A filtering component, a test strip containing the filtering component, a preparation method and an application

Abstract

The present invention discloses a filtering component, a test strip containing the filtering component, a preparation method and an application. The filtering component includes at least one layer of aerogel filtering membrane. Substances such as acrylamide, hydroxypropyl cellulose, ammonium persulfate, polyvinylpyrrolidone, N,N-dimethylbisacrylamide, etc. undergo a polymerization cross-linking reaction under ultraviolet irradiation to form a three-dimensional thin film network structure, reducing the fiber packing density, increasing the pore tortuosity while increasing the porosity, thereby improving the filtering efficiency of blood samples; calcium salts such as soluble calcium salts and calcium lignosulfonate are added to the aerogel filtering membrane, which is beneficial to supplement the missing calcium ions in the blood when the blood passes through the aerogel filtering membrane, restore the blood coagulation factors, enable various anticoagulant blood samples to coagulate, effectively avoid the influence of anticoagulants on the detection of prothrombin time of blood samples, and are used to make test strips for detecting the blood coagulation function, with high accuracy.

Description

Technical Field

[0001] The present invention relates to the technical field of electrochemical detection, and particularly to a filtering component, a test strip containing the filtering component, a preparation method and an application thereof. Background Art

[0002] Whether the blood coagulation function is normal or not is related to the physiological health status of the human body. The evaluation experiment of blood coagulation function is of great significance for the diagnosis, treatment and prognosis judgment of various diseases, such as atherosclerosis, cardiovascular diseases, diabetes, arteriovenous thrombosis, thromboangiitis obliterans, pulmonary embolism, pregnancy-induced hypertension syndrome, disseminated intravascular coagulation, hemolytic uremic syndrome, chronic obstructive pulmonary disease, etc. The determination of blood coagulation function is of great clinical significance for the tests of cases such as hematological diseases, cerebral hemorrhage, liver diseases, acute and chronic infections, cerebral infarction, myocardial infarction, etc.

[0003] Conventional prothrombin time detection methods include optical method, magnetic path method and electrochemical method. Specifically: (1) The optical method has the advantages of simple structure, high sensitivity, easy automation, etc., but the disadvantage is that it is susceptible to specific plasma interference; (2) The magnetic path method has the advantage of not being interfered by specific plasma and less reagent dosage, but the disadvantages are that the quality of magnetic beads, the smoothness of the cup wall, etc. will all affect the measurement results; (3) Although the detection accuracy of the electrochemical method is not as good as that of the optical method and the magnetic bead method, due to the advantages of convenience, quickness, simplicity, easy use, etc., it plays an important role in surgical operations and daily blood coagulation monitoring of anticoagulant patients.

[0004] During the blood coagulation function detection process, after the tester obtains a blood sample to be tested (such as fingertip peripheral blood and venous blood), for the stability of the blood sample, the blood sample is usually pretreated with anticoagulants to avoid blood coagulation during storage or transfer, such as artificially adding anticoagulants such as sodium citrate. After the blood sample to be tested is anticoagulated, anticoagulants such as sodium citrate contained in the blood prevent the occurrence of the blood coagulation process and affect the result of prothrombin time detection.

[0005] Therefore, it is of great significance to develop a product that can process anticoagulated blood to improve the detection accuracy of prothrombin time. Summary of the Invention

[0006] The present invention provides a filtering component, and the specific technical solution is as follows:

[0007] A filtering component, which includes at least one layer of aerogel filter membrane;

[0008] The preparation process of the aerogel filter membrane includes the following steps:

[0009] Step Sa1: Prepare the slurry. Specifically, dissolve acrylamide and hydroxypropyl cellulose in a buffer solution, and then sequentially add ammonium persulfate, polyvinylpyrrolidone, N,N-dimethylbisacrylamide, soluble calcium salt, and protamine, and mix evenly to obtain a first mixed solution; add calcium lignosulfonate to the first mixed solution, and irradiate it under ultraviolet light with a wavelength of 365 - 450 nm to form a slurry.

[0010] Among them, the dosages of acrylamide, hydroxypropyl cellulose, ammonium persulfate, polyvinylpyrrolidone, N,N-dimethylbisacrylamide, soluble calcium salt, protamine, and calcium lignosulfonate by weight are: 10 - 35, 15 - 25, 0.01 - 0.05, 5 - 15, 0.02 - 0.1, 5 - 15, 1 - 6, and 0.5 - 3.85.

[0011] Step Sa2: Coat the slurry on a substrate. Specifically, coat the slurry obtained in Step Sa1 on a substrate, and dry it to obtain a semi-transparent filter membrane.

[0012] Step Sa3: Obtain an aerogel filter membrane. Specifically, subject the semi-transparent filter membrane obtained in Step Sa2 to freezing, drying, and fumigation reinforcement to obtain an aerogel filter membrane.

[0013] Preferably, in Step Sa1: the buffer solution is one of Tris-HCl, 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid sodium salt, and 3-(N-morpholino)propanesulfonic acid sodium salt, and its pH is 5 - 10; the mixing evenly is specifically carried out by stirring in a water bath at 25°C - 35°C for 1 - 2 h; the irradiation is specifically: irradiate continuously at intervals of 5 - 10 min for 2 - 5 times, and the irradiation duration for each time is 10 - 20 s; the soluble calcium salt is at least one of calcium chloride, calcium nitrate, calcium gluconate, and calcium acetate.

[0014] In Step Sa2: the substrate is a fiber filter substrate; the drying is specifically carried out at 40°C - 60°C for 45 - 60 min; in Step Sa3: the freezing is specifically carried out at a low temperature of -20°C - -40°C for 10 - 15 h; the drying is specifically carried out in a vacuum freeze dryer at a vacuum degree of 5 - 10 Pa for 20 - 30 h; the pore size of the dried semi-transparent filter membrane is 100 um - 300 um; the fumigation reinforcement is specifically carried out in a sealed tank filled with the steam of a fumigation solvent, and the fumigation solvent is ethanol and N,N-dimethylformamide with a volume ratio of 1:0.2 - 0.8, and the fumigation temperature is 85°C - 110°C.

[0015] The filter component adopted by the present invention includes at least one layer of aerogel filter membrane, and the aerogel filter membrane is obtained by coating a slurry containing substances such as acrylamide, hydroxypropyl cellulose, ammonium persulfate, polyvinylpyrrolidone, N,N-dimethylbisacrylamide, and soluble calcium salt on a substrate and then successively undergoing freezing, drying, and fumigation reinforcement. Substances such as acrylamide, hydroxypropyl cellulose, ammonium persulfate, polyvinylpyrrolidone, and N,N-dimethylbisacrylamide undergo a polymerization cross-linking reaction under ultraviolet irradiation to form a three-dimensional thin film network structure, reducing the fiber packing density, increasing the pore tortuosity while increasing the porosity, thereby improving the filtration efficiency of blood samples; calcium salts such as soluble calcium salt and calcium lignosulfonate are added to the aerogel filter membrane, which is beneficial to supplement the missing calcium ions in the blood when the blood passes through the aerogel filter membrane, restoring the blood coagulation factors, enabling various anticoagulant blood samples to coagulate, effectively avoiding the influence of anticoagulants on the detection of prothrombin time of blood samples, and improving the accuracy of detection.

[0016] The present invention also discloses a test strip, and the specific scheme is as follows:

[0017] A test strip includes an electrode substrate, an adhesive layer, and a hydrophilic membrane;

[0018] The electrode substrate includes a substrate and an electrode and an enzyme layer printed on the substrate, and an enzyme reagent layer is provided on the reaction area of the electrode substrate;

[0019] On one side of the electrode substrate having the enzyme reagent layer, an adhesive layer, a carrier membrane, the above-mentioned filter component, an anti-fouling membrane, and a hydrophilic membrane are sequentially arranged; a sample addition port is provided on the hydrophilic membrane, and the carrier membrane, the filter component, and the anti-fouling membrane are correspondingly arranged with the sample addition port; a channel for facilitating the blood sample to flow into the reaction area is provided on the adhesive layer.

[0020] Preferably, the electrode includes a counter electrode and a working electrode arranged in parallel.

[0021] Preferably, air holes communicating with the electrode substrate are further provided on the hydrophilic membrane.

[0022] The test strip of the present invention includes the above-mentioned filter component, pre-treats the blood sample before detecting the prothrombin time of the blood sample, restores the blood coagulation factors, and improves the accuracy of detecting the prothrombin time of the blood sample.

[0023] The present invention also discloses a preparation method of the above-mentioned test strip, including the following steps:

[0024] Print an electrode and an enzyme layer on the substrate in sequence, and perform the first drying to obtain an electrode substrate with a reaction area;

[0025] Print an enzyme reagent on the reaction area of the electrode substrate to form an enzyme reagent layer, and perform the second drying to obtain a preliminary test strip;

[0026] A test strip is obtained by sequentially pasting an adhesive layer, a carrier film, a filtering member, an anti-fouling film, and a hydrophilic film on the initial product of the test strip.

[0027] Preferably, the first drying is specifically: drying treatment is carried out under the condition of 100°C - 120°C; the second drying is specifically: first drying under the condition of 30°C - 35°C for 2 - 8 minutes, then drying under the condition of 45°C - 50°C for 8 - 15 minutes; and finally drying under the condition of 30°C - 35°C for 2 - 8 minutes. The preparation method has concise steps and easy-to-control process parameters, and is suitable for industrial application.

[0028] The present invention also provides an application of the above-mentioned test strip, specifically for detecting the blood coagulation function, and the detection accuracy is high. Description of the Drawings

[0029] Figure 1 It is a schematic diagram of the overall structure of the test strip in Example 2;

[0030] Figure 2 is Figure 1 The explosion structure schematic diagram of;

[0031] Wherein: 1 - substrate, 2 - electrode, 3 - enzyme layer, 4 - adhesive layer, 4.1 - channel, 5 - hydrophilic film, 5.1 - sample addition port, 5.2, air hole, 5.3, air permeable sieve, 6 - carrier film, 7 - filtering member, 8 - anti-fouling film, 9, reaction area. Detailed Embodiments

[0032] The embodiments of the present invention will be described in detail below with reference to the drawings, so that the advantages and features of the present invention can be more easily understood by those skilled in the art, thereby making a clearer and more definite definition of the protection scope of the present invention.

[0033] Example 1:

[0034] A filtering member, which includes at least one layer of aerogel filtering film, and the specific number of layers can be designed according to actual needs.

[0035] The preparation process of the aerogel filtering film specifically includes the following steps:

[0036] Step Sa1, preparing a slurry, specifically: dissolving acrylamide and hydroxypropyl cellulose in a buffer solution, and then sequentially adding ammonium persulfate, polyvinylpyrrolidone, N,N-dimethylbisacrylamide, soluble calcium salt, and protamine, and mixing evenly to obtain a first mixed solution; adding calcium lignosulfonate to the first mixed solution, and irradiating it under ultraviolet light of 365 - 450 nm to form a slurry;

[0037] Wherein: the acrylamide, hydroxypropyl cellulose, ammonium persulfate, polyvinyl pyrrolidone, N,N-dimethylbisacrylamide, soluble calcium salt, protamine and calcium lignin sulfonate are used in the following amounts by weight: 10-35, 15-25, 0.01-0.05, 5-15, 0.02-0.1, 5-15, 1-6 and 0.5-3.85; the buffer solution is one of Tris-HCl, 4-hydroxyethylpiperazineethanesulfonic acid sodium salt and 3-morpholinepropanesulfonic acid sodium salt, and its pH is 5-10; the mixing is specifically stirred in a water bath at 25-35°C for 1-2h; the irradiation is specifically irradiated 2-5 times with a continuous interval of 5-10min, and each irradiation time is 10-20s to form a slurry; the soluble calcium salt can be calcium chloride (CaCl 2 ), calcium nitrate (Ca(NO 3 ) 2 ), at least one of calcium gluconate and calcium acetate, wherein calcium gluconate is preferred.

[0038] Step Sa2, coating the slurry on a substrate, specifically: coating the slurry obtained in step Sa1 on a substrate, and obtaining a translucent filter membrane after drying; the substrate is a fiber filter substrate; the drying is specifically drying at 40°C to 60°C for 45 to 60 minutes.

[0039] Step Sa3, obtaining an aerogel filter membrane, specifically: freezing, drying and fumigating the translucent filter membrane obtained in step Sa2 to obtain an aerogel filter membrane. Wherein: the freezing is specifically freezing at a low temperature of -20°C to -40°C for 10 to 15 hours; the drying is specifically drying in a vacuum freeze dryer at a vacuum degree of 5 to 10 Pa for 20 to 30 hours; the pore size of the dried translucent filter membrane is 100um to 300um; the fumigation reinforcement is specifically placed in a sealed tank filled with the steam of a fumigation solvent for fumigation reinforcement, wherein the fumigation solvent is ethanol and N,N-dimethylformamide in a volume ratio of 1:0.2 to 0.8, and the fumigation temperature is 85°C to 110°C.

[0040] Example 2

[0041] The preparation process of the filter element in this embodiment is as follows:

[0042] 1), Dissolve 11 g of acrylamide and 17 g of hydroxypropyl cellulose in 100 ml of Tris-HCl buffer with a pH of 6.0. Then, sequentially add 0.05 g of ammonium persulfate, 5 g of polyvinylpyrrolidone (PVP), 0.03 g of N,N-dimethylbisacrylamide (MBA), 10 g of soluble calcium salt, and 1 g of protamine. Stir for 1.5 h in a 30°C water bath to obtain a first mixed solution; add 0.5 calcium lignosulfonate to the first mixed solution, and irradiate it twice continuously at intervals of 6 min under a 365 - 450 nm ultraviolet lamp, with each irradiation lasting for 15 s to obtain a slurry;

[0043] 2), Use a spatula to evenly apply the slurry on the surface of the fibrous filter substrate, and dry it at 45°C for 60 min to form a semi-transparent filter membrane;

[0044] 3), Freeze the semi-transparent filter membrane at -20°C for 12 h, and then place it in a vacuum freeze dryer to dry it at a vacuum degree of 10 Pa for 24 h to remove the water molecules in the semi-transparent filter membrane, thereby obtaining an aerogel filter membrane with a pore size of 180 - 200 μm; Place the aerogel filter membrane in a sealed tank filled with the vapor of the fumigation solvent for fumigation and reinforcement, where the fumigation solvent is ethanol and N,N-dimethylformamide (DMF) with a volume ratio of 1:0.3, and the fumigation temperature is 100°C; Demold and cut the fumigated aerogel filter membrane to obtain the finished product.

[0045] Apply the above filter component to make a test strip. The structure of the test strip is detailed in Figure 1 and Figure 2 , specifically including an electrode substrate, an adhesive layer 4, and a hydrophilic membrane 5;

[0046] The electrode substrate includes a substrate 1, an electrode 2, and an enzyme layer 3 printed on the substrate 1. An enzyme reagent layer is provided on the reaction area 9 of the electrode substrate;

[0047] On one side of the electrode substrate with the enzyme reagent layer, an adhesive layer 4, a carrier membrane 6, a filter component 7, an anti-fouling membrane 8, and a hydrophilic membrane 5 are sequentially arranged; A sample addition port 5.1 is provided on the hydrophilic membrane 5, and the carrier membrane 6, the filter component 7, and the anti-fouling membrane 8 are arranged corresponding to the sample addition port 5.1; A channel 4.1 for facilitating the blood sample to flow into the reaction area is provided on the adhesive layer 4. The channel 4.1 is a slender through-groove structure, and an enlarged part is provided in the middle of the channel. After the blood sample is added through the sample addition port 5.1, it sequentially passes through the anti-fouling membrane 8, the filter component 7, the carrier membrane 6, and then enters the channel 4.1 and flows downstream to the reaction area.

[0048] Preferably, the electrode 2 includes a counter electrode and a working electrode arranged in parallel, and the electrode material is silver-carbon, gold or palladium-carbon. The hydrophilic membrane 5 is also provided with air holes 5.2 and a breathable sieve 5.3 communicating with the electrode substrate. The breathable sieve 5.3 is correspondingly arranged with the enlarged part of the channel, which is beneficial to the blood sample entering from the sampling port to smoothly flow into the reaction area 9.

[0049] The preparation process of the above test strip is as follows:

[0050] 1), Print the electrode 2 and the enzyme layer 3 on the substrate 1 in sequence, dry at 110 °C, and cut to obtain the electrode substrate;

[0051] 2), Print the enzyme reagent on the reaction area 9 of the electrode substrate and dry to obtain the initial product of the test strip; The drying is specifically: first heat up to 30 °C and keep warm for 5 min, then heat up to 50 °C and keep warm for 10 min; Finally, keep warm at 35 °C for 5 min;

[0052] 3), Paste the adhesive layer 4 (the adhesive layer is preferably double-sided adhesive), the carrier film 6, the above-mentioned filtering member, the anti-fouling film 8 and the hydrophilic membrane 5 on the initial product of the test strip in sequence, roll cut and bottle to obtain the test strip.

[0053] Examples 3-4

[0054] The difference between Example 3 and Example 2 is: (1) Dissolve 35 g of acrylamide and 20 g of hydroxypropyl cellulose in 100 ml of 4-hydroxyethylpiperazineethanesulfonic acid sodium salt buffer solution with a pH of 6.0, and then add 0.04 g of ammonium persulfate, 10 g of polyvinylpyrrolidone (PVP), 0.04 g of N,N-dimethylbisacrylamide (MBA), 9.4 g of soluble calcium salt and 6 g of protamine in sequence, stir in a 35 °C water bath for 2 h to obtain the first mixed solution; Add 3.83 g of calcium lignosulfonate to the first mixed solution, and irradiate continuously at intervals of 7 min under ultraviolet light with a wavelength of 365-450 nm for 2 times, and the irradiation time for each time is 20 s; (2) Dry at 45 °C for 50 min to form a semi-transparent filter membrane; (3) Freeze the semi-transparent filter membrane at -40 °C for 12 h, and then place it in a vacuum freeze dryer and dry at a vacuum degree of 7 Pa for 24 h to obtain an aerogel filter membrane with a pore size of 280-300 um; (4) The fumigation temperature is 90 °C; (5) The drying is specifically: first heat up to 35 °C and keep warm for 5 min, then heat up to 50 °C and keep warm for 10 min; Finally, keep warm at 35 °C for 5 min. Others are the same as Example 2.

[0055] Example 4 is different from Example 2 in the following aspects: (1) 20 g of acrylamide and 22 g of hydroxypropyl cellulose are dissolved in 100 ml of 3-morpholinopropanesulfonic acid sodium salt buffer solution with a pH of 6.0, and then 0.03 g of ammonium persulfate, 8 g of polyvinylpyrrolidone (PVP), 0.08 g of N,N-dimethylbisacrylamide (MBA), 6.2 g of soluble calcium salt, and 4.8 g of protamine are added in sequence. Stir for 2 h in a 35°C water bath to obtain the first mixed solution; add 3.03 g of calcium lignosulfonate to the first mixed solution, and irradiate continuously at intervals of 5 min under ultraviolet light with a wavelength of 365 - 450 nm for 2 times, with each irradiation duration being 15 s; (2) Dry at 45°C for 51 min to form a semi-transparent filter membrane; (3) Freeze the semi-transparent filter membrane at -30°C for 12 h, and then place it in a vacuum freeze dryer and dry it at a vacuum degree of 10 Pa for 24 h to obtain an aerogel filter membrane with a pore size of 120 - 160 μm; (4) The fumigation solvent is ethanol and N,N-dimethylformamide (DMF), and the volume ratio is 1:0.7, and the fumigation temperature is 95°C; (5) The drying process is as follows: First, heat up to 35°C and keep warm for 5 min, then heat up to 50°C and keep warm for 10 min; finally, keep warm at 35°C for 5 min. Other conditions are the same as in Example 2.

[0056] Comparative example:

[0057] The comparative example is different from Example 2 in that 10 g of soluble calcium salt and 0.5 g of calcium lignosulfonate are not added. Other conditions are the same as in Example 2.

[0058] For self-recruited volunteers, fingertip blood and venous blood are collected (where fingertip blood is used as a control sample, and venous blood is collected in a sodium citrate anticoagulant tube and used as a test sample). The test strips obtained in Examples 2 - 4 and the comparative example are used in conjunction with a supporting electrochemical analyzer to test 2 blood samples respectively, and the test results are shown in Table 1:

[0059] Table 1 Statistical table of test results of fingertip blood and venous blood in Examples 2 - 4 and the comparative example

[0060]

[0061]

[0062] Result analysis: From the analysis of the test results of fingertip blood and sodium citrate anticoagulated blood, the coagulation function of sodium citrate anticoagulated blood is restored through the solution of the present invention, and the deviation of the PT / INR results of fingertip blood and anticoagulated blood tests is within ±10%; in the comparative example, due to the removal of calcium ions by sodium citrate, the anticoagulated blood cannot coagulate or the coagulation time exceeds a certain range, so the instrument has no result and shows NO CONG.

[0063] The above are only embodiments of the present invention, and do not limit the patent scope of the present invention. Any equivalent structure or equivalent process transformation made by using the content of the specification and drawings of the present invention, or directly or indirectly applied in other related technical fields, shall be equally included in the patent protection scope of the present invention.

Claims

1. A filtering component, characterized in that: the filtering component includes at least one layer of aerogel filtering membrane; the preparation process of the aerogel filtering membrane includes the following steps: Step Sa1, preparing a slurry, specifically: dissolving acrylamide and hydroxypropyl cellulose in a buffer solution, then adding ammonium persulfate, polyvinylpyrrolidone, N,N-dimethylbisacrylamide, soluble calcium salt and protamine, and mixing evenly to obtain a first mixed solution; adding calcium lignosulfonate to the first mixed solution, and irradiating under ultraviolet light at 365-450 nm to form a slurry; wherein: the dosages of acrylamide, hydroxypropyl cellulose, ammonium persulfate, polyvinylpyrrolidone, N,N-dimethylbisacrylamide, soluble calcium salt, protamine and calcium lignosulfonate by weight are: 10-35, 15-25, 0.01-0.05, 5-15, 0.02-0.1, 5-15, 1-6 and 0.5-3.85; Step Sa2, coating the slurry on a substrate, specifically: coating the slurry obtained in Step Sa1 on a substrate, and drying to obtain a semi-transparent filtering membrane; Step Sa3, obtaining an aerogel filtering membrane, specifically: freezing, drying and fumigation reinforcement of the semi-transparent filtering membrane obtained in Step Sa2 to obtain an aerogel filtering membrane.

2. The filtering component according to claim 1, characterized in that, in Step Sa1: the buffer solution is one of Tris-HCl, 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid sodium salt and 3-(N-morpholino)propanesulfonic acid sodium salt, and its pH is 5-10; mixing evenly is specifically stirring in a water bath at 25°C-35°C for 1-2 h; irradiation is specifically: irradiating continuously at intervals of 5-10 min for 2-5 times, and the irradiation duration each time is 10-20 s; the soluble calcium salt is at least one of calcium chloride, calcium nitrate, calcium gluconate and calcium acetate.

3. The filtering component according to claim 1, characterized in that, in Step Sa2: the substrate is a fiber filtering substrate; the drying is specifically drying at 40°C-60°C for 45-60 min; in Step Sa3: freezing is specifically freezing at a temperature of -20°C to -40°C for 10-15 h; the drying is specifically drying in a vacuum freeze dryer at a vacuum degree of 5-10 Pa for 20-30 h; the pore diameter of the dried semi-transparent filtering membrane is 100 um-300 um; the fumigation reinforcement is specifically carried out in a sealed tank filled with the steam of the fumigation solvent, wherein the fumigation solvent adopts ethanol and N,N-dimethylformamide with a volume ratio of 1:0.2-0.8, and the fumigation temperature is 85°C-110°C.

4. A test strip, characterized in that, it includes an electrode substrate, an adhesive layer (4) and a hydrophilic membrane (5); the electrode substrate includes a substrate (1) and an electrode (2) and an enzyme layer (3) printed on the substrate (1), and an enzyme reagent layer is provided on the reaction area of the electrode substrate. On one side of the electrode substrate having an enzyme reagent layer, a glue layer (4), a carrier film (6), a filtering member (7) as described in any one of claims 1-2, an anti-fouling film (8), and a hydrophilic film (5) are sequentially provided; a sample adding port (5.1) for adding a blood sample is provided on the hydrophilic film (5), and the carrier film (6), the filtering member (7), and the anti-fouling film (8) are correspondingly arranged with the sample adding port (5.1); a channel (4.1) facilitating the inflow of the blood sample into the reaction area is provided on the glue layer (4).

5. The test strip according to claim 4, characterized in that, the electrode (2) includes a counter electrode and a working electrode arranged in parallel.

6. The test strip according to claim 4, characterized in that, air holes (5.2) communicating with the electrode substrate are further provided on the hydrophilic film (5).

7. A method for manufacturing a test strip, characterized in that, for manufacturing the test strip as described in any one of claims 4-6, the manufacturing method includes the following steps: printing an electrode (2) and an enzyme layer (3) on a substrate in sequence, and performing a first drying to obtain an electrode substrate having a reaction area; printing an enzyme reagent on the reaction area of the electrode substrate to form an enzyme reagent layer, and performing a second drying to obtain a preliminary test strip; pasting a glue layer (4), a carrier film (6), a filtering member (7), an anti-fouling film (8), and a hydrophilic film (5) on the preliminary test strip in sequence to obtain the test strip.

8. The manufacturing method according to claim 7, characterized in that, the first drying is specifically: performing a drying treatment at 100°C - 120°C; the second drying is specifically: first drying at 30°C - 35°C for 2 - 8 min, then drying at 45°C - 50°C for 8 - 15 min; and finally drying at 30°C - 35°C for 2 - 8 min.

9. An application of the test strip as described in any one of claims 4-6, characterized in that, for detecting the blood coagulation function of blood.

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