Electrochemical-based analytical test strip with a soluble electrochemically-active coating opposite a bare electrode

Patent metadata

Field	Value
Publication number	US-2016187283-A1
Application number	US-201414892666-A
Country	US
Kind code	A1
Filing date	Jun 6, 2014
Priority date	Jun 7, 2013
Publication date	Jun 30, 2016
Grant date	—

Abstract

Electrochemical-based analytical test strip with a soluble electrochemically-active coating opposite a bare electrode An electrochemical-based analytical test strip (EBATS) for the determination of an analyte in a bodily fluid sample includes an electrically insulating base layer, a patterned electrically conductive layer disposed on the electrically insulating base layer and including a plurality of electrodes, and an enzymatic reagent layer disposed on a portion of the patterned conductor layer and defining a bare electrode(s) and a plurality of enzymatic reagent covered electrodes from the plurality of electrodes. The EBATS also includes a patterned spacer layer, a top layer having an underside surface (USS), and a soluble electrochemically-active coating (SEAC) disposed on the USS of the top layer. In addition, at least the patterned spacer layer and top layer define a sample-receiving chamber within the EBATS. Furthermore, the SEAC is disposed on the USS of the top layer within at least a portion the sample-receiving chamber and in an opposing relationship to the bare electrodes.

First claim

1 - 29 . (canceled)

30 . An electrochemical-based analytical test strip for the determination of an analyte in a bodily fluid sample, the electrochemical-based analytical test strip comprising:
an electrically insulating base layer; a patterned electrically conductive layer disposed on the electrically insulating base layer and including a plurality of electrodes; an enzymatic reagent layer disposed on a portion of the patterned conductor layer to define at least one bare electrode and a plurality of enzymatic reagent covered electrodes from the plurality of electrodes; a patterned spacer layer; a top layer having an underside surface; and a soluble electrochemically-active coating on the underside surface of the top layer;
wherein at least the patterned spacer layer and top layer define a sample-receiving chamber within the electrochemical-based analytical test strip; and
wherein the soluble electrochemically-active coating is disposed on the underside surface of the top layer within at least a portion the sample-receiving chamber and in an opposing relationship to the bare electrodes.

31 . The electrochemical-based analytical test strip of claim 30 wherein the soluble electrochemically-active coating includes a redox agent.

32 . The electrochemical-based analytical test strip of claim 30 wherein the soluble electrochemically-active coating includes an enzymatic mediator.

33 . The electrochemical-based analytical test strip of claim 30 wherein the soluble electrochemically-active coating includes ferricyanide.

34 . The electrochemical-based analytical test strip of claim 30 wherein the soluble electrochemically-active coating is enzyme-free.

35 . The electrochemical-based analytical test strip of claim 30 wherein the at least one bare electrode is one bare electrode.

36 . The electrochemical-based analytical test strip of claim 30 wherein the soluble electrochemically-active coating is disposed opposite the at least one bare electrode and spaced apart from the plurality of enzymatic reagent covered electrodes.

37 . The electrochemical-based analytical test strip of claim 36 wherein the soluble electrochemically-active coating is spaced apart from the plurality of enzymatic reagent covered electrodes by a distance in the range of 150 microns to 450 microns.

38 . The electrochemical-based analytical test strip of claim 30 wherein the at least one bare electrode is configured to generate a current response upon the introduction of a bodily fluid sample into the sample-receiving chamber that is measurable by an associated test meter.

39 . The electrochemical-based analytical test strip of claim 34 wherein the bodily fluid sample is a whole blood sample and the current response of the at least one bare electrode is dependent on hematocrit of the whole blood sample.

40 . The electrochemical-based analytical test strip of claim 30 wherein an electrochemical response of the bare electrode is independent of analyte concentration of the bodily fluid sample

41 . The electrochemical-based analytical test strip of claim 30 wherein the bodily fluid sample is a whole blood sample.

42 . The electrochemical-based analytical test strip of claim 30 wherein at least the top layer and soluble electrochemically-active coating are integrated as an engineered top tape.

43 . The electrochemical-based analytical test strip of claim 30 wherein the analyte is glucose and the bodily fluid sample is a whole blood sample.

44 . The electrochemical-based analytical test strip of claim 30 wherein the soluble electrochemically-active coating and at least one bare electrode of the patterned electrically conductor layer are separated by a vertical distance of in the range of approximately 50 microns to approximately 150 microns in the sample-receiving chamber.

45 . A method for employing an analytical test strip, the method comprising:
introducing a bodily fluid sample into a sample-receiving chamber of an electrochemical-based analytical test strip, the electrochemical-based analytical test strip including:
a top layer with an underside surface;
at least one bare electrode in the sample-receiving chamber; and
a soluble electrochemically-active coating on the underside surface within at least a portion the sample-receiving chamber and in an opposing relationship to the at least one bare electrode, and

wherein the introduction is such that the soluble electrochemically-active coating operably dissolves in the bodily fluid sample;
detecting an electrochemical response of the at least one bare electrode of the electrochemical-based analytical test strip; and
determining an analyte in the bodily fluid sample based in part on the detected electrochemical response of the at least one bare electrode.

46 . The method of claim 45 wherein the electrochemical-based analytical test strip further includes:
an electrically insulating base layer;
a patterned electrically conductive layer disposed on the electrically insulating base layer and including a plurality of electrodes;
an enzymatic reagent layer disposed on at least a portion of the patterned electrically conductor layer to define the at least one bare electrode and a plurality of enzymatic reagent covered electrodes from the plurality of electrodes and
a patterned spacer layer; and

wherein at least the patterned spacer layer and top layer define the sample-receiving chamber within the electrochemical-based analytical test strip; and

47 . The method of claim 45 wherein the detecting of an electrochemical response also includes detecting an electrochemical response of the plurality of enzymatic reagent covered electrodes.

48 . The method of claim 45 wherein the soluble electrochemically-active coating contains an enzymatic mediator.

49 . The method of claim 45 wherein the soluble electrochemically-active coating contains a redox agent.

Assignees

• Lifescan Scotland Ltd

Inventors

• Cooper Alexander
• Rodgers James Iain
• Macfie Gavin

Classifications

• G01N27/3272 Primary

  Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels (optical biosensors G01N33/52) · CPC title

• C12Q1/004

  mediator-assisted · CPC title

• C12Q1/001

  Enzyme electrodes · CPC title

• C12Q1/006

  for glucose · CPC title