METHODS FOR MEASURING ANALYTE CONCENTRATION

• US 20160320327A1
• Filed: 08/28/2015
• Published: 11/03/2016
• Est. Priority Date: 04/28/2015
• Status: Active Grant

• Current Assignee: Industrial Technology Research Institute
• Original Assignee: Industrial Technology Research Institute
• Inventors: CHEN, Chu-Hsuan, YEN, Yu-Fang, YUAN, Yi-Yen, SHEN, Hui-Ju, LIN, Fen-Fei, TUNG, Yi-Ting, HSIEH, Wen-Pin
• Granted Patent: US 9,903,832 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 27/48 using polarography, i.e. measuring changes in current under a slowly-varying voltage

Abstract

The present disclosure provides a method for detecting an analyte concentration. The method includes providing a test strip, which includes a first electrode set including a first reaction area, a second electrode set including a second reaction area, and a reaction reagent layer disposed on the second reaction area. The method includes providing a blood sample and bringing the blood sample into contact with the first electrode set and the second electrode set, applying a first voltage to the first electrode set by voltammetry to obtain a first response value, calculating a hematocrit value according to the first response value, applying a second voltage to the second electrode set to obtain a second response value, and calculating the actual value of the analyte concentration by using the hematocrit value and the second response value.

Claims

1. A method for detecting an analyte concentration, comprising:

providing a test strip comprising;

a first electrode set comprising a first reaction area;

a second electrode set comprising a second reaction area; and

a reaction reagent layer disposed on the second reaction area;

providing a blood sample and bringing the blood sample into contact with the first electrode set and the second electrode set;

applying a first voltage to the first electrode set by a voltammetry to obtain a first response value;

calculating a hematocrit value according to the first response value;

applying a second voltage to the second electrode set to obtain a second response value; and

calculating an actual value of the analyte concentration by using the hematocrit value and the second response value.

2. The method for detecting the analyte concentration as claimed in claim 1, wherein the reaction reagent layer comprises a reaction enzyme and an electrical medium.

3. The method for detecting the analyte concentration as claimed in claim 1, wherein the voltammetry is a square wave voltammetry (SWV).

4. The method for detecting the analyte concentration as claimed in claim 1, wherein the first electrode set and the second electrode set respectively comprises a working electrode and a reference electrode.

5. The method for detecting the analyte concentration as claimed in claim 3, wherein the first electrode set comprises a working electrode and a reference electrode, the working electrode and the reference electrode of the first electrode set has a spacer in a range of 0.01 mm to 5 mm and/or the working electrode and the reference electrode of the first electrode set has an area ratio between 1 and 1.5.

6. The method for detecting the analyte concentration as claimed in claim 3, wherein a frequency of the first voltage is more than or equals to 100 Hz, an amplitude of the first voltage is more than or equals to 0.01 V, and/or an increment voltage of the first voltage is between 0.01 V and 0.4 V.

7. The method for detecting the analyte concentration as claimed in claim 3, wherein a voltage scan range of the first voltage is between 0 V and 0.8 V and/or the applying time of the first voltage is between 0.01 seconds and 4 seconds.

8. The method for detecting the analyte concentration as claimed in claim 1, further comprising:

conducting a calibration to a linear equation related with the analyte concentration by using the hematocrit value to obtain a calibrated linear equation; and

calculating an actual value of the analyte concentration according to the second response value and the calibrated linear equation.

9. The method for detecting the analyte concentration as claimed in claim 8, wherein the method for conducting the calibration to the linear equation related with the analyte concentration by using the hematocrit value to obtain the calibrated linear equation comprises:

obtaining a slope coefficient and an interception coefficient corresponding to the hematocrit value according to a reference table or a relationship equation; and

conducting a calibration to the linear equation related with the analyte concentration by using the slope coefficient and the interception coefficient to obtain the calibrated linear equation.

10. The method for detecting the analyte concentration as claimed in claim 9, wherein the reference table comprises the slope coefficients and the interception coefficients corresponding to a plurality of hematocrit values, wherein the hematocrit values are in a range of 10% to 70%.

11. The method for detecting the analyte concentration as claimed in claim 8, wherein the linear equation related with the analyte concentration is y=ax+b, wherein y is the second response value, a is a slope parameter, x is the analyte concentration, b is an interception parameter, wherein the linear equation y=ax+b is a conversion equation of the second response value and the analyte concentration when the hematocrit value of the blood sample is 0%.

12. The method for detecting the analyte concentration as claimed in claim 8, wherein the linear equation related with the analyte concentration is y=ax+b, wherein y is the second response value, a is a slope parameter, x is the analyte concentration, b is an interception parameter, wherein the linear equation y=ax+b is a conversion equation of the second response value and the analyte concentration when the hematocrit value of the blood sample is 40% to 45%.

13. The method for detecting the analyte concentration as claimed in claim 9, wherein the calibrated linear equation is y=a′

x+b′

, wherein y is the second response value, a′

is a slope parameter calibrated by the slope coefficient, x is the actual value of the analyte concentration, b′

is an interception parameter calibrated by the interception coefficient.

14. A method for detecting an analyte concentration, comprising:

providing a test strip comprising;

a first electrode set comprising a first reaction area;

a second electrode set comprising a second reaction area; and

a reaction reagent layer disposed on the second reaction area;

providing a blood sample and bringing the blood sample into contact with the first electrode set and the second electrode set;

obtaining a hematocrit value by using the first electrode set;

conducting a calibration to a linear equation related with an analyte concentration by using the hematocrit value to obtain a calibrated linear equation;

applying a voltage to the second electrode set to obtain a response value; and

calculating an actual value of the analyte concentration by using the response value and the calibrated linear equation.

15. The method for detecting the analyte concentration as claimed in claim 14, wherein the method for conducting a calibration to the linear equation related with the analyte concentration by using the hematocrit value to obtain the calibrated linear equation comprises:

obtaining a slope coefficient and an interception coefficient corresponding to the hematocrit value according to a reference table or a relationship equation; and

conducting a calibration to the linear equation related with the analyte concentration by using the slope coefficient and the interception coefficient to obtain the calibrated linear equation.

16. The method for detecting the analyte concentration as claimed in claim 15, wherein the reference table comprises the slope coefficients and the interception coefficients corresponding to a plurality of hematocrit values, wherein the hematocrit values are in a range of 10% to 70%.

17. The method for detecting the analyte concentration as claimed in claim 14, wherein the linear equation related with the analyte concentration is y=ax+b, wherein y is the response value, a is a slope parameter, x is the analyte concentration, b is an interception parameter, wherein the linear equation y=ax+b is a conversion equation of the response value and the analyte concentration when the hematocrit value of the blood sample is 0%.

18. The method for detecting the analyte concentration as claimed in claim 14, wherein the linear equation related with the analyte concentration is y=ax+b, wherein y is the response value, a is a slope parameter, x is the analyte concentration, b is an interception parameter, wherein the linear equation y=ax+b is a conversion equation of the response value and the analyte concentration when the hematocrit value of the blood sample is 40% to 45%.

19. The method for detecting the analyte concentration as claimed in claim 15, wherein the calibrated linear equation is y=a′

x+b′

, wherein y is the response value, a′

is a slope parameter calibrated by the slope coefficient, x is the actual value of the analyte concentration, b′

is an interception parameter calibrated by the interception coefficient.

20. The method for detecting the analyte concentration as claimed in claim 14, wherein the method for obtaining a hematocrit value by using the first electrode set comprises using amperometry, coulometry, potentiometry, voltammetry, impedance, or a combination thereof.