A magnetic microparticle chemiluminescence kit

Abstract

This utility model relates to a magnetic microparticle chemiluminescence reagent kit, which includes a box body, a box cover connected to the box body, an inner tray placed inside the box body, and reagents. The inner tray is cylindrical with openings on the left and right sides, and retaining edges on the upper edges of the front and rear sides. This utility model facilitates production and use, and helps improve production efficiency and reduce production costs.

Description

Technical Field

[0001] This utility model relates to a test kit, specifically a packaging box and contents of a magnetic microparticle chemiluminescent reagent. Background Technology

[0002] Chemiluminescence immunoassay is a cutting-edge immunoassay technique developed after radioimmunoassay, enzyme immunoassay, fluorescence immunoassay, and time-resolved fluorescence immunoassay. Its rapid development due to its high sensitivity, specificity, stability, speed, and automation has made it the most popular in vitro diagnostic reagent detection method in clinical testing. Among these methods, magnetic microparticle chemiluminescence (also known as magnetic microparticle acridinium ester direct chemiluminescence) is the most commonly used. These reagent kits are characterized by a large number of components, typically including two detection reagents, 2-3 concentration levels of quality control and / or calibrators, and the detection reagents are liquids. To ensure the kit contains all the reagents and maintains a relatively fixed position, a bottle holder or inner holder is often included. The holder has corresponding slots for each reagent bottle. However, to ensure the relative position of the inner holder and the outer box is stable, the outer diameter of the inner holder is almost identical to the inner diameter of the outer box to increase friction. This makes packing difficult and can easily cause deformation of the inner holder, affecting production efficiency and the overall appearance of the product. Similarly, the slots for placing quality control and / or calibrators also require similar consideration. Quality control and calibrators typically come in vials ranging from 0.3 to 1.5 ml, and the vials are all regular cylinders. The overall size of the vials is relatively small, and there may be differences between different varieties. If the locking mechanism is loose, they can easily be pulled out during transportation. Therefore, the existing locking aperture is also relatively small compared to the size of the quality control and calibrator vials. Furthermore, if the size of the quality control and calibrator vials in different test kits is different, the inner trays cannot be interchanged, which is disadvantageous both in terms of reducing production costs and conserving resources. Utility Model Content

[0003] To address the aforementioned technical problems, this utility model provides a magnetic microparticle chemiluminescence reagent kit. The inner tray of this kit has been improved for stronger support and better relative stability with the box body. Furthermore, it is interchangeable between different projects, making the packaging process more convenient and efficient, and further optimizing packaging and production costs. The specific technical solution is as follows:

[0004] A magnetic microparticle chemiluminescence reagent kit includes a box body, a lid connected to the box body, an inner tray placed inside the box body, and related reagents (such as detection reagents, quality control materials, and calibrators). The inner tray is cylindrical with openings on the left and right sides, and retaining edges on the upper edges of the front and rear sides. The box body and the lid together constitute an outer box, which is cuboid in shape. The inner tray, placed inside, is also cylindrical and cuboid. Viewed from the direction the outer box is opened, the inner tray has openings on the left and right sides, and retaining edges on the upper edges of the front and rear sides. The outer box and inner tray are preferably made of paper, more preferably 350g or heavier white cardboard, balancing low cost, recyclability, and required strength. The reagent kit also includes an instruction manual and an RFID card (or QR code containing the main calibration curve information). The outer box is a conventional structure for packaging boxes in the field and will not be described in detail.

[0005] The aforementioned inner tray is formed by dividing a cardboard of a specific size into five parts: a front side, a top surface, a back side, a bottom surface, and an adhesive surface. Each part has creases between it. The tray is folded along these creases, and the adhesive surface is then fixed to the inside of the front side. The creases between the top surface and the two sides are discontinuous; the break points are the locations of the gussets. The two sides of the inner tray have cuts parallel to the creases, as well as cuts from the two ends of these cuts to the top surface. When the inner tray is folded into a cylindrical shape, the cut sections do not deform or bend, thus forming gussets that connect to and extend from the top surface. The protruding length of these gussets is 1-2 mm, and the number is no less than two, preferably two to four. The width of the gussets (the length parallel to the edge of the crease) can be determined based on the number of gussets on the same side, as well as the length, material, and thickness of the inner tray. When there are two card rims, they are set separately and crosswise. That is, there is one card rim on the upper surface and one on the lower edge, with one position slightly to the left and the other slightly to the right. The vertical distance between the extended lines of the outer edges of the two card rims (the cutting edges parallel to the indentation edge) is consistent with the inner diameter of the outer box.

[0006] The addition of the clip structure described in this invention allows for a slight reduction in the size of the inner tray, thereby reducing friction when inserting it into the outer box and making production operations easier and faster. The clip connects to the upper surface, essentially extending it, and makes close contact with the inner wall of the outer box to secure the inner tray. Because the clip is positioned high and has a small contact area with the inner wall of the outer box, its impact on the packaging process is negligible.

[0007] The upper surface of the inner tray has multiple slots and holes, including reagent slots and circular control / calibrator holes with locking collars. The reagent slots are used to secure reagent bottles, and their shape and size are determined according to the reagent bottles being secured.

[0008] The aforementioned "choke point" refers to a circular control or calibrator orifice that is not a hollow hole, but rather a hole where the material inside is still present, but cut along the diameter with at least two, preferably three, cuts evenly distributed to form four or more fan-shaped surfaces of equal area. When the control and / or calibrator orifice is inserted, the fan-shaped surfaces move downwards from the center of the orifice, forming a hole and enveloping the orifice for fixation. This structure eliminates the need to strictly control the hole size according to the orifice diameter while still achieving a stable cylindrical orifice. It solves the problems of difficult, time-consuming, labor-intensive, and easily deformed insertion in existing technologies, while also providing flexibility for the orifice's applicability to different orifice sizes. After insertion, the choke point tightly encloses the orifice under tension, and slight fluctuations in the orifice diameter do not substantially affect this fixation. Therefore, it is applicable to reagent kits for different testing items where differences in the volume of control / calibrator orifices result in inconsistent orifice sizes.

[0009] Maintaining a stable relative position between the inner tray and the outer box is crucial for ensuring the stability of the items inside the box during transportation and for facilitating the removal of reagent bottles from the inner tray. Under normal transportation conditions and with the addition of a locking design in this invention, the required fixing force to achieve these two objectives is not excessive. When the width of the locking lip (the length parallel to the indentation edge) is 1-3 cm, although the contact area between the locking lip and the outer box is small, its specific position is sufficient to meet the requirements. In a preferred embodiment, two locking lipes are provided on the upper surface and at the top and bottom edges, with an extension length of 1.5 mm and a width of 2 cm. The long side (folded edge) of the inner tray is 13.8 cm. Excessive extension length or insufficient width of the locking lip will directly affect the fixing effect.

[0010] Preferably, there are two reagent slots and 2-6 control / calibrator holes, with a hole diameter of 10-15 mm. The slots are located centrally on the upper surface of the inner tray, and the control / calibrator holes are evenly distributed in the upper and / or lower parts of the slots. The size and shape of the reagent slots are determined by the reagent bottle, which in turn is determined by the testing equipment and is not affected by the testing item (different biomarkers). Generally, various models of luminescence devices from the same manufacturer use the same reagent tray, and therefore, the same slot is also suitable. However, the volume of control / calibrators required for different testing items often varies. Therefore, improving the design of the control / calibrator slots in the inner tray is of practical significance.

[0011] The height of the inner holder described in this invention is preferably between 43% and 70% of the height of the reagent bottle it fixes. Within this range, it can achieve the function of fixing the reagent (bottle) while also controlling costs relatively well. When the heights of the reagent bottles being fixed are different, it is preferably no less than 43% of the height of the taller reagent bottle and no more than 70% of the height of the shorter reagent bottle.

[0012] Due to the implementation of the above technical solutions, the beneficial effects of this utility model compared with the prior art are as follows: it is easier to operate when the inner tray is boxed and when inserting and removing the quality control / calibrator bottles, which improves production efficiency and facilitates use during testing. In addition, it increases the applicability of the inner tray, which is not affected by the different capacities of quality control / calibrators for different testing items, saving costs and being environmentally friendly. Attached Figure Description

[0013] Figure 1 This is a schematic diagram showing the unfolded inner tray of the reagent kit described in this utility model;

[0014] Figure 2 This is a front view schematic diagram of the inner tray of the reagent kit described in this utility model.

[0015] Figure label:

[0016] 1. Clip 2. Clip slot 3. Quality control / calibration sample hole 4. Locking throat 5. Front side

[0017] 6. Rear side 7. Top surface 8. Bottom surface 9. Adhesive surface Detailed Implementation

[0018] like Figure 1-2 As shown, this embodiment provides a magnetic microparticle chemiluminescence reagent kit. The kit's outer packaging box contains an inner tray for securing related reagents (bottles). This inner tray is cylindrical, with openings on both sides when viewed from the direction the outer box is open. Two retaining edges 1 are located on the upper edges of both the front side 5 and the rear side 6. The upper surface 7 has multiple slots, specifically two reagent slots 2 and six circular control / calibrator holes 3 with throats 4. The diameter of each control / calibrator hole 3 is 1.3 cm. The throats 4 are formed by three evenly distributed diameter cuts. The slots 2 are located in the center of the upper surface 7, and the control / calibrator holes 3 are evenly distributed above and below the slots 2. The outer box has an inner diameter of 14.0cm (length) and 12.5cm (width). The test reagent bottles (including bottle holders) placed inside are 6.8cm high, and the quality control / calibrator bottles are 4.7cm high. The inner holder has a long side (folded side) of 13.8cm, a wide side of 12.2cm, and a height of 3cm. The protruding length of the retaining rim 1 is 1.5mm, and its width is 2cm. This combination of structures ensures relative stability between the inner holder and the outer box while facilitating packaging operations, making it easy to handle reagents (bottles), and ensuring high versatility of the inner holder.

[0019] The present utility model has been described in detail above, with the purpose of enabling those skilled in the art to understand its contents and implement it. However, this description should not be construed as limiting the scope of protection of the present utility model. All equivalent changes or modifications made in accordance with the spirit and essence of the present utility model should be covered within the scope of protection of the present utility model.

Claims

1. A magnetic microparticle chemiluminescence reagent kit, comprising a box body, a box cover connected to the box body, an inner tray placed in the box body, and reagents, characterized in that: The inner tray is a square tube with openings on the left and right sides and a retaining edge on the upper edge of the front and rear sides. The upper surface of the inner tray has a slot, including a reagent slot and a circular quality control / calibrator hole with a throat. The throat refers to the material inside the quality control / calibrator hole being cut along the diameter, with no less than two cuts that are evenly distributed to form four or more fan-shaped surfaces of equal area.

2. The kit of claim 1, wherein: The number of the aforementioned brackets is 2-4.

3. The kit of claim 1, wherein: The protruding length of the gusset is 1-2mm.

4. The kit of claim 1, wherein: The number of wells for the quality control / calibrator is 2-6.

5. The kit of claim 1, wherein: The diameter of the orifice for the quality control / calibrator is 10-15 mm.

6. The kit of claim 1, wherein: The height of the inner tray is 43%-70% of the height of its fixed reagent bottle.

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