capable of relative movement while being coupled to each other, the relative movement causing at least one of the first and second regions R1 and R2 to be exposed to outside for easy cleaning thereof.

Abstract: A colorimetric assay to detect certain compounds and a kit therefore are provided.

Abstract: Saliva sample collection systems are configured with special attention to ease-of-use for the unskilled user and safe transport and delivery by a conventional delivery services such as Federal Express. A sealed cavity is formed by tight coupling of two primary elements: a receiving vessel element and a sealing cap element. The receiving vessel has integrated therewith: a standing means, a fill-line window, a funnel system, a knife, a threadset, and containment tube among others. A complementary cap element includes a cooperating threadset, label receiving surface, gripping surface, seal means and reservoir with piercable thin-film membrane. These two primary elements may be accommodated in an application-specific shipping container which support two shipping modes whereby the system may be shipped safely to and from a donor user each way in a different shipping mode.

Abstract: The invention relates to a heated reaction chamber for processing a biochip and to a method for controlling said reaction chamber. The heated reaction chamber for processing a biochip comprises a chamber wall, constituted by a flexible circuit board (10), a circuit path (10.3) being configured on the flexible circuit board (10) and being used as the heating device. The use of a flexible circuit board as the wall of a reaction chamber allows for a low thermal capacity of the reaction chamber in the area of the heating device, thereby allowing the chamber to be heated up quickly.

Abstract: The present invention is related to a diagnostic test kit for detecting luteinizing hormone (LH) in a biological sample at a concentration relative to a threshold concentration of LH. The device can include a release medium formed of a first material and including a labeled conjugate with a detectable label and a first binding member reactive with a first epitope of LH and a capture medium formed of a second, different material, in fluid communication with the release medium. The capture medium includes a result site having immobilized thereon a capture component capable of directly or indirectly binding LH that is bound to the labeled conjugate. The device is calibrated such that color development at the result site occurs only when the LH concentration of the liquid sample is greater than the threshold concentration.