WO2020042596A1

WO2020042596A1 - Fully-automatic magnetic bead time-resolved fluoroimmunoassay instrument

Info

Publication number: WO2020042596A1
Application number: PCT/CN2019/078574
Authority: WO
Inventors: 李根平
Original assignee: 广州源起健康科技有限公司
Priority date: 2018-09-02
Filing date: 2019-03-19
Publication date: 2020-03-05
Also published as: CN109142708A; CN109142708B

Abstract

A fully-automatic magnetic bead time-resolved fluoroimmunoassay instrument, wherein the instrument is divided into an inner chamber and an outer chamber by means of a rack (1); an electronic component box (7) is fixed on an upper layer of the inner chamber, a dark chamber shell is located on a lower layer of the inner chamber, and a dark chamber door device (5) is arranged on the rack (1) and cooperates with the dark chamber shell to form a dark chamber space, one side of which can be opened; a tray module (2) is located on a lower layer of the outer chamber, and can hold multiple reagent strips (3) and convey the reagent strips to the lower layer of the inner chamber or withdraw same to the lower layer of the outer chamber; a puncturing and pipetting module (4) is located on the upper layer of the outer chamber, and can automatically pierce a reagent top-face covering film and automatically draw or discharge a liquid; and a scanning and reading module (6) is located on the lower layer of the inner chamber and is located in the dark chamber shell, and can trigger, photograph and collect fluorescence information of a magnetic bead after incubation. By means of the rational layout of the inner chamber and the outer chamber and the compact and scientific design of the related functional modules, the structure is simple and compact, the cost is low, and furthermore, the degree of automation of the overall instrument is improved.

Description

Full-automatic magnetic bead time-resolved fluorescence immune analyzer

Technical field

The invention relates to the field of time-resolved fluorescent immunoassay instruments used in the in vitro diagnostic and biomedical industries, and in particular relates to a fully-automatic magnetic bead time-resolved fluorescence immunoanalyzer with a simple and compact structure and a high degree of automation.

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Background technique

Point of Care Testing (POCT) is an important development direction and the fastest-growing branch of the in vitro diagnostics industry in recent years. POCT involves a variety of technologies. In summary, it can be divided into simple color development, enzyme labeling, immunoassay, optical and electrical biosensors, electrochemical detection, spectrophotometry, and biochips.

Marked immune technology has more than 100 years of development history. According to the different markers, the detection methods of labeled immune technology can be divided into: 1, radioimmunoassay, immunoradioassay (RIA, IRMA); 2, fluorescent immunoassay (FIA ); 3. Enzyme immunoassay (EIA); 4. Gold-labeled immunoassay; 5. Bioluminescence immunoassay (BIA); 6. Enzyme-fluorescence immunoassay (E-CIA); 7. Chemiluminescence immunoassay (CLIA) 8. Time-resolved fluorescence immunoassay (TRFIA); 9. Electrochemiluminescence immunoassay (ECLIA).

Time-Resolved Fluorescence Immunoassay (TRFIA) uses lanthanide chelates dysprosium, europium, dysprosium, and dysprosium as markers. It has a broad excitation spectrum and a narrow emission spectrum, which is beneficial to reduce background and increase sensitivity; Excitation has the advantages of higher quantum yield, larger Stokes shift, avoiding the coincidence of excitation spectrum and fluorescence emission spectrum and the emission spectrum of biological matrix, and long fluorescence decay time. It has a wider detection range and better specificity than traditional fluorescent substances.

The magnetic bead time-resolved fluorescence immunoassay is based on the immunomagnetic bead time-resolved fluorescence immunoassay technology using rare earth ion chelate as a label. It is a highly sensitive, specific, stable, non-radioactive pollution, good detection repeatability, Wide range of standard curve and wide range of immunoassay methods, overcome the shortcomings of radioimmunoassay (RIA) isotope contamination, short half-life and poor stability of enzyme immunoassay (EIA), etc. It is considered to be one of the most promising micro detection methods for biomedical research and clinical medical testing.

Magnetic beads used in magnetic bead time-resolved fluorescence immunoassay refer to immunomagnetic microspheres (IMMS) or immunomagnetic beads (IMB). They are a new type of material developed by combining immunology and superparamagnetic magnetic beads. Immune magnetic beads are superparamagnetic microspheres coated with antibodies or with antibody binding function. When they are incubated with a sample containing a target substance, they can specifically bind to the target substance to form a complex with magnetic response. The complex can be retained by the magnetic field to separate it from other impurities in the sample. Immune magnetic bead technology has the advantages of high separation purity, retention of target substance activity, high sensitivity, high specificity, fast detection speed, low toxicity, good repeatability, simple operation, and does not require expensive equipment.

Chemical group-modified superparamagnetic microspheres can be covalently coupled to magnetic beads as a coating medium, antigen or antibody, which has stronger physical adsorption than polystyrene-based microplates. Larger surface area, can bind more protein molecules, greatly reduce antibody loss compared to plate adsorption; realize immune separation and enrichment and integration; as a small mobile phase carrier, it can make the reaction reach dynamic equilibrium faster, thus Accelerate the reaction speed; integrate multiple magnetic beads coupled with antibodies against different antigens, making it possible to detect different analytes in the same sample; no need to coat polystyrene plates (solid-phase carriers), low reagent costs, and production Controllable quality.

The immune complex formed by magnetic separation technology is directly precipitated in an external magnetic field, and the immune complex can be separated from the unbound substance without centrifugation. Because the magnetic beads have a larger binding area and can be dispersed in the liquid phase to fully react, the detection range is expanded, the reaction time is shortened, and the sensitivity is greatly improved. Because the magnetic beads are covalently coupled to the antigen or antibody, the instability of physical adsorption is overcome, so the immune magnetic beads are stored for a longer time and are more stable.

However, the development of automatic magnetic bead time-resolved fluorescence immunoassay in China's domestic research and development in recent years is still in its infancy. How to independently develop a fully-automatic magnetic bead time-resolved with a simple and compact structure and a high degree of automation Fluorescence immunoassay analyzer has become one of the important research directions in in vitro diagnostics and biomedical industry.

technical problem

In order to solve the above technical problems, the present invention provides a full-automatic magnetic bead time-resolved fluorescence immunoassay analyzer, which has a simpler and more compact structure, lower cost, high degree of automation, and simple and fast operation.

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Technical solutions

The technical solution of the present invention is as follows: a fully automatic magnetic bead time-resolved fluorescence immunoassay analyzer, comprising: a rack, a tray module, a puncture and pipetting module, a darkroom housing, a darkroom door device, and a code reading module; : The frame divides the entire instrument into two parts, the inner and outer chambers; the upper part of the inner chamber is fixed with an electronic component box; the dark room shell is located in the lower area of the inner room; the dark room door device is arranged on the rack to cooperate with the dark room The housing forms a dark room space that can be opened and closed on one side; the tray module is located in the lower area of the outer room, and is used to place and fix multiple reagent strips to be tested, and sends the reagent strips to the lower area of the inner room or exits to the outside The lower area of the chamber; the puncture pipetting module is located in the upper area of the outer chamber and is used to automatically pierce the membrane on the top surface of the reagent tube and automatically suck or discharge liquid; the scan code reading module is located in the lower area of the inner chamber. It is located inside the shell of the dark room, and is used to excite the magnetic beads completed in the incubation operation, take pictures and collect fluorescence information.

The automatic magnetic bead time-resolved fluorescence immunoassay analyzer, wherein the tray module is composed of a tray module power mechanism and a tray module body, and the tray module body is installed on the tray module power mechanism. The tray module power mechanism is used to feed the tray module body side by side with multiple reagent strips to the lower area of the inner chamber or exit to the lower area of the outer chamber; the tray module power mechanism includes a tray stepper motor , Two tray slide rails, an encoder and a tray timing belt assembly; the tray timing belt assembly is located above one of the tray slide rails, and the tray module body is mounted on the two tray slide rails, and the tray One side of the module body is connected to the timing belt in the timing belt assembly of the tray via corresponding connecting pieces; the pallet stepping motor and encoder are respectively located at both ends of the timing belt assembly of the tray, and are fixed to the timing belt through respective fixing members. The two ends of the tray slide rail under the tray timing belt assembly are connected to the timing belt in the tray timing belt assembly via the timing pulley and corresponding bearing in the tray timing belt assembly; Said encoder for a stepping motor with the tray main body module stays in the tray reach the desired position.

The automatic magnetic bead time-resolved fluorescence immunoassay analyzer, wherein the tray module body includes a tray bottom plate, a needle holder, a reagent bar tray, a reagent bar tablet, a reagent bar clip, a heating plate, and a heating plate fixing Plate, magnet assembly, magnet assembly power mechanism, and magnet upper and lower optocoupler assembly; the tray bottom plate is erected on two tray slide rails, and one side of the tray bottom plate is fixed for connecting with the timing belt in the tray timing belt assembly The needle tube holder and the reagent strip tray are fixed above the bottom plate of the tray via corresponding left and right supports; the needle tube holder is provided with multiple rows of needle holes for placing three needles, each row The needle holes are located on the extension line corresponding to the rear end of the corresponding opening slot. The needle tube holder is also provided with a plurality of sample holes for placing the test tube containing the sample to be tested, and each sample hole is also located corresponding to it. And the needle holes arranged in a row are located between the corresponding opening grooves and the sample holes; a plurality of suitable holes are arranged side by side on the reagent strip tray. An opening slot into which a reagent strip is placed; the reagent strip tablet is distributed on the top surface of the reagent strip tray on both sides of the opening slot; the reagent strip clip is located on the bottom surface of the reagent strip tray at the front of the opening slot; the heating The sheet is mounted on the bottom surface of the heating sheet fixing plate, which is located at the tail of the open slot and fixed below the reagent strip tray. The heating sheet fixing plate is provided with a plurality of heating projections spaced apart from the top surface of the heating sheet fixing plate. The magnet assembly, the magnet assembly power mechanism, and the magnet upper and lower optical coupling components are located between the tray bottom plate and the reagent strip tray, and the magnet assembly is located under the heating plate fixing plate and the heating plate; the magnet component power mechanism is used for lifting Lifting or lowering the magnet assembly to complete the magnetic bead separation step of the reagent strip; the magnet upper and lower photocoupler assemblies are installed between the magnet assembly and the magnet assembly power mechanism, and are used to detect the position of the magnet assembly in the tray module body. position.

The automatic magnetic bead time-resolved fluorescence immunoassay analyzer, wherein: the magnet assembly includes a magnet fixing base, a plurality of large magnets, two guide posts, and two guide post springs; the bottoms of the two guide posts are fixed on a tray bottom plate, The magnet fixing seat can be moved up and down on the two guide posts through corresponding linear bearing sets, and the two guide post springs are respectively set on the two guide posts, and are pressed between the magnet fixing seat and the heating plate fixing plate for auxiliary magnets. The fixed base moves downwards; all large magnets are vertically spaced on the magnet fixed base and are located on the extension line of the rear end of the corresponding open slot, and the top of each large magnet is divided by two along the length of the open slot. The oblique top surfaces intersect to form a tapered surface. Correspondingly, the heating plate fixing plate between the two heating projections is provided with a magnet via hole adapted to pass through the corresponding large magnet.

The automatic magnetic bead time-resolved fluorescence immunoassay analyzer, wherein: the magnet assembly power mechanism includes a motor mounting plate, a DC brushless motor, an eccentric disk, a bearing and a connecting shaft thereof; the motor mounting plate is vertically mounted on a tray On the bottom plate, and the large surface of the motor mounting plate faces the magnet fixing base; the DC brushless motor is laterally fixed on the motor mounting plate, and the output shaft of the DC brushless motor passes through the motor mounting plate toward the magnet fixing base; The eccentric disk is connected to the output shaft of the DC brushless motor, the bearing and its connecting shaft are fixed on the disk surface of the eccentric disk, and the fixed position is deviated from the output shaft of the DC brushless motor; the magnet fixing seat faces the magnet assembly One side of the power mechanism is horizontally provided with an oblong hole through which the adaptive bearing and its connecting shaft roll, and is used to drive the large magnet to move up or down under the driving of the DC brushless motor.

The automatic magnetic bead time-resolved fluorescence immunoassay analyzer, wherein the puncture and pipetting module includes a puncture and pipette stepper motor, a puncture and pipette synchronous belt component, a puncture and pipette screw transmission component, and a pipette ejection component The needle ejection selection component, the puncture pipetting slide block and the large sliding plate; the liquid ejection tube and the needle ejection selection component are installed in the middle and lower part of the front of the large sliding plate; the back of the large sliding plate is screwed It is connected with the slider in the puncture pipette slider assembly, and the two guide rails in the puncture pipette slider assembly are fixed vertically on the front of the rack through a screw interval; the puncture pipette stepper motor is The fixing member is vertically installed on the back of the rack, and the output shaft of the puncture pipetting stepper motor is set upward, and is connected to a timing belt wheel of the puncture pipette timing belt assembly through a corresponding bearing; The screw in the liquid screw transmission assembly is also installed vertically on the back of the rack via corresponding bearings and fixings, and the upper end of the screw is connected with the puncture and transfer timing belt assembly via the corresponding bearing Another synchronous belt wheel is connected; the nut in the puncture pipette screw transmission assembly is installed on the back of the large sliding plate via a corresponding fixing member, and the nut is located on the longitudinal center axis of the large sliding plate; the puncture The timing belt of the pipetting timing belt assembly is set on the two timing belt wheels, and is used to drive the screw to rotate under the driving of the puncture pipetting stepper motor, and the large sliding plate and the large sliding plate are driven by the nut matching the screw. The slider on the back slides up and down along the guide rail, so that the pipetting and ejection tube assembly and needle ejection selection component installed on the front of the large sliding plate are moved up and down as a whole.

The automatic magnetic bead time-resolved fluorescence immunoassay analyzer, wherein the pipetting and ejecting assembly includes a pipetting motor fixing plate, a pipetting screw motor, a pipetting guide rail slider assembly, and a small slide Plate, syringe push plate, pipette motor nut, multiple puncture needles, syringe fixing plate, multiple pipette syringes, and optocoupler sensors; the pipette motor fixing plate is fixed horizontally and vertically on the front of the large sliding plate The pipette screw motor is installed on the pipette motor fixing plate, and the screw of the pipette screw motor passes vertically through the pipette motor fixing plate; the pipette nozzle The two guide rails in the guide rail slider assembly are fixed to the front of the large sliding plate below the fixed plate of the pipetting motor through vertical intervals by screws, and the back of the small sliding plate is connected to the slider in the pipe sliding guide module. The syringe push plate is fixed on the top of the small sliding plate, and the screw cap of the pipetting motor is mounted on the syringe push plate and cooperates with the screw of the pipetting screw motor; a plurality of puncture needles are vertically spaced fixed The bottom surface of the small sliding plate; the syringe fixing plate is located below the pipetting motor fixing plate and is connected to the pipetting motor fixing plate via two columns; multiple pipetting syringes are installed at a fixed interval on the syringe On the top surface of the board, the front edge of the syringe push plate is provided with a plurality of adapter slots at the tails of the plurality of pipette syringes; the photocoupler sensor is connected to the pipette motor through a corresponding fixing member and fixed The front of the large sliding board on the board.

The automatic magnetic bead time-resolved fluorescence immunoassay analyzer, wherein the ejection needle component includes a plurality of ejection needle columns, a plurality of ejection plates, an ejection stepper motor, an ejection timing belt assembly and an ejection needle guide slide Block assembly; of which, two ejector posts are mounted on the syringe fixing plate behind each pipette via corresponding linear bearings, and a spring is set on the upper half of each ejector post, and these two ejector posts A lower ejection plate is connected to the lower end of the needle ejection plate, and a notch adapted to eject the needle of the head of the pipette is provided at the front end of the ejection plate; the stepping motor of the ejection needle is connected to the small sliding plate inwardly through a corresponding fixing member And the output shaft of the needle-back stepping motor is connected to one of the timing belt pulleys of the needle-back timing belt assembly via a corresponding bearing, and the other timing pulley of the needle-back timing belt assembly is connected via a corresponding The bearing and the connecting shaft are connected to the other side of the small sliding plate; the guide rail in the needle ejection rail slider assembly is laterally fixed to the lower end of the front of the small sliding plate by screws, and the needle ejection rail The slide block assembly is connected via a respective connecting member and the needle back belt assembly belt, the belt package and the needle back in the belt assembly belt round two.

The automatic magnetic bead time-resolved fluorescence immunoassay analyzer, wherein: the darkroom door device includes a darkroom door, two darkroom door guide rail slider assemblies, and a darkroom door power mechanism; and the back of the darkroom door is respectively provided with an adaptive embedding. The grooves and slider connection holes of two darkroom door rail slider assemblies, the darkroom door is connected to the sliders in the darkroom door rail slider assemblies through screws through the slider connection holes, and the darkroom door rail slider assemblies The guide rail in the vertical is fixed on the front of the rack by screws; one side of the darkroom door is connected to the darkroom door power mechanism via a corresponding darkroom door connector; the darkroom door power mechanism is a darkroom door stepper motor, the aforementioned darkroom The door connecting piece, the dark room door timing belt component, and the dark room door power mechanism support component are composed of the timing belt in the dark room door timing belt component, which is vertically located on one side of the dark room door. Between darkroom doors; at the upper end of the timing belt, the darkroom door stepper motor is fixed via the darkroom door stepper motor support in the darkroom door power mechanism support assembly On the front side of the frame, one of the timing belt wheels of the darkroom door timing belt assembly is connected to the output shaft of the darkroom door stepper motor via a corresponding bearing; at the lower end of the timing belt, the darkroom door power mechanism support assembly The timing belt support in the middle is fixed on the front of the frame, and the other timing belt wheel in the darkroom door timing belt assembly is connected to the timing belt support via a corresponding bearing and a connecting shaft; the timing belt is set here On two synchronous pulleys.

The automatic magnetic bead time-resolved fluorescence immunoassay analyzer, wherein: the reading module is composed of a reading X-axis power mechanism, a reading Y-axis power mechanism, a lens assembly and a barcode device; the reading X-axis The power mechanism and the read Y-axis power mechanism are respectively used to move the lens assembly in the X-axis direction and the Y-axis direction in the horizontal plane, and the read X-axis power mechanism is also used to move the lens assembly in the horizontal plane along with the X-axis direction. Mobile bar code device; the lens assembly is used for effective luminescence data collection of reagent tubes that need to be read on multiple reagent bars placed in the tray module, and the bar code device is fixed on the reading Y axis power mechanism through corresponding fixing pieces For reading the barcode information on multiple reagent strips; the read X-axis power mechanism includes a read X-axis stepper motor, a read X-axis synchronous wheel assembly, a read X-axis guide slider assembly, and a read Value X-axis fixing plate; the reading value X-axis fixing plate is erected on the bottom plate of the rack via two columns; the X-axis stepping motor is mounted on the reading value X-axis fixing plate in the Y-axis direction through corresponding fixing members One end, and the X-axis stepping The output shaft of the machine is connected to one synchronous pulley of the reading X-axis synchronous wheel assembly via a corresponding bearing, and the other synchronous pulley of the reading X-axis synchronous wheel assembly is via a corresponding bearing, connecting shaft and fixed Pieces are fixed on the other end of the reading X-axis fixing plate; the guide rail in the reading X-axis guide rail slider assembly is fixed on the reading X-axis fixing plate between the two synchronous belt pulleys along the X-axis direction by screws, so The bottom surface of one end of the reading Y-axis fixing plate in the reading Y-axis power mechanism is connected to the slider in the reading X-axis guide rail slider assembly, and the top surface of one end of the reading Y-axis fixing plate is connected through the corresponding connection. The components are connected to the timing belt in the reading X-axis synchronous wheel assembly; the reading Y-axis power mechanism includes a reading Y-axis stepping motor, a reading Y-axis synchronous wheel assembly, a reading Y-axis guide slider assembly, The aforementioned read Y-axis fixed plate, read Y-axis roller, and read Y-axis support plate; wherein the read Y-axis support plate is also erected on the bottom plate of the rack via two columns, and the read Y-axis The roller is installed at the other end of the reading Y-axis fixing plate; the Y-axis stepper motor is fixed by the corresponding The component is installed along the X-axis direction on the roller end of the reading Y-axis fixing plate, and the output shaft of the Y-axis stepping motor is connected to a synchronous belt wheel in the reading Y-axis synchronous wheel assembly via a corresponding bearing. The other synchronous pulley in the Y-axis synchronous wheel assembly is fixed at the other end of the Y-axis fixing plate via the corresponding bearing, connecting shaft and fixing member; the guide in the Y-axis guide slider assembly is driven along the screw by The Y-axis direction is fixed on the reading Y-axis fixing plate between the two synchronous belt wheels, the lens assembly is connected to the slider in the reading Y-axis guide slider assembly, and the lens assembly is connected to the reading Y-axis The timing belts in the timing wheel assembly are connected.

Beneficial effect

The automatic magnetic bead time-resolved fluorescence immunoassay analyzer provided by the present invention adopts a reasonable layout using internal and external chambers and a compact and scientific design of related functional modules, which not only has a simpler and more compact structure and lower cost, And it has a high degree of automation. It is especially suitable for using ready-to-use reagents. It can detect one or more samples at the same time. The sample is used in a small amount and the operation is simple and fast. It is also more stable; very suitable for the use, promotion and popularization of medical units in China.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of a full-automatic magnetic bead time-resolved fluorescent immunoanalyzer of the present invention (with the dark room casing removed);

2 is a perspective view of the tray module in FIG. 1 according to the present invention;

FIG. 3 is an enlarged perspective view of the tray module body in FIG. 2 of the present invention (it has been cut away from the first slot);

4 is an enlarged perspective view of the magnet assembly and the magnet power mechanism in FIG. 3 according to the present invention;

Figure 5 is an enlarged perspective view of the reagent strip used in Figure 2 of the present invention;

6 is an enlarged perspective view of the puncture pipetting module in FIG. 1 according to the present invention;

FIG. 7 is an enlarged perspective view of the pipetting and ejecting tube assembly of FIG. 6 according to the present invention; FIG.

FIG. 8 is an enlarged perspective view of the needle ejection needle selection component of FIG. 6 according to the present invention; FIG.

9 is an enlarged perspective view of the darkroom door device of FIG. 1 according to the present invention;

FIG. 10 is an enlarged perspective view of the code reading module in FIG. 1 according to the present invention.

Zh

Best Mode of the Invention

Hereinafter, specific implementations and embodiments of the present invention will be described in detail with reference to the accompanying drawings. The specific embodiments described are only used to explain the present invention, and are not intended to limit the specific implementations of the present invention.

As shown in FIG. 1, FIG. 1 is a perspective view of an embodiment of a fully automatic magnetic bead time-resolved fluorescent immunoanalyzer according to the present invention (with the dark room casing removed). The fully-automatic magnetic bead time-resolved fluorescent immune analyzer includes a rack 1 and a tray. Module 2, puncture and pipetting module 4, dark room housing (not shown), dark room door device 5 and scan code reading module 6; of which:

The rack 1 is connected in an inverted T shape by a horizontal bottom plate 11 and a vertical bracket plate assembly 12 to divide the entire instrument into two parts or areas, an inner chamber and an outer chamber. The bracket plate assembly 12 is formed by a left side plate of the instrument. , The right side plate, the upright plate, and the upright plate constitute a frame structure; the bottoms of the left and right plates are respectively fixed on both sides of the bottom plate 11, and the upright plates are provided on the left and right plates There is an avoidance gap under the vertical plate to allow the tray module 2 to enter and exit the lower space of the inner and outer chambers. The vertical plate is arranged on the top of the vertical plate and connected to the top of the left and right plates. .

An electronic component box 7 is fixed on the bracket board assembly 12 for installing related electronic components such as a power supply, a circuit board, a cooling fan, and a switch button. The electronic component box 7 is located in the upper area of the inner chamber and belongs to the instrument. Inactive area; the electronic component box 7 is composed of a power supply folding plate, a fan folding plate, and an anti-interference plate. Both sides of the power folding plate are triangular, and the front end of the power folding plate is arranged on the left side of the bracket plate assembly 12 of the rack 1. The side plate and the right plate, the fan folding plate is arranged at the rear end of the power folding plate, and the anti-interference plate is located above the power folding plate.

The tray module 2 is located in the lower area of the outer chamber, and is used for placing and fixing a plurality of reagent strips 3 to be detected, and sending the reagent strips to the lower area of the inner chamber or exiting to the lower area of the outer chamber;

The puncture and pipetting module 4 is located in the upper area of the outer chamber. Through program control, the entire automatic lifting, automatic loading or detachment of the pipette tip can be realized, and the coating for automatically piercing the top surface of the reagent tube can be achieved automatically. Suck or discharge liquid;

The dark room shell is located in the lower area of the inner room, and is used to form a dark room space that blocks or blocks external light, because the code reading module 6 has strict requirements for light blocking; in order to facilitate the display of the lower area of the inner room of the instrument Internal structure, Figure 1 removed the darkroom shell parts;

The dark room door device 5 is disposed on the vertical plate of the bracket plate assembly 12 and cooperates with the dark room shell to form a dark room space that can be opened and closed on one side;

The code scanning and reading module 6 is located in the lower area of the inner chamber and inside the dark room shell. The horizontal movement of the X-axis and Y-axis can be realized automatically by program control. It is used to complete the magnetic beads incubation in the reagent tube. Perform excitation, take pictures and read fluorescence information.

The automatic magnetic bead time-resolved fluorescence immunoanalyzer of the present invention adopts a reasonable layout of the inner and outer chambers and a compact and scientific design of related functional modules, which not only has a simpler and more compact structure, lower cost, but also improves the overall instrument performance. The degree of automation is particularly suitable for the use of ready-to-use reagents, which can detect one or more samples at the same time, which is very suitable for the use, promotion and popularization of medical units in China.

In a preferred embodiment of the automatic magnetic bead time-resolved fluorescence immunoassay analyzer of the present invention, as shown in FIG. 2, FIG. 2 is a perspective view of the tray module in FIG. 1 of the present invention. Specifically, the tray module 2 is composed of The tray module power mechanism 21 is composed of a tray module body 22 mounted on the tray module power mechanism 21, and the tray module power mechanism 21 is used for loading multiple reagent bars 3 side by side. The tray module body 22 is sent to the lower area of the inner chamber or exits to the lower area of the outer chamber. The embodiment of the full-automatic magnetic bead time-resolved fluorescence immunoanalyzer of the present invention and the accompanying drawings show that it can be placed at the same time at most. Tray module 2 of 5 reagent strips 3.

Specifically, the tray module power mechanism 21 includes a tray stepper motor 211, two tray slide rails 212, an encoder 214, and a tray timing belt assembly 215. The tray timing belt assembly 215 is located on one of the tray slide rails 212. Above, the tray module body 22 is mounted on two tray slide rails 212, and one side of the tray module body 22 is connected to the timing belt in the tray timing belt assembly 215 via corresponding connectors, and Driven back and forth along the length of the tray slide 212 by the tray timing belt assembly 215; the tray stepper motor 211 and encoder 214 are respectively located at both ends of the tray timing belt assembly 215 and are fixed by respective fixing members The two ends of the tray slide rail 212 below the tray timing belt assembly 215 are connected to the timing belt in the tray timing belt assembly 215 via the timing pulley and corresponding bearing in the tray timing belt assembly 215; the encoder 214 is used for In cooperation with the pallet stepping motor 211, the pallet module body 22 is stayed at the position to be reached. When the encoder 214 detects that the pallet stepping motor 211 is running to the position where the pallet module body 22 is to be reached , The feedback signal to the circuit board in the electronic component box 7 stops sending pulse signals to the tray stepper motor 211, so that when the dark room door device 5 is opened, the tray module body 22 containing the reagent strip 3 is passed through the bracket board assembly The avoidance gap at the bottom of the riser in 12 is sent to the lower area of the inner chamber or exits to the exact location of the lower area of the outer chamber.

3 and FIG. 4, FIG. 3 is an enlarged perspective view of the tray module body in FIG. 2 of the present invention (which has been cut away from the first slot), and FIG. 4 is a magnet assembly and magnet power in FIG. 3 of the present invention. An enlarged perspective view of the mechanism; specifically, the tray module body 22 includes a tray bottom plate 221, a needle holder block 222, a reagent strip tray 223, a reagent strip pressing piece 224, a reagent strip clip 228, a heating piece 225, and a heating piece fixing plate 2251, a magnet assembly 226, a magnet assembly power mechanism 227, and a magnet upper and lower photocoupler assembly 229; specifically:

The tray bottom plate 221 is mounted on two tray slide rails 212 of the tray module power mechanism 21 shown in FIG. 2, and a side of the tray bottom plate 221 is fixed for connecting with the timing belt in the tray timing belt assembly 215. Connector (as shown in Figure 2);

The needle tube holder 222 and the reagent strip tray 223 are fixed above the tray bottom plate 221 via corresponding left and right support members in FIG. 2; wherein the needle tube holder 222 is correspondingly provided with multiple rows for placing three needles 2222. Each needle hole 2221 is located on the extension line of the rear end of the corresponding opening slot 2231, and a plurality of sample holes 2223 are also provided on the needle tube holder 222, which are used for placing the nucleic acid to be detected. For each sample tube (not shown) of the sample, each sample hole 2223 is also located on the extension of the rear end of the corresponding opening slot 2231, and the needle holes 2221 arranged in a row are located in the corresponding opening slot 2231 and the sample hole 2223. between;

The reagent strip tray 223 is provided side by side with a plurality of opening grooves 2231 adapted to be inserted into the reagent strip 3 described in FIG. 2 to restrict the lateral movement of the reagent strip 3; the reagent strip pressing pieces 224 are distributed in the opening. The top surface of the reagent strip tray 223 on both sides of the groove 2231 is used to press the reagent strip 3 pushed into the opening groove 2231 to restrict the vertical movement of the reagent strip 3; the reagent strip clip 228 is located at the front of the opening groove 2231 The bottom surface of the reagent strip tray 223 is used to clamp the outer wall of the test tube at the front end of the reagent strip 3 to restrict the forward and backward movement of the reagent strip 3.

The heating plate 225 is attached to the bottom surface of the heating plate fixing plate 2251. The heating plate fixing plate 2251 is located at the tail of the opening groove 2231 and is fixed below the reagent strip tray 223. The top surface of the heating plate fixing plate 2251 is A plurality of heating projections 2252 are arranged on the upper space, and the heat emitted by the heating sheet 225 is conducted to the heating projections 2252 through the heating sheet fixing plate 2251 for heating the reagent strip 3 located between the two heating projections 2252. Reagent tube.

The magnet assembly 226, the magnet assembly power mechanism 227, and the magnet upper and lower optical coupling assemblies 229 are all located between the tray bottom plate 221 and the reagent strip tray 223, and the magnet assembly 226 is located below the heating plate fixing plate 2251 and the heating plate 225; The magnet assembly power mechanism 227 is used to raise or lower the magnet assembly 226 to complete the magnetic bead separation step of the reagent strip 3. The magnet upper and lower photocoupler assemblies 229 are installed between the magnet assembly 226 and the magnet assembly power mechanism 227. It is used to detect whether the position of the magnet assembly 226 in the tray module body 22 is in an upper position or a lower position.

Specifically, the magnet assembly 226 includes a magnet fixing base 2261, a plurality of large magnets 2262, two guide posts 2263, and two guide post springs 2264; the bottom of the two guide posts 2263 is fixed on the tray bottom plate 221, and the magnet fixing base 2261 It can be moved up and down on the two guide posts 2263 through corresponding linear bearing sets. Two guide post springs 2264 are respectively set on the two guide posts 2263 and pressed between the magnet fixing seat 2261 and the heating plate fixing plate 2251 to assist the magnets. The fixed base 2261 moves downwards; the large magnets 2262 are rectangular parallelepiped and have magnetic properties. All the large magnets 2262 are vertically spaced on the magnet fixed base 2261 and are located on the extension line corresponding to the rear end of the corresponding open slot 2231. The tops of the two large magnets 2262 are intersected by two inclined top surfaces along the length of the opening groove 2231 to form a tapered surface. Correspondingly, a heating plate fixing plate 2251 provided between the two heating bumps 2252 is provided with a corresponding large magnet. 2262 passes through the magnet through hole 2253, so that the magnet holder 2261 drives the large magnet 2262 to rise or fall.

Specifically, the magnet assembly power mechanism 227 includes a motor mounting plate 2271, a DC brushless motor 2272, an eccentric disk 2273, and a bearing and a connecting shaft 2274 thereof; the motor mounting plate 2271 is vertically mounted on a tray bottom plate 221, and the motor The large surface of the mounting plate 2271 faces the magnet fixing base 2261; the DC brushless motor 2272 is laterally fixed on the motor mounting plate 2271, and the output shaft of the DC brushless motor 2272 passes through the motor mounting plate 2271 toward the magnet fixing base 2261; The eccentric disk 2273 is connected to the output shaft of the DC brushless motor 2272, the bearing and its connecting shaft 2274 are fixed on the disk surface of the eccentric disk 2273, and the fixed position is offset from the output shaft of the DC brushless motor 2272; The side of the magnet holder 2261 facing the magnet assembly power mechanism 227 is horizontally provided with an elongated hole 2275 in which an adaptive bearing and its connecting shaft 2274 roll, for driving the magnet holder under the drive of a brushless DC motor 2272. 2261 drives the large magnet 2262 to rise or fall; in order to overcome the defect of the eccentric transmission mechanism itself having a locking point, the two guide post springs 2264 in the rotation of the DC brushless motor 2272 During the movement, it can also prevent the eccentric disk 2273 from being jammed.

With reference to FIG. 5, FIG. 5 is an enlarged perspective view of the reagent strip used in FIG. 2 of the present invention. Specifically, the reagent strip 3 is, from left to right, a first beveled reagent tube 311, a second beveled reagent tube 312, and a first Cylindrical removable reagent tube sleeve 321, second cylindrical removable reagent tube sleeve 322, first cylindrical reagent tube 331, first oval reagent tube 341, second oval reagent tube 342, second cylindrical reagent tube 332, third cylindrical reagent The tube 333, the fourth cylindrical reagent tube 334, the fifth cylindrical reagent tube 335, the sixth cylindrical reagent tube 336, and the seventh cylindrical reagent tube 337 are arranged in a row; wherein the first beveled reagent tube 311 and the second beveled reagent tube 312 The first cylindrical removable reagent tube sleeve 321 and the second cylindrical removable reagent tube sleeve 322 are located at the tail of the reagent strip 3 for magnetic bead separation, and are respectively used for loading the first cylindrical removable reagent tube and the second cylindrical Removable reagent tube (none shown in FIG. 5); when the reagent strip 3 is pushed in, the reagent strip clip 228 of the tray module body 22 can hold the seventh cylindrical reagent tube at the head of the reagent strip 3 337's outer wall.

With reference to FIG. 6, FIG. 6 is an enlarged perspective view of the puncture liquid transfer module in FIG. 1 of the present invention. Specifically, the puncture liquid transfer module 4 includes a puncture liquid transfer stepper motor 41 and a puncture liquid transfer timing belt assembly. 42, puncture pipette screw transmission assembly 43, pipette ejection assembly 44, ejection needle selection assembly 45, puncture pipette slide assembly (not shown) and large sliding plate 46; specifically:

The pipetting and ejecting tube assembly 44 and the needle ejection selection module 45 are both installed on the middle and lower part of the front of the large sliding plate 46; the back of the large sliding plate 46 is connected to the slider in the puncture pipetting slider assembly by screws. The two guide rails of the puncture pipette slide block assembly are fixed vertically on the front surface of the stand plate in the bracket plate assembly 12 of FIG. 1 by screws; the puncture pipette stepper motor 41 is installed vertically in the figure through corresponding fixing members. 1 The back of the vertical plate in the bracket plate assembly 12 and the output shaft of the puncture pipetting stepper motor 41 is set upward, and is connected to a timing belt wheel of the puncture pipette timing belt assembly 42 through a corresponding bearing;

The screw in the puncture pipette screw transmission assembly 43 is also vertically mounted on the back of the vertical plate in the support plate assembly 12 in FIG. 1 via corresponding bearings and fixing members, and the upper end of the screw is connected with the puncture pipette timing belt through corresponding bearings. The other synchronous belt wheel in the assembly 42 is connected; the nut in the puncture pipetting screw transmission assembly 43 is installed on the back of the large sliding plate 46 via a corresponding fixing member, and the nut is located in the longitudinal direction of the large sliding plate 46 On the central axis; the timing belt in the puncture pipetting timing belt assembly 42 is set on the two timing pulleys, and is used to drive the screw to rotate under the drive of the puncture and stepping motor 41, The matched nut drives the large sliding plate 46 and the slider on the back side of the large sliding plate 46 to slide up and down along the guide rail, so that the pipetting and ejecting tube assembly 44 and the needle ejection selecting component 45 installed on the front of the large sliding plate 46 are moved up and down as a whole. Perform puncture, pipetting, and / or selective needle withdrawal.

With reference to FIG. 7 and FIG. 8, FIG. 7 is an enlarged perspective view of the pipetting and ejecting tube assembly of FIG. 6 according to the present invention, and FIG. 8 is an enlarged perspective view of the ejection needle selection assembly of FIG. 6 according to the present invention; The liquid ejection tube assembly 44 includes a pipette motor fixing plate 442, a pipette screw motor 441, a pipette guide rail slider assembly 444, a small slide plate 451, a syringe push plate 452, and a pipette motor nut 458, a plurality of puncture needles 456, a syringe fixing plate 443, a plurality of pipette syringes 445, and an optical coupling sensor 457; specifically:

The pipette motor fixed plate 442 is horizontally and vertically fixed on the front surface of the large sliding plate 46. The pipette screw motor 441 is mounted on the pipette motor fixed plate 442, and the pipette screw motor The screw of 44 passes vertically through the pipette motor fixing plate 442 and is vertically downward; the two guide rails in the pipette tube slider assembly 444 are fixed at a vertical interval below the pipette motor fixing plate 442 by screws. The front side of the slide plate 46, the back side of the small slide plate 451 is connected to the slider in the pipetting and ejection rail slider assembly 444, the syringe push plate 452 is fixed on the top of the small slide plate 451, The tube motor nut 458 is mounted on the syringe push plate 452 and cooperates with the screw of the pipetting and ejecting screw motor 441. It is used for driving the pipetting and ejecting screw motor 44 to drive the liquid The tube motor nut 458 drives the syringe push plate 452, the small sliding plate 451 and the slider on the back of the tube to slide up and down along the guide rail; a plurality of puncture needles 456 are fixed on the bottom surface of the small sliding plate 451 at vertical intervals for completing puncture according to the detection needs Actions;

The syringe fixing plate 443 is located below the pipette motor fixing plate 442, and is connected to the pipette motor fixing plate 44 via two columns; a plurality of pipette syringes 445 are mounted on the syringe fixing plate 443 at a vertical interval. On the top surface, the front edge of the syringe push plate 452 is provided with a plurality of adapter slots at the tails of the plurality of pipetting syringes 445, which are used to complete the pipetting action according to the detection needs;

The photocoupler sensor 457 is connected to the front of the large sliding plate 46 below the pipette motor fixing plate 442 via a corresponding fixing member, and is used to sense whether the position of the syringe push plate 452 is in the upper or lower position.

Specifically, the ejection needle assembly 45 includes a plurality of ejection needle posts 446, a plurality of ejection needle plates 447, an ejection stepper motor 453, an ejection timing belt assembly 454, and an ejection guide rail slider assembly 455; On the syringe fixing plate 443 behind the pipette syringe 445, two withdrawal needle posts 446 are mounted via corresponding linear bearings, and a spring is set on the upper half of each withdrawal needle post 446 for the internal withdrawal needle post. 446 returns to its original position without external force, and the lower end of the two needle ejection post 446 is connected with a needle ejection plate 447, and the front end of the needle ejection plate 447 is provided with a needle adapted to eject the pipette syringe 445 head Gap

The step-back motor stepper motor 453 is connected to one side of the small sliding plate 451 inwardly and laterally through corresponding fixing members, and the output shaft of the step-back motor stepper motor 453 is connected to the One timing belt pulley is connected, and the other timing belt pulley in the ejection head timing belt assembly 454 is connected to the other side of the small sliding plate 451 through corresponding bearings and connecting shafts; in the ejection head guide slider assembly 455 The guide rail is fixed laterally on the lower end of the front face of the small sliding plate 451 by screws. The slider in the withdrawing needle guide slider assembly 455 is connected to the timing belt in the withdrawing timing belt assembly 454 through a corresponding connection, and the synchronization The belt is set on two synchronous belt wheels in the needle ejection timing belt assembly 454, and is used to drive the slider along the guide rail to the pipette that needs to withdraw the needle through the timing belt driven by the needle ejection stepper motor 453. Above the two ejection needle columns 446 behind the syringe 445, and driven by the pipetting screw motor 441, the small sliding plate 451 and the slider are moved down by the nut to press the corresponding two ejection needle columns 446 Overcome the elastic force of the two springs and move the needle ejection plate 447 at the lower end of the two needle ejection columns 446 downward to complete the action of ejecting the needle of the pipette syringe 445 head. When the small sliding plate 451 and the slider are moved up, use the set The elastic force of the two springs on the two retracting needle posts 446 moves the two retracting needle posts 446 and the retracting plate 447 connected to the lower ends thereof to the upper positions.

With reference to FIG. 9, FIG. 9 is an enlarged perspective view of the darkroom door device in FIG. 1 of the present invention. Specifically, the darkroom door device 5 includes a darkroom door 51, two darkroom door rail slider assemblies (not shown), and Darkroom door power mechanism 52; the back of the darkroom door 51 is respectively provided with a groove 511 and a slider connection hole 512 adapted to be embedded in two darkroom door rail slider assemblies, and the darkroom door 51 passes through the slider connection holes through screws 512 is connected to the slider in the dark room door guide rail slider assembly, and the guide rail in the dark room door rail slider assembly is vertically fixed by screws on the front surface of the stand plate of the bracket plate assembly 12 in FIG. 1; one side of the dark room door 51 It is connected to the dark room door power mechanism 52 via the corresponding dark room door connector 522. It is used to drive the dark room door power mechanism 52 to rise or fall along the guide rail through the slider to cooperate with the dark room shell to open or close the lower layer of the inner chamber of the instrument. The space of the area includes opening or blocking the lower part of the vertical plate in the bracket plate assembly 12 to avoid the avoidance gap for allowing the tray module 2 to enter and exit the lower space of the inner and outer rooms, thereby opening or closing the dark room space; closing Darkroom space closed state can play the role of the tray open state to meet the module body 3 with the reagent strip 22 between the lower region of the outer chamber and out of the chamber in the lower region of the instrument.

Specifically, the darkroom door power mechanism 52 is composed of the darkroom door stepper motor 521, the aforementioned darkroom door connector 522, the darkroom door timing belt assembly 523, and the darkroom door power mechanism support assembly 524; the darkroom door timing belt assembly 523 The timing belt in the middle is vertically located on one side of the darkroom door 51, and the aforementioned darkroom door connector 522 is connected between the timing belt and the darkroom door 51 by screws; at the upper end of the timing belt, the darkroom door stepper motor 521 passes through the darkroom door The darkroom door stepper motor support in the power mechanism support assembly 524 is fixed on the front surface of the stand plate of the bracket plate assembly 12 in FIG. 1. One of the timing belt pulleys of the darkroom door timing belt assembly 523 is connected to the darkroom door via a corresponding bearing. On the output shaft of the stepper motor 521; at the lower end of the timing belt, the timing belt support in the dark room door power mechanism support assembly 524 is fixed to the front surface of the stand plate of the support plate assembly 12 in FIG. 1, and the dark room door is synchronized The other timing belt pulley in the belt assembly 523 is connected to the timing belt support via a corresponding bearing and a connecting shaft; the timing belt is sleeved on the two timing belt pulleys, and is used for Artery and connected by gate 522 drives darkroom darkroom door 51 moves up and down.

With reference to FIG. 10, FIG. 10 is an enlarged perspective view of the code scanning reading module in FIG. 1 of the present invention. Specifically, the reading module 6 is composed of a reading X-axis power mechanism 61 and a reading Y-axis power mechanism. 62. The lens assembly 63 and the barcode 64 are composed; the reading X-axis power mechanism 61 and the reading Y-axis power mechanism 62 are respectively used to move the lens assembly 63 in the X-axis direction and the Y-axis direction in the horizontal plane, and the reading value The X-axis power mechanism 61 is also used to move the barcode assembly 64 while moving the lens assembly 63 in the X-axis direction in the horizontal plane; the lens assembly 63 can realize the control of multiple placements in the tray module 2 in FIG. 1 through program control. The reagent tube 3 on the reagent strip 3 needs to read the value for effective luminescence data collection, and the barcode device 64 is fixed on the reading Y-axis power mechanism 62 through the corresponding fixing member for reading the barcode information on the plurality of reagent strips 3.

Specifically, the read X-axis power mechanism 61 includes a read X-axis stepping motor 611, a read X-axis synchronous wheel assembly 612, a read X-axis guide slider assembly 613, and a read X-axis fixing plate 614; The reading value X-axis fixing plate 614 is erected on the bottom plate 11 of the frame 1 in FIG. 1 via two columns; the X-axis stepping motor 611 is installed on the reading value X-axis and fixed in the Y-axis direction through corresponding fixing members. One end of the plate 614, and the output shaft of the X-axis stepping motor 611 is connected to a synchronous pulley in the reading X-axis synchronous wheel assembly 612 via a corresponding bearing. The other synchronous pulley is fixed to the other end of the reading X-axis fixing plate 614 via a corresponding bearing, a connecting shaft, and a fixing member; the guide in the reading X-axis guide slider assembly 613 is fixed here by a screw in the X-axis direction. On the reading X-axis fixing plate 614 between the two synchronous pulleys, the bottom surface of one end of the reading Y-axis fixing plate 624 in the reading Y-axis power mechanism 62 and the slide in the reading X-axis guide slider assembly 613 Blocks are connected, and the top surface of one end of the reading Y-axis fixing plate 624 is synchronized with the reading X-axis via a corresponding connector The timing belt in the component 612 is connected and is used to drive the reading Y-axis power mechanism 62 and the lens component 63 and The barcode 64 moves back and forth in the X-axis direction.

Specifically, the read Y-axis power mechanism 62 includes a read Y-axis stepper motor 621, a read Y-axis synchronous wheel assembly 622, a read Y-axis guide slider assembly 623, the aforementioned read Y-axis fixing plate 624, The reading Y-axis roller 625 and the reading Y-axis support plate 615; wherein the reading Y-axis support plate 615 is also erected on the bottom plate 11 of the frame 1 in FIG. 1 via two columns, and the reading Y-axis The roller 625 is installed at the other end of the reading Y-axis fixing plate 624, and is used to roll back and forth on the reading Y-axis support plate 615. The Y-axis stepping motor 621 is installed on the reading Y-axis and fixed in the X-axis direction through a corresponding fixing member. The roller end of the plate 624, and the output shaft of the Y-axis stepping motor 621 is connected to a synchronous belt pulley in the reading Y-axis synchronous wheel assembly 622 via a corresponding bearing, in the reading Y-axis synchronous wheel assembly 622 The other synchronous belt pulley is fixed to the other end of the reading Y-axis fixing plate 624 via corresponding bearings, connecting shafts and fixing members; the guide rail in the reading Y-axis guide slider assembly 623 is fixed in the Y-axis direction by screws. The reading Y-axis fixing plate 624 between the two synchronous pulleys, the lens assembly 63 and the reading Y-axis guide The slider in the block assembly 623 is connected, and the lens assembly 63 is connected to the timing belt in the reading Y-axis synchronization wheel assembly 622, and is used to drive the reading Y axis through the reading Y axis stepper motor 621 The timing belt of the timing wheel assembly 622 drives the lens assembly 63 to move back and forth in the Y-axis direction.

Specifically, the lens assembly 63 includes a photomultiplier tube (PMT) 631, a direct-connected light guide convex seat, a direct-connected light guide recess, and a fiber probe block 632; the photomultiplier tube (PMT) 631 is installed in the direct-connected guide On the optical convex seat, the optical fiber probe block 632 is installed on a direct-connected light guide recess, and the optical fiber probe block 632 is located below a photomultiplier tube (PMT) 631; the directly connected light-guide convex block and the aforementioned reading Y The timing belt in the shaft synchronization wheel assembly 622 is connected, and the directly connected light guide recess is connected with the slider in the reading Y-axis guide slider assembly 623.

In the following, a conventional blood nucleic acid sample detection is taken as an example. The working principle and detection process of the embodiment of the automatic magnetic bead time-resolved fluorescence immunoassay analyzer of the present invention are as follows:

Step S800: Put 1 to 5 test tubes containing blood (nucleic acid) samples to be tested in the multiple sample holes 2223 on the needle tube holder 222 in FIG. 3, and put 1 to 5 reagent strips 3 into the corresponding openings. The groove 2231 is pushed forward, so that 1 to 5 reagent bar clips 228 respectively clamp the outer walls of the test tubes (ie, the seventh cylindrical reagent tube 337 in FIG. 5) at the front end of the respective reagent bar 3 respectively.

Step S810: Activate the corresponding detection switch on the instrument, and the darkroom door 51 is driven to move up by the darkroom door stepper motor 521 of FIG. 9; the tray stepper motor 211 of FIG. 2 is used to drive the tray module body 22 with the reagent strip 3 along the tray slide rail. 212 moves to the lower space of the inner chamber of the instrument, and the barcode reader 64 is driven by the X-axis stepping motor 611 to move in the X-axis direction as shown in Fig. 10, and then reads the barcode on 1 to 5 reagent strips 3 for confirmation; 2 Tray stepper motor 211 drives the tray module body 22 to move below the puncture pipette module 4 with the reagent strip 3, and cooperates with the puncture pipette stepper motor 41 in Fig. 6 to drive the large slide plate 46 to move down, with the choice of needle withdrawal One to five puncture needles 456 in the lower part of the module 45 pierce the films on the top surfaces of all reagent tubes sealed on the reagent strip 3 in sequence.

In step S820, the instrument loads the blood (nucleic acid) samples in the corresponding sample wells 2223 to the reagent strip trays located in FIG. 3 through 1 to 5 pipette syringes 445 installed on the top surface of the syringe fixing plate 443 in FIG. 7. 223 corresponds to the first beveled reagent tube 311 and the second beveled reagent tube 312 on the reagent strip 3 in the opening groove 2231 and is mixed (or stirred) with the magnetic beads therein; Drive the syringe pusher 452 of FIG. 8 to move up and down, and drive 1 to 5 pipette syringes 445 to complete the suction and discharge action to achieve pipetting and mixing (or stirring), where the mixing (or stirring) passes through the pipetting syringe 445 multiple times Suction and release are realized.

It should be noted that, since only three needles 2222 are available in the needle hole 2221 in the same row in FIG. 3, for this reason, the same needle 2222 is used in relation to the first beveled reagent tube 311 of each reagent strip 3. One beveled reagent tube 311 uses the same needle 2222 for pipetting and aspirating; similarly, the second beveled reagent tube 312 associated with each reagent strip 3 uses another needle 2222; the remaining third needle 2222 is specifically designed to enhance pipetting and pipetting of fluids.

In step S820, each pipette syringe 445 replaces the respective needle 2222, and respectively loads the blood (nucleic acid) sample to be detected into the corresponding reagent strip 3 first beveled reagent tube 311 and second beveled reagent tube 312, and Mix with the magnetic beads by multiple suction and discharge.

When the needle 2222 is installed, the tray stepper motor 211 in FIG. 2 drives the tray module body 22 to move below the puncture pipetting module 4 and positions the needle 2222 specified in FIG. 3 directly below the corresponding pipette syringe 445 in FIG. 7. The large slide plate 46 is driven downward by the puncture and pipetting stepper motor 41 in FIG. 6, and the heads of 1 to 5 pipette syringes 445 are moved downward, and then the corresponding needles 2222 are installed.

When the needle 2222 is retracted, the slider in the needle ejection rail slider assembly 455 is driven by the needle ejection stepper motor 453 in FIG. 8 to move along its guide rail, and as shown in FIG. 7, it moves to the two ejectors behind the corresponding pipette syringe 445 Above the needle post 446 and driven by the pipetting and ejecting screw motor 441, the ejection guide rail slider assembly 455 moves down relative to the pipetting and ejection tube assembly 44 so that the slider in the ejection guide rail slider assembly 455 presses the two located below it. Each ejection needle post 446 drives the ejection needle plate 447 downward, and then the needle 2222 installed on the head of the corresponding pipette syringe 445 is returned. The returned needle 2222 is also placed in the original needle hole 2221, so as to install another 2222, thereby achieving the purpose of replacing the needle 2222.

In step S830, each pipette syringe 445 replaces the respective needle 2222, and adds the marker diluent in the corresponding reagent strip 3 first cylindrical reagent tube 331 to the first cylindrical removable reagent tube 321 and The marker in the second cylindrical detachable reagent tube 322 is mixed by multiple suction and discharge; wherein, when the diluted marker in the first cylindrical detachable reagent tube 321 is sucked and released, the same as the first inclined reagent tube 311 is used. The relevant needle 2222 is used when the diluted marker in the second cylindrical removable reagent tube 322 is sucked and put, and the needle 2222 related to the second beveled reagent tube 312 is used.

Step S840, each pipette injector 445 replaces the respective needle 2222, and respectively applies the neutralizing agent in the corresponding reagent strip 3, the fourth cylindrical reagent tube 334, and the fifth cylindrical reagent tube 335 to the first beveled reagent tube 311, respectively. And two beveled reagent tubes 312, and mixed by multiple suction and discharge; thereby starting the incubation stage.

Step S850: After a specified incubation time, the DC brushless motor 2272 drives the magnet holder 2261 to move up, and 1 to 5 large magnets 2262 are raised to the first inclined reagent tube 311 corresponding to the reagent strip 3 and Between the second beveled reagent tube 312, the magnetic beads in the first beveled reagent tube 311 and the second beveled reagent tube 312 are magnetically attracted and moved to the inclined surface to complete magnetic bead separation.

Step S860, each pipette syringe 445 sucks the reaction liquid in the first beveled reagent tube 311 and the second beveled reagent tube 312 of the corresponding reagent strip 3 by replacing the respective needle 2222, and discharges them to the magnetic beads of the respective beveled surface. This step needs to be repeated several times to ensure that the reaction liquid is in full contact with the magnetic beads.

In step S870, each pipette syringe 445 sucks the cleaning liquid in the first oval reagent tube 341 and the second oval reagent tube 342 of the corresponding reagent strip 3 by replacing the respective needle 2222, and cleans the magnetic beads on the respective inclined surfaces; This step also needs to be repeated several times and repeated washing; and at the last cleaning, the DC brushless motor 2272 drives the magnet holder 2261 to move down, and 1 to 5 large magnets 2262 are lowered, and the pipette syringe 445 is to be piped Flush the magnetic beads on the respective inclined surfaces to the bottom of the reagent tube with the cleaning solution, and suck away the cleaning waste solution.

It should be noted that the cleaned waste liquid can be placed in the useless reagent tube on the corresponding reagent strip, such as the useless seventh cylindrical reagent tube 337, and the second cylindrical reagent tube 332 and the third cylindrical reagent tube which are spared. 333. The fourth cylindrical reagent tube 334 and the fifth cylindrical reagent tube 335, which have been used to hold the neutralizing agent, can be used to hold the waste liquid after cleaning.

Step S880: The DC brushless motor 2272 drives the magnet fixing base 2261 to move upward, and 1 to 5 large magnets 2262 are raised to between the first beveled reagent tube 311 and the second beveled reagent tube 312 corresponding to the reagent strip 3. Magnetic beads in the first beveled reagent tube 311 and the second beveled reagent tube 312 are magnetically attracted and moved to the inclined surfaces to complete magnetic bead separation. (Same as step S850)

In step S890, each pipette syringe 445 sucks the diluted markers in the first cylindrical removable reagent tube 321 and the second cylindrical removable reagent tube 322 by replacing the respective needles 2222, and discharges them to the respective inclined surfaces. This step needs to be repeated several times to ensure that the marker is in full contact with the magnetic beads; thus the incubation period ends.

In step S900, the magnetic beads in the first beveled reagent tube 311 and the second beveled reagent tube 312 are washed again, and step S870 is repeated.

Step S910, each pipette syringe 445 is replaced with a third needle 2222 dedicated to sucking the enhancement solution, sucking the enhancement solution in the sixth cylindrical reagent tube 336, and adding the sample to the first beveled reagent tube 311 and the second beveled reagent, respectively. Tube 312 and mixed by multiple suction and discharge.

Step S920: The tray module body 22 is driven by the tray stepper motor 211 of FIG. 2 to enter the lower space of the inner chamber of the instrument along the tray slide 212 with the reagent strip 3 that has been incubated; the dark room door is driven by the stepper motor 521 of the dark room door of FIG. 9. 51 moves down, closing the space inside the darkroom enclosure.

Step S930: The lens assembly 63 is driven by the reading X-axis stepping motor 611 and the reading Y-axis stepping motor 621 in FIG. 10 to stay above the reagent strip 3 to be read, and the first inclined reagent tube of the reagent strip 3 311 and the second beveled reagent tube 312 perform excitation, photograph, and read fluorescence information to complete the collection of luminescence data.

Step S940: The darkroom door 51 is driven upward by the darkroom door stepper motor 521 of FIG. 9; the tray module body 22 is driven by the tray stepper motor 211 of FIG. 2 to move the reagent strip 3 along the tray slide 212 to the lower layer of the outer chamber of the instrument with the reagent strip 3 Space; the dark room door 51 is driven by the dark room door stepper motor 521 to move down; the reagent strip 3 to be removed therefrom.

It can be seen that when the automatic magnetic bead time-resolved fluorescent immunoanalyzer of the present invention performs detection, it only needs to place the reagent strip to be detected in the reagent strip tray and push it into the clamp, and the entire instrument can realize the reagent strip to be detected. Perform a series of automated steps of puncture, adding reagents, liquid suction and stirring, washing, incubation, magnetic bead separation, and dark room luminescence detection, so the entire magnetic bead time-resolved fluorescence immunoassay analyzer has a high degree of automation; it can detect one or With multiple samples, the amount of samples is small, the operation is simple and fast, and the results can be obtained in 30 minutes, which greatly reduces the waiting time for patients and the test results are more stable.

It should be understood that the above descriptions are only the preferred embodiments of the present invention, and are not sufficient to limit the technical solutions of the present invention. For those of ordinary skill in the art, within the spirit and principles of the present invention, it may be based on the above. The description adds, subtracts, replaces, changes, or improves, and all these added, subtracted, replaced, changed, or improved technical solutions should belong to the protection scope of the appended claims of the present invention.

Zh

Claims

A full-automatic magnetic bead time-resolved fluorescence immunoassay analyzer, comprising: a rack, a tray module, a puncture and pipetting module, a darkroom housing, a darkroom door device, and a code reading module; of which: a rack The entire instrument is divided into two parts, the inner chamber and the outer chamber; the upper part of the inner chamber is fixed with an electronic component box, the dark room shell is located in the lower area of the inner room, and the dark room door device is arranged on the rack to cooperate with the dark room shell to form a Dark room space that can be opened and closed on the side; the tray module is located in the lower area of the outer room, used to place and fix multiple reagent strips to be tested, and send the reagent strips to the lower area of the inner room or exit to the lower layer of the outer room Area; the puncture pipetting module is located in the upper area of the outer chamber, and is used to automatically pierce the membrane on the top surface of the reagent tube and automatically suck or discharge liquid; the scan code reading module is located in the lower area of the inner room and in the dark room The inside of the shell is used to excite the magnetic beads after the incubation operation, take pictures and collect fluorescence information.
The automatic magnetic bead time-resolved fluorescence immunoassay analyzer according to claim 1, wherein the tray module is composed of a tray module power mechanism and a tray module body, and the tray module body is mounted on the tray module. In the group power mechanism, the tray module power mechanism is used to feed the tray module body side by side with multiple reagent strips to the lower area of the inner chamber or exit to the lower area of the outer chamber; the tray module power The mechanism includes a tray stepping motor, two tray slides, an encoder and a tray timing belt assembly; the tray timing belt assembly is located above one of the tray slides, and the tray module body is mounted on the two tray slides Above, and one side of the tray module body is connected with the timing belt in the timing belt assembly of the tray via corresponding connecting pieces; the pallet stepping motor and encoder are respectively located at both ends of the timing belt assembly of the tray, and pass through Respective fixing parts are fixed at both ends of the tray slide rail below the tray timing belt assembly, and through the timing pulleys in the tray timing belt assembly and corresponding bearings and the tray timing belt assembly The synchronous belt drive connection; the encoder is used to cooperate with the pallet stepping motor to keep the pallet module body at the position to be reached.
The automatic magnetic bead time-resolved fluorescence immunoassay analyzer according to claim 2, wherein the tray module body comprises a tray bottom plate, a needle holder, a reagent strip tray, a reagent strip tablet, a reagent strip clip, A heating plate, a heating plate fixing plate, a magnet assembly and a magnet assembly power mechanism and a magnet upper and lower optical coupling assembly; the tray bottom plate is erected on two tray slide rails, and a timing belt assembly for the tray is fixed on one side of the tray bottom plate The connecting pieces connected by the synchronous belt in the middle; the needle tube holder and the reagent strip tray are fixed above the bottom plate of the tray via corresponding left and right support members; the needle tube holder is provided with multiple rows for placing three needles correspondingly Each row of needle holes is located on the extension line corresponding to the rear end of the corresponding opening slot. The needle tube holder is also provided with a plurality of sample holes for placing test tubes containing samples to be tested. Each sample hole They are also located on the extension line at the rear end of the corresponding opening slot, and the needle holes arranged in a row are located between the corresponding opening slot and the sample hole; the reagent strip tray A plurality of opening grooves adapted to be placed in the reagent strip are arranged side by side; the reagent strip pressing pieces are distributed on the top surface of the reagent strip tray on both sides of the opening groove; and the reagent strip clamps the reagent strips at the front of the opening groove. The bottom surface of the tray; the heating plate is mounted on the bottom surface of the heating plate fixing plate, which is located at the tail of the open slot and is fixed below the reagent strip tray, and the top surface of the heating plate fixing plate faces upward A plurality of heating bumps are arranged at intervals; the magnet assembly, the magnet assembly power mechanism, and the magnet upper and lower optical coupling assemblies are all located between the tray bottom plate and the reagent strip tray, and the magnet assembly is located under the heating plate fixing plate and the heating plate; The magnet assembly power mechanism is used to raise or lower the magnet assembly to complete the magnetic bead separation step of the reagent strip; the upper and lower photocoupler assemblies of the magnet are installed between the magnet assembly and the magnet assembly power mechanism to detect the presence of the magnet assembly. The position of the tray module body.
The fully automatic magnetic bead time-resolved fluorescence immunoassay analyzer according to claim 3, wherein the magnet assembly comprises a magnet holder, a plurality of large magnets, two guide posts, and two guide post springs; and the bottom of the two guide posts It is fixed on the bottom plate of the tray, and the magnet fixing seat can be moved up and down on the two guide posts through corresponding linear bearings. The two guide post springs are respectively set on the two guide posts, and are pressed against the magnet fixing seat and the heating plate fixing plate. It is used to assist the downward movement of the magnet holder; all large magnets are arranged on the magnet holder at a vertical interval and are on the extension line of the rear end of the corresponding opening slot, and the top of each large magnet is along the opening slot. In the length direction, two inclined top surfaces intersect to form a tapered surface. Correspondingly, a heating plate fixing plate between two heating projections is provided with a magnet via hole adapted to pass through a corresponding large magnet.
The fully automatic magnetic bead time-resolved fluorescence immunoassay analyzer according to claim 4, characterized in that: the magnet assembly power mechanism comprises a motor mounting plate, a DC brushless motor, an eccentric disc and a bearing and a connecting shaft thereof; The mounting plate is vertically mounted on the tray bottom plate, and the large surface of the motor mounting plate faces the magnet mount; the brushless DC motor is laterally fixed on the motor mounting plate, and the output shaft of the DC brushless motor passes through the motor mounting plate. Facing the magnet fixing seat; the eccentric disk is connected to the output shaft of the DC brushless motor, the bearing and its connecting shaft are fixed on the disk surface of the eccentric disk, and the fixed position is deviated from the output shaft of the DC brushless motor; The side of the magnet holder facing the power mechanism of the magnet assembly is horizontally provided with an oblong hole in which the adapting bearing and its connecting shaft roll, and is used to drive the large magnet to move up or down by driving the magnet holder under the drive of a DC brushless motor. decline.
The automatic magnetic bead time-resolved fluorescence immunoassay analyzer according to claim 1, wherein the puncture and transfer module comprises a puncture and transfer stepper motor, a puncture and transfer timing belt assembly, and a puncture and transfer screw transmission assembly , Pipetting and ejection components, needle ejection selection components, puncture pipetting slide block components and large slide plates; the pipette and ejection needle selection components are installed in the middle and lower part of the front of the large slide plate; the large The back of the sliding plate is connected to the slider in the puncture pipette slider assembly by screws, and the two guide rails in the puncture pipette slider assembly are vertically fixed on the front of the rack by screws; the puncture pipette The stepper motor is vertically installed on the back of the rack via a corresponding fixing member, and the output shaft of the puncture pipetting stepper motor is set upward, and is connected to a timing belt wheel of the puncture pipette timing belt assembly through a corresponding bearing. Connection; the screw in the puncture pipetting screw transmission assembly is also vertically installed on the back of the rack via the corresponding bearing and fixing member, and the upper end of the screw is connected with the penetrating through the corresponding bearing The other timing belt wheel of the puncture pipetting timing belt assembly is connected; the nut in the puncture pipetting screw transmission assembly is installed on the back of the large sliding plate via a corresponding fixing member, and the nut is located on the large sliding plate On the longitudinal central axis; the timing belt in the puncture pipetting timing belt assembly is set on the two timing pulleys, and is used to drive the screw to rotate under the driving of the puncture and stepping motor, and cooperates with the screw The nut drives the large sliding plate and the slider on the back side of the large sliding plate to slide up and down along the guide rail, and thus the pipetting and ejection tube assembly and needle ejection selection component installed on the front of the large sliding plate are moved up and down as a whole.
The automatic magnetic bead time-resolved fluorescence immunoassay analyzer according to claim 6, characterized in that the pipetting and ejecting component comprises a pipetting motor fixing plate, a pipetting screw motor, and a pipetting guide rail Slider assembly, small slide plate, syringe push plate, pipette motor nut, multiple puncture needles, syringe fixing plate, multiple pipette syringes, and optocoupler sensors; the pipette motor fixing plate is fixed horizontally and vertically On the front side of the large sliding plate, the pipetting screw motor is mounted on the pipetting motor fixing plate, and the screw of the pipetting screw motor passes vertically through the pipetting motor fixing plate and is arranged downward; The two guide rails of the pipetting and ejection guide rail slider assembly are fixed to the front of the large sliding plate below the pipetting motor fixing plate by screws at a vertical interval, and the back of the small sliding plate and the pipetting and sliding guide rail slider assembly The slider is connected, the syringe push plate is fixed on the top of the small slide plate, the pipette motor screw cap is installed on the syringe push plate and cooperates with the screw of the pipette screw motor; Multiple The puncture needles are fixed on the bottom surface of the small sliding plate at vertical intervals; the syringe fixing plate is located below the pipetting motor fixing plate, and is connected to the pipetting motor fixing plate via two columns; multiple pipetting syringes Vertically mounted on the top surface of the syringe fixing plate, the front edge of the syringe push plate is provided with a plurality of adapter slots at the tail of multiple pipette syringes; the optocoupler sensor is connected to the Front of the large sliding plate on the fixed plate side of the pipetting motor.
The fully automatic magnetic bead time-resolved fluorescence immunoassay analyzer according to claim 6, wherein the ejection needle assembly comprises a plurality of ejection columns, a plurality of ejection plates, an ejection stepper motor, and an ejection timing belt Assembly and ejection guide rail slider assembly; wherein, on the syringe fixing plate behind each pipette, two ejection posts are installed via corresponding linear bearings, and a spring is set on the upper half of each ejection post, The lower end of these two needle ejection columns is connected to a needle ejection plate, and the front end of the needle ejection plate is provided with a notch adapted to eject the needle of the pipette syringe head; the needle ejection stepper motor is directed laterally through a corresponding fixing member It is internally connected to one side of the small sliding plate, and the output shaft of the stepped-back stepper motor is connected to one of the timing belt pulleys of the stepped-back timing belt assembly through the corresponding bearing, and the other of the stepped-back timing belt assembly The timing belt pulley is connected to the other side of the small sliding plate via a corresponding bearing and a connecting shaft; the guide rail in the needle ejection guide rail slider assembly is laterally fixed on the lower side of the small sliding plate by screws. End, the slider in the ejection head guide slider assembly is connected to the timing belt in the ejection head timing belt assembly via a corresponding connecting piece, and the timing belt is set on two timing belt wheels in the ejection head timing belt assembly on.
The fully automatic magnetic bead time-resolved fluorescence immunoassay analyzer according to claim 1, characterized in that the dark room door device comprises a dark room door, two dark room door guide rail slider assemblies, and a dark room door power mechanism; a back side of the dark room door Grooves and slider connection holes adapted to be embedded in two darkroom door rail slider assemblies are respectively provided, and the darkroom door is connected to the sliders in the darkroom door rail slider assembly through screws through the slider connection holes, The guide rail in the darkroom door rail slider assembly is vertically fixed to the front of the rack by screws; one side of the darkroom door is connected to the darkroom door power mechanism via a corresponding darkroom door connector; the darkroom door power mechanism is by the darkroom door The stepper motor, the aforementioned darkroom door connector, the darkroom door timing belt assembly, and the darkroom door power mechanism support assembly; the timing belt in the darkroom door timing belt assembly is vertically located on one side of the darkroom door, and the aforementioned darkroom door connector passes through Screwed between the timing belt and the darkroom door; at the upper end of the timing belt, the darkroom door stepper motor passes the darkroom in the darkroom door power mechanism support assembly The door stepper motor support is fixed on the front of the frame. One of the timing belt pulleys of the darkroom door timing belt assembly is connected to the output shaft of the darkroom door stepper motor via a corresponding bearing; at the lower end of the timing belt, all The timing belt support in the dark room door power mechanism support assembly is fixed on the front of the frame, and another timing belt wheel in the dark room door timing belt assembly is connected to the timing belt support via a corresponding bearing and a connecting shaft. ; The timing belt is set on the two timing belt wheels.
The fully automatic magnetic bead time-resolved fluorescence immunoassay analyzer according to claim 1, wherein the reading module is composed of a reading X-axis power mechanism, a reading Y-axis power mechanism, a lens assembly, and a barcode device; The reading X-axis power mechanism and the reading Y-axis power mechanism are respectively used to move the lens assembly in the X-axis direction and the Y-axis direction in the horizontal plane, and the reading X-axis power mechanism is also used in the X-axis direction in the horizontal plane. The lens assembly is accompanied by a mobile barcoder; the lens assembly is used for effective luminescence data collection of reagent tubes that need to be read on multiple reagent strips placed in the tray module, and the barcoder is fixed by corresponding fixing parts On the reading Y-axis power mechanism, it is used to read the barcode information on multiple reagent bars;

The read-out X-axis power mechanism includes a read-out X-axis stepping motor, a read-out X-axis synchronous wheel assembly, a read-out X-axis guide slider assembly, and a read-out X-axis fixing plate. Two columns are erected on the bottom plate of the rack; the X-axis stepping motor is installed at one end of the reading X-axis fixing plate in the Y-axis direction through corresponding fixing members, and the output shaft of the X-axis stepping motor is passed through the corresponding The bearing is connected to one of the timing pulleys of the reading X-axis timing wheel assembly, and the other timing pulley of the reading X-axis timing wheel assembly is fixed to the reading X-axis via the corresponding bearing, connecting shaft and fixing member. The other end of the plate; the guide rail in the read-out X-axis guide rail slider assembly is fixed on the read-out X-axis fixing plate between the two synchronous pulleys along the X-axis direction by screws, and the read-out Y-axis power mechanism The bottom surface of one end of the reading Y-axis fixing plate is connected to the slider in the reading X-axis guide rail slider assembly, and the top surface of one end of the reading Y-axis fixing plate is synchronized with the reading X-axis via a corresponding connector. The timing belts in the wheel assembly are connected;

The read Y axis power mechanism includes a read Y axis stepper motor, a read Y axis synchronous wheel assembly, a read Y axis guide slider assembly, the aforementioned read Y axis fixing plate, a read Y axis roller, and a read value. Y-axis support plate; wherein the read Y-axis support plate is also erected on the bottom plate of the rack via two columns, and the read Y-axis roller is installed at the other end of the read Y-axis fixed plate; the Y-axis The stepping motor is mounted on the roller end of the reading Y-axis fixing plate along the X-axis direction through the corresponding fixing member, and the output shaft of the Y-axis stepping motor is connected to a timing belt in the reading Y-axis synchronous wheel assembly through the corresponding bearing. Wheel-to-wheel connection, the other synchronous belt pulley of the reading Y-axis synchronous wheel assembly is fixed at the other end of the reading Y-axis fixing plate via corresponding bearings, connecting shafts and fixings; the reading Y-axis guide slider The guide rail in the module is fixed on the reading Y-axis fixing plate between the two synchronous belt pulleys along the Y-axis direction by a screw. The lens assembly is connected to the slider in the reading Y-axis guide slider assembly, and the The lens assembly is connected to the timing belt in the reading Y-axis synchronization wheel assembly.