A microfluidic immunochromatographic reagent kit

Abstract

This invention relates to the field of point-of-care testing devices, and more particularly to a microfluidic immunochromatographic reagent kit. It includes a chip shell and an external diluent addition component. The chip shell has a blood collection head at its front end, and a chromatography chamber for placing test strips inside the chip shell. The blood collection head communicates with the chromatography chamber through a microfluidic channel within the chip shell. The external diluent addition component is detachably connected to the front end of the chip shell and is used to add diluent to the chromatography chamber through the blood collection head and the microfluidic channel. The blood collection head collects blood samples. The microfluidic channel has a capillary structure to ensure that the blood sample is premixed with the diluent as it passes through the microfluidic channel, and to slow down the flow rate of the mixture into the chromatography chamber. With this invention, medical personnel only need three steps—"puncture-merge-observation"—to complete the operation and testing, requiring no professional training.

Description

Technical Field

[0001] This utility model relates to the field of point-of-care testing devices, specifically a microfluidic immunochromatographic reagent kit. Background Technology

[0002] In vitro diagnostics (IVD) technology refers to obtaining relevant clinical diagnostic information by testing samples from the body, including blood, body fluids, and tissues, outside the human body, thereby helping to determine diseases or bodily functions. Currently, the IVD technology with the greatest development potential and fastest growth is point-of-care testing (POCT).

[0003] In the field of point-of-care testing (POCT), traditional colloidal gold test strips, while simple to operate and low in cost, suffer from numerous problems such as poor sensitivity, insufficient specificity, difficulty in quantification, weak sample adaptability, and lack of quality control. Meanwhile, microfluidic diagnostic products from companies like NOW Diagnostics and Lumos Diagnostics, while representing technological breakthroughs (NOW Diagnostics uses direct finger-prick blood testing, and Lumos Diagnostics integrates a multi-functional cartridge), are still limited in their widespread application and adoption due to the former's susceptibility to blood component interference and suboptimal chromatographic design, and the latter's complex structure and high cost.

[0004] Taking the previously mentioned similar products as an example, NOW Diagnostics directly uses fingertip blood to draw into the microfluidic chip for chromatography without diluent assistance. This not only makes the test results susceptible to interference from blood components, but also, due to the small amount of blood from the fingertip, the chromatography strips are prone to failure if not optimized.

[0005] Lumos Diagnostics integrates skin puncture, capillary collection, and sample dilution within a housing. This complex structure, numerous components, and cumbersome manufacturing process significantly increase material and processing costs, hindering the product's market promotion.

[0006] Therefore, there is an urgent need for a finger-prick blood diagnostic product that can ensure testing accuracy, reduce costs, and be suitable for the general public. Utility Model Content

[0007] The purpose of this invention is to provide a microfluidic immunochromatographic reagent kit to solve the problems mentioned in the background art.

[0008] To achieve the above objectives, this utility model provides the following technical solution:

[0009] A microfluidic immunochromatographic assay kit, comprising:

[0010] The chip casing has a blood collection head at its front end and a chromatography chamber for placing test strips inside the chip casing. The blood collection head is connected to the chromatography chamber through a microfluidic channel inside the chip casing.

[0011] An external diluent addition component is provided, which is detachably connected to the front end of the chip housing and is used to add chromatographic diluent to the chromatography chamber through the blood collection head and microfluidic channel.

[0012] The blood collection head is used to collect blood samples. The microfluidic channel has a capillary structure, which is used to ensure that the blood sample is premixed with the diluent when passing through the microfluidic channel and to slow down the speed at which the mixture flows through the microfluidic channel into the chromatography chamber.

[0013] Furthermore, the capillary structure is a cylindrical structure arranged in a fishbone pattern.

[0014] Furthermore, the chip casing is made of transparent plastic, and the chip casing is fixed by a base plate and an upper plate located on the base plate.

[0015] Furthermore, the chromatography chamber is located on the opposite surfaces of the bottom plate and the top plate, and the chromatography chamber has protrusions for supporting the test strip and slots for holding the test strip in place.

[0016] Furthermore, the upper plate has a viewing window for observing the reaction area of ​​the test strip.

[0017] Furthermore, the external diluent addition assembly includes an end cap and a reservoir located within the end cap. The end cap is inserted into the front end of the chip housing, and the reservoir has an aluminum foil for puncturing by the blood collection head.

[0018] Furthermore, the end cap is square in shape and has an opening, and has a protrusion inside the end cap to restrict further movement of the blood collection head.

[0019] Furthermore, the external diluent addition assembly includes an end cap and a reservoir located within the end cap. The end cap is screwed to the front end of the chip housing, and the reservoir has an aluminum foil for puncturing by the blood collection head.

[0020] Furthermore, the end cap is circular and has an opening and internal threads. The front end of the chip shell has an outer ring that protects the blood collection head, and the outer ring has an external thread that mates with the internal thread of the end cap.

[0021] Furthermore, the reservoir has a recessed socket for pre-insertion of the blood collection head, and the recessed socket has an aluminum foil for easy puncture by the blood collection head.

[0022] Compared with the prior art, the beneficial effects of this utility model are:

[0023] In this invention, the chip casing is made of ordinary transparent plastic, and the chip casing is fixed together by a base plate and an upper plate located on the base plate. The chip casing can be mass-produced quickly using injection molding, reducing casing costs.

[0024] In this invention, the test strip pre-installed inside the chip casing uses a common lateral chromatography material. Utilizing its natural hydrophilicity and good chromatographic performance, and by optimizing the cutting size to fit the amount of fingertip blood sample, it ensures that the blood sample can smoothly reach the reaction area, reducing the cost increase caused by special materials.

[0025] This invention designs an external diluent addition component, using a low-cost plastic material sealed with aluminum foil to create a small liquid storage structure, serving as a diluent storage device. In use, the aluminum foil seal is applied through a puncture-resistant interface, allowing it to be inserted into a blood collection head. Medical personnel insert the blood collection head, with the blood sample already collected, into the end cap through the opening. The head punctures the aluminum foil, allowing the diluent to enter the chromatography chamber through a microfluidic channel. This simplifies the overall product structure, facilitates diluent replenishment and replacement, and reduces the cost of complex internal diluent systems.

[0026] This invention allows the reservoir to be designed as a replaceable, independent component, adaptable to the dilution requirements of different detection projects. By changing the buffer solution formulation and test strip markers within the reservoir, it can be adapted to various colloidal gold detection projects (such as infectious disease and hormone detection).

[0027] This invention features a microfluidic channel with a small, fishbone-shaped cylindrical structure. This design ensures that the blood pressure sample collected by the blood collection head is premixed with the diluent as it passes through the microfluidic channel. The premixed solution slows down the flow rate as it passes through the channel, preventing the liquid in the reservoir from rushing into the test strip in the chromatography chamber due to excessive pressure release after the blood collection head punctures the aluminum foil. This would prevent detection problems.

[0028] This invention features an external diluent addition component that is fixed to the blood collection head of the chip casing via a plug-in or screw connection, simplifying operation. Medical personnel can complete the operation and testing in just three steps: "puncture-merge-observe," requiring no specialized training. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the structure of Embodiment 1 of this utility model.

[0030] Figure 2 This utility model Figure 1 A diagram showing the result after removing the top plate.

[0031] Figure 3 This utility model Figure 1Schematic diagram of cross-section at point AA.

[0032] Figure 4 This utility model Figure 1 A diagram showing the product after the end caps have been removed.

[0033] Figure 5 This utility model Figure 1 Exploded view diagram.

[0034] Figure 6 This utility model Figure 5 Another perspective illustration.

[0035] Figure 7 This utility model Figure 5 A schematic diagram of the specific structure at point A in the middle.

[0036] Figure 8 This is a schematic diagram of the cylindrical structure of this utility model, arranged in a fishbone pattern.

[0037] Figure 9 This is a schematic diagram of the structure of Embodiment 2 of this utility model.

[0038] Figure 10 This is a schematic diagram of the structure of Embodiment 3 of this utility model.

[0039] Figure 11 This utility model Figure 10 Exploded view diagram.

[0040] Figure 12 This utility model Figure 11 Another perspective illustration.

[0041] In the diagram: 1-Chip casing, 2-Base plate, 3-Top plate, 4-End cap, 5-Protrusion, 6-Reservoir, 7-Aluminum foil, 8-Blood collection head, 9-Microfluidic channel, 10-Capillary structure, 11-Branching channel, 12-Chromatography chamber, 13-Protrusion, 14-Slot, 15-Viewing window, 16-Splitter tip, 17-Extension, 18-Cylindrical, 19-Outer ring, 20-Concave insertion port, 21-Test strip. Detailed Implementation

[0042] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0043] In the description of this utility model, it should be noted that the terms "upper end," "lower end," "inner," "outer," "front end," "rear end," "both ends," "one end," and "the other end," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model. In addition, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0044] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installed," "equipped with," "sleeved with," "connected," etc., should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0045] Example 1

[0046] Please see Figures 1 to 8 This utility model provides a technical solution:

[0047] A microfluidic immunochromatographic reagent kit for finger-prick blood diagnosis includes:

[0048] The chip housing 1 has a blood collection head 8 at its front end and a chromatography chamber 12 for placing the test strip 21 inside the chip housing 1. The blood collection head 8 is connected to the chromatography chamber 12 through a microfluidic channel 9 inside the chip housing 1.

[0049] An external diluent addition component is provided, which is detachably connected to the front end of the chip housing 1 and is used to add chromatographic diluent to the chromatography chamber 12 through the blood collection head 8 and the microfluidic channel 9.

[0050] The blood collection head 8 is used to collect blood samples. The microfluidic channel 9 has a capillary structure 10. The capillary structure 10 is used to ensure that the blood sample is premixed with the diluent when passing through the microfluidic channel 9, and to slow down the speed at which the mixture flows through the microfluidic channel 9 into the chromatography chamber 12.

[0051] In this embodiment, a disposable blood collection head 8 is made of conventional medical-grade plastic material, which is compatible with commercially available blood collection needles. Its simple structure reduces the research and development and manufacturing costs of the blood collection head 8. The capillary structure 10 designed inside the blood collection head 8 utilizes capillary principles to collect blood samples (such as fingertip blood), controlling the collection volume to the minimum effective amount required for testing, thus avoiding blood sample waste.

[0052] Specifically, the chip casing 1 is made of ordinary transparent plastic, and the chip casing 1 is fixed by a base plate 2 and an upper plate 3 located on the base plate 2. The chip casing 1 can be mass-produced quickly through injection molding, reducing casing costs.

[0053] In this embodiment, as Figure 5 As shown, the test strip 21 pre-installed inside the chip casing 1 uses common lateral chromatography materials. Utilizing its natural hydrophilicity and good chromatographic performance, the optimized cutting size is adapted to the amount of fingertip blood sample, ensuring that the blood sample can smoothly reach the reaction zone a, reducing the cost increase caused by special materials.

[0054] Because the chip casing 1 is made of common materials and low-cost processing technology, the base plate 2 and the top plate 3 are fixed together by snap-fit ​​or adhesive bonding to form the chip casing 1. The test strip 21 uses existing common cellulose filter paper chromatography strips, which controls costs while ensuring performance. The shape is a general rectangle with a length of 6-6.5cm and a width of 3-3.5mm, or it can be designed into a corresponding shape according to the requirements.

[0055] Specifically, such as Figure 2 , Figure 3 and Figure 5 As shown, the chromatography chamber 12 is located on the opposite surfaces of the bottom plate 2 and the top plate 3. The chromatography chamber 12 has a protrusion 13 for supporting the test strip 21 and a slot 14 for securing the test strip 21. Both the upper and lower chromatography chambers 12 have protrusions 13, which not only support the test strip 21 but also hold the test strip 21 firmly after the bottom plate 2 and the top plate 3 are fixed, preventing it from shaking. The slot 14 is used for pre-positioning the test strip 21.

[0056] Specifically, the upper plate 3 has a viewing window 15 for observing the reaction area a of the test strip 21. The viewing window 15 is positioned corresponding to the C line (Control Line) and the T line (Test Line). After the mixture reacts in the reaction area a of the test strip 21, medical personnel can observe the displayed results through the viewing window 15.

[0057] The C-line and T-line are used to indicate the presence of the target substance (such as viruses, hormones, etc.). The test result is valid only when the C-line shows color; if the T-line also shows color, the result is positive.

[0058] In this embodiment, mature immunochromatographic assay technology is used for detection on test strip 21. By rationally designing the spacing between the T and C lines and the concentration of the injected mixture on the test strip as needed, the test results can be accurately determined. The results are displayed visually; medical personnel can determine the test results by observing the reaction area a of the test strip 21 through the viewing window 15.

[0059] Specifically, the external diluent addition assembly includes an end cap 4 and a reservoir 6 located within the end cap 4. The end cap 4 is inserted into the front end of the chip housing 1. The reservoir 6 has an aluminum foil 7 for piercing by the blood collection head 8. The end cap 4 is square in shape and has an opening. Inside the end cap 4 are protrusions 5 for restricting further movement of the blood collection head 8. Figure 3 and Figure 5 As shown, when the end of the blood collection head 8 contacts the protrusion 5, it can completely pierce the aluminum foil 7.

[0060] In this embodiment, an external diluent addition component is designed. It is made of low-cost plastic material and sealed with aluminum foil 7 to form a small liquid storage structure, which serves as a diluent storage device.

[0061] In use, the aluminum foil 7 is used to seal the puncture-proof interface, allowing it to be inserted into the blood collection head 8. When in use, the blood collection head 8 with the blood sample already collected is inserted into the end cap 4 through the opening. This punctures the aluminum foil 7, allowing the diluent (or buffer solution) to enter the chromatography zone (i.e., chromatography chamber 12) through the microfluidic channel 9. This simplifies the overall product structure, facilitates the replenishment and replacement of the diluent, and reduces the cost of the built-in complex diluent system.

[0062] In this embodiment, the reservoir 6 can be designed as a replaceable, independent component to adapt to the dilution requirements of different detection projects. Specifically, during production, the manufacturer can use the same reservoir 6 structure to fill different buffer solutions and then install them inside different end caps 4 according to different projects. During use, it simply plugs into the front end of different chip housings 1. In this way, by changing the buffer solution formulation and test strip markers inside the reservoir 6, it can be adapted to various colloidal gold detection projects (such as infectious disease and hormone detection).

[0063] Specifically, such as Figure 2 , Figure 7 and Figure 8 As shown, the capillary structure 10 is a cylindrical structure 18 arranged in a fishbone (or V-shape) pattern.

[0064] In this embodiment, the microfluidic channel 9 is designed with a (small) fishbone-shaped arrangement of cylindrical 18s. This ensures that the blood pressure sample collected by the blood collection head 8 is premixed with the diluent when passing through the microfluidic channel 9. The premixed mixture slows down the flow rate as it flows through the microfluidic channel 9, ensuring that after the blood collection head 8 punctures the aluminum foil 7 of the reservoir 6, the liquid in the reservoir 6 will not rush into the test strip 21 in the chromatography chamber 12 due to excessive pressure release, thus preventing detection problems.

[0065] In this embodiment, the external diluent addition component is plugged in: the end cap 4 is square and is plugged into the blood collection head 8. When the end cap 4 and the blood collection head 8 are plugged in, the blood collection head 8 punctures the aluminum foil 7 of the reservoir 6, so that the diluent in the reservoir 6 and the collected blood sample flow together from the microfluidic channel 9 into the chromatography chamber 12 and are detected by the test strip 21.

[0066] In this embodiment, there can be one or more chromatography chambers 12. For example... Figure 2 and Figure 7 As shown, this section describes two independent chromatography chambers 12, which are not interconnected. At the tail end of the microfluidic channel 9, there is a splitting tip 16. The splitting tip 16 has an extension 17 extending towards the blood collection head 8. The extension 17 divides the microfluidic channel 9 into two independent sub-channels, each of which is connected to its respective chromatography chamber 12 via a branch channel 11. This allows the mixture entering the microfluidic channel 9 to be pre-splitled, thus allowing it to enter each chromatography chamber 12.

[0067] Example 2

[0068] Please see Figure 9 This utility model provides a technical solution:

[0069] In this embodiment, it is basically the same as in Embodiment 1, except that there is no extension 17. In this way, the mixture entering the microfluidic channel 9 must flow to the splitting tip 16 before it can enter each chromatography chamber 12 through the branch channel 11. Compared with Embodiment 1, the mixture entering the microfluidic channel 9 is "post" split so that it enters each chromatography chamber 12.

[0070] Example 3

[0071] Please see Figures 10 to 12 This utility model provides a technical solution:

[0072] Specifically, it is basically the same as Embodiment 1 or Embodiment 2, except that: the external diluent addition assembly includes an end cap 4 and a reservoir 6 located inside the end cap 4. The end cap 4 is screwed to the front end of the chip housing 1. The reservoir 6 has an aluminum foil 7 for piercing by the blood collection head 8. The end cap 4 is circular and has an opening and internal threads. The front end of the chip housing 1 has an outer ring 19 that protects the blood collection head 8. The outer ring 19 has an external thread that mates with the internal thread of the end cap 4. The reservoir 6 has a recessed insertion port 20 for pre-insertion of the blood collection head 8. The recessed insertion port 20 has an aluminum foil 7 for easy piercing by the blood collection head 8.

[0073] The external diluent addition component is screwed on: the end cap 4 is round and is threaded to the blood collection head 8. When the end cap 4 is screwed on the blood collection head 8, the blood collection head 8 punctures the aluminum foil 7 of the reservoir 6, allowing the diluent in the reservoir 6 and the collected blood sample to flow together from the microfluidic channel 9 into the chromatography chamber 12 and be detected by the test strip 21.

[0074] In this embodiment, since the end cap 4 needs to rotate, in order to prevent the reservoir 6 inside the end cap 4 from rotating with the end cap 4, which may cause the aluminum foil 7 to not be aligned with the blood collection head 8, a concave insertion port 20 is designed. That is, the aluminum foil 7 is recessed inward by a certain distance. In this way, the blood collection head 8 is aligned and extended into the concave insertion port 20 by a certain distance beforehand, and the blood collection head 8 will not puncture the aluminum foil 7 in advance. Then, the end cap 4 is rotated. As the end cap 4 continuously squeezes the reservoir 6, the aluminum foil 7 will eventually be punctured.

[0075] This invention integrates an end cap 4 and a reservoir 6 as a cap structure for puncturing the blood collection head 8. It not only adopts an external, convenient insertion method, but also triggers the release of the buffer solution stored inside by simply inserting it into the blood collection head 8. The buffer solution and the blood sample pre-collected by the blood collection head 8 are combined into a mixture in the microfluidic channel 9 and finally flow into the chromatography chamber 12. The mixture is then detected by the test strip 21, and the test result can be determined by observing the reaction area a of the test strip 21 through the viewing window 15. This greatly simplifies the operation process and reduces costs.

[0076] This invention is easy to operate: medical staff only need to complete the operation and testing in three steps: "puncture-merge-observe", without the need for professional training.

[0077] The parts of this utility model not described are existing technologies.

[0078] Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the present invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A microfluidic immunochromatographic reagent kit, characterized in that, include: The chip housing (1) has a blood collection head (8) at its front end and a chromatography chamber (12) for placing a test strip (21) inside the chip housing (1). The blood collection head (8) is connected to the chromatography chamber (12) through a microfluidic channel (9) inside the chip housing (1). An external diluent addition assembly is detachably connected to the front end of the chip housing (1) and is used to add chromatographic diluent to the chromatography chamber (12) through the blood collection head (8) and the microfluidic channel (9); The blood collection head (8) is used to collect blood samples. The microfluidic channel (9) has a capillary structure (10). The capillary structure (10) is used to ensure that the blood sample is premixed with the diluent when passing through the microfluidic channel (9) and to slow down the speed at which the mixture flows through the microfluidic channel (9) into the chromatography chamber (12).

2. The microfluidic immunochromatographic reagent kit as described in claim 1, characterized in that, The capillary structure (10) is a cylindrical (18) structure arranged in a fishbone pattern.

3. The microfluidic immunochromatographic reagent kit as described in claim 1, characterized in that, The chip casing (1) is made of transparent plastic and is fixed by a base plate (2) and an upper plate (3) located on the base plate (2).

4. The microfluidic immunochromatographic reagent kit as described in claim 3, characterized in that, The chromatography chamber (12) is located on the opposite surfaces of the bottom plate (2) and the top plate (3), and the chromatography chamber (12) has a protrusion (13) for supporting the test strip (21) and a slot (14) for holding the test strip (21).

5. A microfluidic immunochromatographic reagent kit as described in claim 3 or 4, characterized in that, The upper plate (3) has a viewing window (15) for observing the reaction area of ​​the test strip (21).

6. The microfluidic immunochromatographic reagent kit as described in claim 1, characterized in that, The external diluent addition assembly includes an end cap (4) and a reservoir (6) located inside the end cap (4). The end cap (4) is inserted into the front end of the chip housing (1). The reservoir (6) has an aluminum foil (7) for puncture by the blood collection head (8).

7. A microfluidic immunochromatographic reagent kit as described in claim 6, characterized in that, The end cap (4) is square in shape and has an opening. Inside the end cap (4) there is a protrusion (5) for restricting further movement of the blood collection head (8).

8. A microfluidic immunochromatographic reagent kit as described in claim 1, characterized in that, The external diluent addition assembly includes an end cap (4) and a reservoir (6) located inside the end cap (4). The end cap (4) is screwed to the front end of the chip housing (1). The reservoir (6) has an aluminum foil (7) for puncture by the blood collection head (8).

9. A microfluidic immunochromatographic reagent kit as described in claim 8, characterized in that, The end cap (4) is circular and has an opening and internal threads. The front end of the chip shell (1) has an outer ring (19) that protects the blood collection head (8). The outer ring (19) has an external thread that matches the internal thread of the end cap (4).

10. A microfluidic immunochromatographic reagent kit as described in claim 8, characterized in that, The reservoir (6) has a recessed socket (20) for pre-insertion of the blood collection head (8), and the recessed socket (20) has an aluminum foil (7) for easy puncture by the blood collection head (8).

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