Electrochemical detection test paper, electrochemical detection system and operation method thereof

Abstract

The present invention discloses an electrochemical detection test strip for reducing interference, an electrochemical detection system and an operation method thereof. The electrochemical detection test strip comprises an inlet, an anti-interference zone and a detection zone connected in sequence, and a phase change valve is arranged between the anti-interference zone and the detection zone. The present invention is provided with a phase change valve between the anti-interference zone and the detection zone, and the phase change valve can accurately control the opening time according to the different interferences to be removed, thereby ensuring the accuracy of the detection results, and the phase change valve will not introduce new interference, thereby ensuring the stability of the detection results. The present invention also discloses a detection system comprising the above-mentioned electrochemical detection test strip and an operation method thereof.

Description

Technical Field

[0001] The present invention relates to the field of electrochemical test strips, and in particular to an electrochemical test strip capable of reducing interference, an electrochemical detection system and an operation method thereof, which can reduce the influence of interference on an analyte to be detected in a blood sample. Background Art

[0002] With the development of social economy and the changes in people's lifestyle and dietary structure, the prevalence of chronic diseases in my country has increased year by year. Hyperglycemia, hypertension, hyperlipidemia and hyperuricemia have become the most common diseases that endanger people's health. Therefore, the rapid and instant detection of these indicators has become an urgent need for people with chronic diseases, and the most commonly used micro-rapid instant detection method is electrochemical test strips. Electrochemical test strips mainly identify the analyte to be tested through a sensitive membrane and convert its biomass into a receivable electrical signal. Patients only need to use these disposable electrochemical test strips at home to obtain the current analyte level in the subject's blood. Electrochemical test strips can not only detect relevant analytes in a short period of time at home, but also facilitate long-term monitoring and instant inspection of certain diseases.

[0003] However, electrochemical test strips have poor anti-interference ability. Interfering substances such as ascorbic acid, bilirubin, methyldopa, dopamine and glucose will affect the accuracy of their test results.

[0004] Electrodes are often chemically modified in laboratories to achieve the purpose of anti-interference, such as modifying the electrode surface with Nafion, which can repel all negatively charged chemicals. Generally, most interfering substances such as ascorbate are negatively charged, and the Nafion membrane can prevent these interfering substances from reaching the electrode surface to generate interference signals. However, some interfering substances such as paracetamol do not carry a negative charge, which does not play an anti-interference role. In addition, the production methods of these chemically modified electrodes are complicated, and they are not easy to mass produce. They are also not suitable for self-monitoring and are only suitable for laboratory determination.

[0005] The technology involved in CN104569088B is to set a size-selective sieve membrane at the sample suction port to filter out certain substances in the sample, such as red blood cells, etc. This method can effectively remove some interferences, but this sieve membrane can only block interferences with a molecular weight greater than the mesh.

[0006] The strategy in CN1902479A is to set two working electrodes, the first electrode is used to test the electrical signals generated by the analyte to be tested and the interferent, and the second electrode is used to test the electrical signal generated by the interferent, and the real electrical signal of the analyte to be tested is obtained by measuring the electrical signals of the two working electrodes. This strategy can well remove the electrical signal generated by the interferent, but the presence of the analyte to be tested will affect the electrical signal of the second working electrode testing the interferent, so that the electrical signal obtained by the second working electrode has low accuracy.

[0007] The electrochemical sensor invented by CN101349667B mixes active substances that catalyze the analyte to be measured and active substances that eliminate interference and applies them on the test electrode. However, this method has limited effect in reducing the influence of interference, because when blood is sucked into the electrode detection area, the detection time is only very short, only part of the interference substances are removed, and some of the interference substances interfere with the determination of the analyte.

[0008] The anti-interference flow channel flow rate control electrochemical test paper invented by CN104777194B has a speed control area and a blocking area before the detection area. The sample first enters the speed control area, which is coated with the anti-interference test kit flow rate control substance, and then stops flowing after entering the blocking area, and enters the detection area after the powder in the blocking area is dissolved. This method of removing interferences in advance can greatly improve the accuracy of the test results, but the method of using flow rate control and dissolution blocking has poor repeatability, which reduces the credibility of the results.

[0009] Therefore, it is necessary to improve the existing electrochemical test strips to enhance their anti-interference performance. Summary of the invention

[0010] The present invention aims to solve at least one of the above-mentioned problems existing in electrochemical test strips. To this end, the present invention provides an electrochemical test strip, an electrochemical detection system and a method for using the same. The connection between the anti-interference zone and the detection zone is controlled by a phase change valve to ensure that the anti-interference substance reacts completely and no new interference substances are introduced.

[0011] Specifically, the present invention adopts the following technical solutions:

[0012] In a first aspect, the present invention provides an electrochemical test strip, comprising an injection port, an anti-interference zone and a detection zone connected in sequence, wherein a phase change valve is arranged between the anti-interference zone and the detection zone.

[0013] According to some embodiments provided by the present invention, an anti-interference reagent layer is provided in the anti-interference area, and the anti-interference reagent layer is coated with an active substance that can react with the interferent.

[0014] According to some embodiments of the present invention, a full-blood electrode is provided in the anti-interference zone.

[0015] According to some embodiments of the present invention, the phase change valve is provided with a melting electrode, a phase change material and a groove.

[0016] According to some specific embodiments of the present invention, the phase change material is paraffin.

[0017] According to some specific embodiments of the present invention, the melting point of the paraffin wax is 50-60°C.

[0018] According to some embodiments of the present invention, the melting electrode comprises a thick electrode end and a thin electrode end, and the thin electrode end is close to the phase change material.

[0019] According to some embodiments of the present invention, the material of the thin end of the electrode is silver paste, and the material of the thick end of the electrode is carbon paste.

[0020] In a second aspect, the present invention provides an electrochemical detection system, comprising the electrochemical detection test paper and the electrochemical tester described above.

[0021] According to some embodiments of the present invention, the electrochemical tester has a socket for inserting the electrochemical test paper.

[0022] In a third aspect, the present invention provides an operating method of an electrochemical detection system, comprising the steps of: inserting an electrochemical detection test paper into an electrochemical tester, and then flowing the detection sample into an anti-interference zone from a sample loading port of the electrochemical detection test paper, and after the anti-interference reaction is completed, opening a phase change valve, and allowing the detection sample to flow into the detection zone to complete the detection reaction.

[0023] According to some embodiments of the present invention, a method for operating an electrochemical detection system comprises the steps of:

[0024] S1: Provide electrochemical test paper and insert it into the electrochemical tester;

[0025] S2: Detect the impedance value of the power-on electrode group and obtain a power-on signal;

[0026] S3: Add the test sample into the sample adding port of the electrochemical test paper;

[0027] S4: Detect the impedance value of the full blood electrode group to obtain a full blood signal;

[0028] S5: providing a DC voltage to the melting electrode group and opening the phase change valve;

[0029] S6: Provide a DC voltage to the reaction electrode group, detect the current of the reaction electrode group, and obtain a detection result.

[0030] The present invention has the following technical effects:

[0031] In the electrochemical test paper provided by the present invention, an anti-interference zone is arranged before the detection zone, and the anti-interference zone can pre-process the test sample to remove the interference therein; a full-blood electrode is also arranged in the anti-interference zone, and the full-blood electrode is used to receive the test sample filling signal and then start timing the interference reaction time, which can ensure that the interference reaction time is sufficient and the interference is removed more completely; a phase change valve is arranged between the anti-interference zone and the detection zone, and the phase change valve can accurately control the opening time according to the different interferences to be removed, thereby ensuring the accuracy of the test results, and the phase change valve will not introduce new interference, thereby ensuring the stability of the test results. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 A schematic diagram showing the structure of an electrochemical test paper according to an embodiment of the present invention is shown;

[0033] Figure 2 The structure of the electrochemical test paper according to the embodiment of the present invention is shown in an exploded view;

[0034] Figure 3 A schematic diagram showing the structure of an electrochemical test paper phase change valve according to an embodiment of the present invention is shown;

[0035] Figure 4 A schematic diagram showing the structure of an electrochemical testing system according to an embodiment of the present invention is shown;

[0036] Figure 5 A flow chart of a detection method of an electrochemical detection system according to an embodiment of the present invention is shown.

[0037] In the figure: 10-injection port, 20-anti-interference area, 21-anti-interference reagent layer, 30-detection area, 31-detection reagent layer, 40-phase change valve, 41-phase change material, 42-groove, 50-electrode system, 51-reference electrode, 52-full blood electrode, 53-molten electrode, 54-working electrode, 55-power-on electrode, 60-transparent observation window, 61-first pore, 62-second pore, 100-electrochemical tester, 101-socket, A-insulating substrate, B-insulating layer, C-hydrophilic layer. DETAILED DESCRIPTION

[0038] Unless otherwise specified, all scientific and technological terms used in the present invention have the same meaning as those commonly understood by those skilled in the art to which the present invention belongs. All patents and publications related to the present invention are incorporated herein by reference in their entirety. The term "comprising" or "including" is an open expression, that is, including the contents specified in the present invention, but does not exclude contents in other aspects.

[0039] The embodiments of the present invention will be described in detail below with reference to examples, but those skilled in the art will appreciate that the following examples are only used to illustrate the present invention and should not be construed as limiting the scope of the present invention.

[0040] Embodiment 1

[0041] This embodiment provides an electrochemical test paper, such as Figure 1 , Figure 2 As shown, it includes: an injection port 10, an anti-interference zone 20 and a detection zone 30 connected in sequence. An anti-interference reagent layer 21 is provided in the anti-interference zone 20, and an active substance that can react with an interferent is coated on the anti-interference reagent layer 21. The detection zone 30 is provided with a detection reagent layer 31, and a detection reagent is coated on the detection reagent layer 31, which is used to test whether the target marker is contained in the test sample. The test sample enters from the injection port 10, passes through the anti-interference zone 20, and the interferent contained in the test sample reacts with the active substance in the anti-interference zone 20 and is eliminated. After that, the test sample flows into the detection zone 30 for detection, thereby achieving the anti-interference effect of the electrochemical test paper detection.

[0042] A full blood electrode 52 is also provided in the anti-interference area 20. When the test sample fills the entire anti-interference area 20, the full blood electrode 52 is connected to the reference electrode 51 to detect a full signal, and then the reaction time of the interferent and the active substance is started. After the anti-interference reaction is completed, the test sample is flowed into the detection area 30 for detection. The reaction time of the interferent and the active substance is 15-60s.

[0043] A working electrode 54 is also disposed in the detection area 30. The working electrode 54 is connected to the reference electrode 51 to display a detection signal, and the detection signal is used to determine whether the detection sample contains the target marker.

[0044] A phase change valve 40 is provided between the anti-interference zone 20 and the detection zone 30. Before the electrochemical test strip is used for detection, the phase change valve 40 is in a closed state. After the detection begins, the detection sample enters the anti-interference zone 20 from the injection port 10. At this time, the closed phase change valve 40 can block the detection sample to prevent the detection sample from flowing into the detection zone 30. After the detection sample completes the reaction of removing the interference in the anti-interference zone 20, the phase change valve 40 is controlled to be in an open state. At this time, the detection sample from which the interference has been removed flows into the detection zone 30 by siphon force, and the detection of the target marker is completed in the detection zone 30.

[0045] The phase change valve 40 is provided with a melting electrode 53, a phase change material 41 and a groove 42. When the phase change valve 40 is in a closed state, the phase change material 41 is in a solid state. The melting electrode 53 can heat the phase change material 41 to a liquid state and flow into the groove 42 under the thrust of the test sample, so that the phase change valve 40 is changed to an open state. The phase change material 41 does not react with substances such as the test sample, the anti-interference reagent and the test reagent, or is dissolved. Therefore, the use of the phase change valve 40 will not interfere with the detection process, ensuring the stability of the test results. Usually, different test samples contain different interfering substances. The phase change valve 40 can accurately control the opening time according to the different interfering substances to be removed, so that the interfering substances in the test sample are completely removed in the anti-interference zone 20, ensuring the accuracy of the test results.

[0046] The phase change material 41 of this embodiment is paraffin, and the melting point of the paraffin is 50-60°C.

[0047] The melting electrode 53 of this embodiment includes a thick end of the electrode and a thin end of the electrode, and the thin end of the electrode is close to the phase change material 41. The cross-sectional area of ​​the thin end of the electrode is small, so that the thin end of the electrode can generate heat and quickly heat up after the melting electrode 53 and the reference electrode 51 are connected, thereby achieving the effect of melting the phase change material 41. The cross-sectional area of ​​the thick end of the electrode is large, so that the thick end of the electrode generates less heat after the melting electrode 53 and the reference electrode 51 are connected, thereby ensuring the safe use of the electrochemical test paper. The material of the thin end of the electrode is silver paste, and the material of the thick end of the electrode is carbon paste, which further improves the heating performance of the thin end of the electrode and reduces the heating of the thick end of the electrode. Therefore, in the present invention, the opening effect of the phase change valve 40 can be achieved quickly, simply and effectively by using the melting electrode 53.

[0048] The electrochemical test strip of this embodiment is also provided with an electrode system 50, and the electrode system 50 is located at one end of the electrochemical test strip away from the injection port 10. Among them, one end of the full blood electrode 52 is located in the anti-interference area 20, and the other end is located in the electrode system 50; one end of the molten electrode 53 is located in the phase change valve 40, and the other end is located in the electrode system 50; one end of the working electrode 54 is located in the reaction area 30, and the other end is located in the electrode system 50; one end of the reference electrode 51 is connected with the full blood electrode 52, the molten electrode 53 and the working electrode 54 respectively, and the other end is located in the electrode system 50.

[0049] The electrochemical test strip of this embodiment is further provided with a start-up electrode 55 , one end of which is connected to the reference electrode 51 , and the other end of which is inside the electrode system 50 .

[0050] Specifically, the full-blood electrode 52 and the reference electrode 51 constitute a full-blood electrode group, the molten electrode 53 and the reference electrode 51 constitute a molten electrode group, the working electrode 54 and the reference electrode 51 constitute a reaction electrode group, and the start-up electrode 55 and the reference electrode 51 constitute a start-up electrode group.

[0051] Continue to refer Figure 2 , the electrochemical test paper includes an insulating substrate A, an insulating layer B and a hydrophilic layer C. Each electrode and the electrode system 50 are arranged on the insulating substrate A. The insulating layer B is a through groove at the corresponding positions of the injection port 10, the anti-interference zone 20 and the detection zone 30. When the insulating substrate A, the insulating layer B and the hydrophilic layer C are superimposed together, the injection port 10, the anti-interference zone 20, the detection zone 30 and the channel connecting them for the flow of the test sample are formed. The insulating layer B and the hydrophilic layer C do not cover the electrode system 50 on the insulating substrate A. The hydrophilic layer C is provided with a transparent observation window 60 at the corresponding positions of the injection port 10, the anti-interference zone 20 and the detection zone 30. The transparent observation window 60 is provided with air holes to ensure that the test sample flows in the electrochemical test. The transparent observation window 60 is provided with a first air hole 61 at the corresponding position of the anti-interference zone 20, and a second air hole 62 at the corresponding position of the detection zone 30.

[0052] Figure 3 Schematic diagram of the cross section of the phase change valve 40 of this embodiment. The phase change material 41 is located on the channel formed by the insulating substrate A, the insulating layer B and the hydrophilic layer C. The groove 42 is located on the insulating substrate A. In the direction of the flow of the detection sample, the phase change material 41 is located at the front end of the groove 42. The groove 42 is a slope structure in the direction toward the phase change material 41, so that the phase change material 41 can flow into the groove 42 after melting.

[0053] Embodiment 2

[0054] This embodiment provides an electrochemical detection system, such as Figure 4 As shown, it includes the electrochemical test paper and electrochemical tester 100 of embodiment 1, and the electrochemical tester 100 has a socket 101 for inserting the electrochemical test paper. Specifically, when in use, the electrode system 50 end of the electrochemical test paper is inserted into the socket 101 of the electrochemical tester 100, so that each electrode group forms a detection path. The electrochemical tester also has a processor module and a display module. The processor receives and processes the signals of each electrode group, and then displays the results on the display. The detection path of the full-blood electrode group also includes an amplifier module and a mode conversion module; the detection path of the melting electrode group also includes a heating switch circuit module and a power supply module; the detection path of the reaction electrode group also includes an amplifier module and a mode conversion module; the detection path of the power-on electrode group also includes an insertion sensing module.

[0055] refer to Figure 5 As shown, the operating method of the electrochemical detection system in this embodiment includes:

[0056] S1: Provide an electrochemical test paper and insert it into an electrochemical tester. Specifically, insert the electrode system end of the electrochemical test paper into the socket of the electrochemical tester.

[0057] S2: Detect the impedance value of the power-on electrode group and obtain the power-on signal. When the impedance value meets the set value, it is determined that the instrument is powered on normally, and then proceed to the next step.

[0058] S3: Add the test sample to the sample adding port of the electrochemical test paper. The added test sample will flow into the anti-interference area along the sample adding port.

[0059] S4: Detect the impedance value of the full blood electrode group and obtain a full signal. When the test sample fills the anti-interference area, a full signal is obtained, and then the anti-interference reaction time is started to ensure that the anti-interference reaction time is sufficient and the interference is completely removed.

[0060] S5: Provide DC voltage to the melting electrode group and open the phase change valve. After the melting electrode is connected, the thin end of the electrode heats up quickly to melt the phase change material, open the phase change valve, and the test sample in the anti-interference area that has been free of interferences flows into the test area by siphon force.

[0061] S6: Provide a DC voltage to the reaction electrode group, detect the current of the reaction electrode group, and obtain the test result. The test sample reacts with the test reagent in the test area, and the test result can be determined by detecting the current of the reaction electrode group.

[0062] In the description of this specification, the description with reference to the terms "some embodiments", "other embodiments", "embodiment", "example", etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, unless they are contradictory.

[0063] Although the embodiments and examples of the present invention have been shown and described above, it is to be understood that the above embodiments and examples are exemplary and are not to be construed as limitations of the present invention. A person skilled in the art may change, modify, replace and modify the above embodiments and examples within the scope of the present invention.

Claims

1. An electrochemical test paper, characterized in that: It comprises an injection port, an anti-interference zone and a detection zone connected in sequence, wherein a phase change valve is arranged between the anti-interference zone and the detection zone; The phase change valve is provided with a molten electrode, a phase change material and a groove; the phase change material is paraffin, and the melting point of the paraffin is 50-60°C; the molten electrode includes a thick electrode end and a thin electrode end, and the thin electrode end is close to the phase change material; the electrochemical test paper includes an insulating substrate, an insulating layer and a hydrophilic layer; the phase change material is located on a channel formed by the insulating substrate, the insulating layer and the hydrophilic layer, the groove is located on the insulating substrate, and the phase change material is located at the front end of the groove; The material of the thin end of the electrode is silver paste, and the material of the thick end of the electrode is carbon paste; A full-blood electrode is provided in the anti-interference zone; The electrochemical test paper is also provided with an electrode system, which is located at one end of the electrochemical test paper away from the sampling port; wherein one end of the full blood electrode is located in the anti-interference zone, and the other end is located in the electrode system; one end of the molten electrode is located in the phase change valve, and the other end is located in the electrode system.

2. The electrochemical test paper according to claim 1, characterized in that: An anti-interference reagent layer is arranged in the anti-interference area, and an active substance capable of reacting with the interfering substance is coated on the anti-interference reagent layer.

3. An electrochemical detection system, characterized in that: It comprises the electrochemical test paper and an electrochemical tester as described in any one of claims 1 to 2, wherein the electrochemical tester has a socket for inserting the electrochemical test paper.

4. An operating method of the electrochemical detection system according to claim 3, characterized in that: The method comprises the following steps: inserting an electrochemical test paper into an electrochemical tester, and then flowing a test sample into an anti-interference zone from a sample addition port of the electrochemical test paper; after the anti-interference reaction is completed, opening a phase change valve, and flowing the test sample into the test zone to complete the test reaction.

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