CN117647642A - Chemiluminescent immunoassay system and method - Google Patents

Abstract

The invention discloses a chemiluminescent immunoassay system and an analytical method. The detection tube piece with a simple structure is used as a bearing container, and the magnetic control module and the liquid driving mechanism are combined to complete multi-step magnetic particle chemiluminescence immune reaction in the detection tube piece which is low in cost and easy to manufacture, and the detection process is completed by the detection dark bin mechanism. Compared with a complex chamber structure test card, a test groove or a microfluidic chip in the prior art, the chemiluminescent immunoassay system provided by the embodiment of the invention obviously reduces the manufacturing difficulty and cost of an analyzer, solves the problems such as flow channel blockage or bubble interference and the like, and improves the detection reliability.

Description

Chemiluminescent immunoassay system and method

Technical Field

The invention relates to the technical field of medical examination, in particular to a chemiluminescent immunoassay system and an analytical method.

Background

The chemiluminescence immunoassay analyzer is based on autonomous luminescence, an excitation light source is not needed to be additionally arranged, and the background light signal is small and high in sensitivity. The biological modified magnetic particles are used as carriers for specifically capturing the markers to be detected and carrying out luminous reaction, so that the biological modified magnetic particles are convenient to control, have large specific surface area, and have the advantages of good mixing effect, high reaction speed and the like. Magnetic particles as a flexible solid phase carrier have been widely used in the field of biochemical detection. Compared with the immobilization on the wall surface, the magnetic particle immobilization can provide a large specific surface area, and the contact opportunity with a target to be detected can be improved through stirring, vibration and other modes, so that higher target capturing efficiency and higher detection sensitivity are obtained. However, chemiluminescent immunoassay based on magnetic particle immobilization requires precise control of multiple liquid phase sequential release and actuation, and control of multiple aggregation and redispersion of magnetic particles, which has high requirements for both the detection support container and the actuation control mechanism.

The existing chemiluminescence immunoassay technology is often required to be carried out in a test card and a microfluidic chip with complex cavity structures or to be frequently switched among the detection cup arrays based on complex mechanical arm structures, so that the manufacturing cost of consumable materials is high, the required operating mechanism is complex, and the large-scale popularization of the consumable materials is limited. For example, in the CN114814261a patent, the disc-type detecting chip includes five layers of a sample processing layer, a reagent processing layer, an upper cover plate, a lower cover plate and an intermediate layer, where the sample processing layer and the reagent processing layer further include a chamber structure such as a reagent tank and a reaction tank, and a microfluidic channel, and the chip parts require high requirements for manufacturing and assembling and sealing, and it is noted that the solution is easy to block or generate bubbles due to abrupt change of structural flow resistance when the complex chamber and the microfluidic channel move. As another example, in patent CN111157753B, a plurality of structures such as a gripper device, a puncture re-melting device, an incubation turntable and the like are arranged in the instrument, and the operations of filling and removing samples and reagents require two-way control of suction and pumping, so that the operation flow is complex. In the prior art, the complex structure detection bearing container is used as a disposable consumable, or a complex operation flow based on suction and pumping bidirectional control is carried out by a complex driving mechanism such as a mechanical arm, so that the cost is difficult to be reduced.

Disclosure of Invention

The present invention aims to solve at least one of the technical problems existing in the prior art. Therefore, the invention provides a chemiluminescent immunoassay system which solves the problem of the lack of a chemiluminescent immunoassay analyzer with simple and convenient structure and operation flow.

The invention also provides a chemiluminescent immunoassay method.

A chemiluminescent immunoassay system according to an embodiment of the first aspect of the present invention comprises:

a bottom plate;

the sample injection mechanism is arranged on the bottom plate and used for transferring the kit to a preset sample injection position, the kit is provided with a plurality of cavities, and each cavity is filled with different types of solutions;

the detection dark bin mechanism is arranged on the bottom plate and used for detecting chemiluminescence immune reaction;

the detection tube sheet is arranged in the detection dark bin mechanism and is used as a bearing container for the chemiluminescent immunoreaction;

the magnetic control module is arranged on the bottom plate and used for controlling magnetic particles in the liquid phase in the detection segment;

the liquid driving mechanism is arranged on the bottom plate and is used for sucking different types of solutions in the kit into the detection tube piece;

the control module is arranged on the bottom plate and is respectively and electrically connected with the sample injection mechanism, the magnetic control module and the liquid driving mechanism.

The chemiluminescent immunoassay system according to the embodiment of the invention has at least the following beneficial effects:

the detection tube piece with a simple structure is used as a bearing container, and the magnetic control module and the liquid driving mechanism are combined to complete multi-step magnetic particle chemiluminescence immune reaction in the detection tube piece which is low in cost and easy to manufacture, and the detection process is completed by the detection dark bin mechanism. Compared with a complex chamber structure test card, a test groove or a microfluidic chip in the prior art, the chemiluminescent immunoassay system provided by the embodiment of the invention obviously reduces the manufacturing difficulty and cost of an analyzer, solves the problems such as flow channel blockage or bubble interference and the like, and improves the detection reliability.

According to some embodiments of the invention, the sample injection mechanism comprises:

the sample injection bin gate is vertically arranged on one side of the bottom plate;

the sliding block is arranged on the bottom plate in a sliding manner, and one end of the sliding block is connected with the bottom of the inner side of the sample injection bin gate;

the transfer groove positioning sliding table is arranged on the sliding block and used for horizontally or vertically moving;

the transfer groove is arranged on the transfer groove positioning sliding table and used for placing the kit;

the needle tube fixing bracket is arranged on the bottom plate;

And the tube bodies of the sample injection needle tubes are fixed on the needle tube fixing bracket, and each sample injection needle tube is used for respectively transmitting different types of solutions in each cavity to the detection tube piece.

According to some embodiments of the invention, the detecting dark-bin mechanism comprises:

the optical detector positioning sliding table is arranged on the bottom plate and positioned at one side of the sliding block and used for horizontally moving;

the adapter plate is arranged on the optical detector positioning sliding table;

the optical detector is arranged on the adapter plate and is used for detecting optical signals generated by the chemiluminescent immune reaction and converting the optical signals into electric signals;

the optical detector adapting piece is arranged on the optical detector and is used for reducing interference of an ambient light signal on the optical detector;

and the bin body shell is sleeved on the optical detector positioning sliding table, the adapter plate, the optical detector and the optical detector adapter for forming a light-shielding cavity.

According to some embodiments of the invention, the light detector adapter comprises:

an adapter body disposed on the photodetector;

the optical filter is arranged on the adapter main body and is used for filtering interference light signals;

And the diaphragm is arranged on the optical filter and used for limiting the optical detector to receive the interference optical signal by adjusting the aperture.

According to some embodiments of the invention, the test tube sheet comprises:

the sheet body is arranged on the optical detector adapting piece;

the capillary channels are arranged in the sheet body in parallel;

one end of each first conical tube is connected with one end of each capillary channel, and the other end of each first conical tube is connected with each sample injection needle tube;

and one end of each second conical tube is connected with the other end of each capillary channel respectively, and the other end of each second conical tube is connected with the liquid driving mechanism respectively.

According to some embodiments of the invention, the magnetic control module comprises:

the substrate is arranged on the bottom plate and positioned between the sliding block and the optical detector positioning sliding table;

the motor is arranged on the substrate, and the shaft body of the motor faces upwards;

one end of the motor push rod is connected with the shaft body of the motor;

the magnetic support is connected with the other end of the motor push rod, the magnetic support is a frame body, a plurality of columnar magnetic cores are embedded into the inner side of an upper beam and the inner side of a lower beam of the frame body to form a magnetic array, and a plurality of first conical pipes penetrate through the frame body;

And one end of each guide sliding column is connected with the substrate, and the other end of each guide sliding column sequentially passes through the lower beam and the upper beam of the frame body.

According to some embodiments of the invention, the liquid drive mechanism comprises:

the displacement sliding table is arranged on the bottom plate;

the injector bracket is arranged on the displacement sliding table in a sliding way;

the injectors are arranged on the injector brackets in parallel, each injector comprises an injector tube body and an injector push rod, one end of each injector push rod is connected with the injector bracket respectively, and the other end of each injector push rod is arranged in each injector tube body respectively;

the capillary joint bracket is arranged at one end of the displacement sliding table;

the capillary joints are arranged on the capillary joint support in parallel, one end of each capillary joint is connected with an injection port of each syringe tube body, and the other end of each capillary joint is connected with the other end of each second taper tube.

According to some embodiments of the invention, the chemiluminescent immunoassay system further comprises a protective bin cover disposed on the base plate, the protective bin cover for protecting the liquid drive mechanism and the control module.

According to a second aspect of the present invention, a chemiluminescent immunoassay method is provided for use in a chemiluminescent immunoassay system according to any one of the first aspect of the present invention, comprising the steps of:

starting the chemiluminescent immunoassay system to complete system initialization;

placing a kit in a sample injection mechanism and starting the sample injection mechanism so that the kit is transported to a preset sample injection position, wherein the kit is provided with a plurality of cavities, and each cavity is filled with a different type of solution;

starting the liquid driving mechanism to enable the detecting tube piece to alternately absorb different types of solutions and air;

starting the magnetic control module to enable chemiluminescent immunoreaction to be carried out in the detection tube piece;

and starting a dark bin detection mechanism to collect the light signals generated by each luminous liquid column section after the chemiluminescent immunoreaction, and analyzing and displaying the light signals.

The chemiluminescent immunoassay method according to the embodiment of the invention has at least the following beneficial effects:

by applying the chemiluminescent immunoassay method of the embodiment of the invention, the method does not need to adopt complex driving mechanisms such as a mechanical arm and the like to carry out complex operation flow based on suction and pumping bidirectional control, and can complete detection by only carrying out unidirectional suction operation (only suction is needed and pumping operation is not needed) by the liquid driving device, so that the problem of suitability between a detection bearing container and a liquid column type magnetic particle chemiluminescent immunoassay flow is solved, and capturing, eluting, marking and chemiluminescent quantitative process of a target to be detected can be completed by only relying on unidirectional suction operation in a detection segment with a simple structure, thereby realizing low-cost and simple chemiluminescent immunoassay, being beneficial to simplifying an executing mechanism and operation steps and saving cost and time.

According to some embodiments of the invention, each of the chambers is filled with a different type of solution comprising: the kit comprises magnetic particle liquid, sample antigen liquid, first cleaning liquid, enzyme-labeled antibody liquid, second cleaning liquid and chemiluminescent substrate liquid.

Additional features and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention.

Drawings

The foregoing and/or additional aspects and advantages of the invention will become apparent and may be better understood from the following description of embodiments taken in conjunction with the accompanying drawings in which:

FIG. 1a is a schematic diagram of a chemiluminescent immunoassay system according to an embodiment of the present invention at a viewing angle A;

FIG. 1B is a schematic diagram of a chemiluminescent immunoassay system according to an embodiment of the present invention at a B viewing angle;

FIG. 2 is a schematic diagram of a sample injection mechanism according to an embodiment of the present invention;

FIG. 3 is a schematic diagram of the structure of the detecting dark room mechanism, the detecting segment and the magnetic control module according to one embodiment of the invention;

FIG. 4 is a schematic structural view of a photodetector adapter according to an embodiment of the invention;

FIG. 5 is a schematic view of the liquid drive mechanism of one embodiment of the present invention;

FIG. 6 is a flow chart of a chemiluminescent immunoassay method of an embodiment of the present invention;

FIG. 7 is a schematic diagram of chemiluminescent immunoreaction detection in accordance with one embodiment of the present invention.

Reference numerals:

a base plate 100;

a sample injection mechanism 200; a sample inlet bin gate 210; a slider 220; a transfer slot positioning slide 230; a transfer tank 240; a needle tube fixing holder 250; a sample injection needle tube 260; a kit 270;

detecting a dark room mechanism 300; a light detector positioning slipway 310; an adapter plate 320; a photodetector 330; a photodetector adapter 340; an adapter body 341; a filter 342; a diaphragm 343;

detecting the segment 400; a sheet 410; capillary channel 420; a first cone-shaped tube 430; a second cone 440;

a magnetic control module 500; a substrate 510; a motor 520; a motor push rod 530; a magnetic sub-mount 540; a magnetic subarray 550; a slide guide 560;

a liquid driving mechanism 600; a displacement slide 610; a syringe holder 620; a syringe 630; capillary joint holder 640; capillary fitting 650;

a control module 700;

a protective bin cover 800;

magnetic particle liquid 910; sample antigen liquid 920; a first cleaning fluid 930; enzyme-labeled antibody liquid 940; a second cleaning liquid 950; chemiluminescent substrate solution 960.

Detailed Description

Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to like or similar elements or elements having like or similar functions throughout. The embodiments described below by referring to the drawings are illustrative only and are not to be construed as limiting the invention.

In the description of the present invention, the description of first, second, etc. is for the purpose of distinguishing between technical features only and should not be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated or implicitly indicating the precedence of the technical features indicated.

In the description of the present invention, it should be understood that the direction or positional relationship indicated with respect to the description of the orientation, such as up, down, etc., is based on the direction or positional relationship shown in the drawings, is merely for convenience of describing the present invention and simplifying the description, and does not indicate or imply that the apparatus or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present invention.

In the description of the present invention, unless explicitly defined otherwise, terms such as arrangement, installation, connection, etc. should be construed broadly and the specific meaning of the terms in the present invention can be determined reasonably by a person skilled in the art in combination with the specific content of the technical solution.

The following description of the embodiments of the present invention will be made with reference to the accompanying drawings, in which it is apparent that the embodiments described below are some, but not all embodiments of the invention.

Referring to fig. 1a and 1b, a schematic structural diagram of a chemiluminescent immunoassay system according to an embodiment of the present invention is shown, the system comprises: the device comprises a bottom plate 100, a sample injection mechanism 200, a dark bin detection mechanism 300, a detection duct piece 400, a magnetic control module 500, a liquid driving mechanism 600 and a control module 700. The sample injection mechanism 200 is disposed on the bottom plate 100, and is used for transferring the kit 270 to a predetermined sample injection position, wherein the kit 270 has a plurality of cavities, and each cavity is filled with a different type of solution; the detection dark room mechanism 300 is arranged on the bottom plate 100 and is used for detecting chemiluminescence immune reaction; the detecting segment 400 is arranged in the detecting dark room mechanism 300 and is used as a bearing container for chemiluminescent immunoreaction; the magnetic control module 500 is disposed on the bottom plate 100 and is used for controlling and detecting magnetic particles in the liquid phase in the tube sheet 400; the liquid driving mechanism 600 is disposed on the bottom plate 100, and is used for sucking different types of solutions in the reagent kit 270 into the detecting tube piece 400; the control module 700 is disposed on the bottom plate 100 and electrically connected to the sample feeding mechanism 200, the magnetic control module 500, and the liquid driving mechanism 600, respectively.

Specifically, as shown in fig. 1a and 1b, it can be understood that the bottom plate 100 is a rectangular long plate, and a sample feeding mechanism 200 is disposed on one side of an end of the bottom plate 100, and the sample feeding mechanism 200 can electrically transport the reagent kit 270 outside the device to a predetermined sample feeding position; the detection dark bin mechanism 300 is arranged next to the sample injection mechanism 200, meanwhile, the detection tube piece 400 is arranged in the detection dark bin mechanism 300, and the detection tube piece 400 can absorb the solution in the kit 270 from the sample injection position to perform chemiluminescent immunoreaction.

Specifically, the chemiluminescent immune reaction is realized through a magnetic control module 500 and a liquid driving mechanism 600, wherein the magnetic control module 500 is arranged between the sample injection mechanism 200 and the detection dark bin mechanism 300, and magnetic particles in a liquid phase in the detection segment 400 are controlled to oscillate back and forth between the tube walls or are enriched in the tube walls; the liquid driving mechanism 600 is arranged beside the detection dark room mechanism 300 and connected with the detection tube piece 400, and can drive the sucking action so that the detection tube piece 400 can suck the solution in the reagent kit 270, the liquid driving mechanism 600 sucks the liquid phase matched with the magnetic control module 500 to enrich or release magnetic particles, and the magnetic particles can be transferred between different reagents, so that the magnetic particles can be mixed and separated with a sample or the reagents, and immune reaction and chemiluminescence reaction can be sequentially generated; after the chemiluminescent reaction is initiated, the detection dark-box mechanism 300 will detect, thereby realizing the chemiluminescent immunoassay function of the system. A control module 700 is also arranged next to the detection dark room mechanism 300, and the control module 700 is used for executing actions of the electric control sample injection mechanism 200, the magnetic control module 500 and the liquid driving mechanism 600.

In this embodiment, by using the detecting segment 400 with a simple structure as a carrying container and combining the magnetic control module 500 and the liquid driving mechanism 600, the multi-step magnetic particle chemiluminescent immunoreaction can be completed in the detecting segment 400 which is cheap and easy to manufacture, and the detecting process can be completed by using the detecting dark bin mechanism 300. Compared with a complex chamber structure test card, a test groove or a microfluidic chip in the prior art, the chemiluminescent immunoassay system provided by the embodiment of the invention obviously reduces the manufacturing difficulty and cost of an analyzer, solves the problems such as flow channel blockage or bubble interference and the like, and improves the detection reliability.

In some embodiments, as shown in fig. 2, the sample injection mechanism 200 includes: sample introduction bin gate 210, slider 220, transfer slot positioning sliding table 230, transfer slot 240, needle tube fixing support 250, and a plurality of sample introduction needle tubes 260. The sample inlet bin gate 210 is vertically arranged on one side of the bottom plate 100; the sliding block 220 is slidably disposed on the bottom plate 100, and one end of the sliding block 220 is connected to the bottom of the inner side of the sample inlet bin gate 210; the transfer slot positioning sliding table 230 is arranged on the sliding block 220 and is used for horizontal or vertical movement; the transfer slot 240 is disposed on the transfer slot positioning sliding table 230, and is used for placing a reagent kit 270; the needle tube fixing bracket 250 is disposed on the base plate 100; the tube body of each sample injection needle tube 260 is fixed on the needle tube fixing support 250, and each sample injection needle tube 260 is used for respectively transmitting different types of solutions in each cavity to the detecting tube piece 400.

Specifically, referring to FIG. 2, it will be appreciated that the sample gate 210 is shown as being vertically disposed on the side of the base plate 100, and will be directed to the channel through the entire housing of the system for loading the cartridge 270 into the instrument; the sliding block 220 can slide on the bottom plate 100, and the bottom structural member at the inner side of the sample introduction bin gate 210 is fixed on the front end of the sliding block 220 through a screw, so that the sliding block 220 can slide out or slide in horizontally along with the opening or closing of the sample introduction bin gate 210; in some embodiments, a pull ring is provided on the outside of the sample introduction door 210, and the closing and opening operations of the door can be completed by pushing and pulling the pull ring.

Further, the rear end of the sliding block 220 is provided with a transfer slot positioning sliding table 230, the transfer slot positioning sliding table 230 is formed by orthogonally combining a horizontal electric sliding table and a vertical electric sliding table, so as to realize horizontal or vertical movement on the sliding block 220, it is understood that the electric sliding table can be composed of a sliding table body and a motor 520, the motor 520 is electrically connected with the control module 700, and the sliding table can be driven to execute movement under the electric control of the control module 700. The transfer slot positioning sliding table 230 is provided with a transfer slot 240 for placing the reagent kit 270, and the transfer slot 240 can simultaneously load a plurality of reagent kits 270 with multiple chambers and accurately move the reagent kits to a preset sample feeding position.

Further, a plurality of sample injection syringes 260 are placed in a row above the transfer slot 240, and in some embodiments, the sample injection syringes 260 are hard syringes made of stainless steel; the needle tip of the sample injection needle tube 260 is suspended on the needle tube fixing bracket 250 arranged on the bottom plate 100, namely, the tube body of the sample injection needle tube 260 is fixed by the needle tube fixing bracket 250, and the other end of the sample injection tube needle is connected with the detecting tube piece 400.

In this embodiment, by completely closing the sample introduction bin gate 210, the row of reagent strips can be pushed to the sample introduction position, and the transfer slot positioning sliding table 230 is controlled to lift the reagent kit 270 to the needle tip of the sample introduction needle tube 260, so that the sealing film of the reagent kit 270 is pierced by the needle tip, so that the subsequent liquid suction operation can be performed.

In some embodiments, as shown in fig. 3, detecting the dark-bin mechanism 300 includes: the optical detector comprises an optical detector positioning sliding table 310, an adapter plate 320, an optical detector 330, an optical detector adapter 340 and a bin body shell. The light detector positioning sliding table 310 is arranged on the bottom plate 100 and is positioned at one side of the sliding block 220 for horizontal movement; the adapter plate 320 is arranged on the optical detector positioning sliding table 310; the photodetector 330 is disposed on the adapter plate 320, and is configured to detect an optical signal generated by the chemiluminescent immune reaction and convert the optical signal into an electrical signal; the photodetector adapter 340 is disposed on the photodetector 330, for reducing interference of the ambient light signal to the photodetector 330; the housing is covered on the optical detector positioning sliding table 310, the adapter plate 320, the optical detector 330 and the optical detector adapter 340, and is used for forming a light-shielding chamber.

Specifically, referring to FIG. 3, it will be appreciated that the detection dark-compartment mechanism 300 includes a light-shielded chamber and its internal mechanisms for performing chemiluminescent immunoreactions detection, as illustrated in the figures. The optical detector positioning sliding table 310 is an electric sliding table capable of performing precise horizontal movement and is arranged on the bottom plate 100; the photodetector positioning sliding table 310 is provided with a high-sensitivity photodetector 330 through an adapter plate 320, and the photodetector 330 is used for detecting the luminous intensity of an optical signal generated by chemiluminescent immunoreaction and converting the luminous intensity into an electric signal; the photodetector 330 is connected with a photodetector adapter 340, and the photodetector adapter 340 is used for reducing the interference of the ambient light signals; referring to fig. 1a and 1b in combination, the above-described parts are enclosed by a cartridge body housing.

In some embodiments, as shown in fig. 4, the photodetector adapter 340 comprises: an adapter body 341, a filter 342, a diaphragm 343. The adapter body 341 is disposed on the light detector 330; the optical filter 342 is disposed on the adapter main body 341 and is used for filtering out the interference light signal; a diaphragm 343 is disposed on the filter 342 for limiting the light detector 330 from receiving the interfering light signal by adjusting the aperture.

Specifically, referring to fig. 4, it can be understood that an optical filter 342 and a diaphragm 343 are sequentially provided on the adapter body 341. Optionally, the filter 342 employs a narrow band pass filter 342 that is transparent to only light near the peak wavelength of the chemiluminescent signal to be detected; the aperture of the diaphragm 343 is adjustable to limit the light detector 330 from receiving interfering light outside the local range of the luminescent liquid column segment.

In some embodiments, as shown in fig. 3, the test strip 400 includes: a sheet 410, a plurality of capillary channels 420, a plurality of first tapered tubes 430, a plurality of second tapered tubes 440. The sheet 410 is disposed on the photodetector adapter 340; the plurality of capillary channels 420 are disposed in parallel with each other in the sheet 410; one end of each first taper pipe 430 is connected with one end of each capillary channel 420, and the other end of each first taper pipe 430 is connected with each sample injection needle tube 260; one end of each second cone 440 is connected to the other end of each capillary channel 420, and the other end of each second cone 440 is connected to the liquid driving mechanism 600.

Specifically, referring to fig. 3, it can be understood that, as illustrated in the drawing, the detecting segment 400 is a carrying container for chemiluminescent immunoreactions, and the middle section of the detecting segment 400 is located directly above the photodetector adapter 340 in the detecting dark space structure; the two ends of the detecting tube piece 400 pass through the through holes of the detecting dark bin mechanism 300 and are fixed on the bin body shell.

Further, the sheet body 410 of the detecting tube sheet 400 encapsulates the plurality of capillary channels 420 into a sheet shape at equal intervals, and two ends of the capillary channels 420 are respectively connected with the plurality of first taper tubes 430 and the plurality of second taper tubes. In some embodiments, the number of capillary channels 420 may be adjusted according to the detection flux requirements; optionally, the detecting segment 400 is made of a material with higher transparency, so as to facilitate observation of the liquid column state and luminescence detection; the cross-sectional shape of the capillary channel 420 may be circular, or may be other shapes, preferably circular.

In some embodiments, as shown in fig. 3, the magnetic control module 500 includes: a substrate 510, a motor 520, a motor pushrod 530, a magnetic sub-mount 540, a plurality of slide guides 560. The substrate 510 is arranged on the bottom plate 100 and is positioned between the slider 220 and the optical detector positioning sliding table 310; the motor 520 is disposed on the substrate 510 with the shaft of the motor 520 facing upward; one end of the motor push rod 530 is connected with the shaft body of the motor 520; the magnetic support 540 is connected with the other end of the motor push rod 530, the magnetic support 540 is a frame body, a plurality of columnar magnetic cores are embedded in the inner side of an upper beam and the inner side of a lower beam of the frame body to form a magnetic array 550, and a plurality of first cone-shaped pipes 430 penetrate through the frame body; one end of each guide strut 560 is connected to the base plate 510, and the other end of each guide strut 560 passes through the lower and upper beams of the frame in turn.

Specifically, referring to fig. 3, it can be appreciated that the magnetic control module 500 is illustrated as a device for controlling magnetic particles in a liquid phase in the detection segment 400 in a chemiluminescent immunoassay procedure. The substrate 510 is fixed on the base plate 100, and the motor 520, the motor push rod 530 and the slide guide 560 are vertically fixed on the substrate 510; the motor push rod 530 is fixedly connected with the magnetic sub-support 540, and the upper beam and the lower beam of the magnetic sub-support 540 are vertically embedded with a symmetrical magnetic sub-array 550 consisting of a plurality of columnar magnetic sub-assemblies; the needle tip of the detector tile 400 passes through the magnetic sub-mount 540 and is placed in a vertically centered position. In this embodiment, when the motor 520 is started, the magnetic subarray 550 on the magnetic sub-support 540 may be controlled to vertically approach or separate from the liquid column segment in the detection segment 400, so as to control the enrichment and release of the magnetic particles in the liquid column segment.

In some embodiments, as shown in fig. 5, the liquid drive mechanism 600 includes: displacement slide 610, syringe holder 620, plurality of syringes 630, capillary fitting holder 640, plurality of capillary fittings 650. The displacement sliding table 610 is arranged on the bottom plate 100; the syringe support 620 is slidably disposed on the displacement sliding table 610; the plurality of syringes 630 are arranged on the syringe bracket 620 in parallel, each syringe 630 comprises a syringe 630 tube body and a syringe 630 push rod, one end of each syringe 630 push rod is respectively connected with the syringe bracket 620, and the other end of each syringe 630 push rod is respectively arranged in each syringe 630 tube body; the capillary joint support 640 is arranged at one end of the displacement sliding table 610; the capillary joints 650 are disposed on the capillary joint holders 640 in parallel with each other, one end of each capillary joint 650 is connected to an injection port of the body of each syringe 630, and the other end of each capillary joint 650 is connected to the other end of each second taper pipe 440.

Specifically, referring to fig. 5, it can be understood that, by taking the illustration as an example, the liquid driving mechanism 600 is a power mechanism for sample feeding and pipetting in the system, and is used for sequentially sucking the component reagents in the reagent kit 270 into the detecting segment 400, and completing operations such as enrichment, separation, redispersion and the like of the magnetic particles in the liquid column segment of the detecting segment 400 in cooperation with the magnetic control module 500. The electric displacement sliding table 610 capable of being controlled by a program is fixed on the bottom plate 100, the displacement sliding table 610 is provided with a syringe bracket 620, the syringe bracket 620 is in threaded connection with a plurality of microinjectors 630 arranged in a row through a push rod, the tail end of each microinjector 630 is connected with a capillary joint 650, the capillary joint 650 is embedded and fixed on the capillary joint bracket 640, and the capillary joint bracket 640 is arranged at the tail end of the displacement sliding table 610. In this embodiment, the liquid driving mechanism 600 connects the plurality of syringes 630 with the detecting segment 400 via the plurality of capillary joints 650, thereby performing the driving operation of the liquid column segment.

In some embodiments, as shown in fig. 1a and 1b, the chemiluminescent immunoassay system further comprises a protective housing cover 800, the protective housing cover 800 being disposed on the base plate 100, the protective housing cover 800 being configured to protect the liquid drive mechanism 600 and the control module 700.

In particular, referring to fig. 1a and 1b, it can be appreciated that the protective cartridge cover 800 overlies the protective liquid drive mechanism 600 and the control module 700 for protecting the structure of the liquid drive mechanism 600, as well as the circuitry of the control module 700.

In addition, as shown in fig. 6, the embodiment of the invention further provides a chemiluminescent immunoassay method, which is applied to the chemiluminescent immunoassay system of the embodiment of the invention, and comprises the following steps:

starting a chemiluminescent immunoassay system to complete system initialization;

placing the kit 270 in the sampling mechanism 200 and activating the sampling mechanism 200 such that the kit 270 is transported to a predetermined sampling location, the kit 270 having a plurality of cavities, each cavity being filled with a different type of solution;

activating the liquid driving mechanism 600 to enable the detecting tube segment 400 to alternately suck different types of solutions and air;

activating the magnetic control module 500 to make chemiluminescent immunoreaction in the test tube piece 400;

the dark room detection mechanism 300 is started to collect the light signals generated by the luminous liquid column sections after the chemiluminescent immune reaction and analyze and display the light signals.

Specifically, referring to fig. 6, it can be understood that the chemiluminescent immunoassay system according to the embodiment of the present application is used to execute the chemiluminescent immunoassay method according to the embodiment of the present invention, the chemiluminescent immunoassay method according to the embodiment of the present application corresponds to the chemiluminescent immunoassay system described above, and the specific processing procedure is referred to the chemiluminescent immunoassay system described above and is not repeated herein.

In this embodiment, by applying the chemiluminescent immunoassay method of the embodiment of the present invention, the method does not need to adopt a complex driving mechanism such as a mechanical arm to perform a complex operation flow based on suction and pumping bidirectional control, and only performs unidirectional suction operation (only suction is needed without pumping operation) by means of the liquid driving device to complete detection, thereby solving the problem of suitability between the detection bearing container and the liquid column type magnetic particle chemiluminescent immunoassay flow, and capturing, eluting, marking and chemiluminescent quantification processes of a target to be detected can be completed in the detection segment 400 with a simple structure by only relying on unidirectional suction operation, so as to realize low-cost and simple chemiluminescent immunoassay, facilitate simplifying execution mechanisms and operation steps, and save cost and time.

In some embodiments, the different types of solutions that each cavity fills include: magnetic particle solution 910, sample antigen solution 920, first washing solution 930, enzyme-labeled antibody solution 940, second washing solution 950, and chemiluminescent substrate solution 960.

Specifically, referring to fig. 7, it should be noted that, when the solution filled in each cavity of the kit 270 is sequentially the magnetic particle solution 910, the sample antigen solution 920, the first cleaning solution 930, the enzyme-labeled antibody solution 940, the second cleaning solution 950, and the chemiluminescent substrate solution 960, under the action of the sample injection system and the liquid driving mechanism 600, the liquid column sections of the magnetic particle solution 910, the sample antigen solution 920, the first cleaning solution 930, the enzyme-labeled antibody solution 940, the second cleaning solution 950, and the chemiluminescent substrate solution 960 respectively reach the position of the magnetic subarray 550, under the action of magnetic attraction, the magnetic particles are anchored and the solution portion continuously moves along the capillary, so as to realize that the magnetic particle solution 910 sequentially contacts with the sample antigen solution 920, the first cleaning solution 930, the enzyme-labeled antibody, the second cleaning solution 950, and the chemiluminescent substrate, to complete sandwich immunization and chemiluminescent reaction, and finally the liquid driving mechanism continuously absorbs each liquid column section forwards until the final luminescent liquid column section reaches the position of the photodetector 330 in the dark detection bin structure at time t6, thereby starting the detector to obtain a light intensity proportional to the quantitative detection of the antigen concentration of the sample.

In order to better illustrate the chemiluminescent immunoassay method according to the present invention, based on the complete structure of the chemiluminescent immunoassay system according to the present invention, the following provides a preferred embodiment of the method according to the present invention, which comprises the following steps:

(1) Starting an instrument and initializing a system;

(2) Unsealing the sealing film of the sample position of the kit 270, and filling different types of sample solutions to be tested into each cavity;

(3) Opening the sample introduction bin gate 210, placing the reagent kit 270 into the transfer slot 240, and pushing the transfer slot 240 to the vicinity of the sample introduction position by the slide block 220 connected with the sample introduction bin gate 210 when the sample introduction bin gate 210 is closed;

(4) Starting a transfer groove positioning sliding table 230, transversely translating a reagent kit 270 to enable a first reagent cavity filled with magnetic particle solution to be aligned under the needle point of a sample injection needle tube 260, vertically lifting the reagent kit 270 to enable the needle point of the sample injection needle tube 260 to puncture a sealing film of the first reagent cavity, starting a liquid driving mechanism 600, and sucking the magnetic particle solution to a detection segment 400 under the action of negative pressure;

(5) Starting the transfer slot positioning sliding table 230, lowering the reagent kit 270 to separate from the sample injection needle tube 260, and then sucking an air column under negative pressure to form a partition;

(6) Repeating the steps (4) to (5), and continuously and alternately sucking the sample liquid to be detected, the first cleaning liquid 930, the enzyme-labeled antibody liquid 940, the second cleaning liquid 950, the chemiluminescent substrate liquid 960 and the air in the second to sixth reagent chambers of the reagent kit 270, so that each component enters the detection segment 400 to form an independent liquid column segment with air barrier;

(7) When the first liquid column section rich in the magnetic particle solution reaches the magnetic control module 500, the magnetic subarray 550 is started, the magnetic subarray 550 is firstly circularly and vertically oscillated to uniformly mix the antibody-coupled magnetic particles in the liquid column section, then the magnetic subarray 550 is controlled to be close to the detection tube sheet 400 and stand for a period of time to adsorb the magnetic particles on the tube wall, the liquid driving mechanism 600 is started to absorb each liquid column section to advance along the capillary pipeline 420 until the magnetic particles enriched on the tube wall are separated from the original solution and are dispersed in the newly arrived sample liquid again, the process of oscillating-enriching the magnetic particles and separating-re-dissolving the magnetic particles from the liquid column section is repeated, and the process of removing unbound antigen, binding the magnetic particle-target antigen complex with the enzyme-labeled antibody, removing unbound enzyme-labeled antibody and other double-antibody sandwich immunoreactions are completed;

(8) After the magnetic particle-target antigen-enzyme-labeled antibody complex is uniformly mixed with the chemiluminescent reagent, the double antibody sandwich immune product is enabled to excite the detection reagent to generate a detectable optical signal proportional to the concentration of the target to be detected, the magnetic particle array 550 is evacuated, and the liquid driving mechanism 600 absorbs the luminescent liquid column section to a dark bin detection position;

(9) The photodetector 330 is started and translates and sweeps each luminous liquid column segment of the dark bin detection position under the cross section of the detection segment 400, and multichannel signals are collected, analyzed and displayed.

In addition, the embodiment of the invention also provides a chemiluminescent immunoassay device, which comprises: at least one control processor and a memory for communication connection with the at least one control processor.

The memory, as a non-transitory computer readable storage medium, may be used to store non-transitory software programs as well as non-transitory computer executable programs. In addition, the memory may include high-speed random access memory, and may also include non-transitory memory, such as at least one magnetic disk storage device, flash memory device, or other non-transitory solid state storage device. In some embodiments, the memory optionally includes memory remotely located relative to the processor, the remote memory being connectable to the processor through a network. Examples of such networks include, but are not limited to, the internet, intranets, local area networks, mobile communication networks, and combinations thereof.

A non-transitory software program and instructions required to implement a chemiluminescent immunoassay method of the above embodiments are stored in a memory that, when executed by a processor, performs a chemiluminescent immunoassay method of the above embodiments, for example, the method of fig. 6 described above.

The system embodiments described above are merely illustrative, in that the units illustrated as separate components may or may not be physically separate, i.e., may be located in one place, or may be distributed over a plurality of network elements. Some or all of the units may be selected according to actual needs to achieve the purpose of the solution of this embodiment.

Furthermore, embodiments of the present invention provide a computer-readable storage medium storing computer-executable instructions that are executed by one or more control processors to cause the one or more control processors to perform a chemiluminescent immunoassay method of the method embodiment described above, e.g., to perform the method of fig. 6 described above.

Those of ordinary skill in the art will appreciate that all or some of the steps, systems, and methods disclosed above may be implemented as software, firmware, hardware, and suitable combinations thereof. Some or all of the physical components may be implemented as software executed by a processor, such as a central processing unit, digital signal processor, or microprocessor, or as hardware, or as an integrated circuit, such as an application specific integrated circuit. Such software may be distributed on computer readable media, which may include computer storage media (or non-transitory media) and communication media (or transitory media). The term computer storage media includes both volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data, as known to those skilled in the art. Computer storage media includes, but is not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital Versatile Disks (DVD) or other optical disk storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by a computer. Furthermore, as is well known to those of ordinary skill in the art, communication media typically embodies computer readable instructions, data structures, program modules or other data in a modulated data signal such as a carrier wave or other transport mechanism and includes any information delivery media.

In the description of the present specification, reference to the terms "one embodiment," "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiments or examples. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

The embodiments of the present invention have been described in detail with reference to the accompanying drawings, but the present invention is not limited to the above embodiments, and various changes can be made within the knowledge of one of ordinary skill in the art without departing from the spirit of the present invention.

Claims (10)

1. A chemiluminescent immunoassay system comprising:

a bottom plate;

the sample injection mechanism is arranged on the bottom plate and used for transferring the kit to a preset sample injection position, the kit is provided with a plurality of cavities, and each cavity is filled with different types of solutions;

The detection dark bin mechanism is arranged on the bottom plate and used for detecting chemiluminescence immune reaction;

the detection tube sheet is arranged in the detection dark bin mechanism and is used as a bearing container for the chemiluminescent immunoreaction;

the magnetic control module is arranged on the bottom plate and used for controlling magnetic particles in the liquid phase in the detection segment;

the liquid driving mechanism is arranged on the bottom plate and is used for sucking different types of solutions in the kit into the detection tube piece;

the control module is arranged on the bottom plate and is respectively and electrically connected with the sample injection mechanism, the magnetic control module and the liquid driving mechanism.

2. The chemiluminescent immunoassay system of claim 1, wherein the sample injection mechanism comprises:

the sample injection bin gate is vertically arranged on one side of the bottom plate;

the sliding block is arranged on the bottom plate in a sliding manner, and one end of the sliding block is connected with the bottom of the inner side of the sample injection bin gate;

the transfer groove positioning sliding table is arranged on the sliding block and used for horizontally or vertically moving;

the transfer groove is arranged on the transfer groove positioning sliding table and used for placing the kit;

the needle tube fixing bracket is arranged on the bottom plate;

And the tube bodies of the sample injection needle tubes are fixed on the needle tube fixing bracket, and each sample injection needle tube is used for respectively transmitting different types of solutions in each cavity to the detection tube piece.

3. The chemiluminescent immunoassay system of claim 2, wherein the detection dark-bin mechanism comprises:

the optical detector positioning sliding table is arranged on the bottom plate and positioned at one side of the sliding block and used for horizontally moving;

the adapter plate is arranged on the optical detector positioning sliding table;

the optical detector is arranged on the adapter plate and is used for detecting optical signals generated by the chemiluminescent immune reaction and converting the optical signals into electric signals;

the optical detector adapting piece is arranged on the optical detector and is used for reducing interference of an ambient light signal on the optical detector;

and the bin body shell is sleeved on the optical detector positioning sliding table, the adapter plate, the optical detector and the optical detector adapter for forming a light-shielding cavity.

4. The chemiluminescent immunoassay system of claim 3, wherein the photodetector adapter comprises:

an adapter body disposed on the photodetector;

The optical filter is arranged on the adapter main body and is used for filtering interference light signals;

and the diaphragm is arranged on the optical filter and used for limiting the optical detector to receive the interference optical signal by adjusting the aperture.

5. The chemiluminescent immunoassay system of claim 3, wherein the detector tile comprises:

the sheet body is arranged on the optical detector adapting piece;

the capillary channels are arranged in the sheet body in parallel;

one end of each first conical tube is connected with one end of each capillary channel, and the other end of each first conical tube is connected with each sample injection needle tube;

and one end of each second conical tube is connected with the other end of each capillary channel respectively, and the other end of each second conical tube is connected with the liquid driving mechanism respectively.

6. The chemiluminescent immunoassay system of claim 5, wherein the magnetic control module comprises:

the substrate is arranged on the bottom plate and positioned between the sliding block and the optical detector positioning sliding table;

the motor is arranged on the substrate, and the shaft body of the motor faces upwards;

One end of the motor push rod is connected with the shaft body of the motor;

the magnetic support is connected with the other end of the motor push rod, the magnetic support is a frame body, a plurality of columnar magnetic cores are embedded into the inner side of an upper beam and the inner side of a lower beam of the frame body to form a magnetic array, and a plurality of first conical pipes penetrate through the frame body;

and one end of each guide sliding column is connected with the substrate, and the other end of each guide sliding column sequentially passes through the lower beam and the upper beam of the frame body.

7. The chemiluminescent immunoassay system of claim 6, wherein the liquid drive mechanism comprises:

the displacement sliding table is arranged on the bottom plate;

the injector bracket is arranged on the displacement sliding table in a sliding way;

the injectors are arranged on the injector brackets in parallel, each injector comprises an injector tube body and an injector push rod, one end of each injector push rod is connected with the injector bracket respectively, and the other end of each injector push rod is arranged in each injector tube body respectively;

the capillary joint bracket is arranged at one end of the displacement sliding table;

the capillary joints are arranged on the capillary joint support in parallel, one end of each capillary joint is connected with an injection port of each syringe tube body, and the other end of each capillary joint is connected with the other end of each second taper tube.

8. The chemiluminescent immunoassay system of claim 1 further comprising a protective cover disposed on the base plate, the protective cover for protecting the liquid drive mechanism and the control module.

9. A chemiluminescent immunoassay method applied to the chemiluminescent immunoassay system according to any one of claims 1-8 comprising the steps of:

starting the chemiluminescent immunoassay system to complete system initialization;

placing a kit in a sample injection mechanism and starting the sample injection mechanism so that the kit is transported to a preset sample injection position, wherein the kit is provided with a plurality of cavities, and each cavity is filled with a different type of solution;

starting the liquid driving mechanism to enable the detecting tube piece to alternately absorb different types of solutions and air;

starting the magnetic control module to enable chemiluminescent immunoreaction to be carried out in the detection tube piece;

and starting a dark bin detection mechanism to collect the light signals generated by each luminous liquid column section after the chemiluminescent immunoreaction, and analyzing and displaying the light signals.

10. The chemiluminescent immunoassay of claim 9, wherein each of the chambers is filled with a different type of solution comprising: the kit comprises magnetic particle liquid, sample antigen liquid, first cleaning liquid, enzyme-labeled antibody liquid, second cleaning liquid and chemiluminescent substrate liquid.