CN111257556A

CN111257556A - Immunoassay analyzer and sample analysis method

Info

Publication number: CN111257556A
Application number: CN201811455175.6A
Authority: CN
Inventors: 王锐; 刘治志
Original assignee: Shenzhen Dymind Biotechnology Co Ltd
Current assignee: Shenzhen Dymind Biotechnology Co Ltd
Priority date: 2018-11-30
Filing date: 2018-11-30
Publication date: 2020-06-09

Abstract

The invention discloses an immunoassay analyzer and a sample analysis method, wherein the immunoassay analyzer comprises: the sample introduction device is used for accommodating an original sample and a reagent and transferring the original sample, the reagent and a sample to be detected according to a preset sequence, wherein the sample to be detected is prepared from at least the original sample and the reagent; the reaction control device is used for preparing a sample to be detected through preset operation, and the preset operation at least comprises cleaning and separating operation; the optical detection device is used for detecting a sample to be detected and outputting a detection result; wherein the reagent comprises at least one magnetic bead. By the mode, the method can perform multi-item joint inspection on the original sample, and is high in detection efficiency.

Description

Immunoassay analyzer and sample analysis method

Technical Field

The invention relates to the field of medical instruments, in particular to an immunoassay analyzer and a sample analysis method.

Background

An immunoassay analyzer is a commonly used medical instrument, in particular to an immunoassay analyzer, and is used for detecting various immunity indexes in a sample. With the increasing health awareness of people, the number of items to be detected is increasing, and therefore, the improvement of the detection efficiency of the immunoassay analyzer is the key point of research.

In the prior art, each item needs to be detected by independently inputting a sample into different reaction cups, so that the time cost and the material cost of the detection process are increased, and the requirement for rapidly detecting multiple indexes cannot be met.

In a long-term research and development process, the inventor of the application finds that the existing immunoassay analyzer cannot carry out multi-item joint inspection, and the detection efficiency is low.

Disclosure of Invention

The invention mainly solves the technical problem of providing the immunoassay analyzer and the sample analysis method, which can carry out multi-item joint inspection on an original sample and have high detection efficiency.

In order to solve the technical problems, the invention adopts a technical scheme that: an immunoassay analyzer is provided.

Wherein, immunoassay appearance includes: the sample introduction device is used for accommodating an original sample and a reagent and transferring the original sample, the reagent and a sample to be detected according to a preset sequence, wherein the sample to be detected is prepared from at least the original sample and the reagent; the reaction control device is used for preparing a sample to be detected through preset operation, and the preset operation at least comprises cleaning and separating operation; the optical detection device is used for detecting a sample to be detected and outputting a detection result; wherein the reagent comprises at least one magnetic bead.

In order to solve the technical problem, the invention adopts another technical scheme that: a method for analyzing a sample is provided.

The method comprises the following steps: an immunoassay analyzer is provided;

transferring the reagent and the original sample to a reaction cup by a sample introduction device in sequence;

the reaction control device performs at least one preset operation on the mixture in the reaction cup, wherein the preset operation comprises a separation operation to obtain a magnetic bead composition;

repeatedly carrying out reagent adding operation and preset operation on the reaction cup containing the magnetic bead composition until the preset repeated times are reached to obtain a sample to be detected;

the sample introduction device sucks a sample to be detected into the optical detection device so as to detect the sample to be detected and output a detection result.

The invention has the beneficial effects that: different from the prior art, the reagent comprises at least one magnetic bead, different magnetic beads can be combined with different types of antigens in the original sample to form different magnetic bead complexes, the joint detection operation that the original sample is input into the same reaction cup once to detect various parameter indexes is realized, the detection process is simple to operate, and the detection efficiency is high.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts. Wherein:

FIG. 1 is a schematic structural view of a first embodiment of an immunoassay analyzer of the present invention;

FIG. 2 is a schematic structural view of a second embodiment of an immunoassay analyzer according to the present invention;

FIG. 3 is a schematic diagram of an exploded view of an embodiment of the immunoassay analyzer provided herein;

FIG. 4 is a schematic block diagram of the structural connection of FIG. 3;

FIG. 5 is a schematic diagram of the sample injection device in FIG. 3;

FIG. 6 is a schematic structural diagram of the sample injection mechanism in FIG. 5;

FIG. 7 is a schematic structural view of the pusher member of FIG. 6;

FIG. 8 is a schematic diagram of the detection drive assembly of FIG. 5;

FIG. 9 is an enlarged schematic view of portion A of FIG. 8;

FIG. 10 is a schematic diagram of the mixing mechanism of FIG. 3;

FIG. 11 is a schematic view of the kneading mechanism of FIG. 10 in the direction B;

FIG. 12 is a schematic diagram of the sampling mechanism of FIG. 3;

FIG. 13 is a flow diagram of a first embodiment of a sample analysis method of the present invention;

FIG. 14 is a flowchart illustrating an embodiment of step 1320 of FIG. 13;

FIG. 15 is a flowchart illustrating an embodiment of step 1330 in FIG. 13.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Referring to fig. 1, fig. 1 is a schematic structural diagram of an embodiment of an immunoassay analyzer 100A according to the present invention, including: a sample introduction device 110A, a reaction control device 120A and an optical detection device 130A. The sample introduction device 110A is used for accommodating an original sample and a reagent, and transferring the original sample, the reagent and a sample to be detected according to a preset sequence, wherein the sample to be detected is prepared from at least the original sample and the reagent; the reaction control device 120A is configured to prepare a sample to be tested through a preset operation, where the preset operation at least includes a separation operation; the optical detection device 130A is used for detecting a sample to be detected and outputting a detection result; wherein the reagent comprises at least one magnetic bead.

In the embodiment, the reagent comprises at least one magnetic bead, and different magnetic beads can be combined with different types of antigens in the original sample to form different magnetic bead complexes, so that joint detection operation for detecting various parameter indexes by inputting the original sample into the same reaction cup once can be realized, the detection process is simple to operate, and the detection efficiency is high.

Specifically, the immunomagnetic bead separation technology is a new separation technology combining the high specificity of immunology and the specific magnetic responsiveness of magnetic beads, is an immunological detection method and an antigen purification means with strong specificity and high sensitivity, and is widely applied to the aspects of cell separation, protein detection, immunological detection, microbiological detection and the like.

Further, the optical detection device 130A may be located at any position in the immunoassay analyzer, and in one embodiment, in order to shorten the detection process and improve the detection efficiency, the optical detection device 130A is located as close to the sample introduction device 110A as possible, especially close to the measurement needle in the measurement needle assembly 116A of the sample introduction device 110A.

Furthermore, the magnetic bead complex is the sample to be detected, and the magnetic bead complex comprises magnetic beads, antigens, antibodies and fluorescent biotin used for being combined on the antibodies. The antigen is from the original sample, the source of the original sample and the type of the reagent correspond to the index to be detected. In one embodiment, the primary sample comprises serum or whole blood, and the reagents comprise magnetic beads, antigens, fluorescent biotin, and the like. Furthermore, the preparation process of the magnetic bead complex includes a process of reacting the magnetic beads with the reagent and the magnetic beads with the original sample. The immunoassay analyzer can be used for preparation and detection of a sample to be detected and output of a detection result.

The magnetic bead comprises a magnetic central body and a specific antibody arranged on the magnetic central body. When the specific antibody on the magnetic bead is combined with the corresponding microorganism or specific antigen substance, a magnetic bead complex of antigen-specific antibody-magnetic bead is formed. In order to detect the magnetic bead complex, the magnetic bead complex may further include a fluorescein-labeled antibody, and the magnetic bead complex is a sandwich structure of a fluorescein-labeled antibody-antigen-specific antibody-magnetic bead.

Different magnetic beads may have different sizes of magnetic centrosomes and/or different kinds of specific antibodies. In the process of preparing different magnetic beads into different magnetic bead compounds and detecting the magnetic bead compounds, the fluorescent substance in the magnetic bead compounds irradiated by the light is excited to emit different optical signals from the different magnetic bead compounds, and the optical detection device 130A analyzes the different magnetic bead compounds according to the difference of the received optical signals to obtain detection indexes corresponding to the different magnetic bead compounds. Of course, it is also possible to prepare a magnetic bead complex having different fluorescence intensities from the same magnetic bead for the joint detection. Different magnetic bead compounds are formed by adding different magnetic beads or fluorescent biotin-labeled antibodies with different intensities, so that the magnetic bead compounds corresponding to different detection indexes are prepared after a sample is input into the same reaction cup for one time, and then detection results of different indexes are obtained, so that multi-project joint detection is realized, and the detection efficiency of the immunoassay analyzer is improved in a geometric grade manner.

In one embodiment, please refer to fig. 1 and fig. 2, fig. 2 is a schematic structural diagram of a second embodiment of an immunoassay analyzer of the present invention, wherein the sample injection device 110A includes a sampling needle assembly 111A, the sampling needle assembly 111A is used for sucking an original sample and transferring the original sample into a reaction cup, which is located above the automatic sample injection assembly 113A and the reaction tray 121A, and includes a sample sucking station and a sample injecting station arranged in a horizontal direction. Further, the primary sample comprises whole blood, the primary sample is contained in a sample tube, and the sample tube is provided with a sealing rubber plug; the sampling needle assembly 111A includes a sampling needle that includes a piercing portion for piercing the sealing plug and a sample intake port from which the raw sample is drawn. In this embodiment, because the sampling needle has the part of impaling, can impale directly gather the original sample of holding in sealed sample pipe behind the sealed plug, need not carry out the manual separation before the detection, also need not arrange the original sample after the separation in uncovered container and detect, easy operation not only is favorable to improving the degree of automation of testing process, and detection efficiency is showing and is promoting.

In addition, be equipped with the recess on the lateral wall of sampling needle, the recess is rectangular form, and the recess extends along the length direction of needle body portion, punctures the sealed stopper of sample pipe and gets into the in-process of sample pipe at the sampling needle, and the recess can introduce the air in to the sample pipe, and the sampling needle of being convenient for inhales the original sample in the sample pipe, improves sampling efficiency. Simultaneously, the recess is along keeping away from the direction size of its tank bottom and diminishing gradually, and the size that also the recess is close to sampling needle outer wall department is less, reduces the size that the notch on the groove is located the sampling needle outer wall and can avoid the sample needle to pierce through the plug piece that produces when the sealed plug of sample pipe gets into the recess, and then avoids original sample contaminated.

Further, the sample introduction device further comprises a reaction cup processing assembly 112A, an automatic sample introduction assembly 113A, a reagent storage tray assembly 114A, a reagent needle assembly 115A, and a measurement needle assembly 116A.

Wherein, the reaction cup processing component 112A is used for screening, arranging and moving the reaction cups. Specifically, the reaction cup processing assembly comprises a cup feeding mechanism 1121A, a cup throwing mechanism 1122A and a cup grabbing mechanism (not shown), the cup feeding mechanism 1121A comprises a reaction cup shaping mechanism and a reaction cup filling channel, the reaction cup shaping mechanism can screen reaction cups, so that the reaction cups are arranged in order according to a preset posture and are conveyed to a preset position through the filling channel, the preset posture can be set according to actual conditions, for example, the reaction cups are vertically placed, and the filling openings of the reaction cups are upward; the predetermined position includes a reaction tray. The cup throwing mechanism 1122A is located above the reaction tray and the predetermined container, and is configured to take out the reaction cup that has performed the reaction task and move the reaction cup into the predetermined container. The reaction task is executed, namely the preparation of the sample to be detected is completed in the reaction cup, and the sample to be detected is sucked by the measuring needle for detection. The reaction cups which have executed the reaction task are taken out and moved to a preset container, so that the rest reaction cups in the reaction tray can be conveniently rotated to the reagent adding position, and the preparation of the next sample to be detected is continued, so that the reaction process is continuous and uninterrupted, and the detection efficiency is favorably improved. The cup grabbing mechanism is used for moving the reaction cup from the reaction disc to the magnetic separation assembly for magnetic separation, or moving the reaction cup after magnetic separation to the reaction disc for continuously adding other reagents.

The reagent storage tray assembly 114A is used for accommodating reagents required for preparing a sample to be tested, and transferring the reagents which need to be added into the reaction cup at present to a reagent station, so that the reagent needle assembly 115A sucks corresponding reagents. In addition, the reagent storage tray assembly 114A may provide a storage environment that satisfies the preservation conditions for different reagents, e.g., the reagent storage tray assembly 114A may include a refrigeration device to provide a refrigerated environment to ensure long term storage of reagents.

Further, the reagent needle assembly 115A can accurately and quantitatively add the reagents located at the reagent positions into the reaction cups corresponding to the reaction tray 121A; the reagent needle assembly 115A is disposed between the reagent storage disk assembly 114A and the reaction disk 121A, and the reagent needle assembly 115A is located above the reagent storage disk assembly 114A and the reaction disk 121A in operation; according to the motion trail, four absolute stations including a first reagent position 1151A, a second reagent position 1152A, a cleaning position 1153A and a reagent filling position 1154A are respectively arranged in the horizontal direction. First reagent site 1151A and second reagent site 1152A correspond to reagent sites of reagent storage tray assembly 114A for reagent needle assembly 115A to aspirate a desired reagent. Specifically, the reagent storage disk assembly 114A includes a first index circle and a second index circle, each including a plurality of reagent bits located on the respective index circle, with the first index circle having a diameter that is less than the diameter of the second index circle. Reagent positions on the first graduated circle are used for containing magnetic beads, and reagent positions on the second graduated circle are used for containing other reagents. First reagent level 1151A is located at a position corresponding to a reagent level on the first reference circle, i.e., where the path of movement of the first reference circle of reagent storage disk assembly 114A intersects the path of reagent needle assembly 115A. The second reagent level 1152A is located at a position corresponding to a reagent level on the second circle of graduation, i.e. a position where the trajectory of the second circle of graduation of the reagent storage disk assembly 114A intersects the trajectory of the reagent needle assembly 115A.

The reagent filling position is located above the reaction tray 121A, corresponds to the reagent filling position of the reaction tray 121A, and is used for filling the sucked reagent into the reaction cup located at the reagent filling position. The cleaning station is used for cleaning the reagent needle assembly 115A after one reagent is filled, so that the reagent needle assembly 115A is prevented from polluting other reagents in the reusing process.

In this embodiment, the first reagent to be added is a magnetic bead, and then the original sample needs to be added. Specifically, the automatic sample introduction assembly 113A is configured to mix and move the original sample to a sample suction station, and includes a sample introduction mechanism 1131A, an exit mechanism 1133A, and a mixing mechanism 1132A, and correspondingly, the automatic sample introduction assembly 113A further includes a sample introduction station, a mixing station, and a sample suction station. The sample feeding mechanism 1131A is configured to arrange the original samples in a sample feeding station, and convey the samples to a blending station according to a predetermined sequence; the blending mechanism 1132A is used for uniformly mixing the original samples conveyed by the sampling mechanism 1131A and conveying the mixed samples to a sample suction station, and a sampling needle in the sampling needle assembly 111A sucks the original samples at the sampling station; the withdrawing mechanism 113A is configured to move the original sample after the sample suction is completed out of the sample suction station, so that the next original sample is moved to the sample suction station, which is convenient for the sampling needle to start a new original sample collection. Therefore, the automatic sample feeding assembly 113A is adopted to continuously carry out the acquisition process of the original sample, and the efficiency of the detection process is improved.

After the addition of the primary sample, the antigen in the primary sample is required to bind to the specific antibody in the magnetic beads, and the reaction cup is incubated in the reaction tray 121A for a certain period of time. Before the incubation begins, the reaction cup is rotated to a stirring station. The measurement needle assembly 116A includes a measurement needle and a stirring mechanism, and the measurement needle is used for sucking the sample to be detected into the optical detection device 130A for detection; the stirring mechanism stirs the mixture of the original sample and the magnetic beads, so that the antigen in the original sample is fully combined with the specific antibody in the magnetic beads. The measuring needle and the stirring mechanism are arranged on the same mounting plate, the measuring needle and the stirring mechanism are driven by the same driving mechanism to move to respective working positions, the corresponding actions of the measuring needle and the stirring mechanism can be guaranteed to be smoothly completed by adopting a displacement driving mechanism, the arrangement space of the device can be saved, the structure of the device is simplified, and the miniaturization of the device is facilitated.

Optionally, the reaction control device 120A includes a reaction disk 121A and a magnetic separation assembly 122A; the reaction disc 121A is used for accommodating a reaction cup and providing an incubation environment for preparing a magnetic bead composition by combining magnetic beads in the reaction cup with a reagent or an original sample, and the reaction disc 121A comprises a heat preservation pot and a rotating disc, wherein the heat preservation pot is fixed and mainly used for providing a closed space for incubation; the turntable is provided with a certain number of hole sites for placing the reaction cups along the circumferential direction, and is driven by a motor to rotate, so that the current reaction cup can be conveniently rotated to a required working position; specifically, the desired working positions include: the reagent feeding position corresponds to the reagent feeding position of the reagent needle assembly 115A, the sample feeding position corresponds to the sample feeding position of the sample needle assembly, and the stirring position corresponds to the working position of the stirring mechanism. In addition, the bottom of the rotating disc is provided with a temperature control device, the temperature of the heat preservation pot can be adjusted to increase the proper incubation temperature, and in one embodiment, the incubation temperature is 37 ℃.

The magnetic separation assembly 122A is used for performing magnetic separation on the mixture in the reaction cup after incubation and washing the magnetic bead composition obtained by the magnetic separation. Specifically, the magnetic separation assembly 122A includes a magnetic separation disc, a liquid injection mechanism and a liquid suction mechanism; the liquid suction mechanism is used for sucking waste liquid in the reaction cup; the liquid injection mechanism is used for injecting cleaning liquid into the reaction cup after waste liquid is absorbed. Specifically, the number of times of injecting the cleaning solution may be determined according to the nature of the added reagent, and the reagent that is not bound to the magnetic beads in the reaction cup and other waste may be cleaned. Specifically, the number of washing may be 2 to 6, e.g., 3, etc.

And after the magnetic separation is finished, moving the reaction cup to a reaction plate, adding other reagents, and repeating the incubation and magnetic separation processes for each reagent until the sample to be detected is prepared. The sample to be measured is then drawn into the optical detection device 130A by the measurement tip for detection. In addition, before the sample to be detected is sucked into the optical detection device 130A, the sample to be detected is further uniformly mixed, the uniformly mixing method comprises one or more combinations of mechanical uniformly mixing, bubble uniformly mixing or sucking and spitting uniformly mixing, in one embodiment, the measurement needle is mixed in a mode of sucking and spitting the sample in the reaction cup, a stirring device is not separately arranged, and the structure of the immunoassay analyzer is favorably simplified.

Optionally, the immunoassay analyzer analyzes the sample to be detected by using a flow fluorescence analysis method, and the optical detection device 130A includes a flow chamber and an optical detection mechanism; forming sheath flow in the flow chamber by the sample to be detected and enabling the sample to pass through the outlet of the flow chamber one by one; the optical detection mechanism is used for detecting an optical signal of the sample to be detected passing through the outlet of the flow chamber. Specifically, a laser emitting device is arranged at the position, perpendicular to the sheath flow, of the outlet of the flow chamber, a detector and the like are arranged at the position, perpendicular to the laser emitting device, and the sheath flow, the laser emitting device and the detector are perpendicular to each other and focus on one point to achieve hydrodynamic focusing. The fluorescent marked magnetic bead compound (sample to be detected) emits emission waves of scattered light and fluorescence under the excitation of laser, the scattered light and the fluorescence are obtained by a detector, interference is removed through a series of optical filters and grating processing, and an optical signal is obtained, is subjected to photoelectric conversion and amplification and then is input into a data analysis device for analysis. Further, the data analysis device is used for counting the detected optical signals generated by different magnetic beads and converting the detected optical signal data of the whole blood into the optical signal data of the serum.

In another embodiment, referring to fig. 3 and fig. 4 together, fig. 3 is an exploded schematic structural diagram of an embodiment of an immunoassay analyzer 100B provided herein, and fig. 4 is a schematic block diagram of structural connection in fig. 3, in which the sample analyzer 100B in this embodiment includes a sample introduction device 110B and a sampling device 30.

Referring to fig. 5, fig. 5 is a schematic structural diagram of the sample injection device 110B in fig. 3, wherein the sample injection device 20 includes a sample injection platform 21 and a sample injection mechanism 22.

The sample platform 21 is used for placing a sample holder 211, and the sample holder 211 is used for carrying a sample container 212, and the sample container 212 contains a sample therein.

Optionally, the sample container 212 includes a container body 2121 and a cap 2122, the sample is accommodated in the container body 2121, and the cap is covered on the container body 2121, so as to prevent the sample from flowing out of the container body 2121 when the container body 2121 shakes during the sample injection process, thereby improving the stability and safety of the sample injection process.

Optionally, cap 2122 is a rubber cap.

Optionally, a plurality of sample containers 212 are carried on the sample holder 211.

Further, be equipped with on the sample support 211 and stir the cooperation portion, should stir the cooperation portion and can be for stirring the cooperation groove.

Optionally, the quantity of should stirring the cooperation portion is a plurality of, and a plurality of stir cooperation portion intervals and set up.

Optionally, the sample holder 211 is further provided with a positioning matching part, which may be a positioning matching groove.

Optionally, the number of the positioning matching parts is multiple, and the multiple positioning matching parts are arranged at intervals.

Optionally, the number of the sample holder 211 is plural.

Referring to fig. 6 and 7 together, fig. 6 is a schematic structural diagram of the sample injection mechanism 22 in fig. 5, and fig. 7 is a schematic structural diagram of the pushing member 223 in fig. 6, wherein the sample injection mechanism 22 includes a sample injection driving mechanism 221, a sample injection connecting member 222, and the pushing member 223, and the sample injection driving mechanism 221 is connected with the sample injection connecting member 222 to drive the sample injection connecting member 222 to reciprocate.

Optionally, the sample driving mechanism 221 includes a sample motor 2211 and a sample conveyor 2212, and the sample conveyor 2212 is connected to the output shaft of the sample motor 2211 and the sample connector 222, respectively, so as to drive the sample connector 222 to reciprocate in the process of driving the sample conveyor 2212 to reciprocate by the sample motor 2211.

Optionally, sample drive mechanism 221 further comprises sample guide 2213, such that sample connection 222 reciprocates in the guiding direction of guide 2213.

Optionally, the sample introduction guide 2213 is a guide rail, and the sample introduction connector 222 is connected to the guide rail through a slider.

Further, the pushing member 223 is elastically connected to the sample feeding connector 222, so that when the sample feeding driving mechanism 221 drives the connector 222 to move, the pushing member 223 can abut against the sample holder 211, and further the sample holder 211 can move along the sample platform 21 under the elastic action between the sample feeding connector 222 and the pushing member 223, so that when the placement position of the sample holder 211 is incorrect, and in the process that the sample holder 211 moves along the sample platform 21, the pushing member 223 can move relative to the sample feeding connector 222 under the action of the friction force between the sample holder 211 and the sample platform 21, and further the placement angle of the sample holder 211 abutting against the pushing member 223 is adjusted.

Optionally, the pushing member 223 is elastically pivoted to the sample feeding connector 222, so that in the process that the sample holder 211 moves along the sample platform 21, the sample holder 211 can rotate in the first direction relative to the sample feeding connector 222 under the action of friction between the sample holder 211 and the sample platform 21, thereby adjusting the angle of the sample holder 211.

Optionally, the pushing member 223 includes a first connection portion 223a, a second connection portion 223b and a pushing portion 223c, the first connection portion 223a is elastically pivoted to the sample injection connection member 222, and the first connection portion 223a, the second connection portion 223b and the pushing portion 223c are sequentially connected in an end-to-end bending manner, so that the pushing member 223 is disposed in an Contraband shape.

Optionally, the pushing portion 223c includes a first sub-pushing portion 2231 and a second sub-pushing portion 2232, the first sub-pushing portion 2231 is connected to the second connecting portion 223b in a bending manner, and one side of the second sub-pushing portion 2232 facing the movement direction of the sample holder 211 protrudes from one side of the first sub-pushing portion 2231 facing the movement direction of the sample holder 211, so that when the sample injection driving mechanism 221 drives the sample injection connector 222 to move, one side of the second sub-pushing portion 2232 facing the movement direction of the sample holder 211 abuts against the sample holder 211.

Further, when the number of the sample holders 211 is plural, the plural sample holders 211 are arranged at intervals along the driving direction of the sample driving mechanism 221, so that after the sample driving mechanism 221 drives the previous sample holder 211 to move, and the sample driving mechanism 221 drives the pushing member 223 to move in the direction opposite to the moving direction of the previous sample holder 211, the pushing member 223 abuts against the next sample holder 211 to rotate in the second direction opposite to the first direction with respect to the sample connecting member 222 until the pushing member 223 disengages from the abutting state with respect to the next sample holder 211, so that the pushing member 223 rotates in the first direction with respect to the sample connecting member 222 to return to the initial state and is located on the side of the next sample holder 211 away from the moving direction of the previous sample holder 211, at this time, the sample driving mechanism 221 can drive the next sample holder 211 to move along the sample platform 21 as in the manner of driving the previous sample holder 211 to move, therefore, a plurality of sample supports 211 can continuously move on the sample platform 21, and the sample discharging work can be continuously completed.

Optionally, the pushing member 223 includes an inclined guide surface 2233 arranged away from the moving direction of the previous sample holder 211, so that when the pushing member 223 abuts against the next sample holder 211, the pushing member 223 rotates in the second direction relative to the sample injection connector 222 under the action of the next sample holder 211 and the inclined guide surface 2233, and the inclined guide surface 2233 can reduce the abutting force required to be overcome when the pushing member 223 rotates, and in this embodiment, the inclined guide surface 2233 is arranged on the side of the pushing portion 223c away from the moving direction of the previous sample holder 211.

It is understood that the former and the latter indicate the former and the latter in the sequential order of the plurality of sample holders 211.

Optionally, the number of the pushing members 223 is two, and the two pushing members 223 are respectively disposed at two ends of the sample injection connector 222.

Further, the sample injection mechanism 22 in this embodiment further includes a sample injection detector 224, and the sample injection detector 224 is configured to detect whether the sample holder 211 moves to the sample outlet position.

Optionally, the sample detector 224 is a distance sensor.

Referring to fig. 5 and 8 together, fig. 8 is a schematic structural diagram of the detection driving assembly 25 in fig. 5, wherein the sample injection device 110B in the present embodiment further includes a detection platform 23, a toggle member 24, and the detection driving assembly 25.

The detection platform 23 is used to carry the sample holder 211, and in this embodiment, the detection platform 23 is connected to the sample feeding platform 21 to receive the sample holder 211 entering from the sample feeding platform 21.

The toggle piece 24 is used for cooperating with the toggle fitting such as when the toggle fitting is a toggle fitting slot, one end of the toggle piece 24 can be inserted into the toggle fitting slot and cooperate with the toggle fitting slot.

Optionally, the sample feeding device 20 in this embodiment further includes a first detecting connector 241, and the toggle member 24 is pivotally connected to the first detecting connector 241, so that the toggle member 24 can rotate relative to the first detecting connector 241.

Optionally, the toggle member 24 is elastically pivoted to the first detecting connecting member 241.

Optionally, the number of the toggle pieces 24 is multiple, and the multiple toggle pieces 24 are arranged at intervals.

The detection driving assembly 25 is used for driving the stirring piece 24 to move along the detection platform 23, so that when the stirring piece 24 is matched with the stirring matching part, the sample support 211 is driven to move to a position to be detected along the detection platform 23, so that the detection driving assembly 25 drives the sample support 211 to move to the position to be detected through the stirring piece 24, the position of the sample support 211 is controlled in the movement process through the mutual matching of the stirring piece 24 and the stirring matching part, the position of the sample support 211 in the movement process is prevented from being deviated, and further the deviation is caused to appear in the position to be detected, and the position accuracy of the sample support 211 in the position to be detected is improved.

Optionally, in this embodiment, the detection driving assembly 25 is configured to drive the toggle member 24 to rotate relative to the first detection connecting member 241, so as to drive the first detection connecting member 241 to move along the detection platform 23 when the toggle member 24 rotates to be matched with the toggle matching portion, so as to drive the toggle member 24 to move along the detection platform 23.

Referring to fig. 8 and 9 together, fig. 9 is an enlarged schematic view of a portion a in fig. 8, wherein the detecting driving assembly 25 includes a detecting driving mechanism 251 and a second detecting connecting member 252, the second detecting connecting member 252 is connected to the detecting driving mechanism 251 and is provided with a first driving matching portion 2521, so that when the detecting driving mechanism 251 drives the second detecting connecting member 252 to move in the first direction, the first driving matching portion 2521 can abut against the toggle member 24, thereby pushing the toggle member 24 to rotate to a position where the toggle matching portion can be matched with each other.

Further, the second detecting connector 252 further has a second driving matching portion 2522, so that when the toggle member 24 rotates to a position where the toggle matching portion can be matched with each other, the detecting driving mechanism 251 drives the second detecting connector 252 to move in the second direction, and the second driving matching portion 2522 abuts against the first detecting connector 241, thereby pushing the first detecting connector 241 to move along the detecting platform 23, and further driving the toggle member 24 to move along the detecting platform 23.

Optionally, when the toggle member 24 is elastically pivoted to the first detecting connecting member 241, and the detecting driving mechanism 251 drives the second detecting connecting member 252 to move in the first direction, the toggle member 24 needs to be pushed to rotate to a portion capable of cooperating with the toggle member by overcoming the elastic action between the toggle member 24 and the first detecting connecting member 241, and when the detecting driving mechanism 251 drives the second detecting connecting member 252 to move in the second direction, the first driving portion 2521 is separated from the toggle member 24, and the toggle member 24 cooperates with the toggle portion at a position where the toggle member 24 cooperates with each other under the elastic action.

Alternatively, in other embodiments, the toggle member 24 may also be overlapped with the first driving matching portion 2521 under the action of gravity, so that when the detection driving mechanism 251 drives the second detection connecting member 252 to move in the first direction, the toggle member 24 is pushed to rotate against the action of gravity to a position where the toggle matching portion can be matched with each other, and when the detection driving mechanism 251 drives the second detection connecting member 252 to move in the second direction, the toggle member 24 is matched with the toggle matching portion under the action of gravity in the position where the toggle matching portion is matched with each other.

Alternatively, the number of the first driving matching parts 2521 is plural, and the plural driving matching parts 2521 can be abutted against the plural toggle pieces 24, respectively.

Optionally, the detection driving mechanism 251 includes a detection motor 2511 and a detection conveyor belt 2512, and the detection conveyor belt 2512 is respectively connected to the output shaft of the detection motor 2511 and the second detection connecting member 252, so as to drive the second detection connecting member 252 to reciprocate in the process of driving the detection conveyor belt 2512 to reciprocate by the detection motor 2511.

Further, when the quantity of stirring the cooperation portion on sample holder 211 is a plurality of, a plurality of stirring cooperation portions set up along the direction of motion interval of sample holder 211 on testing platform 23 to make stir piece 24 can stir the cooperation each other with a plurality of, thereby drive sample holder 211 along testing platform 23 gradual movement, and then make the sample in a plurality of sample container 212 can be in proper order waiting to detect the position.

For example, in the embodiment, when the sample holder 211 is driven by the toggle member 24 and the previous toggle matching portion to move to the position to be detected in the manner described above, the detection driving mechanism 251 drives the second detection connecting member 252 to move in the first direction until the first drive matching portion abuts against the toggle member 24, so that the toggle member 24 rotates to be disengaged from the toggle matching portion until the toggle member 24 moves to a position where it can be matched with the next toggle matching portion, and then the sample holder 211 is driven to move in the manner described above, and the process is repeated.

Further, the sample introduction device 110B in this embodiment further includes a positioning element 26, which is configured to be matched with the positioning matching portion on the sample holder 211 when the sample holder 211 moves to the position to be detected, so as to further improve the position accuracy of the sample holder 211 on the position to be detected.

Optionally, the positioning element 26 is elastically pivoted to the detection platform 23, so that when the sample holder 211 moves from the position to be detected to the position not to be detected, the sample holder 211 overcomes the elastic action between the positioning element 26 and the detection platform 23, so that the positioning element 26 rotates relative to the detection platform 23, and further disengages from the positioning matching portion.

Further, when the number of the positioning matching parts is plural, the plural positioning matching parts are arranged at intervals along the moving direction of the sample holder 211 on the detecting platform 23, so that when the sample holder 211 moves gradually on the detecting platform 23 as described above, the plural positioning matching parts can be sequentially matched with the positioning part 26, so that when each sample container 212 on the sample holder 211 moves to a position to be detected, the positioning part 26 is matched with the corresponding positioning matching part.

Specifically, when the previous sample container 212 moves to the position to be detected, the positioning element 26 is matched with the corresponding positioning matching portion, at this time, the sample holder 211 continues to move, the positioning element 26 is separated from the matching state with the positioning matching portion as described above, until the next sample container moves to the position to be detected, the positioning element 26 returns to the state matched with the next positioning matching portion under the elastic action between the positioning element 26 and the detection platform 23, and the process is repeated.

Optionally, the number of the positioning members 26 is multiple, and the multiple positioning members 26 are arranged at intervals.

Optionally, the sample feeding device 110B in this embodiment further includes a sample discharging platform 27, and the sample discharging platform 27 is connected to the detecting platform 23 to receive the sample holder 211 entering from the detecting platform 23.

Referring to fig. 10 and 11 together, fig. 10 is a schematic structural diagram of the blending mechanism 31 in fig. 3, and fig. 9 is a schematic structural diagram of the blending mechanism in the B direction in fig. 8, in which the sampling device 30 includes a blending mechanism 1132B and a sampling mechanism 32.

The blending mechanism 1132B includes a clamping mechanism 311 and a first blending driving mechanism 312, the clamping mechanism 311 is used for clamping the sample container 212, and the first blending driving mechanism 312 is connected to the clamping mechanism 311 to drive the clamping mechanism 311 to swing back and forth, so as to blend the sample in the sample container 212.

Specifically, the first blending driving mechanism 312 includes a blending motor 3121 and a blending conveyer 3122, and the blending conveyer 3122 is connected with an output shaft of the blending motor 3121 and the clamping mechanism 311 respectively, so as to drive the clamping mechanism 311 to swing back and forth in the process of the blending motor 3121 driving the blending conveyer 3122 to reciprocate.

Optionally, the blending mechanism 1132B in this embodiment further includes a second blending driving mechanism 313, and the second blending driving mechanism 313 is connected to the first blending driving mechanism 312 to drive the first blending mechanism 312 to reciprocate, so as to drive the clamping mechanism 311 to move to the grippable position, and further cause the clamping mechanism 311 to clamp the sample container 212 at the grippable position, in this embodiment, the second blending driving mechanism 313 drives the clamping mechanism 311 to move to the grippable position in the horizontal direction.

Optionally, the second kneading drive mechanism 313 may adopt a drive mode of driving a conveyor belt by a motor, and in other embodiments, the second kneading drive mechanism 313 may also adopt other drive modes, such as a motor-driven screw rod, a cylinder drive, and the like, which is not limited herein.

Optionally, the blending mechanism 1132B in this embodiment further includes a third blending driving mechanism 314, and the third blending driving mechanism 314 is connected to the first blending driving mechanism 312, so that after the sample container 212 is gripped by the gripping mechanism 311, the sample container 212 is driven to be separated from the sample holder 211, in this embodiment, the third blending driving mechanism 314 drives the sample container 212 to be separated from the sample holder 211 in the vertical direction.

Optionally, the third blending driving mechanism 314 may adopt a driving manner of driving a conveyor belt by a motor, and in other embodiments, the third blending driving mechanism 314 may also adopt other driving manners, such as a motor-driven screw rod, a cylinder driving manner, and the like, which is not limited herein.

The specific blending process of the blending mechanism 31 in this embodiment is as follows: first, the third kneading drive mechanism 314 drives the gripping mechanism 311 to move to the grippable position in the horizontal direction, so as to grip the sample container 212 on the sample holder 211, then the second kneading drive mechanism 313 drives the gripping mechanism 311 to move away from the sample holder 211, so as to take the sample container 212 off the sample holder 211, and finally the first kneading drive mechanism 312 drives the gripping mechanism 311 to swing back and forth to blend the sample.

Optionally, the blending mechanism 1132B in this embodiment further includes a first blending detector 315, where the first blending detector 315 is configured to detect whether the sample container 212 returns to the initial angle before blending after blending is finished.

It can be understood that, when the sample in the sample container 212 is mixed completely, the sample container 212 needs to be placed on the sample holder 211 again for the next work, and if the sample container 212 does not return to the initial angle before mixing, the sample container 212 may not be placed on the sample holder 211 due to incorrect angle, and therefore, the first mixing detector 315 in this embodiment can improve the accuracy of the placement position of the sample container 212.

Optionally, the first blending detector 315 is an optical coupler.

Optionally, the blending mechanism 1132B in this embodiment further includes a second blending detector 316, and the second blending detector 316 is configured to detect whether the gripping mechanism 311 moves to the grippable position during the process that the second blending driving mechanism 313 drives the gripping mechanism 311 to move, so as to prevent risks such as failure in gripping or breaking of the sample container 212 when the gripping mechanism 311 does not move to the grippable position.

Optionally, the second blend detector 316 is an optocoupler.

Optionally, the blending mechanism 1132B in this embodiment further includes a first detector 317, and the first detector 317 is configured to detect whether the sample container 212 moves to a position where the sample container 212 is detached from the sample holder 211 and can swing in the process that the third blending mechanism 314 drives the sample container 212 to detach from the sample holder 211.

Optionally, the second detector 317 is an optocoupler.

Referring to fig. 12, fig. 12 is a schematic structural diagram of the sampling mechanism 32 in fig. 3, wherein the sampling mechanism 32 includes a sampling seat 321 and a first sampling driving mechanism 322, the sampling seat 321 is used for installing the sampling needle 301, the first sampling driving mechanism 322 is connected to the sampling seat 321 to drive the sampling needle 301 to be inserted into the sample container 212 for sampling, and in this embodiment, the first sampling driving mechanism 322 drives the sampling needle 301 to be inserted into the sample container 212 in a vertical direction.

Optionally, in the process of driving the sampling needle 301 to be inserted into the sample container for sampling by the first sampling driving mechanism 322 in this embodiment, the sampling needle pierces the cap 2122 of the sample container 212 and is further inserted into the container body 2121 for sampling.

Optionally, the first sampling driving mechanism 322 includes a sampling motor 3221 and a sampling conveyor belt 3222, and the sampling conveyor belt 3222 is respectively connected to the output shaft of the sampling motor 3221 and the sampling seat 321, so as to drive the sampling needle 301 to reciprocate in the process of driving the sampling conveyor belt 3222 to reciprocate by the sampling motor 3221.

Optionally, the sampling mechanism 32 in this embodiment further includes a second sampling driving mechanism 323, the second sampling driving mechanism 323 is connected to the first sampling driving mechanism 322 to drive the sampling needle 301 to move to the insertable position, in this embodiment, the second sampling driving mechanism 323 drives the sampling needle 301 to reciprocate in the horizontal direction, and after moving to the insertable position, the first sampling driving mechanism 322 drives the sampling needle to insert into the sample container 212.

Optionally, the second sampling driving mechanism 323 in this embodiment adopts a driving manner of driving the conveyor belt by a motor, and in other embodiments, other driving manners may also be adopted, for example, driving manners of driving a screw rod, an air cylinder, and the like by a motor, which is not limited herein.

Optionally, the sampling mechanism 32 in this embodiment further includes a sampling detector for detecting whether the sampling needle 301 moves to the usable position during the process of driving the sampling needle 301 to be inserted into the sample container 212 by the first sampling driving mechanism 322.

Optionally, the detector is an optical coupler.

Optionally, the sampling mechanism 32 in this embodiment further includes a second detector 324, and the second detector 324 is configured to detect whether the sampling needle 301 moves to the insertable position during the process of driving the sampling needle 301 to move by the second sampling driving mechanism 323.

Optionally, the third detector 324 is an optocoupler.

Referring to fig. 13, fig. 13 is a schematic flow chart of a first embodiment of a sample analysis method according to the present invention, the method including the steps of:

s1310, providing the immunoassay analyzer.

In step S1310, the immunoassay analyzer includes a sample introduction device configured to receive an original sample and a reagent, and transfer the original sample, the reagent, and a sample to be detected according to a preset sequence, where the sample to be detected is prepared from at least the original sample and the reagent; a reaction control device for preparing a sample to be tested by a preset operation, the preset operation at least comprising a separation operation; the optical detection device is used for detecting a sample to be detected and outputting a detection result; wherein the reagent comprises at least one magnetic bead.

S1320, transferring the reagent and the original sample to a reaction cup by the sample introduction device.

In step S1320, to prepare a magnetic bead complex (sample to be tested) with a sandwich structure, a magnetic bead is first added into a reaction cup, where the magnetic bead includes a magnetic central body and specific antibodies disposed on the magnetic central body, and then an original sample is added to provide antigen to be combined with the specific antibodies in the magnetic bead, where the original sample includes serum or whole blood.

Specifically, referring to fig. 14, fig. 14 is a schematic flow chart of an embodiment of step 1320 in fig. 13, and the method for sequentially transferring the reagent and the original sample to the cuvette by the sample injection device includes the steps of:

s1421, the reagent needle assembly rotates to the reagent position, takes out the first reagent from the reagent storage tray assembly, rotates to the reagent filling position, and fills the first reagent into the target reaction cup in the reaction tray.

In step S1421, the first reagent is a magnetic bead, the reagent storage tray assembly rotates the first reagent to a reagent station under the action of the driving mechanism, the reagent station corresponds to a reagent position of the reagent needle assembly, the sample needle assembly rotates to a reagent filling position after absorbing the magnetic bead, at this time, the target reaction cup rotates to a reagent filling position under the driving of the motor, the reagent filling position corresponds to the reagent filling position, and the reagent needle assembly discharges the first reagent into the target reaction cup.

S1422, the target reaction cup rotates to the sample adding position along with the reaction disc, the sampling needle assembly moves to the sample sucking station to suck the original sample, and moves to the sample injecting station to add the original sample into the target reaction cup.

In step S1422, the sample application position corresponds to the sample application station, and the sampling needle of the sampling needle assembly pierces the sealing rubber plug containing the original sample and sucks the original sample under the driving of the linear motor.

S1423, after the target reaction cup added with the original sample is incubated for a period of time at a preset temperature, the reaction cup assembly transfers the target reaction cup to a magnetic separation assembly to perform magnetic separation operation for a preset number of times, so as to obtain a magnetic bead composition.

In step S1423, the preset temperature is 37 ℃, and the human body temperature environment is simulated, which is beneficial to better combination of the specific antibody in the magnetic bead and the antigen in the original sample. Certainly, before the incubation, the mixture in the target reaction cup can be stirred, which is beneficial to fully combining the specific antibody in the magnetic bead with the antigen in the original sample, shortens the incubation time and further improves the detection efficiency. And after the incubation is finished, the cup grabbing mechanism in the reaction cup assembly moves the target reaction cup to the magnetic separation mechanism.

S1330, the reaction control device performs at least one preset operation on the mixture in the reaction cup, wherein the preset operation comprises a separation operation, and a magnetic bead composition is obtained.

In step S1330, the predetermined operation includes a magnetic separation operation, where the magnetic separation operation is used to discharge the waste liquid in the reaction cup, and specifically includes separating the complex bound to the magnetic bead from the waste liquid, and discharging the waste liquid, so as to facilitate the binding of the magnetic bead to the subsequent reagent.

Specifically, referring to fig. 15, fig. 15 is a schematic flowchart illustrating an implementation of step 1330 in fig. 13, where the magnetic separation operation includes the steps of:

s1531, rotating the target reaction cup to a liquid injection station, injecting cleaning liquid, then rotating to a liquid absorption station, and magnetically separating for a period of time to suck out waste liquid in the target reaction cup.

In step S1531, the time for the magnetic separation may be determined according to the kind of the reagent added, e.g., 10-30 seconds, etc. The liquid injection station corresponds to the position of the liquid injection needle, and the liquid injection needle injects cleaning liquid into the target reaction cup. And transferring the target reaction cup to a liquid drainage station after magnetic separation for a period of time, wherein the liquid drainage station corresponds to the position of a liquid drainage needle, and the liquid drainage needle sucks the waste liquid in the target reaction cup out of a waste liquid barrel.

S1532, moving the target reaction cup which completes the magnetic separation operation for the preset times to the reaction plate.

In step S1532, after the magnetic separation is completed for the preset number of times, the target cuvette rotates to the cup discharging station along with the magnetic separation tray, and the target cuvette is moved to the reaction tray by the cup grasping mechanism in the cuvette processing assembly, so as to add the next reagent.

And S1340, repeating the reagent adding operation and the preset operation to the reaction cup containing the magnetic bead composition for a preset repetition number to obtain the sample to be detected.

In step S1340, the number of times of repeating reagent addition is determined by the structure of the sample to be tested. In this embodiment, the sample to be detected is a sandwich structure of antigen + specific antibody + magnetic bead + antibody + fluorescent biotin, so after the magnetic bead is combined with the antigen, the antibody and the fluorescent biotin need to be added, and three times of incubation and magnetic separation operations need to be performed in the process of preparing the sample to be detected.

And S1350, the sample introduction device sucks the sample to be detected into the optical detection device so as to detect the sample to be detected and output a detection result.

In step S1350, the optical detection mechanism analyzes the sample to be detected by using a flow fluorescence analysis method, and the optical detection device includes a flow chamber and an optical detection mechanism; forming sheath flow in the flow chamber by the sample to be detected and enabling the sample to pass through the outlet of the flow chamber one by one; the optical detection mechanism is used for detecting an optical signal of the sample to be detected passing through the outlet of the flow chamber. Specifically, a laser emitting device is arranged at the position, perpendicular to the sheath flow, of the outlet of the flow chamber, a detector and the like are arranged at the position, perpendicular to the laser emitting device, and the sheath flow, the laser emitting device and the detector are perpendicular to each other and focus on one point to achieve hydrodynamic focusing. The fluorescent marked magnetic bead compound (sample to be detected) emits emission waves of scattered light and fluorescence under the excitation of laser, the scattered light and the fluorescence are obtained by a detector, interference is removed through a series of optical filters and grating processing, and an optical signal is obtained, is subjected to photoelectric conversion and amplification and then is input into a data analysis device for analysis. Further, the data analysis device is used for counting the detected optical signals generated by different magnetic beads and converting the detected optical signal data of the whole blood into the optical signal data of the serum.

In the embodiment, the reagent comprises at least one magnetic bead, and different magnetic beads can be combined with different types of antigens in the initial sample to form different magnetic bead complexes, so that the joint detection operation of detecting various parameter indexes by inputting the initial sample into the same reaction cup once is realized, the detection process is simple to operate, and the detection efficiency is high.

In addition, the sample analysis method further comprises the steps of starting the immune analyzer, executing a starting initialization process by the system, resetting all motion mechanisms of the immune analyzer, and automatically cleaning the sampling needle, the reagent needle assembly, the measuring needle, the stirring mechanism and the pipeline. Then, the reaction cup enters a shaping mechanism, a sample rack with a sample tube is conveyed to a preset position through a sample introduction mechanism of the automatic sample introduction assembly, an original sample is filled in the sample tube, and the analyzer can start testing after the temperature of the reaction disc reaches 37 ℃.

In summary, the present invention discloses an immunoassay analyzer and a sample analysis method, the immunoassay analyzer includes: the sample introduction device is used for accommodating an original sample and a reagent and transferring the original sample, the reagent and a sample to be detected according to a preset sequence, wherein the sample to be detected is prepared from at least the original sample and the reagent; the reaction control device is used for preparing a sample to be detected through preset operation, and the preset operation at least comprises cleaning and separating operation; the optical detection device is used for detecting a sample to be detected and outputting a detection result; wherein the reagent comprises at least one magnetic bead. By the mode, the method can perform multi-item joint inspection on the original sample, and is high in detection efficiency.

The above description is only an embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications of equivalent structures and equivalent processes, which are made by using the contents of the present specification and the accompanying drawings, or directly or indirectly applied to other related technical fields, are included in the scope of the present invention.

Claims

1. An immunoassay analyzer, the immunoassay analyzer comprising:

the sample introduction device is used for accommodating an original sample and a reagent and transferring the original sample, the reagent and a sample to be detected according to a preset sequence, wherein the sample to be detected is at least prepared from the original sample and the reagent;

the reaction control device is used for preparing the sample to be detected through preset operation, and the preset operation at least comprises cleaning and separating operation;

the optical detection device is used for detecting the sample to be detected and outputting a detection result;

wherein the reagent comprises at least one magnetic bead.

2. The immunoassay analyzer of claim 1, wherein the magnetic beads comprise a magnetic central body and specific antibodies disposed on the magnetic central body, and when the magnetic beads are two or more, the magnetic beads have different sizes of the magnetic central body and/or different kinds of specific antibodies.

3. The immunoassay analyzer of claim 1, wherein the sample introduction device comprises a sampling needle assembly for aspirating the raw sample and transferring the raw sample into a reaction cuvette.

4. The immunoassay analyzer of claim 3, wherein the primary sample comprises whole blood, the primary sample contained within a sample tube having a sealing plug; the sampling needle assembly comprises a sampling needle, the sampling needle comprises a puncture part and a sample sucking port, and the puncture part is used for puncturing the sealing rubber plug and sucking the original sample by the sample sucking port.

5. The immunoassay analyzer of claim 3, wherein the sample introduction device further comprises a reaction cup handling assembly, an automatic sample introduction assembly, a reagent storage tray assembly, a reagent needle assembly, a measuring needle assembly;

the reaction cup processing assembly is used for screening, arranging and moving the reaction cups;

the reagent storage disc assembly is used for accommodating a reagent required for preparing the sample to be detected and transferring the reagent to a reagent station;

the reagent needle assembly moves to a position corresponding to the reagent station, sucks corresponding reagent and transfers the reagent into the reaction cup;

the automatic sample feeding assembly is used for uniformly mixing the original samples and moving the original samples to a sample suction station;

the measuring needle assembly is used for sucking the sample to be detected into the optical detection device for detection.

6. The immunoassay analyzer of claim 3, wherein the automatic sample injection assembly comprises a sample injection mechanism, an exit mechanism and a mixing mechanism;

the sampling mechanism is used for arranging and conveying original samples to a blending station;

the blending mechanism is used for uniformly mixing the original samples conveyed by the sample introduction structure and conveying the mixed samples to a sample suction station;

and the withdrawing mechanism is used for moving the original sample after the sample suction is finished out of the sample suction station.

7. The immunoassay analyzer of claim 1, wherein the reaction control device comprises a reaction disk and a magnetic separation assembly;

the reaction disc is used for accommodating the reaction cup and providing an incubation environment for the process of preparing the magnetic bead composition in the reaction cup;

the magnetic separation assembly is used for carrying out magnetic separation on the mixture in the reaction cup after incubation and cleaning the magnetic bead composition obtained by magnetic separation.

8. The apparatus of claim 7, wherein the magnetic separation assembly comprises a magnetic separation disc, a liquid injection mechanism, and a liquid suction mechanism; the liquid suction mechanism is used for sucking waste liquid in the reaction cup; and the liquid injection mechanism is used for injecting cleaning liquid into the reaction cup after waste liquid is absorbed.

9. The device of claim 1, wherein the optical detection device comprises a flow cell and an optical detection mechanism; the samples to be tested form sheath flow in the flow chamber and pass through the outlet of the flow chamber one by one; the optical detection mechanism is used for detecting an optical signal of the sample to be detected passing through the outlet of the flow chamber.

10. The device of claim 9, wherein the optical detection device further comprises a data analysis device for counting the detected optical signals generated by different magnetic beads and converting the detected optical signal data of the whole blood into optical signal data of serum.

11. A method of sample analysis, the method comprising:

providing an immunoassay analyzer comprising the immunoassay analyzer of any one of claims 1-10;

repeating the reagent adding operation and the preset operation to the reaction cup containing the magnetic bead composition for a preset repetition number to obtain a sample to be detected;

and the sample introduction device sucks the sample to be detected into the optical detection device so as to detect the sample to be detected and output a detection result.

12. The method of claim 10, wherein the method comprises:

rotating the reagent needle assembly to a reagent position to take out a first reagent from the reagent storage disc assembly, and rotating to a reagent filling station to fill the first reagent into a target reaction cup in the reaction disc;

the target reaction cup rotates to a sample adding position along with the reaction disc, the sampling needle assembly moves to a sample sucking station to suck an original sample, and moves to a sample injecting station to add the original sample into the target reaction cup;

and after the target reaction cup added with the original sample is incubated for a period of time at a preset temperature, the reaction cup is transferred to a magnetic separation assembly by a reaction cup processing assembly to carry out magnetic separation operation for preset times, so that the magnetic bead composition is obtained.

13. The method of claim 12, wherein the magnetic separating operation comprises:

rotating the target reaction cup to a liquid injection station, injecting cleaning liquid, then rotating to a liquid absorption station, and separating out waste liquid in the target reaction cup after magnetic separation for a period of time;

and moving the target reaction cup which finishes the magnetic separation operation for the preset times to the reaction disc.