CN109142768B - Automatic analyzer and sample analyzing method - Google Patents

Automatic analyzer and sample analyzing method Download PDF

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Publication number
CN109142768B
CN109142768B CN201811163381.XA CN201811163381A CN109142768B CN 109142768 B CN109142768 B CN 109142768B CN 201811163381 A CN201811163381 A CN 201811163381A CN 109142768 B CN109142768 B CN 109142768B
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reaction
unit
filling
transfer
incubation
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CN109142768A (en
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张震
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Shenzhen Increcare Biotech Co Ltd
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Shenzhen Increcare Biotech Co Ltd
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/0092—Scheduling

Abstract

The present invention relates to an automatic analysis device, including: the filling unit comprises a first filling unit and a second filling unit, wherein the first filling unit is used for filling a sample or the sample and a part of reagent into the reaction container, and the second filling unit is used for filling the reagent into the reaction container; a reaction container supply unit for storing and supplying reaction containers; a filling station for receiving and carrying reaction vessels to be filled with samples or/and reagents, the filling station being movable back and forth between the reaction vessel supply unit, the first filling unit and the second filling unit; and a transfer unit that transfers the reaction vessel between different positions. Therefore, the sample and the reagent are completed by the first filling unit and the second filling unit in a coordinated and matched mode, the filling action of the filling units is completed at the independent filling stations, and the purpose of improving the testing speed on the basis of ensuring the compact layout of the whole machine is finally achieved.

Description

Automatic analyzer and sample analyzing method
Technical Field
The invention relates to the field of in-vitro diagnostic equipment, in particular to an automatic analysis device and a sample analysis method.
Background
In recent years, the development and progress of clinical examination and automation technology not only improves the automation level of clinical laboratories, improves the efficiency of medical examination, but also improves the quality and reliability of examination results. However, as the amount of samples to be detected increases, the clinical laboratory needs to add large-scale automatic detection systems to meet the detection requirements, so that the laboratory is increasingly crowded and the detection cost is increased. Therefore, how to improve the inspection efficiency, ensure the result, fully utilize the existing laboratory resources and reduce the detection cost expenditure under the pressure and the challenge of medical insurance control fee is an urgent problem to be solved in clinical inspection.
For convenience, the present invention is described herein In the context of a fully automated immunoassay analyzer In Vitro Diagnostics (IVD), and In particular, in the context of a luminescence immunoassay analyzer, and it will be understood by those skilled In the art that the present invention is also applicable to other clinical testing automation devices, such as fluorescence immunoassay devices, electrochemical immunoassay, and the like. The full-automatic immunoassay is mainly applied to mechanisms such as clinical laboratory of hospitals, third-party independent laboratories, blood examination centers and the like, carries out quantitative, semi-quantitative or qualitative detection on the content of each analyte in human body fluid, and diagnoses infectious diseases, tumors, endocrine functions, cardiovascular diseases, prenatal and postnatal care, autoimmune diseases and the like. A fully automatic immunoassay analyzer is generally composed of a sampling unit, a reaction unit, a supply and waste liquid unit, a system control unit, and the like. The luminescence immunity is the mainstream technology of the current automated immunity due to the advantages of quantitative detection, high sensitivity, good specificity, wide linear range, high automation degree and the like. The full-automatic luminescence immunoassay comprises enzymatic chemiluminescence, direct chemiluminescence, electrochemical luminescence and the like according to different labeling methods and different luminescence systems.
Referring to fig. 1-3, the luminescence immunoassay can be generally divided into a one-step method, a time-delay one-step method, a two-step method, etc. according to the test principle and mode, and the main test steps generally include sample and reagent injection, reactant mixing, incubation, washing separation (Bound-Free, abbreviated as B/F), signal reagent addition, measurement, etc. It is noted that for convenience, the present invention distinguishes between reagent and signal reagents, incubations and signal incubations. The reagent and the analysis items are in a one-to-one correspondence relationship, that is, the specific reagents corresponding to different analysis items are generally different in terms of formula, reagent amount, component amount and the like. Depending on the particular assay, the reagent typically comprises a plurality of components, such as 2-5 components as is common, including magnetic microparticle reagents, enzyme-labeled reagents, diluents, and the like. According to different reaction modes, a plurality of reagent components of one analysis item can be added at one time or in a plurality of steps, and the step-by-step adding is defined as a first reagent, a second reagent, a third reagent and the like according to the adding sequence. The signal reagent is used for measuring signal generation, and is usually one of the common reagents, and corresponds to the analysis items in a one-to-many manner, that is, the signal reagent is shared by different analysis items. The incubation of the invention refers to the process of antigen-antibody binding reaction or biotin-avidin binding reaction of reactants in a reaction unit under a constant temperature environment before the reaction container is washed and separated, specifically, the one-step incubation is performed once, and for the one-time incubation before washing and separating, the two-time delayed one-step incubation is performed twice, including the first incubation before adding a second reagent and the second incubation before washing and separating, and the two-step incubation is performed twice, including the first incubation before the first washing and separating and the second incubation before the second washing and separating. And the signal incubation refers to a process of adding a signal reagent into the reaction container after cleaning and separation, and reacting for a period of time in a constant temperature environment to enhance a signal. Depending on the reaction system and the luminescence principle, not all assays require signal incubation, and assays requiring signal incubation are generally enzymatic chemiluminescent immunoassays. The test steps corresponding to the different test modes are detailed as follows:
1) A one-step method: referring to fig. 1, the sample (S) and the reagent (R) are added, mixed (some test methods may not be mixed, and the same description is omitted), incubated (generally for 5-60 minutes), washed and separated after incubation, the signal reagent is added, the signal incubation (generally for 1-6 minutes), and finally measured. It should be noted that some luminescent systems do not require signal incubation due to the difference of the specific components of the signal reagent, and can directly measure the signal reagent during or after the signal reagent is added. The signaling agent may be one or more, and referring to fig. 2, the signaling agent includes a first signaling agent and a second signaling agent.
2) A delayed one-step method: the difference from the one-step method is that the reagent is added and incubated twice, the first reagent is added and mixed uniformly, then the first incubation is carried out, and the second reagent is added and mixed uniformly after the first incubation is finished. Compared with the one-step method, the method has more operations of one-time incubation, reagent filling and uniform mixing, and the rest processes are the same as the one-step method.
3) A two-step method: the difference of the delayed one-step method is that one more cleaning and separating step is added, and other steps are the same.
In order to implement the above process automation test, the existing specific implementation technical solution is as follows:
the first prior art scheme separates incubation, washing separation and measurement into independent layouts, and three rotating discs respectively complete corresponding functions, and a reaction vessel is transferred between different units by a mechanical gripper arm. The technical scheme has a plurality of components and units, incubation transfer displacement, cleaning separation transfer displacement and measurement transfer displacement are dispersed on different discs, the distance is long, and a reaction container needs to be transferred among transfer positions, so that the problems of large volume, high cost, multiple movement paths, complex control flow and the like are caused.
The second prior art scheme arranges incubation and measurement together to form an incubation measurement unit, and the cleaning and separation are completed by another independent unit, although compared with the first prior art scheme, the second prior art scheme reduces a measurement disc, is beneficial to controlling the size and cost of the whole machine to a certain extent, and has the same problems as the first prior art scheme. In order to realize flexible incubation time, the incubation measuring unit is complex to control, incubation and measurement can be mutually restricted in control, and the technical scheme has the defects that high-speed automatic test cannot be realized, and flexible signal incubation cannot be realized.
In addition, in order to realize the delayed one-step method and two-step method test, at least two sample adding mechanisms and at least two cleaning and separating mechanisms are required, so that the material, processing and production cost and the size of the whole machine are increased. On the other hand, the technical scheme also limits the incubation time, and causes the problems of fixed incubation time, overlong result output time and the like. In addition, the technical scheme is difficult to realize the darkroom environment required by measurement, an additional shutter mechanism is required to be added, and flexible signal incubation cannot be realized.
Disclosure of Invention
In order to solve the defects and problems commonly existing in the prior art, the invention provides an automatic analysis device and a sample analysis method which can make the layout of the whole machine compact and improve the test speed.
In one aspect of the present invention, there is provided an automatic analyzer comprising:
the filling unit comprises a first filling unit and a second filling unit, wherein the first filling unit is used for filling a sample or the sample and a part of reagent into the reaction container, and the second filling unit is used for filling the reagent into the reaction container;
a reaction container supply unit for storing and supplying reaction containers;
a filling station for receiving and carrying reaction vessels to be filled with samples or/and reagents, the filling station being movable back and forth between the reaction vessel supply unit, the first filling unit and the second filling unit; and
a transfer unit that transfers the reaction vessel between different positions.
According to another aspect of the present invention, there is provided a sample analysis method comprising:
a filling step of moving a filling station back and forth among the reaction container supply unit, the first filling unit and the second filling unit, providing a reaction container to the filling station by using the reaction container supply unit, adding a sample or the sample and a part of reagent into the reaction container by using the first filling unit, and adding the reagent into the reaction container by using the second filling unit;
an incubation step of incubating a reaction vessel including at least two incubations into the reaction unit through at least one incubation transfer site;
a cleaning and separating step of cleaning and separating the reaction vessel entering the reaction unit through at least one cleaning and separating transfer site to remove unbound components in the reactant;
a step of filling a signal reagent, in which the signal reagent is filled into the reaction vessel,
and a measuring step of measuring a reaction signal in the reaction vessel by a measuring device.
The reaction container filling device is provided with independent filling stations for filling samples and reagents, and the filling stations can move back and forth among the reaction container supply unit, the first filling unit and the second filling unit so as to receive the reaction containers supplied by the reactor supply unit, the samples or the samples and part of the reagents filled by the first filling unit and the reagents filled by the second filling unit. Therefore, the sample and the reagent are completed by the first filling unit and the second filling unit in a coordinated and matched mode, the filling action of the filling units is completed at the independent filling stations, and the purpose of improving the testing speed on the basis of ensuring the compact layout of the whole machine is finally achieved.
Drawings
FIG. 1 is a schematic diagram of a one-step reaction scheme;
FIG. 2 is a schematic diagram of a one-step reaction scheme (another signal measurement mode);
FIG. 3 is a schematic of the delayed one-step and two-step reaction modes;
FIG. 4 is a schematic view of a first embodiment of an automatic analyzer according to the present invention;
FIG. 5 is a one-step test flow chart;
FIG. 6 is a flow chart of the delayed one-step test;
FIG. 7 is a flow diagram of a two-step test;
FIG. 8 is a schematic view of a second embodiment of an automatic analyzer according to the present invention;
FIG. 9 is a schematic view of a third embodiment of the automatic analyzer of the present invention;
FIG. 10 is a schematic view of a fourth embodiment of the automatic analyzer of the present invention;
FIG. 11 is a schematic view of an automatic analyzer according to a fifth embodiment of the present invention.
Detailed Description
The present invention will be described in further detail with reference to the following detailed description and accompanying drawings.
An automatic analyzer according to the present invention includes: the reaction unit comprises a rotating device, wherein a plurality of reaction container positions are arranged on the rotating device and used for bearing and fixing the reaction containers, at least one incubation transfer position and at least one cleaning separation transfer position are arranged on the reaction unit, and the at least one incubation transfer position and the at least one cleaning separation transfer position of the reaction unit are in the horizontal movement range of the transfer unit.
The reaction container provides a reaction site for a reaction between a sample and a reagent, and may be a reaction tube, a reaction cup, a multi-well reaction cup strip, a reaction chip, or the like, having various shapes and configurations, and is generally disposable. The material of the reaction vessel is usually plastic, such as polystyrene or the like. The reaction container may or may not be coated with antigen or antibody on its inner wall, and may have coated magnetic beads or plastic beads stored inside. The storage and supply of the reaction vessels is accomplished by a reaction vessel supply unit. For simplification of the mechanism, the reaction vessel supply unit is preferably in a pre-arrangement type in which reaction vessels are arranged in advance on a reaction vessel tray, cassette or a reaction vessel rack, or a channel, and the reaction vessel supply unit can transport an entire tray, an entire cassette of reaction vessels, or a row or a line of reaction vessels to a target position at a time. In other embodiments, the reaction vessel supply unit may be of a silo type, the reaction vessels may be dumped into the silo of the reaction vessel supply unit in a pack, and then the reaction vessel supply unit automatically arranges the reaction vessels one by one in order, supplying the reaction vessels to the transfer unit.
The transfer of the reaction vessels between different positions in the apparatus of the invention can be accomplished by a transfer unit. The transfer unit may be any suitable mechanism capable of transferring or moving the reaction vessel, and the preferred transfer unit of the present invention mainly comprises a driving mechanism, a horizontal motion mechanical arm, a pick-and-place mechanism, and the like. The grabbing and placing mechanism is usually a mechanical finger and can grab and place the reaction containers, and the horizontal motion mechanical arm can move the grabbing and placing mechanism along the X direction, the Y direction, the X direction and the Y direction, the radial direction, the circumferential direction and the like under the driving of the driving mechanism to move the reaction containers grabbed by the grabbing and placing mechanism to different positions. In addition to the horizontal movement, the transfer unit can also move up and down to place the reaction vessels in different positions or take them out of different positions. One or more transfer units may be provided depending on the test speed and overall layout.
And the filling unit is used for filling the sample and the reagent. The filling unit is generally composed of components such as a steel needle or a disposable suction nozzle (Tip), a filling motion driving mechanism, an injector or an infusion pump, a valve, a fluid pipeline, a cleaning pool (or no cleaning pool when Tip is used), and the like. In order to complete the actions of sucking the sample, the reagent and filling the reagent, the filling unit can move up and down and also can move horizontally, and the horizontal movement generally has several movement modes such as rotation, X direction, Y direction and the like and the combination thereof. The filling unit can be one, and can be used for adding the sample and the reagent, so that the whole machine is more compact in structure and lower in cost. In order to improve the testing speed, the filling unit can further comprise one or more sample filling units and one or more reagent filling units, wherein the sample filling unit only fills the sample or fills the sample and part of the reagent, and the reagent filling unit fills the reagent.
To facilitate filling of the filling unit, the invention may also include a filling station. The filling station is located in the movement range of the transfer unit and the filling unit or can be moved into the movement range of the transfer unit and the filling unit by a horizontal movement. The filling station receives and carries the reaction container transferred by the transfer unit, and the receiving and filling unit fills the sample and the reagent into the reaction container. The filling station is provided with a reaction container position for placing a reaction container which needs to be filled with a sample and a reagent. In order to enable the sample and the reagent to be mixed more uniformly and react more fully, and meanwhile, in order to simplify the structure of the whole machine and reduce the volume, the invention preferably integrates a mixing mechanism in a filling station, and carries out ultrasonic mixing, biased rotation or vibration mixing on the reaction container after each filling. Of course, a blending mechanism, such as an ultrasonic generator, may also be integrated into the filling unit, and the blending is achieved by the ultrasonic generated by the filling unit while filling the sample and the reagent or after the filling operation is completed. Those skilled in the art will appreciate that the filling station may not incorporate a blending mechanism, and blending may be accomplished by suction or impact of the filling unit.
The reaction unit carries and holds the reaction vessel. The reaction unit mainly comprises a heat preservation device, a rotating device and a cleaning and separating device. The periphery of the heat preservation device is usually provided with heat insulation materials such as heat preservation cotton and the like, the heat insulation materials are usually wrapped or enclosed at the bottom, the periphery and the upper part of the rotating device, the side surface or the inner side of the bottom can be provided with a heating device and a sensor, the upper part is generally of a cover plate and other structures, a constant temperature incubation environment is provided for the reaction unit, and the heat dissipation of the reaction unit is prevented or reduced. Of course, the heating means may also be mounted on the rotating means for higher heat transfer efficiency. Besides providing an incubation environment, the heat preservation device can also support and fix the magnetic field generating device of the cleaning and separating device so as to provide a magnetic field environment for cleaning and separating. In addition, if the measuring device is installed on the reaction unit, the heat preservation device not only can provide an installation position for the light measuring device, but also can realize a darkroom environment required by the light measuring device. The rotating device is preferably one, and includes a driving mechanism, a transmission mechanism and related control circuits, etc., and controls and drives the rotating device to rotate for a fixed angle at fixed time intervals (e.g., one cycle or period) to forward the reaction container position to a certain position (e.g., forward one reaction container position). The rotating device is provided with a plurality of independent holes, grooves, brackets, bases or other structures suitable for bearing reaction containers, and the position of the reaction container is defined as the position of the reaction container. The reaction vessel site may also hold a reaction vessel in addition to the reaction vessel site. By "fixed" is meant that the reaction vessel does not move or slide within the reaction vessel site, but is movable with the reaction vessel site as a whole. Therefore, the reaction container and the reaction container are attached more tightly, the gap is smaller, the heat transfer incubation and the accurate positioning of the reaction container are facilitated, the structure of the rotating device can be simplified, more reaction container positions can be accommodated, and the production and manufacturing cost is lower, so that the defects that in the prior art, the heat transfer efficiency is poor, the space is wasted, the structure is complex and the like due to the fact that the reaction container moves in the reaction container positions are effectively overcome. In addition to carrying and fixing, the reaction unit also incubates the reactants within the reaction vessel. For tests requiring signal incubation, the reaction unit of the invention may also perform a signal incubation function.
In order to move the reaction vessel into and out of the reaction unit, at least two transfer positions are provided on the reaction unit. The transfer position is defined as a fixed position of the reaction vessel on the reaction unit to and from the reaction unit within the horizontal movement range of the transfer unit, and does not rotate with the rotation of the reaction vessel position. The reaction container positions at different positions can be transferred and positioned to the transfer position under the rotation of the rotating device, and receive the reaction containers or withdraw the reaction containers thereon so that the reaction containers can complete the subsequent corresponding functions, such as entering a reaction unit for incubation or transferring to other reaction container positions for cleaning and separation, and the like. According to the different stages of the inlet and outlet of the reaction vessel and the different main functions of the realization, the transfer position can be divided into an incubation transfer position and a cleaning separation transfer position. The transfer position through which a reaction container to be incubated enters a reaction unit and is transferred out of the reaction unit after incubation for a certain time or after incubation is finished is defined as incubation transfer position; and defining a transfer position through which the reaction container needing to be cleaned and separated enters the reaction unit or/and the reaction container completing cleaning and separation is transferred out of the reaction unit after a certain incubation time or after the incubation is finished as a cleaning and separation transfer position. At least one incubation transfer position of the reaction unit is arranged, and the specific incubation transfer position can only enter or only exit or not enter or both exit and enter the reaction container according to the requirement, so that flexible incubation time and various overall layouts can be realized. It should be noted that, in order to solve the disadvantages and problems of the prior art, the reaction vessel moved into and out of the reaction unit by the incubation transfer includes a reaction vessel requiring one incubation, two incubations or more, so that the reaction vessel requiring one incubation, two incubations or more can be incubated collectively, thereby reducing the size of the reaction unit and increasing the space utilization rate of the reaction unit. The cleaning and separating transfer position can be one, and the reaction containers can be moved out and in, so that the cleaning and separating device is more compact, and at least one cleaning and separating device can be arranged, so that the cleaning and separating device can be more flexibly arranged. In a word, the arrangement of the rotary displacement on the reaction unit solves the problems that the rotary displacement is dispersed on a plurality of different units and reaction containers needing incubation are dispersed and placed in the prior art, not only can the movement path of the transfer unit be less and the distance be shorter, but also the space of the reaction unit is fully utilized, so that the whole machine is simpler to control and has smaller size.
In addition to the above functions, the cleaning and separating device on the reaction unit can also realize cleaning and separation to remove the unbound components in the reactants. The cleaning and separating device of the reaction unit comprises a magnetic field generating device and a flushing mechanism. The magnetic field generating device provides a magnetic field environment, so that the paramagnetic particles in the reaction container are adsorbed to the inner wall of the reaction container. Due to factors such as response time, moving distance and resistance in the magnetic field, the paramagnetic particles need a certain amount of time, usually several seconds to several tens of seconds, to adsorb to the inner wall of the reaction vessel, so that the reaction vessel needs to pass through the magnetic field for a certain period of time before waste liquid (including unbound components) is sucked each time. In a preferred embodiment of the invention, the magnetic field generating device can be directly installed or fixed on the heat preservation device of the reaction unit, so that not only can an additional fixing mechanism be saved and the cost be reduced, but also the magnet generating device can be closer to the reaction container, thereby reducing the adsorption time of paramagnetic particles and improving the cleaning and separation efficiency. The flushing mechanism comprises a liquid suction and injection device, sucks the unbound components in the reaction container and injects a washing buffer solution into the reaction after suction. The liquid suction device comprises a liquid suction part suitable for sucking liquid, such as a liquid suction needle, a liquid suction pipe or a liquid suction nozzle, the liquid suction part is arranged above the reaction unit, and can be driven by a driving mechanism to enter and exit the reaction container on the reaction container position to suck the unbound components in the reaction container. The liquid injection device comprises a liquid injection part suitable for discharging and injecting liquid, such as a liquid injection needle, a pipe, a nozzle and the like, the liquid injection part is also arranged above the reaction container position of the reaction unit, and the pumped reaction container is injected with cleaning buffer liquid. Each washing comprises one time of imbibition and one time of injection of washing buffer solution and process, and the washing is generally carried out three times or four times, namely three times or four times of washing, although the washing times can also be flexible and variable. In order to ensure more thorough cleaning and less residue, a mixer can be arranged at the liquid injection position to uniformly mix the reaction container or the paramagnetic particles are resuspended and uniformly dispersed in the cleaning buffer solution while or after the cleaning buffer solution is injected by using the impact force during liquid injection. When the reaction unit rotating device transfers the reaction vessel to the cleaning and separating device, the cleaning and separating device starts to clean and separate the reaction vessel. In addition, for simplifying the mechanism, the cleaning and separating device may further be coupled with a signal reagent filling mechanism, after the reaction vessel is cleaned and separated, all or part of the signal reagent, such as all of the first and second signal reagents or only the first signal reagent, is filled therein, and the rest of the signal reagent may be filled during the measurement. Therefore, the function of the cleaning and separating mechanism can be fully utilized, the volume of the mechanism is reduced, and the cost is saved.
It can be known from the above description that the cleaning and separating device is arranged at the periphery of the reaction unit rotating device or above the rotating device, and can directly clean and separate the reaction vessel on the reaction unit rotating device, so that the arrangement of an independent cleaning and separating rotating device, such as an independent cleaning and separating disc or a cleaning and separating track, is avoided, not only are the components and the whole machine mechanism simplified, the whole machine mechanism is more compact and lower in cost, but also the transfer of the reaction vessel between the independent cleaning and separating device and the reaction unit is avoided, the whole machine control process is simpler and more efficient, and the processing efficiency and the reliability are improved.
The measuring device measures the signal in the reaction vessel. The signal is an electric signal, a fluorescent signal or a weak chemiluminescent signal generated after a signal reagent is added into the reaction container. The measuring device comprises a weak light detector Photomultiplier (PMT) or other sensitive photoelectric sensing devices, and can convert measured optical signals into electric signals and transmit the electric signals to a control center. In addition, in order to improve the measurement efficiency and ensure the measurement consistency, the measurement device can further comprise optical devices such as optical signal collection and calibration. Taking weak chemiluminescence signals as an example, in order to avoid interference of ambient light, the measuring device has three implementation modes for measuring signals in the reaction vessel. In a first embodiment, the measuring device is mounted on the reaction unit and measures the reaction signals in the reaction vessels on the reaction vessel sites of the reaction unit. Therefore, the reaction container position on the reaction unit can be fully utilized, so that the whole machine is more compact and the cost is lower. The second embodiment comprises a measurement darkroom and a measurement position, wherein the measurement device is arranged on the measurement darkroom and is used for measuring the signal in the reaction container on the measurement position. The measuring position is within the horizontal movement range of the transfer unit or can be moved horizontally into the horizontal movement range of the transfer unit. The third embodiment mainly comprises a measuring disc, a measuring darkroom, a measuring device and the like. The measuring disc comprises at least one circle of reaction container position which takes the rotation center of the measuring disc as the circle center and is used for bearing the reaction container which needs to be measured. For tests requiring signal incubation, the reaction vessel sites on the measurement plate may also perform a signal incubation function. Through the rotation of the measuring disc, the reaction container on any reaction container position on the measuring disc can be rotated to the measuring device for measurement, so that flexible signal incubation is realized, and the flexibility and the efficiency of the test are improved. The measuring darkroom of the measuring unit is wrapped or surrounded on the periphery of the measuring disc to provide a closed darkroom environment for the measuring unit. Further, in order to realize the signal incubation function of some tests, a heating device and a sensor can be arranged on the side surface or the bottom of the measurement darkroom, so that a constant-temperature incubation environment is provided for the measurement unit, and the heat dissipation of the reaction unit is prevented or reduced. Of course, the heating device may also be mounted on the measuring disk for a higher heat transfer efficiency. The measuring device can be connected or mounted on the measuring dark room in a general way, for example, directly mounted and fixed on the measuring dark room or mounted on the measuring dark room through optical fiber connection, so that the signal in the reaction container on the reaction container position of the measuring disc can be directly measured, and the processing efficiency and the reliability can be higher. The measuring device can be flexibly arranged according to design requirements, not only is the darkroom environment easy to realize, but also flexible signal incubation can be realized, and the defects that the darkroom structure is complex, the arrangement of the measuring device is difficult and the like in the prior art are overcome.
In addition, the automatic analyzer of the present invention may further include a sample transfer unit, a reagent storage unit, and the like for transferring a sample and storing a reagent.
The sample conveying unit is used for placing a sample tube to be detected and conveying a target sample tube to a sample sucking position. The sample conveying unit has three main modes of track sample introduction, sample disc sample introduction and fixed area sample introduction, sample tubes are usually placed on sample racks, each sample rack is generally placed with 5 or 10 sample tubes, and the sample racks are placed on a transmission track, a sample disc or a fixed area of an analysis device.
The reagent storage unit refrigerates the reagent and transfers the target reagent to the reagent sucking site. The reagent storage unit generally adopts two modes of a reagent disk and a fixed reagent storage area, and in order to ensure the stability of the reagent, the reagent disk generally has a refrigeration function, such as 4-10 ℃. The reagent tray is generally provided with a plurality of reagent container positions for placing reagent containers. Each reagent container is provided with a plurality of independent cavities and is used for storing different reagent components, such as magnetic particle reagents, enzyme labeling reagents, diluent and other reagent components.
A first embodiment of the automatic analyzer of the present invention is described with reference to fig. 4. The automatic analyzer 100 mainly includes a sample transfer unit 30, a reagent storage unit 40, a filling unit 20, a filling station 90, a reaction container supply unit 70, a transfer unit 50, a reaction unit 10, a measurement device 86, and the like. The functions and actions of each part are described below.
The sample transport unit 30 is used to place a sample tube 31 to be tested and transport a target sample tube to a suction sample position. In this embodiment, the sample conveying unit 30 is a sample tray, and arc-shaped sample racks (not shown) are placed on the sample tray, and 10 sample tubes 31 are placed on each arc-shaped sample rack. The sample tray can be driven by a driving mechanism under the control of a control center to transfer the target sample to a sample sucking position, and the sample sucking position is positioned at the intersection point of the horizontal moving range of the filling unit 20 and the central circle of the sample tube.
The reagent storage unit 40 refrigerates the reagent vessel 41 and transfers the target reagent to the reagent-sucking site. In this embodiment, the reagent storage unit 40 is a reagent tray, which is provided with 25 reagent sites and can accommodate 25 reagent containers 41 (or reagent boxes and reagent bottles, for convenience, hereinafter referred to as reagent bottles). In this embodiment, each reagent bottle 41 has 4 cavities 41a, 41b, 41c, and 41d, which can be used to store magnetic particle reagents, enzyme labeling reagents, and diluents. The reagent tray can be driven by the driving mechanism under the control of the control center to transfer the target reagent bottle to a reagent sucking position, and the reagent sucking position is positioned at the intersection point of the horizontal movement range of the filling unit and the central circle of the reagent cavity.
The filling unit 20 completes filling of the sample and the reagent. The horizontal movement range of the filling unit is respectively intersected with the sample position on the sample tray 30, the reagent position on the reagent tray 40 and the reaction container position on the measuring tray, and the intersection points are respectively a sample sucking position, a reagent sucking position and a filling position. In this embodiment, the filling unit is a single sample filling mechanism, and can perform vertical and horizontal rotation motions to fill a sample and a reagent, so that the whole machine is more compact in structure and lower in cost. In some embodiments, a blending mechanism such as an ultrasonic generator may be further integrated on the filling unit 20 to perform ultrasonic blending on the reaction container after each filling.
The filling station 90 is located under the horizontal movement track of the transfer unit 50 and the filling unit 20, receives and carries the reaction container transferred by the transfer unit 50, and receives the filling unit 20 to fill the sample and the reagent into the reaction container. The filling station is provided with a reaction container position for placing a reaction container needing to be filled with a sample and a reagent. In this embodiment, the filling station integrates the blending mechanism, and the reaction vessel after filling each time is subjected to ultrasonic blending or eccentric oscillation blending, preferably eccentric oscillation blending, so that the technical implementation difficulty is lower, and the structure is more compact.
The reaction container supply unit 70 stores and supplies reaction containers. In this embodiment, the reactor supply unit is arranged in advance in order to make the entire apparatus more compact and lower in cost. The reaction container supply unit 70 includes two reaction container trays, on which a plurality of reaction container positions for storing unused reaction containers are provided. The reaction vessel supply unit 70 is within the horizontal range of motion of the transfer unit 50 so that the transfer unit 50 can traverse unused reaction vessels at each reaction vessel location on the tray to provide unused reaction vessels for newly initiated tests.
The transfer unit 50 transfers the reaction vessels between different positions of the automatic analysis apparatus 100. In this embodiment, the number of the transfer units 50 is 1, and three-dimensional movement can be performed, so that the whole machine is more compact and the cost is lower. The transfer unit 50 includes an X-direction moving robot 50b, a Y-direction guide 50a, a Y-direction moving robot 50c, a vertical moving mechanism, a robot finger (not shown), and the like. The transfer unit 50 can move the robot fingers horizontally in the X-direction and the Y-direction at the same time, the horizontal movement range covers the range within the boundary rectangle 56, and the reaction containers can be transferred among the reaction container supply unit 70, 9 incubation transfer positions (12 a1-3, 12b1-3, 12c1-3) on the reaction unit 10, 2 washing separation transfer positions (12 d1 and 12d 2) on the reaction unit 10, and the lost reaction container position 60. Furthermore, since the movement range of the transfer unit 50 covers a plurality of incubation transfer positions on the reaction unit 10, the transfer unit can be placed into or transferred out of the reaction vessel by different incubation transfer positions to achieve a flexible incubation time.
The reaction unit 10 carries and fixes the reaction vessel, incubates and washes and separates the reactants in the reaction vessel. In this embodiment, the heat-insulating device of the reaction unit 10 is a pot 12 and an upper cover (not shown), the rotating device is a reaction tray 11, and the cleaning and separating device is a cleaning and separating device 16. The side surface or the inner side of the bottom of the pot body 12 is provided with a heater and a sensor which surround the bottom and the periphery of the reaction disc 11, so as to provide a constant temperature incubation environment for the reaction unit 10 and prevent or reduce the heat loss of the reaction unit 10. In addition to providing an incubation environment, the pan body 12 also supports and secures the magnetic field generating means of the washing and separating device 16 to provide a magnetic field environment for washing and separating. In this embodiment, the magnet generating means of the cleaning and separating device 16 is a permanent magnet device, which provides a stronger and more stable magnetic field environment. The flushing mechanism of the cleaning and separating device 16 comprises a liquid suction device, a liquid injection device and a blending mechanism. The cleaning and separating device 16 may further be coupled with a signal reagent filling mechanism for filling all or part of the signal reagent into the reaction vessels on the reaction vessel sites of the reaction unit 10 after the cleaning and separating are completed.
The measuring device 86 in this embodiment is directly installed on the side of the pot body 12, and of course, may also be installed on the upper cover of the heat-insulating device, and may directly measure the reaction signal in the reaction vessel on the reaction vessel position of the reaction disk 11. Therefore, the reaction container position on the reaction unit can be fully utilized, so that the whole machine is more compact and the cost is lower.
In this embodiment, the reaction disk 11 of the reaction unit 10 can rotate around the central axis, and four reaction container positions are arranged on the reaction disk, which uses the rotation center as the center of the circle, of course, the number of the turns can be changed, but at least 2 turns, such as 2 turns, 3 turns, 5 turns, or more turns, etc., each turn is provided with a plurality of reaction container positions, the number of the reaction container positions in each turn can be the same or different, and in this embodiment, each turn is provided with 30 reaction container positions. Each reaction vessel position is a hole groove with proper size on the reaction disc, can contain one reaction vessel, bears and fixes the reaction vessel, and the reaction vessel can not move or slide in the reaction vessel position after being placed in the corresponding reaction vessel position. The reaction vessel positions on the three circles 11a, 11b, 11c in the reaction tray perform the incubation function and accommodate the reaction vessels being incubated. The reaction vessel on the outer ring 11d mainly contains the reaction vessel to be cleaned or separated after the incubation is finished or after the incubation is carried out for a certain time, and mainly realizes the functions of cleaning, separating and measuring. In order to ensure that reaction vessels can pass in and out of reaction vessel positions on different circles of the reaction disc 11 and flexible incubation time can be realized, an upper cover of the heat preservation device is provided with openings, positions of the openings are transfer positions, and 9 incubation transfer positions 13a1-3, 13b1-3, 13c1-3 and 2 cleaning separation transfer positions 13d1 and 13d2 are arranged, wherein the incubation transfer positions 13a1-3, 13b1-3 and 13c1-3 respectively correspond to three circles 11a, 11b and 11c in the reaction disc and are respectively used for the reaction vessels to pass in and out of the reaction vessel positions on the reaction disc 11a, 11b and 11 c; the cleaning separation transfer positions 12d1 and 12d2 correspond to the outer ring 11d of the reaction disk, and are used for the reaction vessels to enter and exit the reaction vessel positions on the outer ring 11 d. The reaction tray rotates a fixed angle at fixed intervals, and may rotate counterclockwise or clockwise, for example, 12 degrees every 30 seconds, to advance one reaction vessel position. By rotating the reaction disk, the reaction vessel at the reaction vessel position can be transferred to the incubation transfer position or the washing and separating transfer position. The transfer unit may transfer the reaction vessels from the plurality of incubation transfer positions and washing separation transfer positions to and from the reaction tray during an intermittent time after each rotation of the reaction tray. After the reaction vessel enters the reaction tray through the incubation transfer position, the incubation is started at the reaction vessel position on 11a, 11b or 11c, and after the incubation is finished or after a certain period of time, the reaction vessel is transferred out from the incubation transfer position. The reaction vessel transferred into and out of the reaction tray by the incubation transfer includes a reaction vessel incubated once, incubated twice or more, so that the space of the reaction tray can be fully utilized. It should be noted that the reaction vessel may be incubated in the inner three circles 11a, 11b, 11c and then transferred to the outer circle 11d for washing and separation, or may be incubated in the inner three circles for a certain period of time, for example, for most of the incubation period, then transferred to the outer circle 11d, and then incubated for the remaining period of time while the reaction disk is transferred to the magnetic separation apparatus. Three circles need not to set up many reaction vessel positions in the former implementation, just can support the hatching of accomplishing reaction vessel, and the outer lane also need not extra reaction vessel position and is used for hatching to can make the reaction disc size littleer, the cost is lower. For the latter implementation, for example, if a reaction vessel under test requires 25 minutes of incubation, the incubation may be performed for a majority of the time, e.g., 24 minutes, in one or more of the inner three loops 11a, 11b, 11c, and then transferred to the outer loop 11d, with the remaining 1 minute of incubation being performed before transfer to the washing and separation device. According to the scheme, the outer ring shares a partial incubation function, so that the number of the reaction vessel positions of the inner ring and the outer ring can be properly reduced, the number of the reaction vessel positions of the inner ring and the outer ring can be balanced, the size of the reaction disc is optimized, and the inner space of the reaction disc is fully utilized.
The following describes the measurement process and steps of the automatic analyzer 100 in a one-step test with reference to fig. 4 and 5. After the start of the test, the test was started,
step 200 loading a reaction vessel: the transfer unit 50 transfers an unused reaction vessel from the reaction vessel supply unit 70 to the reaction vessel position of the filling station 90,
step 201 filling samples and reagents: the filling unit 20 sucks a sample and a reagent from the sample sucking site and the reagent sucking site respectively and fills the sample and the reagent into the reaction vessel on the filling station 90,
step 202, mixing uniformly: and if the sample and the reagent need to be uniformly mixed, uniformly mixing the sample and the reagent in the reaction container by the uniformly mixing mechanism. If no blending is required, the step is omitted,
step 203 incubation: the transfer unit 50 transfers the reaction vessel filled with the sample and the reagent from the filling station 90 to a certain reaction vessel position on three circles 11a, 11b, 11c in the reaction tray 11 by an incubation transfer position (one of 12a1-3, 12b1-3,12c 1-3), and the reaction vessel starts incubation on the reaction tray. While the reaction vessel is incubated, it advances 1 position at regular intervals with the rotation of the reaction disk 11. The incubation time varies depending on the particular test item, and is generally 5 to 60 minutes,
step 204, cleaning and separating: after completion of the incubation or after a certain period of incubation, the transfer unit 50 moves the reaction vessel out of the reaction vessel position of the inner three circles 11a, 11b or 11c of the reaction tray 11 by the incubation transfer position (one of 13a1-3, 13b1-3, 13c 1-3), and moves the reaction vessel into the reaction vessel position of the outer circle 11d of the reaction tray 11 by the washing separation transfer position (13 d1 or 13d 2). The reaction disk 11 is rotated and advanced 1 position at fixed time intervals, and the reaction vessel on the reaction vessel position of the outer ring 11d is transferred to the cleaning and separating device 16. If the reaction vessel has been incubated completely, there is no need to continue incubation on the outer lane 11d during transfer, and if the reaction vessel has not been incubated completely, the rest of the incubation is completed during transfer to the washing and separating device 16. When the reaction vessel on the reaction vessel position of the outer ring 11d passes through the magnetic field of the cleaning and separating device 16, the washing mechanism and the uniform mixing mechanism of the cleaning and separating device 16 complete the liquid absorption, the cleaning buffer liquid injection, the cleaning and uniform mixing of the reaction vessel until the cleaning and separation are completed,
step 205, filling a signal reagent: after the cleaning and separation are finished, the reaction disk 11 transfers the reaction container on the reaction container position of the outer ring 11d to leave the magnetic field area, the signal reagent injection mechanism coupled on the cleaning and separation mechanism injects all or part of the signal reagent into the reaction container,
step 206 signal incubation: if the signal incubation is required, the signal incubation is completed while the reaction vessel on the outer ring 11d is transferred to the measuring device 86 by the reaction disk 11, and if the signal incubation is not required, the step is omitted,
step 207 measurement: after the reaction container to be measured is transferred to the measuring unit 86 on the outer ring 11d, if necessary, all or part of the signal reagent is injected, the reaction signal in the reaction container is measured by the measuring unit 86, the measurement result is processed and then transferred to the control center of the automatic analyzer,
step 208 discards the reaction vessel: the reaction tray 11 continues to transfer the reaction container on the outer ring 11d to the cleaning and separating transfer position (13 d1 or 13d 2), and the transfer unit 50 moves the measured reaction container out of the reaction tray, transfers it to the discard reaction container hole 60, and discards it.
Referring to fig. 4 and fig. 6, the main difference between the delayed one-step test procedure and the one-step test procedure is that in steps 301-305, the reagents are divided into two portions and added with one incubation, and other steps are similar to the one-step test procedure and are not described again.
Step 301 priming sample and first reagent: the filling unit 20 sucks the sample and the first reagent from the sample sucking site and the reagent sucking site respectively and fills them into the reaction vessels on the filling station 90,
step 302, mixing uniformly: and if the sample and the reagent are required to be uniformly mixed, uniformly mixing the sample and the reagent in the reaction container by the uniformly mixing mechanism. If no blending is required, the step is omitted,
step 303 first incubation: the transfer unit 50 transfers the reaction vessel filled with the sample and the reagent from the filling station 90 to a certain reaction vessel position on three circles 11a, 11b, 11c in the reaction tray 11 by an incubation transfer position (one of 13a1-3, 13b1-3, 13c 1-3), and the reaction vessel starts incubation on the reaction tray. While the reaction vessel is incubated, it advances 1 position at regular intervals with the rotation of the reaction disk 11. The incubation time varies depending on the particular test item, and is generally 5 to 60 minutes,
step 304 fills with a second reagent: after the first incubation is finished, the transferring unit 50 transfers the reaction vessels from the reaction vessel positions on the three circles 11a, 11b and 11c in the reaction tray 11 to the reaction vessel positions on the filling station 90 by the incubation transferring position (one of 13a1-3, 13b1-3 and 13c 1-3), the filling unit 20 sucks the second reagent from the reagent sucking position and fills the second reagent into the reaction vessels on the filling station 90,
step 305, blending: and if the sample and the reagent are required to be uniformly mixed, uniformly mixing the sample and the reagent in the reaction container by the uniformly mixing mechanism. If no blending is required, the step is omitted,
referring to fig. 4 and 7, the two-step test procedure and steps are mainly different from the delayed one-step test procedure in that step 404 is added and a washing separation is added:
step 404 cleaning and separating: after the first incubation is completed or the first incubation is performed for a certain time, the transfer unit 50 moves the reaction container out of the reaction container position of the three circles 11a, 11b or 11c in the reaction tray 11 by the incubation transfer position (one of 13a1-3, 13b1-3 and 13c 1-3), and moves the reaction container into the reaction container position of the outer circle 11d in the reaction tray 11 by the washing separation transfer position (13 d1 or 13d 2). The reaction disk 11 is rotated and advanced 1 position at fixed time intervals, and the reaction vessel on the reaction vessel position of the outer ring 11d is transferred to the cleaning and separating device 16. If the reaction vessel has been incubated completely, there is no need to continue incubation on the outer lane 11d during transfer, and if the reaction vessel has not been incubated completely, the rest of the incubation is completed during transfer to the washing and separating device 16. When the reaction vessel on the reaction vessel position of the outer ring 11d passes through the magnetic field of the cleaning and separating device 16, the washing mechanism and the mixing mechanism of the cleaning and separating device 16 complete liquid absorption, cleaning buffer solution injection, cleaning and mixing on the reaction vessel until the first cleaning and separating is completed. After the first washing separation is completed, the transferring unit 50 transfers the reaction vessels from the reaction vessel positions on the three circles 11a, 11b and 11c in the reaction tray 11 to the reaction vessels on the filling station 90 through the incubation transferring position (one of 13a1-3, 13b1-3 and 13c 1-3), the filling unit 20 sucks the second reagent from the reagent sucking position and fills the second reagent into the reaction vessels on the filling station 90,
the other steps of the two-step method are similar to those of the delayed one-step method, and are not described in detail.
As can be seen from the above description, in this embodiment, the automatic analyzer 100 first incubates or incubates for a certain time in the inner three circles, and then the reaction container incubated or incubated for a certain time is transferred to the outer circle to incubate for the remaining time, and complete the cleaning, separation and measurement, and the transfer of the reaction container between different circles is completed by the transfer unit through at least one incubation transfer position and one cleaning, separation and measurement transfer position arranged on the reaction unit, so that not only are separate cleaning separation discs and light measurement discs used in the prior art saved, but also the size of the whole machine and the cost are reduced, the test steps are simplified, the complexity and difficulty of control are reduced, and the transfer of the reaction container between a plurality of discs is avoided. In addition, the reaction unit can be adjusted, set and balance the number of the inner and outer circle reaction container positions through setting different transfer positions, not only can realize flexible incubation time, but also can fully utilize the inner space of the reaction disc, thereby further reducing the size of the reaction unit, leading the whole structure to be more compact, having lower cost and higher test efficiency.
A second embodiment of the invention is shown in fig. 8. The sample delivery unit 30, the reagent storage unit 40, and the filling unit 20 in this embodiment are the same as or similar to those in the first embodiment, and are not described again. In this embodiment, the number of the transfer units 50 is 1, and two-dimensional movement is possible, so that the whole machine is more compact and the cost is lower. The transfer unit 50 includes a Y-direction guide 50a, a Y-direction moving robot 50b, a vertical moving mechanism, a robot finger (not shown), and the like. The transfer unit 50 can horizontally move the robot finger along the Y direction, has a one-dimensional linear region 56 in the horizontal movement range, and can transfer the reaction container among the reaction container supply unit 70, 2 incubation transfer positions (13 b, 13 c) on the reaction unit 10, 1 washing separation transfer position (13 a) on the reaction unit 10, 1 measurement transfer position (13 d) on the reaction unit 10, and the discard reaction container position 60. Furthermore, since the movement range of the transfer unit 50 covers a plurality of incubation transfer positions on the reaction unit 10, the transfer unit may be transferred into or out of the reaction vessel by different incubation transfer positions to achieve a flexible incubation time. The filling station 90 differs from the first embodiment mainly in that it is horizontally movable along the X-direction into the horizontal movement range of the transfer unit 50. The reaction container supply unit 70 is mainly different from the first embodiment in that only one row of reaction containers is in the horizontal movement range of the transfer unit 50, and in order to continuously supply the reaction containers, the reaction container supply unit 70 is horizontally movable in the X direction so as to pass the rows of reaction containers thereon through the horizontal movement range of the transfer unit 50, so that the transfer unit 50 can traverse the unused reaction containers at each reaction container position on the tray to provide the unused reaction containers for a newly started test. The reaction unit is mainly different from the first embodiment in the arrangement of the cleaning and separating device and the arrangement of the transfer position. In the present embodiment, the cleaning and separating device 16 is disposed in the inner ring 11a of the reaction disk, and cleans and separates the reaction vessels that have entered the inner ring 11a of the reaction disk through the cleaning and separating transfer portion 13 a. The measuring device 86 is mounted on the side of the heat retaining device and measures the signal entering the reaction vessel on the outer ring 11d of the reaction disk through the measuring transfer portion 13d. The reaction vessel sites in the middle two circles 11b, 11c incubate the reaction vessels that enter the processing unit via the incubation transfer site (13 b, 13 c). In this embodiment, corresponding to the horizontal one-dimensional movement range of the transfer unit 50 and the intersection points of the reaction container positions on the four circles 11a, 11b, 11c, and 11d of the reaction disk, 4 transfer positions, i.e., the cleaning separation transfer position 13a, the incubation transfer positions 13b and 13c, and the measurement transfer position 13d, are sequentially disposed on the reaction unit from inside to outside. The cleaning and separating device is arranged on the inner ring of the reaction unit, so that the cleaning and separating device is more compact, and the adverse effects of temperature fluctuation, interference of introduced ambient light and the like possibly caused by the cleaning and separating device on measurement are reduced.
It can be understood by those skilled in the art that the test procedure and steps of the present embodiment are similar to those of the first embodiment, and therefore, the following description is only briefly made. During testing, the filling station 90 moves horizontally along the X direction to the horizontal movement range of the transfer unit 50, the transfer unit 50 transfers an unused reaction container from the reaction container supply unit 70 to be placed on the reaction container position of the filling station 90, then the filling station 90 moves to the horizontal movement track of the filling unit 20, the filling unit 20 fills a sample and a reagent into the reaction container on the filling station 90, and after filling is completed, a mixer integrated in the filling station 90 can mix the reaction containers uniformly. After or during blending, the filling station 90 again moves horizontally into the horizontal movement range of the transfer unit 50. Thus, the reaction container to be incubated in the filling station 90 is first transferred to one of the two middle circles 11b and 11c by the transfer unit 50 through the incubation transfer position 13b or 13c, and when incubation is completed or after a certain incubation time, the reaction container to be incubated is required to be cleaned and separated, the reaction container is transferred to the filling station 90 by the transfer unit 50 through the incubation transfer position 13b or 13c, and then transferred to the inner circle 11a through the cleaning and separation transfer position 13a, and the reaction container is cleaned and separated by the cleaning and separation device 86 under the rotation transfer of the reaction disk, and when cleaning and separation are completed, the reaction container is transferred to the filling station 90 by the transfer unit 50 through the cleaning and separation transfer position 13a and then transferred to the inner circle 11d, and if a second reagent is required to be added, the reaction container is filled with the second reagent; if a measurement is required, the reaction vessel is moved into the outer ring 11d by the transfer unit 50 via the measurement transfer section 13d, and is transferred to the measuring device for measurement while the reaction disk is rotating.
A third embodiment of the invention is shown in fig. 9. The main difference between this implementation and the implementation is in the arrangement of the measuring devices. The present embodiment further includes a measurement dark room (not shown) and a measurement station 82 independent from the reaction unit 10, wherein a measurement device 86 is installed in the measurement dark room to measure the signal in the reaction vessel at the measurement station 82. The measurement camera provides the desired camera environment for the measurement device 86, with the measurement site 82 being within the horizontal range of motion of the transfer unit 50 or being horizontally movable into the horizontal range of motion of the transfer unit 50. In order to easily realize light shielding, the measuring position 82 can be made into a fixed position, the inlet and the outlet of the reaction container are provided with a skylight mechanism, the skylight mechanism is closed at ordinary times to ensure the darkroom environment of a measuring darkroom, and the reaction container is opened when the reaction container enters and exits; the measuring station 82 may also be configured to move into a position where the measuring station 82 may be moved away from or closer to the measuring device 86, such as by pushing or pulling a drawer, for ease of shielding from light. Of course, the measurement site 82 and the corresponding light shielding structure may be other suitable implementations. In addition, the filling of the signaling agent may also be accomplished at the measurement site 82. This embodiment can make measuring device 86 relatively independent, and the airtight darkroom environment when more easily realizing the measurement, and the reaction unit need not set up the structure that special aim at measuring device 86 light-resistant required again. It can be understood by those skilled in the art that other units of this embodiment are the same as or similar to those of the first embodiment, and the test flow and steps of this embodiment refer to fig. 5, fig. 6 and fig. 7, and are mainly different from those of the first embodiment in the three steps of filling the signal reagent, measuring, and discarding the reaction container, and the rest are the same as or similar to those of the first embodiment. The step of filling the signal reagent in this embodiment may be completed at the reaction container position of the outer ring 11d of the reaction disk, may also be completed at the measurement position 82, and may also be completed at the reaction container position of the outer ring 11d of the reaction disk, and completed at the measurement position 82 is the filling of the first signal reagent; a measuring step, in which the transfer unit 50 transfers the reaction vessel to be measured from the reaction vessel position of the outer ring 11d of the reaction disk to the measuring position 82 through the cleaning separation transfer position 13d1 or 13d2, and the measuring device 86 measures the reaction signal in the reaction vessel positioned at the measuring position 82; a reaction container discarding step in which the transfer unit 50 transfers the reaction container, the measurement of which is completed, from the measurement site 82 to the discard hole 60 to discard.
A fourth embodiment of the invention is shown in fig. 10. The embodiment is different from the embodiment in that it further comprises a measurement dark room 82 and a measurement plate 81 which are independent from the reaction unit 10, and the measurement device 86 is installed on the measurement dark room 82. In this embodiment, the filling station (not shown) may be integrated in the measurement tray 81, and the reaction container position of the measurement tray 81 and the rotational positioning function thereof may be fully utilized, so that an independent filling station may be omitted, the mechanism may be omitted, the overall cost may be lower, and the structure may be more compact. The mixing mechanism can be integrated in the filling station and is used for carrying out ultrasonic mixing or vibration mixing on the filled reaction container. The measuring disc 81 is provided with a circle of reaction container positions 81a which take the rotation center of the measuring disc as the center of a circle and are used for bearing the reaction containers to be measured. In this embodiment, a plurality of reaction container positions are provided, and all or part of signal incubation can be realized. The measuring disc 81 rotates every time, the reaction container on any signal incubation position can be rotated to the measuring device 86 for measurement, so that flexible signal incubation is realized, and the flexibility and efficiency of testing are improved. In order to move the reaction vessel into and out of the measurement tray 81, a measurement transfer section 82a is provided at the upper part of the measurement dark room 82. The measurement transfer section 82a is in the horizontal movement range of the transfer unit 50, and the transfer unit 50 can move the reaction container to be measured out of the reaction disk 11 by the cleaning separation transfer section 13d1 or 13d2 of the reaction unit 10, and into the measurement disk 81 by the measurement transfer section 82a. The measurement darkroom 82 is wrapped or enclosed at the periphery of the measurement tray 81 to provide a darkroom environment for the measurement device 86, and for the signal incubation test, a heating device and a sensor can be optionally arranged at the side or the bottom of the measurement darkroom 82 to provide a constant temperature signal incubation environment for the reaction container position 81a of the measurement tray. The measurement device 86 includes a weak light detector Photomultiplier (PMT) directly mounted to the measurement darkroom 82 for measuring a weak chemiluminescent signal generated after the signal reagent is added to the reaction vessel. In addition, in order to facilitate the filling of the signal reagent, a signal reagent filling mechanism (not shown) may be further provided on the upper portion of the measuring tray 81 or on the periphery of the measuring dark room 82, so as to fill all or part of the signal reagent into the reaction container on the reaction container position of the measuring tray 81. It will be understood by those skilled in the art that other units of this embodiment are the same as or similar to those of embodiment one, and the test flow and steps of this embodiment refer to fig. 5, fig. 6 and fig. 7, and the main differences from embodiment one are that the three steps of initially loading the reaction vessel, filling the sample and reagent, and finally filling the signal reagent, measuring, discarding the reaction vessel, and the like, and the rest are the same as or similar to those of embodiment one. The transfer unit 50 moves an unused reaction container from the reaction container supply unit 70 to a reaction container position on the measurement tray 81 through the measurement transfer portion 82a, the measurement tray 81 rotates, the reaction container is transferred to the filling station, the filling unit 20 sucks a sample and a reagent and fills the sample and the reagent into the reaction container located on the filling station, and after the filling is completed, the mixing mechanism integrated in the filling station mixes the mixture in the reaction container. After completion of the mixing, the transfer unit 50 transfers the reaction container for which the measurement is completed from the reaction container position on the measurement plate 81 to the reaction unit for incubation by the measurement transfer portion 82a. The step of filling the signal reagent in this embodiment may be completed at the reaction container position on the outer ring 11d of the reaction disk, may also be completed at the reaction container position on the measurement disk 81, and may also be completed at the reaction container position on the outer ring 11d of the reaction disk, and completed at the reaction container position on the measurement disk 81; a measurement step in which the transfer unit 50 moves the reaction container to be measured out of the reaction container position on the outer ring 11d of the reaction disk by the cleaning/separating transfer position 13d1 or 13d2, moves the reaction container to be measured into the reaction container position on the measurement disk 81 by the measurement transfer position 82a, rotates the measurement disk 81, transfers the reaction container to the measurement device 86, and measures the reaction signal in the reaction container by the measurement device 86; a reaction container discarding step in which the transfer unit 50 transfers the reaction container, the measurement of which has been completed, from the reaction container position on the measurement tray 81 to the discard hole 60 by the measurement transfer position 82a to discard.
The automatic analysis device of the invention can also be flexibly expanded and reused to the maximum extent, and realizes the serialization of products. On the basis of the fourth embodiment, in order to further improve the specification parameters and the test throughput of the whole machine and meet the requirements of terminal customers with larger sample amount, the method can be realized by increasing the number of the transfer units and the filling units, and properly increasing the size of the reaction units or increasing the number of the reaction units. FIG. 11 is a schematic view of an automatic analyzer according to a fifth embodiment of the present invention. The sample conveying unit 30 adopts a sample introduction mode of a track and a sample rack, so that more samples can be accommodated, the samples can be added in real time, and the operation is more convenient. The sample rack 32 and the sample tube 31 thereon can be transported under the range of motion of the first filling unit 21. The reagent storage unit 40 increases reagent storage locations and allows more reagent containers to be placed. The filling unit 20 comprises a first filling unit 21 and a second filling unit 22, the first filling unit 21 fills only the sample or fills the sample and a part of the reagent, and the second filling unit 22 fills the reagent, although more filling units can be added, so that the speed of filling the sample and the reagent is improved. The reaction vessel supply unit 70 adopts a silo type, and the reaction vessels can be dumped into the silo of the reaction vessel supply unit 70 in a scattered manner, which can make the supply of the reaction vessels more, faster and more convenient. The reaction disk 11 of the reaction unit 10 includes an outer ring 11d reaction vessel site and an inner region 11a reaction vessel site which are arranged around the center of rotation of the reaction disk. The reaction vessel positions on the inner area 11a are distributed in a honeycomb shape, so that the space on the reaction disk 11 can be fully utilized, more reaction vessel positions are arranged, more reaction vessels are accommodated for incubation, and the test flux is improved. In order to move the reaction vessel into and out of the reaction vessel position on the reaction tray 11, the reaction unit 10 is provided with an incubation transfer area 13a (including 7 incubation transfer areas) and a washing separation transfer area 13d. The measurement dark room 82 and the measurement plate 81 and the measurement device 86 can be completely reused in the fourth embodiment, but in order to improve the test efficiency, the filling level is not set. The measurement dark room 82 is provided with a measurement transfer part 82a for the reaction vessel to enter and exit the measurement tray. The transfer unit 50 includes a first transfer unit 51 and a second transfer unit 52 that are independently movable in three dimensions, the first reaction container unit 51 mainly transfers reaction containers between the positions of the incubation transfer area 13a and the washing separation transfer area 13d of the reaction unit 10, the measurement tray 81, and the reaction container discard hole 60b, and the second transfer unit 52 mainly transfers reaction containers between the reaction container supply unit 70, the filling station 90, the incubation transfer area 13a and the washing separation transfer area 13d of the reaction unit 10, and the reaction container discard hole 60 b. It will be appreciated by those skilled in the art that with proper layout and distribution, the transfer of reaction vessels between any two locations can be accomplished by either the first or second transfer units or both. Of course, the number of the transfer units can be more than 2, and more transfer units can be arranged according to the needs to improve the efficiency and the speed of the transfer of the reaction vessel. In order to make the layout of the whole device compact and increase the testing speed, the present embodiment adopts the mode of the independent filling station 90 to fill the sample and the reagent. The filling station 90 is movable back and forth between the reaction container supply unit 70, the first filling unit 21, and the second filling unit 22, and receives the reaction containers supplied from the reaction container supply unit 70, the sample or the sample and a part of the reagent filled from the first filling unit 21, and the reagent filled from the second filling unit 22. A mixing mechanism may be integrated in the filling station 90 or the filling unit 20 to mix the reaction vessels filled with the sample and/or the reagent. After completion of the mixing, the reaction vessel at the filling station 90 is transferred from the transfer unit 50 to the reaction unit 10. It can be understood by those skilled in the art that other units of this embodiment are the same as or similar to those of the fourth embodiment, and the testing process and steps of this embodiment are mainly different from those of the first embodiment in that the filling of the sample and the reagent are performed by the coordination of the first and second filling units, the transfer of the reaction container is performed by the coordination of the first and second transfer units, the filling operation of the filling unit is performed at a separate filling station, and other operations and processes are the same as or similar to those of the first embodiment, and are not repeated herein with reference to fig. 5 to 7. Compared with the prior art, the embodiment avoids an extra large-size cleaning separation disc, the measuring device independent of the reaction unit can easily realize darkroom environment and flexible measurement, and the size of the reaction unit is reduced by the subareas of the reaction container positions with different functions, so that the whole machine is more compact, the cost is lower, the efficiency is higher and the reliability is better.
The embodiment of the invention also provides a sample analysis method, which specifically comprises the following steps:
a filling step of filling a sample and/or a reagent into the reaction vessel;
an incubation step of at least two incubations into the reaction unit via at least one incubation transfer site
Incubating the container;
a cleaning and separating step of cleaning and separating the reaction vessel which enters the reaction unit through at least one cleaning and separating transfer position
Separating to remove the unbound components in the reactant;
a step of filling a signal reagent, in which the signal reagent is filled into the reaction vessel,
and a measuring step of measuring a reaction signal in the reaction vessel by a measuring device.
Further, a transfer step is included, wherein the reaction container is moved in and out of the reaction unit through the transfer unit from the at least one incubation transfer position and the at least one washing separation transfer position; also comprises a mixing step of mixing the reactants in the reaction container.
The reaction unit is used as the center to realize incubation, cleaning and separation of reactants in the reaction container, the reaction unit is provided with at least one incubation transfer position and at least one cleaning and separating transfer position, and the transfer unit can transfer the reaction container between the incubation transfer position and the cleaning and separating position, so that not only can flexible incubation be realized, but also the problem that a plurality of cleaning and separating mechanisms are needed to realize two-step testing in the prior art can be solved, and efficient cleaning and separation can be fully realized. In addition, the measuring device can be flexibly arranged or arranged according to the requirements of the whole machine layout or structure realization, for example, the measuring device can be directly arranged on the reaction unit, arranged on an independent position or arranged on an independent measuring disc, and the problems that the arrangement of the measuring device is limited, the measuring environment is easy to interfere and the like in the prior art are solved. The invention improves the working efficiency of the analysis device, reduces the realization difficulty of the automation function, well solves the technical problems of large volume, low detection speed, high cost, poor performance and the like of the existing automation instrument, saves the laboratory space, improves the test efficiency, is beneficial to reducing the expense expenditure, lightens the burden of a testee and finally saves a large amount of natural resources and social resources.
The technical features or operational steps described in the embodiments of the present invention may be combined in any suitable manner. One of ordinary skill in the art will readily appreciate that the order of steps or actions in the methods described in the embodiments of the present invention may be varied. Accordingly, unless otherwise specified a certain order is required, any order in the drawings or detailed description is for illustrative purposes only and is not necessarily required.
Embodiments of the present invention may include various steps, which may be embodied in machine-executable instructions, which may be executed by a general-purpose or special-purpose computer (or other electronic device). Alternatively, the steps may be performed by hardware components that include specific logic for performing the steps, or by a combination of hardware, software, and/or firmware.
The present invention has been described above with reference to specific examples, but the present invention is not limited to these specific examples. It will be understood by those skilled in the art that various changes, substitutions of equivalents, variations, and the like can be made thereto without departing from the spirit of the invention, and the scope of the invention is to be determined from the following claims. Note that "one embodiment", "the present embodiment", and the like described in the plural points above represent different embodiments, and it is needless to say that all or part of them may be combined in one embodiment.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is specific and detailed, but not to be understood as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (10)

1. An automatic analysis device, comprising:
the filling unit comprises a first filling unit and a second filling unit, the first filling unit is used for filling a sample or the sample and part of the reagent into the reaction container, and the second filling unit is used for filling the reagent into the reaction container;
a reaction container supply unit for storing and supplying reaction containers;
a filling station for receiving and carrying reaction vessels to be filled with samples or/and reagents, the filling station being movable back and forth between the reaction vessel supply unit, the first filling unit and the second filling unit; and
a transfer unit that transfers the reaction vessel between different positions;
the reaction unit is used for incubating, cleaning and separating reactants in the reaction container, and the filling station is independent of the reaction unit; the reaction unit comprises a rotatable reaction disc, the reaction disc is provided with a plurality of circles of reaction container positions which are arranged at intervals along the radial direction of the reaction disc, the outermost outer circle of reaction container positions can be used for incubation, cleaning separation and measurement, and other reaction container positions are used for incubation;
the reaction vessel position for incubation is at least two circles, the reaction vessel position for incubation corresponds to at least two incubation transfer positions arranged along the circumferential direction of the reaction disc at intervals, and the reaction vessel position at the outermost circle corresponds to at least one cleaning separation transfer position arranged along the circumferential direction of the reaction disc at intervals.
2. The automated analysis device of claim 1, wherein the filling station is within a horizontal range of motion of the transfer unit or is horizontally movable into a horizontal range of motion of the transfer unit.
3. The automatic analysis device according to claim 1, wherein the number of the first filling unit and the second filling unit is one.
4. The automated analysis device of claim 1, wherein the at least one incubation transfer location and the at least one washing separation transfer location of the reaction unit are within a horizontal range of motion of the transfer unit.
5. The automatic analysis device according to claim 4, wherein the reaction unit further comprises a cleaning and separating device for cleaning and separating the reaction vessels entering the reaction unit through the cleaning and separating transfer site to remove unbound components of the reactants; the reaction vessel is incubated in the reaction vessel position for a certain period of time and then transferred to the outermost reaction vessel position, and the incubation is completed for the remaining period of time before transferring to the washing and separating device.
6. The automated analyzer of claim 4, wherein the reaction vessels entering the reaction unit through the incubation transfer site comprise at least two times of incubation required for the reaction vessels that enter the reaction unit through the incubation transfer site.
7. The automatic analysis device according to claim 4, characterized in that: the reaction unit comprises a rotating device which is a reaction disk, and the reaction disk rotates for a fixed angle at fixed time intervals to transfer the reaction container position to the incubation transfer position or the cleaning separation transfer position.
8. A sample analysis method using the automatic analysis device according to any one of claims 1 to 7, comprising:
a filling step of moving a filling station back and forth among the reaction container supply unit, the first filling unit and the second filling unit, providing the reaction container to the filling station by using the reaction container supply unit, adding the sample or the sample and a part of the reagent to the reaction container by using the first filling unit, and adding the reagent to the reaction container by using the second filling unit;
an incubation step of incubating a reaction vessel which enters the reaction unit through at least one incubation transfer site and comprises at least two incubations;
a cleaning and separating step of cleaning and separating the reaction vessel entering the reaction unit through at least one cleaning and separating transfer site to remove unbound components in the reactant;
a step of adding a signal reagent, a step of adding a signal reagent into the reaction vessel, and
and a measuring step of measuring a reaction signal in the reaction vessel by a measuring device.
9. The sample analysis method according to claim 8, wherein: further comprising a transfer step of transferring the reaction vessel into and out of the reaction unit by means of a transfer unit from the at least one incubation transfer site, the at least one washing separation transfer site.
10. The sample analysis method according to claim 8, characterized in that: also comprises a mixing step of mixing the reactants in the reaction container.
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