Fully automatic chemiluminescence immunoassay analyzer

Abstract

The present invention discloses a fully automatic chemiluminescence immunoassay analyzer, wherein the reagent system is a circular structure, and the sample system concentrically surrounds the circumferential outer side of the reagent system; the detection module comprises a rotatably arranged circular tray and a luminescent detection assembly located outside the circular tray, and detection notches for installing reaction cups are distributed on the circumferential edge of the circular tray; the incubation module is integrated in the central area of ​​the circular tray; a transfer module is arranged between the washing module and the detection module, and the transfer module is used to place the reaction cup, and the washing module, the transfer module and the detection module are located on the same straight line, and a mechanical clamp arm is arranged horizontally above them; the filling system is located between the sample system and the transfer module, and comprises a column and a cantilever arranged at the top of the column, and the lower end of the cantilever is provided with a filling needle sliding along its length direction. The beneficial effects of the present invention are: a reasonable structural layout is adopted between the modules to ensure the compactness of the analyzer structure.

Description

Technical Field

[0001] The invention relates to the technical field of medical detection, and in particular to a fully automatic chemiluminescence immunoassay analyzer. Background Art

[0002] Chemiluminescence immunoassay (CLIA) is a technique that combines highly sensitive chemiluminescence assay technology with highly specific immune reactions and is used for the detection and analysis of various antigens, haptens, antibodies, hormones, enzymes, fatty acids, vitamins, and drugs. It is the latest immunoassay technology developed after radioimmunoassay, enzyme immunoassay, fluorescence immunoassay, and time-resolved fluorescence immunoassay.

[0003] In order to avoid the influence of uncertain factors such as cumbersome operations, long sample turnover cycle and human interference in traditional biomedical testing, chemiluminescence immunoassay equipment is also developing in the direction of full automation, that is, an integrated analyzer that can realize filling, shaking, dilution, incubation, washing and detection.

[0004] In the existing technology, although some fully automatic chemiluminescence immunoassays have appeared on the market, the internal modules of the analyzer still have technical problems such as poor layout compactness, and the activity span and movement trajectory of the mechanical gripper are complex, resulting in reduced detection efficiency and increased equipment size. Summary of the invention

[0005] In view of this, the present invention provides a fully automatic chemiluminescence immunoassay analyzer to solve the technical problems pointed out in the background technology.

[0006] To achieve the above purpose, the technical solution of the present invention is as follows:

[0007] A fully automatic chemiluminescence immunoassay analyzer includes an equipment frame, wherein a sample system, a reagent system, a washing module, an incubation module, a detection module and a filling system are arranged in the equipment frame. The key points are:

[0008] The reagent system is of circular structure, and the sample system concentrically surrounds the outer circumference of the reagent system;

[0009] The detection module includes a rotatable circular tray and a light-emitting detection assembly located outside the circular tray, and detection notches for installing reaction cups are distributed on the circumferential edge of the circular tray; the incubation module is integrated in the central area of ​​the circular tray;

[0010] A transfer module is provided between the washing module and the detection module, and the transfer module is used to place the reaction cup. The washing module, the transfer module and the detection module are located on the same straight line, and a mechanical clamp arm is horizontally placed above them;

[0011] The filling system is located between the sample system and the transfer module, and includes a column and a cantilever arranged at the top of the column. A filling needle is fixedly installed at the lower part of the distal end of the cantilever. The filling needle rotates around the column axis and slides along the column axis together with the cantilever.

[0012] Preferably, the device further comprises a cup arrangement system, wherein the cup arrangement system comprises a guide rail mechanism obliquely arranged above the detection module, wherein the lower end of the guide rail mechanism is connected to the transfer module, and a hopper is arranged at the upper end.

[0013] Preferably, the transfer module comprises a positioning ring and a turntable rotatably mounted inside the positioning ring, at least two groups of positioning grooves are arranged on the edge of the turntable, a guide cup groove is arranged on the guide rail mechanism, and a transition notch is arranged on the positioning ring to dock with the lower end of the guide cup groove.

[0014] Preferably, the cup arrangement system further comprises a vertically arranged support plate, the guide rail mechanism and the hopper are respectively located on both sides of the support plate, wherein the bottom of the hopper comprises a tilted bottom plate, a gap is provided between the bottom plate and the support plate, a lifting block movable up and down is installed in the gap, the upper end of the lifting block comprises an inclined supporting surface, an acute-angle groove is formed between the inclined supporting surface and the side wall of the support plate.

[0015] Preferably, the washing module comprises a base, the base has a chamber with an open upper end, a support plate is rotatably mounted in the chamber, and support holes are distributed in a circumferential array on the support plate;

[0016] A shaking mechanism is provided at the lower part of the base, and the shaking mechanism is arranged below one of the supporting holes so as to be movable up and down through a lifting assembly.

[0017] Preferably, a plurality of magnetic blocks are embedded in the base, and the magnetic blocks are distributed in an array along the circumferential direction of the support disk, and the height of each magnetic block gradually decreases along the circumferential direction of the support disk.

[0018] Preferably, the sample system and the reagent system are integrated together through an inner liner component, wherein the reagent system is rotatably installed in an inner area of ​​the inner liner component, the sample system is ringed around the circumference of the inner liner component, and a gear drive mechanism and a belt drive mechanism are installed in the device frame, which are respectively used to drive the sample system and the reagent system to rotate.

[0019] Preferably, the detection module includes a shell seat with an annular structure, the circular tray is rotatably arranged inside the shell seat, the luminous detection component is fixed outside the shell seat, the shell seat is provided with a detection channel at a position corresponding to the luminous detection component, and the shell seat is provided with a spring clip at a position above the detection channel, and when the reaction cup in the detection notch stays at the detection channel position, the spring clip can make the reaction cup tightly attached to the inner wall of the detection notch, and the relative position remains consistent every time.

[0020] Preferably, the spring sheet is arranged horizontally, and both ends thereof are fixedly connected to the inner side wall of the housing seat.

[0021] Preferably, the filling needle extends in a vertical direction and is mounted on the lower end of the cantilever via a linear module.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] 1. The sample system and reagent system are integrated together in a rotating concentric manner, the incubation module is integrated in the central area of ​​the circular tray of the detection module, and the washing module and the detection module are connected in a straight line through the transfer module, all of which help to make the internal structure of the chemiluminescence immunoassay analyzer more compact and occupy less space.

[0024] 2. By setting up the transfer module as a temporary placement for the reaction cup, the range of motion and movement trajectory of the mechanical clamp arm can be greatly reduced. The mechanical clamp arm can transfer the reaction cup only by linear motion, which helps to ensure the detection efficiency of the equipment. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 A schematic diagram showing the internal distribution relationship of the sample system 2, the reagent system 3, the washing module 4, the incubation module 5, the detection module 6, the filling system 7 and the transfer module 8 in the fully automatic chemiluminescence immunoassay analyzer;

[0026] Figure 2 It is a structural schematic diagram of a fully automatic chemiluminescence immunoassay analyzer;

[0027] Figure 3 Another structural schematic diagram of a fully automatic chemiluminescence immunoassay analyzer;

[0028] Figure 4 It is a structural schematic diagram of the cup arrangement system 1 and the transfer module 8;

[0029] Figure 5 It is a schematic diagram of the structure of the cup arrangement system 1 after the outer baffle 1e is hidden;

[0030] Figure 6 A partial structural diagram showing the positional relationship between the support plate, the hopper and the lifting block in the cup arrangement system 1;

[0031] Figure 7 It is a structural schematic diagram of the detection module 6;

[0032] Figure 8 It is a structural schematic diagram of the housing seat 6d of the detection module 6;

[0033] Fig. 9 is a cross-sectional view of the detection module 6;

[0034] Fig.10 is a cross-sectional view of the washing module 4;

[0035] Fig.11 Schematic diagram of the three-dimensional structure of the washing module 4 after the base 4a is hidden;

[0036] Fig.12 A schematic diagram showing the installation of the support plate 4b inside the base 4a and the lifting assembly 4dd at the bottom of the base 4a;

[0037] Fig.13 for Fig.12 A schematic diagram of the structure after the base 4a is hidden;

[0038] Fig.14 It is a schematic diagram of the structure of the sample system 2 and the reagent system 3. DETAILED DESCRIPTION

[0039] The present invention is further described below in conjunction with embodiments and drawings.

[0040] like Figure 1 and 2 As shown, a fully automatic chemiluminescence immunoassay analyzer includes an equipment frame A, in which a cup arrangement system 1, a sample system 2, a reagent system 3, a washing module 4, an incubation module 5, a detection module 6, a filling system 7 and a transfer module 8 are arranged.

[0041] For example Figure 1 As shown, the reagent system 3 is a circular structure, and the sample system 2 concentrically surrounds the reagent system 3 on the circumferential outside. The sample system 2 and the reagent system 3 are integrated together in a rotating concentric layout, which occupies a small space and has a high degree of structural compactness, which helps the chemiluminescence immunoassay analyzer to achieve a compact and miniaturized design.

[0042] For further information, see Fig.14 The sample system 2 and the reagent system 3 are integrated together through the inner liner component 11, wherein the reagent system 3 is rotatably installed in the inner area of ​​the inner liner component 11, and the sample system 2 is ringed around the inner liner component 11. A gear drive mechanism 12 and a belt drive mechanism 13 are installed in the equipment frame A, and the gear drive mechanism 12 and the belt drive mechanism 13 can independently drive the sample system 2 and the reagent system 3 to rotate.

[0043] For example Figure 7 As shown, the detection module 6 includes a rotatable circular tray 6a and a light-emitting detection component 6b located outside the circular tray 6a. Detection notches 6c for installing reaction cups a are distributed on the circumferential edge of the circular tray 6a. The reaction cups a are installed one by one in the detection notches 6c. As the circular tray 6a rotates, the reaction cups a in the detection notches 6c can pass through the light-emitting detection component 6b one by one, thereby completing the detection.

[0044] In this embodiment, the middle area of ​​the circular tray 6a is provided with two circles of incubation holes 5a distributed in a circular array. In other words, the incubation module 5 is integrated in the central area of ​​the circular tray 6a of the detection module 6. Such a design can make full use of the space of the circular tray 6a and integrate the incubation module 5 and the detection module 6 of the analyzer together, which can reduce the total space occupied by the incubation module 5 and the detection module 6 inside the chemiluminescence immunoassay, which is conducive to the compact and miniaturized design of the product.

[0045] For further information, see Figure 8 and Fig. 9 As shown, the detection module 6 also includes a housing seat 6d of an annular structure, a circular tray 6a is rotatably arranged inside the housing seat 6d, a light-emitting detection component 6b is fixed outside the housing seat 6d, the housing seat 6d is provided with a detection channel 6e at a position corresponding to the light-emitting detection component 6b, and the housing seat 6d is provided with a spring 6f at a position above the detection channel 6e. In this embodiment, the spring 6f is arranged horizontally, and both ends thereof are fixedly connected to the inner side wall of the housing seat 6d. When the reaction cup a in the detection notch 6c stays at the position of the detection channel 6e, the light-emitting detection component 6b analyzes and detects the reaction cup a through the detection channel 6e. At the same time, the spring 6f can fix the reaction cup a in the detection notch 6c without shaking, so that the reaction cup a is closely attached to the inner wall of the detection notch 6c and the position is consistent, thereby ensuring that the distance between the light-emitting detection component 6b and the reaction cup a is constant, which helps to ensure the detection accuracy of the analyzer.

[0046] For example Figure 1 As shown, the transfer module 8 is arranged between the washing module 4 and the detection module 6. By setting up the transfer module 8, it can be used to temporarily put the reaction cup a as a transfer station for adding reagents and samples, avoiding the filling needle of the filling system 7 from moving to the washing module 4 or the incubation module position to add reagents and samples, which can significantly reduce the complexity of the mechanism and optimize the activity trajectory of the filling needle 7c of the filling system 7, thereby ensuring that the analyzer equipment has a high degree of compactness.

[0047] Furthermore, the washing module 4, the transfer module 8 and the detection module 6 are located on the same straight line, and a mechanical clamp arm 9 is placed horizontally above the straight line. Such a design can simplify the movement trajectory of the mechanical clamp arm 9, and only one set of linear drive modules is needed to realize the transfer of the reaction cup between the washing module 4, the transfer module 8 and the detection module 6. Such a design also helps to ensure the compactness of the analyzer equipment.

[0048] For example Figure 1 and 2As shown, the filling system 7 is located between the sample system 2 and the transfer module 8, and the filling system 7 includes a column 7a and a cantilever 7b arranged at the top of the column 7a, and a filling needle 7c is fixedly installed at the lower part of the distal end of the cantilever 7b. The filling needle 7c rotates along the axis of the column 7a and slides along the axis of the column 7a with the cantilever 7b, so that the blood sample of the sample system 2 and the detection reagent of the reagent system 3 can be added to the reaction cup on the transfer module 8. Using such a motion mode to fill samples and reagents can also reduce the complexity of the device, thereby making it more compact.

[0049] like Figure 3 and 4 As shown, the cup arrangement system 1 includes a guide rail mechanism 1a tiltedly arranged above the detection module 6, the lower end of the guide rail mechanism 1a is connected to the transfer module 8, and the upper end is provided with a hopper 1b. After the reaction cup a is placed in the hopper 1b, the guide rail mechanism 1a can move the reaction cups one by one to the transfer module 8. The guide rail mechanism 1a of the cup arrangement system 1 is tiltedly arranged above the detection module 6, which can make full use of the upper space of the analyzer, and contribute to the compact and miniaturized design of the product.

[0050] The implementation structure of the cup arrangement system 1 to realize automatic cup arrangement is as follows:

[0051] Please refer to Figure 5 and Figure 6 As shown, the cup arrangement system 1 also includes a vertically arranged support plate 1c, and the guide rail mechanism 1a and the hopper 1b are respectively located on both sides of the support plate 1c, wherein the bottom of the hopper 1b has an inclined bottom plate 1b1, and there is a gap between the bottom plate 1b1 and the support plate 1c, and a lifting block 1d that can move up and down is installed in the gap, and the upper end of the lifting block 1d has an inclined support surface 1d1, and an acute angle groove c is formed between the inclined support surface 1d1 and the side wall of the support plate 1c. The guide rail mechanism 1a on the other side is provided with a cup guide groove 1a1.

[0052] Please refer to Figure 5 As shown, the reaction cup a of the cup arrangement system 1 is an overall cylindrical structure with a circular step b on the upper part. Based on the structural characteristics of the reaction cup a, after the operator randomly grabs a large number of reaction cups a into the hopper 1b, at least one or two reaction cups a will slide from the bottom plate 1b1 into the acute angle groove c at the upper end of the lifting block 1d. Under the action of the external driving mechanism, the lifting block 1d rises along the side wall of the support plate 1c. When it rises to the point where the top of the lifting block 1d is flush with the upper end of the support plate 1c, the reaction cup a in the acute angle groove c will slide from the top of the support plate 1c into the guide rail mechanism 1a on the other side. Finally, the reaction cup a is arranged vertically on the guide groove 1a1 of the guide rail mechanism 1a under the action of its own gravity, thereby realizing automatic cup arrangement.

[0053] For example Figure 4As shown, in this embodiment, the transfer module 8 includes a positioning ring 8a and a rotating disk 8b rotatably mounted inside the positioning ring 8a, at least two groups of positioning grooves 8c are provided on the edge of the rotating disk 8b, and a transition notch 8d is provided on the positioning ring 8a, and the lower end of the cup guide groove 1a1 of the guide rail mechanism 1a is butted with the transition notch 8d. Based on this, when the rotating disk 8b rotates to the point where one of the positioning grooves 8c is directly opposite to the transition notch 8d, the reaction cup a on the guide groove 1a1 will automatically slide into the positioning groove 8c under the action of gravity. At this time, the rotating disk 8b can be rotated again to bring out the reaction cup a, thereby facilitating filling or the mechanical clamp arm 9 to grab the reaction cup.

[0054] For example Fig.10 , 12 As shown in FIG. 13 , in this embodiment, the washing module 4 includes a base 4a, which is a rectangular block structure, and a circular chamber 4a1 is provided at its upper end, and a support plate 4b is rotatably installed in the chamber 4a1, and a circular array of support holes 4b1 are provided on the support plate 4b, and the support holes 4b1 are used to position and install the reaction cup a. A shaking mechanism 4c is provided at the lower part of the base 4a, and the shaking mechanism 4c is arranged below one of the support holes 4b1 so as to be movable up and down through a lifting assembly 4d.

[0055] When the reaction cup a rotates to above the shaking mechanism 4c, the lifting component 4d drives the shaking mechanism 4c to move upward, so that the bottom of the reaction cup a enters the shaking mechanism 4c. The shaking mechanism 4c is started to complete the shaking work. After the shaking is completed, the lifting component 4d drives the shaking mechanism 4c to return downward, and the support plate 4b rotates further forward.

[0056] like Fig.10 As shown, a liquid supply and extraction system 14 is arranged above the base 4a, which is used to add liquid to the reaction cup a or extract waste liquid, so as to achieve washing. By arranging the support plate 4b in a rotating manner, in addition to satisfying the functions of conventional filling and liquid aspiration, the washing module 4 can also achieve the shaking of the liquid in the reaction cup a, avoiding the mechanical clamping arm 9 from frequently transferring the reaction cup during the washing process, which can significantly improve the detection accuracy of the analyzer, and also help the product to achieve a compact and miniaturized design.

[0057] Please refer to Fig.12 As shown, the specific structure for realizing the lifting function of the shaking mechanism is as follows:

[0058] The lifting assembly 4d includes a support plate e located below the base 4a, a motor f fixed on the support plate e, and a nut sleeve h fixed on the lower part of the base 4a. Two guide rods d are provided at both ends of the lower part of the base 4a. The two ends of the support plate e can be slidably mounted on the guide rods d. A screw g is provided on the output shaft of the motor f, and the screw g is threadedly connected to the nut sleeve h. The shaking mechanism 4c is fixedly installed on the support plate e. Based on this, the forward and reverse rotation of the motor f can drive the shaking mechanism 4c to move up and down. The working principle of the shaking mechanism 4c is a mature technical means in the field of chemiluminescent immunoassay technology, which will not be further described here.

[0059] For example Fig.11 As shown, a plurality of magnetic blocks 4e are embedded inside the base 4a, and each magnetic block 4e is distributed in an array along the circumferential direction of the support disk 4b, and the height of each magnetic block 4e gradually decreases along the circumferential direction of the support disk 4b. After the reaction cup a is installed in the support hole 4b1 on the support disk 4b, as the support disk 4b rotates, each reaction cup will pass through the side of each magnetic block 4e. Since the height of each magnetic block in the circumferential direction of the support disk is gradually reduced, after the reaction cup passes through the side of all the magnetic blocks 4e, the magnetic particles inside the reaction cup a can be gradually guided to the bottom of the reaction cup by the magnetism of each magnetic block 4e, so that all the effective substances in the cup sink to the bottom of the cup, thereby preventing the effective substances in the liquid from being sucked away by the liquid supply and extraction system 14 along with the waste liquid, thereby improving the accuracy of immunoassay detection.

[0060] Finally, it should be noted that the above description is only a preferred embodiment of the present invention. Under the guidance of the present invention, ordinary technicians in this field can make various similar expressions without violating the purpose and claims of the present invention, and such changes all fall within the scope of protection of the present invention.

Claims

1. A fully automatic chemiluminescence immunoassay analyzer, comprising an equipment frame (A), wherein the equipment frame (A) is provided with a sample system (2), a reagent system (3), a washing module (4), an incubation module (5), a detection module (6) and a filling system (7), characterized in that: The reagent system (3) is of circular structure, and the sample system (2) concentrically surrounds the outer side of the reagent system (3); The detection module (6) comprises a rotatable circular tray (6a) and a light emitting detection component (6b) located outside the circular tray (6a), and detection notches (6c) for mounting a reaction cup are distributed on the circumferential edge of the circular tray (6a); the incubation module (5) is integrated and arranged in the central area of ​​the circular tray (6a); the detection module (6) further comprises a shell seat (6d) of an annular structure, the circular tray (6a) is rotatably arranged inside the shell seat (6d), the light emitting detection component (6b) is fixed outside the shell seat (6d), the shell seat (6d) is provided with a detection channel (6e) at a position corresponding to the light emitting detection component (6b), and the shell seat (6d) is provided with a spring piece (6f) at a position above the detection channel (6e), and when the reaction cup in the detection notch (6c) stays at the position of the detection channel (6e), the spring piece (6f) can make the reaction cup closely attached to the inner wall of the detection notch (6c); the spring piece (6f) is arranged horizontally, and both ends of the spring piece (6f) are fixed to the inner side wall of the shell seat (6d); A transfer module (8) is provided between the washing module (4) and the detection module (6), and the transfer module (8) is used to place a reaction cup. The washing module (4), the transfer module (8) and the detection module (6) are located on the same straight line, and a mechanical clamping arm (9) is horizontally placed above them. The filling system (7) is located between the sample system (2) and the transfer module (8), and comprises a column (7a) and a cantilever (7b) arranged at the top of the column (7a); a filling needle (7c) is fixedly mounted at the lower part of the far end of the cantilever (7b); the filling needle (7c) rotates along the axis of the column (7a) and slides along the axis of the column (7a) along with the cantilever (7b); The washing module (4) comprises a base (4a), the base (4a) having a chamber (4a1) with an open top, a support plate (4b) rotatably mounted in the chamber (4a1), and support holes (4b1) distributed in a circumferential array on the support plate (4b); a shaking mechanism (4c) is provided at the bottom of the base (4a), and the shaking mechanism (4c) is arranged below one of the support holes (4b1) so as to be movable up and down via a lifting component (4d); when the reaction cup rotates to above the shaking mechanism (4c), the lifting component (4d) drives the shaking mechanism (4c) to move upward, so that the bottom of the reaction cup enters the shaking mechanism (4c), and after the shaking mechanism (4c) completes the shaking process on the reaction cup, the lifting component (4d) drives the shaking mechanism (4c) to return downward, and the support plate (4b) further rotates forward; A plurality of magnetic blocks (4e) are embedded inside the base (4a), and the magnetic blocks (4e) are distributed in an array along the circumferential direction of the support disk (4b), and the height of each magnetic block (4e) gradually decreases along the circumferential direction of the support disk (4b).

2. The fully automatic chemiluminescence immunoassay analyzer according to claim 1, characterized in that: It also comprises a cup arrangement system (1), the cup arrangement system (1) comprising a guide rail mechanism (1a) arranged obliquely above the detection module (6), the lower end of the guide rail mechanism (1a) being docked with the transfer module (8), and the upper end being provided with a hopper (1b).

3. The fully automatic chemiluminescence immunoassay analyzer according to claim 2, characterized in that: The transfer module (8) comprises a positioning ring (8a) and a turntable (8b) rotatably mounted inside the positioning ring (8a); at least two groups of positioning grooves (8c) are provided on the edge of the turntable (8b); a guide cup groove (1a1) is provided on the guide rail mechanism (1a); and a transition notch (8d) abutting against the lower end of the guide cup groove (1a1) is provided on the positioning ring (8a).

4. The fully automatic chemiluminescence immunoassay analyzer according to claim 2, characterized in that: The cup arrangement system (1) further comprises a vertically arranged support plate (1c), wherein the guide rail mechanism (1a) and the hopper (1b) are respectively located on both sides of the support plate (1c), wherein the bottom of the hopper (1b) comprises a bottom plate (1b1) arranged obliquely, wherein a gap is provided between the bottom plate (1b1) and the support plate (1c), wherein a lifting block (1d) movable up and down is installed in the gap, wherein the upper end of the lifting block (1d) comprises an oblique supporting surface (1d1), wherein an acute angle groove (c) is formed between the oblique supporting surface (1d1) and the side wall of the support plate (1c).

5. The fully automatic chemiluminescence immunoassay analyzer according to claim 1, characterized in that: The sample system (2) and the reagent system (3) are integrated together via an inner liner component (11), wherein the reagent system (3) is rotatably mounted in an inner region of the inner liner component (11), the sample system (2) is sleeved around the circumference of the inner liner component (11), and a gear drive mechanism (12) and a belt drive mechanism (13) are mounted in the device frame (A), which are used to drive the sample system (2) and the reagent system (3) to rotate, respectively.

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