Microfluidic chip-based, universal coagulation assay
Inventors
Bakhru, Sasha • Laulicht, Bryan • Zappe, Stefan • Steiner, Solomon
Assignees
Perosphere Technologies Inc • Perosphere Pharmaceuticals Inc
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Publication Number
US-9910053-B2
Publication Date
2018-03-06
Expiration Date
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.
Core Innovation
The microassay device measures clotting in a blood or plasma sample from an individual using a test microchip that includes an inlet communicating with one or more microchannels and test chambers having defined volumes. At least one microchannel test chamber includes an anionically charged surface that activates clotting upon entry of the sample, and the anionically charged surface does not include chemical agents activating clotting. The test chamber is formed of a material that allows changes in viscosity, impedance, acoustic properties, or optical properties in the sample.
The test microchip is inserted into a reader comprising a detector and temperature control regulating the temperature of the test chamber. The detector determines changes in viscosity, impedance, acoustic properties, or optical properties in the sample to measure clotting time. The detector outputs measured clotting time determined from the time of activation of the sample to the time of the change in the measured physical property indicative of clotting.
A method for measuring clotting time introduces a blood or plasma sample into a test microchip inserted into a reader. The microchip again uses one or more microchannels and test chambers with anionically charged surfaces that activate clotting without chemical agents activating clotting. The reader detector measures clotting time from activation to a detected change in viscosity, impedance, acoustic properties, or optical properties, while temperature control regulates the temperature of the test chamber.
Claims Coverage
The document provides two independent claims, a microassay device claim and a method claim. The independent claims are centered on clotting activation by an anionically charged surface without chemical clotting agents, a microfluidic structure with one or more microchannels and test chambers having defined volumes, measurement of clotting time via changes in viscosity, impedance, acoustic properties, or optical properties, and a reader with detection plus temperature control.
Clotting activation by anionically charged surface without chemical clotting agents
An anionically charged surface in the one or more microchannels or test chamber activates clotting of the blood or plasma sample upon entry, and the anionically charged surface does not include chemical agents activating clotting.
Microfluidic structure with defined volumes
The test microchip includes an inlet communicating with one or more microchannels and test chambers having defined volumes.
Test chamber material enabling measurable physical property changes
The test chamber is formed of a material which allows changes in viscosity, impedance, acoustic properties, or optical properties in the sample in the test chamber.
Reader detector determining clotting time from property change
A reader includes a detector that determines changes in viscosity, impedance, acoustic properties, or optical properties in the sample to measure clotting time, and the detector outputs measured clotting time determined from the time of activation of the sample to the time of the change indicative of clotting.
Temperature control regulating the test chamber temperature
The reader includes temperature control regulating the temperature of the test chamber.
Method of introducing the sample into an inserted microchip and detecting property changes
Introducing a blood or plasma sample into a test microchip inserted into a reader, where the anionically charged surface activates clotting without chemical agents, and the reader detector measures clotting time based on the time of activation to the time of a detected change in viscosity, impedance, acoustic properties, or optical properties in the test chamber.
Across the independent device and method claims, the inventive concept is a microfluidic coagulation assay in which clotting is activated by an anionically charged surface without chemical clotting agents, while clotting time is determined by a reader detector from activation time to the time of change in viscosity, impedance, acoustic properties, or optical properties, with temperature control regulating the test chamber.
Stated Advantages
Documented Applications
No documented applications found
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