Microfluidic chip-based, universal coagulation assay
First Claim
1. A microassay device for measuring clotting in a blood or plasma sample from an individual, the device comprisinga test microchip, the test microchip comprisingAn inlet for the blood or plasma sample, the inlet communicating with one or more microchannels having a length between tens of microns and millimeters, each microchannel comprising one or more test chambers, each microchannel having a defined volume between nanoliters and milliliters,the one or more microchannels each comprising at least one anionically charged surface which activates clotting of the blood or plasma sample upon entry of the blood or plasma sample into the one or more microchannels or test chamber, wherein the anionically charged surface does not include chemical agents activating clotting andthe test chamber is formed of a material which allows changes in viscosity, impedance, acoustic properties, or optical properties in the blood or plasma in the test chamber,wherein the test microchip is inserted into a reader, the reader comprisinga detector which determines changes in viscosity, impedance, acoustic properties, or optical properties in the blood or plasma sample in the test chamber to measure clotting time, anda temperature control regulating the temperature of the test chamber,wherein the detector is configured to output the measured clotting time determined from the time of activation of the sample to the time of the change in viscosity, impedance, acoustic properties, or optical properties in the test chamber indicative of clotting.
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Accused Products
Abstract
A microfluidic, chip-based assay device has been developed for measuring physical properties of an analyte (particularly, whole blood or whole blood derivatives). The technologies can be applied to measure clotting times of whole blood or blood derivatives, determine the effects of anticoagulant drugs on the kinetics of clotting/coagulation, as well as evaluate the effect of anticoagulant reversal agents. These technologies can additionally be used to optimize the dosage of anticoagulation drugs and/or their reversal agents. The assay is independent of the presence of anticoagulant; clotting is activated by exposure of the blood sample in the device to a glass (or other negatively charged material such as oxidized silicon) surface, which activates the intrinsic pathway and can be further hastened by the application of shear flow across the activating materials surface. The absence of chemical activating agents and highly controlled and reproducible micro-environment yields a point of care universal clotting assay.
41 Citations
16 Claims
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1. A microassay device for measuring clotting in a blood or plasma sample from an individual, the device comprising
a test microchip, the test microchip comprising An inlet for the blood or plasma sample, the inlet communicating with one or more microchannels having a length between tens of microns and millimeters, each microchannel comprising one or more test chambers, each microchannel having a defined volume between nanoliters and milliliters, the one or more microchannels each comprising at least one anionically charged surface which activates clotting of the blood or plasma sample upon entry of the blood or plasma sample into the one or more microchannels or test chamber, wherein the anionically charged surface does not include chemical agents activating clotting and the test chamber is formed of a material which allows changes in viscosity, impedance, acoustic properties, or optical properties in the blood or plasma in the test chamber, wherein the test microchip is inserted into a reader, the reader comprising a detector which determines changes in viscosity, impedance, acoustic properties, or optical properties in the blood or plasma sample in the test chamber to measure clotting time, and a temperature control regulating the temperature of the test chamber, wherein the detector is configured to output the measured clotting time determined from the time of activation of the sample to the time of the change in viscosity, impedance, acoustic properties, or optical properties in the test chamber indicative of clotting.
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8. A method for measuring clotting time comprising introducing a blood or plasma sample into
a test microchip inserted into a reader for measuring clotting in a blood or plasma sample, the test microchip comprising An inlet for the blood or plasma sample, the inlet communicating with one or more microchannels having a length between tens of microns and millimeters, each microchannel comprising one or more test chambers, each microchannel having a defined volume between nanoliters and milliliters, the one or more microchannels each comprising at least one anionically charged surface which activates clotting of the blood or plasma sample upon entry of the blood or plasma sample into the one or more microchannels or test chamber wherein the anionically charged surface does not include chemical agents activating clotting, wherein the test chamber is formed of a material which allows changes in viscosity, impedance, acoustic properties, or optical properties in the blood or plasma sample to be measured in the test chamber, and the reader comprising a detector which determines changes in viscosity, impedance, acoustic properties, or optical properties in the blood or plasma sample in the test chamber to measure clotting time, and a temperature control regulating the temperature of the test chamber, wherein the detector is configured to output the measured clotting time determined from the time of activation of the blood or plasma sample to the time of the change in viscosity, impedance, acoustic properties, or optical properties in the test chamber indicative of clotting.
Specification