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-11243219-B2
Publication Date
2022-02-08
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 invention relates to a point-of-care universal microfluidic coagulation assay using a disposable test microchip and a reusable reader. A blood or plasma sample is drawn into one or more microchannels and test chambers by passive capillary action, and clotting is activated by contact with an anionically charged surface that does not include chemical agents activating clotting.
The system measures clot formation by monitoring changes in optical properties indicative of clot formation. These optical-property changes can be measured using infrared transmission and related detection of optical changes in the test chamber material that supports infrared transmission, and the measurements are used to determine clotting time.
The disposable microfluidic test microchip is inserted into a reusable reader providing a detector configured to determine changes in optical properties and temperature control regulating the temperature of the test chamber. The reader outputs measured clotting time from the time of activation of the sample to the time of change in optical properties in the test chamber indicative of clotting.
Claims Coverage
Two independent claims are covered. The inventive features relate to a disposable test microchip that activates clotting via an anionically charged surface without chemical clot activators, and to measuring clotting time from optical-property changes in a reader with temperature control, including infrared detection and reader output behavior.
Anionically charged clot activation in passive capillary microchannels
A test microchip for measuring clotting in a blood or plasma sample having an inlet communicating with one or more microchannels and one or more test chambers, where the sample is drawn into the one or more test chambers by passive capillary action, and where each microchannel includes at least one anionically charged surface that activates clotting upon entry, with the anionically charged surface not including chemical agents activating clotting.
Optical-property change detection indicative of clot formation
Changes in optical properties indicative of clot formation can be measured from the blood or plasma sample in the test microchip.
Reader with detector and temperature control to output clotting time
The test microchip is inserted into a reader comprising a detector that determines changes in optical properties to measure clotting time and temperature control regulating the temperature of the test chamber, where the detector is configured to output the measured clotting time from the time of activation of the sample to the time of change in the optical properties indicative of clotting.
The independent claims primarily cover microchannel/test-chamber clot activation using anionically charged surfaces without chemical clot activators, and determining clotting time by detecting changes in optical properties in a reader that also regulates temperature and outputs clotting time based on optical-change timing.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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