ANALYTICAL TEST STRIP WITH BODILY FLUID PHASE-SHIFT MEASUREMENT ELECTRODES

• US 20130084590A1
• Filed: 09/30/2011
• Published: 04/04/2013
• Est. Priority Date: 09/30/2011
• Status: Abandoned Application

• Current Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: LUGO JIMENEZ, Gustavo C.
• Application Number:
  US13/250,658
• Publication Number:
  US 20130084590A1
• Time in Patent Office: Days
• US Class Current: 435/14
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

An analytical test strip (“ATS”) for use with a hand-held test meter (“HHTM”) in the determination of an analyte in a bodily fluid sample (“BFS”) includes a first patterned conductive layer with a working electrode and a reference electrode, as well as a method for determining an analyte in BFS. The ATS also includes an enzymatic reagent layer disposed on the working electrode, a patterned spacer layer disposed over the first patterned conductive layer and configured to define a sample chamber (“SC”) within the ATS, and a second patterned conductive layer disposed above the first patterned conductive layer. The second patterned conductive layer includes a first phase-shift measurement electrode and a second phase-shift measurement electrode, which electrodes are disposed in the SC and are configured to measure, along with the HHTM, a phase shift of an electrical signal forced through a BFS introduced into the SC during the ATS'"'"' use.

Claims

1. An analytical test strip for use with a hand-held test meter in the determination of an analyte in a bodily fluid sample, the analytical test strip comprising:

a first patterned conductive layer including;

at least one working electrode; and

a reference electrode;

an enzymatic reagent layer disposed on at least the working electrode;

a patterned spacer layer disposed over the first patterned conductive layer and defining a sample chamber within the analytical test strip;

a second patterned conductive layer disposed above the first patterned conductive layer, the second patterned conductive layer including;

a first phase-shift measurement electrode; and

a second phase-shift measurement electrode, and

wherein the first phase-shift measurement electrode and the second phase-shift measurement electrode are disposed in the sample chamber and are configured to measure, along with the hand-held test meter, a phase shift of an electrical signal forced through a bodily fluid sample introduced into the sample chamber during use of the analytical test strip.

2. The analytical test strip of claim 1 wherein the first phase-shift measurement electrode and the second phase-shift measurement electrode are disposed in the sample chamber such that the first phase-shift measurement electrode and the second phase shift measurement electrode are directly exposed to bodily fluid sample introduced into the sample chamber during use of the analytical test strip.

3. The analytical test strip of claim 1further comprising:

a top electrically-insulating layer disposed above the second patterned conductive layer and having a lower surface; and

wherein the second patterned conductive layer is disposed on the lower surface of the top electrically-insulating layer.

4. The analytical test strip of claim 1further comprising:

a top electrically-insulating layer disposed above the second patterned conductive layer and having a lower surface; and

wherein the second patterned conductive layer is embedded in the lower surface of the top electrically-insulating layer.

5. The analytical test strip of claim 1 wherein the second patterned conductive layer further includes:

a first phase-shift probe contact; and

a second phase-shift probe contact.

6. The analytical test strip of claim 5 wherein the first phase-shift probe contact and the second phase shift probe contact are configured for operational electrical contact with a hand-held test meter when the analytical test strip is inserted in the hand-held test meter.

7. The analytical test strip of claim 1 wherein the first phase-shift measurement electrode and the second phase-shift measurement electrode are configured to force an electrical signal through the bodily fluid sample in the sample chamber.

8. The analytical test strip of claim 1 wherein the first phase-shift measurement electrode and the second phase-shift measurement electrode are configured to force an electrical signal of known frequency through the bodily fluid sample in the sample chamber.

9. The analytical test strip of claim 1 wherein the analytical test strip is an electrochemical-based analytical test strip configured for the determination of glucose in a whole blood sample.

10. The analytical test strip of claim 1 further comprising:

an electrically-insulating substrate layer, and wherein the first patterned conductive layer is disposed on the electrically-insulating substrate layer.

11. A method for determining an analyte in a bodily fluid sample, the method comprising:

introducing a bodily fluid sample into a sample chamber of an analytical test strip, the sample chamber having disposed therein;

at least one working electrode;

a reference electrode;

a first phase-shift measurement electrode; and

a second phase-shift measurement electrode;

measuring a phase shift of an electrical signal forced through the bodily fluid sample in the sample chamber via the first phase-shift measurement electrode and the second phase-shift measurement electrode;

measuring an electrochemical response of the analytical test strip using the at least one working electrode and reference electrode; and

determining an analyte in the bodily fluid sample based on the measured phase shift and the measured electrochemical response.

12. The method of claim 11 wherein the analyte is glucose and the bodily fluid sample is a whole blood sample.

13. The method of claim 11 wherein the first phase shift measurement electrode and the second phase shift measurement electrode are disposed above the at least one working electrode and the reference electrode.

14. The method of claim 11 wherein the bodily fluid sample is introduced into the sample chamber such that the bodily fluid sample makes direct contact with the first phase-shift measurement electrode and the second phase-shift measurement electrode.

15. The method of claim 11 wherein the first phase-shift measurement electrode and the second phase-shift measurement electrode are configured to force an electrical signal through the bodily fluid sample in the sample chamber.

16. The method of claim 11 wherein the first phase-shift measurement electrode and the second phase-shift measurement electrode are configured to force an electrical signal of a predetermined frequency through the bodily fluid sample in the sample chamber.

17. The method of claim 11 wherein the analytical test strip is an electrochemical-based analytical test strip configured for the determination of glucose in a whole blood sample.

18. The method of claim 11 wherein the first phase shift measurement electrode and the second phase shift measurement electrode are separated by a gap in the range of 20 microns to 1100 microns.

19. The method of claim 11 wherein the bodily fluid sample is introduced into the sample chamber such that the bodily fluid sample makes contact with an area of the first phase shift electrode in the range of 0.1 mm² to 2.0 mm² and makes contact with an area of the second phase shift electrode in the range of 0.1 mm² to 2.0 mm².

20. The method of claim 11 wherein the determining step employs the measured phase shift to ascertain the hematocrit of the bodily fluid sample and the ascertained hematocrit is employed in the determining of the analyte.