Systems and methods for correction of on-strip coding

• US 10,073,991 B2
• Filed: 01/25/2018
• Issued: 09/11/2018
• 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:
  US15/879,699
• Publication Number:
  US 20180150655A1
• Time in Patent Office: 229 Days
• Field of Search: 235375, 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 method of making a diagnostic test strip, the method comprising:

determining a base code for a lot of test strips, the base code comprising information that allows a meter designed to work with the lot of test strips to convert raw signal data from the test strips to a concentration value for an analyte of interest;

inspecting one or more test strips in a sub-lot of test strips from the lot of test strips to determine variations in one or more parameters, the one or more parameters comprising 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;

modifying the base code based on the variations in the one or more parameters; and

marking a modified code onto the one or more test strips in the sub-lot of 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 for the lot of test strips and a corresponding value for the one or more test strips in the sub-lot of test strips.

2. The method of claim 1, wherein the base code is determined by testing a representative number of test strips by destructive means.

3. The method of claim 2, wherein the one or more parameters are inspected by non-destructive means.

4. The method of claim 1, wherein the sub-lot comprises a single test strip.

5. The method of claim 1, wherein the sub-lot comprises multiple test strips.

6. The method of claim 4, 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.

7. A test strip comprising a machine readable code obtained by a method comprising:

determining a base code for a lot of test strips, the base code comprising information that allows a meter designed to work with the lot of test strips to convert raw signal data from the test strips to a concentration value for an analyte of interest;

inspecting one or more test strips in a sub-lot of test strips from the lot of test strips by non-destructive means to determine variations in one or more parameters, the one or more parameters comprising 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;

obtaining a machine readable code by modifying the base code based on the variations in the one or more parameters, 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 for the lot of test strips and a corresponding value for the one or more test strips in the sub-lot of test strips.

8. The test strip of claim 7, wherein the base code is determined by testing a representative number of test strips by destructive means.

9. The test strip of claim 8, wherein the one or more parameters are inspected by non-destructive means.

10. The test strip of claim 8, wherein the sub-lot comprises a single test strip.

11. The test strip of claim 8, wherein the sub-lot comprises any subset of the lot of test strips.

12. The test strip of claim 8 further comprising marking the sub-lot of the lot of test strips with the modified base code.

13. The test strip of claim 8, 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.