CN111983249B - Chemiluminescent immunoassay analyzer for in-situ luminescent determination and detection method - Google Patents
Chemiluminescent immunoassay analyzer for in-situ luminescent determination and detection method Download PDFInfo
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- CN111983249B CN111983249B CN202010885431.6A CN202010885431A CN111983249B CN 111983249 B CN111983249 B CN 111983249B CN 202010885431 A CN202010885431 A CN 202010885431A CN 111983249 B CN111983249 B CN 111983249B
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- 238000001514 detection method Methods 0.000 title claims abstract description 42
- 238000003018 immunoassay Methods 0.000 title claims abstract description 18
- 238000011065 in-situ storage Methods 0.000 title claims abstract description 10
- 239000003153 chemical reaction reagent Substances 0.000 claims abstract description 117
- 238000004140 cleaning Methods 0.000 claims abstract description 96
- 238000006243 chemical reaction Methods 0.000 claims abstract description 37
- 238000011534 incubation Methods 0.000 claims abstract description 13
- 230000003287 optical effect Effects 0.000 claims abstract description 13
- 238000003860 storage Methods 0.000 claims abstract description 12
- 239000006249 magnetic particle Substances 0.000 claims abstract description 11
- 238000005070 sampling Methods 0.000 claims description 53
- 239000007788 liquid Substances 0.000 claims description 51
- 230000005284 excitation Effects 0.000 claims description 32
- 239000002699 waste material Substances 0.000 claims description 16
- 230000001360 synchronised effect Effects 0.000 claims description 15
- 230000005540 biological transmission Effects 0.000 claims description 12
- 210000000078 claw Anatomy 0.000 claims description 12
- 239000003085 diluting agent Substances 0.000 claims description 9
- 239000011324 bead Substances 0.000 claims description 7
- 238000010438 heat treatment Methods 0.000 claims description 7
- 238000007885 magnetic separation Methods 0.000 claims description 7
- 239000000243 solution Substances 0.000 claims description 6
- 238000003556 assay Methods 0.000 claims description 3
- 239000011259 mixed solution Substances 0.000 claims description 3
- 238000005259 measurement Methods 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims 1
- 238000000034 method Methods 0.000 abstract description 11
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- 239000003814 drug Substances 0.000 abstract description 2
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- 230000002107 myocardial effect Effects 0.000 abstract description 2
- 238000005406 washing Methods 0.000 description 8
- 238000012360 testing method Methods 0.000 description 6
- 238000012123 point-of-care testing Methods 0.000 description 5
- 239000000758 substrate Substances 0.000 description 5
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- 238000004108 freeze drying Methods 0.000 description 1
- 230000001900 immune effect Effects 0.000 description 1
- 238000003317 immunochromatography Methods 0.000 description 1
- 230000036046 immunoreaction Effects 0.000 description 1
- 239000002906 medical waste Substances 0.000 description 1
- 238000003199 nucleic acid amplification method Methods 0.000 description 1
- 230000001590 oxidative effect Effects 0.000 description 1
- RXNXLAHQOVLMIE-UHFFFAOYSA-N phenyl 10-methylacridin-10-ium-9-carboxylate Chemical compound C12=CC=CC=C2[N+](C)=C2C=CC=CC2=C1C(=O)OC1=CC=CC=C1 RXNXLAHQOVLMIE-UHFFFAOYSA-N 0.000 description 1
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- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/0099—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor comprising robots or similar manipulators
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/76—Chemiluminescence; Bioluminescence
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- G—PHYSICS
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/5302—Apparatus specially adapted for immunological test procedures
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
- G01N35/1004—Cleaning sample transfer devices
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N2035/00346—Heating or cooling arrangements
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- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N2035/00465—Separating and mixing arrangements
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N2035/00465—Separating and mixing arrangements
- G01N2035/00564—Handling or washing solid phase elements, e.g. beads
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Abstract
The invention relates to rapid detection and analysis of hormone, infection markers, myocardial markers, tumor markers and medicines, in particular to a chemiluminescent immunoassay analyzer for in-situ luminescent determination and a detection method. The method can complete a series of operations of reaction, incubation, cleaning, detection, data reading and the like in a chemiluminescent immunoassay process by automatically adding a sample to be detected into a special freeze-dried magnetic particle chemiluminescent reagent tube. Comprises a platform; the platform is divided into four areas: the device comprises a reagent tube storage area, a sample area to be detected, a reaction area, a cleaning area and an optical detection area.
Description
Technical Field
The invention relates to rapid detection and analysis of hormone, infection markers, myocardial markers, tumor markers and medicines, in particular to a chemiluminescent immunoassay analyzer for in-situ luminescent determination and a detection method.
Background
Immunological detection is a method for detecting by utilizing the specific reaction of antigen and antibody, and can amplify and display detection signals by utilizing isotopes, enzymes, chemiluminescent substances and the like, and is used for detecting trace substances such as proteins, hormones and the like.
Chemiluminescent immunoassay is a novel labeled immunoassay technique for detecting minute amounts of antigen or antibody by combining chemiluminescent substrate with an immunoreaction.
The principle of the chemiluminescent reaction is to label a luminescent substance or enzyme on an antigen (or antibody), and to excite the luminescent substance to emit light by oxidizing the substrate or to act on the luminescent substrate by the enzyme to cause the substrate to emit light.
The core device in the chemiluminescent immunoassay analyzer is a single photon counter, which is a vacuum electronic device capable of converting weak light signals into electric signals, and the electric signals are detected by a single photon detector and transmitted to an amplifier, and high-voltage current is applied for amplification, and the amplifier converts analog signals into digital signals, and the digital signals are transmitted to a computer and calculated to obtain final data. The chemiluminescence immunodetection is widely accepted in clinic due to the characteristics of environmental protection, rapidness, accuracy and the like, and becomes a main means of clinical immunodiagnosis at present.
POCT, point-of-CARE TESTING, refers to clinical testing performed at the bedside of patients, and in POCT testing technology, the common methods of the POCT project for immunodetection currently on the market are immunoturbidimetry and immunochromatography. Both methods have the limitation of measurement, the detection sensitivity is low, the full quantitative detection can not be realized, and the detection results can not be transversely compared with the main flow instrument which is a different platform. A small-sized chemiluminescent analyzer is needed, which can be used for detecting with a main stream large-sized chemiluminescent analyzer on the same platform, and can realize transverse comparison.
At present, the main flow of chemiluminescent immunoassay instruments in the market is full-automatic, high-flux and multi-sample, so that the chemiluminescent immunoassay instrument is more suitable for laboratory in a center of a large hospital, is not suitable for instant detection in clinical departments, is not suitable for small sample detection in primary hospitals from the market development and the national trend of advanced grading diagnosis and treatment, and is more required for small chemiluminescent analyzers capable of single-item detection in the market.
Disclosure of Invention
The invention provides a chemiluminescent immunoassay analyzer for in-situ luminescent determination and a detection method thereof, aiming at the defects of the prior art, wherein a series of operations such as reaction, incubation, cleaning, detection, data reading and the like in the chemiluminescent immunoassay process can be completed by automatically adding a sample to be detected into a special freeze-dried magnetic particle chemiluminescent reagent tube.
In order to achieve the above purpose, the invention adopts the following technical scheme that the invention comprises a platform; the platform is characterized by being divided into four areas: the device comprises a reagent tube storage area, a sample area to be detected, a reaction area, a cleaning area and an optical detection area.
The reagent tube storage area comprises a reagent tube rack and a first manipulator.
The sample area to be tested comprises a sample adding device, a sample pipe rack for placing a sample pipe and a sampling needle cleaning device for cleaning a sampling needle.
The sample adding device comprises a group of two-dimensional moving slipways and sampling needles arranged on the two-dimensional moving slipways; the two-dimensional moving sliding table drives the sampling needle to move to the sample tube to absorb the sample; the sampling needle cleaning device comprises a waste liquid tank and a sampling needle cleaning device arranged above the waste liquid tank.
The reaction and cleaning area comprises a semi-closed box body; an incubation reaction track is arranged in the semi-closed box body; the incubation reaction track comprises a synchronous belt transmission mechanism, wherein a plurality of cylindrical teeth are distributed on the outer periphery (track) of the synchronous belt transmission mechanism at equal intervals, and the cross section of each cylindrical tooth is in an hourglass shape; the adjacent columnar teeth form reagent tube clamping parts (or independent test tube racks) for clamping the reagent tubes.
The optical detection area comprises a darkroom, an excitation liquid adding device and a second manipulator.
The darkroom is a semi-closed structure with an opening at the upper end, the lower end of the darkroom is connected with the single photon counter, and after the reagent tube is put in from the opening at the upper end, the upper cover of the darkroom is closed to form the light-proof darkroom.
The excitation liquid adding device comprises a longitudinally moving sliding table II, a darkroom upper cover connected with the sliding table II and an excitation liquid needle; the upper cover is connected with a sliding table sliding block of the sliding table II through the hollow pipe, the excitation liquid needle (device) is fixed on the sliding table sliding block, and the excitation liquid needle body penetrates out of the hollow pipe.
Further, the first manipulator is located the reagent pipe support top, just the reagent pipe support is used for bearing the reagent pipe of freeze-drying magnetic particle chemiluminescence reagent, the first manipulator adopts miniature electric claw, and this miniature electric claw is driven by a set of three-dimensional slip table device.
Further, the sample pipe rack comprises a sample disk and a sample disk driving motor; the motor shaft of the sample disk driving motor drives the sample disk to rotate, and sample pipe placing grooves for placing sample pipes are arranged on the sample disk at equal intervals along the circumferential direction.
Further, the sampling needle cleaning device is positioned between the sample tube and the reaction position; the sampling needle cleaning device consists of a cleaning nozzle and a waste liquid tank and is used for cleaning the sampling needle; the sample adding device also comprises a diluent bottle containing diluent and a cleaning liquid bottle containing cleaning liquid.
Further, the semi-closed box body is provided with a heating device and a temperature controller.
Further, the synchronous belt transmission mechanism comprises a driving belt pulley, a driven belt pulley and a synchronous belt in transmission connection with the driving belt pulley and the driven belt pulley; the driving belt wheel is driven by the synchronous motor; three openings are formed in the upper surface of the box body: sample application, washing and removal.
Further, the reaction and cleaning area also comprises a magnetic bead cleaning device and a magnetic separation device.
The magnetic bead cleaning device is positioned at one side of the track cleaning position and comprises a first longitudinal moving sliding table and a cleaning needle which is connected with the first longitudinal moving sliding table and driven to move by the first longitudinal moving sliding table.
The magnetic separation device is positioned at two sides of the track cleaning position and comprises a magnet fixing frame, two permanent magnets arranged on the magnet fixing frame and a magnet fixing frame driving motor for driving the magnet fixing frame to linearly move; the two permanent magnets are arranged opposite to each other, and a gap is reserved between the two permanent magnets; when the cleaning device is used, the track cleaning position is positioned between the two permanent magnets, and the distance between the two permanent magnets is larger than the diameter of the reagent tube in the cleaning position; the driving motor of the magnet fixing frame is a linear motor, and the motor shaft stretches out or retracts to drive the magnet fixing frame connected with the motor shaft to move forwards or backwards along with the motor shaft.
Further, the second manipulator comprises a miniature electric claw, and the miniature electric claw is driven by a group of two-dimensional sliding table devices.
Further, the driving parts of the reagent tube storage area, the sample area to be detected, the reaction area, the cleaning area and the optical detection area are all connected with the control system.
A chemiluminescent immunoassay method for in situ luminescent assays comprising the steps of:
The reagent tube is placed in a reagent tube rack.
After the ID of the sample tube to be detected is input into the control system, the sample tube to be detected is placed at a designated position of a sample tray, and the sample tray rotates to enable the sample tube to be detected to rotate to a sampling position.
The system selects a project to be detected according to the ID information of the sample tube, the first manipulator grabs the reagent tube of the project to be detected and moves to a sample adding position (a first station) of a track in a box body of the reaction and cleaning area, and the first manipulator resets.
The sampling needle moves to a position to be sampled to absorb a sample, and then the sampling needle moves to a sample adding position of a reaction and cleaning area to add samples; the sampling needle adds a diluent into the reagent tube of the sample adding position, and dilutes the mixed solution of the sample and the freeze-dried reagent in the reagent tube.
The sampling needle repeatedly sucks and spits the solution in the reagent tube for three times, so that the solution is uniformly mixed.
After the sampling needle moves to the sampling needle cleaning device to clean the inner wall and the outer wall, the sampling needle resets.
Starting timing after the sample is added into the reagent tube at the sample adding position (first station), and moving one station along the track from the sample adding position to the cleaning position (ninth station) every 90 seconds; the temperature controller controls the temperature of the rail to 37 ℃.
When the reagent tube moves to a cleaning position, the magnet fixing frame drives the magnet fixing frame to enable the permanent magnet to be attached to one side of the reaction tube, magnetic particles are adsorbed on the wall of the reagent tube, the cleaning needle enters the reagent tube for cleaning, and waste liquid is discharged; then, the cleaning needle withdraws from the reagent tube, and the magnet fixing frame drives the motor to drive the magnet fixing frame to enable the permanent magnet at the other side to be movably attached to the other side of the reagent tube, and cleaning is carried out again; after three washes, the reagent tube was moved to the removal position (tenth station) along with the incubation track.
The second manipulator moves to a moving-out position, the reagent tube is clamped and placed in the darkroom of the optical detection area, the sliding table II is longitudinally moved to drive the upper cover of the darkroom to move downwards, the darkroom is sealed, the excitation liquid needle is used for filling excitation liquid into the reagent tube in the darkroom, the single photon counter is used for detecting the photon number generated in the reagent tube, and data is transmitted to the control system to calculate the concentration of a sample.
And after the detection is finished, the second longitudinally moving sliding table of the excitation liquid adding device moves upwards, and the second manipulator clamps the reagent tube and discards the reagent tube in the waste box to be used as medical garbage for treatment.
The above process was repeated in cycles, with detection being completed every 90 seconds. (40 samples per hour can be tested later except for 12 minutes for the first test).
Compared with the prior art, the invention has the beneficial effects.
The POCT full-automatic chemiluminescence immunoassay analyzer for in-situ detection can automatically add a sample to be detected into a special freeze-dried magnetic particle chemiluminescence reagent tube to complete a series of operations such as reaction, incubation, cleaning, detection, data reading and the like in a chemiluminescence immunoassay process.
The invention adopts the acridinium ester as a luminous reagent substrate to directly emit light, and the reagent does not need to move after the excitation liquid is added, so that the detection time is short, the detection is completed within 1 second, and the luminous efficiency is high, the repeatability is good and the sensitivity is high.
Drawings
The invention is further described below with reference to the drawings and the detailed description. The scope of the present invention is not limited to the following description.
Fig. 1 is a schematic diagram of the overall structure of an embodiment of the present invention.
FIG. 2 is a schematic diagram of a reagent tube rack apparatus according to one embodiment of the present invention.
FIG. 3 is a schematic diagram of a sample tube rack apparatus according to one embodiment of the present invention.
FIG. 4 is a schematic view of a magnetic bead washing apparatus according to an embodiment of the present invention.
FIG. 5 is a schematic view of a track arrangement in a reaction and wash zone enclosure in accordance with one embodiment of the invention.
FIG. 6 is a schematic view of a magnetic separation device according to an embodiment of the present invention.
FIG. 7 is a schematic diagram of an excitation fluid addition apparatus according to an embodiment of the present invention.
Fig. 8 is a schematic view of a first robot according to an embodiment of the present invention.
Fig. 9 is a schematic view of a second robot according to an embodiment of the present invention.
Fig. 10 is a schematic view of a sampling needle cleaning device according to an embodiment of the present invention.
In the figure, 101 is a reagent tube, 102 is a reagent tube rack, 103 is a first manipulator, 201 is a sample tube, 202 is a sample tray, 203 is a sampling position, 204 is a sampling needle, 205 is a sampling needle cleaning device, 301 is a track, 302 is a sample adding position, 303 is a cleaning position, 304 is a magnet fixing frame driving motor, 305 is a magnet fixing frame, 306 is a permanent magnet, 307 is a cleaning needle, 308 is a moving-out position, 309 is a box body, 401 is a second manipulator, 402 is a darkroom, 403 is a longitudinally moving sliding table II, 404 is an upper cover, 405 is an excitation liquid needle, and 406 is a single photon counter.
Detailed Description
As shown in fig. 1-10, the present invention includes a platform; the platform is characterized by being divided into four areas: the device comprises a reagent tube storage area, a sample area to be detected, a reaction area, a cleaning area and an optical detection area.
The reagent tube storage area includes a reagent tube rack 102 and a first robot 103. The reagent pipe frames 102 are used for carrying reagent pipes 101 of freeze-dried magnetic particle chemiluminescent reagents, and each reagent pipe frame 102 carries 8-16 reagent pipes 101; the reagent storage area consists of 1-20 reagent tube racks 102.
The sample area to be tested comprises a sample adding device, a sample pipe rack for placing a sample pipe and a sampling needle cleaning device for cleaning a sampling needle;
The sample adding device comprises a group of two-dimensional moving slipways and sampling needles 204 arranged on the two-dimensional moving slipways; the two-dimensional moving sliding table drives the sampling needle to move to the sample tube to absorb the sample; the sampling needle cleaning device comprises a waste liquid tank and a sampling needle cleaning device arranged above the waste liquid tank.
The reaction and purge zone comprises a semi-enclosed housing 309; an incubation reaction track 301 is provided within the semi-enclosed housing 309; the incubation reaction track comprises a synchronous belt transmission mechanism, wherein a plurality of cylindrical teeth are distributed on the outer periphery (track) of the synchronous belt transmission mechanism at equal intervals, and the cross section of each cylindrical tooth is in an hourglass shape; the adjacent columnar teeth form reagent tube clamping parts (or independent test tube racks) for clamping the reagent tubes. The track moves in the box, and box upper portion has three openings, is sample application position 302, washs position 303 and shifts out the position 308 respectively, and sample application position 302 is located first station, washs position 303 and is located ninth station, shifts out the position 308 and is located tenth station.
The optical detection area comprises a darkroom, an excitation liquid adding device and a second manipulator 401.
The darkroom is a semi-closed structure with an opening at the upper end, the lower end of the darkroom is connected with the single photon counter 406, and after the reagent tube is put in from the opening at the upper end, the upper cover of the darkroom is closed to form the light-proof darkroom.
The excitation liquid adding device comprises a second longitudinally moving sliding table 403, a darkroom upper cover connected with the second sliding table 403, an excitation liquid needle 405, an excitation liquid A (bottle) and an excitation liquid B (bottle). The upper cover is connected with a sliding table sliding block of the sliding table II 403 through the hollow pipe, the excitation liquid needle (device) is fixed on the sliding table sliding block, and the excitation liquid needle body penetrates out of the hollow pipe. Specifically, the darkroom upper cover is connected with the sliding table slide block through the hollow pipe, and the excitation liquid needle penetrates out through the hollow pipe; when the sliding table moves downwards, the darkroom is closed by the darkroom upper cover, and meanwhile, the excitation liquid needle is inserted into the reagent tube, and excitation liquid is added.
Preferably, the first manipulator 103 is located above the reagent tube rack 102, and the reagent tube rack 102 is used for carrying the reagent tube 101 of the freeze-dried magnetic particle chemiluminescent reagent, and the first manipulator 103 adopts a micro electric claw, and the micro electric claw is driven by a set of three-dimensional sliding table devices.
Preferably, the sample pipe rack comprises a sample disk and a sample disk driving motor; the motor shaft of the sample disk driving motor drives the sample disk to rotate (spin), and the sample disk is provided with sample pipe placing grooves for placing sample pipes at equal intervals along the circumferential direction.
Preferably, the sampling needle cleaning device is located between the sample tube 201 and the reaction site; the device consists of a cleaning nozzle and a waste liquid tank, and is used for cleaning a sampling needle; the sample adding device also comprises a diluent bottle containing diluent and a cleaning liquid bottle containing cleaning liquid.
Preferably, the semi-enclosed box 309 is provided with a heating device and a temperature controller. The heating device is used for heating the track, and can adopt heating wires or heating oil and the like. Specifically, the method is a conventional technology in the field and is not repeated.
Preferably, the synchronous belt transmission mechanism comprises a driving belt pulley, a driven belt pulley and a synchronous belt in transmission connection with the driving belt pulley and the driven belt pulley; the driving belt wheel is driven by the synchronous motor; three openings are formed in the upper surface of the box body: a loading station 302, a washing station 303 and a removal station 308.
Preferably, the reaction and washing zone further comprises a magnetic bead washing device and a magnetic separation device.
The magnetic bead cleaning device is positioned at one side of the track cleaning position and comprises a first longitudinal moving sliding table and a cleaning needle 307 which is connected with the first longitudinal moving sliding table and is driven to move by the first longitudinal moving sliding table; also comprises a cleaning liquid (bottle) and a waste liquid (bottle).
The magnetic separation device is positioned at two sides of the track cleaning position and comprises a magnet fixing frame, two permanent magnets arranged on the magnet fixing frame and a magnet fixing frame driving motor for driving the magnet fixing frame to linearly move; the two permanent magnets are arranged opposite to each other, and a gap is reserved between the two permanent magnets; when the cleaning device is used, the track cleaning position is positioned between the two permanent magnets, and the distance between the two permanent magnets is larger than the diameter of the reagent tube in the cleaning position; the driving motor of the magnet fixing frame is a linear motor, and the motor shaft stretches out or retracts to drive the magnet fixing frame connected with the motor shaft to move forwards or backwards along with the motor shaft. The motor drives the magnet to horizontally approach or separate from one side or the other side of the reagent tube on the track, so that the magnetic particles in the reagent tube can move to achieve the aim of cleaning.
Preferably, the second manipulator comprises a miniature electric claw, and the miniature electric claw is driven by a group of two-dimensional sliding table devices.
Preferably, the driving parts of the reagent tube storage area, the sample area to be tested, the reaction and cleaning area and the optical detection area are all connected with the control system.
A chemiluminescent immunoassay method for in situ luminescent assays comprising the steps of: the device of the detection system is reset after power-on and power-on.
1. The reagent tubes 101 (see fig. 2) of the same standard are placed in one reagent tube rack 102, ten reagent tubes can be placed in each row of reagent tube racks, ten reagent tube racks can be placed in the reagent storage area, and the product information (name, lot number, location of the reagent area, etc.) is input into the system.
2. After selecting a sample tube 201 to be tested (see fig. 3) and inputting the ID of the sample tube 201 into the system, the sample tube is placed at a designated position of the sample tray 202, and the motor drives the sample tray 202 to rotate the sample tube to the position 203 to be sampled.
3. The system selects an item to be tested according to the ID information of the sample tube, the first manipulator 103 grabs the reagent tube 101 of the item to be tested and moves to a sample adding position 302 (a first station) of a track 301 (see FIG. 5) in a reaction cleaning zone box 309, and the first manipulator 103 resets.
4. The sampling needle 204 is moved to the sample-to-be-sampled position 203 to aspirate the sample, and then the sampling needle 204 is moved to the sample-to-be-sampled position 302 of the reaction clean-up zone to sample. The sampling needle adds a diluent to the reagent tube of the sample adding position 302, and dilutes the mixed solution of the sample and the freeze-dried reagent in the reagent tube.
5. The sampling needle 204 repeatedly sucks and spits the solution three times in the reagent tube, and mixes the solution uniformly.
6. After the sampling needle 204 is moved to the sampling needle cleaning device 205 to clean the inner and outer walls, the sampling needle is reset.
7. The timing is started after the sample is added to the reagent tube at the sample addition station 302 (first station), and every 90 seconds, the sample is moved along the rail from the sample addition station 302 to the cleaning station 303 (ninth station). The temperature control device controls the temperature of the incubation track at 37 ℃.
8. When the reagent vessel moves to the washing position 303, the motor 304 drives the magnet holder 305 (see fig. 6) to attach the magnet 306 to one side of the reaction vessel, the magnetic particles are adsorbed on the wall of the reagent vessel, the washing needle 307 enters the reagent vessel for washing, and the waste liquid is discharged. Then, the cleaning needle 307 is withdrawn from the reagent tube, and the motor 304 drives the magnet holder 305 to move the magnet on the other side to be attached to the other side of the reagent tube, and cleaning is performed again. After three washes, the reagent tube is moved along the incubation track to the removal station 308 (tenth station).
9. The second manipulator 401 moves to the removal position 308, the reagent tube is clamped and placed in the darkroom 402 of the optical detection area, the longitudinal sliding table 403 drives the darkroom upper cover 404 to move downwards, the darkroom is sealed, the excitation liquid needle 405 fills the excitation liquid into the reagent tube in the darkroom, the single photon counter 406 detects the photon number generated in the reagent tube, and the data is forwarded to the software system, so that the concentration of the sample is calculated.
10. After the detection is finished, the excitation liquid adding device 403 moves upwards, the second manipulator 401 clamps the reagent tube to be discarded in the waste box, and finally the reagent tube is treated as medical waste.
11. The above process was repeated in cycles, with detection being completed every 90 seconds. In addition to the 12 minutes required for the first test, 40 samples can be tested every hour later.
It should be understood that the foregoing detailed description of the present invention is provided for illustration only and is not limited to the technical solutions described in the embodiments of the present invention, and those skilled in the art should understand that the present invention may be modified or substituted for the same technical effects; as long as the use requirement is met, the invention is within the protection scope of the invention.
Claims (1)
1. The chemiluminescent immunoassay analyzer for in-situ luminescent measurement comprises a platform; the platform is characterized by being divided into four areas: a reagent tube storage area, a sample area to be measured, a reaction area, a cleaning area and an optical detection area;
The reagent tube storage area comprises a reagent tube rack and a first manipulator; the sample area to be tested comprises a sample adding device, a sample pipe rack for placing a sample pipe and a sampling needle cleaning device for cleaning a sampling needle;
The sample adding device comprises a group of two-dimensional moving slipways and sampling needles arranged on the two-dimensional moving slipways; the two-dimensional moving sliding table drives the sampling needle to move to the sample tube to absorb the sample; the sampling needle cleaning device comprises a waste liquid tank and a sampling needle cleaning device arranged above the waste liquid tank;
The reaction and cleaning area comprises a semi-closed box body; an incubation reaction track is arranged in the semi-closed box body; the incubation reaction track comprises a synchronous belt transmission mechanism, wherein a plurality of cylindrical teeth are distributed on the outer periphery of the synchronous belt transmission mechanism at equal intervals, and the cross section of each cylindrical tooth is in an hourglass shape; the two adjacent columnar teeth form a reagent tube clamping part for clamping the reagent tube;
the optical detection area comprises a darkroom, an excitation liquid adding device and a second manipulator;
The darkroom is of a semi-closed structure with an opening at the upper end, the lower end of the darkroom is connected with the single photon counter, and after the reagent tube is put in from the opening at the upper end, the upper cover of the darkroom is closed to form a light-proof darkroom;
The excitation liquid adding device comprises a longitudinally moving sliding table II, a darkroom upper cover connected with the sliding table II and an excitation liquid needle; the upper cover is connected with a sliding table sliding block of the sliding table II through the hollow pipe, the excitation liquid needle is fixed on the sliding table sliding block, and the excitation liquid needle body penetrates out of the hollow pipe; the first manipulator is positioned above the reagent pipe rack, the reagent pipe rack is used for bearing a reagent pipe of the freeze-dried magnetic particle chemiluminescent reagent, the first manipulator adopts a miniature electric claw, and the miniature electric claw is driven by a group of three-dimensional sliding table devices;
The sample pipe support comprises a sample disk and a sample disk driving motor; the motor shaft of the sample disk driving motor drives the sample disk to rotate,
Sample tube placing grooves for placing sample tubes are arranged on the sample disc at equal intervals along the circumferential direction;
The sampling needle cleaning device is positioned between the sample tube and the reaction position; the sampling needle cleaning device consists of a cleaning nozzle and a waste liquid tank and is used for cleaning the sampling needle; the sample adding device also comprises a diluent bottle containing diluent and a cleaning liquid bottle containing cleaning liquid;
the semi-closed box body is provided with a heating device and a temperature controller;
The synchronous belt transmission mechanism comprises a driving belt pulley, a driven belt pulley and a synchronous belt in transmission connection with the driving belt pulley and the driven belt pulley; the driving belt wheel is driven by the synchronous motor; three openings are formed in the upper surface of the box body: a sample adding position, a cleaning position and a removing position;
the reaction and cleaning area also comprises a magnetic bead cleaning device and a magnetic separation device; the magnetic bead cleaning device is positioned at one side of the track cleaning position and comprises a first longitudinal moving sliding table and a cleaning needle which is connected with the first longitudinal moving sliding table and driven to move by the first longitudinal moving sliding table;
The magnetic separation device is positioned at two sides of the track cleaning position and comprises a magnet fixing frame, two permanent magnets arranged on the magnet fixing frame and a magnet fixing frame driving motor for driving the magnet fixing frame to linearly move; the two permanent magnets are arranged opposite to each other, and a gap is reserved between the two permanent magnets; when the cleaning device is used, the track cleaning position is positioned between the two permanent magnets, and the distance between the two permanent magnets is larger than the diameter of the reagent tube in the cleaning position; the magnet fixing frame driving motor is a linear motor, and a motor shaft stretches out or retracts to drive the magnet fixing frame connected with the motor shaft to move forwards or backwards along with the motor shaft;
the second manipulator comprises a miniature electric claw, and the miniature electric claw is driven by a group of two-dimensional sliding table devices;
the driving parts of the reagent tube storage area, the sample area to be detected, the reaction area and the cleaning area and the optical detection area are all connected with the control system;
A chemiluminescent immunoassay method based on in situ luminescent assay of a detection analyzer comprising the steps of:
placing the reagent tube into a reagent tube rack;
after inputting the ID of the sample tube to be detected into a control system, placing the sample tube to be detected at a designated position of a sample disc, and rotating the sample disc to enable the sample tube to be detected to rotate to a sampling position;
The system selects an item to be detected according to the ID information of the sample tube, the first manipulator grabs the reagent tube of the item to be detected and moves to a sample adding position of a track in a box body of the reaction and cleaning area, and the first manipulator resets;
The sampling needle moves to a position to be sampled to absorb a sample, and then the sampling needle moves to a sample adding position of a reaction and cleaning area to add samples;
the sampling needle adds diluent into the reagent tube of the sample adding position, and dilutes the mixed solution of the sample and the freeze-dried reagent in the reagent tube;
Repeatedly sucking and spitting the sampling needle in the reagent tube for three times to uniformly mix the solution;
After the sampling needle moves to the sampling needle cleaning device to clean the inner wall and the outer wall, the sampling needle resets;
Starting timing after a sample is added into a reagent tube at a sample adding position, and moving a station along a track from the sample adding position to a cleaning position every 90 seconds; the temperature controller controls the temperature of the rail to be 37 ℃;
when the reagent tube moves to a cleaning position, the magnet fixing frame drives the magnet fixing frame to enable the permanent magnet to be attached to one side of the reaction tube, magnetic particles are adsorbed on the wall of the reagent tube, the cleaning needle enters the reagent tube for cleaning, and waste liquid is discharged; then, the cleaning needle withdraws from the reagent tube, and the magnet fixing frame drives the motor to drive the magnet fixing frame to enable the permanent magnet at the other side to be movably attached to the other side of the reagent tube, and cleaning is carried out again; after three washes, the reagent tube was moved to the removal position along with the incubation track;
The second manipulator moves to a moving-out position, the reagent tube is clamped and placed in the darkroom of the optical detection area, the sliding table II is longitudinally moved to drive the upper cover of the darkroom to move downwards, the darkroom is sealed, the excitation liquid needle is used for filling excitation liquid into the reagent tube in the darkroom, the single photon counter is used for detecting the photon number generated in the reagent tube, and data is transmitted to the control system to calculate the concentration of a sample;
After the detection is finished, the second longitudinally moving sliding table of the excitation liquid adding device moves upwards, and the second manipulator clamps the reagent tube and discards the reagent tube in the waste box to be used as medical garbage for treatment;
the above steps are repeated circularly, and detection is completed every 90 seconds.
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| CN115856312B (en) * | 2022-11-01 | 2024-12-10 | 长春理工大学 | A chemiluminescent imaging device for multi-region shower samples |
| CN117871853B (en) * | 2024-03-13 | 2024-05-24 | 南通戴尔诺斯生物科技有限公司 | Colloidal gold immunochromatography equipment for detecting biotoxin and application method thereof |
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