CN-121995071-A - Full-automatic multimode immunity analyzer

CN121995071ACN 121995071 ACN121995071 ACN 121995071ACN-121995071-A

Abstract

The application belongs to the field of medical examination automation equipment, and particularly relates to a full-automatic multi-mode immunoassay analyzer which comprises a frame module, wherein a sample processing area, a reagent consumable area and a core reaction detection area are respectively arranged on the frame module, the sample processing area and the reagent consumable area are positioned at the front part of the frame module, the core reaction detection area comprises a magnetic separation module consisting of N independent units, a trolley reaction module consisting of 2N independent units and a detection module, the 2N independent units of the trolley reaction module are divided into N groups, each group is distributed in an upper-lower double layer manner, and each group is positioned below each independent unit of the magnetic separation module. The analyzer provided by the application comprises 4 trolley reaction modules, 2 magnetic separation modules, a multi-axis transfer arm and the like, so that the detection flux is more than or equal to 100T/H (four modules are parallel), and the efficiency is improved by 67%. The space utilization rate is improved, the arrangement ratio of the magnetic separator to the trolley reaction module is 1:2, and the magnetic separator is of a vertical nested structure, so that the occupied area is reduced by 40%.

Inventors

ZHANG XINGPENG
CHEN XIN
JIANG NING
XU PAN
CHANG LE
HU GANG
Wei Rundan
YANG SONG

Assignees

成都宜乐芯生物科技有限公司

Dates

Publication Date: 20260508
Application Date: 20260116

Claims (10)

1. The full-automatic multi-mode immunity analyzer is characterized by comprising a frame module (101), wherein a sample processing area, a reagent consumable area and a core reaction detection area are respectively arranged on the frame module (101), the sample processing area and the reagent consumable area are positioned at the front part of the frame module (101), the core reaction detection area is positioned at the rear part of the frame module (101), the core reaction detection area comprises a magnetic separation module (109) formed by N independent units, a trolley reaction module (108) formed by 2N independent units and a detection module (110), 2N independent units of the trolley reaction module (108) are divided into N groups, each group is distributed in an upper-lower double-layer mode, and each group is positioned below each independent unit of the magnetic separation module (109).
2. The full-automatic multimode immunoassay analyzer of claim 1, wherein the detection module (110) comprises a chemiluminescent detection module (117), a flow fluorescent detection module (110) and a flow cell detection module (110), wherein when flow fluorescent or flow cell detection is performed, a liquid flow to be detected is injected into the flow chamber through the sample adding module (112) and is excited by laser to detect fluorescent signals, when chemiluminescent detection is performed, the trolley reaction module (108) carrying the reagent strips after the completion of the reaction moves to a chemiluminescent detection position to perform PMT detection, and at the moment, the PMT is directly aligned with the reaction reagent strips, and can capture optical signals generated by the chemical reaction without laser excitation.
3. The full-automatic multimode immunoassay analyzer of claim 1, wherein the sample processing area comprises a sample pipe rack (102) driven by a synchronous belt, an inversion mixing module (103) and a cover opening module (104), all of which are fixed on the frame module (101), the sample processing area is sequentially arranged along the conveying direction of the sample pipe rack (102), the sample pipe rack (102) is used for loading and conveying sample pipes, the inversion mixing module (103) is positioned on one side of a conveying path, the cover opening module (104) is used for grabbing the sample pipes from a preset position of the sample pipe rack (102) to the inversion mixing module (103), the inversion mixing module (103) clamps the sample pipes for mixing, the cover opening module (104) is positioned behind the inversion mixing module (103) for performing cover opening operation on the mixed sample pipes, and after the sample adding module (112) absorbs samples, the cover opening module (104) returns the sample pipes to the original sample pipes and transfers the sample pipes to the sample rack.
4. The full-automatic multimode immunoassay analyzer of claim 1, wherein the reagent consumable region comprises a reagent storage module (105), a TIP rack module (106) and a TIP head unloading rack (107), the reagent storage module (105) is of a double-layer independent turntable structure, each turntable is driven by an independent stepper motor, and the number of reagent bits of the upper turntable is smaller than that of the lower turntable.
5. The full-automatic multimode immunoassay analyzer of claim 1, wherein the trolley reaction module (108) of the core reaction detection zone comprises a first independent unit (108 a), a second independent unit (108 b), a third independent unit (108 c) and a fourth independent unit (108 d), the magnetic separation module (109) comprises a first magnetic separation module (109 a) and a second magnetic separation module (109 b), the first independent unit (108 a) and the second independent unit (108 b) are arranged in an up-down overlapping mode, the first independent unit (108 a) is provided with a first magnetic separation module (109 a) above, the third independent unit (108 c) and the fourth independent unit (108 d) are arranged in an up-down overlapping mode, the third independent unit (108 c) is provided with a second magnetic separation module (109 b) above, and the first magnetic separation module (109 a) and the second magnetic separation module (109 b) move up and down through an electric lifting mechanism.
6. The fully automatic multi-modal immunoassay analyzer of claim 5, wherein the bottoms of the first (108 a), second (108 b), third (108 c) and fourth (108 d) independent units are provided with temperature controlled heating plates.
7. The full-automatic multimode immunoassay analyzer of claim 1, further comprising a cross-zone operation module, wherein the cross-zone operation module comprises a consumable transfer arm module (111) and a sampling module (112); The consumable transfer arm module (111) comprises a double-axis straight line module, a Z-axis guide rail and an integrated needle group, wherein the integrated needle group comprises a waste liquid needle (111 a), a substrate liquid needle (111 b) and a cleaning liquid needle (111 c), the consumable transfer arm module (111) is arranged on the frame module (101) through the double-axis straight line module of a Y-axis of the consumable transfer arm module, the Z-axis guide rail is arranged on a sliding table of the Y-axis module, and the integrated needle group is fixed on the sliding table of the Z-axis guide rail; The sample adding module (112) comprises a front arm group and a rear arm group, the front arm group comprises a double-shaft straight line module and a Z-axis guide rail, the rear arm group comprises a straight line guide rail and a sample feeding needle for sucking samples to the detection module (110), the front arm group is driven by a set of double-shaft straight line module, the rear arm group is driven by a set of straight line guide rail and carries a sample feeding needle, and the double arm groups independently and asynchronously operate.
8. The full-automatic multimode immunoassay analyzer of claim 1, further comprising an auxiliary system, wherein the auxiliary system comprises a liquid path system (113), an HCT module (114) and a circuit module (115); The liquid path system (113) is connected with the consumable transfer arm module (111), the detection module (110), the sampling module (112) and the HCT module (114) through pipelines, the liquid path system (113) adopts a multi-pump cooperative work system, and the multi-pump cooperative work system comprises three plunger pumps, a peristaltic pump and two diaphragm pumps; The HCT module (114) is fixedly arranged below the moving path of the forearm group of the sampling module (112); The circuit module (115) is connected to all motors, sensors, heating plates, lasers and pump valves by cables.
9. The full-automatic multimode immunoassay analyzer of claim 8, wherein two plunger pumps are respectively connected with a cleaning liquid needle (111 c) and a substrate liquid needle (111 b) of the consumable transfer arm module (111) through pipelines, and a third plunger pump is connected with a sample loading needle of the rear arm group of the sample loading module (112); The peristaltic pump is connected with the HCT module (114); One diaphragm pump is connected with a waste liquid needle (111 a) of the consumable transfer arm module (111) and is used for sucking chemiluminescence detection waste liquid generated in the reaction and cleaning process of the reagent strips, and the other diaphragm pump is connected with a flow detection liquid path of the detection module (110) and is used for rapidly exhausting the flow chamber and the waste liquid after flow fluorescence and flow cell detection in the pipeline.
10. A full-automatic multi-mode immunoassay method comprises the following steps: step 1, sample loading and identification; an operator places a sample tube carrying a sample on a sample tube rack (102) of a sample processing area, the sample tube rack (102) sequentially conveys the sample tube to a pretreatment station under the transmission of a synchronous belt, and an instrument identifies sample information through a bar code scanner; step 2, uniformly mixing the samples and uncapping; After the sample tube reaches a preset position, the cover opening module (104) grabs the sample tube to the reversing and mixing module (103), the sample tube is fully and uniformly mixed for a plurality of times, and after the mixing is finished, the cover opening module (104) moves to the upper part of the sample tube to open the cover; step 3, HCT detection and accurate sampling; The forearm group of the sampling module (112) moves to the TIP frame module (106) to grasp a clean TIP head, the forearm group moves to a uncapped sample tube to absorb a sample, the forearm group carries the sample to the upper part of the HCT module (114) and injects the sample to detect blood cell pressure volume under the control of the liquid path system (113); the cover opening module (104) covers the sample tube back to the original sample tube and moves the sample tube back to the original sample frame preset position, and the sample frame rotates to execute the next cycle; step 4, initializing reaction and distributing in multiple modes; The consumable transfer arm module (111) adds preset reagent strips from a turntable of the reagent storage module (105) to an idle unit of the trolley reaction module (108); According to the HCT calculation result, a forearm group of the sample adding module (112) distributes a sample with an accurate volume into a sample hole of a reagent strip, and meanwhile, a consumable transfer arm module (111) adds a preset reagent into a reaction hole of the same reagent strip from an integrated needle group; step 5, incubation and asynchronous reaction; The sample and the reagent are subjected to incubation reaction in a designated unit of a trolley reaction module (108), and a temperature control heating plate at the bottom of each independent unit maintains constant reaction temperature; The 2N independent reaction units are in an asynchronous control state, and a temperature control board of the circuit module (115) is responsible for carrying out closed-loop control on the temperature of each unit; step6, magnetic separation and cleaning; After incubation, when separating and cleaning the magnetic microspheres, the magnetic separation module (109) receives an instruction and descends to a position attached to the trolley reaction module (108) to adsorb the magnetic microspheres, and in a magnetic adsorption state, a waste liquid needle (111 a) of the consumable transfer arm module (111) absorbs and discards reaction waste liquid; Then, the cleaning liquid is injected into the cleaning liquid needle (111 c) of the consumable transfer arm, the waste liquid needle (111 a) sucks the waste liquid again, the cleaning step is completed, and after the completion, the magnetic separation module (109) is lifted off; step 7, signal detection and multi-mode multiplexing; After the completion of the chemiluminescent detection and the cleaning, a substrate liquid needle (111 b) of a consumable transfer arm module (111) adds a chemiluminescent substrate into a reaction cup, a trolley reaction module (108) carrying the reaction cup moves to a chemiluminescent detection position, and a PMT in a detection module (110) directly captures a luminescent signal; The rear arm group of the sampling module (112) can use a sampling needle to suck the reaction liquid into a flow chamber of the detection module (110), and the reaction liquid is excited by a 488nm/638nm laser, and the generated fluorescent signal is captured by a silicon photomultiplier; step 8, waste treatment and result output; After the detection is completed, the sample adding module (112) discards the used TIP head to the TIP head unloading frame (107), the magnetic separation module (109) pushes the discarded reagent strips into the waste bin (116), and the main control board of the circuit module (115) processes, analyzes and calculates the original data acquired by the detection module (110), and finally generates and outputs a detection report.

Description

Full-automatic multimode immunity analyzer Technical Field The application belongs to the field of medical examination automation equipment, and particularly relates to a full-automatic multi-mode immunity analyzer. Background The full-automatic immunoassay instrument is a core device for clinical detection, and quantitatively analyzes biomarkers through antigen-antibody reaction. In recent years, multi-mode detection technologies such as chemiluminescence, fluorescence immunochromatography, flow cytometry and the like are developed, but the existing equipment has obvious bottlenecks in the aspects of integration level, automation efficiency, multi-mode coordination and the like. The technical core problems include low utilization rate of a turntable type design space on structural layout, reduced parallel efficiency due to the fact that multiple modules cooperate with each other to collide with each other in time sequence, single function and volume contradiction on POCT (point of care testing) adaptation, automatic reliability on cup clamping/shutdown frequent occurrence and positioning errors, discrete multiple-mode integration on-channel, incapability of multiplexing samples, large loading deviation on liquid path precision and cross contamination risk. Disclosure of Invention In order to solve the technical problems in the prior art, the application provides a full-automatic multi-mode immunity analyzer integrating multi-mode detection, high parallel reaction units, online consumable replacement and upgrade liquid path control. In order to achieve the above object, the technical scheme of the present application is as follows: The utility model provides a full-automatic multimode immunity analysis appearance, includes the frame module, be provided with sample processing area, reagent consumable district and core reaction detection area on the frame module respectively, sample processing area and reagent consumable district are located the frame module front portion, the core reaction detection area includes the magnetic separation module that N independent unit constitutes, the dolly reaction module and the detection module that constitute by 2N independent unit, the 2N independent unit of dolly reaction module divide into N group, and every group is upper and lower bilayer distribution, and every group is located the below of every independent unit of magnetic separation module. The detection module comprises a chemiluminescent detection module, a flow fluorescent detection module and a flow cell detection module; When the flow fluorescence or flow cell detection is carried out, the liquid flow to be detected is injected into the flow chamber through the sample adding module, the laser is used for exciting and detecting fluorescent signals, when the chemiluminescence detection is carried out, the trolley reaction module carrying the reagent strips after the reaction is completed moves to the chemiluminescence detection position for PMT detection, and at the moment, the PMT is directly aligned to the reaction reagent strips, and the optical signals generated by the chemical reaction can be captured without laser excitation. The sample treatment area is sequentially arranged along the conveying direction of the sample pipe frame, the sample pipe frame is used for loading and conveying sample pipes, the inversion mixing module is located on one side of a conveying path, the cover opening module is used for grabbing the sample pipes from a preset position of the sample pipe frame to the inversion mixing module, the inversion mixing module clamps the sample pipes for mixing, the cover opening module is located behind the inversion mixing module, cover opening operation is carried out on the mixed sample pipes, after the sample adding module absorbs samples, the cover opening module returns the sample pipes to the original sample pipes, and the sample pipes are transferred to the sample frame. Further, the reagent consumable part comprises a reagent storage module, a TIP frame module and a TIP head unloading frame. The reagent storage module is of a double-layer independent turntable structure, each turntable is driven by an independent stepping motor, and the number of reagent bits of the upper turntable is smaller than that of the lower turntable. Further, the trolley reaction module of the core reaction detection area comprises a first independent unit, a second independent unit, a third independent unit and a fourth independent unit, the magnetic separation module comprises a first magnetic separation module and a second magnetic separation module, the first independent unit and the second independent unit are placed in an up-down overlapping mode, the first magnetic separation module is arranged above the first independent unit, the third independent unit and the fourth independent unit are placed in an up-down overlapping mode, the second magnetic separation module is arranged above the third independ