Method of determining glucose concentration of a whole blood sample

• US 8,184,273 B2
• Filed: 01/10/2011
• Issued: 05/22/2012
• Est. Priority Date: 12/13/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Dosmann, Andrew J., Nelson, Christine D., Warchal-Windham, Mary Ellen
• Primary Examiner(s): Punnoose, Roy M
• Application Number:
  US12/987,516
• Publication Number:
  US 20110102768A1
• Time in Patent Office: 498 Days
• Field of Search: 356/39
• US Class Current: 356/39
• CPC Class Codes: G01N 21/255 Details, e.g. use of specially adapted sources, lighting or optical systems
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/31 Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry G01N21/72 takes precedence
• 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 21/3151 using two sources of radiation of different wavelengths G01N21/33 - G01N21/39 take precedence
• CPC Class Codes: G01N 21/3577 for analysing liquids, e.g. polluted water
• CPC Class Codes: G01N 21/39 using tunable lasers
• CPC Class Codes: G01N 21/78 producing a change of colour

Abstract

A total transmission spectroscopy system for use in determining the analyte concentration in a fluid sample comprises a sample cell receiving area, a light source, a collimating lens, a first lens, a second lens, and a detector. The sample cell receiving area is adapted to receive a sample to be analyzed. The sample cell receiving area is constructed of a substantially optically clear material. The collimating lens is adapted to receive light from the light source and adapted to illuminate the sample cell receiving area with a substantially collimated beam of light. The first lens is adapted to receive regular and scattered light transmitted through the sample at a first angle of divergence. The first lens receives light having a first angle of acceptance. The first lens outputs light having a second angle of divergence. The second angle of divergence is less than the first angle of divergence. The second lens is adapted to receive light from the first lens and adapted to output a substantially collimated beam of light. The detector is adapted to measure the light output by the second lens.

Claims

1. A method of determining glucose concentration of a whole blood sample using an optical test sensor, the method comprising:

providing an optical test sensor including a reagent composition having an enzyme;

measuring transmission levels at two different wavelengths of the whole blood sample;

correcting absorbance bias of the whole blood sample, if any, caused by hematocrit levels using the transmission levels at two different wavelengths; and

determining the glucose concentration using the measured transmission levels and corrected absorbance bias, if any, of the whole blood sample.

2. The method of claim 1 wherein the two different wavelengths includes a visible light wavelength and a near-IR light wavelength.

3. The method of claim 2 wherein the near-IR light wavelength is from about 700 to about 1,100 nm.

4. The method of claim 2 wherein the near-IR light wavelength is from about 750 to about 940 nm.

5. The method of claim 2 wherein the visible wavelength is from about 400 to about 700 nm.

6. The method of claim 2 wherein the visible wavelength is from about 660 to about 680 nm.

7. The method of claim 1 wherein the correction is a ratio of a measured transmission level of a visible light and a measured transmission level of a near-IR light wavelength.

8. The method of claim 7 wherein the visible wavelength is from 400 to 700 nm and the near-IR light wavelength is from 700 to 1,100 nm.

9. The method of claim 7 wherein the visible wavelength is from about 660 to about 680 nm and the near-IR light wavelength is from 700 to 1,100 nm.

10. The method of claim 7 wherein the visible wavelength is from about 660 to about 680 nm and the near-IR light wavelength is from 700 to 940 nm.

11. The method of claim 1 wherein bias due to hematocrit is within +/−

10%.

12. The method of claim 1 wherein bias due to hematocrit is within +/−

10% between 20% to 60% hematocrit levels.

13. The method of claim 1 wherein bias due to hematocrit is within +/−

5%.

14. The method of claim 1 wherein bias due to hematocrit is within +/−

10% between 20% to 60% hematocrit levels.

15. A method of determining glucose concentration of a whole blood sample using an optical test sensor, the method comprising:

providing the optical test sensor including a reagent composition having an enzyme;

contacting the whole blood sample with the reagent composition;

measuring the glucose concentration of the whole blood sample;

correcting bias of the whole blood sample, if any, caused by a hematocrit level; and

determining the glucose concentration using the measured glucose concentration and the corrected bias, if any, of the whole blood sample wherein the bias due to the hematocrit level of the determined glucose concentration is within +/−

5% between 20% to 60% hematocrit levels.

16. The method of claim 15 wherein the determined glucose concentration is between 100 and 400 mg/dL.