CN116840499A - Automatic analysis device and sample analysis method thereof - Google Patents

Automatic analysis device and sample analysis method thereof Download PDF

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Publication number
CN116840499A
CN116840499A CN202310888939.5A CN202310888939A CN116840499A CN 116840499 A CN116840499 A CN 116840499A CN 202310888939 A CN202310888939 A CN 202310888939A CN 116840499 A CN116840499 A CN 116840499A
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CN
China
Prior art keywords
unit
reaction vessel
incubation
reaction
reagent
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CN202310888939.5A
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Chinese (zh)
Inventor
张震
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Shenzhen Increcare Biotech Co Ltd
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Shenzhen Increcare Biotech Co Ltd
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Priority to CN202310888939.5A priority Critical patent/CN116840499A/en
Publication of CN116840499A publication Critical patent/CN116840499A/en
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04Details of the conveyor system
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04Details of the conveyor system
    • G01N2035/0401Sample carriers, cuvettes or reaction vessels
    • G01N2035/0437Cleaning cuvettes or reaction vessels

Abstract

The invention provides an automatic analysis device and a sample analysis method. The automatic analysis device includes: a filling unit (20) for filling a sample and/or a reagent into the reaction container; an incubation unit (80) for incubating the reactants in the reaction vessel; a processing unit (10) for cleaning and separating the reactants in the reaction vessel and measuring the reaction signals in the reaction vessel; a transfer unit (50) for transferring the reaction vessel between different positions. The invention uses the incubation unit as the center to realize the incubation of the reactants in the reaction container, and uses the processing unit independent of the incubation unit as the center to realize the cleaning and separation of the reactants in the reaction container and the measurement of signals in the reaction container. The invention omits the separate cleaning separation disc and the measuring disc, simplifies the system structure and the control flow, can obviously reduce the sizes of the processing unit and the incubation unit, and realizes flexible incubation time.

Description

Automatic analysis device and sample analysis method thereof
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 thereof.
Background
In recent years, development and progress of clinical examination and automation technology have not only improved the automation level of clinical laboratories, improved the efficiency of medical examination, but also improved the quality and reliability of the examination results. However, as the amount of test specimens increases, clinical laboratories need to continually add large automated test systems to meet their testing needs, resulting in increasing laboratory crowding and increasing testing costs. Thus, how to improve the test efficiency, guarantee the results and fully utilize the existing laboratory resources is an urgent problem to be solved by clinical tests under the increasing cost pressure.
For convenience of description, the present technical solution and method are described herein In terms of a fully automatic immunoassay device In vitro diagnosis (In-Vitro Diagnostics, abbreviated as IVD), and In particular, in terms of a luminescent immunoassay device, and those skilled In the art will understand that the present solution and method can also be applied to other clinical test automation devices, such as a fluorescent immunoassay device, an electrochemical immunoassay device, and the like. The full-automatic immunoassay is based on immunological reaction of antigen-antibody combination, uses enzyme label, lanthanide label or chemiluminescent agent to label antigen-antibody, and uses a series of cascade amplification reactions to link optical signal or electric signal with analyte concentration, etc. to analyze antigen or antibody to be tested in human body sample, and is mainly applied to clinical laboratory, third-party independent laboratory, blood test center, etc. mechanisms of hospital to quantitatively, semi-quantitatively or qualitatively detect each analyte in human body fluid, and make diagnosis of infectious disease, tumor, endocrine function, cardiovascular disease, prenatal and postnatal care and autoimmune disease, etc. Fully automatic immunoassays generally consist of a sampling unit, a reaction unit, a supply and waste liquid unit, a system control unit, etc. The luminous immunity is becoming the mainstream technology of the current automatic immunity due to the advantages of quantitative detection, high sensitivity, good specificity, wide linear range, high degree of automation and the like. The full-automatic luminescence immunoassay is different according to a labeling method and a luminescent system, and comprises enzymatic chemiluminescence, direct chemiluminescence, electrochemiluminescence and the like.
Referring to fig. 1-3, the luminescence immunoassay can be generally classified into a one-step method, a time-lapse one-step method, a two-step method, etc. according to the principle and mode of the test, the main test steps generally include filling a sample and a reagent, mixing reactants uniformly, incubating, washing and separating (B/F for short), adding a signal reagent, measuring, etc. It should be noted that for convenience of description, the invention distinguishes between reagent and signal reagent, incubation and signal incubation. The reagents and the analysis items are in a one-to-one correspondence, i.e., the specific reagents corresponding to different analysis items generally differ in terms of formulation, reagent amount, component amount, etc. Depending on the particular assay protocol, the reagents typically comprise a plurality of components, such as the usual 2-5 components, including magnetic particle reagents, enzyme-labeled reagents, diluents, and the like. Depending on the reaction mode, the reagent components of one analysis item may be filled at one time or in a plurality of steps, and the steps may be defined as a first reagent, a second reagent, a third reagent, and the like in the filling order. The signal reagent is used for generating a measurement signal, and is usually one of general-purpose reagents, and corresponds to the analysis item in a one-to-many manner, namely, different analysis items share the signal reagent. The incubation of the invention refers to the process of antigen-antibody binding reaction or biotin-avidin binding reaction of reactants in a reaction vessel under the constant temperature environment of an incubation unit before the reaction vessel starts cleaning and separating, specifically, one-step incubation is carried out for one incubation before cleaning and separating, one-step incubation is delayed for two times, the one-step incubation comprises the first incubation before filling a second reagent and the second incubation after filling the second reagent before cleaning and separating, and two-step incubation comprises the first incubation before cleaning and separating for the first time and the second incubation before cleaning and separating for the second time. And the signal incubation refers to the process of adding signal reagent into the reaction container after washing and separating, and then reacting for a period of time in a constant temperature environment to enhance the signal. Depending on the reaction system and the principle of luminescence, not all tests require signal incubation, and the test requiring signal incubation is typically an enzymatic chemiluminescent immunoassay. The test steps corresponding to the different test modes are described in detail as follows:
1) The one-step method comprises the following steps: referring to fig. 1, sample (S) and reagent (R) are added, mixed uniformly (some test methods may not need to be mixed uniformly, and the same will apply, and will not be repeated), incubated (generally 5-60 minutes), washed and separated after incubation is completed, signal reagent is added, signal incubation (generally 1-6 minutes) is performed, and finally measurement is performed. It should be noted that, due to the different specific components of the signal reagent, some luminescent systems do not require signal incubation and can be directly measured 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 time-delay one-step method: the difference from the one-step method is that the reagent is filled 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 completed. Compared with the one-step method, the method has the advantages that one incubation, reagent filling and uniform mixing actions are added, and the rest processes are the same as those of the one-step method.
3) The two-step method comprises the following steps: the difference from the time-delay one-step method is that a cleaning and separating step is added, and other steps are the same.
In order to realize the automatic testing of the flow, the prior specific implementation technical scheme is as follows:
The first prior art scheme separates incubation, washing separation and measurement into independent layouts, and the corresponding functions are respectively completed by three rotating discs, and the reaction vessel is transferred between different units by a mechanical grabbing arm. The technical proposal has a plurality of components and units, and the reaction vessel needs to be transferred among the units, thereby causing the problems of large volume, high cost, complex control flow and the like.
The second prior art solution arranges incubation and measurement together to form an incubation measurement unit, and the washing and separation are performed by another independent unit, although this solution reduces one measurement disc compared to the first prior art solution, which is advantageous to some extent in controlling the overall size and cost, but also suffers from the same problems as the first solution. In order to achieve flexible incubation time, the incubation measurement unit is complex in control, incubation and measurement are mutually restricted in control, and the defects that high-speed automatic test cannot be achieved and flexible signal incubation cannot be achieved are overcome.
The third prior art scheme realizes incubation, cleaning separation and measurement on a single circle of disc or manifold track, and in order to support longer incubation time, the disc needs to be provided with a plurality of incubation positions besides cleaning separation and measurement positions, so that the disc or manifold track needs to be designed to be large in size for realizing high-speed test, and has great difficulty in production and manufacturing and high cost. On the other hand, the technical scheme also limits the incubation time, so that the problems of fixed incubation time, overlong fruiting time and the like are caused. 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 common defects and problems in the prior art, the invention provides the automatic analysis device and the sample analysis method thereof, which have the advantages of low production and manufacturing cost, simple and compact structure and flexible and efficient test flow or method.
According to an aspect of the present invention, there is provided an automatic analysis device including: a filling unit for filling the sample and/or the reagent into the reaction container; an incubation unit for incubating the reactants in the reaction vessel; a processing unit for washing and separating the reactants in the reaction vessel and measuring the reaction signals in the reaction vessel; a transfer unit transferring the reaction vessel between different positions; the incubation unit comprises a rotation device, wherein an incubation reaction container position is arranged on the rotation device and used for incubating reactants in the reaction container; the processing unit comprises a processing disc, and a cleaning separation reaction container position and a measuring reaction container position are arranged on the processing disc and are respectively used for cleaning reactants in the separation reaction container and measuring reaction signals in the reaction container.
According to still another aspect of the present invention, there is provided a sample analysis method comprising: a filling step of filling a sample and a reagent into the reaction container; an incubation step of incubating the reaction vessel at the reaction vessel position of the incubation unit; an incubation step of incubating reactants in the reaction vessel at the reaction vessel position of the incubation unit; a cleaning and separating step of cleaning and separating reactants in the reaction vessel on the cleaning and separating reaction vessel position of the processing unit; a measurement step of measuring a reaction signal in a reaction vessel at a measurement reaction vessel position of the processing unit; and a transferring step of transferring the reaction vessel between the incubation unit, the processing unit and the washing separation reaction vessel position of the processing unit and the measurement reaction vessel position of the processing unit by a transferring unit.
The incubation unit of the invention realizes incubation of reactants in the reaction container, the processing unit independent of the incubation unit realizes cleaning and separation of the reactants in the reaction container and measurement of signals in the reaction container, and the transfer of the reaction container between the incubation unit and the processing unit is realized through the transfer unit. The invention realizes cleaning separation and measurement on the inner and outer circles on the treatment disc respectively, not only saves an independent cleaning separation disc and measurement disc, but also improves the reliability of the transfer of the reaction container, thereby simplifying the system structure and control flow, obviously reducing the sizes of the incubation unit and the treatment unit, and realizing flexible incubation time through the independent incubation unit. The invention improves the working efficiency of the analysis device, well solves the technical problems of large volume, low detection speed, high cost, poor performance and the like of the existing automatic instrument, saves the space of a laboratory, improves the testing efficiency, is beneficial to reducing the cost and finally saves a large amount of natural resources and social resources.
Drawings
FIG. 1 is a schematic illustration of a one-step reaction scheme;
FIG. 2 is a schematic illustration of a one-step reaction mode (alternative signal measurement);
FIG. 3 is a schematic illustration of the reaction modes of the delayed one-step and two-step processes;
FIG. 4 is a schematic view of a first embodiment of an automatic analyzer of the present invention;
FIG. 5 is a one-step test flow chart;
FIG. 6 is a flow chart of a time-lapse one-step test;
FIG. 7 is a two-step test flow chart;
FIG. 8 is a schematic view of a second embodiment of the automatic analyzer of the present invention.
Detailed Description
The invention will be described in further detail below with reference to the drawings by means of specific embodiments.
An automatic analyzer of the present invention includes: a filling unit for filling the sample and/or the reagent into the reaction container; an incubation unit for incubating the reactants in the reaction vessel; a processing unit for washing and separating the reactants in the reaction vessel and measuring the reaction signals in the reaction vessel; a transfer unit transferring the reaction vessel between different positions; the incubation unit comprises a rotation device, wherein an incubation reaction container position is arranged on the rotation device and used for incubating reactants in the reaction container; the processing unit comprises a processing disc, and a cleaning separation reaction container position and a measuring reaction container position are arranged on the processing disc and are respectively used for cleaning reactants in the separation reaction container and measuring reaction signals in the reaction container.
The reaction vessel provides a reaction place for the reaction of the sample and the reagent, and can be a reaction tube, a reaction cup strip with a plurality of cavities, a reaction chip and the like with various shapes and structures, and is generally disposable. The material of the reaction vessel is typically a plastic, such as polystyrene or the like. The reaction vessel may be coated with antigen or antibody on the inner wall, may not be coated, or may have coated magnetic beads or plastic balls stored therein. The storage and supply of the reaction vessel is completed by a reaction vessel supply unit. The reaction container supply unit mainly adopts two main modes for storing and providing the reaction containers, one is a bin type, the reaction containers can be scattered and poured into a bin of the reaction container supply unit in a packing manner, and then the reaction container supply unit automatically and singly sorts the reaction containers one by one and supplies the reaction containers to the transfer unit; alternatively, the reaction vessels may be arranged in advance in a reaction vessel tray, cassette, or reaction vessel rack, or channel, and the reaction vessel supply unit may transport the entire tray, the entire cassette, or a row or a column of reaction vessels to the target position at a time.
The transfer of the reaction vessel between the different positions in the apparatus according to 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 transfer unit preferably comprises a driving mechanism, a horizontal movement mechanical arm, a grabbing and placing mechanism and the like. The grabbing and placing mechanism is usually a mechanical finger, can grab and place the reaction container, and the horizontal movement mechanical arm can move the grabbing and placing mechanism along the X direction, the Y direction, the radial direction, the circumferential direction and the like under the drive of the driving mechanism, so that the reaction container grabbed by the grabbing and placing mechanism can be moved to different positions. In addition to the horizontal movement, the transfer unit may also be moved up and down to place the reaction vessel in or remove it from different locations. One or more transfer units may be provided according to the test speed and the overall layout.
The filling unit completes filling of the sample and the reagent. The filling unit is generally composed of components such as a steel needle or disposable nozzle (Tip), a filling motion driving mechanism, a syringe or a filling pump, a valve, a fluid line, a cleaning tank (there may be no cleaning tank when Tip is used), and the like. In order to complete the sucking of the sample, the reagent and the filling thereof, the filling unit may be moved horizontally in addition to up and down movements, which generally have several movement forms of rotation, X-direction, Y-direction and the like and combinations thereof. The filling unit can be one, and can be used for filling samples and reagents, so that the whole machine structure is more compact and the cost is lower. In order to increase the test speed, the filling unit may further comprise one or several sample filling units and one or several reagent filling units, wherein the sample filling units only fill samples or fill samples and partial reagents, and the reagent filling units fill reagents.
In order to facilitate filling of the filling unit, the invention may further comprise a filling station. The filling station is located in the range of motion of the transfer unit and the filling unit or can be moved into the range of motion of the transfer unit and the filling unit by a horizontal movement. The filling station receives and bears 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 make the sample and the reagent mix more evenly and react more fully, in order to simplify the whole structure and reduce the volume simultaneously, can integrate the mixing mechanism at the filling station, carry out ultrasonic mixing, deflection rotation or vibration mixing to the reaction vessel after each filling, also can integrate the mixing mechanism such as ultrasonic generator in the filling unit, realize mixing by the ultrasonic wave that the filling unit produced when filling sample and reagent or after the completion of the filling action. Those skilled in the art will appreciate that the filling station may not incorporate a mixing mechanism, and that mixing may be accomplished by suction or impact forces of the filling unit. In order to make the whole machine more compact, the filling station may also be integrally integrated on the incubation unit, so that the filling station may not be located under the track of the transfer unit.
The incubation unit incubates the reactants within the reaction vessel. The incubation unit mainly comprises a heat preservation device and a rotating device. The periphery of the heat preservation device of the incubation unit is usually provided with heat insulation materials such as heat preservation cotton, the heat insulation materials generally wrap or surround the bottom, the periphery and the upper part of the rotation device, a heating device and a sensor can be arranged on the side surface or the inner side of the bottom, and the upper part is generally provided with a cover plate and other structures, so that a constant-temperature incubation environment is provided for the incubation unit. Of course, the heating device may also be mounted on the rotating device for higher heat transfer efficiency. The rotating device of the incubation unit is provided with a plurality of holes, grooves, brackets, bases or other structures suitable for bearing the reaction containers, which are defined as reaction container positions. The reaction vessel site is the primary place for the reaction incubation of the reactants within the reaction vessel, allowing for the interaction between the sample analyte and the corresponding reagents and between the reagents within the reaction vessel. In general, the more reaction vessel positions, the longer the incubation time that can be supported, and the faster the test speed. In order to increase the reaction container position and control the size of the incubation unit, at least two circles of reaction container positions taking the rotation center of the rotation device as the center of a circle can be arranged on the rotation device of the incubation unit. The rotating device is preferably one, and comprises a driving mechanism, a transmission mechanism, a related control circuit and the like, and the rotating device is controlled and driven to rotate according to the test requirement, so that the reaction container is transferred to advance by a plurality of positions. At least one reaction vessel on the rotating means is positioned within the range of motion of the transfer unit such that the transfer unit can move the reaction vessel into and out of the rotating means of the incubation unit.
The processing unit cleans and separates reactants in the reaction vessel and measures reaction signals in the reaction vessel. The processing unit mainly comprises a heat preservation device, a processing disc, a cleaning and separating device and a measuring device. The heat preservation device of the treatment unit is similar to the incubation unit, the periphery is generally provided with heat insulation materials such as heat preservation cotton and the like, the bottom, the periphery and the upper part of the treatment tray are generally wrapped or surrounded, the side surface or the inner side of the bottom can be provided with a heating device and a sensor, and the upper part is generally provided with a cover plate and other structures, so that a constant-temperature incubation environment is provided for the treatment unit. Of course, the heating device may also be mounted on the rotating device for higher heat transfer efficiency. Besides providing a constant temperature environment, the heat preservation device can also support and fix a magnetic field generating device of the cleaning and separating device to provide a magnetic field environment for cleaning and separating. In addition, because the signal to be measured is usually a weak light signal, the measurement is inaccurate due to the interference and influence of ambient light during the test, and the heat preservation device can also provide a closed darkroom environment for the measurement device of the processing unit. Similar to the incubation unit, the treatment tray is provided with a plurality of holes, slots, brackets, bases or other structures suitable for carrying reaction vessels, defined as reaction vessel locations, wherein the reaction vessel locations for washing separation are defined as washing separation reaction vessel locations, and the reaction vessel locations for measurement are defined as measurement reaction vessel locations. The reaction vessel positions on the processing disk can be arranged in at least two circles with the center of the processing disk rotation as a center, the cleaning separation reaction vessel positions are distributed on at least one circle, and the measurement reaction vessel positions are distributed on at least one other circle, so that the mutual interference of cleaning separation and measurement is reduced, and the size and the volume of the processing unit are reduced. For tests requiring signal incubation, measuring the reaction vessel location may also enable signal incubation in addition to measurement. By rotating the processing disk, the reaction vessel on the position of the measurement reaction vessel can be rotated to the measurement device for measurement, thereby realizing signal incubation. Taking the example of signal incubation of enzymatic chemiluminescence, if it takes 5 minutes for signal incubation, the measurement reaction vessel position may be subjected to 5 minutes of signal incubation during transfer of the reaction vessel to the measurement device. The processing tray is preferably one, including a drive, transmission mechanism and associated control circuitry, etc., to control and drive the processing tray to rotate a fixed angle at fixed intervals (e.g., one cycle or period) to advance the reactor vessel position thereon a plurality of positions (e.g., advance one reactor vessel position). At least two reaction vessels on the spin-processing plate are positioned within the range of motion of the transfer unit so that the transfer unit can move the reaction vessels in and out of the processing plate.
In addition to the above functions, the cleaning and separating device of the processing unit can also clean and separate the reaction container on the cleaning and separating reaction container position so as to remove unbound components in the reactant. The cleaning and separating device of the treatment unit comprises a magnetic field generating device and a flushing mechanism. The magnetic field generating device provides a magnetic field environment to enable paramagnetic particles in the reaction vessel to be adsorbed to the inner wall of the reaction vessel. Due to factors such as response time, moving distance and resistance in a magnetic field, the paramagnetic particles need to be adsorbed to the inner wall of the reaction vessel for a certain period of time, usually several seconds to several tens seconds, so that the reaction vessel needs to pass through the magnetic field for a certain period of time before each time the waste liquid (including unbound components) is sucked. In a preferred embodiment of the invention, the magnetic field generating device can be directly arranged or fixed on the heat preservation device of the processing unit, so that an additional fixing mechanism can be saved, the cost is reduced, and 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 includes a liquid suction and injection device for sucking unbound components in the reaction vessel and injecting a wash buffer into the aspirated reaction. The liquid sucking device comprises a liquid sucking part suitable for sucking liquid, such as a liquid sucking needle, a liquid sucking pipe or a liquid sucking nozzle, and the like, wherein the liquid sucking part is arranged above the processing unit, can enter and exit the reaction container on the reaction container position through the driving of the driving mechanism, and sucks 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, and the liquid injection part is also arranged above the reaction container position of the processing unit, and the cleaning buffer liquid is injected into the sucked reaction container. Each flushing includes one pipetting and one injecting of the washing buffer and the process, and is generally performed three or four times, i.e. three or four times, although the number of times of flushing can be varied flexibly. In order to ensure thorough cleaning and less residue, a mixer is arranged at the liquid injection level to mix the reaction vessel or the impact force during liquid injection is utilized, and paramagnetic particles are resuspended and uniformly dispersed in the cleaning buffer solution at the same time of or after the cleaning buffer solution is injected. When the processing unit transfers the reaction vessel to the cleaning and separating device, the cleaning and separating device starts cleaning and separating the reaction vessel. In addition, in order to simplify the mechanism, the cleaning and separating device can be further coupled with a signal reagent filling mechanism, and after the reaction container finishes cleaning and separating, all or part of signal reagents, such as all first signal reagents, second signal reagents and the like or only the first signal reagents and the like, are filled into the reaction container, and the rest signal reagents can be filled during measurement. Therefore, the functions of the cleaning and separating device can be fully utilized, the mechanism volume is reduced, and the cost is saved. The cleaning and separating device is arranged on the periphery or above the processing disc of the processing unit, and can directly clean and separate the reaction container on the processing disc, so that an independent cleaning and separating rotating device, such as an independent cleaning and separating disc or a cleaning and separating track, is avoided, the components and the whole machine mechanism are simplified, the whole machine mechanism is more compact and lower in cost, the reaction container is prevented from being transferred between the independent cleaning and separating device and the incubation unit, and the whole machine control flow is simpler and more efficient, so that the processing efficiency and the reliability are improved.
The measuring device of the processing unit measures the signal in the reaction vessel. The signal is an electric signal, a fluorescent signal or a weak chemiluminescent signal generated after the signal reagent is added into the reaction container. The measuring device comprises a weak light detector Photomultiplier (PMT) or other sensitive photo-sensing device, and can convert the measured optical signals into electrical signals to be transmitted 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, calibration and the like. In a preferred embodiment of the invention, the measuring device can be connected or mounted on the heat preservation device of the processing unit in a general way, for example, the measuring device is directly mounted and fixed on the heat preservation device or is mounted on the heat preservation device through optical fiber connection, thus the signal in the reaction vessel on the position of the reaction vessel can be directly measured by the processing disk, the independent measuring position or the measuring disk is avoided, the whole mechanism is more compact, the cost is lower, the control flow is simpler and more efficient, and the processing efficiency and the reliability are higher. In addition, in order to facilitate the filling of the signal reagent, the processing unit of the present invention may further comprise a signal reagent filling mechanism for filling the signal reagent into the reaction vessel at the reaction vessel position of the processing disk. The processing unit is independent of the incubation unit, not only is cleaning, separating and measuring easy to realize, but also flexible incubation time can be realized, and the defects of oversized whole machine, complex structure, fixed incubation time and the like in the prior art are overcome.
In addition, the automatic analyzer of the present invention may be provided with a sample transporting unit, a reagent storing unit, and the like for transporting a sample and storing a reagent.
The sample conveying unit is used for placing a sample tube to be detected and conveying the target sample tube to the sample sucking position. The sample delivery unit has three main modes of track sample injection, sample tray sample injection and fixed area sample injection, the sample tubes are usually placed on sample racks, each sample rack is typically placed with 5 or 10 sample tubes, and the sample racks are placed on a transmission track, on a sample tray or in a fixed area of an analysis device.
The reagent storage unit freezes the reagent and transfers the target reagent to the reagent sucking position. The reagent storage unit usually adopts two modes of a reagent disk and a reagent bin, and in order to ensure the stability of the reagent, the reagent disk generally has a refrigerating function, for example, 4-10 ℃. A plurality of reagent container positions are generally arranged on the reagent disk and are used for placing reagent containers. Each reagent container is provided with a plurality of independent cavities for storing different reagent components, such as magnetic particle reagents, enzyme-labeled reagents, diluents and the like.
A first embodiment of the automatic analyzer of the present invention is shown in fig. 4. The automatic analysis device 100 includes a sample transfer unit 30, a reagent storage unit 40, a filling unit 20, a reaction container supply unit 70, a transfer unit 50, a processing unit 10, an incubation unit 80, a filling station 90, and the like. The functions and actions of the respective parts are described below.
The sample transport unit 30 is used for placing a sample tube 31 to be inspected and transporting a target sample tube to a sample sucking position. In this embodiment, the sample delivery unit 30 is a sample tray, on which arc-shaped sample racks (not shown) are placed, and 10 sample tubes 31 are placed on each arc-shaped sample rack. The sample tray can be driven by the driving mechanism to transfer the target sample to the sample sucking position under the control of the control center, and the sample sucking position is positioned at the intersection point of the horizontal movement track of the filling unit 20 and the center circle of the sample tube.
The reagent storage unit 40 refrigerates the reagent container 41 and transfers the target reagent to the reagent sucking position. In this embodiment, the reagent storage unit 40 is a reagent disk, and is provided with 16 reagent sites, and can accommodate 16 reagent containers 41 (or reagent kits, reagent bottles, for convenience of description, hereinafter referred to as reagent bottles). In this embodiment, each reagent bottle 41 is provided with 4 cavities 41a, 41b, 41c, 41d, which can be used for storing reagent components such as magnetic particle reagents, enzyme-labeled reagents, diluents and the like. The reagent disk can be driven by the driving mechanism to transfer the target reagent bottle to the reagent sucking position under the control of the control center, and the reagent sucking position is positioned at the intersection point of the horizontal movement track of the filling unit and the center circle of the reagent cavity, and in this embodiment, 4 reagent sucking positions (not shown) are corresponding to the corresponding 4 reagent components.
The filling unit 20 completes filling of the sample and the reagent. The horizontal movement track of the filling unit 20 is 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 filling station 90, 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 filling mechanism, and can perform up-down and horizontal rotation movements, so that both the sample and the reagent can be filled, and the whole machine structure is more compact and the cost is lower. The filling unit 20 may further be integrated with a mixing mechanism such as an ultrasonic generator, etc., to mix the reaction containers after each filling with ultrasound. In other embodiments, a mixing mechanism may be provided on the filling station 90 for ultrasonic or vibratory mixing of the filled reaction vessels.
The reaction vessel supply unit 70 stores and supplies reaction vessels. In this embodiment, the reaction vessel supply units are arranged in advance for the purpose of making the whole machine more compact and lower in cost. The reaction vessel supply unit 70 includes two reaction vessel trays on which a number of reaction vessel sites are provided for storing unused reaction vessels. The reaction vessel supply unit 70 is within the horizontal movement range of the transfer unit 50 so that the transfer unit 50 can traverse the unused reaction vessel at each reaction vessel position on the tray to provide an unused reaction vessel for a new start of the test.
The transfer unit 50 may move horizontally to transfer the reaction vessel between different positions of the automatic analysis device 100. In this embodiment, the number of the transfer units 50 is 1, so that the transfer units can perform three-dimensional movement, and the whole machine is more compact and has lower cost. The transfer unit 50 includes an X-direction moving robot 50b, a Y-direction guide rail 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 finger horizontally in the X-direction and the Y-direction at the same time, and the horizontal movement range covers the range within the boundary polygon 56, so that the reaction container can be transferred between the reaction container supply unit 70, the filling station 90, the reaction container position on the incubation unit 80, the washing separation reaction container position 11a on the processing unit 10, the measurement reaction container position 11b, and the lost reaction container hole 60.
The incubation unit 80 incubates the reactants within the reaction vessel. In this embodiment, the heat preservation device of the incubation unit 80 is a pot 82 and an upper cover (not shown), and the rotation device is an incubation plate 81. The side or bottom of the pan 82 has a heater and a sensor surrounding the bottom and periphery of the incubation plate 81 to provide a constant temperature incubation environment for the incubation unit 80 to prevent or reduce heat dissipation from the incubation unit 80. The incubation plate 81 is rotatable about a central axis, on which three reaction vessel positions 81a, 81b, 81c are arranged around the rotation center, and of course the number of turns may be varied, for example 1, 2, 4 or more turns, etc.
The processing unit 10 is independent of the incubation unit, performs wash separation of the reactants in the reaction vessel and performs measurement of the signals in the reaction vessel. In this embodiment, the heat preservation device of the processing unit 10 is a pan body 12 and an upper cover (not shown in the figure), the processing tray is 11, the cleaning and separating device is 16, and the measuring device is 86. The side or the inner side of the bottom of the pot body 12 is provided with a heater and a sensor, which surrounds the bottom and the periphery of the processing disc 11, provides a constant temperature environment and a darkroom environment for the processing unit 10, and prevents or reduces the heat dissipation of the processing unit 10 and the influence of external stray light. In addition to providing a constant temperature and dark room environment, the pan body 12 also supports and secures a magnetic field generating device of the cleaning and separation device 16, providing a magnetic field environment for cleaning and separation. In this embodiment, the magnet generating means of the cleaning and separating device 16 is a permanent magnet device, which can provide a stronger and more stable magnetic field environment. The flushing mechanism for cleaning the separating apparatus 16 includes a liquid sucking device and a liquid injecting device, and a mixing mechanism. The wash separation device 16 may also be coupled to a signal reagent filling mechanism to fill all or a portion of the signal reagent into the reaction vessel where the wash separation is completed. The measuring device 86 includes a weak photodetector Photomultiplier (PMT) mounted directly on the pot 82 for measuring weak chemiluminescent signals generated by the addition of a signaling agent to the reaction vessel. The processing disk 11 is rotatable about a central axis, on which two circles of reaction vessel positions 11a and 11b are provided with the center of rotation as the center. The reaction container position on the inner ring 11a is a cleaning separation reaction container position, and the reaction container position on the outer ring 11b is a measurement reaction container position, which is not only beneficial to the installation of a cleaning separation device and a measurement device, but also can reduce the overall size of the processing unit. Of course, the number of turns of the reaction vessel position on the treatment tray may be changed, for example, 1 turn, 3 turns, 4 turns or more, etc., depending on the test requirements. After the incubation in the incubation unit 80, the reaction vessel to be washed and separated is transferred from the transfer unit 50 to the washing and separating reaction vessel position on the inner periphery 11a of the processing tray 11, the processing tray rotates, and the reaction vessel on the transfer washing and separating reaction vessel position is washed and separated by the washing and separating device. The reaction vessel to be measured is transferred from the cleaning separation position on the inner ring 11a to the measurement reaction vessel position on the outer ring 11b by the transfer unit 50, the processing disk rotates, the reaction vessel on the measurement reaction vessel position is transferred to the measurement device for measurement, and if the reaction vessel reactant needs signal incubation, signal incubation is realized in the transfer process.
The measurement flow and steps of the automatic analyzer 100 will be briefly described below with reference to fig. 4 and 5, taking a one-step test as an example. After the start of the test, the test was started,
step 200 loads the reaction vessel: the transfer unit 50 transfers an unused reaction vessel from the reaction vessel supply unit 70 to the reaction vessel site of the filling station 90,
step 201 fills the sample and reagents: the filling unit 20 sucks the sample and the reagent from the sample sucking position and the reagent sucking position respectively into the reaction container at the reaction container position of the filling station 90,
step 202, mixing evenly: if mixing is required, a mixing mechanism integrated in the filling station 4 mixes the sample and the reagent in the reaction vessel. If the mixing is not needed, 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 to the reaction vessel position of one of three turns (81 a, 81b, 81 c) of the incubation plate 81, and the reaction vessel starts incubation in the incubation unit. The incubation time of the reaction vessel in the incubation unit 81 varies depending on the specific test item, and is generally 5 to 60 minutes,
step 204, cleaning and separating: after the incubation of the reaction vessel is completed or after a certain period of incubation, the transfer unit 50 transfers the reaction vessel from the reaction vessel position of the incubation unit 80 to the cleaning and separating reaction vessel position on the inner ring 11a of the processing disc 11, the processing disc 11 rotates and advances for 1 position every fixed time, the reaction vessel on the cleaning and separating reaction vessel position is transferred to the cleaning and separating device 16, the reaction vessel is subjected to imbibition, cleaning buffer solution injection and cleaning and mixing by the magnetic field of the cleaning and separating device 16 and the flushing mechanism and the mixing mechanism of the cleaning and separating device 16 until the cleaning and separating are completed,
Step 205 priming with a signaling agent: after the completion of the washing separation, the processing tray 11 transfers the reaction vessel at the position of the washing separation reaction vessel away from the magnetic field region, and all or part of the signal reagent is injected into the reaction vessel by the signal reagent injection mechanism coupled to the washing separation device 16. After filling of all or part of the signal reagent is completed, the transfer unit 50 transfers the reaction vessel from the purge separation reaction vessel position on the inner periphery 11a of the processing tray 11 to the measurement reaction vessel position on the outer periphery 11b,
step 206 signal incubation: if signal incubation is required, all or part of the signal incubation is completed when the processing tray 11 transfers the reaction vessels measuring the reaction vessel positions on the outer lane 11b to the measuring device 86. If signal incubation is not required, this step is omitted,
step 207 measurement: when the reaction vessel to be measured is transferred through the measuring device 86, the measuring device 86 measures the reaction signal in the reaction vessel, the measurement result is processed and then transmitted to the control center of the automatic analysis device,
step 208 discards the reaction vessel: the transfer unit 50 transfers the measured reaction container from the measured reaction container position on the outer ring 11b of the processing disk 11 to the discard reaction container hole 60 for discarding.
Referring to fig. 4 and 6, the time-lapse one-step test procedure and steps are different from the one-step test procedure in that the steps 301 to 305 are divided into two separate injections of the reagent and one additional incubation, and other steps are similar to the one-step test procedure and will not be repeated.
Step 301 fills the sample and the first reagent: priming unit 20 draws sample and first reagent from the sample and reagent draw sites respectively into the reaction vessels on priming station 90,
step 302, mixing evenly: if mixing is desired, a mixer integrated into the filling station 90 mixes the sample and the first reagent in the reaction vessel. If the mixing is not needed, the step is omitted,
step 303, incubation: the transfer unit 50 transfers the reaction vessel filled with the sample and the first reagent from the filling station 4 to the reaction vessel position of one of three turns (81 a, 81b, 81 c) of the incubation plate 81, and the reaction vessel starts to incubate in the incubation unit. The incubation time of the reaction vessel in the incubation unit 81 varies depending on the specific test item, and is generally 5 to 60 minutes,
step 304 fills with a second reagent: after the first incubation has ended, the transfer unit 50 transfers the reaction vessel again from the reaction vessel position of the incubation unit 80 to the filling station 4, the filling unit 20 draws the second reagent from the reagent-sucking position into the reaction vessel on the filling station 90,
Step 305, mixing evenly: if mixing is desired, a mixer integrated into the filling station 90 mixes the sample and the first reagent in the reaction vessel. If the mixing is not needed, the step is omitted,
referring to fig. 4 and 7, the two-step test procedure and steps differ from the time-lapse one-step test in that step 404 is added, adding a single wash separation:
step 404, cleaning and separating: after the incubation of the reaction vessel is completed or the incubation is completed for a certain period of time, the transfer unit 50 transfers the reaction vessel from the reaction vessel position of the incubation unit 80 to the cleaning and separating reaction vessel position on the inner ring 11a of the processing tray 11, the processing tray 11 rotates and advances for 1 position every fixed time, the reaction vessel on the cleaning and separating reaction vessel position is transferred to the cleaning and separating device 16, the reaction vessel is subjected to liquid suction, cleaning buffer solution injection and cleaning and mixing by the flushing mechanism and the mixing mechanism of the cleaning and separating device 16 until the cleaning and separating are completed, and after the first cleaning and separating are completed, the transfer unit 50 transfers the reaction vessel from the cleaning and separating reaction vessel position on the inner ring 11a of the processing tray 11 to the filling station 90. The priming unit 20 draws the second reagent from the reagent-sucking site and priming it into the reaction vessel at the priming station 90,
The other steps of the two-step method are similar to the delay one-step method, and are not repeated.
From the above description, the automatic analysis device 100 adopts the incubation unit and the processing unit which are independent of each other, the incubation unit is not affected by the processing unit, flexible incubation time can be realized, and the processing unit simultaneously realizes cleaning separation and measurement, so that not only is an independent cleaning separation disc and a measurement disc adopted in the prior art omitted, the size of the whole machine reduced, the cost reduced, the testing step simplified, the complexity and difficulty of control reduced, and the transfer of the reaction vessel among a plurality of discs avoided. In addition, the processing unit is provided with different reaction container positions, the cleaning and separating device is arranged on the inner side of the processing unit, the measuring device is arranged on the outer side of the processing unit, cleaning and separating are realized on the cleaning and separating reaction container positions of the inner ring of the processing disc, and measuring is realized on the measuring reaction container positions of the outer ring of the processing disc, so that the mutual influence of cleaning and separating and measuring is eliminated, the size of the processing unit is reduced, the whole machine structure is more compact, the cost is lower, and the testing efficiency is higher.
Besides the unique advantages, the automatic analysis device can be flexibly expanded and reused to the maximum extent, and the serialization of products is realized. On the basis of the first embodiment, in order to further improve the specification parameters and the test flux of the whole machine and meet the requirements of terminal customers with larger sample quantity, the method can be realized by increasing the quantity of the transfer units and the filling units, properly increasing the size of the incubation units or increasing the quantity of the incubation units, and the like. Referring to fig. 8, a schematic diagram of a second embodiment of the automatic analyzer of the present invention is shown. The sample conveying unit 30 adopts a sample feeding mode of a track and a sample rack, so that more samples can be accommodated, samples can be added in real time, and the operation is more convenient. The sample holder 32 and the sample tube 31 thereon can be transported under the movement track of the first filling unit 21. The reagent storage unit 40 adds 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 the sample, the second filling unit 22 fills the reagent, the movement track of the first filling unit 21 and the second filling unit 22 passes through the reaction vessel position of the incubation unit 80, so that the filling unit 20 can directly fill the sample and the reagent into the reaction vessel on the reaction vessel position of the incubation unit 80, i.e. the filling station in the embodiment is located on the incubation unit. Of course, more filling units can be added, so that the speed of adding the sample and the reagent is improved. In order to thoroughly solve the problem of sample carrying pollution, the first filling unit 21 in this embodiment adopts a disposable suction nozzle (Tip head) for filling samples, and 93 and 96 in fig. 8 are a Tip head loading position and a Tip head unloading position, respectively. The reaction vessel supply unit 70 may provide a new Tip head in addition to a new reaction vessel. The transfer unit 50 includes a first transfer unit 51 and a second transfer unit 52 which are independently movable in three dimensions, the first transfer unit 51 transferring the reaction vessel and the Tip head mainly between the reaction vessel supply unit 70, the incubation unit 80, the Tip head loading position and the Tip head unloading position, the reaction vessel discarding hole 60a and the like, and the second transfer unit 52 transferring the reaction vessel mainly between the incubation unit 80, the mixing station 90 and the processing unit 10, and the reaction vessel discarding hole 60 b. Of course, the number of the transfer units is more than 2, and more transfer units can be arranged according to the requirement so as to improve the efficiency and the speed of transferring the reaction vessel. The rotation means of the incubation unit 80 are provided with two rounds of reaction vessel locations 81a, 81b, and the processing unit 10 is independent of the incubation unit and can be fully multiplexed with embodiment one. At least one washing separation reaction vessel position and at least one measuring reaction vessel position on the treatment tray 11 are within the range of motion of the second transfer unit 52, so that the second transfer unit 52 can transfer reaction vessels between the incubation unit, the mixing station, the treatment unit and between the washing separation reaction vessel position and the measuring reaction vessel position.
It should be understood by those skilled in the art that the testing procedure and steps of the present embodiment are mainly different from those of the first embodiment in that: filling the sample and the reagent is completed by the coordination and cooperation of the first filling unit and the second filling unit; filling the sample and the reagent is completed on the reaction container position of the incubation unit; the mixing of the reaction container filled with the sample or the reagent is completed by an independent mixing station; the transfer of the reaction vessel is completed by the coordination of the first transfer unit and the second transfer unit, and other actions and processes are the same as or similar to those of the first embodiment, and are not repeated with reference to fig. 5 to 7. Compared with the prior art, the embodiment avoids the extra large-size cleaning separation disc and measuring disc, and reduces the size of the processing unit by the split-circle distribution of the reaction container positions with different functions, so that the whole machine is more compact, lower in cost, higher in efficiency and better in reliability.
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 a reagent into the reaction container;
an incubation step of incubating the reaction vessel at the reaction vessel position of the incubation unit;
a cleaning and separating step of cleaning and separating reactants in the reaction vessel on the cleaning and separating reaction vessel position of the processing unit;
A measurement step of measuring a reaction signal in a reaction vessel at a measurement reaction vessel position of the processing unit;
and a transferring step of transferring the reaction vessel between the incubation unit, the processing unit and the washing separation reaction vessel position of the processing unit and the measurement reaction vessel position of the processing unit by a transferring unit.
The invention uses the incubation unit as the center to realize the incubation of the reactants in the reaction container, the processing unit independent of the incubation unit cleans and separates the reactants in the reaction container on the cleaning and separating reaction container position and measures the signals in the reaction container on the measuring reaction container position, and the transfer of the reaction container between the incubation unit and the processing unit and the transfer between different reaction container positions of the processing unit are realized by the movement of the transfer unit. The invention not only improves the transfer reliability of the reaction container, omits the separate cleaning of the separation disc and the measuring disc, simplifies the system structure and the control flow, but also can obviously reduce the size of the processing unit, and ensures that the incubation unit realizes flexible incubation time. The invention improves the working efficiency of the analysis device, well solves the technical problems of large volume, low detection speed, high cost, poor performance and the like of the existing automatic instrument, saves the space of a laboratory, improves the test efficiency, is beneficial to reducing the expense and the burden of a testee, and finally saves a great amount of natural resources and social resources.
The technical features or operating steps described in the embodiments of the invention may be combined in any suitable manner. Those of ordinary skill in the art will readily appreciate that the order of steps or acts in the methods described in embodiments of the present invention may be varied. Accordingly, unless otherwise indicated, a certain order is required, any order in the figures or detailed description is for illustrative purposes only and is not a required order.
Various steps may be included in embodiments of the invention, which may be embodied in machine-executable instructions that 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 contain specific logic circuits for performing the steps, or by a combination of hardware, software, and/or firmware.
The present invention has been described above by way of specific examples, but the present invention is not limited to these specific examples. It will be apparent to those skilled in the art that various modifications, equivalent substitutions, variations, etc. can be made to the present invention, and these variations should be within the scope of the present invention without departing from the spirit of the invention. Furthermore, the above-described "one embodiment", "this embodiment", and the like represent different embodiments, and it is needless to say that all or part of them may be combined in one embodiment.
The foregoing examples illustrate only a few embodiments of the invention and are described in detail herein without thereby limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims (14)

1. An automatic analyzer, characterized in that: comprising the following steps:
a filling unit for filling the sample and the reagent into the reaction container;
an incubation unit for incubating the reactants in the reaction vessel;
a processing unit for washing and separating the reactants in the reaction vessel and measuring the reaction signals in the reaction vessel;
a transfer unit transferring the reaction vessel between different positions;
a reaction vessel supply unit for storing and supplying a reaction vessel;
the incubation unit is provided with an incubation reaction container position for incubating reactants in the reaction container; the processing unit comprises a processing disc, wherein a cleaning separation reaction container position and a measuring reaction container position are arranged on the processing disc and are respectively used for cleaning reactants in the separation reaction container and measuring reaction signals in the reaction container;
The incubation unit is independently arranged relative to the treatment tray, and the reaction container is transferred from the reaction container position of the incubation unit to the cleaning separation reaction container position on the treatment tray after the incubation of the reaction container is completed or after the incubation is carried out for a certain time.
2. The automated analyzer according to claim 1, wherein the transfer unit comprises a first transfer unit that transfers the reaction vessel between the reaction vessel supply unit and the incubation unit, and a second transfer unit that transfers the reaction vessel between the incubation unit and the processing unit and is capable of transferring the reaction vessel between a purge separation reaction vessel position of the processing unit and a measurement reaction vessel position of the processing unit.
3. The automated analysis apparatus of claim 1, comprising a filling station having a reaction vessel location for receiving a reaction vessel to be filled with a sample and a reagent.
4. An automated analysis device according to claim 3, wherein the filling station is located within the range of motion of the transfer unit and the filling unit or is movable by horizontal movement into the range of motion of the transfer unit and the filling unit.
5. An automated analysis apparatus according to claim 3, comprising a sample delivery unit for placing a sample tube to be tested and delivering a target sample tube to a sample suction site, and a reagent storage unit for refrigerating the reagent and forwarding the target reagent to the reagent suction site.
6. The automated analyzer of claim 5, wherein the sample delivery unit is a sample tray, the reagent storage unit is a reagent tray, and the horizontal motion path of the filling unit intersects the sample location on the sample tray, the reagent location on the reagent tray, and the reaction vessel location on the filling station, respectively.
7. The automated analysis device of claim 1, wherein the priming unit comprises a first priming unit that priming a sample and a second priming unit that priming a reagent.
8. The automatic analyzer according to claim 7, wherein the reaction container supply unit is further configured to supply a Tip head, and the first filling unit performs sample filling using the Tip head.
9. The automated analyzer of claim 8, further comprising a Tip loading station and a Tip unloading station, the transfer unit being capable of transferring a Tip between the reaction vessel supply unit, the Tip loading station, and the Tip unloading station.
10. An automated analysis device according to any one of claims 7-9, wherein the movement trajectories of the first and second filling units pass through the reaction vessel locations of the incubation unit.
11. The automated analysis apparatus of claim 2, wherein the first transfer unit is capable of transferring the reaction vessel between reaction vessel supply unit, incubation unit, reaction vessel discard well locations.
12. The automated analysis apparatus of claim 2, comprising a mixing station and a reaction vessel discarding well independently disposed, wherein the second transfer unit is capable of transferring reaction vessels between the incubation unit, the mixing station, the processing unit, and between the reaction vessel discarding wells.
13. The automated analysis device of claim 2, wherein the filling unit is configured to fill the sample and reagent directly into the reaction vessel at the incubation unit reaction vessel location.
14. The automated analyzer of claim 1, wherein the processing disk comprises an inner ring and an outer ring reaction vessel locations centered about a center of rotation of the processing disk, the purge separation reaction vessel locations being distributed on the inner ring, and the measurement reaction vessel locations being distributed on the outer ring.
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