A control method for an immunoassay device

Abstract

The present invention discloses a control method for an immunoassay device, comprising loading a blank strip onto a rotating device, and adding a solution containing a sample to be tested and a reaction reagent onto the blank strip. When a mixed solution is prepared by the method, each module cooperates with each other, the action is smooth, the degree of automation is high, and the preparation efficiency is high.

Description

Technical Field

[0001] The invention relates to the technical field of chemiluminescent immunoassay, and in particular to a control method for an immunoassay device. Background Art

[0002] Immunological testing is based on the principle of antigen-antibody specific reaction. Since it can use isotopes, enzymes, chemiluminescent substances, etc. to display the test objects or amplify the signals, it is often used to detect trace biologically active substances such as proteins and hormones.

[0003] Chemiluminescent immunoassay is a non-radioactive immunoassay technology that has developed rapidly in recent years. Its principle is to use chemiluminescent substances to amplify signals and directly measure the immune binding process with the help of its luminescence intensity. This method has become one of the important directions of immunological detection. However, when preparing the mixed solution of the existing immunoassay device, the various modules do not cooperate closely, the movement is not smooth, and the degree of automation is not high. In addition, the control method of the immunoassay is not closely connected, the various components do not cooperate smoothly, the detection efficiency is low, and the detection accuracy is low. Summary of the invention

[0004] In view of the above technical problems existing in the prior art, the present invention proposes a control method for an immunoassay device, which comprises the following steps:

[0005] S1, control the plate rack module and the moving mechanism to load the blank slats onto the rotating device;

[0006] S2. Control the rotation device and the sample adding device to add a solution containing the sample to be tested and a reaction reagent onto the blank strip.

[0007] As a further improvement to this method, step S1 comprises:

[0008] Controlling the plate rack taking mechanism in the plate rack taking module to take out the plate rack carrying the blank slats from the stack in the plate rack taking module;

[0009] The first pushing mechanism in the moving mechanism is controlled to drive the blank slats on the taken-out rack to move along the first preset direction, so that the blank slats move onto the rotating device.

[0010] As a further improvement to this method, step S1 further includes:

[0011] The plate rack taking mechanism and the plate rack transmission mechanism in the plate rack taking module are controlled to operate so that each time the plate rack taking mechanism takes out a layer of plate racks from the top of the stack, the stack rises to a height between adjacent plate racks driven by the plate rack transmission mechanism.

[0012] As a further improvement to the present method, the rotating device is a turntable, the upper surface of which is divided into a plurality of test areas arranged in sequence, and when each test area moves to a designated position with the turntable, a batch of tests is completed.

[0013] As a further improvement to the method, each test area is divided into a plurality of sample areas, and each sample area can carry the same or different solutions containing the sample to be tested.

[0014] As a further improvement to the method, the space occupied by the turntable is divided into a plurality of execution areas arranged in sequence, wherein the first execution area is used to execute the step S1, and the remaining execution areas are used to execute the step S2.

[0015] As a further improvement to the present method, the space occupied by the turntable is divided into a D0 area, a D1 area, a D2 area and a D3 area arranged in sequence, wherein the D0 area is used to execute the step S1, and the D1, D2 and D3 areas are used to execute the step S2.

[0016] As a further improvement to this method, step S2 includes:

[0017] Controlling the turntable to rotate so that the blank slats reach the D1 area;

[0018] Controlling the sample adding mechanism in the sample adding working device to add a solution containing the sample to be tested to the blank strip;

[0019] Controlling the rotation of the turntable so that the strips added with the solution containing the sample to be tested reach the D2 area;

[0020] Controlling the rotation of the turntable so that the strip containing the solution of the sample to be tested reaches the D3 area;

[0021] The reagent adding mechanism in the sample adding working device is controlled to add the reaction reagent to the strip into which the sample to be tested is added.

[0022] As a further improvement to this method, step S2 further includes:

[0023] When the blank strips reach the D1 area, the reagent adding mechanism is controlled to add additional reaction reagents to the blank strips in the D1 area.

[0024] As a further improvement to this method, step S2 further includes:

[0025] When the blank strip reaches the D1 area, the reagent adding mechanism is controlled to add the pre-dilution liquid into the pre-dilution plate in the dilution oscillation module;

[0026] Controlling the sample adding mechanism to add the solution containing the sample to be tested into the pre-dilution plate in the dilution and oscillation module;

[0027] Controlling the dilution oscillation module to oscillate the pre-dilution plate to obtain a diluted sample;

[0028] The sample adding mechanism is controlled to add the diluted sample into the blank strip in the D1 area.

[0029] As a further improvement to the method, the sample adding mechanism is controlled to add the diluted sample into a partial sample area of ​​the blank strip in the D1 region.

[0030] As a further improvement to the present method, at least two reaction reagents are added into the D3 region.

[0031] As a further improvement to this method, the method further comprises the steps of:

[0032] S3. Control the unloading mechanism to unload the slats carrying the solution containing the sample to be tested and the mixed solution of the reaction reagent from the rotating device.

[0033] As a further improvement to this method, the method further comprises the steps of:

[0034] S4, controlling the moving mechanism to move the unloaded slats to the incubation module.

[0035] As a further improvement to the present method, step S4 includes: controlling the second pushing mechanism in the moving mechanism to drive the slat carrying the mixed solution to move along a second preset direction, so that the slat carrying the mixed solution moves to the incubation module.

[0036] As a further improvement to this method, the method further comprises the steps of:

[0037] S5. Control the incubation module to incubate the mixed solution on the unloaded slats.

[0038] As a further improvement to this method, step S5 includes:

[0039] Controlling the sliding mechanism in the incubation module to drive the unloaded slats to slide back and forth, so as to mix the mixed liquid on the slats;

[0040] During the mixing process, the incubation plate in the incubation module is controlled to incubate the mixed solution.

[0041] As a further improvement to this method, the method further comprises the steps of:

[0042] S6. Control the moving mechanism to move the slat carrying the incubated mixed solution to the detection module.

[0043] As a further improvement to this method, step S6 includes:

[0044] The moving arm in the moving mechanism is controlled to move the strip carrying the incubated mixed solution to the detection module.

[0045] As a further improvement to this method, the method further comprises the steps of:

[0046] S7, controlling the detection module to irradiate the incubated mixed solution with a laser and record the amount of emitted light. As a further improvement to the method, step S7 includes:

[0047] The slat transfer component in the detection module is controlled to drive the slat carrying the incubated mixed solution to move below the optical path component in the detection module, and the optical path component is controlled to perform laser irradiation on the incubated mixed solution.

[0048] As a further improvement to the method, the mixed solution on the strips is incubated at least twice using the incubation module.

[0049] As a further improvement of the present method, a plurality of incubation modules are used to incubate the mixed solution on the unloaded slats at least twice; the moving mechanism is controlled to move the slats carrying the incubated mixed solution to the detection module; the detection module is controlled to irradiate the mixed solution with laser after each incubation and record the amount of emitted light, including:

[0050] Controlling the first incubation module to perform a first step of incubation on the mixed solution;

[0051] Moving the strip carrying the mixed solution after the first step of incubation to the detection module;

[0052] Controlling the detection module to perform a first laser irradiation on the mixed solution after the first step of incubation and recording the amount of emitted light;

[0053] Move the plate carrying the mixed solution after the first step of reading to the second incubation module;

[0054] Controlling the second incubation module to perform a second incubation on the mixed solution after the first step reading;

[0055] Moving the strip carrying the mixed solution after the second step of incubation to the detection module;

[0056] The detection module is controlled to perform a second laser irradiation on the mixed solution after the second step of incubation and record the amount of emitted light.

[0057] As a further improvement of the method, the method further includes: controlling the processor to determine whether a high-dose-hook effect exists based on the emission light amounts recorded after two incubations.

[0058] As a further improvement to the method, the control processor determines whether a high-dose-hook effect exists based on the emission light amounts recorded after two incubations, including:

[0059] Calculate the difference between the amount of emission light recorded after the first incubation and the amount of emission light recorded after the second incubation;

[0060] Determine whether the difference is greater than a preset threshold;

[0061] When it is determined that the difference is greater than the preset threshold, it is determined that the high-dose hook effect exists.

[0062] Compared with the prior art, the present invention has the advantage that it proposes a control method for an immunoassay device, by which when a mixed solution is prepared, each module cooperates with each other, the operation is smooth, the degree of automation is high, and the preparation efficiency is high. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] The preferred embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings. In the drawings:

[0064] Figure 1 The flow chart of a control method of an immunoassay device according to an embodiment of the present invention is shown. Figure 1 .

[0065] Figure 2 The flow chart of a control method of an immunoassay device according to an embodiment of the present invention is shown. Figure 2 .

[0066] Figure 3 The flow chart of a control method of an immunoassay device according to an embodiment of the present invention is shown. Figure 3 . Figure 4 A schematic structural diagram showing the front side of an immunoassay device according to an embodiment of the present invention.

[0067] Figure 5 A schematic structural diagram showing the back side of an immunoassay device according to an embodiment of the present invention.

[0068] Figure 6 for Figure 3 Schematic diagram of the structure of the middle slat clamping device.

[0069] Figure 7 for Figure 3 Exploded view of the center slat clamping device.

[0070] Figure 8 for Figure 3 Schematic diagram of the structure of the middle slat clamping device without the slat pressing plate.

[0071] Fig. 9 for Figure 3Schematic diagram of the structure of the turntable module.

[0072] Fig.10 for Figure 3 Exploded view of the turntable module in .

[0073] Fig.11 for Figure 3 Exploded view of the turntable assembly in .

[0074] Fig.12 for Figure 3 A top view of the pushing device in FIG.

[0075] Fig.13 for Figure 3 Schematic diagram of the structure of the pushing device.

[0076] Fig.14 for Figure 3 Schematic diagram of the structure of the working state of the Y-direction pushing mechanism.

[0077] Fig.15 for Figure 3 Schematic diagram of the structure of the working state of the X-direction pushing mechanism.

[0078] Fig.16 for Figure 3 Schematic diagram of the structure of the plate rack module.

[0079] Fig.17 for Figure 3 Exploded view of the plate removal module.

[0080] Fig.18 for Figure 3 Schematic diagram of the structure of the plate-taking rack mechanism in the plate-taking and plate-separating state.

[0081] Fig.19 for Figure 3 Schematic diagram of the structure of the plate-taking frame mechanism in the plate-taking and engaging state.

[0082] Fig. 20 for Figure 3 Exploded diagram of the plate removal rack mechanism.

[0083] Fig.21 for Figure 3 Schematic diagram of the structure of the detection module in .

[0084] Fig. 22 for Figure 3 Exploded diagram of the detection module in .

[0085] Fig.23 for Figure 3 Schematic diagram of the structure of the slat transfer assembly.

[0086] Fig.24 for Figure 3 Schematic diagram of the structure of the slat plug-in.

[0087] Fig.25 for Figure 3 Schematic diagram of the structure of the slat transfer channel.

[0088] Fig.26 for Figure 3 Schematic diagram of the structure of the sample rack module.

[0089] Fig. 27 for Figure 3 Exploded view of the sample rack module in the PCB with the sample rack base plate removed.

[0090] Fig.28 for Figure 3 Exploded view of the sample rack module with the reverse side of the sample rack base removed.

[0091] In the drawings, the same reference numerals are used for the same components. The drawings are not drawn to scale. DETAILED DESCRIPTION

[0092] The present invention will be further described below in conjunction with the accompanying drawings.

[0093] Figure 1 The flow chart of a control method of an immunoassay device according to an embodiment of the present invention is shown. Figure 1 .

[0094] like Figure 1 As shown, the control method of the immunoassay device of this embodiment mainly includes the following steps:

[0095] S1, control the plate rack module and the moving mechanism to load the blank slats onto the rotating device;

[0096] S2. Control the rotation device and the sample adding device to add the solution containing the sample to be tested and the reaction reagent to the blank strip.

[0097] When the mixed solution is prepared by this method, the modules cooperate with each other, the operation is smooth, the degree of automation is high, and the preparation efficiency is high.

[0098] In a preferred embodiment, the solution containing the sample to be tested may include a diluent or other samples in addition to the sample to be tested, that is, the sample to be tested and the diluent or other samples are mixed in advance to form the above solution.

[0099] In a preferred embodiment, the reaction reagent is not limited to one or more of the first reagent R1, the second reagent R2 and the third reagent R3. Step S1 comprises: first, controlling the plate rack taking mechanism in the plate rack taking module to take out the plate rack carrying the blank strips from the stack in the plate rack taking module; second, controlling the first pushing mechanism in the moving mechanism to drive the blank strips on the taken-out plate rack to move along the first preset direction, so that the blank strips move on the rotating device.

[0100] In a preferred embodiment, step S1, in addition to controlling the plate retrieval mechanism to take out the plate rack carrying blank slats from the stack, and controlling the first pushing mechanism to move the blank slats to the rotating device, may also include: controlling the plate retrieval mechanism and the plate rack transmission mechanism in the plate retrieval module to operate so that every time the plate retrieval mechanism takes out a layer of plate rack from the top of the stack, the stack rises to a height between adjacent plate racks driven by the plate rack transmission mechanism.

[0101] The rotating device is a turntable, and its upper surface is divided into multiple test areas arranged in sequence. When each test area moves to a designated position with the turntable, a batch of tests is completed. Each test area is divided into multiple sample areas, and each sample area can carry the same or different solutions containing the sample to be tested.

[0102] The space occupied by the turntable is divided into a plurality of execution areas arranged in sequence, wherein the first execution area is used to execute step S1 , and the remaining execution areas are used to execute step S2 .

[0103] Figures 4 to 28 FIG. 2 shows a schematic diagram of the structure of an immunoassay device according to an embodiment of the present invention. Figure 4 As shown, the immunoassay device includes a frame 2, a strip 3 for detection, a plate rack module 83 arranged on the frame 2, a pushing device 84, a sample loading arm module 4, a turntable module 85, a sample rack module 86, an incubation module 87, a reagent module 5 and a detection module 88. The plate rack module 83 is arranged at the front of the frame 2, the turntable is arranged at the rear of the plate rack module 83, the incubation module 87 is arranged at one side of the turntable, the sample rack module 86 and the reagent module 5 are respectively located on both sides of the plate rack module 83, and the pushing device 84 includes an X-axis pushing device. Mechanism 6 and Y-direction pushing mechanism 7, the slats on the plate rack module 83 are pushed to the turntable by the Y-direction pushing mechanism 7, and the sample and reaction reagent are added to the reaction cup on the slats 3 on the turntable through the sample adding arm module, and the slats on the turntable are pushed into the incubation module 87 by the X-direction pushing mechanism 6, and enter the detection module 88 for detection after the incubation is completed. The incubation module 87 includes an incubation plate 8 and a first sliding mechanism, and the incubation plate 8 is slidably connected to the frame 2 by the first sliding mechanism, and a slat clamping device 90 is provided on the incubation plate 8.

[0104] In this embodiment, the incubation module 87 includes two incubation plates 8 arranged in parallel with each other, which are respectively slidably connected to the frame 2 through a set of first sliding mechanisms, the first sliding mechanism includes a first motor 9 and a first slide rail 10, the incubation plate 8 is arranged on the first slide rail 10, the first motor 9 is connected to the incubation plate 8 through a first synchronous belt 11, and the first motor 9 rotates to drive the incubation plate 8 to slide along the first slide rail 10. Incubation is carried out on two incubation plates 8 separately, and different incubation times can be achieved respectively, and the speed of rotation of the first motor 9 can determine the speed of the incubation plate 8 moving back and forth, thereby achieving different degrees of oscillation mixing, and the operation is more flexible and changeable.

[0105] In this embodiment, the slat clamping device 90 includes a clamping bottom plate 89, a vertical plate 12 and a slat pressing piece 13. The vertical plate 12 is provided with an elastic piece slot 14, and a slat elastic piece 15 is provided in the elastic piece slot 14. The outer side surface of the slat elastic piece 15 protrudes from the vertical side wall of the vertical plate 12. The slat pressing piece 13 is fixed to the upper end surface of the vertical plate 12 and presses the slat elastic piece 15 in the vertical direction. The slat 3 is arranged between two adjacent vertical plates 12 and is pressed in the horizontal direction by the slat elastic piece 15. The slat clamping device 90 can clamp the slat 3 in the horizontal direction and the vertical direction at the same time. The slat elastic piece 15 can clamp the slat 3 horizontally, and the slat pressing piece 13 can press the slat 3 in the vertical direction, thereby making the slat 3 more stable during the movement.

[0106] In this embodiment, the turntable module 85 includes a turntable base 16, a disk assembly, a shaft assembly 17, a turntable motor 18 and a sensing assembly. The turntable base 16 is fixed on the frame 2. The disk assembly includes a turntable 19, a first gear 20 and a gear pressing plate 21. Four slat clamping devices 90 are arranged symmetrically on the same circumference on the upper surface of the turntable 19. The shaft assembly 17 passes through the gear pressing plate 21 and the first gear 20 from bottom to top. The upper part of the shaft assembly 17 is fixed on the lower surface of the turntable 19. A second gear 22 is arranged on the output end of the turntable motor 18, and the second gear 22 is meshed with the first gear 20. Each time the turntable 19 rotates 90 degrees, operations such as adding samples, adding diluents, and adding reaction reagents are realized respectively. A plurality of slat clamping devices 90 are arranged on the turntable 19, and a plurality of slats 3 can be placed in one station, thereby improving the detection efficiency.

[0107] In this embodiment, the sensing component includes a turntable zero position sensor 23 and a turntable working position sensor 24. A boss 25 is provided on the lower surface of the turntable 19 below the slat clamping device 90. The boss 25, the turntable zero position sensor 23 and the turntable working position sensor 24 are located on the same circumference. When the turntable 19 rotates, the lower end of the boss 25 intermittently passes through the turntable zero position sensor 23 and the turntable working position sensor 24. The turntable zero position sensor 23 and the turntable working position sensor 24 record the number of times the turntable 19 rotates in real time, and then convert it into a working position.

[0108] In this embodiment, the plate rack module 83 includes a plate rack 26 for placing slats, a stack 27, a plate rack mechanism and a plate rack transmission mechanism. The plate rack mechanism is fixed to the stack 27 by a fixing plate 28; the plate rack mechanism includes a first plate support plate 29, a second plate support plate 30 and a second sliding mechanism. The first plate support plate 29 is slidably connected to the second sliding mechanism by a plate connecting plate 31. A rectangular opening 32 is provided on the first plate support plate 29. The second plate support plate 30 is horizontally slidably arranged at the rectangular opening 32 by a screw 33. A spring is provided between the first plate support plate 29 and the second plate support plate 30. 34, an arc-shaped projection 35 is provided on the outer side of the second plate-taking support plate 30, and the projection 35 extends outward beyond the outer edge of the first plate-taking support plate 29; two support ribs 36 are provided on the lower surface of the plate rack 26, and a clamping rib 37 is provided on the inner side of each of the two support ribs 36, wherein an arc-shaped depression 38 is provided on the clamping rib 37 located on one side of the projection 35. When the first plate-taking support plate 29 and the second plate-taking support plate 30 enter the stack 27 and extend under the top plate rack 26, the first plate-taking support plate 29 and the second plate-taking support plate 30 are located between the two clamping ribs 37, and the projection 35 sinks into the depression 38. The plate rack module 83 smoothly takes the plate rack 26 out of the stack 27 by clamping the clamping rib 37 with the elastic projection 35. When all the slats 3 are transferred to the turntable 19, the plate rack 26 automatically falls into the collection frame and can be used next time.

[0109] In this embodiment, the plate rack transmission mechanism includes a lifting motor 39, a plate bracket 40, a screw 41 and two guide rods 42. The two guide rods 42 and the screw 41 are parallel to each other and vertically arranged on one side of the stack 27. The two guide rods 42 and the screw 41 are provided with a lifting slider 43. The plate bracket 40 is fixed on the lifting slider 43 and extends into the stack 27. The plate rack 26 with the slats 3 placed thereon is longitudinally superimposed on the plate bracket 40. The superimposed plate racks 26 are located inside the stack 27. The lower end of the screw 41 is connected to the lifting motor 39 through a lifting motor synchronous belt (not shown in the figure). The plate racks 26 are stacked in the stack 27 in sequence. When the top plate rack 26 is taken out, all the plate racks 26 are raised by one position through the plate rack transmission mechanism. In this way, the plate racks 26 of a column are taken out in sequence, and then the plate racks 26 of a column are manually loaded.

[0110] In this embodiment, the second sliding mechanism includes a second motor 44 and a second slide rail 45. The plate-taking connecting plate 31 is disposed on the second slide rail 45 and slides along the second slide rail 45. The second motor 44 is connected to the plate-taking connecting plate 31 through a second synchronous belt 46. The second motor 44 rotates to drive the plate-taking connecting plate 31 to slide along the second slide rail 45. The second sliding mechanism can enable the plate-taking frame mechanism to move left and right, thereby taking out the plate frame 26 from the stack 27.

[0111] In this embodiment, the detection module 88 includes an optical path component 47, a slat transfer component, a detection base plate 48 and a third sliding mechanism. A slat drop groove 49 is provided on the detection base plate 48. The slat transfer component is movably arranged on the upper surface of the detection base plate 48. The optical path component 47 is arranged on the upper surface of the detection base plate 48 through a slat transfer channel 50. When performing detection, the slat 3 on the slat transfer component is located directly below the optical path component.

[0112] In this embodiment, the slat transfer assembly includes a slide block 51, a slat plug-in 52 and a DC motor 53. A guide rail 54 is provided on the upper surface of the slide block 51. The slat plug-in 52 is arranged on the guide rail 54. The DC motor 53 is arranged on the slide block 51, and a third gear 55 is provided at the output end. A rack 56 is provided on the slat plug-in 52. The third gear 55 and the rack 56 are meshed with each other. The DC motor 53 rotates to drive the slat plug-in 52 to slide along the guide rail 54. A plurality of plugs 57 arranged parallel to each other are provided on the side of the slat plug-in 52 close to the optical path assembly 47, and the slat 3 is mounted on the plug 57. The slat 3 to be inspected enters the inspection module 88 from one side of the slat transfer channel 50. At this time, the slat plug-in 52 moves toward the slat transfer channel 50, and the insert 57 is inserted into the slat 3 from the side. At this time, the slat plug-in 52 can move the slat 3 left and right or forward and backward. The slat plug-in 52 moves the slat 3 to the bottom of the optical path component 47 for inspection. When the inspection is completed, the DC motor 53 rotates and moves the slat plug-in 52 away from the slat transfer channel 50. When the slat 3 moves to the top of the slat drop groove 49, the slat 3 stops moving due to being blocked by the sliding block 51, and the slat plug-in 52 continues to move away from the slat transfer channel 50, and then the slat plug-in 52 disengages from the slat 3. At this time, the slat 3 falls downward from the slat drop groove 49.

[0113] In this embodiment, the third sliding mechanism includes a third motor 58 and a third slide rail 59. The slide block 51 is disposed on the third slide rail 59 and slides along the third slide rail 59. The third motor 58 is connected to the slide block 51 through a third synchronous belt 60. The third motor 58 rotates to drive the slide block 51 to slide along the third slide rail 59. The third sliding mechanism enables the slat transfer assembly to move left and right.

[0114] In this embodiment, the sample rack module 86 includes a sample rack bottom plate 61, a test tube rack 62 and a test tube rack adapter 63. The test tube rack 62 is provided with a plurality of test tube insertion holes 64, and the test tube insertion holes 64 are provided with test tube clamping pieces 65. The test tubes 82 for holding samples are inserted into the test tube clamping pieces 65. The sample rack bottom plate 61 is provided with a plurality of guide blocks 66. The bottom surface of the test tube rack adapter 63 is provided with a guide groove 67. The test tube rack 62 is fixed to the test tube rack adapter 63, and then the test tube rack 62 and the test tube rack adapter 63 are inserted together from one side of the sample rack bottom plate 61. The sample rack module 86 with this structure is convenient for users to operate, and the test tubes 82 for holding samples are relatively stable.

[0115] In this embodiment, one and two magnets 68 are respectively provided on the front end and the lower surface of the test tube rack adapter 63, and the three magnets 68 are all sunk into the test tube rack adapter 63. The magnets 68 can absorb the sample rack bottom plate 61, thereby making the test tube rack adapter 63 more stable.

[0116] In this embodiment, the pushing device 84 also includes a push rod base plate 69. The X-direction pushing mechanism 6 and the Y-direction pushing mechanism 7 of the pushing device 84 have the same structure and are slidingly connected to the push rod base plate 69 through a fourth sliding mechanism and a fifth sliding mechanism respectively. The X-direction pushing mechanism 6 and the Y-direction pushing mechanism 7 both include a push rod 70, a push rod motor 71 and a push rod arm 72. A push rod slide rail 73 is horizontally provided on the push rod arm 72. The push rod 70 is slidably provided on the push rod slide rail 73 and is connected to the push rod motor 71 through a push rod synchronous belt 74.

[0117] In this embodiment, the fourth sliding mechanism includes a fourth motor 75 and a fourth slide rail 76. The push rod arm 72 is arranged on the fourth slide rail 76. The fourth motor 75 is connected to the push rod arm 72 through a fourth synchronous belt 77. The fourth motor 75 rotates and drives the push rod arm 72 to slide along the fourth slide rail 76. The fifth sliding mechanism and the fourth sliding mechanism have the same structure.

[0118] In this embodiment, the fully automatic photochemiluminescence detector also includes a universal liquid module 78, a liquid circuit module 79 and a dilution and oscillation module 80. The sample rack module 86, the reagent module 5, the universal liquid module 78 and the dilution and oscillation module 80 realize the operation of adding liquid during the detection process through the liquid circuit module 79.

[0119] In this embodiment, a needle washing pool 81 is respectively provided on one side of the sample rack module 86 and the reagent module 5. The needle washing pool 81 can clean the sample adding needle on the sample adding arm module 4, and then use it multiple times.

[0120] Refer to the following Figures 4 to 28 The control method of the immunoassay device of this embodiment will be described in detail.

[0121] The space occupied by the turntable 19 (fixed position, does not rotate with the rotation of the turntable 19) is divided into a D0 area, a D1 area, a D2 area and a D3 area arranged in sequence (the D0 area, the D1 area and the D3 area are as follows Fig.12 As shown in FIG. 1 , the D2 area is not shown because it is covered by the moving mechanism, wherein the D0 area is used to perform step S1, and the D1, D2 and D3 areas are used to perform step S2. In some preferred embodiments, the D1 area is also used to complete the operation of adding the diluted sample. The D3 area is used to complete the operation of adding the reaction reagent and unloading. Four slat clamping devices 90 are provided on the turntable 19 to clamp the blank slats in the horizontal direction and the vertical direction.

[0122] In this embodiment, the moving mechanism is a pushing device 84, the first pushing mechanism in the moving mechanism is a Y-direction pushing mechanism 7, the second pushing mechanism in the moving mechanism is an X-direction pushing mechanism 6, the first preset direction is the Y direction, and the second preset direction is the X direction.

[0123] When the detection program is started, the plate rack mechanism in the plate rack module 83 first takes out the plate rack 26 carrying the blank slats from the stack 27 in the plate rack module 83, and then controls the Y-axis pushing mechanism 7 to drive the blank slats on the plate rack 26 to move in the Y direction, so that the blank slats are moved to the position corresponding to the D0 area of ​​the turntable 19, and are clamped by the slat clamping device 90 to make the slats more stable during the movement.

[0124] In the plate rack taking module 83, the plate racks 26 are stacked in the stack 27 in sequence. When the plate rack taking mechanism takes out a layer of plate racks 26 from the top of the stack 27, the plate rack transmission mechanism drives the stack 27 to rise by one position, that is, the height between adjacent plate racks 26. In this way, the plate racks 26 of a column are taken out in sequence, and then the plate racks 26 of a column are manually loaded.

[0125] In this embodiment, the sample adding mechanism in the sample adding working device is the left sample adding arm in the sample adding arm module 4, and the reagent adding mechanism in the sample adding working device is the right sample adding arm in the sample adding arm module 4. After the solution containing the sample to be tested is added to the left sample adding arm, it can be cleaned by the first needle washing pool in the needle washing pool 81, and after the reaction reagent is added to the right sample adding arm, it can be cleaned by the second needle washing pool in the needle washing pool 81.

[0126] After the blank slat is clamped on the turntable 19 by the slat clamping device 90, specifically, the turntable 19 is controlled to rotate so that the blank slat reaches the D1 area; the left arm of the sample loading arm is controlled to add the solution containing the sample to be tested to the blank slat; the turntable 19 is controlled to rotate so that the slat added with the solution containing the sample to be tested reaches the D2 area; the turntable 19 is controlled to rotate so that the slat added with the solution containing the sample to be tested reaches the D3 area; the right arm of the sample loading arm is controlled to add the reaction reagent to the slat added with the solution containing the sample to be tested. In a preferred embodiment, step S2 may also include: when the blank slat reaches the D1 area, the right arm of the sample loading arm is controlled to add the additional reaction reagent to the blank slat in the D1 area. This embodiment does not limit the order of adding the solution containing the sample to be tested and adding the additional reaction reagent. Preferably, additional reaction reagents need to be added before sample distribution. Specifically, when the blank strip reaches the D1 area, the right arm of the loading arm is controlled to add the additional reaction reagent to the blank strip in the D1 area, and then the left arm of the loading arm is controlled to add the sample to the blank strip.

[0127] In a preferred embodiment, the solution containing the sample to be tested is also diluted before being added to the blank strip. Step S2 specifically also includes: when the blank strip reaches the D1 area, controlling the right arm of the sample loading arm to add the pre-diluted liquid to the pre-dilution plate in the dilution oscillation module 80; controlling the left arm of the sample loading arm to add the solution containing the sample to be tested to the pre-dilution plate in the dilution oscillation module 80; controlling the dilution oscillation module 80 to oscillate the pre-dilution plate to obtain the diluted sample; controlling the left arm of the sample loading arm to add the diluted sample to the blank strip in the D1 area. More preferably, the diluted sample can be added to a partial sample area of ​​the blank strip in the D1 area.

[0128] Specifically, the sample adding process can adopt a combined sample adding method of one aspiration and multiple distribution. For example, if n projects need to be done, only one of which needs to be pre-diluted, the sample adding mechanism aspirates n samples, only distributes one sample to the pre-dilution plate, and distributes the other n-1 samples to the blank strips in the D1 area. After the dilution of one sample in the pre-dilution plate is completed, the left arm of the robot arm is controlled to add the diluted sample from the pre-dilution plate to the blank strips in the D1 area.

[0129] In a preferred embodiment, when the slat reaches the D3 area, the right arm of the robot is controlled to add one or more reaction reagents to the slat.

[0130] In a preferred embodiment, the reaction reagents added to the strips are all aqueous solutions.

[0131] In a preferred embodiment, the method further comprises the step: S3, controlling the unloading mechanism to unload the slat carrying the mixed solution containing the solution of the sample to be tested and the reaction reagent from the rotating device. Figure 4 After the solution containing the sample to be tested and the reaction reagent are mixed, the unloading mechanism is controlled to unload the slats on the turntable 19 from the slat clamping device 90 .

[0132] In a preferred embodiment, the method further comprises the step: S4, controlling the moving mechanism to move the unloaded slats to the incubation module. Step S4 comprises: controlling the second pushing mechanism in the moving mechanism to drive the slats carrying the mixed solution to move along the second preset direction, so that the slats carrying the mixed solution move to the incubation module. Specifically, see Figure 4 as well as Fig.12 , control the X-direction pushing mechanism 6 to drive the slats carrying the mixed solution to move along the X direction, so that the slats carrying the mixed solution move to the incubation module 87.

[0133] In a preferred embodiment, the method further comprises the step of: S5, controlling the incubation module to incubate the mixed solution on the unloaded slats. Step S5 comprises: controlling the sliding mechanism in the incubation module to drive the unloaded slats to slide back and forth to mix the mixed solution on the slats; and controlling the incubation plate in the incubation module to incubate the mixed solution during the mixing process. Figure 4 as well as Fig.12 When the slats carrying the mixed liquid are incubated, the first sliding mechanism in the incubation module 87 is controlled to drive the unloaded slats to slide back and forth to mix the mixed liquid on the slats; during the mixing process, the incubation plate 8 in the incubation module 87 is controlled to incubate the mixed liquid.

[0134] In a preferred embodiment, the method further comprises the step: S6, controlling the moving mechanism to move the slat carrying the incubated mixed solution to the detection module. Step S6 comprises: controlling the moving arm in the moving mechanism to move the slat carrying the incubated mixed solution to the detection module. Figure 4 as well as Figure 21-24 After the incubation is completed, the moving arm in the moving mechanism is controlled to move the slat carrying the incubated mixed solution to the detection module 88. When the slat carrying the incubated mixed solution enters the detection module 88, the slat transfer assembly in the detection module 88 is controlled to drive the slat carrying the incubated mixed solution to move to the bottom of the optical path assembly 47 in the detection module 88, and the optical path assembly 47 is controlled to perform laser irradiation on the incubated mixed solution.

[0135] In a preferred embodiment, the method further comprises the step: S7, controlling the detection module to perform laser irradiation on the incubated mixed solution and recording the amount of emitted light.

[0136] Figure 2 A flow chart showing a preferred method for controlling an immunoassay device Figure 2 The method comprises the steps of:

[0137] S1, control the plate rack module and the moving mechanism to load the blank slats onto the rotating device;

[0138] S2, controlling the rotation device and the sample adding device to add a solution containing the sample to be tested and a reaction reagent to the blank strip;

[0139] S3, controlling the unloading mechanism to unload the slats carrying the solution containing the sample to be tested and the mixed solution of the reaction reagent from the rotating device;

[0140] S4, controlling the moving mechanism to move the unloaded slats to the incubation module;

[0141] S5, controlling the incubation module to incubate the mixed solution on the unloaded slats;

[0142] S6, controlling the moving mechanism to move the slat carrying the incubated mixed solution to the detection module;

[0143] S7, controlling the detection module to irradiate the incubated mixed solution with laser and record the amount of emitted light.

[0144] The immunoassay performed by this method has close coordination among various steps, is simple and smooth, and has high detection efficiency and high detection accuracy.

[0145] In a preferred embodiment, the specific process is shown in Figure 3 , use multiple incubation modules 87 to incubate the mixed solution on the unloaded slats twice, and determine whether the high-dose-hook effect is detected. First, control the first incubation module to perform the first incubation on the mixed solution; move the slat carrying the mixed solution after the first incubation to the detection module; control the detection module to perform the first laser irradiation on the mixed solution after the first incubation and record the amount of emitted light; move the slat carrying the mixed solution after the first reading to the second incubation module; control the second incubation module to perform the second incubation on the mixed solution after the first reading; move the slat carrying the mixed solution after the second incubation to the detection module; control the detection module to perform the second laser irradiation on the mixed solution after the second incubation and record the amount of emitted light. During the first incubation process, control the right arm of the sample loading arm to absorb the universal liquid from the universal liquid module 78 and add it to the mixed solution being incubated.

[0146] The control processor determines whether there is a high-dose-hook effect based on the emission light amount recorded after two incubations. Wherein, the control processor determines whether there is a high-dose-hook effect based on the emission light amount recorded after two incubations, including: calculating the difference between the emission light amount recorded after the first incubation and the emission light amount recorded after the second incubation; judging whether the difference is greater than a preset threshold; if it is judged that the difference is greater than the preset threshold, it is determined that there is a high-dose-hook effect; otherwise, if it is judged that the difference is less than or equal to the preset threshold, it is determined that there is no high-dose-hook effect. Here, the preset threshold is the maximum value of the standard curve, and the standard curve is measured when the sample to be tested is a standard substance, and the concentration of the standard substance is lower than the concentration when the high-dose-hook effect exists. In a preferred embodiment, when the processor determines that there is a high-dose-hook effect in the immunoassay, the dilution oscillation module 80 is controlled to dilute the current mixed solution until there is no high-dose-hook effect.

[0147] The following is a test process with only two reagents, the first reagent R1 and the second reagent R2, without pre-dilution:

[0148] 1) Assume that eight blank slats are pushed into the turntable 19 from the retrieval rack module 83 each time;

[0149] 2) The blank slat rotates from position D0 to position D1;

[0150] 3) Control the left arm of the sample loading arm to draw samples (or calibration products, reference products, quality control products, etc.) from the sample rack module 86 and distribute them into the strip at the D1 position. The sample distribution uses one aspiration and eight points. After the distribution is completed, move the left arm of the sample loading arm to the first needle washing pool for cleaning;

[0151] 4) After the sample is added, the slat rotates from position D1 to position D2, there is no movement at position D2, and the slat rotates from position D2 to position D3;

[0152] 5) Control the right arm of the sample loading arm to absorb the reaction reagent from the reagent module 5 and distribute it to the strip at the D3 position. The reaction reagent distribution uses one suction and eight points. At this position, after dispensing the first reagent R1, the right arm of the sample loading arm is moved to the second needle washing pool for cleaning. After cleaning, the first reagent R2 is immediately distributed. After the distribution is completed, the right arm of the sample loading arm is moved to the second needle washing pool for cleaning again;

[0153] 6) The slats are pushed from position D3 into the first incubation module by the X-direction pushing mechanism 6 for the first step of incubation;

[0154] 7) During the incubation process, the right arm of the sample loading arm is controlled to draw the universal liquid from the universal liquid module 78 and add it to the mixed liquid being incubated;

[0155] 8) moving the strip carrying the mixed solution after the first step of incubation to the detection module 88, and performing the first laser irradiation on the mixed solution after the first step of incubation and recording the amount of emitted light;

[0156] 9) moving the mixed solution to the second incubation module again, and controlling the second incubation module to perform a second step of incubation on the mixed solution;

[0157] 10) moving the slat carrying the mixed solution after the second step of incubation to the detection module 88, and controlling the detection module 88 to perform a second laser irradiation on the mixed solution after the second step of incubation and record the amount of emitted light;

[0158] 11) Based on the amount of emission light recorded after two incubations, determine whether a high-dose-hook effect exists.

[0159] The above process allocates two reaction reagents, the first reagent R1 and the second reagent R2, in the reaction reagent allocation stage. It can be understood that in addition to allocating the first reagent R1 and the second reagent R2, the third reagent R3 can also be allocated. Assuming that R1, R2 and R3 are all added after the sample allocation is completed, for example, HBeAb, R3 is 50μl neutralizing e antigen, the operation process is similar to the case where only the first reagent R1 and the second reagent R2 are used, except that the third reagent R3 is allocated once more in the D3 area, and the allocation order of the first reagent R1, the second reagent R2 and the third reagent R3 is arbitrary.

[0160] It can also be understood that if among the first reagent R1, the second reagent R2 and the third reagent R3, the third reagent R3 needs to be added before the sample is distributed, then the third reagent R3 is an additional reaction reagent, such as CA19-9, and R3 is a 15μl sample diluent. The right arm of the robotic arm is used at position D1 to complete the distribution of the additional reaction reagent R3, and then the left arm of the sample loading arm completes the distribution of the sample to be tested. The other processes are the same as the case where there are only the first reagent R1 and the second reagent R2.

[0161] It is also understandable that if the third reagent R3 among the first reagent R1, the second reagent R2 and the third reagent R3 needs to be added before the sample is distributed, then the third reagent R3 is an additional reaction reagent. If the additional reaction reagent R3 is a pre-dilution liquid, such as HCV, 10μl sample + 100μl diluent, then take 25μl of the diluted sample to participate in the test. Specifically, after the blank strip rotates to D1, the right arm of the sample loading arm distributes the pre-dilution liquid R3 to the pre-dilution plate in the dilution oscillation module 80, and the left arm of the sample loading arm distributes the sample to be tested to the pre-dilution plate, wherein the process of distributing the sample to be tested can be carried out in a one-absorption-multiple-distribution manner, for example, if five projects are to be done, one project needs to be pre-diluted, and the other four projects do not need to be pre-diluted, then the left arm of the robot arm absorbs five samples to be tested, one is distributed to the pre-dilution plate in the left arm of the sample loading arm, and the other four are distributed to the blank strips in the D1 area. Afterwards, the dilution oscillation module 80 is controlled to oscillate the pre-dilution plate. After sufficient dilution, the left arm of the sample loading arm distributes the diluted solution containing the sample to be tested into the strip, and then the turntable 19 is rotated to D2. The subsequent process is the same as the case where only the first reagent R1 and the second reagent R2 are present, and will not be described in detail here.

[0162] In a preferred embodiment, for the current batch test and the next batch test, the following steps are performed to realize parallel processing of multiple batch tests. Specifically, the turntable 19 is controlled to rotate so that the blank slats of the current batch arrive at the D1 area; the sample adding action is performed on the slats of the current batch in the D1 area, and at the same time, the plate rack module 83 and the moving mechanism are controlled to load the blank slats of the next batch onto the turntable in the D0 area; the turntable 19 is controlled to rotate so that the slats of the current batch arrive at the D2 area, and at the same time, the blank slats of the next batch arrive at the D1 area; the sample adding action is performed on the slats of the next batch in the D1 area; the turntable 19 is controlled to rotate so that the slats of the current batch arrive at the D3 area, and at the same time, the slats of the next batch arrive at the D2 area; the reagent adding action is performed on the current slats in the D3 area, and then the slats of the current batch are unloaded from the turntable 19 to perform subsequent operation steps; the turntable 19 is controlled to rotate so that the slats of the next batch arrive at the D3 area; the reagent adding action is performed on the slats of the next batch in the D3 area, and then the slats of the next batch are unloaded from the turntable 19 to perform subsequent operation steps.

[0163] Compared with the prior art, the advantage of the present invention is that the present invention proposes a control method for an immunoassay device, and when preparing a mixed solution by this method, each module cooperates with each other, the operation is smooth, the degree of automation is high, and the preparation efficiency is high. The above is only a preferred embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any technician in the field can easily make changes or variations within the technical scope disclosed by the present invention, and such changes or variations should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention shall be based on the protection scope of the claims.

Claims

1. A method for controlling an immunoassay device, characterized in that: The following steps are involved: S1, control the plate rack module and the moving mechanism to load the blank slats onto the rotating device; S2, controlling the rotation device and the sample adding device to add a solution containing the sample to be tested and a reaction reagent to the blank strip; S3, controlling the unloading mechanism to unload the slats carrying the solution containing the sample to be tested and the mixed solution of the reaction reagent from the rotating device; S4, controlling the moving mechanism to move the unloaded slats to the incubation module; The rotating device is a turntable, the upper surface of which is divided into a plurality of test areas arranged in sequence, and when each test area moves to a designated position with the turntable, a batch of tests is completed.

2. The control method according to claim 1, characterized in that: The step S1 comprises: Controlling the plate rack taking mechanism in the plate rack taking module to take out the plate rack carrying the blank slats from the stack in the plate rack taking module; The first pushing mechanism in the moving mechanism is controlled to drive the blank slats on the taken-out rack to move along the first preset direction, so that the blank slats move onto the rotating device.

3. The control method according to claim 2, characterized in that: The step S1 further comprises: The plate rack taking mechanism and the plate rack transmission mechanism in the plate rack taking module are controlled to operate so that each time the plate rack taking mechanism takes out a layer of plate racks from the top of the stack, the stack rises to a height between adjacent plate racks driven by the plate rack transmission mechanism.

4. The control method according to claim 3, characterized in that: Each test area is divided into a plurality of sample areas, each of which can carry the same or different solutions containing the sample to be tested.

5. The control method according to claim 4, characterized in that: The space occupied by the turntable is divided into a plurality of execution areas arranged in sequence, wherein the first execution area is used to execute the step S1, and the remaining execution areas are used to execute the step S2.

6. The control method according to claim 5, characterized in that: The space occupied by the turntable is divided into a D0 area, a D1 area, a D2 area and a D3 area arranged in sequence, wherein the D0 area is used to execute the step S1, and the D1, D2 and D3 areas are used to execute the step S2.

7. The control method according to claim 6, characterized in that: Step S2 includes: Controlling the turntable to rotate so that the blank slats reach the D1 area; Controlling the sample adding mechanism in the sample adding working device to add a solution containing the sample to be tested to the blank strip; Controlling the rotation of the turntable so that the strips added with the solution containing the sample to be tested reach the D2 area; Controlling the rotation of the turntable so that the strip containing the solution of the sample to be tested reaches the D3 area; The reagent adding mechanism in the sample adding working device is controlled to add the reaction reagent to the strip to which the solution containing the sample to be tested is added.

8. The control method according to claim 7, characterized in that: Step S2 also includes: When the blank strips reach the D1 area, the reagent adding mechanism is controlled to add additional reaction reagents to the blank strips in the D1 area.

9. The control method according to claim 7, characterized in that: Step S2 also includes: When the blank strip reaches the D1 area, the reagent adding mechanism is controlled to add the pre-dilution liquid into the pre-dilution plate in the dilution oscillation module; Controlling the sample adding mechanism to add the solution containing the sample to be tested into the pre-dilution plate in the dilution and oscillation module; Controlling the dilution oscillation module to oscillate the pre-dilution plate to obtain a diluted sample; The sample adding mechanism is controlled to add the diluted sample into the blank strip in the D1 area.

10. The control method according to claim 9, characterized in that: The sample adding mechanism is controlled to add the diluted sample into a partial sample area of ​​the blank strip in the D1 area.

11. The control method according to claim 7, characterized in that: At least two reaction reagents are added in the D3 region.

12. The control method according to claim 1, characterized in that: Step S4 includes: controlling the second pushing mechanism in the moving mechanism to drive the slat carrying the mixed solution to move along a second preset direction, so that the slat carrying the mixed solution moves to the incubation module.

13. The control method according to claim 1, characterized in that: Also includes the steps: S5, controlling the incubation module to incubate the mixed solution on the unloaded slats, and during the incubation process, drawing the universal solution and adding it into the mixed solution being incubated.

14. The control method according to claim 13, characterized in that: Step S5 includes: Controlling the sliding mechanism in the incubation module to drive the unloaded slats to slide back and forth, so as to mix the mixed liquid on the slats; During the mixing process, the incubation plate in the incubation module is controlled to incubate the mixed solution.

15. The control method according to claim 1, characterized in that: Also includes the steps: S6. Control the moving mechanism to move the slat carrying the incubated mixed solution to the detection module.

16. The control method according to claim 15, characterized in that: Step S6 includes: The moving arm in the moving mechanism is controlled to move the strip carrying the incubated mixed solution to the detection module.

17. The control method according to claim 1, characterized in that: Also includes the steps: S7, controlling the detection module to irradiate the incubated mixed solution with laser and record the amount of emitted light.

18. The control method according to claim 17, characterized in that: Step S7 includes: The slat transfer component in the detection module is controlled to drive the slat carrying the incubated mixed solution to move below the optical path component in the detection module, and the optical path component is controlled to perform laser irradiation on the incubated mixed solution.

19. The control method according to claim 13, characterized in that: The mixed solution on the strip is incubated at least twice using the incubation module.

20. The control method according to claim 19, characterized in that: Incubate the mixed solution on the unloaded slats at least twice using a plurality of incubation modules; control the moving mechanism to move the slats carrying the incubated mixed solution to the detection module; Controlling the detection module to perform laser irradiation on the mixed solution after each incubation and recording the amount of emitted light, including: Controlling the first incubation module to perform a first step of incubation on the mixed solution; Moving the strip carrying the mixed solution after the first step of incubation to the detection module; Controlling the detection module to perform a first laser irradiation on the mixed solution after the first step of incubation and recording the amount of emitted light; Move the plate carrying the mixed solution after the first step of reading to the second incubation module; Controlling the second incubation module to perform a second incubation on the mixed solution after the first step reading; Moving the strip carrying the mixed solution after the second step of incubation to the detection module; The detection module is controlled to perform a second laser irradiation on the mixed solution after the second step of incubation and record the amount of emitted light.

21. The control method according to claim 20, characterized in that: Also includes: The control processor determines whether a high-dose-hook effect exists based on the amount of emission light recorded after two incubations.

22. The control method according to claim 21, characterized in that: The control processor determines whether a high-dose-hook effect exists based on the amount of emission light recorded after two incubations, including: Calculate the difference between the amount of emission light recorded after the first incubation and the amount of emission light recorded after the second incubation; Determine whether the difference is greater than a preset threshold; When it is determined that the difference is greater than the preset threshold, it is determined that the high-dose hook effect exists.

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