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Publication Number
US-9056318-B2
Publication Date
2015-06-16
Expiration Date
Abstract
A device and method for the separation of a component in a liquid sample prior to the detection of an analyte in said sample, wherein a sample is added to a receiving zone on a substrate, said substrate further optionally comprising a reaction zone, a transport or incubation zone connecting the receiving and reaction zone, respectively, forming a flow path on a substrate, wherein said substrate is a non-porous substrate, and at least part of said flow path consists of areas of projections substantially vertical to said surface, and having a height (H), diameter (D) and reciprocal spacing (t1, t2) such, that lateral capillary flow of said liquid sample in said zone is achieved, and where means for separation are provided adjacent to the zone for receiving the sample. Said means for separation are chosen among filter means, optionally enhanced by affinity binding and/or aggregation; magnetic means, also optionally enhanced by affinity binding and/or aggregation; and acoustic means.
Core Innovation
The invention relates to a device for the separation of a component in a liquid sample prior to the detection of an analyte in the liquid sample. The device includes a non-porous substrate with a sample receiving zone and a separator element, and the separator element includes a filtration zone with a plurality of first projections extending substantially vertical to the substrate surface.
The filtration zone is arranged as a threshold adjacent to and raised in relation to the sample receiving zone. The plurality of first projections has a height, diameter, and reciprocal spacing such that, based on at least one of the dimensions or the reciprocal spacing between the first projections, a gradient is formed in a direction of flow to cause separation of the component.
A transport or incubation zone is connected to the filtration zone, thereby forming a lateral flow path on the non-porous substrate extending from the sample receiving zone to the transport or incubation zone. At least part of the flow path outside of the filtration zone has areas of second projections substantially vertical to the substrate surface, and lateral capillary flow is induced solely due to the height, diameter and reciprocal spacing of the first and second projections without requiring additional structure to induce or assist said flow.
Separation can further be achieved by filtration adjacent the receiving zone and, in certain embodiments, by affinity binding, aggregation, magnetic separation, or acoustic separation. The device is stated to separate unwanted sample components, notably red blood cells, prior to analyte detection.
Claims Coverage
Independent claim clm-00001 covers a non-porous substrate device with vertically oriented projection arrays that create a filtration threshold and a lateral capillary flow path induced solely by projection geometry, prior to analyte detection. Dependent claim coverage includes affinity-based separation elements, magnetic separation with magnetic beads and a magnet, and ultrasonic standing-wave exposure with a node pattern.
Non-porous substrate with sample receiving zone and separator element threshold filtration
A device for the separation of a component in a liquid sample prior to the detection of an analyte, comprising a non-porous substrate having a sample receiving zone portion, and a separator element provided adjacent to or in the receiving zone, wherein the separator element includes a filtration zone having a plurality of first projections arranged as a threshold adjacent to and raised in relation to the sample receiving zone.
Gradient in flow direction from first projection height, diameter, and reciprocal spacing
The plurality of first projections extending substantially vertical to the substrate surface has a height, diameter, and reciprocal spacing such that, based on at least one of the dimensions or the reciprocal spacing between the first projections, forms a gradient in a direction of flow such that separation of the component occurs.
Lateral capillary flow path induced solely by projection geometry
A transport or incubation zone connected to said filtration zone forming a lateral flow path extending from the sample receiving zone to the transport or incubation zone, wherein at least part of the flow path outside of the filtration zone has areas of second projections substantially vertical to the substrate surface, and wherein said first and second projections each have a height, a diameter and a reciprocal spacing such that lateral capillary flow is achieved, with the flow path defined by an open flow path in which the lateral capillary flow is induced solely due to the height, diameter and reciprocal spacing of said first and said second projections without requiring additional structure to induce or assist said flow.
Affinity-based second separator element for the component
A second separator element having affinity for the component to be separated that is soluble or dispersible in the liquid sample and predispensed in the receiving zone.
Magnetic separation using derivatized magnetic beads
Magnetic separation using a magnet and magnetic separation elements in which magnetic beads are used as derivatized binding/retention elements.
Ultrasonic standing waves producing a pattern of nodes
An element for subjecting the sample to ultrasonic standing waves, wherein at least two ultrasonic energy sources are arranged to establish a pattern of nodes within the flow path by interference between their outputs, defining a standing wave.
Overall, the claims are centered on a non-porous, projection-array separator that creates separation in a raised threshold filtration zone using a flow-direction gradient from first projections, while simultaneously enabling lateral capillary flow through an open flow path induced solely by the height, diameter, and reciprocal spacing of first and second projections. Additional dependent claim coverage includes affinity-based separation elements, magnetic separation with magnetic beads and a magnet, and ultrasonic standing-wave exposure establishing a node pattern via interference.
Stated Advantages
Faster operation compared with porous chromatography strips.
Simplified reagent/derivatization.
Improved uniformity and repeatability.
Controllable separation without a centrifugation step.
Documented Applications
Separating unwanted sample components, notably red blood cells, prior to detection of an analyte.
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