Methods of determining initiation and variable end points for measuring a chemical reaction

• US 5,885,839 A
• Filed: 04/15/1997
• Issued: 03/23/1999
• Est. Priority Date: 04/15/1997
• Status: Expired due to Term

• Current Assignee: LXN Corporation (Johnson & Johnson)
• Original Assignee: LXN Corporation (Johnson & Johnson)
• Inventors: Lingane, Paul J., Goins, Michael D., Goins, Karen A., Burd, John F.
• Primary Examiner(s): Soderquist, Arlen
• Application Number:
  US08/842,616
• Time in Patent Office: 707 Days
• Field of Search: 436/34, 436/46, 436/50, 436/67, 436/87, 436/93-95, 436/169, 436/183
• US Class Current: 436/34
• 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: Y10T 436/112499 with sample on test slide
• CPC Class Codes: Y10T 436/115831 Condition or time responsive
• CPC Class Codes: Y10T 436/142222 Hetero-O [e.g., ascorbic acid, etc.]
• CPC Class Codes: Y10T 436/143333 Saccharide [e.g., DNA, etc.]
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

The present invention provides a method of using a reflectance-reading device to determine an initiation time point for measuring the chemical reaction of an analyte from a biological liquid sample on a test surface. The initiation time point is determined by using a device to read a reflectance of a test surface at a plurality of time points, and calculating the K/S ratio of the test surface at each time point according to the Kubelka-Munk equation. As the device continues to calculate a K/S ratio for each time point, the device monitors the rate of change of the K/S ratio with respect to time. The device then determines the initiation time point to be when the rate of change of the K/S ratio is maximal. The present invention also provides a method of measuring the concentration of an analyte on a test surface. The concentration is measured by determining an initiation time point according to the method described above and then measuring the concentration of the analyte at a variable end point. The variable end point is essentially determined to be the time at which the rate of change of a concentration parameter is less than a threshold value.

Claims

1. A method of using a reflectance-reading device to determine an initiation time point for measuring a chemical reaction of an analyte from a biological liquid sample on a test surface, comprising the steps of

(a) using a device to read a reflectance R of a test surface at a plurality of time points,

(b) calculating a K/S ratio of the test surface at each time point according to an equation

View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)

2. The method of claim 1, wherein the analyte is glucose.

3. The method of claim 1, wherein the analyte is glycated protein.

4. The method of claim 3, wherein the analyte is fructosamine.

5. A method of using a reflectance-reading device to measure the concentration of an analyte on a test surface, comprising the steps of

(a) determining an initiation time point according to the method of claim 1, and

(b) measuring the concentration of an analyte at a variable end point, wherein the variable end point is determined by the steps comprising of

(1) using a device to read a reflectance R of a test surface at a plurality of time points,

(2) calculating a K/S ratio from R at each time point,

(3) calculating a concentration parameter corresponding to the K/S ratio at each time point,

(4) monitoring a rate of change of the concentration parameter with respect to time,

(5) comparing the rate of change of the concentration parameter against a threshold value, and

(6) determining the variable end point to be the time at which the rate of change of the concentration parameter is less than the threshold value,

with the proviso that during a testing period that began at the initiation time point, if the rate of change of the concentration parameter is never less than the threshold value, then the variable end point is determined to be the end of the testing period.

6. The method of claim 5, wherein subject to the proviso, the variable end point is determined to be the time at which the rate of change of the concentration parameter is less than the threshold value for a plurality of consecutive measurements of the rate of change of the concentration parameter.

7. The method of claim 6, wherein the number of consecutive measurements of the rate of change of the concentration parameter is 2.

8. The method of claim 5, wherein the analyte is glucose.

9. The method of claim 5, wherein the testing period is about 30 seconds.

10. The method of claim 5, wherein the threshold value is about 1% change of concentration parameter per second.

11. A method of using a reflectance-reading device to measure the concentration of an analyte on a test surface, comprising the steps of

(a) determining an initiation time point according to the method of claim 1, and

(b) measuring the concentration of an analyte at a variable end point, wherein the variable end point is determined by the steps comprising of

(1) using a device to read a reflectance R of a test surface at a plurality of time points,

(2) calculating a K/S ratio from R at each time point,

(3) monitoring a rate of change of the K/S ratio with respect to time,

(4) comparing the rate of change of the K/S ratio against a threshold value, and

(5) determining the variable end point to be the time at which the rate of change of the K/S ratio is less than the threshold value,

with the proviso that during a testing period that began at the initiation time point, if the rate of change of the K/S ratio is never less than the threshold value, then the variable end point is determined to be the end of the testing period.

12. The method of claim 11, wherein subject to the proviso, the variable end point is determined to be the time at which the rate of change of the K/S ratio is less than the threshold value for a plurality of consecutive measurements of the rate of change of the K/S ratio.

13. The method claim 12, wherein the number of consecutive measurements of the rate of change of the K/S ratio is 2.

14. The method of claim 11, wherein the analyte is glucose.

15. The method of claim 11, wherein the testing period is about 30 seconds.

16. The method of claim 11, wherein the threshold value is about 1% change of K/S ratio per second.