ANALYTICAL TEST STRIP

• US 20150330936A1
• Filed: 07/29/2015
• Published: 11/19/2015
• Est. Priority Date: 12/20/2012
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cilag Gmbh International (Johnson & Johnson)
• Inventors: RITCHIE, Lawrence, MOFFAT, James T., SETFORD, Steven John, SCOTT, John, WEBSTER, Graeme J.
• Granted Patent: US 9,541,520 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

An analytical test strip has mutually-insulated first and second electrodes arranged to define a sample-receiving chamber. Electrically-insulating layers are disposed over respective electrodes. First and second electrical contact pads are electrically connected to the first electrode, and a third pad to the second electrode. A first side of the test strip has a first electrically-insulating layer and the third pad, and a second side has the second electrically-insulating layer and the first and second pads. The third pad extends longitudinally from the sample-receiving chamber farther than does the first electrically-insulating layer. Methods for determining an analyte in a bodily-fluid sample and analytical test systems for use in the determination of an analyte in a bodily-fluid sample are also described.

Claims

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

receiving an analytical test strip inserted in a longitudinal direction into a test-strip-receiving module of a test meter so that first and second electrical contact pads exposed on a second side of the analytical test strip make electrical contact with first and second electrical connector pins of the test-strip-receiving module, respectively, and a third electrical contact pad exposed on a first side of the analytical test strip makes electrical contact with a third electrical connector pin of the test-strip receiving module, the analytical test strip including a sample-receiving chamber adapted to receive a bodily-fluid sample;

wherein the third electrical contact pad is arranged laterally between the first and second electrical contact pads of the analytical test strip, and

wherein the third electrical contact pad is disposed such that said third electrical pad extends longitudinally from the sample-receiving chamber by a distance greater than either the first electrical contact pad or the second electrical contact pad;

sensing, using a signal processing module of the test meter, electrical continuity between the first electrical connector pin of the test-strip-receiving module and the second electrical connector pin of the test strip receiving module via the first electrical contact pad and the second electrical contact pad of the analytical test strip;

when continuity is sensed, the signal processing module automatically applying a selected electrical signal to the third electrical connector pin and either the first or the second electrical connector pin and measuring a resulting electrical signal; and

the signal processing module automatically processing the resulting electrical signal to detect whether a bodily-fluid sample has been applied to the sample-receiving chamber and, if so, the signal-processing module automatically determining the analyte in the applied bodily-fluid sample using the resulting electrical signal.

2. The method of claim 1, wherein the analyte is glucose and the bodily-fluid sample is a whole blood sample.

3. The method of claim 1, wherein the sensing step further includes sensing electrical discontinuity between the third electrical connector pin and either the first or the second electrical connector pin, and wherein the applying step is performed when both continuity between the first and second electrical connector pins and discontinuity between the third electrical connector pin and either the first or the second electrical connector pin are sensed.

4. The method of claim 1, further including, after the sensing step, the signal processing module automatically detecting an electrode configuration of the analytical test strip.

5. The method of claim 1, further including, after the processing step, the signal processing module automatically displaying an indication of the determined analyte.

6. An analytical test system for use in the determination of an analyte in a bodily-fluid sample, the analytical test system comprising:

a) a test meter with;

i) a test-strip-receiving module with first, second, and third electrical connector pins; and

ii) a signal processing module; and

b) an analytical test strip with lateral and longitudinal axes, the test strip having;

i) first and second electrodes;

ii) first and second electrical contact pads electrically connected to the first electrode, each pad configured to communicate an electrical response of the first electrode to the test meter should the test meter be in electrical communication with that pad;

iii) a third electrical contact pad protruding longitudinally beyond the first and second electrical contact pads and electrically connected to the second electrode, the third electrical contact pad being configured to communicate an electrical response of the second electrode to the test meter should the test meter be in electrical communication with the third electrical contact pad; and

iv) in which the test-strip-receiving module is arranged such that the first, second, and third electrical connector pins make electrical connection with the first, second, and third electrical contact pads, respectively, when the analytical test strip is inserted into the test-strip receiving module;

wherein the signal processing module is configured to;

i) detect the test strip by sensing electrical continuity between the first and second electrical connector pins;

ii) apply a selected electrical signal to the third electrical pin and either the first or the second electrical connector pin after the test strip is detected and measure a result electrical signal; and

iii) process the result electrical signal to detect the bodily-fluid sample and, if the bodily-fluid sample is present, determine the analyte.

7. The analytical test system according to claim 6, wherein the third electrical contact pad is arranged laterally between the first and second electrical contact pads.

8. The analytical test system according to claim 6, wherein the test strip has a first side and a second side, the first and second electrical connector pins being arranged to make electrical contact with the first and second electrical contact pads from the second side of the test strip, and in which the third electrical connector pin is arranged to make electrical contact with the third electrical contact pad from the first side of the test strip.

9. The analytical test system according to claim 6, wherein the signal processing module is further adapted to detect the test strip by sensing electrical discontinuity between the third electrical connector pin and either the first or the second electrical connector pin.

10. The analytical test system according to claim 6, wherein:

a) the test strip includes opposed first and second sides;

b) the second side including a second electrically-insulating layer disposed over the second electrode; and

c) each of the second electrically-insulating layer and the second electrode including corresponding first and second cutout portions, wherein the cutout portions expose corresponding areas of the first electrode to define the first and second electrical contact pads.

11. The analytical test system according to claim 6, wherein the first and second cutout portions are arranged on opposing lateral sides of the test strip.