Assay test strips and reading same

• US 7,521,260 B2
• Filed: 11/16/2005
• Issued: 04/21/2009
• Est. Priority Date: 04/22/2005
• Status: Active Grant

• Current Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Original Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Inventors: Curry, Bo U., Zhou, Rong, Brosnan, Michael J., Roitman, Daniel B., Petruno, Patrick T., Petrilla, John F.
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US11/280,640
• Publication Number:
  US 20060240568A1
• Time in Patent Office: 1,252 Days
• Field of Search: 436/514, 436/518, 436/169, 436/172, 436/175, 436/530, 436/533, 436/807, 436/170, 436/823, 435/823, 435/287.7, 435/287.9, 435/805, 422/56, 422/57, 422/58, 422/59, 422/60
• US Class Current: 436/514
• 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

An assay test strip includes a flow path, a sample receiving zone, a label, a detection zone that includes a region of interest, and at least one position marker. The at least one position marker is aligned with respect to the region of interest such that location of the at least one position marker indicates a position of the region of interest. A diagnostic test system includes a reader that obtains light intensity measurement from exposed regions of the test strip, and a data analyzer that performs at least one of (a) identifying ones of the light intensity measurements obtained from the test region based on at least one measurement obtained from the at least one reference feature, and (b) generating a control signal modifying at least one operational parameter of the reader based on at least one measurement obtained from the at least one reference feature.

Claims

1. An assay test strip, comprising:

a flow path for a fluid sample;

a sample receiving zone coupled to the flow path;

a label that specifically binds a target analyte;

a detection zone coupled to the flow path and comprising a region of interest and an immobilized test reagent that specifically binds the target analyte; and

at least one position marker aligned with respect to the region of interest such that location of the at least one position marker indicates a position of the region of interest, wherein the at least one position marker is calibrated to provide at least one reference optical response to illuminating light within a specified wavelength range.

2. The assay test strip of claim 1, wherein the at least one position marker encodes at least one position in the detection zone.

3. The assay test strip of claim 2, wherein the at least one position marker produces a series of contrast variations on a surface of the test strip.

4. The assay test strip of claim 3, wherein the at least one position marker has different optical reflection or emission properties than adjacent areas of the surface.

5. The assay test strip of claim 2, wherein the region of interest is a test region in the detection zone that comprises the immobilized test reagent, and the at least one position marker comprises a spatial arrangement of the immobilized test reagent in the test region.

6. The assay test strip of claim 5, wherein the immobilized test reagent is arranged in a series of spaced-apart areas of the test region.

7. The assay test strip of claim 6, wherein each of the spaced-apart areas is rectangular.

8. The assay test strip of claim 1, wherein the region of interest is a test region in the detection zone that comprises the immobilized test reagent, and the position marker is adjacent to the test region.

9. The assay test strip of claim 8, wherein the position marker has a different response than the label with respect to illuminating light within a target wavelength range.

10. The assay test strip of claim 9, wherein the label comprises quantum dots capable of fluorescent emission at a first characteristic wavelength and the position marker comprises quantum dots capable of fluorescent emission at a second characteristic wavelength different from the first characteristic wavelength.

11. The assay test strip of claim 1, wherein the position marker is beside an edge of the detection zone.

12. The assay test strip of claim 1, wherein the position marker is located centrally over the flow path in the detection zone.

13. The assay test strip of claim 12, wherein the position marker is elongated in a direction perpendicular to the flow path.

14. The assay test strip of claim 1, wherein the position marker comprises a calibrated amount of the label.

15. The assay test strip of claim 14, further comprising one or more additional labels that specifically bind respective target analytes to form one or more additional labeled target analyte complexes, and the at least one position marker comprises a respective calibrated amount of each of the additional labels.

16. The assay test strip of claim 1, wherein the region of interest is a test region in the detection zone that comprises the immobilized test reagent, and the position marker is located over the flow path upstream of the test region.

17. The assay test strip of claim 16, wherein the at least one position marker comprises a second position marker over the flow path downstream of and adjacent to the test region.

18. The assay test strip of claim 1, wherein each of the at least one position marker comprises a respective electrical conductor on a surface of the test strip.

19. The assay test strip of claim 1, wherein the at least one position marker comprises a mechanical feature having a different surface profile on the test strip than adjacent areas of the test strip.

20. The assay test strip of claim 1, further comprising an illumination source calibration region exposed for optical inspection on a surface of the detection zone and capable of reflecting or emitting light within a target wavelength range.

21. The assay test strip of claim 20, wherein the illumination source calibration region has a reflection or emission greater than adjacent regions of the surface with respect to light within the target wavelength range.

22. The assay test strip of claim 20, wherein the illumination source calibration region comprises a metal film.

23. The assay test strip of claim 20, wherein the region of interest is a test region in the detection zone that comprises the immobilized test reagent, and the illumination source calibration region is located over the flow path upstream of the test region.

24. The assay test strip of claim 23, further comprising a second illumination source calibration region capable of reflecting or emitting light within the target wavelength range and located over the flow path downstream of the test region.

25. The assay test strip of claim 1, wherein the region of interest is a test region having the immobilized test reagent, and further comprising a control region in the detection zone having an immobilized control reagent that specifically binds the label;

wherein the at least one position marker comprises a first position marker adjacent the test region and a second position marker adjacent the control region, and each of the first and second position markers has an optical characteristic different from adjacent regions of a surface of the detection zone exposed for optical inspection.

26. The assay test strip of claim 25, wherein each of the first and second position markers has a different response than the label with respect to illuminating light within a target wavelength range.

27. The assay test strip of claim 25, wherein each of the first and second position markers comprises a respective calibrated amount of the label.