Method for reducing effect of hematocrit on measurement of an analyte in whole blood

• US 7,323,315 B2
• Filed: 02/02/2004
• Issued: 01/29/2008
• Est. Priority Date: 02/11/2003
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Marfurt, Karen L.
• Primary Examiner(s): Le; Long V.
• Assistant Examiner(s): Yang; N
• Application Number:
  US10/770,235
• Publication Number:
  US 20040157275A1
• Time in Patent Office: 1,457 Days
• Field of Search: 436/63, 436/71, 436/95, 435/14, 435/22
• US Class Current: 435/7.25
• CPC Class Codes: G01N 15/0205 by optical means
• CPC Class Codes: G01N 2015/012 Red blood cells
• 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 21/8483 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

Abstract

A method for determining the presence and/or amount of an analyte in a sample of whole blood comprises the step of treating the sample with a nonlytic hypertonic salt composition to reduce the hematocrit by reducing the size of the red blood cells. In optical detection systems, the smaller red blood cells create greater scatter, which allows a more accurate correction to be applied in a dual-wavelength detection system. In electrochemical detection systems, as well as in optical detection systems, the smaller red blood cells provide less obstruction to the diffusion of analyte and reagents in the sample, to facilitate the reactions thereof.

Claims

1. A method for determining the presence and/or amount of an analyte in a sample of whole blood, the method comprising the steps of

(a) providing a sample of whole blood for qualitative or quantitative determination of an analyte,

(b) contacting the whole blood sample with a nonlytic hypertonic salt composition to adjust the hematocrit of the whole blood sample, and

(c) detecting the presence and/or amount of analyte in the whole blood sample by measuring the analyte in the treated whole blood sample in the absence of a separation step.

2. The method of claim 1 where said analyte is selected from the group consisting of glucose, cholesterol, triglycerides, ethanol, lactic acid, beta-hydroxy butyrate, ketone bodies, and fructosamine.

3. The method of claim 1 wherein the detection of the presence and/or amount of analyte in the sample is performed by an optical detection method.

4. The method of claim 3 wherein said optical detection method is selected from the group consisting of reflectance, absorbance, and transmittance.

5. The method of claim 3 wherein a first optical measurement is made at a wavelength at which the reading is a function of the analyte and the hematocrit, a second optical measurement is made at a wavelength at which the reading is not substantially a function of the analyte, and the reading of the first measurement is corrected in accordance with the reading of the second measurement.

6. The method of claim 1 wherein the detection of the presence and/or amount of analyte in the sample is performed by an electrochemical detection method.

7. The method of claim 6 wherein said electrochemical method is a selected from the group consisting of amperometric and coulometric methods.

8. The method of claim 1 wherein said hypertonic salt composition comprises one or more organic salts, one or more inorganic salts, or any combination thereof.

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

10. The method of claim 1 wherein treating the sample with a nonlytic hypertonic salt composition includes depositing a sufficient amount of nonlytic hypertonic salt composition on a test strip and contacting the sample with the test strip.

11. The method of claim 1 wherein treating the sample with a nonlytic hypertonic salt composition includes depositing a sufficient amount of nonlytic hypertonic salt composition on a test article and contacting the sample with the test article.

12. The method of claim 1 wherein treating the sample with a nonlytic hypertonic salt composition includes depositing a sufficient amount of nonlytic hypertonic salt composition in a microfluidic device including a well or chamber and contacting the sample in the well or chamber.

13. The method of claim 1 wherein the nonlytic hypertonic salt composition is NA-HEPES.

14. The method of claim 1 wherein the nonlytic hypertonic salt composition is prepared at at least 100 mM.

15. The method of claim 1 wherein the hypertonic salt composition comprises one or more organic salts.

16. The method of claim 1 wherein the hypertonic salt composition comprises one or more inorganic salts.

20. The method of claim 1 wherein the detection of the presence and/or amount of analyte in the sample is performed by an optical detection method.

21. The method of claim 1 wherein the detection of the presence and/or amount of analyte in the sample is performed by an electrochemical detection method.

17. A method for determining the presence and/or amount of an analyte in a sample of whole blood, the method comprising the steps of

(a) providing a sample of whole blood for qualitative or quantitative determination of an analyte,

(b) contacting the whole blood sample with a nonlytic hypertonic salt composition prepared at at least 200 mM to adjust the hematocrit of the whole blood sample to adjust the hematocrit of the whole blood sample, and

(c) detecting the presence and/or amount of analyte in the whole blood sample in the absence of a separation step.

18. The method of claim 17 where said analyte is selected from the group consisting of glucose, cholesterol, triglycerides, ethanol, lactic acid, beta-hydroxy butyrate, ketone bodies, and fructosamine.

19. The method of claim 18 where said analyte is glucose.

22. The method of claim 17 wherein the nonlytic hypertonic salt composition is prepared at at least 400 mM.

23. A method for determining the presence and/or amount of an analyte in a sample of whole blood, the method comprising the steps of

(a) providing a sample of whole blood for qualitative or quantitative determination of an analyte,

(b) contacting the whole blood sample with a nonlytic hypertonic salt composition, and

(c) detecting the presence and/or amount of analyte in the whole blood sample by measuring the analyte in the treated whole blood sample in the absence of a separation step.

24. The method of claim 23 wherein the nonlytic hypertonic salt composition is prepared at at least 200 mM and the analyte is glucose.

25. The method of claim 23 wherein the nonlytic hypertonic salt composition is prepared at at least 400 mM.

27. The method of claim 23 wherein the nonlytic hypertonic salt composition is prepared at at least 200 mM and the analyte is glucose.

26. A method for determining the presence and/or amount of an analyte in a sample of whole blood, the method comprising the steps of

(a) providing a sample of whole blood for qualitative or quantitative determination of an analyte,

(b) contacting the whole blood sample with a nonlytic hypertonic salt composition to modify the effect of the hematocrit of the whole blood sample, and

(c) detecting the presence and/or amount of analyte in the whole blood sample by measuring the analyte in the treated whole blood sample in the absence of a separation step.

28. The method of claim 26 wherein the nonlytic hypertonic salt composition is prepared at at least 400 mM.