CN116908435A - Chemiluminescence immunoassay kit - Google Patents

Chemiluminescence immunoassay kit Download PDF

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Publication number
CN116908435A
CN116908435A CN202310674702.7A CN202310674702A CN116908435A CN 116908435 A CN116908435 A CN 116908435A CN 202310674702 A CN202310674702 A CN 202310674702A CN 116908435 A CN116908435 A CN 116908435A
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CN
China
Prior art keywords
oscillating
chemiluminescent immunoassay
chamber
immunoassay kit
piece
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202310674702.7A
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Chinese (zh)
Inventor
齐兴峰
胡文浩
朱灵华
袁胜霞
陈十燕
龚宏勋
汤莹
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900th Hospital of the Joint Logistics Support Force of PLA
Original Assignee
900th Hospital of the Joint Logistics Support Force of PLA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 900th Hospital of the Joint Logistics Support Force of PLA filed Critical 900th Hospital of the Joint Logistics Support Force of PLA
Priority to CN202310674702.7A priority Critical patent/CN116908435A/en
Publication of CN116908435A publication Critical patent/CN116908435A/en
Pending legal-status Critical Current

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54313Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
    • G01N33/54326Magnetic particles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F31/00Mixers with shaking, oscillating, or vibrating mechanisms
    • B01F31/80Mixing by means of high-frequency vibrations above one kHz, e.g. ultrasonic vibrations
    • B01F31/86Mixing by means of high-frequency vibrations above one kHz, e.g. ultrasonic vibrations with vibration of the receptacle or part of it
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/5302Apparatus specially adapted for immunological test procedures

Abstract

The application discloses a chemiluminescent immunoassay kit, which comprises a kit body and a membrane component covering an opening of the kit body; a plurality of chambers are arranged in the box body, and each chamber is correspondingly packaged with a reagent; the diaphragm assembly is provided with liquid taking holes corresponding to each cavity; one of the chambers is a first chamber for packaging the magnetic particle reagent, and the liquid taking hole corresponding to the first chamber is a first liquid taking hole; the diaphragm assembly is provided with a flexible oscillating part at the periphery of the first liquid taking hole, and the oscillating part is contacted with the main probe when the main probe is inserted into the first liquid taking hole and can oscillate along with the main probe; the bottom of the first chamber is provided with an oscillating piece, and the oscillating piece is connected with the oscillating part through a connecting piece, so that the oscillating piece vibrates along with the oscillating part to mix the magnetic particle reagent uniformly. The application can improve the mixing efficiency of the magnetic particle reagent and avoid detection errors caused by poor mixing effect.

Description

Chemiluminescence immunoassay kit
Technical Field
The application relates to the technical field of chemiluminescent immunoassay, in particular to a chemiluminescent immunoassay kit.
Background
Chemiluminescent immunoassay (CLIA) is a detection and analysis technique for various antigens, antibodies, hormones, enzymes, fatty acids, vitamins, drugs, etc., by combining a chemiluminescent assay technique with high sensitivity with a highly specific immune reaction. Chemiluminescent immunoassay comprises two components, an immunoreaction system and a chemiluminescent analysis system, which produce light by a chemical reaction to label an antibody to determine the concentration of an analyte. The chemiluminescence immunoassay has the advantages of high analysis sensitivity, wide linear range, no interference of scattered light, no radioactive pollutant and the like. Therefore, the method is widely applied to the fields of life science, clinical diagnosis and the like. Chemiluminescent immunoassay comprises a sandwich or competition method, wherein the competition method competes the antibody with the enzyme-labeled antigen and the standard antigen, and the larger the standard antigen concentration, the less enzyme-labeled antigen is bound to the antibody, the smaller the RLU and the B/B. The smaller the value. As shown in fig. 1, a schematic diagram of the execution steps of the contention method is shown.
In the prior art, dxi, dxi, access2 and the like of Beckmann Coulter are all widely used full-automatic chemiluminescence immunoassay analyzers. In the chemiluminescent immunoassay step, magnetic particles coated with corresponding antibodies are required to be added, so that immunoreaction products are combined on the magnetic particles, then a luminescent substrate is added after magnetic field separation and washing, and finally luminescent intensity (RLU) is detected by a luminescence analyzer, so that the content of an antigen in a specimen is determined. Thus, a plurality of solution chambers are integrated into a chemiluminescent immunoassay kit, one of which is used to encapsulate the antibody-coated magnetic particle reagent. Because the mass of the magnetic particles is heavy, the magnetic particles may be precipitated at the bottom in a stationary state. Therefore, the analyzer needs to mix the magnetic particle solution uniformly when sucking the magnetic particle solution. In the full-automatic chemiluminescence immunoassay analyzers such as Dxi, dxi and Access2 of Beckmann corporation, magnetic particle solutions are mixed and sucked mainly through probes with ultrasonic oscillation functions. However, the inventors found that the probe cannot penetrate into the bottom of the kit during the above-described mixing process, so that the mixing effect of the probe on the magnetic particles is poor and a long mixing time is required. Particularly, when the kit is kept stand for a long time, the concentration of the magnetic particles in the magnetic particle solution sucked by the probe is low because the magnetic particles are not completely mixed uniformly when detecting the previous one to two specimens, thereby influencing the detection result of the specimens.
Disclosure of Invention
In view of the above problems, the present application provides a chemiluminescent immunoassay kit for solving the technical problem of low mixing efficiency of magnetic particle solution of the chemiluminescent immunoassay kit in the above technology.
In order to achieve the above object, the present inventors provide a chemiluminescent immunoassay kit for use on a chemiluminescent immunoassay analyzer provided with a main probe provided with an ultrasonic oscillation module for driving the main probe to oscillate at high frequency while sucking a magnetic particle reagent;
the chemiluminescent immunoassay kit comprises a kit body and a membrane assembly covering an opening of the kit body; a plurality of chambers are arranged in the box body, and each chamber is correspondingly packaged with a reagent; the diaphragm assembly is provided with liquid taking holes corresponding to each cavity; one of the chambers is a first chamber for packaging the magnetic particle reagent, and the liquid taking hole corresponding to the first chamber is a first liquid taking hole;
the diaphragm assembly is provided with a flexible oscillating part at the periphery of the first liquid taking hole, and the oscillating part is contacted with the main probe when the main probe is inserted into the first liquid taking hole and can oscillate along with the main probe;
the bottom of the first chamber is provided with an oscillating piece, and the oscillating piece is connected with the oscillating part through a connecting piece, so that the oscillating piece oscillates along with the oscillating part to mix the magnetic particle reagent uniformly.
In some technical schemes, the oscillating portion includes a sleeve hole coaxially arranged at the bottom of the first liquid taking hole, when the main probe is inserted into the first liquid taking hole, the sleeve hole is sleeved at the periphery of the main probe, and the sleeve hole has elasticity and has a pore diameter smaller than the outer diameter of the main probe.
In some aspects, the membrane assembly comprises a flexible film layer; the oscillating portion is a part of the flexible film layer, and a thinned ring is arranged around the periphery of the oscillating portion, and the thickness of the thinned ring is smaller than that of the flexible film layer.
In some technical schemes, the liquid sampling device comprises two connecting pieces, wherein the two connecting pieces are symmetrically distributed on two sides of the first liquid sampling hole.
In some embodiments, the connector is integrally formed with the flexible film layer from the same material; and connecting holes for connecting the oscillating piece with the connecting piece are formed at two ends of the oscillating piece.
In some technical solutions, the oscillation piece is uniformly provided with a plurality of through holes, and the magnetic particle reagent shuttles through the through holes to form a flocculation flow around the oscillation piece when the oscillation piece oscillates.
In some embodiments, the oscillating piece is made of aluminum, aluminum alloy, or magnesium alloy.
In some embodiments, the membrane assembly further includes a sealing film disposed on a side of each of the liquid taking holes near the box body to seal each of the chambers; the connecting piece passes through the sealing membrane and extends into the first cavity, and the sealing membrane is connected with the connecting piece in a sealing way.
In some embodiments, the access opening is a self-sealing opening surrounded by a plurality of flexible membrane flaps.
In some technical schemes, the inner wall of the first chamber is provided with more than two limit protruding blocks, and the limit protruding blocks are located above the oscillating piece and used for limiting the upward moving space of the oscillating piece.
Compared with the prior art, the chemiluminescent immunoassay kit according to the technical scheme is characterized in that the periphery of the first liquid taking hole is provided with the oscillating part capable of oscillating along with the main probe, and the bottom of the first chamber is provided with the oscillating piece, and the oscillating piece is connected with the oscillating part through the connecting piece, so that when the main probe is inserted into the first chamber to perform high-frequency oscillation so as to mix magnetic particle reagents, the main probe can drive the connecting piece and the oscillating piece at the bottom to perform oscillation together through the oscillating part, so that the first chamber can be uniformly mixed in all aspects, and particularly the oscillating piece arranged at the bottom can effectively disturb magnetic particles deposited in a test, the mixing efficiency of the magnetic particle reagents is greatly improved, and detection errors caused by poor mixing effect are avoided.
The foregoing summary is merely an overview of the present application, and may be implemented according to the text and the accompanying drawings in order to make it clear to a person skilled in the art that the present application may be implemented, and in order to make the above-mentioned objects and other objects, features and advantages of the present application more easily understood, the following description will be given with reference to the specific embodiments and the accompanying drawings of the present application.
Drawings
The drawings are only for purposes of illustrating the principles, implementations, applications, features, and effects of the present application and are not to be construed as limiting the application.
In the drawings of the specification:
FIG. 1 is a schematic diagram of a competition immunoassay step in the prior art;
FIG. 2 is a schematic diagram showing a three-dimensional structure of a chemiluminescent immunoassay kit according to an embodiment;
FIG. 3 is a schematic diagram showing the internal structure of a chemiluminescent immunoassay kit according to an embodiment;
FIG. 4 is a cross-sectional view of a chemiluminescent immunoassay kit according to the specific embodiment taken along line A-A of FIG. 1;
FIG. 5 is an enlarged view of a portion B of FIG. 4;
reference numerals referred to in the above drawings are explained as follows:
1. a chemiluminescent immunoassay kit; 2. a main probe; 21. a clamping groove;
11. a diaphragm assembly; 12. a case body; 13. a connecting piece; 14. an oscillating piece; 111. a liquid taking hole; 112. an oscillating section; 113. a first liquid taking hole; 114. a socket hole; 121. a chamber; 122. a first chamber; 141. a limit bump;
Detailed Description
In order to describe the possible application scenarios, technical principles, practical embodiments, and the like of the present application in detail, the following description is made with reference to the specific embodiments and the accompanying drawings. The embodiments described herein are only for more clearly illustrating the technical aspects of the present application, and thus are only exemplary and not intended to limit the scope of the present application.
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 application. The appearances of the phrase "in various places in the specification are not necessarily all referring to the same embodiment, nor are they particularly limited to independence or relevance from other embodiments. In principle, in the present application, as long as there is no technical contradiction or conflict, the technical features mentioned in each embodiment may be combined in any manner to form a corresponding implementable technical solution.
Unless defined otherwise, technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present application pertains; the use of related terms herein is for the purpose of describing particular embodiments only and is not intended to limit the application.
In the description of the present application, the term "and/or" is a representation for describing a logical relationship between objects, which means that three relationships may exist, for example a and/or B, representing: there are three cases, a, B, and both a and B. In addition, the character "/" herein generally indicates that the front-to-back associated object is an "or" logical relationship.
In the present application, terms such as "first" and "second" are used merely to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual number, order, or sequence of such entities or operations.
Without further limitation, the use of the terms "comprising," "including," "having," or other like open-ended terms in this application are intended to cover a non-exclusive inclusion, such that a process, method, or article of manufacture that comprises a list of elements does not include additional elements in the process, method, or article of manufacture, but may include other elements not expressly listed or inherent to such process, method, or article of manufacture.
As in the understanding of "review guidelines," the expressions "greater than", "less than", "exceeding" and the like are understood to exclude this number in the present application; the expressions "above", "below", "within" and the like are understood to include this number. Furthermore, in the description of embodiments of the present application, the meaning of "a plurality of" is two or more (including two), and similarly, the expression "a plurality of" is also to be understood as such, for example, "a plurality of" and the like, unless specifically defined otherwise.
In the description of embodiments of the present application, spatially relative terms such as "center," "longitudinal," "transverse," "length," "width," "thickness," "up," "down," "front," "back," "left," "right," "vertical," "horizontal," "vertical," "top," "bottom," "inner," "outer," "clockwise," "counter-clockwise," "axial," "radial," "circumferential," etc., are used herein as a basis for the description of the embodiments or as a basis for the description of the embodiments, and are not intended to indicate or imply that the devices or components referred to must have a particular position, a particular orientation, or be configured or operated in a particular orientation and therefore should not be construed as limiting the embodiments of the present application.
Unless specifically stated or limited otherwise, the terms "mounted," "connected," "affixed," "disposed," and the like as used in the description of embodiments of the application should be construed broadly. For example, the "connection" may be a fixed connection, a detachable connection, or an integral arrangement; the device can be mechanically connected, electrically connected and communicated; it can be directly connected or indirectly connected through an intermediate medium; which may be a communication between two elements or an interaction between two elements. The specific meaning of the above terms in the embodiments of the present application can be understood by those skilled in the art to which the present application pertains according to circumstances.
Referring to fig. 2 to 5, the present embodiment provides a chemiluminescent immunoassay kit. The chemiluminescent immunoassay kit 1 can be applied to chemiluminescent immunoassay instruments such as Dxi, dxi and Access2 of Beckmann coulter company, different immunoassay reagents and magnetic particle reagents required by the same immunoassay can be packaged in the chemiluminescent immunoassay kit 1, one chemiluminescent immunoassay kit 1 corresponds to one immunoassay, wherein the magnetic particle reagent is a magnetic particle solution coated with antibodies corresponding to immunoassay items, and therefore, the chemiluminescent immunoassay kit can be used for HCG value detection, CA199 tumor markers, alpha embryo concentration detection and other immunoassays. At least one main probe is arranged on Dxi, dxi and Access2 of Kelman Kort company, and is connected with a precision valve, a precision pump, a flushing valve and a flushing pump, and the main probe can automatically suck detected specimens (serum), flushing liquid and detection reagents, so that the chemiluminescent immunoassay analyzer can automatically detect. The main probe is provided with an ultrasonic oscillation module to drive the main probe to perform high-frequency oscillation, the main probe needs to move to a cleaning tower (cleaning liquid flows in the cleaning tower) after absorbing one liquid, and the main probe is driven to perform high-frequency oscillation cleaning through the ultrasonic oscillation module; and when the main probe is inserted into the magnetic particle reagent of the chemiluminescent immunoassay kit to absorb the magnetic particle reagent, the ultrasonic oscillation module is started to drive the main probe to oscillate at high frequency so as to mix the magnetic particle reagent uniformly. The magnetic particles in the magnetic particle reagent are precipitated at the bottom of the kit, and the contact surface of the main probe is limited, so that the magnetic particles are not easy to be fully and uniformly mixed. In this embodiment, the oscillation piece is disposed at the bottom of the first chamber for encapsulating the magnetic particle reagent, and the oscillation piece is physically connected to the main probe, so that the main probe can drive oscillation, and therefore, the magnetic particles deposited at the bottom can be uniformly mixed by oscillation, and the oscillation efficiency of the magnetic particle reagent is improved.
As shown in fig. 2 and 3, the chemiluminescent immunoassay kit 1 is used on a chemiluminescent immunoassay analyzer, the chemiluminescent immunoassay analyzer is provided with a main probe 2, the main probe is provided with an ultrasonic oscillation module, and the ultrasonic oscillation module is used for driving the main probe to perform high-frequency oscillation when absorbing magnetic particle reagents.
The chemiluminescent immunoassay kit 1 comprises a kit body 12 and a membrane assembly 11 covering an opening of the kit body; a plurality of chambers 121 are arranged in the box body 12, and each chamber is correspondingly packaged with a reagent; the diaphragm assembly 11 is provided with a liquid taking hole 111 corresponding to each chamber; one of the chambers is a first chamber 122 for packaging the magnetic particle reagent, and the liquid taking hole corresponding to the first chamber is a first liquid taking hole 113.
The diaphragm assembly 11 has a flexible oscillating portion 112 at the outer periphery of the first liquid taking hole, and the oscillating portion 112 is in contact with the main probe 2 and can oscillate with the main probe 2 when the main probe 2 is inserted into the first liquid taking hole 113; the bottom of the first chamber 122 is provided with an oscillating plate 14, and the oscillating plate 14 is connected with the oscillating portion 112 through a connecting piece 13, so that the oscillating plate 14 vibrates along with the oscillating portion 112 to mix the magnetic particle reagent.
The main probe may be, but is not limited to, the main probes on the Kman Coulter Dxi, dxi, 600, access2 chemiluminescent immunoassay analyzer described above. The main probe can also be a probe on other immunity analyzers which are provided with an ultrasonic oscillation module for carrying out oscillation and uniform mixing, similar to Dxi and 800. The case may be made of medical grade plastic such as PVC, PP, etc., and the membrane assembly 11 includes the flexible film layer made of an elastic nonmetallic material provided on the topmost layer, and a sealing film laminated with the flexible film layer. The flexible film layer can be made of flexible silica gel, rubber and the like, the sealing film is arranged on the lower surface of the flexible film layer, and the liquid taking holes are formed in the flexible film layer and penetrate through the upper surface and the lower surface of the flexible film layer. The sealing film is in sealing connection with the opening of the box body, and the sealing film is in sealing connection with the opening of each cavity.
The oscillating piece 14 may be made of iron, aluminum alloy, etc., the oscillating piece 14 is in a sheet structure, the oscillating piece 14 may be rectangular, circular, triangular, etc., and the size of the oscillating piece 14 may be equal to (slightly smaller than) the bottom size of the first chamber. The oscillating piece can be attached to the bottom surface of the first chamber under the action of gravity, so that the magnetic particles can be directly deposited on the upper surface of the oscillating piece.
In the production process, the oscillating piece 14 can be connected with the connecting piece 13, then the oscillating piece 14 is arranged at the bottom of the first cavity, then corresponding reagents are injected into each cavity of the box body, then the sealing film is covered at the opening of the box body through the sealing equipment, the connecting piece penetrates through the sealing film, finally the flexible film layer is covered, and the oscillating part of the flexible film layer is connected with the top of the connecting piece.
In the process of sucking the magnetic particle reagent by the main probe, the main probe 2 is inserted into the first liquid taking hole 113, the middle part of the oscillating part 112 is tightly matched with the main probe 2, and when the main probe 2 starts the ultrasonic oscillating module to perform oscillation and uniform mixing, the main probe 2 drives the oscillating part 112 to oscillate (or vibrate), and the oscillating part 112 drives the connecting piece 13 and the oscillating piece to vibrate. Therefore, the main probe can drive the connecting piece and the oscillating piece at the bottom to oscillate together through the oscillating part, so that the first chamber 122 can be subjected to full-scale oscillation and uniform mixing, and particularly the oscillating piece at the bottom can effectively disturb magnetic particles deposited in a test question, so that the uniform mixing efficiency of the magnetic particle reagent is greatly improved, and detection errors caused by poor uniform mixing effect are avoided.
In some embodiments, to avoid contamination of the chemiluminescent immunoassay kit after use, the access well is a self-sealing aperture defined by a plurality of flexible membrane flaps. A liquid taking hole can be formed by encircling 3, 4 or more flexible membrane petals, when a main probe is inserted into the liquid taking hole, the flexible membrane petals can be elastically spread outwards, and when the main probe is extracted from the liquid taking hole, the flexible membrane petals can rebound towards the middle part to be closed, so that the cavity is isolated from the outside.
As shown in fig. 4 and 5, in an embodiment, in order to enable the oscillating portion 112 to be in close contact with the main probe 2, the oscillating portion is made to oscillate with the main probe 2 more well. The oscillating portion 112 includes a socket hole 114 coaxially disposed at the bottom of the first liquid taking hole 113, when the main probe 2 is inserted into the first liquid taking hole 113, the socket hole 114 is sleeved on the periphery of the main probe, and the socket hole 114 has elasticity and has a pore diameter smaller than the outer diameter of the main probe 2.
Since the socket hole 114 has elasticity and has a smaller diameter than the outer diameter of the main probe 2, when the main probe 2 is inserted into the first liquid-taking hole 113, the socket hole 114 can be tightly sleeved on the outer circumference of the main probe 2, so that the high-frequency oscillation of the main probe 2 can be transmitted to the oscillating part in a limited manner by the static friction force between the socket hole 114 and the main probe 2. As shown in fig. 5, in some embodiments, a clamping groove 21 adapted to the socket hole 114 is further provided on the outer periphery of the main probe 2. The clamping groove 21 can be formed by inwards recessing the outer surface of the main probe 2, and the thickness of the sleeving hole is equal to the width of the clamping groove 21, so that the outer ring of the sleeving hole can be well clamped into the clamping groove.
As shown in fig. 4, in one embodiment, the diaphragm assembly 11 comprises a flexible film layer; the oscillating portion is a part of the flexible film layer, and a thinned ring 1121 is provided around the outer circumference of the oscillating portion, and the thickness of the thinned ring 1121 is smaller than that of the flexible film layer. Wherein, the liquid taking holes are all arranged on the flexible film layer, and the thinning ring 1121 is an annular groove with the first liquid taking hole 113 as the center formed by thinning treatment. The thinning treatment comprises the steps of digging out the material on the periphery of the oscillating part after the flexible film layer is formed, or arranging a retainer ring in a glue injection model of the flexible film layer so as to thin the thickness of the corresponding position.
In the present embodiment, the thinned ring 1121 is provided at the outer periphery of the oscillating portion, so that the oscillating resistance of the oscillating portion 112 is made smaller, the oscillating response of the oscillating portion 112 is better, and the oscillating energy is blocked inside the thinned ring 1121, avoiding the transmission of idle work outside the oscillating portion.
As shown in fig. 3 and 4, in some embodiments, two connectors 13 are included, and the two connectors are symmetrically distributed on two sides of the first liquid taking hole 113. That is, the oscillating portion 112 is connected with two connectors 13, the two connectors 13 are symmetrically distributed on two sides of the first liquid taking hole 113, and bottoms of the two connectors 13 are respectively connected with two sides of the oscillating piece 14. Therefore, the whole oscillating piece can be driven to oscillate together better.
In some embodiments, the sealing film in the diaphragm assembly 11 is disposed on a side of each liquid taking hole near the box body to seal each chamber; and the connecting member 13 extends into the first chamber through the sealing membrane, and the sealing membrane is in sealing connection with the connecting member.
In other embodiments, the connector 13 is integrally formed with the flexible film layer from the same material; and connecting holes for connecting the oscillating piece with the connecting piece are formed at two ends of the oscillating piece. In this embodiment, the flexible film layer may be directly connected with the box 12 in a sealing manner, and seal each cavity through the flexible film layer, the liquid taking holes are disposed on the flexible film layer, and the sealing film is disposed on the upper surface of the flexible film layer to seal each liquid taking hole. In this embodiment, the connecting member 13 and the flexible film layer are integrally formed of the same material, so that the production process of the chemiluminescent immunoassay kit can be reduced. During production, corresponding reagents can be injected into each cavity of the box body, the oscillating piece is connected with the connecting piece and is put into the first cavity, then the flexible film layer connected with the oscillating piece is sealed at the opening of the box body, and finally the sealing film is sealed on the upper surface of the flexible film layer. The sealing membrane may be removed at the time of use or pierced directly by the main probe.
In some embodiments, the oscillation plate 14 is uniformly provided with a plurality of through holes, and the magnetic particle reagent shuttles around the oscillation plate to form a flocculation flow around the oscillation plate when the oscillation plate oscillates.
In the present embodiment, the provision of the through holes in the oscillation plate 14 allows for a reduction in the weight of the oscillation plate 14 on the one hand and a reduction in the resistance to oscillation in the reagent on the other hand, both of which allow for a better oscillation response of the oscillation plate. And when the oscillating piece 14 oscillates, the magnetic particle reagent shuttles through the through holes to form flocculation flow around the oscillating piece, and the flocculation flow can stir the reagent at the bottom of the first chamber up and down, so that the magnetic particles deposited at the bottom are more fully mixed.
In some embodiments, the oscillating piece is made of aluminum, aluminum alloy, or magnesium alloy. In this embodiment, the aluminum, aluminum alloy or magnesium alloy has a good cold insulation effect, and when the chemiluminescent immunoassay kit is taken down from the analyzer, the oscillation piece of the aluminum, aluminum alloy or magnesium alloy can slow down the temperature rise of the reagent in the chemiluminescent immunoassay kit, so that the probability of deterioration of the chemiluminescent immunoassay kit caused by long-time placement outside the machine is reduced.
As shown in fig. 4, in some embodiments, the inner wall of the first chamber is provided with more than two limiting protrusions 141, and the limiting protrusions 141 are located above the oscillating piece 14 and are used for limiting the upward movement space of the oscillating piece 14.
Finally, it should be noted that, although the embodiments have been described in the text and the drawings, the scope of the application is not limited thereby. The technical scheme generated by replacing or modifying the equivalent structure or equivalent flow by utilizing the content recorded in the text and the drawings of the specification based on the essential idea of the application, and the technical scheme of the embodiment directly or indirectly implemented in other related technical fields are included in the patent protection scope of the application.

Claims (10)

1. The chemiluminescent immunoassay kit is used for a chemiluminescent immunoassay analyzer, the chemiluminescent immunoassay analyzer is provided with a main probe, the main probe is provided with an ultrasonic oscillation module, and the ultrasonic oscillation module is used for driving the main probe to oscillate at high frequency when absorbing magnetic particle reagents;
the chemiluminescent immunoassay kit is characterized by comprising a kit body and a membrane assembly covering an opening of the kit body; a plurality of chambers are arranged in the box body, and each chamber is correspondingly packaged with a reagent; the diaphragm assembly is provided with liquid taking holes corresponding to each cavity; one of the chambers is a first chamber for packaging the magnetic particle reagent, and the liquid taking hole corresponding to the first chamber is a first liquid taking hole;
the diaphragm assembly is provided with a flexible oscillating part at the periphery of the first liquid taking hole, and the oscillating part is contacted with the main probe when the main probe is inserted into the first liquid taking hole and can oscillate along with the main probe;
the bottom of the first chamber is provided with an oscillating piece, and the oscillating piece is connected with the oscillating part through a connecting piece, so that the oscillating piece vibrates along with the oscillating part to mix the magnetic particle reagent uniformly.
2. The chemiluminescent immunoassay kit of claim 1 wherein the oscillating portion comprises a socket hole coaxially disposed at the bottom of the first access hole, the socket hole being in socket contact with the outer circumference of the primary probe when the primary probe is inserted into the first access hole, the socket hole having elasticity and a smaller diameter than the outer diameter of the primary probe.
3. The chemiluminescent immunoassay kit of claim 1 or 2 wherein the membrane assembly comprises a flexible film layer; the oscillating portion is a part of the flexible film layer, and a thinned ring is arranged around the periphery of the oscillating portion, and the thickness of the thinned ring is smaller than that of the flexible film layer.
4. The chemiluminescent immunoassay kit of claim 2 comprising two of the connectors symmetrically disposed on opposite sides of the first access well.
5. The chemiluminescent immunoassay kit of claim 3 wherein the connector and the flexible film layer are integrally formed of the same material; and connecting holes for connecting the oscillating piece with the connecting piece are formed at two ends of the oscillating piece.
6. The chemiluminescent immunoassay kit of claim 1 or 2 wherein the oscillation plate is uniformly provided with a plurality of through holes, wherein the magnetic particle reagent shuttles around the oscillation plate as the oscillation plate oscillates to form a flocculation flow around the oscillation plate.
7. The chemiluminescent immunoassay kit of claim 1 wherein the shaker sheet is made of aluminum, aluminum alloy or magnesium alloy.
8. The chemiluminescent immunoassay kit of claim 1 wherein the membrane assembly further comprises a sealing membrane disposed on a side of each access aperture adjacent the cartridge body to seal each chamber; the connecting piece passes through the sealing membrane and extends into the first cavity, and the sealing membrane is connected with the connecting piece in a sealing way.
9. The chemiluminescent immunoassay kit of claim 1 wherein the access aperture is a self-sealing aperture defined by a plurality of flexible membrane flaps.
10. The chemiluminescent immunoassay kit of claim 1 wherein the inner wall of the first chamber is provided with two or more stop bumps, the stop bumps being positioned above the oscillation plate for limiting the upward space of the oscillation plate.
CN202310674702.7A 2023-06-08 2023-06-08 Chemiluminescence immunoassay kit Pending CN116908435A (en)

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CN202310674702.7A CN116908435A (en) 2023-06-08 2023-06-08 Chemiluminescence immunoassay kit

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