Method for bodily fluid sample transfer during analyte determination

• US 8,580,576 B2
• Filed: 08/04/2011
• Issued: 11/12/2013
• Est. Priority Date: 08/04/2011
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cilag Gmbh International (Johnson & Johnson)
• Inventors: Quraishi, Khalid R., Matzinger, David
• Primary Examiner(s): Cole, Monique
• Application Number:
  US13/198,510
• Publication Number:
  US 20130034870A1
• Time in Patent Office: 831 Days
• Field of Search: 436/180, 436/63, 436/174, 436/807
• US Class Current: 436/180
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/54387 Immunochromatographic test strips
• CPC Class Codes: Y10T 436/25 including sample preparation
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A method for the transfer of a bodily fluid sample (such as a whole blood sample) during the determination of an analyte (e.g., glucose) in the bodily fluid sample includes applying the bodily fluid sample to a sample collection reservoir of an analytical test strip (for example, an electrochemical-based analytical test strip). During such application, the sample collection reservoir is isolated from fluid communication with a determination chamber of the analytical test strip. The analytical test strip is subsequently inserted into a test meter such that the sample collection reservoir is placed into fluid communication with the determination chamber and such that at least a portion of the bodily fluid sample is consequentially transferred from the sample collection reservoir to the determination chamber. The method further includes determining the analyte in the bodily fluid sample transferred to the determination chamber.

Claims

1. A method for the transfer of a bodily fluid sample during the determination of an analyte in the bodily fluid sample, the method comprising:

applying a bodily fluid sample to a sample collection reservoir of an analytical test strip, the sample collection reservoir being isolated from fluid communication with a determination chamber of the analytical test strip;

inserting the analytical test strip into a test meter such that the sample collection reservoir is placed into fluid communication with the determination chamber and such that at least a portion of the bodily fluid sample is consequentially transferred from the sample collection reservoir to the determination chamber; and

determining an analyte in the bodily fluid sample transferred to the determination chamber.

2. The method of claim 1 further comprising:

pre-treating, following application of the bodily fluid sample and prior to the determining of the analyte, the applied bodily fluid sample in the sample collection reservoir.

3. The method of claim 2 wherein the pre-treating includes one of a chemical pre-treatment of the applied bodily fluid sample and an enzymatic pre-treatment of the applied bodily fluid sample.

4. The method of claim 1 wherein the sample collection reservoir is a capillary sample collection reservoir and the determination chamber is a capillary determination chamber.

5. The method of claim 4 wherein at least one dimension of the capillary sample chamber is in the range of 0.15 mm to 0.5 mm and one dimension of the capillary determination chamber is in the range of 0.025 mm to 0.18 mm.

6. The method of claim 5 wherein the inserting step is such that at least a portion of the bodily fluid sample is transferred from the capillary sample collection reservoir to the capillary determination chamber by capillary action upon insertion of the analytical test strip into the test meter.

7. The method of claim 1 wherein the analytical test strip is configured such that the sample collection reservoir and the determination chamber are moveable with respect to one another;

and

wherein the inserting step establishes fluid communication between the sample collection chamber and determination chamber by movement of the sample collection reservoir and determination chamber with respect to one another.

8. The method of claim 7 wherein the sample collection reservoir is slidable with respect to the determination chamber and wherein insertion of the analytical test strip into the test meter serves to slide the sample collection chamber such that the sample collection chamber is in fluid communication with the determination chamber.

9. The method of claim 1 wherein the analytical test strip is an electrochemical-based analytical test strip and includes at least one electrode in the determination chamber.

10. The method of claim 1 wherein the analytical test strip is configured to include dual sample collection reservoirs.

11. The method of claim 1 wherein the bodily fluid sample is a whole blood sample and the analyte is glucose.