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 measured and a reaction reagent onto the blank strip. When preparing the 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 reaction between antigen and antibody. Since it can use isotopes, enzymes, chemiluminescent substances, etc. to display or amplify the signal 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 the signal and directly measure the immunobinding process by means of its luminescence intensity. This method has become one of the important directions in immunological detection. However, when preparing the mixed solution in the existing immunoassay device, the cooperation of each module is not tight, the movement is not smooth, and the degree of automation is not high. Moreover, the control method of immunoassay is not closely connected, 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 provides 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 measured and a reaction reagent onto the blank plate strip.

[0007] As a further improvement of this method, 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, 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 every 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 under the drive of 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 step S1, and the remaining execution areas are used to execute 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 step S1, and the D1, D2, and D3 areas are used to execute step S2.

[0016] As a further improvement to this method, 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 the 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, 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, 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 an oscillation process 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 the D1 area.

[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 the D1 area.

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

[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: 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.

[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] 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;

[0040] During the mixing process, control the incubation plate in the incubation module to perform an incubation process on 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] Controlling the moving arm in the moving mechanism to move the strip carrying the incubated mixed solution to the detection module.

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

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

[0047] Controlling the strip transfer component in the detection module to drive the strip carrying the incubated mixed solution to move below the optical path component in the detection module, and controlling the optical path component to perform laser irradiation on the incubated mixed solution.

[0048] As a further improvement to this method, the incubation module is used to incubate the mixed solution on the strip at least twice.

[0049] As a further improvement to this method, multiple incubation modules are used to incubate the mixed solution on the unloaded strip at least twice; controlling the moving mechanism to move the strip 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 record the emitted light quantity, including:

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

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

[0052] Controlling the detection module to perform the first laser irradiation on the mixed solution after the first-step incubation and record the emitted light quantity;

[0053] Moving the strip carrying the mixed solution after the first reading to the second incubation module;

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

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

[0056] Controlling the detection module to perform the second laser irradiation on the mixed solution 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 judge whether there is a high-dose hook effect according to the emitted light quantities recorded after two incubations.

[0058] As a further improvement to this method, the control processor determines whether there is a high-dose hook effect based on the amount of emitted light recorded after two incubations, including:

[0059] Calculating the difference between the amount of emitted light recorded after the first incubation and the amount of emitted light 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 accompanying drawings. In the figures:

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

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

[0068] Figure 6 Is Figure 3 A schematic structural diagram of the middle plate clamping device.

[0069] Figure 7 Is Figure 3 An exploded view of the middle plate clamping device.

[0070] Figure 8 Is Figure 3 A schematic structural diagram of the middle plate clamping device with the plate pressing piece removed.

[0071] Figure 9 Is Figure 3Schematic diagram of the turntable module in

[0072] Figure 10 is Figure 3 Exploded view of the turntable module in

[0073] Figure 11 is Figure 3 Exploded view of the turntable component in

[0074] Figure 12 is Figure 3 Top view of the pushing device in

[0075] Figure 13 is Figure 3 Schematic diagram of the structure of the pushing device in

[0076] Figure 14 is Figure 3 Schematic diagram of the working state of the Y-direction pushing mechanism in

[0077] Figure 15 is Figure 3 Schematic diagram of the working state of the X-direction pushing mechanism in

[0078] Figure 16 is Figure 3 Schematic diagram of the structure of the plate-taking frame module in

[0079] Figure 17 is Figure 3 Exploded view of the plate-taking frame module in

[0080] Figure 18 is Figure 3 Schematic diagram of the structure of the plate-taking separation state of the plate-taking frame mechanism in

[0081] Figure 19 is Figure 3 Schematic diagram of the structure of the plate-taking clamping state of the plate-taking frame mechanism in

[0082] Figure 20 is Figure 3 Exploded view of the plate-taking frame mechanism in

[0083] Figure 21 is Figure 3 Schematic diagram of the structure of the detection module in

[0084] Figure 22 is Figure 3 Exploded view of the detection module in

[0085] Figure 23 is Figure 3 Schematic diagram of the structure of the slat transfer component in

[0086] Figure 24 isFigure 3 Schematic diagram of the structure of the slat insert in

[0087] Figure 25 is Figure 3 Schematic diagram of the structure of the slat transfer channel in

[0088] Figure 26 is Figure 3 Schematic diagram of the structure of the sample rack module in

[0089] Figure 27 is Figure 3 Exploded view of the front side of the sample rack bottom plate removed from the sample rack module in

[0090] Figure 28 is Figure 3 Exploded view of the back side of the sample rack bottom plate removed from the sample rack module in

[0091] In the drawings, like parts are denoted by like reference numerals. The drawings are not drawn to actual scale. Detailed implementation manners

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

[0093] Figure 1 shows the flow of a control method for an immunoassay device according to an embodiment of the present invention Figure 1 .

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

[0095] S1. Control the plate rack module and the moving mechanism to load a blank slat onto the rotating device;

[0096] S2. Control the rotating device and the sample adding working device to act to add a solution containing the sample to be measured and a reaction reagent onto the blank slat.

[0097] When preparing the mixture by this method, each module cooperates with each other, the action is smooth, the automation degree is high, and the preparation efficiency is high.

[0098] In a preferred embodiment, the solution containing the sample to be measured may further include a diluent or other samples in addition to the sample to be measured. That is, the sample to be measured can be pre-mixed with the diluent or other samples to form the above solution.

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

[0100] In a preferred embodiment, in addition to including controlling the plate rack mechanism to take out the plate rack carrying the blank plate strips from the stack and controlling the first pushing mechanism to move the blank plate strips onto the rotation device, step S1 may further include: controlling 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 racks from above the stack, the stack rises by the height between adjacent plate racks under the drive of the plate rack transmission mechanism.

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

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

[0103] Figures 4 to 28 Shows a schematic structural diagram of an immunoassay device according to an embodiment of the present invention. As Figure 4 shown, the immunoassay device includes a frame 2, a plate strip 3 for detection, and a plate rack module 83, a pushing device 84, a sample adding 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 provided on the frame 2. The plate rack module 83 is provided at the front of the frame 2, the turntable is provided behind the plate rack module 83, the incubation module 87 is provided on 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. The pushing device 84 includes an X-direction pushing mechanism 6 and a Y-direction pushing mechanism 7. The plate strips on the plate rack module 83 are pushed onto the turntable by the Y-direction pushing mechanism 7, and samples and reaction reagents are added into the reaction cups on the plate strips 3 located on the turntable through the sample adding arm module. The plate strips 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 plate strip 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, 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 can be carried out separately on the two incubation plates 8, which can achieve different incubation times respectively. Moreover, 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 variable.

[0105] 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 and vertical directions. 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.

[0106] In this embodiment, the turntable module 85 includes a turntable base 16, a turntable 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 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. Moreover, 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.

[0107] In this embodiment, the induction 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 is located on the same circumference as the turntable zero position sensor 23 and the turntable working position sensor 24. When the turntable 19 rotates, the lower end of the convex column 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 rotations of the turntable 19 in real time, and then convert it into working positions.

[0108] In this embodiment, the board rack module 83 includes a board rack 26 for placing slats, a stack 27, a board rack taking mechanism, and a board rack transmission mechanism. The board rack taking mechanism is fixed to the stack 27 through a fixing plate 28; the board rack taking mechanism includes a first board taking support plate 29, a second board taking support plate 30, and a second sliding mechanism. The first board taking support plate 29 is slidably connected to the second sliding mechanism through a board taking connecting plate 31. A rectangular opening 32 is provided on the first board taking support plate 29. The second board 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 board taking support plate 29 and the second board taking support plate 30. An arc-shaped convex block 35 is provided on the outer side of the second board taking support plate 30, and the convex block 35 extends outward beyond the outer edge of the first board taking support plate 29; two support ribs 36 are provided on the lower surface of the board 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 the side of the convex block 35. When the first board taking support plate 29 and the second board taking support plate 30 enter the stack 27 and extend below the uppermost board rack 26, the first board taking support plate 29 and the second board taking support plate 30 are located between the two clamping ribs 37, and the convex block 35 falls into the depression 38. The board rack module 83 smoothly takes out the board rack 26 from the stack 27 by the elastic convex block 35 clamping the clamping rib 37. When all the slats 3 are transferred to the turntable 19, the board rack 26 automatically falls into the collection box and can be used continuously next time.

[0109] In this embodiment, the board rack transmission mechanism includes a lifting motor 39, a board 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 penetrated through the two guide rods 42 and the screw rod 41. The board support 40 is fixed to the lifting slider 43 and extends into the stack 27. The board racks 26 on which the slats 3 are placed are longitudinally stacked on the board support 40, and the stacked board 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 board racks 26 are stacked in the stack 27 in sequence. After the uppermost board rack 26 is taken out, all the board racks 26 are lifted by one position through the board rack transmission mechanism, so that a column of board racks 26 is taken out in sequence, and then a column of board racks 26 can be manually loaded.

[0110] In this embodiment, the second sliding mechanism includes a second motor 44 and a second slide rail 45. The board taking connecting 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 board taking connecting plate 31 through a second synchronous belt 46. The second motor 44 rotates to drive the board taking connecting plate 31 to slide along the second slide rail 45. The second sliding mechanism can enable the board rack taking mechanism to move left and right, so as to take out the board rack 26 from the stack 27.

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

[0112] In this embodiment, the strip transfer component 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 are meshed 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 one side of the strip plug-in 52 close to the optical path component 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 be directly below the optical path component 47 for detection. After the detection is completed, the DC motor 53 rotates to drive the strip plug-in 52 to move away from the strip transfer channel 50. When the strip 3 moves directly above the strip dropping groove 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 groove 49.

[0113] In this embodiment, the third sliding mechanism includes a third motor 58 and a third slide rail 59. The sliding block 51 is arranged on the third slide rail 59 and slides along the third slide 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 slide rail 59. The third sliding mechanism enables the strip transfer component to move left and right.

[0114] In this embodiment, the sample rack module 86 includes a sample rack base plate 61, a test tube rack 62, and a test tube rack adapter 63. A number of test tube insertion holes 64 are provided on the test tube rack 62, and 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 number of groups of guide blocks 66 are provided on the sample rack base plate 61, and 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 base 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.

[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 all three magnets 68 are recessed into the test tube rack adapter 63. The magnets 68 can play a role in adsorbing the sample rack base plate 61, thereby making the test tube rack adapter 63 more stable.

[0116] In this embodiment, the pushing device 84 further 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 respectively slidably connected to the push rod base 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 provided 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.

[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. 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.

[0118] In this embodiment, the fully automatic photochemiluminescence immunoassay analyzer further includes a general 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 general 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.

[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 sampling needles on the sampling arm module 4, and thus can be used repeatedly.

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

[0121] 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 as shown in Figure 12 shown, 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 the reaction reagent and unloading. Four strip clamping devices 90 are provided on the turntable 19 to clamp the blank strip in the horizontal and vertical directions.

[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 starting the detection program, the plate taking mechanism in the plate taking module 83 first takes out the plate rack 26 carrying the blank strip from the stack 27 in the plate taking module 83, and then controls the Y-direction pushing mechanism 7 to drive the blank strip on the plate rack 26 to move in the Y direction, so that the blank strip moves to the position corresponding to the D0 area of the turntable 2, and is clamped by the strip clamping device 90 to make the strip more stable during the movement.

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

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

[0126] After clamping the blank strip on the turntable 19 by the strip clamping device 90, specifically, control the turntable 19 to rotate so that the blank strip reaches the D1 area; control the left arm of the sample adding arm to add the solution containing the sample to be tested to the blank strip; control the turntable 19 to rotate so that the strip added with the solution containing the sample to be tested reaches the D2 area; control the turntable 19 to rotate so that the strip added with the solution containing the sample to be tested reaches the D3 area; control the right arm of the sample adding arm to add the reaction reagent to the strip added with the solution containing the sample to be tested. In a preferred embodiment, step S2 may further include: when the blank strip reaches the D1 area, control the right arm of the sample adding arm to add the additional reaction reagent to the blank strip 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, the additional reaction reagent needs to be added before sample distribution. Specifically, when the blank strip reaches the D1 area, control the right arm of the sample adding arm to add this additional reaction reagent into the blank strip in the D1 area, and then control the left arm of the sample adding arm to add the sample into this blank strip.

[0127] In a preferred embodiment, the solution containing the sample to be tested has also been diluted before being added to the blank strip. Step S2 specifically further includes: when the blank strip reaches the D1 area, control the right arm of the sample adding arm to add the pre-diluent to the pre-dilution plate in the dilution oscillation module 80; control 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 oscillation module 80; control the dilution oscillation module 80 to perform oscillation treatment on the pre-dilution plate to obtain the diluted sample; control 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.

[0128] Specifically, the sample adding process can adopt a combined sample adding method of one suction and multiple distributions. For example, in the case of n items to be tested, where only 1 item needs pre-dilution, the sample adding mechanism sucks n portions of samples, only distributes 1 portion of the sample into the pre-dilution plate, and distributes the other n - 1 portions of samples into the blank strips 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 this pre-dilution plate to the blank strip in the D1 area.

[0129] 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.

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

[0131] In a preferred embodiment, the method further includes the step: 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. Specifically, refer toFigure 4 After completing the mixing of the solution containing the sample to be tested and the reaction reagent, control the unloading mechanism to unload the strip on the turntable 19 from the strip clamping device 90.

[0132] 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 mixed solution to move along the second preset direction, so that the strip carrying the mixed solution moves to the incubation module. Specifically, refer to Figure 4 and Figure 12 , controlling the X-direction pushing mechanism 6 to drive the strip carrying the mixed solution to move along the X direction, so that the strip carrying the mixed solution moves to the incubation module 87.

[0133] In a preferred embodiment, the method further includes the step: S5, controlling the incubation module to incubate the mixed solution 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 mixed solution on the strip; controlling the incubation plate in the incubation module to incubate the mixed solution during the mixing process. Specifically, refer to Figure 4 and Figure 12 , when incubating the strip carrying the mixed solution, controlling the first sliding mechanism in the incubation module 87 to drive the unloaded strip to slide back and forth to mix the mixed solution on the strip; controlling the incubation plate 8 in the incubation module 87 to incubate the mixed solution during the mixing process.

[0134] In a preferred embodiment, it further includes the step: S6, controlling the moving mechanism to move the strip carrying the incubated mixed solution to the detection module. Step S6 includes: controlling the moving arm in the moving mechanism to move the strip carrying the incubated mixed solution to the detection module. Specifically, refer 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 mixed solution to the detection module 88. When the strip carrying the incubated mixed solution enters the detection module 88, controlling the strip transfer component in the detection module 88 to drive the strip carrying the incubated mixed solution to move below the optical path component 47 in the detection module 88, and controlling the optical path component 47 to irradiate the incubated mixed solution with laser light.

[0135] In a preferred embodiment, the method further includes the step: S7, controlling the detection module to irradiate the incubated mixed solution with laser light and record the emitted light quantity.

[0136] Figure 2 shows the flow of a control method for a preferred immunoassay device Figure 2 . The method includes the steps:

[0137] S1. Control the blank plate rack module and the moving mechanism to load the blank plate strip onto the rotating device;

[0138] S2. Control the rotating device and the sampling working device to act to add a solution containing the sample to be tested and a reaction reagent to the blank plate strip;

[0139] S3. Control the unloading mechanism to unload the plate strip carrying the mixture of the solution containing the sample to be tested and the reaction reagent from the rotating device;

[0140] S4. Control the moving mechanism to move the unloaded plate strip to the incubation module;

[0141] S5. Control the incubation module to incubate the mixture on the unloaded plate strip;

[0142] S6. Control the moving mechanism to move the plate strip carrying the incubated mixture to the detection module;

[0143] S7. Control the detection module to perform laser irradiation on the incubated mixture and record the emitted light quantity.

[0144] Each step of the immunoassay performed by this method is closely coordinated, simple and smooth, with not only high detection efficiency but also high detection accuracy.

[0145] In a preferred embodiment, for the specific process, refer to Figure 3 , use multiple incubation modules 87 to incubate the mixture on the unloaded plate strip twice and determine whether there is a high-dose hook effect in the detection. First, control the first incubation module to perform the first-step incubation on the mixture; move the plate strip carrying the mixture after the first-step incubation to the detection module; control the detection module to perform the first laser irradiation on the mixture after the first-step incubation and record the emitted light quantity; move the plate strip carrying the mixture after the first reading to the second incubation module; control the second incubation module to perform the second-step incubation on the mixture after the first reading; move the plate strip carrying the mixture after the second-step incubation to the detection module; control the detection module to perform the second laser irradiation on the mixture after the second-step incubation and record the emitted light quantity. During the first-step incubation, control the right arm of the sampling arm to suck the general solution from the general solution module 78 and add it to the mixture being incubated.

[0146] The control processor determines whether there is a high-dose hook effect based on the amount of emitted light recorded after two incubations. Among them, the control processor determines whether there is a high-dose hook effect based on the amount of emitted light recorded after two incubations, including: calculating the difference between the amount of emitted light recorded after the first incubation and the amount of emitted light recorded after the second incubation; determining whether the difference is greater than a preset threshold; in the case where it is determined that the difference is greater than the preset threshold, it is determined that there is a high-dose hook effect; otherwise, in the case where it is determined 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 test sample is a reference substance, and the concentration of the reference substance is lower than the concentration when there is a high-dose hook effect. In a preferred embodiment, when the processor determines that there is a high-dose hook effect in the immunoassay, the control dilution oscillation module 80 dilutes the current mixture until there is no high-dose hook effect.

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

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

[0149] 2) The blank strip plate rotates from the D0 position to the D1 position;

[0150] 3) Control the left arm of the sampling arm to suck the sample (or calibration product, reference product, quality control product, etc.) from the sample rack module 86 and dispense it into the strip plate at the D1 position. For sample dispensing, one suction and eight divisions are used. After dispensing is completed, move the left arm of the sampling arm to the first needle washing pool for cleaning;

[0151] 4) After sample dispensing is completed, the strip plate rotates from the D1 position to the D2 position, and there is no action at the D2 position. Then the strip plate rotates from the D2 position to the D3 position;

[0152] 5) Control the right arm of the sampling arm to suck the reaction reagent from the reagent module 5 and dispense it into the strip plate at the D3 position. For reaction reagent dispensing, one suction and eight divisions are used. At this position, after dispensing the first reagent R1, move the right arm of the sampling 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 sampling arm to the second needle washing pool for cleaning again;

[0153] 6) Push the strip plate from the D3 position into the first incubation module by the X-direction pushing mechanism 6 for the first-step incubation;

[0154] 7) During the incubation process, control the right arm of the sampling arm to suck the general solution from the general solution module 78 and add it to the mixture being incubated;

[0155] 8) Move the strip carrying the mixture after the first incubation to the detection module 88, and perform the first laser irradiation on the mixture after the first incubation and record the amount of emitted light;

[0156] 9) Move the mixture to the second incubation module again, and control the second incubation module to perform the second incubation on the mixture;

[0157] 10) Move the strip carrying the mixture after the second incubation to the detection module 88, and control the detection module 88 to perform the second laser irradiation on the mixture after the second incubation and record the amount of emitted light;

[0158] 11) Determine whether there is a high-dose hook effect according to the amount of emitted light recorded after the two incubations.

[0159] In the above process, two reaction reagents, the first reagent R1 and the second reagent R2, are dispensed in the reaction reagent dispensing stage. It can be understood that in addition to dispensing the first reagent R1 and the second reagent R2, the third reagent R3 can also be dispensed. Assume that R1, R2, and R3 are all added after the sample dispensing is completed. For example, for HBeAb, R3 is 50 μl of neutralizing e antigen. The running process is similar to the case where there are only the first reagent R1 and the second reagent R2, except that the third reagent R3 is dispensed one more time in the D3 area. The dispensing order of the first reagent R1, the second reagent R2, and the third reagent R3 is arbitrary.

[0160] Similarly, it can 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 dispensing, then this third reagent R3 is an additional reaction reagent. For example, for CA19-9, R3 is 15 μl of sample diluent. Then the additional reaction reagent R3 is dispensed at the D1 position using the right arm of the robotic arm, and then the test sample is dispensed by the left arm of the pipetting arm. The other processes are the same as the case where there are only the first reagent R1 and the second reagent R2.

[0161] Similarly, it can 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 sample dispensing, then the third reagent R3 is an additional reaction reagent. If this additional reaction reagent R3 is a pre-diluent, such as HCV, 10 μl of sample + 100 μl of diluent, and then 25 μl of the diluted sample is taken for testing. Specifically, after the blank strip is rotated to D1, the right arm of the sample addition arm dispenses the pre-diluent R3 into the pre-dilution plate in the pre-dilution and oscillation module 80, and the left arm of the sample addition arm dispenses the sample to be tested into the pre-dilution plate. Among them, the process of dispensing the sample to be tested can be in the way of one aspiration and multiple dispensing. For example, when doing five items, one item needs pre-dilution and the other four items do not need pre-dilution, then the left arm of the robotic arm aspirates five portions of the sample to be tested, one portion is dispensed into the pre-dilution plate in the left arm of the sample addition arm, and the other four portions are dispensed into the blank strips in the D1 area. After that, the control dilutes and oscillates the pre-dilution plate in the pre-dilution and oscillation module 80. After sufficient dilution, the left arm of the sample addition arm dispenses the diluted solution containing the sample to be tested into the strip, and then rotates the turntable 19 to D2. The subsequent process is the same as the case where there are only the first reagent R1 and the second reagent R2, and will not be elaborated here.

[0162] In a preferred embodiment, for the current batch of tests and the next batch of tests, the following steps are performed to achieve parallel processing of multiple batches of tests. Specifically, control the rotation of the turntable 19 to make the blank strips of the current batch reach the D1 area; perform the action of adding samples to 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 to make 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 action of adding samples to the strips of the next batch in the D1 area; control the rotation of the turntable 19 to make the strips of the current batch reach the D3 area, and at the same time, make the strips of the next batch reach the D2 area; perform the action of adding reagents to 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 to make the strips of the next batch reach the D3 area; perform the action of adding reagents to 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.

[0163] 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 description 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 should 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 plate fetching rack module and the Y-direction pushing mechanism in 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 to add a solution containing the sample to be tested and reaction reagents onto the blank plate strip; S3. Control the X-direction pushing mechanism in the moving mechanism to drive the plate strip carrying the mixture of the solution containing the sample to be tested and reaction reagents to move along a preset direction, so that the plate strip carrying the mixture moves to the incubation module; Wherein, the rotating device is a turntable, and its upper surface is divided into a plurality of test areas arranged in sequence. When each test area moves to a specified position point with the turntable, one batch of tests is completed; 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; Step S2 includes: Control the turntable to rotate so that the blank plate strip reaches the D1 area; Control the sample adding mechanism in the sample adding working device to add the solution containing the sample to be tested to the blank plate strip; Control the turntable to rotate so that the plate strip added with the solution containing the sample to be tested reaches the D2 area; Control the turntable to rotate so that the plate strip added with the solution containing the sample to be tested reaches the D3 area; Control the reagent adding mechanism in the sample adding working device to add reaction reagents to the plate strip added with the solution containing the sample to be tested.

2. The control method according to claim 1, wherein Step S2 further includes: When the blank plate strip reaches the D1 area, control the reagent adding mechanism to add additional reaction reagents to the blank plate strip in the D1 area.

3. The control method according to claim 2, characterized in that, Step S2 further includes: When the blank plate strip reaches the D1 area, control the reagent adding mechanism to add the pre-diluted solution into the pre-dilution plate in the dilution oscillation module; Control the sample adding mechanism to add the solution containing the sample to be tested into the pre-dilution plate in the dilution oscillation module; Control the dilution oscillation module to perform an oscillation process on the pre-dilution plate to obtain a diluted sample; Control the sample adding mechanism to add the diluted sample into the blank plate strip in the D1 area.

4. The control method according to claim 3, wherein Control the sample adding mechanism to add the diluted sample into a partial sample area of the blank plate strip in the D1 area.

5. The control method according to claim 1, characterized in that The immunoassay device is provided with a needle washing pool, and the needle washing pool cleans the sample adding mechanism or the reagent adding mechanism of the sample adding working device.

6. The control method according to claim 5, characterized in that A needle washing pool is respectively set for the sample adding mechanism and the reagent adding mechanism of the sample adding working device.

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