Multi-index quantitative detection kit for coronary heart disease

Abstract

The utility model discloses a multi-index quantitative detection kit for coronary heart disease. The multi-index quantitative detection kit comprises H-FABP, cMyC, Cyr61 and MIF. The kit comprises a shell and a test strip, wherein a sample adding groove is formed in the shell, and the bottom surface of the sample adding groove obliquely extends downwards; an ejector pin is also arranged on the bottom surface of the sample adding groove; the kit further comprises a sample adding box which contains a sample diluent and can be inserted into the sample adding groove, the sample adding box comprises a box body, a cover film and a cover body, the box body is internally provided with a liquid cavity, the two ends of the box body are provided with openings, the cover film is arranged on the opening in one end of the box body, the cover body covers the opening in the other end of the box body, and the cover film can be punctured by the ejector pin when the sample adding box is inserted into the sample adding groove. The ejector pin arranged in the sample adding groove is used for directly puncturing the cover film for sample adding, so that unnecessary contact and pollution are reduced. Slope drainage is adopted, a sample completely reacts with the test strip, and the accuracy of a detection result is improved. And by using multiple indexes, the detection specificity and sensitivity are improved.

Description

Technical Field

[0001] The utility model relates to the technical field of biological diagnosis, and particularly relates to a multi-index quantitative detection kit for coronary heart disease. Background Art

[0002] Coronary heart disease, the full name of which is coronary atherosclerotic heart disease, sometimes also called ischemic heart disease, refers to the heart disease caused by myocardial ischemia and hypoxia due to coronary atherosclerosis. The coronary artery is the only blood vessel that supplies blood to the heart. Its shape is like a crown, so it is called the coronary artery. This blood vessel also hardens like the blood vessels throughout the body, showing atherosclerotic changes, causing obstacles to the blood circulation that supplies the heart, leading to myocardial ischemia and hypoxia, which is coronary heart disease. Coronary heart disease is a common and frequently-occurring disease among middle-aged and elderly people, seriously endangering people's lives.

[0003] Coronary heart disease is one of the cardiovascular and cerebrovascular diseases that seriously threaten human survival and health. How to improve the early diagnosis ability of coronary heart disease, especially acute coronary syndrome, has always been an important research direction in cardiovascular diseases.

[0004] At present, the detection means for four markers of coronary heart disease are very limited. Although a few companies have developed chemiluminescence immunoassay products based on magnetic beads, they are expensive, inefficient, and require independent calibration and quality control for the detection of multiple indicators, with cumbersome operations. Therefore, developing a multi-index detection kit that can simultaneously improve the diagnostic accuracy and specificity, improve efficiency, reduce costs, and simplify operations has important clinical significance.

[0005] Existing detection kits generally include a shell and a test strip disposed inside the shell. A sample addition port or a sample addition hole is opened on the shell. When adding a sample, the sample is first diluted with a diluent and then added to the sample addition port or the sample addition hole. The diluted sample then contacts the sample pad on the test strip through the sample addition hole or the sample addition port, thereby achieving detection. The bottom surface of the sample addition hole of this detection kit is flat, with a relatively simple structure. The speed at which the diluted sample drains onto the test strip after being added through the sample addition hole is slow, resulting in low detection efficiency. Moreover, part of the sample may remain in the sample addition groove (specifically, on the side far from the test strip), which may lead to insufficient sample volume and thus affect the accuracy of the detection result. There is still room for further improvement. In addition, the existing detection kit is not matched with the sample diluent, which brings certain inconvenience to the detection to a certain extent. Moreover, there may be problems such as sample contamination caused by operation errors, which in turn affect the detection result. Therefore, it is necessary to design a new detection kit. Summary of the Utility Model

[0006] Aiming at at least one of the above existing technical problems, the purpose of the utility model is to provide a multi-index quantitative detection kit for coronary heart disease.

[0007] The technical solution of the present utility model is as follows:

[0008] The purpose of the present utility model is to provide a multi-index quantitative detection kit for coronary heart disease. The multi-indices include H-FABP, cMyC, Cyr61, and MIF. The kit includes a housing and a test strip disposed inside the housing. A sample addition groove is formed on the housing and recessed downward along its thickness direction, and the bottom surface of the sample addition groove extends obliquely downward from the end far away from the test strip towards the end close to the test strip.

[0009] A thimble protruding towards the notch of the sample addition groove is further provided on the bottom surface of the sample addition groove.

[0010] The kit further includes a sample addition box filled with a sample diluent and insertable into the sample addition groove. The sample addition box includes a box body having a liquid cavity inside and openings at both ends, a covering film disposed on one of the openings of the box body, and a cover body covering the other opening of the box body. When the sample addition box is inserted into the sample addition groove, the covering film can be punctured by the thimble.

[0011] Preferably, the housing includes an upper shell and a lower shell. The sample addition groove is disposed on one side of the inner surface of the lower shell, and a sample addition port is formed on the upper shell corresponding to the notch of the sample addition groove.

[0012] Preferably, the test strip is fixed on the inner surface of the lower shell. On the inner surface of the lower shell, on the side opposite to the sample addition groove, a plurality of limiting bars protruding towards the upper shell and arranged at intervals are provided. The plurality of limiting bars enclose a fixing space for clamping the test strip.

[0013] Preferably, the limiting bars include two opposite and spaced first limiting bars close to the sample addition groove and two opposite and spaced second limiting bars far away from the sample addition groove and opposite to the two first limiting bars. The two first limiting bars and the two second limiting bars enclose a quadrilateral area, and the area is the fixing space.

[0014] The bottom surface of the sample addition groove extends to be connected to the two first limiting bars, and the interval between the two first limiting bars forms a drainage channel.

[0015] Preferably, a third limiting bar is further provided between the two first limiting bars and the two second limiting bars.

[0016] Preferably, any one of the first limiting bars and / or the second limiting bars is in an L shape or an inverted L shape, and the third limiting bar is in a "1" shape.

[0017] Preferably, on the outer surface of the upper shell, on one side of the sample adding port, there is also a viewing window that can see through the test strip.

[0018] Preferably, the test strip includes a bottom plate, and a sample pad, a conjugate pad, a detection pad, and a sample absorbing pad that are sequentially lapped on the bottom plate. The sample pad is arranged close to the sample adding groove.

[0019] Preferably, the test strip includes a bottom plate, and a sample pad, a conjugate pad, a blood filtering pad, a detection pad, and a sample absorbing pad that are sequentially lapped on the bottom plate. The sample pad is arranged close to the sample adding groove.

[0020] Compared with the prior art, the advantages of the present utility model are as follows:

[0021] The multi-index quantitative detection kit for coronary heart disease of the present utility model realizes the combined detection of multiple coronary heart disease indexes, can quantitatively detect the above four indexes within 15 minutes, and the results are accurate. It is suitable for use in hospital emergency departments and primary medical institutions. When in use, the sample is added and the liquid is mixed by opening the lid of the sample adding box. The top needle of the lower card of the reagent card pierces the bottom film of the sample adding box so that the mixed liquid flows out completely along the slope onto the sample pad for chromatography, reducing unnecessary contact and contamination, and avoiding the influence of sample adding operation errors on the results. The sample can be completely drained onto the test strip through the drainage effect of the slope on the bottom surface of the sample adding groove for chromatography reaction, solving the problems in the prior art that the drainage speed is slow due to the flat bottom surface of the sample adding groove or sample adding hole, which affects the detection efficiency, and the problem that the sample may remain on the side of the sample adding groove far from the test strip. Description of the Drawings

[0022] The following further describes the present utility model in conjunction with the drawings and embodiments:

[0023] Figure 1 It is a sectional structure schematic diagram of a test strip in one form after omitting the housing of the multi-index quantitative detection kit for coronary heart disease according to an embodiment of the present utility model;

[0024] Figure 2 For Figure 1 The top view structure schematic diagram of the test strip of the kit;

[0025] Figure 3 It is a structure schematic diagram of the multi-index quantitative detection kit for coronary heart disease according to an embodiment of the present utility model (including a sample adding box and the sample adding box is not inserted into the sample adding groove);

[0026] Figure 4 For Figure 3 The structure schematic diagram of the kit when the sample adding box is inserted into the sample adding groove for detection;

[0027] Figure 5Schematic structural diagram of the upper shell of the multi-index quantitative detection kit for coronary heart disease according to an embodiment of the present utility model;

[0028] Figure 6 Schematic structural diagram of the inner bottom surface facing upward of the lower shell of the multi-index quantitative detection kit for coronary heart disease according to an embodiment of the present utility model;

[0029] Figure 7 Schematic side view structural diagram of the lower shell of the multi-index quantitative detection kit for coronary heart disease according to an embodiment of the present utility model;

[0030] Figure 8 Schematic structural diagram of the sampling box (when the box body and the cover body are separated, the left part in the figure is the box body and the covering film, and the right part is the cover body) of the multi-index quantitative detection kit for coronary heart disease according to an embodiment of the present utility model;

[0031] Figure 9 Schematic sectional view structural diagram of another form of test strip after omitting the shell of the multi-index quantitative detection kit for coronary heart disease according to an embodiment of the present utility model;

[0032] Figure 10 For Figure 9 Top view structural diagram of the test strip of the kit.

[0033] Wherein: 10, shell; 11, upper shell; 111, sampling port; 112, inspection window; 12, lower shell; 121, sampling groove; 122, limiting bar; 1221, first limiting bar; 1222, second limiting bar; 1223, third limiting bar; 13, thimble; 20, test strip; 21, bottom plate; 22, sampling pad; 23, detection pad; 24, binding pad; 25, sample pad; 26, blood filtering pad; C, quality control line; T1, first detection line; T2, second detection line; T3, third detection line; T4, fourth detection line; 30, sampling box; 31, box body; 32, covering film; 33, cover body. Specific embodiments

[0034] To make the objectives, technical solutions and advantages of the present utility model clearer and more understandable, 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 exemplary and are not intended to limit the scope of the present utility model. In addition, in the following descriptions, the descriptions of well-known structures and technologies are omitted to avoid unnecessarily confusing the concepts of the present utility model.

[0035] A multi-index quantitative detection kit for coronary heart disease according to an embodiment of the present utility model, the multi-indices include H-FABP, cMyC, Cyr61 and MIF. The advantages and functions of these four biomarkers are introduced separately as follows:

[0036] Heart-type fatty acid binding protein (H-FABP) is a novel low-molecular-weight cytoplasmic protein and a subtype of the fatty acid binding protein family. It has a relative molecular mass of 14,500 and consists of 132 amino acid residues. It mainly exists in the cytoplasm of cardiomyocytes and is one of the most abundant proteins in cardiomyocytes, with high cardiac specificity. When acute myocardial infarction (AMI) occurs, irreversible damage occurs to cardiomyocytes, and H-FABP is rapidly released into the blood and enters the blood circulation. It may be detected earlier than high-sensitivity troponin, and at the same time, H-FABP has high cardiac specificity. Kim et al. found that for the diagnosis of AMI within 4 hours after chest pain onset, H-FABP has obvious advantages over cTnT, CK-MB, and MYO. The diagnostic significance of H-FABP, cTnI, MYO, CK-MB, and CK at different time periods was studied, and the diagnostic efficacy of each index was clearly shown by drawing the ROC curve. The results showed that within 3 hours after chest pain onset, the diagnostic value of H-FABP was much higher than that of other indicators; within 3-6 hours after chest pain onset, H-FABP, cTnI, and MYO all had high diagnostic value; within 6-12 hours after chest pain onset, H-FABP and each index had diagnostic significance, but the advantage of H-FABP was not obvious. Thus, within the most critical 3 hours for saving AMI patients, H-FABP has obvious advantages and is the best diagnostic marker.

[0037] The myosin binding protein C (cMyC) family was initially discovered in 1973 and consists of 3 subtypes. It is specifically expressed in the myocardium and its expression runs through the entire life process starting from neonatal. Some studies suggest that cMyC can be used as a new biomarker for cardiac injury. Similar to cardiac troponin T (cTnT) and cardiac troponin I (cTnI), the expression of cMyC is limited to the heart but is more abundant. The increase rate of cMyC in the systemic circulation after acute myocardial infarction (AMI) is faster than that of high-sensitivity cardiac troponin T (hs-cTnT). Studies have found that cMyC has the potential for earlier diagnosis of acute myocardial infarction, evaluation of the effect of PCI surgery, and assessment of the prognosis of patients with myocardial infarction. The diagnostic accuracy of cardiac myosin-binding protein C for acute myocardial infarction is similar to that of high-sensitivity cardiac troponin T and high-sensitivity cardiac troponin I in the complete cohort, but it is superior to high-sensitivity cardiac troponin T in patients with chest pain less than 3 hours (early manifestation).

[0038] Cysteine-rich protein 61 (Cyr61) is one of the members of the connective issue growth factor (CCN) family. CYR61 is a secreted heparin-binding protein that is rich in cysteine. It is a transient protein produced by epithelial cells, fibroblasts, vascular endothelial cells, and smooth muscle cells under the stimulation of serum platelet-derived growth factor (PDGF) and transforming growth factor-β (TGF-β). Studies have found that the level of Cyr61 in the plasma of patients with coronary heart disease is significantly higher than that of patients without coronary heart disease, and it is related to the severity of coronary artery lesions. Therefore, Cyr61 is expected to become a new biomarker for coronary heart disease and a potential intervention target.

[0039] Macrophage migration inhibitory factor (MIF) is a pro-inflammatory cytokine encoded within a functionally polymorphic gene locus. MIF is a highly conserved 12.5 kDa secreted protein that is involved in many biological processes. The expression and secretion profile of MIF indicate that MIF is ubiquitous and constitutively expressed in almost all mammalian cells and plays a role in all aspects of cardiovascular disease. MIF is produced by different types of cells in human atherosclerotic lesions and may promote the development and pathological progression of early plaques, resulting in more advanced and complex lesions. Studies have shown that an increase in the concentration of MIF can promote the formation and progression of atherosclerotic plaques, leading to the formation of complex lesions and may contribute to plaque instability. An increase in plasma MIF levels can be used to reflect the presence and severity of complex coronary artery lesions.

[0040] The kit of the embodiment of the present utility model combines four biomarkers, namely H-FABP, cMyC, Cyr61, and MIF, to achieve the combined detection of multiple coronary heart disease indicators, improve the specificity and sensitivity of detection, and can quantitatively detect the above four indicators within 15 minutes with accurate results, making it suitable for use in hospital emergency departments and primary medical institutions.

[0041] Specifically, see Figures 1 to 10 , the detection kit of the embodiment of the present utility model includes a housing 10 and a test strip 20 disposed within the housing 10. Among them, a sample addition groove 121 extending downward in the thickness direction is provided on the housing 10, and the bottom surface of the sample addition groove 121 is not a flat surface, but is like Figure 7As shown, it extends obliquely downward from one end far away from the test strip 20 towards the end close to the test strip 20. That is to say, the bottom surface of the sample addition groove 121 is a slope. As for the inclination angle, no special description and limitation are made. For example, 30°, 45°, etc. Those skilled in the art can select and design according to the actual situation. The purpose of such design is that after adding the diluted sample through the sample addition groove 121, the diluted sample can be completely drained onto the test strip 20 through the drainage effect of the slope for chromatographic reaction, solving the problems in the prior art that the bottom surface of the sample addition groove 121 or the sample addition hole is a plane, resulting in slow drainage speed and affecting the detection efficiency, and the problem that the sample may remain on the side of the sample addition groove 121 far away from the test strip 20.

[0042] In a preferred embodiment, the detection kit of the embodiment of the present invention further includes a sample addition box 30. The sample addition box 30 can be inserted into the sample addition groove 121. That is to say, the outer shape of the sample addition box 30 matches the sample addition groove 121. More specifically, as Figure 7 shown, in the embodiment of the present invention, on the bottom surface of the sample addition groove 121, there is a thimble 13 protruding and extending towards the notch direction of the sample addition groove 121 (the specific material is not described and limited, it can be a medical plastic material, or a stainless steel material, and the shape is not particularly limited either. It can be needle-shaped, or a cone body or a cylinder with a pointed top, etc.). As Figure 8As shown, the sampling cartridge 30 includes a cartridge body 31 with a cavity inside and openings at both ends, a covering film 32 covering one of the openings of the cartridge body 31 (in the embodiment of the present invention, the covering film 32 is provided on the bottom opening of the cartridge body 31, and the specific material of the covering film 32 is not particularly limited and described. It is a film made of conventional medical materials on the market that can be damaged by a hard object such as the thimble 13 on the bottom surface of the above-mentioned sampling groove 121, which can be easily known and implemented by those skilled in the art), and a cover body 33 that can be opened and closed and covers the other opening of the cartridge body 31. In the embodiment of the present invention, during detection, first, the cover body 33 of the sampling cartridge 30 is opened, the sample is added to the sample diluent in the cartridge body 31, the cover body 33 is covered and shaken to mix the sample and the sample diluent evenly, and then the covering film 32 is inserted downward into the sampling groove 121 so that the covering film 32 contacts the thimble 13 and is punctured by the thimble 13, thereby releasing the diluted sample in the cartridge body 31 from the punctured through hole. In the embodiment of the present invention, when the outer surface of the cover body 33 of the sampling cartridge 30 is flush with the notch of the sampling groove 121, the covering film 32 can be punctured by the thimble 13 to allow the diluted sample to drain through the slope on the bottom surface of the sampling groove 121. Preferably, during operation, the reagent kit can be held and shaken gently so that all the diluted sample in the cartridge body 31 of the sampling cartridge 30 flows out through the through hole punctured on the covering film 32, and then drains to the test strip 20 through the slope on the bottom surface of the sampling groove 121. By directly puncturing the covering film 32 at the bottom of the sampling cartridge 30 with the thimble 13 provided in the sampling groove 121 for sampling, unnecessary contact and contamination are reduced, and the problem of affecting the test result caused by operation errors during sampling is reduced.

[0043] As Figures 5 to 7 shown, the housing 10 of the embodiment of the present invention includes an upper shell 11 and a lower shell 12. Both the upper shell 11 and the lower shell 12 are rectangular. More specifically, the sampling groove 121 is provided on one side of the inner surface of the lower shell 12, such as Figure 6 and Figure 7 shown on the right side. The sampling groove 121 protrudes from the inner surface of the lower shell 12, that is, the sampling groove 121 has a wall surface around it, and the surrounding wall surface of the sampling groove 121 can fix the sampling cartridge 30 when it is inserted. As Figure 5 shown, at the notch of the upper shell 11 corresponding to the sampling groove 121, a sampling port 111 with a matching shape and size is provided, and the sampling port 111 penetrates through the thickness of the upper shell 11. Regarding the connection method between the upper shell 11 and the lower shell 12, no special description and limitation are made, and it can be snap connection or bonding.

[0044] As Figure 6 shown, the test strip 20 is fixed on the inner surface of the lower shell 12. Specifically, on the inner surface of the lower shell 12, on the side opposite to the sampling groove 121, that is, as Figure 6On the left side as shown, there are multiple spacing - arranged limiting bars 122. The test strip 20 is fixed on the lower shell 12 through the fixed space enclosed by the limiting bars 122. More specifically, the limiting bars 122 include two first limiting bars 1221, two second limiting bars 1222, and one third limiting bar 1223. Among them, the two first limiting bars 1221 are opposite (that is, one above the other as Figure 6 shown) and spaced apart and close to the sample - adding slot 121 (that is, on the right side as shown in the figure), the two second limiting bars 1222 are opposite (that is, one above the other as Figure 6 shown) and spaced apart and far from the sample - adding slot 121 (that is, on the left side as Figure 6 shown), and the third limiting bar 1223 is arranged between the two first limiting bars 1221 and the two second limiting bars 1222. More specifically, any one of the first limiting bars 1221 is in an L - shape or an inverted L - shape, any one of the second limiting bars 1222 is in an L - shape or an inverted L - shape, and the third limiting bar 1223 is in a "1" - shape. The two first limiting bars 1221 and the two second limiting bars 1222 enclose a quadrilateral area, which is the fixed space of the test strip 20. That is to say, the two first limiting bars 1221 and the two second limiting bars 1222 respectively limit and fix the two ends of the test strip 20, and the third limiting bar 1223 mainly supports the middle part of the test strip 20. The low - end of the bottom surface of the sample - adding slot 121 extends to the right ends of the two first limiting bars 1221 and is connected to the two first limiting bars 1221. The space between the two first limiting bars 1221 forms a drainage channel (not labeled). The end of the drainage channel directly extends to the sample - adding pad 25 of the test strip 20, or rather, the sample - adding pad 25 of the test strip 20 directly extends into the drainage channel.

[0045] As Figure 3 and Figure 5 shown, in order to facilitate observing the test result, on the upper surface of the upper shell 11 of the present utility model embodiment, on one side of the sample - adding port 111, there is also a viewing window 112 that can penetrate through the test strip 20. Regarding the viewing window 112, no specific description and limitation are made, and it can be made of a transparent material, such as transparent plastic or transparent glass, etc. Regarding the size of the viewing window 112, its projection on the test strip 20 covers at least the detection pad 23 of the test strip 20.

[0046] Regarding the test strip 20, in one embodiment, as Figure 2 and Figure 3 shown, the test strip 20 includes a bottom plate 21 and a sample pad 25, a conjugate pad 24, a detection pad 23, and a sample - absorbing pad 22 that are sequentially lapped on the bottom plate 21. More specifically, as Figure 2As shown in the figure, the detection pad 23 is disposed at the middle position of the bottom plate 21. The combination pad 24 and the sample pad 25 are sequentially lapped on the right side of the detection pad 23, and the sample absorption pad 22 is lapped on the left side of the detection pad 23. The sample pad 25 is disposed close to the sample addition slot 121. The detection pad 23 is provided with a detection line and a quality control line, and the detection line and the quality control line are located below the inspection window 112. After adding the diluted sample liquid into the sample addition slot 121, the test strip 20 can move the sample liquid from the side of the sample pad 25 to the sides of the combination pad 24 and the detection pad 23 under the capillary suction of the sample absorption pad 22 for chromatographic reaction detection and analysis. It should be noted that the combination pad 24 is coated with a monoclonal antibody coated with a fluorescent label, and the monoclonal antibody is a monoclonal antibody for detecting the index H-FABP or cMyC or Cyr61 or MIF and a monoclonal antibody for binding to the quality control line. For the detection pad 23 on the test strip 20, the detection pad 23 is provided with a detection line and a quality control line. For the number of detection lines, it can be selected according to the number of test strips 20 or the detection indexes. That is to say, the number of detection lines can be selected from one to four, and there is only one quality control line. The detection line is coated with a paired antibody or antigen that specifically binds to a fluorescent (time-resolved fluorescent microsphere or quantum dot microsphere) labeled antibody (i.e., a monoclonal antibody of H-FABP or cMyC or Cyr61 or MIF).

[0047] Preferably, as Figure 2 shown, the number of the test strips 20 is one, and the test strip 20 is provided with four detection lines. Each detection line is coated with a paired antibody or antigen that specifically binds to a fluorescently labeled antibody of one of the four detection indexes. For the convenience of distinction, the four detection lines are sequentially described as the first detection line T1, the second detection line T2, the third detection line T3, and the fourth detection line T4 from left to right. Exemplarily, the first detection line T1 is an H-FABP detection line, the second detection line T2 is a cMyC detection line, the third detection line T3 is a Cyr61 detection line, and the fourth detection line T4 is an MIF detection line. The substance used to coat the quality control line C can be 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. By providing four detection lines coated with specific capture antibodies for four indexes respectively and the quality control line coated with a hapten or antibody that binds to the specific detection antibody, the kit can be used for the detection and risk assessment of coronary heart disease. The above four indexes can be quantitatively detected simultaneously within 15 minutes, with simple operation, high sensitivity, strong specificity and accurate results.

[0048] As an alternative embodiment of the test strip 20, as Figure 9 and Figure 10As shown, the test strip 20 includes a bottom plate 21, and a sample pad 25, a conjugate pad 24, a blood filtration pad 26, a detection pad 23, and a sample absorption pad 22 that are sequentially overlapped and arranged on the bottom plate 21. More specifically, as Figure 9 shown, the detection pad 23 is arranged at the middle position of the bottom plate 21. A blood filtration pad 26, a conjugate pad 24, and a sample pad 25 are sequentially overlapped on the right side of the detection pad 23, and a sample absorption pad 22 is overlapped on the left side of the detection pad 23. The sample pad 25 is arranged close to the sample addition slot 121. Detection lines (T1, T2, T3, T4) and a quality control line (C) are provided on the detection pad 23. Both the (T1, T2, T3, T4) and the quality control line (C) are located below the viewing window 112, that is, located on the projection of the viewing window 112 on the lower housing 12.

[0049] Usage process of the multi-index quantitative detection kit according to the embodiment of the present utility model:

[0050] (1) Take out the test strip 20 including the housing 10 and the sample addition box 30 stored at room temperature from the sealed bag, and place them flat on the detection table;

[0051] (2) Open the cover 33 of the sample addition box 30, suck the test sample balanced to room temperature, add it to the sample diluent in the sample addition box 30, cover the cover 33, and fully mix the test sample and the sample diluent;

[0052] (3) Insert one side of the covering film 32 at the bottom of the sample addition box 30 downward into the sample addition slot 121 on the test kit;

[0053] (4) Press the sample addition box 30 until the outer surface of the cover 33 is in the same plane as the outer surface of the upper housing 11 of the test kit, and the thimble 13 pierces the covering film 32 at the bottom of the sample addition box 30, and the diluted sample solution in the sample addition box 30 is released;

[0054] (5) After waiting for 15 minutes, turn the side of the upper housing 11 of the test kit with the viewing window 112 upward, and horizontally insert it into the corresponding detection device in the direction from top to bottom as Figure 4 shown, and quantitatively analyze H-FABP, cMyC, Cyr61, and MIF according to the pre-set standard curve;

[0055] (6) If the fluorescence signal cannot be detected by the quality control line C, the experiment fails and needs to be retested.

[0056] Regarding the detection principle of the reagent of the present utility model, no detailed description and limitation are made. It is the prior art and is known to those skilled in the art. Qualitative judgment can be made through the depth of the fluorescence color of the detection line, and the concentrations of H-FABP, cMyC, Cyr61, and MIF are calculated and the results are displayed according to the standard curve pre-set in the dry-type immunofluorescence analyzer to achieve quantitative detection.

[0057] The detection kit of the present utility model can use serum, plasma or whole blood as detection samples, with strong versatility, and can simultaneously detect H-FABP, cMyC, Cyr61, and MIF, doubling the detection efficiency, greatly reducing the workload and time required for detecting markers related to the renal function assessment of heart failure patients, quickly predicting the disease or assessing the disease course, and enabling patients to receive more timely targeted treatment. The bottom surface of the sample addition groove 121 is set as a slope, which is beneficial for all the diluted sample liquid added into the sample addition groove 121 to drain onto the test strip 20 for subsequent chromatographic reaction. In addition, a thimble 13 is provided on the bottom surface of the sample addition groove 121. When the sample mixing box 30 is inserted into the sample addition groove 121 after the sample and the diluent are mixed, the thimble 13 can pierce the covering film 32 at the bottom of the sample mixing box 30 to achieve automatic sample addition. This solves the problems in the detection kit of the prior art that the sample liquid cannot all drain onto the test strip 20 for chromatographic reaction and the slow drainage speed leads to low detection efficiency.

[0058] It should be understood that the above specific embodiments of the present utility model are only used for exemplary illustration or explanation of the principle of the present utility model, and do not constitute a limitation to the present utility model. Therefore, any modifications, equivalent replacements, improvements, etc. made without departing from the spirit and scope of the present utility model shall be included within the protection scope of the present utility model. In addition, the appended claims of the present utility model are intended to cover all changes and modification examples that fall within the scope and boundary of the appended claims, or equivalent forms of such scope and boundary.

Claims

1. A multi-index quantitative detection kit for coronary heart disease, characterized in that, The multiple indicators include H-FABP, cMyC, Cyr61, and MIF; the kit includes a housing and a test strip disposed inside the housing. A sample addition groove is formed on the housing and recessed downward along its thickness direction, and the bottom surface of the sample addition groove is inclined downwardly and extends from the end far away from the test strip towards the end close to the test strip. A thimble protruding towards the notch of the sample addition groove is further disposed on the bottom surface of the sample addition groove. The kit further includes a sample addition box filled with a sample diluent and insertable into the sample addition groove. The sample addition box includes a box body having a liquid cavity therein and openings at both ends, a covering film disposed on the opening at one end of the box body, and a cover body covering the opening at the other end of the box body. When the sample addition box is inserted into the sample addition groove, the covering film can be punctured by the thimble.

2. The detection kit according to claim 1, wherein The housing includes an upper shell and a lower shell. The sample addition groove is disposed on one side of the inner surface of the lower shell, and a sample addition port is formed on the upper shell corresponding to the notch of the sample addition groove.

3. The detection kit according to claim 2, wherein The test strip is fixed on the inner surface of the lower shell. On the inner surface of the lower shell, on the side opposite to the sample addition groove, a plurality of limiting bars protruding towards the upper shell and arranged at intervals are provided, and the plurality of limiting bars enclose a fixing space for clamping the test strip.

4. The detection kit according to claim 3, wherein The limiting bars include two opposite and spaced first limiting bars close to the sample addition groove and two opposite and spaced second limiting bars far away from the sample addition groove and opposite to the two first limiting bars. The two first limiting bars and the two second limiting bars enclose a quadrilateral area, and the area is the fixing space. The bottom surface of the sample addition groove extends to be connected to the two first limiting bars, and the interval between the two first limiting bars forms a drainage channel.

5. The detection kit according to claim 4, wherein A third limiting bar is further disposed between the two first limiting bars and the two second limiting bars.

6. The detection kit according to claim 5, wherein Any one of the first limiting bars and / or the second limiting bars is in an L shape or an inverted L shape, and the third limiting bar is in a "1" shape.

7. The detection kit according to claim 2, wherein, A viewing window for viewing through the test strip is further disposed on the outer surface of the upper shell on one side of the sample addition port.

8. The detection kit according to claim 7, characterized in that, The test strip includes a bottom plate, and a sample pad, a conjugate pad, a detection pad, and a sample absorption pad are sequentially overlapped and arranged on the bottom plate. The sample pad is close to the sample addition groove.

9. The detection kit according to claim 7, wherein, The test strip includes a bottom plate, and a sample pad, a conjugate pad, a blood filtering pad, a detection pad, and a sample absorption pad are sequentially overlapped and arranged on the bottom plate. The sample pad is close to the sample addition groove.

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