COMBINED VISUAL/FLUORESCENCE ANALYTE DETECTION TEST

• US 20090289201A1
• Filed: 06/10/2009
• Published: 11/26/2009
• Est. Priority Date: 05/20/2008
• Status: Active Grant

• Current Assignee: Rapid Pathogen Screening, Inc
• Original Assignee: Rapid Pathogen Screening, Inc
• Inventors: Rivas, Richard JR., Kanaujia, Ganga, Sambursky, Robert P., VanDine, Robert W., Babu, Uma Mahesh
• Granted Patent: US 8,470,608 B2
• Time in Patent Office: Days
• US Class Current: 250/459.100
• 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 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/582 with fluorescent label

Abstract

The sensitivity of visually read lateral flow immunoassay tests is enhanced by adding a small quantity of fluorescing dye or fluorescing latex bead conjugates to the initial conjugate material. When the visible spectrum test line is visibly present, the test result is observed and recorded. However, in the case where the result is indeterminate, a light of an appropriate spectrum, such as a UV, visible, or infrared spectrum, is cast on the test line to excite and fluoresce the fluorescing latex beads which are bound in the test line in true positive tests to enhance the visible color at the test line.

Claims

1. A method for the detection of at least one target, comprising the steps of:

a) transferring a sample to a sample analysis device, wherein the sample analysis device comprises a plurality of visible labels and a plurality of fluorescing elements, wherein the visible labels and the fluorescing elements are each coupled with at least one specific binding partner for the target in the sample; and

b) analyzing the sample.

2. The method of claim 1, wherein the specific binding partner comprises an antibody or an antigen.

3. The method of claim 1, further comprising, before step a), the step of collecting the sample.

4. The method of claim 1, wherein step b) comprises the substeps of:

i) determining if a label is visible at a test zone of the sample analysis device; and

ii) if a visibility of the label is indeterminate, casting a fluorescent light source on the test zone to determine whether a result is positive.

5. The method of claim 4, wherein substep ii) enhances a sensitivity of the method at least tenfold compared to a method that only uses a visual label to determine a result.

6. The method of claim 4, wherein step b) is performed within 10 minutes of transferring the sample to the sample analysis device.

7. The method of claim 1, wherein step b) is performed within 10 minutes of transferring the sample to the sample analysis device.

8. The method of claim 1, wherein the visual labels are selected from the group consisting of a plurality of colloidal gold particles;

a plurality of dyed latex beads;

a plurality of selenium particles; and

a plurality of carbon particles.

9. The method of claim 1, wherein the fluorescing element is a fluorescing dye.

10. The method of claim 1, wherein the fluorescing element comprises a plurality of colorless fluorescing latex beads.

11. The method of claim 10, wherein a volume of the fluorescing latex beads coupled with the specific binding partner is approximately 0.1% to 10% of a volume of the visible labels coupled with the specific binding partner.

12. The method of claim 1, wherein the visible labels and the fluorescing elements are blocked with a blocking agent.

13. The method of claim 12, wherein the blocking agent is bovine serum albumin.

14. The method of claim 1, wherein the sample analysis device comprises at least two test lines to determine a presence of at least two targets.

15. The method of claim 1, wherein the sample analysis device comprises a single test line to determine a presence of at least two targets.

16. The method of claim 1, wherein a visible color of the visible label is the same as a fluorescing color of the fluorescing element.

17. The method of claim 1, wherein a visible color of the visible label is different than a fluorescing color of the fluorescing element.

18. A method for the detection of at least one target, comprising the step of using a plurality of fluorescing elements coupled to a first plurality of a specific binding partner for the target and at least one visual label coupled to a second plurality of the specific binding partner for the target to determine a presence of the target in a single assay.

19. A test kit comprising:

a) a collection device for collecting a sample; and

b) a sample analysis device comprising reagents for determining the presence and/or amount of at least one target, wherein the reagents comprise a plurality of visible labels and a plurality of fluorescing elements, wherein the visible labels and the fluorescing elements are each coupled with at least one specific binding partner for at least one target in the sample.

20. A sample analysis device for detection of at least one target, comprising:

a) an application zone for applying a sample to the sample analysis device;

b) a detection zone for detecting the analyte; and

c) a plurality of visible labels and a plurality of fluorescing elements, wherein the visible labels and the fluorescing elements are each coupled with at least one specific binding partner for the target in the sample.