Sensor devices

• US 9,868,974 B2
• Filed: 07/26/2010
• Issued: 01/16/2018
• Est. Priority Date: 07/27/2009
• Status: Active Grant

• Current Assignee: Suresensors Limited (LumiraDx Ltd. (Cayman Islands))
• Original Assignee: Suresensors Limited (LumiraDx Ltd. (Cayman Islands))
• Inventors: Hall, Geoffrey Frank
• Primary Examiner(s): Hendricks, Keith
• Assistant Examiner(s): CARLSON, KOURTNEY SALZMAN
• Application Number:
  US13/387,072
• Publication Number:
  US 20120135509A1
• Time in Patent Office: 2,731 Days
• Field of Search: 20440301-40315, 2057775, 205778, 205787, 205792, 4352871, 4352876
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

Abstract

The present invention relates to a sensor device for measuring a level of an analyte of interest in a fluid, such as body fluid (for example blood, plasma, urine, interstitial fluid, saliva), a method of manufacturing a sensor device, a reagent film for use in a sensor, a method of manufacturing a reagent film for use in a sensor, a method of conducting an assay using a sensor, a method of calibrating a measurement from a sensor, a method of calibrating a batch of sensors, a meter for use with a sensor and a kit comprising a meter and a sensor according to the invention. A first aspect of the invention provides a sensor device for measuring a level of an analyte of interest In a fluid comprising: a flowpath for the fluid; on the flowpath, a reagent for the analyte of interest adjacent to an internal standard comprising a first predetermined amount of a first calibration analyte; and further wherein the reagent and the predetermined amount of a first calibration analyte are in dry form. A second aspect of the invention provides a device comprising: a first calibration electrode having the first predetermined amount of first calibration analyte and reagent for the analyte of interest located thereon; a first working electrode having reagent for the analyte of interest thereon, and further wherein the first calibration electrode lies upstream of the first working electrode.

Claims

1. An electrochemical sensor device for measuring a level of an analyte of interest in a fluid comprising:

a flowpath for a fluid;

a substrate on one side of the flowpath;

on the substrate, a calibration electrode comprising;

i) a first layer comprising a first measurement electrode;

ii) a second layer located on the first layer, the second layer comprising an internal standard comprising a first predetermined amount of first dry calibration analyte; and

iii) a third layer located on the second layer, the third layer comprising a dry reagent film layer comprising a reagent for the analyte of interest,

wherein at least part of the third layer comprising the dry reagent film layer overlays at least part of the second layer comprising the first predetermined amount of the first dry calibration analyte located on the first layer comprising the first measurement electrode to form the calibration electrode; and

wherein a distance between at least part of the dry reagent film layer and at least part of the first predetermined amount of the first dry calibration analyte is within about 15 μ

m.

2. A device according to claim 1, in which the first dry calibration analyte and the analyte of interest are the same analyte.

3. A device according to claim 1, in which the dry reagent film layer comprises a dry film having two exposed opposing, generally parallel, generally planar surfaces prior to being located on the second layer to form the dry reagent film layer.

4. A device according to claim 1, in which the dry reagent film layer comprises a water soluble dry film having two, opposing, generally parallel, generally planar surfaces.

5. A device according to claim 4, wherein the dry reagent film layer is in physical contact with the first predetermined amount of first dry calibration analyte.

6. A device according to claim 1, in which the dry reagent film layer comprises a water soluble dry film having two exposed opposing, generally parallel, generally planar surfaces.

7. A device according to claim 1, wherein a distance between at least part of the dry reagent film layer and at least part of the first predetermined amount of the first dry calibration analyte is within about 10 μ

m.

8. A device according to claim 1, wherein a distance between at least part of the dry reagent film layer and at least part of the first predetermined amount of the first dry calibration analyte is within about 5 μ

m.

9. A device according to claim 1, in which the dry reagent film layer is in physical contact with the first predetermined amount of the first dry calibration analyte.

10. A device according to claim 1, in which the dry reagent film layer is in the form of water soluble dry film having two exposed opposing, generally parallel, generally planar surfaces, and at least part of the water soluble dry film (i) overlays at least part of the first predetermined amount of first dry calibration analyte to form the dry reagent film layer having one exposed surface, or (ii) overlays at least part of the first predetermined amount of first dry calibration analyte and at least part of the first measurement electrode to form the dry reagent film layer having one exposed surface.

11. A device according to claim 1, further comprising:

a second measurement electrode;

wherein the second measurement electrode is free from calibration analyte;

wherein the dry reagent film layer comprises a dry film having two exposed opposing, generally parallel, generally planar surfaces prior to being located on the flowpath, the dry film located on the second measurement electrode to form a first working electrode free from calibration analyte.

12. A device according to claim 11, wherein the calibration electrode lies upstream of the first working electrode.

13. A device according to claim 11, further comprising a second working electrode, the second working electrode comprising:

a third measurement electrode free from calibration analyte; and

a portion of the dry reagent film layer, wherein the portion of the dry reagent film layer is located on the third measurement electrode.

14. A device according to claim 11, wherein the flowpath is a single flowpath or a single linear flowpath, further comprising a component that is configured to provide an assay time for a measurement at one of the first and second measurement electrodes that is less than the time it takes for diffusion of reagent or reaction products from the other of the first and second measurement electrodes, wherein the component is selected from the group consisting of one or more of:

a geometry of the flowpath, a height of the flowpath, a width of the flowpath, a length of the flowpath, a location along the flowpath of at least the first measurement electrode, a location along the flowpath of the second measurement electrode, a distance between the first and second measurement electrodes, a dissolution rate of the reagent, a dissolution rate of the first predetermined amount of the first dry calibration analyte, and a thickness of the dry reagent film layer.

15. A device according to claim 1, further comprising:

a first working electrode comprising;

a second measurement electrode free from calibration analyte; and

a portion of the dry reagent film layer comprising the reagent for the analyte of interest,

wherein the calibration electrode lies upstream of the first working electrode.

16. A device according to claim 15, wherein the flowpath is a single flowpath or a single linear flowpath.

17. A device according to claim 1, further comprising:

a first working electrode, the first working electrode comprising a second measurement electrode free from calibration analyte having the dry reagent film layer for the analyte of interest thereon to form the first working electrode,

wherein the calibration electrode and the first working electrode are located on the flowpath,

wherein the flowpath is a single flowpath or a single linear flowpath, and

a component configured to enable a suitable measurement indicative of the concentration of the analyte of interest to be taken at the first working electrode before first dry calibration analyte or reaction products from the calibration electrode can travel by diffusion or otherwise from the calibration electrode to the first working electrode, wherein the component is selected from a group consisting of one or more of;

a geometry of the flowpath, height of the flowpath, a width of the flowpath, a length of the flowpath, a location along the flowpath of at least the calibration electrode, a location along the flowpath of at least the first working electrode, a distance between the calibration electrode and the first working electrode, a dissolution rate of the reagent, a dissolution rate of the predetermined amount of the first dry calibration analyte, and a thickness of the dry reagent film layer.

18. A device according to claim 1, in which the dry reagent film layer is in the form of a water soluble dry reagent film having two exposed opposing, generally parallel, generally planar surfaces prior to being located on the flowpath, the dry reagent film comprising:

a first film forming ingredient; and

a first active ingredient sensitive to the analyte of interest.

19. A device according to claim 18, the dry reagent film comprising a first film forming ingredient selected from the group of a polymer, a modified starch, pulluan, hydroxethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, polyvinyl pyrrolidone vinyl acetate, polyvinyl alcohol, sodium alginate, natural gums, water dispersible polyacrylates, sodium carboxymethyl cellulose and hydroxyl propyl methyl cellulose.

20. A device according to claim 19, the dry reagent film further comprising a second film forming ingredient selected from a polymer, a modified starch, pulluan, hydroxethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, polyvinyl pyrrolidone vinyl acetate, polyvinyl alcohol, sodium alginate, natural gums, water dispersible polyacrylates, sodium carboxymethyl cellulose and hydroxyl propyl methyl cellulose.

21. A device according to claim 18, further comprising a first film forming ingredient and a second film forming ingredient;

the second film forming ingredient having better dissolution and less hydrophobic properties than the first film forming ingredient.

22. A device according to claim 18, further comprising at least one further film forming ingredient selected from the group consisting of:

a plasticizer, a disintegrant, and a surfactant.

23. A device according to claim 22, wherein the at least one further film forming ingredient is a plasticizer, and wherein the plasticizer is selected from the group consisting of:

xylitol, sorbitol, erythritol, and polyethylene glycol.

24. A device according to claim 22, wherein the at least one further film forming ingredient is a disintegrant, and wherein the disintegrant is selected from the group consisting of:

microcrystalline cellulose, sodium croscarmellose, and sodium starch glycate.

25. A device according to claim 1, further comprising a second measurement electrode and a third measurement electrode, wherein the dry reagent film layer comprises a dry film having two opposing, generally parallel, generally planar surfaces, and wherein the dry film extends between and is located on at least two of the first, second, and third measurement electrodes.

26. A device according to claim 25, wherein the dry film extends between and is located on all of the first, second, and third measurement electrodes.

27. An electrochemical sensor device for measuring a level of an analyte of interest in a fluid comprising:

a sample chamber comprising a flowpath for the fluid and a substrate;

on the flowpath, a calibration electrode, comprising;

i. a first measurement electrode on the substrate,

ii. a dry reagent film layer comprising a reagent for the analyte of interest, and

iii. an internal standard comprising a first predetermined amount of a first dry calibration analyte located on the first measurement electrode,

wherein at least part of the dry reagent film layer is located on at least part of the first predetermined amount of first dry calibration analyte located on the first measurement electrode, to form the calibration electrode and,

wherein a distance between at least part of the dry reagent film layer and at least a part of the first predetermined amount of first dry calibration analyte is within about 15 μ

m.

28. A device according to claim 27, further comprising a second measurement electrode and a third measurement electrode, wherein the dry reagent film layer comprises a water soluble dry film having two exposed opposing, generally parallel, generally planar surfaces prior to being located on the flowpath, and wherein the water soluble dry film extends between and is located on at least two of the first, second, and third measurement electrodes.

29. A device according to claim 28, wherein the water soluble dry film extends between and is located on all of the first, second, and third measurement electrodes.

30. A device according to claim 27, wherein a distance between at least part of the dry reagent film layer and at least part of the first predetermined amount of the first dry calibration analyte is within about 10 μ

m.

31. A device according to claim 27, wherein a distance between at least part of the dry reagent film layer and at least part of the first predetermined amount of the first dry calibration analyte is within about 5 μ

m.