BIOSENSOR AND USAGE THEREOF

• US 20120061259A1
• Filed: 05/24/2010
• Published: 03/15/2012
• Est. Priority Date: 05/25/2009
• Status: Active Grant

• Current Assignee: Leadway (Hk) Limited (Akatsuki Corp.)
• Original Assignee: Leadway (Hk) Limited (Akatsuki Corp.)
• Inventors: Lin, Jinn-Nan, Wang, Chia-Lin, Zhang, Ziyi
• Granted Patent: US 8,834,702 B2
• Time in Patent Office: Days
• US Class Current: 205/792
• CPC Class Codes: C12Q 1/005 involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• 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 33/5438 Electrodes

Abstract

A biosensor for quantifying an analyte in a sample and usage thereof are provided. The biosensor includes an insulative substrate, a cover, a sample supply port, an electrode system including at least a working electrode, a counter electrode and a third electrode, and a reaction layer at least formed over the working electrode. The third electrode, used for estimating whether the amount of the sample is sufficient, is disposed nearer to the sample supply port than the counter electrode is. Whether the amount of the added sample is sufficient is estimated by comparing the electrical current value detected between the working electrode and the counter electrode with the electrical current value detected between the working electrode and the third electrode. This invention has a simple structure and produces accurate measurements.

Claims

1. A biosensor, including an insulative substrate, a reaction layer, a covering layer and a sample introducing port, the insulative substrate having an electrode system on one surface thereof, the electrode system at least including a working electrode, a counter electrode and a third electrode, the reaction layer at least covering the working electrode, wherein the third electrode, which is used to estimate if sample liquid to be tested is sufficiently supplied, is nearer to the sample introducing port than the counter electrode.

2. The biosensor according to claim 1, wherein the working electrode is located between the counter electrode and the third electrode.

3. The biosensor according to claim 1, wherein the working electrode is nearer to the sample introducing port than the counter electrode.

4. The biosensor according to claim 1, wherein the working electrode cannot be the farthest to the sample introducing port.

5. The biosensor according to claim 1, wherein the covering layer is above the electrode system and a gap is formed between the covering layer and the insulative substrate, thereby forming the sample introducing port.

6. The biosensor according to claim 1, wherein the covering layer is attached to the surface of the insulative substrate having the electrode system by laminating or stuck by glue.

7. The biosensor according to claim 1, wherein at least an inner surface of the covering layer is formed by hydrophilic material.

8. The biosensor according to claim 1, wherein the reaction layer includes Oxidoreductase and electron mediator.

9. A method of estimating if sufficient sample is supplied, including:

providing a biosensor, the biosensor including an insulative substrate, a reaction layer, a covering layer and a sample introducing port, the insulative substrate having an electrode system on a surface thereof, the electrode system at least including a working electrode, a counter electrode and a third electrode, the reaction layer at least covering the working electrode;

applying a sample liquid to the biosensor;

applying a voltage between the working electrode (103) and the counter electrode (105), measuring the electrical parameter 1 between the working electrode (103) and the counter electrode (105);

turning off the electrical circuit connecting the working electrode (103) and the counter electrode (105);

applying a voltage between the working electrode (103) and the third electrode (107), measuring the electrical parameter 2 between the working electrode (103) and the third electrode (107);

calculating the parameter 1 and the parameter 2, and comparing them with the predetermined threshold, then estimating if the supplied sample liquid is sufficient or not.

10. The method according to claim 9, wherein the third electrode, which is used to estimate if the supplied sample liquid is sufficient, is nearer to the sample introducing port than the counter electrode.

11. The method according to claim 9, wherein the electrical parameters are current values.

12. The method according to claim 11, wherein to calculate the absolute bias of the current value 1 and current value 2 and comparing the absolute bias with the predetermined threshold;

if the absolute bias is greater than the predetermined threshold, then estimating that the supplied sample liquid cannot meet the test requirement;

if the absolute bias is less than the predetermined threshold, then estimating that the supplied sample liquid can meet the test requirement.

13. The method according to claim 11, wherein to calculate the absolute bias rate between the current value 1 and the current value 2, and to compare the absolute bias rate with the predetermined threshold;

if the absolute bias rate is greater than the predetermined threshold, then estimating that the supplied sample liquid cannot meet the test requirement;

if the absolute bias rate is less than the predetermined threshold, then estimating that the supplied sample liquid can meet the test requirement.

14. The method according to claim 9, wherein the electrical parameter 1 and the electrical parameter 2 are detected within one second.

15. The method according to claim 14, wherein the electrical parameter 1 and the electrical parameter 2 are detected within 0.1 second.

16. The method according to claim 9, wherein the electrical parameters 1 and 2 are circularly detected and compared within a predetermined time.

17. The method according to claim 16, wherein the electrical parameters are current values, within the predetermined time, if the comparison of the current value 1 and the current value 2 does not match the predetermined condition that the sample liquid is sufficient, then outputting an error message of insufficient sample liquid;

if the comparison of the current value 1 and the current value 2 matches the predetermined condition that the sample liquid is sufficient, then stopping comparison and outputting a message of sufficient sample liquid.

18. A method of estimating if a sample liquid is sufficiently applied, the method comprising the following steps:

providing a biosensor, the biosensor including an insulative substrate, a reaction layer, a covering layer and a sample introducing port, the insulative substrate having an electrode system on a surface thereof, the electrode system at least including a working electrode, a counter electrode and a third electrode, the reaction layer at least covering the working electrode;

applying a sample liquid to the biosensor;

applying a voltage between the working electrode (103) and the third electrode (107), measuring the electrical parameter 2 between the working electrode (103) and the third electrode (107);

turning off the electrical circuit connecting the working electrode (103) and the third electrode (107);

applying a voltage between the working electrode (103) and the counter electrode (105), measuring the electrical parameter 1 between the working electrode (103) and the counter electrode (105);

calculating the electrical parameter 1 and the electrical parameter 2, and comparing them with the predetermined threshold, then estimating if the applied sample liquid is sufficient or not.

19. The method according to claim 18, wherein the third electrode, which is used to estimate if the amount of supplied sample liquid is sufficient, is nearer to the sample introducing port than the counter electrode.

20. The method according to claim 18, wherein the electrical parameters are current values.

21. The method according to claim 20, wherein to calculate the absolute bias of the current value 1 and current value 2 and comparing the absolute bias with the predetermined threshold;

if the absolute bias is greater than the predetermined threshold, then estimating that the supplied sample liquid cannot meet the test requirement;

if the absolute bias is less than the predetermined threshold, then estimating that the supplied sample liquid can meet the test requirement.

22. The method according to claim 20, wherein to calculate the absolute bias rate between the current value 1 and the current value 2, and to compare the absolute bias rate with the predetermined threshold;

if the absolute bias rate is greater than the predetermined threshold, then estimating that the supplied sample liquid cannot meet the test requirement;

if the absolute bias rate is less than the predetermined threshold, then estimating that the supplied sample liquid can meet the test requirement.

23. The method according to claim 18, wherein the electrical parameter 1 and the electrical parameter 2 are detected within one second.

24. The method according to claim 23, wherein electrical parameter 1 and the electrical parameter 2 are detected within 0.1 second.

25. The method according to claim 18, wherein the electrical parameter 1 and the electrical parameter 2 are circularly detected and compared within a predetermined time.

26. The method according to claim 25, wherein the electrical parameters are current values, within the predetermined time, if the comparison of the current value 1 and the current value 2 does not match the predetermined condition that the sample liquid is sufficient, then outputting an error message of insufficient sample liquid;

if the comparison of the current value 1 and the current value 2 matches the predetermined condition that the sample liquid is sufficient, then stopping comparison and outputting a message of sufficient sample liquid.