Abstract: An analytical test cartridge is provided. The analytical test cartridge can be used for medical analyses of liquid samples removed from a patient, for example blood. The analytical test cartridge is configured to provide for titration experiments. An example of a titration experiment that can be performed with the arrangement, is titration of heparin with protamine. Methods of assembly and use are provided.

Abstract: An apparatus for measuring blood clotting time includes a blood clot detection instrument and a cuvette for use with the blood clot detection instrument. The cuvette includes a blood sample receptor-inlet; a channel arrangement including at least one test channel for performing a blood clotting time measurement, a sampling channel having at least one surface portion that is hydrophilic, communicating with the blood sample receptor-inlet and the at least one test channel, and a waste channel having at least one surface portion that is hydrophilic, communicating with the sampling channel; and a vent opening communicating with the sampling channel. The sampling channel, the vent opening and the waste channel, coact to automatically draw a requisite volume of a blood sample deposited at the blood receptor-inlet, into the sampling channel.

Abstract: An apparatus for measuring blood clotting time includes a blood clot detection instrument and a cuvette for use with the blood clot detection instrument. The cuvette includes a blood sample receptor-inlet; a channel arrangement including at least one test channel for performing a blood clotting time measurement, a sampling channel having at least one surface portion that is hydrophilic, communicating with the blood sample receptor-inlet and the at least one test channel, and a waste channel having at least one surface portion that is hydrophilic, communicating with the sampling channel; and a vent opening communicating with the sampling channel. The sampling channel, the vent opening and the waste channel, coact to automatically draw a requisite volume of a blood sample deposited at the blood receptor-inlet, into the sampling channel.

Abstract: A system for operating at least first and second amperometric sensors includes a cartridge and a control device. The cartridge includes a first amperometric sensor and a second amperometric sensor. The first amperometric sensor is in fluid flow communication with a liquid sample inlet and includes a first electrode. The second amperometric sensor is in fluid flow communication with a liquid sample and includes a second electrode. The control device sets the first and second electrodes to about the same potential such that the first and second amperometric sensors can be operated simultaneously.

Abstract: A prothrombin time reagent for determination of low molecular weight heparin in fresh whole blood and in anti-coagulant treated blood is provided. The reagent is composed of recombinant animal tissue factor, and a mixture of synthetic phospholipids, which mixture includes a phosphatidylalcohol. A formulation buffer which includes a sensitivity adjuster is used in formulating the reagent. The recombinant animal tissue factor includes rabbit brain. The synthetic phospholipids of the mixture include palmitoyloleoylphosphatidylcholine (POPC), palmitoyloleoyl-phosphatidylserine (POPS), and a phosphatidylalcohol. The phosphatidyl alcohol includes dioleoylphosphatidylethanol, dioleoylphosphatidylmethanol, dioleoylphosphatidylpropanol, dioleoylphosphatidylbutanol, and dioleoylphosphatidylinositol. The sensitivity adjuster included in the formulation buffer is ?-Cyclodextrin. The formulated reagent is air-dried and remains stable for at least 3 weeks at 37° C.

Abstract: An apparatus for measuring blood clotting time includes a blood clot detection instrument and a cuvette for use with the blood clot detection instrument. The cuvette includes a blood sample receptor-inlet; a channel arrangement including at least one test channel for performing a blood clotting time measurement, a sampling channel having at least one surface portion that is hydrophilic, communicating with the blood sample receptor-inlet and the at least one test channel, and a waste channel having at least one surface portion that is hydrophilic, communicating with the sampling channel; and a vent opening communicating with the sampling channel. The sampling channel, the vent opening and the waste channel, coact to automatically draw a requisite volume of a blood sample deposited at the blood receptor-inlet, into the sampling channel.

Abstract: An analytical test cartridge is provided. The analytical test cartridge can be used for medical analyses of liquid samples removed from a patient, for example blood. The analytical test cartridge is configured to provide for titration experiments. An example of a titration experiment that can be performed with the arrangement, is titration of heparin with protamine. Methods of assembly and use are provided.

Abstract: A prothrombin time reagent for determination of low molecular weight heparin in fresh whole blood and in anti-coagulant treated blood is provided. The reagent is composed of recombinant animal tissue factor, and a mixture of synthetic phospholipids, which mixture includes a phosphatidylalcohol. A formulation buffer which includes a sensitivity adjuster is used in formulating the reagent. The recombinant animal tissue factor includes rabbit brain. The synthetic phospholipids of the mixture include palmitoyloleoylphosphatidylcholine (POPC), palmitoyloleoyl-phosphatidylserine (POPS), and a phosphatidylalcohol. The phosphatidyl alcohol includes dioleoylphosphatidylethanol, dioleoylphosphatidylmethanol, dioleoylphosphatidylpropanol, dioleoylphosphatidylbutanol, and dioleoylphosphatidylinositol. The sensitivity adjuster included in the formulation buffer is ?-Cyclodextrin. The formulated reagent is air-dried and remains stable for at least 3 weeks at 37° C.

Abstract: The apparatus and method for quickly measuring the hemoglobin content of a sample of blood uses a light reflectance measurement of the hemoglobin sample lysed in a membrane. The reflection is inversely proportional to hemoglobin concentration. A blood sample is loaded on to a nylon mesh and dispersed within a nylon membrane, both of which have been treated with a hemolyzing agent and surfactant, and air-dried. As soon as the blood sample contacts the reagent on the membrane, the red blood cells are lysed and the hemoglobin molecules are released and dispersed into the membrane by the action of surfactant. The hemoglobin apparatus emits light at 522 nm to the reflective surface of the membrane. The intensity of the reflected light is measured by a detector in less than 29 seconds. The intensity of the reflected light is converted to hemoglobin concentration, g/dL, or mmol/L by an interpolative comparison with stored reflection data indicative of known hemoglobin contents.

Abstract: A prothrombin time reagent for determination of low molecular weight heparin in frsh whole blood and in anti-coagulant treated blood is provided. The reagent is composed of recombinant animal tissue factor, and a mixture of synthetic phospholipids, which mixture includes a phosphatidylalcohol. A formulation buffer which includes a sensitivity adjuster is used in formulating the reagent. The recombinant animal tissue factor includes rabbit brain. The synthetic phospholipids of the mixture include palmitoyloleoylphosphatidylcholine (POPC), palmitoyloleoyl-phosphatidylserine (POPS), and a phosphatidylalcohol. The phosphatidyl alcohol includes dioleoylphosphatidylethanol, dioleoylphosphatidylmethanol, dioleoylphosphatidylpropanol, dioleoylphosphatidylbutanol, and dioleoylphosphatidylinositol. The sensitivity adjuster included in the formulation buffer is ?-Cyclodextrin. The formulated reagent is air-dried and remains stable for at least 3 weeks at 37° C.

Abstract: A portable system for analysis of blood or other bodily fluids removable from a patient is disclosed. The system includes a temperature sensing device and a temperature control circuit. The temperature sensing device senses a temperature of a surface of a sensor substrate of a cartridge having an electrical heater device without direct contact with the cartridge or direct exposure to the heating device. The temperature sensing device also generates an electrical signal related to the sensed temperature. The temperature control circuit controls an electrical input to the heater device based on the sensed temperature and a designed control temperature.

Abstract: An apparatus and method for measuring conductance are provided. The method and apparatus are particularly well adapted for use with a removable or replaceable cartridge in a blood analysis system. The apparatus generally involves providing a system having a first, unfiltered, conductance measurement cell and a second, filtered, conductance measurement cell. The preferred method involves relating values measured in the two cells for a whole blood sample and for a known calibrant together, to obtain a value, for example hematocrit, for the unknown whole blood sample.

Abstract: A reagent for determining prothrombin time (PT) including a recombinant protein tissue factor, a mixture of synthetic phospholipids, and a beta, gamma, or delta amino acid stabilizing compound is described for monitoring extrinsic blood coagulation activities. The source for the recombinant protein tissue factor is rabbit brain, and the phospholipids employed are palmitoyloleoylphosphatidylcholine (POPC) and palmitoyloleoylphosphatidylserine (POPS). The particular formulation buffer used to dilute the lipidated tissue factor provides a reagent that is optionally dried without lyophilization and remains stable for at least about 2 weeks at 37 C as either a liquid or a dried powder. A method for preparing the improved PT reagent and a method of using the reagent to analyze blood PT is also provided.

Abstract: An activated partial thromboplastin time (APTT) test is described which employs fresh, whole blood that has not been anticoagulated. The method employs a disposable cuvette having specific reagents placed therein. A sample of whole blood is introduced into the cuvette which is drawn into at least one conduit by a pneumatic pump. Initially, the calcium in the sample is chelated at a first reaction site in the conduit, and thereafter is moved through the conduit to a second reaction site where the sample is coagulated by an APTT reagent. After a predetermined incubation time, the sample is moved to a third reaction site where it is recalcified. Clotting time is measured from the time that the sample is recalcified to the time that clot formation is visibly detected.

Abstract: A device for making an incision in skin, having a housing with a slotted opening, and a triggering mechanism disposed within the housing for propelling a blade coupled thereto, through the slotted opening of the housing to make an incision in the skin. The triggering mechanism includes a finger engageable trigger located external to the housing for actuating the triggering mechanism and a spring anchoring assembly for automated machine arming the device after the triggering mechanism has been assembled into the housing.

Abstract: A method for preparation of an air-dried prothrombin time (PT) reagent which uses a recombinant protein and synthetic phospholipids is described. The source for the recombinant protein is rabbit brain, and the phospholipids employed are palmitoyloleoylphosphatidylcholine (POPC) and palmitoyloleoylphosphatidylserine (POPS). The particular formulation buffer used to dilute the lipidated tissue factor provides a reagent that is dried without lyophilization and remains stable for at least 2 weeks at 37 C. A method for preparing the improved PT reagent and a method of using the reagent to analyze blood PT is also provided.

Abstract: There is disclosed a system for detecting and timing the coagulation of blood from a liquid to a clot. The system comprises a vessel containing blood, a member of ferromagnetic material disposed within the vessel, means for providing relative motion between the vessel and the member, and a plurality of Hall effect sensors coupled through the walls of the vessel for sensing the strength of the magnetic flux lines and varying the electrical conductance upon change in the magnetic flux lines when the blood transforms itself and the member changes position relative to the plurality of sensors.

Abstract: An apparatus for implementing a skin incision has a torsion spring and a method of assembling the apparatus. The apparatus has a housing having a pair of housing sections, each of the housing section having a base and a plurality of walls. The housing defines an inner space and an exterior. A pivot arm is pivotally mounted to a base of a housing section. The pivot arm is guided between a first position and a second position by a follower in a cam carried by the housing. A torsion spring carried by a spring post is coupled to the arm to exert a spring force on the arm in the first position. The housing has an indentation with a raised level and a lower groove on the base for receiving a portion of the spring post. The opening through the base extends from the lower groove. The spring post has a cylindrical base portion adapted to be received by the indentation in the base and a detent portion.

Abstract: A low cost safety lancet device for creating a skin incision. The lancet contains a unitarily formed plastic body, thereby making the lancet device easy to manufacture at a low cost. The lancet device includes a blade beam having a cutting blade disposed at one end for generating an incision in a patient's skin. The blade beam is pivotally coupled within the device, engages a beam keeper arm in a first position and disengages the beam keeper arm in a second position. Upon activation of the device, the blade beam member resiliently deflects in a first direction as the beam keeper arm moves from the first position to the second position thereby causing a buildup of a biasing force in the beam member. When the blade beam disengages the beam keeper arm in the second position, the biasing force built up in the beam member causes the beam member to pivot, thereby accelerating the cutting blade through an aperture in the lancet device to incise the user's skin.

Abstract: A portable device that includes a plurality of test modules for analyzing preselected concentrations of various body fluids of a patient. The portable diagnostic device interfaces and utilizes disposable cartridges and reagent diagnostic test strips and other fluid sample diagnostic devices to determine the amounts of preselected parameters in a patient's blood through either electrochemical, electrical, optical, or mechanical analysis. The disposable fluid sample diagnostic devices may include sample chambers with inlet ports, electrical, physical, or chemical sensors, in situ calibration media, a plurality of electrical interface terminals, and temperature control elements. An electrical interface interconnects the various test modules with one or more corresponding integrated circuits which in turn are electrically coupled to a common interactive display, printer, power supply, and communication ports.