Coagulation or lysis assays using an electroactive species
First Claim
1. A device for performing a coagulation or lysis assay of a sample, the device comprising:
- a housing having an exterior surface and defining an interior area;
means for receiving the sample through the housing into the interior area;
a non-porous substrate positioned within the interior area for receiving the sample;
a reagent in the housing and in contact with the sample for accelerating the coagulation of the sample;
an electroactive species in contact with the sample;
means for measuring the viscosity of the sample and generating a signal which correlates to a curve of the coagulation or lysis assay; and
processing means being positioned within the interior area and connected to the measuring means for receiving and converting the signal into an output external to the housing corresponding to the coagulation or lysis assay using assay calibration information stored in the device.
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Accused Products
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 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.
61 Citations
37 Claims
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1. A device for performing a coagulation or lysis assay of a sample, the device comprising:
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a housing having an exterior surface and defining an interior area; means for receiving the sample through the housing into the interior area; a non-porous substrate positioned within the interior area for receiving the sample; a reagent in the housing and in contact with the sample for accelerating the coagulation of the sample; an electroactive species in contact with the sample; means for measuring the viscosity of the sample and generating a signal which correlates to a curve of the coagulation or lysis assay; and processing means being positioned within the interior area and connected to the measuring means for receiving and converting the signal into an output external to the housing corresponding to the coagulation or lysis assay using assay calibration information stored in the device. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A test card for a device determining a coagulation or lysis assay of a sample, the test card comprising:
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a non-porous substrate defining a surface for receiving the sample; an electroactive species in contact with the sample on the substrate; and means for measuring the viscosity of the sample and generating a signal which correlates to a curve of the coagulation or lysis assay. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. A method of determining the coagulation or lysis of a sample, the steps of the method comprising:
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contacting the sample with an electroactive species; accelerating coagulation of the sample by chemically reacting the sample with at least one reagent to produce a detectable change in the viscosity of the sample which correlates with a state of coagulation or lysis of the sample; measuring the viscosity of the sample and generating a signal which correlates to a curve of the coagulation or lysis; and processing the signal into an output corresponding to a coagulation or lysis assay using assay calibration information. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33, 34)
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- 35. In a coagulation or lysis assay of a sample performed by measuring the conductivity/resistivity of the sample, the improvement comprising using an electroactive species in contact with the sample during the assay.
Specification