Compositions for fabric based lateral flow assay device using electrochemical detection means, and devices therefrom

Inventors

Choudhary, TripurariGururaj, K BLal, Ashish KumarTahasildar, Manjunath

Assignees

Achira Labs Pvt Ltd

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Publication Number

US-9714912-B2

Patent

Publication Date

2017-07-25

Expiration Date


Abstract

The invention provides a composition for lateral flow assay device that comprises at least one fabric strand coated with a conducting material and a diagnostic material. The invention also provides a lateral flow assay device(10) having a proximal end(12), a distal end(14) and a testing zone intermediate between the proximal end(12) and the distal end(14). The lateral flow assay device(20) is made of a fabric comprising at least one strand(22) that defines a flow path. The at least one strand of the fabric in the testing zone is coated with a conducting material(24). The at least one strand is made of at least one of a cotton, a silk-based material, and combinations thereof. The invention also provides a lateral flow assay system(40) comprising the lateral flow assay device(42) of the invention, wherein the at least one electrode(52) connected to the strand(50) coated with the conducting material and measurement means(54) to measure the output from the at least one electrode(52).

Core Innovation

The invention relates to an electrochemical assay device comprising a fabric made of a plurality of strands interwoven together. The fabric has a proximal end, a distal end and a testing zone intermediate between the proximal end and the distal end. Within the testing zone, at least one conducting strand includes a conducting material.

The plurality of strands further includes at least one hydrophilic strand and at least one hydrophobic strand, where the at least one hydrophobic strand is interwoven with the at least one conducting strand and the at least one hydrophilic strand. This interweaving provides a patterned flow path across the testing zone while using the fabric as the structure for electrochemical detection.

In the described embodiments, conducting materials on woven strands define electrode functions and enable electrochemical detection by connecting coated strands to measurement electronics. Diagnostic compositions include diagnostic materials positioned on electrode-forming strands, including glucose oxidase, and the electrochemical assay uses a mediator for amperometric measurement of glucose, with reference and counter electrode functionality provided by coated conducting strands.

Claims Coverage

The disclosed inventive subject matter is covered by one independent claim defining an electrochemical assay device architecture with a woven fabric testing zone and patterned capillary flow path, with multiple dependent claims refining electrode formation, diagnostic materials, mediator, and structural features. The main inventive features are as follows.

Woven fabric electrochemical assay with proximal/distal ends and intermediate testing zone

An electrochemical assay device comprising a fabric made of a plurality of strands interwoven together, wherein the fabric has a proximal end, a distal end and a testing zone intermediate between the proximal end and the distal end.

Conducting strand in the testing zone

At least one conducting strand comprising a conducting material at least in the testing zone.

Patterned flow path from interwoven hydrophilic and hydrophobic strands with conducting strands

At least one hydrophilic strand and at least one hydrophobic strand, wherein the at least one hydrophobic strand is interwoven with the at least one conducting strand and the at least one hydrophilic strand to provide a patterned flow path.

Counter electrode from coated conducting strand with resistance constraint

The electrochemical assay device includes a counter electrode formed by coating at least one conducting strand, wherein the counter electrode has a resistance less than about 1000 ohms/cm.

Working electrode from diagnostic-coated conducting strand

The electrochemical assay device includes a working electrode formed by coating at least one conducting strand with a diagnostic material.

Glucose oxidase as the diagnostic material

The electrochemical assay device uses glucose oxidase as the diagnostic material.

Mediator comprising potassium ferricyanide

The electrochemical assay device uses a mediator comprising potassium ferricyanide.

Housing with sample introduction port and/or transparent viewing port

The electrochemical assay device includes a housing having at least one of a sample introduction port and a transparent viewing port.

Overall, the claim coverage centers on a fabric-based electrochemical assay device in which interwoven hydrophilic and hydrophobic strands pattern a flow path and a conducting strand supports electrode formation in the testing zone. Dependent claims further specify counter and working electrode constructions, including diagnostic material coatings, a mediator, and optional housing features such as a sample introduction port and transparent viewing port.

Stated Advantages

Allows electrochemical detection using a fabric-based lateral flow assay architecture with patterned flow paths defined by interwoven strand types.

Enables electrode functionality through coatings on strands within the fabric testing zone, including working, reference, and counter electrode roles.

Supports calibration/linearity discussion and electrochemical glucose assay performance using amperometric measurement.

Provides weaving-based manufacturing advantages for single- and multiplexing.

Documented Applications

Electrochemical glucose assays using glucose oxidase as a diagnostic material and amperometric measurement based on glucose concentration.

Single- and multiplexing diagnostic formats using the woven fabric lateral flow assay structure.

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