Diagnostic test carrier with a capillary gap

• US 5,851,838 A
• Filed: 07/21/1997
• Issued: 12/22/1998
• Est. Priority Date: 07/23/1996
• Status: Expired due to Fees

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Vogel, Peter, Fritz, Michael, Vetter, Peter, Macho, Heinz
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/897,509
• Time in Patent Office: 519 Days
• Field of Search: 422/56, 422/58, 422/61, 422/101, 422/102, 422/100, 436/68, 436/86, 436/169, 436/170, 436/177
• US Class Current: 436/170
• CPC Class Codes: G01N 33/526 the element being adapted for a specific analyte
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

The invention concerns a diagnostic test carrier (1) containing a supporting layer (2) with a detection layer (3) arranged thereon containing reagents required for the determination of an analyte in a liquid sample and an inert layer (4) covering the detection layer (3) wherein the inert layer (4) is arranged at such a distance (5) from the detection layer to enable a capillary active liquid transport between the detection layer and inert layer (3,4), characterized in that the inert layer (4) extends beyond the detection layer and wherein the area (10) that extends beyond the detection layer is attached to the supporting layer (2) in such a way that a continuous capillary active liquid transport between the inert layer and detection layer (4,3) and between the inert layer and supporting layer (4,2) is possible and in addition the inert layer (4) contains several holes (7) in the area of the detection layer (3) through which the sample to be examined and the components contained therein can be applied to the detection layer (3) as well as its use for the determination of an analyte in a liquid.

Claims

1. A diagnostic test carrier, comprising

a supporting layer;

a detection layer arranged on the supporting layer, said detection layer carrying reagents for the detection of an analyte in a liquid sample; and

an inert layer covering and extending beyond the detection layer onto the supporting layer, to which supporting layer the inert layer is attached,

wherein the inert layer contains at least one hole in the area of the inert layer covering the detection layer, through which at least one hole the liquid sample can be applied to the detection layer,

wherein the inert layer is spaced from the detection layer at a distance which allows a capillary liquid transport between the detection layer and the inert layer,

and wherein the inert layer is spaced from the supporting layer at a distance such that a capillary liquid transport between the inert layer and the supporting layer is also possible.

2. The diagnostic test carrier according to claim 1, wherein the supporting layer comprises a material which is essentially non-absorbent.

3. The diagnostic test carrier according to claim 2, wherein the supporting layer comprises a polyester foil.

4. The diagnostic test carrier according to claim 1, wherein the detection layer comprises a material that can absorb liquid.

5. The diagnostic test carrier according to claim 4, wherein the detection layer comprises a porous membrane.

6. The diagnostic test carrier according to claim 1, wherein the liquid sample is a body fluid.

7. The diagnostic test carrier according to claim 6, wherein the liquid sample is whole blood and the detection layer further comprises a layer which is able to separate plasma or serum from the whole blood.

8. The diagnostic test carrier according to claim 1, wherein the inert layer comprises a material which is essentially non-absorbent.

9. The diagnostic test carrier according to claim 1, wherein the inert layer has a plurality of holes exposing 30% to 80% of the surface area of the detection layer.

10. The diagnostic test carrier according to claim 1, wherein the inert layer has a plurality of holes exposing 40% to 70% of the surface area of the detection layer.

11. The diagnostic test carrier according to claim 1, wherein the distance between the inert layer and the supporting layer is less than the distance between the inert layer and the detection layer.

12. The diagnostic test carrier according to claim 1, wherein the distance between the inert layer and the supporting layer is between about 0.02 mm and about 1.2 mm.

13. The diagnostic test carrier according to claim 1, wherein the distance between the inert layer and the supporting layer is between about 0.4 mm and about 1 mm.

14. The diagnostic test carrier according to claim 1, wherein the distance between the inert layer and the detection layer is between about 0.02 mm and about 1.2 mm.

15. The diagnostic test carrier according to claim 1, wherein the distance between the inert layer and the detection layer is between about 0.4 mm and about 1 mm.

16. The diagnostic test carrier according to claim 1, wherein a plurality of spacers define the distance between the detection layer and the inert layer, and between the supporting layer and the inert layer, said spacers being distanced from one another such that capillary liquid transport is possible between the spacers and between the layers separated by the spacers.

17. The diagnostic test carrier according to claim 16, wherein the spacers are discrete hot-melt adhesive zones.

18. The diagnostic test carrier according to claim 17, wherein the hot-melt adhesive zones are attached to the inert layer, and the hot-melt adhesive zones are substantially unattached to the detection layer.

19. The diagnostic test carrier according to claim 16, wherein the spacers cover between 10% and 70% of the area between the spaced apart respective layers.

20. The diagnostic test carrier according to claim 16, wherein the spacers cover between 15% and 50% of the area between the respective layers to be kept at a distance from one another.

21. The diagnostic test carrier according to claim 1, wherein the detection layer has two sides and is visible from at least one side.

22. The diagnostic test carrier according to claim 21, wherein the supporting layer is substantially transparent to permit the detection layer to be visible therethrough.

23. The diagnostic test carrier according to claim 21, wherein the supporting layer has at least one hole, through which the detection layer is visible, and wherein the hole is smaller than the detection layer such that the detection layer contacts at least a portion of an area of the supporting layer surrounding the hole.

24. The diagnostic test carrier according to claim 1, wherein the detection layer has reagents embedded therein for the detection of an analyte in a liquid.

25. A method of using a diagnostic test carrier comprising a supporting layer;

a detection layer arranged on the supporting layer, said detection layer carrying reagents, and an inert layer covering and extending beyond the detection layer onto the supporting layer, to which said inert layer is attached, wherein the inert layer contains at least one hole in the area of the inert layer covering the detection layer, through which at least one hole a liquid sample containing analytes to be detected is applied to the detection layer, wherein the inert layer is spaced from the detection layer at a distance which allows a capillary liquid transport between the detection layer and the inert layer, and wherein the inert layer is spaced from the supporting layer at a distance such that a capillary liquid transport between the inert layer and the supporting layer is also possible, comprising

passing the liquid sample through the inert layer to the diagnostic layer, with removal of excess liquid through capillary action, to produce a detectable signal in the diagnostic layer from reaction of the liquid sample with the reagents in the diagnostic layer; and

detecting the signal.

26. The method of using a diagnostic test carrier according to claim 25, wherein the detectable signal is a color change signal.

27. The method of using a diagnostic test carrier according to claim 25, wherein the liquid sample is blood.

28. The method of using a diagnostic test carrier according to claim 25, wherein the detection layer has reagents embedded therein.

29. A diagnostic test carrier, comprising

a supporting layer;

a detection layer means, arranged on the supporting layer, for determining an analyte in a liquid sample; and

an inert layer means, spaced on the supporting layer and on the detection layer means, for holding the test carrier components together, for allowing transport therethrough from the exterior of the test carrier to the detection layer, and for defining a capillary space between the inert layer means and the detection layer means and between the inert layer means and the supporting layer, wherein excess liquid is removed through the capillary space by capillary action.