CN115015565A

CN115015565A - Control method of immunoassay device

Info

Publication number: CN115015565A
Application number: CN202210280870.3A
Authority: CN
Inventors: 张晶鑫; 刘贵东; 吴栋杨; 刘宇卉; 李临
Original assignee: Chemclin Diagnostics Corp
Current assignee: Chemclin Diagnostics Corp
Priority date: 2017-03-28
Filing date: 2018-02-06
Publication date: 2022-09-06
Also published as: CN114839389A; CN106980024A; CN114705875A; CN108663530B; CN114705876A; CN115728499A; CN108663530A; CN108663529B; CN108663529A; CN114675043A

Abstract

The invention discloses a control method of an immunoassay device, which comprises the steps of loading a blank plate strip on a rotating device, and adding a solution containing a sample to be detected and a reaction reagent on the blank plate strip. When the mixed liquid is prepared by the method, all the modules are mutually matched, the action is smooth, the automation degree is high, and the preparation efficiency is high.

Description

Control method of immunoassay device

Technical Field

The invention relates to the technical field of chemiluminescence immunoassay, in particular to a control method of an immunoassay device.

Background

Immunological detection is based on the principle of antigen-antibody specific reaction, and is often used for detecting a trace amount of bioactive substances such as proteins and hormones because it allows display of a sample or amplification of a signal using an isotope, enzyme, chemiluminescent substance, or the like.

Chemiluminescence immunoassay is a non-radioactive immunoassay which is developed rapidly in recent years, and the principle is that a chemiluminescence substance is used for amplifying signals and an immunological binding process is directly measured by virtue of the luminous intensity, and the method is one of important directions of immunological detection. However, when the conventional immunoassay device prepares a mixed solution, the modules are not tightly matched, the action is not smooth, and the automation degree is not high. And the control method of immunoassay is not closely linked, all the parts are not smoothly matched, the detection efficiency is low, and the detection accuracy is low.

Disclosure of Invention

In view of the above-mentioned problems in the prior art, the present invention provides a method for controlling an immunoassay device, comprising the steps of:

s1, controlling the plate taking frame module and the moving mechanism to load the blank plate strip onto the rotating device;

and S2, controlling the rotation device and the sample adding working device to act so as to add the solution containing the sample to be detected and the reaction reagent on the blank strip.

As a further improvement to the method, the step S1 includes:

controlling a plate taking mechanism in the plate taking module to take the plate frame bearing blank plates out of the stack in the plate taking module;

and controlling a first pushing mechanism in the moving mechanism to drive the blank laths on the taken-out plate frame to move along a first preset direction so as to enable the blank laths to move on the rotating device.

As a further improvement to the method, the step S1 further includes:

and controlling the plate taking frame mechanism and the plate frame transmission mechanism in the plate taking frame module to act so that each layer of plate frame is taken out from the upper part of the stack by the plate taking frame mechanism, and the stack is driven by the plate frame transmission mechanism to rise by the height between adjacent plate frames.

As a further improvement of the method, the rotating device is a turntable, the upper surface of the rotating device is divided into a plurality of test areas which are sequentially arranged, and when each test area moves to a designated position along with the turntable, a batch of tests are completed.

As a further improvement of the method, each test area is subdivided into a plurality of sample areas, each of which can carry the same or different solutions containing the sample to be tested.

As a further improvement of the method, the space occupied by the turntable is divided into a plurality of execution areas arranged in sequence, wherein the first execution area is used for executing the step S1, and the rest of the execution areas are used for executing the step S2.

As a further improvement to the method, the space occupied by the turntable is divided into a D0 region, a D1 region, a D2 region and a D3 region arranged in sequence, wherein the D0 region is used for executing the step S1, and the D1, D2 and D3 regions are used for executing the step S2.

As a further improvement to the method, step S2 includes:

controlling the turntable to rotate so that the blank lath reaches the D1 area;

controlling a sample adding mechanism in the sample adding working device to add a solution containing a sample to be detected to the blank lath;

controlling the turntable to rotate so that the strip added with the solution containing the sample to be detected reaches the D2 area;

controlling the turntable to rotate so that the strip added with the solution containing the sample to be detected reaches the D3 area;

and controlling a reagent adding mechanism in the sample adding working device to add a reaction reagent into the lath added with the sample to be detected.

As a further improvement to the method, step S2 further includes:

when the blank strip reaches the D1 area, the reagent adding mechanism is controlled to add additional reagent to the blank strip in the D1 area.

As a further improvement to the method, step S2 further includes:

controlling the reagent adding mechanism to add a pre-dilution liquid into a pre-dilution plate in a dilution shaking module when the blank slat reaches the D1 area;

controlling the sample adding mechanism to add a solution containing a sample to be detected into a pre-dilution plate in the dilution oscillation module;

controlling the dilution oscillation module to perform oscillation treatment on the pre-dilution plate to obtain a diluted sample;

the sample adding mechanism is controlled to add the diluted sample into the blank lath in the D1 area.

As a further improvement to the method, the sample addition mechanism is controlled to add the diluted sample to a portion of the sample area of the blank panel in the region D1.

As a further improvement to the process, at least two reactants are added in the D3 region.

As a further improvement to the method, the method further comprises the following steps:

and S3, controlling an unloading mechanism to unload the lath carrying the mixed solution containing the solution of the sample to be tested and the reaction reagent from the rotating device.

s4, controlling the moving mechanism to move the unloaded lath to the incubation module.

As a further improvement to the method, step S4 includes: and controlling a second pushing mechanism in the moving mechanism to drive the lath bearing the mixed solution to move along a second preset direction so as to enable the lath bearing the mixed solution to move to the incubation module.

and S5, controlling the incubation module to incubate the mixed liquor on the unloaded lath.

As a further improvement to the method, step S5 includes:

controlling a sliding mechanism in the incubation module to drive the unloaded lath to slide back and forth so as to uniformly mix the mixed liquor on the lath;

controlling an incubation plate in the incubation module to perform an incubation treatment on the mixture during the mixing process.

and S6, controlling the moving mechanism to move the lath loaded with the mixed liquid after incubation to the detection module.

As a further improvement to the method, step S6 includes:

and controlling a moving arm in the moving mechanism to move the lath loaded with the mixed liquid after incubation to a detection module.

and S7, controlling the detection module to perform laser irradiation on the incubated mixed solution and recording the emission light quantity. As a further improvement to the method, step S7 includes:

and controlling a batten transfer component in the detection module to drive the batten loaded with the mixed liquid after incubation to move to the position below a light path component in the detection module, and controlling the light path component to perform laser irradiation on the mixed liquid after incubation.

As a further improvement of the method, the mixed liquor on the strip is incubated at least twice with the incubation module.

As a further improvement to the method, the mixed liquor on the unloaded staves is incubated at least twice using a plurality of incubation modules; controlling the moving mechanism to move the lath carrying the mixed solution after incubation to the detection module; controlling the detection module to perform laser irradiation on the mixed solution after each incubation and recording the emission light quantity, and the method comprises the following steps:

controlling a first incubation module to perform a first incubation step on the mixed liquor;

moving the lath loaded with the mixed solution after the first-step incubation to a detection module;

controlling the detection module to perform first laser irradiation on the mixed solution after the first-step incubation and recording the emitted light quantity;

moving the plate bearing the mixed solution after the first-step reading to a second incubation module;

controlling a second incubation module to perform a second incubation on the mixed solution after the first reading;

moving the lath carrying the mixed solution after the second incubation to a detection module;

and controlling the detection module to perform secondary laser irradiation on the mixed solution after the second incubation and recording the emission light quantity.

As a further improvement to the method, the method further comprises: the control processor determines whether a high dose-hook effect is present based on the amount of light emitted recorded after two incubations.

As a further improvement to the method, the control processor determines the presence or absence of the high dose-hook effect based on the amount of light emitted recorded after two incubations, including:

calculating the difference between the amount of light emitted recorded after the first incubation and the amount of light emitted recorded after the second incubation;

judging whether the difference value is larger than a preset threshold value or not;

determining that the high dose-hook effect is present if the difference is determined to be greater than the preset threshold.

Compared with the prior art, the method for controlling the immunoassay device has the advantages that when the mixed liquid is prepared by the method, all modules are matched with each other, the action is smooth, the automation degree is high, and the preparation efficiency is high.

Drawings

Preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings. In the figure:

FIG. 1 shows a first flowchart of a method of controlling an immunoassay device according to an embodiment of the present invention.

FIG. 2 shows a second flowchart of a method of controlling an immunoassay device according to an embodiment of the present invention.

FIG. 3 shows a flowchart III of a control method of an immunoassay device according to an embodiment of the present invention. FIG. 4 shows a schematic structural view of the front face of an immunoassay device according to an embodiment of the present invention.

FIG. 5 shows a schematic view of the structure of the back side of an immunoassay device according to an embodiment of the present invention.

Fig. 6 is a schematic view of the slat clamping device of fig. 3.

Fig. 7 is an exploded view of the slat clamping device of fig. 3.

Fig. 8 is a schematic view of the slat clamping device of fig. 3 shown with the slat pressing piece removed.

Fig. 9 is a schematic structural diagram of the turntable module in fig. 3.

Fig. 10 is an exploded view of the turntable module of fig. 3.

Fig. 11 is an exploded view of the turntable assembly of fig. 3.

Fig. 12 is a top view of the pushing device of fig. 3.

Fig. 13 is a schematic structural diagram of the pushing device in fig. 3.

Fig. 14 is a schematic structural diagram of an operating state of the Y-direction pushing mechanism in fig. 3.

Fig. 15 is a schematic structural diagram of an operating state of the X-direction pushing mechanism in fig. 3.

Fig. 16 is a schematic structural diagram of the rack fetching module in fig. 3.

Fig. 17 is an exploded view of the rack removal module of fig. 3.

Fig. 18 is a schematic structural view of the plate taking frame mechanism in fig. 3 in a plate taking and separating state.

Fig. 19 is a schematic structural view of the plate-taking engagement state of the plate-taking frame mechanism in fig. 3.

Fig. 20 is an exploded view of the pallet retrieval mechanism of fig. 3.

Fig. 21 is a schematic structural diagram of the detection module in fig. 3.

Fig. 22 is an exploded view of the detection module of fig. 3.

Fig. 23 is a schematic view of the slat transfer unit of fig. 3.

Fig. 24 is a schematic view of the slat insert of fig. 3.

Fig. 25 is a schematic view showing the structure of the slat transfer passage in fig. 3.

Fig. 26 is a schematic structural view of the sample rack module in fig. 3.

FIG. 27 is an exploded view of the sample rack module of FIG. 3 with the front face of the sample rack base removed.

Fig. 28 is an exploded view of the sample rack module of fig. 3 with the back side of the sample rack base removed.

In the drawings, like parts are provided with like reference numerals. The figures are not drawn to scale.

Detailed Description

The invention will be further explained with reference to the drawings.

As shown in fig. 1, the method for controlling an immunoassay device of the present embodiment mainly includes the steps of:

When the mixed liquid is prepared by the method, all the modules are mutually matched, the action is smooth, the automation degree is high, and the preparation efficiency is high.

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. The sample to be tested may be mixed with a diluent or other sample in advance to form the solution.

In a preferred embodiment, the reaction reagent is not limited to include one or more of the first reagent R1, the second reagent R2, and the third reagent R3. Step S1 includes: firstly, controlling a plate taking mechanism in a plate taking frame module to take a plate frame bearing blank plates out of a stack in the plate taking frame module; and secondly, controlling a first pushing mechanism in the moving mechanism to drive the blank laths on the taken-out plate frame to move along a first preset direction so as to enable the blank laths to move on the rotating device.

In a preferred embodiment, step S1 may include, in addition to controlling the rack taking mechanism to take the rack carrying the blank slats out of the stack and controlling the first pushing mechanism to move the blank slats onto the rotating device: and controlling the plate taking frame mechanism and the plate frame transmission mechanism in the plate taking frame module to act so that when one layer of plate frame is taken out from the upper part of the stack by the plate taking frame mechanism, the stack is driven by the plate frame transmission mechanism to rise by the height between adjacent plate frames.

The rotating device is a turntable, the upper surface of the rotating device is divided into a plurality of test areas which are sequentially arranged, and when each test area moves to a designated position along with the turntable, a batch of tests are completed. Each test area is divided into a plurality of sample areas, and each sample area can bear the same or different solutions containing samples to be tested.

The space occupied by the dial is divided into a plurality of execution regions arranged in sequence, wherein the first execution region is used for executing the step S1, and the rest of the execution regions are used for executing the step S2.

Fig. 4 to 28 show schematic structural views of an immunoassay device according to an embodiment of the present invention. As shown in fig. 4, the immunoassay device includes a rack 2, a strip 3 for detection, a strip taking 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, which are arranged on the rack 2, the strip taking rack module 83 is arranged at the front of the rack 2, the turntable is arranged at the rear of the strip taking rack module 83, the incubation module 87 is arranged at one side of the turntable, the sample rack module 86 and the reagent module 5 are respectively arranged at two sides of the strip taking rack module 83, the pushing device 84 includes an X-direction pushing mechanism 6 and a Y-direction pushing mechanism 7, the strip on the strip taking rack module 83 is pushed to the turntable by the Y-direction pushing mechanism 7, a sample and a reaction reagent are added to a reaction cup on the strip 3 on the turntable by the sample adding arm module, the strip on the turntable is pushed to the incubation module 87 by the X-direction pushing mechanism 6, after the incubation is finished, the incubation module 87 detects the incubation in the detection module 88, and the incubation module 87 comprises an incubation plate 8 and a first slide mechanism, the incubation plate 8 is slidably connected with the frame 2 through the first slide mechanism, and the incubation plate 8 is provided with a lath clamping device 90.

In this embodiment, the incubation module 87 includes two incubation plates 8 that are parallel to each other, and are connected with the frame 2 through a set of first slide mechanism and a slide rail 10, respectively, and first slide mechanism includes a first motor 9 and a first slide rail 10, and the incubation plate 8 is arranged on the first slide rail 10, and the first motor 9 is connected with the incubation plate 8 through a first synchronous belt 11, and the first motor 9 rotates and then drives the incubation plate 8 to slide along the first slide rail 10. The incubation is divided into two incubation plates 8 to be respectively carried out, different times of incubation can be respectively realized, and the speed of the incubation plate 8 moving back and forth can be determined by the rotation speed of the first motor 9, so that the oscillation and uniform mixing of different degrees can be realized, and the operation is more flexible and changeable.

In this embodiment, lath clamping device 90 is including pressing from both sides tight bottom plate 89, riser 12 and lath compressing blade 13, be equipped with shell fragment draw-in groove 14 on the riser 12, be equipped with lath shell fragment 15 in the shell fragment draw-in groove 14, the lateral surface of lath shell fragment 15 protrudes the vertical lateral wall of riser 12, lath compressing blade 13 is fixed in on the up end of riser 12, and compress tightly lath shell fragment 15 in vertical direction, lath 3 is located between two adjacent risers 12, and compress tightly on the horizontal direction through lath shell fragment 15. The batten clamping device 90 can clamp the batten 3 in the horizontal direction and the vertical direction at the same time, the batten elastic piece 15 can horizontally clamp the batten 3, and the batten pressing piece 13 can press the batten 3 in the vertical direction, so that the batten 3 is more stable in the moving process.

In this embodiment, the turntable module 85 includes a turntable base 16, a tray body assembly, a rotating shaft assembly 17, a turntable motor 18 and an induction assembly, the turntable base 16 is fixed on the rack 2, the tray body assembly includes a turntable 19, a first gear 20 and a gear pressing sheet 21, four lath clamping devices 90 symmetrically arranged on the same circumference are arranged on the upper surface of the turntable 19, the rotating shaft assembly 17 passes through the gear pressing sheet 21 and the first gear 20 from bottom to top, the upper portion of the rotating shaft assembly 17 is fixed on the lower surface of the turntable 19, a second gear 22 is arranged on the output end of the turntable motor 18, and the second gear 22 is meshed with the first gear 20. Carousel 19 rotates 90 degrees at every turn and has realized the application of sample respectively, has added the diluent, has added operations such as reaction reagent to set up the lath clamping device 90 of a plurality of quantity on the carousel 19, a plurality of laths 3 can be placed to a station, and then have improved detection efficiency.

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 arranged below the batten clamping device 90 on the lower surface of the turntable 19, the convex column 25, the turntable zero position sensor 23 and the turntable working position sensor 24 are located on the same circumference, and 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 rotation times of the turntable 19 in real time, and then convert the rotation times into working positions.

In this embodiment, the rack taking module 83 includes a rack 26 for placing the slats, a stack 27, a rack taking mechanism and a rack transmission mechanism, and the rack taking mechanism is fixed on the stack 27 through a fixing plate 28; the plate taking frame mechanism comprises 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 connected with the second sliding mechanism in a sliding mode through a plate taking connection plate 31, a rectangular opening 32 is formed in the first plate taking support plate 29, the second plate taking support plate 30 is horizontally arranged at the rectangular opening 32 in a sliding mode through a screw 33, a spring 34 is arranged between the first plate taking support plate 29 and the second plate taking support plate 30, an arc-shaped protruding block 35 is arranged on the outer side of the second plate taking support plate 30, and the protruding block 35 extends outwards to exceed the outer edge of the first plate taking support plate 29; two support ribs 36 are arranged on the lower surface of the plate frame 26, a clamping rib 37 is arranged on each of the inner sides of the two support ribs 36, a circular arc-shaped recess 38 is formed in the clamping rib 37 positioned 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 into the lower portion of the uppermost plate frame 26, the first plate taking support plate 29 and the second plate taking support plate 30 are positioned between the two clamping ribs 37, and the convex block 35 is recessed into the recess 38. The plate frame 26 is smoothly taken out from the stack 27 by the plate frame taking module 83 in a mode that the clamping ribs 37 are clamped by the elastic lugs 35, and when all the plate bars 3 are transferred onto the rotary disc 19, the plate frames 26 automatically fall into the collecting frame and can be continuously used next time.

In this embodiment, grillage drive mechanism includes elevator motor 39, board support 40, screw rod 41 and two guide rods 42, two guide rods 42 and screw rod 41 are parallel to each other and are vertically located storehouse 27 one side, wear to be equipped with lifting slide 43 on two guide rods 42 and the screw rod 41, board support 40 is fixed in on lifting slide 43, and stretch into inside the storehouse 27, the vertical stack of grillage 26 that will place lath 3 is on board support 40, superimposed grillage 26 is located inside the storehouse 27, the lower extreme of screw rod 41 is connected with elevator motor 39 through elevator motor hold-in range (not shown in the figure). The plate frames 26 are sequentially stacked in the stack 27, and after the uppermost plate frame 26 is taken out, all the plate frames 26 are lifted to one position through the plate frame transmission mechanism, so that the plate frames 26 in a longitudinal row are sequentially taken out, and then the plate frames 26 in the longitudinal row are manually loaded into the plate frame 26.

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 disposed on the second slide rail 45 and slides along the second slide rail 45, the second motor 44 is connected with the board taking connecting plate 31 through a second synchronous belt 46, and the second motor 44 rotates to drive the board taking connecting plate 31 to slide along the second slide rail 45. The second slide mechanism allows the rack removal mechanism to move left and right to remove the rack 26 from the stack 27.

In this embodiment, the detection module 88 includes a light path component 47, a slat transfer component, a detection bottom plate 48 and a third sliding mechanism, a slat falling groove 49 is formed on the detection bottom plate 48, the slat transfer component is movably disposed on the upper surface of the detection bottom plate 48, the light path component 47 is disposed on the upper surface of the detection bottom plate 48 through a slat transfer channel 50, and when detection is performed, a slat 3 on the slat transfer component is located right below the light path component.

In this embodiment, the slat transfer component includes a sliding block 51, a slat plug-in 52 and a dc motor 53, a guide rail 54 is disposed on the upper surface of the sliding block 51, the slat plug-in 52 is disposed on the guide rail 54, the dc motor 53 is disposed on the sliding block 51, and a third gear 55 is disposed at the output end, a rack 56 is disposed on the slat plug-in 52, the third gear 55 and the rack 56 are engaged with each other, the dc motor 53 rotates to drive the slat plug-in 52 to slide along the guide rail 54, a plurality of parallel insertion pieces 57 are disposed on one side of the slat plug-in 52 close to the optical path component 47, and the slat 3 is mounted on the insertion pieces 57. The slat 3 to be detected enters the detection module 88 from the slat transfer path 50 side, at this time, the slat connector 52 moves toward the slat transfer path 50, the insertion piece 57 is inserted into the slat 3 from the side, at this time, the slat connector 52 can carry the slat 3 left and right or move back and forth, the slat connector 52 moves the slat 3 right under the optical path component 47 for detection, after the detection is completed, the dc motor 53 rotates to carry the slat connector 52 to move away from the slat transfer path 50, when the slat 3 moves right above the slat drop groove 49, the slat 3 stops moving due to being stopped by the sliding block 51, the slat connector 52 continues to move away from the slat transfer path 50, and the slat connector 52 is separated from the slat 3, at this time, the slat 3 drops downward from the slat drop groove 49.

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

In this embodiment, sample frame module 86 includes sample frame bottom plate 61, test-tube rack 62 and test-tube rack adapter 63, be equipped with a plurality of test tube jack 64 on the test-tube rack 62, be equipped with test-tube grip 65 in the test tube jack 64, be used for the test tube 82 of dress sample to insert in the test-tube grip 65, be equipped with a plurality of guide blocks 66 of group on the sample frame bottom plate 61, be equipped with a guide way 67 on the bottom surface of test-tube rack adapter 63, be fixed in test-tube rack 62 on the test-tube rack adapter 63, insert test-tube rack 62 and test-tube rack adapter 63 from sample frame bottom plate 61 one side again. The sample rack module 86 of this configuration is convenient for the user to handle and the test tube 82 for placing the sample is relatively stable.

In this embodiment, the front end and the lower surface of the test tube rack adapter 63 are respectively provided with one and two magnetic steels 68, and the three magnetic steels 68 are all sunk into the test tube rack adapter 63. The magnetic steel 68 can play a role in adsorbing the sample rack base plate 61, and further, the test tube rack adapter 63 is more stable.

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 slidably connected to the push rod bottom plate 69 through a fourth sliding mechanism and a fifth sliding mechanism, respectively, the X-direction pushing mechanism 6 and the Y-direction pushing mechanism 7 both include a push rod 70, a push rod motor 71 and a push rod arm 72, a push rod slide rail 73 is horizontally disposed on the push rod arm 72, and the push rod 70 is slidably disposed on the push rod slide rail 73 and is connected to the push rod motor 71 through a push rod synchronous belt 74.

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

In this embodiment, the full-automatic photoexcitation chemiluminescence detector further comprises a universal liquid module 78, a liquid path module 79 and a dilution oscillation module 80, and the sample rack module 86, the reagent module 5, the universal liquid module 78 and the dilution oscillation module 80 realize the operation of adding liquid in the detection process through the liquid path module 79.

In this embodiment, one needle washing pool 81 is disposed on each of the sample rack module 86 and the reagent module 5. The needle washing pool 81 can wash the sample adding needle on the sample adding arm module 4, and then can be used for multiple times.

The method for controlling the immunoassay device according to the present embodiment will be described in detail below with reference to fig. 4 to 28.

The space occupied by the dial 19 (fixed in position, not rotating with the rotation of the dial 19) is divided into a D0 region, a D1 region, a D2 region, and a D3 region (the D0 region, the D1 region, and the D3 region are shown in fig. 12, and the D2 region is not shown because it is covered by the moving mechanism) arranged in sequence, wherein the D0 region is used to perform step S1, and the D1, D2, and D3 regions are used to perform step S2. In some preferred embodiments, the D1 region is also used to complete the operation of adding the diluted sample. The region D3 is used to complete the reagent addition and discharge operations. Four slat gripping devices 90 are provided on the turntable 19 to grip the blank slats in the horizontal direction and the vertical direction.

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 predetermined direction is the Y-direction, and the second predetermined direction is the X-direction.

When the detection program is started, the rack taking mechanism in the rack taking module 83 first takes out the rack 26 bearing the blank slats from the stack 27 in the rack taking module 83, and then controls the Y-direction pushing mechanism 7 to drive the blank slats on the rack 26 to move in the Y direction, so that the blank slats move to the position of the turntable 2 corresponding to the D0 area, and are clamped by the slat clamping device 90, so that the slats are more stable in the moving process.

In the rack-removing module 83, the racks 26 are stacked in the stack 27 in sequence, and when the rack-removing mechanism removes one rack 26 from above the stack 27, the rack-driving mechanism drives the stack 27 to move up to a position, i.e., a height between adjacent racks 26. This is done by removing a vertical row of plates 26 and manually loading the plates 26 into the vertical row.

In this embodiment, the sample adding mechanism in the sample adding device is a left arm of the sample adding arm in the sample adding arm module 4, and the reagent adding mechanism in the sample adding device is a right arm of the sample adding arm in the sample adding arm module 4. The first needle washing pool in the needle washing pool 81 can be used for washing after the left arm of the sample adding arm is added with the solution containing the sample to be detected, and the second needle washing pool in the needle washing pool 81 can be used for washing after the right arm of the sample adding arm is added with the reaction reagent.

After the blank slats are clamped to the turntable 19 by the slat clamping device 90, specifically, the turntable 19 is controlled to rotate so that the blank slats reach the area D1; controlling a left arm of the sample adding arm to add a solution containing a sample to be detected into the blank lath; controlling the turntable 19 to rotate so that the strip added with the solution containing the sample to be measured reaches the area D2; controlling the turntable 19 to rotate so that the strip added with the solution containing the sample to be measured reaches the area D3; and controlling the right arm of the sample adding arm to add a reaction reagent to the strip added with the solution containing the sample to be detected. In a preferred embodiment, step S2 may further include: when the blank plate bar reaches the area D1, the right arm of the sample adding arm is controlled to add additional reaction reagent to the blank plate bar in the area D1. This example does not limit the order of adding the solution containing the sample to be tested and adding the additional reagent. Preferably, additional reaction reagents need to be added before the sample is dispensed, specifically, when the blank panel reaches the area D1, the right arm of the sample application arm is controlled to add such additional reaction reagents into the blank panel of the area D1, and then the left arm of the sample application arm is controlled to add the sample into the blank panel.

In a preferred embodiment, the solution containing the sample to be tested is also diluted before being added to the blank strip. Step S2 specifically includes: when the blank bar reaches the area D1, controlling the right arm of the sample adding arm to add the pre-dilution liquid into the pre-dilution plate in the dilution oscillation module 80; controlling the left arm of the sample adding arm to add the solution containing the sample to be detected into the pre-dilution plate in the dilution oscillation module 80; controlling the dilution oscillation module 80 to perform oscillation processing on the pre-dilution plate to obtain a diluted sample; the left arm of the sample application arm is controlled to apply the diluted sample to the blank plate in the D1 area. More preferably, the diluted sample may be added to a portion of the sample area of the blank panel in the region D1.

Specifically, the sample application process can adopt a multi-sample-absorption combined sample application mode, for example, in the case of n items, wherein only 1 item needs to be pre-diluted, the sample application mechanism absorbs n samples, only 1 sample is distributed into the pre-dilution plate, and n-1 samples are distributed into the blank strip in the area D1. After 1 sample in the pre-dilution plate is completely diluted, the left arm of the mechanical arm is controlled to add the diluted sample from the pre-dilution plate into a blank slat in the area D1.

In a preferred embodiment, the right arm of the robot is controlled to add one or more reagents to the strip when the strip reaches the region D3.

In a preferred embodiment, the reactants are all aqueous solutions that are added to the strip.

In a preferred embodiment, the method further comprises the steps of: and S3, controlling the unloading mechanism to unload the lath loaded with the mixed solution containing the solution of the sample to be tested and the reaction reagent from the rotating device. Specifically, referring to fig. 4, after the mixing of the solution containing the sample to be measured and the reaction reagent is completed, the unloading mechanism is controlled to unload the slats on the turntable 19 from the slat-holding device 90.

In a preferred embodiment, the method further comprises the steps of: s4, controlling the moving mechanism to move the unloaded lath to the incubation module. Step S4 includes: and controlling a second pushing mechanism in the moving mechanism to drive the lath bearing the mixed liquor to move along a second preset direction so as to move the lath bearing the mixed liquor to the incubation module. Specifically, referring to fig. 4 and 12, the X-direction pushing mechanism 6 is controlled to move the slat carrying the mixed liquor in the X direction, so that the slat carrying the mixed liquor moves to the incubation module 87.

In a preferred embodiment, the method further comprises the steps of: s5, controlling the incubation module to incubate the mixed liquor on the unloaded lath. Step S5 includes: controlling a sliding mechanism in the incubation module to drive the unloaded laths to slide back and forth so as to uniformly mix the mixed solution on the laths; the incubation plate in the incubation module is controlled during the mixing process to incubate the mixture. Specifically, referring to fig. 4 and fig. 12, when the slat carrying the mixed liquor is incubated, the first sliding mechanism in the incubation module 87 is controlled to drive the unloaded slat to slide back and forth, so as to mix the mixed liquor on the slat; the incubation plate 8 in the control incubation module 87 performs an incubation process on the mixture during the mixing process.

In a preferred embodiment, the method further comprises the steps of: s6, controlling the moving mechanism to move the lath carrying the mixed liquid after incubation to the detection module. Step S6 includes: and controlling a moving arm in the moving mechanism to move the lath loaded with the mixed liquid after the incubation to the detection module. Specifically, referring to fig. 4 and 21-24, after incubation is complete, the moving arm in the moving mechanism is controlled to move the slat carrying the post-incubation mixture to the detection module 88. After the slat carrying the mixed liquid after incubation enters the detection module 88, the slat transfer component in the detection module 88 is controlled to drive the slat carrying the mixed liquid after incubation to move to the position below the light path component 47 in the detection module 88, and the light path component 47 is controlled to perform laser irradiation on the mixed liquid after incubation.

In a preferred embodiment, the method further comprises the steps of: s7, controlling the detection module to irradiate the incubated mixed solution with laser and record the emitted light quantity.

FIG. 2 shows a second flow chart of a preferred method of controlling the immunoassay device. The method comprises the following steps:

s1, controlling the plate taking frame module and the moving mechanism to load the blank plate strip on the rotating device;

s2, controlling the rotation device and the sample adding working device to act so as to add a solution containing a sample to be detected and a reaction reagent on the blank strip;

s3, controlling an unloading mechanism to unload the lath carrying the mixed solution containing the solution of the sample to be tested and the reaction reagent from the rotating device;

s4, controlling the moving mechanism to move the unloaded lath to the incubation module;

s5, controlling the incubation module to incubate the mixed solution on the unloaded lath;

s6, controlling the moving mechanism to move the lath loaded with the mixed solution after incubation to the detection module;

and S7, controlling the detection module to perform laser irradiation on the incubated mixed solution and recording the emission light quantity.

The immunoassay carried out by the method has the advantages of close matching of all steps, simplicity, convenience and smoothness, high detection efficiency and high detection accuracy.

In a preferred embodiment, and with specific flow in reference to FIG. 3, the mixture on the unloaded staves is incubated twice using a plurality of incubation modules 87 and tested for the presence of the high dose-hook effect. Firstly, controlling a first incubation module to perform first-step incubation on the mixed solution; moving the lath loaded with the mixed solution after the first-step incubation to a detection module; controlling a detection module to perform first laser irradiation on the mixed solution after the first-step incubation and recording the emitted light quantity; moving the plate bearing the mixed solution after the first-step reading to a second incubation module; controlling a second incubation module to perform a second incubation on the mixed solution after the first reading; moving the lath carrying the mixed solution after the second incubation to a detection module; and controlling a detection module to perform secondary laser irradiation on the mixed solution after the second incubation and recording the emission light quantity. During the first incubation step, the right arm of the sample addition arm is controlled to draw the universal solution from the universal solution module 78 and add it to the incubation mixture.

The control processor determines whether a high dose-hook effect is present based on the amount of light emitted recorded after two incubations. Wherein the control processor determines whether a high dose-hook effect is present based on the amount of light emitted recorded after two incubations, comprising: calculating the difference between the amount of light emitted recorded after the first incubation and the amount of light emitted recorded after the second incubation; judging whether the difference value is larger than a preset threshold value or not; determining that a high dose-hook effect exists when the difference is judged to be greater than a preset threshold; otherwise, in case it is judged that the difference is less than or equal to the preset threshold, it is determined that the high dose-hook effect is not present. Here, the preset threshold is the maximum value of a standard curve measured in the case where the sample to be measured is a standard substance having a concentration lower than that in the case where the high dose-hook effect exists. In a preferred embodiment, in the case that the processor determines that the immunoassay has a high dose-hook effect, the dilution oscillation module 80 is controlled to perform dilution processing on the current mixed solution until the high dose-hook effect does not exist.

The following shows a test procedure with only two reagents, first reagent R1 and second reagent R2, without pre-dilution:

1) suppose that eight blank slats are pushed into the carousel 19 at a time from the pick rack module 83;

2) the blank lath rotates from the position D0 to the position D1;

3) controlling the left arm of the sample adding arm to suck a sample (or a calibration product, a reference product, a quality control product and the like) from the sample rack module 86 and distribute the sample into the lath at the position D1, wherein one sucking eighth point is used for sample distribution, and after the distribution is finished, the left arm of the sample adding arm is moved to the first needle washing pool to be washed;

4) after the sample adding is finished, the lath rotates to the position D2 from the position D1, the position D2 does not move, and the lath rotates to the position D3 from the position D2;

5) and controlling the right arm of the sample adding arm to suck the reaction reagent from the reagent module 5 and distribute the reaction reagent into the strip at the position D3, wherein one eighth suction is used for distributing the reaction reagent. At the position, after the first reagent R1 is distributed, the right arm of the sample adding arm is moved to the second needle washing pool for washing, after washing, the first reagent R2 is distributed immediately, and after distribution, the right arm of the sample adding arm is moved to the second needle washing pool again for washing;

6) the lath is pushed into the first incubation module from the position D3 by the X-direction pushing mechanism 6 to carry out the first incubation step;

7) during the incubation process, the right arm of the sample adding arm is controlled to suck the universal solution from the universal solution module 78 and add the universal solution into the mixed solution undergoing the incubation;

8) moving the lath carrying the mixed solution after the first-step incubation to a detection module 88, performing first laser irradiation on the mixed solution after the first-step incubation, and recording the emission light quantity;

9) moving the mixed liquor to the second incubation module again, and controlling the second incubation module to perform a second incubation step on the mixed liquor;

10) moving the lath carrying the mixed solution after the second incubation to a detection module 88, and controlling the detection module 88 to perform second laser irradiation on the mixed solution after the second incubation and recording the emitted light quantity;

11) the presence of the high dose-hook effect was judged from the amount of light emitted recorded after two incubations.

The above process distributes two reagents, i.e., the first reagent R1 and the second reagent R2, in the reagent distribution stage, it is understood that, in addition to the first reagent R1 and the second reagent R2, the third reagent R3 can be distributed, assuming that R1, R2 and R3 are all added after the distribution of the sample is completed, e.g., HBeAb, R3 is 50 μ l of neutralizing e antigen, the operation is similar to the case of only the first reagent R1 and the second reagent R2, except that the third reagent R3 is distributed once more in the D3 region, and the distribution sequence of the first reagent R1, the second reagent R2 and the third reagent R3 is arbitrary.

It can also be understood that, if the third reagent R3 of the first reagent R1, the second reagent R2 and the third reagent R3 needs to be added before the sample is dispensed, the third reagent R3 is an additional reaction reagent, for example, CA19-9, and R3 is 15 μ l of sample diluent, the dispensing of the additional reaction reagent R3 is completed by using the right arm of the mechanical arm at the position D1, and then the dispensing of the sample to be tested is completed by the left arm of the loading arm, and other processes are consistent with the case of only the first reagent R1 and the second reagent R2.

It will also be appreciated that if the third reagent R3 of the first, second and third reagents R1, R2 and R3 needs to be added before the sample is dispensed, then this third reagent R3 is an additional reagent, and if this additional reagent R3 is a pre-dilution, for example HCV, 10 μ l sample +100 μ l dilution, then 25 μ l diluted sample is taken to participate in the test. Specifically, after the blank slat is rotated to D1, the right arm of the loading arm distributes the pre-dilution liquid R3 to the pre-dilution plate in the dilution oscillation module 80, and the left arm of the loading arm distributes the sample to be tested to the pre-dilution plate, wherein the process of distributing the sample to be tested can be performed in a one-to-many manner, for example, five items are made, one item needs pre-dilution, and the other four items do not need pre-dilution, and then the left arm of the mechanical arm sucks five samples to be tested, one sample is distributed to the pre-dilution plate in the left arm of the loading arm, and the other four samples are distributed to the blank slat in the D1 area. And then, controlling the dilution oscillation module 80 to oscillate the pre-dilution plate, after the pre-dilution plate is fully diluted, distributing the diluted solution containing the sample to be detected into the lath by the left arm of the sample adding arm, and then rotating the turntable 19 to D2. The subsequent processes are the same as those of the first reagent R1 and the second reagent R2 only, and are not repeated here.

In a preferred embodiment, the following steps are performed for the current lot of tests and its next lot of tests to achieve parallel processing of multiple lots of tests. Specifically, the turntable 19 is controlled to rotate, so that the blank lath of the current batch reaches the D1 area; performing a sample adding action on the current batch of laths in the area D1, and simultaneously controlling the rack taking module 83 and the moving mechanism to load the blank laths of the next batch onto the turntable in the area D0; controlling the turntable 19 to rotate, so that the current batch of laths reaches the D2 area, and meanwhile, the next batch of blank laths reaches the D1 area; performing a sample adding action on the next batch of battens in the area D1; controlling the turntable 19 to rotate so that the lath of the current batch reaches the D3 area, and simultaneously, the lath of the next batch reaches the D2 area; performing a loading action on the current stave in area D3, and subsequently unloading the current batch of staves from the carousel 19 for subsequent processing steps; controlling the rotary table 19 to rotate to enable the next batch of battens to reach the D3 area; the loading action is performed on the next batch of strips in area D3, and the next batch of strips is then unloaded from carousel 19 for subsequent processing steps.

Compared with the prior art, the method for controlling the immunoassay device has the advantages that when the mixed liquid is prepared by the method, all modules are matched with each other, the action is smooth, the automation degree is high, and the preparation efficiency is high. The above description is only a preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art can easily make changes or variations within the technical scope of the present invention disclosed, and such changes or variations should be covered within the 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 method for controlling an immunoassay device, comprising the steps of:

2. The method of controlling an immunoassay device according to claim 1, further comprising

And S3, controlling a pushing mechanism in the moving mechanism to drive the lath bearing the mixed solution to move along a preset direction so as to move the lath bearing the mixed solution to the incubation module.

3. The control method of claim 1, wherein the rotating means is a turntable, the upper surface of the rotating means is divided into a plurality of test zones arranged in sequence, and each test zone moves to a designated position along with the turntable to complete a batch of tests.

4. The control method of claim 3, wherein 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.

5. The control method according to claim 4, wherein the space occupied by the dial is divided into a plurality of execution areas arranged in sequence, wherein the first execution area is used for executing the step S1, and the rest of the execution areas are used for executing the step S2.

6. The control method according to claim 5, wherein the space occupied by the dial is divided into a D0 region, a D1 region, a D2 region and a D3 region arranged in sequence, wherein the D0 region is used for executing the step S1, and the D1, D2 and D3 regions are used for executing the step S2.

7. The control method according to claim 6, wherein step S2 includes:

controlling the turntable to rotate so that the blank lath reaches the D1 area;

and controlling a reagent adding mechanism in the sample adding working device to add a reaction reagent to the strip added with the solution containing the sample to be detected.

8. The control method according to claim 7, wherein step S2 further includes:

9. The control method according to claim 8, wherein step S2 further includes:

10. The control method of claim 9, wherein the sample adding mechanism is controlled to add the diluted sample to a portion of the sample area of the blank panel in the region D1.

11. The control method according to claim 7, characterized in that at least two reactants are added in the region D3.

12. The control method of claim 2, further comprising controlling the sample adding mechanism to draw a common solution into the mixture being incubated during the incubation.