An assembly tool for immunochromatographic reagent strips and a method of use thereof

Abstract

The present invention discloses an assembly tool and a method for use for large plates of immunochromatographic reagent strips, comprising a base and a film-applying mold, wherein the upper surface of the base is provided with a groove, the film-applying mold is engaged in the groove, buckles are symmetrically provided at both ends of the groove, the inner side of the film-applying mold is provided with no less than a set of bilaterally symmetrical positioning slots, any set of the positioning slots and the buckles are provided correspondingly, and the film-applying mold is provided with a film-applying window. The present invention has a simple structure, and the assembly of large plates of immunochromatographic reagent strips no longer requires manual alignment. Instead, the accessories need only be placed in the mold and pressed, thereby avoiding contact with the nitrocellulose membrane during manual operation. The assembly process is simple and more standardized, which not only improves the efficiency of assembly, but also improves the qualified rate of the finished product. At the same time, it is more tolerant to the age, gender, and vision of the operators, which to a certain extent alleviates the problem of staff turnover on the production line.

Description

Technical Field

[0001] The invention relates to the field of preparation of immunochromatographic test paper, in particular to an assembly tool used for a large immunochromatographic reagent strip plate and a use method thereof. Background Art

[0002] Immunochromatography technology is a simple and rapid diagnostic method, and is also an important tool for point-of-care testing (POCT). This technology is mainly completed with the help of immunochromatography test strips. Immunochromatography technology is not only simple to operate, fast in detection, highly specific, and stable, but also easy to carry. It has been widely used in clinical diagnosis, food safety, drug testing, environmental pollution and other fields. The most mature colloidal gold immunochromatography technology developed in recent years is an immunochromatography detection method that uses colloidal gold nanoparticles as immune markers. The results are intuitive and do not require any instruments or equipment. The core focus of this technology is the colloidal gold immunochromatography reagent strip inside the test kit. This reagent strip is made by cutting the reagent strip plate into certain specifications. It can be seen that the key to the successful detection of the colloidal gold immunochromatography reagent strip is the production of the immunochromatography reagent strip plate. Immunochromatographic reagent strips are relatively fragile and easily damaged. Prior art requires manual assembly of the entire strip. Furthermore, because the strip's "accessories" are mostly made of fiberglass, which is inherently lighter in color, the nitrocellulose membrane in the center of the strip, in particular, cannot be touched by hand, and the strip application process requires adherence to printed lines. This requires the applicator to possess good eyesight, a gentle touch, quick movements, and steady application. However, in practice, low product qualification rates can still occur due to non-standard operation. Therefore, the production line for the immunochromatographic reagent strip strip assembly process generally requires young women. However, the tedious nature of this work and the high requirements of the assembly process itself lead to rapid staff turnover. Furthermore, because manual assembly is performed without uniform standards, the quality of the finished strips after application varies widely. Even with strict quality control, the qualification rate is only 97%. Furthermore, manual operation is inefficient, seriously impacting production efficiency and profitability. Summary of the Invention

[0003] The purpose of the present invention is to provide an assembly tool and a method for using the assembly tool for a large plate of an immunochromatographic reagent strip to solve the problems raised in the above background technology.

[0004] To achieve the above object, the present invention provides the following technical solutions:

[0005] An assembly tool for large plates of immunochromatographic reagent strips, comprising a base and a film-sticking mold. The upper surface of the base is provided with a groove, the film-sticking mold is engaged in the groove, and buckles are symmetrically provided at both ends of the groove. The inner side surface of the film-sticking mold is provided with at least one set of left-right symmetrical positioning slots, and any set of the positioning slots is arranged corresponding to the buckles. The film-sticking mold is provided with a film-sticking window.

[0006] As a further solution of the present invention: the positioning slots include a group of left-right symmetrical first positioning slots and a group of left-right symmetrical second positioning slots, and the distance between the first positioning slots and the second positioning slots is smaller than the width of the film window.

[0007] As a further solution of the present invention: the upper portion of the film window is a funnel-shaped structure that is wide at the top and narrow at the bottom.

[0008] As a further solution of the present invention: one end of the inner side surface of the film-sticking mold close to the film-sticking window is a beveled surface.

[0009] As a further solution of the present invention: the base is a rectangular structure, a smooth notch is provided in the middle of a long side of one side of the base, and the film-sticking mold is provided with a notch corresponding to the base.

[0010] As a further solution of the present invention: the film-sticking mold is fixedly provided with a handle.

[0011] As a further solution of the present invention: the groove includes a bottom plate groove and a handle groove, the bottom plate groove and the handle groove are an integrated structure, the film window of the film mold corresponds to the bottom plate groove, the handle corresponds to the handle groove, the bottom plate groove is a rectangular structure, and the handle groove is a rectangular structure with a notch corresponding to the base.

[0012] A method for using an assembly tool for an immunochromatographic reagent strip plate, wherein the immunochromatographic reagent strip plate includes a base plate, a gold label pad, a sample absorption pad, and a basic support sheet of glass fiber. The base plate is a rectangular structure, and the middle portion of the long side of the base plate is covered with a nitrocellulose membrane. A water-absorbing pad is fixed to one side of the long side of the base plate, and the water-absorbing pad is overlapped on the nitrocellulose membrane. The method for using the assembly tool includes the following steps:

[0013] Step 1: Place the base on a horizontal workbench with the notch on the outer edge of the workbench;

[0014] Step 2: Place the base plate in the base plate groove, with the upper and lower sides of the base plate flush with the sides of the base plate groove. The long side of the base plate with the absorbent pad is adjacent to the handle groove. Align the first symmetrical positioning slots of the film application mold with the buckles on the base and fasten them. The corresponding position of the film application window is the adhesive position of the gold label pad, and a part of the nitrocellulose membrane is placed in the film application window.

[0015] Step 3: Place the gold label pad into the film window and press the gold label pad with your fingertips so that part of the gold label pad overlaps the nitrocellulose membrane in the film window and the other part fits tightly with the base plate;

[0016] Step 4: Lift the film-mounting mold and align the second symmetrical positioning slots on the left and right sides of the film-mounting mold with the buckles on the base and fasten them. The corresponding position of the film window is now the adhesive position of the sample absorption pad, and part of the gold label pad is now placed in the film window.

[0017] Step 5: Place the sample absorption pad into the film window and press the sample absorption pad with your fingertips so that part of the sample absorption pad overlaps the gold label pad in the film window and part of it fits tightly against the base plate.

[0018] Step 6: Lift the film mold and place it on the side of the workbench. Since the upper and lower sides of the bottom plate are flush with the bottom plate groove, place the basic support sheet glass fiber tightly against the upper part of the bottom plate groove, and press the basic support sheet glass fiber with your fingertips so that part of the basic support sheet glass fiber overlaps the sample absorption pad and part fits tightly with the bottom plate. The assembly of the immunochromatographic reagent strip large plate is completed.

[0019] As a further solution of the present invention: in the step 1, a detection line and a quality control line are sequentially provided on the nitrocellulose membrane.

[0020] As a further solution of the present invention: in step 3 and step 5, the size of the gold label pad and the sample absorption pad is consistent with the film window.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] 1. When using the present invention to assemble a large plate of immunochromatographic reagent strips, it is only necessary to place the accessories into the mold and press them, without the need for manual alignment operations. The use of the mold makes the assembly process more standardized, which not only improves the assembly efficiency, but also improves the qualified rate of the finished product.

[0023] 2. The present invention is used to assemble the large plate of immunochromatographic reagent strips, and at the same time, the nitrocellulose membrane located in the middle of the large plate is also protected, because the nitrocellulose membrane cannot be touched by hand. During the assembly process, the bottom plate is placed in the base, and then the film mold is engaged with the base, and the film mold is moved to assemble other accessories. During the assembly process, the operator's fingers will not touch the nitrocellulose membrane in the middle of the large plate, which protects the nitrocellulose membrane. At the same time, a beveled surface is set on the inner side of the film mold, which reduces the contact area between the film mold and the large plate, reduces the possibility of adhesion to the large plate during the movement of the mold, and further improves work efficiency and finished product qualification rate.

[0024] 3. The present invention simplifies the process of assembly itself. Since manual alignment operations are no longer required, the sensitivity requirements of operators in various aspects during the manual assembly of large immunochromatographic reagent strips are reduced. It is more tolerant to the age, gender and vision of operators, and to a certain extent alleviates the problem of personnel loss on the production line. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a structural schematic diagram of the present invention;

[0026] Figure 2 An exploded view of the present invention;

[0027] Figure 3 A top view of the groove structure on the base of the present invention;

[0028] Figure 4 This is a structural diagram of the outer side of the film-sticking mold of the present invention;

[0029] Figure 5 This is a structural diagram of the inner side of the film-sticking mold of the present invention;

[0030] Figure 6 Schematic diagram of the inner side bevel structure of the film laminating mold of the present invention;

[0031] Figure 7 This is a cross-sectional view of the large plate of immunochromatographic reagent strip.

[0032] In the figure: 1-base, 11-groove, 111-bottom plate groove, 112-handle groove, 12-clip; 2-film mold, 21-positioning slot, 211-first positioning slot, 212-second positioning slot, 22-film window, 23-handle, 24-bevel; 3-immunochromatography reagent strip plate, 31-bottom plate, 32-gold label pad, 33-sample absorption pad, 34-basic support sheet glass fiber, 35-water absorbent pad, 36-nitrocellulose membrane, 361-test line, 362-quality control line. DETAILED DESCRIPTION

[0033] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0034] See also Figures 1-6In an embodiment of the present invention, an assembly tool for a large plate of an immunochromatographic reagent strip includes a base 1 and a film-applying mold 2. The upper surface of the base 1 is provided with a groove 11. The film-applying mold 2 is engaged with the groove 11. Buckles 12 are symmetrically provided at both ends of the groove 11. The inner side of the film-applying mold 2 is provided with at least one set of bilaterally symmetrical positioning slots 21. Any set of the positioning slots 21 is provided correspondingly to the buckles 12. The film-applying mold 2 is provided with a film-applying window 22. The base 1 and the film-applying mold 2 are relatively independent and coordinated film-applying tools. The film-applying mold 2 is engaged with the groove 11 of the base 1. At the same time, the width of the film-applying mold 2 is smaller than the width of the groove 11, so that the film-applying mold 2 can switch its position within the groove 11 through the connection between the positioning slots 21 at different positions and the buckles 12. The film-applying window 22 is used to fix the position of the accessories of the large plate 3 of the immunochromatographic reagent strip, so that the position fixation of the accessories is more precise.

[0035] Further, such as Figure 5 As shown, the positioning slots 21 include a pair of bilaterally symmetrical first positioning slots 211 and a pair of bilaterally symmetrical second positioning slots 212. The distance between the first positioning slots 211 and the second positioning slots 212 is less than the width of the film window 22. Because the components of the immunochromatographic reagent strip plate 3 are overlapped during assembly, the distance between the first positioning slots 211 and the second positioning slots 212 is less than the width of the film window 22. This ensures that when the positioning slots 212 are switched, the component that has been fixed in the film window 22 when the first positioning slot 211 is positioned is still partially located in the film window 22 when the second positioning slot 212 is positioned, allowing for the next component to be overlapped.

[0036] Further, such as Figure 4 As shown, the upper portion of the film window 22 is a funnel-shaped structure that is wider at the top and narrower at the bottom. Because the film mold 2 is made of a steel or plastic plate of a certain thickness, the bottom size of the film window 22 is consistent with the size of the relevant accessories. The funnel-shaped structure is cut obliquely from the bottom opening upward to expand the size of the upper opening. The funnel structure is more suitable for the operator's fingertips to press the accessories into the film window 22.

[0037] Further, such as Figure 6 As shown, the inner side of the film laminating mold 2 near the film laminating window 22 has a chamfered surface 24. Providing a chamfered surface 24 at one end can reduce the contact area between the inner side of the film laminating mold 2 and the accessory, reduce the possibility of adhesion between the film laminating mold 2 and the accessory during movement, and improve film laminating efficiency and yield rate.

[0038] Furthermore, the base 1 is a rectangular structure, with a smooth notch in the middle of one long side of the base 1, and the film-applying mold 2 is provided with a notch corresponding to the base 1. Providing the notch in the base 1 allows the orientation of the base 1 to be quickly determined based on the position of the notch, thereby improving work efficiency. Furthermore, the present invention reduces the use of materials and saves production costs.

[0039] Furthermore, the film-sticking mold 2 is provided with a handle 23. The handle 23 is provided to facilitate the position change and engagement of the film-sticking mold 2.

[0040] Further, such as Figure 3 As shown (the dotted line is for reference only), the groove 11 includes a bottom plate groove 111 and a handle groove 112. The bottom plate groove 111 and the handle groove 112 are an integrated structure. The position of the film window 22 of the film mold 2 corresponds to the bottom plate groove 111, and the position of the handle 23 corresponds to the handle groove 112. The bottom plate groove 111 is a rectangular structure, and the handle groove 112 is a rectangular structure with a notch corresponding to the base 1. The bottom plate groove 111 is used to place the bottom plate 31 in the large plate 3 of the immunochromatographic reagent strip. The length and width of the bottom plate groove 111 are consistent with the bottom plate 31. The bottom plate groove 111 is used to engage the film mold 2 panel at the film window 22 of the film mold 2. The handle groove 112 is used to engage the film mold 2 panel at the handle 23 of the film mold 2. The size and shape of the bottom plate groove 111 are fixed according to the bottom plate 31. The shape of the handle groove 112 is preferably a rectangular structure slightly smaller than the bottom plate groove 111. The film mold 2 is adapted to the shape of the overall groove 11.

[0041] A method for using an assembly tool for a large plate of immunochromatographic reagent strips, such as Figure 7 As shown, the immunochromatographic reagent strip plate 3 includes a base plate 31, a gold label pad 32, a sample absorption pad 33, and a basic support sheet glass fiber 34. The base plate 31 is a rectangular structure. The middle of the long side of the base plate 31 is covered with a nitrocellulose membrane 36. A water-absorbing pad 35 is fixed to one side of the long side of the base plate 31. The water-absorbing pad 35 is overlapped on the nitrocellulose membrane 36. The method of use includes the following steps:

[0042] Step 1: Place the base 1 on a horizontal workbench, with the notch of the base 1 located at the outer edge of the workbench;

[0043] Step 2: Place the bottom plate 31 in the bottom plate groove 111, making sure that the top and bottom edges of the bottom plate 31 are flush with the sides of the bottom plate groove 111, and the long side of the bottom plate 31 with the absorbent pad 35 fixed thereon is adjacent to the handle groove 112; align and fasten the left-right symmetrical first positioning slots 211 of the film-applying mold 2 with the buckles 12 on the base. The corresponding position of the film-applying window 22 is now the adhesive position of the gold label pad 32, and a portion of the nitrocellulose membrane 36 is now placed in the film-applying window 22;

[0044] Step 3: Place the gold label pad 32 into the film window 22 and press the gold label pad 32 with your fingertips so that a portion of the gold label pad 32 overlaps the nitrocellulose membrane 36 located in the film window 22 and a portion of the gold label pad 32 is tightly attached to the bottom plate 31;

[0045] Step 4: Lift the film-applying mold 2 and align the left-right symmetrical second positioning slots 212 of the film-applying mold 2 with the buckles 12 on the base 1 and fasten them. The corresponding position of the film-applying window 22 is now the attachment position of the sample absorption pad 33, and a portion of the gold label pad 32 is now placed in the film-applying window 22.

[0046] Step 5: Place the sample absorption pad 33 into the film window 22 and press the sample absorption pad 33 with your fingertips so that a portion of the sample absorption pad 33 overlaps the gold label pad 32 located in the film window 22 and a portion of the sample absorption pad 33 is tightly attached to the bottom plate 31;

[0047] Step 6: Lift the film-sticking mold 2 and place it on one side of the workbench. Since the upper and lower sides of the bottom plate 31 are flush with the bottom plate groove 111, place the basic support sheet glass fiber 34 tightly against the upper part of the bottom plate groove 111, and press the basic support sheet glass fiber 34 with your fingertips so that part of the basic support sheet glass fiber 34 overlaps the sample absorption pad 33 and part is tightly fitted with the bottom plate 31. The assembly of the immunochromatographic reagent strip large plate 3 is completed.

[0048] Furthermore, in the step 1, a detection line T361 and a quality control line C362 are sequentially provided on the nitrocellulose membrane 36. When the liquid to be tested is dripped onto the position of the basic support sheet glass fiber 34 of the reagent strip, the liquid to be tested moves forward by capillary diffusion, and passes through the sample absorption pad 33 containing the marker, so that the marker is rehydrated, and the markers on the gold label pad 32 form a complex of the test substance, and are chromatographed together. The complex of the marker and the test substance will be intercepted by the detection line T361 (inherent specific antigen or antibody) due to the antibody-antigen specific reaction, thereby showing an obvious and intuitive red result. If the test liquid does not contain the complex of the test substance, the free marker will cross the detection line T361 and reach the quality control line C362, that is, the quality control line C362 will show an obvious and intuitive red result, and the excess test liquid will be absorbed by the absorption pad 33 to prevent the test liquid from overflowing and causing pollution.

[0049] Furthermore, in steps 3 and 5, the size of the gold label pad 32 and the sample absorption pad 33 is consistent with the film window 22. The film window 22 is consistent with the size of the accessory gold label pad 32 and the sample absorption pad 33. During operation, it is only necessary to align the accessories with the film window 22, ensuring the standardization of the film application operation and improving work efficiency.

[0050] The present invention has a novel structure and stable operation. When the present invention is used to assemble the immunochromatographic reagent strip plate, there is no need to manually align the accessories. The accessories only need to be placed in the mold and pressed, so that the assembly of the immunochromatographic reagent strip plate 3 is more standardized. The mold operation also avoids touching the nitrocellulose membrane 36 during manual operation, which not only improves the assembly efficiency, but also improves the qualified rate of the finished product; at the same time, it also reduces the sensitivity requirements of the operator in various aspects during the manual assembly of the immunochromatographic reagent strip plate 3, is more tolerant to the operator's age, gender and vision, and alleviates the problem of personnel loss on the production line to a certain extent.

[0051] Although this specification is described according to implementation methods, not every implementation method contains only one independent technical solution. This narrative method of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment can also be appropriately combined to form other implementation methods that can be understood by those skilled in the art.

[0052] Therefore, the above description is only a preferred embodiment of the present application and is not intended to limit the scope of implementation of the present application; that is, all equivalent modifications made according to the scope of the claims of the present application are within the scope of protection of the claims of the present application.

Claims

1. An assembly tool for large immunochromatographic reagent strips, characterized in that: The invention comprises a base (1) and a film-sticking mold (2), wherein the upper surface of the base (1) is provided with a groove (11), the film-sticking mold (2) is engaged in the groove (11), and buckles (12) are symmetrically provided at both ends of the groove (11), and the inner side surface of the film-sticking mold (2) is provided with at least one set of bilaterally symmetrical positioning grooves (21), and any set of the positioning grooves (21) is provided correspondingly to the buckles (12), and the film-sticking mold (2) is provided with a film-sticking window (22); The positioning slots (21) include a group of left-right symmetrical first positioning slots (211) and a group of left-right symmetrical second positioning slots (212), and the distance between the first positioning slots (211) and the second positioning slots (212) is smaller than the width of the film window (22); The upper portion of the film-sticking window (22) is a funnel-shaped structure that is wide at the top and narrow at the bottom; and one end of the inner side surface of the film-sticking mold (2) close to the film-sticking window (22) is a beveled surface (24).

2. The assembly tool for immunochromatographic reagent strips according to claim 1, characterized in that: The base (1) is a rectangular structure, a smooth notch is provided in the middle of a long side of one side of the base (1), and the film-sticking mold (2) is provided with a notch corresponding to the base (1).

3. The assembly tool for immunochromatographic reagent strips according to claim 2, characterized in that: The film-sticking mold (2) is fixedly provided with a handle (23).

4. The assembly tool for immunochromatographic reagent strips according to claim 3, characterized in that: The groove (11) includes a bottom plate groove (111) and a handle groove (112), the bottom plate groove (111) and the handle groove (112) are an integrated structure, the film window (22) of the film mold (2) is located corresponding to the bottom plate groove (111), and the handle (23) is located corresponding to the handle groove (112), the bottom plate groove (111) is a rectangular structure, and the handle groove (112) is a rectangular structure with a notch corresponding to the base (1).

5. A method for using the assembly tool for immunochromatographic reagent strips according to any one of claims 1 to 4, characterized in that: The immunochromatographic reagent strip plate (3) comprises a bottom plate (31), a gold label pad (32), a sample absorption pad (33), and a basic support sheet glass fiber (34). The bottom plate (31) is a rectangular structure. The middle of the long side of the bottom plate (31) is covered with a nitrocellulose membrane (36). A water-absorbing pad (35) is fixed to one side of the long side of the bottom plate (31). The water-absorbing pad (35) is overlapped on the nitrocellulose membrane (36). The method of use comprises the following steps: Step 1: Place the base (1) on a horizontal workbench, with the notch of the base (1) located at the outer edge of the workbench; Step 2: Place the bottom plate (31) in the bottom plate groove (111) so that it fits perfectly from top to bottom and from left to right, so that the top and bottom sides of the bottom plate (31) are flush with the sides of the bottom plate groove (111), and the long side of the bottom plate (31) on which the absorbent pad (35) is fixed is adjacent to the handle groove (112); align and fasten the left-right symmetrical first positioning slots (211) of the film-sticking mold (2) with the buckles (12) on the base, so that the corresponding position of the film-sticking window (22) is the sticking position of the gold label pad (32), and a portion of the nitrocellulose membrane (36) is placed in the film-sticking window (22); Step 3: Place the gold label pad (32) into the film window (22) and press the gold label pad (32) with the fingertips so that a portion of the gold label pad (32) overlaps the nitrocellulose membrane (36) located in the film window (22) and a portion of the gold label pad (32) is tightly attached to the bottom plate (31); Step 4: Lift the film mold (2), align and fasten the left-right symmetrical second positioning slots (212) of the film mold (2) with the buckles (12) on the base (1), and the corresponding position of the film window (22) is the pasting position of the sample absorption pad (33), and a part of the gold label pad (32) is placed in the film window (22); Step 5: Place the sample absorption pad (33) into the film window (22), and press the sample absorption pad (33) with the fingertips so that a portion of the sample absorption pad (33) overlaps the gold label pad (32) located in the film window (22), and a portion of the sample absorption pad (33) is tightly attached to the bottom plate (31); Step 6: Lift the film mold (2) and place it on one side of the workbench. Since the upper and lower sides of the bottom plate (31) are flush with the bottom plate groove (111), place the basic support sheet glass fiber (34) tightly against the upper part of the bottom plate groove (111), and press the basic support sheet glass fiber (34) with your fingertips so that a part of the basic support sheet glass fiber (34) overlaps the sample absorption pad (33) and a part is tightly fitted with the bottom plate (31). The assembly of the immunochromatographic reagent strip large plate (3) is completed.

6. The method for using the assembly tool for immunochromatographic reagent strips according to claim 5, characterized in that: In the step 1, a detection line T (361) and a quality control line C (362) are sequentially provided on the nitrocellulose membrane (36).

7. The method for using the assembly tool for immunochromatographic reagent strips according to claim 5, characterized in that: In the steps 3 and 5, the sizes of the gold label pad (32) and the sample absorption pad (33) are consistent with the size of the film window (22).

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