Reagent test strip for blood glucose determination

• US 5,753,452 A
• Filed: 04/04/1996
• Issued: 05/19/1998
• Est. Priority Date: 04/04/1996
• Status: Expired due to Term

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Smith, John L.
• Primary Examiner(s): LEARY, LOUISE N
• Application Number:
  US08/627,630
• Time in Patent Office: 775 Days
• Field of Search: 435/14, 435/4, 435/287, 435/970, 435/808, 435/287.1, 422/50, 422/55, 422/68.1
• US Class Current: 435/14
• 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 33/523 the element being adapted for a specific analyte
• CPC Class Codes: Y10S 435/808 Optical sensing apparatus
• CPC Class Codes: Y10S 435/97 Test strip or test slide

Abstract

A reagent test strip is adapted for use in a blood glucose meter. A sample of whole blood is applied to one surface of a matrix on the strip and the meter measures the reflectance of the opposite surface of the matrix at about 635 nm and 700 nm and calculates from the reflectances the concentration of glucose in the sample. The portion of the applied sample that penetrates the matrix and is visible from the testing surface does not absorb to any appreciable extent at 700 nm. Nevertheless, the glucose-containing sample interacts with the components of the reagent-containing matrix to cause a change in reflectance at 700 nm that simulates the effect of the blood color. As a result, the strip can be used in meters that measure glucose concentration in whole blood samples in the presence of optically visible hemoglobin.

Claims

1. A reagent test strip having a matrix near one end for use in an apparatus for determining a concentration of glucose in a sample of whole blood, the apparatus comprising optical means for detecting intensity of light at wavelengths of about 635 nm and about 700 nm reflected from at least a portion of the matrix, which matrix comprises

a) a sample receiving surface for receiving the whole blood sample and passing a portion of the sample toward a testing surface opposite thereto, the testing surface having a reflectance at about 700 nm that, when the testing surface becomes wet, undergoes a change that is substantially equivalent to that produced by the absorbance of hemoglobin in blood

b) a structure that selectively retards the passage of red blood cells through the matrix and minimizes the lysing of the cells in the matrix, whereby any portion of the sample that is visible from the testing surface does not absorb light to any appreciable extent at about 700 nm, and

c) a reagent for indicating the glucose concentration by creating at the testing surface a change in reflectance at about 635 nm.

2. The strip of claim 1 in which the matrix comprises a membrane that has pores that trap the red blood cells of the whole blood sample.

3. The strip of claim 1 in which the matrix comprises an anisotropic membrane.

4. The strip of claim 3 in which the membrane has pores that are larger near the sample receiving surface and smaller near the testing surface.

5. The strip of claim 1 in which the matrix comprises a polyamide membrane.

6. The strip of claim 1 in which the matrix has an interior region that absorbs 700 nm light and that is visible from the testing surface only when the surface is wet.

7. The strip of claim 6 in which the matrix interior region comprises a nonwoven material having substantial absorbance at 700 nm.

8. The strip of claim 1 in which the matrix further comprises a water-soluble dye that has light absorption at 700 nm that is substantially increased when the dye goes into solution.

9. The strip of claim 8 in which the dye comprises copper phthalocyanine.

10. The strip of claim 1 in which the reagent comprises a dye precursor that forms a chromophore indicative of the glucose concentration, the chromophore absorbing light at 635 nm.

11. The strip of claim 10 in which the reagent dye precursor is selected from the group consisting of 3-methyl-2-benzothlazolinone hydrazone hydrochloride (MBTH) with 3-dimethylaminobenzoic acid (DMAB);

MBTH with 8-anilino-1-naphthalenesulfonate (ANS);

MBTH with its formaldehyde azine and combinations thereof.

12. The strip of claim 11 in which the reagent dye precursor comprises MBTH and ANS.

13. The strip of claim 11 in which the reagent dye precursor comprises MBTH combined with DMAB.