Test element for analyzing body fluids

• US 8,303,906 B2
• Filed: 06/15/2010
• Issued: 11/06/2012
• 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: Babic, Branislav, Frank, Martin, Griesheimer, Hans-Ludwig, Hoferer, Juergen, Pachl, Rudolf, Schmid, Wilfried
• Primary Examiner(s): Alexander, Lyle
• Application Number:
  US12/815,751
• Publication Number:
  US 20100278693A1
• Time in Patent Office: 875 Days
• Field of Search: 436/63, 436/95, 422/400, 422/401, 422/430
• US Class Current: 422/401
• 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. A system for determining the concentration of an analyte in a body fluid sample, comprising:

at least one analytical test element, the analytical test element comprising;

an application site adapted to receive a body fluid sample;

a detection area configured for analyzing the body fluid sample and comprising a reagent that reacts with a blood analyte;

a contamination area at least partially adjoining the application site, the contamination area comprising an adhesive exposed for contact by the body fluid sample and adapted to adhere a dried portion of the body fluid sample to the analytical test element; and

a top layer which defines a top exposed surface of the analytical test element, the top exposed surface of the top layer at least partially comprising the contamination area and being at least partially covered with the adhesive.

2. The system of claim 1, further comprising a magazine, wherein the analytical test element is configured to be retracted after use into the magazine.

3. The system of claim 2, wherein the magazine comprises a carriage that moves in a guide chamber, the analytical test element being carried by the carriage.

4. The system of claim 2, wherein the magazine comprises a plurality of guide chambers circumferentially arranged around the magazine.

5. The system of claim 1, further comprising a transport element disposed between the application site and detection area, the transport element being configured to transport the body fluid sample from the application site to the detection area.

6. The system of claim 5, wherein the transport element comprises a capillary channel.

7. The system of claim 5, wherein the transport element comprises a hydrophilic coating.

8. The system of claim 1, wherein the analytical test element further comprises a carrier layer, the cover layer and the carrier layer defining top and bottom exposed surfaces of the analytical test element, respectively, the exposed surfaces being at least partially covered with the adhesive.

9. The system of claim 8, 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 a transport element.

10. The system of claim 1, wherein the adhesive comprises polyvinyl acetate.

11. The system of claim 1, wherein the adhesive contains dextrin or caoutchouc.

12. The system of claim 1, wherein the adhesive includes water soluble components.

13. The system of claim 1, wherein the adhesive substance is disposed on the application site.

14. The system of claim 1, wherein the application site is essentially free of the adhesive.

15. A process for producing an analytical test element for determining presence or 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 a surface of the at least one layer;

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 having a reagent that reacts with a blood analyte, and a contamination area adjacent the application site, the at least one layer forming a top layer of the test element and the surface of the at least one layer defining an exposed surface of the contamination area having the adhesive applied thereto.

16. The process of claim 15, wherein the step of providing material comprises providing material for the top 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 top layer overlying the carrier layer.

17. The process of claim 16, further comprising providing a spacer layer between the carrier layer and the top layer in the assembled analytical aid, the top 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.

18. The process of claim 17, further comprising applying a hydrophilic substance on or near the transport element.

19. The process of claim 15, further comprising applying a reagent layer to the detection area.

20. The process of claim 15, further comprising the step of arranging a plurality of the test elements in respective guide chambers of a magazine.

21. The process of claim 15, wherein the step of applying an adhesive to a surface of the at least one layer comprises applying the adhesive over the entire surface of the at least one layer.

22. The process of claim 15, wherein the step of applying an adhesive to a surface of the at least one layer comprises applying the adhesive on only parts of the surface of the at least one layer.