Microfluidic, electrochemical devices

1. A microfluidic, electrochemical analysis device comprising:

plural porous, hydrophilic layers, respectively separated by a fluid impermeable layer defining one or more openings in alignment with at least a portion of one or more hydrophilic channels within a hydrophilic layer to permit vertical fluidic communication through said fluid impermeable layer between said hydrophilic layers, wherein a porous, hydrophilic layer comprises a fluid sample deposition region and a patterned, fluid impermeable boundary that substantially permeates the thickness of the hydrophilic layer and defines the one or more hydrophilic channels therewithin in fluidic communication with said deposition region which permit fluidic flow within the one or more channels; and

an electrode assembly comprising one or more electrodes in fluidic communication with said deposition region through the one or more hydrophilic channels, wherein said electrode assembly is disposed in fluidic communication with the one or more hydrophilic channels on one hydrophilic layer and a sample deposition region disposed on another hydrophilic layer.

2. The device of claim 1 wherein the electrode assembly is supported by or comprises a portion of said porous, hydrophilic layer.

3. The device of claim 1 wherein the device further comprises a substrate layer supporting the electrode assembly.

4. The device of claim 3 wherein the substrate comprises paper or plastic film.

5. The device of claim 1 wherein the fluid impermeable boundary further defines said sample deposition region.

6. The device of claim 1 further comprising a filter or an assay reagent in a hydrophilic channel.

7. The device of claim 1 wherein a said fluid impermeable layer comprises a polymer sheet or an adhesive sheet.

8. The device of claim 1 wherein said porous, hydrophilic layer comprises paper.

9. The device of claim 1 wherein said porous, hydrophilic layer comprises chromatography paper.

10. The device of claim 1 further comprising a fluid sink in fluidic communication with and downstream of one end of the hydrophilic channel and said electrode assembly enabling flow of a fluid through the hydrophilic channel and across said electrode assembly.

11. The device of claim 1 wherein the electrode assembly comprises an electrically conductive region of said hydrophilic layer surrounded at least in part by a fluid impermeable boundary.

12. The device of claim 1 wherein the fluid impermeable boundary comprises a wax or a polymerized photoresist.

13. The device of claim 1 wherein the electrode assembly comprises a working electrode and a counter electrode.

14. The device of claim 13 wherein the electrode assembly further comprises a reference electrode.

15. The device of claim 1 wherein the electrodes of said electrode assembly are arranged side by side on one of said hydrophilic layers.

16. A microfluidic, electrochemical analysis device comprising:

plural porous, hydrophilic layers, respectively separated by a fluid impermeable layer defining one or more openings in alignment with at least a portion of one or more hydrophilic channels within a hydrophilic layer to permit vertical fluidic communication through said fluid impermeable layer between the hydrophilic layers, wherein a porous, hydrophilic layer comprises a fluid sample deposition region and a patterned, fluid impermeable boundary that substantially permeates the thickness of the hydrophilic layer and defines the one or more hydrophilic channels therewithin in fluidic communication with said deposition region which permit fluidic flow within the one or more hydrophilic channels; and

an electrode assembly comprising one or more electrodes in fluidic communication with said deposition region through the one or more hydrophilic channels, wherein the electrode assembly comprises electrodes arranged facing one another in adjacent layers.

17. The device of claim 3 wherein an electrode of the electrode assembly is screen-printed on the substrate layer.

18. A method of determining the presence or concentration of one or more analytes in a fluid sample using a microfluidic, electrochemical device of claim 1 , comprising:

depositing a fluid sample onto said deposition region;

permitting the sample to wick along a hydrophilic channel to provide fluidic contact of the sample with said electrode assembly; and

measuring an electrochemical parameter with said electrode assembly as an indicator of the presence or concentration of an analyte in the sample.

19. The method of claim 18 wherein the electrochemical parameter is correlated with a concentration of an analyte.

20. The method of claim 18 wherein the electrochemical parameter is correlated with the presence of the one or more analytes.

21. The method of claim 18 wherein said sample deposition region is positioned over said electrode assembly.

22. The method of claim 18 wherein the microfluidic, electrochemical device further comprises

a fluid sink in fluidic communication with a distal end of a said hydrophilic channel comprising a hydrophilic region in fluidic communication with the electrode assembly; and

the method further comprising:

depositing a fluidic sample onto said deposition region disposed at a proximal end of a said hydrophilic channel; and

permitting transport of fluid in the sample through capillary action over the electrode assembly and into the fluid sink.

23. The method of claim 18 wherein measuring an electrochemical parameter comprises measuring impedance, current, or voltage.

24. The method of claim 18 wherein the step of measuring an electrical parameter is done by a method selected from the group consisting of amperometry, biamperometry, stripping voltammetry, differential pulse voltammetry, cyclic voltammetry, coulometry, chronoamperometry, and potentiometry.

25. The method of claim 18 wherein the analyte comprises glucose, cholesterol, uric acid, lactate, blood gases, DNA, haemoglobin, nitric oxide, or blood ketones.

26. The method of claim 18 wherein measuring an electrochemical parameter comprises anodic stripping voltammetry.