Containers for reading and handling diagnostic reagents and methods of using the same

• US 8,178,351 B2
• Filed: 03/15/2011
• Issued: 05/15/2012
• 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.
• Primary Examiner(s): Hill, Jr., Robert J
• Assistant Examiner(s): Gerido, Dwan A
• Application Number:
  US13/048,271
• Publication Number:
  US 20110165685A1
• Time in Patent Office: 427 Days
• Field of Search: 436/44, 436/43, 436/165, 436/169, 422/401, 422/420, 422/82.05, 422/82.09
• US Class Current: 436/44
• 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. 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.

2. The method of claim 1, wherein the white-reflectance calibration standard is located within the container.

3. The method of claim 1, wherein the container further includes at least one seal operative to limit moisture from entering into the container.

4. The method of claim 1, wherein the diagnostic reagent is disposed in or on the continuous tape.

5. The method of claim 1, wherein the continuous tape further includes a plurality of membranes attached thereto, the diagnostic reagent being disposed on the plurality of membranes.

6. The method of claim 1, wherein at least a portion of the second segment of the continuous tape is flat against at least a portion of the optical reagent-sensing device.

7. The method of claim 1, wherein the optical reagent-sensing device is at least partially disposed within the container.

8. The method of claim 1, further comprising providing a lancet.

9. The method of claim 1, further comprising calibrating the optical reagent-sensing device using the white-reflectance calibration standard.

10. The method of claim 9, wherein the optical reagent-sensing device is calibrated before determining the glucose concentration.

11. 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;

providing a desiccant to assist in providing a lower humidity environment in 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.

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

13. The method of claim 11, wherein at least a portion of the second segment of the continuous tape is flat against at least a portion of the optical reagent-sensing device.

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

15. The method of claim 11, wherein the container further includes at least one seal operative to limit moisture from entering into the container.

16. The method of claim 11, wherein the diagnostic reagent is disposed in or on the continuous tape.

17. The method of claim 11, wherein the continuous tape further includes a plurality of membranes attached thereto, the diagnostic reagent being disposed on the plurality of membranes.

18. The method of claim 11, further comprising providing a lancet.

19. The method of claim 11, further comprising calibrating the optical reagent-sensing device using the white-reflectance calibration standard.

20. The method of claim 19, wherein the optical reagent-sensing device is calibrated before determining the glucose concentration.

21. 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;

providing a desiccant within 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.

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

23. The method of claim 21, wherein the optical reagent-sensing device is at least partially disposed within the container.

24. The method of claim 21, wherein the container further includes at least one seal operative to limit moisture from entering into the container.

25. The method of claim 21, wherein the diagnostic reagent is disposed in or on the continuous tape.

26. The method of claim 21, wherein the continuous tape further includes a plurality of membranes attached thereto, the diagnostic reagent being disposed on the plurality of membranes.

27. The method of claim 21, further comprising providing a lancet.

28. The method of claim 21, further comprising calibrating the optical reagent-sensing device using the white-reflectance calibration standard.

29. The method of claim 28, wherein the optical reagent-sensing device is calibrated before determining the glucose concentration.