Single-serve magnetic microparticle chemiluminescent reagent strip

Abstract

The application discloses a single-person portion magnetic microparticle chemiluminescence reagent strip, which comprises a reagent strip body and a light measuring unit, the light measuring unit is clamped on the reagent strip body, and the light measuring unit is provided with a light measuring hole and a first substrate hole; the reagent strip body is sequentially provided with a first hole, a second hole, a clamping jaw hole, a third hole, a reaction hole, a fourth hole, a first washing liquid hole and a magnetic bead cleaning hole from the first substrate hole to the other end; the first hole, the second hole, the third hole, the reaction hole and the fourth hole are provided with the same hole outline; and the clamping jaw hole is close to the middle position of the reagent strip body. The light measuring hole is located at the leftmost end of the reagent strip body, so that the reaction reagent is prevented from polluting the light measuring hole in the sample adding and taking process and causing light measuring error, and the reliability of the detection result is improved; the magnetic bead cleaning hole is located at the other end of the reagent strip body, so that the magnetic bead cleaning hole provides a space for the magnet to enter and exit, the adsorption of the magnetic bead in the cleaning process is realized, and the normal performance of the cleaning step is ensured; and the hole outlines of the holes are unified, so that the unified puncture is facilitated.

Description

Technical Field

[0001] The present invention relates to the field of in vitro diagnosis, and in particular to a single-dose magnetic particle chemiluminescence reagent strip. Background Art

[0002] Magnetic particle chemiluminescence immunoassay technology is an emerging analytical method that combines magnetic separation technology, chemiluminescence technology, and immunoassay technology. It is a highly sensitive micro-determination technology that has developed very rapidly worldwide in the past decade. It is used for the detection and analysis of various antigens, haptens, antibodies, hormones, enzymes, fatty acids, vitamins, and drugs.

[0003] Currently, most fully automated chemiluminescence immunoassay devices on the market, based on magnetic microparticle chemiluminescence immunoassay technology, are designed for multi-person testing. Large-scale test reagents are concentrated in the device's reagent compartment, and batches of samples are tested simultaneously during testing. This testing method currently has the following drawbacks: First, the injection needle needs to repeatedly draw up different reagents used in the test items and add them to different samples to process the samples, inevitably leading to cross-contamination between different reagents or between different samples. Second, because most reagents are packaged in large, multi-person packages, when the sample test volume is small, there is no guarantee that the reagents will be used up within their validity period, resulting in unnecessary reagent waste. Frequent bottle openings can also cause some of the reagents to evaporate, affecting the reliability of the test results. Furthermore, fully automated chemiluminescence equipment is designed for batch testing and cannot meet the urgent testing needs of clinical emergency or outpatient samples.

[0004] POCT, or point-of-care testing, refers to clinical and bedside testing performed next to the patient. It is fast, easy to use, and cost-effective, and has been widely used in the field of biological testing, such as cardiac marker POCT.

[0005] Most POCT instruments currently on the market are magnetic microparticle chemiluminescence detection instruments. The reagent strips used with these instruments are single-dose reagent strips (i.e., one strip per sample). The wells of the reagent strips contain reaction reagents, magnetic beads, and wash solutions to meet the testing requirements of the sample. Existing single-dose reagent strips have multiple wells integrated into a connecting plate. However, the following problems are common during use:

[0006] First, before the test, the black photometric cup needs to be manually installed in the mounting hole of the connecting plate, which is cumbersome to operate; second, the shapes of the holes of the reagent strip vary greatly, which is not conducive to uniform puncture; third, when in use, it needs to be manually placed in the test chamber and positioned, which is inaccurate and easy to rotate, and it is inconvenient to place and easy to tip over; after the test is completed, the reagent strip needs to be manually removed from the test chamber, which requires a lot of manual intervention; fourth, the washing holes of some reagent strips are equipped with reusable brush rods and bristles, and the brush bristles are used to clean the residue in the cleaning hole, which inevitably leads to cross contamination. Summary of the Invention

[0007] In view of this, the present invention provides a single-person magnetic particle chemiluminescence reagent strip, which not only integrates the photometric hole on the reagent strip body, eliminating the need for manual installation of the photometric hole, but also unifies the shape of the hole openings of each hole, facilitating unified puncture; it also has a clamping hole, through which the reagent strip can be clamped and removed, thereby improving the degree of automation.

[0008] To achieve the above object, the present invention adopts the following technical solutions:

[0009] The single-dose magnetic microparticle chemiluminescent reagent strip of the present invention comprises a reagent strip body made of a transparent material and a photometric unit made of a light-shielding material, with a sealing film on the reagent strip body. The photometric unit is mounted on one end of the reagent strip body, has a photometric hole and a first substrate hole, and is interference-fitted into the mounting hole of the reagent strip body. A sealing film is provided above the first substrate hole. During use, there is no need to manually install the photometric unit or add a substrate separately.

[0010] The reagent strip body has a first hole, a second hole, a clamping hole, a third hole, a reaction hole, a fourth hole, a first washing liquid hole and a magnetic bead washing hole in sequence from the first substrate hole to the other end. The first hole, the second hole, the third hole, the reaction hole and the fourth hole have the same hole opening profile, which is conducive to the puncture head on the detection instrument to uniformly puncture the sealing film and avoid incomplete puncture.

[0011] The clamping claw hole is close to the middle of the reagent strip body, and the lower part of the hole wall of the clamping claw hole has a plurality of vertical through slots to allow the clamping claw to extend, so as to facilitate the taking, placing and transferring of the reagent strip.

[0012] In the above scheme, the photometric hole of the photometric unit is located at one end of the reagent strip body, that is, the photometric hole is located at the leftmost end of the reagent strip body (that is, the end of the detection instrument), thereby preventing the reaction reagent from contaminating the photometric hole during the sample addition and sampling process, thereby improving the reliability of the detection results. The magnetic bead washing hole is located at the other end of the reagent strip body, providing space for the magnet to enter and exit, so as to achieve the adsorption of magnetic beads during the washing process and ensure the normal progress of the washing step.

[0013] This technical solution also unifies the orifice contours of each well as much as possible, so as to puncture multiple wells of the reagent strip as uniformly as possible, thereby facilitating subsequent sampling and adding of samples.

[0014] Preferably, the first, second, and third wells have the same structure, each comprising a connected upper cylindrical section and a lower conical section. The first and second wells are reagent wells containing reagents, and the second well is a second wash well containing wash solution. The third well is a first dilution well containing sample diluent. The number of second wells is 2-4 to meet the cleaning requirements of different testing projects. The number of third wells is 2-4, allowing the sample to be diluted to different concentrations to meet testing requirements.

[0015] Preferably, there are two first holes, namely a second substrate hole and a signal enhancer hole;

[0016] The fourth holes are conical structures that are larger at the top and smaller at the bottom. There are three fourth holes, which are the enzyme hole, the second dilution hole and the sample hole from left to right. The sealing film has openings corresponding to the sample holes.

[0017] During actual processing, the bottom of the signal enhancer hole and the first wash solution hole are provided with cross-shaped positioning ribs. The signal enhancer hole and the first wash solution hole are located at both ends of the reagent strip body. The positioning ribs have a supporting function, which facilitates the placement of the reagent strip.

[0018] The first hole, the second hole, the clamping hole, the third hole, the reaction hole, the fourth hole, the first washing liquid hole and the magnetic bead washing hole are connected together by reinforcing ribs to improve the structural strength of the reagent strip body.

[0019] Preferably, one end of the sealing film extends to the position of the first substrate well to seal the first substrate well. The first substrate well of the photometric unit is pre-loaded with substrate A, so the sealing film is used to seal the first substrate well during heat sealing to achieve the encapsulation of substrate A and ensure normal detection of the test item;

[0020] During actual processing, the photometric hole is a conical structure with a taper less than 2°. The photometric hole has a relatively small taper, so that the internal light signal can be completely emitted, and the luminescent substance can be as close as possible to the instrument's photometric system under quantitative liquid conditions; the inner diameter of the upper port of the photometric hole is controlled at 4 to 8 mm to avoid contact between external air and the mixture in the photometric hole as much as possible, thereby reducing detection errors; the wall thickness of the photometric hole is 0.4 to 0.8 mm, and heating incubation can be achieved while meeting the requirements of light-proof detection, so that the reaction system in the photometric hole can heat up rapidly.

[0021] Preferably, the upper edges of the first, second, clamping, third, reaction, fourth, first wash, and magnetic bead wash holes are provided with encapsulation bosses of equal height. Furthermore, reinforcing bosses of equal height are provided between the first, second, clamping, third, reaction, and fourth holes, with the encapsulation bosses and reinforcing bosses being of the same height. During film sealing, the encapsulation bosses facilitate heat sealing, while the reinforcing bosses reinforce and support the film, further ensuring a satisfactory film seal.

[0022] More preferably, the upper surface of the reagent strip body is further provided with a circle of heat-sealing protrusions whose height is lower than the packaging boss, and the heat-sealing protrusions surround all the holes except the magnetic bead cleaning hole and the photometric unit, making the sealing film bonded to the reagent strip body more beautiful.

[0023] Preferably, the openings of the first, second, third, reaction, and fourth holes are annular openings formed by alternating straight and arcuate segments. The consistent contours of the openings of the multiple holes facilitate uniform puncture of the sealing membrane by the puncture head of the detection instrument. In actual processing, the annular opening is preferably formed by alternating two straight segments of uniform length and two arcuate segments of equal size.

[0024] During actual processing, the magnetic bead cleaning hole is composed of a frustum-shaped section with a larger top and a smaller bottom, a vertical magnetic bead enrichment section and an arc-shaped bottom with a larger top and a smaller bottom, from top to bottom. The upper port of the frustum-shaped section is a square structure. The magnetic bead enrichment section has an enrichment surface for adsorbing magnetic beads, and the angle between the enrichment surface and the central axis of the magnetic bead cleaning hole is less than 5°.

[0025] In this solution, the magnetic bead cleaning hole has a frustum-shaped section with a square upper end, which can maximize the capacity of the magnetic bead cleaning hole to meet cleaning needs. The frustum-shaped section is similar to a trumpet mouth, and the frustum-shaped section and the packaging boss at its edge cooperate to effectively prevent liquid from splashing onto the upper surface or adjacent holes during repeated liquid injection during the cleaning process, thereby avoiding contamination.

[0026] The enrichment surface of the magnetic bead enrichment section is nearly vertical, which can achieve rapid enrichment of magnetic beads and prevent the magnetic beads from hanging on the wall during enrichment or movement;

[0027] The magnetic bead washing hole has a curved bottom that is larger at the top and smaller at the bottom. When injecting liquid, a vortex can be formed to fully mix the magnetic beads and reagents and collect them at the bottom, making the liquid extraction more complete and reducing the residual amount of reagents after extraction.

[0028] Preferably, during actual processing, the reagent strip body is an integrally formed structure, and the photometric unit is an integrally formed structure, to avoid improper assembly during use; in addition, the reagent strip of the present invention is a disposable consumable, to avoid contamination caused by repeated use.

[0029] Preferably, a positioning groove is provided at one end of the reagent strip body near the light measuring cup for clamping the pin on the reagent strip supporting platform, and the fourth hole of the conical structure is inserted into the conical hole on the reagent strip platform, thereby realizing the positioning and clamping of the reagent strip body on the reagent strip supporting platform, and preventing the reagent strip from shaking or shifting during operation; the other end of the reagent strip body is a handheld end, and the handheld end is provided with anti-slip grooves, which can increase friction, facilitate hand-held taking and placement, and prevent slipping.

[0030] Compared with the prior art, the present invention has the following advantages:

[0031] The present invention processes the photometric hole and the first substrate hole into an integrated structure, and encapsulates the first substrate hole on the reagent strip body. The photometric hole is interference-fitted on the reagent strip, thereby achieving pre-installation of the photometric hole on the reagent strip body. Manual installation is not required during testing, simplifying the operation.

[0032] The photometric hole of the present invention is located at one end of the reagent strip body, which prevents the reaction reagent from contaminating the photometric cup during the sample addition and sampling process, thereby improving the reliability of the test results. The magnetic bead cleaning hole is located at the other end of the reagent strip body, providing space for the magnet to enter and exit, thereby achieving the adsorption of magnetic beads during the cleaning process and ensuring the normal progress of the cleaning step.

[0033] The orifice profiles of the various holes of the present invention are consistent in structure, so that the multiple holes of the reagent strip can be punctured as uniformly as possible, which is convenient for subsequent sampling and addition. In addition, a clamping claw hole is provided near the middle of the reagent strip body, which is matched with the clamping claw of the POCT instrument to facilitate the removal, placement and transfer of the reagent strip. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 It is a structural schematic diagram of the present invention.

[0035] Figure 2 yes Figure 1 sectional view of .

[0036] Figure 3 yes Figure 1 Schematic diagram of the enlarged structure of part A in the middle.

[0037] Figure 4 yes Figure 1 Schematic diagram of the structure of the middle metering unit. DETAILED DESCRIPTION

[0038] The core purpose of the present invention is to provide a single-person magnetic particle luminescent reagent strip. The embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. This embodiment is implemented based on the technical solution of the present invention, and a detailed implementation method and specific operation process are given. However, the scope of protection of the present invention is not limited to the following embodiments.

[0039] like Figure 1-2 As shown, the single-dose magnetic microparticle chemiluminescent reagent strip described in this embodiment includes a reagent strip body made of a transparent material and a photometric unit 1 made of a light-proof material (the color of the photometric unit 1 is preferably black, but it can also be other light-proof colors). The photometric unit 1 is inserted into the two mounting holes at the left end of the reagent strip body. The photometric unit 1 has a photometric hole 1.1 and a first substrate hole 1.2 (encapsulating substrate A). The reagent strip body and the first substrate hole 1.2 are provided with a sealing film 2. The right end of the reagent strip body is a handheld end, which has anti-slip grooves F for easy hand-held placement. The photometric unit 1 is inserted into the mounting hole of the reagent strip body, and the first substrate hole 1.2 is provided with a sealing film 2. When in use, there is no need to manually reinstall the photometric unit 1, which simplifies the detection steps.

[0040] Combine Figure 1 and Figure 4 It can be seen that the photometric aperture 1.1 has a conical structure with a taper of less than 2°, which allows the internal light signal to be fully emitted and minimizes the distance between the luminescent material and the instrument's photometric system when using a fixed amount of liquid. In addition, the inner diameter of the upper end of the photometric aperture 1.1 is controlled to be 4-8mm, which can minimize contact between external air and the luminescent material in the photometric aperture, reducing detection errors.

[0041] The wall thickness of the photometric hole 1.1 is 0.4 to 0.8 mm, which can achieve heating incubation while meeting the light-shielding detection requirements, so that the reaction system in the photometric hole can be heated quickly.

[0042] like Figure 1-2 As shown, the reagent strip body is provided with a first hole 3, a second hole 4, a clamping hole 5, a third hole 6, a reaction hole 7, a fourth hole 8, a first wash liquid hole 9 and a magnetic bead washing hole 10 from left to right, and the hole opening contours of the first hole 3, the second hole 4, the third hole 6, the reaction hole 7 and the fourth hole 8 are the same, which is conducive to the puncture head on the detection instrument to uniformly puncture the sealing film 2 and avoid incomplete puncture.

[0043] To facilitate hole forming and processing, the openings of the first hole 3, the second hole 4, the third hole 6, the reaction hole 7, and the fourth hole 8 are annular openings formed by alternating two straight segments of the same length and two arc segments of the same arc length and radius. The consistent opening contours facilitate the uniform puncture of the sealing film 2 by the puncture head on the detection instrument.

[0044] In addition, in this embodiment, the photometric hole 1.1 is located at the leftmost end of the reagent strip body, which prevents the reaction reagent from contaminating the photometric hole 1.1 during the sample addition and sampling process and causing photometric errors, thereby improving the reliability of the test results; the magnetic bead cleaning hole 10 is located at the rightmost end of the reagent strip body, providing entry and exit space for the magnet on the instrument, thereby realizing the adsorption of magnetic beads and ensuring the normal progress of the cleaning step.

[0045] like Figure 1-2 As shown, the first hole 3, the second hole 4 and the third hole 6 have the same structure, and all include an upper cylindrical section and a lower conical section connected together. The capacity of the first hole 3, the second hole 4 and the third hole 6 is determined by the detection item and the type of packaged reagent. This embodiment is not limited to their capacity.

[0046] During actual processing, there are two first holes 3, which are the second substrate hole 3.1 encapsulating substrate B and the signal enhancer hole 3.2 from left to right; there are four second holes 4 and they are the second wash liquid holes encapsulating wash liquid; there are three third holes 6, which can dilute the sample into different concentrations to meet the detection requirements.

[0047] Combine Figure 1-2 It can be seen that the fourth hole 8 is a conical structure with a larger top and a smaller bottom. There are three fourth holes 8, which are enzyme hole 8.1, second dilution hole 8.2 and sample hole 8.3 from left to right. The sealing film 2 has an opening corresponding to the sample hole 8.3 to facilitate the injection of the sample.

[0048] Combine Figure 1-2 It can be seen that the reaction hole 7 is a conical structure with a taper less than 2 and has an arc bottom, which has a positioning function. The reaction hole 7 is mounted on the positioning card on the reagent strip carrier, which has a positioning function to prevent the reagent strip from shaking or shifting during operation.

[0049] like Figure 1 As shown, a positioning groove 11.1 is provided at the left end portion of the reagent strip body, which can be positioned with the pin on the reagent strip carrier to achieve positioning of the other end portion of the reagent strip body and improve stability;

[0050] The reaction hole 7 and the positioning groove 11.1 cooperate with each other to realize the positioning and placement of the reagent strip body on the carrier, thereby avoiding shaking or deviation during the detection process.

[0051] A cross-shaped positioning rib 11.2 is provided at the bottom of the signal enhancer hole 3.2 and the first washing liquid hole 9 (the bottom height of the positioning rib 11.2 is consistent). The signal enhancer hole 3.2 and the first washing liquid hole 9 are located at both ends of the reagent strip body, stably supporting the entire reagent strip and facilitating the placement of the reagent strip.

[0052] Preferably, the clamping hole 5 is located between the second washing liquid hole and the third hole 6, and the lower part of the hole wall of the clamping hole 5 has multiple vertical through grooves to allow the clamping claws to extend, so as to facilitate the placement and transfer of the reagent strip.

[0053] In other embodiments of the present invention, the first hole 3, the second wash hole, the clamp hole 5, the third hole 6, the reaction hole 7, the fourth hole 8, the first wash hole 9 and the magnetic bead cleaning hole 10 are connected together by reinforcing ribs 11.3 to improve the structural strength of the reagent strip body.

[0054] In actual processing, the upper port of the first washing liquid hole 9 is a large-capacity hole with a square structure to meet the cleaning requirements of the test items. Figure 1-3 It can be seen that the magnetic bead cleaning hole 10 comprises, from top to bottom, a frustum-shaped section 10.1 that is larger at the top and smaller at the bottom, a vertical magnetic bead enrichment section 10.2, and a curved bottom 10.3 that is larger at the top and smaller at the bottom. The frustum-shaped section 10.1, with its upper end being a square structure, maximizes the capacity of the magnetic bead cleaning hole to meet cleaning requirements.

[0055] The frustum-shaped section of the magnetic bead cleaning hole 10 makes the entire hole resemble a trumpet mouth. The frustum-shaped section 10.1 cooperates with the splash-proof convex edge 10.4 at its edge to prevent liquid from splashing onto the upper surface or adjacent holes during repeated injection during the cleaning process, further avoiding contamination.

[0056] The magnetic bead enrichment section 10.2 has an enrichment surface 10.2a for adsorbing magnetic beads, and the angle between the enrichment surface 10.2a and the central axis of the magnetic bead washing hole 10 is less than 5°. The enrichment surface 10.2a is nearly vertical, which not only enables rapid enrichment of magnetic beads but also prevents the magnetic beads from clinging to the wall during enrichment or movement.

[0057] The arc-shaped bottom 10.3 of the magnetic bead cleaning hole 10 can form a vortex when injecting liquid, realize vortex mixing, and make the reagent gather at the bottom after cleaning, so that the liquid extraction is more complete, the residual amount of reagent is reduced, and the magnetic bead cleaning effect is further ensured.

[0058] In other embodiments of the present invention, encapsulation bosses 11.4 of the same height are provided at the upper edge of the first hole 3, the second hole 4, the clamping hole 5, the third hole 6, the reaction hole 7, the fourth hole 8, the first wash solution hole 9, and the magnetic bead washing hole 10. That is, the upper surface of the reagent strip body corresponding to each hole is provided with an annular encapsulation boss 11.4 having the same structure as the hole opening, so as to facilitate heat sealing of the sealing film 2; a reinforcing boss 11.5 of the same height as the encapsulation boss may also be provided at the connection between two adjacent holes to provide reinforcement and support, thereby further ensuring the effectiveness of the sealing film 2.

[0059] More preferably, the upper surface of the reagent strip body is further provided with a circle of heat-sealing protrusions 11.6 whose height is lower than the packaging boss 11.4. The heat-sealing protrusions surround all the holes except the magnetic bead cleaning hole 10 and the photometric unit 1, making the sealing film 2 bonded to the reagent strip body more beautiful.

[0060] During actual processing, the reagent strip body is an integrally formed structure, and the light measuring unit 1 is an integrally formed structure, which avoids improper assembly during use; in addition, the reagent strip of the present invention is a disposable consumable, which avoids pollution caused by repeated use.

[0061] It should be noted that, in the description of the present invention, unless otherwise expressly specified or limited, the terms "installed," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integral connections; they may refer to mechanical connections or electrical connections; they may refer to direct connections or indirect connections through an intermediate medium; and they may refer to internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0062] Finally, it should be emphasized that the above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments without inventive effort, or replace some of the technical features therein with equivalents. Therefore, any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

Claims

1. A single-dose magnetic microparticle chemiluminescent reagent strip, comprising a reagent strip body made of a transparent material and a photometric unit made of a light-proof material, characterized in that: The photometric unit is clamped in the mounting hole at one end of the reagent strip body, the photometric unit has a photometric hole and a first substrate hole, the reagent strip body and the first substrate hole are provided with a sealing film, the photometric hole is a conical structure with a taper less than 2°, the inner diameter of the upper end of the photometric hole is 4 to 8 mm, and the wall thickness of the photometric hole is 0.4 to 0.8 mm; the reagent strip body has a first hole, a second hole, a clamping hole, a third hole, a reaction hole, a fourth hole, a first washing liquid hole and a magnetic bead washing hole in sequence from the first substrate hole to the other end, and the orifice profiles of the first hole, the second hole, the third hole, the reaction hole and the fourth hole are the same; the clamping hole is close to the middle position of the reagent strip body, and the lower part of the hole wall of the clamping hole has a plurality of vertical through grooves to allow the clamping claw to extend; the reagent strip body is an integrally formed structure, and the photometric unit is an integrally formed structure; There are two first holes, namely the second substrate hole and the signal enhancer hole. The bottoms of the signal enhancer hole and the first wash liquid hole are provided with cross-shaped positioning ribs; the first hole, the second hole, the clamp hole, the third hole, the reaction hole, the fourth hole, the first wash liquid hole and the magnetic bead washing hole are connected together by reinforcing ribs; The upper edges of the first hole, the second hole, the clamping hole, the third hole, the reaction hole, the fourth hole, the first wash solution hole, and the magnetic bead washing hole are provided with encapsulation bosses of the same height; reinforcing bosses of the same height are provided between the first hole, the second hole, the clamping hole, the third hole, the reaction hole, and the fourth hole, and the heights of the encapsulation bosses and the reinforcing bosses are consistent; the upper surface of the reagent strip body is also provided with a circle of heat-sealing bosses whose height is lower than the encapsulation bosses; The magnetic bead washing hole comprises, from top to bottom, a frustum-shaped section that is larger at the top and smaller at the bottom, a vertical magnetic bead enrichment section, and an arc-shaped bottom that is larger at the top and smaller at the bottom. The upper port of the frustum-shaped section is a square structure. The magnetic bead enrichment section has an enrichment surface for adsorbing magnetic beads, and the angle between the enrichment surface and the central axis of the magnetic bead washing hole is less than 5°.

2. The single-dose magnetic microparticle chemiluminescent reagent strip according to claim 1, characterized in that: The first hole, the second hole and the third hole have the same structure, and all include an upper cylindrical section and a lower conical section connected together; the first hole and the second hole are reagent holes encapsulated with reagents, and the second hole is a second washing liquid hole encapsulated with washing liquid; the third hole is a first dilution hole encapsulated with sample diluent.

3. The single-dose magnetic microparticle chemiluminescent reagent strip according to claim 2, characterized in that: The fourth holes are conical structures that are larger at the top and smaller at the bottom. There are three fourth holes, which are the enzyme hole, the second dilution hole and the sample hole from left to right. The sealing film has openings corresponding to the sample holes.

4. The single-dose magnetic microparticle chemiluminescent reagent strip according to claim 1, characterized in that: The openings of the first hole, the second hole, the third hole, the reaction hole and the fourth hole have the same shape, and are all annular openings formed by alternating straight line segments and arc segments.

5. The single-dose magnetic microparticle chemiluminescent reagent strip according to claim 1, characterized in that: A positioning groove is provided at one end of the reagent strip body near the light measuring hole; the other end of the reagent strip body is a hand-held end, and the hand-held end is provided with anti-slip grooves.

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