METHOD FOR DETERMINING AN ANALYTE USING AN ANALYTICAL TEST STRIP WITH A MINIMAL FILL-ERROR VIEWING WINDOW

• US 20100112612A1
• Filed: 10/30/2008
• Published: 05/06/2010
• Est. Priority Date: 10/30/2008
• Status: Abandoned Application

• Current Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: WHYTE, Lynsey, DARLING, Ramsay Raymond Donald, MACLEOD, Robert Hamish, DILLEEN, John William
• Application Number:
  US12/261,372
• Publication Number:
  US 20100112612A1
• Time in Patent Office: Days
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

A method for determining an analyte (such a glucose) in a bodily fluid sample includes introducing a bodily fluid sample (e.g., a whole blood sample) into a sample-receiving chamber of an analytical test strip. The method also includes verifying that the bodily fluid sample has filled at least a working portion of the sample-receiving chamber by user visual observation of the working portion through a first portion of a top layer of the analytical test strip, while an opaque second portion of the top layer precludes user visual observation of a non-working portion of the sample-receiving chamber. Thereafter, in the method, the concentration of analyte in the bodily fluid sample is determined only if during the verifying step the user has verified that the bodily fluid sample has filled the working portion.

Claims

1. A method for determining an analyte in a bodily fluid sample comprises:

introducing a bodily fluid sample into a sample-receiving chamber of an analytical test strip;

verifying that the bodily fluid sample has filled a working portion of the sample-receiving chamber by user visual observation of the working portion through a first portion of a top layer of the analytical test strip while an opaque second portion of the top layer precludes user visual observation of a non-working portion of the sample-receiving chamber; and

determining the concentration of analyte in the bodily fluid sample only if during the verifying step the user has verified that the bodily fluid sample has filled the working portion.

2. The method of claim 1 wherein the analytical test strip is an electrochemical-based analytical test strip.

3. The method of claim 1 wherein the bodily fluid sample is a whole blood sample.

4. The method of claim 1 wherein the analyte is glucose.

5. The method of claim 1 wherein the determining step occurs regardless of whether the bodily fluid sample has filled the non-working portion of the sample-receiving chamber.

6. The method of claim 1 wherein the analytical test strip is a photometric analytical test strip.

7. The method of claim 1 wherein the working portion of the sample receiving chamber has a volume of approximately 0.95 micro-liters and the sample-receiving chamber has a volume of approximately 1.1 micro-liters.

8. The method of claim 1 wherein the working portion of the sample receiving chamber constitutes approximately 86 percent of the sample-receiving chamber.

9. The method of claim 1 wherein the determining step employs a meter.