Wedge shaped test strip system useful in analyzing test samples, such as whole blood

• US 5,082,626 A
• Filed: 08/08/1988
• Issued: 01/21/1992
• Est. Priority Date: 08/08/1988
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Grage, Henry M. Jr.
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): Alexander, Lyle A.
• Application Number:
  US07/230,303
• Time in Patent Office: 1,261 Days
• Field of Search: 422/56, 422/58, 436/165, 436/169
• US Class Current: 422/408
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/54386 Analytical elements

Abstract

An apparatus useful in analyzing samples, such as body fluids, is presented. The device is especially useful in analyzing whole blood because its configuration, with a differential vertical dimension permits rapid flow and uniform draw through the device, with contact of the relevant portion of the sample to a reagent means. Also disclosed is a method for analyzing a sample using the device.

Claims

1. Apparatus for analysis of a fluid sample, comprising:

a carrier means and a covering means, each of which has two end portions and two sides between said two end portions, wherein a portion of said carrier means and said covering means are joined and a second portion of said carrier means and said covering means are joined to form a hollow space between said covering means and said carrier means, wherein said joined first portions have a greater vertical dimension than said joined second portions so as to form a wedge shape thereby, said covering means having a sample application port positioned thereon, a fluid transport facilitating means positioned in said hollow space beginning at said first end and terminating before said second end, at least one reagent means positioned between said fluid transport facilitation means and said second end, and a fluid absorption means positioned between said at least one reagent means and said second end wherein there is hollow space even when the reagent means, fluid transport facilitating means and absorption means are positioned in the apparatus.

2. Apparatus of claim 1, wherein said joining means for said first end portion and said fluid transport facilitation means form a one piece construction.

3. Apparatus of claim 1, wherein said reagent means is a surface exposed reagent means.

4. Apparatus of claim 1, wherein said reagent means is a matrix exposed reagent means.

5. Apparatus of claim 1, wherein said reagent means is positioned on said covering means.

6. Apparatus of claim 1, wherein said reagent means is positioned on said carrier means.

7. Apparatus of claim 1, further comprising a flow regulating means positioned in said hollow space.

8. Apparatus of claim 1, further comprising a mesh means positioned in said hollow space and extending from at least a part of said reagent means and into said absorption means.

9. Apparatus of claim 1, wherein said carrier means and said reagent means are separated by a distance G defined by:

space="preserve" listing-type="equation">G=H1-D/D1 (H1-H2)-(T1+T2)

wherein H1 is the vertical dimension of said joined first ends, D is the distance between said first end and said reagent means at which horizontal point the value of G is desired, D1 is the distance between joined first and second ends, H2 is the vertical dimensions of said second end, T1 is the vertical dimension of said covering means, and T2 is the vertical dimension of said carrier means.

10. Apparatus of claim 1, wherein said port is treated with a surfactant.

11. Apparatus of claim 1, wherein said covering means and said carrier means are arranged parallel to each other for a portion of their length between said two end portions and are not parallel for the remaining portion between said two end portions.

12. Apparatus of claim 11, wherein said sample port is positioned in said parallel portion of said covering means.

13. Apparatus of claim 1, wherein said absorption means is in fluid contact with said reagent means.

14. Apparatus of claim 13, wherein said flow regulating means is positioned on said carrier means.

15. Method for determining an analyte in a sample comprising contacting said sample to the apparatus of claim 1 and determining a detectable signal with said reagent means as an indication of said analyte.

16. Method of claim 15, wherein said sample is whole blood.

17. Apparatus of claim 1, wherein said first and second ends are joined by joining means.

18. Apparatus of claim 17, wherein said joining removable means are removable.

19. Apparatus of claim 17, wherein said joining means are solid.

20. Apparatus of claim 17, wherein said joining means are hollow.

21. Apparatus of claim 17, wherein said joining means are cylindrical or rectangular.

22. Apparatus of claim 17, wherein said joining means comprise monofilament.

23. Apparatus of claim 17, wherein said joining means comprise double stick tape, hot melt, or glue.

24. Apparatus of claim 17, wherein said carrier means, first joining means and second joining means form a one piece construction.

25. Apparatus of claim 17, wherein said covering means and said joined first portion form an angle of from 0.6 to 1.6 degrees relative to said covering means and said joined second portion.

26. Apparatus of claim 17, wherein said carrier means, first joining means, fluid transport facilitation means and second joining means form a one piece construction.

27. Apparatus of claim 26, wherein said one piece construction is produced by extrusion processes.