Method of Differentiating Between Blood and Control Solutions Containing a Common Analyte

• US 20080145878A1
• Filed: 12/12/2005
• Published: 06/19/2008
• 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: Marfurt, Karen L.
• Granted Patent: US 8,102,517 B2
• Time in Patent Office: Days
• US Class Current: 435/14
• CPC Class Codes: G01N 1/28 Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Qmounting specimens on microscopic slides G02B21/34; means for supporting the objects or the materials to be analysed in electron microscopes H01J37/20 ; laboratory gas handling apparatus B01L5/00
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/110833 Utilizing a moving indicator strip or tape
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

Glucose measured in blood samples is distinguished from glucose measured in the control solutions used to test the optical instruments which make such measurements. The control solutions contain a labeling substance recognized by the optical instrument to distinguish glucose measurements made of control solutions from those made of blood samples.

Claims

1. A control solution for testing the performance of an optical instrument adapted to measure the concentration of glucose in blood in proportion to the optical response of an indicator, the solution comprising a labeling substance recognized by the optical instrument as identifying the presence of the control solution.

2. The control solution of claim 1, wherein the labeling substance has a characteristic response to excitation by a light-emitting diode in the optical instrument that is distinguishable from the response of the indicator.

3. The control solution of claim 1, wherein the labeling substance has a peak absorbance of light that is distinguishable from the absorbance of the indicator.

4. The control solution of claim 3, wherein the labeling substance is indocyanine green.

5. The control solution of claim 4, wherein the labeling substance is distinguished from a tetrazolium salt indicator.

6. A method of distinguishing between measurements in an optical instrument of glucose in blood and glucose in a control solution used to test the performance of the optical instrument, the method comprising the act of adding to the control solution a labeling substance recognized by the optical instrument.

7. The method of claim 6, wherein the labeling substance has a characteristic response to excitation by a light-emitting diode in the optical instrument that is distinguishable from the response of the indicator.

8. The method of claim 6, wherein the labeling substance has a peak absorbance of light that is distinguishable from the absorbance of the indicator.

9. The method of claim 6, wherein the labeling substance is indocyanine green.

10. The method of claim 8, wherein the labeling substance is distinguished from a tetrazolium salt indicator.

11. A method of measuring the glucose in blood by an optical instrument, the method comprising the acts of testing the performance of the instrument by adding a control solution containing a known amount of glucose to a test strip adapted to react with the glucose and produce an optical response from an indicator and measuring the response, the control solution contains a labeling substance recognized by the optical instrument and distinguished from the response of the indicator.

12. The method of claim 11, wherein the labeling substance has a characteristic response to excitation by a light-emitting diode in the optical instrument that is distinguishable from the response of the indicator.

13. The method of claim 11, wherein the labeling substance has a peak absorbance of light that is distinguished from the absorbance of the indicator.

14. The method of claim 13, wherein the labeling substance is indocyanine green.

15. The method of claim 14, wherein the labeling substance is distinguished from a tetrazolium salt indicator.

16. An optical instrument for correlating the glucose content of blood samples with the optical response obtained by contact of the sample with a test strip adapted to provide the optical response by reaction with the blood sample, the optical instrument comprising a light-emitting diode to excite a response from a labeling substance in a control solution used to distinguish the control solution from the blood samples.

17. The optical instrument of claim 16, wherein the optical instrument compiles glucose measurements and excludes such measurements made of control solutions.

18. The optical instrument of claim 16, wherein the labeling substance has a peak absorbance of light distinguished from the peak absorbance of an indicator used to measure the amount of glucose present.

19. The optical instrument of claim 18, wherein the substance is indocyanine green.

20. A method of distinguishing control solutions from biological samples in optical instruments used to measure analytes in such biological samples, the method comprising the acts of adding to the control solutions a substance that labels the control solution and enables the optical instruments to identify the control solutions and distinguish the control solutions from the biological samples.

21. The method of claim 20, wherein the labeling substance is a dye adapted to being dissolved in the control solution, the dye-absorbing light at a wavelength distinguished from the wavelength of light characterizing the analyte.