Hemosense, Inc.

Other

Lifescan Corporation

Arvind N Jina

John L Smith

Loren Robert Larson

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. A method of determining the coagulation or lysis of a sample provides for measuring the impedance of the sample and generating an electrical signal which correlates to a curve of the coagulation/lysis assay.

Coagulation or lysis assays by measuring impedance

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 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. A reagent accelerates the coagulation of the sample and is positioned on the substrate and in contact with the sample. Optionally, an electroactive species may also be reacted with the sample. The device also includes means for measuring the viscosity of the sample and generating an electrical signal which correlates to a curve of the coagulation/lysis assay. Processing means positioned within the interior space is connected to the measuring means for receiving and converting the electrical signal into a digital output corresponding to the coagulation/lysis assay using assay calibration information stored therein. Display means visually displays the digital output external to the housing and is connected to the processing means. A method of determining the coagulation or lysis of a sample provides for accelerating the coagulation of the sample by chemically reacting the sample with at least one reagent on the substrate to produce a detectable change in the viscosity of the sample which correlates with the state of coagulation or lysis of the sample and measuring the viscosity of the sample and generating an electrical signal which correlates to a curve of the coagulation/lysis assay.

Method and device for measuring blood coagulation or lysis by viscosity changes

Coagulation or lysis assays using an electroactive species

Method and device for measuring blood coagulation or lysis by viscosity

For measuring an analyte in a liquid, a test strip and apparatus each have an asymmetry. The asymmetries combine to permit a test strip to be inserted into the apparatus when it is correctly aligned but prevent the test strip from being fully inserted if it is wrong side up. The apparatus also detects whether or not the strip has been fully inserted.

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Milpitas, CA, United States of America

Arvind N Jina