Test-sensor production monitoring using XRF spectrometry

• US 8,005,188 B2
• Filed: 04/05/2007
• Issued: 08/23/2011
• Est. Priority Date: 04/11/2006
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Rey, Theresa A., Wu, Huan-Ping, Carpenter, Scott E.
• Primary Examiner(s): Prouty; Rebecca
• Assistant Examiner(s): Martin; Paul
• Application Number:
  US12/225,832
• Publication Number:
  US 20090310743A1
• Time in Patent Office: 1,601 Days
• Field of Search: None
• US Class Current: 378/45
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 2223/076 X-ray fluorescence
• CPC Class Codes: G01N 23/223 by irradiating the sample with X-rays or gamma-rays and by measuring X-ray fluorescence
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

A method for monitoring test sensors comprising the steps of, providing a test sensor comprising a reagent including an enzyme and a metal mediator; monitoring the amount of metal in the mediator of the reagent using X-ray fluorescence spectrometry and determining from the amount of metal in the mediator an amount of the reagent on the test sensor.

Claims

1. A method for on-line monitoring of test sensors using x-ray fluorescence (XRF) spectrometry, the method comprising:

providing a test sensor comprising a reagent, the reagent including an enzyme and a mediator, the mediator including metal;

monitoring an amount of metal in the mediator of the reagent of the test sensor using XRF spectrometry; and

determining from the amount of metal an amount of the reagent on the test sensor.

2. The method of claim 1, wherein the mediator is a ferricyanide derivative and wherein the monitoring of the amount of metal in the mediator includes measuring the iron.

3. The method of claim 2, wherein the ferricyanide derivative is potassium ferricyanide.

4. The method of claim 1, wherein the mediator is a ferrocene derivative.

5. The method of claim 4, wherein the ferrocene derivative is 1,1′

dimethylferrocene, hydroxymethylferrocene, 2-hydroxyethylferrocene or carboxylateferrocene.

6. The method of claim 1, wherein the mediator is ruthenium hexaamine.

7. The method of claim 6, wherein the enzyme is a glucose oxidase.

8. The method of claim 1, wherein the enzyme is a glucose-specific enzyme.

9. The method of claim 1, wherein the metal comprises at least two metallic elements.

10. A method for on-line monitoring of electrochemical test sensors using x-ray fluorescence (XRF) spectrometry, the method comprising:

providing an electrochemical test sensor comprising a reagent printed thereon, the reagent including an enzyme and a mediator, the mediator including metal; and

monitoring an amount of metal in the mediator of the reagent of the test sensor using XRF spectrometry; and

determining from the amount of metal an amount of the reagent on the test sensor.

11. The method of claim 10, wherein the mediator is a ferricyanide derivative and wherein the monitoring of the amount of metal in the mediator of the reagent of the test sensor includes measuring the iron.

12. The method of claim 10, wherein the ferricyanide derivative is potassium ferricyanide.

13. The method of claim 10, wherein the mediator is a ferrocene derivative.

14. The method of claim 13, wherein the ferrocene derivative is 1,1′

dimethylferrocene, hydroxymethylferrocene, 2-hydroxyethylferrocene or carboxylateferrocene.

15. The method of claim 10, wherein the mediator is ruthenium hexaamine.

16. The method of claim 10, wherein the enzyme is a glucose-specific enzyme.

17. The method of claim 16, wherein the enzyme is a glucose oxidase.

18. A method of maintaining consistency in the printing of reagents on test sensors comprising:

providing a test sensor comprising a reagent printed thereon, the reagent including an enzyme and a mediator, the mediator including metal; and

measuring an amount of metal in the mediator of the reagent of the test sensor wherein the measuring comprises scanning a region of the test sensor with an x-ray fluorescence (XRF) spectrometer; and

determining from the measurement of the amount of metal an amount of the reagent printed on the electrochemical test sensor.

19. The method of claim 18, further comprising repeating the providing, measuring, and determining for a number of sample test sensors of the set of test sensors.

20. The method of claim 19, further comprising evaluating the consistency of the printing of the reagent on the test sensors from the determinations of the amounts of the reagents of the sample test sensors.

21. A method for on-line monitoring using x-ray fluorescence (XRF) spectrometry, the method comprising:

providing a substrate comprising an organic compound printed thereon, the organic compound including metal;

monitoring an amount of the metal in the organic compound on the substrate using XRF spectrometry; and

determining from the amount of metal an amount of the organic compound printed on the substrate.

22. The method of claim 21, wherein the organic compound is a reagent including an enzyme and a mediator, and wherein the mediator comprises the metal.

23. The method of claim 21, wherein the substrate comprises a test sensor.