CALIBRATION SYSTEM FOR USE WITH LATERAL FLOW ASSAY TEST STRIPS

• US 20120185198A1
• Filed: 01/20/2012
• Published: 07/19/2012
• Est. Priority Date: 07/05/2005
• Status: Active Grant

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Irvin, Benjamin R.
• Granted Patent: US 9,671,401 B2
• Time in Patent Office: Days
• US Class Current: 702/104
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A method of adjusting a final signal value measured on a lateral flow assay test strip, by: identifying a pre-determined calibration method for the test strip, wherein the pre-determined calibration method corresponds to the manufacturing lot from which the test strip has been made; measuring signal values while performing a lateral flow assay reaction on a test strip; determining a final signal value; and adjusting the final signal value based upon the identified pre-selected calibration method for the test strip.

Claims

1. A method of adjusting a final signal value measured on a lateral flow assay test strip, comprising:

measuring signal values while performing a lateral flow assay reaction on a test strip;

determining an extreme signal value;

determining the time at which the extreme signal value is measured, determining a final signal value; and

adjusting the final signal value based upon the time at which the extreme signal value is measured.

2. The method of claim 1, wherein the signal values are reflectance values.

3. The method of claim 1, wherein adjusting the final signal value based upon the time at which the extreme signal value is measured comprises:

pre-determining a relationship between the time at which the extreme signal value is measured and the final signal value for the manufacturing lot from which the test strip has been made; and

adjusting the final signal value based upon the pre-determined relationship between the time at which the extreme signal value is measured and the final signal value for the manufacturing lot from which the test strip has been made.

4. The method of claim 3, wherein pre-determining a relationship between the time at which the extreme signal value is measured and the final signal value for the manufacturing lot from which the test strip has been made comprises:

determining the relationship between the time at which the extreme signal value is measured and the final signal value for an exemplary test strip from the manufacturing lot from which the test strip has been made.

5. The method of claim 1, wherein the extreme signal value is a minimum signal value.

17. The method of claim 1, wherein the signal values are electrochemical signal values.

20. The method of claim 1, wherein the signal values are direct light transmission signal values.

6. A method of adjusting a final signal value measured on a lateral flow assay test strip, comprising:

measuring signal values while performing a lateral flow assay reaction on a test strip, determining a total signal below a threshold value;

determining a final signal value; and

adjusting the final signal value based upon the total measured signal below the threshold value.

7. The method of claim 6, wherein the signal values are reflectance values.

8. The method of claim 7, wherein adjusting the final signal value based upon the total measured signal below the threshold value comprises:

pre-determining a relationship between the total signal below the threshold and the final signal value for the manufacturing lot from which the test strip has been made; and

adjusting the final signal value based upon the pre-determined relationship between the total signal below the threshold value for the manufacturing lot from which the test strip has been made.

9. The method of claim 8, wherein pre-determining the relationship between the total signal below the threshold and the final signal value for the manufacturing lot from which the test strip has been made comprises:

determining the relationship between the total signal below the threshold and the final signal value for an exemplary test strip from the manufacturing lot from which the test strip has been made.

18. The method of claim 6, wherein the signal values are electrochemical signal values.

21. The method of claim 6, wherein the signal values are direct light transmission signal values.

10. A method of adjusting a final signal value measured on a lateral flow assay test strip, comprising:

identifying a pre-determined calibration method for the test strip, wherein the predetermined calibration method corresponds to the manufacturing lot from which the test strip has been made;

measuring signal values while performing a lateral flow assay reaction on a test strip;

determining a final signal value; and

adjusting the final signal value based upon the identified pre-selected calibration method for the test strip.

11. The method of claim 10, wherein the pre-determined calibration method for the test strip comprises:

measuring signal values while performing a lateral flow assay reaction on a test strip;

determining an extreme signal value;

determining an interim signal value, wherein the interim signal value is measured a pre-determined time period after the extreme signal value is measured;

determining a final signal value; and

adjusting the final signal value based upon the interim signal value.

12. The method of claim 10, wherein the pre-determined calibration method for the test strip comprises:

measuring signal values while performing a lateral flow assay reaction on a test strip;

determining an extreme signal value;

determining the time at which the extreme signal value is measured, determining a final signal value; and

adjusting the final signal value based upon the time at which the extreme signal value is measured.

13. The method of claim 10, wherein the pre-determined calibration method for the test strip comprises:

measuring signal values while performing a lateral flow assay reaction on a test strip, determining a total signal below a threshold value;

determining a final signal value; and

adjusting the final signal value based upon the total measured signal below the threshold value.

14. The method of claim 10, wherein identifying a pre-determined calibration method for the test strip comprises:

reading an identifier indicating the pre-determined calibration method.

15. The method of claim 14, wherein the identifier is disposed on the test strip.

16. The method of claim 14, wherein the identifier is received within an assembly connected to the test strip.

19. The method of claim 10, wherein the signal values are electrochemical signal values.

22. The method of claim 10, wherein the signal values are direct light transmission signal values.

23. An apparatus for adjusting a final signal value measured on a lateral flow assay test strip, comprising:

an identifier containing a pre-determined calibration method for a test strip, wherein

the pre-determined calibration method corresponds to the manufacturing lot from which the test strip has been made;

a signal measuring system for measuring signal values while performing a lateral flow assay reaction on a test strip; and

a calibration system for adjusting the final signal value based upon the identified pre-selected calibration method for the test strip.

24. The apparatus of claim 23, wherein the identifier is disposed on the test strip.

25. The apparatus of claim 23, wherein the identifier is disposed within an assembly connected to the test strip.