Volume-independent diagnostic test carrier and methods in which it is used to determine an analyte

• US 5,846,837 A
• Filed: 07/21/1997
• Issued: 12/08/1998
• Est. Priority Date: 07/23/1996
• Status: Expired due to Term

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Leininger, Helmut, Thym, Detlef
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/900,401
• Time in Patent Office: 505 Days
• Field of Search: 436/63, 436/86, 436/169, 436/170, 436/177, 436/178, 422/56, 422/58, 422/61, 422/100-104
• US Class Current: 436/170
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• 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 present invention concerns a diagnostic test carrier (1) containing a supporting layer (2) with a detection layer (3) arranged thereon containing the reagents required to determine analyte in a liquid sample and a network (4) covering the detection layer (3) which is larger than the detection layer (3) and which is attached to the supporting layer (2), which is characterized in that the network (4) is hydrophilic but not capillary active on its own and an inert cover (5) made of sample-impermeable material is arranged over the areas (6) of the network that extend beyond the detection layer in such a way that a sample application site (7) remains free on the region of the network (4) covering the detection layer as well as the use of such a test carrier for the determination of analyte in a liquid. In addition the invention concerns a method for the determination of an analyte in a liquid sample with the aid of a test carrier according to the invention.

Claims

1. A diagnostic test carrier for the determination of an analyte in a liquid sample, comprising

a supporting layer;

at least one detection layer which contains reagents to determine an analyte in a liquid sample, and which detection layer is located on the supporting layer;

a network which covers the at least one detection layer and is larger than the at least one detection layer such that the network extends beyond the at least one detection layer to the supporting layer, to which supporting layer the network is attached, wherein the network is hydrophilic but essentially not capillary active; and

a cover located over areas of the network which extend beyond each detection layer to define at least one sample application site which is not covered by the cover in the region of the network that covers the at least one detection layer;

wherein the network defines a capillary gap between the cover and the at least one detection layer, and the cover and the supporting layer, for the removal of excess liquid.

2. The diagnostic test carrier according to claim 1, wherein the supporting layer has a perforation, comprising at least one hole, over which at least one detection layer is located.

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

4. The diagnostic test carrier according to claim 3, wherein the liquid sample is a whole blood sample.

5. The diagnostic test carrier according to claim 1, wherein at least two detection layers are located next to one another on the supporting layer.

6. The diagnostic test carrier according to claim 5, wherein the perforation of the supporting layer comprises at least two holes over each of which a different detection layer is located.

7. The diagnostic test carrier according to claim 5, wherein each detection layer can detect separate analytes at the same time.

8. The diagnostic test carrier according to claim 1, wherein each detection layer contains at least two reaction zones, wherein each reaction zone has reagents capable of determining a different analyte.

9. The diagnostic test carrier according to claim 8, wherein the supporting layer contains a hole over which a detection layer containing the at least two reaction zones is located.

10. The diagnostic test carrier according to claim 6, wherein a sample application site is located over at least one detection layer.

11. The diagnostic test carrier according to claim 8, wherein a sample application site is located over at least one reaction zone.

12. The diagnostic test carrier according to claim 1, wherein the supporting layer is transparent.

13. The diagnostic test carrier according to claim 1, wherein the network is a monofilament fabric.

14. The diagnostic test carrier according to claim 1, wherein the network is attached to the supporting layer by means of an adhesive tape.

15. The diagnostic test carrier according to claim 1, wherein the cover and supporting layer are essentially impermeable to the liquid sample.

16. The diagnostic test carrier according to claim 1, wherein the network is a coarse-meshed monofilament fabric.

17. The diagnostic test carrier according to claim 1, wherein the at least one detection layer comprises at least one layer of material which is able to absorb the liquid together with the analyte to be determined contained therein.

18. The diagnostic test carrier according to claim 1, wherein the reagents for each of the at least one detection layers are impregnated in at least one layer of material.

19. The diagnostic test carrier according to claim 1, wherein the reagents for each of the at least one detection layers are coated on at least one layer of material.

20. The diagnostic test carrier according to claim 1, wherein each detection layer includes at least one layer which can separate plasma from whole blood.

21. The diagnostic test carrier according to claim 1, wherein the detection layer is a paper.

22. The diagnostic test carrier according to claim 1, wherein the detection layer is a porous plastic material.

23. The diagnostic test carrier according to claim 1, wherein the network is attached to the supporting layer beyond each detection layer by spacers which are about the same thickness as the detection layer.

24. A diagnostic test carrier for the determination of an analyte in a liquid sample, comprising

a supporting layer;

at least one detection layer which contains reagents to determine an analyte in a liquid sample, and which detection layer is located on the supporting layer;

a network which covers the at least one detection layer and is larger than the at least one detection layer such that the network extends beyond each detection layer to the supporting layer, to which supporting layer the network is attached, wherein the network is hydrophilic but essentially not capillary active; and

a cover located over areas of the network which extend beyond each detection layer to define at least one sample application site which is not covered by the cover in the region of the network that covers the at least one detection layer;

wherein the network defines a capillary gap between the cover and the detection layer, and between the cover and the supporting layer, for the removal of excess liquid; and

wherein the detection layer comprises a transparent foil having a bottom foil side defining the detection side of the detection layer, and a top non-foil side, wherein a first film layer is applied to the top non-foil side and a second film layer is applied thereon, wherein the first film layer while in a wet state scatters light less than the second film layer scatters light.

25. The diagnostic test carrier according to claim 24, wherein the transparent foil is polycarbonate.

26. The diagnostic test carrier according to claim 24, wherein the first film layer has a swelling agent.

27. The diagnostic test carrier according to claim 24, wherein the second film layer has a swelling agent and at least one pigment that scatters light strongly.

28. The diagnostic test carrier according to claim 24, wherein the second film layer contains a pigment which has a refractive index of at least 2.5.

29. The diagnostic test carrier according to claim 24, wherein the first film layer contains no fillers.

30. The diagnostic test carrier according to claim 24, wherein the first film layer contains fillers whose refractive index is about the refractive index of water.

31. The diagnostic test carrier according to claim 24, wherein the first film layer has a pigment of sodium aluminum silicate.

32. The diagnostic test carrier according to claim 24, wherein the second film layer has a pigment of titanium dioxide.

33. The diagnostic test carrier according to claim 24, wherein the first film layer and the second film layer contain a non-haemolyzing wetting agent.

34. The diagnostic test carrier according to claim 24, wherein the thickness of the first film layer and the second film layer together in the dry state are a maximum of 0.20 mm.

35. The diagnostic test carrier according to claim 24, wherein the thickness of the first film layer and the second film layer together in the dry state are a maximum of 0.08 mm.

36. The diagnostic test carrier according to claim 24, wherein the second film layer is about two times to about five times thicker than the first film layer.

37. A method of determining an analyte in a liquid sample, using a diagnostic test carrier comprising a supporting layer, at least one detection layer containing at least one reagent, wherein the at least one detection layer is located on the supporting layer, a network which covers the at least one detection layer and is larger than the at least one detection layer such that the network extends beyond the at least one detection layer to the supporting layer, to which supporting layer the network is attached, and wherein the network is hydrophilic but essentially not capillary active, a cover located over areas of the network which extend beyond each detection layer to define at least one sample application site which is not covered by the cover in the region of the network that covers each detection layer, wherein the network defines a capillary gap between the cover and the detection layer, and between the cover and the supporting layer, for the removal of excess liquid, comprising

applying the liquid sample at the at least one application site to the network, to pass the liquid sample through the network, and remove the excess sample by capillary action, wherein the liquid sample contacts at least one detection layer, to produce a detectable signal in the detection layer from the reaction of the sample with the reagents;

and

detecting the signal.

38. The method of determining an analyte in a liquid sample according to claim 37, wherein the detectable signal is a color change signal.

39. The method of determining an analyte in a liquid sample according to claim 37, wherein the liquid sample is a body fluid.

40. The method of determining an analyte in a liquid sample according to claim 39, wherein the liquid sample is blood.