Electrochemical test strip and method for testing a sample using the same

• US 8,852,423 B2
• Filed: 01/11/2013
• Issued: 10/07/2014
• Est. Priority Date: 01/16/2012
• Status: Expired due to Fees

• Current Assignee: Delbio, Inc.
• Original Assignee: Delbio, Inc.
• Inventors: Liao, Hung-Yun, Chen, Chi-Yan, Chen, Cheng-Chuan
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US13/739,801
• Publication Number:
  US 20130180869A1
• Time in Patent Office: 634 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792
• US Class Current: 205/792
• 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 27/3275 Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction

Abstract

An electrochemical test strip is provided, including a substrate, an electrode structure and an insulative film. The electrode structure is formed on the substrate, including a first electrode and a second electrode. The second electrode includes a first end, a second end, an extension portion, and a bent portion. The extension portion connects the first end with the bent portion, and the bent portion is connected to the second end. The extension portion and the first electrode define a space therebetween for receiving the bent portion. The insulative film covers at least a part of the electrode structure and forms an opening. A sample fluid enters the electrochemical test strip through the opening, and the sample fluid sequentially contacts the first electrode and the second electrode.

Claims

1. An electrochemical test strip, comprising:

a substrate, comprising a test end;

an electrode structure, formed on the substrate, comprising;

a first electrode;

a second electrode, comprising a first end, a second end, an extension portion, and a bent portion, wherein the extension portion is connected between the first end and the bent portion, the bent portion is connected to the second end, and the extension portion and the first electrode define a space therebetween for receiving the bent portion; and

an insulative layer, covering at least a part of the electrode structure and forming an opening corresponding to the test end, wherein a sample is injected through the opening into the electrochemical test strip and sequentially contacts the first electrode and the second electrode;

wherein a testing voltage is applied between the first electrode and the second electrode for electrochemical measurement of the sample;

wherein the bent portion comprises a first section, a second section and a connecting section, wherein the first section is connected between the extension portion and the connecting section, the second section is connected between the second end and the connecting section, and the first section, the second section, and the connecting section form a U-shaped structure;

wherein the bent portion further comprises a protruding section, and the protruding section is connected to the second section and extended toward the test end.

2. The electrochemical test strip as claimed in claim 1, wherein the electrode structure comprises metal material.

3. The electrochemical test strip as claimed in claim 1, wherein the electrode structure comprises non-metal material.

4. The electrochemical test strip as claimed in claim 3, wherein the electrode structure comprises carbon.

5. The electrochemical test strip as claimed in claim 1, wherein the electrochemical test strip further comprises a metal material layer disposed between the electrode structure and the substrate.

6. The electrochemical test strip as claimed in claim 5, wherein the metal material layer comprises gold, silver, palladium, platinum, nickel, copper, molybdenum, cobalt, chromium, zinc, tin, plumbum, or titanium.

7. An electrochemical test strip, comprising:

a substrate, comprising a test end;

an electrode structure, formed on the substrate, comprising;

a first electrode;

a second electrode, comprising a first end, a second end, an extension portion, and a bent portion, wherein the extension portion is connected between the first end and the bent portion, the bent portion is connected to the second end, and the extension portion and the first electrode define a space therebetween for receiving the bent portion; and

an insulative layer, covering at least a part of the electrode structure and forming an opening corresponding to the test end, wherein a sample is injected through the opening into the electrochemical test strip and sequentially contacts the first electrode and the second electrode;

wherein a testing voltage is applied between the first electrode and the second electrode for electrochemical measurement of the sample;

wherein the bent portion comprises a first section, a second section and a connecting section, wherein the first section is connected between the extension portion and the connecting section, the second section is connected between the second end and the connecting section, and the first section, the second section, and the connecting section form a U-shaped structure;

wherein the bent portion comprises a first section, a second section and a connecting section, wherein the first section is connected between the extension portion and the connecting section, the second section is connected between the second end and the connecting section, and the connecting section forms a U-shaped structure with an opening toward a direction perpendicular to the first and second sections.

8. An electrochemical test strip, comprising:

a substrate, comprising a test end;

an electrode structure, formed on the substrate, comprising;

a first electrode;

an second electrode, comprising a first end, a second end, an extension portion, and a bent portion, wherein the extension portion is connected between the first end and the bent portion, the bent portion is connected to the second end, and the extension portion and the frist electrode define a space therebetween for receiving the bent portion; and

an insulative layer, covering at least apart of the electrode structure and forming an opening corresponding to the test end, wherein a sample is injected through the opening into the electrochemical test strip and sequentially contacts the first electrode and the second electrode;

wherein a testing voltage is applied between the first electrode and the second electrode for electrochemical measurement of the sample;

wherein the bent portion comprises a first section, a second section and a connecting section, wherein the first section is connected between the extension portion and the connecting section, the second section is connected between the second end and the connecting section, and the connecting section forms a U-shaped channel therein.

9. An electrochemical test strip, comprising:

a substrate, comprising a test end;

an electrode structure, formed on the substrate, comprising;

a first electrode;

a second electrode, comprising a first end, a second end, an extension portion, and a bent portion, wherein the extension portion is connected between the first end and the bent portion, the bent portion is connected to the second end, and the extension portion and the first electrode define a space therebetween for receiving the bent portion; and

an insulative layer, covering at least a part of the electrode structure and forming an opening corresponding to the test end, wherein a sample is injected through the opening into the electrochemical test strip and sequentially contacts the first electrode and the second electrode;

wherein a testing voltage is applied between the first electrode and the second electrode for electrochemical measurement of the sample;

wherein the bent portion comprises a first section, a second section and a connecting section, wherein the first section is connected between the extension portion and the connecting section, the second section is connected between the second end and the connecting section, and the connecting section forms a comb-shaped structure.

10. A method for testing a sample by an electrochemical test strip, wherein the electrochemical test strip includes a first electrode, a second electrode insulated from the first electrode, and a third electrode connected to the second electrode, the method comprising:

applying a first testing voltage between the second and third electrodes;

recording a background current value between the second and third electrodes according to the first voltage;

applying a second testing voltage between the first and second electrodes;

recording a first time when the sample flows through the first electrode to the second electrode;

applying a third testing voltage between the second and third electrodes and recording a current signal between the second and third electrodes according to the first voltage;

recording a second time when the current signal has a slope exceeding a predetermined value due to the sample flowing through the second electrode to the third electrode;

calculating a time period from the first time to the second time;

calculating a hematocrit value of the sample according to the time period; and

determining if the electrochemical test strip is underfilled with the sample according to a difference between the background current value and the current signal.

11. The method as claimed in claim 10, further comprising the step of:

measuring a glucose concentration of the sample and calibrating the glucose concentration by the hematocrit value if the difference between the background current value and the current signal exceeds a threshold value.

12. The method as claimed in claim 10, further comprising the step of:

prompting the user to change the electrochemical test strip if the difference between the background current value and the current signal is less than a threshold value.