Whole blood glucose test strip

• US 5,563,042 A
• Filed: 03/21/1995
• Issued: 10/08/1996
• Est. Priority Date: 08/13/1986
• Status: Expired due to Term

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Phillips, Roger, McGarraugh, Geoffery, Jurik, Franklin A., Underwood, Raymond D.
• Primary Examiner(s): Gitomer, Ralph J.
• Application Number:
  US08/408,064
• Time in Patent Office: 567 Days
• Field of Search: 435/4, 435/14, 435/25, 435/28, 435/805, 435/808, 435/968, 435/970, 422/56, 422/57, 422/58
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 2021/4757 Geometry 0/45° or 45/0°
• CPC Class Codes: G01N 21/314 with comparison of measurements at specific and non-specific wavelengths dual wavelength spectrometry G01J3/427
• CPC Class Codes: G01N 21/4738 Diffuse reflection precedence is given to G01N21/55 - G01N21/57 if specular component is taken into consideration, e.g. also for testing fluids, fibrous materials
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 35/1016 Control of the volume dispensed or introduced
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/808 Optical sensing apparatus
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10T 436/112499 with sample on test slide
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A whole blood glucose test strip for measuring glucose in an unmeasured whole blood sample which does not require removal of excess sample, and which is adapted for use in a reflectance reading apparatus which measures reflectance at about 635 nm and about 700 nm, the test strip comprising a handle having an aperture defined therein; and a porous, hydrophilic matrix disposed over the aperture such that one surface of the matrix is exposed to the atmosphere adjacent to one side of the strip and the other surface of the matrix is exposed to the atmosphere on the other side of the strip through the aperture, one of the surfaces being an upper sample receiving surface adapted to receive the whole blood sample on one side of the matrix and the second of the surfaces being a lower testing surface from which diffuse reflected light is measurable, the testing surface being opposite to the sample receiving surface. The matrix allows the blood color of the blood sample to be observed from the testing surface, allows at least a portion of the blood sample to penetrate through the matrix from the sample receiving surface to the testing surface, and filters out red blood cells such that they do not reach the testing surface. The matrix comprises reagent means for chemically reacting with glucose to create a change in reflectance which is indicative of the concentration of glucose present in the sample.

Claims

1. A whole blood glucose test strip for measuring a concentration of glucose in an unmeasured whole blood sample which does not require removal of excess sample, said test strip being adapted for use in a reflectance reading apparatus which measures reflectance at about 635 nm and about 700 nm, said test strip comprising:

a handle having an aperture defined therein; and

a porous, hydrophilic matrix disposed over said aperture such that one surface of the matrix is exposed to atmosphere adjacent to one side of the strip and the other surface of the matrix is exposed to atmosphere on the other side of said strip through said aperture, one of said surfaces being an upper sample receiving surface adapted to receive said whole blood sample on one side of the matrix and the second of said surfaces being a lower testing surface from which diffuse reflected light is measurable, said testing surface being opposite to said sample receiving surface,

said matrix allowing at least a portion of said blood sample to penetrate through the matrix from said sample receiving surface to said testing surface, allowing blood color of said blood sample to be observed from the testing surface, and filtering out red blood cells such that they do not reach the testing surface,

said matrix comprising reagent means for chemically reacting with glucose to create a change in reflectance which change is indicative of the concentration of glucose present in said sample, whereby upon application of said unmeasured whole blood sample to the sample receiving surface, said sample will penetrate through the matrix sufficiently to allow said change in reflectance to be determined from said testing surface.

2. The test strip of claim 1 wherein said matrix is a single layer.

3. The test strip of claim 1 wherein said matrix further comprises ethylenediamine tetraacetic acid.

4. The test strip of claim 1 wherein said matrix further comprises polypeptide.

5. The test strip of claim 1 wherein said matrix further comprises citrate buffer.

6. The test strip of claim 1 wherein said matrix further comprises polymethylvinyl ether/maleic anhydride.

7. The test strip of claim 1 wherein said matrix further comprises medium viscosity copolymer of polymethylvinyl ether/maleic anhydride.

8. The test strip of claim 1 wherein said matrix further comprises ethylenediamine tetraacetic acid, polypeptide, citrate buffer, and polymethylvinyl ether/maleic anhydride.

9. The test strip of claim 1 wherein said matrix comprises polyamide.

10. The test strip of claim 1 wherein said matrix comprises a microfiltration membrane made from nylon cast on a core of non-woven polyester fibers.

11. The test strip of claim 1 wherein the surface of said matrix is positively charged.

12. The test strip of claim 1 wherein the surface of said matrix is functionalized with quaternary amine groups.

13. The test strip of claim 1 wherein the surface of said matrix is negatively charged.

14. The test strip of claim 1 wherein the surface of said matrix is functionalized with carboxyl groups.

15. The test strip of claim 1 wherein said matrix comprises unfunctionalized nylon.

16. The test strip of claim 1 wherein said matrix has an average pore size of from about 0.2 to 2.0 μ

m.

17. The test strip of claim 1 wherein said matrix has an average pore size of from about 0.5 to 1.2 μ

m.

18. The test strip of claim 1 wherein said matrix has an average pore size of from about 0.6 to 1.0 μ

m.

19. The test strip of claim 1 wherein said matrix has an average pore size of about 0.8 μ

m.

20. The test strip of claim 1 wherein said matrix has a thickness of less than about 0.5 mm.

21. The test strip of claim 1 wherein said matrix has a thickness of from about 0.1 mm to about 0.3 mm.

22. The test strip of claim 1 wherein said matrix has a thickness of from about 0.1 mm to about 0.2 mm.

23. The test strip of claim 1 wherein said reagent means comprises dye precursors which form a dye couple which develops color in the presence of oxygen.

24. The test strip of claim 23 wherein said dye precursors comprise 3-dimethylaminobenzoic acid and 3-methyl-2-benzothiazolinone hydrazone hydrochloride.

25. The test strip of claim 1 wherein said reagent means comprises dye precursors comprising 4-aminoantipyrene and chromotropic acid.