Diabetes multi-index monitoring kit

Abstract

The utility model discloses a diabetes mellitus multi-index monitoring kit. Multiple indexes comprise three indexes of HBA1C, INS and ADPN. The kit comprises a blood taking needle, a diluent and a reagent card, the reagent card comprises a shell and a test strip, and the shell is provided with a time indicating device used for indicating reaction time and fluorescent colorimetric scales used for colorimetric detection of a detection fluorescence value obtained by the test strip so as to perform semi-quantitative detection on a detection result. The time indicating device reacts to change color when the diluent is added, the reaction is finished when the color is changed, the fluorescent colorimetric scales comprise a plurality of fluorescent sections with different intensities which are sequentially arranged along the same straight line, and the fluorescent sections with different intensities can display fluorescence with different brightness under the irradiation of an ultraviolet lamp. Colorimetric scales are arranged, so that visual semi-quantitative interpretation is supported; the kit has a time indication function, and when the color of the time indication changes, the reading can be carried out when the reaction is completed, so that constant-temperature incubation is not needed, and an accurate result can be obtained under the conventional room-temperature reaction.

Description

Technical Field

[0001] This utility model relates to the field of biotechnology diagnostic technology, specifically to a multi-indicator monitoring kit for diabetes. Background Technology

[0002] Diabetes mellitus, a global chronic metabolic disease, has 140 million diagnosed patients in my country, 90% of whom have type 2 diabetes (T2DM). This disease is characterized by insulin resistance and β-cell dysfunction, and long-term hyperglycemia can lead to serious complications such as retinopathy, nephropathy, and cardiovascular disease. Clinical studies have shown that simple blood glucose monitoring cannot comprehensively assess the degree of metabolic disorder; a comprehensive assessment must be made by combining insulin sensitivity indicators (INS), long-term blood glucose control markers (HbA1c), and adiponectin (ADPN). HbA1c reflects the average blood glucose level over the past 8-12 weeks and is the WHO-recognized gold standard for diabetes diagnosis, with an ideal control target of <7%. Dynamic monitoring of INS levels can quantify the degree of insulin resistance; fasting INS >15 μIU / mL indicates abnormal β-cell compensatory function. ADPN, as an adipocyte-specific protein, has a serum concentration positively correlated with insulin sensitivity (normal values ​​are 4-23 μg / mL for men and 5-28 μg / mL for women); levels below 4 μg / mL indicate a significantly increased risk of cardiovascular events.

[0003] The current diabetes testing system suffers from three major pain points: 1. Fragmented testing methods: Hospital laboratories typically use separate testing protocols: HbA1c testing relies on high-performance liquid chromatography (HPLC), requiring 2mL of venous blood and taking ≥45 minutes; INS testing uses chemiluminescence immunoassay, requiring fasting blood collection and low-temperature centrifugation; ADPN testing is performed using ELISA, involving 8-step pipetting procedures and taking 3 hours in total. Patients need at least two hospital visits (separate fasting / non-fasting states) to complete all three tests, with a total blood collection volume of 4mL, and a report turnaround time of 2-3 days. The 2019 "China Diabetes Diagnosis and Treatment Survey Report" showed that only 38.7% of patients regularly complete the three-test combination annually. 2. Limited functionality of home testing devices: Home testing devices have significant limitations: Currently, most of the above tests are performed in hospitals. Home devices typically include blood glucose meters, which can only measure immediate blood glucose and cannot reflect core indicators such as HbA1c.

[0004] Therefore, it is necessary to design a kit for diabetes monitoring to solve the above-mentioned technical problems. Utility Model Content

[0005] In view of at least one of the above-mentioned technical problems, the purpose of this utility model is to provide a multi-indicator monitoring kit for diabetes.

[0006] The technical solution of this utility model is:

[0007] The purpose of this invention is to provide a multi-indicator monitoring kit for diabetes, wherein the multi-indicators include three indicators: HBA1C, INS, and ADPN. The kit includes a blood collection needle, diluent, and a reagent card. The reagent card includes a shell and a test strip disposed within the shell. The shell is provided with a time indicator for indicating the reaction time and a fluorescence colorimetric scale for colorimetric comparison with the fluorescence value obtained from the test strip to perform semi-quantitative detection of the test results. The time indicator changes color when the diluent is added, indicating that the reaction is complete. The fluorescence colorimetric scale includes multiple fluorescent segments of different intensities arranged sequentially along the same straight line, and the fluorescent segments of different intensities can display different brightness of fluorescence under ultraviolet light irradiation.

[0008] Preferably, the time indication device includes a housing connected to the outer shell and having an opening, the housing having receiving cavities containing powdered indicators, enzymes and indicators respectively, the opening of the housing being covered with a removable plastic film, the receiving cavities being separated by partitions, and any of the partitions being configured to allow the flow of liquid media but not solid media.

[0009] Preferably, the housing and the outer shell are integrally formed.

[0010] Preferably, any of the separating components is a separating plate with a channel in the middle, and any of the channels is provided with a thin film that allows liquid media to flow but does not allow solid media to pass through.

[0011] Preferably, the partition plate is integrally formed with the housing.

[0012] Preferably, the outer casing is further provided with a viewing window through which the test strip inside can be seen, and the time indicator and the fluorescence colorimetric scale are respectively located on both sides of the viewing window.

[0013] Preferably, the test strip includes a base plate and a blood filter pad, a sample pad, a conjugate pad, a detection pad, and a sample absorption pad that are sequentially overlapped on the base plate.

[0014] Preferably, the sampling pad is absorbent paper, the detection pad is a nitrocellulose membrane, and the conjugation pad, sample pad, and blood filtration pad are made of glass fiber. The detection pad has three detection lines and one control line distributed at intervals. The three detection lines are respectively coated with specific capture antibodies corresponding to the three indicators, and the control line is coated with haptens or antibodies that bind to the specific detection antibodies.

[0015] Preferably, a sample application hole is also provided on the outer shell, and the orthographic projection of the sample application hole falls on the blood filter pad.

[0016] Compared with the prior art, the advantages of this utility model are:

[0017] This novel multi-indicator monitoring kit for diabetes enables the combined detection of multiple coronary heart disease indicators. It can quantitatively detect the above three indicators within 15 minutes, providing accurate results and is suitable for use in hospital outpatient and emergency departments as well as primary healthcare institutions.

[0018] ① Integrated detection: Three key indicators can be obtained simultaneously from a single 10μL finger prick blood sample using fluorescence immunochromatography.

[0019] ② Extremely simplified operation: Eliminates professional steps such as centrifugation and incubation. The entire testing process only requires four steps: "dilution-sample drop-wait-reading". Even non-professional technicians can operate it correctly.

[0020] ③ Rapid testing: Test results can be provided in just 15 minutes, which is a significant improvement over current technical solutions.

[0021] ④Supports semi-quantitative analysis: The bar-shaped inspection window is equipped with a colorimetric scale, which supports visual semi-quantitative interpretation and precise quantification using instruments. Even without using instruments, relatively reliable results can be obtained.

[0022] ⑤ Time indicator: The reagent card has a built-in time indicator function. Depending on the reaction temperature, the reaction time required for the product will vary. The reagent card will generate different time indicators according to the temperature. When the time indicator changes color, the reaction is complete and the reading can be taken. Therefore, there is no need for constant temperature incubation. Accurate results can be obtained under normal room temperature reaction conditions. Attached Figure Description

[0023] The present invention will be further described below with reference to the accompanying drawings and embodiments:

[0024] Figure 1 This is a schematic diagram of the structure of the multi-index monitoring kit for diabetes according to an embodiment of the present invention;

[0025] Figure 2 for Figure 1 A top view of the test strip structure of the reagent kit;

[0026] Figure 3 for Figure 1 A perspective view of the time indicator device in the reagent kit.

[0027] The components are: 1. Outer shell; 2. Time indicator; 3. Inspection window; 4. Fluorescent colorimetric scale; 5. Sample application well; 6. Sample aspiration pad; 7. Quality control line; 8. First detection line; 9. Second detection line; 10. Third detection line; 11. Detection pad; 12. Conjugate pad; 13. Sample pad; 14. Blood filtration pad; 15. First receiving cavity; 16. First separating component; 17. Second receiving cavity; 18. Second separating component; 19. Third receiving cavity; 20. Shell. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of this utility model clearer, the present utility model will be further described in detail below with reference to specific embodiments and accompanying drawings. It should be understood that these descriptions are merely exemplary and not intended to limit the scope of this utility model. Furthermore, descriptions of well-known structures and technologies are omitted in the following description to avoid unnecessarily obscuring the concept of this utility model.

[0029] This invention relates to a multi-indicator monitoring kit for diabetes, in which the multi-indicators include HBA1C (glycated hemoglobin), INS (insulin), and ADPN (adiponectin).

[0030] The kit of this invention combines three biomarkers, HBA1C, INS, and ADPN, to achieve the combined detection of multiple diabetes indicators, improving the specificity and sensitivity of the detection. It can quantitatively detect the above three indicators within 15 minutes, with accurate results. Patients can perform self-testing at home, making it suitable for use in hospital outpatient and emergency departments and primary healthcare institutions.

[0031] For details, see Figures 1 to 3The test kit of this utility model embodiment includes three parts: a blood collection needle (not shown), a diluent (not shown), and a reagent card. These three parts can be placed in the same package (not shown), such as a box or bag. The blood collection needle is a conventional needle used for collecting patient blood samples; its specific structure is not described or limited. For the diluent, conventional options such as PBS buffer, Tris (aminomethane buffer), and HEPES buffer can be selected. The reagent card includes a casing 1 and a test strip housed within the casing 1. The kit of this utility model embodiment mainly improves and optimizes the reagent card. Existing reagent cards typically improve the casing 1, for example, by using a sliding or flip-top casing. This is to facilitate exposing the test strip during testing to add the blood sample to the test strip for reaction, while simultaneously sealing the test strip during testing to prevent external contaminants from affecting the accuracy of the test results. It also protects the test strip from exposure when not in use, preventing it from affecting the accuracy of the test. However, existing kits typically only allow quantitative analysis using equipment such as a dry fluorescence immunoassay analyzer, and require further improvement. The multi-indicator detection kit for diabetes in this embodiment mainly adds a time indicator 2 and a fluorescence colorimetric scale 4 to the reagent card. This allows users to easily understand whether the reaction is complete during the test and achieve semi-quantitative analysis through fluorescence colorimetry. Of course, precise quantitative analysis can also be performed after the reaction is complete using a dry fluorescence immunoassay analyzer. During the test, a blood sample is taken from the patient using a lancet and added to the diluent. The diluent is then added to the time indicator 2 for reaction. The remaining diluent containing the blood sample is added to the test strip in the reagent card for reaction. By observing the color change in the time indicator 2, the reaction is complete when a color change occurs. At this time, ultraviolet light is used for irradiation, and the fluorescence is compared with that of the fluorescence colorimetric scale 4 (which is equipped with standard fluorescent microspheres; specifically, the fluorescence colorimetric scale 4 includes microspheres along the same straight line, for example...). Figure 1 The diagram shows multiple fluorescent segments of different fluorescence intensities arranged sequentially from top to bottom, as exemplified by... Figure 1 The fluorescence intensity changes from bright to dark from top to bottom. For example, in this embodiment, there are five fluorescence segments, represented by 1 to 5. 1 represents the analyte being below the normal value, i.e., hypoglycemia; 2 represents the analyte being at a normal level, i.e., normal blood sugar; and 3 to 5 represent different degrees of high analyte levels, i.e., different degrees of hyperglycemia. The fluorescence value detected on the test strip is used for semi-quantitative judgment. Similar to pH test strips, the fluorescence intensity of the fluorescence segment on the fluorescence colorimetric scale 4 is closest to the fluorescence value detected on the test strip, indicating whether the fluorescence value is below, normal, or above the normal level. This allows for a semi-quantitative judgment of whether it is hypoglycemia, hyperglycemia, or normal blood sugar.

[0032] Specifically, such as Figure 3As shown, the time indicator 2 includes a housing 20 and an indicator, i.e., a substrate, an enzyme, and an indicator disposed within the housing 20. More specifically, the housing 20 is a rectangular container with an opening at the top, hollow inside, and divided by two partitions (for ease of description and distinction, from...). Figure 3 As shown from left to right, the first partition component 16 and the second partition component 18 divide the space into three receiving cavities (for ease of description and differentiation, from left to right, the three cavities are divided into three receiving cavities). Figure 3 The three chambers, from left to right, are described as a first receiving chamber 15, a second receiving chamber 17, and a third receiving chamber 19. Each chamber contains a powdered indicator (e.g., lyophilized solid powder), an enzyme, and an indicator, respectively. For example, the first receiving chamber 15 contains the indicator, the second receiving chamber 17 contains the enzyme, and the third receiving chamber 19 contains the indicator. The housing 20 is preferably made of the same material as the outer shell 1 of the reagent card, such as commercially available medical ABS plastic. Preferably, the housing 20 is integrally formed with the outer shell 1. For example, a downwardly recessed groove (not shown) is formed on the upper surface of the outer shell 1, which constitutes the housing 20 of the time indicator device 2. To prevent the indicator, enzyme, and indicator inside the housing 20 from being exposed to air and thus becoming ineffective, and to facilitate the subsequent addition of diluent for reaction, a removable plastic film (not shown) is covered over the top opening of the housing 20 in this embodiment. The material of this plastic film is not described or limited, but is a commercially available medical plastic film. Furthermore, to ensure that the indicator, enzyme, and reagent can mix and react after the diluent is added, in this embodiment, a hole, exemplarily circular, is formed in each separating component, namely the first separating component 16 and the second separating component 18, to create a channel. It should be noted that the channel can be as follows: Figure 3The circular hole shown can also be a large circular hole formed by multiple small circular holes, similar to a sieve. However, to prevent the indicator, enzyme, and reagent from mixing and affecting its effectiveness when not in use, a thin film (not shown) is provided at each channel. This film is a conventional commercially available polymer film with fine pores that allows liquid media to pass through but not solid media such as the powder mentioned above. The specific material and pore size are not described or limited, and those skilled in the art can choose and design according to actual needs. Thus, when not in use, the powdered indicator, enzyme, and reagent cannot mix due to the obstruction of the thin film on the separator between their respective housing cavities. However, when a diluent containing blood sample is added, the powdered indicator, enzyme, and reagent dissolve in the diluent and can mix through the thin film on the separator between their respective housing cavities. The indicator and enzyme react, and the resulting reactants cause the indicator to change color. In this embodiment, the time when the indicator changes color corresponds to the time when blood is added to the test strip for reaction. Therefore, when the indicator changes color, it indicates that the reaction on the test strip is complete, and the test is finished. The separator is preferably a plate-shaped separator integrally formed with the housing 20. As an alternative embodiment, the separator can also be a separate separator fixedly connected to the inside of the housing 20, such as by adhesive.

[0033] The indicators, enzymes, and pH indicators (acid-base indicators or pH indicators) used in this embodiment are not particularly limited and can be any commercially available multicolor combination. For example, the indicator in this embodiment is pyruvate at a concentration of 50 mM; the enzyme is lactate dehydrogenase (LDH) at a concentration of 500 U / mL; and the indicator is chlorophenol red. During detection, when the diluent is added, the indicator pyruvate and the enzyme lactate dehydrogenase react to produce lactic acid (at room temperature, the reaction time is 12-15 minutes, and the lactic acid yield is approximately 90%), ultimately reaching a pH of around 5.0, and the indicator changes from purple-red to yellow.

[0034] In this embodiment, the specific structure of the outer shell 1 is not described or limited. It is exemplarily a cuboid shell structure with an internal cavity, and the test strip is fixed inside the outer shell 1, for example, on the inner bottom surface. In this embodiment, the test strip is fixed inside the outer shell 1, so it is not necessary to open the outer shell 1 to expose the test strip for adding blood samples during testing. Therefore, preferably, to facilitate direct sample addition, in this embodiment, the upper surface of the outer shell 1 has an exemplary circular sample application hole 5. The test strip is elongated. Preferably, as... Figure 1As shown, to facilitate observation of the test results, in this embodiment of the invention, the upper surface of the outer shell 1 is further provided with a viewing window 3 that allows visibility of the test strip on one side of the sample application hole 5. The viewing window 3 is not specifically described or limited, but is made of a transparent material, such as transparent plastic or transparent glass. Regarding the size of the viewing window 3, its projection onto the test strip should at least cover the test pad 11 of the test strip. Preferably, as shown... Figure 1 As shown, in this embodiment, the time indicator 2 and the fluorescence colorimetric scale 4 are distributed on the left and right sides of the inspection window 3, which can enhance the aesthetic appearance of the reagent card to a certain extent. The fluorescence colorimetric scale 4 is located on one side of the inspection window 3, that is, the bar-shaped inspection window 3 is equipped with a colorimetric scale, supporting visual semi-quantitative interpretation.

[0035] For test strips, such as Figure 2 As shown, the test strip includes a base plate (not shown) and, sequentially overlapping on the base plate, a blood filter pad 14, a sample pad 13, a conjugate pad 12, a detection pad 11, and a sample absorption pad 6. More specifically, as... Figure 2 As shown, the test pad 11 is positioned in the middle of the base plate. From top to bottom, the lower side of the test pad 11 is successively connected to the conjugate pad 12, sample pad 13, and blood filter pad 14, while the upper side of the test pad 11 is connected to the absorbent pad 6. The blood filter pad 14 is positioned corresponding to the sample application well 5; that is, the projection of the sample application well 5 on the test strip falls onto the blood filter pad 14. The test pad 11 has a test line and a control line 7, located below the viewing window 3. It should be noted that the conjugate pad 12 is coated with a monoclonal antibody that binds to time-resolved immunofluorescent microspheres. The monoclonal antibody is either the detection index HBA1C, INS, or ADPN monoclonal antibody or the monoclonal antibody used for binding to the control line 7. For the test pad 11 on the test strip, the test pad 11 has a test line and a control line 7. The number of test lines can be selected according to the number of test strips or detection indicators; that is, the number of test lines can be one to three, while there is only one control line 7. The detection line is coated with a paired antibody or antigen that specifically binds to a fluorescently labeled antibody (i.e., HBA1C, INS, or ADPN monoclonal antibody). Preferably, such as Figure 2As shown, this embodiment uses one test strip with three detection lines. Each detection line is coated with a fluorescently labeled antibody that specifically binds to one of the three detection indicators. This antibody can be a polyclonal antibody or a monoclonal antibody. For easy differentiation, the three detection lines are described from top to bottom as the first detection line 8T1, the second detection line 9T2, and the third detection line 10T3. For example, the first detection line 8T1 is the HBA1C detection line, the second detection line 9T2 is the INS detection line, and the third detection line 10T3 is the ADPN detection line. The antibody used to coat the control line 7C can be a hapten, goat anti-mouse IgG, goat anti-chicken IgY, or goat anti-rabbit IgG. By setting the three detection lines to be coated with specific capture antibodies for the three indicators respectively, and the control line 7 to be coated with a hapten or antibody that binds to the specific detection antibody, this kit can be used for the detection and risk assessment of coronary heart disease. It can simultaneously quantitatively detect the above three indicators within 15 minutes, and is simple to operate, highly sensitive, highly specific, and accurate in its results. During testing, after adding diluted sample liquid to sample well 5, the test strip moves the sample liquid from the blood filter pad 14 side to the sample pad 13, conjugate pad 12 and test pad 11 side under the capillary suction of the sample pad 6 for chromatographic reaction detection and analysis. The blood filter pad 14 can filter out interfering substances in the blood, and the sample pad 13 can further remove interference through chromatography. The blood binds to the specific labeled antibodies of the above three indicators on the conjugate pad 12 and enters the test pad 11. The antigens of the three indicators bind to the specific capture antibodies coated on the test line respectively, thus playing a detection role.

[0036] Preferably, in this embodiment, the sampling pad 6 is absorbent paper, the detection pad 11 is a nitrocellulose membrane, the conjugation pad 12, the sample pad 13 and the blood filtration pad 14 are made of glass fiber, and the base plate is a PVC board.

[0037] The method of using the reagent kit of this utility model embodiment is as follows:

[0038] (1) Use a blood collection needle to collect blood;

[0039] (2) Add a drop of capillary blood to the diluent;

[0040] (3) Fill the time indicator 2 with the diluted sample solution, and add the remaining sample solution through the sample dispensing hole 5;

[0041] (4) Let stand until the time indicator 2 changes color;

[0042] (5) Use ultraviolet light to compare the colorimetric scale and perform semi-quantitative interpretation.

[0043] As an alternative embodiment, step (5) of the method of using the reagent kit in this embodiment of the present invention may be, or may include, step (5) after the following:

[0044] (6) With the test window 3 of the reagent card facing up, perform precise quantitative analysis using a dry fluorescence immunoassay analyzer.

[0045] Note: If the fluorescence signal is not detected at the quality control line 7C or is lower than the set value, the instrument will report an experimental failure and the test needs to be repeated.

[0046] The detection principle of this reagent is not described in detail or limited, as it is existing technology and known to those skilled in the art. Qualitative judgment can be made by observing the intensity of the fluorescence color of the detection line. The concentrations of HBA1C, INS, and ADPN are calculated and displayed based on a standard curve pre-set in the dry immunofluorescence analyzer to achieve quantitative detection.

[0047] This novel diagnostic kit can use serum, plasma, or whole blood as test samples, offering high versatility. It can simultaneously detect HBA1C, INS, and ADPN, significantly improving detection efficiency and greatly reducing the workload and time required for testing related biomarkers in diabetic patients. This allows for rapid disease detection, enabling patients to receive more timely and targeted treatment. Integrated detection: Utilizing fluorescence immunochromatography, a single 10μL finger-prick blood sample can simultaneously acquire three key indicators. The reagent card features a built-in time indicator. Depending on the reaction temperature, the required reaction time varies, and the reagent card displays different time indicators based on the temperature. When the time indicator changes color, the reaction is complete and the result can be read. Therefore, constant temperature incubation is unnecessary; accurate results can be obtained at standard room temperature. The bar-shaped inspection window 3 is equipped with a colorimetric scale, supporting semi-quantitative visual interpretation as well as precise quantification using instruments. Even without instruments, relatively reliable results can be obtained. Extremely simplified operation: Eliminating professional steps such as centrifugation and constant temperature incubation, the entire testing process only requires four steps: "dilution-sample dropping-waiting-reading," which can be operated correctly even by non-technical personnel. Rapid testing: Test results are available in only about 15 minutes, a significant improvement in speed compared to current technical solutions.

[0048] It should be understood that the specific embodiments described above are merely illustrative or explanatory of the principles of this utility model and do not constitute a limitation thereof. Therefore, any modifications, equivalent substitutions, improvements, etc., made without departing from the spirit and scope of this utility model should be included within its protection scope. Furthermore, the appended claims are intended to cover all variations and modifications falling within the scope and boundaries of the appended claims, or equivalent forms of such scope and boundaries.

Claims

1. A multi-indicator monitoring kit for diabetes, characterized in that, The multiple indicators include three indicators: HBA1C, INS, and ADPN. The reagent kit includes a blood collection needle, diluent, and reagent card. The reagent card includes a shell and a test strip inside the shell. The shell has a time indicator for indicating the reaction time and a fluorescence colorimetric scale for colorimetric comparison with the fluorescence value obtained from the test strip to perform semi-quantitative detection of the test results. The time indicator changes color when the diluent is added, indicating that the reaction is complete. The fluorescence colorimetric scale includes multiple fluorescent segments of different intensities arranged sequentially along the same straight line. Different fluorescent segments can display different brightness of fluorescence under ultraviolet light.

2. The reagent kit according to claim 1, characterized in that, The time indication device includes a housing connected to the outer casing and having an opening. The housing has cavities containing powdered indicators, enzymes, and indicators, respectively. The opening of the housing is covered with a removable plastic film. The cavities are separated by partitions, and any partition is configured to allow the flow of liquid media but not solid media.

3. The reagent kit according to claim 2, characterized in that, The housing and the outer shell are integrally formed.

4. The kit according to claim 2 or 3, characterized in that, Each of the aforementioned partition components is a partition plate with a channel in the middle, and each of the aforementioned channels is provided with a thin film that allows liquid media to flow but does not allow solid media to pass through.

5. The reagent kit according to claim 4, characterized in that, The partition plate is integrally formed with the shell.

6. The reagent kit according to claim 1, characterized in that, The outer casing is also provided with a viewing window through which the test strip inside can be seen, and the time indicator and the fluorescence colorimetric scale are respectively located on both sides of the viewing window.

7. The kit according to claim 1, characterized in that, The test strip includes a base plate and a blood filter pad, a sample pad, a conjugate pad, a detection pad, and a sample absorption pad that are sequentially overlapped on the base plate.

8. The reagent kit according to claim 7, characterized in that, The sampling pad is absorbent paper, the detection pad is a nitrocellulose membrane, and the conjugation pad, sample pad, and blood filtration pad are made of glass fiber. The detection pad has three detection lines and one control line distributed at intervals. The three detection lines are respectively coated with specific capture antibodies corresponding to the three indicators, and the control line is coated with haptens or antibodies that bind to the specific detection antibodies.

9. The reagent kit according to claim 7, characterized in that, The outer shell also has a sample application hole, the orthographic projection of which falls on the blood filter pad.

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