Test strip, detecting device and detecting method

• US 9,816,125 B2
• Filed: 02/03/2014
• Issued: 11/14/2017
• Est. Priority Date: 02/08/2013
• Status: Active Grant

• Current Assignee: Hmd Biomedical Inc.
• Original Assignee: YSP Co., Ltd.
• Inventors: Hsu, Tien-Tsai
• Primary Examiner(s): Kaur, Gurpreet
• Application Number:
  US14/170,787
• Publication Number:
  US 20140224672A1
• Time in Patent Office: 1,380 Days
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• 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

Abstract

A test strip, a detecting device, and a detecting method are disclosed. The test strip includes a first specimen path, a first electrode set, a second specimen path, a second electrode set, and a reaction reagent. When the specimen contacts the first electrode set and the second electrode set, a first pulse signal and a second pulse signal are generated for obtaining a flow time of the specimen. When the specimen contacts the reaction reagent, the analyte concentration of the specimen can be obtained, and the concentration of the analyte can be corrected by the flow time.

Claims

1. A test strip used with an electrochemical instrument to detect a specimen, the test strip comprising:

a first specimen path comprising an inlet end;

a first electrode set having at least a portion thereof disposed in the first specimen path, the first electrode set at least comprising a first electrode and a first reference electrode;

a second specimen path comprising a discharge end, the second specimen path connected to the first specimen path, wherein the first specimen path and the second specimen path are aligned and adjacent, such that the inlet end is the inlet end for the first specimen path and the second specimen path;

an isolating bar or a middle spacing bar disposed between the first specimen path and the second specimen path;

a second electrode set having at least a portion thereof disposed in the second specimen path, the second electrode set at least comprising a working electrode and a second reference electrode, the working electrode extending into the first specimen path, the working electrode being formed in a bar shape or a fork shape, the working electrode having the isolating bar or the middle spacing bar disposed thereon or therebetween;

a reaction reagent disposed in the second specimen path, and there is no reagent disposed in the first specimen path, the reaction reagent at least comprising an enzyme for detecting a concentration of an analyte of the specimen;

when the test strip receives a first voltage and a second voltage, a first impulse signal is generated when the specimen is in contact with the first electrode and the first reference electrode, and a second impulse signal is generated when the specimen is in contact with the first reference electrode and the working electrode, thereby obtaining a flow time of the specimen according to the first impulse signal and the second impulse signal, and the flow time can be used to correct the concentration of the analyte of the specimen.

2. The test strip as claimed in claim 1, wherein the first voltage is substantially 1.24 V.

3. The test strip as claimed in claim 1, wherein the second electrode set further comprises a detector electrode disposed near the discharge end of the second specimen path.

4. The test strip as claimed in claim 1, wherein the first reference electrode and the second reference electrode are the same electrode.

5. The test strip as claimed in claim 1, wherein the specimen comprises blood, urine, or saliva.

6. The test strip as claimed in claim 1, wherein the analyte comprises blood glucose, lipid, cholesterol, uric acid, alcohol, triglycerides, ketone body, creatinine, lactic acid, or haem.

7. The test strip as claimed in claim 1, wherein the specimen is a blood specimen, and the concentration of the analyte is a concentration of blood glucose.

8. The test strip as claimed in claim 1, wherein the inlet end of the first specimen path is disposed at a front end or a side of the test strip.

9. The test strip as claimed in claim 1, wherein the first electrode is disposed near the inlet end of the first specimen path.

10. The test strip as claimed in claim 1, wherein the reaction reagent covers at least a portion of the second electrode set.

11. The test strip as claimed in claim 1, wherein further comprises a through hole communicating with the discharge end of the second specimen path.

12. The test strip as claimed in claim 1, wherein the first specimen path has a width less than a width of the second specimen path.

13. The test strip as claimed in claim 1, wherein the first voltage and the second voltage are the same.

14. The test strip as claimed in claim 1, wherein further comprises:

a substrate for disposing the first electrode set and the second electrode set thereon;

a spacer layer covering the substrate and exposing a portion of the first electrode set and the second electrode set; and

a cap layer covering the spacer layer to form the first specimen path and the second specimen path.

15. The test strip as claimed in claim 1, wherein further comprises:

a substrate for disposing the first electrode of the first electrode set and the working electrode of the second electrode set thereon;

a spacer layer covering the substrate, the spacer layer exposing a portion of the first electrode of the first electrode set and the working electrode of the second electrode set; and

a cap layer covering the spacer layer to form the first specimen path and the second specimen path, wherein the first reference electrode of the first electrode set and the second reference electrode of the second electrode set cover a lower surface of the cap layer.

16. The test strip as claimed in claim 14, further comprising a gasket layer disposed between the substrate and the spacer layer.

17. The test strip as claimed in claim 15, further comprising a gasket layer disposed between the substrate and the spacer layer.

18. The test strip as claimed in claim 1, wherein the first electrode set at least comprises a second electrode, and a third impulse signal is generated when the specimen is in contact with the second electrode and the first reference electrode, thereby obtaining a flow time of the specimen according to the first impulse signal, the second impulse signal, and the third impulse signal.

19. The test strip as claimed in claim 18, wherein the second electrode is disposed near the first electrode.

20. The test strip as claimed in claim 18, wherein the second electrode is disposed between the first electrode and the working electrode.

21. A detecting method using an electrochemical instrument to detect a specimen, the detecting method comprising the following steps:

providing the test strip as claimed in claim 1;

providing a first voltage to the first electrode, and providing a second voltage to the working electrode;

receiving the specimen in the first specimen path and the second specimen path;

recording a first impulse signal generated when the specimen is in contact with the first electrode and the first reference electrode, and recording a second impulse signal generated when the specimen is in contact with the first reference electrode and the working electrode;

using the first impulse signal and the second impulse signal to obtain a flow time of the specimen;

providing a reaction voltage to the working electrode;

enabling an electrochemical reaction between the reaction reagent and the analyte of the specimen;

using the electrochemical reaction to calculate an uncorrected concentration of the analyte; and

using the flow time to correct the uncorrected concentration of the analyte.

22. The detecting method as claimed in claim 21, wherein further comprises:

obtaining a viscosity of the specimen according to the flow time.

23. The detecting method as claimed in claim 21, after the step of using the first impulse signal and the second impulse signal to obtain a flow time of the specimen, the detecting method comprising:

providing an AC signal to the first electrode set to let the specimen generate a reaction current; and

determining whether a first hematocrit obtained from the reaction current is the same as a second hematocrit obtained from the flow time.

24. The detecting method as claimed in claim 21, after the step of using the first impulse signal and the second impulse signal to obtain a flow time of the specimen, the detecting method comprising:

providing a voltage to the first electrode set to let the specimen generate an electrochemical reaction current; and

using the electrochemical reaction current to calculate and compensate the concentration of the analyte.

25. A detecting method using an electrochemical instrument to detect a specimen, the detecting method comprising the following steps:

providing the test strip as claimed in claim 18;

providing a first voltage to the first electrode and the second electrode, and providing a second voltage to the working electrode;

receiving the specimen in the first specimen path and the second specimen path;

recording a first impulse signal generated when the specimen is in contact with the first electrode and the first reference electrode, a second impulse signal generated when the specimen is in contact with the first reference electrode and the working electrode, and a third impulse signal generated when the specimen is in contact with the first reference electrode and the second electrode;

using the first impulse signal, the second impulse signal and the third impulse signal to obtain a flow time of the specimen;

providing a reaction voltage to the working electrode;

enabling an electrochemical reaction between the reaction reagent and the analyte of the specimen;

using the electrochemical reaction to calculate an uncorrected concentration of the analyte; and

using the flow time to correct the uncorrected concentration of the analyte.