Analytical element and the analytical method using the element

• US 4,966,856 A
• Filed: 10/15/1987
• Issued: 10/30/1990
• Est. Priority Date: 06/19/1985
• Status: Expired due to Fees

• Current Assignee: Konishiroku Photo Industry Co., Ltd.
• Original Assignee: Konishiroku Photo Industry Co., Ltd.
• Inventors: Kawakatsu, Satoshi, Takekoshi, Masayo, Onishi, Akira, Ito, Tsukasa
• Primary Examiner(s): Marcus, Michael S.
• Assistant Examiner(s): Johnston, Jill
• Application Number:
  US07/110,096
• Time in Patent Office: 1,111 Days
• Field of Search: 422/56, 422/57, 422/58, 435/805, 435/4, 435/7, 435/28, 436/170, 436/804, 436/805, 436/172
• US Class Current: 436/170
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/581 with enzyme label (including co-enzymes, co-factors, enzyme inhibitors or substrates)
• CPC Class Codes: G01N 33/582 with fluorescent label
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/804 Radioisotope, e.g. radioimmunoassay
• CPC Class Codes: Y10S 436/805 Optical property

Abstract

An analytical element and method using the element for measuring a specific component in a fluid sample such as blood, serum, plasma, urine, sweat etc. The fluid sample is applied on the element with a labeled-material formed by binding the specific component or the analogue of it with a labeling material causing a signal. The element comprises a reaction layer and an absorption layer. The reaction layer contains a material which is capable of specifically binding with the component to be measured and the absorption layer contains a material which capable of binding with the labeled material and decreasing a signal caused by the labeling material. A strength of the signal caused labeled-material in the reaction layer is determined to measure the specific component.

Claims

1. An analytical element for measuring a specific component (X) in a fluid sample by means of competing reactions between a reaction of said component (X) with a material (R) which is capable of being specifically bound to said component (X) or an analogue (AX) of said component (X), and a reaction of a labeled-material (LX), which is formed from binding said specific component (X) or the analogue thereof (AX) with a labeling material (L), with said material (R), said analytical element comprising

a first layer containing said material (R) immobilized therein and, a second layer containing a material (A) which is capable of at least reducing a signal caused by said labeling material (L) in said labeled-material (LX) by specifically binding with a labeling portion of said labeled-material (LX), said first and said second layers being porous.

2. The analytical element of claim 1, wherein said material (A) is contained in said second layer in an immobilized state.

3. The analytical element of claim 2, wherein said material (R) contained in said first layer is an antigen which is capable of specifically binding with an antibody.

4. The analytical element of claim 2, wherein said material (R) contained in said first layer is an antibody which is capable of specifically binding with an antigen.

5. The analytical element of claim 4, wherein said labeling material (L) is an enzyme and said material (A) contained in said second layer is an enzyme inhibitor which is capable of specifically binding with said enzyme and of reducing an activity of said enzyme.

6. The analytical element of claim 2, further comprising a layer containing said labeled-material (LX).

7. The analytical element of claim 6, further comprising a layer containing a color-forming reagent which forms a color with an enzyme.

8. The analytical element of claim 2, further comprising a layer containing the labeled-material (LX) and a color-forming reagent.

9. The analytical element of claim 2, further comprising a timing layer provided between the first layer and the second layer.

10. The analytical element of claim 1, wherein said material (R) contained in said first layer is an antigen which is capable of specifically binding with an antibody.

11. The analytical element of claim 1, wherein said material (R) contained in said first layer is an antibody which is capable of specifically binding with an antigen.

12. The analytical element of claim 1, wherein said material (A) contained in said second layer is an enzyme inhibitor which is capable of specifically binding with an enzyme (being used as the labeling material (L) and of reducing an activity of said enzyme.

13. The analytical element of claim 1, wherein said material (A) is contained in said second layer is capable of specifically binding with the labeling portion of the labeled-material (LX) and of reducing a fluorecence as a signal caused by a fluorecent substance (being used as the labeling material (L)).

14. The analytical element of claim 1, wherein said element further comprises a layer containing said labeled-material (LX).

15. The analytical element of claim 1, wherein said element further comprises a layer containing a color-forming reagent which forms a color with enzyme material.

16. The analytical element of claim 1, wherein said element further comprises a layer containing the labeled-material (LX) and a color-forming reagent.

17. The analytical element of claim 1, 14, 15 or 16, wherein said element further comprises a timing layer provided between the first layer and the second layer.

18. A method for the measurement of a specific component (X) in a fluid sample by means of competing reactions between a reaction of said component (X) with a material (R) which is capable of being specifically bound with said component (X) or an analogue of said component (AX), and a reaction of a labeled-material (LX), which is formed from binding said component (x) or the analogue thereof (Ax) with a labeling material (L), with said material (R), said method comprising,

providing said fluid sample and said labeled-material (LX) into an analytical element comprising as its structural member;

a first layer containing said material (R) immobilized therein and, a second layer containing a material (A) which is capable of at least reducing a signal caused by said labeling material (L) in said labeled-material (LX) by specifically binding with a labeling portion of said labeled-material (LX), said first and said second layers being porous; and

measuring strength of signal caused by said labeling material (L).