[ Invention ]
The invention aims to provide the full-automatic chemiluminescence immunoassay analyzer, which has the advantages that the full automation is realized without manual intervention in the operation process, the convenience and the rapidness are realized, and the accuracy of detection analysis is improved.
The invention aims at realizing the technical scheme that the full-automatic chemiluminescence immunoassay analyzer comprises the following components:
A machine table;
the reagent strip module is arranged on the machine;
The suction head module is arranged on the machine table and can move relative to the reagent strip module, and is configured to suck a sample to the reagent strip module and mix reagents and magnetic beads in the reagent strip module with the sample;
The device comprises a machine table, a puncture and liquid separation module, a liquid separation module and a liquid separation module, wherein the puncture and liquid separation module is arranged on the machine table and can move relative to the reagent strip module;
The incubation and cleaning module is arranged on the machine table and can move relative to the reagent strip module, and is configured to perform temperature control treatment on the reagent strip module and extract and clean a mixture coated by magnetic beads in the reagent strip module by using a magnetic rod;
The measuring module is arranged on the machine table and can move relative to the reagent strip module, and is configured to measure and read the reagent strip module;
The reagent strip module comprises at least two groups of reagent strip units, the incubation and cleaning module comprises an incubation unit for controlling the temperature of the reagent strip units and a cleaning and separating unit for extracting and cleaning the mixture of the reagent strip units, the incubation unit comprises an incubation base for placing each group of reagent strip units and arranged in a hollow mode, and a heating piece arranged on the incubation base, and the heating piece is used for heating the incubation base.
In one embodiment, the incubation unit further comprises a temperature control plate and a temperature control protection switch, wherein the temperature control plate is arranged on the incubation base and used for controlling the temperature of the incubation base, and the temperature control protection switch is used for switching off the incubation base when the temperature control plate is electrically shorted.
In one embodiment, the cleaning and separating unit comprises a frame body, a magnetic rod motor arranged on the frame body, a magnetic rod connected with the magnetic rod motor, a magnetic rod resetting optocoupler for detecting whether the magnetic rod is reset or not, and a magnetic sleeve motor arranged on one side of the magnetic rod motor.
In one embodiment, one of the machine and the incubation base is provided with a first slide rail, the other one of the machine and the incubation base is provided with a slide groove in sliding fit with the first slide rail, and the incubation cleaning module further comprises a reagent strip driving assembly for driving the reagent strip unit to move, wherein the reagent strip driving assembly is arranged on one side of the first slide rail.
In one embodiment, the tip module comprises a tip unit and a tip driving unit connected with the tip unit, wherein the tip driving unit is used for driving the tip unit to move along a first direction, a second direction and a third direction, and the first direction, the second direction and the third direction are mutually perpendicular.
In one embodiment, the suction head unit comprises a suction head body for sucking and an air pump connected with the suction head body and used for generating negative pressure.
In one embodiment, the suction head module further comprises a supporting seat erected on the machine table, the suction head driving unit is arranged on the supporting seat, the suction head driving unit comprises a first suction head driving assembly, a second suction head driving assembly and a third suction head driving assembly, and the third suction head driving assembly is connected with the suction head unit.
In one embodiment, the lancing and dispensing module includes a base plate connected to the machine, a lancet driving unit disposed on the base plate, and a lancing unit connected to the lancet driving unit.
In one embodiment, the lancing unit comprises a lancing body and a code scanner connected with the lancing body, and the lancing drive unit comprises a first lancing drive assembly for driving the lancing unit to move along a first direction and a second lancing drive assembly for driving the lancing unit to move along a third direction.
In one embodiment, the full chemistry chemiluminescent immunoassay analyzer further comprises a tip loading module disposed above the reagent strip module to interface with the tip module.
Compared with the prior art, the invention has the advantages that the suction head module, the puncture liquid-separating module and the incubation cleaning module are independently arranged, so that the suction head module mixes a sample with reagents and magnetic beads in the reagent strip module, the puncture liquid-separating module punctures the reagent strip module, adds cleaning liquid, substrate liquid and the like, and the incubation cleaning module extracts and cleans the mixture coated by the magnetic beads in the reagent strip module by using the magnetic rod, thereby ensuring that the sample and the substrate are not polluted, and the invention is convenient and quick;
the incubation cleaning module is provided with a heating part, and the heating part heats the incubation base so that the reagent strip body can fully react under the environment with the set temperature, thereby being convenient and quick.
[ Detailed description ] of the invention
In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention. It should be further noted that, for convenience of description, only some, but not all of the structures related to the present invention are shown in the drawings. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The terms "comprising" and "having" and any variations thereof herein are intended to cover a non-exclusive inclusion. For example, a process, method, system, article, or apparatus that comprises a list of steps or elements is not limited to only those listed steps or elements but may include other steps or elements not listed or inherent to such process, method, article, or apparatus.
Reference herein to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment may be included in at least one embodiment of the invention. The appearances of such phrases in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Those of skill in the art will explicitly and implicitly appreciate that the embodiments described herein may be combined with other embodiments.
Referring to fig. 1 to 7, a full-automatic chemiluminescence immunoassay analyzer in a preferred embodiment of the present invention includes a machine 1, a reagent strip module 2 disposed on the machine 1, a suction head module 3, a piercing and separating module 4, an incubation and cleaning module 9, and a measurement module 5, wherein the suction head module 3, the piercing and separating module 4, the incubation and cleaning module 9, and the measurement module 5 are all movable relative to the reagent strip module 2 to perform corresponding operations on the reagent strip module 2.
Specifically, the reagent strip module 2 includes at least two groups of reagent strip units, and when one group of reagent strip units is moved to the incubation and cleaning module 9 and the measurement module 5 after the completion of the dispensing and mixing reaction, the tip module 3 and the puncture and liquid separation module 4 can perform the dispensing and mixing reaction operation on the next group of reagent strip units so as to improve the detection and analysis efficiency.
Each set of reagent strip units comprises a reagent strip body 21 and a handle 22 connected to the reagent strip body 21, the handle 22 being adapted to facilitate the handling and placement of the reagent strip units by a user within the incubation and washing module 9. The reagent strip body 21 is provided with a cleaning position 211, a reaction position 212, a measuring position 213, a packaging position 214 and a cleaning hole 215 of the puncture needle body of the puncture needle module, and the cleaning position 211, the reaction position 212, the measuring position 213, the packaging position 214 and the cleaning hole 215 are sequentially arranged along the transverse length direction of the reagent strip body 21. In this embodiment, three washing sites 211 are provided to sufficiently extract and wash the mixture coated with the magnetic beads. Indeed, in other embodiments, the number of the cleaning stations 211 may be other, and is not limited herein, and may be determined according to practical situations.
The packaging position 214 comprises a first hole for placing a substrate, a second hole for placing a magnetic bead and a third hole for placing an enzyme-labeled reagent, wherein the first hole, the second hole and the third hole are sequentially arranged, and a packaging film is arranged above the first hole, the second hole and the third hole so as to prevent objects in the holes from leaking. In this embodiment, the packaging film is an aluminum foil composite film that is capable of being sealed and simultaneously is also capable of being pierced by the lancet body or the tip body 322. Similarly, since the cleaning liquid is placed in the cleaning hole 215, a packaging film is also provided in the cleaning hole 215, and the packaging film is the same as described above. In contrast, since the washing station 211, the reaction station 212 and the measurement station 213 are not packed with any reagent in the initial state of the reagent strip body 21, no packaging film is provided.
The cleaning hole 215 comprises a cleaning solution packaging hole 2151 and a lancet body cleaning hole 2152 arranged in the cleaning solution packaging hole 2151, wherein the height of the lancet body cleaning hole 2152 is smaller than that of the cleaning solution packaging hole 2151 in the height direction of the reagent strip body 21, the cleaning solution is sprayed out when the lancet body is transferred to the lancet body cleaning hole 2152, the inner wall of the lancet body 421 is cleaned by the cleaning solution under a certain pressure and a certain flow velocity, and the sprayed cleaning solution performs vortex motion in the lancet body cleaning hole 2152 so as to clean the outer wall of the lancet body 421. Notably, the height of the cleaning fluid within the lancet body cleaning aperture 2152 is less than the aperture height to prevent vortex motion failure, which is achieved by quantitative packaging and filling of the cleaning fluid.
The reagent strip unit further comprises a magnetic sleeve 216 preloaded on one side of the handle, i.e. the magnetic sleeve 216 is preloaded between the handle and the wash well 215.
The incubation and washing module 9 is configured to perform a temperature control process on the reagent strip module 2, and to extract and wash the mixture coated with the magnetic beads in the reagent strip module 2 with the magnetic sheath 216. The incubation and cleaning module 9 includes an incubation unit 91 for controlling the temperature of the reagent strip units and a cleaning and separating unit 92 for extracting and cleaning the mixture of the reagent strip units, wherein the incubation unit 91 is used for placing an incubation base 911 of each group of reagent strip units and arranged in a hollow manner, a reagent strip body 21 arranged in the incubation base 911, and a heating member 913 arranged on the incubation base 911, and the heating member 913 is used for heating the incubation base 911. Because the reagent strip body 21 is typically stored in cold air, the reaction temperature of the reagent strip body 21 is preferably 37 ℃. After the incubation base 911 is heated, the temperature of the reagent strip body 21 is gradually raised to the reaction temperature in a certain temperature environment, so that the method is convenient and quick. In this embodiment, the heating member 913 is a heating film, and the heating film at least partially covers the incubation base 911. Indeed, in other embodiments, the heating element 913 may be other, and is not limited herein, depending on the actual situation. In this embodiment, the heating film is fixedly arranged at the bottom of the incubation base 911, so that uniformity of a temperature field of the incubation base 911 is ensured.
The incubation unit 91 further includes a temperature control plate 912 disposed on the incubation base 911, and a temperature control protection switch 914, wherein the temperature control plate 912 is used for controlling the temperature of the incubation base 911, and the temperature control protection switch 914 is used for switching off the incubation base 911 when the temperature control plate 912 is electrically shorted. Wherein, the temperature control plate 912 is disposed on the side wall of the incubation base 911. As described above, since the optimal reaction temperature of the reagent strip body 21 is 37 ℃, the temperature control plate 912 precisely controls the incubation temperature to be maintained at 37 〒 0.5.5 ℃. Correspondingly, a temperature control protection switch 914 is disposed on the side wall of the incubation base 911 and is disposed close to the temperature control plate 912.
Each group of reagent strip units can move along the Y-axis direction of the machine 1, so in this embodiment, a first slide rail is disposed on one of the machine 1 and the incubation base 911, and a slide slot slidably engaged with the first slide rail is disposed on the other of the machine 1 and the incubation base 911. Correspondingly, the incubation and cleaning module 9 further comprises a reagent strip driving assembly 915 for driving the reagent strip unit to move, and the reagent strip driving assembly 915 is arranged at one side of the first slide rail. In this embodiment, the reagent strip driving unit is a driving motor.
The incubation unit 91 further includes a reset optocoupler disposed on the other side of the first sliding rail, where the reset optocoupler is used to detect whether the reagent strip unit is reset.
The cleaning and separating unit 92 includes a frame body, a magnetic rod motor 921 disposed on the frame body, a magnetic rod connected with the magnetic rod motor 921, a magnetic rod resetting optocoupler for detecting whether the magnetic rod is reset, and a magnetic sleeve motor 922 disposed on one side of the magnetic rod motor 921, wherein the magnetic sleeve motor 922 and the magnetic rod motor 921 can drive the magnetic rod to move up and down along the Z axis. The magnetic sleeve motor 922 and the magnetic rod motor 921 move downwards to enable the magnetic rod to extend out, move to the position of the magnetic sleeve 216 to enable the magnetic sleeve 216 to be attracted to the magnetic rod, move the cleaning position 211 to attract the magnetic beads to obtain a mixture coated with the magnetic beads, clean and extract the mixture coated with the magnetic beads, finally transfer the mixture coated with the magnetic beads to the measuring position 213 through the magnetic sleeve 216, enable the mixture of the magnetic beads and a substrate added in advance to fully react, stably emit sustainable light with the wavelength of 470nm, and finally convert and measure and read through the measuring unit.
The tip module 3 comprises a tip unit 32 and a tip driving unit 31 connected with the tip unit 32, wherein the tip driving unit 31 is used for driving the tip unit 32 to move along a first direction, a second direction and a third direction, and the first direction, the second direction and the third direction are mutually perpendicular. In this embodiment, the first direction is the X-axis direction, the second direction is the Y-axis direction, and the third direction is the Z-axis direction. Indeed, in other embodiments, the first direction, the second direction, and the third direction may also have other indications, which are not specifically limited herein, and are according to the actual situation. Specifically, the tip drive unit 31 comprises a first tip drive assembly 311, a second tip drive assembly 312 and a third tip drive assembly 313, the third tip drive assembly 313 being connected to the tip unit 32. In this embodiment, the first tip driving component 311, the second tip driving component 312 and the third tip driving component 313 are the same as the reagent strip driving components and are driving motors, and the first tip driving component 311, the second tip driving component 312 and the third tip driving component 313 can drive the tip unit 32 to move through chain transmission, which is a conventional structure and will not be described herein.
The suction head unit 32 includes a suction head body 322 for sucking, and an air pump 321 connected to the suction head body 322 for generating negative pressure, and the suction head body 322 is in butt joint with a pump body of the air pump 321. The air pump 321 can automatically load and unload the suction head, judge whether the suction head is in place or not, discharge liquid quantitatively, detect the liquid level, and the like. The tip driving unit 31 drives the tip body 322 to move to the sample to suck the sample, and places the sample in the reaction site 212. Wherein the air pump 321 is connected to the third tip driving assembly 313. The tip module 3 further includes a support base mounted on the machine table 1, and the tip driving unit 31 is disposed on the support base. In the present embodiment, the tip driving unit 31 is provided above the reagent strip module 2, and operates the reagent strip module 2. The suction head body 322 is generally made of plastic material, which can easily puncture the packaging film. Indeed, in other embodiments, the material of the suction head body 322 may be other as long as the above effects are achieved, and the invention is not limited thereto, and the invention is applicable to practical situations.
The tip driving unit 31 drives the tip unit 32 to move so as to add the sample into the reaction site 212, and simultaneously, the tip moves downwards to puncture the packaging film, and simultaneously, the packaging film enters into the second hole and the third hole to suck and add the magnetic beads and the enzyme-labeled reagent into the reaction site 212 so as to form a mixture coated by the magnetic beads in the reaction site 212.
The lancing and dispensing module 4 is configured to puncture the sealing membrane of the reagent strip module 2 to achieve dispensing of the cleaning solution and the substrate solution. Lancing module 4 includes a base plate connected to machine 1, a lancet drive unit 41 disposed on the base plate, and a lancing unit 42 connected to lancet drive unit 41. In this embodiment, the height of the substrate is lower than the height of the supporting seat, i.e. the puncturing and separating module 4 is located below the suction head module 3. Wherein, puncture unit 42 includes a puncture needle body 421 and a code scanner 422 connected with puncture needle body 421, and puncture needle body 421 is used for puncturing the packaging film to fill the cleaning solution and the substrate of the quantitative package in the reagent strip onto the cleaning position 211 and the measuring position 213 on reagent strip body 21. The bar code scanner 422 reads the bar code of each reagent bar unit to record that the reagent bar unit has completed dispensing and the like.
It should be noted that, in order to prevent the contamination, in this embodiment, before sucking the substrate, the lancet body 421 needs to be cleaned, which is specifically performed by sucking a certain amount of cleaning solution, then sucking a section of air column, and then sucking a certain amount of substrate before sucking the substrate after filling the cleaning solution.
The lancet driving unit 41 includes a first lancet driving element 411 for driving the lancet unit 42 to move along a first direction, and a second lancet driving element 412 for driving the lancet unit 42 to move along a third direction, where in this embodiment, the first direction is an X-axis direction, the third direction is a Z-axis direction, and the first lancet driving element 411 and the second lancet driving element 412 are consistent with the above and are both driving motors, and the connection between the two is achieved by rotation of a chain, which is a conventional structure and will not be described herein.
The measurement module 5 is configured to measure and read the reagent strip module 2. The measuring module 5 comprises a measuring base plate 51 arranged on the machine table 1, a cassette 52, a photomultiplier 53 connected with the cassette 52, a first measuring driving assembly 54 for driving the photomultiplier 53 to move along the z-axis, and a second measuring driving assembly 55 arranged on the measuring base plate 51 and used for driving the photomultiplier 53 to move along the X-axis. When the incubation base 911 drives the reagent strip body 21 to move along the first sliding rail to right under the cassette 52, the first measurement driving assembly 54 drives the cassette 52 to descend and compress the reagent strip body 21, and at this time, the photomultiplier 53 is opened to start measurement.
The full-automatic chemiluminescence immunoassay analyzer further comprises a suction head loading module 7, wherein the suction head loading module 7 is arranged above the reagent strip module 2 so as to be in butt joint with the suction head module 3. The tip loading module 7 is mainly used for storing disposable tips, and can prevent cross contamination between different projects. The suction head loading module 7 comprises a suction head box bottom plate 61 arranged on the machine table 1, a second sliding rail 62 arranged on the suction head box bottom plate 61, a suction head box seat 64 which is in sliding fit with the second sliding rail 62 and is used for placing the suction head body 322, a positioning bearing 63 arranged on one side of the second sliding rail 62, and a support plate 65 which is arranged on the suction head box bottom plate 61 and is opposite to the suction head box seat 64, wherein a sensor 66 used for detecting whether the suction head box seat 64 is in place or not is arranged on the support plate 65 so as to ensure that the suction head body 322 is loaded smoothly. The support plate 65 is further provided with a magnet 67, and correspondingly, the suction head box seat 64 is provided with a magnetic piece matched with the magnet 67, or the suction head box seat 64 is made of metal capable of being magnetically attracted, which is not particularly limited herein, and is determined according to practical situations.
When the suction head box seat 64 is pulled out when the suction head body 322 needs to be replaced, and the suction head box seat 64 is pushed back after replacement, the automatic positioning in the X-axis direction is completed under the action of the four positioning bearings 63, and the positioning and the fixing in the Y-axis direction are completed through the magnets 67 fixed on the support plates 65.
The full-automatic chemiluminescence immunoassay analyzer further comprises a waste collection module 8 for collecting the waste suction head body 322 and a sample loading module 7 for placing samples, wherein the waste collection module 8 is a waste box 8, and the sample loading module 7 is arranged on the waste box 8. The sample loading module 7 includes a sample holder 72 and a test tube 71 placed in the sample holder 72, and samples are stored in the test tube 71. The sample loading module 7 further comprises a limit bar arranged on the waste box 8, a guide pin arranged on one side of the limit bar, a positioning plunger used for positioning the sample frame 72 and an in-place sensor used for detecting whether the sample frame 72 is in place, wherein the sample frame 72 can slide along the guide pin and the limit bar, a blanking channel is arranged on the positioning plunger, and the blanking channel is communicated with the waste box.
The whole action flow of the invention is that after the sample and the reagent strip body 21 are loaded, the suction head module 3 loads a disposable suction head, the sample, the enzyme-labeled reagent and the magnetic beads are respectively and quantitatively added into the reaction position 212 of the reagent strip body 21 to form a mixture coated with the magnetic beads, the mixture in the reagent strip body 21 fully reacts under the environment of 37 ℃ of the incubation unit 91, the puncture needle body 421 on the puncture liquid separation module 4 is punctured in the incubation process to pre-fill the cleaning liquid and the substrate which are quantitatively packaged in the reagent strip body 21 into the corresponding cleaning position 211 and the measuring position 213 of the reagent strip body 21, the incubation unit 91 moves to the cleaning position 211 after the incubation is finished, the mixture coated with the magnetic beads is extracted and cleaned by the magnetic sleeve motor 922 and the magnetic rod motor 921, the magnetic bead mixture is finally transferred to the measuring position 213 by the magnetic sleeve 216, the mixture is fully reacted with the pre-added substrate, and then the sustainable light with the wavelength of 470nm is stably emitted, and finally the measurement module 5 is used for conversion and reading. The tip module 3 will continuously sample the next item during incubation and cleaning, so that other operation flows are parallel operation and do not interfere with each other except that the tip module 3 is serial operation.
In summary, by arranging the suction head module 3, the puncturing and liquid separating module 4 and the incubation and cleaning module 9 independently, the suction head module 3 mixes the sample with the reagent and the magnetic beads in the reagent strip module 2, the puncturing and liquid separating module 4 punctures the reagent strip module 2 to add cleaning liquid and the like, the incubation and cleaning module 9 sucks the magnetic sleeve 216 of the reagent strip module 2 to extract and clean the mixture coated by the magnetic beads, so that the sample and the substrate are not polluted, and the detection and the cleaning are convenient and quick;
the incubation and cleaning module 9 is provided with a heating member 913, and the heating member 913 heats the incubation base 911 to make the reagent strip body 21 fully react in the environment of the set temperature, which is convenient and quick.
The foregoing is merely one specific embodiment of the invention, and any modifications made in light of the above teachings are intended to fall within the scope of the invention.