Analytical test element with a narrowed capillary channel

• US 6,592,815 B1
• Filed: 05/19/2000
• Issued: 07/15/2003
• 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: Zimmer, Volker
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US09/554,842
• Time in Patent Office: 1,152 Days
• Field of Search: 422/58, 422/50, 422/55, 422/56, 422/57, 436/63, 436/169, 436/170
• US Class Current: 422/412
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing

Abstract

The invention concerns an analytical test element for the determination of an analyte in a liquid containing a detection element and a channel capable of capillary liquid transport which has a sample application opening at one end of the channel capable of capillary liquid transport, wherein the channel capable of capillary liquid transport is continuously narrowed from the sample application opening in the direction of capillary transport at least up to the beginning of the detection element. In addition 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 determining an analyte in a liquid sample with the aid of the said analytical test element.

Claims

1. Analytical test element for the determination of an analyte in a liquid, the test element comprising:

a detection element and

a channel capable of capillary liquid transport, the channel having a sample application opening at one end capable of capillary liquid transport and wherein the channel is continuously narrowed from the sample application opening in the direction of capillary transport at least up to the beginning of the detection element,

wherein at least one of the surfaces that form the inner surface of the channel capable of capillary liquid transport is hydrophilized, the hydrophilization is achieved by using a hydrophilic material or by coating a material which is only slightly hydrophilic with a hydrophilic layer, and a layer of oxidized aluminium is used for hydrophilization.

2. Analytical test element for the determination of an analyte in a liquid, the test element comprising:

a detection element,

a base, and

a cover, the base and cover spaced-apart from one another a distance sufficient to create a capillary channel capable of capillary liquid transport, the channel having a sample application opening at one end capable of capillary liquid transport and wherein the channel is continuously narrowed from the sample application opening in the direction of capillary transport at least up to the beginning of the detection element,

wherein the narrowing of the channel capable of capillary liquid transport relates to that dimension of the channel that causes its capillarity.

3. Analytical test element as claimed in claim 2, wherein the channel capable of capillary liquid transport is linearly narrowed.

4. Analytical test element as claimed in claim 2, wherein the channel capable of capillary liquid transport is terminated at the opposite end to the sample application opening by an abrupt widening of that dimension of the channel which causes its capillarity.

5. Analytical test element as claimed in claim 2, wherein at least one of the surfaces that form the inner surface of the channel capable of capillary liquid transport is hydrophilized.

6. Analytical test element as claimed in claim 5, wherein the hydrophilization is achieved by using a hydrophilic material or by coating a material which is only slightly hydrophilic with a hydrophilic layer.

7. Analytical test element as claimed in claim 2, wherein the detection element is a multilayer detection element having a sample application zone and a detection zone arranged adjacent to one another in which the detection element is arranged in the test element such that only the sample application zone is in contact enabling liquid transfer with the channel capable of capillary liquid transport.

8. Analytical test element as claimed in claim 7, wherein the multilayer detection element comprises at least one layer of reagent for the detection reaction of the target analyte in the sample.

9. Analytical test element as claimed in claim 7, wherein the multilayer detection element contains means for filtering particulate sample components.

10. Analytical test element as claimed in claim 7, wherein the multilayer detection element comprises a fleece and a porous membrane that are arranged in a stack-like sandwich such that planar liquid transfer is possible.

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

providing an analytical test element for the determination of an analyte in a liquid, the test element including a detection element, a base, and a cover, the base and cover spaced-apart from one another a distance sufficient to create a capillary channel capable of capillary liquid transport, the channel having a sample application opening at one end capable of capillary liquid transport, wherein the channel is continuously narrowed from the sample application opening in the direction of capillary transport at least up to the beginning of the detection element, wherein the narrowing of the channel capable of capillary liquid transport relates to that dimension of the channel that causes its capillarity,

contacting the test element with a liquid sample at the sample application opening so that the liquid sample is transported by capillary forces into the channel until the liquid sample wets and penetrates the surface of the detection element that faces the channel in the region of the sample application zone, and

observing the liquid sample in the detection element to draw conclusions about the presence of the analyte in the liquid sample.

12. The method of claim 11, 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.

13. The method of claim 12, wherein the observing step includes visual observation.

14. The method of claim 12, wherein the observing step includes optical observation.

15. The method of claim 12, wherein the observing step includes the step of conducting a reflection photometric measurement.