Analytical element for the analysis of whole blood

• US 6,255,061 B1
• Filed: 12/15/1999
• Issued: 07/03/2001
• Est. Priority Date: 12/15/1998
• Status: Expired due to Fees

• Current Assignee: Fuji Photo Film Co Limited (Fujifilm Holdings Corporation)
• Original Assignee: Fuji Photo Film Co Limited (Fujifilm Holdings Corporation)
• Inventors: Amano, Yoshikazu, Arai, Takaki, Mori, Toshihiro
• Primary Examiner(s): Leary, Louise N.
• Application Number:
  US09/464,613
• Time in Patent Office: 566 Days
• Field of Search: 435/14, 435/28, 435/11, 435/4, 435/283.1, 435/287.1, 435/288.7, 435/966
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: C12Q 1/28 involving peroxidase
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: Y10S 435/966 involving an enzyme system with high turnover rate or complement magnified assay, e.g. multi-enzyme systems

Abstract

An analytical element for quantitative analysis of glucose, cholesterol, or lactic acid in whole blood, composed of a porous layer which has a void volume of 30 to 80% and containing peroxidase, a leuco dye which gives coloring having an absorption peak in the region of 600 to 700 nm, and an oxidase such as glucose oxidase, cholesterol oxidase, or lactate oxidase, respectively. The porous layer can be placed on a transparent support sheet via an adhesive layer in the form of dots or lines, or a hydrophilic adhesive layer.

Claims

1. An analytical element for quantitative analysis of glucose, cholesterol, or lactic acid in a whole blood sample, consisting essentially of a porous layer which has a void volume of 30 to 80% and containing peroxidase, a leuco dye which gives coloring having an absorption peak in the region of 600 to 700 nm, and an oxidase selected from the group consisting of glucose oxidase, cholesterol oxidase and lactate oxidase, respectively.

4. The analytical element of claim 1, wherein the porous layer is made of knitted fabric.

7. The analytical element of claim 1, wherein the porous layer has a thickness of 50 to 300 μ

m and contains the leuco dye in an amount of 1 to 10 g/m².

2. A multilayer analytical element for quantitative analysis of glucose, cholesterol, or lactic acid in a whole blood sample, consisting essentially of a light-transmissive support sheet and a porous layer which has a void volume of 30 to 80% and containing peroxidase, a leuco dye which gives coloring having an absorption peak in the region of 600 to 700 nm, and an oxidase selected from the group consisting of glucose oxidase, cholesterol oxidase and lactate oxidase, respectively, said support sheet and porous layer being combined to each other with an adhesive layer in the form of dots or lines.

5. The analytical element of claim 2, wherein the porous layer is made of knitted fabric.

8. The analytical element of claim 2, wherein the porous layer has a thickness of 50 to 300 μ

m and contains the leuco dye in an amount of 1 to 10 g/m².

3. A multilayer analytical element for quantitative analysis of glucose, cholesterol, or lactic acid in a whole blood sample, consisting essentially of a light-transmissive support sheet, a hydrophilic adhesive layer, and a porous layer which has a void volume of 30 to 80% and containing peroxidase, a leuco dye which gives coloring having an absorption peak in the region of 600 to 700 nm, and an oxidase selected from the group consisting of glucose oxidase, cholesterol oxidase and lactate oxidase, respectively, said adhesive layer being placed between the support sheet and porous layer.

6. The analytical element of claim 3, wherein the porous layer is made of knitted fabric.

9. The analytical element of claim 3, wherein the porous layer has a thickness of 50 to 300 μ

m and contains the leuco dye in an amount of 1 to 10 g/m².

10. A method for quantitatively analyzing glucose, cholesterol, or lactic acid in a whole blood sample, which comprises spotting the whole blood sample on an analytical element and measuring coloring appearing in the analytical element, said analytical element consisting essentially of a porous layer which has a void volume of 30 to 80% and containing peroxidase, a leuco dye which gives coloring having an absorption peak in the region of 600 to 700 nm, and an oxidase selected from the group consisting of glucose oxidase, cholesterol oxidase and lactate oxidase, respectively, and the measurement of coloring being made at a wavelength in the range of 600 to 700 nm.

13. The analytical method of claim 10, wherein the porous layer of the analytical element is made of knitted fabric.

16. The analytical method of claim 10, wherein the porous layer of the analytical element has a thickness of 50 to 300 μ

m and contains the leuco dye in an amount of 1 to 10 g/m².

11. A method for quantitatively analyzing glucose, cholesterol, or lactic acid in a whole blood sample, which comprises spotting the whole blood sample on a multilayer analytical element and measuring coloring appearing in the analytical element, said analytical element consisting essentially of a light-transmissive support sheet and a porous layer which has a void volume of 30 to 80% and containing peroxidase, a leuco dye which gives coloring having an absorption peak in the region of 600 to 700 nm, and an oxidase selected from the group consisting of glucose oxidase, cholesterol oxidase and lactate oxidase, respectively, wherein the support sheet and porous layer is combined to each other with an adhesive layer in the form of dots or lines, and the measurement of coloring being made at a wavelength in the region of 600 to 700 nm.

14. The analytical method of claim 11, wherein the porous layer of the analytical element is made of knitted fabric.

17. The analytical method of claim 11, wherein the porous layer of the analytical element has a thickness of 50 to 300 μ

m and contains the leuco dye in an amount of 1 to 10 g/m².

12. A method for quantitatively analyzing glucose, cholesterol or lactic acid in a whole blood sample, which comprises spotting the whole blood sample on a multilayer analytical element and measuring coloring appearing in the analytical element, said analytical element consisting essentially of a light-transmissive support sheet, a hydrophilic adhesive layer, and a porous layer which has a void volume of 30 to 80% and containing peroxidase, a leuco dye which gives coloring having an absorption peak in the region of 600 to 700 nm, and an oxidase selected from the group consisting of glucose oxidase, cholesterol oxidase and lactate oxidase, respectively, wherein the adhesive layer is placed between the support sheet and porous layer, and the measurement of coloring being made at a wavelength in the region of 600 to 700 nm.

15. The analytical method of claim 12, wherein the porous layer of the analytical element is made of knitted fabric.

18. The analytical method of claim 12, wherein the porous layer of the analytical element has a thickness of 50 to 300 μ

m and contains the leuco dye in an amount of 1 to 10 g/m².