Multilayer analysis element

• US 4,870,005 A
• Filed: 10/16/1985
• Issued: 09/26/1989
• Est. Priority Date: 10/15/1980
• Status: Expired due to Term

• Current Assignee: Fuji Photo Film Co Limited (Fujifilm Holdings Corporation)
• Original Assignee: Fuji Photo Film Co Limited (Fujifilm Holdings Corporation)
• Inventors: Akiyoshi, Yutaka, Kitajima, Masao, Kondo, Asaji
• Primary Examiner(s): Richman, Barry S.
• Assistant Examiner(s): Johnston, Jill
• Application Number:
  US06/787,713
• Time in Patent Office: 1,441 Days
• Field of Search: 422/55-57, 436/169, 436/170, 436/810, 435/7, 435/805
• US Class Current: 435/7.93
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A dry type multilayer analysis element comprises at least one porous medium layer comprising a membrane filter, to which an antigen (or antibody) is immobilized, and at least one reagent layer through which a substance(s) which did not participate in an antigen-antibody reaction can permeate.

The multilayer analysis element is effective for assaying components present in body fluids, blood, urine, etc., in a simple manner.

Claims

1. A multilayer analysis element comprising:

(A) a spreading layer consisting essentially of a textile;

(B) a porous medium layer having immobilized therein a substance which causes a competitive antigen-antibody reaction to form a bound antigen-antibody complex; and

(C) a reagent layer which permeates an unbound free antigen or antibody, wherein the porous medium layer is selected from the group consisting of a membrane filter, woven or knitted fabrics, a non-woven fabric and a water-permeable paper and is interposed between said spreading layer and said reagent layer and the reagent layer comprises a porous material and, as a binder a hydrophilic high molecular weight substance

2. The multilayer analysis element as claimed in claim 1, wherein the substance which causes a competitive antigen-antibody reaction to form a bound antigen-antibody complex is immobilized in the interior of said porous medium layer.

3. The multilayer analysis element as claimed in claim 1 or 2 wherein said porous medium layer comprises a porous material having a void of from about 20 to about 90%.

4. The multilayer analysis element as claimed in claim 3 wherein said porous medium layer has a thickness of about 50 μ

m to about 1 mm.

5. The multilayer analysis element as claimed in claim 1 wherein said textile is a plain weave formed by weaving warp and weft yarns alternately.

6. The multilayer analysis element as claimed in claim 1 wherein said porous medium layer has a thickness of about 50 μ

m to about 1 mm.

7. The multilayer analysis element as claimed in claim 1 wherein said reagent layer has a thickness of 5 to about 200 μ

m.

8. The. multilayer analysis element as claimed in claim 1 wherein a radiation blocking layer is provided between said porous medium layer and said reagent layer.

9. The multilayer analysis element as claimed in claim 8 wherein said radiation blocking layer is a light reflection or absorption layer and has a thickness of about 1 to about 50 μ

m.

10. The multilayer analysis element as claimed in claim 8 or 9 wherein said radiation blocking layer comprises a hydrophilic high molecular weight substance containing 0.5 to 20 wt % of carbon black.

11. The multilayer analysis element as claimed in claim 1 wherein 0.1 to 10 wt % of carbon black is contained in said porous medium layer.

12. The multilayer analysis element as claimed in claim 1 wherein said substance causing a competitive antigen-antibody reaction is an antibody or antigen and said substance which did not undergo the antigen-antibody reaction is an unreacted labelled antigen or unreacted labelled antibody.

13. The multilayer analysis element as claimed in claim 1 wherein the hydrophilic high molecular weight substance is a natural hydrophilic high molecular weight substance.

14. The multilayer analysis element as claimed in claim 13, wherein the natural hydrophilic high molecular weight substance is selected from the group consisting of gelatin, agarose, sodium alginate, carboxymethyl, cellulose and methyl cellulose.

15. The multilayer analysis element as claimed in claim 1 wherein the hydrophilic high molecular weight substance is a synthetic hydrophilic high molecular weight substance selected from the group consisting of polyacryl mide, polyvinyl alcohol, polyvinyl pyrrolidone, sodium polyacrylate, poly hydroxyethyl methacrylate, and copolymers containing maleic acid.

16. The multilayer analysis element as claimed in claim 15 wherein the synthetic hydrophilic high molecular weight substance is selected from the group consisting of polyacrylamide, sodium polyacrylate and copolymers containing acrylic acid.

17. The multilayer analysis element as claimed in claim 1, wherein the porous medium is a membrane filter.

18. The multilayer analysis element as claimed in claim 1, wherein the textile of the spreading layer is hydrophilic.

19. The multilayer analysis element as claimed in claim 1, wherein the hydrophilic high molecular substance is polyacrylamide.

20. The multilayer analysis element as claimed in claim 1, further comprising a transparent support which is light-transmitting and which supports in sequence the reagent layer, the porous medium layer and the spreading layer.

21. The multilayer analysis element as claimed in claim 20, wherein the porous medium layer is a membrane filter.

22. The multilayer analysis element as claimed in claim 20, wherein the textile of the spreading layer is hydrophilic.

23. The multilayer analysis element as claimed in claim 20, wherein the hydrophilic high molecular weight substance is polyacrylamide.

24. The multilayer analysis element as claimed in claim 20, wherein the substance which causes a competitive antigen-antibody reaction to form a bound antigen-antibody complex is immobilized in the interior of the porous medium layer

25. The multilayer analysis element as claimed in claim 20, wherein a radiation blocking layer is provided between the porous medium layer and the reagent layer.

26. The multilayer analysis element as claimed in claim 20, wherein the hydrophilic high molecular weight substance is selected from the group consisting of gelatin, agarose, sodium alginate, carboxymethyl cellulose and methyl cellulose

27. The multilayer analysis element as claimed in claim 20, wherein the hydrophilic high molecular weight substance is a synthetic hydrophilic high molecular weight substance selected from the group consisting of polyacrylamide, polyvinyl alcohol, polyvinyl pyrrolidone, sodium polyacrylate, poly hydroxyethyl methacrylate, and copolymers containing maleic acid.

28. The multilayer analysis element as claimed in claim 20, wherein the synthetic hydrophilic high molecular weight substance is selected from the group consisting of polyacrylamide, sodium polyacrylate and polymers containing acrylic acid.

29. An integral multilayer analysis element comprising:

(a) a porous medium layer having immobilized therein a substance which causes a competitive antigen-antibody reaction to form a bound antigen-antibody complex, and

(b) a reagent layer which permeates an unbound free antigen or antibody,

wherein said porous medium layer comprises a textile and said reagent layer comprises a hydrophilic high molecular weight substance as a binder.

30. The multilayer analysis element as claimed in claim 29, wherein a transparent support having a light transmitting capability is provided on the back surface opposite the surface on which the porous medium layer is provided.

31. The multilayer analysis element as claimed in claim 29, wherein said textile is a plain weave formed by weaving warp and weft yarns alternately.

32. The multilayer analysis element as claimed in claim 29, wherein the substance which causes a competitive antigen-antibody reaction to form a bound antigen-antibody complex is immobilized in the interior of the porous medium layer.

33. The multilayer analysis element as claimed in claim 29, wherein a radiation blocking layer is provided between the porous medium layer and the reagent layer.

34. The multilayer analysis element as claimed in claim 29, wherein the hydrophilic high molecular weight substance is selected from the group consisting of gelatin, agarose, sodium alginate, carboxylmethyl cellulose and methyl cellulose.

35. The multilayer analysis element as claimed in claim 29, wherein the reagent layer is a hydrophilic high molecular weight substance and said hydrophilic high molecular weight substance is a synthetic hydrophilic high molecular weight substance selected from the group consisting of polyacrylamide, polyvinyl alcohol, polyvinyl pyrrolidone, sodium polyacrylate, poly hydroxyethyl methacrylate, and copolymers containing maleic acid.

36. The multilayer analysis element as claimed in claim 31 wherein the reagent layer is a hydrophilic high molecular weight substance and said hydrophilic high molecular weight substance is selected from the group consisting of polyacrylamide, sodium polyacrylate and polymers containing acrylic acid.

37. The multilayer analysis element as claimed in claim 29 wherein the reagent layer is a hydrophilic high molecular weight substance and said hydrophilic high molecular weight substance is polyacrylamide.

38. A multilayer analysis element comprising:

(A) a spreading layer consisting essentially of a textile;

(B) a porous medium layer having immobilized therein a substance which causes a competitive antigen-antibody reaction to form a bound antigen-antibody complex; and

(C) a reagent layer which permeates an unbound free antigen or antibody, wherein the porous medium layer is selected from the group consisting of a membrane filter, woven or knitted fabrics, a non-woven fabric and a water-permeable paper and is interposed between said spreading layer and said reagent layer and the reagent layer comprises a hydrophilic high molecular weight substance as a binder.

39. The multilayer analysis element as claimed in claim 38, further comprising a transparent support which is light-transmitting and which supports in sequence the reagent layer, the porous medium layer and the spreading layer.

40. The multilayer analysis element as claimed in claim 38, wherein a radiation blocking layer is provided between said porous medium layer and said reagent layer.

41. The multilayer analysis element as claimed in claim 38, wherein the hydrophilic high molecular weight substance is selected from the group consisting of gelatin, agarose, sodium alginate, carboxylmethyl cellulose and methyl cellulose.

42. The multilayer analysis element as claimed in claim 38, wherein the hydrophilic high molecular weight substance is a synthetic hydrophilic high molecular weight substance selected from the group consisting of polyacrylamide, polyvinyl alcohol, polyvinyl pyrrolidone, sodium polyacrylate, poly hydroxyethyl methacrylate, and copolymers containing maleic acid.