Lateral flow assay systems and methods

• US 8,128,871 B2
• Filed: 04/22/2005
• Issued: 03/06/2012
• Est. Priority Date: 04/22/2005
• 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:
  US11/112,807
• Publication Number:
  US 20060240541A1
• Time in Patent Office: 2,510 Days
• Field of Search: 422/50, 422/55, 422/56, 422/58, 422/68.1, 422/82.05, 422/99, 422/104
• US Class Current: 422/68.1
• 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 system, comprising:

a housing comprising a port for 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 includes an area that is exposed for optical inspection and is characterized by a first dimension transverse to the lateral flow direction and a second dimension parallel to the lateral flow direction;

a reader that obtains separable light intensity measurements from each of multiple localized regions of the exposed area of the detection zone when the test strip is loaded in the port, wherein each of the multiple localized regions is characterized by at least one surface dimension smaller than the first dimension, wherein the reader comprises;

a light source that scans a light beam to illuminate each of the multiple localized regions of the exposed area of the detection zone; and

a light detector that has a field of view that encompasses the path of the light beam across the exposed area of the detection zone; and

a data analyzer comprising software that identifies ones of the light intensity measurements obtained from the at least one test region and to compute at least one parameter from the identified ones of the light intensity measurements.

2. The system of claim 1, wherein the reader comprises an array of light detectors configured to obtain light intensity measurements from different respective localized regions of the exposed area of the detection zone.

3. The system of claim 2, 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.

4. The system of claim 2, wherein the light source is operable to scan the light beam across the exposed area of the detection zone in a direction substantially parallel to the lateral flow direction.

5. The system of claim 2, wherein the light source is operable to scan the light beam along a circuitous path across the exposed area of the detection zone.

6. The system of claim 1, wherein the reader is operable to illuminate the localized regions with light and to synchronize the obtaining of the light intensity measurements with the illumination of the localized regions.

7. The system of claim 6, wherein the reader is operable to modulate the illuminating light and to synchronize the obtaining of the light intensity measurements with the modulation of the illuminating light.

8. The system of claim 1, wherein the reader comprises an aperture through which the light intensity measurements are obtained, wherein the aperture is positioned over at least one test region when the test strip is loaded in the port.

9. The system of claim 1, wherein the data analyzer is operable to identify ones of the light intensity measurements obtained from the test region based on intensity measurements obtained from at least one position marker on the test strip.

10. The system of claim 1, wherein the reader is operable to obtain a respective set of light intensity measurements from each of multiple corresponding regions of the exposed area of the detection zone.

11. The system of claim 10, wherein:

the reader is operable to illuminate each of the corresponding regions with light and to obtain the respective sets of light intensity measurements after the corresponding regions have been illuminated with the light; and

the data analyzer is operable to determine respective decay time parameters from the respective sets of light intensity measurements and to identify the ones of the light intensity measurements obtained from the at least one test region based on the determined decay time parameters.

12. The system of claim 11, wherein the data analyzer is operable to compute peak intensity parameter values for each of the corresponding regions based at least in part on the determined decay time parameters.

13. The system of claim 12, wherein the data analyzer is operable to identify ones of the light intensity measurements obtained from a second test region in the detection zone based on the determined decay time parameters.

14. The system of claim 13, wherein the data analyzer is operable to compute a parameter value from respective ones of the peak intensity parameter values corresponding to the first and second test regions.

15. The system of claim 10, wherein the reader is operable to illuminate each of the corresponding regions with light having different wavelength profiles and to obtain ones of the multiple light intensity measurements in each set under different wavelength profiles of light illuminating the corresponding regions.

16. The system of claim 15, wherein the data analyzer is operable to determine wavelength response profiles across the exposed area of the detection zone from the respective sets of light intensity measurements and to identify the ones of the light intensity measurements obtained from the at least one test region based on the determined wavelength response profiles.

17. The system of claim 10, wherein the reader is operable to illuminate each of the corresponding regions with light of different respective polarizations and to obtain ones of the multiple light intensity measurements in each set under different polarizations of light illuminating the corresponding regions.

18. The system of claim 17, wherein the data analyzer is operable to determine polarization response profiles across the exposed area of the detection zone from the respective sets of light intensity measurements and to identify the ones of the light intensity measurements obtained from the at least one test region based on the determined polarization response profiles.

19. A diagnostic test system, comprising:

a housing comprising a port for 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 and an area that is exposed for optical inspection;

a reader that obtains a respective set of separable light intensity measurements from each of multiple localized regions of the exposed surface area of the detection zone when the test strip is loaded in the port, wherein the reader comprises;

a light source that scans a light beam to illuminate each of the multiple localized regions of the exposed area of the detection zone; and

a light detector that has a field of view that encompasses the path of the light beam across the exposed area of the detection zone; and

a data analyzer comprising software that computes at least one parameter from at least one of the sets of separable light intensity measurements.

20. The system of claim 19, wherein:

the reader is operable to illuminate each of the multiple corresponding regions with light and to obtain the respective sets of separable light intensity measurements after the multiple corresponding regions have been illuminated with the light; and

the data analyzer is operable to determine respective decay time parameters from the respective sets of separable light intensity measurements and to identify the ones of the separable light intensity measurements obtained from the at least one test region based on the determined decay time parameters.

21. The system of claim 20, wherein the data analyzer is operable to compute peak intensity parameter values for ones of the multiple corresponding regions based at least in part on the determined decay time parameters.

22. The system of claim 21, wherein the data analyzer is operable to identify ones of the separable light intensity measurements obtained from a second test region in the detection zone based on the determined decay time parameters.

23. The system of claim 22, wherein the data analyzer is operable to compute a parameter value from respective ones of the peak intensity parameter values corresponding to the first and second test regions.

24. The system of claim 19, wherein the reader is operable to illuminate one or more of the multiple corresponding regions with light having different wavelength profiles and to obtain ones of the multiple separable light intensity measurements in each set under different wavelength profiles of light illuminating the corresponding regions.

25. The system of claim 24, wherein the data analyzer is operable to determine wavelength-response profiles across the exposed area of the detection zone from the respective sets of separable light intensity measurements and to identify the ones of the separable light intensity measurements obtained from the at least one test region based on the determined wavelength response profiles.

26. The system of claim 19, wherein the reader is operable to illuminate each of the corresponding regions with light of different respective polarizations and to obtain ones of the separable multiple light intensity measurements in each set under different polarizations of light illuminating the corresponding regions.

27. The system of claim 26, wherein the data analyzer is operable to determine polarization response profiles across the exposed area of the detection zone from the respective sets of separable light intensity measurements and to identify the ones of the separable light intensity measurements obtained from the at least one test region based on the determined polarization response profiles.