Preparation method of test strip

Abstract

The invention provides a test strip preparation method, which comprises: S1, preparing a to-be-treated test strip without a hydrophilic film and a reaction reagent layer: forming a sample chamber on the to-be-treated test strip, and covering the sample chamber with a cover plate so as to form a sample introduction reaction channel between the sample chamber and the cover plate; s2, preparing a hydrophilic reaction mixed solution: mixing the hydrophilic solution with a reaction reagent for detection; s3, filling the sample introduction reaction channel with the hydrophilic reaction mixed liquid obtained in the step S2; and S4, putting the to-be-treated test strip into drying equipment for drying treatment to obtain the test strip. The to-be-treated test strip without the hydrophilic film and the reaction reagent layer is prepared firstly, then the hydrophilic reaction mixed liquid is injected into the sample injection reaction channel to fill the sample injection reaction channel, and drying is performed, so that the hydrophilic reaction film is formed on each surface of the sample injection reaction channel, outsourcing of the hydrophilic film is omitted, the reaction reagent layer does not need to be independently arranged, and the cost is reduced. The operation is simple, and the production cost can be reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of test strips, and more particularly to a method for preparing a test strip. Background Art

[0002] Almost all test strips on the market are equipped with a sample injection reaction channel, in which a hydrophilic membrane is arranged. The hydrophilic membrane is obtained by chemically or physically treating the surface of the membrane material, so that the blood sample attached to the sample injection reaction channel will not form water droplets, but diffuse in the sample injection reaction channel.

[0003] For example, the Chinese utility model patent with publication number CN220188418U provides an electrochemical test strip, including a substrate, an electrode layer printed on the substrate, the electrode layer including the plurality of electrodes, an insulating layer provided on the electrode layer, a notch provided on the insulating layer; a double-sided adhesive layer provided on the insulating layer, an opening corresponding to the notch provided on the double-sided adhesive layer; the substrate, the notch and the opening enclose a sample chamber; the sample chamber is covered with a hydrophilic film, a sample injection reaction channel is formed between the sample chamber and the hydrophilic film; the plurality of electrodes include a working electrode, an enzyme layer (i.e., a reaction reagent layer) is provided on the working electrode. The suction of the blood sample is achieved by utilizing the hydrophilicity of the hydrophilic film attached to the double-sided adhesive layer and the siphon effect of the sample chamber. The diffusion rate of the blood sample in the sample chamber can be increased by providing the hydrophilic film. Another example is a Chinese invention patent with publication number CN110291185B, which provides a blood sugar level measurement chip, including a first substrate and a second substrate, wherein the second substrate is disposed above the first substrate, an injection reaction channel is formed between the first substrate and the second substrate, and at least a portion of the first substrate is provided with a reagent layer (i.e., a reaction reagent layer) composed of a blood sugar level measurement reagent, and the material of the second substrate is a hydrophilic treated organic resin material. The two test strips of the above prior art need to be coated with a reaction reagent on the substrate during preparation, and then dried to form a reaction reagent layer, and then covered with a hydrophilic film, which is relatively complicated to operate, and the cost of purchasing a hydrophilic film is relatively high.

[0004] Therefore, the prior art has a large room for improvement. Summary of the invention

[0005] The purpose of the present invention is to make up for the deficiencies of the prior art and to provide a method for preparing a test strip.

[0006] In order to achieve the above object, the present invention is implemented by the following technical solutions:

[0007] The present invention provides a method for preparing a test strip, comprising the following steps:

[0008] S1. preparing a test strip to be processed without a hydrophilic film and a reaction reagent layer: a sample chamber is provided on the test strip to be processed, and a cover plate is covered on the sample chamber so that a sample injection reaction channel is formed between the sample chamber and the cover plate;

[0009] S2, preparing a hydrophilic reaction mixture: mixing the hydrophilic solution with a reaction reagent for detection;

[0010] S3, injecting the hydrophilic reaction mixture in S2 to fill the injection reaction channel;

[0011] S4, placing the test strip to be processed into a drying device for drying, so that a hydrophilic reaction film is formed on each surface of the injection reaction channel, thereby obtaining a test strip.

[0012] The method first prepares a test strip to be processed without a hydrophilic film and a reaction reagent layer, and then injects a hydrophilic reaction mixture into the injection reaction channel to fill the injection reaction channel and dries the mixture, so that a hydrophilic reaction film is formed on each surface of the injection reaction channel, thereby eliminating the need to purchase a hydrophilic film and there is no need to set up a reaction reagent layer separately. The method is simple to operate and is conducive to reducing production costs.

[0013] It is understood that the reaction reagents include, but are not limited to, electrochemical reaction reagents and photochemical reaction reagents conventionally used to detect blood sugar, uric acid, creatinine, TC, TG, blood lipids, blood ketones, lactic acid and other indicators. The above reagents are all prior art and are not limited by the present invention.

[0014] According to the above scheme, the test strip is an electrochemical test strip or a photochemical test strip.

[0015] The structure of the photochemical test strip (also known as the measurement chip) is similar to that of the electrochemical test strip. The only difference is that the substrate and cover of the photochemical test strip are made of light-transmitting / transparent materials, and there are no electrodes in the injection reaction channel. The analyte concentration is determined by irradiating the injection reaction channel with light and then obtaining light reflection / refraction / transmission and other optical signals.

[0016] According to the above scheme, the method for preparing the test strip to be treated without the hydrophilic membrane and the reaction reagent layer in S1 comprises the following steps:

[0017] S11, selecting a substrate, and then laying an electrode layer on the substrate;

[0018] S12, opening a notch corresponding to the sample injection reaction channel on the insulating double-sided adhesive layer, laminating the insulating double-sided adhesive layer on the substrate so that the insulating double-sided adhesive layer covers the electrode layer, the substrate and the notch enclose the sample chamber, and a part of the working electrode and the reference electrode on the electrode layer are located in the sample chamber;

[0019] S13, attaching a cover plate on the insulating double-sided adhesive layer, wherein the cover plate covers the sample chamber, so that the sample injection reaction channel is formed between the sample chamber and the cover plate.

[0020] The test strip to be processed without a hydrophilic film and a reaction reagent layer is prepared through the above preparation steps, and a sample injection reaction channel is provided on the test strip to be processed, so as to facilitate the subsequent injection of a hydrophilic reaction mixture into the sample injection reaction channel. It can be understood that the structure of the test strip to be processed is basically the same as that of the electrochemical test strip in the prior art, except that no hydrophilic film is provided on the insulating double-sided adhesive layer, and the cover plate covers the sample chamber.

[0021] According to the above scheme, the drying temperature in S4 is 40-50° C. and the drying time is 15-30 minutes.

[0022] It is understandable that the drying time and the drying temperature can be specifically set according to the formula of the hydrophilic reaction mixture.

[0023] According to the above scheme, the hydrophilic solution includes a polymer, a binder and a surfactant.

[0024] The addition of polymers is beneficial to improving the film-forming property of the hydrophilic reaction film after drying; the addition of binders is beneficial to improving the adhesion of the hydrophilic reaction film.

[0025] According to the above scheme, the hydrophilic solution includes the following raw materials in weight percentage: 0.01-0.5% polymer, 0.01-0.5% binder, 0.01-0.5% surfactant, and the rest is water.

[0026] According to the above scheme, the polymer is one or more of polyethylene glycol, hydroxyethyl cellulose, carboxymethyl cellulose, methyl cellulose, chitosan, cyclodextrin, sodium alginate, polyvinyl pyrrolidone, PEO, PVA, and PVP / VA.

[0027] According to the above scheme, the binder is one of dextrin, starch and epoxy resin.

[0028] According to the above scheme, the surfactant is one of a zwitterionic surfactant, anionic surfactant and cationic surfactant.

[0029] According to the above scheme, the weight ratio of the hydrophilic solution to the reaction reagent for detection is 1:0.1-0.5.

[0030] The beneficial effects of the present invention are:

[0031] The present invention prepares a test strip to be processed without a hydrophilic film and a reaction reagent layer, and then injects a hydrophilic reaction mixture into a sampling reaction channel and dries the mixture to form a hydrophilic reaction film on each surface of the sampling reaction channel, thereby eliminating the need to purchase a hydrophilic film and setting a reaction reagent layer separately. The operation is simple and is conducive to reducing production costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 is a schematic diagram of the structure of the test strip in Example 1;

[0033] Figure 2 It is a scatter plot for illustrating the test accuracy of the test strips obtained in Example 3 and Comparative Example 1.

[0034] In the figure: 1, substrate; 2, electrode layer; 21, working electrode; 22, reference electrode; 3, insulating double-sided adhesive layer; 31, notch; 4, cover plate. DETAILED DESCRIPTION

[0035] In order to better understand the present invention, the content of the present invention is further explained below in conjunction with the embodiments, but the present invention is not limited to the following embodiments.

[0036] The present invention provides a method for preparing a test strip, comprising the following steps:

[0037] S1. preparing a test strip to be processed without a hydrophilic film and a reaction reagent layer: a sample chamber is provided on the test strip to be processed, and a cover plate is covered on the sample chamber so that a sample injection reaction channel is formed between the sample chamber and the cover plate;

[0038] S2, preparing a hydrophilic reaction mixture: mixing the hydrophilic solution with a reaction reagent for detection;

[0039] S3, injecting the hydrophilic reaction mixture in S2 to fill the injection reaction channel;

[0040] S4, placing the test strip to be processed into a drying device for drying, so that a hydrophilic reaction film is formed on each surface of the injection reaction channel, thereby obtaining a test strip.

[0041] The method first prepares a test strip to be processed without a hydrophilic film and a reaction reagent layer, and then injects a hydrophilic reaction mixture into the injection reaction channel to fill the injection reaction channel and dries the mixture, so that a hydrophilic reaction film is formed on each surface of the injection reaction channel, thereby eliminating the need to purchase a hydrophilic film and there is no need to set up a reaction reagent layer separately. The method is simple to operate and is conducive to reducing production costs.

[0042] Furthermore, the test strip is an electrochemical test strip or a photochemical test strip.

[0043] Furthermore, the method for preparing the test strip to be treated without the hydrophilic membrane and the reaction reagent layer in S1 comprises the following steps:

[0044] S11, selecting a substrate, and then laying an electrode layer on the substrate;

[0045] S12, opening a notch corresponding to the sample injection reaction channel on the insulating double-sided adhesive layer, laminating the insulating double-sided adhesive layer on the substrate so that the insulating double-sided adhesive layer covers the electrode layer, the substrate and the notch enclose the sample chamber, and a part of the working electrode and the reference electrode on the electrode layer are located in the sample chamber;

[0046] S13, attaching a cover plate on the insulating double-sided adhesive layer, wherein the cover plate covers the sample chamber, so that the sample injection reaction channel is formed between the sample chamber and the cover plate.

[0047] Furthermore, in S4, the drying temperature is 40-50° C., and the drying time is 15-30 minutes.

[0048] Furthermore, the hydrophilic solution comprises the following raw materials in weight percentage: 0.01-0.5% polymer, 0.01-0.5% binder, 0.01-0.5% surfactant, and the rest is water.

[0049] Furthermore, the polymer is one or more of polyethylene glycol, hydroxyethyl cellulose, carboxymethyl cellulose, methyl cellulose, chitosan, cyclodextrin, sodium alginate, polyvinyl pyrrolidone, PEO, PVA, PVP / VA. The binder is one of dextrin, starch, and epoxy resin. The surfactant is one of zwitterionic surfactant, anionic surfactant, and cationic surfactant. The weight ratio of the hydrophilic solution to the reaction reagent for detection is 1:0.1-0.5.

[0050] Example 1

[0051] This embodiment provides a method for preparing a test strip, comprising the following steps:

[0052] S1. Prepare a test strip to be processed without a hydrophilic film and a reaction reagent layer: a sample chamber is provided on the test strip to be processed, and the sample chamber is covered with a cover plate 4, so that a sample injection reaction channel is formed between the sample chamber and the cover plate 4;

[0053] Specifically, S1 includes the following steps:

[0054] S11, selecting a substrate 1, and then laying an electrode layer 2 on the substrate 1;

[0055] S12, opening a notch 31 corresponding to the sample injection reaction channel on the insulating double-sided adhesive layer 3, attaching the insulating double-sided adhesive layer 3 to the substrate 1 so that the insulating double-sided adhesive layer 3 covers the electrode layer 2, and the substrate 1 and the notch 31 form the sample chamber, and a part of the working electrode 21 and the reference electrode 22 on the electrode layer 2 are located in the sample chamber;

[0056] S13 , attaching a cover plate 4 on the insulating double-sided adhesive layer 3 , wherein the cover plate 4 covers the sample chamber, so that the sample injection reaction channel is formed between the sample chamber and the cover plate 4 .

[0057] S2. Prepare a hydrophilic reaction mixture: mix the hydrophilic solution with a reaction reagent for detection; wherein the hydrophilic solution includes the following raw materials in weight percentage: 0.2% polyethylene glycol, 0.01% dextrin, 0.01% sodium dodecylbenzene sulfonate, and the rest is water; the reaction reagent is an electrochemical reagent for detecting blood glucose, specifically including the following components in volume percentage: 86% phosphate buffer with pH = 6.8, 1% surfactant Tween-20, 2.5% hydroxyethyl cellulose, 3% glucose dehydrogenase, and 7.5% potassium ferrocyanide; the added weight ratio of the hydrophilic solution to the reaction reagent for detection is 1:0.1.

[0058] S3, injecting the hydrophilic reaction mixture in S2 to fill the injection reaction channel;

[0059] S4, placing the test strip to be processed into a drying device for drying at a temperature of 40-50° C. for a drying time of 15-30 minutes, so that a hydrophilic reaction film is formed on each surface of the injection reaction channel to obtain a test strip.

[0060] Example 2

[0061] The present embodiment provides a method for preparing a test strip, which is basically the same as that of Example 1, except that: the hydrophilic solution in S2 includes the following raw materials in weight percentage: 0.01% carboxymethyl cellulose, 0.2% starch, 0.2% fatty acid glyceride, and the rest is water; the added weight ratio of the hydrophilic solution to the reaction reagent for detection is 1:0.3.

[0062] Example 3

[0063] The present embodiment provides a method for preparing a test strip, which is basically the same as that of Example 1, except that: the hydrophilic solution in S2 includes the following raw materials in weight percentage: 0.5% polyvinyl pyrrolidone, 0.5% epoxy resin, 0.5% dodecyl dimethyl betaine, and the rest is water; the added weight ratio of the hydrophilic solution to the reaction reagent for detection is 1:0.5.

[0064] Comparative Example 1

[0065] This comparative example provides a method for preparing a test strip, comprising the following steps:

[0066] S1. Select a substrate and then lay an electrode layer on the substrate;

[0067] S2, opening a notch corresponding to the sample injection reaction channel on the insulating double-sided adhesive layer, and attaching the insulating double-sided adhesive layer to the substrate, so that the substrate and the notch form the sample chamber, and a part of the working electrode and the reference electrode on the electrode layer are located in the sample chamber;

[0068] S3, preparing a reaction reagent, which is an electrochemical reagent for detecting blood sugar, specifically comprising the following components in volume percentage: 86% phosphate buffer with pH=6.8, 1% Tween-20 surfactant, 2.5% hydroxyethyl cellulose, 3% glucose dehydrogenase, and 7.5% potassium ferrocyanide;

[0069] S4, coating the reaction reagent in S3 on the working electrode in the sample chamber, and then drying it at a temperature of 50° C. for 5 min, so that a reaction reagent layer is formed on the working electrode;

[0070] S5. A cover plate and a hydrophilic film are attached to the insulating double-sided adhesive layer, and the hydrophilic film covers the sample chamber, so that an injection reaction channel is formed between the sample chamber and the cover plate to obtain a test strip; wherein the hydrophilic film is purchased from Suzhou Jianteng Electronic Technology Co., Ltd., model 3M 9901P.

[0071] The injection time of the four test strips obtained in Examples 1-3 and Comparative Example 1 was measured, and the measured results were 0.309 seconds, 0.310 seconds, 0.290 seconds, and 0.301 seconds, respectively. After aging the four test strips obtained in Examples 1-3 and Comparative Example 1 at 60°C for five weeks, the injection time was measured again, and the measured results were 0.437 seconds, 0.421 seconds, 0.401 seconds, and 0.405 seconds, respectively. It can be seen that the test strips prepared by the preparation method of the present invention are basically consistent with the test strips prepared by the prior art in terms of injection speed.

[0072] Blood samples with blood glucose concentrations of 0.89 mmol / L, 2.29 mmol / L, 5.59 mmol / L, 11.8 mmol / L, 18.61 mmol / L and 23.1 mmol / L were taken, and the test strips of Example 3 and Comparative Example 1 were used to measure the blood samples with the above 6 different blood glucose concentrations, respectively. The test results are shown in Table 1 below.

[0073] Table 1

[0074]

[0075] With the actual value as the horizontal axis and the test value as the vertical axis, we can get the following Figure 2 The scatter plot shown is used to illustrate the accuracy of the test strip test. From Table 1 and Figure 2 It can be seen that the test strip prepared by the preparation method of the present invention has a high accuracy for blood samples. The test strips obtained in Example 1 and Example 2 were subjected to the above test, and the test results were basically consistent.

[0076] It can be seen that the test strip prepared by the method of the present invention has basically the same performance as the test strip in the prior art. The test strip prepared by the present invention eliminates the need to purchase a hydrophilic membrane and does not require a separate reaction reagent layer. The operation is simple and helps reduce production costs.

[0077] The above description is only a preferred embodiment of the present invention, so all equivalent changes or modifications made according to the structure, characteristics and principles described in the scope of the patent application of the present invention are included in the scope of the patent application of the present invention.

Claims

1. A method for preparing a test strip, characterized in that: The following steps are involved: S1. preparing a test strip to be processed without a hydrophilic film and a reaction reagent layer: a sample chamber is provided on the test strip to be processed, and the sample chamber is covered with a cover plate (4) so ​​that a sample injection reaction channel is formed between the sample chamber and the cover plate (4); S2, preparing a hydrophilic reaction mixture: mixing the hydrophilic solution with a reaction reagent for detection; S3, injecting the hydrophilic reaction mixture in S2 to fill the injection reaction channel; S4, placing the test strip to be processed into a drying device for drying, so that a hydrophilic reaction film is formed on each surface of the injection reaction channel, thereby obtaining a test strip.

2. The method for preparing the test strip according to claim 1, characterized in that: The test strip is an electrochemical test strip or a photochemical test strip.

3. The method for preparing the test strip according to claim 1, characterized in that: The method for preparing the test strip to be treated without a hydrophilic membrane and a reaction reagent layer in S1 comprises the following steps: S11, selecting a substrate (1), and then laying an electrode layer (2) on the substrate (1); S12, a notch (31) corresponding to the sample injection reaction channel is provided on the insulating double-sided adhesive layer (3), and the insulating double-sided adhesive layer (3) is attached to the substrate (1) so that the insulating double-sided adhesive layer (3) covers the electrode layer (2), and the sample chamber is enclosed between the substrate (1) and the notch (31), and a part of the working electrode (21) and the reference electrode (22) on the electrode layer (2) is located in the sample chamber; S13, attaching a cover plate (4) onto the insulating double-sided adhesive layer (3), wherein the cover plate (4) covers the sample chamber, so that the sample injection reaction channel is formed between the sample chamber and the cover plate (4).

4. The method for preparing the test strip according to claim 1, characterized in that: In the step S4, the drying temperature is 40-50° C. and the drying time is 15-30 minutes.

5. The method for preparing the test strip according to claim 1, characterized in that: The hydrophilic solution comprises a polymer, a binder and a surfactant.

6. The method for preparing the test strip according to claim 5, characterized in that: The hydrophilic solution comprises the following raw materials in weight percentage: 0.01-0.5% of polymer, 0.01-0.5% of binder, 0.01-0.5% of surfactant, and the rest is water.

7. The method for preparing the test strip according to claim 5, characterized in that: The polymer is one or more of polyethylene glycol, hydroxyethyl cellulose, carboxymethyl cellulose, methyl cellulose, chitosan, cyclodextrin, sodium alginate, polyvinyl pyrrolidone, PEO, PVA, and PVP / VA.

8. The method for preparing the test strip according to claim 5, characterized in that: The binder is one of dextrin, starch and epoxy resin.

9. The method for preparing the test strip according to claim 5, characterized in that: The surfactant is one of a zwitterionic surfactant, anionic surfactant and cationic surfactant.

10. The method for preparing the test strip according to claim 1, characterized in that: The weight ratio of the hydrophilic solution to the reaction reagent for detection is 1:0.1-0.5.

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