TEST ELEMENT FOR ANALYZING BODY FLUIDS

• US 20080060424A1
• Filed: 09/22/2007
• Published: 03/13/2008
• Est. Priority Date: 03/22/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Schmid, Wilfried, Pachl, Rudolf, Frank, Martin, Babic, Branislav, Griesheimer, Hans-Ludwig, Hoferer, Juergen
• Granted Patent: US 7,763,470 B2
• Time in Patent Office: Days
• US Class Current: 73/61.41
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10T 29/49982 Coating
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

An analytical test element for determining an analyte in a body fluid comprises a detection area in which the analyte is detected and an application site at which the body fluid can be applied to the test element. The application site is spaced apart from the detection area, wherein at least some of the body fluid applied to the application site moves from the application site to the detection area. The test element also comprises a contamination area which at least partially adjoins the application site, wherein an adhesive substance is applied to at least part of the contamination area of the test element. The adhesive substance adheres to the contamination area of the test element and is able to interact with an excess amount of applied body fluid such that at least some of the body fluid adheres to the test element and thereby an excess amount of body fluid remains in the contamination area. An additional embodiment provides for test elements which, after use, can be stored in a storage container. Another embodiment provides for the production of the test elements.

Claims

1. An analytical test element for determining presence or concentration of an analyte in a body fluid, comprising:

an application site adapted to receive a body fluid sample;

a detection area spaced from the application site and configured for analyzing the body fluid sample;

a transport element disposed between the application site and the detection area, the transport element being configured to transport a first portion of the body fluid sample from the application site to the detection area; and

a contamination area adjacent the application site and exposed for contact by the body fluid sample, the contamination area comprising an adhesive adapted to adhere a second portion of the body fluid sample to the analytical test element.

2. The analytical test element of claim 1, wherein the adhesive comprises polyvinyl acetate.

3. The analytical test element of claim 1, wherein the adhesive contains dextrin or caoutchouc.

4. The analytical test element of claim 1, wherein the adhesive includes water soluble components.

5. The analytical test element of claim 1, wherein the transport element comprises a capillary channel.

6. The analytical test element of claim 1, wherein the transport element includes a hydrophilic coating.

7. The analytical test element of claim 1, further comprising a cover layer and a carrier layer which define top and bottom exposed surfaces of the analytical test element, respectively, the exposed surfaces being at least partially covered with the adhesive.

8. The analytical test element of claim 7, further comprising a spacer layer disposed between the carrier layer and the cover layer, the spacer layer defining a recess which cooperates with the cover and carrier layers to form the transport element.

9. The analytical test element of claim 1, wherein the adhesive substance is applied to the application site.

10. The analytical test element of claim 1, wherein the application site is essentially free of the adhesive.

11. A system for determining the concentration of an analyte in a body fluid sample, comprising:

a magazine; and

at least one analytical test element moveably mounted within the magazine, the analytical test element comprising;

an application site adapted to receive a body fluid sample;

a detection area spaced from the application site and configured for analyzing the body fluid sample;

a transport element disposed between the application site and the detection area, the transport element being configured to transport a first portion of the body fluid sample from the application site to the detection area; and

a contamination area adjacent the application site and exposed for contact by the body fluid, the contamination area comprising an adhesive adapted to adhere a second portion of the body fluid to the analytical test element.

12. The system of claim 11, wherein the analytical test element is retracted after use into the magazine.

13. The system of claim 11, wherein the magazine comprises a carriage that moves in a guide chamber, the analytical test element being carried by the carriage.

14. A method of using an analytical test element to determine the presence or concentration of an analyte in a body fluid sample, the method comprising:

applying a body fluid sample to an application site of the analytical test element;

adhering a first portion of the body fluid sample to a contamination area of the analytical test element;

transporting a second portion of the body fluid sample from the application site to a detection area of the analytical test element; and

analyzing the second portion of the body fluid sample for the presence or concentration of the analyte.

15. The method of claim 14, further comprising dissolving some of the adhesive into the second portion of the sample before the transporting step.

16. The method of claim 14, further comprising completing the analyzing step before the first portion of the body fluid dries on the contamination area.

17. The method of claim 14, further comprising using capillary action to transport the second portion of the body fluid to the detection area.

18. The method of claim 17, wherein the adhering step is performed with an adhesive that includes polyvinyl acetate.

19. The method of claim 14, wherein the adhering step is performed with an adhesive that includes one or more of dextrin, caoutchouc and water soluble components.

20. The method of claim 14, further comprising drying the second portion of the sample that is adhered to the contamination area, wherein the second portion substantially adheres to the contamination area after the drying.

21. A process for producing an analytical test element for determining presence of concentration of an analyte in a body fluid, comprising:

providing material that is to be formed into at least one layer of the analytical test element;

applying an adhesive to an area of the material;

drying the adhesive; and

assembling the material into an analytical test element having an application site, a detection area spaced from the application site, and a contamination area adjacent the application site, an exposed surface of the contamination area having the adhesive applied thereto.

22. The process of claim 21, wherein the step of providing material comprises providing material for a cover layer and a carrier layer and the step of assembling the material into an analytical test element comprises forming the analytical test element with the cover layer overlying the carrier layer.

23. The process of claim 22, further comprising providing a spacer layer between the carrier layer and the cover layer in the assembled analytical aid, the cover layer, carrier layer and the spacer layer cooperating to form a transport element configured to transport a fluid sample from the application site to the detection area by capillary action.

24. The process of claim 23, further comprising applying a hydrophilic substance on or near the transport element.

25. The process of claim 21, further comprising applying a reagent layer to the detection area.