Assay method utilizing capillary transport on non-porous substrates

Inventors

Bergman, DavidMendel-Hartvig, IbUhrberg, Simon

Assignees

Crimson International Assets LLC

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Publication Number

US-8722423-B2

Patent

Publication Date

2014-05-13

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 an assay system and a method for use in the detection of an analyte in a liquid sample on a non-porous substrate. A receiving zone on the substrate receives the liquid sample, and at least a subset of the liquid sample is transported by capillary action from the receiving zone toward an optional zone where a reaction/detection takes place. The transport defines a lateral flow path, where at least part of the lateral flow path comprises areas of projections substantially vertical to the substrate surface.

The vertical projections have a height (H), a diameter (D), and reciprocal spacing (t1, t2) such that lateral capillary flow is spontaneously induced without requiring a cover to contribute to the induced capillary flow. The substrate further includes a zone opposite the receiving zone exerting capillary force and having the capacity to receive liquid sample along the flow path, while allowing processing without interrupting capillary flow.

The method further includes separating unwanted components in the sample during capillary transport. The separation step is achieved using means for separation comprising a filter that retains the unwanted components, and the device retaining the substrate is constructed to induce capillary action without the need for a cover.

Claims Coverage

The independent claim covers a capillary-action analyte detection method on a non-porous substrate using spontaneously induced lateral capillary flow along a lateral flow path defined by substantially vertical projections, combined with an in-line separation step using a filter while capillary flow remains uninterrupted. It further defines structural constraints for the projections and includes the use of a zone opposite the receiving zone that exerts capillary force.

Non-porous substrate with spontaneous lateral capillary flow without a cover

Transporting at least a subset of the liquid sample through capillary action from a receiving zone along a lateral flow path, where the substrate is non-porous and at least part of the lateral flow path includes areas of projections substantially vertical to the surface, having a height (H), diameter (D) and reciprocal spacing (t1, t2) such that lateral capillary flow is spontaneously induced without requiring a cover to contribute to the induced capillary flow.

Opposite zone exerting capillary force along the flow path

Including a zone opposite the receiving zone exerting capillary force and having the capacity to receive liquid sample along said flow path.

In-line separation of unwanted components without interrupting capillary flow using a filter

Separating unwanted components in the sample without interruption of said capillary flow, wherein the separation step is achieved using means for separation comprising a filter that retains said unwanted components, and wherein the device retaining said substrate is constructed to induce capillary action without the need for a cover.

Overall, the claim coverage focuses on spontaneously induced lateral capillary flow on a non-porous substrate using substantially vertical projections with defined geometry, a capillary-force exerting opposite zone along the flow path, and an in-line filter-based separation of unwanted components while maintaining uninterrupted capillary flow without a cover.

Stated Advantages

Faster determinations.

Simplified reagent placement/derivatization.

Improved device uniformity and assay repeatability.

Controllable separation degree.

Documented Applications

Separating red blood cells from plasma/serum in a whole-blood/whole-sample context to avoid clotting, hemolysis/rupture, light interference, and variability related to hematocrit.

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