WO2018126773A1 - Automatic analyzer and sample analysis method - Google Patents

Abstract

An automatic analyzer and a sample analysis method. The automatic analyzer (100) comprises: a filling unit (20) for filling a reaction vessel with a sample and/or a reagent; a reacting unit (10) for incubating, cleaning, and separating reactants in the reaction vessel; a measuring apparatus (86) for measuring a reaction signal in the reaction vessel; and a transferring unit (50) for transferring the reaction vessel between different positions. At least one incubation transfer position (13a_1-3, 13b_1-3, and 13c_1-3) and at least one cleaning and separating transfer position (13d_1-2) are provided on the reacting unit (10). The transferring unit (50) is capable of transferring the reaction vessel between the incubation transfer position (13a_1-3, 13b_1-3, and 13c_1-3) and the cleaning and separating position (13d_1-2). Not only flexible incubation can be implemented, but the problem in the prior art in which multiple cleaning and separating mechanisms must be employed to implement a two-step test is also solved, and efficient cleaning and separation are fully implemented.

Description

Automatic analysis device and sample analysis 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 technique

In recent years, the development and advancement of clinical testing and automation technology has not only improved the level of clinical laboratory automation, but also improved the efficiency of medical testing and improved the quality and reliability of testing results. However, as the number of specimens is increased, clinical laboratories are continually adding large automated inspection systems to meet their testing needs, resulting in increasing laboratory congestion and rising testing costs. Therefore, how to improve the inspection efficiency, ensure the results and make full use of existing laboratory resources and reduce the cost of testing under the pressure and challenge of medical insurance control is an urgent problem to be solved by clinical testing.

For convenience of description, the present invention is described in the context of a fully automated immunoassay instrument in In-Vitro Diagnostics (IVD), in particular, a luminescent immunoassay analyzer, which should be understood by those skilled in the art. The protocols and methods of the present invention are also applicable to other clinical test automation devices, such as fluorescent immuno devices, electrochemical immunization, and the like. Automated immunoassay based on immunological reactions in which antigen and antibody bind to each other, labeling antigen antibodies with enzyme labels, lanthanide labels or chemiluminescent agents, and optical or electrical signals and analytes through a series of cascade amplification reactions The concentration is related to the analysis of the antigen or antibody to be tested in the human sample, and is mainly used in hospitals, third-party independent laboratories, blood test centers, etc., to quantify the content of each analyte in human body fluids. Quantitative or qualitative testing for the diagnosis of infectious diseases, tumors, endocrine functions, cardiovascular diseases, prenatal and postnatal diseases, and autoimmune diseases. The automatic immunoassay analyzer usually consists of a sampling unit, a reaction unit, a supply and waste waste unit, a system control unit, and the like. Luminescence immunity has become the mainstream technology of automatic immunity due to its advantages of quantitative detection, high sensitivity, good specificity, wide linear range and high degree of automation. The fully automatic luminescence immunoassay differs according to the labeling method and the luminescence system, and includes enzymatic chemiluminescence, direct chemiluminescence, and electrochemiluminescence.

Referring to Figures 1-3, the luminescence immunoassay can be generally divided into a one-step method, a one-step one-step method, a two-step method, etc. according to the test principle and mode. The main test steps generally include adding a sample and a reagent, mixing the reactants, and incubating. Cleaning separation (Bound-Free, referred to as B/F), adding signal reagents, measuring, etc. It should be noted that the present invention distinguishes between reagents and signal reagents, incubation and signal incubation for ease of presentation. The reagents and analysis items have a “one-to-one correspondence” relationship, that is, the specific reagents corresponding to different analysis items generally differ in formula, reagent amount, and component quantity. Depending on the specific analytical item, the reagent typically includes multiple components, such as the usual 2-5 components, including reagent components such as magnetic particle reagents, enzyme labeling reagents, diluents, and the like. Depending on the reaction mode, multiple reagent components of an analysis item can be filled in one time or in multiple steps. When the step is added, the first reagent, the second reagent, and the third reagent are defined according to the order of filling. Wait. The signal reagent is used to measure the generation of the signal, usually a kind of general-purpose reagent, and the analysis item is "one-to-many" correspondence, that is, different analysis items share the signal reagent. The incubation of the present invention specifically refers to the process of antigen-antibody binding reaction or biotin-avidin binding reaction of the reactants in the constant temperature environment of the reaction unit before the start of washing and separation, specifically, one-step incubation, To enter an incubation prior to wash separation, delay the incubation by one step in a single step, including the first incubation before the second reagent is added and the second incubation before the wash separation, and the two-step incubation twice, including the first The first incubation before the separation is separated and the second incubation before the second cleaning separation. The signal incubation refers to a process in which the reaction vessel after the separation and separation is added to the signal reagent and reacted in a constant temperature environment for a period of time to enhance the signal. Depending on the reaction system and the principle of luminescence, not all tests require signal incubation, and tests that require signal incubation are typically enzymatic chemiluminescence immunoassays. The test steps corresponding to different test modes are detailed as follows:

1) One-step method: Refer to Figure 1, add sample (S) and reagent (R), mix (some test methods can also do not need to mix, the same below, no longer repeat), incubate (generally 5-60 Minutes), after the incubation is completed, wash and separate, add signal reagent, signal incubation (usually 1-6 minutes), and finally measure. It should be pointed out that some luminescent systems do not require signal incubation due to the specific composition of the signal reagents. During the filling of the signal reagents or after the filling of the signal reagents It can be measured directly afterwards. The signal reagent may be one or more. Referring to Figure 2, the signal reagent includes a first signal reagent and a second signal reagent.

2) One-step delay method: the difference from the one-step method is that the reagent is added twice, and requires two incubations. After the first reagent is mixed, the first incubation is performed, and after the first incubation, the second reagent is added. Mix well. One more incubation, reagent addition, and mixing action than the one-step method, and the rest of the procedure is the same as the one-step method.

3) Two-step method: The difference from the one-step method is that there is one more cleaning and separation step, and the other steps are the same.

In order to achieve the above process automation test, the existing specific implementation technical solutions are as follows:

The first prior art solution separates the incubation, wash separation, and measurement into separate layouts, each of which is accomplished by three rotating disks, and the reaction vessel is transferred between the different units by a mechanical gripper. The technical scheme has many components and units, the incubation transfer position, the cleaning separation transfer position and the measurement transfer position are dispersed on different discs, and the distance is long, and the reaction container needs to be transferred between the transfer positions, resulting in large volume and high cost. There are many problems such as many moving paths and complicated control processes.

A second prior art solution arranges the incubation and measurement together to form an incubation measurement unit, which is performed by another separate unit, although the technical solution reduces one measurement disc compared to the first prior scheme. To a certain extent, it is advantageous to control the size and cost of the whole machine, but there are also the same problems as the first technical solution. In order to achieve flexible incubation time, the incubation measurement unit is complicated to control, and the incubation and measurement are also controlled by each other. There are not only shortcomings such as high-speed automated testing, but also flexible signal incubation.

A third prior art solution achieves incubation, wash separation and measurement on a single-turn disc or a trajectory track. In order to support longer incubation times, the disc needs to be set in addition to cleaning separation and measurement positions. A lot of incubation positions, so in order to achieve high-speed testing, the size of the disc or the trajectory track needs to be designed to be large, difficult to manufacture, and costly. In addition, in order to achieve the one-step and two-step test, at least two A loading mechanism and at least two cleaning separation mechanisms increase material, processing, production costs and overall machine size. On the other hand, this technical solution also limits the incubation time, resulting in problems such as a fixed incubation time and an excessively long time. In addition, this technical solution is not only difficult to achieve the darkroom environment required for measurement, it requires an additional shutter mechanism, and flexible signal incubation is not possible.

Summary of the invention

In order to solve the shortcomings and problems common in the prior art, the present invention provides an automatic analysis device and a sample analysis method with low manufacturing cost, simple and compact structure, flexible and efficient test procedure or method.

According to an aspect of the invention, there is provided an automatic analysis device comprising: a filling unit, filling a sample and/or a reagent into a reaction vessel, a reaction unit, incubating and washing the reactants in the separation reaction vessel, measuring the device, measuring the reaction a reaction signal in the vessel, a transfer unit, transferring the reaction vessel between different positions, the reaction unit comprising a rotating device, the rotating device is provided with a plurality of reaction vessel positions for carrying and fixing the reaction vessel, the reaction At least one incubation transfer site and at least one wash separation transfer site are disposed on the unit, the at least one incubation transfer site of the reaction unit and the at least one wash separation transfer site being within a horizontal range of motion of the transfer unit.

According to another aspect of the present invention, there is provided a sample analysis method comprising: a filling step of filling a sample and/or a reagent in a reaction vessel, and an incubating step of performing a reaction vessel entering the reaction unit through at least one incubation transfer position Incubating, washing and separating the step, washing and separating the reaction vessel entering the reaction unit through at least one washing and separating transfer position, removing unbound components in the reactant, adding a signal reagent step, adding a signal reagent to the reaction container, and measuring In the step, the reaction signal in the reaction vessel is measured by a measuring device.

The invention realizes the incubation and washing separation of the reactants in the reaction vessel centering on the reaction unit, and at least one incubation transfer position and at least one cleaning separation transfer position are arranged on the reaction unit, and the transfer unit can be transferred between the incubation transfer position and the cleaning separation position. The reaction vessel can not only realize flexible incubation, but also solve the problem that the two-step test must be implemented by using multiple cleaning and separating mechanisms in the prior art, and fully realize efficient cleaning separation. In addition, the measuring device can be flexibly arranged or arranged according to the needs of the whole machine layout or structure realization, for example, can be directly installed on the reaction unit, set in a separate position or mounted on an independent measuring disk, etc., and solves the measurement in the prior art. The device layout is limited, and the measurement environment is easy to interfere. The invention improves the working efficiency of the analysis device and reduces the difficulty of realizing the realization of the automation function, and is well solved At present, the technical problems of large size, slow detection speed, high cost and poor performance of the automatic instrument not only save the laboratory space, improve the test efficiency, but also help reduce the expenses, reduce the burden on the testee, and ultimately save a lot of Natural and social resources.

DRAWINGS

Figure 1 is a schematic diagram of a one-step reaction mode;

Figure 2 is a schematic diagram of a one-step reaction mode (another signal measurement mode);

Figure 3 is a schematic diagram of a one-step and two-step reaction mode;

Figure 4 is a schematic view showing a first embodiment of the automatic analyzer of the present invention;

Figure 5 is a one-step test flow chart;

Figure 6 is a flow chart of a one-step delay test;

Figure 7 is a two-step test flow chart;

Figure 8 is a schematic view showing a second embodiment of the automatic analyzing device of the present invention;

Figure 9 is a schematic view showing a third embodiment of the automatic analyzer of the present invention;

Figure 10 is a schematic view showing a fourth embodiment of the automatic analyzer of the present invention;

Figure 11 is a schematic view showing a fifth embodiment of the automatic analyzer of the present invention.

detailed description

The present invention will be further described in detail below with reference to the accompanying drawings.

An automatic analysis device of the present invention comprises: a filling unit, filling a sample and/or a reagent into a reaction vessel, a reaction unit, incubating and washing the reactants in the separation reaction vessel, measuring the device, and measuring the reaction signal in the reaction vessel a transfer unit that transfers the reaction vessel between different positions, the reaction unit comprising a rotating device, wherein the rotating device is provided with a plurality of reaction vessel positions for carrying and fixing the reaction vessel, and at least one of the reaction units is disposed Incubating the transfer site and at least one wash separation transfer site, at least one incubation transfer site and at least one wash separation transfer site of the reaction unit are within a range of horizontal motion of the transfer unit.

The reaction vessel provides a reaction site for the reaction of the sample and the reagent, and may be a reaction tube of various shapes and configurations, a reaction cup, a reaction cup of a plurality of chambers, a reaction chip, etc., and is generally used at one time. The material of the reaction vessel is usually a plastic such as polystyrene. The reaction container may be coated with an antigen or an antibody in advance on the inner wall, or may be pre-stored with a magnetic bead or a plastic ball. The storage and supply of the reaction vessel is completed by the reaction vessel supply unit. In order to streamline the mechanism, the reaction vessel supply unit is preferably pre-arranged, and the reaction vessel is pre-arranged in the reaction vessel tray, the box or the reaction vessel rack, and the channel, and the reaction vessel supply unit can be used for the whole tray, the whole box of reaction vessels or a row at a time. A series of reaction vessels are delivered to the target location. In other embodiments, the reaction vessel supply unit may be a silo type, and the reaction vessel may be poured into a silo of the reaction vessel supply unit in a scattered manner, and then the reaction vessel supply unit automatically sorts the reaction vessels one by one, and supplies the reaction vessel to the transfer unit. .

The transfer of the reaction vessel between different locations in the apparatus of the invention can be accomplished by the transfer unit. The transfer unit can be any suitable mechanism for transferring or moving the reaction vessel. The preferred transfer unit of the present invention primarily comprises a drive mechanism, a horizontal motion robot arm, a pick and place mechanism, and the like. The pick and place mechanism is usually a mechanical finger, which can hold the reaction container. The horizontal motion mechanical arm can be driven along the X direction, the Y direction, the X direction and the Y direction, the radial direction, the circumferential direction, the radial direction and the circumferential direction by the driving mechanism. Move the pick and place mechanism in the direction, and move the reaction container grabbed by the pick and place mechanism to different positions. In addition to horizontal movement, the transfer unit can also move up and down, placing the reaction vessels in different positions or taking them out from different locations. Depending on the test speed and the overall layout, one or more transfer units can be set.

The filling unit completes the filling of the sample and the reagent. The filling unit is generally composed of a steel needle or a disposable nozzle (Tip), a motion driving mechanism, a syringe or a liquid injection pump, a valve, a fluid line, and a cleaning tank (or a cleaning pool when a Tip is used). . In order to complete the suction sample, the reagent and the filling action, the filling unit can move horizontally in addition to the up and down movement, and the horizontal movement usually has several movement forms such as rotation, X direction and Y direction, and a combination thereof. The filling unit can be one, adding both the sample and the reagent, which makes the structure of the whole machine more compact and lower cost. In order to improve the test speed, The filling unit may further comprise one or several sample filling units, one or several reagent filling units, the sample filling unit only filling the sample or filling the sample and a part of the reagent, and the reagent filling unit is filling the reagent.

In order to facilitate the filling of the filling unit, the invention may also include a filling station. The filling station is located within the range of motion of the transfer unit and the filling unit or can be moved by horizontal motion to the range of motion of the transfer unit and the filling unit. The filling station receives and carries the reaction vessel transferred from the transfer unit, and accepts the filling unit to fill the reaction container with the sample and the reagent. A reaction vessel is placed on the filling station for placing a reaction vessel to which the sample and reagents need to be filled. In order to make the sample and the reagent mixture more uniform and more complete, and in order to simplify the structure of the whole machine and reduce the volume, the present invention preferably integrates the mixing mechanism at the filling station, and ultrasonically mixes and biases the reaction container after each filling. Rotate or shake to mix. Of course, it is also possible to integrate a mixing mechanism, such as an ultrasonic generator, into the filling unit, and mix the ultrasonic waves generated by the filling unit at the same time as the filling of the sample and the reagent or after the filling operation is completed. It will be understood by those skilled in the art that the filling station may not integrate the mixing mechanism, and the mixing may be performed by the suction and discharge action or the impact force of the filling unit.

The reaction unit carries and fixes the reaction vessel. The reaction unit mainly includes a heat preservation device, a rotation device, and a cleaning separation device. The periphery of the heat preservation device usually has insulation materials such as heat insulating cotton, and usually wraps or surrounds the bottom, the periphery and the upper portion of the rotating device, and the heating device and the sensor may be disposed on the inner side of the side or the bottom, and the upper portion is generally a structure such as a cover plate to provide a constant temperature for the reaction unit. Incubate the environment and prevent or reduce the loss of heat in the reaction unit. Of course, for higher heat transfer efficiency, the heating device can also be mounted on the rotating device. In addition to providing an incubation environment, the holding device can also support and secure the magnetic field generating device of the cleaning separation device to provide a magnetic field environment for cleaning separation. In addition, if the measuring device is mounted on the reaction unit, the heat insulating device can not only provide a mounting position for the photometric device, but also a darkroom environment required for the photometric device. Preferably, the rotating device comprises a driving device, a transmission mechanism and an associated control circuit, etc., and controls and drives the rotating device to rotate at a fixed angle every fixed time (such as a cycle or a cycle), and forwards the reaction vessel to a certain position. (such as advancing a reaction container bit). The rotating device is provided with a plurality of independent holes, slots, brackets, bases or other structures suitable for carrying the reaction vessel, defined as the reaction vessel position. In addition to carrying the reaction vessel position, the reaction vessel can also hold the reaction vessel. By "fixed" herein is meant that the reaction vessel does not move or slide within the reaction vessel position, but can move integrally with the reaction vessel site. In this way, the reaction vessel and the reaction vessel can be tightly packed, and the gap is smaller, which not only facilitates heat transfer incubation and precise positioning of the reaction vessel, but also makes the structure of the rotating device more compact, accommodates more reaction vessel positions, and has manufacturing costs. Lower, which effectively solves some shortcomings and defects in the prior art due to poor heat transfer efficiency, space waste, and complicated structure due to the movement of the reaction vessel in the reaction vessel position. In addition to carrying and immobilizing, the reaction unit also incubates the reactants in the reaction vessel. For tests that require signal incubation, the reaction unit of the present invention can also implement a signal incubation function.

In order to allow the reaction vessel to enter and exit the reaction unit, at least two transfer sites are provided on the reaction unit. The transfer position is defined as the fixed position of the reaction vessel in and out of the reaction unit on the reaction unit within the horizontal motion range of the transfer unit, which does not rotate with the rotation of the reaction vessel position. The reaction vessel position at different positions can be transferred and positioned to the transfer position under the rotation of the rotating device, and the reaction vessel can be received or withdrawn from the reaction vessel to complete the subsequent corresponding functions, such as entering the reaction unit for incubation or transferring to other reactions. The container position is cleaned and separated. Depending on the stage in which the reaction vessel enters and exits and the main functions achieved, the transfer position can be divided into an incubation transfer position and a wash separation transfer position. The present invention defines a transfer site through which the reaction vessel to be incubated into the reaction unit, after a certain period of incubation or at the end of the incubation, and the transfer site through which the reaction unit is transferred is defined as the incubation transfer position; after a certain period of incubation or after the end of the incubation, the separation needs to be cleaned. The transfer site through which the reaction vessel enters the reaction unit or/and the reaction vessel that completes the purge separation is transferred to the reaction unit is defined as the wash separation transfer site. The incubation unit of the present invention has at least one incubation transfer position, and the specific incubation transfer position can be inaccessible, only in or out, and into the reaction container as needed, so that flexible incubation time and various machine layouts can be realized. It should be noted that in order to solve the disadvantages and problems of the prior art, the reaction vessel that enters and exits the reaction unit by incubating the transfer site includes a reaction vessel that needs to be incubated once, incubated two or more times, so that it may be incubated once or twice. And more times the reaction vessel is concentrated in the first step, thereby reducing the size of the reaction unit and increasing the space utilization rate of the reaction unit. The cleaning separation transfer position can be set one by one, and the reaction container can be both retracted and further, so that the cleaning separation device can be made more compact, and at least one can be set, so that the cleaning separation device can be arranged more flexibly. In short, the setting of the transfer bit on the reaction unit solves the present In the prior art, the problem that the transfer sites are dispersed on a plurality of different units and the reaction vessels that need to be incubated are dispersed can not only make the transfer unit have fewer moving paths, shorter distances, but also make full use of the space of the reaction unit, thereby making the whole machine Control is simpler and smaller.

In addition to the functions described above, the reaction unit can also perform cleaning separation to remove unbound components of the reactants. The cleaning and separating device of the reaction unit of the present invention comprises a magnetic field generating device and a flushing mechanism. The magnetic field generating device provides a magnetic field environment for adsorbing paramagnetic particles in the reaction vessel to the inner wall of the reaction vessel. Due to factors such as response time, moving distance and resistance in the magnetic field, it takes a certain time for the paramagnetic particles to adsorb to the inner wall of the reaction vessel, usually ranging from several seconds to several tens of seconds, so that each time the waste liquid is taken (including unbound Before the component), the reaction vessel needs to pass through the magnetic field for a period of time. In a preferred embodiment of the present invention, the magnetic field generating device can be directly mounted or fixed on the heat insulating device of the reaction unit, which not only saves an additional fixing mechanism, reduces the cost, but also brings the magnet generating device closer to the reaction container. Thereby reducing the adsorption time of the paramagnetic particles and improving the cleaning separation efficiency. The rinsing mechanism includes a liquid absorbing and injecting device that sucks unbound components in the reaction vessel and injects a washing buffer into the reaction after suction. The liquid absorption device comprises a liquid absorption part suitable for pumping liquid, such as a liquid suction needle, a liquid suction tube or a liquid suction nozzle, and the liquid absorption part is arranged above the reaction unit, and the reaction container can be driven into and out of the reaction container through the driving mechanism. The unbound components in the reaction vessel are aspirated. The liquid injection device includes a liquid injection portion suitable for discharging liquid, such as a liquid injection needle, a tube, a mouth, and the like, and the liquid injection portion is also disposed above the reaction container position of the reaction unit, and the cleaning buffer is injected into the reaction container after the suction. Each flush includes one aspirate and one injection buffer and process, usually three or four times, ie three or four rinses, although the number of flushes can be varied. In order to make the cleaning more thorough and less residue, it is also possible to set the mixer to mix the reaction vessel in the filling position or to use the impact force when injecting the liquid, and to make the paramagnetic particles heavy after the injection buffer or the cleaning buffer. Suspended and uniformly dispersed in the wash buffer. When the reaction unit rotating device transfers the reaction vessel to the washing and separating device, the washing and separating device starts cleaning and separating the reaction vessel. In addition, in order to streamline the mechanism, the cleaning and separating device may further couple the signal reagent filling mechanism, and after the cleaning and separation of the reaction container, all or part of the signal reagent is added thereto, for example, all the first and second signal reagents are added. Wait for or only add the first signal reagent, etc., and the remaining signal reagents can be added during the measurement. This makes full use of the function of the cleaning and separating mechanism, reducing the size of the mechanism and saving costs.

It can be seen from the above description that the cleaning and separating device is arranged around the rotating unit of the reaction unit or above the rotating device, and the reaction container on the rotating unit of the reaction unit can be directly cleaned and separated, thereby avoiding the installation of independent cleaning and separating rotating device, such as independent cleaning. Separating the disc or cleaning the separation rail, etc., not only streamlining the components and the whole mechanism, making the whole mechanism more compact and lower in cost, but also avoiding the transfer of the reaction vessel between the independent cleaning and separating device and the reaction unit, so that the whole machine Control processes are simpler and more efficient, increasing processing efficiency and reliability.

The measuring device measures the signal in the reaction vessel. The signal is an electrical signal, a fluorescent signal or a weak chemiluminescence signal generated after the signal reagent is added to the reaction vessel. The measuring device includes a weak photodetector photomultiplier tube (PMT) or other sensitive photoelectric sensing device that converts the measured optical signal into an electrical signal for transmission to the control center. In addition, in order to improve measurement efficiency and ensure measurement uniformity, the measuring device may further include optical devices such as optical signal collection and calibration. Taking the weak chemiluminescence signal as an example, in order to avoid interference of ambient light, the measuring device of the present invention has three implementations for measuring the signal in the reaction container. In the first implementation, the measuring device is installed in the reaction unit, and the reaction signal in the reaction vessel at the reaction vessel reaction vessel position is measured. This makes full use of the reaction vessel position on the reaction unit, making the machine more compact and less costly. The second embodiment includes measuring the darkroom and the measuring position, and the measuring device is mounted on the measuring darkroom to measure the signal in the reaction vessel at the measuring position. The measurement position is within the horizontal range of motion of the transfer unit or can be moved horizontally to the horizontal range of motion of the transfer unit. The third embodiment mainly includes a measuring disk, a measuring dark room, a measuring device, and the like. The measuring disk comprises at least one reaction vessel position centered on the center of rotation of the measuring disk for carrying a reaction vessel to be measured. For tests that require signal incubation, the reaction vessel position on the measurement pan also enables signal incubation. By measuring the rotation of the disc, the reaction vessel on any of the reaction vessel positions can be rotated to the measuring device for measurement, thereby achieving flexible signal incubation and improving test flexibility and efficiency. The measuring darkroom of the measuring unit is wrapped or enclosed around 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, the heating device and the sensor may be disposed at the side or the bottom of the measurement darkroom to provide a constant temperature incubation environment for the measurement unit and prevent or reduce the loss of heat of the reaction unit. Of course, for higher heat transfer efficiency, the heating device can also be mounted on the measuring plate. The measuring device can be connected or mounted to the measuring darkroom in a general manner, such as directly mounted on the measuring darkroom or mounted to the measuring darkroom via a fiber optic connection, so that the signal in the reaction vessel on the measuring disc reaction vessel can be directly measured. Can make processing efficiency and reliability higher. The measuring device of the invention can be flexibly arranged according to the design requirements, not only easy to realize the darkroom environment, but also realize flexible signal incubation, and solves the defects of the complicated structure of the prior art darkroom and the difficulty of the layout of the measuring device.

Further, in order to transport the sample and store the reagent, the automatic analyzer of the present invention may further be provided with a unit such as a sample transport unit, a reagent storage unit, and the like.

The sample transport unit is used to place the sample tube to be inspected and deliver the target sample tube to the sample site. The sample transport unit has three main modes: orbital injection, sample tray injection and fixed area injection. The sample tubes are usually placed on the sample holder. Each sample holder is usually placed with 5 or 10 sample tubes, and the sample holder is placed in the transmission. A fixed area on the track, on the sample tray, or on the analysis device.

The reagent storage unit refrigerates the reagent and transfers the target reagent to the aspirating reagent position. The reagent storage unit usually adopts two ways of reagent tray and fixed reagent storage area. In order to ensure the stability of the reagent, the reagent tray generally has a cooling function, such as 4 _- 10 °C. A plurality of reagent container positions are generally set on the reagent tray for placing the reagent container. Each reagent container is provided with a plurality of independent chambers for storing different reagent components, such as magnetic particle reagents, enzyme labeling reagents, diluents and the like.

A first embodiment of the automatic analyzer of the present invention is referred to FIG. The automatic analysis device 100 mainly includes a sample delivery 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 measuring device 86, and the like. The functions and functions of each part are described below.

The sample delivery unit 30 is used to place the sample tube 31 to be inspected and deliver the target sample tube to the sample site. In this embodiment, the sample transport unit 30 is a sample tray on which a curved sample holder (not shown) is placed, and each of the curved sample holders is placed with 10 sample tubes 31. The sample tray can be driven by the driving mechanism to transfer the target sample to the suction sample position under the control of the control center, and the suction sample position is located at the intersection of the horizontal movement range 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 aspirating reagent position. In the present embodiment, the reagent storage unit 40 is a reagent tray, and 25 reagent positions are provided, and 25 reagent containers 41 (or kits and reagent bottles are conveniently used for the description, hereinafter referred to as reagent bottles). In this embodiment, each of the reagent bottles 41 is provided with four chambers 41a, 41b, 41c, and 41d, and can be used for storing reagent components such as magnetic particle reagents, enzyme labeling reagents, and diluents. The reagent tray can be driven by the driving mechanism to transfer the target reagent bottle to the suction reagent position under the control of the control center. The suction reagent position is located at the intersection of the horizontal movement range of the filling unit and the center circle of the reagent chamber. In this embodiment, the corresponding 4 Corresponding to the reagent components, there are 4 aspirating reagent sites (not shown).

The filling unit 20 completes the filling of the sample and the reagent. The horizontal movement range of the filling unit intersects the sample position on the sample tray 30, the reagent position on the reagent disk 40, and the reaction container position on the measuring disk, respectively, and the intersection point is the suction sample position, the suction reagent position, and the filling position. In this embodiment, the filling unit is a single sample loading mechanism, which can perform up and down and horizontal rotation movements, and both the sample and the reagent are added, so that the structure of the whole machine is more compact and the cost is lower. In some embodiments, a mixing mechanism such as an ultrasonic generator may be integrated on the filling unit 20 to ultrasonically mix 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, and receives and transfers the reaction container transferred from the transfer unit 50, and accepts the filling unit 20 to fill the reaction container with the sample and the reagent. A reaction vessel is placed on the filling station for placing a reaction vessel to which the sample and reagents need to be added. In this embodiment, the mixing mechanism is integrated in the filling station, and the reaction container after each filling is ultrasonically mixed or eccentrically oscillated and mixed, preferably eccentrically oscillating and mixing, so that the technology is less difficult to implement and the structure is more compact.

The reaction vessel supply unit 70 stores and supplies a reaction vessel. In this embodiment, in order to make the whole machine more compact and lower in cost, the reaction container supply unit adopts a pre-arranged type. The reaction vessel supply unit 70 includes two reaction vessel trays on which a number of reaction vessel positions are disposed to store unused reaction vessels. Reaction vessel supply Unit 70 is within the horizontal range of motion of transfer unit 50 such that transfer unit 50 can traverse unused reaction vessels at each reaction vessel location on the tray to provide an unused reaction vessel for the newly initiated test.

The transfer unit 50 transfers the reaction vessels between different positions of the automated analysis device 100. In the present embodiment, the transfer unit 50 is set to one, and the three-dimensional movement can be performed, which makes the whole machine more compact and lower in cost. The transfer unit 50 includes an X-direction moving robot arm 50b, a Y-direction guide rail 50a, a Y-direction moving robot arm 50c, and a vertical motion mechanism and a mechanical finger (not shown). The transfer unit 50 can simultaneously move the mechanical finger horizontally along the X direction and the Y direction, and the horizontal movement range covers the range within the boundary rectangle 56, and the 9 incubation transfer positions of the reaction container on the reaction container supply unit 70 and the reaction unit 10 can be 12a _1-3 , 12b _1-3 , 12c _1-3 ), 2 cleaning separation transfer sites (12d ₁ and 12d ₂ ) on the reaction unit 10, and transfer between the lost reaction vessel sites 60. In addition, since the range of motion of the transfer unit 50 covers a plurality of incubation transfer sites on the reaction unit 10, the transfer unit can be placed in the reaction vessel through different incubation transfer positions or transferred from the different incubation transfer sites to achieve a flexible incubation time. .

The reaction unit 10 carries and fixes the reaction vessel, incubates and cleans the reactants in the separation reaction vessel. In the present embodiment, the heat retaining device of the reaction unit 10 is a pot body 12 and an upper cover (not shown), and the rotating device is a reaction disk 11 and a cleaning and separating device 16 . A heater and a sensor are arranged on the side or the bottom side of the pot body 12, surrounding the bottom and the periphery of the reaction disk 11, providing a constant temperature incubation environment for the reaction unit 10 to prevent or reduce the loss of heat of the reaction unit 10. In addition to providing an incubation environment, the pot 12 also supports and secures the magnetic field generating means of the cleaning separation device 16 to provide a magnetic field environment for cleaning separation. In the present embodiment, the magnet generating device of the cleaning and separating device 16 is a permanent magnet device, which can provide a stronger and more stable magnetic field environment. The rinsing mechanism of the cleaning separation device 16 includes a liquid absorbing device and a liquid injection device, and a mixing mechanism. The cleaning and separating device 16 can also be coupled with a signal reagent filling mechanism, and after the cleaning container is separated from the reaction vessel at the reaction vessel position of the reaction unit 10, all or part of the signal reagent is filled therein.

The measuring device 86 in this embodiment is directly mounted on the side of the pot body 12, and of course can also be mounted on the upper cover of the heat retaining device, and can directly measure the reaction signal in the reaction vessel on the reaction vessel position of the reaction disk 11. . This makes full use of the reaction vessel position on the reaction unit, making the machine more compact and less costly.

In this embodiment, the reaction disk 11 of the reaction unit 10 is rotatable about a central axis, and a four-turn reaction vessel position centered on the center of rotation is disposed thereon. Of course, the number of turns can be changed, but at least 2 turns, for example, 2 cycles, 3 turns, 5 turns or more, etc., a plurality of reaction vessel positions are arranged per turn, and the number of reaction vessel positions per turn may be the same or different. In this embodiment, 30 reaction vessel positions are set per turn. Each reaction vessel is located in a suitable size tank on the reaction tray, and can accommodate a reaction vessel for carrying and fixing the reaction vessel. After the reaction vessel is placed in the corresponding reaction vessel position, no movement or sliding occurs in the reaction vessel position. The reaction vessel position on the three turns 11a, 11b, 11c in the reaction tray achieves an incubation function to accommodate the reaction vessel being incubated. The reaction vessel position on the outer ring 11d mainly accommodates the separation of the reaction vessel after the end of the incubation or after a certain period of incubation, mainly to achieve the cleaning separation and measurement functions. In order to allow the reaction vessel to enter and exit the reaction vessel on different circles of the reaction disk 11 and to achieve flexible incubation time, an opening is provided on the upper cover of the thermal insulation device, and the position of the opening is the transfer position, and a total of 9 incubation transfers are set. Positions 13a _1-3 , 13b _1-3 , 13c _1-3 and 2 wash separation transfer sites 13d ₁ and 13d ₂ , wherein the incubation sites 13a _1-3 , 13b _1-3 , 13c _1-3 correspond to the reactions Three turns 11a, 11b, 11c in the tray are respectively supplied to the reaction vessel in the reaction vessel 11a, 11b, 11c; the cleaning separation transfer sites 12d ₁ and 12d ₂ correspond to the reaction disk outer ring 11d, and the reaction vessel enters and exits 11d. Container bit. The reaction plate is rotated at a fixed angle every fixed time and can be rotated counterclockwise or clockwise, for example by 12 degrees every 30 seconds, advancing a reaction vessel position. By rotating the reaction disk, the reaction vessel at the reaction vessel can be transferred to the incubation transfer site or to the wash separation site. The transfer unit can shift the reaction vessel from the plurality of incubation transfer positions and the cleaning separation into and out of the reaction tray during the intermittent time after each rotation of the reaction tray. After the reaction vessel enters the reaction disk by incubating the transfer site, it begins to incubate in the reaction vessel at 11a, 11b or 11c, and is transferred from the incubation transfer site after the incubation or incubation for a certain period of time. The reaction vessel that enters and exits the reaction disk by incubating the transfer site includes a reaction vessel that is incubated once, incubated twice or more, so that the space of the reaction disk can be fully utilized. It should be noted that the reaction vessel can be incubated on the inner three rings 11a, 11b, 11c, and then transferred to the outer ring 11d for washing and separation, or after a certain period of incubation in the inner three rings, for example, most of the time is completed. Incubate, transfer to the outer ring 11d, and then complete the incubation for the remainder of the time while the reaction disk is transferred to the magnetic separation device. In the former implementation, it is possible to support the completion of the incubation of the reaction vessel without the need for a plurality of reaction vessel positions in the inner three circles, and the outer ring does not require an additional reaction vessel position for the incubation, thereby making the reaction tray smaller in size and lower in cost. . For the latter implementation, for example, if a test reaction container needs to be incubated for 25 minutes, it can be done for most of the time, such as 24 minutes, on one or several turns of the inner three rings 11a, 11b, and 11c. Transfer to the outer ring 11d and complete the remaining 1 minute incubation before transferring to the wash separation unit. Because this kind of scheme shares the function of partial incubation, the number of reaction vessels in the inner three rings can be appropriately reduced, so that the number of reaction vessels in the inner and outer rings can be balanced, thereby optimizing the size of the reaction disk and making full use of the internal space of the reaction disk. .

Taking a one-step test as an example, the measurement flow and steps of the automatic analysis device 100 will be briefly described with reference to FIGS. 4 and 5. After the test starts,

Step 200 loads the reaction vessel: Transfer unit 50 transfers an unused reaction vessel from reaction vessel supply unit 70 to the reaction vessel location of fill station 90.

The step 201 is to fill the sample and the reagent: the filling unit 20 respectively sucks the sample and the reagent from the suction sample position and the suction reagent position into the reaction container on the filling station 90.

Step 202: Mixing: If mixing is required, the mixing mechanism mixes the sample and reagents in the reaction vessel. If no mixing is required, this step is omitted.

Step 203: The transfer unit 50 transfers the reaction container filled with the sample and the reagent from the filling station 90 to the reaction tray 11 by incubating the transfer position (one of 12a _1-3 , 12b _1-3 , 12c _1-3 ) Within one of the three reaction chambers 11a, 11b, 11c, the reaction vessel begins to incubate on the reaction tray. While the reaction vessel is being incubated, the reaction disk 11 is rotated one position at a fixed time. The incubation time varies depending on the specific test item, typically 5 to 60 minutes.

Step 204: Washing and separating: After the incubation is completed or after a certain period of incubation, the transfer unit 50 passes the transfer position (one of 13a _1-3 , 13b _1-3 , 13c _1-3 ) from the reaction tray 11 three times 11a The reaction vessel of 11b or 11c is displaced, and the reaction vessel is moved to the reaction vessel position of the outer ring 11d of the reaction disk 11 by washing and separating the transfer sites (13d ₁ or 13d ₂ ). The reaction disk 11 is rotated one position at a fixed time, and the reaction container on the outer ring 11d reaction container position is transferred to the cleaning and separating device 16. If the reaction vessel has been incubated, no incubation is required on the outer ring 11d during the transfer. If the reaction vessel incubation is not completed, the remaining time incubation is completed during the transfer to the wash separation device 16. When the reaction vessel on the outer ring 11d reaction vessel passes through the magnetic field of the cleaning and separating device 16, the washing mechanism and the mixing mechanism of the washing and separating device 16 complete the liquid absorption, the washing buffer, and the washing and mixing until the cleaning separation is completed. .

Step 205 is filled with a signal reagent: after the cleaning separation is completed, the reaction tray 11 is transferred to the outer ring 11d. The reaction container at the reaction container is separated from the magnetic field region, and the signal reagent injection mechanism coupled by the cleaning and separating mechanism injects all or part of the reaction container into the reaction container. Signal reagent.

Step 206 Signal Incubation: If signal incubation is desired, signal incubation is accomplished during transfer of the reaction vessel 11 to the reaction vessel on the outer race 11d to the measurement device 86. This step is omitted if no signal incubation is required.

Step 207: The reaction container to be measured is transferred to the measuring unit 86 on the outer ring 11d, and if necessary, all or part of the signal reagent is injected, and the reaction signal in the reaction container is measured by the measuring device 86, and the measurement result is processed. It is then sent to the control center of the automatic analyzer.

Step 208 discards the reaction vessel: the reaction tray 11 continues to transfer the reaction vessel on the outer ring 11d to the washing separation transfer position (13d ₁ or 13d ₂ ), and the transfer unit 50 removes the measured reaction vessel from the reaction tray and transfers to the discarded reaction vessel. Hole 60 is discarded.

Referring to Figure 4 and Figure 6, the one-step one-step test procedure and procedure differs from the one-step test in that steps 301-305 are used to separate the reagents and add one incubation. The other steps are similar to the one-step method. ,No longer.

Step 301 fills the sample and the first reagent: the filling unit 20 injects the sample and the first reagent from the suction sample position and the suction reagent position into the reaction container on the filling station 90, respectively.

Step 302: Mix well: If mixing is required, if mixing is required, the mixing mechanism feeds the sample and reagents in the reaction vessel. Mix well. If no mixing is required, this step is omitted.

Step 303 First incubation: Transfer unit 50 transfers the reaction container filled with sample and reagent from the filling station 90 through the incubation transfer position (one of 13a _1-3 , 13b _1-3 , 13c _1-3 ) to One of the three reaction chambers 11a, 11b, 11c has a reaction vessel position, and the reaction vessel begins to incubate on the reaction tray. While the reaction vessel is being incubated, the reaction disk 11 is rotated one position at a fixed time. The incubation time varies depending on the specific test item, typically 5 to 60 minutes.

Step 304: filling the second reagent: after the first incubation is completed, the transfer unit 50 passes the reaction vessel through the incubation transfer position (one of 13a _1-3 , 13b _1-3 , 13c _1-3 ) from the reaction tray 11 The reaction vessel locations on the loops 11a, 11b, 11c are transferred to the reaction vessel location on the fill station 90, and the fill unit 20 draws the second reagent from the draw reagent station into the reaction vessel on the fill station 90.

Mixing in step 305: If mixing is required, if mixing is required, the mixing mechanism mixes the sample and reagents in the reaction vessel. If no mixing is required, this step is omitted.

Referring to Figure 4 and Figure 7, the two-step test procedure and steps differ primarily from the one-step delay test in that step 404 is added to add a wash separation.

Step 404: Washing separation: After the first incubation is completed or after the first incubation for a certain period of time, the transfer unit 50 removes the reaction vessel from the reaction by incubating the transfer sites (one of 13a _1-3 , 13b _1-3 , 13c _1-3 ) The reaction vessel of the three turns 11a, 11b or 11c in the tray 11 is displaced, and the reaction vessel is moved into the reaction vessel position of the outer ring 11d of the reaction disk 11 by the washing separation transfer position (13d ₁ or 13d ₂ ). The reaction disk 11 is rotated one position at a fixed time, and the reaction container on the outer ring 11d reaction container position is transferred to the cleaning and separating device 16. If the reaction vessel has been incubated, no incubation is required on the outer ring 11d during the transfer. If the reaction vessel incubation is not completed, the remaining time incubation is completed during the transfer to the wash separation device 16. When the reaction vessel on the outer ring 11d reaction vessel passes through the magnetic field of the cleaning and separating device 16, the washing mechanism and the mixing mechanism of the washing and separating device 16 complete the liquid absorption, the cleaning buffer, and the washing and mixing until the first completion is completed. Separate cleaning. After the first washing separation is completed, the transfer unit 50 passes the reaction vessel through the incubation transfer position (one of 13a _1-3 , 13b _1-3 , 13c _1-3 ) from the three turns 11a, 11b, 11c in the reaction disk 11. The reaction vessel position is transferred to a reaction vessel on the filling station 90, and the filling unit 20 draws a second reagent from the aspirating reagent site into the reaction vessel on the filling station 90.

The other steps of the two-step method are similar to the one-step method of delay, and will not be described again.

As can be seen from the above description, in the present embodiment, the automatic analysis device 100 is first concentrated or incubated for a certain period of time in the inner three rounds, and the reaction container that has been incubated or incubated for a certain period of time is transferred to the outer ring for the remaining time to complete the cleaning and separation. And measuring, the transfer of the reaction vessel between different circles is completed by the transfer unit through at least one incubation transfer position and one cleaning separation transfer position disposed on the reaction unit, which not only saves the independent cleaning separation disk and the optical disk used in the prior art. , reducing the size of the machine and reducing the cost, but also streamlining the test steps and reducing the complexity and difficulty of the control, avoiding the transfer of the reaction vessel between multiple disks. In addition, the reaction unit can adjust, set and balance the number of reaction vessels in the inner and outer ring by setting different transfer positions, which not only can realize flexible incubation time, but also fully utilize the internal space of the reaction disk, thereby further reducing the reaction unit. The size makes the whole structure more compact, lower cost and more efficient.

A second embodiment of the invention is shown in FIG. The sample transport 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 will not be described again. In this embodiment, the transfer unit 50 is set to one, which can perform two-dimensional motion, which makes the whole machine more compact and lower in cost. The transfer unit 50 includes a Y-direction guide rail 50a, a Y-direction moving robot arm 50b, and a mechanism such as a vertical motion mechanism and a mechanical finger (not shown). The transfer unit 50 can move the mechanical finger horizontally along the Y direction, the horizontal movement range is a one-dimensional linear region 56, and the two reaction transfer positions (13b, 13c) of the reaction container on the reaction container supply unit 70 and the reaction unit 10 can be One wash separation transfer position (13a) on the reaction unit 10, one measurement transfer position (13d) on the reaction unit 10, and a lost reaction container position 60 are transferred. In addition, since the range of motion of the transfer unit 50 covers a plurality of incubation transfer sites on the reaction unit 10, the transfer unit can be transferred into the reaction vessel through different incubation shifts or transferred from the different incubation transfer positions to achieve flexible incubation. Breeding time. The main difference between the filling station 90 and the first embodiment is that it can move horizontally and can move horizontally along the X direction to the horizontal range of motion of the transfer unit 50. The main difference between the reaction vessel supply unit 70 and the first embodiment is that only one column of the reaction vessel thereon is in the horizontal movement range of the transfer unit 50. In order to continuously supply the reaction vessel, the reaction vessel supply unit 70 can move horizontally along the X direction. So that the columns of reaction vessels above it pass the horizontal range of motion of the transfer unit 50, such that the transfer unit 50 can traverse the unused reaction vessels on each of the reaction vessel locations on the tray to provide an unused reaction for the newly initiated test. container. The main difference between the reaction unit and the first embodiment is in the arrangement of the cleaning separation device and the setting 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 container that has entered the reaction disk inner ring 11a by the cleaning separation transfer position 13a. The measuring device 86 is mounted on the side of the heat retaining device and measures the signal in the reaction vessel that has entered the outer ring 11d of the reaction disk by measuring the transfer position 13d. The reaction vessel positions on the middle two turns 11b, 11c are incubated with the reaction vessel entering the treatment unit by incubation of the transfer sites (13b, 13c). In this embodiment, corresponding to the horizontal one-dimensional motion range of the transfer unit 50 and the intersection point of the reaction container positions on the four turns 11a, 11b, 11c, and 11d of the reaction disk, the cleaning separation transfer bit 13a is sequentially disposed from the inside to the outside on the reaction unit. The transfer sites 13b and 13c were incubated, and the transfer sites 13d were measured for a total of 4 transfer sites. In this embodiment, the cleaning and separating device is arranged on the inner ring of the reaction unit, which not only makes the cleaning and separating device more compact, but also reduces the adverse effects of the cleaning and separating device on the temperature fluctuations that may be caused by the measurement and the interference of introducing ambient light.

It will be understood by those skilled in the art that the test procedure and steps of this embodiment are similar to those of the first embodiment, and therefore only a brief description will be given below. At the time of the test, the filling station 90 is moved horizontally in the X direction to the horizontal movement range of the transfer unit 50, and the transfer unit 50 transfers an unused reaction container from the reaction container supply unit 70 to the reaction container position of the filling station 90, and then adds The filling station 90 moves to the horizontal movement track of the filling unit 20, and the filling unit 20 fills the reaction container on the filling station 90 with the sample and the reagent. After the filling is completed, the mixer integrated in the filling station 90 can be Mix the reaction vessel. After the mixing is completed or during the mixing process, the filling station 90 is again horizontally moved to the horizontal movement range of the transfer unit 50. Thus, the reaction vessel to be incubated on the filling station 90 is first transferred by the transfer unit 50 through the incubation transfer position 13b or 13c into one of the middle two loops 11b, 11c, and after the incubation is completed or after a certain period of time, it is necessary to wash and separate and then transfer. The unit 50 moves out of the middle two rings 11b, 11c by the incubation transfer position 13b or 13c, and then moves into the inner ring 11a through the cleaning separation transfer position 13a, and is cleaned and separated by the cleaning and separating device 86 under the rotation transfer of the reaction disk, and the cleaning and separation are completed. Then, the transfer unit 30 removes the inner ring 11d by the cleaning separation transfer position 13a. If the second reagent needs to be added, the transfer unit 50 transfers the reaction container to the filling station 90 to complete the filling of the second reagent; if measurement is required, The transfer unit 50 is moved into the outer ring 11d by measuring the transfer position 13d, and the reaction container is transferred to the measuring device for measurement under the rotation of the reaction disk.

A third embodiment of the present invention is shown in FIG. This embodiment differs from the first embodiment in the arrangement of the measuring device. This embodiment also includes measuring a darkroom (not shown) and a measurement location 82 independent of the reaction unit 10, and the measurement device 86 is mounted on the measurement darkroom to measure the signal in the reaction vessel on the measurement site 82. The measurement darkroom provides the desired darkroom environment for the measurement device 86, which is within the horizontal range of motion of the transfer unit 50 or can be moved horizontally to the horizontal range of motion of the transfer unit 50. In order to avoid light, the measuring position 82 can be made into a fixed position, and the inlet and outlet of the reaction container are provided with a "sunroof" mechanism, which is normally closed to ensure the measurement of the darkroom environment of the darkroom, and the reaction container is opened when it enters and exits; the measuring position 82 can also be made mobile. The position, in order to be easily protected from light, the measuring position 82 can be moved away from or close to the measuring device 86 in the form of a push-pull drawer or the like. Of course, the measurement bit 82 and the corresponding light-shielding structure may be other suitable implementations. In addition, the filling of the signal reagent can also be done at measurement position 82. This embodiment makes the measuring device 86 relatively independent, and it is easier to realize a closed darkroom environment during measurement, and the reaction unit does not need to be provided with a structure specifically for the light-shielding requirement of the measuring device 86. It will be understood by those skilled in the art that other units of the present embodiment are the same as or similar to the first embodiment. The test flow and steps of this embodiment refer to FIG. 5, FIG. 6, and FIG. 7, which are mainly different from the first embodiment. Fill the signal reagent, measure, and discard the reaction vessel in three steps, the same or similar. The step of filling the signal reagent in the embodiment may be completed on the reaction vessel position of the outer ring 11d of the reaction disk, or may be completed at the measurement position 82, and the first signal reagent may be completed on the reaction vessel position of the outer ring 11d of the reaction disk. Filling, the filling of the second signal reagent is completed at the measuring position 82; in the measuring step, the transfer unit 50 transfers the reaction container to be measured through the cleaning separation transfer position 13d ₁ or 13d ₂ from the reaction container position of the outer disk 11d of the reaction disk To measurement location 82, the reaction signal in reaction vessel located at measurement location 82 is measured by measurement device 86; the reaction vessel step is discarded, and transfer unit 50 transfers the measurement vessel from which measurement is completed from measurement location 82 to disposal aperture 60.

A fourth embodiment of the invention is shown in FIG. This embodiment differs from the first embodiment in that it further includes a measuring dark chamber 82 and a measuring disk 81 which are independent of the reaction unit 10, and the measuring device 86 is mounted on the measuring dark room 82. In this embodiment, the filling station (not shown) can be integrated in the measuring disc 81, and the reaction vessel position of the measuring disc 81 and its rotational positioning function can be fully utilized, so that the independent filling station can be omitted, saving The mechanism can make the whole machine cost less and the structure is more compact. The mixing mechanism can be integrated into the filling station for ultrasonic mixing or shaking mixing of the filled reaction vessel. A measuring reaction vessel position 81a is provided on the measuring disk 81 to measure the center of rotation of the disk for carrying the reaction vessel to be measured. In this embodiment, a plurality of reaction vessel positions are provided, and all or part of the signal incubation can be achieved. Each time the measuring disc 81 is rotated, the reaction vessel at any of the signal incubation positions can be rotated to the measuring device 86 for measurement, thereby achieving flexible signal incubation and improving test flexibility and efficiency. In order to allow the reaction container to enter and exit the measuring disk 81, the measurement transfer position 82a is set in the upper portion of the measurement dark room 82. The measurement transfer position 82a is within the horizontal movement range of the transfer unit 50, and the transfer unit 50 can remove the reaction container to be measured from the reaction disk 11 through the cleaning separation transfer position 13d ₁ or 13d _{2 of the} reaction unit 10, and move it in by the measurement transfer position 82a. The disc 81 is measured. The measurement dark chamber 82 is wrapped or surrounded by the periphery of the measuring disc 81 to provide a darkroom environment for the measuring device 86. For the signal incubation test, the heating device and the sensor may be selectively disposed on the side or the bottom of the measuring dark chamber 82 to provide a constant temperature for the measuring disc reaction container position 81a. Signal incubation environment. The measuring device 86 includes a weak photodetector photomultiplier tube (PMT) directly mounted on the measuring dark chamber 82 to measure a weak chemiluminescence signal generated by adding a signal reagent to the reaction vessel. In addition, in order to facilitate the filling of the signal reagent, the upper portion of the measuring disk 81 of the present invention or the periphery of the measuring dark room 82 may be provided with a signal reagent filling mechanism (not shown) to react to the reaction position of the measuring disk 81. Fill all or part of the signal reagent in the container. It will be understood by those skilled in the art that other units of the present embodiment are the same as or similar to the first embodiment. The test flow and steps of the present embodiment are different from those of the first embodiment with reference to FIG. 5, FIG. 6, and FIG. Loading the reaction vessel, filling the sample and reagents, and finally adding the signal reagent, measuring, discarding the reaction vessel, and the like, the others are the same or similar. The transfer unit 50 moves the unused reaction container from the reaction container supply unit 70 through the measurement transfer position 82a to the reaction container position on the measuring disk 81, the measurement disk 81 is rotated, the reaction container is transferred to the filling station, and the filling unit 20 sucks the sample. The reagent is filled into the reaction vessel at the filling station. After the filling is completed, the mixing mechanism integrated in the filling station mixes the mixture in the reaction vessel. After the completion of the mixing, the transfer unit 50 transfers the measurement container that has completed the measurement from the reaction vessel position on the measurement disk 81 to the reaction unit by measuring the transfer position 82a. The step of filling the signal reagent in the embodiment may be completed at the reaction vessel position of the outer ring 11d of the reaction disk, or may be completed at the reaction vessel position on the measuring disk 81, or may be at the reaction vessel position of the outer ring 11d of the reaction disk. The filling of the first signal reagent is completed, and the filling of the second signal reagent is completed in the reaction container position on the measuring disk 81; in the measuring step, the transfer unit 50 passes the reaction container to be measured through the cleaning separation transfer position 13d1 or 13d2 from the reaction disk. The reaction vessel of the outer ring 11d is displaced, moved into the reaction vessel position on the measuring disk 81 by the measuring transfer position 82a, the measuring disk 81 is rotated, and the reaction vessel is transferred to the measuring device 86, and the reaction signal in the reaction vessel is performed by the measuring device 86. The reaction vessel step is discarded, and the transfer unit 50 transfers the measurement container that has completed the measurement from the reaction vessel position on the measuring disk 81 to the disposal hole 60 by the measurement transfer position 82a.

The automatic analysis device of the invention can also be flexibly expanded and maximized to achieve serialization of products. On the basis of the fourth embodiment, in order to further improve the specification parameters and test throughput of the whole machine and meet the needs of end users with larger specimens, the number of transfer units and filling units can be increased, the size of the reaction unit can be appropriately increased, or the reaction can be increased. The number of units is used to achieve this. Referring to Figure 11, there is shown a schematic view of a fifth embodiment of the automatic analyzer of the present invention. The sample transport unit 30 adopts the injection mode of the track and the sample rack, so that more samples can be accommodated, the sample can be added in real time, and the operation is more convenient. The sample holder 32 and the sample tube 31 thereon can be delivered to the range of motion of the first filling unit 21. The reagent storage unit 40 increases the reagent storage position and allows more reagent containers to be placed. The filling unit 20 includes a first filling unit 21 and a second filling unit 22, the first filling unit 21 only filling the sample or filling the sample and the partial reagent, the second The filling unit 22 is filled with reagents, and of course more filling units can be added, which increases the speed of adding the sample and the reagent. The reaction vessel supply unit 70 adopts a silo type, and the reaction vessel can be poured into a silo of the reaction vessel supply unit 70 in a scattered manner, which makes the supply of the reaction vessel more, faster, and more convenient. The reaction disk 11 of the reaction unit 10 includes an outer ring 11d reaction vessel position and an inner region 11a reaction vessel position distributed centering on the center of rotation of the reaction disk. The reaction vessel position on the inner region 11a is distributed in a "honeycomb" manner, so that the space on the reaction disk 11 can be fully utilized, more reaction vessel positions can be set, more reaction vessels can be accommodated, and the test throughput can be increased. In order to allow the reaction vessel to enter and exit the reaction vessel position on the reaction disk 11, an incubation transfer zone 13a (including 7 incubation transfer sites) and a wash separation transfer site 13d are disposed on the reaction unit 10. The measurement dark room 82 and the measuring disk 81 and the measuring device 86 can be completely multiplexed with the fourth embodiment, but in order to improve the test efficiency, the filling bit is no longer set. A measurement transfer position 82a is provided on the measurement dark chamber 82 for the reaction container to enter and exit the measurement disk. The transfer unit 50 includes a first transfer unit 51 and a second transfer unit 52 that can perform three-dimensional movement independently. The first reaction container unit 51 is mainly in the incubation transfer zone 13a of the reaction unit 10, the cleaning separation transfer position 13d, the measurement disk 81, and the reaction. The reaction container is transferred between the container discarding holes 60b and the like, and the second transfer unit 52 is mainly at the reaction container supply unit 70, the filling station 90, the incubation transfer zone 13a of the reaction unit 10, and the cleaning separation transfer position 13d and the reaction container disposal hole 60b. Transfer the reaction vessel between. One of ordinary skill in the art will appreciate that by reasonable placement and distribution, the transfer of the reaction vessel between any two locations can be accomplished simultaneously by the first or second transfer unit or both. Of course, there may be more than two transfer units, and more transfer units may be provided as needed to increase the efficiency and speed of transfer of the reaction vessel. In order to make the layout of the whole machine compact and to improve the test speed, the present embodiment uses the method of the independent filling station 90 to fill the sample and the reagent. The filling station 90 can move back and forth between the reaction container supply unit 70, the first filling unit 21, and the second filling unit 22, receive the reaction container supplied from the reaction container supply unit 70, and accept the filling of the first filling unit 21. The sample or sample and a portion of the reagent are received by the second filling unit 22. The mixing mechanism can be integrated on the filling station 90 or the filling unit 20 to mix the reaction container after the sample or/and the reagent is added. After the mixing is completed, the reaction vessel on the filling station 90 is transferred from the transfer unit 50 to the reaction unit 10. It will be understood by those skilled in the art that other units of the present embodiment are the same as or similar to the fourth embodiment. The test procedure and steps of the present embodiment are mainly different from the first embodiment in that the sample and reagent are filled by the first and second filling. The unit coordination is completed, the reaction container transfer is completed by the first and second transfer units, and the filling operation of the filling unit is completed at the independent filling station. The other actions and processes are the same or similar to those of the first embodiment. - Figure 7, no further details. Compared with the prior art, this embodiment avoids the extra large size of the cleaning separation disc, and the measurement unit independent of the reaction unit is easier to realize the darkroom environment and flexible measurement, and the partition of the reaction vessel position through different functions is also The size of the reaction unit itself is reduced, making the machine more compact, less costly, more efficient and more reliable.

The embodiment of the invention further provides a sample analysis method, which specifically includes:

a filling step of filling a sample and/or reagent in the reaction vessel;

An incubation step of incubating at least one reaction vessel that needs to be incubated twice by entering at least one incubation transfer site into the reaction unit;

a washing and separating step of washing and separating the reaction vessel entering the reaction unit through at least one washing and separating transfer point to remove unbound components in the reactant;

Filling the signal reagent reagent step, adding a signal reagent to the reaction vessel,

The measuring step measures the reaction signal in the reaction vessel by the measuring device.

Further, further comprising a transfer step of moving the reaction vessel into and out of the reaction unit from the at least one incubation transfer position by the transfer unit, at least one wash separation transfer position; further comprising a mixing step of mixing the reactants in the reaction vessel uniform.

The invention realizes the incubation and washing separation of the reactants in the reaction vessel centering on the reaction unit, and at least one incubation transfer position and at least one cleaning separation transfer position are arranged on the reaction unit, and the transfer unit can be transferred between the incubation transfer position and the cleaning separation position. The reaction vessel can not only realize flexible incubation, but also solve the problem that the two-step test must be implemented by using multiple cleaning and separating mechanisms in the prior art, and fully realize efficient cleaning separation. In addition, the measuring device can be The layout or structure of the whole machine needs to be flexibly arranged or arranged, for example, it can be directly installed on the reaction unit, set in a separate position or installed on an independent measuring plate, etc., which solves the limitation of the arrangement of the measuring device in the prior art and the measurement. The environment is prone to interference and other issues. The invention improves the working efficiency of the analysis device and reduces the difficulty of realizing the automatic function, and solves the technical problems of large volume, low detection speed, high cost and poor performance of the current automatic instrument, which not only saves the laboratory space, but also improves the laboratory space. Test efficiency, and help reduce expenses, reduce the burden on the testee, and ultimately save a lot 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. It will be readily understood by those skilled in the art that the order of the steps or actions in the methods described in the embodiments of the present invention can be changed. Therefore, any order in the drawings or the detailed description is merely for the purpose of illustration and not a

Various embodiments may be included in various embodiments of the invention, which may be embodied as machine-executable instructions that are executable by a general purpose or special purpose computer (or other electronic device). Alternatively, these steps may be performed by hardware elements comprising specific logic circuitry to perform the steps or jointly by hardware, software and/or firmware.

The present invention has been described above by way of specific embodiments, but the invention is not limited to the specific embodiments. It will be apparent to those skilled in the art that various modifications, equivalents, changes, and the like may be made without departing from the spirit and scope of the invention. In addition, the "one embodiment", "this embodiment" and the like described above in various places represent different embodiments, and of course, all or part of them may be combined in one embodiment.

The above-mentioned embodiments are merely illustrative of several embodiments of the present invention, and the description thereof is more specific and detailed, but is not to be construed as limiting the scope of the invention. It should be noted that a number of variations and modifications may be made by those skilled in the art without departing from the spirit and scope of the invention. Therefore, the scope of the invention should be determined by the appended claims.

Claims (10)

1. An automatic analysis device, comprising:

   Filling unit, filling the sample and / or reagent into the reaction vessel;

   a reaction unit, incubating and washing the reactants in the separation reaction vessel;

   Measuring device for measuring a reaction signal in the reaction vessel;

   a transfer unit that transfers the reaction vessel between different locations;

   The reaction unit comprises a rotating device, wherein the rotating device is provided with a reaction vessel position for carrying and fixing the reaction vessel, and the reaction unit is provided with at least one incubation transfer position and at least one cleaning separation transfer position, the reaction unit At least one incubation transfer site and at least one wash separation transfer site are within the horizontal range of motion of the transfer unit.
2. The automatic analyzer according to claim 1, wherein the reaction unit comprises a washing and separating device that cleans and separates a reaction vessel that has entered the reaction unit through the washing and separating transfer point to remove the reaction. Unbound ingredients.
3. The automatic analyzer according to claim 1, wherein the reaction vessel entering the reaction unit through the incubation transfer site comprises at least a reaction vessel that needs to be incubated twice, and the reaction unit enters a reaction by transferring the transfer site. The reaction vessel of the unit is incubated.
4. The automatic analyzer according to claim 1, wherein said rotating device is a reaction disk, said reaction disk is rotated at a fixed angle every fixed time, and said reaction container is transferred to said incubation transfer position or The cleaning separates the transfer sites.
5. The automatic analyzer according to claim 1, further comprising a filling station for receiving and carrying a reaction container to which a sample or/and a reagent is to be filled.
6. The automatic analyzer according to claim 5, wherein said filling station is within a horizontal range of motion of said transfer unit or horizontally movable to a horizontal range of motion of said transfer unit.
7. The automatic analyzer according to claim 5, further comprising a mixing mechanism integrated in the filling station for mixing the reactants in the reaction vessel.
8. A sample analysis method, comprising:

   a filling step of filling a sample and/or reagent in the reaction vessel;

   An incubation step of incubating at least one reaction vessel that needs to be incubated twice by entering at least one incubation transfer site into the reaction unit;

   a washing and separating step of washing and separating the reaction vessel entering the reaction unit through at least one washing and separating transfer point to remove unbound components in the reactant;

   Filling the signal reagent reagent step, adding a signal reagent to the reaction vessel,

   The measuring step measures the reaction signal in the reaction vessel by the measuring device.
9. The sample analysis method according to claim 8, further comprising a transferring step of moving the reaction container into and out of the reaction unit by the transfer unit from the at least one incubation transfer position and the at least one wash separation transfer position.
10. The sample analysis method according to claim 8, further comprising the step of mixing to mix the reactants in the reaction vessel.

Images