Abstract: The invention relates to a sterilization testing device comprised of a housing with a test chamber, an indicator placed therein, and with a supply for supplying the sterilization medium. According to the invention, the sterilization testing device consists of at least two housing parts that are matched to one another. A supply channel is made inside the housing part and serves to supply the sterilization medium. The supply channel is configured in such a manner that it forms the base body of the test chamber. The test chamber accommodates the indicator that indicates the completion of the sterilization process. Alternatively to this solution, the invention provides a variant, which is very effective with regard to manufacturing and which permits a quantitative statement regarding the sterilization. Webs are formed inside the housing in the at least partially meandering and/or spiral configuration of the supply channel.

Abstract: The invention relates to methods for determining the activity of a proteolytic coagulation factor of the blood coagulation cascade in a body fluid such as whole blood or plasma. A combination is provided in a reaction mixture. The combination comprises the sample and an activation agent for activating a proteolytic coagulation factor of the blood coagulation cascade or for activating the blood coagulation cascade. The effect of the activating on a reagent system comprising a cleavable moiety is evaluated. The cleavable moiety is or becomes bound to a chemiluminescent agent or a sensitizer agent or both. The chemiluminescent agent and the sensitizer agent are related in that, when in close proximity, energization of the sensitizer agent results in energization of the chemiluminescent agent. The effect of the activating is related to the activity of a proteolytic coagulation factor of the blood coagulation cascade wherein the effect is the extent of cleavage of the cleavable moiety.

Abstract: A method for measuring a generation of thrombin in a sample of whole blood as a function of time includes adding to a sample of whole blood a fluorogenic substrate and a thrombin activator to form an activated sample. A conversion product is permitted to form in the activated sample. Fluorescence is measured as a function of time from a fluorescent group that is released during the formation of the conversion product with the use of a fluorescence detector. The fluorescence detector operates in an extended range mode and has an increased sensitivity. Thrombin generation as a function of time can then be calculated from the measured fluorescence as a function of time.

Abstract: Provided is a method of selecting a stent for implantation in the circulatory system of a human being. The method comprises obtaining a blood sample from a patient who requires implantation of a stent and testing said blood sample to determine a platelet coagulability level. The determined platelet coagulability level of said blood sample is compared with a threshold level of blood platelet coagulability. A determined platelet coagulability level above said threshold level indicates that a risk of restenosis is relatively high. If the determined platelet coagulability level is below said threshold level, a bare metal stent is selected. If the determined platelet coagulability level is at or above said threshold level, a drug-eluting stent is selected.

Abstract: The invention relates to a method for determining the coagulation time of a sample fluid containing blood components by means of a resonator whose vibration parameters are measured and then used as a basis for determining the sample fluid viscosity change, which resonator has an at least partially adhesive surface contacting said sample fluid. The invention is characterized by preincubation of said surface with a preincubation fluid containing blood components, which preincubation fluid has a known way of interacting with the coagulation system, thus resulting in anchoring sites to be formed on the adhesive areas of said surface.

Abstract: The present invention is in the field of coagulation diagnostics and relates to a kit and method for preparing controls for use in test methods for determining thrombocyte function.

Abstract: Method and systems for of evaluating a mechanical property of a material by applying force to the material sufficient to physically displace a portion of the material, measuring displacement of the material, adaptively adjusting the force when the displacement measured is not within a predetermined range of displacement values, wherein the force is increased or decreased depending upon whether the measured displacement is below or above the predetermined range, respectively, and computing a mechanical property value resultant from the displacement of the material

Abstract: The invention provides an accurate, economical, automatable, high throughput method for the determination of the concentration of glycosaminoglycan anticoagulants, including low molecular weight heparin (LMWH) anticoagulants, in aqueous solutions. A method for cleaning a unit of manufacturing equipment used in the preparation of a LMWH to obtain an acceptable residual concentration of LMWH is further provided.

Abstract: The invention lies in the field of platelet function diagnostics and relates to devices and methods for determining the platelet function in a centrifugal analyzer.

Abstract: A method of measuring the combined activity of both and only coagulation factors II and X for the purpose of monitoring anticoagulant therapy, and kits for using the method. The method involves mixing of test plasma from a human to be tested with specially prepared plasma deficient in both and only coagulation factors II and X but with normal levels of other factors (referred to herein as Fiix-deficient plasma or Fiix plasma), in order to correct for any possible deficiency in other coagulation factors than FII and FX in the test sample. By adding a coagulation reagent and calcium, the generation of thrombin or fibrin can be measured. Kits of the invention comprise a coagulation reagent, calcium and specially made plasma that is deficient in both and only factor II and factor FX.

Abstract: An apparatus for detecting the presence of a microorganism in a sample includes a housing that includes a base fixed with a first DNA primer having a nucleotide sequence that is complementary to a DNA sequence of the microorganism of interest, a fibrinogen-splitting agent that is bound with a second DNA primer having a nucleotide sequence that is also complementary to a DNA sequence of the microorganism of interest, a rinsing unit configured to rinse the housing; and a fibrinogen adding unit configured to add fibrinogen to the housing so that the fibrinogen chemically reacts with the fibrinogen-splitting agent to produce a viscous substance, an ultrasonic emitter configured to emit ultrasonic signal to the housing, and an ultrasonic receiver configured to receive ultrasonic signal from the housing and transmit the received ultrasonic signal to an ultrasonic analyzer, wherein the ultrasonic analyzer determines whether the microorganism of interest exists.

Abstract: The invention features a method of identifying therapeutically relevant compositions which include a therapeutic agent and 2,2-Dilinoley 1-4-dimethylaminomethyl-[1,3]-dioxolane by screening for an effect of the agent on the liver of a model subject.

Abstract: The invention relates to an analytical test element for analysis of a liquid sample. The analytical test element may contain a channel which is suitable for capillary transport of the liquid sample and which is provided with an inlet opening for the liquid sample and with an air outlet opening. At least one test field may be arranged in the channel, spaced apart from the inlet opening. The test element comprises a sample application site which is closed with a seal and which is designed in such a way that, when the seal is opened, the sample application site and the inlet opening of the channel are simultaneously open to the outside environment of the test element. The test element can then receive the liquid sample inside the channel via the sample application site and inlet opening, for analysis in the test field. The invention also relates to a test element magazine and to a system for analysis of liquid samples with at least one test element.

Abstract: A method for evaluating an aerosolized test compound includes administering a test compound to a first population of individuals, via inhalation of an aerosol; administering a placebo comprising riboflavin 5?-phosphate to a second population of individuals, via inhalation of an aerosol; and comparing a biological marker for the individuals in the two populations. An aerosol comprising riboflavin 5?-phosphate (also known as flavin mononucleotide) may be used either as a placebo in clinical trials, or therapeutically.

Abstract: The invention is in the field of coagulation diagnostics and relates to a heparin-insensitive method for determining direct coagulation factor inhibitors in a sample, in particular direct thrombin and factor Xa inhibitors.

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: The invention is in the field of in-vitro diagnostics and relates to a photometric method for determining the blood-clotting factor XIII (factor XIII, F XIII) with the aid of NAD(P)H analogues, and a test kit for carrying out the method. The invention is in the field of in-vitro diagnostics and relates to a photometric method for determining the blood-clotting factor XIII (factor XIII, F XIII) with the aid of NAD(P)H analogues, and a test kit for carrying out the method.

Abstract: A liquid delivery apparatus is provided for depositing liquid materials onto prescribed areas. The apparatus includes a sensing and delivery pin and a photo sensor. The apparatus is sized to deliver a droplet of liquid material to the surface of a target area without coming into contact with the target surface. The apparatus is also capable of drawing geometric features, such as lines and grids of liquid material. The photo sensor measures the intensity of light during a processing cycle. Measured reflected-light intensity can be compared in real-time to a reference curve which is based on test process cycles representing the light intensity expected when the process proceeds in the preferred fashion to produce a normal spot having an expected droplet size. The light intensity measurements can also be fitted with a mathematical function such as an asymmetric double sigmoidal curve.

Abstract: Methods and devices for detecting thrombin generation are disclosed. Generally, the methods include combining a blood sample with a reagent composition so that reaction of the reagent composition and thrombin, if present in the sample, produces a detectable signal; and detecting the detectable signal. Generally, the devices include a fluid-tight material forming at least one passageway; a first chamber in fluid communication with at least one passageway; and at least one reagent disposed on a surface of or contained in either a chamber or a passageway. In some embodiments, the passageway is configured to permit capillary flow of fluid, while in other embodiments, fluid flow is accomplished through a pump functionally linked to at least one passageway. In some embodiments, the device may further include a signal detector positioned to detect a signal generated in a chamber or passageway. In certain embodiments, the device may further include a microprocessor functionally linked to the signal detector.

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: The present invention is related to peptides that can be used to reduce the immune response against FVIII or to induce tolerance to human FVIII in patients with, e.g., hemophilia A. Furthermore, the peptides can be used for immunodiagnostic purposes to detect FVIII-specific CD4+ T cells to monitor patients with hemophilia A during replacement therapy and during immune tolerance induction therapy.

Abstract: A reliable, fast and convenient method is provided to determine the change in concentration of enzyme in time in a biological medium in the presence of a signal substrate that corrects for substrate consumption, color-dependency of the signal and non-linearity between the concentration of the leaving group of the signal substrate and the amount of signal. The method comprises the measurement of a calibrator curve in a suitable medium, such as a buffer, to determine the characteristics of the measured curve. These characteristics will then allow to obtain this whole curve or a sufficient part thereof again through a mathematical procedure based on a single-point measurement in a sample of a medium in which the enzyme generation takes place. This has the great advantage that there is no need to measure the whole calibrator curve in each individual medium, since a single-point measurement is adequate.

Abstract: Methods for treating bleeding disorders using non-anticoagulant sulfated polysaccharides (NASPs) as procoagulants are disclosed. NASPs can be administered as single agents, or in combination with one another, or, with other medications (such as factors VII, VIII and IX) to promote hemostasis. In particular, the use of NASPs in treatment of bleeding disorders, including congenital coagulation disorders, acquired coagulation disorders, and trauma induced hemorrhagic conditions is described.

Abstract: The invention features methods and compositions for assessing risk, particularly immediate risk, of thrombotic events in patients with suspected or known vascular disease, and more particularly to assessing risk of thrombotic events in patients with coronary artery disease, particularly acute myocardial infarction, stroke, unstable angina, stable angina, or restenosis. Risk of thrombosis can be assessed by analysis of platelet reactivity and/or velocity of thrombin or fibrin formation, and determining whether the patient has a score associated above a risk threshold value. In other embodiments, risk of thrombosis in a patient is evaluated in the context of a profile generated from values obtained from one or more assays that evaluate various factors associated with thrombosis and/or atherosclerosis.

Abstract: The invention relates to methods and products for analyzing or processing a heparin sample. In one embodiment, the methods comprise contacting the sample with heparinase I, heparinase II and heparinase III, determining the amount of a signature component in the sample using a separation method, and making a determination about the sample based upon a comparison of the amount of the signature component in the sample to a reference database for a heparin.

Abstract: The present invention is directed to a lateral flow assay device for the monitoring and measuring of coagulation and method thereof. Ideally, the invention is directed to a lateral capillary flow device for the monitoring and/or measurement of coagulation in a liquid sample wherein the device comprises a non-porous substrate with a zone for receiving a sample and a defined flow path zone wherein a clotting agent is deposited on at least part of the defined flow path zone to accelerate the coagulation of the liquid sample, enable the formation of an evenly distributed clot along the defined flow path zone and to result in the change in flow rate or cessation of flow of the liquid sample along the defined flow path zone.

Abstract: Methods and kits for measuring levels of von Willebrand factor function in a sample without using a platelet aggregation agonist, such as ristocetin, comprising recombinant glycoprotein Ib? having at least two of a G233V, D235Y and M239V mutations and an agent to detect a complex between the recombinant glycoprotein Ib? and von Willebrand factor.

Abstract: The invention relates to a method for determining the total clotting activity of a blood or plasma sample, characterized in that a highly specific, reversible thrombin inhibitor is added to a blood or plasma sample in a defined amount, the clotting of the blood or plasma sample is induced and, after a defined period of time, the consumed amount of the added thrombin inhibitor is determined in a per se known manner, as well as to a kit for obtaining information about the state of coagulation of a blood sample.

Abstract: A method for characterizing the risk a subject will develop an autoimmune and/or alloimmune disease following tissue transplant includes obtaining a biological sample from the subject, wherein the subject has received the tissue transplant determining in the biological sample a level of at least one protein selected from Tables 1-4, comparing the measured level of the at least one protein to a control value, and characterizing a subject as at greater risk of developing an autoimmune disease and/or alloimmune disease if the level of at least one protein determined is increased or decreased compared to the control value.

Abstract: Provided herein is an animal having a persistent hypercoagulable state by implanting a cell, for example a tumor cell, in which the gene of human tissue factor is implanted to an experimental animal such as a mouse and then growing the cell, thereby persistently supplying human tissue factor to the experimental animal. This animal model is useful for research and development of therapeutic agents for diseases having a persistent hypercoagulable state. Also provided are preventive or therapeutic agents for diseases having a persistent hypercoagulable state, a hypercoagulable state resulting from infections, venous thrombosis, arterial thrombosis, and diseases resulting from the hypertrophy of vascular media, the agent comprising an antibody against human tissue factor (human TF) as an active ingredient.

Abstract: The invention concerns a method for assaying soluble fibrin in a sample, in which said sample is brought into the presence of a plasminogen activator with a high specificity for soluble fibrin (PA-Fb sp) and the soluble fibrin count in the sample is measured by measuring the difference between the count of fibrin degradation products obtained after degrading soluble fibrin with PA-Fb sp and the base count of fibrin degradation products determined before bringing the sample into the presence of PA-Fb sp.

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: In order to determine the intraoperative risk of bleeding preoperatively, both the content of fibrin monomer (FM) and the partial thromboplastin time (PTT) are determined in a blood or plasma sample.

Abstract: The present invention provides a method of forming a blood-clot microvalve by heating blood in a capillary tube of a microfluidic device. Also described are methods of modulating liquid flow in a capillary tube by forming and removing a blood-clot microvalve.

Abstract: Methods and kits to determine thrombin activity are provided. They have the great advantage that there is no need to measure the whole calibrator curve in each individual medium, since a single-point measurement is adequate.

Abstract: A microfluidics device to provide real time monitoring of platelet aggregation of a biological sample obtained from a subject. The device comprises a channel configured for passage of the biological sample, the channel comprising a protrusion configured to induce an upstream region of shear acceleration coupled to a downstream region of shear deceleration and defining there-between a region of peak rate of shear, the downstream region of shear deceleration defining a zone of platelet aggregation. The device further comprises a platelet detection means for detecting aggregation of platelets in the zone of aggregation as a result of passage of the biological sample through the channel. Methods to assess real time platelet aggregation of a biological sample obtained from a subject are further described.

Abstract: A method is provided for producing an analytical element comprising at least one test field for analyzing a liquid sample, wherein provision is made for a carrier on which a polymer fabric is arranged. At least one portion of the polymer fabric is irradiated with UV laser light and thereby hydrophobized.

Abstract: Method for diagnosing a cardiovascular disease in an individual comprising the steps of: providing a sample of an individual; determining the amount of cytokeratin-18 (CK-18) or fragments thereof and/or interleukin-1? precursor (IL-1? precursor) in the sample; comparing the amount of CK-18 or fragments thereof and/or IL-1? precursor in the sample to the amount of CK-18 or fragments thereof and/or IL-1? precursor present in a reference control of at least one individual not suffering from a cardiovascular disease; and diagnosing a cardiovascular disease if the amount of CK-18 or fragments thereof in the sample is increased in comparison to the amount of CK-18 or fragments thereof in the reference control and/or the amount of IL-1? precursor in the sample is decreased in comparison to the amount of IL-1? precursor in the reference control.

Abstract: Articles for testing a coagulation process in whole blood.

Abstract: Disclosed is a technique for obtaining a coagulogen raw material which can irreversibly inactivate the activity of a coagulase while retaining the function of coagulogen in an LAL reagent, a LAL reagent contaminated by an organism-derived biologically active substance or the like, and which can be used in a reagent. An LAL reagent is heated at a predetermined temperature for a predetermined period of time to deactivate only the activity of an enzyme contained in the LAL reagent irreversibly, wherein such an activity inherent in coagulogen that coagulogen can be hydrolyzed with the activated coagulase and converted to coagulin to induce gelatinization or an agglutination reaction is retained.

Abstract: Embodiments disclosed herein relate to a sensor comprising an on-board control system and a testing system. The on-board system can determine viability of the control system or the testing system. Also disclosed are methods of using such a sensor.

Abstract: The invention relates to a lyophilised form of dabigatran of formula (I) its use as a calibrator in the assays for the determination of pharmacodinamic effects of dabigatran etexilate as well as such assays per se. In the preparation of the lyophilised standards, dabigatran is dissolved in an aqueous acidic solution before freeze-drying.

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: Methods and kits for measuring levels of von Willebrand factor function in a sample without using a platelet aggregation agonist, such as ristocetin, comprising recombinant glycoprotein Ib? having at least two of a G233V, D235Y and M239V mutations and an agent to detect a complex between the recombinant glycoprotein Ib? and von Willebrand factor.

Abstract: An in-vitro non-invasive method for quantifying the lesions of the liver of the patient with metabolic steatosis addressing a diagnostic target, i.e. fibrosis, steatosis and/or steato-hepatitis (NASH) and measuring at least one marker selected from the group consisting of biomarkers and possibly clinical markers and possibly scores, the biomarkers being selected from the group consisting of glycemia, AST (aspartate aminotransferase), ALT (alanine aminotransferase), AST/ALT, AST.

Abstract: The invention relates to detecting coagulation and coagulation-related activities including agglutination and fibrinolysis of samples. More particularly the invention relates to methods and apparatus for monitoring coagulation and/or obtaining a coagulation time of a sample using NMR-based detectors.

Abstract: A hemostasis analyzer, such as the Thrombelastograph® (TEG®) hemostasis analyzer is utilized to measure continuously in real time, the hemostasis process from the initial fibrin formation, through platelet-fibrin interaction and lysis to generate blood hemostasis parameters. The measured blood hemostasis parameters permit preparation of an individualized assessment of ischemic event risk and individualized treatment of a subject.

Abstract: The clinical laboratory test apparatus includes: an analyzing unit for analyzing a specimen; a reception part for receiving specimen information before analysis of the specimen; a discrimination part for discriminating whether or not a specimen is suited for analysis based on the specimen information; and a control part for controlling the analyzing unit based on the discrimination result obtained by the discrimination part.

Abstract: The invention features methods and compositions for assessing risk, particularly immediate risk, of thrombotic events in patients with suspected or known vascular disease, and more particularly to assessing risk of thrombotic events in patients with coronary artery disease, particularly acute myocardial infarction, stroke, unstable angina, stable angina, or restenosis. Risk of thrombosis can be assessed by analysis of platelet reactivity and/or velocity of thrombin or fibrin formation, and determining whether the patient has a score associated above a risk threshold value. In other embodiments, risk of thrombosis in a patient is evaluated in the context of a profile generated from values obtained from one or more assays that evaluate various factors associated with thrombosis and/or atherosclerosis.

Abstract: A presence/absence test for Staphylococcus aureus (S. aureus) involves placing a first generation test sample in a solution that will clot in the presence of S. aureus. The solution contains components that will selectively grow S. aureus and also contains clotting factors that will react with S. aureus, if S. aureus is present in the sample, to clot the solution. Examples of specimen samples that can be tested include nasal swabs and lesion swabs, among others. The test can also be modified to detect the presence or absence of methicillin resistant S. Aureus (MRSA).