# US 10,309,899 B2 · Assay devices and methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,309,899 B2 - Document ID: US10309899B2 - Status: Granted - Kind: B2 - Application number: 15/906,489 - Filed: 2018-02-27 - Published: 2018-07-05 - Granted: 2019-06-04 - Earliest claimed: 2003-06-04 - Assignees: Alere Switzerland GmbH - Applicants: Alere Switzerland GmbH - Inventors: Stephen P. Sharrock; Andrew P. Phelan - Web page: https://patentgrep.com/patent/US10309899B2 ## CPC - G01N 21/55: Specular reflectivity - G01N 21/00: Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light (G01N3/00 - G01N19/00 take precedence) - G01N 21/05: Flow-through cuvettes (G01N21/09 takes precedence; handling fluid samples G01N1/10) - G01N 21/274: {Calibration, base line adjustment, drift correction} - G01N 21/4738: {Diffuse reflection (precedence is given to G01N21/55 - G01N21/57 if specular component is taken into consideration), e.g. also for testing fluids, fibrous materials} - G01N 21/78: producing a change of colour - G01N 21/8483: {Investigating reagent band (test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04)} - G01N 31/22: using chemical indicators (G01N31/02 takes precedence) - G01N 2021/7759: {Dipstick; Test strip} - G01N 2021/7773: {Reflection} - G01N 2021/8488: {the band presenting reference patches} - G01N 2021/8494: {Measuring or storing parameters of the band} - G01N 2201/06106: Plural sources used for calibration - G01N 2201/062: LED's - 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 A device for determining an assay result may include a test strip, a light source system, a light detection system, and a processor. ## Claims ### Claim 1 A lateral flow device for determining an assay result, comprising: a test strip comprising at least an upstream first zone and a second zone downstream from the first zone, wherein the upstream first zone is a test zone and the downstream second zone is a control or reference zone, said first zone and second zone are discrete and spaced apart such that a fluid front flows from the first zone to the second zone along a lateral flow path defined by the test strip; a light source system configured to illuminate the first zone and the second zone of the test strip; a photodetector configured to detect light from the first and the second zones when each respective zone is illuminated by the light source and output a first signal from the first zone and a second signal from the second zone; and a processor configured to receive and process the first and second signals and generate a processed value, compare the processed value to a threshold, and generate an output signal if the processed value exceeds the threshold, the output signal indicative of a positive result if the processed value exceeds the threshold, wherein the processor is configured to amend the first signal at the test zone based on the second signal at the control or reference zone. ### Claim 2 (depends on 1) The lateral flow device of claim 1, wherein the first zone comprises a first immobilized reagent and the second zone lacks a second immobilized reagent. ### Claim 3 (depends on 1) The lateral flow device of claim 1, wherein the first zone comprises a first immobilized reagent and the second zone comprises a second immobilized reagent. ### Claim 4 (depends on 1) The lateral flow device of claim 1, wherein the second zone that lacks a second immobilized reagent is a control or reference zone. ### Claim 5 (depends on 1) The lateral flow device of claim 1, wherein the second zone that comprises a second immobilized reagent is a control zone. ### Claim 6 (depends on 1) The lateral flow device of claim 1, wherein a signal from the reference zone is indicative of non-specifically accumulated analyte or sample matrix. ### Claim 7 (depends on 1) The lateral flow device of claim 1, wherein the signal is indicative of an amount of analyte accumulated at the test zone. ### Claim 8 (depends on 1) The lateral flow device of claim 1, wherein the signal is indicative of the rate of accumulation of analyte at the test zone. ### Claim 9 (depends on 1) The lateral flow device of claim 1, wherein the processor is configured to determine the amount or rate of accumulation of analyte in the test zone. ### Claim 10 A lateral flow device for determining an assay result, comprising: a test strip comprising at least an upstream first zone and a second zone downstream from the first zone, wherein the upstream first zone is a control or reference zone and the downstream second zone is a test zone, said first zone and second zone are discrete and spaced apart such that a fluid front flows from the first zone to the second zone along a lateral flow path defined by the test strip; a light source system configured to illuminate the first zone and the second zone of the test strip; a photodetector configured to detect light from the first and the second zones when each respective zone is illuminated by the light source and output a first signal from the first zone and a second signal from the second zone; and a processor configured to receive and process the first and second signals and generate a processed value, compare the processed value to a threshold, and generate an output signal if the processed value exceeds the threshold, the output signal indicative of a positive result if the processed value exceeds the threshold, wherein the processor is configured to amend the second signal at the test zone based on the first signal at the control or reference zone. ### Claim 11 (depends on 10) The lateral flow device of claim 10, wherein the first zone lacks a first immobilized reagent and the second zone comprises a second immobilized reagent. ### Claim 12 (depends on 10) The lateral flow device of claim 10, wherein the first zone that lacks a first immobilized reagent is a reference zone. ### Claim 13 (depends on 10) The lateral flow device of claim 10, wherein the first zone comprises a first immobilized reagent and the second zone comprises a second immobilized reagent. ### Claim 14 (depends on 10) The lateral flow device of claim 10, wherein the first zone that comprises a first immobilized reagent is a control zone. ### Claim 15 (depends on 10) The lateral flow device of claim 10, wherein a signal from the reference zone is indicative of non-specifically accumulated analyte or sample matrix. ### Claim 16 (depends on 10) The lateral flow device of claim 10, wherein the signal is indicative of an amount of analyte accumulated at the test zone. ### Claim 17 (depends on 10) The lateral flow device of claim 10, wherein the signal is indicative of the rate of accumulation of analyte at the test zone. ### Claim 18 (depends on 10) The lateral flow device of claim 10, wherein the processor is configured to determine the amount or rate of accumulation of analyte in the test zone.