Method and apparatus for analyte measurement test time

• US 20140121486A1
• Filed: 01/07/2014
• Published: 05/01/2014
• Est. Priority Date: 12/30/2004
• Status: Abandoned Application

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique M., Boecker, Dirk
• Application Number:
  US14/148,941
• Publication Number:
  US 20140121486A1
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: Y10T 436/110833 Utilizing a moving indicator strip or tape

Abstract

A disposable biosensor test strip includes a plurality of penetrating members, which are associated with a capillary chamber having a depth suitable for capillary flow of blood and holds a volume of less than about 1.0 .μl of the blood sample. A working electrode and a counter or reference electrode are disposed within the capillary chamber. A reagent is proximal to or in contact with at least the working electrode. The reagent includes an enzyme and a mediator. The reagent reacts with glucose to produce an electroactive reaction product. A blood sample, containing glucose, is applied into the capillary chamber. The capillary chamber directs capillary flow of the blood sample into contact with the reagent to cause the blood sample to at least partially solubilize or hydrate the reagent. The blood sample is detected in the capillary chamber. The electroactive reaction product is electro-oxidized or electro-reduced at the working electrode.

Claims

1. A device of determining the concentration of glucose in a blood sample, comprising:

a disposable biosensor test strip including a plurality of penetrating members, each of the penetrating members associated with a capillary chamber having a depth suitable for capillary flow of blood and holding a volume of less than 1.0 μ

l of the blood sample, a working electrode and a counter or reference electrode disposed within the capillary chamber, and a reagent proximal to or in contact with at least the working electrode, the capillary chamber directing capillary flow of the blood sample into contact with the reagent to cause the blood sample to at least partially solubilize or hydrate the reagent; and

a memory with at least one user profile.

2. The device of claim 1, further comprising:

a readout of the analyte concentration in the blood sample provided within 10 seconds after the detecting, determining and providing.

3. The device of claim 1, wherein the capillary chamber holds a volume of about 600 nL.

4. The device of claim 3, further comprising:

a readout of the glucose concentration that is made within about 5 seconds after said detecting.

5. The device of claim 1, wherein the capillary chamber holds a volume of between 0.25 .μ

l and 0.4 μ

l.

6. The device of claim 5, further comprising:

a readout of the glucose concentration made within about 5 seconds after said detecting.

7. The device of claim 1, wherein the capillary chamber holds a volume of about 400 nL.

8. The device of claim 7, further comprising:

a readout of the glucose concentration made within about 5 seconds after said detecting.

9. The device of claim 1, wherein in the capillary chamber holds a volume of about 300 nL.

10. The device of claim 9, further comprising:

a readout of the glucose concentration made within about 5 seconds after said detecting.

11. The device of claim 1, further comprising:

a readout of the glucose concentration made within about 8 seconds of said detecting.

12. The device of claim 1, further comprising:

a readout of the glucose concentration made about 3.5 to about 8 seconds after said detecting.

13. The device of claim 1, further comprising:

a readout of the glucose concentration made within about 5 seconds of said detecting.

14. The device of claim 1, further comprising:

a readout of the glucose concentration made within about 4 seconds of said detecting.

15. The device of claim 1, further comprising:

a readout of the glucose concentration made about 5 seconds after said detecting.

16. The device of claim 1, further comprising:

a readout of the glucose concentration made about 4 seconds after said detecting.

17. A method of determining the concentration of glucose in a blood sample, comprising:

providing a disposable biosensor test strip including a plurality of penetrating members, each of the penetrating members associated with a capillary chamber having a depth suitable for capillary flow of blood and holding a volume of less than 1.0 μ

l of the blood sample, a working electrode and a counter or reference electrode disposed within the capillary chamber, and a reagent proximal to or in contact with at least the working electrode;

storing and using user profiles in a memory;

applying a blood sample containing an analyte into the capillary chamber, the capillary chamber directing capillary flow of the blood sample into contact with the reagent to cause the blood sample to at least partially solubilize or hydrate the reagent; and

detecting the blood sample in the capillary chamber.

18. The method of claim 17, further comprising:

within 10 seconds after said detecting, determining and providing a readout of the analyte concentration in the blood sample.

19. The method of claim 17, wherein the capillary chamber holds a volume of about 600 nL.

20. The method of claim 19, further comprising:

determining and providing a readout of the glucose concentration within about 5 seconds after said detecting.

21. The method of claim 17, wherein the capillary chamber holds a volume of between 0.25 .μ

l and 0.4 μ

l.

22. The method of claim 21, further comprising:

determining and providing a readout of the glucose concentration within about 5 seconds after said detecting.

23. The method of claim 17, wherein the capillary chamber holds a volume of about 400 nL.

24. The method of claim 23, further comprising:

determining and providing a readout of the glucose concentration within about 5 seconds after said detecting.

25. The method of claim 17, wherein in the capillary chamber holds a volume of about 300 nL.

26. The method of claim 25, further comprising:

determining and providing a readout of the glucose concentration within about 5 seconds after said detecting.

27. The method of claim 17, further comprising:

determining and providing a readout of the glucose concentration within about 8 seconds of said detecting.

28. The method of claim 17, further comprising:

determining and providing a readout of the glucose concentration about 3.5 to about 8 seconds after said detecting.

29. The method of claim 17, further comprising:

determining and providing a readout of the glucose concentration within about 5 seconds of said detecting.

30. The method of claim 17, further comprising:

determining and providing a readout of the glucose concentration within about 4 seconds of said detecting.

31. The method of claim 17, further comprising:

determining and providing a readout of the glucose concentration about 5 seconds after said detecting.

32. The method of claim 17, further comprising:

determining and providing a readout of the glucose concentration about 4 seconds after said detecting.