Assay devices and methods

• US 9,933,362 B2
• Filed: 06/30/2014
• Issued: 04/03/2018
• Est. Priority Date: 06/04/2003
• Status: Active Grant

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Sharrock, Stephen P., Phelan, Andrew P.
• Primary Examiner(s): Ayub, Hina F.
• Assistant Examiner(s): Merlino, Amanda
• Application Number:
  US14/319,344
• Publication Number:
  US 20140377879A1
• Time in Patent Office: 1,373 Days
• CPC Class Codes: G01N 2021/7759 Dipstick; Test strip
• CPC Class Codes: G01N 2021/7773 Reflection
• CPC Class Codes: G01N 2021/8488 the band presenting reference patches
• CPC Class Codes: G01N 2021/8494 Measuring or storing parameters of the band
• CPC Class Codes: 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
• CPC Class Codes: G01N 21/05 Flow-through cuvettes G01N21/09 takes precedence; handling fluid samples G01N1/10
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: 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
• CPC Class Codes: G01N 21/55 Specular reflectivity
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: 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
• CPC Class Codes: G01N 2201/06106 Plural sources used for calibration
• CPC Class Codes: G01N 2201/062 LED's
• CPC Class Codes: G01N 31/22 using chemical indicators G01N31/02 takes precedence

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

1. A lateral flow device for determining an assay result, comprising:

a test strip comprising at least an upstream first zone having a first immobilized reagent and a second zone downstream from the first zone having a second immobilized reagent which is different from the first immobilized reagent, wherein the upstream first zone and downstream 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 signal indicative of an amount of an analyte or rate of accumulation of analyte in that zone; and

a processor configured to receive the signal, compare the signal to a threshold, and generate an output signal if the signal exceeds the threshold, the output signal indicative of a positive result if the signal exceeds the threshold.

2. An assay result reading lateral flow device for reading the result of an assay to detect the presence and/or amount of an analyte of interest and wherein the presence or absence, as appropriate, of the analyte of interest causes a reaction which leads to the accumulation of a signal in a time dependent manner, the device comprising:

means for detecting light from an upstream first zone having a first immobilized reagent and a second zone downstream from the first zone having a second immobilized reagent which is different from the first immobilized reagent, wherein the upstream first zone and downstream 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 a test strip;

means for determining the rate or amount of signal accumulation;

means for comparing the determined rate or amount of signal accumulation with an upper threshold value; and

means for declaring the result of the assay if the determined rate or amount of signal accumulation exceeds the upper threshold value before the assay has been completed.

3. A method comprising:

performing a lateral flow assay;

before the assay has reached equilibrium, taking a first measurement at time t(1) and a second measurement at time t(2);

generating a first signal at time t(1) and a second signal at t(2), representing the amount of an analyte or the rate of accumulation of an analyte, wherein the presence of the analyte causes a reaction which leads to the accumulation of the signals in a time dependent manner;

detecting the first and second signals in at least an upstream first zone having first immobilized reagent and a second zone downstream from the first zone having a second immobilized reagent which is different from the first immobilized reagent;

wherein the upstream first zone and downstream 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 a test strip;

determining the rate or amount of the first and second signals;

comparing the determined rate or amount of the first signal with a first threshold value and the determined rate or amount of the second signal to a second threshold; and

declaring the result of the assay prior to reaching equilibrium if the determined rate or amount of the first and second signals exceeds the first and second threshold values before equilibrium.

4. An assay result reading lateral flow device for reading the result of an assay to detect the presence and/or amount of an analyte of interest and wherein the presence of the analyte of interest causes a reaction which leads to the accumulation of a signal in a time dependent manner, the device comprising:

means for detecting light from at least an upstream first zone having a first immobilized reagent and a second zone downstream from the first zone having a second immobilized reagent which is different from the first immobilized reagent, wherein the upstream first zone and downstream 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 a test strip;

means for determining the rate or amount of signal accumulation;

means for comparing the determined rate or amount of signal accumulation with threshold value; and

means for declaring the result of the assay if the determined rate or amount of signal accumulation exceeds the threshold value.

5. A lateral flow device for determining an assay result comprising;

a. a test strip comprising at least an upstream first zone having a first immobilized reagent and a second zone downstream from the first zone having a second immobilized reagent which is different from the first immobilized reagent, wherein the upstream first zone and downstream 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,

b. a light source system configured to illuminate the first zone and the second zone of the test strip,

c. a photodetector configured to detect light from the first and second zones when the respective zone is illuminated by the light source and output a signal indicative of an amount of an analyte or rate of accumulation of analyte in that zone,

d. a processor and/or a computation circuit configured to be responsive to the signal representing the amount of an analyte or the rate of accumulation of an analyte before the assay reaches equilibrium and to compare the signal to an upper threshold and to generate an output signal if the signal exceeds the upper threshold, the output signal indicative of a positive test result if the signal exceeds the upper threshold; and

e. a display, wherein the device displays an early result if analyte accumulation or rate of accumulation exceeds the upper threshold.