Chemiluminescence immunoassay analyzer and magnetic separation device

Abstract

The utility model discloses a chemiluminescence immunoassay analyzer and a magnetic separation device. The magnetic separation device comprises a plurality of inner ring magnetic attraction point positions and a plurality of outer ring magnetic attraction point positions, the inner ring adsorption magnet is fixed on the workbench and is arranged on the inner side of the inner ring magnetic attraction point position; the number of the inner ring adsorption magnets is multiple, and each inner ring adsorption magnet corresponds to any inner ring magnetic attraction point position. The plurality of inner ring adsorption magnets have at least two specifications; the outer ring adsorption magnets are fixed to the workbench and arranged on the outer sides of the outer ring magnetic attraction point positions, the number of the outer ring adsorption magnets is multiple, and each outer ring adsorption magnet corresponds to any outer ring magnetic attraction point position; and the plurality of outer ring adsorption magnets have at least two specifications. A good magnetic bead adsorption effect can be achieved under the working conditions of different liquid injection amounts, the application range of the magnetic separation device is expanded, and the stability of a test result is improved.

Description

Technical Field

[0001] The utility model relates to the technical field of chemiluminescence detection, in particular to a chemiluminescence immunoassay instrument and a magnetic separation device. Background Art

[0002] Chemiluminescent immunoassays, also known as chemiluminescent immunoassays, consist of two components: an immunoassay system and a chemiluminescent analysis system. The chemiluminescent analysis system utilizes a chemiluminescent substance, catalyzed by a catalyst and oxidized by an oxidant, to form an excited intermediate. When this excited intermediate returns to a stable ground state, it simultaneously emits photons, and the quantum yield is measured using a luminescence signal measurement instrument. The immunoassay system involves directly labeling the luminescent substance with an antigen or antibody, or using an enzyme acting on a luminescent substrate.

[0003] The main function of the magnetic separation device in a luminescent immunoassay is to utilize magnetic separation technology to improve the efficiency and purity of immunoassays. Magnetic beads, acting as a solid-phase carrier, are combined with chemiluminescent immunoassays (CLIA). Under the influence of an external magnetic field, they can rapidly separate from the substrate liquid phase. This efficient separation and enrichment significantly reduces the effect of antigens on the immobilized antibodies on the beads during immunoassay reactions. Furthermore, the beads have a large surface area, allowing them to bind more protein molecules, thereby increasing the detection range. The chemical groups on the surface of the beads form a covalent coupling with the protein, which is stronger and more stable than physical adsorption. Furthermore, the beads are evenly suspended in the reaction solution, significantly increasing the contact area with the analytes in the sample, reducing the sample volume required for the reaction, and achieving a more rapid dynamic equilibrium, accelerating the reaction rate and saving reaction time. By combining magnetic beads with multiple capture proteins with multi-labeling technology, it is possible to simultaneously detect multiple analytes in the same sample, enabling fully automated individualized testing.

[0004] Separation of magnetic beads is a key step in luminescent immunoassays. During the luminescent immunoassay process, target molecules (such as antigens) in the sample bind to specific antibodies on the magnetic beads. After the reaction is complete, unbound sample components, excess reagents, and other impurities need to be removed to reduce their interference with subsequent detection steps. By separating the magnetic beads, the target molecule-bound beads can be effectively separated from the unbound background substances, thereby improving the ratio of detection signal to background noise and enhancing the accuracy and sensitivity of the test.

[0005] The magnetic separation device is one of the most important components of a luminescent immunoassay analyzer, and the magnet arrangement is a core element of the magnetic separation structure. However, existing magnetic separation devices use a single-layer arrangement of magnets with uniform specifications. This poor arrangement of magnets in different adsorption conditions can lead to poor adsorption and removal of magnetic beads, or prevent the beads from fully participating in the reaction, resulting in inadequate mixing and poor test result stability.

[0006] In view of this, a chemiluminescence immunoassay analyzer and a magnetic separation device are provided to at least partially solve the problem in the prior art that the poor arrangement structure and single specifications of the magnets cannot meet the magnetic bead adsorption requirements of different liquid levels, thereby resulting in poor stability of the test results. Utility Model Content

[0007] To this end, the embodiments of the present invention provide a chemiluminescence immunoassay analyzer and a magnetic separation device to solve the problems existing in the prior art.

[0008] In order to achieve the above objectives, the present invention provides the following technical solutions:

[0009] The utility model provides a magnetic separation device for a chemiluminescent immunoassay analyzer, the magnetic separation device comprising:

[0010] A workbench, wherein the workbench has a plurality of inner circle magnetic attraction points and a plurality of outer circle magnetic attraction points;

[0011] An inner ring adsorption magnet, the inner ring adsorption magnet is fixed to the workbench and is arranged on the inner side of the inner ring magnetic attraction point; there are multiple inner ring adsorption magnets, and each of the inner ring adsorption magnets is arranged corresponding to any one of the inner ring magnetic attraction points; the multiple inner ring adsorption magnets have at least two specifications;

[0012] The outer ring adsorption magnet is fixed on the workbench and is arranged on the outside of the outer ring magnetic attraction point. There are multiple outer ring adsorption magnets, and each of the outer ring adsorption magnets is arranged corresponding to any one of the outer ring magnetic attraction points; the multiple outer ring adsorption magnets have at least two specifications.

[0013] In this way, the chemiluminescence immunoassay analyzer and magnetic separation device provided by the present invention, by providing a double layer of independently acting magnets and magnets of different specifications, solve the problem in the prior art that the magnetic bead adsorption requirements at different liquid levels cannot be met due to poor magnet arrangement structure and single specifications, thereby leading to poor stability of test results; thereby, good magnetic bead adsorption effect can be achieved under working conditions of different injection volumes, thereby expanding the scope of application of the magnetic separation device and improving the stability of test results.

[0014] In some embodiments, the magnetic separation device further comprises:

[0015] A commutation magnet is disposed between the inner adsorption ring and the outer adsorption ring, and is disposed relative to any set of inner ring magnetic attraction points and outer ring magnetic attraction points;

[0016] The inner adsorption ring is a ring structure formed by the inner-ring adsorption magnets, and the outer adsorption ring is a ring structure formed by the outer-ring adsorption magnets.

[0017] In some embodiments, there are multiple commutation magnets, and each of the commutation magnets is arranged at intervals between the inner adsorption ring and the outer adsorption ring.

[0018] In some embodiments, the specifications of the inner ring adsorption magnet include a basic specification and a first specification, and the size of the first specification is smaller than the size of the basic specification.

[0019] In some embodiments, the specifications of the outer ring adsorption magnet include a basic specification and a second specification, and the size of the second specification is smaller than the size of the first specification.

[0020] In some embodiments, each of the inner ring adsorption magnets and each of the outer ring adsorption magnets are respectively fixed to the workbench through a mounting structure.

[0021] In some embodiments, the mounting structure includes:

[0022] A trough body, the trough body being arranged on the workbench;

[0023] An adhesive layer is laid on the bottom of the tank body. After each outer ring adsorption magnet and each inner ring adsorption magnet are placed in the tank body, they are bonded and fixed by the adhesive layer.

[0024] The utility model also provides a chemiluminescence immunoassay analyzer, comprising the magnetic separation device as described above. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] To more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for the embodiments or the description of the prior art. Obviously, the drawings described below are merely illustrative, and those skilled in the art can, without inventive effort, derive other implementation drawings based on the provided drawings.

[0026] The structures, proportions, sizes, etc. illustrated in this specification are intended solely to complement the contents disclosed herein and to facilitate understanding and reading by persons familiar with the art. They are not intended to limit the conditions under which the present invention may be implemented and therefore have no substantive technical significance. Any structural modifications, changes in proportions, or adjustments in size, without affecting the efficacy and objectives of the present invention, shall remain within the scope of the technical contents disclosed herein.

[0027] Figure 1 A schematic structural diagram of the magnetic separation device provided by the present invention;

[0028] Description of reference numerals:

[0029] 100-inner ring adsorption magnet, 200-outer ring adsorption magnet, 300-commutation magnet. DETAILED DESCRIPTION

[0030] The following describes the implementation of the present invention through specific embodiments. Those skilled in the art can readily understand the other advantages and benefits of the present invention from the contents disclosed in this specification. Obviously, the embodiments described are only a portion of the embodiments of the present invention, not all of them. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without inventive effort are also within the scope of protection of the present invention.

[0031] In a specific embodiment, the magnetic separation device provided by the present invention is used in a chemiluminescent immunoassay instrument, such as Figure 1As shown, the magnetic separation device includes a workbench (not shown in the figure), an inner ring adsorption magnet 100 and an outer ring adsorption magnet 200; wherein, the workbench has a plurality of inner ring magnetic points and a plurality of outer ring magnetic points, each magnetic point is provided with a reaction cup, and during the reaction process, the magnetic beads will be concentratedly adsorbed on the inner side of the reaction cup, and the inner ring adsorption magnet 100 is fixed on the workbench and arranged on the inner side of the inner ring magnetic points; the inner ring adsorption magnet 100 is multiple, and each of the inner ring adsorption magnets 100 is arranged corresponding to any one of the inner ring magnetic points; the multiple inner ring adsorption magnets 100 have at least two specifications; the outer ring adsorption magnet 200 is fixed on the workbench and arranged outside the outer ring magnetic points, the outer ring adsorption magnet 200 is multiple, and each of the outer ring adsorption magnets 200 is arranged corresponding to any one of the outer ring magnetic points; the multiple outer ring adsorption magnets 200 have at least two specifications. The different specifications of the inner ring adsorption magnets 100 and the different specifications of the outer ring adsorption magnets 200 both refer to different sizes. That is, the multiple inner ring adsorption magnets 100 have different specifications, some large and some small, and the multiple outer ring adsorption magnets 200 have different specifications, some large and some small. This facilitates selection of the appropriate size adsorption magnet based on the injection volume, ensuring optimal adsorption at varying injection volumes. The independent operation of the inner and outer rings of the magnetic separation significantly reduces magnet adsorption time. Setting the magnets to different sizes before injection for different injection volumes ensures better coverage of the magnetic beads, resulting in a more complete reaction.

[0032] In this way, the chemiluminescence immunoassay analyzer and magnetic separation device provided by the present invention, by providing a double layer of independently acting magnets and magnets of different specifications, solve the problem in the prior art that the magnetic bead adsorption requirements at different liquid levels cannot be met due to poor magnet arrangement structure and single specifications, thereby leading to poor stability of test results; thereby, good magnetic bead adsorption effect can be achieved under working conditions of different injection volumes, thereby expanding the scope of application of the magnetic separation device and improving the stability of test results.

[0033] Furthermore, the magnetic separation device also includes a reversing magnet 300, which is disposed between the inner adsorption ring and the outer adsorption ring. The reversing magnet 300 is disposed opposite any set of inner and outer magnetic attraction points. The inner adsorption ring is an annular structure formed by the inner adsorption magnets 100, and the outer adsorption ring is an annular structure formed by the outer adsorption magnets 200. By providing the reversing magnet 300, when the magnet is located inside the reaction cup, the magnetic beads are concentratedly adsorbed on the inside of the reaction cup. When the magnet is reversibly installed outside the reaction cup, the magnet is concentrated and freed toward the right outer side of the reaction cup. This freeing of the magnetic beads from the innermost side to the outer side increases physical mixing, allowing for more complete contact between the cleaning solution and the magnetic beads, thereby achieving more complete mixing by providing the reversing magnet.

[0034] Specifically, there are multiple commutation magnets 300, each of which is spaced apart between the inner and outer adsorption rings. Each commutation magnet 300 can be positioned at different locations depending on the operating conditions. The specifications of the inner ring adsorption magnet 100 include a basic specification and a first specification, with the first specification being smaller than the basic specification. The specifications of the outer ring adsorption magnet 200 include a basic specification and a second specification, with the second specification being smaller than the first specification.

[0035] To ensure reliable magnet installation, each inner ring adsorption magnet 100 and each outer ring adsorption magnet 200 are secured to the workbench via a mounting structure. Specifically, the mounting structure comprises a trough disposed on the workbench and an adhesive layer applied to the bottom of the trough. After each outer ring adsorption magnet 200 and each inner ring adsorption magnet 100 is placed in the trough, they are bonded and secured via the adhesive layer.

[0036] Theoretically, the mounting structure may also be in other structural forms such as a slot, as long as it can ensure reliable installation of the magnet.

[0037] For ease of understanding, the structure and working process of the magnetic separation device provided by the present invention are briefly described below using a specific usage scenario as an example.

[0038] This embodiment takes a magnetic separation device applied to a specific target project (hereinafter referred to as L3) and applied to other projects other than the specific target project (hereinafter referred to as general projects) as an example. The magnets used for magnetic separation in the magnetic separation device are divided into two circles of magnets, an inner circle and an outer circle. The inner circle is the inner circle adsorption magnet 100, and the outer circle is the outer circle adsorption magnet 200. The outer circle adsorption magnet 200 performs general projects; the inner circle adsorption magnet 100 only performs pre-processing of the special project L3. The inner circle adsorption magnet 100 and the outer circle adsorption magnet 200 work independently, which greatly reserves the reaction time for the magnets; the magnets are arranged according to their functions and are divided into adsorption magnets and commutation magnets 300. Figure 1 The 3rd, 12th, 20th and 27th points are all pre-set commutation magnets 300; the magnets are divided into A, B and C type magnets according to the strength of action, among which the size of type A magnet is the base specification and is set as the base magnet. It is used before the cleaning fluid is injected and can be selected according to the injection height. The type B magnet is smaller than the type A magnet and is used before the L3 fluid is injected. The specification of the type B magnet is the first specification; the type C magnet is smaller than the type B magnet and is used before the substrate is injected with fluid. The specification of the type C magnet is the second specification. Among them, the size of the magnet is set according to the amount of fluid added. It should be pointed out that the injection volume of the ordinary project> the injection volume of the pre-treatment cleaning fluid of the L3 project> the injection volume of the substrate.

[0039] The standard project process is to add enzyme, magnetic beads, and then sample, incubate for 600 seconds, wash three times, and then add luminescent liquid for photometry. The L3 project process is composed of pre-treatment and a one-step sandwich method. The process is to add separation magnetic beads and then add sample, incubate for 300 seconds, wash with cleaning solution 1, then wash with cleaning solution 2, collect the supernatant, and then perform a one-step sandwich method; after adding enzyme and magnetic beads, add eluted sample, incubate for 600 seconds, wash three times, and add luminescent liquid for photometry.

[0040] The movement process is as follows: the inner circle performs pretreatment of the L3 project, position 1 grabs the reaction cup, reaches position 3 and 4 and experiences the action of the outer ring magnet as a reversal, positions 5-7 use high-strength magnets for adsorption, because the injection volume of the L3 project pretreatment is lower than that of the ordinary project and higher than the substrate injection volume, the magnet before injection uses a B-type magnet, positions 8-9 use a B-type magnet to adsorb the magnetic beads downward, and reaches position 10 to inject and mix the cleaning solution 1. Positions 12 and 13 are affected by the ordinary project and experience the adsorption of the outer ring magnet once, and reach positions 19 and 20 for adsorption by the outer ring magnet, and reach position 21. , position 22 is adsorbed by type A magnet, and when it reaches positions 23 and 24, the high-strength type A magnet is replaced by the type B magnet, and the magnetic beads are adsorbed downward, the waste liquid is sucked out at position 24, and the cleaning liquid 2 is injected and mixed at position 25. After the reaction time at positions 26-33, it arrives at positions 34, 35, 36 and 1, and adsorbs toward the inner circle. After the L3 pretreatment is completed, the supernatant must be taken to participate in the next reaction, so a type B magnet is used to adsorb the magnetic beads downward. When it returns to position 1 again, the reaction cup is taken out. At this position, the L3 project pretreatment is completed, and then the outer circle ordinary project operation is carried out.

[0041] For common items in the outer circle, after the reaction cup at position 1 is put into the cup, the cleaning solution is injected into position 2 to dilute the reactant. The magnets at positions 3 and 4 attract the magnetic beads in the reaction cup. When it reaches position 5, the magnet reverses and attracts the magnetic beads. After reversing, the mixing is more complete. After the adsorption action of positions 5-9, the magnetic beads are adsorbed on the cup wall in the outer circle direction. When it reaches position 9, the waste suction needle is used to suck waste. At position 10, the cleaning solution is injected and mixed. After mixing, it reaches positions 12 and 13, and the magnetic beads are attracted by the magnet in the inner circle direction. When it reaches position 14, the direction is reversed again. It reaches position 17 to suck waste liquid. It reaches position 18 to inject the cleaning solution and mix. Positions 26 and 27 are used to adsorb the beads, and the beads are adsorbed as much as possible at position 28. After adsorption, the beads are injected into the liquid and mixed evenly. The beads are then adsorbed in the inner circle at positions 21 and adsorption is reversed. The waste liquid is sucked away for the third time at position 24. The beads are injected and mixed evenly at position 25. After injection and mixing, the beads are adsorbed again at position 26 and 27. When the beads are injected, adsorption is reversed at position 28. When the beads are injected, 200 ml of substrate is injected. The magnet is replaced with a C-type magnet to adsorb the beads as much as possible. After adsorption, the liquid is added and the liquid surface covers the magnetic beads to make the reaction more complete. The substrate is injected at position 34 and mixed evenly at position 35. When the beads are injected again at position 1, the cup is removed from the entrance and is ready to enter the light measurement process.

[0042] In addition to the magnetic separation device described above, the present invention also provides a chemiluminescence immunoassay instrument including the magnetic separation device. For the structures of other parts of the chemiluminescence immunoassay instrument, please refer to the prior art and will not be described in detail here.

[0043] It is understood that the same or similar parts in the above-mentioned embodiments can refer to each other, and the content not described in detail in some embodiments can refer to the same or similar content in other embodiments. It should be noted that, in the description of this application, the terms "first", "second", etc. are used only for descriptive purposes and are not to be understood as indicating or implying relative importance. In addition, in the description of this application, unless otherwise specified, the meaning of "plurality" refers to at least two.

[0044] Any process or method description in a flowchart or otherwise described herein may be understood to represent a module, segment or portion of code comprising one or more executable instructions for implementing the steps of a specific logical function or process, and the scope of the preferred embodiments of the present application includes alternative implementations in which functions may be performed out of the order shown or discussed, including performing functions in a substantially simultaneous manner or in the reverse order depending on the functions involved, which should be understood by those skilled in the art to which the embodiments of the present application belong.

[0045] Throughout this specification, reference to terms such as "one embodiment," "some embodiments," "examples," "specific examples," or "some examples" means that a specific feature, structure, material, or characteristic described in conjunction with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

[0046] The above specific implementation methods further describe in detail the purpose, technical solutions and beneficial effects of the utility model. It should be understood that the above are only specific implementation methods of the utility model and are not used to limit the scope of protection of the utility model. Any modifications, equivalent replacements, improvements, etc. made on the basis of the technical solution of the utility model should be included in the scope of protection of the utility model.

Claims

1. A magnetic separation device, characterized in that: For use in a chemiluminescent immunoassay analyzer, the magnetic separation device comprises: A workbench, wherein the workbench has a plurality of inner circle magnetic attraction points and a plurality of outer circle magnetic attraction points; An inner ring adsorption magnet, the inner ring adsorption magnet is fixed to the workbench and is arranged on the inner side of the inner ring magnetic attraction point; there are multiple inner ring adsorption magnets, and each of the inner ring adsorption magnets is arranged corresponding to any one of the inner ring magnetic attraction points; the multiple inner ring adsorption magnets have at least two specifications; The outer ring adsorption magnet is fixed on the workbench and is arranged on the outside of the outer ring magnetic attraction point. There are multiple outer ring adsorption magnets, and each of the outer ring adsorption magnets is arranged corresponding to any one of the outer ring magnetic attraction points; the multiple outer ring adsorption magnets have at least two specifications.

2. The magnetic separation device according to claim 1, characterized in that Also includes: A commutation magnet is disposed between the inner adsorption ring and the outer adsorption ring, and is disposed relative to any set of inner ring magnetic attraction points and outer ring magnetic attraction points; The inner adsorption ring is a ring structure formed by the inner-ring adsorption magnets, and the outer adsorption ring is a ring structure formed by the outer-ring adsorption magnets.

3. The magnetic separation device according to claim 2, characterized in that There are multiple commutation magnets, and each of the commutation magnets is arranged at intervals between the inner adsorption ring and the outer adsorption ring.

4. The magnetic separation device according to claim 1, characterized in that The specifications of the inner ring adsorption magnet include a basic specification and a first specification, and the size of the first specification is smaller than the size of the basic specification.

5. The magnetic separation device according to claim 4, characterized in that The specifications of the outer ring adsorption magnet include a basic specification and a second specification, and the size of the second specification is smaller than the size of the first specification.

6. The magnetic separation device according to claim 1, characterized in that Each of the inner ring adsorption magnets and each of the outer ring adsorption magnets are respectively fixed on the workbench through a mounting structure.

7. The magnetic separation device according to claim 6, characterized in that The mounting structure includes: A trough body, the trough body being arranged on the workbench; An adhesive layer is laid on the bottom of the tank body. After each outer ring adsorption magnet and each inner ring adsorption magnet are placed in the tank body, they are bonded and fixed by the adhesive layer.

8. A chemiluminescence immunoassay instrument, characterized in that: Comprising the magnetic separation device according to any one of claims 1 to 7.

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