Rapid self-contained assay format

• US 5,824,268 A
• Filed: 10/14/1997
• Issued: 10/20/1998
• Est. Priority Date: 05/19/1995
• Status: Expired due to Fees

• Current Assignee: Committee Of Unsecured Creditors Of Medical Diagnostic Products, Inc., Wood Gundy Limited
• Original Assignee: Universal Health Watch, Inc.
• Inventors: Wier, Majorie, Bernstein, David, Trainor, William, Childs, Mary Ann, Gray, Erick
• Primary Examiner(s): LUDLOW, JAN M
• Application Number:
  US08/950,331
• Time in Patent Office: 371 Days
• Field of Search: 422/56, 422/58, 422/61, 436/180, 436/530, 436/528, 436/531, 436/161, 435/7.1, 435/969, 435/970, 435/975, 435/7.94, 435/7.92
• US Class Current: 422/408
• CPC Class Codes: B01D 15/3804 Affinity chromatography
• CPC Class Codes: G01N 30/02 Column chromatography
• CPC Class Codes: G01N 33/538 by sorbent column, particles or resin strip , i.e. sorbent materials
• CPC Class Codes: G01N 33/54386 Analytical elements
• 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: Y10S 435/97 Test strip or test slide

Abstract

A test strip, a device incorporating the test strip and a method for use of the test strip within the device detecting an analyte in a solution or bodily fluid are disclosed. The test strip was three zones, a reaction zone coated with a substance that binds the analyte, a sample zone with a region for addition of the sample of solution or fluid, and a detection region zone with a region coated with detection reagent. An absorbent pad underlies the reaction zone. The reaction zone is a small membrane and is physically in contact on its upper surface with both the sample zone and the detection zone. The test strip is incorporated into a device which includes a sample collection/transferring device, a housing for holding the test strip, and a container for holding solvent solutions at both outer ends of the test strip such that the solvent solutions can come into contact with the outer ends of the test strip when pressure is applied to the ends. The method involves placing a sample onto the strip using the sample collection/transferring device, causing solvent solutions to come into contact with the sample and detection membranes, and observing the test results. The resulting orthogonal buffer flow is an improvement over current methods because it reduces the number of steps and the time required for performance of a sequential assay.

Claims

1. A test strip for use in determining analyte in a test sample, comprising:

(a) a reservoir consisting essentially of an absorbent pad;

(b) a reaction zone lying directly above the reservoir comprising an upper surface and a lower surface, a first portion of the upper surface containing analyte binding substance and a second portion lacking the substance, and wherein the lower surface is in physical contact with the reservoir pad;

(c) an elongated sample zone lying above and in physical contact with a portion of the upper surface of the reaction zone that does not contain analyte binding substance; and

(d) an elongated detection reagent zone lying above and in physical contact with the portion of the upper surface of the reaction zone that does not contain analyte binding substance,

wherein the sample and detection reagent zones lie opposite each other over the reaction zone with their long axes perpendicular to the physical contact between the lower surface of the reaction zone and the reservoir.

2. The test strip of claim 1, wherein said reaction zone, said sample zone, and said detection reagent zone comprise separate chromatographic materials.

3. The test strip of claim 1 further comprising a water impermeable housing which holds said reservoir, said reaction zone, said sample zone and said detection zone, and wherein the housing comprises an orifice for admission of said test sample.

4. The test strip of claim 3 further comprising a water solution reagent.

5. The test strip of claim 3 further comprising a test sample collecting/transferring device having a size that matches the size of said orifice to allow a surface of said test sample collecting/transferring device to enter said housing.

6. The test strip of claim 5 wherein said test sample collecting/transferring device has a width equal to the width of said sample zone.

7. The test strip of claim 5 wherein said test sample is whole blood.

8. The test strip of claim 7 wherein said test sample collecting/transferring device comprises an absorbent that traps red blood cells.

9. A test strip for use in determining analyte in a test sample, comprising:

(a) a reservoir consisting essentially of an absorbent pad;

(b) a reaction zone lying directly above the reservoir comprising an upper surface and a lower surface, a first portion of the reaction zone containing analyte binding substance and a second portion of the reaction zone lacking the binding substance, wherein the lower surface of the first portion but not of the second portion is in physical contact with the reservoir;

(c) an elongated sample zone lying above and in physical contact with the upper surface of the second portion of the reaction zone; and

(d) an elongated detection reagent zone lying above and in physical contact with the upper surface of the second portion of the reaction zone,

wherein the sample and detection reagent zones lie opposite each other with their long axes perpendicular to the physical contact between the lower surface of the reaction zone and the reservoir.

10. The test strip of claim 9 wherein said first portion of reaction zone is a narrow line placed perpendicular to said long axes of the sample and detection reagent zones.

11. The test strip of claim 9 further comprising a water solution reagent.

12. The test strip of claim 9 further comprising a water impermeable housing which holds said reservoir, said reaction zone, said sample zone and said detection zone, and wherein the housing comprises an orifice with a size suitable for admitting said test sample within the housing.

13. The test strip of claim 12 further comprising a test sample collecting/transferring device having a size that matches said orifice size to allow a surface of the test sample collecting/transferring device to enter said housing.

14. The test strip of claim 13 wherein said test sample collecting/transferring device has a width equal to the width of said sample zone.

15. The test strip of claim 14, wherein said test sample is whole blood.

16. The test strip of claim 15 wherein said test sample collecting/transferring device comprises an absorbent that traps red blood cells.