Test kits for a variety of immunosuppressants

Abstract

The utility model relates to detection instrument technical field, concretely is detection kit for multiple immunosuppressants, including reagent box body, detachable multi -hole detection board and sample adding shunt cover, the array type detection card groove is equipped in multi -hole detection board, can freely plug in or plug out the micro -size detection chip of preloading different antibodies, sample adding shunt cover adopts the funnel type feed hole to connect multichannel transmission channel, through the sample is synchronously shunted to each array type detection card groove through the liquid distribution board, the medical silica gel buffer layer is arranged at the bottom of liquid distribution board and realizes dynamic seal, and the electric connection of cooperation chip bottom electrode contact and integrated bottom plate is completed electrochemical signal acquisition. This reagent box supports the user to select the detection item according to the need, and can complete multiple index synchronous detection in single sample adding, and the efficiency is improved obviously and the pollution risk is reduced.

Description

Technical Field

[0001] This utility model relates to the field of testing instrument technology, specifically a test kit for various immunosuppressants. Background Technology

[0002] Immunosuppressants (such as tacrolimus, cyclosporine, sirolimus, everolimus, mycophenolate mofetil, etc.) are key drugs for preventing rejection after organ transplantation. However, their therapeutic window is narrow and there are large individual differences, so therapeutic drug monitoring (TDM) is required to ensure efficacy and avoid toxic side effects.

[0003] Traditional multi-index detection requires multiple sample additions and pipetting, which is cumbersome (averaging 6-8 steps) and easily leads to cross-contamination. In addition, the combination of detection kits is fixed (e.g., only supporting tacrolimus + cyclosporine), and it is impossible to add or remove detection items as needed; the lack of flexibility leads to problems such as reduced detection efficiency. In view of the above problems, this technical solution designs a detection kit for multiple immunosuppressants. Utility Model Content

[0004] The purpose of this invention is to provide a detection kit for various immunosuppressants to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, this utility model provides the following technical solution: A diagnostic kit for multiple immunosuppressants includes a kit body, a removable multi-well detection plate, and a sample dispensing cap. The sample dispensing cap is fitted onto the top of the kit body. The removable multi-well detection plate is interference-fitted into the kit body, with its top lower than the upper surface of the kit body. The removable multi-well detection plate has multiple arrayed detection slots inside, each containing an independently embedded microchip. A corresponding microchip slot is located at the bottom of the microchip, allowing the microchip to be snapped into place. Inside the chip slot, each micro-detection chip is pre-loaded with specific antibodies / antigens of different immunosuppressants, allowing users to freely combine detection items according to their requirements. For example, only inserting the tacrolimus + sirolimus chip avoids wasting resources. Each micro-detection chip has electrode contacts at its bottom for electrochemical detection. The micro-detection chip slot corresponding to the electrode contacts has an integrated base plate inside. The bottoms of the integrated base plates are connected by integrated circuits. That is, after the micro-detection chip is inserted into the micro-detection chip slot, the electrode contacts and the integrated base plate contact circuit are connected to perform reading detection. The sample dispensing cover is transparent, with a funnel-shaped feed hole in the middle. A liquid distribution plate is installed at the bottom of the sample dispensing cover directly above each array-type detection card slot. The liquid distribution plate has a liquid outlet in the middle. The liquid outlet is connected to the bottom of the funnel-shaped feed hole through a transmission channel located inside the sample dispensing cover. That is, through the cooperation between the funnel-shaped feed hole, the transmission channel, and the liquid outlet, the sample to be tested can be simultaneously transferred to each array-type detection card slot and then contact the micro detection chip for detection.

[0006] Compared with the prior art, the beneficial effect of this utility model is that the detachable multi-hole detection board allows users to freely combine micro detection chips, avoiding the waste of resources caused by fixed combinations.

[0007] By using a sample dispensing cap, a funnel-shaped feed hole, a transfer channel, and a separatory plate, a single sample dispensing can be used to achieve multiple streams, simplifying the traditional one-step operation into a single step and reducing testing time.

[0008] By directly connecting the electrode contacts of the micro-detection chip to the integrated baseboard, and combining it with a three-electrode system (working / reference / counter electrode), accurate acquisition of current signals can be achieved. Attached Figure Description

[0009] Figure 1 This is a schematic diagram of the structure of a detection kit for multiple immunosuppressants.

[0010] Figure 2 This is a top view schematic diagram of a test kit for use with multiple immunosuppressants.

[0011] Figure 3 This is a schematic diagram of a partial structure of the kit in a detection kit for multiple immunosuppressants.

[0012] Figure 4 This is a bottom view of the sample dispensing cap in a test kit for multiple immunosuppressants.

[0013] Figure 5 This is a schematic diagram of the separatory plate in a test kit for various immunosuppressants.

[0014] Figure 6 for Figure 3 A magnified structural diagram of A in the diagram.

[0015] Figure 7 for Figure 2 A magnified structural diagram of B in the diagram.

[0016] Figure 8 for Figure 1 An enlarged structural diagram of C.

[0017] The components include: reagent kit 10, detachable multi-well detection plate 11, sample dispensing cap 12, array detection slot 13, micro detection chip slot 14, embedded hole 15, embedded rod 16, integrated base plate 17, micro detection chip 18, chip frame 19, integrated circuit 20, funnel-shaped feed hole 21, hole cap 22, annular slot 23, dispensing plate 24, fixing layer 25, buffer layer 26, transmission channel 27, and liquid outlet hole 28. Detailed Implementation

[0018] It should be noted that, unless otherwise specified, the embodiments and features described in these embodiments can be combined with each other.

[0019] In the description of this utility model, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are 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, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this utility model, unless otherwise stated, "a plurality of" means two or more.

[0020] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of 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.

[0021] The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0022] Please see Figures 1-5A test kit for detecting multiple immunosuppressants includes a kit body 10, a detachable multi-well test plate 11, and a sample dispensing cap 12. The sample dispensing cap 12 is fitted onto the top of the kit body 10. The detachable multi-well test plate 11 is installed inside the kit body 10 via an interference fit. The top of the detachable multi-well test plate 11 is lower than the upper surface of the kit body 10. Multiple array-type detection slots 13 are formed inside the detachable multi-well test plate 11. Each array-type detection slot 13 independently embeds a micro-detection chip 18. A micro-detection chip slot 14 is formed inside the corresponding array-type detection slot 13 at the bottom of the micro-detection chip 18. The micro-detection chip 18 is inserted into the micro-detection chip slot 14. Each micro-detection chip 18 is pre-loaded with specific antibodies / antigens of different immunosuppressants, meaning that users can freely combine detection items according to requirements. For example, only inserting the tacrolimus + sirolimus chip can avoid wasting resources. Each micro-detection chip 18 has electrode contacts at its bottom for electrochemical detection. The micro-detection chip slot 14 corresponding to the electrode contacts has an integrated base plate 17 inside. The bottoms of the integrated base plates 17 are connected by integrated circuits 20. That is, after the micro-detection chip 18 is inserted into the micro-detection chip slot 14, the electrode contacts and the integrated base plate 17 contact the circuit to perform reading detection. The sample dispensing cover 12 is transparent, with a funnel-shaped feed hole 21 in the middle. A liquid dispensing plate 24 is installed at the bottom of the sample dispensing cover 12 directly above each array-type detection card slot 13. A liquid outlet hole 28 is opened in the middle of the liquid dispensing plate 24. The liquid outlet hole 28 is connected to the bottom of the funnel-shaped feed hole 21 through a transmission channel 27 located inside the sample dispensing cover 12. That is, through the cooperation between the funnel-shaped feed hole 21, the transmission channel 27, and the liquid outlet hole 28, the sample to be tested can be simultaneously transmitted to the inside of each array-type detection card slot 13, and then contact the micro detection chip 18 for detection.

[0023] In this embodiment of the invention, a sealing ring is provided on the inner sidewall of the sample dispensing cap 12 to increase the sealing performance of the sample dispensing cap 12 after it is fitted onto the top of the reagent kit 10. The upper side of the dispensing plate 24 is fixed to the bottom of the sample dispensing cover 12 by the fixing layer 25. A buffer layer 26 is provided at the bottom of the fixing layer 25. The buffer layer 26 is made of medical silicone and is located below the fixing layer 25. The bottom of the outlet hole 28 opens downward through the buffer layer 26. After the sample dispensing cover 12 is fitted onto the top of the reagent kit 10, the buffer layer 26 simultaneously covers the upper side of the array detection card slot 13. At this time, the buffer layer 26 is in a state of stress deformation, which keeps the outlet hole 28 connected to the inside of the array detection card slot 13 while ensuring the seal of the top of the array detection card slot 13. The material of the fixing layer 25 is the same as that of 12; Meanwhile, a control valve exposed outside the bottom of the sample dispensing cover 12 is provided on the transmission channel 27 between adjacent dispensing plates 24. This valve is used to control the transmission of the sample, that is, to control the transmission direction of the sample to be tested according to the requirements of the test and whether the array-type detection card slot 13 is used. Control valves typically include pneumatic diaphragm valves and piezoelectric microvalves.

[0024] In one embodiment of the present invention, the specific antibodies / antigens of immunosuppressants include enzyme-labeled antigens, fluorescent probes, etc. It should be noted that the operating principle between the micro-detection chip 18 and the integrated baseboard 17 is as follows: The structure of the micro-detection chip 18 is as follows: a reaction area is provided on its surface: an immobilized antibody layer; a nano-gold labeled secondary antibody-enzyme complex is provided on its lower side; and an electrode layer (three-electrode system) is provided at the bottom: a working electrode, a reference electrode, and a counter electrode. The immobilized antibody layer is used to capture the target immunosuppressant; the gold nanoparticle-labeled secondary antibody-enzyme complex is used for horseradish peroxidase (HRP) labeling; the working electrode undergoes a redox reaction, the reference electrode stabilizes the potential reference, and the counter electrode closes the current loop. The micro-detection chip 18 is combined with the integrated base plate 17 and electrochemical detection is adopted. The steps are as follows: (1) Immunobinding reaction Immunosuppressants (antigens) in the sample bind to antibodies immobilized on the chip surface to form "antibody-antigen" complexes; Enzyme-catalyzed colorimetric reaction Upon addition of the substrate solution, the HRP enzyme on the complex catalyzes the oxidation of TMB, generating a blue product (reversible oxidation state). (3) Electrochemical signal conversion The integrated substrate 17 applies a constant voltage (typically +0.1V vs. Ag / AgCl) to the chip electrodes, and the blue product undergoes a reduction reaction on the surface of the working electrode: TMB(ox) + 2H⁺ + 2e⁻ → TMB(red) The change in current (ΔμA) is inversely proportional to the antigen concentration; (4) Signal amplification and output The integrated circuit 17 on the base plate amplifies the current signal and converts it into antigen concentration (ng / mL) through an algorithm, which is then displayed on an external reader.

[0025] This is how the entire testing process is accomplished.

[0026] As a preferred embodiment of the present invention, see [reference]. Figure 6 , Figure 7A chip frame 19 is provided on the outside of the micro detection chip 18. Two insert rods 16 are symmetrically arranged on the bottom two sides of the chip frame 19. The micro detection chip slot 14 corresponding to the insert rod 16 has a hole 15 on the top two sides. The insert rod 16 is engaged with the hole 15, which is used for the engagement and positioning of the micro detection chip 18. See Figure 8 A cap 22 is embedded on the top of the funnel-shaped feed hole 21. A ring is installed on the bottom edge of the cap 22. An annular groove 23 is opened on the top of the funnel-shaped feed hole 21 corresponding to the ring. The ring is embedded in the annular groove 23. At the same time, a sealing gasket is laid on the bottom wall of the cap 22 corresponding to the bottom of the ring to ensure the sealing of the connection between the cap 22 and the funnel-shaped feed hole 21.

[0027] The elastic sealing and cushioning materials used in this technical solution are generally medical-grade silicone rubber.

[0028] The working principle of this utility model is as follows: In the idle position of this device, all the aforementioned driving components (representing power elements, electrical devices, and compatible power supplies) are connected via wires. The electrical connections are completed in sequence between the working components. The detailed connection methods are well-known in the field. The following mainly describes the working principle and process, without further explanation of the electrical control. Chip assembly: The user inserts the required micro detection chip 18 into the array detection card slot 13. The insert rod 16 at the bottom of the chip frame 19 engages with the insert hole 15 for positioning. At this time, the bottom electrode contacts of the chip are automatically connected to the integrated base plate 17.

[0029] Sample addition and diversion: Open the hole cover 22, the sample is injected from the funnel-shaped feed hole 21, and diverted to each liquid distribution plate 24 through the transmission channel 27. Through the control valve, the passage corresponding to the unactivated chip is closed in the transmission channel, and the sample flows only to the selected card slot 13.

[0030] Immunological reaction: The sample enters the array detection card slot 13 through the outlet 28, binds with the antibody immobilized on the chip surface to form a complex, and after the substrate solution is added, the HRP enzyme on the complex catalyzes the TMB color development.

[0031] Electrochemical detection: When a +0.1V voltage is applied to the working electrode by the integrated base plate 17, TMB(ox) is reduced to TMB(red) at the working electrode, generating a current. TMB(ox) + 2H⁺ + 2e⁻ → TMB(red) The current change value ΔμA is amplified by integrated circuit 20 and converted into antigen concentration.

[0032] Dynamic sealing maintenance: When the sample dispensing cap 12 is closed, the buffer layer 26 is compressed and deformed to fill the gap at the top of the array-type detection card slot 13, which keeps the liquid outlet 28 unobstructed and blocks the exchange of gas inside and outside the tank.

[0033] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of the present invention.

Claims

1. A detection kit for multiple immunosuppressants, characterized in that, Includes the reagent kit (10), a removable multi-well detection plate (11), and a sample dispensing cap (12); The detachable multi-hole detection plate (11) is press-fitted into the inside of the reagent kit (10), and an array of detection slots (13) are provided inside it. The sample dispensing cap (12) is fitted onto the top of the reagent kit (10), and its bottom is provided with a dispensing plate (24) corresponding to the array-type detection card slot (13).

2. The detection kit for multiple immunosuppressants according to claim 1, characterized in that, The array-type detection slot (13) is embedded with a micro detection chip slot (14), and a micro detection chip (18) is detachably attached to the micro detection chip slot (14). The micro detection chip (18) is preloaded with immunosuppressant-specific antibodies / antigens.

3. The detection kit for multiple immunosuppressants according to claim 2, characterized in that, The micro-detection chip (18) has electrode contacts at its bottom, and the micro-detection chip slot (14) has an integrated base plate (17) at its bottom; when the chip is inserted, the electrode contacts and the integrated base plate (17) form an electrical connection.

4. The test kit for various immunosuppressants according to claim 1, characterized by, The sample dispensing cover (12) is provided with a funnel-shaped feed hole (21) in the middle. The funnel-shaped feed hole (21) is connected to the liquid outlet (28) of each liquid dispensing plate (24) through the transmission channel (27). A control valve is provided on the transmission channel (27) between adjacent liquid dispensing plates (24).

5. The detection kit for multiple immunosuppressants according to claim 4, characterized in that, The dispensing plate (24) includes a fixing layer (25) and a buffer layer (26); the fixing layer (25) is connected to the bottom of the sample dispensing cap (12), and the buffer layer (26) is made of medical silicone and is located below the fixing layer (25); the outlet hole (28) penetrates the buffer layer (26).

6. The detection kit for multiple immunosuppressants according to claim 2, characterized in that, The micro detection chip (18) has a chip frame (19) on its outer side, and the bottom of the chip frame (19) has symmetrically arranged insert rods (16); the top two sides of the micro detection chip slot (14) have insert holes (15) that match the insert rods (16).

7. The detection kit for multiple immunosuppressants according to claim 1, characterized in that, The sample dispensing cover (12) is provided with a hole cover (22) at the top. The bottom ring of the hole cover (22) is engaged with the annular groove (23) at the top of the funnel-shaped feed hole (21), and a sealing gasket is provided at the bottom of the ring.

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