Lateral flow assay device for coagulation monitoring and method thereof
Inventors
Killard, Anthony Joseph • Dudek, Magdalena Maria • MacCraith, Brian • Mendel-Hartvig, Ib • Öhman, Ove
Assignees
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Publication Number
US-9347931-B2
Publication Date
2016-05-24
Expiration Date
Abstract
The present invention is directed to a lateral flow assay device for the monitoring and measuring of coagulation and method thereof. Ideally, the invention is directed to a lateral capillary flow device for the monitoring and/or measurement of coagulation in a liquid sample wherein the device comprises a non-porous substrate with a zone for receiving a sample and a defined flow path zone wherein a clotting agent is deposited on at least part of the defined flow path zone to accelerate the coagulation of the liquid sample, enable the formation of an evenly distributed clot along the defined flow path zone and to result in the change in flow rate or cessation of flow of the liquid sample along the defined flow path zone.
Core Innovation
The invention relates to an open lateral capillary flow device for monitoring and/or measurement of coagulation in a liquid sample. The device includes a non-porous substrate with a zone for receiving a sample and a defined flow path zone, and a fibrinogen or thrombin clotting agent, or a derivative thereof, is deposited on at least part of the defined flow path zone to accelerate coagulation of the liquid sample.
The device enables formation of an evenly distributed clot along the defined flow path zone and results in a change in flow rate or cessation of flow of the liquid sample along the defined flow path zone. The defined flow path zone is structured to improve or increase the surface area to volume ratio between the sample and the defined flow path of the device.
The flow path zone comprises a planar surface with a plurality of regularly spaced projections that induce capillary action in the liquid sample along the defined flow path, and in further implementations comprises a plurality of vertical projections or micropillars protruding from the surface of the substrate. The clotting agent can be deposited on the entire surface of the defined flow path zone and can comprise a supporting reagent material selected from poly(ethylene glycol) (PEG), sugars, non-ionic surfactants, and combinations thereof.
Claims Coverage
The claims coverage includes five inventive features centered on an open lateral capillary flow device with coagulation-dependent flow behavior and defined projection geometry.
Open lateral capillary flow device with clotting agent deposited for coagulation-dependent flow behavior
A non-porous substrate forming an open lateral flow device with a zone for receiving a sample and a defined flow path zone, wherein a fibrinogen or thrombin clotting agent or a derivative thereof is deposited on at least part of the defined flow path zone to accelerate coagulation, enable formation of an evenly distributed clot along the defined flow path zone, and result in a change in flow rate or cessation of flow along the defined flow path zone.
Improved surface area-to-volume ratio using a planar flow path with regularly spaced projections
The surface area to volume ratio between the sample and defined flow path is improved or increased so that the flow path zone comprises a planar surface with a plurality of regularly spaced projections that induce capillary action along the defined flow path, wherein the regularly spaced projections extend along substantially the entire length of the flow path zone.
Vertical micropillars with defined height, diameter, and reciprocal spacing for lateral capillary flow
A flow path zone with a plurality of vertical projections or micropillars protruding from the surface of the substrate, wherein the vertical projections consist of areas substantially vertical to the surface and having a height (H), diameter (D), and reciprocal spacing such that lateral capillary flow of the liquid sample in the flow path zone is achieved.
Full-surface deposition of clotting agent on the defined flow path zone
The clotting agent is deposited on the entire surface of the defined flow path zone.
Clotting agent comprising a supporting reagent material
The clotting agent comprises a supporting reagent material selected from poly(ethylene glycol) (PEG), sugars, non-ionic surfactants, and combinations thereof.
Across the claims, the core coverage is the combination of an open lateral capillary flow device having a non-porous substrate and a defined planar flow path with regularly spaced projections that induce capillary action, together with a fibrinogen or thrombin clotting agent deposited on at least part or the entire surface of the defined flow path zone to accelerate coagulation and cause a change in flow rate or cessation of flow. Refinements include vertical micropillars with specified geometric parameters and supporting reagents such as PEG, sugars, and non-ionic surfactants.
Stated Advantages
Accelerates coagulation of the liquid sample.
Enables formation of an evenly distributed clot along the defined flow path zone.
Results in a change in flow rate or cessation of flow of the liquid sample along the defined flow path zone.
Improves or increases the surface area to volume ratio between the sample and defined flow path.
Documented Applications
Monitoring and/or measurement of coagulation in a liquid sample using an open lateral capillary flow device.
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