Abstract: Disclosed is an assay device for the determination of the presence and/or extent if an analyte in a liquid sample over an extended concentration range comprising a first assay and a second assay, wherein the first assay for an analyte comprises a first flow-path having a sole detection zone capable of immobilizing a labelled binding reagent and the second assay for said analyte comprises a second flow-path having a sole detection zone capable of immobilizing a labelled binding reagent, wherein the presence of labelled binding reagent at the detection zones provides an indication of the presence and/or extent of analyte in said liquid sample.

Abstract: Provided is a method of measuring blood coagulation time, the method being capable of LA detection easily and with high sensitivity as compared with the method recommended by the ISTH, without being affected by deficiency of blood coagulation factors even in a blood sample of a warfarin taker, a person who suffers from vitamin K deficiency, or a hepatic failure patient. Disclosed is a method of measuring the blood coagulation time to detect lupus anticoagulant, the method including adding a buffer solution composition containing blood coagulation factors to a blood sample before measurement or at the time of measurement of the blood coagulation time, and measuring the blood coagulation time.

Abstract: Provided is the development of a convenient LA detection method in which even a sample derived from a patient who receives anticoagulant therapy of warfarin, heparin or the like, is not affected by the anticoagulant therapy, discrimination from the deficiency of blood coagulation factors is enabled, and healthy person's plasma is not used. The method for detecting lupus anticoagulant includes the following steps (A), (B) and (C): (A) a step of adding a buffer solution composition containing blood coagulation factors to each of a blood sample and a diluted sample of the blood sample before measurement or at the time of measurement of the blood coagulation time; (B) a step of measuring the blood coagulation times for the various samples of step (A); and (C) a step of comparing the blood coagulation times for the various samples obtained in step (B).

Abstract: Provided is a reagent, which prolongs a blood coagulation time sufficiently and enhances an optical change, thereby enabling a correct and high-sensitive blood coagulability test. The present invention provides a blood coagulation time prolonging agent, including, as an active ingredient, a guanidine compound represented by the following formula (1) or an acid addition salt thereof (in the formula, R1 represents a hydrogen atom, an amino group, or an alkyl group which may have a substituent).

Abstract: Provided herein are methods of determining a subject's need for anti-coagulation therapy. In exemplary embodiments, the method comprises measuring a level of derivatives of reactive oxygen metabolites (DROMs) in a biological sample obtained from the subject. In exemplary embodiments, the method comprises measuring a level of C-reactive protein (hs-CRP).

Abstract: The invention is directed towards methods and compositions for identifying the amount of hydrofluoric acid in a buffered oxide etching composition. In buffered oxide etching compositions it is very difficult to measure the amount of hydrofluoric acid because it has varying equilibriums and it is toxic so it hard to handle and sample. When used to manufacture microchips however, incorrect amounts of hydrofluoric acid will ruin those chips. The invention utilizes a unique method of spectrographically measuring the hydrofluoric acid when in contact with added chromogenic agents to obtain exact measurements that are accurate, immediate, and safe.

Abstract: Disclosed are antibodies that selectively bind to blood coagulation factor FVIII, and highly sensitive immunological assays comprising these antibodies. Preferred assays can detect FVIII at about 3500-fold below the normal physiological levels, and have a wide array of applications including accurate monitoring of FVIII concentration in pharmaceutical products for treatment of blood coagulation disorders, and determination of FVIII levels in plasma of human patients, including those with blood coagulation disorders such as hemophilia.

Abstract: Methods and devices for determining factor Xa inhibitors, in particular heparins and fractionated or low-molecular-weight heparins, as well as direct factor Xa inhibitors in blood samples. The methods include contacting a blood sample with a detection reagent that contains at least one thrombin substrate having a peptide residue that can be cleaved by thrombin and is amidically bound via the carboxyl end to an electrogenic substance, and with a known amount of factor X reagent and an activator reagent which induces the conversion of factor X into factor Xa. Subsequently, in a second step, the amount or activity of the electrogenic substance that is cleaved from the thrombin substrate by the factor Xa-mediated thrombin activation and/or the time course thereof is determined as the measurement signal using electrochemical methods.

Abstract: The present invention relates to a liquid flow device, in particular a capillary testing device provided as a chip, comprising a second pathway which intersects the first pathway at a downstream point of convergence, so that the two pathways share an outlet and when liquid in the second pathway reaches the point of convergence, liquid flow in the first pathway stops. Means for measuring the distance travelled by liquid in the first pathway are provided to determine the extent of liquid flow and to enable correlation with the amount of analyte in the liquid.

Abstract: The present invention provides a method for the real-time continuous monitoring of a change or density and/or viscosity within a test sample. Such methods can be used to determine the occurrence of a chemical reaction within a test sample where the same causes and increase or decrease in the density and/or viscosity of the sample due to, for example, a gelation, precipitation or coagulation occurring within the test sample. There is further provided a multi-resonator apparatus for use in measuring the density and/or viscosity of a test sample in which the multi-beam resonator is immersed.

Abstract: A multilayered optical sensing patch, for the measurement of conditions, such as pH, oxygen level, etc, within containers, is provided. The multilayered optical sensing patch of the present invention is comprised of a heat sealable polymer substrate layer, and a polymeric sensing membrane later attached thereto. The polymer sensing membrane layer is formed of a porous polymer support membrane, and an optical sensing composition (comprising a reactive indicator) covalently bonded thereto. The heat sealable polymer substrate layer is capable of being securely bonded to the inner layer of bioreactor bags, as well as the porous polymer support substrate layer. Further, the porous polymer support membrane layer provides a firm supporting structure for the polymeric sensing layer, thereby protecting the optical sensing composition disposed therein from degradation/damage.

Abstract: Compositions and methods for measuring coagulation parameters using very small volumes of blood are provided. Advantageously, the methods described herein can be performed from a single drop of blood (about 20 ?L) while generally leaving enough sample to perform other measurements, optionally in a multiplexed format. The methods and devices do not require a skilled operator and can be performed at the point of service, which can be an important feature for managing blood coagulation disorders and treatments thereof.

Abstract: The present application discloses the effects of endothelial cell-dependent activation of the protein C anticoagulant pathway via detection of thrombin generation correlated with the activation of the protein C anticoagulant pathway in plasma in the presence of endothelial cells using a fluorogenic substrate-based thrombin generation assay.

Abstract: The present invention relates to a routine in vitro method for determining platelet-associated analytes, for example VWF, factor XIII, fibrinogen or D-dimer, in a sample of platelet-rich plasma.

Abstract: An assay apparatus comprising: i) an assay cartridge (52, 53) comprising at least one well (57-62) and a pipette (50) positionable in at least one said well; ii) a holder arranged to received said cartridge; iii) drive means operable to position said pipette in selected wells of said cartridge; iv) a gas pressure applicator couplable to said pipette whereby to cause liquid flow through said membrane; and v) a radiation detector operable to detect radiation from a well of said cartridge of said cartridge or from said pipette.

Abstract: It is provided with a medical inquiry processing unit for acquiring the response to a medical inquiry presenting medical inquiry items to a person to be examined, a nutrient requirement amount calculating unit for calculating the nutrient requirement amount of the person to be examined from the response to the medical inquiry, a nutritional supplement suggesting unit for suggesting the blend of a nutritional supplement based on the nutrient requirement amount of the person to be examined and a nutritional supplement blending unit for blending nutrients to prepare the nutritional supplement based on the blend of the nutritional supplement.

Abstract: A method of detecting protein S abnormalities of the invention includes the steps of: measuring an activity value of total protein S and a protein content of total protein S in a specimen, and comparing between the protein activity of the total protein S and the protein content of total protein S, which are obtained from the measurements.

Abstract: Aspects of the invention include methods for identifying one or more NASP (non-anticoagulant sulfated polysaccharide) compositions that are suitable for treating a subject having a blood coagulation disorder. In practicing methods according to certain embodiments, NASP compositions are evaluated by determining the coagulation activity and chemical makeup of the NASP composition and the molecular structure of the NASP. Systems for practicing methods of the invention as well as compositions suitable for treating a subject having a blood coagulation disorder are also described.

Abstract: The invention relates to a procedure for biphasic preparation of liposomes, in the course of which technically simple and cheap mechanical mixing methods are used to commingle non-polar organic phase containing an individual mixture of natural and synthetic phospholipids and polar aqueous (buffer) phase not miscible with it, resulting in a liposome emulsion of a unique structure. Furthermore, the invention comprises embodiments of the procedure related to the in vitro diagnostic use of liposomes prepared in this way, when protein type active components are anchored to the surface of liposome membranes without application of any detergents and non-protein type active components are simply mixed with the liposome emulsion of a unique structure. In one of the possible embodiments of the procedure a Prothrombin Time (PT) reagent is prepared. Another possible embodiment of the procedure is the preparation of an activated partial thromboplastin time (APTT) reagent.

Abstract: A microfluidic-based flow assay and methods of manufacturing the same are provided. Specifically, the microfluidic flow assay includes a substrate surface comprising lipid coated particles and microfluidic channels through which a blood product can flow. The lipid coated particles comprise functional molecules that can induce or inhibit the coagulation cascade.

Abstract: Novel methods are described for measuring the rate of ADAMTS13-mediated cleavage of von Willebrand Factor (VWF) multimers. Through the use of the reagent, ristocetin, the method can advantageously be performed in the absence of an applied shear stress or added denaturing agent. Also described are methods for diagnosing ADAMTS13-associated disorders and methods for providing improved treatment of those disorders by evaluating the efficacy of the treatment using the methods as described.

Abstract: Methods and devices for analyzing fluid variables. The devices analyze fluid variables by measuring cessation of fluid flow through the medium or a change in flow rate due to an inherent property of the fluid variable, or due to a modification of the fluid variable as the fluid migrates through the medium; or by measuring relative rates of capillary flow down two or more arms of a common element of porous media in some alternatives, converging in which at least one of the arms has been modified by the addition of flow-modifying agents which affect the flow rate in response to the concentration of the analyte; or by detecting changes in the rate of the capillary flow of the sample fluid along a path through an element of porous media, or through multiple elements of porous media.

Abstract: In one aspect, a diagnostic test system includes a receptacle, optical detectors, and a logic circuit. Each of the optical detectors has a corresponding view in the receptacle and produces an electrical signal at a respective detector output in response to light from the corresponding view. The logic circuit includes logic inputs that are respectively coupled to the detector outputs and that produce an output logic signal corresponding to a logical combination of signals received at the logic inputs. In another aspect, respective detection signals are produced in response to light received from respective ones of multiple views of the test strip, and at least one output logic signal corresponding to a respective logical combination of the detection signals is generated.

Abstract: Aspects of the invention include methods for enhancing blood coagulation in a subject. In practicing methods according to certain embodiments, an amount of a non-anticoagulant sulfated polysaccharide (NASP) is administered to a subject to enhance blood coagulation in the subject. Also provided are methods for preparing a NASP composition having blood coagulation enhancing activity. Compositions and kits for practicing methods of the invention are also described.

Abstract: The invention generally relates to methods of measuring cleaved von Willebrand factor (VWF) fragments. More specifically, the invention relates to methods of measuring the ability of a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13) to cleave VWF in vivo. The invention also relates to methods of using various animal models which demonstrate ADAMTS13 activity similar to that of a human. The invention further relates to methods of measuring the cleavage products of rVWF in mammals, particularly in humans and in human plasma.

Abstract: The present invention relates to improved human FVIII variants having at least one substitution in the A2 and/or C2 domain. The present invention also relates to their uses in the treatment of hemophilia A, particularly in patients with inhibitors.

Abstract: The present invention is in the area of coagulation analysis and relates to a reagent which is based on recombinant or native tissue factor and phospholipids and which can be stabilized by adding a polyphenol.

Abstract: In some embodiments, a method is provided that includes (1) obtaining a plasma sample from a patient; (2) performing a coagulation assay on the plasma sample; (3) measuring a coagulation property of the plasma sample using a coagulation analyzer so as to generate measured data; (3) performing waveform analysis on the measured data so as to obtain turbidity characteristics; and (4) employing the waveform analysis to determine a coagulation status of the coagulation assay not provided by the coagulation analyzer. Numerous other embodiments are provided.

Abstract: The present invention provides, inter alia, transgenic non-human animals, such as transgenic mice. The animals contain in their genome a polynucleotide encoding a von Willebrand factor (VWF) polypeptide, which polypeptide forms a thrombus when in the presence of human platelets. Nucleic acid sequences and vectors for generating the transgenic non-human animals, and methods for using the transgenic non-human animals are provided as well. Chimeric VWF proteins are also provided.

Abstract: Substrates for thrombin and assays for determining the level of bioactive thrombin in a sample are disclosed, wherein the substrate has the general formula: A-X—Z-A? wherein one of either A or A? comprises a luminescent chelate and the other one of A or A? comprises a first partner of a binding pair, X forms a tri- or tetra-peptide, and Z comprises a linker.

Abstract: The present invention relates to a method for in vitro determining generation of a haemostatis factor such as thrombin and/or plasmin in a test sample using a chemiluminescent substrate specific for said blood clotting factor. Upon cleavage of the substrate, a luminescent signal is generated via aminoluceferin with the aid of a luciferase. The invention also relates to a kit for in vitro determining generation of a haemostasis factor in a test sample, and to novel chemiluminescent substrates for the determination of thrombin and plasmin.

Abstract: A micro vial assembly for performing microwave-assisted chemical reactions on small reaction mixture volumes is disclosed, wherein a reaction vessel (10) is sealed through a diaphragm (30) that is capped over an open end of the reaction vessel. The reaction vessel mouths in an end plane of a sleeve (20) surrounding the reaction vessel, the diaphragm being clamped for sealing the open end of the vessel by means of a cap (40) which is secured to the sleeve. The sleeve provides a radial extension of the reaction vessel in order to bridge the radial distance between a wall of the reaction vessel and other components in a system for performing microwave-assisted chemical reactions.

Abstract: The present invention relates to the use of a container, made of an inorganic additive containing plastic material, for reducing physical/chemical interaction between the container and an oil, fat and/or wax containing formulation contained therein.

Abstract: A method for determining the activity of a proteolytic coagulation factor in a sample may include (a) providing and incubating a reaction mixture comprising (i) the sample, (ii) an agent for direct or indirect activation of the proteolytic coagulation factor in the sample, (iii) a cleavable substrate which has at least one cleavage site for the activated coagulation factor, (iv) a solid phase to which the cleavable substrate is bound or becomes bound during the incubation; (b) separating off the solid phase; and (c) determining the amount of solid-phase-bound, uncleaved substrate, wherein the determined amount of solid-phase-bound, uncleaved substrate indicates a quantitative measure of the activity of the proteolytic coagulation factor in the sample.

Abstract: The invention relates to a novel polypeptide vitamin K epoxide recycling polypeptide (VKORC1) as a target for coumarin and its derivatives. The invention further provides methods for identifying coumarin derivatives, and also claims VKORC1 polypeptides and VKORC1 nucleic acids containing a sequence abnormality associated with a VKORC1 associated deficiency such as warfarin resistance, wherein the VKORC1 polypeptides and VKORC1 nucleic acids can be used for diagnosing these deficiencies. Moreover, the invention relates to methods for identifying coumarin derivatives usable in pest control of rodents.

Abstract: Objects of the present invention are to provide a DNA fragment encoding a limulus-derived pro-clotting enzyme, a virus harboring the DNA fragment, a cell harboring the virus, a method of producing the pro-clotting enzyme by use of the cell, and means for assaying an endotoxin or (1?3)-?-D-glucan employing the enzyme, wherein these elements are capable of producing an endotoxin or (1?3)-?-D-glucan assay reagent of satisfactory quality, steadily, at low cost, and on a large scale. In the present invention, for example, a DNA fragment encoding a protein having an amino acid sequence defined by SEQ ID NO: 4 is selected as a nucleic acid fragment encoding a limulus-derived pro-clotting enzyme, and the corresponding recombinant pro-clotting enzyme. Use of the enzyme can provide a high-sensitivity method and kit for detecting (1?3)-?-D-glucan and an endotoxin, utilizing a cascade reaction system in a horseshoe crab lysate.

Abstract: Methods, systems, and computer readable media for using actuated surface-attached posts for assessing biofluid rheology are disclosed. According to one aspect, a method for testing properties of a biofluid specimen includes placing the specimen onto a micropost array having a plurality of microposts extending outwards from a substrate, wherein each micropost includes a proximal end attached to the substrate and a distal end opposite the proximal end, and generating an actuation force in proximity to the micropost array to actuate the microposts, thereby compelling at least some of the microposts to exhibit motion. The method further includes measuring the motion of at least one of the microposts in response to the actuation force and determining a property of the specimen based on the measured motion of the at least one micropost.

Abstract: A method for preparing and isolating clotting serum. The method includes adding reagent and a clotting serum source to a reaction chamber of a clotting serum production device that includes an activator. The reagent, clotting serum source and activator are mixed by shaking the serum production device to bring the contents to a foam. The serum production device is placed in either a vacuum or at room temperature for a period of time, and the clotting serum is extracted from the reaction chamber.

Abstract: The present invention provides a blood coagulation promoter capable of exerting both excellent blood coagulation promoting ability and excellent blood clot detaching ability; and a blood collection tube accommodating the blood coagulation promoter. The present invention provides a blood coagulation promoter which includes a hardly water soluble polyoxyalkylene derivative; a partially saponificated polyvinyl alcohol; at least one substance selected from the group consisting of adsorptive inorganic substances and hydrolases capable of hydrolyzing a bond between Arg and an arbitrary amino acid reside and/or a bond between Lys and an arbitrary amino acid residue in a peptide chain; a polyvinylpyrrolidone; and preferably a water-soluble silicone oil, and a blood collection tube in which the blood coagulation promoter is accommodated in a tubular vessel having a bottom.

Abstract: Aspects of the invention include methods for enhancing blood coagulation in a subject. In practicing methods according to certain embodiments, an amount of a non-anticoagulant sulfated polysaccharide (NASP) is administered to a subject to enhance blood coagulation in the subject. Also provided are methods for preparing a NASP composition having blood coagulation enhancing activity. Compositions and kits for practicing methods of the invention are also described.

Abstract: The present invention relates to a method for detecting at least one direct factor Xa inhibitor in a sample other than citrate plasma, comprising the step of mixing a sample containing a factor Xa inhibitor with a composition containing factor Xa under conditions which allow the factor Xa to release a detectable substance from a chromogenic substrate.

Abstract: To provide a method for stabilizing unstable ?-thrombin in a thrombin-containing solution, a solution containing stabilized ?-thrombin, and a liquid fibrinogen assay reagent containing the solution. The method for stabilizing ?-thrombin in a thrombin-containing solution, which includes adjusting the percentage of ?-thrombin to 70% or more with respect to the amount of total thrombin in the thrombin-containing solution.

Abstract: A method of detecting an abnormal amount of a biomarker associated with biliary tract cancer in a subject can comprise: a) quantitating an amount of a fragment of prothrombin having an m/z value of about 4204 m/z in a biological sample from the subject; and b) comparing the quantitated value obtained in (a) with a threshold value.

Abstract: This invention relates to the use of clotting compositions containing prothrombin activators to produce high quality blood serum samples for pathology and other biological assays, and to containers containing such clotting compositions, and related methods of use.

Abstract: The present invention provides a reagent kit for detecting lupus anticoagulant which includes a first clotting time-measuring reagent containing manganese salt and a second clotting time-measuring reagent which contains manganese salt at a concentration lower than that of the first clotting time-measuring reagent or does not contain manganese salt and a method of determining the presence or absence of lupus anticoagulant using the kit.

Abstract: A method of preparing a fibrinogen rich composition is disclosed. One embodiment of the method involves contacting plasma with a hydrogel capable of increasing in mass upon contact with said plasma; maintaining said contact for a period of time sufficient for said hydrogel to absorb a substantial amount of at least the water from said plasma to produce a swollen hydrogel and a fibrinogen rich phase; and separating said fibrinogen rich phase from said swollen hydrogel; whereby said fibrinogen rich composition is produced.

Abstract: A sensor substrate includes a base and fibrous projections on an upper surface of the base. The fibrous projections have fixed ends fixed to the upper surface of the base and free ends opposite to the fixed ends, respectively. The fibrous projections provide a fixed end-side region including the fixed ends and a free end-side region including the free ends. The total surface area at which the fibrous projections in the fixed end-side region is larger than that in the free end-side region.

Abstract: A method of determining the course of enzyme activity that is variable in time, wherein the activity is probed by conversion of a substrate of the enzyme, includes, in a selected test set up and for a determined substrate of the enzyme, determining the velocity of signal production (dFdiag/dt) resulting from a time curve of the signal (Fdiao=f(A)) obtained from splitting the substrate when it is contacted with a determined initially fixed concentration of the enzyme (E) and providing a “diagnostic plot” with the values of (dFdiag/dt) against the signal (Fdiag) and determining whether the diagnostic plot is either a straight line or a parabola and in the same test conditions, for a given test sample, determining the signal production (Fexp) resulting from splitting the substrate by the enzyme generating in and/or disappearing from the sample and providing the time curve of signal Fexp=f(t); and transforming the obtained experimental value of the signal (Fexp) into an ideal value (Ftransf).

Abstract: The invention is composition comprising red blood cells in an aqueous suspension medium and one or more cis di-ahls; wherein more than 6 percent by weight of the hemoglobin in the red blood cells is S-Alc glycated hemoglobin. In another embodiment, the invention is a method comprising contacting red blood cells in a suspension medium having a concentration of S-Alc glycated hemoglobin of greater than 6 percent by weight of the hemoglobin in the red blood cells with a sufficient amount of one or more cis di-ahls such that the concentration of S-Alc glycated hemoglobin in resulting composition as measured by high pressure liquid chromatography, immunoassay and boronate affinity methods is consistent.

Abstract: For the separation, removal, isolation, purification, characterization, identification or quantification of fibrinogen or a protein that is a fibrinogen analogue, an affinity adsorbent is used that is a compound of formula II wherein one X is N and the other is N, C—Cl or C—CN; Y is O, S or NR2; 0 Z is O, S or NR3; R2 and R3 are each H, alkyl, hydroxyalkyl, benzyl or &bgr; -phenylethyl; n is 0 to 6; A is a support matrix, optionally linked to the triazine ring by a spacer; R7 is a group bearing a positive charge at neutral pH; W is an optional linker; V is an aromatic group; and R8 and R9 are each H, OH, alkyl, alkoxy, amino, NH2, acyloxy, acylamino, CO2H, sulphonic acid, carbamoyl, sulphamoyl, alkylsulphonyl or halogen or a cyclic structure such as a morpholino group, or R8 and R9 are linked to form such a cyclic structure.