Detection kit and biochemical immunoassay method

Abstract

The present invention is applicable to the field of in vitro diagnosis (IVD) technology, and discloses a detection kit and a biochemical immunoassay method, wherein the detection kit includes a first box body for accommodating a first reagent, a second box body for accommodating a second reagent, and a box cover for covering and installing on the top of the first box body, and the first box body includes a hollow shell body whose bottom can be inserted into the second box body and whose top can be stuck outside the second box body, a sealing plug for sealing the bottom of the hollow shell body, and a sealing sheet for sealing the top of the hollow shell body. The detection kit of the present invention is used for biochemical immunoassay, and only one liquid transfer and sample addition is required, which reduces the cumulative error of multiple sample additions, improves the accuracy and reliability of the detection, and also improves the efficiency of the detection and the risk of error in manual operation; and the detection kit constitutes a sealed detection environment, which reduces the biological infection hazard to the operator and avoids the biological infection hazard to the operator during the collection and treatment of waste.

Description

Technical Field

[0001] The present invention relates to the technical field of in vitro diagnosis (IVD), and in particular to a detection kit and a biochemical immunoassay method using the detection kit. Background Art

[0002] In vitro diagnostics (IVD), especially in the field of IVD based on rapid diagnosis (POCT), requires adding human or animal body fluids, mainly blood (plasma, serum, whole blood, etc.) to one or more reagents for biochemical reactions. In the existing technology, there are roughly two schemes for biochemical immunoassays:

[0003] 1) Separate multiple independent chambers on a test kit, and then use a pipette or machine to take samples in turn, mix them, and then perform biochemical reactions. When using this test kit for biochemical immunoassays, it is necessary to pipette different reagents into the same experimental sample reaction vessel multiple times, so frequent pipetting is required during the test process. If manual testing is used, multiple sampling is required, which is time-consuming and inefficient. There is also a risk of contamination that may cause biochemical hazards, affecting test results and even endangering the health of the test operator. If machine testing is used, it is necessary to overcome the cross-contamination of each reagent, and at the same time overcome the impact of the cumulative errors of multiple sampling on the test results.

[0004] 2) The solid or liquid reagents are fixed in the reaction box by encapsulation, and then the samples and other reagents are added in sequence. Although this scheme reduces one sample addition during the detection process, multiple sample additions and reagent additions are still required. At the same time, the reaction box in this scheme cannot meet the mixing requirements as a reaction vessel, and it does not minimize the cumulative error source of multiple sample additions. In addition, the open reaction box still has the risk of infecting the operator for manual testing methods. Summary of the invention

[0005] The first purpose of the present invention is to provide a detection kit, which aims to solve the technical problems that the detection kit used in the existing biochemical immunoassay process requires multiple sample additions, has low detection efficiency, low detection accuracy and reliability, and is easy to cause biological infection to the operator.

[0006] To achieve the above-mentioned purpose, the solution provided by the present invention is: a detection kit, comprising a first box body for accommodating a first reagent, a second box body for accommodating a second reagent, and a box cover for covering and installing on the top of the first box body, the first box body comprising a hollow shell body whose bottom can be inserted into the second box body and whose top can be stuck outside the second box body, a sealing plug for sealing the bottom of the hollow shell body, and a sealing sheet for sealing the top of the hollow shell body.

[0007] Optionally, the hollow shell includes a first barrel portion inserted in the second box body and having an outer wall sealingly matched with an inner wall of the second box body, and a locking portion protruding from the top of the first barrel portion and locked to the second box body.

[0008] Optionally, the outer side wall of the first barrel portion is provided with a plurality of first annular convex ribs spaced along the axial direction thereof for sealingly cooperating with the inner side wall of the second box body; and / or,

[0009] The hollow shell further includes a second barrel portion located below the first barrel portion and having an outer diameter smaller than that of the first barrel portion, and a tapered barrel portion connected between the first barrel portion and the second barrel portion; and / or,

[0010] An annular groove is concavely formed on the top of the locking portion.

[0011] Optionally, a rod is protruded from the bottom of the box cover and is used to pass through the sealing sheet and the hollow shell and push open the sealing plug to connect the first box body and the second box body.

[0012] Optionally, the box cover includes the rod body, a card insert body for snap-fitting with the hollow shell, a cover plate protruding from the top of the card insert body and snap-fitted to the outside of the hollow shell, and an undercut provided at the outer edge of the cover plate and for snap-fitting with the outer side of the hollow shell, and the rod body is protruding from the bottom end of the card insert body.

[0013] Optionally, the cover plate includes a flat plate portion and an inclined plate portion, the flat plate portion extends straightly from the top end of the card insert body in a direction away from the central axis of the card insert body, the inclined plate portion extends obliquely downward from an edge of the flat plate portion away from the card insert body in a direction away from the central axis of the card insert body, and the undercut protrudes downward from the edge of the inclined plate portion away from the flat plate portion.

[0014] Optionally, the sealing plug includes a plug body for being inserted into the hollow shell from the bottom of the hollow shell and a plug cap protruding from one end of the plug body and being inserted outside the hollow shell, and the plug body is inserted into the hollow shell in an interference fit manner.

[0015] Optionally, the outer side wall of the plug body is provided with a plurality of second annular ribs spaced apart along its axial direction for sealingly cooperating with the inner side wall of the hollow shell.

[0016] Optionally, the sealing sheet is a metal foil or a metal foil; and / or,

[0017] The sealing plug is an elastic rubber plug; and / or,

[0018] A sampling capillary tube for taking a blood sample is detachably mounted on the bottom end of the box cover.

[0019] The second object of the present invention is to provide a biochemical immunoassay method, which comprises:

[0020] The first box body is loaded with a first reagent and sealed, and the second box body is loaded with a second reagent, and then the first box body is installed on the second box body by plugging;

[0021] Taking a blood sample through a pipette tip or a sampling capillary, then piercing the sealing sheet on the first box body with the pipette tip or the sampling capillary, and mixing the blood sample in the pipette tip or the sampling capillary with the first reagent in the first box body;

[0022] Installing a box cover on the first box body from the top of the first box body, and pressing the box cover downward to open the sealing plug through the box cover, so that the blood sample and the first reagent in the first box body flow into the second box body and mix with the second reagent;

[0023] Shaking the test kit manually or by a mechanical mechanism to evenly shake the blood sample, the first reagent and the second reagent;

[0024] After the detection kit is left to stand for a period of time, the detection result is read by a detection instrument.

[0025] The detection kit and biochemical immunoassay method provided by the present invention are provided with two mutually independent first and second box bodies for accommodating the first reagent and the second reagent respectively, and the first box body is designed to be a structure in which the bottom can be inserted into the second box body, the top can be stuck outside the second box body, and the bottom is sealed by a sealing plug, and the top is sealed by a sealing sheet. In this way, during the detection, a blood sample is taken by a pipette tip or a sampling capillary, and then the pipette tip or the sampling capillary is used to pierce the sealing sheet on the first box body, and the blood sample in the pipette tip or the sampling capillary is mixed with the first reagent in the first box body, and then the sealing plug is pushed open by a box cover or other external mechanism, thereby achieving mixing of the blood sample, the first reagent and the second reagent, and the detection result can be interpreted after the mixture is evenly mixed and left to stand for a period of time. Compared with the prior art, the scheme of the present invention has the following beneficial effects:

[0026] 1) The detection kit of the present invention is used for biochemical immunoassay, which only requires one pipetting and sample addition, thus reducing the cumulative error of multiple sample additions, reducing the risk of manual errors, and improving the accuracy, reliability and efficiency of the detection;

[0027] 2) Only one sample addition is required during the test, and the subsequent operations are simple, which is convenient for a large number of manual test operations and can also realize automated flow operations. The test efficiency is high and the operation is simple and convenient, which is especially suitable for rapid test (POCT) projects;

[0028] 3) The test kit forms a sealed testing environment, eliminating biological infection hazards to operators;

[0029] 4) After the test is completed, the blood samples and reagents are sealed and stored in the test kit and treated as waste, which reduces the difficulty of subsequent collection and treatment of biomedical waste and avoids biological infection hazards to operators during the collection and treatment of waste. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the structures shown in these drawings without paying creative work.

[0031] Figure 1 is a half-exploded schematic diagram of a detection kit provided by an embodiment of the present invention;

[0032] Figure 2 is a half-section assembly schematic diagram of a first box body loaded with a first reagent stacked on a second box body loaded with a second reagent provided by an embodiment of the present invention;

[0033] Figure 3 is Figure 2 Schematic diagram of the state when the box cover is installed;

[0034] Figure 4 Yes Figure 3 Schematic diagram of the state when the box cover is pressed down to open the sealing plug;

[0035] Figure 5 is a half-section schematic diagram of a first box body loaded with a first reagent provided by an embodiment of the present invention;

[0036] Figure 6 is a half-section schematic diagram of a second box body loaded with a second reagent provided by an embodiment of the present invention;

[0037] Figure 7 is a half-section schematic diagram of a box cover provided by an embodiment of the present invention;

[0038] Figure 8 It is a half-section assembly diagram of a box cover and a blood sampling capillary provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0039] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0040] It should be noted that all directional indications in the embodiments of the present invention (such as up, down, left, right, front, back, etc.) are only used to explain the relative position relationship, movement status, etc. between the components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly.

[0041] It should also be noted that when an element is referred to as being "fixed on" or "disposed on" another element, it may be directly on the other element or there may be an intermediate element at the same time. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or there may be an intermediate element at the same time.

[0042] In addition, the descriptions of "first", "second", etc. in the present invention are only used for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In addition, the technical solutions between the various embodiments can be combined with each other, but they must be based on the ability of ordinary technicians in the field to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0043] like Figure 1-8As shown, the detection kit provided by the embodiment of the present invention includes a first box body 100 for accommodating a first reagent 500, a second box body 200 for accommodating a second reagent 600, and a box cover 300 for covering and installing on the top of the first box body 100. The first box body 100 includes a hollow shell 110 whose bottom can be inserted into the second box body 200 and whose top can be stuck outside the second box body 200, a sealing plug 120 for sealing the bottom of the hollow shell 110, and a sealing sheet 130 for sealing the top of the hollow shell 110. In the embodiment of the present invention, two independent first box bodies 100 and second box bodies 200 are provided to respectively accommodate the first reagent 500 and the second reagent 600, and the first box body 100 can be inserted and stacked on the second box body 200. At the same time, the first box body 100 is designed to be sealed at the bottom by a sealing plug 120 and sealed at the top by a sealing sheet 130, and the second box body 200 is designed to be sealed at the bottom and open at the top. In this way, when the detection kit provided by the embodiment of the present invention is used for biochemical immunoassay, a blood sample is taken through a pipette tip or a sampling capillary 400, and then the pipette tip or the sampling capillary 400 is used to pierce the sealing sheet 130 on the first box body 100, and the blood sample in the pipette tip or the sampling capillary 400 is mixed with the first reagent 500 in the first box body 100, and then the sealing plug 120 is pushed open by the box cover 300 or other external mechanism, so as to achieve mixing of the blood sample, the first reagent 500 and the second reagent 600. After the mixture is evenly mixed and left to stand for a period of time, the test result can be interpreted. The detection kit provided by the embodiment of the present invention is used for biochemical immunoassay, and only one pipetting and sample addition is required, which reduces the cumulative error of multiple sample additions, reduces the risk of manual error, and improves the accuracy, reliability and efficiency of the detection; and the subsequent actions are simple to operate, which is convenient for a large number of manual detection operations, and can also realize automated flow operations, with high detection efficiency and simple and convenient operation, which is particularly suitable for rapid detection (POCT) projects. In addition, during the detection process, the detection kit constitutes a sealed detection environment, eliminating the biological infection hazard to the operator; after the detection is completed, the blood sample and reagent are sealed and stored in the form of the detection kit as waste, which reduces the difficulty of subsequent collection and treatment of biological medical waste, and avoids the biological infection hazard to the operator during the collection and treatment of waste.

[0044] Preferably, the sealing sheet 130 is fitted and packaged on the top of the hollow shell 110 .

[0045] Preferably, the sealing sheet 130 is a sheet that is easily punctured by a pipette tip or a sampling capillary 400. This makes it easy to quickly puncture the sealing sheet 130 by a pipette tip or a sampling capillary 400 during the detection process, thereby facilitating the injection of the blood sample into the first box body 100, effectively improving the detection efficiency.

[0046] Preferably, in this embodiment, the sealing sheet 130 is a metal foil or a metal foil sheet. Metal foil is a thin metal sheet made of metal, and metal foil is a composite paper composed of two materials: metal foil and base paper. Metal foil or metal foil can meet the strength and sealing performance requirements of the sealing sheet 130, and can be easily pierced by a pipette tip or a sampling capillary 400. In addition, the metal foil or metal foil can be quickly fitted and packaged, which can make the assembly operation of the sealing sheet 130 and the first box body 100 easier to achieve. The metal foil or metal foil can specifically be a foil or foil of a metal such as aluminum or tin. As a preferred implementation scheme of this embodiment, the sealing sheet 130 is an aluminum foil or an aluminum foil sheet.

[0047] Preferably, refer to Figure 2 and Figure 5 As shown, the hollow shell 110 includes a first barrel 111 inserted into the second box body 200 and the outer side wall of which is sealed with the inner side wall of the second box body 200, and a clamping portion 112 protruding from the top of the first barrel 111 and clamped outside the second box body 200. The clamping cooperation of the clamping portion 112 and the second box body 200 can realize the axial limit of the first box body 100 installed on the second box body 200. The insertion and insertion cooperation of the first barrel 111 and the second box body 200 can realize the radial limit of the first box body 100 installed on the second box body 200. The outer side wall of the first barrel 111 is sealed with the inner side wall of the second box body 200, so as to prevent the reagents and blood samples in the detection kit from flowing out of the detection kit from the matching gap between the first barrel 111 and the second box body 200 during the detection process, and effectively prevent the occurrence of biological infection hazards of the reagents and blood samples to the operator during the detection process.

[0048] Preferably, refer to Figure 2 and Figure 5 As shown, the outer side wall of the first barrel 111 is provided with a plurality of first annular convex ribs 113 arranged at intervals along the axial direction thereof for sealing with the inner side wall of the second box body 200. In this embodiment, the first barrel 111 realizes a tight fit and a sealing fit with the second box body 200 through the first annular convex ribs 113, which is conducive to reducing the contact area between the outer side wall of the first box body 100 and the inner side wall of the second box body 200, thereby reducing the difficulty of assembling the first box body 100 and the second box body 200, and can also make the outer side wall of the first barrel 111 and the inner side wall of the second box body 200 have a better sealing effect. Of course, in a specific application, as an alternative implementation scheme, the sealing between the outer side wall of the first barrel 111 and the inner side wall of the second box body 200 can also be achieved by arranging a sealing ring between the outer side wall of the first barrel 111 and the inner side wall of the second box body 200.

[0049] Preferably, the number of the first annular convex ribs 113 is at least two, so that the outer wall of the first box body 100 and the inner wall of the second box body 200 can have at least two sealing points in the axial direction, which is conducive to improving the sealing effect between the outer wall of the first box body 100 and the inner wall of the second box body 200. As a preferred implementation of this embodiment, there are four first annular convex ribs 113. Of course, in specific applications, the number of the first annular convex ribs 113 is not limited thereto.

[0050] Preferably, refer to Figure 2 and Figure 5 As shown, the hollow shell 110 also includes a second barrel 114 located below the first barrel 111 and having an outer diameter smaller than that of the first barrel 111, and a tapered barrel 115 connected between the first barrel 111 and the second barrel 114. Here, the lower end portion of the hollow shell 110 is designed to have a smaller outer diameter, so that the lower end portion of the hollow shell 110 does not affect the assembly difficulty of the first box body 100 and the second box body 200, so that the axial length of the hollow shell 110 can be designed to be longer, and the assembly operation of the first box body 100 and the second box body 200 can be easier to achieve. The design of the tapered barrel 115 is mainly used for transitional connection between the first barrel 111 and the second barrel 114, so that the first barrel 111, the tapered barrel 115, and the second barrel 114 can be designed to have the same wall thickness, thereby reducing the manufacturing difficulty of the hollow shell 110 and saving material costs.

[0051] Preferably, an annular groove 116 is concavely formed at the top of the locking portion 112. During the detection process, when the reagents and blood samples in the detection kit splash from the first box body 100 to the top of the first box body 100, even if the reagents and blood samples flow along the inner side of the top of the first box body 100 to the outer edge of the first box body 100, the reagents and blood samples flowing to the outer edge of the first box body 100 will be collected in the annular groove 116, and will not directly flow out of the detection kit, thereby helping to better prevent the occurrence of biological infection hazards to operators caused by the reagents and blood samples during the detection process.

[0052] Preferably, refer to Figure 3 , Figure 4 and Figure 7As shown, the bottom of the box cover 300 is convexly provided with a rod 310 for passing through the sealing sheet 130 and the hollow shell 110 and pushing the sealing plug 120 to conduct the first box body 100 and the second box body 200. During the detection process, after the box cover 300 is installed on the first box body 100 from the top of the first box body 100, the box cover 300 is continued to be pressed downward, and the rod 310 can push the sealing plug 120, thereby realizing the conduction between the first box body 100 and the second box body 200, so that the blood sample and the first reagent 500 in the first box body 100 flow into the second box body 200 and mix with the second reagent 600. Here, the design of the rod 310 at the bottom of the box cover 300 allows the sealing plug 120 to be directly pushed open by the box cover 300 during the detection process, without the need for an additional mechanism designed to push open the sealing plug 120.

[0053] Preferably, refer to Figure 3 , Figure 4 and Figure 7 As shown, the box cover 300 includes a rod body 310, a card insert body 320 for plugging and matching with the hollow shell 110, a cover plate 330 protruding from the top of the card insert body 320 and stuck outside the hollow shell 110, and an undercut 340 provided at the outer edge of the cover plate 330 and used for snap-fitting with the outer side of the hollow shell 110. The rod body 310 is protruding from the bottom end of the card insert body 320. The outer side wall of the card insert body 320 abuts against the inner side wall of the first barrel 111. The cover plate 330 is used to cover the top opening of the hollow shell 110. The undercut 340 is used to press the box cover 300 downward to open the sealing plug 120 during the detection process, so that the box cover 300 can be fastened on the first box body 100, thereby facilitating the stability and reliability of the connection between the box cover 300 and the first box body 100.

[0054] Preferably, refer to Figure 3 , Figure 4 and Figure 7 As shown, the cover plate 330 includes a flat plate portion 331 and an inclined plate portion 332, the flat plate portion 331 extends straight from the top of the card insert body 320 in a direction away from the central axis of the card insert body 320, the inclined plate portion 332 extends obliquely downward from the edge of the flat plate portion 331 away from the card insert body 320 in a direction away from the central axis of the card insert body 320, and the undercut 340 extends downward from the edge of the inclined plate portion 332 away from the flat plate portion 331. The arrangement of the inclined plate portion 332 allows the inclined plate portion 332 to fit tightly against the first box body 100 after the box cover 300 is pressed and assembled on the first box body 100, thereby facilitating the improvement of the sealing effect of the box cover 300 covering the first box body 100.

[0055] Preferably, there are at least two undercuts 340 , and the undercuts 340 are evenly distributed along the outer edge of the cover plate 330 .

[0056] Preferably, the sealing plug 120 is an elastic rubber plug, so that the sealing plug 120 installed on the bottom of the hollow shell 110 has a good sealing effect and the sealing plug 120 is easier to be pushed open under the action of external force.

[0057] Preferably, refer to Figure 2 , Figure 4 and Figure 5 As shown, the sealing plug 120 includes a plug body 121 for being inserted into the hollow shell 110 from the bottom of the hollow shell 110 and a plug cap 122 protruding from one end of the plug body 121 and being stuck outside the hollow shell 110. The outer diameter of the plug cap 122 is greater than the outer diameter of the plug body 121. The plug cap 122 is engaged with the hollow shell 110 to achieve axial limitation of the sealing plug 120 installed on the hollow shell 110. The plug body 121 is engaged with the hollow shell 110 to achieve radial limitation of the sealing plug 120 installed on the hollow shell 110 and sealing cooperation between the outer wall of the plug body 121 and the inner wall of the hollow shell 110.

[0058] Preferably, the plug body 121 is plugged into the hollow shell 110 in an interference fit manner. The outer diameter of the plug body 121 is greater than the inner diameter of the second barrel 114. In this embodiment, the plug body 121 is elastic, and the plug body 121 is matched with the hollow shell 110 in an interference fit manner, which is beneficial to ensure the sealing effect of the plug body 121 and the hollow shell 110, and is convenient for the installation and opening of the plug body 121.

[0059] Preferably, refer to Figure 2 , Figure 4 and Figure 5 As shown, the outer wall of the plug body 121 is provided with a plurality of second annular convex ribs 123 arranged at intervals along the axial direction thereof for sealing with the inner wall of the hollow shell 110. In this embodiment, the plug body 121 achieves a tight fit and a sealing fit with the hollow shell 110 through the second annular convex ribs 123, which is beneficial to reduce the contact area between the outer wall of the plug body 121 and the inner wall of the hollow shell 110, thereby reducing the difficulty of assembling the sealing plug 120 and the hollow shell 110, and can also achieve a better sealing effect between the outer wall of the plug body 121 and the inner wall of the hollow shell 110. Of course, in a specific application, as an alternative implementation scheme, the sealing between the outer wall of the plug body 121 and the inner wall of the hollow shell 110 can also be achieved by providing a sealing ring between the outer wall of the plug body 121 and the inner wall of the hollow shell 110.

[0060] Preferably, the number of the second annular ribs 123 is at least two, so that the outer wall of the plug body 121 and the inner wall of the second barrel portion 114 have at least two sealing points in the axial direction, which is beneficial to improving the sealing effect between the outer wall of the plug body 121 and the inner wall of the second barrel portion 114.

[0061] Reference Figure 8 As shown, in specific applications, a sampling capillary 400 for collecting blood samples can be detachably installed at the bottom of the rod body 310. In this way, in specific applications, the sampling capillary 400 on the box cover 300 can be used to directly collect samples from the patient's fingertips, without the need for separate blood sampling, reducing the pain of the patient, collecting less blood samples, and having low environmental requirements for collecting blood samples, and low technical and operational risks. The blood sample specifically refers to a blood specimen.

[0062] Furthermore, an embodiment of the present invention also provides a biochemical immunoassay method, which comprises:

[0063] The first reagent 500 is loaded into the first box body 100 and the first box body 100 is sealed, and the second reagent 600 is loaded into the second box body 200, and then the first box body 100 is installed on the second box body 200 by plugging;

[0064] A blood sample is collected by a pipette tip or a sampling capillary tube 400, and then the sealing sheet 130 on the first box body 100 is pierced by the pipette tip or the sampling capillary tube 400, and the blood sample in the pipette tip or the sampling capillary tube 400 is mixed with the first reagent 500 in the first box body 100;

[0065] The box cover 300 is installed on the first box body 100 from the top of the first box body 100, and the box cover 300 is pressed downward to open the sealing plug 120 through the box cover 300, so that the blood sample and the first reagent 500 in the first box body 100 flow into the second box body 200 and mix with the second reagent 600;

[0066] Shake the test kit manually or mechanically to evenly mix the blood sample, the first reagent 500 and the second reagent 600;

[0067] After the test kit is left to stand for a period of time, the test results are interpreted by the testing instrument.

[0068] The biochemical immunoassay method of the embodiment of the present invention is specifically a biochemical reaction in which two reagents and a sample undergo immune binding. During the test, the first reagent 500 and the second reagent 600 required for the test are first encapsulated in a test kit that can be acted by external force. In this embodiment, the first reagent 500 and the second reagent 600 in the test kit are mixed by puncturing and applying force through the box cover 300, and only one sampling is required to complete the entire test sample addition process. The biochemical immunoassay method of the embodiment of the present invention, since only one liquid transfer sample addition is required, the cumulative error of multiple sample additions is reduced, the risk of manual error is reduced, and the accuracy, reliability and efficiency of the test are improved; and the test kit constitutes a sealed test environment, eliminating the biological infection hazard to the operator; after the test is completed, the blood sample and the reagent are sealed and stored in the test kit as waste, which reduces the difficulty of subsequent collection and treatment of biological medical waste, and avoids the biological infection hazard to the operator during the collection and treatment of waste.

[0069] In the embodiment of the present invention, the two reagents required to participate in the detection are respectively pre-sealed into independent cavities (the first box body 100 and the second box body 200 in this embodiment). After the blood sample is added, the cavities where the two reagents required to participate in the detection reaction are located can be connected through one action, and then the blood sample and the two reagents are mixed together to perform a biochemical reaction, wherein a part of the seal (the sealing plug 120 in this embodiment) also serves as a mixing device. After the reaction is completed, the entire liquid waste is sealed and stored in the detection kit and discarded into the biochemical waste recovery vessel. Only one sample addition is required in the entire detection, and the subsequent actions are simple to operate, which is convenient for a large number of manual detection operations, and can also realize automated flow operations, with high detection efficiency and simple and convenient operation, which is particularly suitable for rapid detection (POCT) projects.

[0070] As a preferred implementation scheme of this embodiment, the packaging method of the detection kit is as follows: the first reagent 500 and the second reagent 600 required for the same detection test are respectively packaged in the first box body 100 and the second box body 200 in advance. Here, we first seal the top opening of the hollow shell 110 of the first box body 100 with a special easily punctured sealing aluminum foil, and quantitatively add the first reagent 500 required for a detection item from the bottom of the hollow shell 110 into the first box body 100, and then seal the bottom opening of the hollow shell 110 with a sealing plug 120 (when Of course, in specific applications, the bottom opening of the hollow shell 110 of the first box body 100 can also be sealed with a sealing plug 120, and the first reagent 500 required for a test item is quantitatively added to the first box body 100 from the top of the hollow shell 110, and then the top opening of the hollow shell 110 is sealed with a special easy-to-puncture sealing aluminum foil), and then the second reagent 600 required for the test is quantitatively added to the second box body 200, and finally the first box body 100 that has been packaged and loaded with the first reagent 500 is packaged in the second box body 200. Different test items can be automatically identified by the QR code (barcode) or other identification posted on the side of the test kit.

[0071] A preferred method of rapid testing using the test kit of this embodiment is as follows: directly pierce the sealed aluminum foil on the top of the first box body 100 with a pipette tip loaded with the blood sample required for the test, and then add the blood sample into the first box body 100 (or if the sampling capillary 400 on the box cover 300 is used to directly sample from the patient's fingertips, the box cover is pressed into the first box body 100 to directly pierce the sealed aluminum foil on the top of the first box body 100, and the fingertip blood sample in the sampling capillary 400 is directly mixed with the first reagent 500 in the first box body 100); then, the first box body 100 is sealed by applying force to the box cover 300, and at the same time, the rod 310 at the bottom of the box cover 300 will The sealing plug 120 at the bottom of the first box body 100 is pushed open to allow the sealing plug 120 and the first reagent 500 and the blood sample in the first box body 100 to fall into the second box body 200. The detection kit is shaken manually or mechanically, and the second box body 200 and the sealing plug 120 therein are shaken to mix the blood sample, the first reagent 500 and the second reagent 600 participating in the reaction. Then, the detection kit loaded with the blood sample, the first reagent 500 and the second reagent 600 is placed in a designated incubation chamber (environment). After 3 to 5 minutes, the detection is performed using a detection instrument (fluoroscope or other optical detection instrument) and the result is interpreted. After the detection is completed, the entire detection kit is discarded into a biochemical waste recovery container.

[0072] In the preferred implementation of this embodiment, the sealing barrier (the sealing plug 120 in this embodiment) between the first reagent 500 and the second reagent 600 is opened by applying force externally through the box cover 300. Of course, in specific applications, the sealing barrier between the first reagent 500 and the second reagent 600 can also be opened by other methods, for example: first use an external mechanism to push open the sealing plug 120, and then cover the first box body 100 with the box cover 300, or use a biochemical reaction to open the sealing barrier between the first reagent 500 and the second reagent 600.

[0073] The detection kit and biochemical immunoassay method provided by the embodiments of the present invention are used in rapid diagnosis (POCT), especially in detection where different reagents need to be added multiple times during the reaction process, and can achieve the following significant effects: reducing sampling time, improving detection efficiency, reducing the cumulative sampling error of multiple samplings, improving the accuracy and reliability of detection, eliminating contamination during detection, and solving a series of technical problems such as the biochemical hazards of waste after the reaction.

[0074] The above description is only a preferred embodiment of the present invention, and does not limit the patent scope of the present invention. All equivalent structural changes made by using the contents of the present invention specification and drawings under the inventive concept of the present invention, or directly / indirectly applied in other related technical fields are included in the patent protection scope of the present invention.

Claims

1. A detection kit, characterized in that: The invention comprises a first box body for accommodating a first reagent, a second box body for accommodating a second reagent, and a box cover for covering and installing on the top of the first box body, wherein the first box body comprises a hollow shell body whose bottom can be inserted into the second box body and whose top can be stuck on the second box body, a sealing plug for sealing the bottom of the hollow shell body, and a sealing sheet for sealing the top of the hollow shell body, wherein the sealing sheet is a metal foil or a metal foil sheet; The hollow shell comprises a first barrel portion inserted in the second box body and having an outer wall sealingly matched with the inner wall of the second box body, and a clamping portion protruding from the top of the first barrel portion and clamped on the second box body; The outer side wall of the first barrel portion is provided with a plurality of first annular convex ribs spaced along the axial direction thereof for sealingly cooperating with the inner side wall of the second box body; and / or the hollow shell further comprises a second barrel portion located below the first barrel portion and having an outer diameter smaller than that of the first barrel portion, and a tapered barrel portion connected between the first barrel portion and the second barrel portion; and / or the top of the locking portion is provided with an annular groove; The bottom of the box cover is convexly provided with a rod body for passing through the sealing sheet and the hollow shell and pushing the sealing plug open to connect the first box body and the second box body; The box cover comprises the rod body, a plug-in body for plugging with the hollow shell, a cover plate convexly arranged at the top of the plug-in body and clamped outside the hollow shell, and an undercut arranged at the outer edge of the cover plate and used for plugging with the outer side of the hollow shell, wherein the rod body is convexly arranged at the bottom end of the plug-in body; The cover plate includes a flat plate portion and an inclined plate portion, wherein the flat plate portion extends straightly from the top end of the card insert body in a direction away from the central axis of the card insert body, the inclined plate portion extends obliquely downward from an edge of the flat plate portion away from the card insert body in a direction away from the central axis of the card insert body, and the undercut extends downwardly and protrudes from the edge of the inclined plate portion away from the flat plate portion.

2. The detection kit according to claim 1, characterized in that The sealing plug includes a plug body used to be inserted into the hollow shell from the bottom of the hollow shell and a plug cap protruding from one end of the plug body and stuck outside the hollow shell. The plug body is inserted into the hollow shell in an interference fit manner.

3. The detection kit according to claim 2, characterized in that The outer side wall of the plug body is provided with a plurality of second annular ribs spaced apart along its axial direction for sealingly cooperating with the inner side wall of the hollow shell.

4. The detection kit according to claim 1, characterized in that The sealing plug is an elastic rubber plug; and / or, A sampling capillary tube for taking a blood sample is detachably mounted on the bottom end of the box cover.

5. A biochemical immunoassay method based on the detection kit according to any one of claims 1 to 4, characterized in that: include: The first box body is loaded with a first reagent and sealed, and the second box body is loaded with a second reagent, and then the first box body is installed on the second box body by plugging; Taking a blood sample through a pipette tip or a sampling capillary, then piercing the sealing sheet on the first box body with the pipette tip or the sampling capillary, and mixing the blood sample in the pipette tip or the sampling capillary with the first reagent in the first box body; Installing a box cover on the first box body from the top of the first box body, and pressing the box cover downward to open the sealing plug through the box cover, so that the blood sample and the first reagent in the first box body flow into the second box body and mix with the second reagent; Shaking the test kit manually or by a mechanical mechanism to evenly shake the blood sample, the first reagent and the second reagent; After the detection kit is left to stand for a period of time, the detection result is read by a detection instrument.

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