CALIBRATION METHOD, TEST STRIP AND CALIBRATION SYSTEM FOR BLOOD GLUCOSE OF BLOOD SAMPLE

• US 20130334064A1
• Filed: 04/25/2013
• Published: 12/19/2013
• Est. Priority Date: 06/13/2012
• Status: Active Grant

• Current Assignee: Delbio, Inc.
• Original Assignee: Delbio, Inc.
• Inventors: NIEN, Po-Chin, CHEN, Cheng-Chuan, YIN, Chien-Yu, CHEN, Chi-Yan
• Granted Patent: US 9,354,198 B2
• Time in Patent Office: Days
• US Class Current: 205/782
• 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 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence

Abstract

A calibration method for blood glucose of blood sample comprises the following steps: applying a first voltage to a blood sample to obtain an original level of blood glucose of the blood sample; applying a second voltage to a blood sample to obtain a hematocrit index of the blood sample; and processing the hematocrit index and calibrating the original level of blood glucose of the blood sample. The absolute value of the first voltage is lower than 1 volt and is not equal to 0 volt. The absolute value of the second voltage is higher than or equal to 1 volt. A sensing current corresponding to the original blood level and the hematocrit index corresponding to blood sample are obtained by applying at least two-stage voltages in the specific range to the blood sample, thereby calibrating the original blood glucose according to the hematocrit index.

Claims

1. A calibration method for blood glucose of blood sample, comprising the steps of:

applying a first voltage to a blood sample to obtain an original level of blood glucose of the blood sample;

applying a second voltage to the blood sample to obtain a hem hematocrit index of the blood sample; and

processing the hematocrit index and calibrating the original level of blood glucose of the blood sample,

wherein the absolute value of the first voltage is lower than 1 volt and is not equal to 0 volt, and the absolute value of the second voltage is higher than or equal to 1 volt.

2. The calibration method according to claim 1, wherein the absolute value of the second voltage is in a range between 1 volt and 4 volts.

3. The calibration method according to claim 1, wherein the first voltage and the second voltage are direct current voltages.

4. The calibration method according to claim 1, wherein the step of processing the hematocrit index comprises obtaining a hematocrit according to a linear correlation formula.

5. The calibration method according to claim 1, further comprising a step of:

applying a third voltage to the blood sample to obtain a second hematocrit index of the blood sample.

6. A test strip for blood glucose of a blood sample, comprising:

a bottom layer having a reaction section;

two electrodes disposed on the bottom layer and partially contacting the reaction section;

a middle layer disposed on the electrodes, the middle layer has an inlet section corresponding to the reaction section of the bottom layer;

a top layer disposed on the middle layer; and

a reagent accommodated in the reaction section of the bottom layer, the reagent comprises at least one electron transfer substance, and

wherein the two electrodes are continuously applied with a first voltage and a second voltage therebetween, the absolute value of the first voltage is lower than 1 volt and is not equal to 0 volt, and the absolute value of the second voltage is higher than or equal to 1 volt.

7. The test strip according to claim 6, wherein the absolute value of the second voltage is in a range between 1 volt and 4 volts.

8. The test strip according to claim 6, wherein the first voltage and the second voltage are direct current voltages.

9. A calibration system for blood glucose of a blood sample, comprising:

a test strip, comprising;

a bottom layer having a reaction section;

two electrodes disposed on the bottom layer and partially contacting the reaction section;

a middle layer disposed on the electrodes, the middle layer has an inlet section corresponding to the reaction section of the bottom layer;

a top layer disposed on the middle layer; and

a reagent accommodated in the reaction section of the bottom layer, the reagent comprises at least one electron transfer substance, and

wherein the two electrodes are continuously applied with a first voltage and a second voltage therebetween, the absolute value of the first voltage is lower than 1 volt and is not equal to 0 volt, and the absolute value of the second voltage is higher than or equals to 1 volt;

a converting module electrically connecting to the test strip to convert a current signal generated by the test strip to a voltage signal;

a controlling module electrically connecting to the converting module to generate the voltage set previously to the converting module; and

a processing module electrically connecting to the controlling module.

10. The calibration system according to claim 9, wherein the absolute value of the second voltage is in a range between 1 volt and 4 volts.

11. The calibration system according to claim 9, wherein the first voltage and the second voltage are direct current voltages.