Determining The Concentration Of Analytes In Sample By Direct Mediation Of Enzymes

• US 20070275430A1
• Filed: 08/22/2005
• Published: 11/29/2007
• Est. Priority Date: 08/24/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Warchal-Windham, Mary, Marfurt, Karen
• Granted Patent: US 7,867,728 B2
• Time in Patent Office: Days
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: Y10T 436/144444 Glucose
• CPC Class Codes: Y10T 436/173076 Nitrite or nitrate
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

The glucose content of blood can be determined by contacting a blood sample with a test strip containing a glucose dehydrogenase dependent on PQQ (or derivatives or isomers) thereof as a co-factor, a tetrazolium salt indicator, but in the absence of a mediator.

Claims

1. A reagent for measuring the concentration of glucose in blood comprising:

(a) a glucose dehydrogenase (GDH);

(b) as a co-factor for GDH, pyrrolo-quinoline quinone (PQQ) or a PQQ derivative or isomer, said GDH and co-factor being capable of reducing to a colored formazan a tetrazolium salt indicator in the substantial absence of a mediator; and

(c) a tetrazolium salt indicator.

2. A reagent of claim 1 wherein said glucose dehydrogenase of (a) is classified according to NC-IUBMB as EC1.1.99.17 (now EC1.1.5.2).

3. A reagent of claim 1 wherein said co-factor is PQQ.

4. A reagent of claim 1 wherein said co-factor is a PQQ derivative or isomer.

5. A reagent of claim 1 wherein said tetrazolium salt indicator is WST-4.

6. A reagent of claim 1 wherein said tetrazolium salt indicator is an analog of HTC-45.

7. A test strip for measuring the glucose in blood comprising:

(a) a support;

(b) a reagent layer disposed on said support, said reagent system comprising;

(1) a glucose dehydrogenase (GDH);

(2) as a co-factor for GDH, pyrrolo-quinoline quinone (PQQ) or a PQQ derivative or isomer, said GDH and co-factor being capable of reducing to a colored formazan a tetrazolium salt indicator in the substantial absence of a mediator; and

(3) a tetrazolium salt indicator.

8. A test strip of claim 7 wherein said glucose dehydrogenase of (b)(1) is classified according to NC-IUBMB as EC1.1.99.17 (now EC1.1.5.2).

9. A test strip of claim 7 wherein said co-factor is PQQ.

10. A test strip of claim 7 wherein said co-factor is a PQQ derivative or isomer.

11. A test strip of claim 7 wherein said tetrazolium salt indicator is WST-4.

12. A test strip of claim 7 wherein said tetrazolium salt indicator is an analog of HTC-45.

13. A method for measuring glucose in blood comprising:

(a) a support;

(b) a reagent system disposed on said support, said reagent system comprising a glucose dehydrogenase (GDH), as a co-factor for GDH pyrrolo-quinoline quinono (PQQ) or a (PQQ) analog, said GDH and co-factor being capable of reducing a colored formazan a tetrazolium salt indicator in the absence of a mediator, and a tetrazolium salt indicator;

(c) measuring the color developed from said tetrazolium salt indicator; and

(d) correlating the color developed in step (b) with the glucose content of said blood sample.

14. The method of claim 13 wherein said glucose dehydrogenase is classified as EC1.1.99.17.

15. The method of claim 13 wherein said co-factor is PQQ.

16. The method of claim 13 wherein said co-factor is a PQQ derivative or isomer.

17. The method of claim 13 wherein said tetrazolium salt indicator is WST-4.

18. The method of claim 13 wherein said tetrazolium salt indicator is an analog of HTC-45.