Magnetic separation cleaning device and method for chemiluminescence immunity analyzer

Abstract

The invention discloses a magnetic separation and cleaning device for a chemiluminescence immunoassay analyzer. The magnetic separation and cleaning device comprises a mounting bottom plate, a turntable and an operating mechanism, wherein the turntable is arranged on the mounting bottom plate and rotates around a central shaft; the operating mechanism moves along the axis direction of the central shaft; a plurality of hole sites are formed in the top surface of the turntable along the circumferential surface in an annular array stroke manner, the hole sites are used for placing reaction cups, and the reaction cups are used for placing magnetic beads to be cleaned for multiple rounds; wherein the N-2 magnetic suction hole sites and the waste liquid pumping hole site are provided with permanent magnet assemblies for gathering the magnetic beads of the reaction cup; an oscillating and uniformly mixing mechanism for oscillating and uniformly mixing magnetic beads in the reaction cup is arranged at the bottom of the hole site; and the operating mechanism comprises a needle mounting plate which is parallel to the top surface of the turntable. The invention further provides a magnetic separation cleaning method. The device provided by the invention is small in size, and each flow in the reaction process is optimized, so that the cleaning effect is improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of in vitro diagnostic medical devices, and particularly relates to a magnetic separation and cleaning device and method for a chemiluminescence immunoassay analyzer. Background Art

[0002] In the field of in vitro diagnosis, such as chemiluminescence immunoassay analyzers, nucleic acid extractors, etc., in order to measure the concentration of the target analyte in a sample, the target analyte is first extracted, and then some labeled substances are added to react to generate a light signal or a color signal. The intensity of the signal is measured, and then the concentration of the result is obtained. The extraction of the target analyte often uses magnetic particles for extraction, that is, a substance that can specifically bind to the target analyte is coated on the magnetic particles. A test sample and magnetic particles are added to a reaction cup for reaction. If the sample contains the target analyte, the target analyte binds to the magnetic particles. The magnetic separation and cleaning technology is to clean other interfering substances in the reaction cup except for the magnetic particles and the target analyte.

[0003] Patent document CN 116944126 A discloses a magnetic separation and cleaning device and method. The method includes that the turntable rotates counterclockwise once every T seconds and rotates five hole positions each time, and reaction cups are placed in sequence, so that the reaction cups are arranged in the order of the first hole position (1), the second hole position (2), the third hole position (3), the fourth hole position (4), the fifth hole position (5), the sixth hole position (6), the seventh hole position (7), the eighth hole position (8), the ninth hole position (9), the tenth hole position (10), the eleventh hole position (11), the twelfth hole position (12), the thirteenth hole position (13) and the fourteenth hole position (14), the first hole position (1), and stay at each hole position for T seconds in sequence to complete three rounds of cleaning; wherein, the first hole position (1) is used to put into or take out the reaction cup from the hole position (101), the second hole position (2), the sixth hole position (6) and the tenth hole position (10) are used to add cleaning liquid into the reaction cup and shake and mix evenly, the third hole position (3), the seventh hole position (7) and the eleventh hole position (11) are used to collect the magnetic beads in the reaction cup in the first stage, the fourth hole position (4), the eighth hole position (8) and the twelfth hole position (12) are used to collect the magnetic beads in the reaction cup in the second stage, the fifth hole position (5), the ninth hole position (9) and the thirteenth hole position (13) are used to extract the waste liquid in the reaction cup, and the fourteenth hole position (14) is used to add the chemiluminescence substrate solution required for subsequent operations into the reaction cup.

[0004] Patent document CN115958029A discloses a magnetic separation and cleaning device and an immunoassay analyzer. Among them, the magnetic separation and cleaning device includes a carrying mechanism, and a separation mechanism, a cleaning mechanism, and a liquid drainage mechanism arranged on the carrying mechanism; the separation mechanism includes a transfer disk with a cup placement through-hole, and the transfer disk is arranged to rotate controllably on the carrying mechanism to transfer reaction cups; the cleaning mechanism includes a liquid needle assembly and a mixing assembly arranged on the upper side of the transfer disk; the liquid drainage mechanism includes a liquid pipe assembly arranged on the lower side of the transfer disk, and the liquid pipe assembly is arranged to move up and down axially relative to the transfer disk controllably, so as to be sleeved and communicated with the liquid needle assembly after extending into or passing through the cup placement through-hole.

[0005] To sum up, in all aspects of magnetic bead cleaning and separation, there are many problems to be optimized and improved, resulting in poor cleaning effect of the device, high magnetic bead loss rate, large overall size of the machine, and low overall efficiency of the machine. Therefore, there is an urgent need to provide a new magnetic separation and cleaning device. Summary of the Invention

[0006] The purpose of the present invention is to provide a magnetic separation and cleaning device and method for a chemiluminescence immunoassay analyzer. The device has a compact structure and a small volume, and at the same time optimizes the process in each reaction process, thereby improving the cleaning effect.

[0007] To achieve the first object of the present invention, a magnetic separation and cleaning device for a chemiluminescence immunoassay analyzer is provided, including a mounting base plate, a turntable rotating around the central axis on the mounting base plate, and an operating mechanism moving along the axis direction of the central axis;

[0008] A plurality of hole positions are formed in a circumferential array along the top surface of the turntable, and each hole position corresponds to a process. The plurality of hole positions are designed and arranged in the following manner: the first hole position is designed as an inlet / outlet hole position for the reaction cup to enter and exit. Each round of cleaning the reaction cup passes through N hole positions in sequence, which are respectively a cleaning liquid injection / vibration hole position, N - 2 magnetic attraction hole positions, and a waste liquid extraction hole position. The hole positions corresponding to each round of cleaning are sequentially set on the circumferential surface of the turntable in the way of rotating k hole positions each time, and a substrate liquid injection hole position for the next rotation and stop is designed after the waste liquid hole position in the last round of cleaning. There are a total of m*N + 2 hole positions, where m is the number of cleaning rounds required for one cleaning. After one cleaning, the reaction cup returns to the inlet / outlet hole position through the substrate liquid injection hole position, and k is relatively prime to m*N + 2;

[0009] The reaction cup is used to place magnetic beads to be cleaned in multiple rounds, and permanent magnet assemblies for aggregating the magnetic beads in the reaction cup are provided at both the magnetic attraction hole positions and the waste liquid extraction hole positions;

[0010] An oscillation and mixing mechanism for oscillating and mixing the magnetic beads in the reaction cup is provided at the bottom of the hole position;

[0011] The operating mechanism comprises a needle mounting plate arranged parallel to the top surface of the rotating disk, the needle mounting plate is provided with a needle tube corresponding to the hole position and a pump valve assembly used in conjunction with the needle tube;

[0012] The needle tube comprises a cleaning liquid needle corresponding to the cleaning liquid injection position / oscillation hole position, a waste liquid extraction needle corresponding to the waste liquid extraction hole position, and a substrate liquid injection needle corresponding to the substrate liquid injection hole position.

[0013] The present invention optimizes the arrangement of the holes and the corresponding operating mechanism, thereby reducing the volume of the entire machine while ensuring its cleaning efficiency.

[0014] Specifically, the cleaning round m refers to the total number of turns that the reaction cup needs to make on the turntable after being placed in the entry and exit holes, that is, the number of times the reaction cup needs to pass through the cleaning liquid injection position / oscillation hole, N-2 magnetic suction holes and the waste liquid extraction hole.

[0015] Specifically, the one-time cleaning refers to placing the reaction cup through the inlet and outlet hole, undergoing m rounds of cleaning, and then taking it out from the inlet and outlet hole.

[0016] Specifically, the oscillation mixing mechanism includes a mounting seat arranged at the bottom of the hole, the mounting seat is provided with a mixing block whose top contacts the bottom of the reaction cup, a stepping motor that drives the mixing block to rotate, and a photoelectric controller for controlling the output power of the stepping motor. The top of the mixing block is provided with a protrusion that contacts the wall of the reaction cup, and the protrusion repeatedly moves the wall of the reaction cup when the mixing block rotates. Relying on the cooperation of the photoelectric switch and the stepping motor, the position control and speed control of the mixing block can be easily completed. This method has a simple structure, small size, and good mixing effect.

[0017] Specifically, the rotation speed of the mixing block ranges from 3 to 5 rps. If the rotation speed is too low, the cleaning effect will be affected, the aggregated magnetic beads cannot be shaken off, and the substances wrapped in the magnetic bead aggregates cannot be effectively cleaned. If the rotation speed is too high, liquid splashing will be caused, and the magnetic beads, test substances and reaction volume will be lost, affecting the test results.

[0018] Specifically, the center eccentricity between the mixing block and the hole is 1.5 mm.

[0019] Specifically, the oscillating and mixing mechanism includes a mounting seat arranged at the bottom of the hole position, a mixing block arranged on the mounting seat, and a driving motor for driving the mixing block to rotate. An eccentric groove eccentrically arranged with the hole position is provided at the top end of the mixing block. The groove is used to place the reaction cup. An inclined groove is provided on the peripheral surface of the mixing block, and parallel grooves are provided at both ends of the inclined groove. A pin shaft matched with the inclined groove is arranged in the groove wall of the hole position. When the driving motor is started, it drives the central axis of the hole position to rotate. The pin shaft slides in the inclined groove to drive the mixing block to move outwards, so that the reaction cup falls into the eccentric groove, and thus performs a mixing motion along with the mixing block. This method has a simple structure. Only one driving motor can realize the lifting and rotation of the mixing device, with a small size and good mixing effect.

[0020] Specifically, the helix angle of the inclined groove is 20°, and the rotation speed of the driving motor is 5 rps.

[0021] Specifically, the central offset distance between the eccentric groove and the hole position is 2 mm, and the groove depth of the eccentric groove is 4 mm.

[0022] Specifically, the permanent magnet assembly includes a magnetic adsorption channel arranged along the rotation direction of the turntable for the reaction cup to pass through. Permanent magnet grooves corresponding to the hole positions are provided on both sides of the magnetic adsorption channel, and first permanent magnets are arranged in the permanent magnet grooves on both sides corresponding to the magnetic adsorption hole positions, and second permanent magnets are arranged in the permanent magnet grooves on both sides corresponding to the waste liquid extraction hole positions. Moreover, the permanent magnet grooves do not change their positions as the turntable rotates;

[0023] There is a gap between each group of corresponding permanent magnet grooves and the hole positions, and when the reaction cup rotates to the corresponding hole position, it can be directly opposite to the magnetic pole surface of the permanent magnet;

[0024] The first permanent magnet is formed by splicing two magnets with opposite magnetic poles along the rotation direction of the turntable. Moreover, the plane where the splicing gap is located is parallel to the central axis of the turntable, so that the magnetic field distribution is relatively uniform, thereby accelerating the adsorption of magnetic beads and improving the agglomeration effect;

[0025] The second permanent magnet is formed by stacking two magnets with opposite magnetic poles perpendicular to the rotation direction of the turntable. Moreover, the plane where the stacking gap is located passes through the central axis of the turntable, so that the magnetic field is stronger along the horizontal direction, aggregating the magnetic beads linearly distributed vertically in front into clusters, thereby reducing the magnetic absorption time, making the magnetic beads aggregate faster, and finally the magnetic beads form clusters, reducing the loss during waste liquid extraction.

[0026] Specifically, the magnetic adsorption channel selects Q235 with high magnetic permeability to strengthen the internal field strength, reduce magnetic leakage at the same time, and avoid external interference.

[0027] Specifically, the tip of the cleaning liquid needle is a blind hole, and the blind hole includes liquid outlet holes evenly distributed on the circumferential surface of the needle tip. The cleaning liquid is ejected from the liquid outlet holes, which can completely cover the inner wall of the reaction cup, wash down the residual liquid on the cup wall, reduce the loss of magnetic beads, and at the same time assist in dispersing the agglomerated magnetic beads to improve the cleaning effect.

[0028] Specifically, the tip of the substrate injection liquid needle is conical to reduce liquid hanging and thus improve the liquid injection accuracy.

[0029] Specifically, the tip of the waste liquid extraction needle is provided with a cross groove for increasing the contact surface, and a spring assembly is provided at the fixed end of the waste liquid extraction needle to provide a buffering force. When the waste liquid extraction needle contacts the bottom of the reaction cup, the waste liquid can be better extracted to prevent blockage.

[0030] To achieve the second object of the present invention, a magnetic separation cleaning method is provided, which is realized by the above-mentioned magnetic separation cleaning device for a chemiluminescence immunoassay analyzer, including:

[0031] When the detection throughput is set to T / h, the time interval t between the results of two adjacent tests is t = 3600 / T, and the rotation period of the magnetic separation turntable can be set to t / 2, where T represents the total number of tests;

[0032] Put the first unwashed reaction cup into the inlet and outlet hole position in the first t / 2 s. At this time, put the reaction cup that has been washed at least once into the inlet and outlet hole position in the second t / 2 s, put the second unwashed reaction cup into the inlet and outlet hole position in the third t / 2 s, and put the reaction cup that has been washed at least once into the inlet and outlet hole position in the fourth t / 2 s, and so on. Reaction cups in different test states are placed in both odd and even positions.

[0033] The present invention improves the rotation period (t / 2) of the turntable while ensuring the magnetic absorption efficiency, shortening the residence time of the reaction cup at each hole position, more efficiently completing the cleaning task, and facilitating the speed increase of the whole machine equipment.

[0034] Compared with the prior art, the beneficial effects of the present invention are:

[0035] The present invention proposes to optimize the structural components and timing of the magnetic separation cleaning device, thereby dispersing the operation processes that occupy a large volume to improve the space utilization rate;

[0036] At the same time, by using the one-step method and the two-step method in the t / 2 cycle alternately, the reaction cups for the first cleaning and the second cleaning are within one t cycle, without waiting for all to enter the magnetic separation device for cleaning, reducing the idle time and being beneficial to the improvement of the efficiency of the whole machine equipment. Description of the Drawings

[0037] Figure 1Schematic structural diagram of a magnetic separation and cleaning device for a chemiluminescence immunoassay analyzer provided in this embodiment;

[0038] Figure 2 Top view of the turntable provided in this embodiment;

[0039] Figure 3 Diagram of the positional relationship between the first permanent magnet and the reaction cup provided in this embodiment;

[0040] Figure 4 Diagram of the positional relationship between the second permanent magnet and the reaction cup provided in this embodiment;

[0041] Figure 5 Magnetic field change diagram with permanent magnets arranged on one side provided in this embodiment;

[0042] Figure 6 Magnetic field change diagram with permanent magnets arranged on both sides provided in this embodiment;

[0043] Figure 7 Schematic structural diagram of the operating mechanism provided in this embodiment;

[0044] Figure 8 Schematic structural diagram of a kind of oscillation and mixing mechanism provided in this embodiment;

[0045] Figure 9 Schematic structural diagram of another kind of oscillation and mixing mechanism provided in this embodiment;

[0046] Figure 10 Schematic structural diagram of the waste liquid extraction needle provided in this embodiment;

[0047] Figure 11 Magnified view of the tip of the cleaning liquid needle provided in this embodiment;

[0048] Figure 12 Magnified view of the tip of the substrate liquid injection needle provided in this embodiment;

[0049] In the figure, 1 is the mounting base plate; 2 is the operating mechanism; 3 is the turntable; 4 is the oscillating and mixing mechanism; 5 is the substrate liquid injection needle; 6 is the guide rod; 7 is the cleaning liquid needle; 8 is the waste liquid suction needle; 901 is the first hole position; 902 is the second hole position; 903 is the third hole position; 904 is the fourth hole position; 905 is the fifth hole position; 906 is the sixth hole position; 907 is the seventh hole position; 908 is the eighth hole position; 909 is the ninth hole position; 910 is the tenth hole position; 911 is the eleventh hole position; 912 is the twelfth hole position; 913 is the thirteenth hole position; 914 is the fourteenth hole position; 101 is the first permanent magnet; 102 is the second permanent magnet; 103 is the magnetic attraction channel; 11 is the photoelectric switch; 12 is the sensor baffle; 13 is the mixing block; 14 is the mounting seat; 15 is the stepping motor; 16 is the reaction cup; 17 is the pin shaft; 18 is the central shaft; 19 is the drive motor; 20 is the eccentric groove; 21 is the nut; 22 is the needle mounting seat; 23 is the spring; 24 is the needle mounting plate; 25 is the liquid outlet hole. Detailed implementation mode

[0050] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, but not all, of the embodiments of the present invention. Usually, the components of the embodiments of the present invention described and illustrated herein can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0051] As Figure 1 shown, a magnetic separation and cleaning device for a chemiluminescence immunoassay analyzer provided in this embodiment includes a mounting base plate 1, a turntable 3 provided on the mounting base plate 1 and rotating around the central axis, and an operating mechanism 2 moving along the axis direction of the central axis.

[0052] Taking the example that the reaction cup needs to be cleaned three times in this embodiment, it is set that each cleaning needs to go through the operations of injecting cleaning liquid level / oscillating, two magnetic attractions, and sucking waste liquid. Therefore, each round of cleaning the reaction plate needs to pass through four hole positions, that is, as Figure 2 shown, fourteen hole positions that rotate with the turntable 3 are evenly opened on the top surface of the turntable 3 along the circumferential surface. At the same time, to meet the design requirements, the rotation amount of the turntable 3 is set to five hole positions, and this rotation amount and the total number of hole positions are relatively prime to each other.

[0053] Based on the rotation amount of five hole positions, along the rotation direction of the turntable 3, the positions of each hole are sequentially numbered as the first hole 901, the fourth hole 904, the seventh hole 907, the tenth hole 910, the thirteenth hole 913, the second hole 902, the fifth hole 905, the eighth hole 908, the eleventh hole 911, the fourteenth hole 914, the third hole 903, the sixth hole 906, the ninth hole 909, and the twelfth hole 912. The positions indicated by each groove number do not change with the turntable 3. Except for the tenth hole 910, the second hole 902, the fourteenth hole 914, and the sixth hole 906, corresponding permanent magnet assemblies are provided.

[0054] Among them, the first hole 901 is the inlet and outlet hole position;

[0055] The tenth hole 910, the second hole 902, and the sixth hole 906 are the cleaning liquid level / vibration hole positions;

[0056] The third hole 903, the seventh hole 907, the eleventh hole 911 are the first round magnetic attraction hole positions;

[0057] The fourth hole 904, the eighth hole 908, and the twelfth hole 912 are the second round magnetic attraction hole positions;

[0058] The thirteenth hole 913, the fifth hole 905, and the ninth hole 909 are the waste liquid extraction hole positions;

[0059] The fourteenth hole 914 is the substrate liquid injection hole position

[0060] The permanent magnet assembly includes a magnetic attraction channel 103 arranged along the rotation direction of the turntable for the reaction cup to pass through. On both sides of the magnetic attraction channel 103, there are permanent magnet grooves corresponding to the hole positions, a first permanent magnet 101 arranged in the permanent magnet grooves on both sides corresponding to the magnetic attraction hole positions, and a second permanent magnet 102 arranged in the permanent magnet grooves on both sides corresponding to the waste liquid extraction hole positions. And the permanent magnet grooves do not change their positions with the rotation of the turntable;

[0061] There is a gap between each group of corresponding permanent magnet grooves and hole positions, and when the reaction cup rotates to the corresponding hole position, it can be directly opposite to the magnetic pole surface of the permanent magnet.

[0062] As Figure 3 shown, it is the relative position of the first permanent magnet 101 and the reaction cup provided in this embodiment. Among them, the first permanent magnet 101 is formed by splicing two magnets with opposite magnetic poles (S pole and N pole) along the rotation direction of the turntable.

[0063] As Figure 4 shown, it is the relative position of the second permanent magnet 102 and the reaction cup provided in this embodiment, which is formed by stacking two magnets with opposite magnetic poles (S pole and N pole) perpendicular to the rotation direction of the turntable, and the plane where the stacking gap is located passes through the central axis of the turntable.

[0064] Since this embodiment takes the reaction cup needing to complete three rounds of cleaning as an example, a set of second permanent magnets 102 is arranged to be used in pair with the waste liquid pumping holes. The second permanent magnets 102 are composed of two stacked magnets of 10*10*8, making the magnetic field stronger in the horizontal direction, aggregating the magnetic beads linearly distributed vertically in front into clusters, thereby reducing the magnetic absorption time, increasing the speed of magnetic bead aggregation, finally forming magnetic bead clusters, and reducing the loss during waste liquid pumping.

[0065] Two sets of first permanent magnets 101 are arranged to be used in pair with the first-round magnetic absorption holes and the second-round magnetic absorption holes respectively. Among them, the first permanent magnet 101 corresponding to the first-round magnetic absorption holes is formed by splicing two magnets of 5*10*16 on the left and right, and the first permanent magnet 101 corresponding to the second-round magnetic absorption holes is formed by splicing two magnets of 5*10*10 on the left and right. The magnetic field at the splicing part is more concentrated, thereby accelerating the adsorption of proximal magnetic beads.

[0066] In addition, the arrangement scheme of the permanent magnets on both sides adopted in this embodiment, compared with the existing single-side design scheme, the magnetic field changes as Figure 5 and Figure 6 shown, Figure 5 in (a) is the magnetic field direction when the reaction cup is viewed from the side with the permanent magnet arranged on one side, Figure 5 in (b) is the magnetic field direction when the reaction cup is viewed from above with the permanent magnet arranged on one side, Figure 6 in (a) is the magnetic field direction when the reaction cup is viewed from the side with the permanent magnets arranged on both sides, Figure 6 in (b) is the magnetic field direction when the reaction cup is viewed from above with the permanent magnets arranged on both sides.

[0067] It can be clearly observed from the figure that by arranging the permanent magnets on both sides, the movement distance of the magnetic beads can be effectively reduced to accelerate the aggregation speed, and at the same time, it can also ensure that the distribution of the magnetic beads at each position in the reaction cup is consistent.

[0068] As Figure 7 shown, the operating mechanism 2 includes a needle mounting plate arranged parallel to the top surface of the turntable 3. The needle mounting plate 24 is provided with needle tubes arranged in pair with the holes and a pump valve assembly used in combination with the needle tubes. The needle tubes include a cleaning liquid needle 7 arranged in pair with the tenth hole 910, the second hole 902, and the sixth hole 906, a waste liquid pumping needle 8 arranged in pair with the thirteenth hole 913, the fifth hole 905, and the ninth hole 909, and a substrate liquid injection needle 5 arranged in pair with the fourteenth hole 914.

[0069] The cleaning liquid needle 7 is used to add cleaning liquid to the reaction cup, the waste liquid pumping needle 8 is used to pump the waste liquid in the reaction cup, and the substrate liquid injection needle 5 is used to add the chemiluminescent substrate liquid required for chemiluminescence immunoassay to the reaction cup.

[0070] In addition, a guide rod 6 is provided between the needle mounting plate 24 and the rotary disk 3 and is arranged parallel to the central axis and used for auxiliary guidance.

[0071] The pump valve assembly includes a first compression pump for extracting waste liquid from the reaction cup and a matching waste liquid barrel, and a second compression pump for providing cleaning liquid and a matching liquid storage barrel.

[0072] The design structure of the above-mentioned fourteen holes and five hole rotation amounts can ensure that the adjacent two sides of the entry and exit holes are magnetic holes, and the magnetic holes do not require matching needles and tubes. Therefore, a path is left in the vertical space for the mechanical gripper to pick up and place the reaction cup, which further miniaturizes the volume of the overall device.

[0073] A shaking and mixing mechanism 4 for shaking and mixing the magnetic beads in the reaction cup is provided at the bottom of the well.

[0074] like Figure 8 As shown, a vibration mixing mechanism 4 provided in this embodiment includes a mounting seat 14 arranged at the bottom of the hole groove, the mounting seat 14 is provided with a mixing block 13 for moving the reaction cup 16 for mixing, a stepping motor 15 for driving the mixing block 13 to rotate, and a photoelectric controller for controlling the output power of the stepping motor, the photoelectric controller includes a sensor baffle 12 and a photoelectric switch 11, wherein there is a protrusion on the top of the mixing block 13, when the mixing block 13 rotates, the protrusion of the mixing block 13 will repeatedly move the reaction cup 16 to mix the magnetic beads in the reaction cup 16. When the protrusion of the mixing block 13 is in a specific position, the reaction cup 16 can pass through. Relying on the cooperation of the photoelectric switch 11 and the stepping motor 15, the position control and speed control of the mixing block 13 can be easily completed.

[0075] More specifically, the center eccentricity of the center deviation setting is 1.5 mm, and the rotation speed range of the mixing block is 3-5 rps.

[0076] like Figure 9 As shown, the second oscillating mixing mechanism 4 provided in this embodiment comprises a mounting seat 14 arranged at the bottom 3 of the hole, a mixing block 13 arranged on the mounting seat 14, and a driving motor 19 for driving the mixing block 13 to rotate. The top of the mixing block 13 is provided with an eccentric groove 20 arranged eccentrically with the hole, and the eccentric groove 20 is used to place the reaction cup 16. The circumferential surface of the mixing block 13 is provided with an inclined groove, and parallel grooves are provided at both ends of the inclined groove. A pin 17 used in conjunction with the inclined groove is provided in the groove wall of the hole. When the motor is not rotating, the mixing block 13 falls on the bottom of the hole, and the relative position of the pin 17 and the mixing block 13 is as shown in FIG. Figure 9 As shown in the main perspective, the pin 17 is located in the parallel groove on the upper right side of the main perspective. When the motor starts to rotate, the mixing block 13 will slide along the inclined groove to Figure 9In the parallel groove at the lower left in the main view, at this time, the mixing block 13 will achieve spiral upward relative to the bottom of the hole position and continue to rotate at the same speed as the motor. During the upward movement, the reaction cup 16 will fall into the eccentric groove 20, so as to perform the mixing movement along with the mixing block 13.

[0077] As Figure 10 shown, the waste liquid extraction needle 8 provided in this embodiment has a nut 21, a needle mounting seat 22, a spring 23, and a needle mounting plate 24 at its top end. When the waste liquid extraction needle descends with the needle mounting plate 24 to extract the liquid at the bottom of the reaction cup 16, the needle tip can better contact the bottom of the reaction cup 16 to drain the liquid dry, and at the same time plays a protective role for the needle and the mechanism. At the same time, a cross groove for increasing the contact surface is opened at the needle tip.

[0078] As Figure 11 shown, it is an enlarged view of the needle tip of the cleaning liquid needle 7 provided in this embodiment. The needle tip of the cleaning liquid needle 7 adopts a blind hole, and the blind hole includes liquid outlet holes 25 evenly distributed on the circumferential surface of the needle tip.

[0079] As Figure 12 shown, it is the substrate liquid injection needle provided in this embodiment, and its needle tip adopts a conical shape to reduce liquid hanging, so as to improve the liquid injection accuracy.

[0080] This embodiment also provides a magnetic separation cleaning method, which is realized by the magnetic separation cleaning device provided in the above embodiment, and includes:

[0081] Put the first unwashed reaction cup into the inlet and outlet hole positions in the first t / 2 s. At this time, put the reaction cup that has been washed at least once into the inlet and outlet hole positions in the second t / 2 s, put the second unwashed reaction cup into the inlet and outlet hole positions in the third t / 2 s, and put the reaction cup that has been washed at least once into the inlet and outlet hole positions in the fourth t / 2 s, and so on. Reaction cups in different test states are placed in both odd and even positions.

[0082] For this control method, the first advantage is that on the premise of ensuring the magnetic absorption efficiency, the rotation period (t / 2) of the turntable is increased, and the residence time of the reaction cup in each hole position is shortened. The cleaning task is completed more efficiently, which is beneficial to the speed increase of the whole machine equipment.

[0083] The second advantage is that the control logic is simplified. It is ensured that the reaction cups for the first cleaning and the second cleaning are within one t cycle, without waiting for all to enter the magnetic separation device for cleaning, reducing the idle time, which is beneficial to the improvement of the efficiency of the whole machine equipment.

[0084] In addition, the terms "upper", "lower", "inner", "outer", "front", and "rear" are for descriptive purposes only and should not be construed as indicating or implying relative importance. Unless otherwise specifically stated, the relative steps, numerical expressions, and numerical values of the components and steps set forth in these embodiments do not limit the scope of the present invention.

[0085] Of course, the above are only specific embodiments of the present invention and are not intended to limit the scope of the present invention. Any equivalent changes or modifications made according to the structure, features, and principles described in the scope of the patent application of the present invention should be included in the scope of the patent application of the present invention.

[0086] Finally, it should be noted that the above embodiments are only specific implementation manners of the present invention, used to illustrate the technical solutions of the present invention, rather than limiting them. The protection scope of the present invention is not limited thereto. Although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: any person skilled in the art within the technical scope disclosed by the present invention can still modify the technical solutions described in the foregoing embodiments or can easily conceive of changes, or perform equivalent replacements on some of the technical features; and these modifications, changes, or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention and should all be covered by the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

1. A magnetic separation and cleaning device for a chemiluminescent immunoassay analyzer, characterized in that, It includes a mounting base plate, a turntable arranged on the mounting base plate and rotating around a central axis, and an operating mechanism moving along the axis direction of the central axis; A plurality of holes are formed in a circular array along the circumference of the top surface of the turntable, each hole corresponding to a process, and the plurality of holes are designed and arranged in the following manner: the first hole is designed as an in-and-out hole for entering and exiting the reaction cup, and the reaction cup passes through N holes in sequence in each round of cleaning, which are respectively a cleaning liquid injection position / oscillation hole, N-2 magnetic suction holes, and a waste liquid extraction hole. The hole positions corresponding to each round of cleaning are set in sequence on the circumferential surface of the turntable in the manner of k holes per rotation, and a substrate liquid injection hole for the next rotation is designed after the waste liquid hole in the last round of cleaning, with a total of m*N+2 holes, wherein m is the number of cleaning rounds required for a cleaning task, and after a cleaning task, the reaction cup passes through the substrate liquid injection hole and returns to the in-and-out hole, and k is mutually prime to m*N+2; The reaction cup is used to place magnetic beads to be washed for multiple rounds, and both the magnetic suction hole and the waste liquid extraction hole are provided with a permanent magnet assembly for gathering the magnetic beads in the reaction cup; The bottom of the well is provided with an oscillating and mixing mechanism for oscillating and mixing the magnetic beads in the reaction cup; The operating mechanism comprises a needle mounting plate arranged parallel to the top surface of the rotating disk, the needle mounting plate is provided with a needle tube corresponding to the hole position and a pump valve assembly used in conjunction with the needle tube; The needle tube comprises a cleaning liquid needle corresponding to the cleaning liquid injection position / oscillation hole position, a waste liquid extraction needle corresponding to the waste liquid extraction hole position, and a substrate liquid injection needle corresponding to the substrate liquid injection hole position.

2. The magnetic separation and cleaning device for a chemiluminescence immunoassay analyzer according to claim 1, wherein The oscillating mixing mechanism includes a mounting seat arranged at the bottom of the hole, the mounting seat is provided with a mixing block whose top contacts the bottom of the reaction cup, a progressive motor driving the mixing block to rotate, and a photoelectric controller for controlling the output power of the progressive motor, and the top of the mixing block is provided with a protrusion contacting the wall of the reaction cup, and the protrusion repeatedly moves the wall of the reaction cup when the mixing block rotates.

3. The magnetic separation and cleaning device for a chemiluminescent immunoassay analyzer according to claim 2, wherein The rotation speed of the mixing block ranges from 3 to 5 rps.

4. The magnetic separation and cleaning device for a chemiluminescence immunoassay analyzer according to claim 1, characterized in that, The oscillating mixing mechanism includes a mounting seat arranged at the bottom of the hole, a mixing block arranged on the mounting seat, and a driving motor that drives the mixing block to rotate. The top of the mixing block is provided with an eccentric groove eccentrically arranged with the hole, and the groove is used to place a reaction cup. The circumferential surface of the mixing block is provided with an inclined groove, and parallel grooves are provided at both ends of the inclined groove. The inner wall of the hole is provided with a pin shaft used in conjunction with the inclined groove. When the driving motor is started, it drives the central axis of the hole to rotate, and the pin shaft slides in the inclined groove to drive the mixing block to move outward so that the reaction cup falls into the eccentric groove, thereby performing mixing movement with the mixing block.

5. The magnetic separation and cleaning device for a chemiluminescent immunoassay analyzer according to claim 4, wherein The helix angle of the inclined groove is 20°, and the rotation speed of the driving motor is 5 rps.

6. The magnetic separation and cleaning device for a chemiluminescence immunoassay analyzer according to claim 1, wherein The permanent magnet assembly includes a magnetic attraction channel arranged along the rotation direction of the turntable for the reaction cup to pass through, and permanent magnet grooves corresponding to the hole positions are arranged on both sides of the magnetic attraction channel, and first permanent magnets are arranged in the permanent magnet grooves on both sides corresponding to the magnetic attraction hole positions, and second permanent magnets are arranged in the permanent magnet grooves on both sides corresponding to the waste liquid extraction hole positions, and the permanent magnet grooves do not change position with the rotation of the turntable; There is a gap between each corresponding permanent magnet slot and the hole position, and when the reaction cup rotates to the corresponding hole position, it can be directly opposite to the magnetic pole surface of the permanent magnet; The first permanent magnet is formed by splicing two magnets with opposite magnetic poles along the rotation direction of the turntable, and the plane where the splicing gap is located is parallel to the central axis of the turntable; The second permanent magnet is formed by stacking two magnets with opposite magnetic poles perpendicular to the rotation direction of the turntable, and the plane where the stacking gap is located passes through the central axis of the turntable.

7. The magnetic separation and cleaning device for a chemiluminescent immunoassay analyzer according to claim 1, wherein, The tip of the cleaning liquid needle adopts a blind hole, and the blind hole includes liquid outlet holes evenly distributed on the circumferential surface of the needle tip.

8. The magnetic separation and cleaning device for a chemiluminescence immunoassay analyzer according to claim 1, characterized in that, The tip of the substrate injection liquid needle is conical.

9. The magnetic separation and cleaning device for a chemiluminescent immunoassay analyzer according to claim 1, wherein The tip of the waste liquid extraction needle is provided with a cross groove for increasing the contact surface, and a spring assembly for providing a buffering force is arranged at the fixed end of the waste liquid extraction needle.

10. A magnetic separation cleaning method, characterized in that, It is realized by the magnetic separation cleaning device for a chemiluminescence immunoassay analyzer according to any one of claims 1 to 9, including: When the detection throughput is set to T / h, the time interval t between the results of two adjacent tests is t = 3600 / T, and the rotation period of the magnetic separation turntable can be set to t / 2, where T represents the total number of tests; Put the first unwashed reaction cup into the inlet and outlet hole position in the first t / 2 s. At this time, put the reaction cup that has been washed at least once into the inlet and outlet hole position in the second t / 2 s, put the second unwashed reaction cup into the inlet and outlet hole position in the third t / 2 s, and put the reaction cup that has been washed at least once into the inlet and outlet hole position in the fourth t / 2 s, and so on. Reaction cups in different test states are put into the odd and even positions.

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