Chemiluminescence detection reagent strip

Abstract

The present invention discloses a chemiluminescence detection reagent strip, which comprises a reagent strip body. The reagent strip body includes a connecting piece in a strip structure and a first test tube assembly fixedly connected to the connecting piece. It further includes a reinforcement assembly for connecting the first test tube assembly and the connecting piece together, and a second test tube assembly encapsulated at one end of the connecting piece. The second test tube assembly has a reaction tube. In the present invention, the top of the reinforcement assembly is fixedly connected to the connecting piece, each orifice of the first test tube assembly is fixedly connected to the connecting piece, and the pore wall of each pore of the first test tube assembly is fixedly connected to the reinforcement assembly, which not only improves the structural stability of the reagent strip body, but also makes the appearance of the reagent strip beautiful and generous.

Description

Technical Field

[0001] The present invention relates to the field of in vitro diagnosis, and particularly to a chemiluminescence detection reagent strip. Background Art

[0002] At present, most of the mainstream chemiluminescence immunoassay instruments on the market are large-scale chemiluminescence instruments with high throughput, high sensitivity and high detection cost. This type of detection instrument is generally set in large hospitals or large testing institutions, so it is impossible to achieve on-site sampling, timely detection and quick results. At the same time, from the perspective of market development and the national promotion of hierarchical diagnosis and treatment, large-scale chemiluminescence instruments cannot meet the needs of primary hospitals, community hospitals and small testing institutions. Therefore, point-of-care testing (POCT) instruments have emerged on the market one after another.

[0003] Most of the existing POCT instruments on the market are magnetic particle chemiluminescence detection instruments. The reagent strip supporting this chemiluminescence detection instrument is a single-person reagent strip (that is, each sample corresponds to a reagent strip). The reaction reagent, magnetic beads, washing solution, etc. are encapsulated in the holes of the reagent strip to meet the detection needs of the sample.

[0004] Multiple holes of the existing single-person reagent strip are integrated on the connecting plate, and an installation opening is provided on the connecting plate. During detection, the reaction cup with black light shielding is manually clamped in the installation opening. This type of reagent strip has the following problems during detection: First, the reagent strip lacks a positioning structure and cannot achieve quick positioning and clamping of the reagent strip and the detection instrument; and because there are many integrated hole positions on the reagent and the length is often long, it is easy to deform during detection and affect subsequent detection; Second, manually placing the reaction cup not only increases the detection process and reduces the detection efficiency, but also the reaction cup is prone to tilt, affecting the reading, and the black reaction cup has a great influence on the photometric result, further affecting the accuracy of the detection result. Summary of the Invention

[0005] The purpose of the present invention is to provide a chemiluminescence detection reagent strip, which uses a reinforcement component to increase the structural strength of the reagent strip body and effectively avoid the deformation problem caused by too long length.

[0006] To achieve the above purpose, the present invention adopts the following technical solutions:

[0007] The chemiluminescence detection reagent strip of the present invention includes a connecting piece in a strip structure and a first test tube assembly fixedly connected to the connecting piece; it also includes a reinforcement component connecting the first test tube assembly and the connecting piece together, and a second test tube assembly movably clamped at one end of the connecting piece.

[0008] In a preferred embodiment of the present invention, the reinforcement assembly includes a reinforcing plate in a ring structure fixedly connected to the lower surface of the connecting member. The first test tube assembly is located inside the reinforcing plate, and the tube walls of the first test tube assembly are fixedly connected to the reinforcing plate through reinforcing ribs respectively.

[0009] In a preferred embodiment of the present invention, the first test tube assembly includes a sample test tube, a reagent test tube, and a washing solution test tube that are sequentially arranged at intervals from left to right on the connecting member. The mouths of the sample test tube, the reagent test tube, and the washing solution test tube are all provided with flanging edges fixedly connected to the connecting member, and the tops of the reagent test tube and the washing solution test tube are sealed with a first sealing film.

[0010] In a preferred embodiment of the present invention, a handle with anti-slip patterns is extended at the other end of the connecting member. More preferably, the bottom surface of the handle has a plurality of anti-slip grooves.

[0011] In a preferred embodiment of the present invention, an installation portion is extended to the right at one end of the connecting member, and an installation opening with an installation concave surface is formed on the installation portion; the second test tube assembly is on the installation opening through a second sealing film, including

[0012] an installation plate, the lower surface of the installation plate is attached to the installation concave surface, and the second sealing film seals the installation plate on the installation portion;

[0013] at least one substrate test tube, vertically fixedly connected to the installation plate, and at least one of the substrate test tubes extends downward out of the installation opening; and

[0014] a reaction tube, vertically arranged on the installation plate, and the reaction tube extends downward out of the installation opening.

[0015] In a preferred embodiment of the present invention, the reaction tube is a double-layer structure, which includes a light-shielding outer shell with an upper mouth fixedly connected to the installation plate and an inner reaction cup clamped inside the light-shielding outer shell; the substrate test tube is a light-shielding tube made of a light-shielding material.

[0016] In a preferred embodiment of the present invention, the upper mouth edge of the inner reaction cup extends upward out of the light-shielding outer shell to form a first limiting platform, and a second limiting platform in a ring structure is arranged on the outer periphery of the upper mouth edge of the light-shielding outer shell. The second limiting platform and the first limiting platform are arranged with a gap to form a positioning slot that matches the detection head of the detection instrument.

[0017] In a preferred embodiment of the present invention, the right side wall of the light-shielding outer shell is inclined and gradually converges leftward from top to bottom, and the right side wall of the inner reaction cup is attached to the inner side surface of the right side wall of the light-shielding outer shell.

[0018] The advantages of the present invention are that the top of the reinforcement component is fixedly connected to the connecting piece, each orifice of the first test tube component is fixedly connected to the connecting piece, and the pore wall of each pore of the first test tube component is fixedly connected to the reinforcement component, which not only improves the structural stability of the reagent strip body, but also makes the appearance of the reagent strip beautiful and generous.

[0019] The present invention integrates the substrate test tube and the reaction tube, and encapsulates the substrate test tube and the reaction tube on the connecting piece, realizing the fixed connection between the reaction tube and the connecting piece. When in use, there is no need to manually place the reaction tube, which simplifies the detection process, improves the detection efficiency, and can also prevent the reaction tube from tilting, laying a foundation for light measurement.

[0020] The bottoms of the sample test tube, reagent test tube and washing solution test tube of the present invention are all conical structures, which can position and clamp the reagent strip body in the mounting seat of the POCT detection instrument, not only improving the quick positioning and installation of the reagent strip body, but also improving the stability of the reagent strip body. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a schematic structural diagram of the present invention.

[0022] Figure 2 is Figure 1 the sectional view taken along the line A-A of

[0023] Figure 3 is an axonometric view of the present invention (the second test tube component is in an exploded state).

[0024] Figure 4 is Figure 3 the enlarged schematic structural diagram of part B in

[0025] Figure 5 is a schematic structural diagram of the second test tube component. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0026] The following will describe in detail the embodiments of the present invention with reference to the accompanying drawings. The present embodiments are implemented on the premise of the technical solution of the present invention, and detailed implementation manners and specific operation processes are given, but the protection scope of the present invention is not limited to the following embodiments.

[0027] As Figure 1 and Figure 2As shown in the figure, the chemiluminescence detection reagent strip of the present invention includes a connecting member in a strip structure (i.e., the connecting plate 1), a first test tube assembly fixedly connected to the connecting plate 1, a reinforcing assembly connecting the first test tube assembly and the connecting member together, and a second test tube assembly movably clamped at one end of the connecting member. The top of the reinforcing assembly is fixedly connected to the connecting plate 1, which increases the structural strength of the connecting plate 1. The first test tube assembly is not only fixedly connected to the connecting plate 1 but also fixedly connected to the reinforcing assembly, improving the overall strength of the reagent strip and overcoming the deformation problem caused by the too long length of the existing reagent strip.

[0028] As Figure 2 and Figure 3 shown in the figure, the reinforcing assembly includes a reinforcing plate 2 fixedly connected to the lower surface of the connecting plate 1. The reinforcing plate 2 is a rectangular structure surrounded by a pair of long reinforcing ribs and a pair of short reinforcing ribs. The first test tube assembly is located inside the reinforcing plate 2, and each tube wall of the first test tube assembly is fixed to the inner side surface of the reinforcing plate 2. The combined action of the reinforcing plate 2 and the connecting plate 1 provides the overall structural strength of the reagent strip body, improves the structural stability, and avoids the deformation problem caused by the too long length.

[0029] As Figure 1 and Figure 2 shown in the figure, the first test tube assembly includes a sample test tube 3, a reagent test tube 4, and a washing solution test tube 5 that are sequentially arranged at intervals from left to right on the connecting plate 1; among them:

[0030] The mouths of the sample test tube 3, the reagent test tube 4, and the washing solution test tube 5 are all provided with flanging edges fixedly connected to the connecting plate 1, and the height of the flanging edges is higher than the upper surface of the connecting plate 1, which is convenient for film sealing;

[0031] The lower parts of the sample test tube 3, the reagent test tube 4, and the washing solution test tube 5 are all conical curved surfaces, which not only increase the heating area, ensure uniform heating, improve the incubation effect, but also can quickly position and clamp the reagent strip body in the mounting seat of the POCT detection instrument, realizing the quick positioning and installation of the reagent strip body and improving the stability of the reagent strip body;

[0032] The sample test tube 3 includes a whole blood hole 3.1 and a sample hole 3.2 that are spaced left and right. A separation reagent is encapsulated in the whole blood hole 3.1 for separating the whole blood sample; the sample hole 3.2 is used to hold the sample;

[0033] The reagent test tube 4 includes a magnetic bead hole 4.1 (encapsulating magnetic beads), an enzyme hole 4.2 (encapsulating enzymes), a sample diluent hole 4.3 (encapsulating sample diluent), a sample dilution hole 4.4, and a substrate enhancer hole 4.5 (encapsulating substrate enhancer) that are sequentially arranged at intervals from left to right. The reagent test tube 4 encapsulates a variety of reagents, which can meet the detection needs of different detection items;

[0034] The washing solution test tube 5 includes washing solution holes arranged at intervals (a cleaning solution for cleaning the pipetting needle and magnetic beads is encapsulated in the washing solution holes), and the number of washing solution holes can be flexibly selected according to the reaction requirements;

[0035] A first sealing film is encapsulated on the upper surface of the connecting plate 1 to achieve the encapsulation of the reagent test tube, the washing solution test tube and the sample test tube; and an opening is provided on the first sealing film corresponding to the sample hole 3.2 to facilitate putting the sample (including serum and whole blood) into the sample hole 3.2.

[0036] Such as Figure 2 As shown, a handle 6.1 with anti-slip lines on its upper surface extends leftward from the left end of the connecting plate 1, and a plurality of anti-slip grooves 6.2 (i.e., anti-slip recesses) are provided on the bottom surface of the handle 6.1 to increase the friction force and facilitate hand-holding.

[0037] Such as Figure 4 As shown, the right end part of the connecting plate 1 is an installation part, and an installation opening 1.1 with an installation concave surface 1.2 is provided in the installation part; the second test tube assembly is clamped in the installation opening 1.1. The second test tube assembly includes an installation plate 7 clamped on the installation concave surface 1.2. Substrate test tubes 8 (two, encapsulated with a luminescent substrate) and reaction tubes are arranged at intervals from left to right on the installation plate 7. A second sealing film is encapsulated on the upper surface of the installation plate 7, and the second sealing film extends to the installation part of the connecting plate 1, which not only realizes the encapsulation of the substrate test tube 8, but also realizes the fixed connection between the installation plate 7 and the connecting plate 1, improving the stability of the second test tube assembly.

[0038] During actual processing, the substrate test tube 8 is a light-shielding tube made of a light-shielding material (such as black material); the reaction tube is of a double-layer structure, including a light-shielding outer shell 9.1 with its upper pipe mouth fixedly connected to the installation plate 7 and an inner reaction cup 9.2 (made of a white low-light-transmitting material) clamped in the light-shielding outer shell 9.1.

[0039] During actual processing, an annular positioning groove is provided in the upper part of the inner side surface of the light-shielding outer shell 9.1. Four convex strips 9.5 that cooperate with the positioning groove are arranged at intervals along the circumferential direction on the upper part of the outer side surface of the inner reaction cup 9.2. The convex strips 9.5 are clamped in the positioning groove to realize the positioning and clamping of the inner reaction cup 9.2 and the light-shielding outer shell 9.1. Specifically, as Figure 5 shown. Of course, during actual processing, a double-mold one-piece forming process can also be adopted to fixedly connect the formed light-shielding outer shell 9.1 and the inner reaction cup 9.2 together. Other positioning structures can also be adopted to realize the rapid positioning and installation of the inner reaction cup 9.2 and the light-shielding outer shell 9.1.

[0040] Such as Figure 2 And Figure 4As shown, the right side wall of the light-shielding housing 9.1 is inclined and gradually slopes inward from top to bottom. The right side wall of the inner reaction cup 9.2 is attached to the inner side surface of the right side wall of the light-shielding housing 9.1 (i.e., the inclination degree and direction of the right side wall of the inner reaction cup 9.2 are the same as those of the right side wall of the light-shielding housing 9.1). The right side wall of the inner reaction cup 9.2 and the right side wall of the inner reaction cup 9.2 are inclined, and magnetic beads are adsorbed on the right side wall of the inner reaction cup 9.2 (i.e., the inclined wall), ensuring the rinsing effect of the magnetic beads;

[0041] As Figure 4 shown, the upper edge of the inner reaction cup 9.2 extends upward out of the light-shielding housing 9.1 to form a first limiting platform 9.3. The upper edge of the light-shielding housing 9.1 is horizontally folded outward, and a second limiting platform 9.4 with an annular structure is arranged on the outer periphery of the upper edge of the light-shielding housing 9.1. The second limiting platform 9.4 and the first limiting platform 9.3 are arranged with a gap therebetween, enclosing a positioning slot 9.6 that matches the detection head of the detection instrument. During detection, the detection head can be clamped in the positioning slot 9.6 between the second limiting platform 9.4 and the first limiting platform 9.3, forming a light-shielding light-measuring environment and improving the light-measuring accuracy.

[0042] During heat sealing, the second limiting platform 9.4 and the light-shielding housing 9.1 are both encapsulated on the connecting plate 1 through a second sealing film, realizing the fixed connection between the light-shielding housing 9.1 and the connecting plate 1, improving the stability of the light-shielding housing 9.1, and effectively avoiding the phenomenon of skew of the light-shielding housing 9.1 during the detection process; the second sealing film corresponding to the inner reaction cup 9.2 has an opening, facilitating the addition of reagents and samples. During actual heat sealing, the first sealing film and the second sealing film can be an integral structure and are integrally encapsulated during encapsulation; the first sealing film and the second sealing film can also be a split structure and can be separately encapsulated during encapsulation.

[0043] The usage process of the reagent strip of the present invention is as follows: Hold the handle 6.1 with one hand and insert the reagent strip into the reagent rack of the detection instrument. Add a serum sample into the sample hole 3.2 (when the sample is a whole blood sample, add the whole blood into the sample hole 3.2, and then transfer the whole blood sample to the whole blood hole 3.1, and use the reagent encapsulated in the whole blood hole to separate the whole blood to meet the detection requirements). The pipetting needle of the detection instrument extracts a quantitative sample into the sample dilution hole 4.4, and then extracts the diluent in the sample diluent hole 4.3 into the sample dilution hole 4.4 to fully mix the diluent and the sample; Wash the pipetting needle with a washing solution. After the washing is completed, use the pipetting needle to transfer the diluted sample into the inner reaction cup 9.2, and then sequentially extract magnetic beads and enzymes into the inner reaction cup 9.2, mix the reagents and the sample in the inner reaction cup 9.2 evenly, and then perform a incubation reaction using the detection instrument;

[0044] After the reaction is completed, the magnet of the detection instrument is placed close to the right side wall of the light-proof housing 9.1. The magnetic beads are adsorbed on the right side wall of the inner reaction cup 9.2 under the action of the magnet. The waste liquid is removed with a pipette needle, and then the washing liquid is drawn with the pipette needle. The pipette needle is directly facing the right side wall of the inner reaction cup 9.2 and the liquid is injected, that is, the magnetic beads are washed along the slope of the inner reaction cup 9.2. The washing is repeated multiple times (the number of washing times can be flexibly selected according to the test items) to ensure the washing effect of the magnetic beads.

[0045] After the magnetic beads are washed, the substrate is extracted into the inner reaction cup 9.2, the substrate and the magnetic beads are mixed evenly, the substrate and the reactants on the magnetic beads undergo a luminescent reaction, and then the substrate enhancer is transferred into the inner reaction cup 9.2 to enhance the luminescence; the light measuring head of the detection instrument is moved to the reaction tube, and the light measuring head is sealed and clamped in the gap between the second limit platform 9.4 and the first limit platform 9.3. The light measuring head covers the inner reaction cup 9.2 to form a closed light-proof environment, and then light measurement is performed to complete the sample detection.

[0046] It should be noted that all directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of the present invention are only used to explain the direction of the object in a specific posture (such as the attached image). Figure 1 The relative positional relationship and movement conditions between the components (as shown) under the directional indication are as follows. If the specific posture changes, the directional indication will also change accordingly. In the present invention, unless otherwise clearly specified and limited, the terms "connection" and "fixed" should be understood in a broad sense. For example, "fixed" can be a fixed connection, a detachable connection, or an integral whole; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0047] In addition, the terms "first," "second," and so on, used in this disclosure are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, features specified as "first" or "second" may explicitly or implicitly include at least one of these features.

[0048] Finally, it should be noted that the present invention is not limited to the above-described embodiments and may be subject to many variations. All variations that can be directly derived or conceived by those skilled in the art from the disclosure of the present invention should be considered within the scope of protection of the present invention.

Claims

1. A chemiluminescence detection reagent strip, comprising a reagent strip body, the reagent strip body including a connecting member in a strip structure and a first test tube assembly fixedly connected to the connecting member; characterized in that: It further includes a reinforcement component for connecting the first test tube assembly to the connecting piece, and a second test tube assembly encapsulated at one end of the connecting piece, and the second test tube assembly has a reaction tube; the reinforcement component includes a reinforcing plate in a ring structure fixedly connected to the lower surface of the connecting piece, the first test tube assembly is located inside the reinforcing plate, and the tube walls of the first test tube assembly are all fixedly connected to the reinforcing plate; The first test tube assembly includes a sample test tube, a reagent test tube, and a washing solution test tube sequentially arranged on the connecting piece from left to right. The mouths of the sample test tube, the reagent test tube, and the washing solution test tube all have flanges fixedly connected to the connecting piece, and the tops of the reagent test tube and the washing solution test tube are encapsulated with a first sealing film; among them, the sample test tube includes a whole blood hole and a sample hole arranged at intervals left and right. A separation reagent is encapsulated in the whole blood hole, and the sample hole is used to hold a sample. The tube walls of the sample hole, the reagent test tube, and the washing solution test tube are sequentially fixedly connected; One end of the connecting piece extends rightward to be provided with an installation part, and an installation opening with an installation concave surface is formed in the installation part; the second test tube assembly is clamped in the installation opening, and it includes an installation plate, at least one substrate test tube, and the reaction tube. The lower surface of the installation plate is attached to the installation concave surface, and a second sealing film encapsulates the installation plate on the installation part; at least one substrate test tube is vertically fixedly connected to the installation plate, and at least one substrate test tube extends downward out of the installation opening; the reaction tube is vertically arranged on the installation plate, and the reaction tube extends downward out of the installation opening; The reaction tube is of a double-layer structure, and it includes a light-shielding outer shell with an upper tube mouth fixedly connected to the installation plate and an inner reaction cup clamped in the light-shielding outer shell; the substrate test tube is a light-shielding tube made of a light-shielding material.

2. The chemiluminescence detection reagent strip according to claim 1, wherein: The other end of the connecting piece extends to be provided with a handle with anti-slip patterns.

3. The chemiluminescence detection reagent strip according to claim 2, wherein: The bottom surface of the handle has a plurality of protective grooves.

4. The chemiluminescence detection reagent strip according to claim 1, characterized in that: The upper mouth edge of the inner reaction cup extends upward out of the light-shielding outer shell to form a first limiting platform, and a second limiting platform in a ring structure is arranged on the outer periphery of the upper mouth edge of the light-shielding outer shell. The second limiting platform and the first limiting platform are arranged at intervals to form a positioning slot that matches the detection head of the detection instrument.

5. The chemiluminescence detection reagent strip according to claim 1, wherein: The right side wall of the light-shielding outer shell is inclined and gradually inwardly converges from top to bottom, and the right side wall of the inner reaction cup is attached to the inner side surface of the right side wall of the light-shielding outer shell.

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