Calibration system for use with lateral flow assay test strips

• US 20070010022A1
• Filed: 07/05/2005
• Published: 01/11/2007
• Est. Priority Date: 07/05/2005
• Status: Active Grant

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Metrika, Inc. (Bayer AG)
• Inventors: Irvin, Benjamin
• Granted Patent: US 8,101,415 B2
• Time in Patent Office: Days
• US Class Current: 436/80
• 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 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.

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

3. The method of claim 1, wherein the pre-determined time period is pre-determined for the manufacturing lot from which the test strip has been made.

4. The method of claim 1, wherein adjusting the final signal value based upon the interim signal value comprises:

pre-determining a relationship between the interim signal value 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 interim signal value and the final signal value for the manufacturing lot from which the test strip has been made.

5. The method of claim 4, wherein pre-determining the relationship between the interim signal value and the final signal value for a plurality of test strips from the manufacturing lot from which the test strip has been made comprises:

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

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

7. The method of claim 1, further comprising:

determining the time at which the extreme signal value is measured, wherein the pre-determined time period after the extreme signal value has been measured is a function of the time at which the extreme signal value is measured for the manufacturing lot from which the test strip has been made.

8. The method of claim 7, wherein adjusting the final signal value based upon the interim signal value comprises:

pre-determining a relationship between the time at which the extreme signal value is measured and the time at which the interim signal value is measured for the plurality of test strips from the same manufacturing lot;

pre-determining a relationship between the interim signal value and the final signal value for the plurality of test strips from the same manufacturing lot; and

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

9. The method of claim 8, wherein pre-determining a relationship between the time at which the extreme signal value is measured and the time at which the interim signal value is measured for the plurality of test strips from the same manufacturing lot comprises:

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

10. The method of claim 8, wherein pre-determining a relationship between the interim signal value and the final signal value for the plurality of test strips from the same manufacturing lot comprises:

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

20. The method of claim 1, further comprising:

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

adjusting the final signal value based upon both the interim signal value and the second interim signal value.

21. The method of claim 20, wherein adjusting the final signal value based upon both the interim signal value and the second interim signal value comprises:

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

pre-determining a relationship between the second interim signal value 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 relationships between the interim signal value and the final signal value and the second interim signal value and the final signal value for the manufacturing lot from which the test strip has been made.

22. The method of claim 21, wherein pre-determining the relationships between the interim signal value and the final signal value and the second interim signal value and the final signal value for the manufacturing lot from which the test strip has been made comprises:

determining the relationships between the interim signal value and the final signal value and the second interim signal value and the final signal value for an exemplary test strip from the manufacturing lot from which the test strip has been made.

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

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

11. 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.

12. The method of claim 11, wherein the signal values are reflectance values.

13. The method of claim 11, 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.

14. The method of claim 13, 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.

15. The method of claim 11, wherein the extreme signal value is a minimum signal value.

31. The method of claim 11, wherein the signal values are electrochemical signal values.

35. The method of claim 11, wherein the signal values are direct light transmission signal values.

16. 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.

17. The method of claim 16, wherein the signal values are reflectance values.

18. The method of claim 17, 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.

19. The method of claim 18, 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.

32. The method of claim 16, wherein the signal values are electrochemical signal values.

36. The method of claim 16, wherein the signal values are direct light transmission signal values.

23. 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 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.

24. The method of claim 23, 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.

25. The method of claim 23, 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.

26. The method of claim 23, 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.

27. The method of claim 23, wherein identifying a pre-determined calibration method for the test strip comprises:

reading an identifier indicating the pre-determined calibration method.

28. The method of claim 27, wherein the identifier is disposed on the test strip.

29. The method of claim 27, wherein the identifier is received within an assembly connected to the test strip.

33. The method of claim 23, wherein the signal values are electrochemical signal values.

37. The method of claim 23, wherein the signal values are direct light transmission signal values.

38. 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.

39. The apparatus of claim 38, wherein the identifier is disposed on the test strip.

40. The apparatus of claim 38, wherein the identifier is disposed within an assembly connected to the test strip.