Method of differentiating between blood and control solutions containing a common analyte

• US 8,681,324 B2
• Filed: 03/06/2013
• Issued: 03/25/2014
• Est. Priority Date: 12/13/2004
• Status: Expired due to Fees

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Marfurt, Karen L.
• Primary Examiner(s): Geisel, Kara E
• Application Number:
  US13/787,305
• Publication Number:
  US 20130183699A1
• Time in Patent Office: 384 Days
• Field of Search: 356/39, 356/436, 422/50
• US Class Current: 356/39
• 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 method of distinguishing between measurements in an optical instrument of at least one analyte in a biological sample and the at least one analyte 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, wherein the labeling substance has a peak absorbance of light that is distinguishable from the absorbance of an indicator used to measure the amount of the at least one analyte present in the biological sample.

2. The method 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 method of claim 1, wherein the labeling substance is indocyanine green.

4. The method of claim 1, wherein the indicator is a tetrazolium salt.

5. 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, the substance being distinguished from the response of an indicator used to measure the amount of analyte present in the biological sample, wherein the substance has a peak absorbance of light that is distinguishable from the absorbance of the indicator.

6. The method of claim 5, wherein the substance that labels the control solution 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.

7. The method of claim 5, wherein the substance that labels the control solution 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 5, wherein the substance that labels the control solution is indocyanine green.

9. The method of claim 5, wherein the indicator is a tetrazolium salt.

10. A method of checking the performance of an optical system used to measure at least one analyte in a biological sample, the method comprising the act of using a control solution including a labeling substance recognized by the optical instrument to verify that the instrument is operating properly, wherein the labeling substance has a peak absorbance of light that is distinguishable from the absorbance of an indicator used to measure the amount of the at least one analyte present in the biological sample.

11. The method of claim 10, 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.

12. The method of claim 10, 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.

13. The method of claim 10, wherein the labeling substance is indocyanine green.

14. The method of claim 10, wherein the indicator is a tetrazolium salt.