ELECTROCHEMICAL TEST STRIP, ELECTROCHEMICAL TEST SYSTEM, AND MEASUREMENT METHOD USING THE SAME

• US 20100089775A1
• Filed: 12/18/2009
• Published: 04/15/2010
• Est. Priority Date: 12/19/2006
• Status: Active Grant

• Current Assignee: Apex Biotechnology Corporation
• Original Assignee: Apex Biotechnology Corporation
• Inventors: CHEN, Guan-Ting, Teng, Kai-Tsung, Lin, Yueh-Hui, Shen, Thomas Y. S., Chen, Sz-Hau
• Granted Patent: US 8,409,424 B2
• Time in Patent Office: Days
• 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

Abstract

An electrochemical test strip, an electrochemical test system, and a measurement method using the same are provided. The electrochemical test strip includes an insulating substrate, an electrode system formed on the insulating substrate, and an insulating layer formed on the electrode system. The electrode system includes a set of measurement electrodes, a set of identifying electrodes, and a resistive path having a predetermined resistance value. The set of identifying electrodes is made of metal material, and the resistive path is made of non-metal material. The set of measurement electrodes includes a reference electrode and a working electrode insulated from each other, and the set of identifying electrodes includes a first identifying electrode and a second identifying electrode connected with each other through the resistive path. The insulating layer covers a part of the electrode system, wherein a part of the electrode system not covered by the insulating layer forms a reaction region with a supply port. When a sample is injected into the supply port of the reaction region, the injected sample reaches the set of measurement electrodes and the set of identifying electrodes in sequence.

Claims

1. An electrochemical test strip, comprising:

an insulating substrate;

an electrode system formed on the insulating substrate, the electrode system comprising a set of measurement electrodes, a set of identifying electrodes and a resistive path having a predetermined resistance value, wherein the set of identifying electrodes is made of metal material and the resistive path is made of non-metal material, wherein the set of measurement electrodes comprises a reference electrode and a working electrode insulated from each other, and the set of identifying electrodes comprises a first identifying electrode and a second identifying electrode connected with each other through the resistive path; and

an insulating layer covering a part of the electrode system, wherein a part of the electrode system not covered by the insulating layer forms a reaction region with a supply port;

wherein when the sample is injected into the supply port of the reaction region, the sample reaches the set of measurement electrodes and the set of identifying electrodes in sequence.

2. The electrochemical test strip of claim 1, further comprising a cover disposed on the insulating layer, the cover comprising a vent hole for discharging air in the reaction region.

3. The electrochemical test strip of claim 1, further comprising a reaction layer disposed on the reaction region, wherein the reaction layer comprises an enzyme.

4. The electrochemical test strip of claim 1, wherein the set of identifying electrodes is made of silver, gold, platinum, or platinum, and the resistive path is made of carbon.

10. An electrochemical test system, comprising:

the electrochemical test strip of claim 1; and

a measurement instrument, comprising;

a switch module coupled to the electrode system and configured to switch an electrical path between the electrode system and the measurement instrument;

an analog-digital converter coupled to the switch module;

an AC power module configured to provide AC power;

a DC power module configured to provide DC power;

an AC-DC power switch coupled to the AC power module, the DC module, and the switch module, and configured to selectively connect either the DC power module or the AC power module to the switch module;

a processor coupled to the analog-digital converter, the switch module, the DC power module, the AC power module, and the AC-DC power switch, and configured to control the switch module, the DC power module, the AC power module, and the AC-DC power switch; and

an insertion detector coupled to the switch module and the processor, and configured to detect an electrical connection between the electrochemical test strip and the measurement instrument.

11. The electrochemical test system of claim 10, wherein the DC power module applies a DC voltage between the first identifying electrode and the second identifying electrode before and after the sample is injected into the reaction region to measure a resistance variation between the first identifying electrode and the second identifying electrode.

12. The electrochemical test system of claim 10, wherein the AC power module applies an AC voltage between the first identifying electrode and the second identifying electrode after the sample is injected into the reaction region of the electrochemical test strip to measure a capacitance value or an AC impedance value between the first identifying electrode and the second identifying electrode.

13. The electrochemical test system of claim 10, wherein the DC power module applies a DC voltage between the reference voltage and the working electrode after the sample is injected into the reaction region, and a current corresponding to the DC voltage is transmitted to the processor through the switch module and the analog-digital converter.

14. The electrochemical test system of claim 10, wherein the measurement instrument further comprises a display coupled to the processor and configured to display an electrical variation of the electrode system.

15. A method for analyzing a sample using the electrochemical test strip of claim 1, comprising:

(a) inserting the electrochemical test strip into a measurement instrument to initiate the measurement instrument by forming a loop among the first identifying electrode, the resistive path, the second identifying electrode, and the measurement instrument;

(b) providing the sample in the reaction region of the electrochemical test strip;

(c) after providing the sample in the reaction region, applying an AC voltage between the first identifying electrode and the second identifying electrode, and measuring a capacitance value or an AC impedance value between the first identifying electrode and the second identifying electrode; and

(d) applying a DC voltage between the reference electrode and the working electrode, and measuring a current corresponding to the DC voltage.

16. The method of claim 15, further comprising the following step between the step (a) and the step (b):

(a1) before providing the sample in the reaction region, measuring a first resistance value between the first identifying electrode and the second identifying electrode to determine whether the electrochemical test strip is inserted into the measurement instrument properly.

17. The method of claim 16, further comprising the following step between the step (b) and the step (c):

(b1) after providing the sample in the electrochemical test strip, measuring a second resistance value between the first identifying electrode and the second identifying electrode; and

determining whether the sample covers the reference electrode and the working electrode by comparing the first resistance value and the second resistance value.

18. The method of claim 15, wherein the step (c) further comprises determining characteristics of the sample according to the capacitance value or the AC impedance value, wherein the characteristics of the sample comprises viscosity, red blood cell count, hematocrit, total plate count, or the combination thereof.

19. The method of claim 18, further comprising the following step after the step (d):

calibrating the current according to the characteristics of the sample.

20. The method of claim 15, wherein the loop causes a voltage variation either in an anode of a diode by turning on the diode or in a collector of a transistor by turning on the transistor, and the voltage variation initiates the measurement instrument.

5. An electrochemical test strip, comprising:

an insulating substrate;

an electrode system formed on the insulating substrate, the electrode system comprising a first electrode, a second electrode, a third electrode, and a resistive path having a predetermined resistance value, wherein the second and the third electrode are made of metal material and the resistive path is made of non-metal material, wherein the first electrode and the second electrode are insulated from each other, and the second electrode and the third electrode are connected with each other through the resistive path; and

an insulating layer covering a part of the electrode system, wherein a part of the electrode system not covered by the insulating layer forms a reaction region with a supply port;

wherein when the sample is injected into the supply port of the reaction region, the sample reaches the first electrode, the second electrode, and the third electrode in sequence.

6. The electrochemical test strip of claim 5, further comprising a fourth electrode insulated from the first electrode, the second electrode, and the third electrode, and wherein when the sample is injected into the supply port of the reaction region, the sample reaches the first electrode, the fourth electrode, the second electrode, and the third electrode in sequence.

7. The electrochemical test strip of claim 5, further comprising a cover disposed on the insulating layer, the cover comprising a vent hole for discharging air in the reaction region.

8. The electrochemical test strip of claim 5, further comprising a reaction layer disposed on the reaction region, wherein the reaction layer comprises an enzyme.

9. The electrochemical test strip of claim 5, wherein the second and the third electrode are made of silver, gold, platinum, or platinum, and the resistive path is made of carbon.