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, a second box body, at least one third box body, and a box cover for covering and installing on the top of the first box body, the first box body includes a first hollow shell body whose bottom can be inserted into the third box body and whose top can be stuck outside the third box body, a first sealing plug for sealing the bottom of the first hollow shell body, and a sealing sheet for sealing the top of the first hollow shell body, and each third box body includes a second hollow shell body whose bottom can be inserted into the second box body or another third box body and whose top can be stuck outside the second box body or another third box body, and a second sealing plug for sealing the bottom of the second hollow shell body. The present invention only needs one time of pipetting and adding samples during biochemical immunoassay, thereby improving the accuracy, reliability and efficiency of the detection, and reducing the risk of biological infection hazards to the operator.

Description

Technical Field

[0001] This invention relates to the field of in vitro diagnostics (IVD) technology, and more particularly to a test kit and a biochemical and immunoassay method using the test kit. Background Technology

[0002] In in vitro diagnostics (IVD), particularly in the field of point-of-care testing (POCT), the detection process requires the addition of human or animal bodily fluids, primarily blood (plasma, serum, whole blood, etc.), to one or more reagents for biochemical reactions. Currently, biochemical and immunoassay detection generally employs two main approaches:

[0003] 1) This kit consists of multiple independent chambers. Samples are taken sequentially using a pipette or machine, mixed, and then subjected to a biochemical reaction. Using this kit for biochemical and immunoassay detection requires multiple pipetting of different reagents into the same experimental sample reaction dish, necessitating frequent pipetting during the testing process. Manual testing requires multiple sampling, which is time-consuming and inefficient, and carries the risk of biochemical contamination, affecting test results and even endangering the health of the operator. Machine testing, on the other hand, requires overcoming cross-contamination of reagents and mitigating the cumulative error from multiple sampling on the test results.

[0004] 2) Solid or liquid reagents are sealed and fixed in a reaction chamber, and then the sample and other reagents are added sequentially. Although this method reduces one sample addition during the detection process, it still requires multiple additions of samples and reagents. In addition, the reaction chamber, as a reactor vessel, cannot meet the requirements for homogenization, nor does it minimize the cumulative error sources from multiple sample additions. Furthermore, the open reaction chamber still poses a risk of infection to operators using manual testing methods. Summary of the Invention

[0005] The first objective of this invention is to provide a detection kit that addresses the technical problems of existing biochemical and immunoassay kits requiring multiple sample additions, resulting in low detection efficiency, low accuracy and reliability, and a high risk of biological infection for operators.

[0006] To achieve the above objectives, the present invention provides a test kit comprising: a first box for containing a first reagent, a second box for containing a second reagent, at least one third box for containing at least one third reagent, and a lid for closing the top of the first box. The first box comprises a first hollow shell with its bottom insertable into the third box and its top snapping onto the outside of the third box, a first sealing plug for sealing the bottom of the first hollow shell, and a sealing sheet for sealing the top of the first hollow shell. Each third box comprises a second hollow shell with its bottom insertable into the second box or another third box and its top snapping onto the second box or another third box, and a second sealing plug for sealing the bottom of the second hollow shell.

[0007] Optionally, the first hollow housing includes a first cylindrical portion that is inserted into the third box and whose outer side wall is sealed to the inner side wall of the third box, and a first locking portion that protrudes from the top of the first cylindrical portion and is locked to the outside of the third box.

[0008] Optionally, the outer wall of the first cylindrical portion is provided with a plurality of first annular ribs spaced apart along its axial direction for sealing engagement with the inner wall of the third box; and / or,

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

[0010] The top of the first locking part is recessed with a first annular groove.

[0011] Optionally, the second hollow housing includes a third cylindrical portion that is inserted into the second box body or another third box body and whose outer side wall is sealed to the inner side wall of the second box body or the other third box body, and a second locking portion that protrudes from the top of the third cylindrical portion and is locked to the second box body or the other third box body.

[0012] Optionally, the outer wall of the third cylindrical portion is provided with a plurality of second annular ribs spaced axially thereon for sealing and engaging with the inner wall of the second box or the inner wall of the other third box; and / or,

[0013] The second hollow shell further includes a fourth cylindrical portion located below the third cylindrical portion and having an outer diameter smaller than that of the third cylindrical portion, and a second conical cylindrical portion connecting the third cylindrical portion and the fourth cylindrical portion; and / or,

[0014] The top of the second locking part is recessed with a second annular groove.

[0015] Optionally, the bottom of the lid has a protruding rod for passing through the sealing sheet and the first hollow shell and sequentially pushing open the first sealing plug and the second sealing plug to conduct through the first box body, the second box body and each of the third boxes.

[0016] Optionally, the lid includes the rod, a snap-fit ​​body for engaging with the first hollow shell, a cover plate protruding from the top of the snap-fit ​​body and snapped onto the outside of the first hollow shell, and a buckle located on the outer edge of the cover plate for engaging with the outer side of the first shell, wherein the rod protrudes from the bottom end of the snap-fit ​​body.

[0017] Optionally, the cover plate includes a flat plate portion and an inclined plate portion. The flat plate portion extends straight from the top of the insert body in a direction away from the central axis of the insert body. The inclined plate portion extends obliquely downward from the edge of the flat plate portion away from the insert body in a direction away from the central axis of the insert body. The buckle extends downward from the edge of the inclined plate portion away from the flat plate portion and protrudes.

[0018] Optionally, the first sealing plug includes a first plug body for inserting into the first hollow housing from the bottom of the first hollow housing and a first plug cap protruding from one end of the first plug body and locked outside the first hollow housing, wherein the first plug body is inserted into the first hollow housing in an interference fit; and / or,

[0019] The second sealing plug includes a second plug body for inserting into the second hollow housing from the bottom of the second hollow housing and a second plug cap protruding from one end of the second plug body and locked outside the second hollow housing, wherein the second plug body is inserted into the second hollow housing in an interference fit; and / or

[0020] The sealing sheet is a metal foil or a metal foil sheet; and / or,

[0021] Both the first sealing plug and the second sealing plug are elastic rubber plugs; and / or,

[0022] The bottom of the lid is detachably fitted with a sampling capillary tube for taking blood samples.

[0023] A second objective of this invention is to provide a biochemical immunoassay method, comprising:

[0024] The first reagent is loaded into the first box and the first box is sealed. At the same time, the second reagent is loaded into the second box. A third reagent is loaded into each of the third boxes. Then, each of the third boxes is sequentially inserted and installed into the second box or another third box. The first box is inserted and installed into the third box located at the top.

[0025] Blood samples are taken using a pipette tip or a sampling capillary tube, and then the pipette tip or sampling capillary tube is used to puncture the sealing sheet on the first box, so that the blood sample in the pipette tip or sampling capillary tube is mixed with the first reagent in the first box.

[0026] Install the lid onto the first box body from the top of the first box body, and press the lid down to open the first sealing plug and each of the second sealing plugs in sequence through the lid, so that the blood sample, the first reagent, each of the third reagents are mixed with the second reagent in the second box body;

[0027] The test kit is shaken manually or mechanically to evenly distribute the blood sample, the first reagent, the second reagent, and each of the third reagents.

[0028] After the test kit is left to stand for a period of time, the test results are interpreted using a testing instrument.

[0029] The detection kit and biochemical immunoassay method provided by this invention utilizes a set of independent first, second, and at least one third box to respectively contain a first reagent, a second reagent, and at least one third reagent. The first box is designed with its bottom insertable into the third box, its top able to be locked out of the third box, and its bottom sealed by a first sealing plug and its top sealed by a sealing sheet. The third box is designed with its bottom insertable into the second box or another third box, its top able to be locked out of the second box or another third box, and its bottom sealed by a second sealing plug. During detection, a blood sample is taken using a pipette tip or sampling capillary. The pipette tip or sampling capillary then punctures the sealing sheet on the first box, mixing the blood sample with the first reagent in the first box. The first and second sealing plugs are then sequentially opened by the box lid or other external mechanism, thus mixing the blood sample, the first reagent, the second reagent, and each of the third reagents. After thorough mixing and standing for a period of time, the test results can be interpreted. Compared to existing technologies, the solution of this invention has the following advantages:

[0030] 1) Biochemical and immunological detection using the detection kit of the present invention only requires one pipetting and sample addition, which reduces the cumulative error of multiple sample additions, reduces the risk of errors in manual operation, and improves the accuracy, reliability and efficiency of detection.

[0031] 2) Only one sample needs to be added during the test, and the subsequent operations are simple, which is convenient for a large number of manual testing operations. It can also realize automated assembly line operation, with high testing efficiency and simple and convenient operation, especially suitable for rapid testing (POCT) projects.

[0032] 3) The test kit creates a sealed testing environment, eliminating the risk of biological infection to the operator;

[0033] 4) After the test is completed, the blood sample and reagents are stored in a sealed container in the form of the test kit and disposed of as waste. This reduces the difficulty of subsequent collection and treatment of biomedical waste and avoids the risk of biological infection to the operator during the collection and treatment of waste. Attached Figure Description

[0034] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0035] Figure 1 This is a partially exploded view of the detection kit provided in an embodiment of the present invention;

[0036] Figure 2 This is a half-section assembly diagram of a third box containing a third reagent and a first box containing a first reagent stacked on a second box containing a second reagent, according to an embodiment of the present invention.

[0037] Figure 3 This is a schematic diagram of the state of the first box containing the first reagent when the lid is just put on, according to an embodiment of the present invention.

[0038] Figure 4 The embodiments of the present invention provide that Figure 3 A diagram showing the state of the box when the lid is pressed down to open the first sealing plug;

[0039] Figure 5 This is a half-sectional schematic diagram of the first box containing the first reagent provided in an embodiment of the present invention;

[0040] Figure 6 This is a half-sectional schematic diagram of a third box containing a third reagent provided in an embodiment of the present invention;

[0041] Figure 7 This is a half-sectional schematic diagram of the second box containing the second reagent provided in an embodiment of the present invention;

[0042] Figure 8 This is a half-sectional schematic diagram of the box lid provided in an embodiment of the present invention;

[0043] Figure 9 This is a schematic diagram of the partial assembly of the box cover and the blood collection capillary provided in an embodiment of the present invention. Detailed Implementation

[0044] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0045] It should be noted that all directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of the present invention are only used to explain the relative positional relationship and movement of each component in a certain specific posture (as shown in the figure). If the specific posture changes, the directional indication will also change accordingly.

[0046] It should also be noted that when a component is described as "fixed to" or "set on" another component, it can be directly on the other component or there may be an intervening component present. When a component is described as "connected to" another component, it can be directly connected to the other component or there may be an intervening component present.

[0047] Furthermore, the use of terms such as "first" and "second" in this invention is for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. Additionally, the technical solutions of the various embodiments can be combined with each other, but only on the basis of being achievable by those skilled in the art. When the combination of technical solutions is contradictory or impossible to implement, such a combination of technical solutions should be considered non-existent and not within the scope of protection claimed by this invention.

[0048] like Figure 1-9As shown, the test kit provided in this embodiment of the invention includes a first box 100 for containing a first reagent 500, a second box 200 for containing a second reagent 600, at least one third box 700 for containing at least one third reagent 800 respectively, and a lid 300 for covering the top of the first box 100. The first box 100 includes a first hollow shell 110 whose bottom can be inserted into the third box 700 and whose top can be locked outside the third box 700, a first sealing plug 120 for sealing the bottom of the first hollow shell 110, and a sealing sheet 130 for sealing the top of the first hollow shell 110. Each third box 700 includes a second hollow shell 710 whose bottom can be inserted into the second box 200 or another third box 700 and whose top can be locked outside the second box 200 or another third box 700, and a second sealing plug 720 for sealing the bottom of the second hollow shell 710. When there is one third box 700, the third box 700 is stacked on top of the second box 200, and the first box 100 is stacked on top of the third box 700. When there are at least two third boxes 700, each third box 700 is connected by stacking one third box 700 on top of another, with the bottom third box 700 installed on the second box 200 and the first box 100 installed on the top third box 700. Each third box 700 contains a different third reagent 800.

[0049] This invention provides an embodiment of a first box 100, a second box 200, and at least one third box 700, which are independent of each other, to respectively contain a first reagent 500, a second reagent 600, and at least one third reagent 800. The first box 100 is snap-fitted onto the third box 700, and each third box 700 is sequentially snap-fitted onto the second box 200 and the first box 100. The first box 100 is designed with its bottom sealed by a first sealing plug 120 and its top sealed by a sealing sheet 130. The second box 200 is designed with its bottom sealed and its top open. The third box 700 is designed with its bottom sealed by a second sealing plug 720 and its top open. The open structure of the test kit provided in this embodiment allows for biochemical and immunoassay testing. Blood samples are collected using a pipette tip or sampling capillary 400. The pipette tip or capillary 400 then punctures the sealing strip 130 on the first housing 100, mixing the blood sample with the first reagent 500 in the first housing 100. The first sealing plug 120 and each of the second sealing plugs 720 are then sequentially opened by the lid 300 or other external mechanisms, achieving mixing of the blood sample, the first reagent 500, the second reagent 600, and each of the third reagents 800. After thorough mixing and standing for a period of time, the test results can be interpreted. Using the test kit provided in this embodiment for biochemical and immunoassay testing requires only one pipetting operation, reducing the cumulative error of multiple additions, lowering the risk of manual errors, and improving the accuracy, reliability, and efficiency of the test. Furthermore, subsequent operations are simple, facilitating large-scale manual testing and enabling automated assembly line operations. The high efficiency and ease of operation make it particularly suitable for point-of-care testing (POCT) projects. In addition, during the testing process, the test kit constitutes a sealed testing environment, eliminating the risk of biological infection to the operator; after the test is completed, the blood sample and reagents are stored in the test kit in a sealed manner and disposed of as waste, which reduces the difficulty of subsequent collection and treatment of biomedical waste and avoids the risk of biological infection to the operator during the collection and treatment of waste.

[0050] Preferably, the sealing sheet 130 is fitted and encapsulated at the top of the first hollow housing 110.

[0051] Preferably, the sealing sheet 130 is a sheet that can be easily punctured by the pipette tip or the sampling capillary 400. This facilitates the rapid puncture of the sealing sheet 130 by the pipette tip or the sampling capillary 400 during the detection process, thereby facilitating the injection of blood samples into the first box 100 and effectively improving the detection efficiency.

[0052] Preferably, in this embodiment, the sealing sheet 130 is a metal foil or a metal foil sheet. A metal foil sheet is a thin metal sheet stretched from metal, while metal foil paper is a composite paper composed of metal foil and base paper. Both metal foil paper and metal foil sheets meet the strength and sealing performance requirements of the sealing sheet 130, and are easily punctured by pipette tips or sampling capillaries 400. Furthermore, metal foil paper or metal foil sheets can be quickly bonded and sealed, making the assembly operation of the sealing sheet 130 with the first housing 100 relatively easy to achieve. Specifically, the metal foil paper or metal foil sheet can be aluminum or tin foil paper or foil sheet. As a preferred embodiment of this invention, the sealing sheet 130 is aluminum foil paper or aluminum foil sheet.

[0053] Preferably, refer to Figure 1 , Figure 2 and Figure 5 As shown, the first hollow housing 110 includes a first cylindrical portion 111 that is inserted into the third housing 700 and whose outer side wall is sealed to the inner side wall of the third housing 700, and a first locking portion 112 that protrudes from the top of the first cylindrical portion 111 and is locked to the outside of the third housing 700. The locking engagement of the first locking portion 112 with the third housing 700 enables axial positioning of the first housing 100 mounted on the third housing 700. The insertion engagement of the first cylindrical portion 111 with the third housing 700 enables radial positioning of the first housing 100 mounted on the third housing 700. The sealed engagement of the outer side wall of the first cylindrical portion 111 with the inner side wall of the third housing 700 prevents reagents and blood samples in the test kit from flowing out of the test kit through the gap between the first cylindrical portion 111 and the third housing 700 during the testing process, effectively preventing biological hazards to the operator from reagents and blood samples during the testing process.

[0054] Preferably, refer to Figure 1 , Figure 2 and Figure 5 As shown, the outer wall of the first cylindrical portion 111 is provided with a plurality of first annular ribs 113 spaced apart along its axial direction for sealing engagement with the inner wall of the third housing 700. In this embodiment, the first cylindrical portion 111 achieves a tight fit and sealing engagement with the third housing 700 through the first annular ribs 113. This not only reduces the contact area between the outer wall of the first housing 100 and the inner wall of the third housing 700, thereby reducing the assembly difficulty of the first housing 100 and the third housing 700, but also provides a better sealing effect between the outer wall of the first cylindrical portion 111 and the inner wall of the third housing 700. Of course, in specific applications, as an alternative implementation, the sealing between the outer wall of the first cylindrical portion 111 and the inner wall of the third housing 700 can also be achieved by setting a sealing ring between the outer wall of the first cylindrical portion 111 and the inner wall of the third housing 700.

[0055] Preferably, there are at least two first annular ribs 113, which allows the outer wall of the first box 100 and the inner wall of the third box 700 to have at least two sealing points in the axial direction, thereby improving the sealing effect between the outer wall of the first box 100 and the inner wall of the third box 700. As a preferred embodiment of this invention, there are four first annular ribs 113. Of course, in specific applications, the number of first annular ribs 113 is not limited to this.

[0056] Preferably, refer to Figure 1 , Figure 2 and Figure 5 As shown, the first hollow shell 110 also includes a second cylindrical portion 114 located below the first cylindrical portion 111 and having an outer diameter smaller than that of the first cylindrical portion 111, and a first conical cylindrical portion 115 connecting the first cylindrical portion 111 and the second cylindrical portion 114. Here, the lower end of the first hollow shell 110 is designed with a smaller outer diameter, so that the lower end of the first hollow shell 110 does not affect the assembly difficulty of the first box 100 and the third box 700. This allows for a longer axial length of the first hollow shell 110 and makes the assembly operation of the first box 100 and the third box 700 easier to achieve. The design of the first conical cylindrical portion 115 is mainly used for transitional connection between the first cylindrical portion 111 and the second cylindrical portion 114, so that the first cylindrical portion 111, the first conical cylindrical portion 115, and the second cylindrical portion 114 can be designed with the same wall thickness, which helps to reduce the manufacturing difficulty of the first hollow shell 110 and save material costs.

[0057] Preferably, refer to Figure 1 , Figure 2 and Figure 5 As shown, the top of the first locking part 112 is recessed with a first annular groove 116. During the testing process, when reagents or blood samples from the test kit splash from inside the first box 100 to the top of the first box 100, even if some reagents or blood samples flow along the inner side of the top of the first box 100 towards the outer edge of the first box 100, the reagents or blood samples flowing towards the outer edge of the first box 100 will be collected in the first annular groove 116 and will not flow directly out of the test kit. This helps to better prevent biological infection hazards to the operator caused by reagents or blood samples during the testing process.

[0058] Preferably, refer to Figure 1 , Figure 2 and Figure 6As shown, the second hollow housing 710 includes a third cylindrical portion 711 that is inserted into the second housing 200 or another third housing 700 and whose outer side wall is sealed to the inner side wall of the second housing 200 or another third housing 700, and a second locking portion 712 that protrudes from the top of the third cylindrical portion 711 and is locked to the outside of the second housing 200 or another third housing 700. The locking engagement of the second locking portion 712 on one third housing 700 with the second housing 200 or another third housing 700 can achieve axial limiting of the third housing 700 when it is installed on the second housing 200 or another third housing 700. The snap-fitting of the third cylindrical portion 711 on one third housing 700 with the second housing 200 or another third housing 700 enables radial limiting of the installation of one third housing 700 on the second housing 200 or another third housing 700. The sealing fit between the outer wall of the third cylindrical portion 711 on one third housing 700 and the inner wall of the second housing 200 or another third housing 700 prevents reagents and blood samples in the test kit from flowing out of the test kit through the gap between the third housing 700 and the second housing 200 or the two third housings 700 during the test process, effectively preventing biological infection hazards to the operator caused by reagents and blood samples during the test process.

[0059] Preferably, refer to Figure 1 , Figure 2 and Figure 6 As shown, the outer side wall of the third cylindrical portion 711 is provided with a plurality of second annular ribs 713 that are spaced apart along its axial direction for sealing and engaging with the inner side wall of the second box 200 or the inner side wall of another third box 700. In this embodiment, the third cylindrical portion 711 of a third box 700 achieves a tight and sealed fit with the second box 200 or another third box 700 through the second annular rib 713. This reduces the contact area between the outer wall of one third box 700 and the inner wall of the second box 200, or between the outer wall of one third box 700 and the inner wall of another third box 700, thereby reducing the assembly difficulty between the third box 700 and the second box 200, or between the two third boxes 700. It also ensures a better sealing effect between the outer wall of the third cylindrical portion 711 of one third box 700 and the inner wall of the second box 200, or between the outer wall of the third cylindrical portion 711 of one third box 700 and the inner wall of another third box 700. Of course, in specific applications, as an alternative implementation, the seal between the outer wall of the third cylindrical portion 711 of the third box 700 and the inner wall of the second box 200 or the inner wall of another third box 700 can also be achieved by setting a sealing ring between the outer wall of the third cylindrical portion 711 of the third box 700 and the inner wall of the second box 200 or the inner wall of another third box 700.

[0060] Preferably, there are at least two second annular ribs 713. This allows at least two axial sealing points between the outer wall of one third housing 700 and the inner wall of the second housing 200 or another third housing 700, thereby improving the sealing effect between them. In a preferred embodiment, four second annular ribs 713 are provided. However, in specific applications, the number of second annular ribs 713 is not limited to this.

[0061] Preferably, refer to Figure 1 , Figure 2 and Figure 6 As shown, the second hollow shell 710 also includes a fourth cylindrical portion 714 located below the third cylindrical portion 711 and having an outer diameter smaller than that of the third cylindrical portion 711, and a second conical cylindrical portion 715 connected between the third cylindrical portion 711 and the fourth cylindrical portion 714. Here, the lower end portion of the second hollow shell 710 is designed with a smaller outer diameter structure, so that the lower end portion of the second hollow shell 710 does not affect the assembly difficulty between the third box 700 and the second box 200 or the two third box 700. In this way, the axial length of the second hollow shell 710 can be designed to be longer, and the assembly operation between the third box 700 and the second box 200 or the two third box 700 can be more easily realized. The design of the second conical cylindrical section 715 is mainly used to transition between the third cylindrical section 711 and the fourth cylindrical section 714, so that the third cylindrical section 711, the second conical cylindrical section 715, and the fourth cylindrical section 714 can be designed with the same wall thickness, which helps to reduce the manufacturing difficulty of the second hollow shell 710 and save material costs.

[0062] Preferably, refer to Figure 1 , Figure 2 and Figure 6 As shown, the top of the second locking part 712 is recessed with a second annular groove 716. During the testing process, when reagents or blood samples from the test kit splash from inside the third box 700 to the top of the third box 700, even if some reagents or blood samples flow along the inner side of the top of the third box 700 to the outer edge of the third box 700, the reagents or blood samples flowing to the outer edge of the third box 700 will be collected in the second annular groove 716 and will not flow directly out of the test kit. This helps to better prevent biological infection hazards to the operator caused by reagents or blood samples during the testing process.

[0063] Preferably, the first sealing plug 120 and each of the second sealing plugs 720 are elastic rubber plugs. This ensures that the first sealing plug 120 installed at the bottom of the first hollow housing 110 and each of the second sealing plugs 720 installed at the bottom of the second hollow housing 710 have a good sealing effect, and that the first sealing plug 120 and each of the second sealing plugs 720 are relatively easy to be opened under external force.

[0064] Preferably, refer to Figure 1 , Figure 2 and Figure 5 As shown, the first sealing plug 120 includes a first plug body 121 for inserting into the first hollow housing 110 from the bottom of the first hollow housing 110, and a first plug cap 122 protruding from one end of the first plug body 121 and locked outside the first hollow housing 110. The outer diameter of the first plug cap 122 is larger than the outer diameter of the first plug body 121. The locking engagement between the first plug cap 122 and the first hollow housing 110 enables axial positioning of the first sealing plug 120 on the first hollow housing 110. The locking engagement between the first plug body 121 and the first hollow housing 110 enables radial positioning of the first sealing plug 120 on the first hollow housing 110 and a sealing engagement between the outer wall of the first plug body 121 and the inner wall of the first hollow housing 110.

[0065] Preferably, the first plug 121 is inserted into the first hollow shell 110 with an interference fit. The outer diameter of the first plug 121 is larger than the inner diameter of the second cylindrical portion 114. In this embodiment, the first plug 121 is elastic, and the interference fit between the first plug 121 and the first hollow shell 110 not only ensures the sealing effect at the joint between the first plug 121 and the first hollow shell 110, but also facilitates the installation and opening of the first plug 121.

[0066] Preferably, refer to Figure 1 , Figure 2 and Figure 5 As shown, the outer wall of the first plug 121 is provided with a plurality of third annular ribs 123, spaced axially for sealing engagement with the inner wall of the first hollow housing 110. In this embodiment, the first plug 121 achieves a tight and sealed fit with the first hollow housing 110 through the third annular ribs 123. This reduces the contact area between the outer wall of the first plug 121 and the inner wall of the first hollow housing 110, thereby reducing the assembly difficulty of the first sealing plug 120 and the first hollow housing 110, and also provides a better sealing effect between the outer wall of the first plug 121 and the inner wall of the first hollow housing 110. Of course, in specific applications, as an alternative implementation, sealing between the outer wall of the first plug 121 and the inner wall of the first hollow housing 110 can also be achieved by setting a sealing ring between the outer wall of the first plug 121 and the inner wall of the first hollow housing 110.

[0067] Preferably, there are at least two third annular ribs 123, so that the outer wall of the first plug 121 and the inner wall of the second cylinder 114 have at least two sealing points in the axial direction, which helps to improve the sealing effect between the outer wall of the first plug 121 and the inner wall of the second cylinder 114.

[0068] Preferably, refer to Figure 1 , Figure 2 and Figure 6 As shown, the second sealing plug 720 includes a second plug body 721 for inserting into the second hollow housing 710 from the bottom of the second hollow housing 710, and a second plug cap 722 protruding from one end of the second plug body 721 and locked outside the second hollow housing 710. The locking engagement of the second plug cap 722 with the second hollow housing 710 enables axial positioning of the second sealing plug 720 on the second hollow housing 710. The locking engagement of the second plug body 721 with the second hollow housing 710 enables radial positioning of the second sealing plug 720 on the second hollow housing 710 and a sealing engagement between the outer wall of the second plug body 721 and the inner wall of the second hollow housing 710.

[0069] Preferably, the second plug 721 is inserted into the second hollow shell 710 with an interference fit. The outer diameter of the second plug 721 is larger than the inner diameter of the fourth cylindrical portion 714. In this embodiment, the second plug 721 is elastic, and the interference fit between the second plug 721 and the second hollow shell 710 not only ensures the sealing effect at the joint between the second plug 721 and the second hollow shell 710, but also facilitates the installation and opening of the second plug 721.

[0070] Preferably, refer to Figure 1 , Figure 2 and Figure 6 As shown, the outer wall of the second plug 721 is provided with a plurality of fourth annular ribs 723, spaced axially for sealing engagement with the inner wall of the second hollow housing 710. In this embodiment, the second plug 721 achieves a tight fit and sealing engagement with the second hollow housing 710 through the fourth annular ribs 723. This reduces the contact area between the outer wall of the second plug 721 and the inner wall of the second hollow housing 710, thereby reducing the assembly difficulty of the second sealing plug 720 and the second hollow housing 710, and also provides a better sealing effect between the outer wall of the second plug 721 and the inner wall of the second hollow housing 710. Of course, in specific applications, as an alternative implementation, sealing between the outer wall of the second plug 721 and the inner wall of the second hollow housing 710 can also be achieved by setting a sealing ring between the outer wall of the second plug 721 and the inner wall of the second hollow housing 710.

[0071] Preferably, there are at least two fourth annular ribs 723, so that the outer wall of the second plug 721 and the inner wall of the fourth cylinder 714 have at least two sealing points in the axial direction, which helps to improve the sealing effect between the outer wall of the second plug 721 and the inner wall of the fourth cylinder 714.

[0072] Preferably, refer to Figure 1 , Figure 2 , Figure 3 , Figure 4 and Figure 8 As shown, the bottom of the lid 300 has a protruding rod 310 for passing through the sealing sheet 130 and the first hollow shell 110 and sequentially opening the first sealing plug 120 and the second sealing plug 720 to conduct communication between the first box 100, the second box 200, and each of the third boxes 700. During the testing process, after the lid 300 is installed on the first box 100 from the top, pressing the lid 300 further down will cause the rod 310 to sequentially open the first sealing plug 120 and each of the second sealing plugs 720, thereby achieving communication between the first box 100, the second box 200, and each of the third boxes 700. This allows the blood sample, the first reagent 500 in the first box 100, and each of the third reagents 800 in each of the third boxes 700 to flow into the second box 200 and mix with the second reagent 600. Here, the design of the bottom rod 310 of the cover 300 allows the first sealing plug 120 and each of the second sealing plugs 720 to be opened directly by the cover 300 during the testing process, without the need for an additional mechanism to open the first sealing plug 120 and each of the second sealing plugs 720.

[0073] Preferably, refer to Figure 1 , Figure 2 , Figure 3 , Figure 4 and Figure 8 As shown, the lid 300 includes a rod 310, a snap-fit ​​body 320 for engaging with the first hollow housing 110, a cover plate 330 protruding from the top of the snap-fit ​​body 320 and snapped onto the outside of the first hollow housing 110, and a snap fastener 340 located on the outer edge of the cover plate 330 and engaging with the outer side of the first housing. The rod 310 protrudes from the bottom end of the snap-fit ​​body 320. The outer side wall of the snap-fit ​​body 320 abuts against the inner side wall of the first cylindrical portion 111. The cover plate 330 covers the top opening of the first hollow housing 110. The snap fastener 340 allows the lid 300 to be fastened to the first housing 100 when the lid 300 is pressed down to open the first sealing plug 120 and each of the third sealing plugs during testing, thereby improving the stability and reliability of the connection between the lid 300 and the first housing 100.

[0074] Preferably, refer to Figure 1 , Figure 2 , Figure 3 , Figure 4and Figure 8 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 insert body 320 in a direction away from the central axis of the insert body 320. The inclined plate portion 332 extends obliquely downward from the edge of the flat plate portion 331 away from the insert body 320 in a direction away from the central axis of the insert body 320. The buckle 340 extends downward from the edge of the inclined plate portion 332 away from the flat plate portion 331 and protrudes outward. The inclined plate portion 332 is provided so that after the cover 300 is pressed and assembled onto the first box body 100, the inclined plate portion 332 can fit tightly against the first box body 100, thereby improving the sealing effect of the cover 300 covering the first box body 100.

[0075] Preferably, there are at least two inverted buckles 340, and each inverted buckle 340 is evenly distributed at equal intervals along the outer edge of the cover plate 330.

[0076] Reference Figure 9 As shown, in specific applications, a sampling capillary 400 for collecting blood samples can be detachably installed at the bottom of the rod 310. This allows for direct sampling from the patient's fingertip using the sampling capillary 400 on the cover 300, eliminating the need for separate blood collection, reducing patient discomfort, and minimizing the amount of blood collected. Furthermore, it reduces environmental requirements for blood collection and carries lower technical and operational risks. The blood sample specifically refers to a blood sample.

[0077] Furthermore, embodiments of the present invention also provide a biochemical immunoassay method, comprising:

[0078] The first reagent 500 is loaded into the first box 100 and the first box 100 is sealed. At the same time, the second reagent 600 is loaded into the second box 200. A third reagent 800 is loaded into each of the third boxes 700. Then, each of the third boxes 700 is sequentially inserted and installed into the second box 200 or another third box 700. The first box 100 is inserted and installed into the third box 700 located at the top.

[0079] A blood sample is taken using a pipette tip or a sampling capillary 400. Then, the pipette tip or sampling capillary 400 is used to puncture the sealing sheet 130 on the first container 100, and the blood sample in the pipette tip or sampling capillary 400 is mixed with the first reagent 500 in the first container 100.

[0080] Install the lid 300 onto the first box body 100 from the top of the first box body 100, and press the lid 300 down to open the first sealing plug 120 and each of the second sealing plugs 720 in sequence through the lid 300, so that the blood sample, the first reagent 500, each of the third reagents 800 and the second reagent 600 in the second box body 200 are mixed.

[0081] The test kit is shaken manually or mechanically to ensure even distribution of the blood sample, first reagent 500, second reagent 600, and each third reagent 800.

[0082] After the test kit has been left to stand for a period of time, the test results are interpreted using a testing instrument.

[0083] The biochemical immunoassay method of this invention specifically involves a biochemical reaction in which at least three reagents bind to a blood sample in an immune binding process. During testing, the reagents required for the test are first encapsulated in independent chambers of a test kit that can be manipulated by external force. In this embodiment, the reagents in the test kit are mixed by applying force through a puncture at the lid 300. Furthermore, the entire sample addition process can be completed with a single sampling. Because the biochemical immunoassay method of this invention only requires one pipetting, it reduces the cumulative error from multiple sample additions, lowers the risk of errors in manual operation, and improves the accuracy, reliability, and efficiency of the test. Moreover, the test kit constitutes a sealed testing environment, eliminating the risk of biological infection to the operator. After the test is completed, the blood sample and reagents are disposed of as waste in a sealed form within the test kit, reducing the difficulty of subsequent collection and treatment of biomedical waste and avoiding the risk of biological infection to the operator during waste collection and treatment.

[0084] In this embodiment of the invention, at least three reagents to be tested are pre-sealed into independent cavities (in this embodiment, the first container 100, the second container 200, and the third container 700). After the blood sample is added, a single action connects the cavities containing the reagents to be tested. The blood sample and reagents are then mixed together for a biochemical reaction. Part of the seal (in this embodiment, the second sealing plug 720) also functions as a mixing device. After the reaction is complete, the entire liquid waste is sealed and stored in the test kit and discarded into a biochemical waste recycling container. The entire test requires only one sample addition, and subsequent operations are simple, facilitating large-scale manual testing operations. It can also achieve automated assembly line operations, resulting in high testing efficiency and simple, convenient operation, making it particularly suitable for point-of-care testing (POCT) projects.

[0085] As a preferred embodiment of this example, the packaging method of the test kit is as follows: the first reagent 500, the second reagent 600 and at least one third reagent 800 required for the same test are pre-packaged into the first box 100, the second box 200 and the third box 700 respectively. In this embodiment, the first reagent 500 is packaged in the first box 100 as follows: First, the top of the first hollow shell 110 of the first box 100 is sealed with a special easily puncturable sealing aluminum foil to cover the top opening of the first hollow shell 110. The required amount of the first reagent 500 for one test item is quantitatively added into the first box 100 from the bottom of the first hollow shell 110. Then, the bottom opening of the first hollow shell 110 is sealed with a first sealing plug 120. (Of course, in specific applications, the bottom opening of the first hollow shell 110 of the first box 100 can also be sealed with a first sealing plug 120 first, and the required amount of the first reagent 500 for one test item can be quantitatively added into the first box 100 from the top of the first hollow shell 110. Then, the top opening of the first hollow shell 110 is sealed with a special easily puncturable sealing aluminum foil.) The third reagent 800 is packaged within the third box 700 as follows: First, the bottom opening of the second hollow shell 710 is sealed with the second sealing plug 720. Then, the required amount of the third reagent 800 for one test item is quantitatively added into the second box 200 from the top of the second hollow shell 710. The second reagent 600 is packaged within the second box 200 as follows: The required amount of the second reagent 600 for the test is quantitatively added into the second box 200. Then, each of the third boxes 700, each containing one type of third reagent 800, is sequentially packaged and stacked on top of the second box 200. Finally, the first box 100, which has already been packaged and contains the first reagent 500, is packaged and stacked on top of the third box 700. Different test items can be automatically identified by the QR code (barcode) or other markings affixed to the side of the test kit.

[0086] A preferred method for rapid testing using the test kit of this embodiment is as follows: After directly piercing the sealing foil at the top of the first container 100 with a pipette tip loaded with the blood sample required for the test, the blood sample is added to the first container 100 (or, if sampling is directly taken from the patient's fingertip using the sampling capillary 400 on the lid 300, the fingertip blood sample in the sampling capillary 400 is directly mixed with the first reagent 500 in the first container 100 by pressing the lid 300 into the first container 100); then, the first container 100 is sealed by pressing the lid 300, and simultaneously, the rod 310 at the bottom of the lid 300 sequentially opens the first sealing plug 120 at the bottom of the first container 100 and each of the other sealing plugs 120 and 120. The second sealing plug 720 at the bottom of the three-box 700 allows the first reagent 500, blood sample, and third reagent 800 from each of the three-box 700 to fall into the second box 200. The test kit is shaken manually or mechanically, and the second box 200 and its internal second sealing plug 720 are shaken to mix the blood sample, first reagent 500, second reagent 600, and each of the third reagent 800 participating in the reaction. Then, the test kit containing the blood sample, first reagent 500, second reagent 600, and third reagent 800 is placed in a designated incubation room (environment). After 3-5 minutes, the test is performed and the results are interpreted using a detection instrument (fluoroscopy or other optical detection instrument). After the test is completed, the entire test kit is discarded into a biochemical waste recycling container.

[0087] In a preferred embodiment of this invention, the sealing barriers (first sealing plug 120 and second sealing plug 720 in this embodiment) between the first reagent 500, the second reagent 600, and each of the third reagents 800 are opened by applying force to the lid 300. Of course, in specific applications, other methods can also be used to open the sealing barriers between the first reagent 500, the second reagent 600, and each of the third reagents 800. For example, an external mechanism can be used to open the first sealing plug 120 and each of the second sealing plugs 720, and then the lid 300 can be used to cover the first box body 100. Alternatively, a biochemical reaction can be used to open the sealing barriers between the first reagent 500, the second reagent 600, and each of the third reagents 800.

[0088] The detection kit and biochemical immunoassay method provided in this invention are used in point-of-care testing (POCT), especially in tests where different reagents need to be added multiple times during the reaction process. They can achieve the following significant effects: reduce sampling time, improve detection efficiency, reduce the cumulative sampling error of multiple samplings, improve the accuracy and reliability of detection, eliminate contamination during detection, and solve a series of technical problems such as the biochemical hazards of waste after the reaction.

[0089] The above description is merely a preferred embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural transformations made using the contents of the present invention's specification and drawings under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included within 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, at least one third box body for accommodating at least one third reagent respectively, and a box cover for covering and installing on the top of the first box body, wherein the first box body comprises a first hollow shell body whose bottom can be inserted into the third box body and whose top can be stuck on the outside of the third box body, a first sealing plug for sealing the bottom of the first hollow shell body, and a sealing sheet for sealing the top of the first hollow shell body, and each of the third box bodies comprises a second hollow shell body whose bottom can be inserted into the second box body or another third box body and whose top can be stuck on the second box body or another third box body, and a second sealing plug for sealing the bottom of the second hollow shell body; The first hollow shell includes a first barrel portion inserted in the third box body and having an outer wall sealed with the inner wall of the third box body, and a first clamping portion protruding from the top of the first barrel portion and clamped on the third box body; The outer side wall of the first cylinder 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 third box body; and / or the first hollow shell further comprises a second cylinder located below the first cylinder and having an outer diameter smaller than that of the first cylinder, and a first conical cylinder connected between the first cylinder and the second cylinder; and / or a first annular groove is concavely provided on the top of the first clamping portion; The second hollow shell includes a third barrel portion inserted in the second box body or the other third box body, and the outer wall of the third barrel portion is sealed with the inner wall of the second box body or the inner wall of the other third box body, and a second clamping portion protruding from the top of the third barrel portion and clamped on the second box body or the other third box body; The outer side wall of the third barrel portion is provided with a plurality of second annular convex ribs spaced along the axial direction thereof for sealingly cooperating with the inner side wall of the second box body or the inner side wall of the other third box body; and / or the second hollow shell further comprises a fourth barrel portion located below the third barrel portion and having an outer diameter smaller than that of the third barrel portion, and a second conical barrel portion connected between the third barrel portion and the fourth barrel portion; and / or a second annular groove is provided on the top of the second clamping portion; The bottom of the box cover is convexly provided with a rod body for passing through the sealing sheet and the first hollow shell and sequentially pushing open the first sealing plug and the second sealing plug to conduct the first box body, the second box body and each of the third box bodies; The box cover comprises the rod body, a plug-in body for plugging with the first hollow shell, a cover plate convexly arranged at the top of the plug-in body and clamped outside the first hollow shell, and an undercut arranged at the outer edge of the cover plate and used for plugging with the outer side of the first hollow shell, and 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 first sealing plug comprises a first plug body for being inserted into the first hollow shell from the bottom of the first hollow shell and a first plug cap protruding from one end of the first plug body and being inserted outside the first hollow shell, and the first plug body is inserted and matched with the first hollow shell in an interference fit manner; and / or, The second sealing plug comprises a second plug body for being inserted into the second hollow shell from the bottom of the second hollow shell and a second plug cap protruding from one end of the second plug body and being inserted outside the second hollow shell, and the second plug body is inserted and matched with the second hollow shell in an interference fit manner; and / or the sealing sheet is a metal foil or a metal foil; and / or, The first sealing plug and the second sealing plug are both elastic rubber plugs; and / or, A sampling capillary tube for taking a blood sample is detachably mounted on the bottom end of the box cover.

3. A biochemical immunoassay method based on the detection kit according to claim 1, characterized in that: include: The first box body is loaded with a first reagent and sealed, the second box body is loaded with a second reagent, and each third box body is loaded with a third reagent, and then each third box body is inserted and installed on the second box body or another third box body in sequence, and the first box body is inserted and installed on the third box body located at the top; 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 the box cover on the first box body from the top of the first box body, and pressing the box cover downward to sequentially open the first sealing plug and each of the second sealing plugs through the box cover, so that the blood sample, the first reagent, each of the third reagents and the second reagent in the second box body are mixed; Shaking the test kit manually or by a mechanical mechanism to evenly shake the blood sample, the first reagent, the second reagent and each third 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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