# US 9,518,985 B2 · Semi-quantitative lateral flow assays

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 9,518,985 B2
- Document ID: US9518985B2
- Status: Granted
- Kind: B2
- Application number: 14/121,488
- Filed: 2014-09-11
- Published: 2015-01-01
- Granted: 2016-12-13
- Earliest claimed: 2012-03-23
- Assignees: Stc.Unm
- Applicants: Stc.Unm
- Inventors: Scott A. Sibbett
- Web page: https://patentgrep.com/patent/US9518985B2

## CPC

- G01N 33/54389: {with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones}
- G01N 33/56988: {HIV or HTLV}
- G01N 2333/005: from viruses
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The present invention provides a semi-quantitative lateral flow assay device and method for generating semi-quantitative data from a lateral flow assay. The device comprises a thin, porous hydrophilic substrate wherein the substrate includes a star-shaped or other geometry taken in plan view having a liquid sample-receiving central region and multiple arms that extend or radiate out from the central region. Each arm includes a reaction zone formed by the presence of an analyte-capturing agent wherein the reaction zone of each arm is located at a different distance from the central region such that the analyte in the sample is captured accumulates in different quantities at at least some of the reaction zones of the arms in a manner that can be analyzed to yield semi-quantitative data from lateral flow assays. The reaction zones on the arms can be analyzed visually and/or by software analysis of a digital image based on color saturation, grayscale, or other characteristics of the reactions zones due to the presence of different amounts of analyte to produce semi-quantitative data of the total loading of a virus or other agent of interest of a patient's blood.

## Claims

### Claim 1

A device for performing semi-quantitative lateral flow assay, comprising:
a porous hydrophilic substrate wherein the substrate includes, in plan view, a liquid sample-receiving central region and multiple arms that extend out from the central region, wherein each arm includes a localized reaction zone, and wherein the reaction zone of every arm is located at a different distance relative to the central region and to one another such that the analyte in the sample resides in different quantities at at least some of the reaction zones of the arms to collectively produce a reaction pattern on the device, which reaction pattern can be analyzed by the unaided human eye to yield semi-quantitative data from the lateral flow assay.

### Claim 2 (depends on 1)

The device of claim 1 wherein the substrate has, in plan view, a star-shaped geometry with a circular central region and the multiple arms radiating out from the central region.

### Claim 3 (depends on 2)

The device of claim 2 wherein the reaction zone of each arm is located at a different radial distance from the circular central region to produce a radially-variable reaction pattern.

### Claim 4 (depends on 1)

The device of claim 1 wherein analyte-capturing material is present at each reaction zone.

### Claim 5 (depends on 4)

The device of claim 4 wherein the analyte- capturing material is present as a strip extending across on each arm.

### Claim 6 (depends on 4)

The device of claim 4 wherein the analyte-capturing material and analyte in the sample form a visually perceptive, colored zone at at least some of the reaction zones.

### Claim 7 (depends on 4)

The device of claim 4 wherein the analyte-capturing material captures the AIDS virus.

### Claim 8 (depends on 6)

The device of claim 6 wherein there is gradual variation of reaction zone color from arm to arm that can be analyzed to yield the semi-quantitative data.

### Claim 9 (depends on 1)

The device of claim 1 wherein the substrate is nitrocellulose.

### Claim 10 (depends on 1)

The device of claim 1 wherein the substrate has a lithographically-patterned central region and a plurality of lithographically-patterned arms.

### Claim 11 (depends on 1)

The device of claim 1 wherein the substrate has a knife cut central region and a plurality of knife-cut arms.

### Claim 12 (depends on 1)

The device of claim 1 wherein said multiple arms comprise more than two arms and wherein said distance varies continuously from arm-to-arm around the central region.

### Claim 13 (depends on 1)

The device of claim 1 wherein said multiple arms comprise more than two arms equally spaced apart around the central region.