DUAL-CHAMBER ANALYTICAL TEST STRIP

• US 20150144505A1
• Filed: 11/22/2013
• Published: 05/28/2015
• Est. Priority Date: 11/22/2013
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cilag Gmbh International (Johnson & Johnson)
• Inventors: ELDER, David, SETFORD, Steven, FAULKNER, Allan, WALSH, Ryan
• Granted Patent: US 9,291,593 B2
• Time in Patent Office: Days
• US Class Current: 205/777.5
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: C12Q 1/006 for glucose
• 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 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875

Abstract

An analytical test strip can include a patterned definition layer defining two fluidically-separated sample cells having respective ports, a common electrode arranged over the definition layer and in electrical communication with each of the cells, and respective cell electrodes. Surface portions of each electrode can be exposed. A method for testing a fluid sample using such a strip includes receiving a first fluid sample in the first sample cell and detecting a first electrical property thereof. It is then determined whether a second fluid sample should be added to the other sample cell. An analyte measurement system can include such a strip and test meter to receive the strip. The test meter can detect respective electrical properties of fluid samples in the cells.

Claims

1. An analytical test strip, comprising:

a patterned definition layer defining two fluidically separated sample cells, each sample cell having a port on a perimeter of the analytical test strip and being adapted to receive a respective fluid sample via the respective port;

a common electrode arranged over the definition layer and in electrical communication with each of the sample cells; and

two cell electrodes, each electrode in electrical communication with a respective one of the sample cells;

wherein the definition layer, the common electrode, and the cell electrodes are arranged to expose a surface portion of the common electrode and respective surface portions of the cell electrodes.

2. The test strip according to claim 1, wherein the cell electrodes are defined by a substantially planar cell-electrode layer having an electrical discontinuity separating the cell electrodes.

3. The test strip according to claim 2, wherein the cell-electrode layer includes gold.

4. The test strip according to claim 1, wherein the definition layer is patterned to define an alignment feature.

5. The test strip according to claim 1, wherein the definition layer is substantially planar.

6. The test strip according to claim 1, wherein the test strip is an electrochemical-based analytical test strip configured for the determination of glucose in a whole blood sample and including a respective reagent in each of the sample cells.

7. A method for testing a fluid sample using an analytical test strip, the method comprising:

receiving the analytical test strip having a first sample cell and a fluidically-separate second sample cell;

receiving a first fluid sample introduced to the first sample cell of the received analytical test strip;

detecting a first electrical property of the first fluid sample; and

determining whether a second fluid sample should be added to the other sample cell.

8. The method according to claim 7, further including, if the second fluid sample should be added:

receiving the second fluid sample introduced to the second sample cell of the received analytical test strip; and

detecting a second electrical property of the second fluid sample.

9. The method according to claim 8, wherein the receiving-test-strip step includes receiving the analytical test strip in a test meter and the detecting step includes automatically detecting the first and second electrical properties using a processor of the test meter.

10. The method according to claim 9, further including automatically detecting the presence of the first fluid sample in the first sample cell of the received analytical test strip using the processor.

11. The method according to claim 9, further including automatically polling the first and second sample cells using the processor to detect the presence of the first fluid sample.

12. The method according to claim 9, further including presenting an indication of the first electrical property via a user interface of the test meter and subsequently receiving a command input via the user interface, wherein the determining step includes determining that the second fluid sample should be added in response to the received command input.

13. The method according to claim 12, further including determining a blood-glucose value from the first electrical property, wherein the presenting step includes presenting the determined blood-glucose value.

14. The method according to claim 9, wherein the test meter includes a common terminal and first and second sample-cell terminals, the common terminal is electrically connected to both the first and the second sample cells in the received analytical test strip, and the first and second sample-cell terminals are electrically connected to the first and second sample cells in the received analytical test strip, respectively, wherein the processor is operatively connected to the common terminal and the first and second sample-cell terminals to determine the first and second electrical properties.

15. The method according to claim 7, further including automatically determining whether the first fluid sample meets a selected criterion using the processor and determining that the second fluid sample should be added if the first fluid sample does not meet the selected criterion.

16. The method according to claim 15, wherein the selected criterion is a proportion of the volume of the first sample cell to be filled by the first fluid sample and the detecting step includes detecting a capacitance of the first sample cell.

17. The method according to claim 7, further including measuring a time elapsed since the analytical test strip was received, and providing an expiry indication via a user interface when the elapsed time exceeds a selected threshold.

18. An analyte measurement system comprising:

an analytical test strip comprising a patterned layer defining two fluidically separated sample cells electrically connected to a common electrode and to respective cell electrodes, each sample cell being adapted to receive a respective fluid sample; and

a test meter adapted to receive the analytical test strip, the test meter having a contained circuit and a processor, the processor being configured to detect the presence of the respective fluid sample in one of the sample cells of the received analytical test strip and detect a first electrical property of the received respective fluid sample using the contained circuit,

wherein the processor is configured to detect a second electrical property of the respective fluid sample in the other of the sample cells of the received analytical test strip using the circuit.

19. The system according to claim 18, the test meter further including a user interface and the processor further configured to present an indication of the first electrical property via the user interface.

20. The system according to claim 18, the test meter further including a user interface and the processor further configured to receive a command input via the user interface and, in response to the received command input, detect the second electrical property and present an indication of the second electrical property via the user interface.