Analytical test element with a capillary channel

• US 7,008,799 B1
• Filed: 12/04/1998
• Issued: 03/07/2006
• Est. Priority Date: 12/04/1997
• Status: Expired due to Term

• Current Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Original Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Inventors: Leichner, Wilhelm, Zimmer, Volker, Mönch, Ronald, Schwöbel, Wolfgang
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US09/554,844
• Time in Patent Office: 2,650 Days
• Field of Search: 435/4, 435/6, 435/7.1, 435/7.9, 435/7.92, 4352871-2873, 4352877-2879, 435/288.5, 435/288.7, 435/808, 435/969, 436/164, 436/172, 436/518, 436/524, 436/532, 436/807, 436/514, 422/68.1, 422/82.05, 422/82.09, 422/82.11
• US Class Current: 436/514
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 2035/00108 Test strips, e.g. paper
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: Y10S 435/808 Optical sensing apparatus
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures

Abstract

The invention concerns an analytical test element for the determination of an analyte in a liquid containing an inert carrier, a detection element and a channel capable of capillary liquid transport which has a sample application opening at one end and a vent opening at the other end of the channel capable of capillary liquid transport, wherein the channel capable of capillary liquid transport is formed at least partially by the carrier and the detection element and extends in the direction of capillary transport from the sample application opening at least to the edge of the detection test element that is nearest to the vent opening and wherein a notch is located in one of the surfaces forming the channel capable of capillary liquid transport at the edge of the test element forming the sample application opening so that one side of the edge of the test element forming the sample application opening is at least partially discontinuous and the surface opposite to the notch is exposed. It also concerns the use of the said analytical test element for the determination of an analyte in a liquid as well as a method for the determination of an analyte in a liquid sample with the aid of the said analytical test element.

Claims

1. Analytical test element comprising:

an inert cover,

an inert carrier having a first surface,

a detection element being formed to permit liquid penetration therein and including at least one reagent contained in the detection element, the detection element including a second surface facing the first surface, and

a capillary channel including a sample opening and a vent opening and extends in a direction of capillary transport from the sample opening to at least an edge of the detection element that is nearest to the vent opening, wherein the capillary channel is formed by the inert carrier, the detection element, and the inert cover, the cover and the detection element being mounted end to end in such a way that the capillary channel extends without interruption from the sample application opening to the vent opening and a notch is positioned at an edge of the test element forming the sample opening so that a surface opposite to the notch is exposed.

2. The analytical test element as claimed in claim 1, wherein at least one of the surfaces forming an inner surface of the channel is hydrophilized.

3. The analytical test element as claimed in claim 2, wherein the exposed surface opposite to the notch is hydrophilized.

4. The analytical test element as claimed in claim 2 wherein a layer of oxidized aluminium is used for the hydrophilization.

5. The analytical test element as claimed in claim 2, wherein the hydrophilization is achieved by a hydrophilic material.

6. The analytical test element as claimed in claim 2, wherein the hydrophilization is achieved by a hydrophilic layer.

7. The analytical test element as claimed in claim 1, wherein the detection element is a filter for particulate sample components.

8. The analytical test element as claimed in claim 1, wherein the channel is at least partially formed by the carrier, the cover and the detection element wherein the cover and detection element are arranged adjacent to one another in such a way that the cover is located on the side facing the sample application opening.

9. The analytical test element as claimed in claim 8, wherein a flexible inert foil is mounted on the side of the cover that faces the channel which extends over the entire length of the cover, covers the entire width of the capillary channel and is at least partially enclosed between the opposing surfaces of the cover and detection element so that the capillary liquid transport does not break down at the site of contact between the detection element and cover.

10. Method of detecting the presence of an analyte in a liquid with an analytical test element as claimed in claim 1, wherein

the test element is contacted with the liquid sample at the edge of the sample application opening, which is interrupted by the notch so that the sample is transported by capillary forces into the channel and wets and penetrates the surface of the detection element specific for the detection of the analyte that faces the channel, and

the liquid sample in the detection element is observed to determine whether optical changes in the detection element exist, wherein the changes relate to a presence of the analyte in the liquid sample.

11. The analytical test element as claimed in claim 1, wherein an intermediate layer is present between the carrier and detection element.

12. The analytical test element as claimed in claim 11, wherein the intermediate layer is formed to bond the carrier and detection element.

13. The analytical test element as claimed in claim 12, wherein the intermediate layer is formed to bond the cover and the carrier.

14. The test element of claim 1 further comprising a cover defining a portion of the channel and wherein the detection element and the sample application opening are non-contiguous.

15. An analytical test apparatus comprising:

an inert cover,

an inert carrier having a first surface, and

a detection element being formed to permit liquid penetration therein and including at least one reagent contained in the detection element, the detection element having a second surface facing the first surface, the channel including a sample opening and a vent opening and extends in a direction of capillary transport from the sample opening to at least an edge of the detection element that is nearest to the vent opening, wherein the capillary channel is formed by the inert carrier, the detection element, and the inert cover, the cover and the detection element being mounted end to end in such a way that the capillary channel extends without interruption from the sample application opening to the vent opening and a notch is positioned at an edge of the test element forming the sample opening so that one side of the edge is discontinuous.

16. The apparatus of claim 15, wherein at least one of the surfaces forming the channel is hydrophilized.

17. The apparatus of claim 16, wherein the hydrophilization is achieved by a hydrophilic material.

18. The apparatus of claim 16, wherein the hydrophilization is achieved by a hydrophilic layer.

19. The apparatus of claim 18, wherein a layer of oxidized aluminium is used for the hydrophilization.

20. The apparatus of claim 15, wherein the surface opposite to the notch is hydrophilized.

21. The apparatus of claim 15, further comprising an inert cover cooperating with the carrier and the detection element to define at least a portion of the channel.

22. The apparatus of claim 21, wherein the cover and the detection element are located on the side of the channel that is opposite the carrier.

23. The apparatus of claim 21, wherein the cover and detection element are arranged adjacent to one another so that the cover is positioned on the side facing the sample application opening.

24. The apparatus of claim 21, wherein the detection element and the cover abut each other.

25. The apparatus of claim 21, further comprising a flexible inert foil mounted on the cover and facing the channel.

26. The apparatus of claim 25, wherein the foil covers the entire width of the channel and is at least partially enclosed between the opposing surfaces of the cover and the detection element.

27. The test element of claim 15 further comprising a cover defining a portion of the channel and wherein the detection element and the sample application opening are non-contiguous.

28. A method for determining an analyte in a liquid sample, the method comprising the steps of:

providing an analytical test element including an inert cover, an inert carrier having a first surface, a detection element being formed to permit liquid penetration therein and including at least one reagent contained in the detection element, the detection element including a second surface facing the first surface, and a capillary channel including a sample opening and a vent opening and extends in a direction of capillary transport from the sample opening to at least an edge of the detection element that is nearest to the vent opening, wherein the capillary channel is formed by the inert carrier, the detection element, and the inert cover, the cover and the detection element being mounted end to end in such a way that the capillary channel extends without interruption from the sample application opening to the vent opening and a notch is positioned at an edge of the test element forming the sample opening so that a surface opposite to the notch is exposed,

contacting the test element with the liquid sample at the notch so that the liquid sample is transported by capillary forces into the channel, and

observing the liquid sample in the detection element to determine whether optical changes in the detection element exist following contact with the liquid sample, wherein the changes relate to a presence of the analyte in the liquid sample.

29. The method of claim 28, further comprising the steps of providing at least one reagent in the detection element and conducting an analyte-specific detection reaction with the at least one reagent.

30. The method of claim 29, wherein the observing step includes visual observation.

31. The method of claim 29, wherein the observing step includes optical observation.

32. The method of claim 29, wherein the observing step includes the step of conducting a reflection photometric measurement.