Analyte test strip and analyte meter device

• US 9,632,056 B2
• Filed: 12/10/2015
• Issued: 04/25/2017
• Est. Priority Date: 07/07/2010
• Status: Active Grant

• Current Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Original Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Inventors: Iyengar, Sridhar, Harding, Ian, Boiteau, Charles, Butters, Colin
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US14/964,756
• Publication Number:
  US 20160091449A1
• Time in Patent Office: 502 Days
• CPC Class Codes: G01J 1/42 using electric radiation detectors optical or mechanical part G01J1/04; by comparison with a reference light or electric value G01J1/10
• CPC Class Codes: G01N 21/255 Details, e.g. use of specially adapted sources, lighting or optical systems
• CPC Class Codes: G01N 21/7703 using reagent-clad optical fibres or optical waveguides using measurement of total internal reflection or attenuated total reflection G01N21/552; optical fibres or waveguides per se G02B
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2201/08 Optical fibres; light guides
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• 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
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

A test strip with an incorporated optical waveguide and deflectors punched through the optical waveguide allows light to exit through a layer of the test strip and be detected by a photo detector. Using light and a photodetector, these uniquely coded strips are identified. The waveguide can be constructed by sandwiching two layers of the test strip around a light transmissible layer. This configuration allows light to be transmitted through the test strip and out the other end, as well as allowing some light to escape the deflector. This light is detected by a photodetector mounted in the analyte test meter. The deflectors may be placed in patterns such that detection of this light indicates certain characteristics of the strip, such as non-counterfeit, regional identification, type of analyte tested, and coding information.

Claims

1. A test strip comprising:

(a) a top substrate;

(b) a bottom substrate;

(c) an electrical connector for connection to a meter disposed at a first end; and

(d) an electrochemical test cell disposed at a second end;

wherein said electrical connector comprises a first tab formed at the first end of the top substrate, and a second tab formed at the first end of the bottom substrate;

wherein the first tab is small in width relative to the second tab;

wherein the first tab is not aligned with the second tab; and

wherein the second tab is notched in a position selected from the group consisting of;

in the middle of the tab, on the edge closest to the first tab, and on the edge farthest from the first tab.

2. The test strip of claim 1 further comprising characteristic information about the strip encoded on the strip and a first tab and/or second tab configuration corresponding to said encoded characteristic information.

3. The test strip of claim 2 wherein the characteristic is selected from the group consisting of regional identification, calibration information, the type of analyte measured by the test strip, and alignment of the test strip.

4. A set of test strips comprising a plurality of individual test strips, each test strip comprising:

(a) a top substrate;

(b) a bottom substrate;

(c) an electrical connector for connection to a meter disposed at a first end; and

(d) an electrochemical test cell disposed at a second end;

wherein said electrical connector comprises a first tab formed at the first end of the top substrate, and a second tab formed at the first end of the bottom substrate;

wherein the first tab is small in width relative to the second tab; and

wherein the first tab is not aligned with the second tab

wherein the plurality of individual test strips are arranged in a plurality of subgroups wherein all test strips in the same subgroup detect the same analyte and are prepared in a single manufacturing process and wherein notches are formed in the second tab of all or all but one of the subgroups to distinguish between subgroups.

5. A method for determining a characteristic of an electrochemical test strip comprising:

(A) providing a test strip comprising

(i) a top substrate;

(ii) a bottom substrate;

(iii) an electrical connector for connection to a meter disposed at a first end; and

(iv) an electrochemical test cell disposed at a second end;

wherein said electrical connector comprises a first tab formed at the first end of the top substrate, and a second tab formed at the first end of the bottom substrate;

wherein the first tab is small in width relative to the second tab;

wherein the first tab is not aligned with the second tab;

wherein the second tab is notched in a position selected from the group consisting of;

in the middle of the tab, on the edge closest to the first tab, and on the edge farthest from the first tab, and

wherein the test strip further comprises characteristic information about the strip encoded on the strip and a first tab and/or second tab configuration corresponding to said encoded characteristic information;

(B) inserting the first end of the strip into an analyte test meter, said meter comprising strip port connector comprising electrical connectors;

(C) detecting electrical connectivity between the electrical connectors; and

(D) correlating electrical connectivity between the electrical connectors with the characteristic information encoded on the test strip.

6. The method of claim 5 wherein the characteristic information is selected from the group consisting of regional identification, calibration information, the type of analyte measured by the test strip, and alignment of the test strip within the analyte test meter.

7. The method of claim 5 wherein the meter has electronics to determine an amount of an analyte in a sample applied to the electrochemical test cell of the test strip.

8. A combination of (A) a test strip and (B) an analyte test meter, the (A) test strip comprising:

(i) a top substrate;

(ii) a bottom substrate;

(iii) an electrical connector for connection to a meter disposed at a first end; and

(iv) an electrochemical test cell disposed at a second end;

wherein said electrical connector comprises a first tab formed at the first end of the top substrate, and a second tab formed at the first end of the bottom substrate;

wherein the first tab is small in width relative to the second tab;

wherein the first tab is not aligned with the second tab;

wherein the second tab is notched in a position selected from the group consisting of;

in the middle of the tab, on the edge closest to the first tab, and on the edge farthest from the first tab, and

wherein the test strip further comprises characteristic information about the strip encoded on the strip and a first tab and/or second tab configuration corresponding to said encoded characteristic information; and

the (B) analyte test meter comprising electrical connectors;

circuitry for detecting electrical connectivity between the electrical connectors; and

circuitry for correlating electrical connectivity between the electrical connectors with the characteristic information encoded on the test strip.

9. The combination of claim 8 wherein the characteristic is selected from the group consisting of regional identification, calibration information, the type of analyte measured by the test strip, and alignment of the test strip within the apparatus.

10. The combination of claim 8, wherein the first end of the test strip is disposed in a strip port connector of the test meter.

11. The combination of claim 8, wherein an electrical connector of the meter is in contact with the first or second tab of the test strip.