Parallel detection heterogeneous chemiluminescence immunoassay analyzer, multi-tube parallel reagent strip and control method

Abstract

The present invention relates to a parallel detection heterogeneous chemiluminescence immunoassay instrument, a multi-tube parallel reagent strip and a control method, wherein the first mobile module on the workbench drives one or more incubation seats to move horizontally relative to the workbench, and the extraction module above the incubation seat extracts and places the contents of the multi-tube parallel reagent strip in the incubation seat, and then the signal acquisition module performs signal acquisition on the chemiluminescence immunoassay result. The present invention has a simple structure, easy electrical control debugging, high capture rate and low background noise for the detected object, flexible channel number configuration, supports reagents of different incubation times to run simultaneously, supports reagents of one-step and two-step methods to run simultaneously, supports direct chemiluminescence and enzymatic chemiluminescence immunoassays, supports urgent queue-jumping detection in outpatient and emergency departments, and has high instrument flexibility and a wide range of applications. The present invention meets the application scenario requirements of multiple industry needs, easy operation, low cost, low maintenance, and convenient upgrade and expansion.

Description

Technical Field

[0001] The invention belongs to the technical field of using optical means, namely using infrared light, visible light or ultraviolet light to test or analyze materials, and particularly relates to a parallel detection heterogeneous chemiluminescence immunoassay instrument, a multi-tube parallel reagent strip and a control method. Background Art

[0002] Chemiluminescence immunoassay (CLIA) started in the early 1980s and developed rapidly in the 1990s, becoming an emerging immunoassay technology after fluorescent immunoassay, radioimmunoassay and enzyme-linked immunosorbent assay.

[0003] The chemiluminescent immunoassay analyzer uses magnetic microparticles as carriers and various enzymes as tracer markers. It adopts the sandwich method or competitive binding method and uses the luminescent substrate as the basis to measure the intensity of the light signal emitted when the chemiluminescent substance transitions from the excited state back to the ground state by utilizing the luminescent phenomenon of the chemiluminescent reaction, thereby achieving accurate quantitative analysis of the concentration of the detected substance.

[0004] However, chemiluminescent immunoassay also has its uncertainties, which mainly come from the detection operation, reagent process and analyzer system. The large, medium and small chemiluminescent immunoassay analyzers on the market usually use serial detection and permanent magnet side suction fixed magnetic beads rinsing method as the main method, which has the following defects:

[0005] 1. Because there are dozens or hundreds of single-use test tube reaction cups sharing the same incubation heating chassis, it is not possible to run reagents with different incubation times at the same time;

[0006] 2. Due to the pipeline design of serial testing, it is not easy to perform emergency queue inspection. Any pause of the whole machine will affect the inspection of other items being tested.

[0007] 3. The magnetic beads are fixed to the side wall of the reaction tube by permanent magnet side suction. It is necessary to use an automatic pipette to add bleaching liquid multiple times and remove the background liquid by suction to repeatedly rinse the magnetic beads. This method leaves a lot of residual liquid. At the same time, the permanent magnets are mostly located on both sides or even on one side of the square test tube reaction cup. Due to the isolation of the reaction cup wall thickness and the bias of the magnet to one side, the capture rate of magnetic beads in the center of the solution is low. When the pipette sucks away the waste liquid, more magnetic beads are taken away. At the same time, the magnetization consistency of the permanent magnet bar is difficult to control. With the influence of external physical factors (heat, vibration, etc.), the magnetism of the magnetic bar will gradually decay. The complexity of the instrument system leads to its long-term stability and difficulty in after-sales maintenance, which is particularly not in line with the low-cost and low-maintenance application scenario requirements of POCT.

[0008] 4. For the permanent magnet magnetic rod extraction method, only the head of the extraction device needs to be magnetic, and other related connecting parts are required to be non-magnetic. Therefore, hard magnetic metal materials are required to shield the magnetic field of the magnetic rods in the non-effective extraction parts to prevent the magnetic beads from climbing up the magnetic rods and contaminating the magnetic beads. The shielding cover of the hard magnetic material has a large coercive force. Even after shrinking on the magnetic rod, it is always in the magnetic induction of the magnetic field and will have weak magnetism. Especially after long-term use, the magnetism is even stronger, which will affect the quality of magnetic rod and magnetic bead extraction;

[0009] 5. Large chemiluminescent immunoassay analyzers usually share 1-2 sets of automatic sample loading systems for cost considerations. The pipette needles of the sample loading system need to be rinsed repeatedly to avoid cross-contamination between channels. The liquid path system for precise sample loading is complex in design and the system stability is poor.

[0010] 6. Although the small chemiluminescent immunoassay analyzer pre-seales each chemical reaction reagent and rinse solution in a long reagent tube strip, eliminating the complex sample addition system, and using disposable rod sleeves and tip heads to avoid cross contamination, greatly simplifying the liquid path system, the existing sleeve removal and sleeve removal methods are generally independent mechanisms. First, a dedicated electromechanical system is used to pick up the rod sleeve for magnetic bead capture and the tip head for sample addition, and then an independent electromechanical system is used to remove the rod sleeve and the tip head. The system is complex and the cost is high;

[0011] 7. For side-suction small-scale chemical optical immunoassay analyzers, for system economic considerations, each channel usually reuses a set of pipetting systems. Although the use of disposable Tip consumables saves the liquid path system and avoids cross contamination, there is still a queue phenomenon in each channel, and efficient parallel detection between channels is not truly achieved. If each channel is designed with an independent pipetting system, the system cost is much higher than designing an independent upward magnetic rod extraction system. Summary of the invention

[0012] The invention solves the problems in the prior art and provides an optimized parallel detection heterogeneous chemiluminescence immunoassay analyzer, a multi-tube parallel reagent strip and a control method.

[0013] The technical solution adopted by the present invention is a parallel detection heterogeneous chemiluminescence immunoassay analyzer, the analyzer comprising:

[0014] A workbench, used to carry the analyzer;

[0015] One or more incubation seats, any one of which is used to place multiple parallel-type reagent strips;

[0016] A signal collection module, arranged at the rear of the workbench, for collecting signals from the chemiluminescent immunoassay results of the multi-tube parallel reagent strips;

[0017] A first moving module is provided on the workbench and is used to move the incubation seat horizontally;

[0018] An extraction module, arranged above the incubation seat, for extracting and placing the contents of the multi-tube parallel reagent strips in the incubation seat;

[0019] The signal acquisition module, the extraction module and the first movement module are connected to the controller.

[0020] Preferably, the workbench is provided with one or more parallel guide rails;

[0021] The first moving module includes a first motor corresponding to any guide rail, a first driving wheel is provided at the output end of any first motor, a first driven wheel is provided at the rear of the workbench corresponding to the first driving wheel, a first synchronous belt is provided outside any group of the first driving wheel and the first driven wheel, any group of the first driving wheel, the first driven wheel and the first synchronous belt are arranged under the workbench, and a first sliding block that cooperates with the guide rail is provided on the first synchronous belt; and an incubation seat is provided on any of the first sliding blocks;

[0022] The first motor is configured in cooperation with a controller;

[0023] One end of any of the guide rails is arranged at the front of the workbench, and the other end is arranged at the rear of the workbench and cooperates with the signal acquisition module. The arrangement direction of the multi-tube parallel reagent strips is parallel to the guide rails.

[0024] Preferably, the extraction module comprises a fixed frame straddling the workbench, a lifting plate is provided on the fixed frame corresponding to any incubation seat, an electromagnet rod is provided downwardly in cooperation with the fixed frame, and a lifting unit for lifting the electromagnet rod is provided between the lifting plate and the fixed frame;

[0025] The lower outer side of the electromagnet rod is sleeved with a shielding sleeve, and the electromagnet rod on the top of the shielding sleeve is provided with a position detection structure for detecting the position of the rod sleeve;

[0026] The lifting unit, the in-position detection mechanism and the controller are arranged in coordination.

[0027] Preferably, the lifting unit includes a second motor arranged at the top of the lifting plate or at the bottom of the fixing frame, the output shaft of the second motor passes through the lifting plate and the fixing frame, a nut is arranged at the bottom of the fixing frame or at the top of the lifting plate to match the output shaft of the second motor, and the output shaft of the second motor is threadedly connected to the nut; the second motor is arranged in cooperation with the controller;

[0028] The lifting unit further comprises at least one conduit arranged between the lifting plate and the fixing frame, and the at least one conduit is connected to the top of the electromagnet rod.

[0029] Preferably, the electromagnet rod comprises a fixing block, and a rod body is coaxially arranged at the bottom of the fixing block;

[0030] The in-place detection mechanism comprises an in-place detection signal plate fixedly sleeved on the rod body at the bottom of the fixed block, and an in-place detection sensor is provided at the end of the in-place detection signal plate outside the rod body;

[0031] The rod body at the bottom of the in-place detection signal plate is detachably sleeved with an in-place detection baffle, and the in-place detection baffle is provided with positioning ribs in cooperation with the rod body;

[0032] The in-position detection baffle is provided with a step hole in coordination with the rod body, an elastic member is provided on the outer sleeve of the rod body in coordination with the step hole, and the in-position detection sensor, the elastic member and the step hole are arranged in coordination;

[0033] The in-position detection sensor is connected to a controller.

[0034] Preferably, the signal acquisition module includes a third motor arranged at the rear of the workbench, a second driving wheel is provided at the output end of the third motor, a second driven wheel is provided at the rear of the workbench corresponding to the second driving wheel, a second synchronous belt is provided outside the second driving wheel and the second driven wheel, and the second synchronous belt is spanned over the rear of the first moving module on the workbench; a second sliding block is provided on the second synchronous belt, and the second sliding block is provided with a shielding cover that cooperates with the incubation seat, a signal acquisition mechanism is provided inside the shielding cover, and a step is provided inside the shielding cover to cooperate with any incubation seat; the third motor and the signal acquisition mechanism are arranged in cooperation with the controller.

[0035] Preferably, a lifting mechanism is provided between the second slider and the shielding cover, and a knife head is provided on the outer side of the shielding cover for acting on the multi-tube parallel reagent strips in a one-to-one correspondence; the lifting mechanism is provided in cooperation with the controller.

[0036] Preferably, the incubation seat is provided with a heating rod corresponding to the multi-tube parallel reagent strips, and a positioning groove is provided at the inner rear part of the incubation seat, and a positioning bead is embedded in the positioning groove.

[0037] A multi-tube parallel reagent strip used in conjunction with the parallel detection heterogeneous chemiluminescent immunoassay analyzer, the multi-tube parallel reagent strip comprising:

[0038] A pre-installed tube, used for pre-installing a new rod sleeve; a gripping portion is provided on the outer side of the front end of the pre-installed tube;

[0039] A waste rod sleeve collecting pipe, used for recovering the waste rod sleeves after use; an inverted cone-shaped sleeve removing plate is provided in the waste rod sleeve collecting pipe;

[0040] a pipette for receiving an initial sample;

[0041] Several reaction tubes for performing several elution, incubation and labeling operations;

[0042] A detection tube is used to cooperate with the signal acquisition module to complete signal acquisition detection.

[0043] A control method for a parallel detection heterogeneous chemiluminescence immunoassay analyzer, the method comprising the following steps:

[0044] Step 1: Heat the incubation seat to the reaction temperature required by the reagent;

[0045] Step 2: Place the multi-tube parallel reagent strip into the incubation seat;

[0046] Step 3: Transferring the sample from the sample tube to the corresponding tube position of the multi-tube parallel reagent strip;

[0047] Step 4: The extraction module takes the rod sleeve built into the multi-tube parallel reagent strip;

[0048] Step 5: The electromagnet rod is powered on, and the extraction module takes the magnetic beads built into the multi-tube parallel reagent strip and moves them to the tube position in step 3 for elution, incubation, and mixing;

[0049] Step 6: The extraction module uses the power on and off of the electromagnet rod and the lifting and lowering movement of the extraction module to label and elute the magnetic beads in several reaction tubes of the multi-tube parallel reagent strip and incubate them based on actual needs;

[0050] Step 7: The incubation seat carries the multi-tube parallel reagent strips to the signal acquisition module, and the signal acquisition module collects signals and analyzes the readings;

[0051] Step 8: The extraction module absorbs and removes the rod sleeve to the corresponding tube position of the multi-tube parallel reagent strip;

[0052] Step 9: The incubation seat moves to the initial position with the multi-tube parallel reagent strips, picks up the multi-tube parallel reagent strips, and ends the analysis.

[0053] The present invention provides an optimized parallel detection heterogeneous chemiluminescent immunoassay analyzer, a multi-tube parallel reagent strip and a control method. A first moving module is arranged on a workbench, and the first moving module drives one or more incubation seats to move horizontally relative to the workbench. After the extraction module above the incubation seat extracts and places the contents of the multi-tube parallel reagent strip in the incubation seat, the signal acquisition module at the rear of the workbench acquires signals of the chemiluminescent immunoassay results of the multi-tube parallel reagent strip to complete the detection.

[0054] The present invention has the following beneficial effects:

[0055] 1. The parallel-designed multi-channel has the functions of independent incubation and independent detection. It can support the simultaneous operation of multi-tube parallel reagent strips with different incubation times, different detection items, and different chemiluminescence detection methods without interfering with each other. Even without affecting the detection tasks of other channels, the detection action of a single channel can be terminated at any time to meet the urgent queue-jumping detection needs of outpatient and emergency medical scenarios;

[0056] 2. The precisely controllable electromagnet rod is combined with a disposable rod cover to realize the upward movement magnetic bead extraction method, avoiding the possibility of cross-contamination between channels. The method of repeatedly beating the liquid up and down to mix it is more efficient than the traditional method of shaking the reagent strip or test tube. The whole machine eliminates the complex and expensive liquid path system;

[0057] 3. When the size of a single reaction tube is the same, the upward-moving electromagnet bar is located in the center of the magnetic bead solution, the magnetic beads are closer to the electromagnet bar and the magnetic field is evenly distributed around it, which has a higher capture rate than the side-suction capture method that is biased on one or both sides of the outer wall of the reaction cup;

[0058] 4. The electromagnet used in the present invention is a soft magnetic material that loses its magnetic source immediately after power is turned off. Even for the weak residual magnetism of the hard magnetic shielding cover, applying a slight reverse current can completely offset its magnetism, which is very convenient for the production commissioning and after-sales calibration of the instrument; at the same time, because the magnetism of the electromagnet rod can be eliminated at any time, there is no need for a complex electromechanical system to pull the magnetic rod upward to avoid the magnetic rod affecting the mixing uniformity of the magnetic bead solution and related chemical reactions during the non-magnetic bead extraction time;

[0059] 5. The real-time rod sleeve in-place detection function design can terminate the channel detection work of the rod sleeve accidentally falling off at any time, and give up the detection channel resources in time to save the efficiency of the whole machine detection project;

[0060] 6. The common rod-in-rod removal method is optimized to the sleeve adsorption removal method, which simplifies the mechanical structure design.

[0061] The present invention can meet the needs of industries such as POCT medical care, food safety, drug detection, and pet medical care, and has application scenario requirements of easy operation, low cost, low maintenance, and convenient upgrading and expansion. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] Figure 1 It is a structural schematic diagram of the analyzer of the present invention;

[0063] Figure 2 is a structural schematic diagram of a first mobile module of the present invention;

[0064] Figure 3 It is a cross-sectional structural schematic diagram of the extraction module of the present invention;

[0065] Figure 4 for Figure 3 A bottom view structural schematic diagram of ;

[0066] Figure 5 It is a cross-sectional structural diagram of the cooperation between the electromagnet rod and the rod sleeve of the present invention;

[0067] Figure 6 It is a schematic structural diagram of a cross-sectional view corresponding to the electromagnetic rod and the rod sleeve of the present invention before they are matched;

[0068] Figure 7 It is a schematic diagram of the cross-sectional structure of the shielding sleeve of the present invention;

[0069] Figure 8 The figure is a schematic diagram of installing the in-place detection baffle of the present invention, and the arrow indicates the installation direction of the in-place detection baffle;

[0070] Fig. 9 A cross-sectional structural diagram of the incubation seat, the signal acquisition module and the multi-tube parallel reagent strip of the present invention;

[0071] Fig.10 It is a schematic diagram of a multi-tube parallel reagent strip according to an embodiment of the present invention. DETAILED DESCRIPTION

[0072] The present invention is further described in detail below in conjunction with embodiments, but the protection scope of the present invention is not limited thereto.

[0073] The present invention relates to a parallel detection heterogeneous chemiluminescence immunoassay analyzer, which includes a workbench 1, an incubation seat 2, a signal acquisition module, a first mobile module, and an extraction module, wherein the signal acquisition module, the extraction module, and the first mobile module are connected to a controller, which is easily understood by those skilled in the art, and those skilled in the art can select and set the controller according to their needs.

[0074] A workbench 1, used for carrying the analyzer;

[0075] A first moving module is provided on the workbench 1 and is used to horizontally move the incubation seat 2;

[0076] The workbench 1 is provided with one or more parallel guide rails 3;

[0077] The first moving module includes a first motor 4 corresponding to any guide rail 3, a first driving wheel 5 is provided at the output end of any first motor 4, a first driven wheel 6 is provided at the rear of the workbench 1 corresponding to the first driving wheel 5, a first synchronous belt 7 is provided outside any group of the first driving wheel 5 and the first driven wheel 6, any group of the first driving wheel 5, the first driven wheel 6, and the first synchronous belt 7 are arranged below the workbench 1, and a first sliding block 8 cooperating with the guide rail 3 is provided on the first synchronous belt 7; and an incubation seat 2 is provided on any first sliding block 8;

[0078] The first motor 4 is arranged in cooperation with the controller;

[0079] One end of any of the guide rails 3 is disposed at the front of the workbench 1 , and the other end is disposed at the rear of the workbench 1 and cooperates with the signal acquisition module. The arrangement direction of the multi-tube parallel reagent strips 9 is parallel to the guide rail 3 .

[0080] In the present invention, one or more detection channels may be arranged on the workbench 1. When multiple detection channels are arranged, the multiple detection channels are operated in parallel without affecting each other.

[0081] In the present invention, taking any detection channel as an example, the first motor 4 drives the first driving wheel 5, the first driven wheel 6 and the first synchronous belt 7 to move in coordination, and the first slider 8 on the first synchronous belt 7 can move back and forth in the guide rail 3, thereby driving the incubation seat 2 to move back and forth.

[0082] One or more incubation seats 2, any incubation seat 2 is used to place multiple parallel-type reagent strips 9;

[0083] The incubation seat 2 is provided with a heating rod 10 corresponding to the multi-tube parallel reagent strips 9, and a positioning groove 11 is provided at the inner rear part of the incubation seat 2, and a positioning bead 12 is embedded in the positioning groove 11.

[0084] In the present invention, the heating rod 10 is generally a cylindrical heating rod 10, which can quickly and evenly heat the multi-tube parallel reagent strips 9 to the required reaction temperature in a 360° ring shape, and can assist in subsequent incubation operations.

[0085] In the present invention, positioning beads 12, generally positioning wave beads, are used to accurately position the insertion and removal of the multi-tube parallel reagent strips 9; in particular, the present invention adopts a multi-tube parallel reagent strip 9, the bottom of which is a structure with multiple arc surfaces connected. When the first arc surface at the end of the multi-tube parallel reagent strip 9 passes through the positioning bead 12 and the positioning bead 12 is stuck between the first arc surface and the second arc surface, the positioning point is reached.

[0086] A signal collection module, arranged at the rear of the workbench 1, for collecting signals of the chemiluminescent immunoassay results of the multi-tube parallel reagent strips 9;

[0087] The signal acquisition module includes a third motor 13 arranged at the rear of the workbench 1, the output end of the third motor 13 is provided with a second driving wheel, and the rear of the workbench 1 corresponding to the second driving wheel is provided with a second driven wheel 15, and the second driving wheel and the second driven wheel 15 are matched with a second synchronous belt 16, and the second synchronous belt 16 is straddled at the rear of the first moving module on the workbench 1; the second synchronous belt 16 is provided with a second slider, and the second slider is provided with a shielding cover 18 that cooperates with the incubation seat 2, and a signal acquisition mechanism is provided in the shielding cover 18, and a step 19 is provided in the shielding cover 18 to cooperate with any incubation seat 2; the third motor 13 and the signal acquisition mechanism are arranged in cooperation with the controller.

[0088] A lifting mechanism 38 is provided between the second slider and the shielding cover 18 . A knife head 20 is provided on the outer side of the shielding cover 18 for correspondingly acting on the multi-tube parallel reagent strips 9 . The lifting mechanism 38 is provided in cooperation with a controller.

[0089] In the present invention, in order to ensure the accuracy of signal collection, a step 19 structure is provided in the incubation seat 2 to cooperate with the shielding cover 18 of the signal collection module, which can almost completely block the ambient light and greatly reduce the background noise during signal collection.

[0090] In the present invention, the third motor 13 drives the second driving wheel, the second driven wheel 15 and the second synchronous belt 16 to move. The second synchronous belt 16 is straddled across the rear of the first moving module on the workbench 1, that is, the second synchronous belt 16 drives the second slider, and then drives the shielding cover 18 to reach the incubation seat 2 where the preliminary operation is completed, and the shielding cover 18 is covered outside the incubation seat 2 for detection.

[0091] In the present invention, a tensioning wheel may be provided in conjunction with the first synchronous belt 7 and the second synchronous belt 16 to ensure the accuracy of the entire instrument.

[0092] In the present invention, the signal acquisition module is provided with a knife head 20 for breaking the membrane, the same number of which is the same as the number of test tubes of the multi-tube parallel reagent strip 9. Breaking the membrane means that the knife head 20 punctures and opens the membrane of each channel of the corresponding multi-tube parallel reagent strip 9, so that the multi-tube parallel reagent strip 9 is open; since the membrane has a tendency to move up and down, the relative movement between the second slider and the shielding cover 18 is completed by the lifting mechanism 38. This lifting mechanism 38 is easy for technical personnel in the field to understand, and technical personnel in the field can set it by themselves according to needs. For example, a motor is set on the second slider and connected to the shielding cover 18 through a screw nut pair, so as to complete the relative movement between the second slider and the shielding cover 18.

[0093] An extraction module, arranged above the incubation seat 2, for extracting and placing the contents of the multi-tube parallel reagent strips 9 in the incubation seat 2;

[0094] The extraction module includes a fixed frame 21 straddling the workbench 1, a lifting plate 22 is provided on the fixed frame 21 corresponding to any incubation seat 2, an electromagnet rod 23 is provided downwardly in cooperation with the fixed frame 21, and a lifting unit for lifting the electromagnet rod 23 is provided between the lifting plate 22 and the fixed frame 21;

[0095] The outer side of the lower part of the electromagnetic rod 23 is sleeved with a shielding sleeve 24, and the outer side of the electromagnetic rod 23 on the top of the shielding sleeve 24 is provided with a position detection structure for detecting the position of the rod sleeve 25;

[0096] The lifting unit, the in-position detection mechanism and the controller are arranged in coordination.

[0097] The lifting unit includes a second motor 26 disposed at the top of the lifting plate 22 or at the bottom of the fixing frame 21. The output shaft of the second motor 26 passes through the lifting plate 22 and the fixing frame 21. A nut 27 is disposed at the bottom of the fixing frame 21 or at the top of the lifting plate 22 to match the output shaft of the second motor 26. The output shaft of the second motor 26 is threadedly connected to the nut 27. The second motor 26 is provided in conjunction with a controller.

[0098] The lifting unit further includes at least one conduit 28 disposed between the lifting plate 22 and the fixing frame 21 . The at least one conduit 28 is connected to the top of the electromagnet rod 23 .

[0099] The electromagnet rod 23 includes a fixing block 231, and a rod body 232 is coaxially disposed at the bottom of the fixing block 231;

[0100] The in-place detection mechanism includes an in-place detection signal plate 29 fixedly sleeved on the outside of a rod body 232 at the bottom of a fixed block 231, and an in-place detection sensor 30 is provided at the end of the in-place detection signal plate 29 outside the rod body 232;

[0101] The rod body 232 at the bottom of the in-place detection signal plate 29 is detachably sleeved with an in-place detection baffle 31, and the in-place detection baffle 31 is provided with a positioning rib 32 in cooperation with the rod body 232;

[0102] The in-position detection baffle 31 is provided with a step hole 33 in cooperation with the rod body 232, and an elastic member 34 is provided on the outer cover of the rod body 232 in cooperation with the step hole 33, and the in-position detection sensor 30, the elastic member 34 and the step hole 33 are provided in cooperation with each other;

[0103] The arrival detection sensor 30 is connected to the controller.

[0104] In the present invention, the overall lifting of the extraction module is completed by the relative movement between the fixed frame 21 and the lifting plate 22; in actual application, the second motor 26 is working, and its output shaft passes through the lifting plate 22 and the fixed frame 21, and the relative distance change between the lifting plate 22 and the fixed frame 21 is controlled by the screw nut substructure to complete the lifting and lowering of the lifting plate 22, thereby driving the lifting and lowering of the electromagnet rod 23; in actual application, taking the second motor 26 being arranged at the bottom of the fixed frame 21 as an example, after it passes through the lifting plate 22 and the fixed frame 21, a nut 27 can be set on the top of the lifting plate 22, or the through hole at the lifting plate 22 can be directly set as a screw hole that cooperates with the output shaft of the second motor 26.

[0105] In the present invention, at least one guide tube 28 is arranged between the lifting plate 22 and the fixed frame 21. During the lifting process of the lifting plate 22, the electromagnetic rod 23 is always vertical relative to the fixed frame 21 by using the guide tube 28, so as to ensure that the bottom of the electromagnetic rod 23 can smoothly penetrate into the multi-tube parallel reagent strip 9. Generally speaking, a sliding bearing sleeve 37 is arranged between the guide tube 28 and the fixed frame 21. In actual application, the output shaft of the second motor 26 is a guide rod 35. Of course, those skilled in the art can arrange other guide rod 35 structures between the fixed frame 21 and the lifting plate 22 to ensure the smooth relative movement between the fixed frame 21 and the lifting plate 22.

[0106] In the present invention, the electromagnet rod 23 includes a fixed block 231 and a rod body 232 coaxial with its bottom, and the shielding sleeve 24 is arranged outside the rod body 232. Specifically, a convex ridge 36 is provided on the outer side of the top of the shielding sleeve 24 for completing the snap fit with the rod sleeve 232. The shielding sleeve 24 is interference fit with the rod sleeve 232, and the bottom of the electromagnet rod 23 passes through the shielding sleeve 24, exposing only a small section for adsorbing the magnetic beads in the reagent; wherein, the shielding sleeve 24 can be fixed on the electromagnet rod 23 by laser spot welding technology, but is not limited to this assembly technology process, and also includes mechanical process technologies such as interference fit, threaded fit, and pipe mouth shrinkage riveting.

[0107] In the present invention, the electromagnet rod 23 is an integrated electromagnet design, but is not limited to this single style, including a separate design of an iron rod and an electromagnet, the principle of which is to convert the iron rod at the center of the magnetization through the electromagnetic conversion of the coil to produce strong magnetism. At the same time, the electromagnet has an integrated shell design, and the surface of the in-place detection signal board 29 tightly mounted on its top surface is nickel-plated, that is, except for the exposed part of the electromagnet rod 23, the magnetic field generated by the electromagnetic coil is shielded inside, and the shell surface hardly generates magnetism when power is turned on.

[0108] In the present invention, the electromagnet rod 23 at the top of the shielding sleeve 24 is provided with an in-position detection structure for detecting the in-position state of the rod sleeve 232, so that the in-position detection mechanism detects whether the position of the rod sleeve 232 is accurate and stable. Specifically, the in-place detection mechanism includes an in-place detection signal plate 29 fixedly sleeved outside the rod body 232 at the bottom of the fixed block 231, an in-place detection sensor 30 is provided at the end of the in-place detection signal plate 29 outside the rod body 232, and an in-place detection baffle 31 is detachably sleeved outside the rod body 232 at the bottom of the in-place detection signal plate 29. The in-place detection baffle 31 is matched with the rod body 232 to be provided with a step hole 33, and the outer sleeve of the rod body 232 matching the step hole 33 is provided with an elastic member 34. After the electromagnetic rod 23 grabs the rod sleeve 25 made of plastic material by interference fitting, the inner side of the in-place detection baffle 31 will be lifted up and squeeze the elastic member 34, so that the in-place detection sensor 30 on the in-place detection signal plate 29 is triggered and the instrument determines that the grabbing is successful; when the grabbing is not reliable, the rod sleeve 25 will be ejected by the elastic member 34, and the in-place detection baffle 31 will not be lifted up, thereby failing to trigger the in-place detection sensor 30 on the in-place detection signal plate 31, and the instrument can determine that the grabbing is unsuccessful and needs to be re-grasped.

[0109] In the present invention, the elastic member 34 is generally a compression spring.

[0110] In the present invention, the in-position detection sensor 30 is generally a photoelectric switch, which can complete the operation.

[0111] In the present invention, further, in order to ensure the stability of the rod sleeve 25 after successful grasping, a positioning rib 32, such as a "T"-shaped positioning rib 32, is provided in the in-place detection baffle 31 to cooperate with the rod body 232. After the operator manually lifts it up and rotates it 90°, it can be hung on a circle of ridges 36 structure of the shielding sleeve 24 on the electromagnetic rod 23 to ensure its cooperation with the shielding sleeve 24.

[0112] The present invention also relates to a multi-tube parallel reagent strip 9 that cooperates with the above-mentioned upward-moving parallel detection heterogeneous chemiluminescence immunoassay analyzer, and the multi-tube parallel reagent strip 9 comprises:

[0113] A pre-installed tube 90 for pre-installing a new rod sleeve 25; a gripping portion 17 is provided on the outer side of the front end of the pre-installed tube 90;

[0114] A waste rod sleeve collecting pipe 91, used to recycle the waste rod sleeves 25 after use; an inverted cone-shaped sleeve removal plate 14 is provided in the waste rod sleeve 25 collecting pipe;

[0115] a pipette 93 for receiving an initial sample;

[0116] A plurality of reaction tubes 94-99, used for performing a plurality of elution, incubation and labeling operations;

[0117] A detection tube 100 is used to cooperate with the signal acquisition module to complete signal acquisition detection.

[0118] In the present invention, the principle of magnetic bead transfer is:

[0119] Take the rod sleeve: Move the multi-tube parallel reagent strip 9 longitudinally, so that the pre-installed tube 90 where the rod sleeve 25 is located moves to the right below the electromagnet rod 23, the electromagnet rod 23 moves downward, and the shielding sleeve 24 probes into the rod sleeve 25; under the squeezing of the shielding sleeve 24, the rod sleeve 25 and the shielding sleeve 24 are interference-connected together;

[0120] Absorbing magnetic beads: After taking the rod cover 25, move the reaction tubes in the multi-tube parallel reagent strip 9 to be absorbed with magnetic beads to the bottom of the electromagnet rod 23, and energize the electromagnet rod 23 to make the end of the electromagnet rod 23 magnetic; the electromagnet rod 23 moves downward, and the bottom of the rod cover 25 is inserted into the liquid containing magnetic beads, and then the extraction module is slowly moved up and down, and the electromagnet rod 23 absorbs the magnetic beads to the bottom of the rod cover 25; the extraction module moves upward, and at the same time, the electromagnet rod 23 moves upward with the rod cover 25, and the magnetic beads are also moved out of the liquid with the rod cover 25;

[0121] Elution of magnetic beads: After absorbing the magnetic beads, move the reaction tubes on the multi-tube parallel reagent strip 9 that will receive the magnetic beads to the bottom of the electromagnet rod 23, move the electromagnet rod 23 downward, and insert the rod cover 25 with the magnetic beads adsorbed into the liquid that will receive the magnetic beads. The electromagnet rod 23 is powered off, so that the bottom of the rod cover 25 loses its magnetism; the extraction module moves up and down with a small amplitude and quickly, and the magnetic beads on the surface of the plastic rod cover 25 are eluted into the liquid;

[0122] Mixing of magnetic beads: After eluting the magnetic beads, the reaction tubes on the multi-tube parallel reagent strip 9 to be mixed with the magnetic beads are moved to the bottom of the electromagnet rod 23. The reaction tubes to be mixed with the magnetic beads refer to the reaction tubes in the incubation process. When the bottom of the rod sleeve 25 is non-magnetic, the extraction module is moved downward, and the bottom of the rod sleeve 25 is inserted into the liquid to be mixed with the magnetic beads, so that the electromagnet rod 23 moves up and down with a small amplitude and relatively fast pumping of the liquid surface, thereby achieving mixing of the magnetic beads and maintaining the optimal suspension chemical reaction state;

[0123] Removal of the rod sleeve: When the rod sleeve 25 is no longer needed, the waste rod sleeve collection tube 91 on the multi-tube parallel reagent strip 9 is moved to the bottom of the electromagnet rod 23, and the extraction module is driven to move downward. The negative pressure adsorption force of the waste rod sleeve collection tube 91 with the inverted cone-shaped removal plate 14 and the friction force of the hole wall are used to absorb and remove the rod sleeve 25 until the rod sleeve 25 is adsorbed and removed from the shielding sleeve 24 on the electromagnet rod 23, so that the rod sleeve 25 falls into the waste rod sleeve collection tube 91 on the multi-tube parallel reagent strip 9.

[0124] The present invention also relates to a control method for the upward parallel detection heterogeneous chemiluminescence immunoassay analyzer, such as Fig.10 As shown, an embodiment is given, wherein the multi-tube parallel reagent strip 9 is numbered from tube 0 to tube 10 from left to right;

[0125] No. 0 tube is a pre-assembled tube 90;

[0126] Tube No. 1 is a waste rod sleeve collection tube 91;

[0127] No. 2 pipe 92 byes;

[0128] Use tube No. 3 as pipette 93;

[0129] Tubes 4 to 9 are reaction tubes 94 to 99, which are sequentially filled with magnetic bead solution, rinsing solution, rinsing solution, tracer marker solution, rinsing solution, and rinsing solution;

[0130] Tube No. 10 is a detection tube 100, which has a built-in luminescent substrate;

[0131] The method comprises the following steps:

[0132] Step 1: Heat the incubation seat 2 to the reaction temperature required by the reagent;

[0133] Step 2: Place the multi-tube parallel reagent strip 9 into the incubation seat 2;

[0134] Step 3: Transfer the sample from the sample tube to the corresponding tube position (tube No. 3) of the multi-tube parallel reagent strip 9;

[0135] Step 4: The extraction module takes the rod sleeve 25 built into the multi-tube parallel reagent strip 9 (tube No. 0);

[0136] Step 5: The electromagnet rod 23 is powered on, and the extraction module takes the magnetic beads in the multi-tube parallel reagent strip 9 (tube No. 4, i.e., reaction tube 94), and moves them to the tube position in step 3 (tube No. 3) for elution, incubation, and mixing;

[0137] Step 6: The extraction module uses the power on and off of the electromagnet rod 23 and the lifting and lowering movement of the extraction module to label and elute the magnetic beads in several reaction tubes of the multi-tube parallel reagent strip 9 and incubate them based on actual needs;

[0138] include:

[0139] The extraction module draws the magnetic beads out of tube 3;

[0140] The extraction module elutes the magnetic beads into tube No. 5 (reaction tube 95) containing magnetic bead rinsing solution. After rinsing, the extraction module draws the magnetic beads out of tube No. 5;

[0141] The extraction module elutes the magnetic beads into tube No. 6 (reaction tube 96) containing magnetic bead rinsing solution. After rinsing, the extraction module draws the magnetic beads out of tube No. 6;

[0142] The extraction module elutes the magnetic beads into tube No. 7 (reaction tube 97) containing the tracer marker solution. The magnetic beads and the tracer marker solution are incubated in tube No. 7 for a preset reaction time, during which the magnetic beads can be mixed; the extraction module draws the magnetic beads out of tube No. 7;

[0143] The extraction module elutes the magnetic beads into tube No. 8 (reaction tube 98) containing a magnetic bead rinsing solution. After rinsing, the extraction module draws the magnetic beads out of tube No. 8;

[0144] The extraction module elutes the magnetic beads into tube No. 9 (reaction tube 99) containing magnetic bead rinsing solution. After rinsing, the extraction module draws the magnetic beads out of tube No. 9;

[0145] The extraction module elutes the magnetic beads into tube No. 10 containing luminescent substrate a;

[0146] Step 7: The incubation seat carries the multi-tube parallel reagent strips 9 to the signal acquisition module, where the signal acquisition module collects signals and analyzes the readings;

[0147] Step 8: The extraction module absorbs and removes the rod cover 25 to the corresponding tube position (tube No. 1) of the multi-tube parallel reagent strip 9;

[0148] Step 9: The incubation seat 2 moves to the initial position with the multi-tube parallel reagent strips 9, picks up the multi-tube parallel reagent strips 9, and ends the analysis.

[0149] Since the present invention has no liquid circuit system, the structure is simple and the electrical control debugging is easy. It has a high capture rate and low background noise for the objects to be detected. The number of channels can be flexibly configured according to the application scenario. It can support the simultaneous operation of reagents with different incubation times, support the simultaneous operation of reagents of one-step and two-step methods, support two immunoassay methods, direct chemiluminescence and enzymatic chemiluminescence, and support urgent queue-jumping detection in outpatient and emergency departments, thereby improving the flexibility and application range of the instrument.

Claims

1. A parallel detection heterogeneous chemiluminescent immunoassay analyzer, characterized in that: The analyzer comprises: A workbench, used to carry the analyzer; One or more incubation seats, any one of which is used to place multiple parallel test strips; the incubation seat is provided with a heating rod corresponding to the multiple parallel test strips, and a positioning groove is provided at the inner rear of the incubation seat, and a positioning bead is embedded in the positioning groove; A signal acquisition module, arranged at the rear of the workbench, for collecting signals of the chemiluminescent immunoassay results of the multi-tube parallel reagent strips; the signal acquisition module comprises a third motor arranged at the rear of the workbench, the output end of the third motor is provided with a second driving wheel, and the rear of the workbench corresponding to the second driving wheel is provided with a second driven wheel, and the second driving wheel and the second driven wheel are matched with a second synchronous belt, and the second synchronous belt is arranged across the rear of the first moving module on the workbench; a second slider is provided on the second synchronous belt, and the second slider is provided with a shielding cover matched with the incubation seat, and a signal acquisition mechanism is provided inside the shielding cover, and a step is provided inside the shielding cover to match any incubation seat; a lifting mechanism is matched between the second slider and the shielding cover, and a knife head corresponding to the multi-tube parallel reagent strips is provided on the outer side of the shielding cover; A first moving module is provided on the workbench and is used to move the incubation seat horizontally; An extraction module, arranged above the incubation seat, for extracting and placing the contents of the multi-tube parallel reagent strips in the incubation seat; The signal acquisition module, the extraction module and the first moving module are connected to the controller; the third motor, the signal acquisition mechanism and the lifting mechanism are arranged in coordination with the controller.

2. A parallel detection heterogeneous chemiluminescent immunoassay analyzer according to claim 1, characterized in that: The workbench is provided with one or more parallel guide rails; The first moving module includes a first motor corresponding to any guide rail, a first driving wheel is provided at the output end of any first motor, a first driven wheel is provided at the rear of the workbench corresponding to the first driving wheel, a first synchronous belt is provided outside any group of the first driving wheel and the first driven wheel, any group of the first driving wheel, the first driven wheel and the first synchronous belt are arranged under the workbench, and a first sliding block that cooperates with the guide rail is provided on the first synchronous belt; and an incubation seat is provided on any of the first sliding blocks; The first motor is configured in cooperation with a controller; One end of any of the guide rails is arranged at the front of the workbench, and the other end is arranged at the rear of the workbench and cooperates with the signal acquisition module. The arrangement direction of the multi-tube parallel reagent strips is parallel to the guide rails.

3. A parallel detection heterogeneous chemiluminescence immunoassay analyzer according to claim 1, characterized in that: The extraction module comprises a fixed frame straddling the workbench, a lifting plate is provided on the fixed frame corresponding to any incubation seat, an electromagnet rod is provided downwardly in cooperation with the fixed frame, and a lifting unit for lifting the electromagnet rod is provided between the lifting plate and the fixed frame; The lower outer side of the electromagnet rod is sleeved with a shielding sleeve, and the electromagnet rod on the top of the shielding sleeve is provided with a position detection structure for detecting the position of the rod sleeve; The lifting unit, the in-position detection mechanism and the controller are arranged in coordination.

4. A parallel detection heterogeneous chemiluminescent immunoassay analyzer according to claim 3, characterized in that: The lifting unit includes a second motor arranged at the top of the lifting plate or at the bottom of the fixing frame, the output shaft of the second motor passes through the lifting plate and the fixing frame, a nut is arranged at the bottom of the fixing frame or at the top of the lifting plate to match the output shaft of the second motor, and the output shaft of the second motor is threadedly connected to the nut; the second motor is arranged in cooperation with the controller; The lifting unit further comprises at least one conduit arranged between the lifting plate and the fixing frame, and the at least one conduit is connected to the top of the electromagnet rod.

5. A parallel detection heterogeneous chemiluminescence immunoassay analyzer according to claim 3, characterized in that: The electromagnet rod comprises a fixing block, and a rod body is coaxially arranged at the bottom of the fixing block; The in-place detection mechanism comprises an in-place detection signal plate fixedly sleeved on the rod body at the bottom of the fixed block, and an in-place detection sensor is provided at the end of the in-place detection signal plate outside the rod body; The rod body at the bottom of the in-place detection signal plate is detachably sleeved with an in-place detection baffle, and the in-place detection baffle is provided with positioning ribs in cooperation with the rod body; The in-position detection baffle is provided with a step hole in coordination with the rod body, an elastic member is provided on the outer sleeve of the rod body in coordination with the step hole, and the in-position detection sensor, the elastic member and the step hole are arranged in coordination; The in-position detection sensor is connected to a controller.

6. A multi-tube parallel reagent strip for use with a parallel detection heterogeneous chemiluminescent immunoassay analyzer according to any one of claims 1 to 5, characterized in that: The multi-tube parallel reagent strip comprises: A pre-installed tube, used for pre-installing a new rod sleeve; a gripping portion is provided on the outer side of the front end of the pre-installed tube; A waste rod sleeve collecting pipe, used for recovering the waste rod sleeves after use; an inverted cone-shaped sleeve removing plate is provided in the waste rod sleeve collecting pipe; a pipette for receiving an initial sample; Several reaction tubes for performing several elution, incubation and labeling operations; A detection tube is used to cooperate with the signal acquisition module to complete signal acquisition detection.

7. A control method for a parallel detection heterogeneous chemiluminescence immunoassay analyzer according to any one of claims 1 to 5, characterized in that: The method comprises the following steps: Step 1: Heat the incubation seat to the reaction temperature required by the reagent; Step 2: Place the multi-tube parallel reagent strip into the incubation seat; Step 3: Transferring the sample from the sample tube to the corresponding tube position of the multi-tube parallel reagent strip; Step 4: The extraction module takes the rod sleeve built into the multi-tube parallel reagent strip; Step 5: The electromagnet rod is powered on, and the extraction module takes the magnetic beads built into the multi-tube parallel reagent strip and moves them to the tube position in step 3 for elution, incubation, and mixing; Step 6: The extraction module uses the power on and off of the electromagnet rod and the lifting and lowering movement of the extraction module to label and elute the magnetic beads in several reaction tubes of the multi-tube parallel reagent strip and incubate them based on actual needs; Step 7: The incubation seat carries the multi-tube parallel reagent strips to the signal acquisition module, and the signal acquisition module collects signals and analyzes the readings; Step 8: The extraction module absorbs and removes the rod sleeve to the corresponding tube position of the multi-tube parallel reagent strip; Step 9: The incubation seat moves to the initial position with the multi-tube parallel reagent strips, picks up the multi-tube parallel reagent strips, and ends the analysis.

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