Multi-index quantitative detection reagent card for acute chest pain diagnosis

Abstract

The utility model discloses a multi-index quantitative detection reagent card for acute chest pain diagnosis, multiple indexes comprise hs-cTnI, MYO and CK-MB, the reagent card comprises a shell and a test strip, the shell comprises a first shell and a second shell, the first shell is arranged above the second shell in a sliding and covering mode to seal the test strip, and the second shell is arranged above the second shell in a sliding and covering mode to seal the test strip. One of the first shell and the second shell can slide back to the other shell under the action of external force so as to open and expose the test strip, and a reset piece is connected to the rear end of the sliding opening direction of the first shell and the second shell; when the shell is in an open state, the reset piece applies bias pressure to the second shell or the first shell, wherein the bias pressure enables one of the second shell or the first shell to slide relative to the other shell so as to reset and close the second shell or the first shell. The multi-index quantitative detection of acute chest pain diagnosis is realized, the shell is automatically reset and closed under the action of the reset piece when reaction detection is carried out after sample adding, the accuracy of a detection result is ensured, the structure is simple and practical, and the processing cost is low.

Description

Technical Field

[0001] The utility model relates to the technical field of biotechnology diagnosis, in particular to a multi-index quantitative detection reagent card for diagnosing acute chest pain. Background Art

[0002] The latest management consensus released by the European Society of Cardiology (ESC) and the Acute Cardiovascular Care Association (ACCA) in 2020 clearly states: Acute chest pain is non-traumatic pain or other chest discomfort within 24 hours of onset; chest pain is defined as located anteriorly between the base of the nose and the umbilicus, and posteriorly between the occipital bone and the 12th thoracic vertebra; pain characteristics include tingling, burning, pressure, tightness, heartburn, and similar discomforts. Acute chest pain is one of the most common clinical symptoms, accounting for 20% to 30% of visits to tertiary hospital emergency rooms.

[0003] There are many diseases that cause acute chest pain, including life-threatening high-risk chest pain such as acute coronary syndrome (ACS); acute aortic syndrome (AAS) mainly characterized by acute aortic dissection (AAD); acute pulmonary syndrome and tension pneumothorax mainly characterized by acute pulmonary embolism (APE); as well as medium- and low-risk chest pain such as stable angina, gastroesophageal reflux disease, intercostal neuralgia, and neurosis.

[0004] Acute chest pain often presents with dyspnea, a leading cause of hospitalization or death for cardiopulmonary disease. The causes of dyspnea involve multiple systems, including the respiratory, circulatory, digestive, nervous, and blood systems; acute onset can last from a few hours to a few days. In 2012, the American Thoracic Society (ATS) defined dyspnea as "a subjective experience of respiratory discomfort of varying intensity and nature." A 2014 consensus among domestic experts updated the definition of dyspnea: dyspnea is the subjective experience of respiratory discomfort of varying intensity and nature, including air shortage, shortness of breath, labored breathing, and suffocation, with or without signs of labored breathing, and may also be accompanied by changes in respiratory rate, depth, and rhythm. This definition differs from the narrow 2012 ATS definition of dyspnea, encompassing both subjective symptoms and objective signs.

[0005] A single biomarker can only provide a partial picture of the disease and cannot fully and accurately assess the pathological and pathophysiological changes in acute chest pain. Therefore, it is necessary to provide a multi-marker test kit to improve the accuracy and specificity of vascular inflammation diagnosis and address the shortcomings of existing tests. Therefore, the development of a multi-marker quantitative test kit for the diagnosis of acute chest pain is of great clinical significance.

[0006] Existing test reagent cards generally include a housing and a test strip disposed within the housing, with a sample loading port or well defined in the housing. Because the housing of such test reagent cards is typically fixed or non-detachable, in order to facilitate loading the sample onto the test strip within the housing for testing, a sample loading port or well must be defined in the housing. This increases processing steps and costs, and also increases the risk that airborne debris may enter the housing through the sample loading port or well during testing, contaminating the sample and thereby affecting the accuracy of the test results. To address the aforementioned technical issues, it is necessary to design a new test reagent card. Utility Model Content

[0007] In view of at least one of the above-mentioned technical problems, the present invention aims to provide a multi-index quantitative detection reagent card for the diagnosis of acute chest pain.

[0008] The technical solution of the utility model is:

[0009] The purpose of the utility model is to provide a multi-index quantitative detection reagent card for the diagnosis of acute chest pain, wherein the multi-index includes hs-cTnI, MYO, and CK-MB, and the reagent card includes a shell and a test strip arranged in the shell, wherein the shell includes a first shell and a second shell, and the test strip is arranged on the inner surface of the second shell, and the first shell is provided with a sliding cover along the length direction of the second shell above the second shell to enclose the test strip in the space enclosed by the first shell and the second shell, and one of the first shell or the second shell can be slid back toward the other by an external force to open and expose the test strip, and a reset member is connected to the rear end of the sliding opening direction of the first shell and the second shell, and when the shell is in the open state, the reset member applies a biasing force to the second shell or the first shell to make one of the second shell or the first shell slide relatively close to the other to reset the closure.

[0010] Preferably, the reset element is a spring.

[0011] Preferably, two fixing members spaced apart from each other are provided on the inner surface of the second shell along its length direction, a fixing space for the test strip to be fixed is defined between the two fixing members, and the test strip is fixed in the fixing space.

[0012] Preferably, any one of the fixing members is a U-shaped structural member with one end open, and the openings of the two fixing members are opposite to each other.

[0013] Preferably, both ends of the second shell in the width direction are formed with protrusions protruding away from the first shell;

[0014] The first shell is provided with a circular groove, and the protrusion is slidably embedded in the circular groove.

[0015] Preferably, the first shell is provided with an inspection window through which the test strip on the second shell can be seen, and the inspection window is sealed with a transparent film.

[0016] Preferably, in the closed state, an end portion of the second shell away from the restoring member is exposed outside the first shell.

[0017] Preferably, the first shell includes a shell body parallel to the sliding opening direction and a bending section provided at one end of the shell body and perpendicular to the shell body, and one end of the reset member is fixed to the bending section.

[0018] Preferably, the test strip comprises a bottom plate and a sample pad, a binding pad, a detection pad and a sample suction pad overlapped on the bottom plate, the sample suction pad is arranged close to the reset member and the sample pad is arranged away from the reset member.

[0019] Preferably, the detection pad includes a nitrocellulose membrane and a quality control line and a detection line provided on the nitrocellulose membrane, and the number of the detection lines corresponds to the three indicators.

[0020] Compared with the prior art, the advantages of the present invention are:

[0021] The utility model is a multi-index quantitative detection reagent card for the diagnosis of acute chest pain. It uses hs-cTnI, MYO, and CK-MB, three biomarkers of heart failure and renal function, as targets, and realizes a multi-index quantitative test for the diagnosis of acute chest pain. It can quantitatively detect the above three indicators within 15 minutes, avoiding the disadvantage that a single indicator cannot evaluate the acute chest pain situation. At the same time, it can greatly save the detection cost, reduce the difference between multiple detections, and provide more accurate detection results. It is suitable for use in hospital outpatient and emergency departments and primary medical institutions. The shell is configured to be slidably connected by two parts, and a reset part is added between the two parts to automatically reset and close when the shell is opened and the sample is added for reaction detection, ensuring that the sample will not be contaminated by the outside world during the reaction detection process on the test strip, ensuring the accuracy of the test results. The structure is simple and practical, and the processing cost is reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The present invention will be further described below with reference to the accompanying drawings and embodiments:

[0023] Figure 1 This is a schematic structural diagram of a multi-index quantitative detection reagent card for acute chest pain diagnosis in a closed state according to an embodiment of the present invention;

[0024] Figure 2 This is a schematic structural diagram of a multi-index quantitative detection reagent card for acute chest pain diagnosis according to an embodiment of the present invention, in which the first housing is omitted;

[0025] Figure 3 This is a cross-sectional view of a multi-index quantitative detection reagent card for diagnosing acute chest pain according to an embodiment of the present invention;

[0026] Figure 4 This is a schematic structural diagram of a test strip of a multi-index quantitative detection reagent card for diagnosing acute chest pain according to an embodiment of the present invention.

[0027] Among them: 10, first shell; 11, inspection window; 12, circular groove; 20, second shell; 21, fixing part; 22, protrusion; 30, test strip; 31, sample pad; 32, binding pad; 33, detection pad; 331, nitrocellulose membrane; 332, first detection line; 333, second detection line; 334, third detection line; 335, quality control line; 34, sample suction pad; 40, reset part. DETAILED DESCRIPTION

[0028] To make the objectives, technical solutions, and advantages of the present invention more clearly understood, the present invention is further described below in conjunction with specific embodiments and with reference to the accompanying drawings. It should be understood that these descriptions are merely illustrative and are not intended to limit the scope of the present invention. Furthermore, descriptions of known structures and technologies are omitted in the following description to avoid unnecessary confusion regarding the concepts of the present invention.

[0029] See also Figures 1 to 2 The present invention provides a multi-index quantitative test kit for acute chest pain diagnosis. The multi-index test kit includes hs-cTnI (high-sensitivity cardiac troponin I or high-sensitivity cardiac troponin I), MYO (myoglobin), and CK-MB (creatine kinase isoenzyme MB). This card can provide clinicians with comprehensive diagnostic information, optimize treatment plans, and improve patients' quality of life. The advantages and functions of these three targets are described below:

[0030] 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.

[0031] Myoglobin (MYO) is a small molecule pigment protein composed of globin and heme. It plays a role in transporting and storing oxygen within myocytes. When the myocardium is damaged, it diffuses out of the myocardial cells and enters the blood circulation. Myoglobin is only present in myocardium and skeletal muscle. Other tissues, including smooth muscle, do not contain this protein. It is released from the infarcted myocardium faster than cTn and CK-MB and can be detected 2 hours after large-area myocardial infarction.

[0032] Creatine kinase isoenzyme MB (CK-MB) was discovered in the 1980s. The creatine kinase molecule is a dimer composed of a brain-type subunit (B) and a muscle-type subunit (M). Three isoenzymes are commonly found in normal human tissue: CK-BB, CK-MB, and CK-MM, in order of electrophoretic speed. CK-BB is primarily found in smooth muscle and brain tissue and is virtually absent in serum. CK-MB is primarily found in myocardial tissue, accounting for 0–4% of serum CK. CK-MM is primarily found in skeletal muscle, accounting for 96–100% of serum CK. CK-MB was once the gold standard for diagnosing acute myocardial infarction. Recent studies have shown that CK-MB lacks specificity, leading to its frequent co-analysis with cTnI and MYO to mitigate the diagnostic risk associated with this lack of specificity.

[0033] Specifically, the detection reagent card of the embodiment of the present invention includes a shell and a test strip 30 arranged in the shell. Compared with the detection reagent card of the prior art, the main improvement of the detection reagent card of the present invention lies in the shell. More specifically, the shell of the reagent card of the embodiment of the present invention includes a first shell 10 and a second shell 20. The test strip 30 is arranged on the inner surface of the second shell 20, that is, on the side facing the first shell 10. The first shell 10 is a sliding cover arranged above the second shell 20 along the length direction of the second shell 20 to enclose the test strip 30 in the space enclosed by the first shell 10 and the second shell 20, thereby preventing the test strip 30 from being contaminated by the outside world and ensuring the accuracy of the detection. In the embodiment of the present invention, one of the first shell 10 or the second shell 20 can be subjected to an external force such as a hand push or hand pull to slide back to the other to open the shell and expose the test strip 30 in the shell, so that the sample can be added to the test strip 30 for detection during detection. At the rear end (with the first shell 10 and the second shell 20 sliding opening direction) of the first shell 10 and the second shell 20, the test strip 30 is opened. Figure 1 For example, the rear side second shell 20 is pulled downward to slide open direction or the front side first shell 10 is pulled upward to slide open direction, then the second shell 20 is upward to slide closed direction or the front side first shell 10 is downward to slide closed direction, the rear end of the sliding opening direction here is Figure 1A reset member 40 is connected to the upper end of the first shell 10 or the second shell 20 shown in the figure. The purpose of the reset member 40 is to apply reset sliding to the first shell 10 or the second shell 20 relative to the other when the shell is in the open state, so as to switch from the open state to the closed state. That is, by providing the reset member 40, after the shell is opened and the sample to be tested is added to the test strip 30 for testing, the second shell or the first shell can be released and the shell can be automatically reset to switch to the closed state, thereby ensuring that the test strip 30 will not be contaminated by the outside world during the testing process, reducing the manual closing operation, simple structure and strong practicality. At the same time, there is no need to open a sample addition groove, sample addition port or sample addition hole on the shell, specifically the first shell 10, thereby reducing processing costs. At the same time, it also solves the problem of low detection accuracy caused by impurities in the air entering the shell through the sample addition groove, sample addition port or sample addition hole, thereby contaminating the sample, thereby improving the accuracy of the test results.

[0034] According to some preferred embodiments of the present invention, Figure 2 As shown, the reset member 40 is a spring. An example is a conventional tubular straight spring. Of course, other reset members 40 known to those skilled in the art that can achieve the same function may also be used, and these are not specifically described here. As described above, the reset member 40 primarily functions to automatically reset to a closed position after sample loading is complete. Furthermore, if the housing is opened due to unintended use, such as misoperation, it can promptly return to its original position and close, thereby sealing the sample loading pad of the test strip 30 and preventing contamination caused by exposure.

[0035] According to some preferred embodiments of the present invention, in order to facilitate the fixation of the test strip 30, the inner surface of the second housing 20 is provided with two ends along the length direction of the second housing 20, that is, Figure 3 As shown, there is a fixing member 21 at each of the upper and lower ends. The two fixing members 21 are relatively spaced to define a fixed space for the test strip 30 to be fixed. The test strip 30 can be directly fixed in the fixed space. For any fixing member 21, it can be selected as follows Figure 3 The U-shaped structure with an opening is shown, and the openings of the two fixing members 21 are arranged opposite to each other. As an alternative embodiment, the test strip 30 of the embodiment of the present utility model can also be directly adhered and fixed on the inner surface of the second housing 20.

[0036] According to some preferred embodiments of the present invention, for the structure of realizing the sliding connection between the first shell 10 and the second shell 20, in the embodiments of the present invention, Figure 4 As shown, the second housing 20 is in an inverted U shape, that is, both ends of the second housing 20 in the width direction are as shown. Figure 4The left and right ends are respectively provided with a protrusion 22 extending downward. Correspondingly, the first shell 10 is provided with a return groove 12, and the protrusion 22 is slidably embedded in the return groove 12. Specifically, as Figure 4 As shown in the cross-section of the first housing 10, a bottom surface has an opening in the middle, with two extensions (not shown) extending upward at each end of the opening. A sliding groove is defined between each extension and the corresponding sidewall. The two sliding grooves form a circular groove 12 between the top surface of the first housing 10. This structural design can fix the first housing 10 and the second housing 20 relative to each other and prevent them from moving freely.

[0037] According to some preferred embodiments of the present invention, Figure 1 As shown, to facilitate observation of the color reaction on the test strip 30 during post-sample reaction testing, the first housing 10 is provided with an inspection window 11 through which the test strip 30 on the second housing 20 can be viewed. While conventional inspection windows 11 on reagent cards are typically hollowed-out, in the present embodiment, inspection window 11 is enclosed by a transparent plastic film. This prevents airborne debris from entering the test strip 30 through inspection window 11 during testing, thereby affecting the accuracy of test results. The shape of inspection window 11 is not specifically defined and can be a long strip, waist-shaped, or other suitable shape.

[0038] According to some preferred embodiments of the present invention, Figure 1 As shown, in the closed state, one end of the second shell 20 away from the reset member 40 is exposed outside the first shell 10. This design makes it convenient to pull the second shell 20 through the part of the second shell 20 exposed outside the first shell 10 to achieve the purpose of opening the shell, thereby improving the convenience of opening the shell.

[0039] According to some preferred embodiments of the present invention, Figure 2 As shown, one end of the reset member 40 is directly fixed to the end of the second housing 20. To facilitate the installation and fixation of the other end of the reset member 40, the first housing 10 includes a housing body (not shown) parallel to the sliding opening direction and a bent section (not shown) provided at one end of the housing body and arranged perpendicular to the housing body. One end of the reset member 40 is fixed to the bent section. In other words, the cross-section of the first housing 10 in the longitudinal direction is roughly L-shaped.

[0040] According to some preferred embodiments of the present invention, Figure 2 and Figure 4As shown, in the embodiment of the present invention, the test strip 30 includes a bottom plate (not shown) and a sample pad 31, a conjugation pad 32, a detection pad 33 and a sample suction pad 34 overlapped and arranged on the bottom plate, the sample suction pad 34 is arranged close to the reset member 40 and the sample pad 31 is arranged away from the reset member 40. That is, the sample pad 31, the conjugation pad 32, the detection pad 33 and the sample suction pad 34 are arranged along the bottom plate. Figure 2 or Figure 4 The directions shown are arranged in sequence from top to bottom. That is, when in the open state, the first part of the test strip 30 to be exposed is the sample pad 31. When the shell is opened for sample addition, it is only necessary to expose the sample pad 31, without pulling it out to expose the entire test strip 30, thereby reducing the possibility of the test strip 30 being contaminated. For the bottom plate, a conventional PVC material can be selected to provide support. After the shell is opened to expose the sample pad 31, the sample liquid can be added directly to the sample pad 31. After the shell is released, it will automatically reset and close under the action of the reset member 40. The test strip 30 can then move the sample liquid from one side of the sample pad 31 to the side of the conjugate pad 32 and the detection pad 33 under the capillary suction of the sample suction pad 34 for detection and analysis. It should be noted that the conjugate pad 32 is coated with a fluorescently labeled monoclonal antibody, which is a detection indicator Hs-cTnI or MYO or CK-MB monoclonal antibody and a monoclonal antibody for binding to the quality control line 335.

[0041] According to some preferred embodiments of the present invention, the detection pad 33 includes a nitrocellulose membrane 331 and a quality control line 335 and a detection line provided on the nitrocellulose membrane 331. The number of detection lines corresponds to the three indicators, that is, there are three detection lines, while there is only one quality control line 335. The detection line is coated with a paired antibody or antigen that specifically binds to a fluorescent (time-resolved fluorescent microspheres or quantum dot microspheres) labeled antibody (i.e., Hs-cTnI or MYO or CK-MB monoclonal antibody). Figure 4 As shown, the control line 335 is located at the upper end of the test lines. The three test lines are described from bottom to top as the first test line 332, the second test line 333, and the third test line 334. For example, the first test line 332 is the Hs-MYO test line, the second test line 333 is the MYO test line, and the third test line 334 is the CK-MB test line. The coating of the control line 335 can be a hapten, goat anti-mouse IgG, goat anti-chicken IgY, or goat anti-rabbit IgG. The fluorescent microspheres used for coupling can be fluorescent microsphere complexes coated with rare metals (such as europium, terbium, samarium, neodymium, or dysprosium) or quantum dot-coated fluorescent microsphere complexes.

[0042] The use process of the multi-index quantitative detection reagent card of the embodiment of the utility model:

[0043] (1) Take out the reagent card and sample processing solution stored at room temperature from the sealed bag and place them flat on the test table;

[0044] (2) Aspirate the sample to be tested that has been equilibrated to room temperature, pull out the second shell 20 of the reagent card by hand or other tools, and add the sample to the bottom of the sample pad 31;

[0045] (3) Release the second housing 20, and the second housing 20 will automatically return to its original position and seal the test strip 30 in the housing;

[0046] (5) After waiting for 15 minutes, insert the reagent card with the inspection window 11 facing upward into the corresponding detection device (not shown);

[0047] (6) The detection device automatically performs quantitative analysis of high-sensitive cardiac troponin I (hs-cTnI), myoglobin (MYO), and creatine kinase isoenzyme MB (CK-MB) based on a pre-set standard curve;

[0048] (7) If the quality control line 335 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 card of the present invention will not be described or limited in detail, as it is prior art and well known to those skilled in the art. The concentrations of high-sensitive cardiac troponin I (hs-cTnI), myoglobin (MYO), and creatine kinase isoenzyme MB (CK-MB) are calculated and displayed based on a standard curve pre-set within a dry-type immunofluorescence analyzer to achieve quantitative detection.

[0050] The detection reagent card of the present invention can use serum, plasma or whole blood as the detection sample, has strong versatility, and can simultaneously detect hs-cTnI, MYO, and CK-MB, which greatly increases the detection efficiency, greatly reduces the workload and time required for marker detection in the diagnosis of acute chest pain, and quickly predicts or evaluates the course of the disease, so that patients can receive more timely targeted treatment. It realizes a multi-index quantitative test for the diagnosis of acute chest pain, and can quantitatively detect the above three indicators within 15 minutes, avoiding the disadvantage that a single indicator cannot evaluate the acute chest pain situation. At the same time, it can greatly save the detection cost, reduce the difference between multiple tests, and provide more accurate test results. It is suitable for use in hospital outpatient and emergency departments and primary medical institutions. The shell is configured to be slidably connected by two parts, and a reset member 40 is added between the two parts to automatically reset and close when the reaction test is carried out after the shell is opened and the sample is added, ensuring that the sample will not be contaminated by the outside world during the reaction test on the test strip 30, ensuring the accuracy of the test results. The structure is simple and practical, and the processing cost is reduced.

[0051] It should be understood that the above-described specific embodiments of the present invention are merely illustrative of or explanation of the principles of the present invention and do not constitute limitations of the present invention. Therefore, any modifications, equivalent substitutions, improvements, etc. made without departing from the spirit and scope of the present invention shall be included within the scope of protection of the present invention. In addition, the appended claims of the present invention are intended to cover all variations and modifications that fall within the scope and metes and bounds of the appended claims, or equivalents thereof.

Claims

1. A multi-index quantitative detection reagent card for the diagnosis of acute chest pain, characterized in that: The multiple indicators include hs-cTnI, MYO, and CK-MB. The reagent card includes a shell and a test strip arranged in the shell. The shell includes a first shell and a second shell. The test strip is arranged on the inner surface of the second shell. The first shell has a sliding cover arranged above the second shell along the length direction of the second shell to enclose the test strip in the space enclosed by the first shell and the second shell. One of the first shell or the second shell can be slid toward the other under the action of external force to open and expose the test strip. A reset member is connected to the rear end of the sliding opening direction of the first shell and the second shell. When the shell is in the open state, the reset member applies a biasing force to the second shell or the first shell to make one of the second shell or the first shell slide relatively close to the other to reset the closure.

2. The multi-indicator quantitative detection reagent card according to claim 1, characterized in that: The reset element is a spring.

3. The multi-indicator quantitative detection reagent card according to claim 1, characterized in that: Two fixing members spaced apart from each other are provided on the inner surface of the second shell along its length direction. A fixing space for the test strip to be fixed is defined between the two fixing members. The test strip is fixed in the fixing space.

4. The multi-indicator quantitative detection reagent card according to claim 3, characterized in that: Any of the fixing members is a U-shaped structural member with one end open, and the openings of the two fixing members are opposite to each other.

5. The multi-indicator quantitative detection reagent card according to claim 1, characterized in that: Both ends of the second shell in the width direction are protruded away from the first shell to form protrusions; The first shell is provided with a circular groove, and the protrusion is slidably embedded in the circular groove.

6. The multi-indicator quantitative detection reagent card according to claim 1, characterized in that: The first shell is provided with an inspection window through which the test strip on the second shell can be seen through, and the inspection window is sealed with a transparent film.

7. The multi-indicator quantitative detection reagent card according to claim 1, characterized in that: In the closed state, an end portion of the second shell away from the restoring member is exposed outside the first shell.

8. The multi-indicator quantitative detection reagent card according to claim 1, characterized in that: The first shell includes a shell body parallel to the sliding opening direction and a bending section provided at one end of the shell body and perpendicular to the shell body, and one end of the reset member is fixed to the bending section.

9. The multi-indicator quantitative detection reagent card according to claim 1, characterized in that: The test strip includes a bottom plate and a sample pad, a binding pad, a detection pad and a sample suction pad overlapped on the bottom plate. The sample suction pad is arranged close to the reset member and the sample pad is arranged away from the reset member.

10. The multi-indicator quantitative detection reagent card according to claim 9, characterized in that: The detection pad includes a nitrocellulose membrane and a quality control line and a detection line arranged on the nitrocellulose membrane. The number of the detection lines corresponds to the three indicators.

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