Capillary test strip to separate particulates

• US 6,696,240 B1
• Filed: 10/25/2000
• Issued: 02/24/2004
• Est. Priority Date: 10/26/1999
• Status: Expired due to Fees

• Current Assignee: Hans Kloepfer
• Original Assignee: Micronix, Inc.
• Inventors: Roach, Charles W., Kloepfer, Hans G., Hafellner, Reinhard, Kloepfer, Mary A., Mlekusch, Bernd
• Primary Examiner(s): GITOMER, RALPH J
• Application Number:
  US09/696,156
• Time in Patent Office: 1,217 Days
• Field of Search: 435/4, 435/14, 435/287.9, 435/805, 435/970, 422/55-58, 436/169, 436/170
• US Class Current: 435/4
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/72 involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood

Abstract

A miniaturized, vented capillary channel test strip device for estimating the concentration of an analyte in a fluid is disclosed. The channel transports analysis fluid through interior capillary space defined by the plastic casing of the device. The casing is preferably manufactured by flow injection molding. The capillary channel includes a reaction and a wicking component. Movement of analysis fluid from sampling to reaction to wicking site is enabled by a gradient of capillary force. The gradient is generated by a differential in surface/volume ratio between reaction and wicking component. The reaction component is comprised of a thin reagent film embodying the reactive chemicals, as well as a rehydrating polymer. The polymer absorbs a defined volume of analysis fluid. When the analysis fluid is whole blood, the polymer absorbs blood plasma. Surprisingly and uniquely, cellular component of blood is wholly removed from the reagent film surface by the gradient of capillary force. In this fashion, the reacted test field becomes exposed for visual or instrumented quantification of analyte.

Claims

1. A test strip device for testing a fluid containing an analyte, comprising a collection component comprising an inlet, a collection capillary structured to draw said fluid into said collection component via said inlet by exerting capillary forces upon said fluid applied to said inlet, and a film operable to collect said analyte from said fluid as said fluid is drawn over said film;

and

a wicking component coupled to said collection component and structured to draw said fluid over said film and into said wicking component by exerting capillary forces on the fluid, whereby the wicking component, without the aid of a filtration device, exerts sufficient capillary forces on the fluid to effectively sweep said film free of particulate matter contained in said fluid.

2. A test strip device for testing a fluid containing an analyte, comprising:

a collection component comprising an inlet, a collection capillary structured to draw said fluid into said collection component via said inlet by exerting capillary forces upon said fluid applied to said inlet, and a film operable to collect said analyte from said fluid as said fluid is drawn over said film; and

a wicking component coupled to said collection component and structured to draw said fluid over said film and into said wicking component, whereby the wicking component exerts sufficient capillary forces on the fluid to effectively sweep said film free of particulate matter of said fluid, without employing filtration materials.

3. The test strip device of claim 2, wherein said fluid is whole blood and said particulate matter comprises cellular matter contained in said blood.

4. The test strip device of claim 2, wherein said wicking component comprises absorbent material positioned to draw said fluid from said film and into said wicking component.

5. The test strip device of claim 2, wherein said wicking component comprises a wicking capillary structured to draw said fluid from said collection component and into said wicking component and whereby the wicking component exerts sufficient capillary forces on the fluid to effectively sweep said film free of particulate matter of said fluid, without employing filtration or other mechanical removal materials.

6. The test strip device of claim 5, wherein the capillary force exerted on said fluid by said wicking component is greater than the force exerted on said fluid by the collection component.

7. The test strip device of claim 5, wherein said wicking component has a greater surface-to-volume ratio than said collection component in order to induce a gradient of capillary force upon said fluid, the gradient facilitating fluid transport from the collection component to the wicking component.

8. The test strip device of claim 2, wherein said wicking component comprises a plurality of wicking capillaries structured to draw said fluid from said collection component and into said wicking component.

9. The test strip device of claim 2, wherein said film absorbs said analyte as said fluid flows over said film.

10. The test strip device of claim 2, wherein said film comprises at least one water soluble polymer.

11. The test strip device of claim 2, wherein said film comprises at least one water insoluble polymer.

12. The test strip device of claim 2, wherein said film is selected from the group consisting of vinylacrylate polymer, ether acrylate polymer, vinylacrylate copolymer and ether acrylate copolymer, urethane/methylpyrolidone hybrid polymer, and vinylacetate.

13. The test strip device of claim 2, wherein said film is transparent and comprises at least one reagent that reacts with said analyte to produce a product suitable for analyzing said analyte with transmittance photometry.

14. The test strip device of claim 13, wherein said product produced by said at least one reagent and said analyte causes said transmittance photometry to generate a signal that is substantially proportional to analyte concentration.

15. The test strip device of claim 2, wherein said film is opaque and comprises at least one reagent that reacts with said analyte to produce a product suitable for analyzing said analyte with reflectance photometry.

16. The test strip device of claim 2, wherein said film comprises at least one reagent that reacts with said analyte to produce a product suitable for analyzing said analyte with fluorimetry.

17. The test strip device of claim 2, wherein said film comprises at least one reagent that reacts with said analyte to produce a product suitable for analyzing said analyte with luminescence photometry.

18. A test strip device for testing a fluid containing an analyte, comprising:

a collection component comprising an inlet, a collection capillary structured to draw said fluid into said collection component via said inlet by exerting capillary forces upon said fluid applied to said inlet, and a film operable to collect said analyte from said fluid as said fluid is drawn over said film; and

a wicking component coupled to said collection component and structured to draw said fluid over said film and into said wicking component by exerting capillary forces on the analyte fluid, wherein said collection component and said wicking component are collectively structured with a particular dimension that progressively decreases cross sectional area from said inlet to said wicking component in order to facilitate a general increase in capillary force exerted upon said fluid as said fluid flows from said inlet to said wicking component, whereby the wicking component without the aid of a filtration device exerts sufficient capillary forces on the fluid to effectively sweep said film free of particulate matter contained in said fluid.

19. The test strip device of claim 18 wherein said collection component and said wicking component are collectively structured having at least two transition steps in a particular dimension in order to facilitate a general increase in capillary force exerted upon said fluid as said fluid flows from said inlet to said wicking component.

20. The test strip device of claim 18, wherein said wicking capillary comprises a venting channel operable to relieve pressure within said wicking capillary as said wicking capillary fills with said fluid, and the cross sectional area decreases in a generally continuous manner from said inlet to said wicking component to thereby generally continuously increase the surface to volume ratio of the collection component.

21. A test strip device for testing blood glucose levels, comprising a first translucent plate coupled to a second translucent plate that collectively include:

a collection component comprising

an entry capillary comprising an inlet and an entry vessel that are structured to exert capillary forces on whole blood applied to said inlet in order to draw said whole blood into said entry vessel,

a collection capillary comprising a collection inlet coupled to said entry vessel and a collection vessel that are structured to draw blood from said entry capillary into said collection vessel by exerting capillary forces on said whole blood in said entry vessel, and a translucent reagent film on at least one wall of said collection capillary, said translucent reagent film comprising a glucose oxidase reagent that reacts with glucose in said whole blood as said glucose diffuses into said translucent reagent film; and

a wicking capillary comprising a wicking inlet coupled to said collection vessel and a wicking vessel that are structured to effectively sweep said translucent reagent film free of red blood cells as said whole blood is drawn over said film and into said wicking vessel, without filtration materials.

22. The test strip device of claim 21, wherein said collection component and said wicking capillary are collectively structured with at least two transition steps in a particular dimension in order to facilitate a general increase in capillary force exerted upon said whole blood as said whole blood is drawn from said inlet of said collection component into said wicking vessel.

23. The test strip device of claim 22, wherein said wicking capillary comprises a venting channel toward an end of said wicking vessel that is distal from said wicking inlet, said venting channel operable to relieve pressure within said wicking capillary as said wicking capillary fills with said whole blood.

24. The test strip device of claim 23, wherein said collection component and said wicking capillary are collectively structured with a particular dimension that decreases in a generally continuous manner from said inlet to said venting channel in order to facilitate a general increase in capillary force exerted upon said whole blood as said whole blood is drawn from said inlet toward said venting channel of said wicking capillary.