Diagnostic test carrier with multilayer field

• US 6,036,919 A
• Filed: 07/21/1997
• Issued: 03/14/2000
• Est. Priority Date: 07/23/1996
• Status: Expired due to Term

• Current Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Original Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Inventors: Knappe, Wofgang-Reinhold, Lorenz, Robert, Pachl, Rudolf, Thym, Detlef, Merdes, Hartmut
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/897,513
• Time in Patent Office: 967 Days
• Field of Search: 422/56, 422/58, 422/61, 436/164, 436/166, 436/169-170, 436/175, 436/66-68
• US Class Current: 422/426
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: Y10T 436/25125 Digestion or removing interfering materials

Abstract

The present invention concerns a diagnostic test carrier for the determination of an analyte from whole blood with the aid of a reagent system contained in the carrier which includes a colour forming reagent with a test field which has a sample application side onto which the blood sample is applied and a detection side on which an optically detectable change takes place as a result of the reaction of analyte with the reagent system and which is constructed in such a way that erythrocytes present in the sample do not reach the detection side, which is characterized in that the test field comprises a transparent foil onto which a first and a second film layer are applied on top of one another and wherein the first layer located on the transparent foil scatters light considerably less in a wet state than the overlying second layer and wherein the side of the foil on which the first layer is applied which is opposite to the foil side is the detection side and the side of the second layer which is opposite to the side with which the second layer rests on the first is the sample application side. In addition the invention concerns a method for the determination of an analyte from whole blood with the aid of a diagnostic test carrier according to the invention.

Claims

1. A diagnostic test carrier for the determination of an analyte from a whole blood sample, comprising

a reagent system;

and

a test field, containing said reagent system, wherein the test field has a sample application side onto which a whole blood sample is applied, and a detection side which produces an optically detectable signal when the analyte reacts with the reagent system;

wherein the test field comprises a transparent foil, a first film layer applied to the top of the foil and a second film layer applied to the top of the first film layer so that the two film layers are fixedly attached one over the other in direct intimate contact with each other;

wherein the transparent foil has a foil side and a non-foil side, and the foil side is the detection side of the test field and the first film layer is applied to the non-foil side;

wherein when in a wet state the first film layer scatters light less than the second film layer scatters light;

wherein the test field is constructed such that erythrocytes present in the sample substantially do not reach the detection side of the test field; and

wherein the first film layer and second film layer are formed from (a) a dispersion of a polymeric film former which contains the polymeric film former and a swelling agent in a homogeneous dispersion, or (b) an emulsion of a polymeric film former which contains the polymeric film former and a swelling agent in a homogeneous emulsion, wherein the swelling capability of the swelling agent is at a level which allows the optically detectable change to be measured on the detection side after a maximum of one minute.

2. The diagnostic test carrier according to claim 1, wherein when in a dry state the thickness of the first film layer and the second film layer together are a maximum of 0.08 mm.

3. The diagnostic test carrier according to claim 1, wherein the reagent system is located in the first film layer.

4. The diagnostic test carrier according to claim 1, wherein the reagent system is located in both the first film layer and the second film layer.

5. The diagnostic test carrier according to claim 1, wherein the transparent foil is polycarbonate foil.

6. The diagnostic test carrier according to claim 1, wherein the first film layer contains no fillers.

7. The diagnostic test carrier according to claim 1, wherein the first film layer contains fillers whose refractive index is about the refractive index of water.

8. The diagnostic test carrier according to claim 1, wherein the second layer contains a pigment with a refractive index of at least 2.5.

9. The diagnostic test carrier according to claim 1, wherein the first film layer has a pigment of sodium aluminum silicate and the second film layer has a pigment of titanium dioxide.

10. The diagnostic test carrier according to claim 1, wherein the detectable signal is a color change signal.

11. The diagnostic test carrier of claim 1 wherein the first and second film layers are produced from coating compounds containing the same polymeric film formers.

12. The diagnostic test carrier of claim 1 wherein the first and second film layers are produced from coating compounds containing different polymeric film formers.

13. The diagnostic test carrier according to claim 1, wherein when in a dry state the thickness of the first film layer and the second film layer together are a maximum of 0.20 mm.

14. The diagnostic test carrier according to claim 13, wherein the second film layer is about two times to about five times thicker than the first film layer.

15. The diagnostic test carrier according to claim 1, wherein the first film layer and the second film layer contain a non-haemolyzing wetting agent.

16. The diagnostic test carrier according to claim 15, wherein the wetting agent of at least one film layer is N-octanoyl-N-methyl-glucamide.

17. A diagnostic test carrier for the determination of an analyte from a whole blood sample, comprising

a test field having a reagent system therein, wherein the test field has a sample application side onto which a whole blood sample is applied, and a detection side which produces an optically detectable signal when the analyte reacts with the reagent system, wherein the test field is constructed such that erythrocytes present in the sample do not reach the detection side of the test field, and wherein the test field comprises a transparent foil, a first film layer applied to the top of the foil and a second film layer applied to the top of the first film layer so that the two film layers are fixedly attached one over the other in direct intimate contact with each other, wherein the first film layer and the second film layer are both formed from (a) a dispersion of a polymeric film former which contains the polymeric film former and a swelling agent in a homogeneous dispersion, or (b) an emulsion of a polymeric film former which contains the polymeric film former and a swelling agent in a homogeneous emulsion, wherein the swelling capability of the swelling agent is at a level which allows the optically detectable change to be measured on the detection side after a maximum of one minute, wherein the transparent foil has a foil side and a non-foil side, and the foil side comprises the detection side of the test field, wherein the first film layer is applied to the non-foil side, and wherein the first film layer scatters light less in a wet state than the second film layer scatters light;

a supporting layer to which the detection side of the test field is attached;

a network which covers the sample application side of the test field, extends beyond the test field, and is attached to the supporting layer beyond the test field by means of spacers; and

a cover arranged over the areas of the network which extend beyond the test field and slightly cover the area of the test field on each side in such a way that a sample application site is substantially not covered by the cover in the region of the network that covers the test field;

wherein the network defines a capillary gap between the cover and the test field and the cover and the supporting layer, such that capillary liquid transport is possible for the removal of excess sample when the test field is saturated with liquid.

18. The diagnostic test carrier according to claim 17, wherein the detectable signal is a color change signal.

19. The diagnostic test carrier according to claim 17, wherein the spacers are about the same thickness as the test field.

20. The diagnostic test carrier according to claim 17, wherein the detection side of the test field is visible through the supporting layer.

21. The diagnostic test carrier according to claim 20, wherein the supporting layer is transparent such that the detection side of the test field is visible therethrough.

22. The diagnostic test carrier according to claim 20, wherein the supporting layer has at least one hole in the area of the detection layer, 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.

23. The diagnostic test carrier according to claim 17, wherein the network is a coarse, meshed, monofilament fabric.

24. The diagnostic test carrier according to claim 23, wherein the network is polyester.

25. The diagnostic test carrier according to claim 17, wherein the network is essentially non-absorptive and essentially does not allow capillary liquid transport, such that the greatest possible amount of blood is available for the test field.

26. The diagnostic test carrier according to claim 17, wherein the thickness of the network is such that if the test field becomes saturated, excess liquid is transported over the saturated test field and the filled meshes of the network by capillary force into the area of the network under the cover and away from the sample application site.

27. The diagnostic test carrier according to claim 26, wherein the thickness of the network is between 50 and 400 μ

m.