Lateral flow assay systems and methods

• US 9,091,631 B2
• Filed: 01/27/2012
• Issued: 07/28/2015
• Est. Priority Date: 04/01/2004
• Status: Active Grant

• Current Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Original Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Inventors: Petruno, Patrick T., Petrilla, John F., Brosnan, Michael J., Zhou, Rong, Roitman, Daniel B.
• Primary Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US13/360,081
• Publication Number:
  US 20120129272A1
• Time in Patent Office: 1,278 Days
• US Class Current: 1/1
• CPC Class Codes: G01N 2021/6439 with indicators, stains, dyes, tags, labels, marks
• CPC Class Codes: G01N 21/17 Systems in which incident light is modified in accordance with the properties of the material investigated where the material investigated is optically excited causing a change in wavelength of the incident light G01N21/63
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• 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 2201/062 LED's
• CPC Class Codes: G01N 2201/067 Electro-optic, magneto-optic, acousto-optic elements
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/54393 Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/58 involving labelled substances G01N33/53 takes precedence
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/823 Acetobacter
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/823 Immunogenic carrier or carrier per se
• CPC Class Codes: Y10T 436/25125 Digestion or removing interfering materials

Abstract

In one aspect, a diagnostic test system includes a housing, a reader, and a data analyzer. The housing includes a port for receiving a test strip. The reader obtains separable light intensity measurements from localized regions of an area of the detection zone exposed for optical inspection, wherein each of the localized regions is characterized by at least one surface dimension smaller than the first dimension. The data analyzer identifies ones of the light intensity measurements obtained from the at least one test region and computes at least one parameter from the identified ones of the light intensity measurements. In another aspect, the reader obtains a respective set of light intensity measurements from each of multiple corresponding regions of the exposed surface area of the detection zone, and the data analyzer computes at least one parameter from at least one of the sets of light intensity measurements.

Claims

1. A diagnostic test method, comprising:

receiving a test strip that supports lateral flow of a fluid sample along a lateral flow direction and comprises a labeling zone containing a labeling substance that binds a label to a target analyte and a detection zone comprising at least one test region containing an immobilized substance that binds the target analyte, wherein the detection zone is characterized by a first dimension transverse to the lateral flow direction and a second dimension parallel to the lateral flow direction;

employing one or more optical components to shape light emitted from a light source to produce a light beam and using the one or more optical components to scan the light beam across the test strip to illuminate each of multiple localized regions of the exposed area of the detection zone, wherein each of the multiple localized regions is characterized by at least one surface dimension smaller than the first dimension, wherein the one or more optical components are selected from the group consisting of a lens and a rotating mirror;

obtaining separable light intensity measurements from each of multiple localized regions of the exposed area of the detection zone;

identifying one or more of the separable light intensity measurements obtained from the at least one test region; and

computing at least one parameter from the identified one or more separable light intensity measurements.

2. The diagnostic test method of claim 1, wherein each of the localized regions illuminated by the light beam has at least one dimension at most as large as a narrowest surface dimension of the test region.

3. The diagnostic test method of claim 1, wherein the light beam is scanned across the exposed area of the detection zone in a direction substantially parallel to the lateral flow direction.

4. The diagnostic test method of claim 1, wherein the light beam is scanned along a circuitous path across the exposed area of the detection zone.

5. The diagnostic test method of claim 1, wherein the steps of scanning a light beam to illuminate each of multiple localized regions of the exposed area of the detection zone;

and obtaining separable light intensity measurements from each of multiple localized regions of the exposed area of the detection zone are synchronized.

6. The diagnostic test method of claim 5, wherein the illumination by the light beam is synchronized with the obtaining of the light intensity measurements.

7. The diagnostic test method of claim 1, wherein the at least one parameter is decay time.

8. The diagnostic test method of claim 1, wherein the at least one parameter is peak intensity.

9. The diagnostic test method of claim 1, wherein the light beam illuminates each of the corresponding regions of the exposed surface area of the detection zone with light having different wavelength profiles.

10. The diagnostic test method of claim 1, wherein the light beam illuminates each of the corresponding regions of the exposed surface area of the detection zone with light of different respective polarizations.

11. The diagnostic test method of claim 1, wherein the light source is fixed.