A control method for an immunoassay device

Abstract

The present invention discloses a control method for an immunoassay device, which includes 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 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.

Description

Technical Field

[0001] The present invention relates to the technical field of chemiluminescence immunoassay, and particularly to a control method for an immunoassay device. Background Art

[0002] Immunological detection is based on the principle of specific antigen-antibody reactions. Since it can use isotopes, enzymes, chemiluminescent substances, etc. to display or amplify signals of the analyte, it is often used to detect trace bioactive substances such as proteins and hormones.

[0003] Chemiluminescence 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 immunobinding process by means of their luminescence intensity. This method has become one of the important directions in immunological detection. However, when preparing the mixture in the existing immunoassay device, the cooperation of each module is not tight enough, the movement is not smooth enough, and the degree of automation is not high. Moreover, the control method of immunoassay is not closely connected enough, the cooperation of each component is not smooth enough, 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 includes the following steps:

[0005] S1. Control the plate rack module and the moving mechanism to load a blank plate strip onto the rotating device;

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

[0007] As a further improvement of this method, the step S1 includes:

[0008] Control the plate rack mechanism in the plate rack module to take out the plate rack carrying the blank plate strip from the stack in the plate rack module;

[0009] Control the first pushing mechanism in the moving mechanism to drive the blank plate strip on the taken-out plate rack to move along a first preset direction so that the blank plate strip moves onto the rotating device.

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

[0011] Control the plate rack mechanism and the plate rack transmission mechanism in the plate rack module to act so that each time the plate rack mechanism takes out a layer of plate rack from above the stack, the stack rises by the height between adjacent plate racks driven by the plate rack transmission mechanism.

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

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

[0014] As a further improvement to this method, the space occupied by the turntable is divided into a plurality of execution areas arranged in sequence. 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 this 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. Among them, 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, the step S2 includes:

[0017] Controlling the rotation of the turntable so that the blank strip reaches the D1 area;

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

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

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

[0021] Controlling the reagent adding mechanism in the sample adding working device to add a reaction reagent to the strip added with the sample to be tested.

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

[0023] When the blank strip reaches the D1 area, controlling the reagent adding mechanism to add an additional reaction reagent to the blank strip in the D1 area.

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

[0025] When the blank strip reaches the D1 area, controlling the reagent adding mechanism to add a pre-diluted solution into the pre-dilution plate in the dilution oscillation module;

[0026] Control 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] Control the dilution and oscillation module to perform oscillation treatment on the pre-dilution plate to obtain the diluted sample;

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

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

[0030] As a further improvement to this method, add at least two reaction reagents in area D3.

[0031] As a further improvement to this method, it further includes the step of:

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

[0033] As a further improvement to this method, it further includes the step of:

[0034] S4. Control the moving mechanism to move the unloaded strip to the incubation module.

[0035] As a further improvement to step S4, it includes: Control the second pushing mechanism in the moving mechanism to drive the strip carrying the mixture to move along the second preset direction, so that the strip carrying the mixture moves to the incubation module.

[0036] As a further improvement to this method, it further includes the step of:

[0037] S5. Control the incubation module to incubate the mixture on the unloaded strip.

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

[0039] Control the sliding mechanism in the incubation module to drive the unloaded strip to slide back and forth to mix the mixture on the strip;

[0040] During the mixing process, control the incubation plate in the incubation module to incubate the mixture.

[0041] As a further improvement to this method, it further includes the step of:

[0042] S6. Control the moving mechanism to move the strip carrying the incubated mixture to the detection module.

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

[0044] Control the moving arm in the moving mechanism to move the strip carrying the incubated mixture to the detection module.

[0045] As a further improvement to this method, it further includes the step of:

[0046] S7. Control the detection module to perform laser irradiation on the incubated mixture and record the emitted light quantity. As a further improvement to this method, step S7 includes:

[0047] Control the strip transfer component in the detection module to drive the strip carrying the incubated mixture to move below the optical path component in the detection module, and control the optical path component to perform laser irradiation on the incubated mixture.

[0048] As a further improvement to this method, use the incubation module to incubate the mixture on the strip at least twice.

[0049] As a further improvement to this method, use multiple incubation modules to incubate the mixture on the unloaded strip at least twice; control the moving mechanism to move the strip carrying the incubated mixture to the detection module; control the detection module to perform laser irradiation on the incubated mixture each time and record the emitted light quantity, including:

[0050] Control the first incubation module to perform the first-step incubation on the mixture.

[0051] Move the strip carrying the mixture after the first-step incubation to the detection module.

[0052] Control the detection module to perform the first laser irradiation on the mixture after the first-step incubation and record the emitted light quantity.

[0053] Move the strip carrying the mixture after the first reading to the second incubation module.

[0054] Control the second incubation module to perform the second-step incubation on the mixture after the first reading.

[0055] Move the strip carrying the mixture after the second-step incubation to the detection module.

[0056] Control the detection module to perform the second laser irradiation on the mixture after the second-step incubation and record the emitted light quantity.

[0057] As a further improvement to this method, this method further includes: controlling the processor to determine whether there is a high-dose hook effect according to the emitted light amount recorded after two incubations.

[0058] As a further improvement to this method, controlling the processor to determine whether there is a high-dose hook effect according to the emitted light amount recorded after two incubations includes:

[0059] Calculating the difference between the emitted light amount recorded after the first incubation and the emitted light amount recorded after the second incubation;

[0060] Determining 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 there is the high-dose hook effect.

[0062] Compared with the prior art, the advantages of the present invention are that the present invention proposes a control method for an immunoassay device. 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. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0064] Figure 1 Shows the flow of a control method for an immunoassay device according to an embodiment of the present invention Figure 1 .

[0065] Figure 2 Shows the flow of a control method for an immunoassay device according to an embodiment of the present invention Figure 2 .

[0066] Figure 3 Shows the flow of a control method for an immunoassay device according to an embodiment of the present invention Figure 3 .

[0067] Figure 4 Shows a schematic structural diagram of the front of an immunoassay device according to an embodiment of the present invention.

[0068] Figure 5 Shows a schematic structural diagram of the back of an immunoassay device according to an embodiment of the present invention.

[0069] Figure 6 Is Figure 4 A schematic structural diagram of a middle plate clamping device.

[0070] Figure 7 Is Figure 4 An exploded view of a middle plate clamping device.

[0071] Figure 8 for Figure 4 Schematic diagram of the structure of the middle slat clamping device without the slat pressing plate.

[0072] Figure 9 for Figure 4 Schematic diagram of the structure of the turntable module.

[0073] Figure 10 for Figure 4 Exploded view of the turntable module in .

[0074] Figure 11 for Figure 4 Exploded view of the turntable assembly in .

[0075] Figure 12 for Figure 4 Top view of the pushing device in.

[0076] Figure 13 for Figure 4 Schematic diagram of the structure of the pushing device.

[0077] Figure 14 for Figure 4 Schematic diagram of the structure of the working state of the Y-direction pushing mechanism.

[0078] Figure 15 for Figure 4 Schematic diagram of the structure of the working state of the X-direction pushing mechanism.

[0079] Figure 16 for Figure 4 Schematic diagram of the structure of the plate rack module.

[0080] Figure 17 for Figure 4 Exploded view of the plate rack module.

[0081] Figure 18 for Figure 4 Schematic diagram of the structure of the plate-taking rack mechanism in the plate-taking and separation state.

[0082] Figure 19 for Figure 4 Schematic diagram of the structure of the plate-taking frame mechanism in the plate-taking and engaging state.

[0083] Figure 20 for Figure 4 Exploded diagram of the plate removal mechanism.

[0084] Figure 21 for Figure 4 Schematic diagram of the detection module in .

[0085] Figure 22 for Figure 4Exploded diagram of the detection module in .

[0086] Figure 23 for Figure 4 Schematic diagram of the structure of the slat transfer assembly.

[0087] Figure 24 for Figure 4 Schematic diagram of the structure of the slat plug-in.

[0088] Figure 25 for Figure 4 Schematic diagram of the structure of the slat transfer channel.

[0089] Figure 26 for Figure 4 Schematic diagram of the structure of the sample rack module.

[0090] Figure 27 for Figure 4 Exploded view of the sample rack module in Figure 1 with the sample rack base plate removed.

[0091] Figure 28 for Figure 4 Exploded view of the reverse side of the sample rack module with the sample rack base removed.

[0092] In the drawings, like parts are given like reference numerals, but the drawings are not necessarily drawn to scale. DETAILED DESCRIPTION

[0093] The present invention will be further described below with reference to the accompanying drawings.

[0094] 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 .

[0095] like Figure 1 As shown, the control method of the immunoassay device of this embodiment mainly includes the following steps:

[0096] S1, control the plate rack module and the moving mechanism to load the blank strips onto the rotating device;

[0097] 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.

[0098] 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.

[0099] In a preferred embodiment, the solution containing the sample to be tested may include a diluent or other sample in addition to the sample to be tested, that is, the sample to be tested and the diluent or other sample may be mixed in advance to form the above solution.

[0100] In a preferred embodiment, the reaction reagents are not limited to one or more of the first reagent R1, the second reagent R2, and the third reagent R3. Step S1 includes: first, controlling the plate retrieval mechanism in the plate retrieval module to remove a plate rack carrying a blank slat from a stack in the plate retrieval module; second, controlling the first pushing mechanism in the moving mechanism to move the blank slat on the removed plate rack in a first predetermined direction, thereby moving the blank slat onto the rotating device.

[0101] In a preferred embodiment, step S1, in addition to controlling the plate retrieval mechanism to take out the plate rack carrying the blank slats from the stack, and controlling the first pushing mechanism to move the blank slats onto the rotating device, may also include: controlling the plate retrieval mechanism and the plate rack transmission mechanism in the plate retrieval module to make the plate retrieval mechanism take out a layer of plate rack from the top of the stack, and the stack rises to a height between adjacent plates driven by the plate rack transmission mechanism.

[0102] The rotating device is a turntable, the top surface of which is divided into multiple test zones arranged in sequence. Each test zone completes a batch of tests when it moves to a designated location. Each test zone is further divided into multiple sample zones, each of which can hold the same or different solutions containing the sample to be tested.

[0103] 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 .

[0104] Figures 4 to 28 FIG. 2 shows a schematic structural diagram of an immunoassay device according to an embodiment of the present invention. Figure 4 As shown, the immunoassay device includes a frame 2, a slat 3 for detection, and a plate retrieval rack module 83, 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 retrieval rack module 83 is located at the front of the frame 2, the turntable is located behind the plate retrieval rack module 83, the incubation module 87 is located on one side of the turntable, the sample rack module 86 and the reagent module 5 are located on both sides of the plate retrieval rack module 83, respectively. The pushing device 84 includes an X-direction pushing mechanism 6 and a Y-direction pushing mechanism 7. The slats on the plate rack module 83 are pushed onto 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 loading arm module. 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. The incubation plate 8 is slidably connected to the frame 2 through the first sliding mechanism, and a slat clamping device 90 is provided on the incubation plate 8.

[0105] 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, and the first motor 9 is connected to the incubation plate 8 through a first synchronous belt 11. When the first motor 9 rotates, it drives the incubation plate 8 to slide along the first slide rail 10. Incubation is carried out separately on the two incubation plates 8, which can achieve different incubation times respectively, and the speed of rotation of the first motor 9 can determine the speed of the back-and-forth movement of the incubation plate 8, thereby realizing different degrees of oscillating and mixing, and the operation is more flexible and changeable.

[0106] In this embodiment, the strip clamping device 90 includes a clamping bottom plate 89, a vertical plate 12 and a strip pressing piece 13. A spring piece slot 14 is provided on the vertical plate 12, and a strip spring piece 15 is arranged in the spring piece slot 14. The outer side surface of the strip spring piece 15 protrudes from the vertical side wall of the vertical plate 12. The strip pressing piece 13 is fixed on the upper end surface of the vertical plate 12 and presses the strip spring piece 15 in the vertical direction. The strip 3 is arranged between two adjacent vertical plates 12 and is pressed in the horizontal direction by the strip spring piece 15. The strip clamping device 90 can clamp the strip 3 in both the horizontal direction and the vertical direction. The strip spring piece 15 can clamp the strip 3 horizontally, and the strip pressing piece 13 can press the strip 3 in the vertical direction, thereby making the strip 3 more stable during the movement process.

[0107] In this embodiment, the turntable module 85 includes a turntable base 16, a turntable body assembly, a rotating shaft assembly 17, a turntable motor 18 and an induction assembly. The turntable base 16 is fixed on the frame 2. The turntable body assembly includes a turntable 19, a first gear 20 and a gear pressing piece 21. Four strip clamping devices 90 that are symmetrically arranged on the same circumference are provided on the upper surface of the turntable 19. The rotating shaft assembly 17 passes through the gear pressing pieces 21 and the first gear 20 from bottom to top, and the upper part of the rotating shaft assembly 17 is fixed on the lower surface of the turntable 19. A second gear 22 is provided at the output end of the turntable motor 18, and the second gear 22 meshes with the first gear 20. Each time the turntable 19 rotates 90 degrees, operations such as sample addition, diluent addition, and reaction reagent addition are realized respectively. And a plurality of strip clamping devices 90 are arranged on the turntable 19, and multiple strips 3 can be placed at one station, thereby improving the detection efficiency.

[0108] In this embodiment, the sensing assembly includes a turntable zero-position sensor 23 and a turntable working-position sensor 24. A convex column 25 is provided on the lower surface of the turntable 19 below the strip clamping device 90. The convex column 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 convex column 25 intermittently passes by 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 rotations of the turntable 19 in real time, and then convert it into working positions.

[0109] In this embodiment, the plate taking and rack module 83 includes a plate rack 26 for placing strips, a stack 27, a plate taking and rack mechanism, and a plate rack transmission mechanism. The plate taking and rack mechanism is fixed to the stack 27 through a fixing plate 28; the plate taking and rack mechanism includes a first plate taking support plate 29, a second plate taking support plate 30 and a second sliding mechanism. The first plate taking support plate 29 is slidably connected to the second sliding mechanism through a plate taking connecting plate 31. A rectangular opening 32 is provided on the first plate taking support plate 29. The second plate taking support plate 30 is horizontally slidably arranged at the rectangular opening 32 through a screw 33. A spring 34 is provided between the first plate taking support plate 29 and the second plate taking support plate 30. An arc-shaped convex block 35 is provided on the outer side of the second plate taking support plate 30. The convex block 35 extends outwards 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 each inner side of the two support ribs 36. An arc-shaped depression 38 is provided on the clamping rib 37 on one side of the convex block 35. When the first plate taking support plate 29 and the second plate taking support plate 30 enter the stack 27 and extend below the uppermost 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 convex block 35 falls into the depression 38. The plate taking and rack module 83 smoothly takes out the plate rack 26 from the stack 27 by the way that the elastic convex block 35 clamps the clamping rib 37. When all the strips 3 are transferred to the turntable 19, the plate rack 26 automatically falls into the collection box and can be used continuously next time.

[0110] In this embodiment, the plate rack transmission mechanism includes a lifting motor 39, a plate support 40, a screw rod 41, and two guide rods 42. The two guide rods 42 and the screw rod 41 are arranged vertically and parallel to each other on one side of the stack 27. A lifting slider 43 is sleeved on the two guide rods 42 and the screw rod 41. The plate support 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 stacked on the plate support 40. The stacked plate racks 26 are located inside the stack 27. The lower end of the screw rod 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. After the uppermost plate rack 26 is taken out, all the plate racks 26 are lifted by one position through the plate rack transmission mechanism, so that a column of plate racks 26 is taken out in sequence, and then a column of plate racks 26 can be manually loaded in.

[0111] In this embodiment, the second sliding mechanism includes a second motor 44 and a second slide rail 45. The plate taking connection plate 31 is arranged on the second slide rail 45 and slides along the second slide rail 45. The second motor 44 is connected to the plate taking connection plate 31 through a second synchronous belt 46. When the second motor 44 rotates, it drives the plate taking connection plate 31 to slide along the second slide rail 45. The second sliding mechanism can enable the plate taking rack mechanism to move left and right, so as to take out the plate rack 26 from the stack 27.

[0112] In this embodiment, the detection module 88 includes an optical path component 47, a slat transfer component, a detection bottom plate 48, and a third sliding mechanism. A slat dropping groove 49 is provided on the detection bottom plate 48. The slat transfer component is movably arranged on the upper surface of the detection bottom plate 48. The optical path component 47 is arranged on the upper surface of the detection bottom plate 48 through a slat transfer channel 50. When detection is carried out, the slat 3 on the slat transfer component is located directly below the optical path component.

[0113] In this embodiment, the strip transfer assembly includes a sliding block 51, a strip plug-in 52, and a DC motor 53. A guide rail 54 is provided on the upper surface of the sliding block 51. The strip plug-in 52 is arranged on the guide rail 54. The DC motor 53 is arranged on the sliding block 51, and a third gear 55 is provided at the output end. A rack 56 is provided on the strip plug-in 52. The third gear 55 and the rack 56 mesh with each other. When the DC motor 53 rotates, it drives the strip plug-in 52 to slide along the guide rail 54. A plurality of parallel inserts 57 are provided on the side of the strip plug-in 52 close to the optical path assembly 47. The strip 3 is placed on the inserts 57. The strip 3 to be detected enters the detection module 88 from one side of the strip transfer channel 50. At this time, the strip plug-in 52 moves towards the strip transfer channel 50, and the inserts 57 are inserted into the strip 3 from the side. At this time, the strip plug-in 52 can move the strip 3 left and right or back and forth. The strip plug-in 52 moves the strip 3 to directly below the optical path assembly 47 for detection. After the detection is completed, the DC motor 53 rotates and drives the strip plug-in 52 to move away from the strip transfer channel 50. When the strip 3 moves directly above the strip dropping slot 49, the strip 3 stops moving due to being blocked by the sliding block 51. Then the strip plug-in 52 continues to move away from the strip transfer channel 50, and then the strip plug-in 52 disengages from the strip 3. At this time, the strip 3 drops downward from the strip dropping slot 49.

[0114] In this embodiment, the third sliding mechanism includes a third motor 58 and a third sliding rail 59. The sliding block 51 is arranged on the third sliding rail 59 and slides along the third sliding rail 59. The third motor 58 is connected to the sliding block 51 through a third synchronous belt 60. When the third motor 58 rotates, it drives the sliding block 51 to slide along the third sliding rail 59. The third sliding mechanism enables the strip transfer assembly to move left and right.

[0115] 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. A plurality of test tube insertion holes 64 are provided on the test tube rack 62. Test tube clamping pieces 65 are provided in the test tube insertion holes 64. The test tubes 82 for loading samples are inserted into the test tube clamping pieces 65. A plurality of groups of guide blocks 66 are provided on the sample rack bottom plate 61. A guide groove 67 is provided on the bottom surface of the test tube rack adapter 63. 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 such a structure is convenient for users to operate, and the test tubes 82 for placing samples are relatively stable.

[0116] In this embodiment, one and two magnetic steels 68 are respectively provided on the front end and the lower surface of the test tube rack adapter 63. The three magnetic steels 68 are all recessed into the test tube rack adapter 63. The magnetic steels 68 can play a role in adsorbing the sample rack bottom plate 61, thereby making the test tube rack adapter 63 more stable.

[0117] In this embodiment, the pushing device 84 further includes a push rod bottom 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 respectively slidably connected to the push rod bottom plate 69 through a fourth sliding mechanism and a fifth sliding mechanism. Both the X-direction pushing mechanism 6 and the Y-direction pushing mechanism 7 include a push rod 70, a push rod motor 71, and a push rod arm 72. A push rod slide rail 73 is horizontally arranged on the push rod arm 72. The push rod 70 is slidably arranged on the push rod slide rail 73 and is connected to the push rod motor 71 through a push rod synchronous belt 74.

[0118] 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. When the fourth motor 75 rotates, it drives the push rod arm 72 to slide along the fourth slide rail 76. The fifth sliding mechanism has the same structure as the fourth sliding mechanism.

[0119] In this embodiment, the fully automatic chemiluminescence immunoassay analyzer further includes a universal liquid module 78, a liquid path 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 perform the operation of adding liquid during the detection process through the liquid path module 79.

[0120] In this embodiment, a washing needle pool 81 is respectively arranged on one side of the sample rack module 86 and the reagent module 5. The washing needle pool 81 can clean the sampling needle on the sampling arm module 4, and thus can be used multiple times.

[0121] Next, refer to Figures 4 to 28 The control method of the immunoassay device in this embodiment will be described in detail.

[0122] The space occupied by the turntable 19 (fixed in position and not rotating with the rotation of the turntable 19) is divided into sequentially arranged D0 area, D1 area, D2 area, and D3 area (the D0 area, D1 area, and D3 area are shown in FIG. 12, and the D2 area is not shown because it is covered by the moving mechanism). Among them, the D0 area is used to execute step S1, and the D1, D2, and D3 areas are used to execute 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 reaction reagents and unloading. Four strip clamping devices 90 are arranged on the turntable 19 to clamp the blank strip in the horizontal and vertical directions.

[0123] In this embodiment, the moving mechanism is the pushing device 84. The first pushing mechanism in the moving mechanism is the Y-direction pushing mechanism 7, the second pushing mechanism in the moving mechanism is the X-direction pushing mechanism 6, the first preset direction is the Y direction, and the second preset direction is the X direction.

[0124] 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 2, and are clamped by the slat clamping device 90 to make the slats more stable during the movement.

[0125] In the plate retrieval module 83, the plates 26 are stacked sequentially in a stack 27. Each time the plate retrieval mechanism removes a layer of plates 26 from the top of the stack 27, the plate transmission mechanism drives the stack 27 up one position, i.e., the height between adjacent plates 26. This allows the stack 27 to be manually loaded after the plates 26 in a column are removed.

[0126] 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. 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.

[0127] After the blank slat is clamped to the turntable 19 by the slat clamping device 90, specifically, the turntable 19 is controlled to rotate so that the blank slat reaches area D1; the left arm of the sample loading arm is controlled to add a solution containing the sample to be tested to the blank slat; the turntable 19 is controlled to rotate so that the slat to which the solution containing the sample to be tested has been added reaches area D2; the turntable 19 is controlled to rotate so that the slat to which the solution containing the sample to be tested has been added reaches area D3; and the right arm of the sample loading arm is controlled to add a reaction reagent to the slat to which the solution containing the sample to be tested has been added. In a preferred embodiment, step S2 may further include: when the blank slat reaches area D1, controlling the right arm of the sample loading arm to add an additional reaction reagent to the blank slat in area D1. 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 sample 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 sample loading arm is controlled to add the sample to the blank strip.

[0128] In a preferred embodiment, the solution containing the sample to be tested is further diluted before being added to the blank strip. Step S2 specifically further includes: when the blank strip reaches the D1 area, controlling the right arm of the sample adding arm to add the pre-diluent to the pre-dilution plate in the dilution and oscillation module 80; controlling the left arm of the sample adding arm to add the solution containing the sample to be tested to the pre-dilution plate in the dilution and oscillation module 80; controlling the dilution and oscillation module 80 to perform oscillation treatment on the pre-dilution plate to obtain the diluted sample; controlling the left arm of the sample adding 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.

[0129] Specifically, the sample adding process can adopt a combined sample adding method of one aspiration and multiple dispensing. For example, in the case of n items to be tested, where only 1 item requires pre-dilution, the sample adding mechanism aspirates n portions of samples, only dispenses 1 portion of the sample into the pre-dilution plate, and dispenses the other n - 1 portions of samples into the blank strip in the D1 area. After the 1 portion of the sample in the pre-dilution plate is diluted, then control the left arm of the robotic arm to add the diluted sample from the pre-dilution plate to the blank strip in the D1 area.

[0130] In a preferred embodiment, when the strip reaches the D3 area, control the right arm of the robotic arm to add one or more reaction reagents to the strip.

[0131] In a preferred embodiment, the reaction reagents added to the strip are all aqueous solutions.

[0132] In a preferred embodiment, the method further includes the step: S3, controlling the unloading mechanism to unload the strip carrying the mixture of the solution containing the sample to be tested and the reaction reagent from the rotating device. Specifically, referring to FIG. 4, after the mixture of the solution containing the sample to be tested and the reaction reagent is completed, control the unloading mechanism to unload the strip on the turntable 19 from the strip clamping device 90.

[0133] In a preferred embodiment, the method further includes the step: S4, controlling the moving mechanism to move the unloaded strip to the incubation module. Step S4 includes: controlling the second pushing mechanism in the moving mechanism to drive the strip carrying the mixture to move along the second preset direction so that the strip carrying the mixture moves to the incubation module. Specifically, referring to Figure 4 and Figure 12 , controlling the X-direction pushing mechanism 6 to drive the strip carrying the mixture to move along the X direction so that the strip carrying the mixture moves to the incubation module 87.

[0134] In a preferred embodiment, the method further includes the step of: S5. Controlling the incubation module to incubate the mixture on the unloaded strip. Step S5 includes: controlling the sliding mechanism in the incubation module to drive the unloaded strip to slide back and forth to mix the mixture on the strip; during the mixing process, controlling the incubation plate in the incubation module to incubate the mixture. Specifically, referring to Figure 4 and Figure 12 , when incubating the strip carrying the mixture, controlling the first sliding mechanism in the incubation module 87 to drive the unloaded strip to slide back and forth to mix the mixture on the strip; during the mixing process, controlling the incubation plate 8 in the incubation module 87 to incubate the mixture.

[0135] In a preferred embodiment, it further includes the step of: S6. Controlling the moving mechanism to move the strip carrying the incubated mixture to the detection module. Step S6 includes: controlling the moving arm in the moving mechanism to move the strip carrying the incubated mixture to the detection module. Specifically, referring to Figure 4 and Figures 21 - 24 , after incubation is completed, controlling the moving arm in the moving mechanism to move the strip carrying the incubated mixture to the detection module 88. When the strip carrying the incubated mixture enters the detection module 88, controlling the strip transfer component in the detection module 88 to drive the strip carrying the incubated mixture to move under the optical path component 47 in the detection module 88, and controlling the optical path component 47 to irradiate the incubated mixture with laser light.

[0136] In a preferred embodiment, the method further includes the step of: S7. Controlling the detection module to irradiate the incubated mixture with laser light and record the emitted light quantity.

[0137] Figure 2 shows the flow of a control method for a preferred immunoassay device Figure 2 . The method includes the steps of:

[0138] S1. Controlling the plate rack module and the moving mechanism to load a blank strip onto the rotating device;

[0139] S2. Controlling the rotating device and the sample adding working device to act to add a solution containing the sample to be tested and a reaction reagent onto the blank strip;

[0140] S3. Controlling the unloading mechanism to unload the strip carrying the mixture of the solution containing the sample to be tested and the reaction reagent from the rotating device;

[0141] S4. Controlling the moving mechanism to move the unloaded strip to the incubation module;

[0142] S5, controlling the incubation module to incubate the mixed solution on the unloaded slats;

[0143] S6, controlling the moving mechanism to move the slat carrying the incubated mixed solution to the detection module;

[0144] S7, controlling the detection module to perform laser irradiation on the incubated mixed solution and record the amount of emitted light.

[0145] 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.

[0146] In a preferred embodiment, the specific process is as follows: Figure 3 The mixed solution on the unloaded slats is incubated twice using multiple incubation modules 87, and the presence of a high-dose hook effect is determined. The first incubation module is controlled to perform the first incubation on the mixed solution. The slat carrying the mixed solution after the first incubation is moved to the detection module. The detection module is controlled to perform the first laser irradiation on the mixed solution after the first incubation and record the amount of emitted light. The slat carrying the mixed solution after the first reading is moved to the second incubation module. The second incubation module is controlled to perform the second incubation on the mixed solution after the first reading. The slat carrying the mixed solution after the second incubation is moved to the detection module. The detection module is controlled 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, the right arm of the sample loading arm is controlled to draw universal solution from the universal solution module 78 and add it to the incubating mixed solution.

[0147] The control processor determines whether a high-dose hook effect exists based on the emission light amounts recorded after the two incubations. The control processor determines whether a high-dose hook effect exists based on the emission light amounts recorded after the two incubations, including: calculating the difference between the emission light amounts recorded after the first incubation and the emission light amounts recorded after the second incubation; determining whether the difference is greater than a preset threshold; if the difference is greater than the preset threshold, determining that a high-dose hook effect exists; otherwise, if the difference is less than or equal to the preset threshold, determining that a high-dose hook effect does not exist. The preset threshold is the maximum value of a standard curve, which 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 a high-dose hook effect exists. In a preferred embodiment, if the processor determines that a high-dose hook effect exists in the immunoassay, it controls the dilution and oscillation module 80 to dilute the current mixed solution until the high-dose hook effect no longer exists.

[0148] The following is a test process that uses only two reagents, the first reagent R1 and the second reagent R2, without pre-dilution:

[0149] 1) Assume that eight blank strips are pushed into the turntable 19 from the plate rack module 83 each time.

[0150] 2) The blank strip rotates from position D0 to position D1.

[0151] 3) Control the left arm of the pipetting arm to aspirate a sample (or calibrator, reference, quality control product, etc.) from the sample rack module 86 and dispense it into the strip at position D1. For sample dispensing, one aspiration and eight dispensations are used. After dispensing is completed, move the left arm of the pipetting arm to the first needle washing pool for cleaning.

[0152] 4) After pipetting is completed, the strip rotates from position D1 to position D2, where no action is taken, and then the strip rotates from position D2 to position D3.

[0153] 5) Control the right arm of the pipetting arm to aspirate the reaction reagent from the reagent module 5 and dispense it into the strip at position D3. For reaction reagent dispensing, one aspiration and eight dispensations are used. At this position, after dispensing the first reagent R1, move the right arm of the pipetting arm to the second needle washing pool for cleaning. After cleaning, immediately dispense the first reagent R2. After dispensing is completed, move the right arm of the pipetting arm to the second needle washing pool for cleaning again.

[0154] 6) The strip is pushed into the first incubation module by the X-direction pushing mechanism 6 from position D3 for the first step of incubation.

[0155] 7) During the incubation process, control the right arm of the pipetting arm to aspirate the general solution from the general solution module 78 and add it to the mixed solution undergoing incubation.

[0156] 8) Move the strip carrying the mixed solution after the first step of incubation to the detection module 88, and perform the first laser irradiation on the mixed solution after the first step of incubation and record the emitted light quantity.

[0157] 9) Move the mixed solution to the second incubation module again, and control the second incubation module to perform the second step of incubation on the mixed solution.

[0158] 10) Move the strip carrying the mixed solution after the second step of incubation to the detection module 88, and control the detection module 88 to perform the second laser irradiation on the mixed solution after the second step of incubation and record the emitted light quantity.

[0159] 11) Based on the emitted light quantities recorded after the two steps of incubation, determine whether there is a high-dose hook effect.

[0160] The above process allocates two reaction reagents, the first reagent R1 and the second reagent R2, during the reaction reagent allocation stage. It is understandable 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 50 μl of 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. The order of allocating the first reagent R1, the second reagent R2, and the third reagent R3 is arbitrary.

[0161] It is also understandable 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 15μl sample diluent. Then 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.

[0162] 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 sample distribution, then the third reagent R3 is an additional reaction reagent. If the additional reaction reagent R3 is a pre-dilution solution, for example, HCV, 10μl sample + 100μl diluent, and then 25μl of the diluted sample is taken for testing. Specifically, after the blank strip rotates to D1, the right arm of the sample loading arm distributes the pre-dilution solution 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. The process of distributing the sample to be tested can be carried out in a one-aspirate-multiple-dispense manner. For example, if five tests are to be performed, one test ... Next, the dilution oscillation module 80 is controlled to oscillate the pre-dilution plate. After sufficient dilution, the left arm of the sample loading arm dispenses the diluted solution containing the sample to be tested into the strips of the plate, and then the turntable 19 is rotated to D2. The subsequent process is the same as when only the first reagent R1 and the second reagent R2 are used, and will not be further described here.

[0163] In a preferred embodiment, the following steps are performed for the current batch of tests and the next batch of tests to achieve parallel processing of multiple batches of tests. Specifically, control the rotation of the turntable 19 so that the blank strips of the current batch reach the D1 area; perform the sample addition action on the strips of the current batch in the D1 area. At the same time, control the plate rack module 83 and the moving mechanism to load the blank strips of the next batch onto the turntable in the D0 area; control the rotation of the turntable 19 so that the strips of the current batch reach the D2 area, and at the same time, the blank strips of the next batch reach the D1 area; perform the sample addition action on the strips of the next batch in the D1 area; control the rotation of the turntable 19 so that the strips of the current batch reach the D3 area, and at the same time, the strips of the next batch reach the D2 area; perform the reagent addition action on the current strips in the D3 area, and then unload the strips of the current batch from the turntable 19 to perform subsequent operation steps; control the rotation of the turntable 19 so that the strips of the next batch reach the D3 area; perform the reagent addition action on the strips of the next batch in the D3 area, and then unload the strips of the next batch from the turntable 19 to perform subsequent operation steps.

[0164] Compared with the prior art, the advantages of the present invention are that the present invention proposes a control method for an immunoassay device. When preparing the mixed solution by this method, each module cooperates with each other, the actions are smooth, the degree of automation is high, and the preparation efficiency is high. The above is only the preferred embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art 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 subject to the protection scope of the claims.

Claims

1. A control method for an immunoassay device, characterized in that, It includes the following steps: S1. Control the blank plate rack module and the moving mechanism to load the blank plate strip onto the rotating device; S2. Control the rotating device and the sample adding working device to act, so as to add the solution containing the sample to be tested and the reaction reagent onto the blank plate strip; S3. Control the pushing mechanism in the moving mechanism to drive the plate strip carrying the mixture of the solution containing the sample to be tested and the reaction reagent to move along the preset direction, so that the plate strip carrying the mixture moves to the incubation module, and use the incubation module to incubate the mixture on the plate strip at least twice; S4. Control the incubation module to incubate the mixture on the unloaded plate strip; S5. Control the moving mechanism to move the plate strip carrying the incubated mixture to the detection module; S6. Control the detection module to irradiate the incubated mixture with laser light and record the emitted light quantity; The control method further includes: controlling the processor to judge whether there is a high-dose hook effect according to the emitted light quantity recorded after two incubations.

2. The control method according to claim 1, wherein Step S4 includes: Controlling the sliding mechanism in the incubation module to drive the unloaded plate strip to slide back and forth to mix the mixture on the plate strip; during the mixing process, controlling the incubation plate in the incubation module to incubate the mixture.

3. The control method according to claim 1, wherein Step S5 includes: Controlling the moving arm in the moving mechanism to move the plate strip carrying the incubated mixture to the detection module.

4. The control method according to claim 1, wherein Step S6 includes: Controlling the plate strip transfer component in the detection module to drive the plate strip carrying the incubated mixture to move below the optical path component in the detection module, and controlling the optical path component to irradiate the incubated mixture with laser light.

5. The control method according to claim 1, characterized in that The incubation module includes a plurality of incubation plates arranged in parallel with each other.

6. The control method according to claim 5, wherein Using a plurality of incubation plates to incubate the mixture on the unloaded plate strip at least twice; controlling the moving mechanism to move the plate strip carrying the incubated mixture to the detection module; Controlling the detection module to irradiate the incubated mixture with laser light and record the emitted light quantity each time, including: Controlling the first incubation module to perform the first-step incubation on the mixture; Moving the plate strip carrying the mixture after the first-step incubation to the detection module; Controlling the detection module to perform the first laser irradiation on the mixture after the first-step incubation and record the emitted light quantity; Moving the plate strip carrying the mixture after the first reading to the second incubation module; Controlling the second incubation module to perform the second-step incubation on the mixture after the first reading; Moving the plate strip carrying the mixture after the second-step incubation to the detection module; Controlling the detection module to perform the second laser irradiation on the mixture after the second-step incubation and record the emitted light quantity.

7. The control method according to claim 1, characterized in that Controlling the processor to judge whether there is a high-dose hook effect according to the emitted light quantity recorded after two incubations, including: Calculating the difference between the emitted light quantity recorded after the first incubation and the emitted light quantity recorded after the second incubation; Judging whether the difference is greater than the preset threshold; In the case of judging that the difference is greater than the preset threshold, determining that there is the high-dose hook effect.

8. The control method according to claim 1, characterized in that The control method further includes sucking the universal liquid and adding it to the mixture being incubated during the incubation process.

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