Sample analysis apparatus and sample analysis method

Abstract

A sample analysis device and method, the sample analysis device comprises a reagent mixing device, a reagent dispensing device and a control device, the control device is respectively connected with the reagent mixing device and the reagent dispensing device, the reagent mixing device is used for mixing magnetic bead reagent, the reagent dispensing device is used for collecting the magnetic bead reagent mixed in the reagent mixing device and transferring it to a reaction container, wherein the reagent mixing device comprises a reagent container storage mechanism, the reagent container storage mechanism has at least one mounting part, the mounting part is used for mounting a magnetic bead liquid container storing magnetic bead reagent, a magnetic field generating mechanism has a magnetic part, the magnetic part is used for generating a magnetic field, the magnetic field is used for adsorbing magnetic beads in the magnetic bead reagent on the mounting part, making the magnetic beads leave the deposition position, the reagent mixing device has the functions of mixing and sample reagent storage, does not need to additionally set a reagent storage device, the overall volume of the device is smaller, and it is more compact.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a sample analysis device and a sample analysis method. Background Technology

[0002] Magnetic bead reagents are widely used in sample analysis. These reagents typically consist of magnetic beads, their labels, and a buffer solution. During use, the magnetic beads are drawn up using a corresponding reagent aspiration device and transferred to the appropriate reaction vessel. Currently, sample analyzers with magnetic bead reagent storage, mixing, and aspiration functions are often too bulky to meet the miniaturization needs of hospitals. Summary of the Invention

[0003] This application provides a novel sample analysis device and a sample analysis method, thereby providing a new sample analysis device.

[0004] To achieve the above objectives, one embodiment of this application provides a sample analysis device, which includes a reagent mixing device, a reagent dispensing device, and a control device. The control device is electrically connected to both the reagent mixing device and the reagent dispensing device. The reagent mixing device is used to mix magnetic bead reagents, and the reagent dispensing device is used to collect the mixed magnetic bead reagents from the reagent mixing device and transfer them to a reaction vessel. The reagent mixing device includes:

[0005] A reagent container storage mechanism, the reagent container storage mechanism having at least one mounting part, the mounting part being used to mount a magnetic bead liquid container containing magnetic bead reagent;

[0006] A magnetic field generating mechanism has a magnetic component for generating a magnetic field, which is used to adsorb magnetic beads in the magnetic bead reagent on the mounting part, causing the magnetic beads to leave the deposition position.

[0007] To achieve the above objectives, one embodiment of this application provides a sample analysis method, which includes:

[0008] Sample addition procedure: Collect the sample and add it to the reaction vessel;

[0009] Reagent mixing steps:

[0010] The magnetic bead liquid container containing the magnetic bead reagent to be mixed is placed in the magnetic field generated by the reagent mixing device, wherein the reagent mixing device includes a magnetic element for generating the magnetic field.

[0011] Reagent addition step: Collect the magnetic bead reagent after it has been mixed in the reagent mixing device and transfer it to the reaction vessel;

[0012] Reaction solution processing steps: The reaction solution in the reaction vessel is mixed, incubated, magnetically separated, and substrate is added to obtain the detection solution; the reaction solution includes at least the sample and magnetic bead reagent;

[0013] Detection steps: Detect the parameters of the target analyte in the detection solution.

[0014] According to the above embodiments, the reagent mixing device can also be used as a reagent storage device, that is, the reagent mixing device has both mixing and sample reagent storage functions, so there is no need to set up a separate reagent storage device, and the overall size of the device is smaller and more compact. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of a magnetic component adsorbing magnetic beads from the side of a magnetic bead liquid container in one embodiment of this application;

[0016] Figure 2 This is a schematic diagram of the reagent mixing device in one embodiment of this application;

[0017] Figure 3 This is a schematic diagram of the reagent mixing device in another embodiment of this application;

[0018] Figure 4 This is a schematic diagram of a magnetic component adsorbing magnetic beads from two different surfaces of a magnetic bead liquid container in one embodiment of this application;

[0019] Figure 5 This is a schematic diagram of a magnetic bead liquid container being attracted by different magnetic adsorption parts in one embodiment of this application;

[0020] Figure 6 This is a schematic diagram of the cooperative structure of the reagent container storage mechanism and the driving mechanism in one embodiment of this application;

[0021] Figure 7-12 This is a schematic diagram of the control steps of the magnetic field generating mechanism and the reagent container storage mechanism in one embodiment of this application;

[0022] Figure 13 This is a schematic diagram of the magnetic field generating mechanism in one embodiment of this application;

[0023] Figure 14 This is a schematic diagram of the magnetic field generating mechanism in the second embodiment of this application;

[0024] Figure 15 This is a schematic diagram of the magnetic field generating mechanism in the third embodiment of this application;

[0025] Figure 16 This is a schematic diagram illustrating the cooperation between the magnetic field generating mechanism and the reagent container storage mechanism in one embodiment of this application;

[0026] Figure 17This is a schematic diagram of the structure of the reagent mixing device in one embodiment of this application when it is also used as a reagent tray;

[0027] Figure 18-19 This is a schematic diagram of the structure of the reagent mixing device and the reagent tray when they are set up independently in one embodiment of this application;

[0028] Figure 20 This is a schematic diagram of the structure of an immunoluminescence analyzer in one embodiment of this application;

[0029] Figure 21 This is a structural block diagram of the control section of an immunoluminescence analyzer in one embodiment of this application;

[0030] Figure 22-24 The following are flowcharts illustrating several different sample analysis methods in one embodiment of this application. Detailed Implementation

[0031] The present invention will now be described in further detail with reference to specific embodiments and accompanying drawings. Similar elements in different embodiments are referred to by associated similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of this application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to this application are not shown or described in the specification. This is to avoid obscuring the core parts of this application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0032] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for the clear description of a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0033] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include both direct and indirect connections (linkages).

[0034] This application provides a sample analysis device capable of detecting and analyzing one or more samples from the human body. These samples may be (but are not limited to) blood, urine, semen, or sweat. For example, the sample analyzer may be a biochemical analyzer, an immunoassay analyzer, or other types of sample analyzers.

[0035] In the process of sample processing and testing, sample reagents are usually added to the sample to prepare it for subsequent testing. Magnetic bead reagents are a commonly used sample reagent in immunoassays and need to be collected when the magnetic beads are evenly distributed to ensure the accuracy of the test results. Therefore, it is necessary to mix the magnetic bead reagents before they are collected and transferred to the reaction vessel.

[0036] Please refer to Figure 2 , 3 And 20, the sample analysis device includes a reagent mixing device 31, a reagent dispensing device 32, and a control device (not shown in the figure). The control device is electrically connected to the reagent mixing device 31 and the reagent dispensing device 32, respectively. The reagent mixing device 31 is used to mix the magnetic bead reagent, and the reagent dispensing device 32 is used to collect the mixed magnetic bead reagent and transfer it to the reaction vessel (e.g., Figure 20 In the reaction vessel 103 shown.

[0037] This control device is used to control the operation of the reagent mixing device 31 and the reagent dispensing device 32. It can be a main control unit, or it can be based on a main control unit with sub-control units set for the reagent mixing device 31 and the reagent dispensing device 32 respectively. The control device can adopt various structures capable of data transmission and reception, data processing, etc., such as controllers or other structures with processors, memory, etc.

[0038] Please refer to Figure 1 , 2 The reagent mixing device 31 includes a reagent container storage mechanism 311, a magnetic field generating mechanism 312, and a driving mechanism 313.

[0039] The reagent container storage mechanism 311 has at least one mounting part 3111 for mounting a magnetic bead liquid container 410 containing magnetic bead reagent. The magnetic component 3121 is used to generate a magnetic field. The magnetic component 3121 can be a permanent magnet, an electromagnet, or a combination of an electromagnet and a permanent magnet. As long as it can generate a magnetic field effect, it belongs to the magnetic component 3121 shown in this embodiment.

[0040] The mounting portion 3111 is disposed corresponding to the magnetic component 3121, so that the magnetic bead container 410 located on the mounting portion 3111 can be placed within the magnetic field. The relative position of the magnetic bead container 410 and the magnetic field is used to define the relative position of the mounting portion 3111 and the magnetic component 3121. In fact, the mounting portion 3111 can be located anywhere relative to the magnetic component 3121, as long as the magnetic bead container 410 located on the mounting portion 3111 falls within the magnetic field of the corresponding magnetic component 3121. For example, the mounting portion 3111 can be located to the side of the magnetic component 3121 or below the magnetic component 3121; the structural arrangement of the mounting portion 3111 and the magnetic bead container 410 ensures that the magnetic bead container 410 ultimately falls within the magnetic field of the corresponding magnetic component 3121.

[0041] Furthermore, such as Figure 2 As shown, in this embodiment, an electromagnet 3121a is used as the magnetic component 3121. By controlling the on and off states of the electromagnet 3121a, the corresponding magnetic field can be turned on and off. Please refer to... Figure 3 This embodiment shows an example of using a permanent magnet 3121b as a magnetic component 3121, which can move between different positions under the drive of a state switching drive, thereby realizing the movement of the magnetic field.

[0042] The control device can control the magnetic component 3121 to switch between working and non-working states. For example, it can control the electromagnet 3121a to be energized, thereby putting the electromagnet 3121a into a working state, or control the permanent magnet 3121b to move to a first position that can attract the magnetic bead reagent, thereby putting the permanent magnet 3121b into a working state; it can control the electromagnet 3121a to be de-energized, thereby putting the electromagnet 3121a into a non-working state, or control the permanent magnet 3121b to move to a second position that can release the magnetic bead reagent, thereby putting the permanent magnet 3121b into a non-working state. The magnetic bead reagent on each mounting part 3111 is located outside the magnetic field generated by the permanent magnet 3121b (not absolutely outside the magnetic field, but also including the case where it is only slightly affected by the magnetic field, in which case the magnetic field has a very small attraction force on the magnetic bead 411, and the effect on the movement of the magnetic bead 411 can be ignored). The first position is the position close to the mounting part 3111, and the second position is the position far away from the mounting part 3111.

[0043] Normally, the magnetic component 3121 is in a non-operating state when mixing is not required. The control device switches the magnetic component 3121 to an operating state only when mixing of the magnetic bead reagent is needed. When the control device keeps the magnetic component 3121 in a non-operating state, it can control the drive mechanism 313 to drive the magnetic bead liquid container 410 to rotate or perform other forms of movement. After being removed from the magnetic field, the magnetic beads can easily move within the magnetic bead liquid container, thus improving the mixing effect.

[0044] Please refer to Figure 1 The magnetic bead solution container 410 mentioned here refers only to the tube itself used to contain the magnetic bead reagent. It can exist alone or be combined with other tubes to form reagent assembly 400, such as... Figure 1 As shown, the reagent assembly 400 includes not only a magnetic bead liquid container 410, but also a reagent support 420 on which the magnetic bead liquid container 410 is mounted. The reagent support 420 is also provided with a reagent compartment 440 for holding other reagent components.

[0045] In one embodiment, the magnetic component 3121 is located on the side of the magnetic bead container 410. This can be understood as the south or north pole of the magnetic component 3121 being positioned at a non-zero angle to the longitudinal axis of the magnetic bead container 410. This non-zero angle can be 15°, 30°, 45°, 60°, 75°, 90°, etc. This arrangement allows the magnetic field lines 110 of the magnetic component 3121 to be more concentrated on the side of the magnetic bead container 410, effectively and quickly adsorbing the magnetic beads 411. This causes the magnetic beads 411 deposited at the bottom of the magnetic bead container 410 to rise rapidly and suspend in the magnetic bead reagent, achieving a mixing effect. Furthermore, the magnetic component 3121 installed on the side does not occupy the vertical space of the magnetic bead container 410, facilitating the loading of the container and reducing the volume of the sample analysis equipment.

[0046] More specifically, the south or north pole of the magnetic element 3121 is perpendicular to the longitudinal axis of the magnetic bead liquid container 410 to further improve the mixing effect. In other embodiments, the magnetic element 3121 may also be mounted above the mounting portion 3111, that is, the magnetic element 3121 adsorbs the magnetic beads 411 deposited at the bottom of the magnetic bead liquid container 410 from above.

[0047] Furthermore, the mounting section 3111 can be configured as one or more. When there is one mounting section 3111, it can accommodate one magnetic bead liquid container 410. Of course, to improve mixing efficiency, please refer to... Figure 2 and 3 In some embodiments, the mounting portion 3111 is provided in multiple ways, allowing multiple magnetic bead liquid containers 410 to be placed simultaneously. To enable the mixing of more than one magnetic bead reagent, the magnetic component 3121 has at least two magnetic attraction portions. These at least two magnetic attraction portions are different parts of a single magnetic component 3121, or they may be independently configured sub-magnetic components. That is, the magnetic component 3121 can be a single integral structure or composed of multiple sub-magnetic components, such as... Figure 2 and 3 In the embodiments shown, the entire magnetic component 3121 is composed of multiple independent electromagnets 3121a or permanent magnets 3121b.

[0048] When the magnetic component 3121 is in a non-operating state, the magnetic beads on each mounting part 3111 are either outside the magnetic field generated by the magnetic component 3121 or the magnetic component 3121 does not generate a magnetic field, and the magnetic beads are in a released state. When the magnetic component 3121 is in an operating state, at least a portion of the magnetic beads on the mounting parts 3111 are within the magnetic field generated by the magnetic component 3121, and the magnetic beads are in an adsorbed state.

[0049] In one embodiment, please refer to Figure 2 and 3 In the working state, the magnetic field generated by the magnetic component 3121 covers a portion of the magnetic bead reagent on the mounting portion 3111. That is, in the working state, it is also possible to prevent the magnetic bead reagent on a portion of the mounting portion 3111 from being attracted by the magnetic field of the magnetic component 3121. For example... Figure 2 In the working state, one electromagnet 3121a corresponds to one mounting part 3111, and the mounting part 3111 that does not correspond to an electromagnet 3121a is outside the magnetic field at this time. Similarly, as Figure 3 As shown, in the working state, one permanent magnet 3121b corresponds to one mounting part 3111, while the mounting parts 3111 not corresponding to the permanent magnet 3121b are outside the magnetic field. Although the magnetic component 3121 does not cover all the magnetic beads on the mounting parts 3111, the relative movement between the mounting parts 3111 and the magnetic component 3121 still allows the magnetic beads on all the mounting parts 3111 to move to the position where they are attracted by the magnetic component 3121 when needed. This design saves material and space occupied by the magnetic component 3121, making the device more compact.

[0050] Please refer to Figure 2 and 3 In one embodiment, the mounting portion 3111 is movable relative to the electromagnet 3121a or the permanent magnet 3121b along the arrangement direction of the mounting portion 3111, and the moving path of the mounting portion 3111 has magnetic attraction positions and non-magnetic attraction positions. When the mounting portion 3111 is in the magnetic attraction position, the magnetic bead reagent on the corresponding mounting portion 3111 can be attracted by the magnetic field generated by the electromagnet 3121a or the permanent magnet 3121b; when the mounting portion 3111 is in the non-magnetic attraction position, the magnetic bead reagent on the corresponding mounting portion 3111 is always outside the magnetic field area generated by the electromagnet 3121a or the permanent magnet 3121b.

[0051] The control device is connected to the drive mechanism 313, which is drively connected to the magnetic bead container 410 and / or the magnetic element 3121. The drive mechanism 313 can be at least one set of drive components; when there are two or more sets of drive components, these drive components are collectively referred to as the drive mechanism 313. The drive mechanism 313 drives the movement of at least one of the magnetic bead container 410 and the magnetic element 3121, ultimately achieving relative rotation or other forms of relative movement between the two components. The drive mechanism 313 can use various power sources (e.g., motors, cylinders, hydraulic cylinders, electromagnets, etc.) as the driving force, and transmits the motion to at least one of the magnetic element 3121, the mounting part 3111, and the magnetic bead container 410 through a corresponding transmission mechanism.

[0052] Please refer to Figure 2 , 3 In a more specific embodiment, the reagent container storage mechanism 311 includes a reagent holder 3112. The reagent holder 3112 is a circular reagent tray, and a mounting portion 3111 is disposed on the reagent holder 3112. The magnetic element 3121 is fixedly disposed. The driving mechanism 313 includes a driving element 3131 and a reagent holder transmission element. The driving element 3131 is connected to the reagent holder 3112 via the reagent holder transmission element to drive the reagent holder 3112 to rotate. The mounting portion 3111 is arranged in a ring around the rotation center line of the reagent holder 3112, and the magnetic element 3121 is disposed within the enclosed area of ​​the mounting portion 3111. If necessary, the position of the magnetic element 3121 may be offset from the position of the mounting portion 3111 so that the magnetic field of the magnetic element 3121 can act on the magnetic bead reagent on the mounting portion 3111. The reagent holder 3112 can rotate and move the magnetic bead container 410 it carries, so as to rotate the magnetic bead container 410 to a specific position, such as the position where the reagent is drawn up by the reagent dispensing device 32. Of course, in addition to this disc-shaped structure, the reagent holder 3112 can also be a structure in which the mounting parts 3111 are arranged linearly, such as a linear reagent holder.

[0053] The reagent holder transmission component includes a first gear disk 3132 that is coaxially arranged and fixedly connected to the reagent holder 3112. The driving component 3131 is connected to the first gear disk 3132 for transmission, so as to drive the first gear disk 3132 and the reagent holder 3112 to rotate coaxially, causing the mounting part 3111 to revolve around the magnetic component 3121.

[0054] Please refer to Figure 2 , 3 In one embodiment, the drive mechanism 313 further includes a second gear disk 3133. The second gear disk 3133 is fixedly disposed and located within the enclosed area of ​​the mounting portion 3111. The teeth of the second gear disk 3133 extend into the mounting area of ​​the magnetic bead liquid container 410 corresponding to the mounting portion 3111. Figure 1As shown, the magnetic bead liquid container 410 may have a gear 430 that meshes with the second gear disk 3133. The teeth of the second gear disk 3133 can mesh with the gear 430 on the magnetic bead liquid container 410, so that when the reagent holder 3112 rotates, the second gear disk 3133 can drive the magnetic bead liquid container 410 to rotate. The magnetic component 3121 may be disposed on the second gear disk 3133 or other components.

[0055] In this embodiment, the driving component drives the mounting part 3111 to rotate the magnetic bead liquid container 410 around the magnetic component 3121, while the magnetic bead liquid container 410 also rotates on its own axis. The revolution of the magnetic bead liquid container 410 around the magnetic component 3121 and the rotation of the magnetic bead liquid container 410 share a single driving component, thus simplifying the structure of the reagent mixing device 31. Other types of structures can also be used in other embodiments. For example, two sets of driving components can be used to drive the reagent holder 3112 to move (including but not limited to revolution or translation) and to drive the magnetic bead reagent to rotate, respectively. Furthermore, for better mixing results, please refer to... Figure 4 and 5 One embodiment employs a two-sided magnetic adsorption mixing method, where magnetic beads 411 are adsorbed from the first side A and the second side B of the magnetic bead liquid container 410, which are opposite to each other, thereby improving the mixing effect. Please refer to... Figure 4 and 5 In this embodiment, the magnetic bead liquid container 410 containing the magnetic bead reagent to be mixed is placed within the magnetic field of the magnetic component 3121. The magnetic component 3121 adsorbs the magnetic beads 411 of the magnetic bead reagent from the first surface A of the magnetic bead liquid container 410. After the magnetic bead liquid container 410 remains stationary within the current magnetic field for a first duration, the second surface B is then oriented towards the magnetic component 3121, causing the magnetic component 3121 to adsorb the magnetic beads 411 from the second surface B of the magnetic bead liquid container 410, which is opposite to the first surface A, and remain stationary for a second duration. This allows the magnetic beads 411 from different regions within the magnetic bead liquid container 410 to be adsorbed, increasing the movement of the magnetic beads 411 and enabling them to be more evenly distributed within the container, thus facilitating the mixing of the magnetic beads 411.

[0056] In particular, such as Figure 4 and 5 As shown, a certain type of magnetic bead liquid container 410 has a rib 412 in the middle, which divides the magnetic bead liquid container 410 into two connected cavities. If the magnetic beads 411 of the magnetic bead reagent are only adsorbed from one side, a small number of magnetic beads will be blocked by the rib 412 and cannot be adsorbed. For this type of magnetic bead liquid container 410, the first surface A shown in this embodiment is the outer wall of one cavity, and the second surface B is the outer wall of the other cavity. This embodiment can adsorb magnetic beads 411 from the outer walls located on both sides of the rib 412, so that the magnetic bead reagent in the magnetic bead liquid container 410 is fully mixed.

[0057] Please refer to Figure 4 and 5 When the first surface A faces the magnetic component 3121, the control device controls the magnetic bead liquid container 410 to remain relatively stationary with respect to the magnetic component 3121 for a first duration, so that the magnetic beads 411 in the corresponding area can be acted upon by the magnetic field as much as possible. Similarly, when the second surface B faces the magnetic component 3121, the control device controls the magnetic bead liquid container 410 to remain relatively stationary with respect to the magnetic component 3121 for a second duration, so that the magnetic beads 411 in the other area can also be acted upon by the magnetic field as much as possible.

[0058] Of course, in this embodiment, the adsorption of magnetic beads from the first surface A and the second surface B, which are opposite to each other in the magnetic bead liquid container 410, does not necessarily require the magnetic bead liquid container 410 to rotate 180°. In fact, since the magnetic field covers a region, the magnetic bead liquid container 410 often does not need to rotate 180° to adsorb the magnetic beads 411 in the two opposite cavities. Therefore, in one embodiment, when the magnetic bead liquid container 410 rotates from the first surface A towards the magnetic component 3121 to the second surface B towards the magnetic component 3121, the rotation angle of the magnetic bead liquid container 410 relative to the magnetic component 3121 is a1, and the value of a1 is in the range of: n1×120°≤a1≤n1×240°, where n1 is a positive integer. The effect of changing the magnetic bead liquid container 410 from facing the magnetic element 3121 from the first side A to facing the magnetic element 3121 from the second side B can be achieved by driving the magnetic bead liquid container 410 to revolve around the magnetic element 3121 while driving the magnetic bead liquid container 410 to rotate on its own axis, or by driving the magnetic element 3121 to revolve around the magnetic bead liquid container 410.

[0059] Furthermore, the first and second durations of the magnetic bead reagent settling time can be flexibly set according to factors such as the type of magnetic bead reagent and the desired mixing effect. In one embodiment, considering that the magnetic element 3121, when adsorbing the magnetic beads 411 from the first surface of the magnetic bead reagent, will also act on other areas of the magnetic bead reagent, such as the area corresponding to the second surface, thereby adsorbing most of the magnetic beads, in this embodiment, the first duration is greater than or equal to the second duration to save time for adsorbing the magnetic bead reagent from the second surface and improve the mixing efficiency.

[0060] Further, please refer to Figure 2In a more specific embodiment, the magnetic component 3121 is divided into at least two electromagnets 3121a, each electromagnet 3121a being equivalent to a magnetic attraction portion of the magnetic component 3121. In some embodiments, all or some of the electromagnets 3121a may be combined into a larger electromagnet. In this embodiment, the number of electromagnets 3121a is less than the number of mounting portions 3111. The electromagnets 3121a are arranged in an arc shape, wherein, in the working state, one electromagnet 3121a corresponds to one magnetic bead reagent on one mounting portion 3111, that is, when the electromagnet 3121a is energized, it mainly plays a magnetic attraction role for the magnetic bead reagent on one mounting portion 3111. The two mounting portions 3111 corresponding to adjacent electromagnets 3121a are not adjacent, and two other mounting portions 3111 are also provided between the two mounting portions 3111. These two mounting portions 3111 are the mounting portions mentioned above that are located outside the magnetic field when the magnetic component 3121 is in the working state.

[0061] The distance between adjacent mounting parts 3111 is one cup position. When the reagent holder 3112 revolves around the magnetic component 3121, it advances in units of one cup position (this can be clockwise or counterclockwise). Since the reagent holder 3112 can also drive the magnetic bead liquid container 410 to rotate (in some embodiments, it can only revolve without rotating) while revolving around the magnetic component 3121, to improve efficiency, in this embodiment, it is designed so that every three cup positions the reagent holder 3112 advances, it simultaneously drives the corresponding magnetic bead liquid container 410 to rotate from facing one electromagnet 3121a with its first face to facing another electromagnet 3121a with its second face. For example, the magnetic bead liquid container 410 is first mixed with its first face facing the first electromagnet 3121a (i.e., the first magnetic attraction part), and then, after moving three cup positions, it is mixed again with its second face facing the second electromagnet 3121a (i.e., the second magnetic attraction part), further improving mixing efficiency.

[0062] In one embodiment, every time the reagent holder 3112 advances 3 cup positions, it causes the corresponding magnetic bead liquid container 410 to rotate by an angle a2. The value of a2 is in the range of n1×120°≤a2≤n1×240°, where n1 is a positive integer.

[0063] Please refer to Figure 2 , 7 -12, In one embodiment, the reagent holder 3112 has 36 mounting portions 3111, which can hold a total of 36 magnetic bead liquid containers 410. The following explanation will take the example that all the magnetic bead reagents in the 36 magnetic bead liquid containers 410 need to be thoroughly mixed.

[0064] Please refer to Figure 2 and 7Six electromagnets 3121a are arranged within a 180° range of the reagent holder 3112. For example, it is assumed that electromagnets 3121a are installed at the positions corresponding to the 11th, 14th, 17th, 20th, 23rd, and 26th magnetic bead reagents (the numbers circled in the figure are the labels of the magnetic bead reagents). Figure 7-12 The positions indicated by the thick lines are electromagnets. There are a total of 6 electromagnets 3121a, and the positions of these 6 electromagnets 3121a remain constant. Of course, in other embodiments, the number of electromagnets 3121a may be increased or decreased.

[0065] Before mixing begins, the control device drives the reagent holder 3112 to find the zero position, and the scanning device scans the code to determine the location (i.e., the number) of the reagent to be mixed.

[0066] When you begin mixing, please refer to... Figure 7 The electromagnet 3121a is energized by the control device for a first preset time ts. When the electromagnet 3121a is in working state, the 11th, 14th, 17th, 20th, 23rd and 26th magnetic beads are attracted by the electromagnet 3121a from the first surface and remain still for a first time, which is greater than, equal to or less than the first preset time ts.

[0067] After this, reagent holder 3112 moves clockwise one cup position. Please refer to [the manual / tool ​​description]. Figure 8 Specifically, magnetic beads numbered 10, 13, 16, 19, 22, and 25 are moved to positions corresponding to the six electromagnets 3121a, while magnetic beads numbered 11, 14, 17, 20, 23, and 26 are moved clockwise to positions between two electromagnets 3121a, where they are either unaffected or only slightly affected by the magnetic field of the electromagnets 3121a. During the clockwise movement of one cup position, the electromagnets 3121a are de-energized for a second preset time t2s, switching to a non-working state to prevent excessive heating of the electromagnets 3121a and to allow the magnetic beads to move freely for a period of time in the absence of the magnetic field. Before, after, or simultaneously with the movement of magnetic beads 10, 13, 16, 19, 22, and 25 to their corresponding positions on the six electromagnets 3121a, the six electromagnets 3121a are energized again and continue for a first preset time ts, so that magnetic beads 10, 13, 16, 19, 22, and 25 are attracted to the electromagnets 3121a from the first surface for a first duration.

[0068] After this, reagent holder 3112 continues to move clockwise one cup position. Please refer to... Figure 9Specifically, magnetic beads numbered 9, 12, 15, 18, 21, and 24 move to their corresponding positions with the six electromagnets 3121a, while magnetic beads numbered 10, 13, 16, 19, 22, and 25 move clockwise between two electromagnets 3121a, at which point they are not affected by or are only slightly affected by the magnetic field of the electromagnets 3121a. During the clockwise movement of one cup position, the electromagnet 3121a is de-energized for a second preset time t2s to prevent it from overheating. Before, after, or simultaneously with the magnetic beads numbered 9, 12, 15, 18, 21, and 24 moving to their corresponding positions with the six electromagnets 3121a, the six electromagnets 3121a are energized again and maintained for another first preset time ts, allowing the magnetic beads numbered 9, 12, 15, 18, 21, and 24 to be attracted by the electromagnets 3121a from the first surface for a first duration.

[0069] At this point, electromagnet 3121a magnetically attracts the first surfaces of the 9th to 26th magnetic beads sequentially, thus completing the mixing of the first surfaces of all 18 magnetic beads. Optionally, in one embodiment, electromagnet 3121a can be de-energized at this time, switching to a non-operating state. Next, reagent holder 3112 can be rotated forward and backward multiple times, using centrifugal force to move the magnetic beads within the reagent, resulting in a more uniform distribution of the magnetic beads. Of course, in some embodiments, this operation can be omitted, and mixing of other magnetic beads can continue directly.

[0070] Next, to further mix the first side of the reagent for the remaining 18 magnetic beads, please refer to... Figure 10 The reagent holder 3112 continues to move clockwise by 18 cup positions (or counterclockwise by 18 cup positions), meaning that the 27th, 30th, 33rd, 36th, 3rd, and 6th magnetic beads move to positions corresponding to the six electromagnets 3121a. The 18 magnetic beads, mixed from the first side in the previous steps, are moved to the side without electromagnets 3121a. During the counterclockwise movement of the 18 cup positions, the electromagnets 3121a are de-energized for a second preset time t2s to prevent excessive heat generation. Before, after, or simultaneously with the 27th, 30th, 33rd, 36th, 3rd, and 6th magnetic beads moving to their corresponding positions, the six electromagnets 3121a are energized again and maintained for another first preset time ts, allowing the 27th, 30th, 33rd, 36th, 3rd, and 6th magnetic beads to be attracted by the electromagnets 3121a from the first side for a first duration.

[0071] After this, reagent holder 3112 moves counterclockwise one cup position. Please refer to [the manual / tool ​​description]. Figure 11Specifically, magnetic beads 28, 31, 34, 1, 4, and 7 move to positions corresponding to the six electromagnets 3121a, while magnetic beads 27, 30, 33, 36, 3, and 6 move counterclockwise to positions between two electromagnets 3121a, where they are not affected or are only slightly affected by the magnetic field of the electromagnets 3121a. During the counterclockwise movement of one cup position, the electromagnet 3121a is de-energized for a second preset time t2s, switching to a non-working state to prevent excessive heat generation. Before, after, or simultaneously with the magnetic beads 28, 31, 34, 1, 4, and 7 moving to positions corresponding to the six electromagnets 3121a, the six electromagnets 3121a are energized again and maintained for a first preset time ts, allowing the magnetic beads 28, 31, 34, 1, 4, and 7 to be attracted by the electromagnets 3121a from the first surface for a first duration.

[0072] After that, continue moving the cup one position counterclockwise. Please refer to... Figure 12 Specifically, magnetic beads 29, 32, 35, 2, 5, and 8 move to their corresponding positions with the six electromagnets 3121a, while magnetic beads 28, 31, 34, 1, 4, and 7 move counterclockwise between two electromagnets 3121a, where they are not affected by or are only slightly affected by the magnetic field of the electromagnets 3121a. During the counterclockwise movement of one cup position, the electromagnet 3121a is de-energized for a second preset time t2s to prevent it from overheating. Before, after, or simultaneously with the magnetic beads 29, 32, 35, 2, 5, and 8 moving to their corresponding positions with the six electromagnets 3121a, the six electromagnets 3121a are energized again and maintained for another first preset time ts, allowing the magnetic beads 29, 32, 35, 2, 5, and 8 to be attracted by the electromagnets 3121a from the first surface for a first duration.

[0073] Up to this point, all 36 magnetic bead reagents have been mixed from the first side. Optionally, in one embodiment, the electromagnet 3121a can be de-energized, switching it to a non-operating state. Alternatively, the reagent holder 3112 can be rotated forward and backward multiple times (e.g., 24 times) to intensify the movement of the magnetic bead reagents with external force, thereby improving the mixing effect. Of course, in some embodiments, this operation can be omitted, and the mixing of other magnetic bead reagents can continue directly.

[0074] After the first side of the 36 magnetic bead reagents is mixed, if two-sided mixing is required, a second side mixing can be performed. If two-sided mixing is not required, a second side mixing is not necessary. In one embodiment, the reagent holder 3112 is moved three cup positions so that the second side of the magnetic bead reagent faces the magnetic component 3121. The number of cup positions moved depends mainly on the angle required to rotate the magnetic bead reagent from the first side facing the magnetic component 3121 to the second side facing the magnetic component 3121; it is sufficient to ensure that the magnetic bead reagent can be rotated from the first side facing the magnetic component 3121 to the second side facing the magnetic component 3121. Then, the first side mixing step is continued, except that at this time, the magnetic component 3121 adsorbs the corresponding magnetic bead 411 from the second side of the magnetic bead reagent.

[0075] In the above control, clockwise rotation can be changed to counterclockwise rotation, and counterclockwise rotation can also be changed to clockwise rotation. Under the above disclosure, those skilled in the art can fully implement this modification.

[0076] After all 36 magnetic bead reagents have been mixed on one or both sides, the reagent holder 3112 can be controlled to rotate forward and backward multiple times (e.g., 24 times) when the electromagnet 3121a is de-energized and in a non-working state, thereby moving the magnetic bead reagents and further improving the mixing effect.

[0077] The 36 mounting parts 3111 shown above are merely an example. In other embodiments, the number of mounting parts 3111 can be flexibly designed according to the device size, requirements, and related factors. Similarly, the number of magnetic suction parts in the magnetic component 3121 can also be flexibly set. The timing control of the reagent holder 3112's movement is designed based on the number and distribution of the mounting parts 3111 and the magnetic suction parts.

[0078] Of course, in some cases, not all sample reagents stored on the mounting section 3111 are magnetic bead reagents that need to be mixed. In this regard, in one embodiment, the control device first calculates the number of cycles required to perform a single-sided mixing operation on all sample reagents on the mounting section 3111 (not necessarily all of them are magnetic bead reagents; it can be assumed that all sample reagents are magnetic bead reagents, so as to calculate the number of cycles). The reagent holder 3112 advances one cup position, which is one cycle. In one cycle, the magnetic element 3121 performs a single-sided mixing operation on the corresponding magnetic bead reagent once. For example, in the above-described electromagnet 3121a scheme, when the reagent holder 3112 advances one cup position, the electromagnet 3121a is energized and de-energized once. In this cycle, 6 electromagnets 3121a can perform a maximum of 6 single-sided mixing operations on 6 magnetic bead reagents once. Taking a total of 36 mounting sections 3111 as an example, 6 sample reagents can be mixed in one cycle. In this case, it takes 6 cycles to perform a single-sided mixing operation on all sample reagents on the mounting section 3111.

[0079] Then, it is determined whether there are magnetic beads of reagent to be mixed on all mounting parts 3111 in each cycle. If there are magnetic beads of reagent to be mixed on one mounting part 3111, the cycle is executed as usual, the reagent holder 3112 moves one cup position, the electromagnet 3121a is energized, the magnetic beads of reagent come to rest, then the power is turned off, and then the reagent holder 3112 continues to move to the next cycle. If there are no magnetic beads of reagent to be mixed on all mounting parts 3111 in the cycle, the cycle is skipped and carried over to the next cycle. That is, the sample reagent that should have been sent into the magnetic field of the magnetic component 3121 in the cycle does not stay at the magnetic attraction position of the magnetic component 3121, or even if it stays, it does not conduct electricity to the electromagnet 3121a and does not generate a magnetic attraction effect on these sample reagents.

[0080] In another embodiment, please refer to Figure 3 , 13 -15, the magnetic component 3121 includes a permanent magnet 3121b. The magnetic field generating mechanism 312 includes a state switching drive. The state switching drive is driveably connected to the mounting part 3111 and / or the permanent magnet 3121b, driving the mounting part 3111 and the permanent magnet 3121b to move closer to each other along a first direction, so that at least a portion of the magnetic bead reagent on the mounting part 3111 is located within the magnetic field generated by the permanent magnet 3121b (the permanent magnet 3121b is in an operating state). The state switching drive is also used to drive the mounting part 3111 and the permanent magnet 3121b to move further apart along the first direction, so that the permanent magnet 3121b moves to a position where it does not produce a magnetic attraction to the magnetic bead reagent or only produces a weak magnetic attraction, thereby releasing the magnetic beads 411 within the magnetic bead reagent (the permanent magnet 3121b is in a non-operating state).

[0081] In this embodiment, the state switching drive is specifically connected to the magnetic component 3121. The state switching drive can drive the magnetic component 3121 to move back and forth between a position where it can adsorb magnetic beads (working state) and a position where it can release magnetic beads (non-working state), so that the magnetic component 3121 switches between the working state and the non-working state. The state switching drive can use various power sources (such as motors, cylinders, hydraulic cylinders, electromagnets, etc.) as the driving force. Figure 3 , 13 In the embodiment shown in -14, the state switching drive is taken as motor 3123.

[0082] Please refer to Figure 3 , 13 -15. In this embodiment, the magnetic field generating mechanism 312 further includes a support base 3122, a mounting base 3128, and a transmission mechanism. The state switching drive is connected to the support base 3122, the permanent magnet 3121b is mounted on the mounting base 3128, and the state switching drive is connected to the mounting base 3128 via the transmission mechanism.

[0083] Please refer to Figure 13 In one embodiment, the transmission mechanism includes a rocker arm 3124, a connector 3125, an adapter 3126, and a connecting rod 3127. One end of the rocker arm 3124 is connected to the output end of the motor 3123, and the other end is connected to the connector 3125. The connector 3125 is movably mounted on the adapter 3126 and can slide or roll on the adapter 3126 to change their relative positions. The adapter 3126 may have an elongated hole (or a protrusion) perpendicular to a first direction to cooperate with the connector 3125. One end of the connecting rod 3127 is connected to a mounting base 3128, and the other end is mounted on the adapter 3126. The support base 3122 has a guide portion extending along a first direction. In this embodiment, the first direction is the radial direction of the disc-shaped reagent holder 3112, but when the reagent holder 3112 has other structures, the first direction may also be other directions. For example, when the reagent holder 3112 is a linear reagent holder, the first direction can be a direction perpendicular to or intersecting the linear reagent holder from the side. The adapter 3126 is slidably disposed on the guide portion, which can be a linear guide rail or other structure. The state switching drive is used to drive the swing arm 3124 and the connector 3125 to rotate. The connector 3125 drives the adapter 3126 to move along the guide portion, and then the adapter 3126 drives the connecting rod 3127, the mounting seat 3128 and the permanent magnet 3121b to move along the first direction, that is, to drive the mounting seat 3128 to move closer to and further away from the magnetic bead reagent in the radial direction of the reagent holder 3112, so as to realize the switching between the working state and the non-working state.

[0084] Please refer to Figure 14 In another embodiment, the transmission mechanism includes a rocker arm 3124 and a connector 3125. One end of the rocker arm 3124 is connected to the motor 3123, and the other end is connected to the connector 3125. The connector 3125 is movably mounted on the mounting base 3128 and can slide or roll on the mounting base 3128 to change the relative position of the two. The adapter 3126 may be provided with an elongated hole (or a protrusion) perpendicular to the first direction to cooperate with the connector 3125. The support base 3122 is provided with a guide portion extending along the first direction. In this embodiment, the first direction is the radial direction of the disc-shaped reagent holder 3112, but when the reagent holder 3112 has other structures, the first direction may also be other directions. The guide portion may be a guide rod 3129 or other structures. The mounting base 3128 is slidably mounted on the guide section. The state switching drive is used to drive the swing arm 3124 and the connector 3125 to rotate. The connector 3125 drives the mounting base 3128 and the permanent magnet 3121b to move along the guide section, that is, it drives the mounting base 3128 to move closer to and further away from the magnetic bead reagent in the radial direction of the reagent holder 3112, so as to realize the switching between working and non-working states.

[0085] Please refer to Figure 15In another embodiment, the state switching drive is a linear motion output device, such as a telescopic electromagnet 3121a or a linear motor. The transmission mechanism includes a connecting rod 3127, which is rotatably connected to a support base 3122. The output end of the telescopic electromagnet 3121a is rotatably connected to one end of the connecting rod 3127. The connecting rod 3127 is rotatably connected to a mounting base 3128. The connection between the connecting rod 3127 and the mounting base 3128 has a movable part arranged in the vertical direction, so that the rotatable connection position of the connecting rod 3127 and the mounting base 3128 can be adjusted vertically. This movable part can be an elongated hole or a protrusion arranged in the vertical direction. The support base 3122 is provided with a guide part extending in a first direction, and the mounting base 3128 is slidably disposed on the guide part. In this embodiment, the first direction is the radial direction of the disc-shaped reagent holder 3112, but when the reagent holder 3112 has other structures, the first direction may also be other directions.

[0086] In this embodiment, when the telescopic electromagnet 3121a extends, it can drive the connecting rod 3127 and the mounting base 3128 away from the magnetic bead reagent on the reagent holder 3112 along the first direction; when the state switching drive retracts, it can drive the connecting rod 3127 and the mounting base 3128 closer to the magnetic bead reagent on the reagent holder 3112 along the first direction, so as to realize the switching between working state and non-working state.

[0087] The above embodiments are merely illustrative representations of how the state-switching drive unit switches the magnetic component 3121 between an operating state and a non-operating state. These embodiments fully utilize the structure of the disc-shaped reagent holder 3112, arranging the magnetic component 3121 within the enclosed area of ​​the mounting portion 3111, resulting in a more compact overall device structure and facilitating the adsorption of magnetic beads by the magnetic component 3121. In reality, the cooperation structure between the state-switching drive unit and the magnetic component 3121 is not limited to the structures described above; it can also be achieved through other structures, such as radially approaching and moving away from the magnetic beads from the outside of the reagent holder 3112.

[0088] Please refer to Figure 3 and 16 In this embodiment, the magnetic component 3121 is divided into at least two permanent magnets 3121b, each permanent magnet 3121b being equivalent to a magnetic attraction portion of the magnetic component 3121. In some embodiments, all or some of the permanent magnets 3121b may be combined into a larger permanent magnet. In this embodiment, the number of permanent magnets 3121b is less than the number of mounting portions 3111. The permanent magnets 3121b are arranged in an arc shape, wherein, in the working state, one permanent magnet 3121b corresponds to one magnetic bead reagent on one mounting portion 3111, that is, in the working state, the permanent magnet 3121b mainly plays a magnetic attraction role for the magnetic bead reagent on one mounting portion 3111. The two mounting portions 3111 corresponding to adjacent permanent magnets 3121b are also adjacent.

[0089] The distance between adjacent mounting parts 3111 is one cup position. When the reagent holder 3112 revolves around the magnetic component 3121, it advances in units of one cup position (forward and reverse rotation). Since the reagent holder 3112 can also drive the magnetic bead liquid container 410 to rotate while revolving around the magnetic component 3121, to improve efficiency, in this embodiment, it is designed so that for every cup position advanced by the reagent holder 3112, the corresponding magnetic bead liquid container 410 rotates from facing one permanent magnet 3121b with its first face to facing another permanent magnet 3121b with its second face. For example, the magnetic bead liquid container 410 is first mixed with its first face facing the first permanent magnet 3121b (i.e., the first magnetic attraction part), and then, after moving one cup position, it is mixed with its second face facing the second permanent magnet 3121b (i.e., the second magnetic attraction part), further improving mixing efficiency.

[0090] In one embodiment, for each cup position advanced by the reagent holder 3112, the corresponding magnetic bead liquid container 410 rotates by an angle a2, where the value of a2 is in the range of n1×120°≤a2≤n1×240°, and n1 is a positive integer.

[0091] Please refer to Figure 16 In one embodiment, the reagent holder 3112 has 36 mounting portions 3111, which can hold a total of 36 magnetic bead liquid containers 410. The following description assumes that the magnetic bead reagents in all 36 magnetic bead liquid containers 410 must be thoroughly mixed.

[0092] Please refer to Figure 16 Seven permanent magnets 3121b are disposed within the reagent holder 3112, and the positions of these seven permanent magnets 3121b remain unchanged. Of course, in other embodiments, the number of permanent magnets 3121b may be increased or decreased.

[0093] Before mixing begins, the control device drives the reagent holder 3112 to reset, and the scanning mechanism scans the code to determine the location of the reagent to be mixed.

[0094] Before, during, or after the reset, the state switching drive can be controlled by the control device to move the permanent magnet 3121b to the working state. At this time, the seven magnetic beads opposite the permanent magnet 3121b are attracted by the permanent magnet 3121b from the first side and remain stationary for a first time duration Xs.

[0095] Please refer to the following: Figure 16The reagent holder 3112 moves clockwise one cup position, meaning the magnetic bead reagent originally located opposite the first permanent magnet 3121b moves to be opposite the second permanent magnet 3121b, and so on for other positions. At this time, the magnetic bead reagent originally located opposite the first permanent magnet 3121b is attracted by the second permanent magnet 3121b. Furthermore, since the magnetic bead reagent rotates by a set angle with each cup position movement, the magnetic bead reagent originally facing the first permanent magnet 3121b (first magnetic attraction part) with its first surface facing the first permanent magnet 3121b (second magnetic attraction part) becomes facing the second permanent magnet 3121b (second magnetic attraction part) with its second surface, completing the mixing of both sides of one magnetic bead reagent. After moving one cup position clockwise, it remains stationary for a second time period Ys to allow the magnetic beads 411 of the reagent to be attracted as fully as possible. The first permanent magnet 3121b adsorbs the magnetic bead reagent on the mounting part of the first permanent magnet 3121b at this time.

[0096] Please refer to the following: Figure 16 The reagent holder 3112 then moves clockwise by 5 positions. The magnetic bead reagent initially located opposite the first permanent magnet 3121b moves to the position corresponding to the seventh permanent magnet 3121b, and so on. At this point, the magnetic bead reagent originally located opposite the first permanent magnet 3121b is attracted by the seventh permanent magnet 3121b. The magnetic bead reagent that was newly moved to the position opposite the first permanent magnet 3121b in the previous step is moved to the position opposite the sixth permanent magnet 3121b. In this state, it remains stationary for a first time period X seconds.

[0097] Please refer to the following: Figure 16 The reagent holder 3112 then moves clockwise by one cup position, and each magnetic bead reagent moves clockwise and remains stationary at the new position for a second duration Ys.

[0098] The above two steps constitute one cycle, which is repeated. The number of repetitions is related to the number of overall mounting parts 3111 and the number of permanent magnets 3121b. Finally, the magnetic bead reagent on all mounting parts 3111 is mixed evenly on both sides.

[0099] After all the magnetic bead reagents are mixed, the control device controls the state switching drive to move the permanent magnet 3121b to the non-working state. At this time, all the magnetic bead reagents are removed from the magnetic field or are only subjected to a weak magnetic field.

[0100] When the permanent magnet 3121b is not in operation, the reagent holder 3112 can be controlled to rotate forward and backward multiple times, thereby moving the magnetic bead reagent and further improving the mixing effect. When the reagent holder 3112 has other shapes, such as a linear structure, the magnetic bead reagent can also be moved by driving the reagent holder 3112 to reciprocate.

[0101] Of course, in some cases, not all sample reagents stored on mounting sections 3111 are magnetic bead reagents that need to be mixed. In one embodiment, similar to the electromagnet 3121a scheme, the control device first calculates the number of cycles required to perform a one-sided mixing operation on the magnetic bead reagents on all mounting sections 3111. Then, it determines whether there are magnetic bead reagents that need to be mixed on all mounting sections 3111 in each cycle. If there are magnetic bead reagents that need to be mixed on one mounting section 3111, the cycle is executed normally. If there are no magnetic bead reagents that need to be mixed on all mounting sections 3111 in the cycle, the permanent magnet 3121b is moved and kept in a non-working state in the cycle until the next cycle arrives.

[0102] Further, please refer to Figure 3 and 16 To reduce the influence of the magnetic field on the magnetic bead reagent, in one embodiment, the magnetic field generating mechanism 312 further includes a first auxiliary magnetic element 3141 and a second auxiliary magnetic element 3142. Both the first auxiliary magnetic element 3141 and the second auxiliary magnetic element 3142 are mounted on the mounting base 3128, and their magnetism is weaker than that of the permanent magnet 3121b. The permanent magnet 3121b is positioned between the first auxiliary magnetic element 3141 and the second auxiliary magnetic element 3142. The magnetic poles of the first auxiliary magnetic element 3141 and the adjacent permanent magnet 3121b are opposite in direction, and the magnetic poles of the second auxiliary magnetic element 3142 are also opposite in direction. Through the interaction of magnetic fields in opposite directions, the first auxiliary magnetic element 3141 and the second auxiliary magnetic element 3142 can converge the magnetic fields located on both sides of the permanent magnet 3121b.

[0103] In the above embodiments, before mixing begins, the control device determines whether there is magnetic bead reagent to be mixed. If so, it controls the mounting part 3111 carrying the magnetic bead reagent to be mixed to move towards the magnetic field coverage area of ​​the magnetic component 3121.

[0104] The methods for determining the presence of magnetic bead reagents requiring mixing include at least one of reagent information comparison and receiving external instructions. This reagent information refers to the identification information of the magnetic bead reagent, which can be obtained by scanning various barcodes, QR codes, or other labels representing identification information, or by receiving relevant reagent information input by the operator to the sample analysis device or transmitted to the sample analysis device by external devices.

[0105] The reagent information comparison and judgment includes, but is not limited to, at least one of the following: reagent type, reagent mixing record, and time interval since the last mixing, in order to determine whether the current magnetic bead reagent needs to be mixed.

[0106] Specifically, the reagent type comparison refers to matching the currently acquired magnetic bead reagent type with the magnetic bead reagent type stored in the sample analysis device. The reagent mixing record comparison is used to check whether the current magnetic bead reagent has been mixed before. If it has not been mixed, the magnetic bead reagent is determined to require mixing. For example, magnetic bead reagents that have not been used before, magnetic bead reagents that have been used but not mixed, and manually loaded magnetic bead reagents can all be considered as magnetic bead reagents that have not been mixed. The time interval between the comparison and the last mixing refers to determining the time interval since the last mixing if the magnetic bead reagent has been mixed before. If this time interval meets the required time interval for mixing, the magnetic bead reagent is determined to require mixing.

[0107] The external command can come from the operator manually inputting the command into the sample analysis device, or it can come from other external devices, such as mobile phones, computers, or other terminals, inputting the command via wired or wireless signals.

[0108] Of course, other methods for determining whether there are magnetic beads that need to be mixed can also be used in existing equipment, and are not limited to those described above.

[0109] On the other hand, this sample analysis device typically includes at least one reagent storage device (e.g., a reagent tray) for storing sample reagents (including magnetic bead reagents). Please refer to [reference needed]. Figure 17 In one embodiment, the reagent mixing device 31 shown in this embodiment can also be used as a reagent storage device, that is, the reagent mixing device 31 has both mixing and sample reagent storage functions. The reagent dispensing device 32 collects the mixed magnetic bead reagent in the reagent mixing device 31 and transfers it to the reaction vessel. This structure eliminates the need for a separate reagent storage device, resulting in a smaller and more compact overall device size.

[0110] Of course, please refer to Figure 18 , 19 In one embodiment, the sample analysis device further includes a reagent storage device 33 and a reagent transfer mechanism 34. The reagent storage device 33 and the reagent mixing device 31 are separately configured. The reagent storage device 33 is used to store the mixed magnetic bead reagent. The reagent transfer mechanism 34 includes a pickup component 341 for picking up the mixed magnetic bead liquid container 410 from the reagent container storage mechanism 311 and a transfer drive component 342 for driving the pickup component 341 to move. The transfer drive component 342 drives the pickup component 341 to move the mixed magnetic bead liquid container 410 into the reagent storage device 33. The reagent dispensing device 32 collects the magnetic bead reagent in the reagent storage device 33 and transfers it to the reaction vessel.

[0111] The reagent storage device 33 can also be used to store unmixed magnetic bead reagents and other related sample reagents. The reagent transfer mechanism 34 transfers the magnetic bead reagents to be mixed from the reagent storage device 33 to the reagent mixing device 31. After the magnetic bead reagents are mixed, the reagent transfer mechanism 34 then transfers them from the reagent mixing device 31 to the reagent storage device 33. Of course, in some embodiments, the reagent storage device 33 may only be used to store the mixed magnetic bead reagents, while unmixed magnetic bead reagents and other sample reagents may be stored in a separate device.

[0112] The following section, using a specific immunoassay analyzer, further illustrates the application of the reagent mixing device 31 shown in this application in sample analysis equipment.

[0113] Please refer to Figure 20 and Figure 21 In one embodiment, the chemiluminescence immunoassay analyzer mainly includes a reaction solution mixing device 10, a sample carrying mechanism 21, a sample dispensing mechanism 22, a reagent mixing device 31 (also used as a reagent storage device), a reagent dispensing device 32, a reaction mechanism 40, a magnetic separation mechanism 50, and a controller 60. The sample carrying mechanism 21, sample dispensing mechanism 22, reagent mixing device 31, reagent dispensing device 32, reaction mechanism 40, magnetic separation mechanism 50, and reaction solution mixing device 10 are all mounted on a base 100. The controller 60 is mounted on the main unit of the base 100, or alternatively, it can be mounted on the base 100. The aforementioned magnetic separation mechanism may not be included in the biochemical analyzer.

[0114] The immunoluminescence analyzer also includes a cup-loading mechanism 71, a cup-throwing position 72, a first transfer mechanism 81, a second transfer mechanism 82, and a measurement mechanism 90, all mounted on the base 100.

[0115] The reaction mechanism 40 is located in the middle, and the reagent mixing device 31, magnetic separation mechanism 50, reaction liquid mixing device 10, upper cup mechanism 71, cup throwing position 72 and measuring mechanism 90 are respectively located around the reaction mechanism 40.

[0116] The cup-loading mechanism 71 is used to store new, unused reaction containers 103. The cup-loading mechanism 71 also has a cup-moving function, which can move the reaction container 103 from the storage position to the position to be grasped.

[0117] The first transfer mechanism 81 is a cup-grabbing mechanism. The first transfer mechanism 81 is used to transfer the new reaction vessel 103 on the upper cup mechanism 71 to the sample feeding position 101 near the reaction mechanism 40, and to transfer the reaction vessel 103 on the sample feeding position 101 into the reaction mechanism 40.

[0118] The cup-discarding position 72 is located near the first transfer mechanism 81, and the cup-discarding position 72 is used to recycle the used reaction vessel 103. The first transfer mechanism 81 is also used to transfer the reaction vessel 103 after it has been tested on the reaction mechanism 40 to the cup-discarding position 72.

[0119] The sample carrier 21 is used to carry samples. In some examples, the sample carrier 21 may include a sample delivery module (SDM); in other examples, the sample carrier 21 may also be a sample tray, which includes multiple sample positions for placing sample tubes, and the sample tray can be rotated to the corresponding position, such as the position for the sample dispensing mechanism 22 to pick up the sample, by rotating its tray structure.

[0120] The sample dispensing mechanism 22 includes a sampling needle, a moving mechanism, and a driving pump. The moving mechanism drives the sampling needle to move between the sample carrying mechanism 21 and the sample dispensing position 101, and the driving pump provides power for the sampling needle to aspirate and dispense samples. The sample dispensing mechanism 22 is used to aspirate the sample from the sample tube on the sample carrying mechanism 21 and to dispense the aspirated sample into the reaction vessel 103 on the sample dispensing position 101.

[0121] The reaction mechanism 40 is used to provide an incubation site for the reaction liquid. The reaction mechanism 40 can be a reaction plate, which is arranged in a disc shape and has one or more placement positions for placing the reaction container 103. The reaction plate can rotate and drive the reaction container 103 in its placement position to rotate, which is used to manage the reaction container 103 and the reaction liquid in the reaction container 103 within the reaction plate.

[0122] The magnetic separation mechanism 50 includes a cleaning fluid dispensing structure, a magnetic attraction structure, a liquid absorption structure, and a substrate dispensing mechanism. The cleaning fluid dispensing structure is used to add cleaning fluid to the incubated reaction solution, and the cleaning fluid is used to separate free substances in the incubated reaction solution. The magnetic attraction structure is used to perform a magnetic attraction operation on the reaction solution to which the cleaning fluid has been added, and the magnetic attraction structure is used to adsorb the reaction complex bound to the magnetic beads. The liquid absorption structure is used to discharge other components except for the reaction complex bound to the magnetic beads from the reaction container 103. The substrate dispensing mechanism is used to add substrate to the reaction solution in the reaction container 103, and the substrate reacts with the reaction complex in the reaction solution, and the substrate luminescently marks the reaction complex.

[0123] There are two magnetic separation mechanisms 50, which can work independently to improve the efficiency of the test.

[0124] A mixing position 102 is provided near the reaction mechanism 40 and the magnetic separation mechanism 50. Both the mixing position 102 and the sample addition position 101 are provided with cup holders for placing the reaction container 103. The second transfer mechanism 82 is used to transfer the reaction container 103 between the reaction mechanism 40, the magnetic separation mechanism 50 and the mixing position 102.

[0125] The measuring mechanism 90 is used to perform photometric measurements on the incubated reaction solution to obtain the sample's reaction data. For example, the measuring mechanism 90 detects the luminescence intensity of the reaction solution to be tested and calculates the concentration of the analyte in the sample through a calibration curve.

[0126] The base 100 is also equipped with a cleaning mechanism and a waste liquid aspiration mechanism. The cleaning mechanism is used to clean the sampling needle and reagent needle, and the waste liquid aspiration mechanism is used to aspirate the reaction liquid after detection. Furthermore, this application also provides a sample analysis method, which can be applied to, but is not limited to, the equipment shown in the above embodiments. If necessary, reference can be made to the description and accompanying drawings of the above embodiments.

[0127] Please refer to Figure 22 The method includes:

[0128] Sample addition procedure: Collect the sample and add it to the reaction vessel.

[0129] In this step, samples can be collected and injected into the reaction vessel using a sampling needle or other type of sample dispensing mechanism.

[0130] Reagent mixing steps:

[0131] Place the magnetic bead reagent that needs to be mixed in a magnetic field, so that the magnetic beads in the magnetic bead reagent are detached from the deposition position by the magnetic field.

[0132] The function of removing the magnetic bead from the magnetic field.

[0133] For the specific method of performing this reagent mixing step, please refer to the sample analysis equipment shown in the above embodiments.

[0134] Reagent addition step: Collect the magnetic bead reagent after it has been mixed in the reagent mixing device and transfer it to the reaction vessel.

[0135] In addition to magnetic beads, other types of reagents can be added during the reagent addition step, depending on the reaction type and sample. The reagent addition step and the sample addition step can be performed simultaneously, or the reagent addition step can be performed before or after the sample addition step.

[0136] Reaction solution processing steps: The reaction solution in the reaction vessel is mixed, incubated, magnetically separated, and substrate is added to obtain the detection solution. The reaction solution includes at least the sample and magnetic bead reagent.

[0137] Detection steps; detection of parameters of the target substance in the solution.

[0138] The control device can calculate the corresponding detection results based on the parameters of the target object being detected.

[0139] In one embodiment, the method further includes: receiving magnetic bead reagent information and determining whether there is magnetic bead reagent that needs to be mixed based on the magnetic bead reagent information.

[0140] The receipt of magnetic bead reagent information can be referenced above, and can be obtained through, but is not limited to, scanning various barcodes, QR codes, or other labels representing identification information, or through inputting relevant reagent information into the device by the operator or external device. The method for determining whether there are magnetic bead reagents requiring mixing includes at least one of reagent information comparison and receiving external instructions. The reagent information comparison includes comparing at least one of the following: reagent type, reagent mixing record, and time interval since the last mixing, to determine whether the current magnetic bead reagent needs mixing.

[0141] Furthermore, in one embodiment, please refer to Figure 23 The method further includes: when there are magnetic bead reagents that need to be mixed, controlling the magnetic component that generates the magnetic field to switch to the working state, in which at least a portion of the magnetic bead reagents are located within the magnetic field;

[0142] Once the magnetic bead reagent is mixed, the magnetic component is switched to a non-working state. In the non-working state, all magnetic bead reagents are located outside the magnetic field generated by the magnetic component or the magnetic component does not generate a magnetic field.

[0143] As mentioned above, the magnetic component can be either an electromagnet or a permanent magnet.

[0144] In one embodiment, the magnetic component generating the magnetic field includes an electromagnet. During the reagent mixing step, when magnetic bead reagent to be mixed is present, the electromagnet is energized to switch to a working state. In the working state, at least a portion of the magnetic bead reagent is located within the magnetic field.

[0145] Once the magnetic bead reagent is mixed evenly, the electromagnet is de-energized to switch to a non-working state.

[0146] In one embodiment, the magnetic component generating the magnetic field includes a permanent magnet. During the reagent mixing step, it is determined whether there are magnetic bead reagents to be mixed. If so, the permanent magnet and the mounting portion are brought closer together, such as in the first direction described above. If not, or if the mixing operation has been completed, the permanent magnet and the mounting portion are controlled to move away from each other, such as in the first direction described above.

[0147] Specifically, in one embodiment, when it is determined that there are magnetic bead reagents that need to be mixed, the permanent magnet is controlled to move to a first position so that the permanent magnet is in working state;

[0148] After the magnetic bead reagent is mixed, the permanent magnet is moved to the second position to switch the permanent magnet to the non-working state.

[0149] In one embodiment, please refer to Figure 24 The method further includes the step of: driving the magnetic bead liquid container for storing magnetic bead reagents to move when the magnetic component is in a non-working state, so as to further mix them.

[0150] Specifically, when a portion or all of the magnetic bead reagents to be mixed are in a released state, the magnetic bead liquid container holding these reagents can be driven to move by a driving mechanism, such as by rotating the reagent seat to drive the magnetic bead reagents to rotate. This movement intensifies the movement of the magnetic beads within the reagents, thereby further mixing the reagents and preventing the magnetic beads from accumulating on one side of the magnetic bead liquid container.

[0151] The above examples illustrate the present invention only to aid in understanding it and are not intended to limit the scope of the invention. Those skilled in the art can make various simple deductions, modifications, or substitutions based on the principles of this invention.

Claims

1. A sample analysis device, characterized in that, The device includes a reagent mixing device, a reagent dispensing device, and a control device. The control device is electrically connected to both the reagent mixing device and the reagent dispensing device. The reagent mixing device is used to mix magnetic bead reagents, and the reagent dispensing device is used to collect the mixed magnetic bead reagents in the reagent mixing device and transfer them to a reaction vessel. The reagent mixing device includes: A reagent container storage mechanism, the reagent container storage mechanism having at least one mounting part, the mounting part being used to mount a magnetic bead liquid container containing magnetic bead reagent; A magnetic field generating mechanism has a magnetic component, which is a permanent magnet. The magnetic component is used to generate a magnetic field, which is used to attract magnetic beads in the magnetic bead reagent on the mounting part, causing the magnetic beads to leave the deposition position. The mounting section is provided in multiple locations. The control device controls the magnetic component to switch between a working state and a non-working state. When there are magnetic bead reagents to be mixed in the reagent mixing device, the control device controls the magnetic component to be in the working state, and at least a portion of the magnetic bead reagents on the mounting section are located within the magnetic field generated by the magnetic component. When the control device controls the magnetic component to switch to the non-working state, the magnetic bead reagents on each mounting section are located outside the magnetic field generated by the magnetic component. The magnetic field generating mechanism further includes a state switching drive, which is connected to the magnetic element. Between a position where the magnetic bead reagent can be adsorbed and a position where the magnetic bead reagent can be released, the state switching drive can drive the magnetic element to move back and forth so that the magnetic element switches between the working state and the non-working state. The state switching drive is used to drive the magnetic component to move to a first position where it can adsorb magnetic bead reagent, so that the magnetic component is in the working state; the state switching drive is also used to drive the magnetic component to move to a second position where it can release magnetic bead reagent, so that the magnetic component is in the non-working state; wherein, the first position is a position close to the mounting part, and the second position is a position away from the mounting part; The reagent mixing device further includes a driving mechanism, which is at least connected to the magnetic bead liquid container in a transmission manner. The driving mechanism is used to drive the magnetic bead liquid container and the magnetic component to rotate relative to each other. The reagent container storage mechanism includes a reagent base, and the mounting part is disposed on the reagent base. The driving mechanism includes a driving component and a reagent base transmission component. The driving component is connected to the reagent base through the reagent base transmission component to drive the reagent base to rotate. The mounting part is arranged in a ring around the rotation center line of the reagent base. The magnetic component is disposed in the enclosed area of ​​the mounting part, and the number of the magnetic component is less than the number of the mounting parts.

2. The sample analysis device as described in claim 1, characterized in that, The magnetic component is located on the side of the magnetic bead liquid container.

3. The sample analysis device as described in claim 1, characterized in that, The control device determines whether there is magnetic bead reagent that needs to be mixed. If so, it controls the mounting part carrying the magnetic bead reagent to move towards the magnetic field coverage area of ​​the magnetic component.

4. The sample analysis device as described in claim 3, characterized in that, The method for determining whether there are magnetic bead reagents that need to be mixed includes at least one of reagent information comparison and receiving external instructions.

5. The sample analysis device as described in claim 4, characterized in that, The reagent information comparison and judgment includes comparing at least one of the following: reagent type, reagent mixing record, and time interval since the last mixing, to determine whether the magnetic bead reagent needs to be mixed.

6. The sample analysis device as described in claim 1, characterized in that, When the magnetic component is in the working state, the magnetic field generated by the magnetic component covers a portion of the magnetic beads on the plurality of mounting portions.

7. The sample analysis device as described in claim 1, characterized in that, The reagent holder transmission component includes a first gear disk coaxially arranged and fixedly connected to the reagent holder. The driving mechanism also includes a second gear disk. The driving component is pulsatorically connected to the first gear disk to drive the first gear disk and the reagent holder to rotate coaxially, causing the mounting part to revolve around the magnetic component. The second gear disk is fixedly arranged and located within the enclosed area of ​​the mounting part. The teeth of the second gear disk extend into the mounting area of ​​the magnetic bead liquid container of the corresponding mounting part, so that the teeth of the second gear disk can mesh with the gear on the magnetic bead liquid container, so that when the reagent holder rotates, the second gear disk can drive the magnetic bead liquid container to rotate.

8. A sample analysis method, characterized in that, include: Sample addition procedure: Collect the sample and add it to the reaction vessel; Reagent mixing steps: When there are magnetic bead reagents to be mixed in the reagent mixing device, the control state switching drive drives the magnetic component that generates the magnetic field to switch to the working state. In the working state, at least a portion of the magnetic bead reagents are located in the magnetic field. The control state switching drive unit drives the magnetic component to switch to the non-working state. In the non-working state, all magnetic bead reagents are located outside the magnetic field generated by the magnetic component. The reagent mixing device includes a magnetic component, which is a permanent magnet, used to generate a magnetic field. A state switching drive is used to drive the magnetic component to a first position capable of adsorbing magnetic bead reagents, thus placing the magnetic component in the working state. The state switching drive is also used to drive the magnetic component to a second position capable of releasing the magnetic bead reagents, thus placing the magnetic component in the non-working state. The first position is near the mounting portion, and the second position is away from the mounting portion. The reagent mixing device also includes a drive mechanism, which is at least connected to the magnetic bead liquid container. The drive mechanism is used to drive the magnetic bead liquid container and the magnetic component to rotate relative to each other. The reagent container storage mechanism includes a reagent seat, with the mounting portion disposed on the reagent seat. The drive mechanism includes a drive component and a reagent seat transmission component. The drive component is connected to the reagent seat via the reagent seat transmission component to drive the reagent seat to rotate. The mounting portion is arranged in a ring around the rotation center line of the reagent seat. The magnetic component is disposed within the enclosed area of ​​the mounting portion, and the number of magnetic components is less than the number of mounting portions. Reagent addition step: Collect the magnetic bead reagent that has been mixed in the reagent mixing device and is located outside the magnetic field generated by the magnetic component, and transfer it to the reaction vessel; Reaction solution processing steps: The reaction solution in the reaction vessel is mixed, incubated, magnetically separated, and substrate is added to obtain the detection solution; the reaction solution includes at least the sample and magnetic bead reagent; Detection steps: Detect the parameters of the target analyte in the detection solution.

Images