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-11852639-B2
Publication Date
2023-12-26
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 document describes a point-of-care universal microfluidic chip assay for measuring clotting time in a blood or plasma sample. The assay uses one or more microchannels that draw the blood or plasma sample into one or more test chambers by passive capillary action. Each microchannel includes at least one anionically charged surface configured to activate clotting upon entry of the blood or plasma sample into the microchannels or test chambers, without including chemical agents activating clotting.
The anionically charged surface activates clotting independent of anticoagulant presence, so the measured clotting time reflects intrinsic pathway activation. The microfluidic test microchip is configured with two or more integrated electrodes that allow changes in electrical impedance in the blood or plasma to be measured to determine clot formation in the sample. In the reader, the detector is configured to determine changes in electrical impedance in the blood or plasma to measure clotting time and to output the measured clotting time from a time of activation to a time of change in the electrical impedance indicative of clotting.
The device includes temperature control for regulating the temperature of the test chamber, enabling temperature-regulated measurement. A reusable reader receives a disposable microfluidic system inserted into a reader housing, where the reader supports electrical impedance measurement and optical measurement using IR transmission with an IR LED and photodiode. The document further indicates optional detection modalities and reader hardware for temperature regulation.
Claims Coverage
The document includes two independent claims. Both claims center on a passive-capillary microfluidic test microchip with an anionically charged surface that activates clotting without chemical clotting agents, combined with two or more integrated electrodes for measuring clot formation by changes in electrical impedance, with clotting-time output from activation to impedance-indicative clotting, and a reader with temperature control.
Anionically charged microfluidic test microchip for impedance-based clotting time measurement
A test microchip for measuring clotting time in a blood or plasma sample, having an inlet communicating with microchannels drawn by passive capillary action into test chambers, where each microchannel includes anionically charged surface(s) configured to activate clotting upon entry without chemical agents activating clotting, and including two or more integrated electrodes to measure changes in electrical impedance to determine clot formation.
Microassay device with inserted microchip, impedance detector, and temperature control
A microassay device for measuring clotting in a blood or plasma sample from an individual, comprising a test microchip and a reader, where the test microchip has inlet/microchannels drawn by passive capillary action and anionically charged surface(s) configured to activate clotting without chemical agents, and includes two or more integrated electrodes for impedance measurement; the test microchip is inserted into the reader with a detector configured to determine changes in electrical impedance to measure clotting time and a temperature control configured to regulate the temperature of the test chamber, with output of measured clotting time from a time of activation to a time of impedance change indicative of clotting.
Across the independent claims, the core coverage is a disposable microfluidic test microchip that activates clotting using an anionically charged surface without chemical clotting agents, while integrated electrodes measure electrical impedance changes to determine clot formation and output clotting time, with reader-based detection and temperature control in the device claim.
Stated Advantages
Activates clotting independent of anticoagulant presence by using an anionically charged surface without chemical agents activating clotting.
Determines clot formation and measures clotting time from changes in electrical impedance.
Outputs measured clotting time from a time of activation to a time of change in electrical impedance indicative of clotting.
Documented Applications
Universal microfluidic chip assay for measuring clotting time in a blood or plasma sample at a point of care.
Measurement and correlation of impedance and IR signals over time for control versus anticoagulant conditions and for reversal by an anticoagulant reversal agent (PER977/ciraparantag).
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