Calibration method, test strip and calibration system for blood glucose of blood sample

• US 9,354,198 B2
• Filed: 04/25/2013
• Issued: 05/31/2016
• 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
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US13/870,805
• Publication Number:
  US 20130334064A1
• Time in Patent Office: 1,132 Days
• US Class Current: 1/1
• 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:

providing a test strip, wherein the test strip comprises only two electrodes and only one reaction section, and each of the two electrodes is at least partially disposed on and covering the reaction section;

injecting a blood sample into the reaction section to contact the two electrodes;

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

applying a second voltage to the blood sample between the two electrodes 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,

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, and the first voltage and the second voltage are direct current voltages.

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 step of processing the hematocrit index comprises obtaining a hematocrit according to a linear correlation formula.

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

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