Laminated assay devices

• US 20050136529A1
• Filed: 12/19/2003
• Published: 06/23/2005
• Est. Priority Date: 12/19/2003
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Yang, Kaiyuan, Song, Xuedong, Kaylor, Rosann
• Granted Patent: US 7,943,089 B2
• Time in Patent Office: Days
• US Class Current: 435/287.100
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

An electrochemical-based assay device capable of detecting the presence or quantity of an analyte of interest that is provided. The device contains two or more substrates, one containing a detection working electrode and another containing an auxiliary electrode, such as a counter/reference electrode(s). The substrates are positioned in a face-to-face relationship so that the electrodes are adjacent to each other during performance of the assay. Besides the electrodes, any of a variety of other components may also be employed in the assay device.

Claims

1. An assay device for detecting the presence or quantity of an analyte residing in a test sample, said assay device comprising a first substrate defining a first surface on which is disposed a detection working electrode, said assay device further comprising a second substrate defining a second surface on which is disposed an auxiliary electrode, said first substrate and said second substrate being at least partially laminated together so that said first surface faces said second surface, wherein said detection working electrode is capable of generating a measurable detection current that is proportional to the amount of the analyte within the test sample.

2. An assay device as defined in claim 1, wherein said first substrate, said second substrate, or combinations thereof, are formed from an insulative material.

3. An assay device as defined in claim 1, wherein said auxiliary electrode is a counter electrode, reference electrode, or combinations thereof.

4. An assay device as defined in claim 1, wherein both a counter electrode and a reference electrode are disposed on said second surface of said second substrate.

5. An assay device as defined in claim 1, wherein said detection working electrode is treated with an affinity reagent.

6. An assay device as defined in claim 5, wherein said detection working electrode is treated with said affinity reagent before said first substrate and said second substrate are at least partially laminated together.

7. An assay device as defined in claim 5, wherein said affinity reagent comprises a specific binding capture ligand for the analyte.

8. An assay device as defined in claim 7, wherein said specific binding capture ligand is selected from the group consisting of antigens, haptens, aptamers, antibodies, and complexes thereof.

9. An assay device as defined in claim 5, wherein said affinity reagent comprises a redox mediator.

10. An assay device as defined in claim 9, wherein said redox mediator is selected from the group consisting of oxygen, ferrocene derivatives, quinones, ascorbic acids, redox polymers with metal complexes, glucose, redox hydrogel polymers, and organometallic complexes.

11. An assay device as defined in claim 1, wherein a redox label is incorporated into the assay device for directly or indirectly binding to the analyte.

12. An assay device as defined in claim 11, wherein said redox label is an enzyme selected from the group consisting of alkaline phosphatase, horseradish peroxidase, glucose oxidase, beta-galactosidase, urease, and combinations thereof.

13. An assay device as defined in claim 11, wherein said redox label is used in conjunction with a particle modified with a specific binding member for the analyte.

14. An assay device as defined in claim 1, wherein a sample channel is formed on said first substrate, said second substrate, or combinations thereof.

15. An assay device as defined in claim 1, wherein the assay device comprises a porous membrane capable of being placed in fluid communication with the test sample.

16. An assay device as defined in claim 1, wherein a calibration working electrode is also disposed on said first surface of said first substrate.

17. An assay device for detecting the presence or quantity of an analyte residing in a test sample, said assay device comprising a first substrate defining a first surface on which is disposed a detection working electrode treated with an affinity reagent, said assay device further comprising a second substrate defining a second surface on which is disposed a counter electrode, a reference electrode, or combinations thereof, said first substrate and said second substrate being at least partially laminated together so that said first surface faces said second surface, wherein said detection working electrode is capable of generating a measurable detection current that is proportional to the amount of the analyte within the test sample.

18. An assay device as defined in claim 17, wherein said first substrate, said second substrate, or combinations thereof, are formed from an insulative material.

19. An assay device as defined in claim 17, wherein both a counter electrode and a reference electrode are disposed on said second surface of said second substrate.

20. An assay device as defined in claim 17, wherein said affinity reagent comprises a specific binding capture ligand for the analyte, a redox mediator, or combinations thereof.

21. A method for forming an assay device, said method comprising:

treating a detection working electrode disposed on a first surface of a first substrate with an affinity reagent; and

thereafter, at least partially laminating said first substrate to a second substrate, said second substrate defining a second surface on which is disposed an auxiliary electrode, wherein said first surface of said first substrate faces said second surface of said second substrate.

22. A method as defined in claim 21, wherein said first substrate, said second substrate, or combinations thereof, are formed from an insulative material.

23. A method as defined in claim 21, wherein said auxiliary electrode is a counter electrode, reference electrode, or combinations thereof.

24. A method as defined in claim 21, wherein said affinity reagent comprises a specific binding capture ligand for an analyte, a redox mediator, or combinations thereof.

25. A method as defined in claim 21, further comprising applying a redox label to said first substrate, said second substrate, or combinations thereof, for directly or indirectly binding to an analyte.

26. A method for detecting the presence or quantity of an analyte residing in a test sample, said method comprising:

treating a detection working electrode disposed on a first surface of a first substrate with an affinity reagent;

thereafter, at least partially laminating said first substrate to a second substrate, said second substrate defining a second surface on which is disposed an auxiliary electrode, wherein said first surface of said first substrate faces said second surface of said second substrate; and

applying a potential difference between said detection working electrode and said auxiliary electrode to generate a detection current.

27. A method as defined in claim 26, wherein said first substrate, said second substrate, or combinations thereof, are formed from an insulative material.

28. A method as defined in claim 26, wherein said auxiliary electrode is a counter electrode, reference electrode, or combinations thereof.

29. A method as defined in claim 26, wherein said affinity reagent comprises a specific binding capture ligand for an analyte, a redox mediator, or combinations thereof.

30. A method as defined in claim 26, further comprising applying a redox label to said first substrate, said second substrate, or combinations thereof, for directly or indirectly binding to an analyte.

31. A method as defined in claim 26, wherein a calibration working electrode is also disposed on said first surface of said first substrate.

32. A method as defined in claim 31, further comprising applying a potential difference between said calibration working electrode and said auxiliary electrode to generate a calibration current.

33. A method as defined in claim 32, further comprising calibrating the detection current with the calibration current.

34. A method as defined in claim 33, further comprising measuring the calibration current.

35. A method as defined in claim 26, further comprising measuring the detection current.