Single-person reagent strip

Abstract

The present application belongs to the technical field of chemiluminescent immunoassays and relates to a single-person reagent strip. The single-person reagent strip comprises a bottom plate and reagent cup sets; magnetic rod sleeving hole positions, a magnetic bead accommodation recess, at least two sets of reagent holes, and at least two mounting slots are provided on the bottom plate; and the reagent cup sets are detachably mounted in the mounting slots, each reagent cup set comprising a fixing plate and at least two reagent cups, the reagent cups being provided on the fixing plate, and the number of reagent cups corresponding to the number of reagent holes. In the technical solution provided in the present application, combined testing of a plurality of items can be carried out on one reagent strip according to medical testing requirements; testing efficiency is improved, and there is no interference between test items.

Description

A single-dose test strip

[0001] This application claims priority to a Chinese patent application filed on September 18, 2023, with application number 202322534194.0 and invention name “A Single-Person Reagent Strip”. The entire contents of the Chinese patent application are incorporated into this application. Technical Field

[0002] The present application relates to the technical field of chemiluminescent immunoassay, and more specifically, to a single-dose reagent strip. Background Art

[0003] Chemiluminescent immunoassays combine the high sensitivity of chemiluminescence with the high selectivity of immunoassays and are widely used in clinical testing, drug analysis, environmental monitoring, and other fields. To meet the needs of community hospitals and small testing institutions, a point-of-care testing (POCT) instrument based on a magnetic microparticle chemiluminescence system has been launched on the market. The instrument usually uses a matching single-person reagent strip for sampling, that is, each sample corresponds to a reagent strip. The existing reagent strips are pre-packaged with reaction reagents, magnetic beads, and a cleaning solution substrate solution to meet the testing needs of the sample.

[0004] However, in actual medical testing, patients often need to undergo multiple tests for different items, and the existing single-person reagent strips can only be used to test a single item for a single person at a time. In order to test multiple items, multiple reagent strips are required, resulting in a large consumption of reagent strips, which is not conducive to environmental protection and energy conservation. Although integrated joint testing of reagent strips has been launched on the market, its fixed item setting has poor adaptability to patients, low cost performance, and inconvenient operation.

[0005] Summary of the Invention

[0006] The technical problem to be solved by this application is that a single-person reagent strip can only be used for single-item testing, the reagent strip consumption is large, which is not conducive to environmental protection and energy saving, the reagent strip integrated joint testing has poor adaptability, low cost performance, and inconvenient operation.

[0007] In order to solve the above technical problems, the present application provides a single-dose test strip, which adopts the following technical solution:

[0008] A single-dose reagent strip comprises a base plate and at least two sets of reagent cups;

[0009] The bottom plate is provided with a magnetic rod cover hole, a magnetic bead receiving groove, a reagent hole and at least two installation grooves;

[0010] The reagent cup group is detachably mounted in the mounting groove. The reagent cup group includes a fixing plate and at least two reagent cups. The reagent cups are mounted on the fixing plate.

[0011] Furthermore, the mounting slot includes a card slot having reagent cup holes corresponding to the number of reagent cups, the shape of the card slot matches the shape of the fixing plate, and the diameter of the reagent cup holes is the same as the outer diameter of the reagent cup;

[0012] The reagent cup is vertically mounted on the fixing plate. When the fixing plate is mounted in the slot, the bottom of the reagent cup is vertically exposed through the reagent cup hole.

[0013] Furthermore, a boss is provided on the upper surface of the fixing plate, and an end surface of the boss away from the reagent cup is lower than the edge of the slot;

[0014] The reagent cup set further includes a first sealing film, which is sealed on the boss.

[0015] Furthermore, the upper surface of the bottom plate is also covered with a second sealing film, and the second sealing film seals the magnetic bead holding tank and the reagent hole as a whole.

[0016] Furthermore, the second sealing film is a light-proof film.

[0017] Furthermore, the reagent cup set includes a first reagent cup and a second reagent cup;

[0018] The material of the first reagent cup is an opaque material, and the first reagent cup contains the R1 reagent;

[0019] The second reagent cup is made of a transparent material and contains R2 reagent.

[0020] Furthermore, the magnetic rod sleeve hole, magnetic bead receiving groove and reagent hole are all integrally formed on the bottom plate;

[0021] The reagent cup is integrally formed on the fixing plate and is arranged perpendicular to the fixing plate.

[0022] Furthermore, the reagent wells include a first reagent well for loading a magnetic bead diluent, a second reagent well for loading a sample diluent, a third reagent well for loading a cleaning solution, and a fourth reagent well for loading a substrate solution.

[0023] Furthermore, the number of the third reagent wells and the number of the fourth reagent wells both correspond to the number of the reagent cups.

[0024] Furthermore, one side of the bottom plate extends outward to form a gripping portion, and an anti-slip structure is distributed on the gripping portion.

[0025] Compared with the prior art, this application has the following beneficial effects:

[0026] The embodiment of the present application enables the testing personnel to combine the testing reagents according to the actual test items of the patient by detachably mounting the reagent cup group on the mounting groove of the base plate, and mounting the reagent cup on the fixed plate to form a reagent cup group, so as to facilitate the testing of multiple required items on a single reagent strip at one time, thereby improving the testing efficiency, simplifying the operation, and being environmentally friendly and energy-saving. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the solution of the present application, a brief introduction is given below to the drawings required for use in the description of the embodiments. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0028] FIG1 is a top view of the reagent strip of the present application;

[0029] FIG2 is a schematic structural diagram of the reagent strip of the present application;

[0030] FIG3 is a schematic structural diagram of the reagent cup set of the present application.

[0031] Figure numerals: 1. Base plate; 11. Magnetic rod sleeve hole position; 12. Magnetic bead holding slot; 13. Mounting slot; 131. First mounting slot; 132. Second mounting slot; 14. Reagent hole; 141. First reagent hole; 142. Second reagent hole; 143. Third reagent hole; 144. Fourth reagent hole; 15. Anti-slip structure; 2. Reagent cup group; 21. Fixing plate; 22. Reagent cup; 221. First reagent cup; 222. Second reagent cup; 23. Boss; 24. First sealing film. DETAILED DESCRIPTION

[0032] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as commonly understood by those skilled in the art to which this application belongs. The terms used in the specification of the application are only for the purpose of describing specific embodiments and are not intended to limit this application. The terms "including" and "having" and any variations thereof in the specification and claims of this application and the above-mentioned drawings are intended to cover non-exclusive inclusions. The terms "first", "second", etc. in the specification and claims of this application or the above-mentioned drawings are used to distinguish different objects, not to describe a specific order.

[0033] References herein to "embodiments" mean that a particular feature, structure, or characteristic described in connection with the embodiments may be included in at least one embodiment of the present application. The appearance of this phrase in various places in the specification does not necessarily refer to the same embodiment, nor does it constitute an independent or alternative embodiment that is mutually exclusive of other embodiments. It is understood, both explicitly and implicitly, by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0034] Example of a single-dose reagent strip of this application

[0035] Referring to FIG. 1 to FIG. 3 , an embodiment of the present application provides a single-dose reagent strip comprising: a base plate 1 and at least two reagent cup sets 2 .

[0036] The base plate 1 is provided with a magnetic rod sleeve hole 11, a magnetic bead receiving groove 12, a reagent hole 14 and at least one mounting groove 13. Each reagent cup group 2 can be detachably installed in the corresponding mounting groove 13. The reagent cup group 2 includes a fixed plate 21 and at least two reagent cups 22. The reagent cups 22 are installed on the fixed plate 21.

[0037] In this embodiment, a single-portion reagent strip capable of performing dual-item testing is used as an example for explanation, wherein the single-portion reagent strip includes two mounting slots, specifically a first mounting slot 131 and a second mounting slot 132. As shown in FIG2 , two groups of magnetic rod sleeve holes 11, a magnetic bead receiving slot 12, a first mounting slot 131, a second mounting slot 132 and a reagent hole 14 are sequentially provided on the bottom plate 1 along a first direction, wherein the single-portion reagent strip includes two reagent cup groups 2, and the reagent cup groups 2 are detachably mounted in the first mounting slot 131 and the second mounting slot 132, respectively.

[0038] As shown in FIG3 , in this embodiment, the reagent cup set 2 includes two reagent cups 22 , specifically a first reagent cup 221 and a second reagent cup 222 . The first reagent cup 221 and the second reagent cup 222 are mounted side by side on the fixed plate 21 . The first reagent cup 221 and the second reagent cup 222 are loaded with different detection reagents according to different detection items.

[0039] The single-person test strip provided in the embodiment of the present application loads different test reagents into different reagent cups 22, and multiple reagent cups 22 are installed in the reagent cup group 2. The reagent cup group 2 is detachably installed on the mounting slot 13 of the base plate 1, so that the test personnel can customize the combination of test reagent types according to the required test items, so as to facilitate the testing of multiple required test items on one test strip at one time, thereby improving the test efficiency, simplifying the operation and saving the number of test strips used.

[0040] Referring to Figures 1 to 3 , in some embodiments, the mounting slot 13 includes a card slot (not shown), which has reagent cup holes (not shown) corresponding to the number of the reagent cups 22. In this embodiment, the shape of the fixing plate 21 matches the shape of the card slot, so that the reagent cup set 2 can be stably mounted on the base plate 1 and does not move relative to the mounting slot 13. The diameter of the reagent cup hole is the same as the outer diameter of the reagent cup 22, so that the reagent cup 22 does not shake relative to the reagent cup hole, thereby improving the installation stability of the reagent cup set 2.

[0041] In this embodiment, the reagent cup 22 is vertically mounted on the lower surface of the fixing plate 21. When the reagent cup group 2 is installed in the mounting groove 13 from top to bottom, the bottom of the reagent cup 22 is vertically exposed through the reagent cup hole, and the fixing plate 21 is placed in the card slot to improve the installation stability of the reagent cup group 2.

[0042] As shown in FIG. 3 , in this embodiment, a boss 23 is provided on the upper surface of the fixing plate 21 , and an end surface of the boss 23 away from the reagent cup 22 is lower than the edge of the slot.

[0043] In some embodiments, the reagent cup group 2 also includes a first sealing film 24, which is sealed on the boss 23 by a heat sealing process. In this embodiment, the first sealing film 24 completely covers the upper surface of the fixed plate 21 and is used to seal the opening of the reagent cup 22 to prevent leakage of the detection reagent and to prevent impurities from contaminating the detection reagent. In this embodiment, the first sealing film 24 is an opaque aluminum foil film, which is used to protect the detection reagent in the reagent cup 22 from being interfered by external light, thereby improving the production quality of the product and the detection accuracy of the single-person test strip.

[0044] In some embodiments, the upper surface of the base plate 1 is also covered with a second sealing film, which seals the magnetic bead holding tank 12 and the reagent hole 14. In this embodiment, the second sealing film is sealed to the upper surface of the base plate 1 through a heat sealing process to achieve sealing of the magnetic bead holding tank 12 and the reagent hole 14, thereby avoiding solvent leakage and preventing external impurities from contaminating the solvent. In this embodiment, since the highest point of the boss 23 is lower than the edge of the card slot, in this embodiment, the second sealing film is an opaque aluminum foil film to isolate the detection reagent from interference from external light, thereby further improving the production quality of the product and the detection accuracy of the single-person test strip.

[0045] As shown in FIG3 , in this embodiment, the reagent cup set 2 includes a first reagent cup 221 and a second reagent cup 222 . The first reagent cup 221 is made of an opaque material. The first reagent cup 221 contains R1 reagent (in the art, the first reagent for the first sample addition is usually referred to as R1 reagent, which is used for project 1). R1 ​​reagent can be a volatile or photoreactive reagent.

[0046] The second reagent cup 222 is made of a transparent material and contains R2 reagent (in this field, the second reagent for the second addition is usually referred to as R2 reagent, which is used for project two).

[0047] In the embodiment of the present application, by providing a first reagent cup group for placing item 1 and a second reagent cup group for placing item 2, the reagent strip can simultaneously perform two different item tests, thereby improving the test efficiency and saving the number of reagent strips used.

[0048] In this embodiment, the magnetic rod sleeve hole 11, the magnetic bead holding groove 12 and the reagent hole 14 are all integrally formed on the base plate 1 by injection molding; the reagent cup 22 is integrally formed on the fixed plate 21 by injection molding and is arranged perpendicular to the fixed plate 21.

[0049] The embodiment of the present application improves the structural strength of the reagent strip and the reagent cup set 2 through an integrated structural design, has good dimensional stability, is suitable for mass production, and reduces production costs.

[0050] Please refer to Figure 2. In this embodiment, the reagent wells 14 include a first reagent well 141 for loading magnetic bead diluent, a second reagent well 142 for loading sample diluent, a third reagent well 143 for loading cleaning solution, and a fourth reagent well 144 for loading substrate solution. The testing personnel add the collected sample to the second reagent well 142 for dilution, put the diluted sample into the first reagent cup 221, add the magnetic beads in the magnetic bead holding tank 12 to the first reagent well 141 for dilution, and add the diluted magnetic beads to the first reagent cup 221 to react with the diluted sample. After the sample that has reacted in the first reagent cup 221 is added to the third reagent well 143 for pre-treatment of soaking and cleaning, the pre-treated sample is added to the fourth reagent well 144 to obtain a reactant, and the reactant is directly transferred to the POCT instrument for detection to obtain the test result, thereby improving the detection efficiency and simplifying the operation steps.

[0051] In some embodiments, the number of the third reagent holes 143 and the number of the fourth reagent holes 144 correspond to the number of the reagent cups 22. In this embodiment, the two reagent cup groups 22 each include a first reagent cup 221 and a second reagent cup 222. The number of the third reagent holes 143 is two, and the number of the fourth reagent holes 144 is two.

[0052] The embodiment of the present application can process different detection reagents separately by providing multiple third reagent holes 143 and multiple fourth reagent holes 144, thereby avoiding the problem of cross contamination between reagents and avoiding waste of resources.

[0053] Please refer to Figures 1 and 2. In some embodiments, one side of the base plate 1 extends outward to form a gripping portion, and an anti-slip structure 16 is distributed on the gripping portion. In this embodiment, the gripping portion is located at the starting end of the first direction, and the anti-slip structure 16 is a plurality of anti-slip ridges arranged at intervals. In other embodiments, the anti-slip structure 16 can also be a plurality of convex points arranged at intervals. The embodiment of the present application increases the design of the gripping portion and the anti-slip structure 16 to prevent the reagent strip from falling off easily and causing waste of the reagent strip.

[0054] Obviously, the embodiments described above are only some of the embodiments of the present application, rather than all of the embodiments. The preferred embodiments of the present application are given in the accompanying drawings, but they do not limit the patent scope of the present application. The present application can be implemented in many different forms. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present application more thorough and comprehensive. Although the present application has been described in detail with reference to the aforementioned embodiments, for those skilled in the art, it is still possible to modify the technical solutions described in the aforementioned specific embodiments, or to make equivalent replacements for some of the technical features therein. Any equivalent structure made using the contents of the present application specification and the accompanying drawings, directly or indirectly used in other related technical fields, is also within the scope of patent protection of the present application.

Claims

1. A single-serving reagent strip, comprising a base plate and at least two sets of reagent cups; The bottom plate is provided with a magnetic rod sleeve hole, a magnetic bead receiving groove, a reagent hole and at least two installation grooves; The reagent cup group is detachably mounted in the mounting groove. The reagent cup group includes a fixing plate and at least two reagent cups. The reagent cups are mounted on the fixing plate.

2. The single-dose test strip according to claim 1, wherein: The mounting slot comprises a card slot, the card slot has reagent cup holes corresponding to the number of reagent cups, the shape of the card slot matches the shape of the fixing plate, and the aperture of the reagent cup hole is the same as the outer diameter of the reagent cup; The reagent cup is vertically mounted on the fixing plate. When the fixing plate is mounted in the slot, the bottom of the reagent cup vertically passes through the reagent cup hole and is exposed.

3. The single-dose test strip according to claim 2, wherein: A boss is provided on the upper surface of the fixing plate, and an end surface of the boss away from the reagent cup is lower than the edge of the slot; The reagent cup set further includes a first sealing film, which is sealed on the boss.

4. The single-dose test strip according to any one of claims 1 to 3, wherein: The upper surface of the bottom plate is also covered with a second sealing film, and the second sealing film seals the magnetic bead holding groove and the reagent hole.

5. The single-dose test strip according to claim 4, wherein: The second sealing film is a light-proof film.

6. The single-dose test strip according to any one of claims 1 to 3, wherein: Each of the reagent cup sets includes a first reagent cup and a second reagent cup; The material of the first reagent cup is an opaque material, and the first reagent cup contains R1 reagent; The material of the second reagent cup is a transparent material, and the second reagent cup contains R2 reagent.

7. The single-dose test strip according to any one of claims 1 to 3, wherein: The magnetic rod sleeve holes, magnetic bead holding slots and reagent holes are all integrally formed on the bottom plate; The reagent cup is integrally formed on the fixing plate, and the cup body of the reagent cup is arranged perpendicular to the fixing plate.

8. The single-dose test strip according to any one of claims 1 to 3, wherein: The reagent wells include a first reagent well for loading a magnetic bead diluent, a second reagent well for loading a sample diluent, a third reagent well for loading a cleaning solution, and a fourth reagent well for loading a substrate solution.

9. The single-dose test strip according to claim 8, wherein: The number of the third reagent wells and the number of the fourth reagent wells both correspond to the number of the reagent cups.

10. The single-dose test strip according to any one of claims 1 to 3, wherein: One side of the bottom plate extends outward to form a gripping portion, and an anti-slip structure is distributed on the gripping portion.

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