Test strip for lateral flow assays

• US 7,704,702 B2
• Filed: 08/10/2006
• Issued: 04/27/2010
• Est. Priority Date: 08/10/2006
• Status: Active Grant

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Inventors: Keren, Tomer, Dwir, Oren Shraga
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US11/502,256
• Publication Number:
  US 20080038759A1
• Time in Patent Office: 1,356 Days
• Field of Search: 436/158, 436/528, 436/538, 436/541, 436/808, 436/810, 436/518, 435/4, 435/7.1, 435/287.1, 435/287.2, 435/287.8, 435/287.9, 435/805, 435/7.4, 435/7.72
• US Class Current: 435/7.4
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A test strip configured for the detection of an analyte in a fluid sample and methods for manufacturing and for using the same. The test strip comprises a first flow matrix and a second flow matrix sequentially arranged to form an interface therebetween. The first flow matrix comprises a detection composition movably bound thereto, wherein the detection composition when exposed to the analyte produces at least one detectable product and wherein the first and second solid matrices are selected so as to accumulate the at least one detectable product at the interface between the two matrices, when the fluid sample travels from the first flow matrix to the second flow matrix.

Claims

1. A test strip configured for the detection of an analyte in a fluid sample, the strip comprising a first flow matrix and a second flow matrix sequentially arranged to form an interface therebetween, said first flow matrix comprises a detection composition movably bound thereto;

wherein the detection composition is selected to chemically react with said analyte to yield at least one detectable product;

wherein said at least one detectable product is a precipitate that does not comprise the analyte; and

wherein the first and second flow matrices are selected so as to accumulate said at least one detectable product at said interface when the fluid sample travels from the first flow matrix to the second flow matrix.

2. The strip of claim 1 wherein at least one component of said detection composition is deposited on said first matrix in a re-dissolvable dry form.

3. The strip of claim 1 wherein said first matrix is of higher porosity than said second matrix.

4. The strip of claim 1 wherein the transport rate of said at least one detectable product through the first matrix is higher than the transport rate of said at least one detectable product through the second matrix.

5. The strip of claim 1 wherein the first matrix is a glass fiber or a filter paper and wherein the second matrix is a nitrocellulose or a nylon membrane.

6. The strip of claim 1 wherein said analyte is soluble.

7. The strip of claim 1 wherein said detection composition is dissolvable in the sample fluid.

8. The strip of claim 1 wherein said first and second matrices are sandwiched between a backing and a top impermeable laminates.

9. The strip of claim 8 wherein at least one of said backing and top laminate is transparent or translucent.

10. The strip of claim 1 wherein said analyte is an enzyme and wherein said detection composition comprises a chromogenic substrate reagent system specific to said enzyme.

18. A method for detecting an analyte in a fluid sample, the method comprising the steps of:

providing a test strip as defined in claim 1;

loading a fluid sample onto the first flow matrix of said test strip; and

observing appearance of a color change at the interface between the first and second flow matrices;

wherein appearance of a distinguished color change indicates presence of the analyte in said fluid sample.

11. A strip for the detection of an enzyme in a fluid sample, the strip comprising a first matrix and a second matrix sequentially arranged on a non-absorbing solid support forming a junction therebetween,

wherein the first matrix is provided with a movably bound enzyme detection composition, which upon exposure to said enzyme produces at least one insoluble detectable product, said

detectable product does not comprise said enzyme;

and

wherein said first and second matrices are selected so as to accumulate said at least one detectable product at said junction when the fluid sample travels from the first flow matrix to the second flow matrix.

12. The strip of claim 11 wherein said enzyme detection composition comprises a chromogenic substrate of said enzyme.

13. The strip of claim 12 wherein said enzyme detection composition further comprises a color intensifier.

14. The strip of claim 12 wherein said substrate comprises an indoxyl group.

15. The strip of claim 14 wherein the enzyme detection composition further comprises a tetrazolium salt.

16. The strip of claim 11 wherein said enzyme detection composition comprises a substrate of said enzyme and a chromogenic reagent, wherein said chromogenic reagent yields a detectable colored product in the presence of enzymatic reaction between the enzyme and the enzyme substrate.

17. The strip of claim 16 wherein said chromogen reagent is an electron donor or an electron acceptor.

19. A test strip configured for the detection of a soluble analyte in a fluid sample, the strip comprising a first flow matrix and a second flow matrix sequentially arranged to form an interface therebetween, said first flow matrix comprises a detection composition movably bound thereto, wherein the detection composition is selected to react with said analyte to yield at least one insoluble detectable product which does not comprise said analyte, and wherein the first and second solid matrices are selected so as to accumulate said at least one detectable product at said interface when the fluid sample travels from the first flow matrix to the second flow matrix.