CONTAINERS FOR READING AND HANDLING DIAGNOSTIC REAGENTS AND METHODS OF USING THE SAME

• US 20110165685A1
• Filed: 03/15/2011
• Published: 07/07/2011
• Est. Priority Date: 06/18/2003
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Charlton, Steven C.
• Granted Patent: US 8,178,351 B2
• Time in Patent Office: Days
• US Class Current: 436/14
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: G01N 2035/00019 cassette structures
• CPC Class Codes: G01N 31/22 using chemical indicators G01N31/02 takes precedence
• CPC Class Codes: G01N 33/48764 Test tape taken off a spool
• CPC Class Codes: G01N 35/00009 provided with a sample supporting tape, e.g. with absorbent zones
• CPC Class Codes: G01N 35/1002 Reagent dispensers
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/110833 Utilizing a moving indicator strip or tape
• CPC Class Codes: Y10T 436/113332 with conveyance of sample along a test line in a container or rack

Abstract

A container with a rotatable lid for reading and handling diagnostic reagents in tape form comprising a body portion, a lid portion, a continuous tape, a reagent-sensing device, and a storage device. The body portion includes an inner and outer surface. The lid portion is attached to the body portion and is adapted to rotate from a closed position to an open position. The continuous tape includes a diagnostic reagent. The reagent-sensing device is attached to either the body portion or the lid portion and adapted to read the diagnostic reagent. The storage device is attached to the body portion that is adapted to hold and dispense an unused portion of the continuous tape. During the rotation of the lid portion, the continuous tape is advanced from the first storage device and is extended over the reagent-sensing device.

Claims

1-10. -10. (canceled)

11. A sensor system for determining a glucose concentration of a fluid sample, the sensor system comprising:

an optical reagent-sensing device; and

a container including first and second storage devices, at least one of the first or second storage devices being a rotatable spool, the container further including a continuous tape comprising a diagnostic reagent and a polymeric material, the continuous tape extending from the first storage device, past the optical reagent-sensing device, to the second storage device such that the first storage device holds and dispenses unused portions of the continuous tape and the second storage device holds and receives used portions of the continuous tape, the container further including a white-reflectance calibration standard, the calibration standard operative to calibrate the optical reagent-sensing device,

wherein the optical reagent-sensing device is operative to read the diagnostic reagent and determine a glucose concentration in less than about 15 seconds for a fluid sample having a volume of less than 1 microliter.

12. The sensor system of claim 11, wherein the white-reflectance calibration standard is located within the container.

13. The sensor system of claim 11, wherein the container further includes at least one seal to assist in limiting moisture from entering into the container.

14. The sensor system of claim 11, wherein the diagnostic reagent is disposed on the continuous tape.

15. The sensor system of claim 11, wherein the continuous tape further comprises a plurality of membranes attached thereto, the diagnostic reagent being disposed on the plurality of membranes.

16. The sensor system of claim 11, wherein diagnostic reagent is disposed in the continuous tape.

17. The sensor system of claim 11, wherein the continuous tape is flat against at least a portion of the optical reagent-sensing device.

18. The sensor system of claim 11, wherein the optical reagent-sensing device is at least partially disposed within the container.

19. The sensor system of claim 11, further comprising a lancet.

20. A method for determining a glucose concentration of a fluid sample with a sensor system, the method comprising the acts of:

providing an optical reagent-sensing device;

providing a container including a first storage device, a second storage device, a continuous polymeric tape, a diagnostic reagent, and a white-reflectance calibration standard operative for calibrating the optical reagent-sensing device, at least one of the first storage device or the second storage device being a rotatable spool, the continuous tape including a first unused segment on the first storage device, a second segment between the first storage device and second storage device that extends over the optical reagent-sensing device, and a third used segment on the second storage device, the second segment being at least partially exposed outside of the container;

placing the fluid sample on the exposed second segment of the continuous tape; and

determining the glucose concentration of the fluid sample in less than about 15 seconds using the diagnostic reagent and the optical reagent-sensing device, the fluid sample having a volume of less than 1 microliter.

21. The method of claim 20, wherein the white-reflectance calibration standard is located within the container.

22. The method of claim 20, wherein the container further includes at least one seal operative to limit moisture from entering into the container.

23. The method of claim 20, wherein the diagnostic reagent is disposed on the continuous tape.

24. The method of claim 20, wherein the continuous tape further includes a plurality of membranes attached thereto, the diagnostic reagent being disposed on the plurality of membranes.

25. The method of claim 20, wherein the diagnostic reagent is disposed in the continuous tape.

26. A sensor system for determining a glucose concentration of a fluid sample, the sensor system comprising:

an optical reagent-sensing device; and

a container including a first storage device, a second storage device, a continuous polymeric tape partially exposed to an exterior of the container, and a diagnostic reagent, at least one of the first storage device or the second storage device being a rotatable spool, the first storage device operative to hold and dispense unused portions of the continuous tape and the second storage device operative to hold and receive used portions of the continuous tape, the container further including desiccant and a white-reflectance calibration standard, the calibration standard operative to calibrate the optical reagent-sensing device,

wherein the optical reagent-sensing device is operative to read the diagnostic reagent to determine a glucose concentration of a fluid sample received via the continuous tape, the fluid sample having a volume of less than 1 microliter.

27. The sensor system of claim 26, wherein the calibration standard is located within the container.

28. The sensor system of claim 26, wherein the container further includes at least one seal to assist in limiting moisture from entering into the container.

29. The sensor system of claim 26, wherein the diagnostic reagent is disposed on the continuous tape.

30. The sensor system of claim 26, wherein the continuous tape further includes a plurality of membranes attached thereto, the diagnostic reagent being disposed on the plurality of membranes.

31. The sensor system of claim 26, wherein the diagnostic reagent is disposed in the continuous tape.

32. The sensor system of claim 26, wherein the continuous tape is flat against at least a portion of the optical reagent-sensing device.

33. The sensor system of claim 26, wherein the optical reagent-sensing device is at least partially disposed within the container.

34. The sensor system of claim 26, further comprising a lancet.

35. A method for determining a glucose concentration of a fluid sample with a sensor system, the method comprising the acts of:

providing an optical reagent-sensing device;

providing a container including a first storage device, a second storage device, a continuous polymeric tape, a diagnostic reagent, and a white-reflectance calibration standard, at least one of the first storage device or the second storage device being a rotatable spool;

storing unused portions of the continuous tape via the first storage device;

storing used portions of the continuous tape via the second storage device;

calibrating the optical reagent-sensing device using the white-reflectance calibration standard;

in response to calibrating the optical reagent-sensing device, rotating the rotatable spool to advance the continuous tape from the first storage device to the second storage device;

determining the glucose concentration of the fluid sample in less than 15 seconds using optical reagent-sensing device to read the diagnostic reagent, the fluid sample having a volume of less than 1 microliter.

36. The method of claim 35, wherein the optical reagent-sensing device is calibrated before determining the glucose concentration.

37. The method of claim 35, wherein the calibration standard is located within the container.

38. The method of claim 35, wherein the continuous tape further includes a plurality of membranes attached thereto, the diagnostic reagent being disposed on the plurality of membranes.

39. The method of claim 35, wherein the continuous tape is flat against at least a portion of the optical reagent-sensing device.

40. A sensor system for determining a glucose concentration of a fluid sample, the sensor system comprising:

an optical reagent-sensing device; and

a container comprising

a first storage device,

a second storage device, at least one of the first storage device or the second storage device including a rotatable spool,

a continuous polymeric tape, the continuous tape including a first unused segment on the first storage device, a second segment between the first storage device and second storage device, and a third used segment on the second storage device, the second segment of the continuous tape being at least partially positioned in front of the optical reagent-sensing device and at least partially exposed to the exterior of the container,

a diagnostic reagent, and

a white-reflectance calibration standard operative for calibrating the optical reagent-sensing device, the rotatable spool being operative to advance the continuous tape after the optical reagent-sensing device is calibrated,

wherein the optical reagent-sensing device is operative to read the diagnostic reagent to determine a glucose concentration of a fluid sample having a volume of less than 1 microliter.

41. The sensor system of claim 40, wherein the optical reagent-sensing device is further operative to read the diagnostic reagent and determine the glucose concentration of the fluid sample in less than 15 seconds.

42. The sensor system of claim 40, wherein the optical reagent-sensing device is calibrated before reading the diagnostic reagent.

43. The sensor system of claim 40, wherein the calibration standard is located within the container.

44. The sensor system of claim 40, wherein the container further includes at least one seal to assist in limiting moisture from entering into the container.

45. The sensor system of claim 40, wherein the diagnostic reagent is disposed on the continuous tape.

46. The sensor system of claim 40, wherein the continuous tape further includes a plurality of membranes attached thereto, the diagnostic reagent being disposed on the plurality of membranes.

47. The sensor system of claim 40, wherein diagnostic reagent is disposed in the continuous tape.

48. The sensor system of claim 40, wherein the continuous tape is flat against at least a portion of the optical reagent-sensing device.

49. The sensor system of claim 40, wherein the optical reagent-sensing device is at least partially disposed within the container.

50. The sensor system of claim 40, further comprising a lancet.