Multi-index quantitative detection reagent card for vasculitis

Abstract

The reagent card comprises a shell and a test strip, a sample adding groove and a test window are formed in the shell at intervals, the sample adding groove sequentially comprises an upper cover, a uniform mixing bin and a blood filtering film from top to bottom, a sample adding hole is formed in the middle of the uniform mixing bin, and the test strip is arranged in the sample adding hole. The upper cover covers the upper end face of the uniform mixing bin in an openable and closable manner to shield the sample adding hole, a first film is arranged on the bottom surface of the sample adding hole, a second film is arranged on the bottom surface of the uniform mixing bin, the second film is positioned below the first film, and a sample diluent is filled between the second film and the first film, the blood filtering film is arranged below the second film, and a sampling needle is arranged on the bottom surface of the upper cover. And a pressing part which can be pressed to deform is arranged on the upper cover corresponding to the sampling needle. Due to the design of the sample adding groove, the applicability of a scene is improved, and a sample dilution step is omitted. The advantages of the four detection indexes complement each other, the operation is simple and rapid, the cost is low, the result is accurate, the sensitivity is high, the specificity is high, and the accuracy of vascular inflammation detection can be effectively improved.

Description

Technical Field

[0001] The utility model relates to the technical field of biotechnological diagnosis, and particularly relates to a multi-index quantitative detection reagent card for vascular inflammation. Background Art

[0002] According to statistics from the World Health Organization, cardiovascular diseases are a major cause of death globally, estimating to claim 17.9 million lives annually. Cardiovascular diseases are a category of heart and blood vessel diseases, including coronary heart disease, cerebrovascular diseases, rheumatic heart disease, and other diseases. More than four-fifths of cardiovascular disease deaths are due to heart attacks and strokes, and one-third of these deaths occur in people under 70 years old.

[0003] In 2020, the Chinese Society of Cardiology released the "Chinese Guidelines for Primary Prevention of Cardiovascular Diseases", which pointed out that the first step in cardiovascular disease risk assessment is to screen out high-risk individuals for cardiovascular diseases, the second step is to assess the 10-year incidence risks of ASCVD and total cardiovascular diseases for individuals who do not meet the high-risk criteria, the third step is to conduct lifetime risk assessment for individuals aged <55 years with intermediate risk of cardiovascular disease onset, and the fourth step is to consider further screening for high-risk individuals for cardiovascular diseases by combining risk enhancement factors for individuals with intermediate 10-year risks, in order to strengthen intervention measures. Cardiovascular disease risk enhancement factors include abnormal target organ damage indicators, abnormal serum biomarkers, family history of cardiovascular diseases, and preeclampsia, etc.

[0004] To accurately assess the risk of cardiovascular diseases and prevent the occurrence of cardiovascular diseases, it is necessary to accurately monitor whether the human serum biomarkers are abnormal. Among them, according to the "Expert Consensus on the Use of Biomarkers for Cardiovascular Disease Risk Assessment in Physical Examination Populations in 2022", it is mentioned that inflammatory response markers can be used for cardiovascular disease risk assessment, and it is recommended to detect C-reactive protein (CRP), lipoprotein-associated phospholipase A2 (Lp-PLA2), growth differentiation factor-15 (GDF-15), galectin-3 (Galectin-3), etc. as inflammatory response markers. Therefore, these four markers are selected for combined detection in order to stage and monitor the diagnosis of diseases in patients. The products for four-marker combined detection have important value in clinical practice, but there is currently no reagent for combined detection of these four indicators in China, which is not conducive to the rapid diagnosis of vascular inflammation.

[0005] C-reactive protein (CRP) is synthesized by hepatocytes. It contains 5 polypeptide chain subunits, which are non-covalently bound into a disc-shaped polymer with a molecular weight of 115,000 - 140,000. CRP not only binds to various polysaccharide substances in the body such as cells, fungi, and protozoa, but also binds to lecithin and nucleic acids in the presence of calcium ions. The resulting complex has an activating effect on the complement system, acting on C1q. CRP can trigger immune opsonization and phagocytosis of invading cells, thereby manifesting an inflammatory response. As a very sensitive indicator of the acute phase response, the concentration of CRP in plasma increases rapidly and significantly during acute myocardial infarction, trauma, infection, inflammation, surgical operation, and cancer infiltration, reaching up to 2000 times the normal level. Combining with the clinical history helps to follow up the course of the disease. Especially during the inflammatory process, it is useful for following up rheumatism, systemic lupus erythematosus, leukemia, etc.

[0006] Lipoprotein-associated phospholipase A2 (Lp-PLA2) is one of the subtypes in the phospholipase superfamily and is also known as platelet-activating factor acetylhydrolase. It is secreted by macrophages, T cells, and mast cells in the vascular intima. The expression of Lp-PLA2 is upregulated in atherosclerotic plaques and is strongly expressed in macrophages in the fibrous cap of vulnerable plaques. Lp-PLA2 can hydrolyze oxidized phospholipids in oxidized low-density lipoprotein (ox-LDL) to generate lipid pro-inflammatory substances such as lysophosphatidylcholine and oxidized free fatty acids, thereby producing various atherosclerotic effects, including endothelial cell death and endothelial dysfunction, and stimulating the production of adhesion factors and cytokines. These substances can further generate a self-reinforcing cycle by chemotaxing inflammatory cells to produce more pro-inflammatory substances. Lp-PLA2 released into the blood circulation mainly binds to lipoproteins rich in apolipoprotein (Apo) B, with low-density lipoprotein (LDL) accounting for 80%, and the rest binding to high-density lipoprotein (HDL), lipoprotein, and very low-density lipoprotein (VLDL). In patients with atherosclerotic diseases, the level of Lp-PLA2 is positively correlated with the level of LDL subfractions.

[0007] Growth differentiation factor-15 (GDF-15) is a distant branch of the members of the transforming growth factor β (TGF-β) superfamily. GDF-15 is a stress response protein. Under physiological conditions, GDF-15 is highly expressed in the prostate and placenta, and is weakly expressed in most other tissues, including the heart tissue. However, under pathological and environmental stress conditions, such as ischemia / reperfusion injury, high cardiac pressure load, heart failure, and atherosclerosis, etc., GDF-15 is highly expressed in cardiomyocytes, and plays a regulatory role in cardiomyocyte structure and apoptosis program. Under special physiological and pathological conditions, the expression level of GDF-15 also increases significantly, such as myocardial, renal, pulmonary or liver injury caused by surgery, ischemia, hypoxia, etc. High expression also exists in tumor lesion sites such as prostate cancer, breast cancer, and colon cancer. A large number of clinical and basic studies have confirmed that it is an important cardiovascular protective factor. As a new biomarker, the level of GDF-15 is a strong predictor of cardiovascular-related death and all-cause death, is related to the risk of cardiovascular disease, and is a potential tool for risk stratification.

[0008] Galectin-3 is a member of the galectin family. It can interact with β-galactoside residues of cell surface and matrix glycoproteins through its carbohydrate-binding domain, and can form peptide binding through its N-terminal region. These structural characteristics endow galectin-3 with multiple functions: regulation of cell adhesion, regulation of cell cycle, mRNA splicing function, high-affinity binding to advanced glycation end products (AGEs), etc. Galectin-3 is mainly produced by immune cells and cardiomyocytes. Under conditions such as atherosclerosis, cardiac remodeling, and myocardial fibrosis, Galectin-3 is abnormally overexpressed and secreted into the blood circulation.

[0009] In summary, a single biomarker can only reflect partial disease information from one aspect and cannot comprehensively and accurately evaluate the pathological and pathophysiological changes of vascular inflammation. Therefore, it is necessary to provide a multi-index reagent to improve the accuracy and specificity of vascular inflammation diagnosis and solve the defects of existing detections. Existing reagent cards generally include a test card, which includes a housing and a test strip disposed inside the housing. A sample addition port or a sample addition hole is formed on the housing, and sampling is performed through the sample addition port or the sample addition hole by using a blood collection needle separate from the reagent card. When reacting and testing after sampling, on the one hand, the sample addition port or the sample addition hole is exposed to the air, and there may be a problem that debris in the air enters through the sample addition port or the sample addition hole, resulting in sample contamination, thereby affecting the accuracy of the test results; on the other hand, the blood collection needle is designed separately from the reagent card, which is not convenient enough during sampling and testing, and it is necessary to carry the blood collection needle separately, resulting in inconvenient carrying. If the number of reagent cards does not correspond to the number of blood collection needles or the blood collection needle is forgotten to be carried, it will cause inconvenience to the detection. In addition, although other tools can be used for sampling in some cases, for some scenarios, only a specific blood collection needle can be used for sampling, and this kind of reagent card cannot be used or is very inconvenient to use. Therefore, it is necessary to design a new multi-index quantitative detection reagent card for improving the accuracy and specificity of vascular inflammation detection. Utility Model Content

[0010] Aiming at at least one of the above existing technical problems, the purpose of the present utility model is to provide a multi-index quantitative detection reagent card for vascular inflammation. The detected indexes include CRP, Lp-PLA2, GDF-15, and Galectin-3, and the above four indexes can be quantitatively detected simultaneously within 15 minutes. The operation is simple and the result is accurate, which is suitable for use in hospital emergency departments and primary medical institutions.

[0011] The technical solution of the present utility model is as follows:

[0012] The present invention provides a multi-indicator quantitative detection reagent card for vascular inflammation. The multi-indicator includes four detection indicators: CRP, Lp-PLA2, GDF-15, and Galectin-3. The reagent card includes a housing and a test strip disposed in an inner cavity of the housing. The housing is separated by a sample loading slot and an inspection window. The sample loading slot comprises, from top to bottom, an upper cover, a mixing chamber, and a blood filter membrane. A sample loading hole is defined in the center of the mixing chamber. The upper cover is openably disposed on the upper end surface of the mixing chamber to shield the sample loading hole. A first puncturable film is disposed on the bottom surface of the sample loading hole to block the sample loading hole. A second puncturable film is disposed on the bottom surface of the mixing chamber. The second film is located below the first film, and a diluent for diluting a sample is filled between the second film and the first film. The blood filter membrane is disposed below the second film. A sampling needle for sampling, which can be received in the sample loading hole, is disposed on the bottom surface of the upper cover. A pressing portion that can be pressed and deformed corresponds to the position of the sampling needle.

[0013] Preferably, the sampling needle extends vertically and is connected to the upper cover via an elastic member that is retractable along the axial direction of the sampling needle. The elastic member applies a biasing force to the sampling needle so that the tip of the sampling needle contacts the first film without puncturing it.

[0014] Preferably, the elastic member is a spring.

[0015] Preferably, the upper cover is adhesively connected to the top peripheral wall of the mixing bin.

[0016] Preferably, a lug portion protruding and extending outward is provided on the outer periphery of the upper cover.

[0017] Preferably, the pressing portion and the upper cover are integrally formed or are designed as separate bodies, made of different materials, and the deformation of the pressing portion is greater than that of the upper cover.

[0018] Preferably, the number of the test strips is one to four, and any of the test strips comprises a base plate and a sample pad, a binding pad, a detection pad and a sample suction pad overlapped and arranged on the base plate.

[0019] Preferably, any one of the detection pads is provided with a quality control line and at least one detection line. When there are multiple detection lines, the multiple detection lines are arranged in parallel and at intervals.

[0020] Preferably, when the number of the test strips is one, the number of the detection lines is one to four; when the number of the test strips is two or three, the number of the detection lines on at least one of the test strips is greater than one; when the number of the test strips is four, the number of the detection lines on any one of the test strips is one.

[0021] Compared with the prior art, the advantages of the present utility model are as follows:

[0022] The multi-index quantitative detection reagent card for vascular inflammation of the present utility model combines the detection of four indexes, namely C-reactive protein (CRP), lipoprotein-associated phospholipase A2 (Lp-PLA2), growth differentiation factor-15 (GDF-15), and galectin-3 (Galectin-3), through a fluorescence immunoassay chromatography detection reagent. The advantages of the four complement each other, and the above four indexes can be quantitatively detected simultaneously within 15 minutes. The operation is simple, fast, low-cost, the results are accurate, the sensitivity is high, and the specificity is high, which can effectively improve the accuracy of vascular inflammation detection and is suitable for use in hospital emergency departments and primary medical institutions. The design of the sample addition slot improves the applicability of the scenario and saves the sample dilution step. Description of the Drawings

[0023] The present utility model will be further described below in conjunction with the drawings and embodiments:

[0024] Figure 1 is a schematic diagram of the overall structure of the multi-index quantitative detection reagent card for vascular inflammation according to an embodiment of the present utility model;

[0025] Figure 2 is a schematic diagram of the structure of the sample addition slot of the multi-index quantitative detection reagent card for vascular inflammation according to an embodiment of the present utility model;

[0026] Figure 3 is Figure 2 an exploded schematic diagram of the sample addition slot;

[0027] Figure 4 is Figure 2 a schematic diagram of the structure of the upper cover of the sample addition slot;

[0028] Figure 5 is a sectional schematic diagram of the multi-index quantitative detection reagent card for vascular inflammation (with four detection lines) according to an embodiment of the present utility model, omitting the housing;

[0029] Figure 6 is Figure 5 a top view schematic diagram of the multi-index quantitative detection reagent card for vascular inflammation;

[0030] Figure 7 is a sectional schematic diagram of the multi-index quantitative detection reagent card for vascular inflammation (with one detection line) according to an embodiment of the present utility model, omitting the housing;

[0031] Figure 8 is Figure 7 a top view schematic diagram of the multi-index quantitative detection reagent card for vascular inflammation.

[0032] Wherein: 1. Housing; 11. Inspection window; 12. Sample addition slot; 121. Upper cover; 1211. Spring; 1212. Sampling needle; 1213. Pressing part; 1214. Lug; 122. Mixing chamber; 1221. Sample addition hole; 1222. Second film; 1223. First film; 123. Blood filtration membrane; 2. Test strip; 21. Bottom plate; 22. Sample pad; 23. Conjugate pad; 24. Detection pad; 241. Detection line; 2411. First detection line; 2412. Second detection line; 2413. Third detection line; 2414. Fourth detection line; 242. Quality control line; 25. Sample absorption pad. Specific embodiments

[0033] To make the objectives, technical solutions and advantages of the present utility model clearer, the present utility model will be further described in detail below in conjunction with specific embodiments and with reference to the accompanying drawings. It should be understood that these descriptions are merely exemplary and are not intended to limit the scope of the present utility model. In addition, in the following description, descriptions of well-known structures and technologies are omitted to avoid unnecessarily obscuring the concepts of the present utility model.

[0034] See Figures 1 to 8 , a multi-index quantitative detection reagent card for vascular inflammation according to an embodiment of the present utility model, the multi-indices including four detection indices: C-reactive protein (CRP), lipoprotein-associated phospholipase A2 (Lp-PLA2), growth differentiation factor-15 (GDF-15), and galectin-3 (Galectin-3). The reagent card includes a housing 1 and a test strip 2 disposed within the housing 1. The housing 1 may be selected as a plastic shell having a rectangular parallelepiped structure as shown in Figure 1 (a plastic material for existing conventional medical devices, which will not be specifically described and limited). Specifically on the housing 1, as shown in Figure 1 , a top surface is spaced apart with an inspection window 11 and a sample addition slot 12. The inspection window 11 is used to observe the color change on the test strip 2 within the housing 1 to judge the test result. The sample addition slot 12 is used to add the collected sample to be tested, such as human whole blood. The main difference between the detection reagent card of the embodiment of the present utility model and the existing conventional detection reagent card lies in the structural design of the sample addition slot 12. Specifically, as shown in Figures 1 to 4As shown in the figure, in the embodiment of the present utility model, the sample adding groove 12 sequentially includes an upper cover 121, a mixing chamber 122 and a blood filtering pad from top to bottom. The mixing chamber 122 is a cylindrical structural member. There is an opening in the middle of the top surface of the mixing chamber. There is a sample adding hole 1221 axially opened in the middle of the mixing chamber 122. A first film 1223 which is used to block the bottom of the sample adding hole 1221 and can be punctured is provided on the bottom surface of the sample adding hole 1221. Only the middle part of the top surface of the mixing chamber 122 is provided with an opening which is the orifice of the sample adding hole 1221. The bottom surface of the mixing chamber 122 is fully open and is provided with a second film 1222 which closes the bottom opening thereof. The second film 1222 is located below the first film 1223 and a diluent for diluting the sample is filled between the two. It should be noted that the bottom of the sample adding hole 1221 can be flush with the bottom surface of the mixing chamber 122. In order to realize the filling of the diluent, the mixing chamber 122 has a structure in which the periphery of the sample adding hole 1221 is hollow to form a liquid chamber for filling the diluent. There is a very small gap between the first film 1223 and the second film 1222, so that after the first film 1223 is punctured, the diluent in the liquid chamber can penetrate into the sample adding hole 1221 through the perforation on the first film 1223 to be mixed with the sample. As an alternative embodiment, the mixing chamber 122 can also be a structural member with only a sample adding hole 1221 opened in the middle, but the bottom of the sample adding hole 1221 should be higher than the bottom surface of the mixing chamber 122, so that a liquid chamber for filling the diluent is defined between the bottom surface of the sample adding hole 1221 and the bottom surface of the mixing chamber 122, that is, between the first film 1223 and the second film 1222. The upper cover 121 is switchably covered on the top surface of the mixing chamber 122 to close the orifice of the sample adding hole 1221. A Figures 2 to 4 is provided on the bottom surface of the upper cover 121 as shown in Figures 2 to 4The vertically downward extending sampling needle 1212 shown is, for example, a conventional blood sampling needle on the existing market. On the top surface of the upper cover 121, a pressing portion 1213 that can be pressed to generate a concave deformation is provided corresponding to the position of the sampling needle 1212. In the unused state, the sampling needle 1212 is accommodated in the sample addition hole 1221 and the tip of the sampling needle 1212 is slightly higher than the first film 1223 or just in contact with the first film 1223. When detecting, after the sampling needle 1212 samples, the pressing portion 1213 is pressed down by a finger to make it deform concavely and drive the sampling needle 1212 to displace downward to pierce the first film 1223. At this time, the sample addition hole 1221 is communicated with the diluent, and the diluent will penetrate into the sample addition hole 1221 through the perforation on the first film 1223 and mix with the sample in the sample addition hole 1221. Then the operator can shake the sample to make the diluent and the sample mix evenly. After mixing evenly, the pressing portion 1213 is pressed down again to make it deform concavely, so that the sampling needle 1212 pierces the second film 1222, and the mixed sample liquid enters the lower blood filtering membrane 123 through the sample addition hole 1221 to filter the sample. It should be noted that in the embodiment of the present invention, the size of the concave deformation of the pressing portion 1213 can be controlled by the downward pressure applied to the pressing portion 1213. In design, the maximum deformation of the pressing portion 1213 can enable the sampling needle 1212 to pierce the second film 1222 without the pressing portion 1213 itself being damaged. The material of the pressing portion 1213 is not described and limited, and it is a conventional material on the existing market that can be used in medical devices and can deform under pressure. For the materials of the first film 1223 and the second film 1222, they are also not described and limited, and they are also conventional film materials that can be used in medical devices on the existing market. For the upper cover 121, it can be optionally made of the same material as the pressing portion 1213, that is, the upper cover 121 and the pressing portion 1213 are integrally formed. Of course, as an alternative embodiment, the two can also be made of different materials and the deformation of the pressing portion 1213 should be greater than that of the upper cover 121. The two can be connected together by pasting or other connection methods well-known and easily implemented by those skilled in the art. The specific materials of the two are also not described and limited, and those skilled in the art can easily know and implement them. In the embodiment of the present invention, the structure of the sample addition slot 12 is improved. By providing the upper cover 121, it can be ensured that the sample addition hole 1221 is shielded during the detection process, so as to ensure that it is not contaminated during the detection process and improve the detection accuracy. At the same time, the sampling needle 1212 is provided on the upper cover 121 and the sampling needle 1212 is used for sampling. On the one hand, the applicability of the scenario is improved. On the other hand, the problem of inconvenient detection when forgetting to bring the sampling needle 1212 or when the number of sampling needles 1212 does not correspond to the number of test reagent cards is solved.In addition, in the specific structural design of the sample adding slot 12, there is no need to add diluent to dilute the sample. The sample and the diluent are directly mixed and diluted by piercing the first film 1223 with the sampling needle 1212, which greatly saves the sample dilution step. The test reagent card of the embodiment of the present utility model improves the accuracy and specificity of vascular inflammation detection through four detection indexes related to vascular inflammation, and can quantitatively detect the above four indexes simultaneously within 15 minutes. The operation is simple and the result is accurate, which is suitable for use in hospital emergency departments and primary medical institutions.

[0035] According to some preferred embodiments of the present utility model, as Figure 4 shown, the sampling needle 1212 is connected to the bottom surface of the upper cover 121 through an elastic member extending along the axial direction of the sampling needle 1212, that is, along the vertical direction as Figure 4 shown. The elastic member applies a biasing force to the sampling needle 1212 to make the tip of the sampling needle 1212, that is, the bottom end, contact but not pierce the first film 1223. By setting the elastic member, the downward pressure of the pressing portion 1213 can be reduced. Due to the action of the elastic member, the tip of the sampling needle 1212 can contact the first film 1223 but not pierce the first film 1223. That is to say, the distance between the tip of the sampling needle 1212 and the first film 1223 can be very short, and only by gently pressing down the pressing portion 1213 can the first film 1223 be pierced. Similarly, the distance between the tip of the sampling needle 1212 and the second film 1222 is also short, and the downward pressure during piercing does not need to be very large. For the elastic member, it is preferably a conventional spring 1211 in the prior art, such as a tubular straight spring 1211.

[0036] According to some preferred embodiments of the present invention, the connection between the upper cover 121 and the top surface of the mixing chamber 122 is preferably connected by gluing, which has a simple structure and is easy to open. Preferably, in order to facilitate the removal of the upper cover 121 from the top surface of the mixing chamber 122 to expose the sample injection hole 1221 and remove the sampling needle 1212 for sampling, the area of the upper cover 121 of the present invention embodiment is larger than the area of the top surface of the mixing chamber 122. Specifically, the upper cover 121 includes a body with an area consistent with the area of the top surface of the mixing chamber 122 and a lug 1214 protruding outward from one side of the outer periphery of the body. The lug 1214 is integrally formed with the body and does not contact any part of the mixing chamber 122. That is, it is exposed on the outside of the mixing chamber 122. When in use, the upper cover 121 is directly removed from the top surface of the mixing chamber 122 by pinching the lug 1214 with the fingers, similar to the film on the top of a box of yogurt. Of course, the lugs 1214 can be omitted, and the upper cover 121 can be directly configured to have an area larger than the top surface of the mixing chamber 122. That is, when not in use, the outer circumference of the upper cover 121 is exposed outside the top surface of the mixing chamber 122. As an alternative embodiment of the connection between the upper cover 121 and the mixing chamber 122, a plug-in connection can also be used. For example, a flange (not shown) protruding downward is provided on the bottom surface of the upper cover 121. The outer diameter of the flange is consistent with the inner diameter of the sample loading hole 1221. When connected, the flange is inserted into the opening of the sample loading hole 1221.

[0037] For test strip 2, if Figures 5 to 8 As shown, the test strip 2 includes a base plate 21 and a sample pad 22, a conjugation pad 23, a detection pad 24 and a sample suction pad 25 overlapped and arranged on the base plate 21. More specifically, as Figure 5 and Figure 7As shown, the detection pad 24 is disposed at the middle position of the bottom plate 21. The binding pad 23 and the sample pad 22 are sequentially lapped on the left side of the detection pad 24, and the sample absorption pad 25 is lapped on the right end of the detection pad 24. The sample pad 22 is located below the blood filtration membrane 123. The detection line 241 and the quality control line 242 are provided on the detection pad 24, and the detection line 241 and the quality control line 242 are located below the inspection window 11. After adding the sample liquid into the sample adding groove 12, the test strip 2 can move the sample liquid from the side of the sample pad 22 to the sides of the binding pad 23 and the detection pad 24 under the capillary suction of the sample absorption pad 25 for detection and analysis. It should be noted that the binding pad 23 is coated with a monoclonal antibody coated with a fluorescent label, and the monoclonal antibody is a monoclonal antibody for detecting the detection index CRP or Lp-PLA2 or GDF-15 or Galectin-3 and a monoclonal antibody for binding to the quality control line 242. The detection line 241 and the quality control line 242 are provided on the detection pad 24. In the embodiment of the present invention, the number of the detection lines 241 is determined according to the number of the test strips 2 or the detection indexes. That is to say, the number of the detection lines 241 can be selected from one to four, and there is only one quality control line 242. The detection line 241 is coated with a paired antibody or antigen specifically binding to a fluorescent (time-resolved fluorescent microsphere or quantum dot microsphere) labeled antibody (i.e., a monoclonal antibody of CRP or Lp-PLA2 or GDF-15 or Galectin-3). Preferably, as Figure 5 and Figure 6 shown, the number of the detection lines 241 corresponds to the number of the detection indexes, that is, the number of the detection lines 241 is four, and each detection line 241 is coated with a paired antibody or antigen specifically binding to a fluorescent labeled antibody of one of the four detection indexes. As Figure 5 shown, the four detection lines 241 are arranged in parallel at intervals and are located on the left side of the quality control line 242. For the convenience of distinction, the four detection lines 241 are sequentially described as the first detection line 2411, the second detection line 2412, the third detection line 2413, and the fourth detection line 2414 from left to right. Exemplarily, the first detection line 2411 is a CRP detection line, the second detection line 2412 is an Lp-PLA2 detection line, the third detection line 2413 is a GDF-15 detection line, and the fourth detection line 2414 is a Galectin-3 detection line. The quality control line 242 can be coated with a hapten or goat anti-mouse IgG, goat anti-chicken IgY or goat anti-rabbit IgG. The fluorescent microspheres used for coupling are polystyrene microspheres filled with chelates of lanthanide elements, and are selected from one of europium, terbium, samarium, neodymium or dysprosium.

[0038] For the number of the test strips 2, it can also be selected from one to four. More specifically, when the number of the test strips 2 is one, the number of the detection lines 241 is one to four, as Figures 5 to 6 shown as four detection lines 241; as Figures 7 to 8As shown, the number of detection lines 241 is one. When the number of test strips 2 is two or three, at least one test strip 2 has more than one detection line 241 (not shown). For example, when there are two test strips 2, the number of detection lines 241 on each test strip 2 may be one, two, two, two on one test strip 2 and one on another, or three on one test strip 2 and one on another. When there are four test strips 2, the number of detection lines 241 on any test strip 2 is one (not shown).

[0039] According to some preferred embodiments of the present invention, the inspection window 11 is made of a transparent material such as transparent glass or plastic. The number of the inspection windows 11 on the housing 1 may not be one, but may correspond to the number of the test strips 2, that is, one to four.

[0040] The use process of the multi-index quantitative detection reagent card of the embodiment of the utility model:

[0041] The user takes out the test card, uncovers the upper cover 121 above the sample loading slot 12 of the test card, uses the sampling needle 1212 on the bottom of the upper cover 121 to collect the sample, adds the sample to be tested to the sample loading hole 1221, covers the upper cover 121, and lightly presses the pressing part 1213 on the top of the upper cover 121 so that the sampling needle 1212 presses down to puncture the first film 1223. The diluent will seep into the hole in the punctured first film 1223 and mix with the sample. Shake the reagent card several times to fully mix the sample and the diluent. Mix well, press the pressing part 1213 again and use the blood collection needle to puncture the second film 1222. After the sample passes through the blood filter membrane 123 under the second film 1222, it is dropped on the sample pad 22. Through chromatography, the antigen in the sample combines with the fluorescently labeled CRP, Lp-PLA2, GDF-15, and Galectin-3 monoclonal antibodies to form a reaction complex. Under the action of chromatography, the reaction complex moves to the right along the detection pad 24 made of nitrocellulose membrane and moves to the detection line 241 (T line). The reaction complex is captured by the hapten or antibody that can bind to the specific detection antibody coated on the detection line 241 to form a final reaction complex; the corresponding monoclonal antibody at the quality control line 242 (C line) captures the formed complex.

[0042] During detection, a dedicated fluorescence detector is used to detect the quality control line 242 and the test line 241 through the inspection window 11. If no fluorescence signal appears at the quality control line 242, it indicates that the detection has failed; if a fluorescence signal appears at the quality control line 242 but no fluorescence signal appears at the test line 241, it indicates that the sample to be tested does not contain the antigen; if a fluorescence signal appears at one or some of the test lines 241, it indicates that the corresponding antigen exists in the sample to be tested, and the content of the corresponding antigen can be read from the fluorescence detector.

[0043] The utility model jointly detects four detection indexes, namely C-reactive protein (CRP), lipoprotein-associated phospholipase A2 (Lp-PLA2), growth differentiation factor-15 (GDF-15), and galectin-3 (Galectin-3), through a fluorescence immunoassay chromatographic test reagent. The advantages of the four complement each other, and the above four indexes can be quantitatively detected simultaneously within 15 minutes. The operation is simple, fast, low-cost, the result is accurate, the sensitivity is high, and the specificity is high. It can effectively improve the accuracy of vascular inflammation detection and is suitable for use in hospital emergency departments and primary medical institutions.

[0044] It should be understood that the above specific embodiments of the utility model are only used for exemplary illustration or explanation of the principle of the utility model, and do not constitute a limitation to the utility model. Therefore, any modifications, equivalent replacements, improvements, etc. made without departing from the spirit and scope of the utility model shall be included within the protection scope of the utility model. In addition, the appended claims of the utility model are intended to cover all changes and modification examples falling within the scope and boundaries of the appended claims, or equivalent forms of such scope and boundaries.

Claims

1. A multi-index quantitative detection reagent card for vascular inflammation, characterized in that, The multiple indicators include four detection indicators: CRP, Lp-PLA2, GDF-15 and Galectin-3. The reagent card includes a shell and a test strip arranged in the inner cavity of the shell. The shell is separated by a sample loading slot and an inspection window. The sample loading slot includes an upper cover, a mixing chamber and a blood filter membrane from top to bottom. A sample loading hole is opened in the middle of the mixing chamber. The upper cover is openably covered on the upper end surface of the mixing chamber to cover the sample loading hole. The bottom surface of the sample loading hole is provided with a first film that blocks the sample loading hole and can be punctured. The bottom surface of the mixing chamber is provided with a second film that can also be punctured. The second film is located below the first film and a diluent for diluting the sample is filled between the two. The blood filter membrane is provided below the second film. A sampling needle for sampling that can be accommodated in the sample loading hole is provided on the bottom surface of the upper cover. The upper cover is provided with a pressing portion that can be pressed and deformed corresponding to the position of the sampling needle.

2. The multi-index quantitative detection reagent card for vascular inflammation according to claim 1, wherein The sampling needle extends vertically and is connected to the upper cover via an elastic member that is retractable along the axial direction of the sampling needle. The elastic member applies a biasing force to the sampling needle to make the tip of the sampling needle contact the first film without puncturing it.

3. The multi-index quantitative detection reagent card for vascular inflammation according to claim 2, wherein The elastic member is a spring.

4. The multi-index quantitative detection reagent card for vascular inflammation according to claim 1, characterized in that The upper cover is adhesively connected to the top peripheral wall of the mixing bin.

5. The multi-index quantitative detection reagent card for vascular inflammation according to claim 4, wherein A lug portion protruding and extending outward is provided on the outer periphery of the upper cover.

6. The multi-index quantitative detection reagent card for vascular inflammation according to claim 1, wherein The pressing portion and the upper cover are integrally formed or are designed as separate parts, made of different materials, and the deformation of the pressing portion is greater than that of the upper cover.

7. The multi-index quantitative detection reagent card for vascular inflammation according to claim 1, characterized in that, The number of the test strips is one to four, and any of the test strips comprises a base plate and a sample pad, a binding pad, a detection pad and a sample suction pad overlapped and arranged on the base plate.

8. The multi-index quantitative detection reagent card for vascular inflammation according to claim 7, wherein Any of the detection pads is provided with a quality control line and at least one detection line. When there are multiple detection lines, the multiple detection lines are arranged in parallel and at intervals.

9. The multi-index quantitative detection reagent card for vascular inflammation according to claim 8, characterized in that When the number of the test strips is one, the number of the detection lines is one to four; when the number of the test strips is two or three, the number of the detection lines on at least one of the test strips is greater than one; when the number of the test strips is four, the number of the detection lines on any one of the test strips is one.

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