Method for determining concentration of an analyte in a test strip

• US 6,541,266 B2
• Filed: 02/28/2001
• Issued: 04/01/2003
• Est. Priority Date: 02/28/2001
• Status: Expired due to Term

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Home Diagnostics Incorporated
• Inventors: Gilmour, Steven B., Modzelewski, Brent E., Bell, Douglas E., Roth, G. Thomas
• Primary Examiner(s): Wallenhorst, Maureen M.
• Application Number:
  US09/794,045
• Publication Number:
  US 20020146835A1
• Time in Patent Office: 762 Days
• Field of Search: 436/14, 436/95, 436/164, 436/165, 436/169, 436/170, 422/55, 422/56, 422/61, 422/82.05, 422/82.09, 435/14
• US Class Current: 436/95
• 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 33/54386 Analytical elements
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

The present invention provides a method of measuring an analyte, such as glucose in a fluid sample, such as whole blood, by a reflectance reading device. The method includes making periodic intermediate calculations of analyte level and dynamically ascertaining when an analytical reaction has reached an end point. Once stable, the process stops making periodic calculations and reports the final, actual glucose concentration. According to an exemplary embodiment, the method is performed by a reflectance photometer using an analytical test strip containing reagents that react with an analyte of interest in the test fluid. The end point is determined by calculating an intermediate analyte level of the testing element at predetermined intervals and calculating a ratio value corresponding to the (n)^th measurement to an (n-5)^th measurement. When two consecutive ratio values are less than or equal to a predetermined value, the end point is deemed reached and the final analyte level ascertained.

Claims

1. A method for measuring an analyte in a fluid sample in a meter system, comprising:

initiating a measuring period for a fluid sample;

measuring a property of the fluid sample at each of n points in time, said points in time being spaced at predetermined intervals to form a sequence of n measurement values, where n is an integer;

comparing two nonconsecutive measurement values to determine at least one ratio;

terminating the measuring of the fluid sample when at least one of said at least one ratio meets predetermined criteria indicating a final analyte value can be accurately determined; and

determining a final analyte value based on said measurement values.

2. The method for measuring an analyte in a fluid sample according to claim 1, wherein the step of measuring comprises measuring a property of an analytic test strip onto which said fluid sample has been applied.

3. The method for measuring an analyte in a fluid sample according to claim 2, wherein the analyte being measured is glucose.

4. The method for measuring an analyte in a fluid sample according to claim 2, wherein said measuring step further comprises the step of measuring a reflectance value of a test strip onto which said fluid sample has been applied.

5. The method for measuring an analyte in a fluid sample according to claim 4, wherein said predetermined intervals are each about one second in duration.

6. The method for measuring an analyte in a fluid sample according to claim 4, wherein n≧

6 and said two nonconsecutive measurement values correspond to the nth measurement value and the (n-5)^th measurement value, wherein the at least one ratio is calculated by dividing the n^th measurement value by the (n-5)^th measurement value.

7. The method for measuring an analyte in a fluid sample according to claim 6, wherein said at least one of said at least one ratio in said terminating step comprises two ratios calculated consecutively that meet the predetermined criteria.

8. The method for measuring an analyte in a fluid sample according to claim 7, wherein said predetermined criteria corresponds to a calculated ratio value of less than or equal to a predetermined value.

9. The method for measuring an analyte in a fluid sample according to claim 8, wherein said predetermined value is 1.025.

10. The method for measuring an analyte in a fluid sample according to claim 7, wherein the determining step includes calculating a final analyte value from a final measurement value obtained before terminating the measuring.

11. The method for measuring an analyte in a fluid sample according to claim 7, wherein the determining step includes calculating a final analyte value from an average of numerators of each of said two consecutive ratios meeting the predetermined criteria.

12. The method for measuring an analyte in a fluid sample according to claim 7, wherein the determining step further comprises the step of extrapolating the measurement values.

13. The method for measuring an analyte in a fluid sample according to claim 2, wherein said initiation step is triggered by proper insertion of the test strip in the meter system.

14. The method for measuring an analyte in a fluid sample in a meter system according to claim 1, wherein said step of determining a final analyte value further comprises extrapolating from the measurement values.

15. A meter system for measuring an analyte in a fluid sample, comprising:

a light intensity control circuit for measuring reflectance values of an analytic test strip onto which a fluid sample has been applied; and

a processor for

(a) initiating a measuring period for the fluid sample;

(b) measuring the reflectance of a portion of the test strip onto which the fluid sample has been applied at each of n points in time, said points in time being spaced at predetermined intervals to form a sequence of n calculated measurement values, where n is an integer;

(c) comparing two nonconsecutive measurement values to determine at least one ratio,

(d) terminating the reflectance measuring when at least one of said at least one ratio meets predetermined criteria indicating a final analyte value can be accurately determined; and

(e) determining a final analyte value based on said measurement values; and

a display for reporting said final analyte value in a user comprehensible format.

16. The meter system according to claim 15, wherein said analyte is glucose.

17. The meter system according to claim 16, wherein said predetermined intervals are each one second in duration.

18. The meter system according to claim 16, wherein n≧

6 and said two nonconsecutive measurement values correspond to the n^th measurement value and the (n-5)^th measurement value, wherein the at least one ratio is calculated by dividing the n^th measurement value by the (n-5)^th measurement value.

19. The meter system according to claim 18, wherein said at least one of said at least one ratio comprises two ratios calculated consecutively that meet the predetermined criteria.

20. The meter system according to claim 19, wherein said predetermined criteria corresponds to a calculated ratio value of less than or equal to a predetermined value.

21. The meter system according to claim 20, wherein said predetermined value is 1.025.

22. The meter system according to claim 19, wherein the determining step includes calculating a final glucose value from a final reflectance value obtained before terminating the measuring.

23. The meter system according to claim 19, wherein the determining step includes calculating a final glucose value from an average of the n^th reflectance values of each of said two consecutive ratios meeting the predetermined criteria.

24. The meter system according to claim 15, further including a strip sensor for determining whether a test strip has been properly inserted in the meter system, wherein the initiation function of the processor is triggered by the strip sensor.

25. The meter system according to claim 15, wherein said processor determines the final analyte value based on an extrapolation of the measurement values.

26. A method for measuring the concentration of glucose in a biological fluid sample in a meter system, comprising:

initiating a measuring period for a biological fluid sample;

measuring a property of the fluid sample at each of n points in time, said points in time being spaced at predetermined intervals to form a sequence of n measurement values, where n is an integer and greater than 2;

comparing two nonconsecutive measurement values to determine at least one ratio;

terminating the measuring of the biological fluid sample when at least one of said at least one ratio meets predetermined criteria indicating a final glucose concentration value can be accurately determined; and

determining a final glucose concentration value based on said measurement values.

27. The method for measuring glucose concentration in a biological fluid sample according to claim 26, wherein the step of measuring comprises measuring an analytic test strip onto which said fluid sample has been applied.

28. The method for measuring glucose concentration in a biological fluid sample according to claim 27, wherein said measuring step further comprises the step of measuring a reflectance value of the test strip onto which said fluid sample has been applied.

29. The method for measuring glucose concentration in a biological fluid sample according to claim 28, wherein said predetermined intervals are each one second in duration.

30. The method for measuring glucose concentration in a biological fluid sample according to claim 28, wherein n≧

6 and said two nonconsecutive measurement values correspond to the n^th measurement value and the (n-5)^th measurement value, wherein the at least one ratio is calculated by dividing the n^th measurement value by the (n-5)^th measurement value.

31. The method for measuring glucose concentration in a biological fluid sample according to claim 30, wherein said at least one of said at least one ratio in said terminating step comprises two ratios calculated consecutively that meet the predetermined criteria.

32. The method for measuring glucose concentration in a biological fluid sample according to claim 31, wherein said predetermined criteria corresponds to a calculated ratio value of less than or equal to a predetermined value.

33. The method for measuring glucose concentration in a biological fluid sample according to claim 32, wherein said predetermined value is 1.025.

34. The method for measuring glucose concentration in a biological fluid sample according to claim 31, wherein the determining step includes calculating a final glucose value from a final measurement value obtained before terminating the measuring.

35. The method for measuring glucose concentration in a biological fluid sample according to claim 31, wherein the determining step includes calculating a final glucose value from an average of the n^th measurement values of each of said two consecutive ratios meeting the predetermined criteria.

36. The method for measuring glucose concentration in a biological fluid sample according to claim 27, wherein said initiation step is triggered by proper insertion of the test strip in the meter system.