Analytical test element

• US 8,252,248 B2
• Filed: 07/05/2005
• Issued: 08/28/2012
• Est. Priority Date: 07/09/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Krämer, Peter
• Primary Examiner(s): Alexander, Lyle
• Assistant Examiner(s): WHITE, DENNIS MICHAEL
• Application Number:
  US11/632,083
• Publication Number:
  US 20080031778A1
• Time in Patent Office: 2,611 Days
• Field of Search: 422/57, 422/58, 422/56, 422/60, 422/946, 422/947, 422/400, 422/401, 422/408, 422/412, 422/417, 422/420, 422/421, 422/422, 422/423, 422/424, 422/425, 422/426, 422/427, 422/428, 422/429, 422/68.1, 422/82.05, 422/82.06, 436/169, 436/164, 436/170, 435/13, 435/283.1, 435/287.1, 435/287.7, 435/287.8, 435/287.9, 435/288.7
• US Class Current: 422/417
• 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: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2300/105 using desiccants
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0694 vents used to stop and induce flow, backpressure valves
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502723 characterised by venting arrangements
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

The invention relates to an analytical test element for analysis of a liquid sample. The analytical test element may contain a channel which is suitable for capillary transport of the liquid sample and which is provided with an inlet opening for the liquid sample and with an air outlet opening. At least one test field may be arranged in the channel, spaced apart from the inlet opening. The test element comprises a sample application site which is closed with a seal and which is designed in such a way that, when the seal is opened, the sample application site and the inlet opening of the channel are simultaneously open to the outside environment of the test element. The test element can then receive the liquid sample inside the channel via the sample application site and inlet opening, for analysis in the test field. The invention also relates to a test element magazine and to a system for analysis of liquid samples with at least one test element.

Claims

1. A test element for analysis of a liquid sample, the test element comprising:

a channel which is suitable for capillary transport of the liquid sample and which is provided with an inlet opening for the liquid sample and with an air outlet opening,

a free space inside the test element, the inlet opening and the air outlet opening each being contiguous with the free space,

at least one test field being arranged inside the channel at a distance from the inlet opening,

the test element comprises a sample application site which is closed with a seal, and which is configured such that, when the seal is opened, the sample application site, the inlet opening of the channel, the air outlet opening of the channel, and the free space are simultaneously opened toward an outside environment of the test element, the sample application site being accessible for direct application of the liquid sample from outside the test element to be received inside the channel via flow of the liquid sample through the sample application site, the free space, and then through the inlet opening, for analysis in the at least one test field, wherein the seal is opened by one of being pierced and being cut.

2. The test element as claimed in claim 1, wherein the inlet opening is arranged at one end of the channel, and the air outlet opening is arranged at the other end of the channel.

3. The test element as claimed in claim 1, wherein in an unused state of the test element, the free space is at least partially delimited on a first side by the seal closing the sample application site and, on a second side remote from the first side, is at least partially delimited by a second seal.

4. The test element as claimed in claim 1, wherein the channel in the test element has one of a U-shaped course and a V-shaped course.

5. The test element as claimed in claim 1, wherein the channel has a substantially rectangular cross section and has a width of less than 5 mm and a height of less than 1 mm.

6. The test element as claimed in claim 1, wherein the channel has a total length of less than 5 cm.

7. The test element as claimed in claim 1, wherein the distance from the sample application site to the inlet opening of the channel is less than the distance from the sample application site to the air outlet opening of the channel.

8. The test element as claimed in claim 1, wherein the channel, in an area of the inlet opening, has an increased wettability by the liquid sample than in the area of the air outlet opening.

9. The test element as claimed in claim 1, wherein in an interior of the channel, a first area of the channel between the inlet opening and the at least one test field has an increased wettability by the liquid sample than a second area of the channel between the at least one test field and the air outlet opening.

10. The test element as claimed in claim 1, wherein the seal closing the sample application site has, on the side directed toward an interior of the test element, an increased wettability by the liquid sample than it does on the side directed away from the interior of the test element.

11. The test element as claimed in claim 1, wherein a desiccant is contained in the test element.

12. The test element as claimed in claim 11, wherein the desiccant contains one of a zeolite gel and a silica gel.

13. The test element as claimed in claim 1, further comprising a waste area for receiving an excess of liquid sample in the test element.

14. The test element as claimed in claim 1, wherein the test element contains a detection window which is directed toward the test field and which serves for photometric analysis of the liquid sample on the test field.

15. The test element as claimed in claim 1, wherein in at least one wall delimiting the channel, conductor tracks are provided for electrochemical analysis of the liquid sample on the test field.

16. The test element as claimed in claim 1, wherein the test element is built up from a multiplicity of layers.

17. The test element as claimed in claim 16, wherein the channel extends through at least one layer of the multiplicity of layers.

18. The test element as claimed in claim 16, wherein the test element comprises at least one sealing layer.

19. The test element as claimed in claim 18, wherein the at least one sealing layer has a hydrophobic coating.

20. The test element as claimed in claim 16, wherein the test element comprises at least one carrier layer and at least one intermediate layer at least partially containing the channel.

21. The test element as claimed in claim 16, wherein the multiplicity of layers are arranged in the following sequence:

A) a first sealing layer comprising the sample application site,

B) a transparent first carrier layer,

C) a first intermediate layer containing a first part of the channel,

D) a second carrier layer containing an opening,

E) a second intermediate layer containing a second part of the channel,

F) a third carrier layer, and

G) a second sealing layer,

wherein the opening in the second carrier layer connects the first part of the channel to the second part of the channel, and the at least one test field is arranged in the first part of the channel, and, when the test element is in an unused state a free space extends through the layers B) to F), into which free space the first and second parts of the channel open.

22. The test element as claimed in claim 21, wherein an outside face of the first sealing layer, and those sides of the second and third carrier layers directed toward the second part of the channel, have a hydrophobic coating.

23. The test element as claimed in claim 21, wherein a desiccant is arranged in the second part of the channel.

24. The test element as claimed in claim 21, wherein the first sealing layer contains a detection window for photometric analysis of the liquid sample on the test field.

25. The test element as claimed in claim 21, wherein the first and the second intermediate layers are hydrophobic.

26. The test element as claimed in claim 21, wherein those sides of the first and second carrier layers directed toward the first part of the channel are one of hydrophilic and have a hydrophilic coating.

27. The test element as claimed in claim 1, wherein the seal is one of a composite film that comprises an aluminum film, an outer layer of one of a PE, a PET and an oriented PA, and an inner layer of one of a PE, a PP and lacquers;

and a high-barrier composite of PET/SiOx.

28. A test element magazine comprising a multiplicity of test elements as claimed in claim 1, wherein the test element magazine is configured as one of a band, a drum, a stack, and a disk.

29. A system for analysis of liquid samples comprising at least one test element as claimed in claim 1, a piercing device for opening the seal of the at least one test element at the sample application site of the at least one test element shortly before application of a liquid sample, and a detector for analysis of the liquid sample in the test field of the at least one test element.

30. The system as claimed in claim 29 further comprising a compression unit for increasing the pressure on the perforated skin of the patient upon withdrawal of the body fluid.

31. The test element of claim 1, wherein the test element is configured for analyzing the glucose content in blood or in interstitial fluid.

32. The system as claimed in claim 29, wherein the piercing device also serves as a perforating device.

33. A test element for analysis of a liquid sample, the test element comprising:

a channel which is suitable for capillary transport of the liquid sample and which is provided with an inlet opening for the liquid sample and with an air outlet opening,

a free space inside the test element, the inlet opening and the air outlet opening each being interfaced with the free space,

at least one test field being arranged inside the channel at a distance from the inlet opening, and

a sample application site which is closed with a seal,

the test element being configured such that, when the seal is opened by one of being pierced and being cut, the sample application site, the inlet opening of the channel, the air outlet opening of the channel, and the free space are simultaneously opened toward an outside environment of the test element, and the free space is in flow communication with the channel through the inlet opening, and the channel is in flow communication with the free space through the air outlet opening.

34. A test element for analysis of a liquid sample, the test element comprising:

a channel which is suitable for capillary transport of the liquid sample and which is provided with an inlet opening for the liquid sample,

a free space inside the test element,

at least one test field being arranged inside the channel at a distance from the inlet opening, and

a sample application site which is closed with a seal, the test element being configured such that, when the seal is opened by one of being pierced and being cut, the sample application site, the inlet opening of the channel, and the free space are simultaneously opened toward an outside environment of the test element,

the channel further including an air outlet opening positioned such that during the capillary transport of the liquid sample inside the channel to the at least one test field, the air outlet opening ensures release of air from the channel to the free space, the inlet opening and the air outlet opening being contiguous with the free space.

35. A test element for analysis of a liquid sample, the test element comprising:

a free space inside the test element;

a channel which is suitable for capillary transport of the liquid sample and which is provided with an inlet opening for the liquid sample at an interface with the free space and with an air outlet opening at another interface with the free space,

at least one test field being arranged inside the channel at a distance from the inlet opening, and

a sample application site which is closed with a seal,

the test element being configured such that, when the seal is opened, the channel is opened toward an outside environment of the test element, and the test element can receive the liquid sample inside the channel via the sample application site and then through the inlet opening, for analysis in the at least one test field,

wherein the channel includes a first portion that extends from the inlet opening, away from the free space, toward the test field, and a second portion that extends away from the test field, toward the free space, to the air outlet opening.

36. A test element for analysis of a liquid sample, the test element comprising:

a channel which is suitable for capillary transport of the liquid sample and which is provided with an inlet opening for the liquid sample and with an air outlet opening,

a free space separate from the channel, the inlet opening and the air outlet opening each being disposed between the channel and the free space, and each being contiguous with the free space,

at least one test field being arranged inside the channel at a distance from the inlet opening, and

a sample application site which is closed with a seal,

the test element being configured such that, when the seal is opened by one of being pierced and being cut, the sample application site, the inlet opening of the channel, the air outlet opening of the channel, and the free space are simultaneously opened toward an outside environment of the test element, and the test element can receive the liquid sample inside the channel via the sample application site and then through the inlet opening, for analysis in the at least one test field.

37. A test element for analysis of a liquid sample, the test element comprising:

a channel which is suitable for capillary transport of the liquid sample and which is provided with an inlet opening for the liquid sample and with an air outlet opening,

a free space inside the test element, the inlet opening and the air outlet opening being interfaced with the free space,

at least one test field being arranged inside the channel at a distance from the inlet opening, and

a sample application site which is closed with a seal,

the test element being configured such that, when the seal is opened by one of being pierced and being cut, the sample application site, the inlet opening of the channel, the air outlet opening of the channel, and the free space are simultaneously opened toward an outside environment of the test element, and the liquid sample, once applied, passes through the sample application site, then through the free space, and is drawn by capillary force through the inlet opening, into the channel and onto the test field for analysis.