CN116519964B

CN116519964B - Automatic analysis system and control method thereof

Info

Publication number: CN116519964B
Application number: CN202310806851.4A
Authority: CN
Inventors: 向裕; 罗全胜; 柳邦源
Original assignee: Zhuhai Livzon Diagnostics Inc
Current assignee: Zhuhai Livzon Diagnostics Inc
Priority date: 2023-07-04
Filing date: 2023-07-04
Publication date: 2023-09-01
Anticipated expiration: 2043-07-04
Also published as: CN116519964A

Abstract

The application relates to an automatic analysis system and a control method thereof. The system comprises a sample container conveying unit, a reagent container storage unit, a detection analysis unit, a sample reagent processing unit and a pipetting unit, wherein the pipetting unit comprises a sample pipetting mechanism, a reagent A pipetting mechanism and a reagent B pipetting mechanism, each of the sample pipetting mechanism, the reagent A pipetting mechanism and the reagent B pipetting mechanism comprises a rotatable pipetting arm and a pipetting channel positioned on the pipetting arm, the gravity center of the automatic analysis system is positioned in a limiting area, and the limiting area is formed by the rotation axis of the pipetting arm of the sample pipetting mechanism, the rotation axis of the pipetting arm of the reagent A pipetting mechanism and the rotation axis of the pipetting arm of the reagent B pipetting mechanism. The problem of the pipetting accuracy that leads to because of each mechanism mutual interference reduces in the prior art is solved. Meanwhile, the chemiluminescence is combined with the multiple liquid phase chip methodology, so that a small amount of samples can be taken to finish detection of multiple targets/disease seeds, and the medical cost is reduced.

Description

Automatic analysis system and control method thereof

Technical Field

The application relates to the technical field of medical instruments, in particular to an automatic analysis system and a control method thereof.

Background

At present, in the field of in-vitro diagnosis of medical instruments, auxiliary diagnosis methods based on different methodologies are layered, and various disease markers are continuously discovered, however, it is not easy to detect the expected markers from the sample to be tested. On the one hand, the detection objects corresponding to the expected markers in the sample to be detected can be various, and the selection of which one or the combination of the two or more types has challenges; on the other hand, the content of different expected markers in the same sample to be tested is different, but the different methodologies generally have natural differences in detection precision, if different markers need to be detected in the same sample to be tested, detection reagents and special equipment based on different methodologies are often needed, such as C-reactive protein for infection auxiliary diagnosis, serum amyloid a is at mg level in blood, and the calcitonin principle also used for infection auxiliary diagnosis is at pg level. This results in the need to collect multiple batches of samples to be tested for detection of different markers, which is very unfriendly to the patient, and requires multiple sampling or single collection of a large number of samples, especially markers for blood drawing detection, which is high in medical cost. Meanwhile, a large number of samples are collected for multiple times or once to perform multi-target/multi-disease detection based on different methodologies, and operational inconvenience is brought to detection personnel, namely, detection is performed on multiple devices by using multiple reagents.

In order to solve the above problems, the present inventors creatively propose a scheme of integrating a chemiluminescent detection assembly and a multiple interpretation assembly in the same analysis system in CN115060886a, and intelligently select different detection modules according to a sample to-be-detected mode, so that the purchase cost of a user such as a medical institution can be effectively reduced, multiple markers of a single small amount of samples can be detected, and the detection efficiency can be improved. In the pretreatment module, a sample moving and taking mechanism, a pipetting mechanism and the like generally adopt a sample adding needle/sampling tube and other modes to take samples/reagents, and the accuracy of the sample moving and taking mechanism is generally required to be in the mu L level, so how to realize the high accuracy of the sample adding/pipetting mechanism is another technical problem faced in the field. The pretreatment module also comprises a plurality of groups of parts which need power driving, such as a washing assembly, an incubation turntable, a moving track and the like, and the rotation/vibration and the like of the power driving parts can further interfere the sample adding/pipetting accuracy of the sample adding/pipetting mechanism.

In the CN110252741B, a manner of controlling the control valve and the first and second diaphragm pumps by using an upper computer is provided, so that adverse effects of waste liquid of the sample adding needle are reduced, and sample adding accuracy is improved.

In patent application CN114441787a, a sample analyzer is provided, which is configured to monitor a change in electrical characteristics of a metal needle by electrically connecting an input end of a liquid level detection circuit with the metal needle, and determine whether the metal needle contacts the liquid level according to the change in electrical characteristics of the metal needle, so as to improve accuracy of liquid level detection and sample application precision.

In the patent CN108614101B, a chemiluminescent immunoassay analyzer is provided, and a cup washing strip frame of a rear Y-direction movement mechanism is driven by a bottom eccentric vibration motor to vibrate magnetic beads through a damping rubber column, so that the cleaning speed of the cup is improved, and the influence on the injection of cleaning liquid by an injection needle is reduced.

In summary, in the prior art, the interference of the power driving component to the sample loading/pipetting accuracy is generally reduced by means of software control, a damping mechanism and the like. However, with the development of integration and automation, more and more functional mechanisms are integrated in the same system, and although high-precision pipetting can be achieved by improving a single mechanism, the interaction between the mechanisms in the whole system still exists.

Disclosure of Invention

The application aims to provide an automatic analysis system for analyzing whether a target object exists or not or the existence amount of the target object in a sample to be detected through a marker, so that the technical problem of reduced pipetting accuracy caused by mutual interference of mechanisms in the prior art is solved, and the pipetting accuracy is effectively improved, so that the carrying pollution rate is effectively reduced. Meanwhile, chemiluminescence is effectively combined with multiple liquid phase chip methodology, so that detection of multiple targets/disease seeds can be completed by taking a small amount of samples, and medical cost is effectively reduced for both patients and medical institutions.

The present invention provides an automatic analysis system for analyzing the presence or amount of a target in a sample to be tested by a marker, comprising: a sample container transporting unit including a transporting mechanism for transporting the sample container to a pre-position and a returning mechanism for transporting the sample container from the pre-position; a reagent container storage unit including a storage mechanism for storing a reagent container and a reagent container driving mechanism for driving the storage mechanism to rotate; a detection analysis unit including a first mode detection mechanism and a second mode detection mechanism that detect the presence or absence or presence amount of a target object; a sample reagent processing unit comprising a mixing mechanism for mixing a sample to be tested with a reagent to form a mixture, a separation mechanism for separating a marker and/or a target from the mixture, and a gripping mechanism for determining to move the marker and/or the target to the first mode detection mechanism or the second mode detection mechanism according to the type of the marker and/or the target; a pipetting unit comprising a sample pipetting mechanism for pipetting a sample to be measured from the predetermined displacement, a reagent A pipetting mechanism for pipetting a first reagent from the storage mechanism, and a reagent B pipetting mechanism for pipetting a second reagent from the storage mechanism, wherein the sample pipetting mechanism, the reagent A pipetting mechanism, and the reagent B pipetting mechanism each comprise a rotatable pipetting arm and a pipetting channel on the pipetting arm; the gravity center of the automatic analysis system is located in a limiting area, and the limiting area is formed by encircling a pipetting arm rotating axis of the sample pipetting mechanism, a pipetting arm rotating axis of the reagent A pipetting mechanism and a pipetting arm rotating axis of the reagent B pipetting mechanism.

Through the gravity center setting to this automatic analysis system, can make to move the highest sample of pipetting accuracy requirement and get the mechanism, reagent A moves and gets the mechanism, reagent B moves and gets the mechanism three and all be located near the focus to can effectively reduce other power parts to pipetting arm, pipetting channel's influence, can promote pipetting accuracy by a wide margin.

Further, the rotation axis of the pipetting arm of the sample pipetting mechanism, the rotation axis of the pipetting arm of the reagent A pipetting mechanism and the rotation axis of the pipetting arm of the reagent B pipetting mechanism are parallel to each other and at least any two of them are not coincident, the center of gravity is located on a limiting surface in the limiting area, and the limiting surface passes through the rotation axis of the pipetting arm of the reagent A pipetting mechanism and the rotation axis of the pipetting arm of the reagent B pipetting mechanism.

Through with the focus setting between reagent A moves the pipetting arm of getting mechanism and reagent B and move the pipetting arm of getting mechanism, promote to move first reagent and the second reagent of getting and have higher precision, can make the reaction more accurate to the test result is more close to the true value.

Further, in the vertical direction, the center of gravity is located within the lower third of the area of the automatic analysis system.

By locating the center of gravity in the lower third of the area, the automatic analysis system can be made to operate more stably.

Further, a balancing weight is also arranged in the lower third area of the automatic analysis system. The gravity center of the automatic analysis system can be effectively adjusted through the arrangement of the balancing weight, so that the automatic analysis system is always located in a limited area.

Further, the balancing weight is also provided with a gravity center mark. The inspection and maintenance are convenient.

Further, the conveying mechanism comprises an emergency channel and a public channel which is arranged in parallel with the emergency channel, and the preset position is positioned at the tail ends of the emergency channel and the public channel; the loop-back mechanism comprises a track changing assembly and a recovery channel which is arranged in parallel with the public channel, the track changing assembly is used for moving the sample container which is preset to the recovery channel, and a pipetting arm rotating area of the sample transferring mechanism covers the preset position.

Further, the reagent container storage unit further comprises a shielding cover, wherein the shielding cover comprises an outer peripheral shell and a shielding cover which is detachably arranged above the outer peripheral shell, and the shielding cover is provided with a first reagent moving position for the reagent A moving mechanism to move a first reagent and a second reagent moving position for the reagent B moving mechanism to move a second reagent; the storage mechanism comprises a bearing table and a reagent container accommodating bin fixedly arranged on the bearing table, the outer Zhou Keti is arranged on the periphery of the bearing table in a surrounding mode, and the shielding cover shields the reagent container accommodating bin from the upper side; the reagent container driving mechanism comprises a first driving part for driving the bearing table to rotate and a second driving part for driving the reagent container to rotate, and the bearing table can enable the reagent container in the reagent container accommodating bin to rotate to the first reagent moving position or the second reagent moving position under the driving of the first driving part.

Further, the first mode detection mechanism is a chemiluminescent detection mechanism and comprises a substrate incubation component and a chemiluminescent detection component, the second mode detection mechanism is a multiple liquid phase detection mechanism and comprises a temporary storage component, a multiple interpretation component and a support frame for supporting the temporary storage component and the multiple interpretation component, the grabbing mechanism comprises a transverse guide rail and a gripper in sliding connection with the transverse guide rail, and the moving path of the transverse guide rail covers at least one part of each of the substrate incubation component, the temporary storage component and the multiple interpretation component.

Further, the mixing mechanism comprises a premixing rotary table, a premixing driving piece for driving the premixing rotary table to rotate, an incubation rotary table for incubating the mixing rotary table and a incubation rotary table driving piece for driving the incubation rotary table to rotate, the separating mechanism comprises a magnetic separating rotary table, a magnetic attraction piece positioned below the magnetic separating rotary table and a magnetic separating driving assembly for driving the magnetic separating rotary table to rotate, the incubation rotary table and the magnetic separating rotary table are coaxially arranged, and the premixing rotary table is closer to the conveying mechanism relative to the incubation rotary table.

Further, the sample moving and taking mechanism further comprises a rotary driving piece for driving the pipetting arm to rotate around the rotary axis and an upper and lower driving piece for driving the pipetting arm to move along the rotary axis, the pipetting arm is hollow, and the pipetting channel is communicated with the hollow of the pipetting arm.

The invention also provides a control method of the automatic analysis system, which comprises the following steps: determining the detection mode according to the type of the marker and/or the target determined by the user; invoking the conveying mechanism according to the determined detection mode to convey the sample to be detected to the pre-positioning; the sample moving and taking mechanism and the reagent A moving and taking mechanism are called to respectively move a sample to be tested and a first reagent to the mixing mechanism so as to form a mixture; or calling the sample moving and taking mechanism, the reagent A moving and taking mechanism and the reagent B moving and taking mechanism to respectively move the sample to be tested, the first reagent and the second reagent to the mixing mechanism to form a mixture; removing the mixture from the mixing mechanism to the separating mechanism; the grabbing mechanism is called according to the determined detection mode, if the determined detection mode is a first mode, the grabbing mechanism moves the marker and/or the target separated by the separating mechanism to the first mode detection mechanism, and if the determined detection mode is a second mode, the grabbing mechanism moves the marker and/or the target separated by the separating mechanism to the second mode detection mechanism; the first mode detection mechanism or the second mode detection mechanism completes detection; the gravity center of the automatic analysis system is located in a limiting area, and the limiting area is formed by encircling a pipetting arm rotating axis of the sample pipetting mechanism, a pipetting arm rotating axis of the reagent A pipetting mechanism and a pipetting arm rotating axis of the reagent B pipetting mechanism.

By applying the control method of the automatic analysis system, the technical problem of reduced pipetting accuracy caused by mutual interference of mechanisms in the prior art can be effectively solved, and the pipetting accuracy is effectively improved, so that the carrying pollution rate can be effectively reduced. Meanwhile, chemiluminescence is effectively combined with multiple liquid phase chip methodology, so that detection of multiple targets/disease seeds can be completed by taking a small amount of samples, and medical cost is effectively reduced for both patients and medical institutions.

Further, the automatic analysis system further comprises a gravity center determining step before the detection mode adopted according to the type determination of the marker and/or the target object determined by the user, and the gravity center determining step comprises judging whether the current signal is matched with the set signal or not through the gravity center detecting sensor.

Further, the center of gravity determining step further includes sending a prompt message if the center of gravity sensor detects that the current signal does not match the set signal.

Compared with the prior art, the automatic analysis system and the control method thereof can solve the technical problem of reduced pipetting accuracy caused by mutual interference of mechanisms in the prior art, and can effectively reduce the carrying pollution rate due to the effective improvement of pipetting accuracy. Meanwhile, chemiluminescence is effectively combined with multiple liquid phase chip methodology, so that detection of multiple targets/disease seeds can be completed by taking a small amount of samples, and medical cost is effectively reduced for both patients and medical institutions.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present application, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic plan view of an automatic analysis system according to an embodiment of the present application;

FIG. 2 is a schematic perspective view of an automatic analysis system according to an embodiment of the present application with the lower part hidden;

FIG. 3 is a front view of an automatic analysis system showing the location of the center of gravity according to an embodiment of the present application;

FIG. 4 is a schematic perspective view of a sample container handling unit of an automated analysis system according to an embodiment of the present application;

FIG. 5 is a schematic perspective view of a reagent container storage unit of an automatic analysis system according to an embodiment of the present application;

FIG. 6 is a schematic perspective view of a detection and analysis unit of an automatic analysis system according to an embodiment of the present application;

FIG. 7 is a schematic perspective view of a sample reagent processing unit of an automatic analysis system according to an embodiment of the present application;

FIG. 8 is a schematic perspective view of a sample removal mechanism of an automated analysis system according to an embodiment of the present application;

FIG. 9 is a schematic, partially enlarged plan view of an automated analysis system according to an embodiment of the present application;

fig. 10 is a flowchart of a control method of an automatic analysis system according to an embodiment of the present application.

1-a sample container transport unit; 2-a reagent container storage unit; a 4-sample reagent processing unit; 101-emergency channels; 102-a common channel; 103-common channel pre-positioning; 111-a track-change assembly; 1110-a track-change channel; 1111-an orbital transfer belt; 1112-a track-change motor; 1113-guide rail; 1114-bar; 112-a recovery channel; 1120—a conveyor belt; 1121—a channel motor; 1122-a baffle; 113-emergency channel pre-positioning; 20-a storage mechanism; 201-a bearing table; 21-a reagent vessel driving mechanism; 202-a reagent container holding bin; 203-first reagent shift positioning; 204-second reagent shift positioning; 2050-outer Zhou Keti; 2051-a shield cover; 211-a first driving member; 212-a second driver; 30-a first mode detection mechanism; 301-a substrate incubation assembly; 3010-detect carousel; 3011-heating the film; 3012-a temperature sensor; 302-a chemiluminescent detection component; 3021-supporting columns; 3022-circumferential wall; 3023-a chemiluminescent detection element; 3024-detecting a turntable motor; 31-a second mode detection mechanism; 311—a temporary storage component; 3110 temporary storage; 3111-a temporary storage chamber; 312-multiple interpretation component; 3120-an interpretation cavity; 3121-cover plate; 3122-interpretation motor; 3123-multiple liquid phase detection elements; 32-a support frame; 401-premixing a uniform rotating disc; 4010-premixing and uniformly placing the cavities; 40100-premixing uniformly placing cavities; 40101-outer premixing and placing the chambers; 403-incubating and uniformly mixing a turntable; 4030-incubating, mixing and placing the mixture in a cavity; 4031-incubating and uniformly mixing the reagent A, and placing; 4032-incubating and uniformly mixing the reagent B, and placing; 404-incubation mixing driving member; 4041-incubation mixing belt; 411-magnetic separation carousel; 4110-magnetic separation placement chamber; 412-magnetic attraction piece; 4120-magnet; 4121-a magnet drive motor; 413-a magnetic separation drive assembly; 4130-magnetic separation drive motor; 4131-a drive belt; 42-a grabbing mechanism; 421-transverse rail; 422-grippers; 430-supporting a skeleton; 44-a first reaction vessel transfer gripper; 45-a second reaction vessel transfer grip; 50-a sample removal mechanism; 501-pipetting arm; 5010—a lateral rotation arm portion; 5011—a vertical pipe section; 502-pipetting channel; 5030-a first belt; 5031-a rotary table; 5032-a rotary drive motor; 5040-sliding block; 5041—a slider guide rail; 5042-a slider drive motor; 5043-a second belt; 51-a reagent a removal mechanism; 52-a reagent B removing mechanism; 60-sample container; 601-test tube; 61-reagent vessel; 62-a reaction vessel; 70-an automatic cup feeding mechanism; 80-a touch screen; 90-balancing weight.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present application more apparent, the technical solutions of the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application, and it is apparent that the described embodiments are some embodiments of the present application, but not all embodiments of the present application. The components of the embodiments of the present application generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the application, as presented in the figures, is not intended to limit the scope of the application, as claimed, but is merely representative of selected embodiments of the application. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further definition or explanation thereof is necessary in the following figures.

In the description of the present application, it should be noted that, directions or positional relationships indicated by terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., are directions or positional relationships based on those shown in the drawings, or those that are conventionally put in use of the product of the application, are merely for convenience of describing the present application and simplifying the description, and do not indicate or imply that the apparatus or elements referred to must have a specific direction, be configured and operated in a specific direction, and thus should not be construed as limiting the present application. Furthermore, the terms "first," "second," "third," and the like are used merely to distinguish between descriptions and should not be construed as indicating or implying relative importance.

Furthermore, the terms "horizontal," "vertical," "overhang," and the like do not denote a requirement that the component be absolutely horizontal or overhang, but rather may be slightly inclined. As "horizontal" merely means that its direction is more horizontal than "vertical", and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.

In the description of the present application, it should also be noted that, unless explicitly specified and limited otherwise, the terms "disposed," "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present application will be understood in specific cases by those of ordinary skill in the art.

Some embodiments of the present application are described in detail below with reference to the accompanying drawings. The following embodiments and features of the embodiments may be combined with each other without conflict.

In the description of the embodiments of the present application, the "chemiluminescent method" refers to: according to the principle that the concentration of an object to be detected in a chemical detection system and the chemiluminescent intensity of the system are in a linear quantitative relation under a certain condition, the trace analysis method for determining the content of the object to be detected is utilized to detect the chemiluminescent intensity of the system by an instrument. The essential difference between chemiluminescence and other luminescence analysis is the energy source absorbed by the system to produce luminescence (optical radiation). The system produces chemiluminescence, and must have a photoradiation reaction that produces a detectable signal and a chemical reaction that provides a single reaction step at a time sufficient to cause the luminescence phenomenon. According to the characteristics of the energy supply reaction, the chemiluminescent method may be classified into a general chemiluminescent method (the energy supply reaction is a general chemical reaction), a biochemical luminescent method (the energy supply reaction is a biochemical reaction), an electrochemiluminescent method (the energy supply reaction is an electrochemical reaction), and the like.

Reference to "chemiluminescent one-step process" means: in the establishment of the reaction system, the identifier which is combined with the target in the sample to be tested, and the marker with the signal are simultaneously added into the system (a mixture is formed). Taking a double-antibody sandwich method as an example, a target object is an antigen to be detected, a recognition object is a primary antibody, a marker with a signal is a secondary antibody with a luminescent substance, and a chemiluminescent one-step method is described. The chemiluminescence one-step method refers to that a primary antibody combined with an antigen to be detected in a sample and a secondary antibody combined with a complex formed by the antigen to be detected in the sample and the primary antibody and provided with a luminescent substance are simultaneously added into a reaction system, the luminescent substance is marked on the secondary antibody, and a primary antibody-antigen-secondary antibody-luminescent substance complex is formed in the system. Meanwhile, if a substrate or an enzyme needs to be added into the reaction system, unreacted substances are removed after the system is cleaned, and the substrate or the enzyme reacts with the luminescent substances on the primary antibody-antigen-secondary antibody-luminescent substance complex, so that an optical signal can be generated under certain excitation (such as excitation light).

The reference to "chemiluminescent two-step process" means: in the establishment of the reaction system, the identifier bound to the target in the sample and the label with the signal are added to the system in two portions (to form a mixture). Taking a double-antibody sandwich method as an example, a target object is an antigen to be detected, a recognition object is a primary antibody, a marker with a signal is a secondary antibody with a luminescent substance, and a chemiluminescent two-step method is described. The chemiluminescence two-step method refers to adding a primary antibody which is combined with an antigen to be detected in a sample into a system with the antigen to be detected in the sample to form an antigen-primary antibody complex. After unreacted substances are removed from the system, adding a secondary antibody with a luminescent substance into the system, and combining the secondary antibody with the antigen-primary antibody complex to form the primary antibody-antigen-secondary antibody-luminescent substance complex. Meanwhile, if a substrate or an enzyme needs to be added into the reaction system, unreacted substances are removed after the system is cleaned, and the substrate or the enzyme reacts with the luminescent substances on the primary antibody-antigen-secondary antibody-luminescent substance complex, so that an optical signal can be generated under certain excitation (such as excitation light).

The mentioned "multiple liquid phase chip two-step method" means: when the reaction system is established, the identifier which is combined with the target in the sample to be detected and fixed on the multi-liquid-phase chip is added into the system in two times (a mixture is formed). Taking a double-antibody sandwich method as an example, taking a target object as an antigen to be detected, taking a recognition object as a primary antibody, taking a marker with a signal as a secondary antibody with a luminescent substance, and describing a multiple liquid phase chip two-step method. In the embodiment of the application, the antigen which is combined with the antibody to be detected in the sample and is fixed on the multiple liquid phase chip is added into a system with the antibody to be detected in the sample, so as to form a multiple liquid phase chip-antigen-antibody to be detected complex. After unreacted substances are removed from the system, adding a secondary antibody with a luminescent substance into the system, and combining the secondary antibody with the multiplex liquid-phase chip-antigen-antibody to be detected to form a multiplex liquid-phase chip-antigen-antibody to be detected-secondary antibody-luminescent substance complex. Meanwhile, if liquid is needed to be added into the reaction system to suspend the multi-liquid-phase chip, reinforcing liquid can be added.

In the description of embodiments of the present application, reference to "a first agent" refers to: a marker having a signal that binds to a target in a sample to be tested in a chemiluminescent one-step process; or, a recognition object which binds to a target in the sample in a chemiluminescent two-step process; or, an identifier immobilized on a multiplex liquid-phase chip that binds to a target in the sample in a two-step method of the multiplex liquid-phase chip.

Reference to "a second agent" means: a label with a signal in a chemiluminescent two-step process; or, a label with a signal in a multiple liquid phase chip two-step process.

Reference to "substrate liquid" refers to: when the identifier is an enzyme, the identifier reacts with the enzyme to generate an optical signal.

The reference to "enhancement fluid" means: and a liquid suspending the multiple liquid phase chip.

The units of the automatic analysis system will be described below in conjunction with the accompanying drawings, it being understood that the description of the units is for clarity of the text only and should not be construed as a split, it being clear to one skilled in the art that organically combining the units together to achieve a particular function is labor intensive.

Integral structure

As shown in fig. 1 and 2, an embodiment of the present application provides an automatic analysis system for analyzing a sample to be tested for the presence or amount of a target by a marker, which may include: a sample container transporting unit 1 including a transporting mechanism for transporting the sample container 60 to a pre-position (103, 113) and a returning mechanism for transporting the sample container 60 from the pre-position; a reagent container storing unit 2 including a storing mechanism 20 for storing a reagent container 61 and a reagent container driving mechanism 21 for driving the storing mechanism 20 to rotate; a detection analysis unit including a first pattern detection mechanism 30 that detects the presence or amount of a target object and a second pattern detection mechanism 31 that detects the presence or amount of a target object; a sample reagent processing unit 4 comprising a mixing mechanism for mixing a sample with a reagent to form a mixture, a separation mechanism for separating a marker and/or a target from the mixture, and a gripping mechanism 42 for moving the marker and/or the target to the first pattern detection mechanism 30 or the second pattern detection mechanism 31 depending on the type of the marker and/or the target; a pipetting unit including a sample pipetting mechanism 50 for pipetting a sample to be measured from the predetermined displacement, a reagent A pipetting mechanism 51 for pipetting a first reagent from the storage mechanism 20, and a reagent B pipetting mechanism 52 for pipetting a second reagent from the storage mechanism 20, wherein each of the sample pipetting mechanism 50, the reagent A pipetting mechanism 51, and the reagent B pipetting mechanism 52 includes a rotatable pipetting arm (501, 511, 521) and a pipetting channel (502, 512, 522) located on the pipetting arm; the center of gravity of the automatic analysis system is located in a limited area I-II-III surrounded by the rotation axis I of the pipetting arm of the sample pipetting mechanism 50, the rotation axis II of the pipetting arm of the reagent a pipetting mechanism 51, and the rotation axis III of the pipetting arm of the reagent B pipetting mechanism 52.

Through the focus of this automatic analysis system of reasonable setting for other power components (such as reagent container actuating mechanism 21, mixing mechanism, separating mechanism, snatch mechanism 42 etc.) are to the liquid-transfering precision interference reduction of pipetting arm and pipetting channel, and then promote the realization of accurate application of sample, because of the pipetting precision obtains effectively improving, can effectively reduce the portable pollution rate. Meanwhile, chemiluminescence is effectively combined with multiple liquid phase chip methodology, so that detection of multiple targets/disease seeds can be completed by taking a small amount of samples, and medical cost is effectively reduced for both patients and medical institutions.

Referring to the schematic plan view shown in fig. 1 and the schematic perspective view shown in fig. 2, the automatic analysis system of the present embodiment at least includes a sample container transporting unit 1, a reagent container storing unit 2, a detection and analysis unit, a sample reagent processing unit 4, a pipetting unit, an automatic cup feeding mechanism 70 for automatically adding a reaction container 62, a touch screen 80 for interaction, and the like.

On the side close to the user's work place, the automatic analysis system comprises a sample container transporting unit 1 for transporting a sample container 60 loaded with a sample to be tested, and the sample container 60 may be loaded with other substances, such as quality control substances and/or calibration substances. In general, to save space occupied by an automated analysis system, the direction in which the transport mechanism transports the sample containers 60 may be opposite to the direction in which the return mechanism returns the sample containers 60. The automated analysis system may also be multiple in series to form a pipeline, where the transport mechanism may serve both as a supply channel for the sample containers 60 of the automated analysis system and as a supply channel for sample containers 60 required by other downstream automated analysis systems.

The whole reagent container storage unit 2 is farther from the user's working position relative to the sample container transporting unit 1, a shielding cover 2051 may be provided above the reagent container accommodating compartment 202, a first reagent transferring position 203 and a second reagent transferring position 204 are provided on the shielding cover 2051, and the storage mechanism 20 is driven to rotate by the reagent container driving mechanism 21, so that only the reagent to be taken is transferred to the corresponding transferring position, and contamination of the reagent not taken can be prevented.

The detection and analysis unit is located farther from the user's working position than the reagent container storage unit 2, and comprises a first mode detection mechanism 30 and a second mode detection mechanism 31, a transverse guide rail 421 parallel to the conveying channel is arranged above the first mode detection mechanism and the second mode detection mechanism, a grip 422 capable of moving up and down is arranged on the transverse guide rail 421, and by arranging the detection and analysis unit at the working position farther from the user, the influence of light disturbance caused by the user's actions such as passing, vibration caused by adding samples or reagents, and the like on the detection result can be reduced.

The sample reagent processing unit 4 is used for preprocessing a sample to be detected, and comprises the steps of uniformly mixing the sample to be detected with a reagent, separating substances formed after the uniform mixing reaction of the sample to be detected and the reagent, and transferring liquid possibly containing a target object into a detection mechanism.

The pipetting unit is used for transferring liquid/fluid, such as sample to be measured, reagent, cleaning solution, substrate solution, enhancement solution, etc., and comprises a sample pipetting mechanism 50 for pipetting the sample, a reagent A pipetting mechanism 51 for pipetting the first reagent from the storage mechanism 20 and a reagent B pipetting mechanism 52 for pipetting the second reagent from the storage mechanism 20, wherein the sample pipetting mechanism 50, the reagent A pipetting mechanism 51 and the reagent B pipetting mechanism 52 each comprise a rotatable pipetting arm and a pipetting channel on the pipetting arm.

The center of gravity of the automatic analysis system is located in a limited area surrounded by the rotation axis I of the pipetting arm of the sample pipetting mechanism 50, the rotation axis II of the pipetting arm of the reagent a pipetting mechanism 51, and the rotation axis III of the pipetting arm of the reagent B pipetting mechanism 52. Through setting the focus of entire system to be closer to each pipetting arm and pipetting channel, can reduce the interference of power component to it on the whole to can effectively improve the pipetting accuracy.

Referring to fig. 1, the rotation axis I of the pipetting arm of the sample pipetting mechanism 50, the rotation axis II of the pipetting arm of the reagent a pipetting mechanism 51, and the rotation axis III of the pipetting arm of the reagent B pipetting mechanism 52 may be parallel to each other and at least any two of them may be misaligned, and the center of gravity of the automatic analysis system is located on a defined surface in the defined area, and the defined surface passes through the rotation axis of the pipetting arm of the reagent a pipetting mechanism 51 and the rotation axis of the pipetting arm of the reagent B pipetting mechanism 52, that is, the center of gravity of the automatic analysis system is located between the rotation axes of the pipetting arms for pipetting reagents, and the requirement of the reagent on pipetting accuracy is higher compared with the requirement of the sample to be measured, so that the center of gravity is closer to the two pipetting arms for pipetting reagents (that is, the reagent a pipetting mechanism 51 and the reagent B pipetting mechanism 52), so that the high-accuracy pipetting requirement is achieved, the reaction is more accurate, and the test result is closer to the true value.

In conjunction with the front view shown in fig. 3, the automatic analysis system may be divided into three parts in the vertical direction, namely, a region a located at the lowest part, wherein the region includes a first storage region for mainly storing various consumables (such as a needle tube, a TIP head, etc.), a second storage region for storing liquid consumables such as cleaning liquid/enhancement liquid/substrate liquid, etc., and a third storage region for optionally configuring the balancing weight 90; the zone B is positioned in the middle and is mainly used for installing each driving mechanism; and a C region located at the uppermost portion, which is a main working region including the sample container transporting unit 1, the detection and analysis unit, the pipetting unit, and the like. It will be appreciated that the score is based on the main functions and mass distribution of the automated analysis system and is not merely dependent on the physical height of the automated analysis system, e.g. a long plastic rod is provided above the pipetting unit, but is not the main mass distribution and is therefore not considered in the division A, B, C. The centre of gravity of the automatic analysis system is preferably located in zone a, i.e. in the lower third of the automatic analysis system, which may further improve the stability of the system.

Still further, still be provided with balancing weight 90 in this lower third area, adjust the focus position of this system through balancing weight 90 for pipetting unit whole is close to focus department, thereby improves pipetting accuracy, reduces the interference of power components such as driver (211, 212), mix the driver in advance, incubation mix driver 404, magnetism separation drive assembly 413 etc. to pipetting unit.

The weight 90 may further be provided with a weight mark for marking the position of the center of gravity of the automatic analysis system, and when the automatic analysis system is routinely checked and maintained, it may be determined whether the center of gravity is shifted.

The gravity center confirming method can adopt a conventional hoisting method, a sensing device detecting method, a software simulation method and the like, such as component mass center simulation by PROE, six-dimensional force sensor detection by ROBOTOUS and the like.

It will be appreciated that the amount of cleaning fluid/enhancing fluid/substrate fluid etc. will vary as the test proceeds, and that the amount of reagent containers 61 and the amount of reaction containers 62 will also vary as the test proceeds, and that by properly setting the center of gravity of the automatic analysis system of the present invention, the center of gravity of the automatic analysis system can be located within the above-described defined area, either in a full load state or in an empty load state. The full state may refer to a state in which the storage spaces of all consumables are full, and the empty state may refer to a state in which the storage spaces of all consumables are empty. Consumables may include various liquids, reagent containers 61, reagents, reaction containers 62, TIP heads, and the like.

Further, the gravity center mark on the balancing weight 90 includes a full load mark and an empty load mark, and when the automatic analysis system is checked and maintained, whether the automatic analysis system is in a good working state can be known by comparing the position of the currently detected gravity center with the mark position.

Sample container transporting unit 1

The sample container transporting unit 1 includes a transporting mechanism for transporting the sample container 60 to a pre-position and a returning mechanism for transporting the sample container 60 from the pre-position. The conveying mechanism comprises an emergency channel 101, a common channel 102 arranged in parallel with the emergency channel 101, the pre-positioning is arranged at the tail ends of the emergency channel 101 and the common channel 102, the returning mechanism comprises a track changing assembly 111 and a recovery channel 112 arranged in parallel with the common channel 102, the track changing assembly 111 is used for moving a pre-positioned sample container 60 onto the recovery channel 112, and the rotating area of a pipetting arm 501 of the sample transferring mechanism 50 covers the pre-positioning.

As shown in fig. 4, the emergency channel 101, the common channel 102 and the track changing assembly 111 are respectively provided with a sample container 60, a plurality of test tubes 601 can be arranged on the sample container 60, and samples to be tested, quality control products, calibration products and the like can be loaded in the test tubes 601. The recovery channel 112 is composed of a pair of baffles 1122, a conveyor 1120, and a channel motor 1121 for driving the conveyor 1120 in rotation, and the emergency channel 101 and the common channel 102 are constructed similarly to the recovery channel 112.

The track assembly 111 includes a track passage 1110, a track belt 1111 positioned below the track passage 1110, a stop lever 1114 positioned at the rear end of the track passage 1110, a track motor 1112 and a guide rail 1113 for driving the track passage 1110 and the track belt 1111 to move in a direction perpendicular to the conveying direction of the common passage 102.

When detection is required, the channel motor 1121 drives the conveyor belt 1120 to rotate so as to transport the sample container 60 located in the public channel 102 to the public channel preset position 103 or transport the sample container 60 located in the emergency channel 101 to the emergency channel preset position 113, after the sample moving mechanism 50 finishes sampling, the conveyor belt 1120 continues to move to transport the sample container 60 to the track changing channel 1110 and is blocked by the stop lever 1114, and then the track changing channel 1110 and the track changing conveyor belt 1111 move along the guide rail 1113 under the driving of the track changing motor 1112 so that the track changing channel 1110 is in butt joint with the recovery channel 112, and the track changing conveyor belt 1111 returns the sample container 60 to the recovery channel 112.

Reagent vessel storage unit 2

As shown in fig. 5, the reagent container storing unit 2 includes a storing mechanism 20 for storing the reagent containers 61 and a reagent container driving mechanism 21 for driving the storing mechanism 20 to rotate. The reagent container storing unit 2 further includes a shielding cover, which includes an outer portion Zhou Keti, 2050 and a shielding cover 2051 detachably disposed above the outer portion Zhou Keti, wherein two through grooves are formed in the shielding cover 2051, that is, a first reagent transferring position 203 for transferring the first reagent by the reagent a transferring mechanism 51 and a second reagent transferring position 204 for transferring the second reagent by the reagent B transferring mechanism 52 are formed.

The storage mechanism 20 includes se:Sup>A disk-shaped carrying table 201 and se:Sup>A reagent container accommodating chamber 202 fixed to the carrying table 201, the outer portion Zhou Keti 2050 is provided around the periphery of the carrying table 201, the shielding cover 2051 shields the reagent container accommodating chamber 202 from above, se:Sup>A plurality of reagent containers 61 are accommodated in the reagent container accommodating chamber 202, and se:Sup>A plurality of reagents such as antigen buffers (which may be se:Sup>A first reagent) of SS-se:Sup>A/Ro, gp210, sp100, LKM-1, LC-1, etc. coated with magnetic stripe codes for assisting diagnosis of autoimmune liver diseases and se:Sup>A phycoerythrin-labeled mouse anti-human IgG antibody buffer (which may be se:Sup>A second reagent) may be preloaded in the reagent container 61.

The reagent vessel driving mechanism 21 comprises a first driving member 211 for driving the carrying platform 201 to rotate and a second driving member 212 for driving the reagent vessel 61 to rotate, wherein the first driving member 211 and the second driving member 212 are arranged below the outer Zhou Keti 2050, a driving shaft of the first driving member 211 penetrates through the outer Zhou Keti 2050 and is in belt transmission connection with a rotating shaft belt on the bottom surface of the carrying platform 201, and a driving shaft of the second driving member 212 penetrates through the outer Zhou Keti 2050 and is in detachable transmission connection with a meshing gear at the lower end of the reagent vessel 61.

The carrying platform 201 is driven by the first driving member 211, so that the target reagent container 61 in the reagent container accommodating bin 202 can be rotated to the first reagent transferring position 203 or the second reagent transferring position 204, thereby facilitating the taking of the first reagent or the second reagent, and the reagent container 61 rotates under the driving of the second driving member 212, so that the reagent in the reagent container 61 can be kept in a uniform state during taking. Meanwhile, by covering the outer circumferences of the carrying table 201 and the reagent container housing chamber 202 with the shielding cover, the entry of the substances which are not allowed into the reagent container housing chamber 202 can be prevented.

Detection analysis unit

Referring to fig. 6, the detection and analysis unit includes a first pattern detection mechanism 30 and a second pattern detection mechanism 31, wherein the first pattern detection mechanism 30 may be a chemiluminescent detection mechanism including a substrate incubation component 301 and a chemiluminescent detection component 302, and the second pattern detection mechanism 31 may be a multiplex liquid phase detection mechanism including a temporary storage component 311, a multiplex interpretation component 312 and a support frame 32 supporting both.

The chemiluminescent detection assembly 302 comprises a plurality of support columns 3021, zhou Xiangbi fixedly connected to the support columns 3021, a detection dial 3010 containing a plurality of reaction vessels 62, a detection dial motor 3024 positioned below the detection dial 3010 and drivingly connected thereto, and a chemiluminescent detection element 3023. Substrate incubation assembly 301 includes a heating membrane 3011 and a temperature sensor 3012 that monitors the temperature of heating membrane 3011. A heating film 3011 may be attached to the interior of Zhou Xiangbi 3022 to facilitate the heated incubation of reactants within reaction vessel 62. The detection dial 3010 is provided with a plurality of luminescence detection chambers for accommodating the reaction containers 62, and the chemiluminescent detection element 3023 can detect optical signals of reactants in the reaction containers 62 through the luminescence detection chambers.

The buffer module 311 includes a buffer 3110 fixedly connected to the support frame 32 and a buffer chamber 3111 provided inside the buffer 3110, the buffer chamber 3111 being for temporarily storing the reaction vessel 62 for the sample reagent processing unit 4 to complete processing, and being loaded with reagents for the multiple liquid phase detection mode. The multiple interpretation component 312 includes an interpretation cavity 3120, a cover plate 3121 for covering the interpretation cavity 3120, an interpretation motor 3122 for driving the cover plate 3121 to close or open the interpretation cavity 3120, and multiple liquid phase detection elements 3123 located below the interpretation cavity 3120.

Sample ofReagent processing unit 4

Referring to fig. 7, the sample reagent processing unit 4 includes a mixing mechanism for mixing a sample with a reagent to form a mixture, a separating mechanism for separating a marker and/or a target from the mixture, and a gripping mechanism 42 for moving the marker and/or the target to the above-described first pattern detection mechanism 30 or second pattern detection mechanism 31 depending on the type of the marker and/or the target. As shown in fig. 9, the mixing mechanism includes a premixing turntable 401, a premixing driving member for driving the premixing turntable 401 to rotate, an incubation mixing turntable 403, and an incubation mixing driving member 404 for driving the incubation mixing turntable 403 to rotate, and the separating mechanism includes a magnetic separating turntable 411, a magnetic attraction member 412 located below the magnetic separating turntable 411, and a magnetic separating driving member 413 for driving the magnetic separating turntable 411 to rotate.

Specifically, a plurality of premixing and uniformly placing cavities 4010 for placing the reaction vessels 62 are arranged on the premixing and uniformly rotating disc 401, the reaction vessels 62 can be automatically placed into the premixing and uniformly placing cavities 4010 through the automatic cup feeding mechanism 70, and a premixing and uniformly driving member is a motor and is in transmission connection with the premixing and uniformly rotating disc 401 through a belt.

The incubation mixing turntable 403 is provided with a plurality of incubation mixing placing cavities 4030 for placing the reaction containers 62, the incubation mixing turntable 403 is in driving connection with the incubation mixing driving piece 404 through an incubation mixing belt 4041, a heating film 3011 is further arranged below the incubation mixing turntable 403, and the heating film 3011 is used for heating the reaction containers 62 on the incubation mixing turntable 403 so as to promote the reaction speed of the reagent and the sample to be tested.

In this embodiment, the pre-mixing turntable 401 and the incubation mixing turntable 403 are separately configured and may be grasped by the first reaction vessel transfer gripper 44 when it is desired to transfer the reaction vessel 62 on the pre-mixing turntable 401 to the incubation mixing turntable 403.

The magnetic separation turntable 411 is also provided with a plurality of magnetic separation placing cavities 4110 for placing the reaction containers 62, and magnetic attraction pieces 412 are correspondingly arranged below the magnetic separation placing cavities 4110, wherein each magnetic attraction piece 412 comprises a magnet 4120 and a magnet driving motor 4121 for driving the magnet 4120 to move up and down, and the magnetic beads, magnetic bar codes and other coatings in the reaction containers 62 can be adsorbed on the bottom wall or the side wall of the reaction containers 62 through the magnet 4120 to finish the steps of washing, eluting and the like.

The magnetic separation drive assembly 413 includes a magnetic separation drive motor 4130 and a drive belt 4131, the magnetic separation drive motor 4130 being drivingly connected to the magnetic separation rotor 411 by the drive belt 4131. The above components are all disposed on the support frame 430.

The incubation and mixing section 403 is disposed coaxially with the magnetic separation section 411, and the premixing section 401 is disposed closer to the conveying mechanism than the incubation and mixing section 403. The space occupation of the automatic analysis system can be effectively reduced by coaxially arranging the incubation and mixing turntable 403 and the magnetic separation turntable 411, the equipment volume is reduced, and when the reaction container 62 after incubation and mixing is required to be transferred onto the magnetic separation turntable 411, the reaction container can be grasped and transferred by the second reaction container transfer handles 45. Compared with the incubation mixing turntable 403, the premixing turntable 401 is arranged closer to the conveying mechanism, so that the waiting time for transporting the sample to be detected can be effectively reduced, and the detection time sequence is more met.

The gripping mechanism 42 includes a lateral rail 421 and a grip 422 slidably connected to the lateral rail 421, and a moving path of the lateral rail 421 covers at least a part of each of the substrate incubation unit 301, the temporary storage unit 311, and the multiple interpretation unit 312. Specifically, the movement path of the lateral rail 421 covers at least a portion of the luminescence detection chamber, at least a portion of the temporary storage chamber 3111, and at least a portion of the interpretation chamber 3120, to facilitate placement of the reaction containers 62 to the corresponding positions by the grippers 422.

Pipetting unit

The pipetting unit includes a sample pipetting mechanism 50 for pipetting a sample to be measured from the predetermined displacement, a reagent a pipetting mechanism 51 for pipetting a first reagent from the storage mechanism 20, and a reagent B pipetting mechanism 52 for pipetting a second reagent from the storage mechanism 20, and the sample pipetting mechanism 50, the reagent a pipetting mechanism 51, and the reagent B pipetting mechanism 52 each include a rotatable pipetting arm and a pipetting channel on the pipetting arm. Since the sample transfer mechanism 50, the reagent A transfer mechanism 51, and the reagent B transfer mechanism 52 are basically identical in structure, only the functions to be realized are different, and thus, only the sample transfer mechanism 50 will be described as an example.

Referring to fig. 8, the sample removal mechanism 50 includes a pipetting arm, a pipetting channel 502 on the pipetting arm, a rotational drive to rotate the pipetting arm, and an up-and-down drive to move the pipetting arm up and down. Specifically, the pipetting arm includes a vertical tube portion 5011 and a lateral rotation arm portion 5010, and the pipetting channel 502 may be a pipetting needle which is provided to be hollow to suck/discharge liquid by suction force, and is provided to be hollow in both the vertical tube portion 5011 and the lateral rotation arm portion 5010 to communicate with the inside of the pipetting needle.

A rotation driving member including a rotary table 5031, a rotation driving motor 5032, and a first belt 5030 drivingly connecting the rotary table 5031 and the rotation driving motor 5032 is provided below the vertical pipe portion 5011, and the vertical pipe portion 5011 is fixedly connected to the rotary table 5031 and communicates with a liquid supply system, not shown, through a pipe.

The up-and-down driving member includes a slider 5040, a slider guide rail 5041, a slider driving motor 5042, and a second belt 5043 driving the slider driving motor 5042 and the slider 5040. The slider 5040 is fixedly connected to the turntable 5031, and is driven by a slider driving motor 5042 to move the pipetting arm in the up-down direction.

Optionally, a shock pad is further provided on the rotary table 5031 to further reduce the influence of the power component on the pipetting needle pipetting/draining accuracy.

Detection process

The detection mode employed is determined based on the type of marker and/or target determined by the user.

As shown in fig. 10, before starting detection, a user needs to determine what detection mode should be adopted according to the type of the marker and/or the target, i.e. what detection mode should be adopted according to the expected content of the expected marker (target) in the sample to be detected, the possible cross reaction, etc.; or the detection mode may be determined according to the type of the label, such as an acridinium ester label or phycoerythrin label or streptavidin label, etc.; the type determination of the tag and the target may also be considered in combination. For example, the alkaline phosphatase-labeled anti-interleukin 6 monoclonal antibody can be determined to be detected by adopting a chemiluminescent detection mode, and the PCNA/Mi-2/Scl-70 antigen-coated magnetic stripe code-phycoerythrin-labeled murine anti-human IgG antibody liquid can be determined to be detected by adopting a multiplex liquid chip detection mode.

And calling the conveying mechanism to convey the sample to be tested to the pre-positioning according to the determined detection mode.

According to the detection mode determined by the steps, the automatic analysis system calls the conveying mechanism to convey the sample to be detected. Specifically, the automatic analysis system instructs the common channel 102 to convey the sample container 60 loaded with the sample to be tested located thereon to the common channel preset position 103, and if the sample to be tested is to be tested immediately, instructs the emergency channel 101 to convey the sample container 60 loaded with the sample to be tested located thereon to the emergency channel preset position 113, i.e. the channel can be used for processing the sample to be tested in priority, thereby improving the flexibility of use of the apparatus.

The sample container 60 for completing the sample conveying to be tested can be transferred to the recovery channel 112 through the rail changing assembly 111, so that the smoothness of the emergency channel 101 and the public channel 102 is ensured, and the efficient operation of the automatic analysis system is realized.

Invoking the sample moving and taking mechanism 50 and the reagent A moving and taking mechanism 51 to respectively move a sample to be tested and a first reagent to the mixing mechanism to form a mixture; or the sample moving and taking mechanism 50, the reagent A moving and taking mechanism 51 and the reagent B moving and taking mechanism 52 are called to respectively move the sample to be tested, the first reagent and the second reagent to the mixing mechanism so as to form a mixture.

The sample moving and taking mechanism 50 moves the sample to be measured on the preset position to the reaction vessel 62 on the premixing and uniformly placing cavity 4010, in this embodiment, the premixing and uniformly placing cavity 4010 comprises an outer premixing and uniformly placing cavity 40101 and an inner premixing and uniformly placing cavity 40100, the reaction vessel 62 conveyed by the automatic cup feeding mechanism 70 is discharged to the outer premixing and uniformly placing cavity 40101 for standby, and when the sample to be measured and/or the first reagent is required to be added, the first reaction vessel transferring gripper 44 grips the reaction vessel 62 of the outer premixing and uniformly placing cavity 40101 to the inner premixing and uniformly placing cavity 40100, so that the space of the premixing and uniformly rotating disc 401 can be fully utilized, and the test efficiency is improved.

After the sample transferring mechanism 50 transfers the sample to be measured into the reaction container 62, the premixing driving member drives the premixing turntable 401 to rotate by one station, the reagent a transferring mechanism 51 transfers the first reagent into the reaction container 62 on the inner premixing and uniformly placing cavity 40100 after sucking the first reagent from the first reagent transferring position 203, at this time, the sample to be measured is mixed with the first reagent to form a premix, the premixing turntable 401 continues to rotate to the action position of the first reaction container transferring grip 44, the first reaction container transferring grip 44 grips the reaction container 62 loaded with the premix into the reagent a incubation and uniformly placing position 4031, the incubation and uniformly mixing driving member 404 drives the incubation and uniformly mixing turntable 403 to rotate, and meanwhile, the heating film 3011 heats the reaction container 62 on the reagent a incubation and uniformly mixing placing position 4031 to promote the mixing and reaction of the sample to be measured and the reagent a to form a mixture.

Meanwhile, the incubation and mixing turntable 403 may further rotate the place where the reaction container 62 is placed to the place where the reagent B is placed for incubation and mixing, and the reagent B moving and taking mechanism 52 moves the second reagent into the reaction container 62 where the sample to be tested and the first reagent are placed, and the second reagent is rotationally and uniformly mixed under the driving of the incubation and mixing driving member 404 to form a mixture.

The mixture is removed from the mixing mechanism to the separating mechanism.

After the reaction vessel 62 loaded with the sample and the reagent to be measured is incubated and mixed in the incubation and mixing placing chamber 4030, the sample and the reagent are grasped to the magnetic separation placing chamber 4110 by the second reaction vessel transfer gripper 45, the magnet driving motor 4121 drives the magnet 4120 to rise so as to adsorb the substance having magnetism or being connected to the magnetic carrier in the reaction vessel 62 on the bottom wall or the side wall of the reaction vessel 62, the residual waste liquid is sucked out by the suction system and a new cleaning liquid is injected, the magnet driving motor 4121 drives the magnet 4120 to fall, the substance having magnetism or being connected to the magnetic carrier in the reaction vessel 62 is mixed with the cleaning liquid, optionally, an oscillating mixing piece can be further provided under the magnetic separation turntable 411 so as to promote the mixing of the cleaning liquid and the substance having magnetism or being connected to the magnetic carrier, and the above steps are repeated several times so as to separate the label and/or the target from the mixture.

The gripping means 42 is invoked according to the determined detection mode, and if the determined detection mode is a first mode, the gripping means 42 moves the marker and/or the target separated by the separation means to the first mode detection means 30, and if the determined detection mode is a second mode, the gripping means 42 moves the marker and/or the target separated by the separation means to the second mode detection means 31.

The labels and/or targets separated in the separation means are transported by the gripper 422 together with the reaction vessel 62 to the detection and analysis unit, wherein if a first mode is determined, it is moved to the first mode detection means 30, and if a second mode is determined, it is moved to the second mode detection means 31. The first mode detection means 30 may be a chemiluminescent detection means, and the second mode detection means 31 may be a multiplex liquid phase detection means.

If the first mode is a chemiluminescent two-step method, the automatic analysis system may also call the substrate incubation component 301, heat the liquid containing the substrate or enzyme (and the label and/or target separated by the separation mechanism in the same reaction system) through the heating film 3011 to promote the reaction, and call the chemiluminescent detection element 3023 to complete the detection of the reaction system.

If the first mode is a chemiluminescent one-step method, the chemiluminescent detection element 3023 may be directly invoked to complete detection of the reaction system without invoking the substrate incubation assembly 301.

If the determined second mode is a two-step method of multiple liquid phase chips, the reaction vessel 62 may be moved to the temporary storage cavity 3111 by the gripper 422 for placement, the chips in the reaction vessel 62 are moved to the interpretation cavity 3120 by the gripper 422 after being settled, and after the reaction vessel 62 is placed in the interpretation cavity 3120, the interpretation motor 3122 drives the cover plate 3121 to close the interpretation cavity 3120, and the multiple liquid phase detection element 3123 performs detection. The reaction vessel 62 may be filled with a substance for assisting a reaction such as an enhancement solution before the interpretation and detection.

The center of gravity of the automatic analysis system is located within a limited area defined by the axis of rotation of the pipetting arm of the sample pipetting mechanism 50, the axis of rotation of the pipetting arm of the reagent a pipetting mechanism 51, and the axis of rotation of the pipetting arm of the reagent B pipetting mechanism 52.

The center of gravity is arranged in the area surrounded by the rotation axis of the pipetting arm of the sample filling and taking mechanism 50, the rotation axis of the pipetting arm of the first reagent filling and taking mechanism 51 and the rotation axis of the pipetting arm of the second reagent filling and taking mechanism 52, so that the filling precision of the sample to be tested, the first reagent and the second reagent with high requirements on the filling precision can be effectively improved, the influence of each power part on the filling precision is reduced, CV can be effectively reduced, the carrying pollution rate is reduced, and the accuracy of the test result is improved when the method is used for testing.

Preferably, the automatic analysis system further includes a center of gravity determination step including determining whether or not the center of gravity detection sensor detects a match between the current signal and the set signal, before determining the detection mode to be adopted according to the type of the marker and/or the target determined by the user.

The center of gravity determining step further includes sending out a prompt message if the center of gravity detecting sensor detects that the current signal is not matched with the setting signal.

The counterweight mark is arranged on the counterweight 90, that is, the gravity center of the automatic analysis system is marked, the current gravity center position is determined through the gravity center detection sensor during routine inspection and maintenance, if the gravity center position is matched with the mark position, the automatic analysis system is considered to work well, and if the gravity center position is not matched with the mark position, a manufacturer is required to be informed to carry out maintenance.

Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present application, and not for limiting the same; although the application has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the application.

Claims

1. An automated analysis system for analyzing a test sample for the presence or amount of a target by a marker, comprising:

a sample container transporting unit including a transporting mechanism for transporting the sample container to a pre-position and a returning mechanism for transporting the sample container from the pre-position;

a reagent container storage unit including a storage mechanism for storing a reagent container and a reagent container driving mechanism for driving the storage mechanism to rotate;

a detection analysis unit including a first mode detection mechanism and a second mode detection mechanism that detect the presence or absence or presence amount of a target object;

a sample reagent processing unit comprising a mixing mechanism for mixing a sample to be tested with a reagent to form a mixture, a separation mechanism for separating a marker and/or a target from the mixture, and a gripping mechanism for determining to move the marker and/or the target to the first mode detection mechanism or the second mode detection mechanism according to the type of the marker and/or the target;

a pipetting unit comprising a sample pipetting mechanism for pipetting a sample to be measured from the predetermined displacement, a reagent A pipetting mechanism for pipetting a first reagent from the storage mechanism, and a reagent B pipetting mechanism for pipetting a second reagent from the storage mechanism, wherein the sample pipetting mechanism, the reagent A pipetting mechanism, and the reagent B pipetting mechanism each comprise a rotatable pipetting arm and a pipetting channel on the pipetting arm;

The gravity center of the automatic analysis system is located in a limiting area, and the limiting area is formed by encircling a pipetting arm rotating axis of the sample pipetting mechanism, a pipetting arm rotating axis of the reagent A pipetting mechanism and a pipetting arm rotating axis of the reagent B pipetting mechanism.

2. The automated analysis system of claim 1, wherein the pipetting arm axis of rotation of the sample pipetting mechanism, the pipetting arm axis of rotation of the reagent a pipetting mechanism, and the pipetting arm axis of rotation of the reagent B pipetting mechanism are parallel to each other and at least any two are not coincident, the center of gravity being located on a defined surface within the defined area that passes through the pipetting arm axis of rotation of the reagent a pipetting mechanism and the pipetting arm axis of rotation of the reagent B pipetting mechanism.

3. The automated analysis system of claim 1 or 2, wherein in a vertical direction, the center of gravity is located within a lower third of the automated analysis system.

4. The automated analysis system of claim 3, wherein a weight is further disposed within a lower third of the automated analysis system.

5. The automated analysis system of claim 4, wherein the weight is further provided with a center of gravity marker.

6. The automated analysis system of claim 1 or 2, wherein the delivery mechanism comprises an emergency path, a common path disposed parallel to the emergency path, the pre-positioning being at an end of the emergency path and the common path;

the loop-back mechanism comprises a track changing assembly and a recovery channel which is arranged in parallel with the public channel, the track changing assembly is used for moving the sample container which is preset to the recovery channel, and a pipetting arm rotating area of the sample transferring mechanism covers the preset position.

7. The automated analysis system of claim 1 or 2, wherein the reagent container storage unit further comprises a shielding cover comprising a peripheral housing and a shielding cover removably disposed over the peripheral housing, the shielding cover being provided with a first reagent transfer station for the reagent a transfer mechanism to transfer a first reagent and a second reagent transfer station for the reagent B transfer mechanism to transfer a second reagent;

the storage mechanism comprises a bearing table and a reagent container accommodating bin fixedly arranged on the bearing table, the outer Zhou Keti is arranged on the periphery of the bearing table in a surrounding mode, and the shielding cover shields the reagent container accommodating bin from the upper side;

The reagent container driving mechanism comprises a first driving part for driving the bearing table to rotate and a second driving part for driving the reagent container to rotate, and the bearing table can enable the reagent container in the reagent container accommodating bin to rotate to the first reagent moving position or the second reagent moving position under the driving of the first driving part.

8. The automated analysis system of claim 1 or 2, wherein the first mode detection mechanism is a chemiluminescent detection mechanism comprising a substrate incubation component and a chemiluminescent detection component, the second mode detection mechanism is a multiplex liquid phase detection mechanism comprising a temporary storage component, a multiplex interpretation component and a support frame supporting the temporary storage component and the multiplex interpretation component, the grasping mechanism comprises a transverse rail and a gripper slidably coupled to the transverse rail, a path of movement of the transverse rail covers at least a portion of each of the substrate incubation component, the temporary storage component and the multiplex interpretation component.

9. The automated analysis system of claim 1 or 2, wherein the mixing mechanism comprises a pre-mixing turntable, a pre-mixing drive member for driving the pre-mixing turntable to rotate, an incubation mixing turntable, and an incubation turntable drive member for driving the incubation mixing turntable to rotate, the separation mechanism comprises a magnetic separation turntable, a magnetic attraction member positioned below the magnetic separation turntable, and a magnetic separation drive assembly for driving the magnetic separation turntable to rotate, the incubation mixing turntable and the magnetic separation turntable are coaxially arranged, and the pre-mixing turntable is closer to the conveying mechanism relative to the incubation mixing turntable.

10. The automated analysis system of claim 1 or 2, wherein the sample removal mechanism further comprises a rotational drive member that drives the pipetting arm to rotate about the rotational axis and an up-down drive member that drives the pipetting arm to move in the direction of the rotational axis, the pipetting arm being configured to be hollow, the pipetting channel being in communication with the hollow of the pipetting arm.

11. A control method applied to the automatic analysis system according to any one of claims 1 to 10, characterized by comprising:

determining the detection mode according to the type of the marker and/or the target determined by the user;

invoking the conveying mechanism according to the determined detection mode to convey the sample to be detected to the pre-positioning;

the sample moving and taking mechanism and the reagent A moving and taking mechanism are called to respectively move a sample to be tested and a first reagent to the mixing mechanism so as to form a mixture; or calling the sample moving and taking mechanism, the reagent A moving and taking mechanism and the reagent B moving and taking mechanism to respectively move the sample to be tested, the first reagent and the second reagent to the mixing mechanism to form a mixture;

removing the mixture from the mixing mechanism to the separating mechanism;

the grabbing mechanism is called according to the determined detection mode, if the determined detection mode is a first mode, the grabbing mechanism moves the marker and/or the target separated by the separating mechanism to the first mode detection mechanism, and if the determined detection mode is a second mode, the grabbing mechanism moves the marker and/or the target separated by the separating mechanism to the second mode detection mechanism;

The first mode detection mechanism or the second mode detection mechanism completes detection;

12. The method according to claim 11, further comprising a center of gravity determination step before the detection mode employed in the determination of the type of the marker and/or the target determined by the user, the automatic analysis system further comprising a center of gravity detection sensor, the center of gravity determination step comprising determining whether or not the center of gravity detection sensor detects a current signal matches a set signal.

13. The method according to claim 12, wherein the center of gravity determining step further includes sending a prompt message if the center of gravity detecting sensor detects that the current signal does not match the set signal.