Multi-index joint detection kit for chest pain risk assessment

Abstract

The utility model discloses a multi-index joint detection kit for chest pain risk assessment, which comprises a detection module, the detection module comprises a shell and a detection card, the detection card comprises a bottom plate, a sample adding pad, a chromatography shunting pad, three groups of detection components and a sample absorbing pad, and the three groups of detection components are respectively arranged at the left, middle and right positions. The three groups of detection assemblies respectively comprise a combination pad and a detection pad; the multiple indexes comprise hypersensitive cardiac troponin, an amino-terminal brain natriuretic peptide precursor and hypersensitive C-reactive protein; the combination pad in the middle comprises a C-reactive protein antibody fluorescent microsphere compound, and the other two combination pads respectively comprise a hypersensitive cardiac troponin antibody fluorescent microsphere compound and an amino-terminal brain natriuretic peptide precursor antibody fluorescent microsphere compound; and a detection line and a quality control line are arranged on the detection pad. According to the utility model, unified sample adding and split-flow chromatography are realized, the detection cost can be greatly saved, the detection efficiency is improved, and a more accurate detection result is provided.

Description

Technical Field

[0001] The utility model relates to the technical field of biotechnology diagnosis, and in particular to a multi-index combined detection kit for chest pain risk assessment. Background Art

[0002] Chest pain mainly refers to pain and discomfort in the chest area. Patients often complain of dull pain, tightness, burning, tingling, squeezing, tearing, knife-like pain, and some difficult-to-describe symptoms. The location of chest pain generally refers to the area from the neck to the lower end of the thorax, and sometimes it can radiate to the maxillofacial area, teeth and throat, shoulders and back, upper limbs or upper abdomen. According to the risk level of chest pain, chest pain can be divided into fatal chest pain and non-fatal chest pain, and can also be divided into cardiac chest pain and non-cardiac chest pain. The manifestations of chest pain of different causes are diverse and complex, the risks are different, and the treatment varies from disease to disease. Improper treatment will delay treatment and lead to serious consequences. Therefore, primary care doctors need to quickly identify the nature of chest pain and accurately assess the risk to ensure that high-risk chest pain patients receive timely and effective treatment. The main biological indicators used in clinical chest pain detection are high-sensitive cardiac troponin I (hs-cTnI), amino-terminal pro-brain natriuretic peptide (NT-proBNP), and C-reactive protein (hs-CRP))

[0003] Cardiac troponin I (cTnI) is a regulatory protein unique to myocardial tissue that can inhibit the binding of myosin to actin and plays an important role in myocardial contraction. A large number of studies have shown that in the process of cardiovascular disease, the level of cardiac troponin I (cTnI) varies greatly and is one of the important serum markers of myocardial cell damage.

[0004] Amino-terminal pro-brain natriuretic peptide (NT-proBNP) is a polypeptide synthesized and secreted by cardiomyocytes. It is the N-terminal cleavage product of the pro-brain natriuretic peptide. Brain natriuretic peptide is an important endogenous antidiuretic hormone that can maintain fluid balance by promoting the excretion of sodium and water. NT-proBNP is mainly produced by ventricular myocytes, and its synthesis and secretion are stimulated by cardiac load. When the cardiac load increases, cardiac muscle cells synthesize and release more NT-proBNP. As an important cardiac biomarker, NT-proBNP has broad clinical application prospects. Numerous studies have shown that it plays an important role in the diagnosis, prognosis assessment, and treatment monitoring of cardiovascular diseases.

[0005] C-reaction protein (CRP) is an acute phase protein with a positive pentamer structure. It is highly stable and accurate, and serves as a nonspecific marker of inflammation and tissue damage. When inflammation or tissue damage occurs, CRP is promptly produced by liver cells and rapidly increases (100-1000 times the normal level), reaching a peak in around 48 hours. Its half-life is only 19 hours. If CRP levels persist after treatment, it may indicate that damage is still present.

[0006] Currently, the detection methods for high-sensitive cardiac troponin I (hs-cTnI), amino-terminal pro-brain natriuretic peptide (NT-proBNP), and C-reactive protein (CRP) are primarily based on existing immunochromatographic reagents. Because the reaction concentrations of NT-proBNP and hs-cTnI are extremely low (pg / mL level) and the C-reactive protein level is relatively high (mg / L level), the combined detection of these three markers is typically based on three separate tests and the combined statistical analysis. This testing method has drawbacks such as high testing cost, low efficiency, and high variability in multiple tests, leading to inaccurate results.

[0007] Therefore, it is necessary to provide a multi-index combined detection kit for chest pain risk assessment to achieve unified sampling and diversion chromatography, so as to achieve the purpose of improving assessment accuracy, increasing efficiency, reducing costs and simplifying operation. Utility Model Content

[0008] In order to solve the above technical problems, the purpose of the present utility model is to provide a multi-index combined detection kit for chest pain risk assessment, which realizes unified sampling and diversion chromatography, can greatly save detection costs, improve detection efficiency, reduce the differences in multiple tests, and provide more accurate test results.

[0009] In order to achieve the above technical objectives and the above technical effects, the present invention is implemented through the following technical solutions:

[0010] A multi-index combined detection kit for chest pain risk assessment includes a detection module, the detection module includes a housing and a detection card installed in the housing, the detection card includes a bottom plate and a sample adding pad, a chromatography shunt pad, three groups of detection components, and a sample suction pad, which are sequentially overlapped and arranged on the bottom plate from front to back, the three groups of detection components are respectively arranged at the left, middle, and right positions between the chromatography shunt pad and the sample suction pad, the sample adding pad is arranged in the middle of the chromatography shunt pad; the three groups of detection components respectively include a binding pad and a detection pad; the multiple indicators include high-sensitive cardiac troponin, amino The test pad comprises three indicators: amino-terminal pro-brain natriuretic peptide and high-sensitive C-reactive protein; the conjugate pad in the middle contains a C-reactive protein antibody fluorescent microsphere complex, and the other two conjugate pads contain a high-sensitive cardiac troponin antibody fluorescent microsphere complex and an amino-terminal pro-brain natriuretic peptide antibody fluorescent microsphere complex respectively; each test pad is provided with a test line and a quality control line, each test line is coated with a specific capture antibody corresponding to the indicator on its corresponding conjugate pad, and the quality control line is coated with a hapten or antibody that can bind to the antibody fluorescent microsphere complex on the conjugate pad.

[0011] Furthermore, the housing includes an upper cover plate and a lower cover plate, the detection card is arranged in a space formed by the upper cover plate and the lower cover plate, and the sample adding pad extends out of the housing.

[0012] Furthermore, an inspection window corresponding to the position of the three groups of detection components is provided on the upper cover plate of the shell.

[0013] Furthermore, the detection kit also includes a sample loading module assembled with the detection module, the sample loading module includes a sample loading shell and a sample loading tank body arranged in the sample loading shell; the inner cavity of the sample loading shell is filled with sample diluent, the sample loading tank body is made of a plastic film and one side of it is open, and the sample loading shell is provided with a sample loading hole corresponding to the open side of the sample loading tank body; the sample loading pad can be inserted into the sample loading tank body through the sample loading hole.

[0014] Furthermore, a snap-fit ​​protrusion is provided on the front side of the shell of the detection module, and a snap-fit ​​groove is provided on the sample loading shell. The sample loading module is assembled with the detection module through the cooperation between the snap-fit ​​groove and the snap-fit ​​protrusion.

[0015] Furthermore, the sample loading housing is a rectangular parallelepiped structure.

[0016] Furthermore, the thickness of the bonding pads located at the left and right portions is greater than the thickness of the bonding pad located at the middle portion.

[0017] Furthermore, the sample loading pad, chromatography shunt pad and binding pad are glass fiber pads or non-woven fabric pads, the detection pad is made of nitrocellulose membrane, the sample absorption pad is made of absorbent filter paper, and the bottom plate is a PVC board.

[0018] Beneficial effects of the utility model:

[0019] The utility model realizes the combined detection of chest pain risk assessment and can quantitatively detect three indicators, high-sensitive cardiac troponin, amino-terminal pro-brain natriuretic peptide, and high-sensitive C-reactive protein, within 15 minutes. The results are accurate and suitable for use in hospital outpatient and emergency departments and primary medical institutions.

[0020] The utility model realizes unified sampling and diversion chromatography for three indicators. Compared with the method of three separate tests and combined statistics, it can greatly save detection costs, improve detection efficiency, reduce the differences in multiple tests, and improve the accuracy of detection results.

[0021] In addition, the test kit of the present invention also includes a sample adding module containing a sample diluent, which binds an appropriate amount of sample diluent to the detection module, not only facilitating the sample dilution operation, but also avoiding the problem of easy loss of the sample diluent during detection; furthermore, when adding the sample, the sample diluent is allowed to slowly seep into the tank body by puncturing the membrane of the sample adding tank body, thereby controlling the reaction speed. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 Schematic diagram of the overall structure of the test kit of the present utility model.

[0023] Figure 2 It is a structural schematic diagram of the detection module (excluding the upper cover) of the test kit of the utility model.

[0024] Figure 3 It is a schematic diagram of the exploded structure of the test kit of the present utility model.

[0025] In the figure, 1: detection module, 10: housing, 101: snap-on protrusion, 102: inspection window, 11: sample loading pad, 12: chromatography diversion pad, 13: binding pad, 14: detection pad, 141: detection line, 142: quality control line, 15: sample suction pad; 2: sample loading module, 21: sample loading shell, 211: snap-on groove, 22: sample loading tank body. DETAILED DESCRIPTION

[0026] The preferred embodiments of the present invention are described in detail below in conjunction with the accompanying drawings so that the advantages and features of the present invention can be more easily understood by those skilled in the art, thereby making a clearer and more precise definition of the protection scope of the present invention.

[0027] In the description of the present invention, it should be understood that the terms "front", "rear", "left", "right", "up", "down", etc., indicating directions or positional relationships, are based on the directions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as a limitation on the present invention.

[0028] like Figures 1 to 3 A multi-index combined detection kit for chest pain risk assessment is shown, comprising a detection module 1, the detection module 1 comprising a housing 10 and a detection card installed in the housing 10, the detection card comprising a base plate and a sample loading pad 11, a chromatography shunt pad 12, three groups of detection components, and a sample suction pad 15, which are overlapped and arranged on the base plate from front to back. The chromatography shunt pad 12 and the sample suction pad 15 extend in the left-right direction. The three groups of detection components are respectively arranged at the left, middle, and right positions between the chromatography shunt pad 12 and the sample suction pad 15. The sample loading pad 11 is arranged in the middle of the chromatography shunt pad 12; the three groups of detection components respectively comprise a conjugation pad 13 and a detection pad 14; the conjugation pad 13 is close to the chromatography shunt pad 12. The thickness of the conjugation pads 13 located on the left and right portions is greater than the thickness of the conjugation pad 13 located in the middle portion. The shape of the base plate corresponds to the shape formed by the overlap of the sample loading pad, the chromatography shunt pad, the three groups of detection components, and the sample suction pad.

[0029] The multiple indicators include high-sensitive cardiac troponin, amino-terminal pro-brain natriuretic peptide, and high-sensitive C-reactive protein; the conjugation pad 13 located in the middle contains a C-reactive protein antibody fluorescent microsphere complex, and the other two conjugation pads contain high-sensitive cardiac troponin antibody fluorescent microsphere complex and amino-terminal pro-brain natriuretic peptide antibody fluorescent microsphere complex, respectively. For example, the conjugation pad located on the left contains a high-sensitive cardiac troponin antibody fluorescent microsphere complex, and the conjugation pad located on the right contains an amino-terminal pro-brain natriuretic peptide antibody fluorescent microsphere complex; each detection pad 14 is provided with a detection line 141 and a quality control line 142, and the quality control line 142 is close to the sample suction pad 15; each detection line 141 is coated with a specific capture antibody corresponding to the indicator on its corresponding conjugation pad, and the quality control line 142 is coated with a hapten or antibody that can bind to the antibody fluorescent microsphere complex on the conjugation pad 13.

[0030] The antibody in the antibody-fluorescent microsphere complex on the conjugate pad 13 may be a polyclonal antibody or a monoclonal antibody, and the fluorescent microsphere complex may be a rare metal-coated fluorescent microsphere complex or a quantum dot-coated fluorescent microsphere complex.

[0031] The specific capture antibody used to coat the test line can be a polyclonal antibody or a monoclonal antibody. The control line can be coated with a hapten, goat anti-mouse IgG, goat anti-chicken IgY, or goat anti-rabbit IgG.

[0032] The sample loading pad 11, chromatography shunt pad 12 and conjugation pad 13 are glass fiber pads or non-woven fabric pads, the detection pad 14 is made of nitrocellulose membrane, the sample absorption pad 15 is made of absorbent filter paper, and the bottom plate is a PVC board.

[0033] The sample pad 11 is used to add the sample. After the sample is added, it is chromatographed upward along the sample pad 11 into the chromatography diversion pad 12 under the action of the chromatography force formed by the sample suction pad 15. On the chromatography diversion pad 12, due to the different diffusion distances of the chromatography liquid to the surrounding areas, more liquid will enter the binding pad 13 in the middle, and less liquid will enter the binding pads on the left and right. This meets the low detection volume required for hs-cTnI and NT-proBNP and the high detection volume required for CRP.

[0034] After the liquid enters the conjugate pad 13 , it combines with the antibody-fluorescent microsphere complex on the conjugate pad 13 , flows upward along the detection pad 14 , and combines with the specific capture antibody on the detection line 141 to form a detection signal.

[0035] The thickness of the conjugate pads on the left and right is greater than that of the conjugate pad in the middle, so the amount of liquid retained is greater, further reducing the amount of reactants.

[0036] The housing 10 includes an upper cover and a lower cover. The detection card is disposed in a space formed by the upper cover and the lower cover, and the sample pad 11 extends out of the housing 10 .

[0037] An inspection window 102 corresponding to the positions of the three detection components is provided on the upper cover of the housing 10. The orthographic projection of the inspection window 102 on the detection pad 14 should be larger than the area formed by the detection line 141, the quality control line 142, and the space between them, so as to facilitate clearer and more direct observation.

[0038] The detection kit also includes a sample loading module 2 assembled with the detection module 1, and the sample loading module 2 includes a sample loading housing 21 and a sample loading tank 22 disposed in the sample loading housing 21; the sample loading housing 21 is a rectangular parallelepiped structure. The internal space enclosed by the sample loading housing 21 and the sample loading tank 22 is an inner cavity, and the inner cavity of the sample loading module 2 is filled with a sample diluent; the sample loading tank 22 is made of a plastic film and one side of it is open. The sample loading housing 21 is provided with a sample loading hole (on the open side of the sample loading tank 22) corresponding to the open side. Figure 3The sample loading hole faces the sample loading pad); the sample loading pad 11 can be inserted into the sample loading slot 22 through the sample loading hole. Two symmetrical snap-in protrusions 101 are provided on the front side of the housing 10 of the detection module 1. The sample loading housing 21 is provided with a snap-in groove 211. The sample loading module 2 is assembled with the detection module 1 through the engagement of the snap-in grooves 211 and the snap-in protrusions 101.

[0039] The sample diluent includes the following components: a buffer system, a protein, a blocking agent, a carbohydrate, a surfactant, and polyethylene glycol. The buffer system can be a phosphate buffer system, a Tris buffer system, or a Hepes buffer system; the buffer system has a pH between 6.0 and 9.0; the protein can be bovine serum albumin, mouse IgG, or a mixture of the two; the blocking agent is known to those skilled in the art and is not described or limited here.

[0040] When adding samples, remove the sample loading module 2, use a pipette tip or a rubber-tipped dropper to pass through the sample loading hole of the sample loading housing 21, and then pierce the plastic film to add the sample to the diluent. After the diluent is added, the mixture of the diluent and the sample will enter the interior of the sample loading tank 22 composed of the plastic film through the rupture of the film; the sample loading module 2 is returned to the detection module 1, and the sample loading pad 11 will contact the mixture of the diluent and the sample and perform chromatography to start detecting the content of the substance to be tested in the sample.

[0041] The method of using the test kit of the present invention is as follows:

[0042] (1) Take out the test kit and sample processing solution stored at room temperature from the sealed bag and place them flat on the test table;

[0043] (2) Remove the sample loading module 2, place it with the sample loading hole facing upward, draw the sample to be tested that has been equilibrated to room temperature, and use a pipette tip or a rubber-tipped dropper to pierce the plastic film of the sample loading tank 22;

[0044] (3) Mixing the sample with the sample diluent in the sample loading module;

[0045] (4) The sample loading module 2 is mounted back on the detection module 1, and the sample loading pad 11 is inserted into the sample loading tank 22. The mixture of the sample and the sample diluent enters the sample loading tank 22 through the holes in the plastic film. The sample loading pad 11 of the detection module 1 contacts the mixture of the sample and the sample diluent, and chromatography automatically begins.

[0046] (5) After waiting for 15 minutes, insert the detection module 1 with the inspection window 102 facing upward into the corresponding detection device (dry immunofluorescence analyzer);

[0047] (6) The detection device automatically performs quantitative analysis of cardiac troponin I (hs-cTnI), amino-terminal pro-brain natriuretic peptide (NT-proBNP), and C-reactive protein (CRP) according to a pre-set standard curve;

[0048] (7) If the quality control line does not detect a fluorescent signal or the fluorescent signal is lower than the set value, the experiment fails and needs to be retested.

[0049] The detection principle of the reagent of the present invention is not described or limited in detail, as it is well known to those skilled in the art. The concentrations of cardiac troponin I (hs-cTnI), amino-terminal pro-brain natriuretic peptide (NT-proBNP), and C-reactive protein (CRP) are calculated and displayed based on a standard curve pre-set within the dry-type immunofluorescence analyzer to achieve quantitative detection.

[0050] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the present invention can be implemented in other specific forms without departing from the spirit or essential features of the present invention. Therefore, the embodiments should be considered in all respects as illustrative and non-restrictive, and the scope of the present invention is defined by the appended claims rather than the foregoing description, and it is intended that all variations that come within the meaning and range of equivalents of the claims be embraced within the present invention.

[0051] In addition, it should be understood that although this specification is described in terms of implementation methods, not every implementation method contains only one independent technical solution. This narrative method of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment can also be appropriately combined to form other implementation methods that can be understood by those skilled in the art.

Claims

1. A multi-index combined detection kit for chest pain risk assessment, characterized in that: The invention comprises a detection module, wherein the detection module comprises a housing and a detection card installed in the housing, wherein the detection card comprises a bottom plate and a sample loading pad, a chromatography shunt pad, three detection components and a sample suction pad which are overlapped on the bottom plate from front to back, respectively. The three detection components are respectively arranged at the left, middle and right positions between the chromatography shunt pad and the sample suction pad, and the sample loading pad is arranged in the middle of the chromatography shunt pad; the three detection components respectively comprise a binding pad and a detection pad; the multiple indicators include high-sensitive cardiac troponin, amino-terminal brain natriuretic peptide precursor, super The binding pad located in the middle contains a C-reactive protein antibody fluorescent microsphere complex, and the other two binding pads contain a high-sensitive cardiac troponin antibody fluorescent microsphere complex and an amino-terminal pro-brain natriuretic peptide antibody fluorescent microsphere complex respectively; each detection pad is provided with a detection line and a quality control line, each detection line is coated with a specific capture antibody corresponding to the indicator on its corresponding binding pad, and the quality control line is coated with a hapten or antibody that can bind to the antibody fluorescent microsphere complex on the binding pad.

2. A multi-index combined detection kit for chest pain risk assessment according to claim 1, characterized in that: The shell comprises an upper cover plate and a lower cover plate, the detection card is arranged in a space formed by the upper cover plate and the lower cover plate, and the sample adding pad extends out of the shell.

3. A multi-index combined detection kit for chest pain risk assessment according to claim 2, characterized in that: An inspection window corresponding to the positions of the three groups of detection components is provided on the upper cover plate of the shell.

4. A multi-index combined detection kit for chest pain risk assessment according to claim 1, characterized in that: The device also includes a sample loading module assembled with the detection module, the sample loading module including a sample loading shell and a sample loading tank disposed in the sample loading shell; the inner cavity of the sample loading shell is filled with a sample diluent, the sample loading tank is made of a plastic film and has one side open, and the sample loading shell is provided with a sample loading hole corresponding to the open side of the sample loading tank; the sample loading pad can be inserted into the sample loading tank through the sample loading hole.

5. A multi-index combined detection kit for chest pain risk assessment according to claim 4, characterized in that: The front side of the shell of the detection module is provided with a clamping protrusion, and the sample loading housing is provided with a clamping groove. The sample loading module is assembled with the detection module through the cooperation of the clamping groove and the clamping protrusion.

6. A multi-index combined detection kit for chest pain risk assessment according to claim 4, characterized in that: The sample adding shell is a rectangular parallelepiped structure.

7. A multi-index combined detection kit for chest pain risk assessment according to claim 1, characterized in that: The thickness of the bonding pads located at the left and right portions is greater than the thickness of the bonding pad located at the middle portion.

8. The multi-index combined detection kit for chest pain risk assessment according to claim 1, characterized in that: The sample loading pad, chromatography shunt pad and binding pad are glass fiber pads or non-woven fabric pads, the detection pad is made of nitrocellulose membrane, the sample absorption pad is made of absorbent filter paper, and the bottom plate is a PVC board.

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