Volume meter testing device and method of use

• US 7,776,608 B2
• Filed: 06/20/2002
• Issued: 08/17/2010
• Est. Priority Date: 07/09/2001
• Status: Expired due to Fees

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Purcell, D. Glenn
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US10/174,833
• Publication Number:
  US 20030007893A1
• Time in Patent Office: 2,980 Days
• Field of Search: 422/99, 422102-104, 422/58, 422/61, 436/180, 436164-166, 436/169
• US Class Current: 436/164
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• 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 test device adapted to test a concentration of an analyte in a fluid has a pickup area having a first volume for receiving the fluid. In fluid communication with the pickup area is a read area having a second volume, which is less than the first volume. Since the second volume is less than the first volume, fluid from the pickup area will flow into the read area only after the pickup area is full. The read area also contains a reagent that is adapted to indicate the concentration of the analyte in the fluid.

Claims

1. A test device adapted to test a concentration of an analyte in a fluid comprising:

a pickup area having a first volume for receiving the fluid; and

a contiguous cover having a read area, a floor of the read area being a top side of the cover, the read area being in fluid communication with the pickup area, the read area including an island having a gap, the read area further including a vent area adjacent to and surrounding the island, the read area being adapted to receive fluid from the pickup area only after the pickup area is full, the read area containing a reagent adapted to produce a reaction indicative of the concentration of the analyte in the fluid, a thickness of the vent area being greater than a thickness of the gap of the island.

2. The test device according to claim 1, wherein the pickup area comprises a first sidewall and a second sidewall independent of a floor or a ceiling.

3. The test device according to claim 1, wherein the read area further comprises a ceiling.

4. The test device according to claim 3, wherein the ceiling of the read area is a plastic film.

5. The test device according to claim 3, wherein the ceiling of the read area is a porous paper.

6. The test device according to claim 5, wherein the floor of the read area is a filter.

7. The test device according to claim 5, wherein the ceiling of the read area includes at least one support, adapted to hold the ceiling a predetermined distance from the floor.

8. The test device according to claim 1, further comprising a transfer area in fluid communication with the read area and the pickup area, adapted to transfer the fluid from the pickup area into the read area.

9. The test device according to claim 8, wherein the transfer area has a volume which is less than the first volume of the pickup area and larger than a volume of the read area.

10. The test device according to claim 9, wherein the transfer area has sidewalls which are thinner than a sidewall of the pickup area.

11. The test device according to claim 8, wherein each of the pickup area, and the transfer area has gaps to draw the fluid into the pickup area and the transfer area.

12. The test device according to claim 11, wherein the gap of the pickup area is thicker than the gap of the transfer area.

13. The test device according to claim 11, wherein the gap of the transfer area is thicker than the gap of the read area.

14. The test device according to claim 1, wherein a volume of the read area is in the range of about 70 to about 80 percent as large as the first volume.

15. The test device according to claim 14, wherein the volume of the read area is in the range of about 3.5 to about 4.0 microliters and the first volume is in the range of about 4.5 to about 5.5 microliters.

16. The test device according to claim 1, wherein the reagent is adapted to produce a colorimetric reaction.

17. The test device according to claim 16, in combination with a colorimetric sensor.

18. The test device according to claim 1, wherein the reagent is adapted to produce an electrochemical reaction.

19. The test device according to claim 18, in combination with an electrochemical sensor.

38. The test device according to claim 1, wherein the gap of the island comprises a top and a bottom independent of any sidewalls.

20. A test device adapted to test a concentration of an analyte in a fluid, comprising:

a pickup area having a first gap adapted to use capillary action to draw the fluid into the pickup area; and

a contiguous cover having a read area, a bottom of the read area being a top side of the cover, the read area being in fluid communication with the pickup area, the read area including an island and a vent area adjacent to and surrounding the island, the island having a second gap such that the fluid is drawn into the second gap of the read area only after the first gap of the pickup area is entirely filled, the read area containing a reagent adapted to produce a reaction indicative of the concentration of the analyte in the fluid, a thickness of the vent area being greater than a thickness of the second gap of the island.

21. The test device according to claim 20, wherein the pickup area comprises a first sidewall and a second sidewall independent of a floor or a ceiling.

22. The test device according to claim 20, wherein the pickup area has a first volume and the read area has a second volume, such that the first volume of the pickup area is greater than the second volume of the read area.

23. The test device according to claim 22, wherein the second volume of the read area is from about 70 to about 80 percent as large as the first volume of the pickup area.

24. The test device according to claim 22, wherein the second volume of the read area is from about 3.5 to about 4.0 microliters and the first volume of the pickup area is from about 4.5 to about 5.5 microliters.

25. The test device according to claim 20, further comprising a transfer area in fluid communication with the read area and the pickup area, adapted to transfer the analyte from the pickup area into the read area.

26. The test device according to claim 25, wherein the pickup area has a first volume, the read area has a second volume, and a transfer area has a third volume, the third volume being less than the first volume of the pickup area and larger than the second volume of the read area.

27. The test device according to claim 20, wherein the second gap of the island comprises a top and a bottom independent of any sidewalls.

28. The test device according to claim 27, wherein the bottom of the read area is a porous paper.

29. The test device according to claim 28, wherein a top of the read area is a filter.

30. The test device according to claim 29, wherein the top of the read area includes at least one support, adapted to hold the top a predetermined distance from the bottom.

31. The test device according to claim 20, wherein the reagent is adapted to produce a colorimetric reaction.

32. The test device according to claim 31, in combination with a colorimetric sensor.

33. The test device according to claim 20, wherein the reagent is adapted to produce an electrochemical reaction.

34. The test device according to claim 33, in combination with an electrochemical sensor.

35. A test device adapted to test a concentration of an analyte in a fluid, comprising:

a pickup area having a first volume for receiving the fluid and a first gap adapted to use capillary action to draw the fluid into the pickup area; and

a contiguous cover having a read area, a bottom of the read area being a top side of the cover, the read area being in fluid communication with the pickup area, the read area including an island and a vent area adjacent to and surrounding the island, the island having a second gap such that the fluid is drawn into the second gap after the first gap is entirely filled, the read area containing a reagent adapted to produce a reaction indicative of the concentration of the analyte in the fluid, wherein a thickness of the vent area is greater than a thickness of the second gap.

36. A test device adapted to test a concentration of an analyte in a fluid comprising:

a pickup area having a first volume for receiving the fluid; and

a contiguous cover having a read area, a bottom of the read area being a top side of the cover, the read area being in fluid communication with the pickup area, the read area configured to receive fluid from the pickup area only after the pickup area is full, the read area including a reagent adapted to produce a reaction indicative of the concentration of the analyte in the fluid, the read area further including an island, a capillary gap, and a vent area adjacent to and surrounding the island, the vent area being in fluid communication with the capillary gap, a thickness of the vent area being greater than a thickness of the capillary gap of the island.

37. A method for determining a concentration of an analyte in a fluid with a test device, the test device comprising a pickup area and a contiguous cover having a read area, a bottom of the read area being a top side of the cover, the read area including an island and a capillary gap, the read area including a reagent and being adjacent to and surrounded by a vent area and being in fluid communication with the pickup area, the method comprising the acts of:

drawing the fluid into the pickup area, the pickup area having a first volume;

filling the pickup area with the fluid;

drawing the fluid into the read area after the pickup area is substantially full of the fluid, the read area having a second volume; and

allowing air to escape into the vent area, the vent area being in fluid communication with the capillary gap, a thickness of the vent area being greater than a thickness of the capillary gap of the island.