Element for analyzing body fluids

• US 5,023,052 A
• Filed: 01/23/1989
• Issued: 06/11/1991
• Est. Priority Date: 01/20/1988
• 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: Tanaka, Mitsutoshi, Nagatomo, Shigeru
• Primary Examiner(s): Lacey, David L.
• Assistant Examiner(s): WARDEN, JILL ALICE
• Application Number:
  US07/300,123
• Time in Patent Office: 869 Days
• Field of Search: 422/56, 422/57, 422/58, 436/169, 436/170, 435/805, 435/7
• US Class Current: 422/421
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: Y10S 435/805 Test papers

Abstract

A multi-layer analytical element for analyzing body fluids includes a light transmitting and water impermeable support having provided thereon a fist non-fibrous porous layer, a second non-fibrous porous layer, and a fibrous porous layer in this order, the three porous layers being bonded together in one piece with an adhesive locally applied in such a manner that small through-holes are formed so as not to substantially interfere with uniform penetration of the liquid. At least one of the non-fibrous porous layers contains a reagent composition which undergoes a detectable optical change in the presence of a component to be analyzed, which optical change is detectable in the first non-fibrous porous layer, and wherein the non-fibrous porous layer comprises polysulfone. The analytical element enables dry analyses with improved precision independently of the hematocrit value of samples.

Claims

1. A multi-layer analytical element comprising in this order, a light transmitting and water impermeable support, a first non-fibrous porous layer, a second non-fibrous porous layer, and a fibrous porous layer, the three porous layers being locally bonded together with an adhesive to allow for through-holes so as not to substantially interfere with uniform penetration of a liquid therethrough, at least one of the non-fibrous porous layers containing a reagent composition which undergoes a detectable optical change in the presence of a component to be analyzed, said optical change being detectable in the first non-fibrous porous layer, wherein said first non-fibrous porous layer comprises a polysulfone.

2. The multi-layer analytical element as claimed in claim 1 wherein said reagent composition is present in the first non-fibrous porous layer.

3. The multi-layer analytical element as claimed in claim 1 wherein said second non-fibrous porous layer has an effective pore size of from 0.8 to 30 μ

m.

4. The multi-layer analytical element of claim 1 wherein the effective pore size of the first non-fibrous porous layer is not more than three times the effective pore size of the second non-fibrous porous layer.

5. The multi-layer analytical element of claim 1 wherein the void volume of the first non-fibrous porous layer is less than that of the second non-fibrous porous layer.

6. The multi-layer analytical element of claim 1 wherein an antibody or an antigen is incorporated into one of the porous layers.

15. In a method for the quantitative analysis of components of body fluids wherein a sample of the fluid to be analyzed is spotted onto a dry analytical element and an optical measurement is thereafter performed on the element, the improvement which comprises the element being the analytical element of claim 1.

16. In a method for the quantitative analysis of components of body fluids wherein a sample of the fluid to be analyzed is spotted onto a dry analytical element and an optical measurement is thereafter performed on the element, the improvement which comprises the element being the analytical element of claim 6.

7. A multi-layer analytical element comprising in this order, a light transmitting and water impermeable support, a water permeable layer, a first non-fibrous porous layer, a second non-fibrous porous layer, and a fibrous porous layer in this order, the three porous layers being bonded locally together with an adhesive to allow for through-holes so as not to substantially interfere with uniform penetration of a liquid therethrough, at least one of the water permeable layer and non-fibrous porous layers containing a reagent composition which undergoes a detectable optical change in the presence of a component to be analyzed, said optical change being detectable in the water permeable layer, wherein said first non-fibrous porous layer comprises polysulfone.

8. The element of claim 7 wherein said second non-fibrous porous layer has an effective pore size of from 0.8 to 30 μ

m.

9. The element of claim 7 wherein the reagent composition is contained in the water permeable layer or the first non-fibrous layer.

10. The element of claim 7 wherein the water-permeable layer is porous.

11. The element of claim 7 wherein the water-permeable layer is non-porous.

12. The element of claim 7 wherein the effective pore size of the first non-fibrous porous layer is not more than three times the effective pore size of the second non-fibrous porous layer.

13. The element of claim 7 wherein the void volume of the first non-fibrous porous layer is less than that of the second non-fibrous porous layer.

14. The element of claim 7 wherein an antibody or an antigen is incorporated into one of the porous layers.