Electrochemical biosensor with improved accuracy

• US 9,753,004 B2
• Filed: 12/01/2014
• Issued: 09/05/2017
• Est. Priority Date: 06/01/2012
• Status: Active Grant

• Current Assignee: i-SENS, Inc.
• Original Assignee: i-SENS, Inc.
• Inventors: Lee, Myeong Ho, Kim, Moon Hwan, Lee, Ung Ki, Park, Han Be, Jung, Sung-Kwon, Nam, Hakhyun, Cha, Geun Sig
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): ROSENWALD, STEVEN ERIC
• Application Number:
  US14/556,891
• Publication Number:
  US 20150083613A1
• Time in Patent Office: 1,009 Days
• Field of Search: None
• CPC Class Codes: C12Q 1/006 for glucose
• 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 27/3277 being a redox reaction, e.g. detection by cyclic voltammetry voltammetry per se G01N27/42, G01N27/48
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

The present invention relates to an electrochemical biosensor with improved hematocrit measurement accuracy for measuring blood glucose. According to the present invention, an electrochemical biosensor including a first electrode part for correcting a measured hematocrit value and a second electrode part for measuring a glucose concentration is effective in improving accuracy of a measured hematocrit value and in more improving accuracy of a measured blood glucose concentration using the measured hematocrit values for correction, because an insulation cover is made thinner than a working electrode and an auxiliary electrode, so that areas of a first working electrode and a first auxiliary electrode of the first electrode part exposed to a blood sample become equal; a distance between the first working electrode and the second working electrode becomes constant; and electrode areas are maintained constantly by the insulation cover even when a positioning error occurs during printing.

Claims

1. An electrochemical biosensor, comprising:

a lower substrate;

a first electrode part comprising a first working electrode and a first auxiliary electrode which are formed on the lower substrate;

a second electrode part comprising a second working electrode and a second auxiliary electrode which are formed on the lower substrate;

a reagent layer formed on the second working electrode or the second auxiliary electrode, the reagent layer including an electron transfer mediator;

an insulation cover having regions which correspond to first, second and third reaction units and are partitioned to have cavities, respectively, wherein the first reaction unit is positioned at the first working electrode, a second reaction unit is positioned at the first auxiliary electrode, and a third reaction unit is positioned at the second working electrode;

an intermediate substrate equipped with a microchannel sample cell part to successively guide a blood sample into the first electrode part and the second electrode part; and

an upper substrate,

wherein the first electrode part is able to be electrically connected to a measuring device used in calculating hematocrit by measuring conductivity of a blood sample at the first electrode part, and wherein the first working electrode is devoid of a reagent layer thereon, and

wherein the first reaction unit positioned at the first working electrode and the second reaction unit positioned at the first auxiliary electrode are each positioned, at least in part, on an imaginary line perpendicular to a longitudinal direction along which blood flows into the microchannel sample cell part.

2. The electrochemical biosensor as set forth in claim 1, wherein the insulation cover covers at least one inclined edge of the first working electrode exposed at the first reaction unit, and at least one inclined edge of the first auxiliary electrode exposed at the second reaction unit.

3. The electrochemical biosensor as set forth in claim 1, wherein a thickness of the insulation cover is smaller than a thickness of the electrode.

4. The electrochemical biosensor as set forth in claim 1, wherein the insulation cover is printed with a hydrophobic insulation ink.

5. The electrochemical biosensor as set forth in claim 4, wherein the hydrophobic insulation ink is one selected from the group consisting of polyacryl-based, epoxy-based and ceramic-based inks.

6. The electrochemical biosensor as set forth in claim 1, wherein the first reaction unit positioned at the first working electrode and the second reaction unit positioned at the first auxiliary unit have the same shape.

7. The electrochemical biosensor as set forth in claim 1, wherein the first reaction unit positioned at the first working electrode and the second reaction unit positioned at the first auxiliary unit are positioned in a decalcomania form with respect to a central line of a longitudinal direction, on a line perpendicular to a longitudinal direction along which blood flows into the microchannel sample cell part.

8. The electrochemical biosensor as set forth in claim 1, wherein the reagent layer further includes a redox enzyme.

9. The electrochemical biosensor as set forth in claim 1, wherein a current caused by a redox reaction of glucose in a blood sample is able to be measured at the second electrode part.

10. The electrochemical biosensor as set forth in claim 1, wherein an alternating current (AC) voltage is able to be applied at the first electrode part so as to measure electrical conductivity.

11. The electrochemical biosensor as set forth in claim 1, wherein the second electrode part measures a current caused by a redox reaction of glucose by applying a direct current (DC) voltage.

12. A method for precisely measuring a blood glucose concentration using the electrochemical biosensor of claim 1,

wherein the method comprises the steps of:

inserting the electrochemical biosensor of claim 1 into a measuring device;

introducing a blood sample into the microchannel sample cell part;

measuring an electrical conductivity of the blood sample at the first electrode part and calculating a hematocrit value using the measuring device and a predetermined equation between hematocrit value and the measured electrical conductivity;

calculating a glucose concentration using the measuring device by measuring a signal at a second electrode part; and

correcting the glucose concentration calculated at the second electrode part by applying the hematocrit value calculated at the first electrode part.

13. The method according to claim 12, wherein the electrical conductivity is measured by applying a predetermined potential between the first working electrode and the first auxiliary electrode.

14. The method according to claim 12, wherein said correcting is conducted using a predetermined equation between a hematocrit value and a calculated glucose concentration.