ELECTROCHEMICAL TEST STRIP, MEASUREMENT SYSTEM AND METHOD FOR DETERMINING SAMPLE CONTENT IN THE REACTIVE REGION OF THE ELECTROCHEMICAL TEST STRIP

• US 20160131610A1
• Filed: 08/21/2015
• Published: 05/12/2016
• Est. Priority Date: 11/10/2014
• Status: Active Grant

• Current Assignee: Apex Biotechnology Corporation
• Original Assignee: Apex Biotechnology Corporation
• Inventors: Chu, Ching Yuan, Wang, Po Min, Cheng, Chun Ming, Wu, Lee Teng Yi
• Granted Patent: US 9,823,213 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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

An electrochemical test strip, measurement system and method for determining sample content in the reactive region of the electrochemical test strip are presented. The electrochemical test strip comprises an insulator substrate which includes an electrode system disposed thereon. The electrode system includes at least one pair of electrodes. A lower plate which includes a reactive region and a sampling cell is disposed on the insulator substrate. An upper plate is disposed on the lower plate, wherein the at least one pair of electrodes is designed as an electrical loop adjacent to the sampling port.

Claims

1. An electrochemical test strip, comprising:

an insulator substrate with an electrode system disposed thereon, the electrode system comprising at least one first set of electrodes and second set of electrodes;

a lower separated plate disposed on the insulator substrate and including a reactive region and a port for sampling;

a reactive layer placed on the reaction region; and

an upper separated plate disposed above the lower plate,

wherein the first set of electrodes is designed for a first signal loop for sample volume and the second set of electrodes is designed for a second signal loop for sample volume characterized in that the first and second signal loops reflect on a volume of the reaction region.

2. The electrochemical test strip as claimed in claim 1, wherein the first set of electrodes comprises a first working electrode and a first reference electrode and the second set of electrodes comprises a second working electrode and a second reference electrode.

3. The electrochemical test strip as claimed in claim 1, wherein the first set of electrodes comprises a first working electrode and a second reference electrode and the second set of electrodes comprises a second working electrode and a first reference electrode.

4. The electrochemical test strip as claimed in claim 1, wherein the reactive layer at least covers one of the first and second sets of electrodes.

5. The electrochemical test strip as claimed in claim 1, wherein the reactive layer generates a signal of volume deviated within a reasonable range.

6. The electrochemical test strip as claimed in claim 1, wherein the set of electrodes closest to the port for sampling of the electrode system is designed as a loop of sampling port.

7. An electrochemical measurement system, comprising:

the electrochemical test strip as claimed in any claim 1;

a connector transmitting a corresponding reaction signal generated from the sample on the electrochemical test strip to the electrochemical measurement system;

a calculation unit configured to convert reaction signals on the electrochemical test strip;

a digital converter configured to transform the corresponding reaction signal to a digital reaction signal; and

a signal processor processing the digital reaction signal and showing a corresponding result on a display.

8. A method for determining a sample volume in a reaction region of an electrochemical test strip, comprising:

providing an electrochemical test strip comprising;

an insulator substrate with an electrode system disposed thereon, the electrode system comprising at least one first set of electrodes and second set of electrodes;

a lower separated plate disposed on the insulator substrate and including a reactive region and a port for sampling;

a reactive layer placed on the reaction region; and

an upper separated plate disposed above the lower plate,

wherein the first set of electrodes is designed for a first signal loop for sample volume and the second set of electrodes is designed for a second signal loop for sample volume characterized in that the first and second signal loops reflect on a volume of the reaction region;

placing the electrochemical test strip into the electrochemical measurement system as claimed in claim 7;

providing a signal to the first and second sets of electrode of the electrochemical test strip;

performing measurement of a first volume signal and a second volume signal using the electrochemical measurement system; and

analyzing and determining a sample volume in the reaction region based on a signal difference using the signal processor, if the sample volume is sufficient, then proceeding with a concentrating measurement step;

if the sample volume is deficient, then demanding redo measurement or adding more sample to the reaction region.

9. The method as claimed in claim 8, further comprising calculating a signal difference between the first and the second volumes based on a diffusion current calculation method using the calculation unit.

10. The method as claimed in claim 9, wherein the diffusion current calculation method satisfies the following equation: