Diagnostic test strip having on-strip calibration

• US 6,168,957 B1
• Filed: 06/25/1997
• Issued: 01/02/2001
• Est. Priority Date: 06/25/1997
• Status: Expired due to Term

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Harding, Ian, Matzinger, David, OʼNeil, Michael
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US08/881,985
• Time in Patent Office: 1,287 Days
• Field of Search: 422/56, 422/57, 422/58, 422/61, 435/7.9, 435/14, 435/28, 435/287.1, 435/287.2, 435/287.7, 435/287.8, 435/805, 435/810, 435/970, 436/514, 436/518, 436/169, 436/170, 436/805, 436/810, 436/815
• US Class Current: 436/518
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/815 Test for named compound or class of compounds

Abstract

A dry phase reagent test strip for measuring the concentration of an analyte in a biological fluid includes a colored indicator whose hue indicates a calibration of the strip. Preferably, the test strip measures the concentration of glucose in whole blood.

Claims

1. A diagnostic test strip for measuring an analyte concentration in a sample of biological fluid, comprising

(a) a membrane, having a sample side, to which the fluid sample is applied, and a testing side, opposite the sample side;

(b) a testing reagent impregnated in the membrane for reacting with the analyte in the sample to cause a detectable color change on the testing side; and

(c) a membrane support, attached to the membrane and having on a major surface a colored indicator, whose hue indicates a calibration of the strip.

2. The strip of claim 1 in which the analyte is glucose and the fluid is whole blood.

3. The strip of claim 2 in which the reagent comprises

(a) a first component for creating hydrogen peroxide from glucose and oxygen and

(b) a second component for reacting with the hydrogen peroxide to cause the color change on the testing side.

4. The strip of claim 1 in which the indicator is colored by a combination of two dyes, and the hue is determined by the relative amounts of the dyes.