Systems and methods for correction of on-strip coding

• US 10,460,133 B2
• Filed: 08/10/2018
• Issued: 10/29/2019
• Est. Priority Date: 03/11/2016
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Inventors: Davies, Stephen
• Primary Examiner(s): Vo, Tuyen K
• Application Number:
  US16/100,393
• Publication Number:
  US 20190042806A1
• Time in Patent Office: 445 Days
• Field of Search: 235375, 23546201, 235494
• 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 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G06K 1/121 by printing code marks applying code marks to labels B65C9/46; marking or coding completed packages B65B61/26
• CPC Class Codes: G06K 19/067 Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components

Abstract

Systems and methods of making a diagnostic test strip, the method including marking a machine-readable pattern onto the diagnostic test strip which contains information that allows a meter designed to work with the test strip to convert raw signal data from the diagnostic test strip into a meaningful concentration value for an analyte of interest. The method further includes printing the machine-readable pattern having a modified based code that is different from a base code of the diagnostic test strip being produced, wherein the modified based code is based on a strip geometry parameter, a chemistry parameter or both the strip geometry and chemistry parameters that are measured for the diagnostic test strip.

Claims

1. A diagnostic test strip comprising:

a base code comprising information that allows a meter designed to work with a plurality of diagnostic test strips to convert raw signal data from one or more electrodes on the plurality of diagnostic test strips into a meaningful concentration value for an analyte of interest; and

a modified code being different from the base code of the plurality of diagnostic test strips,

wherein the modified code modifies information encoded by the base code based on a difference in an average value for the plurality of diagnostic test strips of one or more strip geometry parameters, one or more chemistry parameters, or both the one or more strip geometry parameters and the one or more chemistry parameters and a corresponding value for the diagnostic test strip.

2. The test strip of claim 1, wherein the modified code refers to a lookup table of the meter such that the concentration value of the analyte of interest can be modified based on the modified code.

3. The test strip of claim 1, wherein the meter is a glucose meter and the analyte is blood glucose.

4. The test strip of claim 1, wherein the modified code onto the test strip instructs the meter to offset the base code by a certain amount.

5. The test strip of claim 1, wherein the one or more geometry parameters include one or more of an electrode width of the electrode on the test strip, a distance between electrodes on the test strip, electrode material, a sample well height, and a sample well length.

6. The test strip of claim 1, wherein the one or more chemistry parameters includes one or more of type of enzyme, concentration of enzyme, concentration of a mediator, electrolyte concentration, and chemistry layer thickness.

7. A test strip formed by a method comprising:

marking a base code of a machine-readable pattern onto a diagnostic test strip from a plurality of diagnostic test strips, the base code comprising information that allows a meter designed to work with the plurality of diagnostic test strips to convert raw signal data from one or more electrodes on the plurality of diagnostic test strips into a meaningful concentration value for an analyte of interest;

marking a modified code of a machine-readable pattern onto the diagnostic test strip of the plurality of diagnostic test strips, the modified code being different from the base code of the plurality of diagnostic test strips being produced,

wherein the modified code modifies information encoded by the base code based on a difference in an average value for the plurality of diagnostic test strips of one or more strip geometry parameters, one or more chemistry parameters, or both the one or more strip geometry parameters and the one or more chemistry parameters and a corresponding value for the diagnostic test strip.

8. The test strip of claim 7, wherein the modified code refers to a lookup table of the meter such that the concentration value of the analyte of interest can be modified based on the modified code.

9. The test strip of claim 7, wherein the meter is a glucose meter and the analyte is blood glucose.

10. The test strip of claim 7, wherein the marking of the modified code onto the diagnostic test strip instructs the meter to offset the base code of the first machine-readable pattern by a certain amount.

11. The test strip of claim 7, wherein the one or more geometry parameters include one or more of an electrode width of the electrode on the test strip, a distance between electrodes on the test strip, electrode material, a sample well height, and a sample well length.

12. The test strip of claim 7, wherein the one or more chemistry parameters includes one or more of type of enzyme, concentration of enzyme, concentration of a mediator, electrolyte concentration, and chemistry layer thickness.

13. A diagnostic system comprising:

a plurality of diagnostic test strips; and

a meter designed to perform diagnostic tests using a plurality of diagnostic test strips,

wherein one or more of diagnostic test strips of the plurality of diagnostic test strips comprise;

a base code comprising information that allows the meter to convert raw signal data from one or more electrodes on the plurality of diagnostic test strips into a meaningful concentration value for an analyte of interest; and

a modified code being different from the base code of the plurality of diagnostic test strips,

wherein the modified code modifies information encoded by the base code based on a difference in an average value for the plurality of diagnostic test strips of one or more strip geometry parameters, one or more chemistry parameters, or both the one or more strip geometry parameters and the one or more chemistry parameters and a corresponding value for the one or more diagnostic test strips.

14. The diagnostic system of claim 13, wherein the modified code refers to a lookup table of the meter such that the concentration value of the analyte of interest can be modified based on the modified code.

15. The diagnostic system of claim 13, wherein the meter is a glucose meter and the analyte is blood glucose.

16. The diagnostic system of claim 13, wherein the modified code onto the test strip instructs the meter to offset the base code by a certain amount.

17. The diagnostic system of claim 13, wherein the one or more geometry parameters include one or more of an electrode width of the electrode on the test strip, a distance between electrodes on the test strip, electrode material, a sample well height, and a sample well length.

18. The diagnostic system of claim 13, wherein the one or more chemistry parameters includes one or more of type of enzyme, concentration of enzyme, concentration of a mediator, electrolyte concentration, and chemistry layer thickness.