Glucose test strip for whole blood

• US 5,418,142 A
• Filed: 10/13/1992
• Issued: 05/23/1995
• Est. Priority Date: 08/28/1989
• Status: Expired due to Term

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Tomasco, Michael F., Kiser, Ernest J., Rice, Edward G.
• Primary Examiner(s): Russel, Jeffrey E.
• Assistant Examiner(s): GITOMER, RALPH J
• Application Number:
  US07/960,579
• Time in Patent Office: 952 Days
• Field of Search: 435/4, 435/14, 435/25, 435/28, 422/56, 422/57, 422/101, 436/177, 436/95
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 33/48 Biological material, e.g. blood, urine G01N33/02, G01N33/26, G01N33/44, G01N33/46 take precedence; Haemocytometers counting blood corpuscules distributed over a surface by scanning the surface G06M11/02
• CPC Class Codes: G01N 33/521 Single-layer analytical elements

Abstract

A separation matrix impregnated with a separating agent separates red blood cells or hemoglobin from whole blood. Upon separation, an impregnated test reagent reacts with the separated substantially clear component fluid to form a colored product which enables a visual or meter test for glucose levels in whole blood.

Claims

1. A reagent test strip comprising:

a porous matrix having an internal surface which defines pores and upon which a separating coating and a test reagent are disposed;

an elongated support having two opposite ends said matrix overlying and affixed to at least a portion of said support at one end of said support; and

a porous disc overlying and affixed to said support at the opposing end of said support;

said matrix is capable of passing a sample of whole blood;

wherein said separating coating is capable of separating from said whole blood a substantially clear component fluid containing glucose;

said test reagent is capable of reacting with said analyte in said substantially clear component fluid to vary coloration of said matrix dependent upon the level of said analyte in said whole blood sample; and

the porous disc is secured to one end of said support and the matrix is secured to the opposing end of the support such that an unmeasured blood sample may be placed on said porous disc and thereafter the support can be manipulated to bring a portion of the porous disc into contact with the matrix, and the side of the matrix facing away from said porous disc can be visualized.

6. The reagent test strip of claim 1 wherein said testing reagent is:

4-aminoantipyrene with N-(m-tolyl)-diethanolamine.

2. A reagent test strip comprising:

a porous matrix of a material selected from the group consisting of polyesters, polyamides, polyolefins, and polysulfones, having a sample side and a test side and defining an internal surface, said matrix having disposed upon said internal surface throughout said matrix, both a separation coating and a testing reagent;

wherein said matrix, when applied on said test side with a sample of whole blood suspected of containing glucose is capable of accepting said whole blood sample so as to pass it toward said test side;

said separation coating is capable of separating from said whole blood a substantially clear component fluid containing said glucose;

said testing reagent is present in an amount effective for reacting with said glucose in said clear component fluid to vary coloration of the test side of said matrix, dependent upon the concentration level of the glucose in said fluid; and

said separation coating and said testing reagent being compatible with each other whereby said separating and reacting may occur simultaneously.

3. The reagent test strip of claim 2 wherein said testing reagent is:

3-methyl-2-benzothiazolinone hydrazone hydrochloride with 3,3-dimethylaminobenzoic acid.

4. The reagents test strip of claim 2 wherein said testing reagent is:

3-methyl-2-benzothiazolinone hydrazone hydrochloride with 3,5 dichloro-2-hydroxy-benzene sulfonic acid.

5. The reagent test strip of claim 2 wherein said testing reagent is:

4-aminoantipyrene with 5-oxo-1 (p-sulfophenyl)-2-pryrazoline-3-carboxylic acid.

7. The reagent test strip of claim 2 wherein said testing reagent is:

2,2'"'"'-azino-di(3-ethylenebenzthiazoline) sulfonic acid.

8. The reagent test strip of claim 2 wherein said matrix has a thickness of between 100 microns and 3000 microns and a porosity of between 0.5 microns and 150 microns.

9. The reagent test strip of claim 8 further comprising a porous disc on one side of said strip wherein an unmeasured blood sample may be placed on said porous disc such that said sample passes through said disc and a portion of said disc comes into contact with said matrix, and further wherein the side of said strip opposite said porous disc is visible.

10. A reagent test strip comprising:

a uniform porous matrix capable of absorbing a whole blood sample;

said matrix being selected from the group consisting of polyvinyl sulfonic acid, polyethylene glycol, polystyrene sulfonic acid, polyvinyl pyrrolidone, and polyacrylic acid;

said matrix divided into a separating portion and a reaction portion, said separating portion having a separation coating disposed upon an internal surface of the matrix suitable for separating said sample into red blood cells and a substantially clear fluid suspected of containing glucose and

said reaction portion of said matrix being capable of reacting with said glucose contained in said substantially clear fluid to vary the coloration of said matrix dependent on the concentration of said analyte in said fluid.

11. The reagent test strip of claim 10 wherein said matrix is selected from the group consisting of:

polyesters, polyamides, polyolefins, and polysulfones.

12. The reagent test strip of claim 10 wherein said reaction portion contains a test reagent present in an amount effective to vary the coloration of said reaction portion comprising

3-methyl-2-benzothiazoline hydrazone hydrochloride with 3,3-dimethylaminobenzoic acid.

13. The reagent test strip of claim 10 wherein said reaction portion contains a test reagent present in an amount effective to vary the coloration of said reaction portion comprising

3-methyl-2-benzothiazoline hydrazone hydrochloride with 3,5 dichloro-2-hydroxy-benzene sulfonic acid.

14. The reagent test strip of claim 10 wherein said reaction portion contains a test reagent present in an amount effective to vary the coloration of said reaction portion comprising

4-aminoantipyrene with 5-oxo-1 (p-sulfophenyl)-2-pyrazoline-3-carboxylic acid.

15. The reagent test strip of claim 10 wherein said reaction portion contains a test reagent present in an amount effective to vary the coloration of said reaction portion comprising

4-aminoantipyrene with N-(m-tolyl)-diethanolamine.

16. The reagent test strip of claim 10 wherein said reaction portion contains a test reagent present in an amount effective to vary the coloration of said reaction portion comprising

2,2-azino-di(3-ethylenebenzthiazoline) sulfonic acid.

17. A reagent test strip comprising:

a matrix having an internal surface and comprised of a polyamide;

said matrix containing a reaction agent comprising 3-methyl-2-benzothiazolinone hydrazone hydrochloride;

glucose oxidase;

horseradish peroxidase; and

3, 3-dimethylamino-benzoic acid;

said matrix containing a separating coating on said internal surface of said matrix comprising 25% by volume polyvinyl sulfonic acid at pH 4.5 and 1% by weight bentonite;

wherein said matrix is capable of separating whole blood into read blood cells and a substantially clear fluid suspected of containing glucose, said reaction agent reacting with any glucose in said substantially clear fluid to color said matrix, said color intensity varying with the concentration level of glucose in said fluid.

18. A method for testing glucose levels in a porous matrix reagent test strip having a test side and a sample side and defining an internal surface, said matrix having disposed upon said internal surface throughout said matrix both a separation coating and a testing reagent;

said method comprising;

placing a sample of whole blood upon the sample side of said strip;

interacting said whole blood with the separating coating and thereby separating said whole blood into red blood cells and substantially clear fluid;

reacting said clear fluid with said testing reagent, said testing reagent causing said clear fluid to vary the coloration of said matrix as a function of the concentration of glucose in said fluid; and

observing the change in coloration on said test side.