Medical electrochemical detection test strip with anti-interference effect

Abstract

The utility model discloses a medical electrochemical detection test strip with an anti-interference effect. The medical electrochemical detection test strip sequentially comprises a substrate, a four-electrode system, a sensitive layer, an immunoadsorption layer, a first blood filtering layer and a hydrophilic layer from bottom to top, the hydrophilic layer is prepared by carrying out Plasma hydrophilic treatment on PET (Polyethylene Terephthalate); the first blood filtering layer is made of a glass fiber material; the immunoadsorption layer comprises an anti-interference pad, the anti-interference pad is made of polyester fibers, and the anti-interference pad contains an anti-interference test; the sensitive layer comprises a cellulose acetate fiber pad membrane of which the outer surface is loaded with an antibody; the four-electrode system is composed of a working electrode, a reference electrode, a counter electrode and a contrast electrode, and the four-electrode system is formed by printing carbon paste or silver paste on the substrate. According to the electrochemical detection test strip with the structure, the anti-interference performance can be effectively improved, and the detection accuracy and precision are greatly improved.

Description

Technical Field

[0001] This utility model relates to the field of medical testing technology, and in particular to a medical electrochemical test strip with anti-interference function. Background Technology

[0002] According to the IUPAC classification of biosensors, electrochemical immunosensors are integrated devices based on antigen-antibody reactions, capable of specific quantitative or semi-quantitative analysis. The antigen / antibody acts as a molecular recognition element, directly contacting the electrochemical sensing element, which converts the concentration signal of a specific or similar chemical substance into a corresponding electrical signal. Electrochemical immunosensors combine the specificity of immune reactions with the advantages of high sensitivity, fast analysis speed, simple operation, and low cost of electrochemical sensing. They are also easily miniaturized and can be further integrated with microfluidic technology, screen printing technology, etc., facilitating the construction of miniaturized, intelligent, and integrated electrochemical immunosensor chips for high-throughput multi-parameter analysis of complex samples, showing broad application prospects in the early diagnosis of diseases. Based on different electrochemical converters and their response signals, electrochemical immunosensors can be classified into four types: current-type, potential-type, conductivity-type, and capacitance-type. In practical applications, electrochemical immunosensors are susceptible to non-specific adsorption, leading to a decrease in sensitivity and testing accuracy. Therefore, this application provides a medical electrochemical test strip with anti-interference capabilities to meet this need. Utility Model Content

[0003] The purpose of this application is to provide a medical electrochemical test strip with anti-interference function to solve the technical problem that existing electrochemical immunosensors are susceptible to non-specific adsorption, which leads to a decrease in their sensitivity and test accuracy.

[0004] To achieve the above objectives, this application provides the following technical solution: a medical electrochemical test strip with anti-interference function, comprising, from bottom to top, a substrate, a four-electrode system, a sensitive layer, an immunoadsorption layer, a first blood filtration layer, and a hydrophilic layer;

[0005] The hydrophilic layer is made of polyethylene terephthalate after plasma hydrophilic treatment;

[0006] The first blood filtration layer is made of glass fiber;

[0007] The immunoadsorption layer includes an anti-interference pad, which is made of polyester fiber and contains an anti-interference agent.

[0008] The sensitive layer includes a cellulose acetate pad membrane with antibodies loaded on its outer surface;

[0009] The four-electrode system consists of a working electrode, a reference electrode, a counter electrode, and a control electrode, and is fabricated by printing carbon paste or silver paste onto the substrate.

[0010] As a preferred embodiment of this example, it further includes a second blood filtration layer and a first buffer layer. The first buffer layer is located between the first blood filtration layer and the immunoadsorption layer, and the second blood filtration layer is located between the immunoadsorption layer and the first buffer layer. The first buffer layer is a cotton layer loaded with phosphate buffer solution.

[0011] As a preferred embodiment of this invention, a second buffer layer is further included, which is disposed between the immunoadsorption layer and the second blood filtration layer.

[0012] In a preferred embodiment of this invention, the anti-interference pad film is 0.15-0.45 mm thick.

[0013] In a preferred embodiment of this invention, the cellulose acetate membrane has a thickness of 0.02-0.2 mm.

[0014] In a preferred embodiment of this invention, the glass fiber membrane thickness of the first blood filtration layer and the second blood filtration layer is 0.1-0.4 mm.

[0015] In summary, the technical effects and advantages of this utility model are as follows:

[0016] 1. The present invention has a reasonable structure. The electrochemical test strip of this structure can effectively improve the anti-interference performance and greatly improve the accuracy and precision of the detection.

[0017] 2. In this utility model, a first blood filtration layer, a second blood filtration layer, a first buffer layer, and a second buffer layer are provided. The second blood filtration can ensure that only pure plasma reaches the immunoadsorption layer, thereby further improving the anti-interference ability. The second buffer can ensure that only pure plasma or target components reach the immunoadsorption layer, thereby improving the efficiency and specificity of immunoadsorption. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a schematic diagram of the disassembled structure of this utility model;

[0020] Figure 2 for Figure 1 Schematic diagram of the middle substrate structure.

[0021] In the figure: 1. Substrate; 2. Four-electrode system; 3. Sensitive layer; 4. Immunosorbent layer; 5. Second blood filtration layer; 6. First buffer layer; 7. First blood filtration layer; 8. Hydrophilic layer; 9. Second buffer layer. Detailed Implementation

[0022] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0023] Example: Reference Figure 1-2 The medical electrochemical test strip shown has anti-interference function and is composed of, from bottom to top, a substrate 1, a four-electrode system 2, a sensitive layer 3, an immunoadsorption layer 4, a first blood filtration layer 7, and a hydrophilic layer 8.

[0024] The hydrophilic layer 8 is made of polyethylene terephthalate after plasma hydrophilic treatment;

[0025] The first blood filtration layer 7 is made of glass fiber;

[0026] Immunosorbent layer 4 includes an anti-interference pad, which is made of polyester fiber and contains an anti-interference agent;

[0027] Sensitive layer 3 includes an acetate membrane with antibodies loaded on its outer surface;

[0028] The four-electrode system 2 consists of a working electrode, a reference electrode, a counter electrode, and a control electrode. The four-electrode system is fabricated by printing carbon paste or silver paste on the substrate 1.

[0029] By introducing an anti-interference pad membrane containing anti-interference reagents, interfering substances in the blood, such as impurities that are not related to the target detection, can be effectively removed. This design can significantly improve the specificity and accuracy of the electrochemical immunosensor.

[0030] The four-electrode system includes a working electrode, a reference electrode, a counter electrode, and a control electrode. This design can provide more accurate electrochemical measurement signals and help eliminate errors and interferences in the measurement process. By outputting the reaction results as electrical signals to the testing instrument through the four-electrode system, rapid and accurate electrochemical immunoassay can be achieved.

[0031] First filtration layer 7: Made of glass fiber, it can effectively remove red blood cells from the blood and avoid their impact on electrochemical immune responses;

[0032] Sensitive layer 3: Antibodies are immobilized onto cellulose acetate using immobilization materials, which ensures the stability and activity of the antibodies during the detection process and improves the response speed and sensitivity of the sensitive layer;

[0033] Hydrophilic layer 8: Polyethylene terephthalate is used as the hydrophilic layer after plasma hydrophilic treatment, which can ensure that blood samples can be smoothly drawn into the test strip and quickly reach the sensitive layer for electrochemical immunoreaction;

[0034] Substrate 1: Polyethylene terephthalate is used as the substrate, which has good mechanical strength and chemical stability, ensuring the stability and durability of the electrochemical immunosensor.

[0035] The electrochemical test strip with this structure can effectively improve anti-interference performance and greatly improve the accuracy and precision of detection.

[0036] As a preferred embodiment of this example, it further includes a second blood filtration layer 5 and a first buffer layer 6. The first buffer layer 6 is located between the first blood filtration layer 7 and the immunoadsorption layer 4, and the second blood filtration layer 5 is located between the immunoadsorption layer 4 and the first buffer layer 6. The first buffer layer 6 is a cotton layer loaded with phosphate buffer solution.

[0037] Secondary filtration ensures that only pure plasma reaches the immunoadsorption layer, thereby further improving the anti-interference ability. At the same time, the first buffer layer 6 can reduce the interference to subsequent layers caused by changes in the properties of the blood sample.

[0038] As a preferred embodiment of this invention, a second buffer layer 9 is also included, which is disposed between the immunoadsorption layer 4 and the second blood filtration layer 5.

[0039] After further filtration through the second blood filtration layer 5, although most impurities and interfering substances have been removed from the blood sample, there may still be some tiny interfering components that are difficult to remove through the blood filtration layer.

[0040] Setting up a buffer layer at this stage can further purify the blood sample, ensuring that only pure plasma or target components reach the immunoadsorption layer 4, thereby improving the efficiency and specificity of immunoadsorption.

[0041] As a preferred embodiment of this example, the anti-interference pad film thickness is 0.15-0.45mm.

[0042] The film thickness within this range can further improve its anti-interference effect. Further optimization shows that the film thickness of 0.25 mm has the best effect.

[0043] As a preferred embodiment of this example, the thickness of the cellulose acetate pad film is 0.02-0.2 mm.

[0044] Within this range, the film thickness can further improve the response speed and sensitivity of the sensitive layer. Further optimization shows that the film thickness of 0.15 mm yields the best results.

[0045] In a preferred embodiment of this invention, the glass fiber membrane thickness of the first blood filtration layer 7 and the second blood filtration layer 5 is 0.1-0.4 mm.

[0046] Within this range, the membrane thickness can further effectively remove red blood cells from the blood and avoid their impact on the electrochemical immune response. Further optimization shows that the membrane thickness of 0.25 mm is the most effective.

[0047] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A medical electrochemical test strip having an anti-interference effect, characterized by: It comprises, from bottom to top, a substrate (1), a four-electrode system (2), a sensitive layer (3), an immune adsorption layer (4), a first blood filtration layer (7), and a hydrophilic layer (8). The hydrophilic layer (8) is made of polyethylene terephthalate treated by plasma hydrophilic treatment. The first blood filtration layer (7) is made of glass fiber material. The immune adsorption layer (4) comprises an anti-interference pad film made of polyester fiber material, which contains a de-interference reagent. The sensitive layer (3) comprises an acetic fiber pad film with antibodies on the outer surface. The four-electrode system (2) comprises a working electrode, a reference electrode, a counter electrode, and a control electrode, which are printed on the substrate (1) by carbon paste or silver paste.

2. The medical electrochemical test strip with anti-interference effect according to claim 1, characterized in that: It further comprises a second blood filtration layer (5) and a first buffer layer (6), wherein the first buffer layer (6) is located between the first blood filtration layer (7) and the immune adsorption layer (4), and the second blood filtration layer (5) is located between the immune adsorption layer (4) and the first buffer layer (6), and the first buffer layer (6) is a cotton layer loaded with phosphate buffer.

3. The medical electrochemical test strip with anti-interference effect according to claim 2, characterized in that: It further comprises a second buffer layer (9) arranged between the immune adsorption layer (4) and the second blood filtration layer (5).

4. The medical electrochemical test strip with anti-interference effect according to claim 1, characterized in that: The anti-interference pad film is 0.15-0.45mm thick.

5. The medical electrochemical test strip with anti-interference effect according to claim 1, characterized in that: The acetic fiber pad film is 0.02-0.2mm thick.

6. The medical electrochemical test strip with anti-interference effect according to claim 3, characterized in that: The glass fiber membrane of the first blood filtration layer (7) and the second blood filtration layer (5) is 0.1-0.4mm thick.

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