Abstract: A method is disclosed of assaying circulating microparticles contained in a sample of whole blood or blood plasma from a patient to determine the patient's ability to generate thrombin or Factor Xa as blood-clotting factors, wherein the circulating microparticles are microparticles of platelets, endothelial cells, monocytes, and smooth muscle cells, which carry on their surfaces both negatively charged phospholipids as well as tissue factor. The results of the assay may be used to determine the ability of the patient to generate thrombin or Factor Xa as blood clotting factor based upon the circulating microparticles.

Abstract: A method for determining prothrombin time of a plasma or whole blood sample includes measuring prothrombin time for at least two different dilutions for a test sample to determine tmin or INRmin. The prothrombin time for at least two different dilutions for normal plasma is measured to determine tmin or INRmin values for normal plasma. Next, tPivka or INRPivka values are calculated by subtracting the value for normal plasma from the value for the test sample. The Pivka corrected prothrombin time for the test sample is calculated by subtracting tPivka or INRPivka from the prothrombin time measured for the test sample.

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: To increase the adhesion strength of coagulated blood on a surface by increasing the surface interaction of blood-inherent components like fibrin/fibrinogen and thrombocytes it is described to treat the surface by exposing it to ionized atoms or molecules. The surface treatment according to the invention is applied on plastic disposables used in blood diagnostics (e.g. hemostasis analysis) as well as medical implants like artery sealings. The improved blood clot adhesion results in higher diagnostic security due to reduced measurement failure (e.g., for patients with increased thrombocyte content) and in better significance of special tests (e.g., hyperfibrinolysis diagnosis).

Abstract: The present invention lies in the field of coagulation diagnosis and relates to a procedure for the standardization of coagulation tests, where calibrators are used to which a discrete standard coagulation time is assigned. The procedure is particularly suitable for the standardization of prothrombin time, activated partial thromboplastin time, thrombin time, ecarin time or batroxobin time.

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 evaluation of a patient hemostasis condition.

Abstract: A method of measuring blood clotting ability of a patient. A known volume of blood is dispensed on a reference disc of blotter paper, such that at least one reference blotch is formed on the reference disc. The surface area of the reference blotch formed on the reference disc, such that a relationship between the volume of blood and the surface area of the reference blotch can be obtained. An incision is made at the patient. A piece of blotter paper to the incision is applied to the incision to collect blood flowing therefrom, such that at least one blotch is formed on the piece of blotter paper. The surface area of the blotch formed on the piece of blotter paper is measured. The volume of the blood absorbed blood by the blotter paper is calculated according to the relationship between the blood volume and the surface area of the blotch.

Abstract: A whole-blood-based substitute composition that is useful in coagulation assays as a standard, reference, control, calibrator, linearity verifier, or training material is prepared by combining a red blood cell lysate that is free of plasma, leukocytes, and platelets with a platelet-free plasma of human origin and an antimicrobial agent.

Abstract: A method of selecting a stent for implantation in the circulatory system of a human being includes the steps of determining a threshold level of platelet hyper-coaguability (PHC). One marker of PHC is platelet-fibrin mediated clot strength (MA) of blood. MA above a threshold demonstrates a risk of restenosis that is relatively high. In practicing the method, a sample of blood is obtained from a patient who requires implantation of a stent, the blood sample is tested for its platelet-fibrin mediated clot strength, the clot strength of the blood sample is compared with the threshold level; if the blood sample has a clot strength below the threshold level, selecting a bare metal stent, and if the blood sample has a clot strength at or above the threshold level, selecting a drug-eluting stent. The method includes, in a preferred embodiment, use of a viscoelastic monitor to perform the testing step. Other markers of PHC may also be employed such as measurement of thrombin generation and/or platelet reactivity.

Abstract: The present subject matter concerns methods for determining platelet medicated clot formation. Specifically, the subject matter provides a method for determining platelet-medicated clot formation in a blood sample. The method may include obtaining sample of blood, and optionally mixing same with an anti-coagulant in an amount effective to inhibit clot formation. Additionally, the method may include mixing the sample in a vessel with a minute amount of an initiator to obtain a mixed sample, the amount being effective to initiate coagulation. The method may further include rotating the mixed sample inside the vessel, whereby shear forces are developed at the surface of the vessel in a manner and for a time sufficient to allow adhesion of platelets at the surface of the vessel. In addition, the method may include determining clot formation at the surface of the adherent platelets.

Abstract: A method of determining a prothrombin time is disclosed. A mediator is applied to a stratum corneum. The stratum corneum is penetrated to allow the mediator to enter a region containing interstitial fluid and interact with at least one capillary, causing blood and/or blood components to leak from the at least one capillary into the region containing interstitial fluid. A characteristic affected by the blood and/or blood components is measured in the region containing interstitial fluid which correlates to the prothrombin time. A system for measuring prothrombin time is also disclosed. The system has a mediator, one or more microneedles, and a processor directly or indirectly coupled to the one or more microneedles and configured to determine a coagulation change in blood or blood components in a region around the one or more microneedles after the one or more microneedles penetrate a stratum corneum.

Abstract: Onions (Allium Cepa and its close relatives, as opposed to Allium Sativum) contain potent coagulation modulators, as well as platelet inhibitors. Clinical, in vivo and in vitro testing confirms that the efficacy of commonly consumed quantities of onions in terms of the efficacy of its impact on coagulation and platelet function rivals and in many respects exceeds the potency of any other modalities available today. Additionally, onion compounds have unique effects as described later in this application.

Abstract: System to measure blood coagulation related parameters comprising one first channel (6) adapted to contain a blood sample; said system containing, at least partially, an expandable material which is able to increase its volume when activated by an exciting source; said system furthermore comprising several excitable regions distributed close to said first channel (6), in such a way that, when one of said excitable region is activated, said expandable material increases to such an extend that the channel cross section is reduced to a location situated at or near to said excitable region.

Abstract: A system and method for determining a coagulation time, e.g., thrombin time, PT, aPTT, and ACT, of a blood sample deposited in a test cartridge is disclosed. The test cartridge includes a blood receptacle that is open to the atmosphere into which a blood sample is to be deposited, a vacuum port that is open to atmosphere, and a spiral capillary within the test cartridge having a capillary length and cross-section area, a first capillary end of the spiral capillary open to the blood receptacle and a second capillary end of the spiral capillary open to the vacuum port, whereby the spiral capillary is closed to atmosphere. When a blood sample is deposited in the blood receptacle, a vacuum is drawn through the vacuum port and the blood is drawn through the spiral capillary until coagulation occurs. A pressure change is detected, and the coagulation time is measured.

Abstract: A system and method for determining a coagulation time, e.g., TT, PT, aPTT, and ACT, of a test sample deposited in a test cartridge is disclosed. A cartridge housing having upper and lower major sides and a minor sidewall encloses a test chamber having a test chamber pivot element and is provided with a cartridge port for introducing a test sample into the test chamber. Ferromagnetic agitator vane leaflets extend from an agitator pivot element supported by the test chamber pivot element intermediate the upper and lower major sides for rotational motion. The agitator vane leaflets can be swept, in response to an external magnetic field, through the test sample in the absence of coagulation. A timer is started when the agitator movement is commenced whereupon the agitator moves freely. Resistance to agitator movement due to coagulation is detected, and the coagulation time is measured.

Abstract: Provided is a method of distinguishing among Stanford type A acute aortic dissection, Stanford type B acute aortic dissection, and acute myocardial infarction, which are mutually similar in terms of clinical symptoms, and a kit for the distinguishment. Specifically, provided is a method of distinguishing among Stanford type A acute aortic dissection, Stanford type B acute aortic dissection, and acute myocardial infarction, which comprises detecting both D-dimer and H-FABP in blood separated from a person suspected of having acute aortic dissection and suspected of having acute myocardial infarction, and establishing the diagnosis on the basis of the concentrations detected, and a kit for the distinguishment.

Abstract: A system and method for determining a coagulation time, e.g., TT, PT, aPTT, and ACT, of a blood test sample deposited in a test cartridge is disclosed. A cartridge housing having upper and lower major sides and a minor sidewall encloses a test chamber having a test chamber pivot element and is provided with a cartridge port for introducing a test sample into the test chamber,. Ferromagnetic agitator vane leaflets extend from an agitator pivot element supported by the test chamber pivot element intermediate the upper and lower major sides for rotational motion. The agitator vane leaflets can be swept, in response to an external magnetic field, through the test sample in the absence of coagulation. A timer is started when the agitator movement is commenced whereupon the agitator moves freely. Resistance to agitator movement due to coagulation is detected, and the coagulation time is measured.

Abstract: A method of measuring blood clotting ability of a patient. A known volume of blood is dispensed on a reference disc of blotter paper, such that at least one reference blotch is formed on the reference disc. The surface area of the reference blotch formed on the reference disc, such that a relationship between the volume of blood and the surface area of the reference blotch can be obtained. An incision is made at the patient. A piece of blotter paper to the incision is applied to the incision to collect blood flowing therefrom, such that at least one blotch is formed on the piece of blotter paper. The surface area of the blotch formed on the piece of blotter paper is measured. The volume of the blood absorbed blood by the blotter paper is calculated according to the relationship between the blood volume and the surface area of the blotch.

Abstract: A method of measuring blood clotting ability of a patient. A known volume of blood is dispensed on a reference disc of blotter paper, such that at least one reference blotch is formed on the reference disc. The surface area of the reference blotch formed on the reference disc, such that a relationship between the volume of blood and the surface area of the reference blotch can be obtained. An incision is made at the patient. A piece of blotter paper to the incision is applied to the incision to collect blood flowing therefrom, such that at least one blotch is formed on the piece of blotter paper. The surface area of the blotch formed on the piece of blotter paper is measured. The volume of the blood absorbed blood by the blotter paper is calculated according to the relationship between the blood volume and the surface area of the blotch.

Abstract: The present invention refers to a novel device for measuring coagulation time and platelet activity wherein the patient can measure his or her coagulation time and platelet activity without the aid of medical professionals due to the fact that this device is fully autonomous. A blood sample (14) is deposited in the dish (3) and reacted with a reactant (16). The display (9) then shows the coagulation time and platelet activity of the patient.

Abstract: A blood sample sensing apparatus includes a moving device which moves a sample container containing a blood sample to a sensing position, a turning mechanism which is connected to the moving device and tilts the sample container such that a bottom of the sample container is directed upward when the sample container is located in the sensing position, and an optical sensor which is located in the sensing position and determines whether the blood sample in the sample container is coagulated.

Abstract: A microsystem for determining clotting time of blood and a low-cost, single-use device for use therein are provided wherein the device has no moving parts or expensive optical sensors or magnets. The device includes a microfluidic channel and a microsensor at least partially in fluid communication with the channel. By analyzing changes in the sensor as a drop of blood flows down the microfluidic channel, the time at which the blood clots can be determined.

Abstract: An analyzing method of a blood coagulation reaction by detecting an optical change of a blood sample with an elapse of time, the method includes: setting at least one checkpoint or check region between a starting point of the blood coagulation reaction and the endpoint thereof; and monitoring a reaction state of the blood coagulation reaction at the checkpoint or in the check region to detect an abnormality of the blood coagulation reaction.

Abstract: Methods and apparatus are disclosed for determining a new anticoagulant therapy factor (nATF) for monitoring oral anticoagulant therapy to help prevent excessive bleeding or deleterious blood clots that might otherwise occur before, during or after surgery. In one embodiment, the new anticoagulant therapy factor is based upon a determination of a new fibrinogen transformation rate (nFTR) which, in turn, is dependent on a maximum acceleration point (MAP) for fibrinogen (FBG) conversion. The new anticoagulant therapy factor quantity is also based upon the time to maximum acceleration from the time of reagent injection (TX) into a plasma sample, but does not require the difficulty of obtaining prior art International Normalized Ratio (INR) and International Sensitivity Index (ISI) parameters. Other embodiments provide methods and apparatus for determining an anticoagulant therapy factor without requiring use of a mean normal prothrombin time determination or ISI.

Abstract: A method and kit for testing a multi-channel blood-testing cartridge. In particular, blood-testing cartridges are tested with plasma samples with clotting times measured to indicate whether a batch of cartridges is suitable for testing the blood of a patient.

Abstract: Methods for predicting the presence of haemostatic dysfunction in a patient from a time-dependent measurement profile include performing a time-dependent measurement on an unknown sample and measuring a respective property over time so as to derive a time-dependent measurement profile. The slope of the time-dependent measurement profile is computed prior to clot formation. A biphasic waveform is detected in the time-dependent measurement profile based on the computed slope. The presence of haemostatic dysfunction in the patient is predicted based on the detected biphasic waveform.

Abstract: A sample retention apparatus for use in a device for measuring hemostasis. The device for measuring hemostasis may include a sample articulation apparatus including a guide shaft coupled for articulating motion to a drive motor, a sample carrier secured to and axially moveable along the guide shaft between a sample ready position, a sample testing position and a sample ejection position. The sample carrier therefore articulates in unison with the articulating motion of the guide shaft. A measuring apparatus may include a sensing column. The sample retention apparatus may include a sample cup defining a volume within which a sample may be disposed. The sample cup may be adapted to be operably positioned within an aperture formed within the sample carrier. The sample testing apparatus may also include a sample pin that is engageable with the sensing column. The sample pin may include a tip portion for extending into the sample cup.

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 evaluation of platelet inhibition therapy.

Abstract: Methods and devices for electrochemically detecting a change in the viscosity of a fluid are provided. In the subject methods, a fluid sample (e.g., a whole blood sample) is introduced into an electrochemical test strip's electrochemical cell using a micro-needle integrated into one of oppositely spaced apart working and reference electrodes. An electric potential is applied to the electrochemical cell to first achieve a steady state cell current. A decrease in the steady state cell current is then detected and related to a change in viscosity of the sample. In many embodiments, the sample is blood and the change in viscosity is related to the onset of coagulation in the blood sample, and often the PT of the blood sample. An electrochemical test strip includes an electrochemical cell and an integrated micro-needle. The electrochemical cell includes oppositely spaced apart working and reference electrodes and a reagent mixture (e.g., a redox couple and a coagulation catalyzing agent).

Abstract: The invention includes an in vitro bleeding time device having an opening through a sheet of material across an outlet. At least a portion the sheet of material contains a coating which includes collagen type I, fibrinogen, fibronectin, and von Willebrand factor. The invention includes a blood coagulation analysis system which has a device with an internal chamber for receiving a blood sample through an inlet. A sheet of material spans a flowpath through a single device outlet. A controller regulates pressure and or flow rate within the device. The invention includes a method for analyzing blood coagulation. Blood provided into a device chamber flows out through an opening through a sheet of material which spans the device outlet. A controller is utilized to control pressure and/or flow rate within the device by controlling the flow rate into the device during formation of a clot blockage of the opening.

Abstract: A patient apparatus is configured to receive and analyze information regarding patient compliance with anticoagulation medication and self-test coagulation regimens related to anticoagulation therapy. In addition, a patient apparatus is configured to receive data from a patient, including physiological data, pathophysiological data, biological data, psychological data, neuropsychological data, and/or behavioral data. Utilizing the received patient data, a patient apparatus can modify a warfarin regimen using an algorithm contained within the apparatus. The apparatus can communicate the modified warfarin regimen to the patient and to third parties, such as remotely located healthcare providers. In addition, the apparatus can prompt a patient when to perform a self-test and can prompt a patient to seek immediate medical attention, or to directly contact medical help, when so warranted.

Abstract: To investigate the flowability of a physiological fluid sample, an uptake passage (12) for the fluid sample (16), an actuator device (18) for the cyclic change in orientation of measuring particles (14) in the fluid sample (16), and a detector device (20, 22) for the preferably optical detection of the change in orientation of the measuring particles (14) are provided. In order to make reliable measurements possible with minimal instrument expense, it is proposed that the actuator device is formed by a pump unit (18) to produce a flow of the fluid sample (16) that travels back and forth along the uptake passage (12) and indicates the change in orientation of the measuring particles (14).

Abstract: A method and apparatus for monitoring hemostasis in a connection with a recipient of an artificial surface device provide a multi-phase monitoring protocol. In a first, pre- and intra-operative phase, hemostasis of the recipient is monitored relative to preventing clot formation to achieve artificial surface patency. In a second, post operative phase hemostasis of the recipient is monitored relative to bringing about clot formation to achieve vascular recovery. In a third, stabilizing intensive care phase hemostasis of the recipient is monitored relative to balancing hemostasis toward an anti-coagulation bias. In a fourth, maintenance phase hemostasis is monitored relative to maintaining balanced hemostasis.

Abstract: In connection with a fluidic medical diagnostic device that permits measurement of the coagulation time of blood, software, methods and associated devices for quality control are provided. The fluidic device preferably includes a test strip with one end having a sample port for introducing a sample and a bladder at the other end for drawing the sample to a measurement area. A channel carries sample from the sample port to an assay measurement area and first and second control measurement areas. Preferably a stop junction, between the measurement areas and bladder, halts the sample flow for measurement. If results from measurements taken for each control fall within a predetermined zone or defined limits, the assay measurement is qualified. If not, an error is registered and the test strip is counted as unfit.

Abstract: In connection with a fluidic medical diagnostic device that permits measurement of the coagulation time of blood, software, methods and associated devices for quality control are provided. The fluidic device preferably includes a test strip with one end having a sample port for introducing a sample and a bladder at the other end for drawing the sample to a measurement area. A channel carries sample from the sample port to an assay measurement area and first and second control measurement areas. Preferably a stop junction, between the measurement areas and bladder, halts the sample flow for measurement. If results from measurements taken for each control fall within a predetermined zone or defined limits, the assay measurement is qualified. If not, an error is registered and the test strip is counted as unfit.

Abstract: A method and apparatus for monitoring hemostasis in a connection with a recipient of an artificial surface device provide a multi-phase monitoring protocol. In a first, pre- and intra-operative phase, hemostasis of the recipient is monitored relative to preventing clot formation to achieve artificial surface patency. In a second, post operative phase hemostasis of the recipient is monitored relative to bringing about clot formation to achieve vascular recovery. In a third, stabilizing intensive care phase hemostasis of the recipient is monitored relative to balancing hemostasis toward an anti-coagulation bias. In a fourth, maintenance phase hemostasis is monitored relative to maintaining balanced hemostasis.

Abstract: A system and method for diagnosing hemostasis utilizing a communication network. A blood hemostasis analyzer tests a blood sample and provides a parameter indicative of hemostasis. The blood hemostasis analyzer is communicatively coupled via the communication network to an analysis tool. The analysis tool includes an algorithm operable on the parameter to provide a result. The diagnostic result may indicate normal hemostasis, a coagulopathy or other condition, and may provide a recommended course of treatment.

Abstract: A procedure for hemostasis and blood management, particularly for cardiovascular procedures, provides: sampling instructions, i.e., when to draw blood samples and how to pre-treat the blood samples, a decision tree to assist the interpretation of hemostasis analysis results allowing for the identification of various coagulopathies, and treatment suggestions related to the hemostasis analysis results. The analysis, interpretation and identification may be conducted by a suitably programmed computer.

Abstract: The invention relates to a method for measuring the aggregation or agglutination of platelets, where a reaction mixture is mixed in a first reaction phase, and is mixed less vigorously or not at all in a second reaction phase following the first, and the measurement is preferably carried out in the second reaction phase.

Abstract: The invention includes an in vitro bleeding time device having an opening through a sheet of material across an outlet. At least a portion the sheet of material contains a coating which includes collagen type I, fibrinogen, fibronectin, and von Willebrand factor. The invention includes a blood coagulation analysis system which has a device with an internal chamber for receiving a blood sample through an inlet. A sheet of material spans a flowpath through a single device outlet. A controller regulates pressure and or flow rate within the device. The invention includes a method for analyzing blood coagulation. Blood provided into a device chamber flows out through an opening through a sheet of material which spans the device outlet. A controller is utilized to control pressure and/or flow rate within the device by controlling the flow rate into the device during formation of a clot blockage of the opening.

Abstract: A self-contained analyzer quantitatively detects a clotting event in a biological fluid. The device includes a base having an open reservoir for receiving the biological fluid. A carrier for a dried activator reagent is located in or adjacent to the open reservoir. The biological fluid reconstitutes the dried reagent and starts the clotting process. During the clotting process the fluid travels through a capillary flow channel lined with a precision woven fabric. When clotting is completed, the woven fabric stops the flow of the fluid. A colored bar formed by the fluid flowing through the capillary channel indicates the length of time required for clotting of the sample.

Abstract: Compositions, methods, devices and kits for use in the calibration of coagulation tests. The control compositions include particles capable of aggregating in plasma and calcium ions which, when mixed with plasma, simulate the behavior of whole blood in a coagulation test. The methods include providing calcium ions and particles capable of aggregating in plasma, combining the particles and calcium ions with plasma to form a control composition, and applying the control composition to a coagulation test. The devices include a container having at least two compartments, with one compartment including particles that promote or induce aggregation of a protein or proteins in plasma, and the other compartment includes a solution of calcium ions. The kits include a control composition including a container of calcium ions, a container of particles capable of inducing aggregation of proteins in plasma, and one or more coagulation test devices.

Abstract: A medical system for monitoring a measured value of a patient characterizing blood clotting and/or for setting a medication that influences blood clotting for a patient in a home environment, has a device for acquiring measured values of the patient relating to blood clotting, a device for transmitting the measured values to a system central, a device for interrogating the measured values, and a reception device at a monitoring person. The system central has a memory for the measured values, an analysis device for the measured values by comparing the measured values to stored reference values, an alarm generator which generates an alarm signal upon a recognition of predetermined conditions, and a routing device for forwarding the alarm signal to a reception device of a person to be alerted in a process chain.

Abstract: The invention relates to a method for determining properties of blood, such as the blood viscosity of a person, comprising of generating in vivo for a determined time, by means of an electrical alternating current of a determined frequency, a measurement signal of the impedance of the blood between at least two points centrally in a blood volume, wherein the measurement signal is processed such that variations therein with a frequency in the order of magnitude of the heart frequency are substantially absent therefrom, and comparing the processed measurement signal with predetermined relations between impedance and the properties of the blood, such as the viscosity.

Abstract: The invention is a method, reagent and test cartridge for the determination of the clotting time of a blood sample by means of a reagent containing tissue factor and a sulfatide. In an alternative embodiment, the reagent may contain tissue factor and at least one of the group consisting of a phosphatide and a sulfatide. This invention is preferably used to monitor the effectiveness of heparin therapy in patients that have been administered low to moderate heparin doses to achieve blood heparin levels from 0 to about 3 U/mL, and may also be used for determining clotting time at higher heparin levels of up to about 6 U/mL.

Abstract: The present invention is a container assembly that includes a coating composition on an interior surface of the container assembly and more particularly a coating composition for rapid clotting of a blood sample within a blood collection tube. The coating composition includes an intrinsic coagulation activator and an extrinsic coagulation activator for activating intrinsic and extrinsic pathways for promoting the rapid clotting of the blood sample. In addition, the present invention includes a barrier package for enclosing the container assembly.

Abstract: In connection with a fluidic medical diagnostic device that permits measurement of the coagulation time of blood, software, methods and associated devices for quality control are disclosed. The fluidic device preferably includes a test strip with one end having a sample port for introducing a sample and a bladder at the other end for drawing the sample to a measurement area. A channel carries sample from the sample port to an assay measurement area and first and second control measurement areas. Preferably, a stop junction, between the measurement areas and bladder, halts the sample flow for measurement. If results from measurements taken for each control fall within a predetermined zone or defined limits, the assay measurement is qualified. If not, an error is registered and the test strip is counted as unfit.

Abstract: A method and device for testing a sample of fresh whole blood. In particular the present invention provides a method and device for testing a sample of fresh whole blood to determine whether a patient would benefit from the administration of a blood factor (such as AT III.

Abstract: In connection with a fluidic medical diagnostic device that permits measurement of the coagulation time of blood, software, methods and associated devices for quality control are disclosed. The fluidic device preferably includes a test strip with one end having a sample port for introducing a sample and a bladder at the other end for drawing the sample to a measurement area. A channel carries sample from the sample port to an assay measurement area and first and second control measurement areas. Preferably a stop junction, between the measurement areas and bladder, halts the sample flow for measurement. If results from measurements taken for each control fall within a predetermined zone or defined limits, the assay measurement is qualified. If not, an error is registered and the test strip is counted as unfit.

Abstract: The present invention provides a single-use electronic device and test card for use therein which performs a coagulation or lysis assay of a blood or plasma sample. The device includes a housing having an exterior surface and defining an interior area and means for receiving the sample through the housing into the interior space. A non-porous substrate is positioned within the interior space for receiving the sample thereon. Preferably, a reagent accelerates the coagulation of the sample and is positioned on the substrate and in contact with the sample. An electroactive species is added to the sample. The device also measures the impedance of the sample and generating an electrical signal which correlates to a curve of the coagulation/lysis assay. Optionally, the electrical signal is received and converted into a digital output corresponding to the coagulation/lysis assay using assay calibration information stored therein. The digital output can be displayed external to the housing.