Kit for predicting immunotherapy effect

Abstract

The invention discloses a kit for predicting an immunotherapy effect, and particularly relates to the technical field of kits, the kit comprises a transparent kit body, a transparent positioning drum is mounted in the transparent kit body, and a quantitative synchronous detection mechanism is arranged on one side of the transparent positioning drum; and the quantitative synchronous detection mechanism comprises a linkage screw rod arranged on one side of the transparent positioning rotary drum. A quantitative synchronous detection mechanism is adopted, a PD-L1 detection reagent in a prediction reagent bearing soft barrel enters a butt joint communication needle tube and is poured into the inner position of a transparent positioning rotary barrel, the PD-L1 detection reagents in three insertion pointed heads synchronously enter a plurality of positioning bearing grooves, three times of prediction are synchronously carried out when a single sample is predicted, and the accuracy of the prediction result is improved. And the prediction quantity is a specified quantity, the operation in the prediction process is simpler, the same batch of prediction is realized for the same sample through rapid quantification, and the prediction efficiency is effectively improved.

Description

Technical Field

[0001] This invention relates to the field of reagent kit technology, and more specifically, to a reagent kit for predicting the efficacy of immunotherapy. Background Technology

[0002] In the field of cancer treatment, immunotherapy is one of the feasible medical approaches to conquer this global challenge. Immunotherapy refers to a series of processes that can enhance the immune system, induce or restore the function of cytotoxic T cells or other immune effector cells, and thus eliminate tumor cells. The commonly used clinical method for detecting PD-L1 is immunohistochemical staining, which mainly detects the expression of the PD-L1 gene protein. A PD-L1 expression level higher than 50% often indicates that the cancer patient may respond well to immunotherapy. If the PD-L1 expression level is low or negative, it often indicates that the cancer patient may respond poorly or be completely ineffective to immunotherapy. Therefore, kits for predicting the effectiveness of immunotherapy are particularly important for assessing its efficacy.

[0003] A search of existing published literature reveals that Chinese Patent Publication No. CN110055327B discloses an endothelial cell marker and kit for predicting the efficacy of cancer immunotherapy. The commonly used method for predicting the efficacy of tumor immune checkpoint blockade therapy involves detecting PD-L1 expression levels using techniques such as RT-qPCR or IHC to predict whether a patient will respond to tumor immunotherapy. However, this method based on PD-L1 expression levels is still controversial (Reference: Shen, X., & Zhao, B. (2018). Efficacy of PD-1 or PD-L1 inhibitors and PD-L1 expression status in cancer: meta-analysis. BMJ, 362, k3529.). Although this method is simple and easy to implement, its accuracy is not high. Moreover, some tumors, although expressing PD-L1, do not respond to immune checkpoint inhibitors. Therefore, there is a need to find a more accurate and widely applicable prediction method; that is, one that can better predict the efficacy of immune checkpoint blockade therapy in cancer patients. In addition, the test only requires basic RT-qPCR technology, is relatively simple to operate, has low cost, can be operated by medical institutions with laboratory departments, is suitable for popularization and promotion, requires fewer tissue samples, and is suitable for application in the early stages of tumors; however, this kit still has the following drawbacks.

[0004] The above-mentioned kit requires the user to prepare a specified amount of predictive reagent and a specified amount of predictive specimens when predicting the efficacy of immunotherapy. Moreover, multiple predictions are required for a single specimen. This makes the prediction process complex and difficult to quickly quantify the same batch of specimens, resulting in low prediction efficiency and increased prediction time for medical staff. Therefore, a kit for predicting the efficacy of immunotherapy is needed. Summary of the Invention

[0005] To overcome the above-mentioned deficiencies of the prior art, the present invention provides a kit for predicting the efficacy of immunotherapy.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a reagent kit for predicting the effect of immunotherapy, comprising a transparent reagent kit body, wherein a transparent positioning rotating cylinder is installed inside the transparent reagent kit body, and a quantitative synchronous detection mechanism is provided on one side of the transparent positioning rotating cylinder.

[0007] The quantitative synchronous detection mechanism includes a linkage screw located on one side of the transparent positioning rotary cylinder, and the outer wall of the linkage screw has a long threaded groove. A threaded sleeve push block is threadedly connected to the outer wall of the long threaded groove. Multiple linkage extrusion blocks are fixedly connected in a circular and equidistant manner on the outer wall of the threaded sleeve push block. An extrusion plate is welded to one end of each linkage extrusion block. A predictive reagent container soft tube for holding PD-L1 detection reagent is provided on one side of the extrusion plate. A short threaded groove is located on the outer wall of the linkage screw at the position of the long threaded groove. A linkage collar block is threadedly connected to the outer wall of the short threaded groove. Multiple collar insertion frames are provided on the outer wall of the linkage collar block in a circular and equidistant manner. An insertion guide assembly is installed inside the collar insertion frame. The specimen quantitative guide assembly is located on the outer wall of the transparent positioning rotary cylinder.

[0008] Preferably, one end of the linkage screw penetrates the inner wall of the transparent reagent kit and extends to the outer position of the transparent reagent kit. The linkage screw is rotatably connected to the transparent reagent kit, and the vertical cross-sectional area of ​​one end of the linkage screw is smaller than that of the other end. A first guide slide is provided between two adjacent collar plug-in frames. Multiple first guide slides are fixedly connected to the linkage collar block, and the outer wall of the first guide slide is horizontally slidably connected to the inner wall of the transparent reagent kit. A second guide slide is provided between two adjacent linkage extrusion blocks and is fixedly connected to the outer wall of the threaded sleeve push block. The outer walls of multiple second guide slides are horizontally slidably connected to the inner wall of the transparent reagent kit. A rotating ring is fixedly connected to the outer wall of the linkage screw at a position on the side of the short-sized threaded groove.

[0009] By adopting the above technical solution, the linkage screw drives the long-size threaded groove to rotate, and the long-size threaded groove drives the threaded sleeve push block to move to the right under the action of the thread. At the same time, the linkage screw drives the short-size threaded groove to move the linkage collar block to the right under the action of the thread. The threaded sleeve push block drives multiple second guide slides to move to the right along the inner wall of the transparent reagent kit. The linkage collar block drives multiple first guide slides to move to the right along the inner wall of the transparent reagent kit. The linkage screw drives the rotating ring to rotate at the end of the transparent positioning cylinder. The rightward movement distance of the threaded sleeve push block is greater than the rightward movement distance of the linkage collar block. The linkage collar block drives the predictive reagent container soft cylinder to move the collar insertion frame to the right. The collar insertion frame drives the insertion tip to move to the right, and the insertion tip is inserted into the position of the silicone septum.

[0010] Preferably, the insertion guide assembly includes an insertion tip installed inside the collar insertion frame, and the insertion tip is connected to the predictive reagent container soft cylinder. One side of the transparent positioning rotating cylinder has a positioning container groove equidistantly embedded in a circular shape. A silicone septum is fixedly connected to the inner wall of the positioning container groove. From right to left, the inner wall of the insertion tip has a thin silicone pad and a compression support block. On the outer wall of the compression support block, multiple linkage blocks are equidistantly distributed in a circular shape and fixedly connected to the inner wall of the insertion tip. A connecting needle tube is installed on one side of the silicone septum for horizontal insertion of the thin silicone pad. From left to right, the outer wall of the connecting needle tube has a compression ring, a fixed collar support, and a linkage spring. The outer wall of the connecting needle tube is connected to the fixed collar support... The frames are horizontally slidably connected, and a linkage pull ring is provided at one end of the linkage spring. The inner wall of the linkage pull ring is provided with a docking needle tube that communicates with the docking connecting needle tube. Multiple cutting blades are fixedly connected in a circular pattern near one end of the docking needle tube. A silicone spacer is provided on one side of the cutting blade and fixedly connected to the inner wall of the transparent positioning cylinder. The outer wall of the fixed collar bracket is fixedly connected to the transparent positioning cylinder to which the positioning support groove belongs. The linkage spring is fixedly connected to the fixed collar bracket and the linkage pull ring respectively. The docking connecting needle tube and the linkage pull ring are both welded to the docking needle tube. The tips of the docking connecting needle tubes are symmetrically arranged. One corner line of each cutting blade is chamfered.

[0011] By adopting the above technical solution, the insertion tip drives multiple linkage blocks to move the squeezing support block to the right. The squeezing support block squeezes the left end of the connecting needle tube, while the end of the insertion tip squeezes the left side of the squeezing ring. The connecting needle tube and the squeezing ring move to the right, and the connecting needle tube moves to the right along the inner wall of the fixed collar bracket. The connecting needle tube also drives the connecting needle tube to move to the right, which in turn drives the linkage pull ring to stretch the linkage spring on the fixed collar bracket. The connecting needle tube drives multiple cutting blades to move to the right, and the cutting blades cut the silicone spacer on the right side. The connecting needle tube can also cut the silicone spacer in the middle. This allows the PD-L1 detection reagent inside the three predictive reagent container cylinders and the specimen detection solution inside the three positioning container slots to be quantitatively detected simultaneously. After staining the specimen detection solution, the colors of the three sets of detection reagents in the transparent positioning cylinder inside the transparent reagent kit can be viewed by rotating the reagent color reference ring and observing the various colors outside the reagent color reference ring. Based on the colors and other clinical data, the immunotherapy effect can be predicted.

[0012] Preferably, the specimen quantitative diversion assembly includes a three-hole rubber ring fixedly disposed on the outer wall of the transparent positioning rotating cylinder; a specimen guide hopper with a top inner wall diameter smaller than its bottom inner wall diameter is fixedly connected to the top of the outer wall of the transparent reagent kit; a reagent color reference rotating ring is rotatably connected to the outer wall of the transparent reagent kit and located on one side of the specimen guide hopper; limiting rings are fixedly connected to both sides of the reagent color reference rotating ring on the outer wall of the transparent reagent kit, and both limiting rings are fixedly connected to the transparent reagent kit; and a fixed connection is made to the inner wall of the transparent positioning rotating cylinder at its center point. The device has a rotating shaft extending to the outside of the transparent reagent kit. One end of the rotating shaft is welded with a rotating cap having a vertical cross-section of hexagonal shape. A collar pointer is fixedly connected to the outer wall of the rotating shaft near the rotating cap. Above the collar pointer is a check pointer fixedly connected to the transparent reagent kit. The three-hole rubber ring and the outer wall of the rotating shaft are both rotatably connected to the inner wall of the transparent reagent kit. The bottom tip of the check pointer and the top tip of the collar pointer are on the same vertical line. The collar pointer is rotatably connected to the transparent reagent kit, and there is a gap between the collar pointer and the check pointer.

[0013] By adopting the above technical solution, the prepared predictive sample solution is poured into the sample guide hopper. Rotating the rotating cap drives the rotating shaft to rotate, which in turn drives the transparent positioning cylinder to rotate the three-hole rubber ring. The three-hole rubber ring is located on the inner wall of the transparent reagent kit. When the positioning container is connected to the sample guide hopper, the sample detection liquid inside the sample guide hopper is quantitatively discharged into the gap formed between the positioning container and the silicone spacer. Continuing to rotate the rotating cap drives the rotating shaft to continue rotating the transparent positioning cylinder. Another positioning container can also be quantitatively connected to the sample guide hopper. The third positioning container continues to rotate and connects with the sample guide hopper. The rotating shaft drives the collar pointer to rotate 360 ​​degrees below the verification pointer, so that the gap formed by the three silicone spacers and the positioning container can quantitatively hold the sample detection solution.

[0014] The technical effects and advantages of this invention are as follows:

[0015] 1. This invention employs a quantitative synchronous detection mechanism. A linkage screw drives a long-length threaded groove to rotate, which in turn drives a threaded sleeve pusher to move to the right under the action of the thread. A linkage collar block drives multiple first guide slides to move to the right along the inner wall of the transparent reagent kit. The collar inserter drives the insert tip to move to the right, inserting the tip into the silicone septum position, thereby stretching the silicone septum to align with the connecting needle tube. The PD-L1 detection reagent inside the predictive reagent container soft tube enters the connecting needle tube and is poured into the transparent positioning rotating cylinder. The PD-L1 detection reagent inside the three insert tips simultaneously enters multiple positioning container slots. When predicting a single sample, three predictions are performed simultaneously, and the predicted amount is always the specified amount. The operation is simpler during the prediction process, and rapid quantitative prediction of the same sample in the same batch is achieved, effectively improving prediction efficiency.

[0016] 2. This invention utilizes a plug-in flow guiding assembly. The extrusion block extrudes the left end of the connecting needle tube, while the tip of the plug-in is extruded to the left side of the extrusion ring. The connecting needle tube drives multiple cutting blades to move to the right, and the cutting blades cut the silicone spacer on the right side. The PD-L1 detection reagent inside the three predictive reagent containers and the sample detection solution inside the three positioning containers are simultaneously quantitatively mixed and detected. This not only eliminates the need to measure each specific PD-L1 detection reagent individually, but also enables simultaneous detection, avoiding excessive or insufficient PD-L1 detection reagent, and achieving efficient and accurate detection.

[0017] 3. This invention uses a sample quantitative diversion component to pour the prepared predictive sample solution into the sample guide hopper. The rotating shaft drives the transparent positioning cylinder to rotate the three-hole rubber ring. The three-hole rubber ring is located on the inner wall of the transparent reagent kit. The sample detection liquid inside the sample guide hopper is quantitatively discharged into the gap formed between the positioning container and the silicone spacer. Continuing to rotate the rotating cap, the rotating shaft drives the collar pointer to rotate 360 ​​degrees below the verification pointer. This allows the gap formed by the three silicone spacers and the positioning container to quantitatively hold the sample detection solution. There is no need to measure each sample individually. The rotating three-gap quantitative holding of the sample detection solution allows for direct quantitative holding and detection, resulting in higher detection efficiency.

[0018] Through the interaction of the above-mentioned multiple functions, firstly, by rotating the shaft, the collar pointer rotates 360 degrees below the verification pointer, allowing the gap formed by the three silicone spacers and the positioning container to quantitatively hold the sample detection solution. Then, the PD-L1 detection reagent inside the predictive reagent container enters the connecting needle tube and is poured into the transparent positioning rotating cylinder. Finally, the PD-L1 detection reagent inside the three predictive reagent container and the sample detection solution inside the three positioning container are simultaneously mixed and detected quantitatively. In summary, quantitative and synchronous detection can be achieved without measuring various detection solutions one by one and comparing detections repeatedly, effectively improving detection efficiency. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the overall structure of a reagent kit for predicting the efficacy of immunotherapy according to the present invention.

[0020] Figure 2 This is a schematic diagram of the vertical cross-section of a reagent kit for predicting the efficacy of immunotherapy according to the present invention.

[0021] Figure 3 This is a schematic diagram of the internal structure of a transparent reagent kit for predicting the efficacy of immunotherapy according to the present invention.

[0022] Figure 4 This is a schematic diagram of the structure of the second part of the present invention.

[0023] Figure 5 This is a partial cross-sectional structural diagram of the connection between the docking needle and the cutting blade in a reagent kit for predicting the efficacy of immunotherapy according to the present invention.

[0024] Figure 6 This is a schematic diagram of the vertical cross-section of the connection between the rotating shaft and the transparent positioning cylinder in a reagent kit for predicting the efficacy of immunotherapy according to the present invention.

[0025] Figure 7 This is a bottom view schematic diagram of a reagent kit for predicting the efficacy of immunotherapy according to the present invention.

[0026] The attached figures are labeled as follows: 1. Transparent reagent kit; 2. Transparent positioning rotary cylinder; 3. Linkage screw; 4. Long threaded groove; 5. Threaded sleeve push block; 6. Linkage extrusion block; 7. Extrusion plate; 8. Predictive reagent container cylinder; 9. Short threaded groove; 10. Linkage collar block; 11. Collar insertion bracket; 12. Insertion tip; 13. Silicone septum; 14. First guide slide; 15. Rotating ring; 16. Second guide slide; 17. Silicone thin pad; 18. Extrusion plate. 19. Pressure block; 20. Linkage block; 21. Positioning and receiving groove; 22. Connecting needle tube; 23. Squeezing ring; 24. Fixing collar bracket; 25. Linkage spring; 26. Linkage pull ring; 27. Connecting needle tube; 28. Cutting blade; 29. ​​Silicone spacer; 30. Three-hole rubber ring; 31. Specimen guide hopper; 32. Reagent color reference rotating ring; 33. Limiting ring; 34. Rotating shaft; 35. Collar pointer; 36. Check pointer; 37. Rotating cap. Detailed Implementation

[0027] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0028] As attached Figure 1-7 The kit shown is for predicting the efficacy of immunotherapy. It includes a simultaneous quantitative detection mechanism, a flow guide assembly, and a sample quantitative flow guide assembly. The design of these mechanisms and components enables simultaneous quantitative detection, eliminating the need to measure various test solutions individually and compare results repeatedly, thus effectively improving detection efficiency. The specific structural configuration of each mechanism and component is as follows:

[0029] In some embodiments, as shown in the appendix Figure 1-3 As shown, the quantitative synchronous detection mechanism includes a linkage screw 3 located on one side of the transparent positioning rotary cylinder 2, and the outer wall of the linkage screw 3 is provided with a long threaded groove 4. A threaded sleeve push block 5 is threadedly connected to the outer wall of the long threaded groove 4. Multiple linkage extrusion blocks 6 are fixedly connected in a circular and equidistant manner on the outer wall of the threaded sleeve push block 5. An extrusion plate 7 is welded to one end of each linkage extrusion block 6. A predictive reagent holding soft cylinder 8 for holding PD-L1 detection reagent is provided on one side of the extrusion plate 7. A short threaded groove 9 is provided on the outer wall of the linkage screw 3 located on one side of the long threaded groove 4. A linkage collar block 10 is threadedly connected to the outer wall of the short threaded groove 9. Multiple collar insertion frames 11 are provided on the outer wall of the linkage collar block 10 in a circular and equidistant manner. An insertion guide assembly is installed inside the collar insertion frame 11. The specimen quantitative guide assembly is located on the outer wall of the transparent positioning rotary cylinder 2.

[0030] In some embodiments, as shown in the appendix Figure 2-3 As shown, a first guide slide 14 is provided between each two adjacent collar insertion frames 11. Multiple first guide slides 14 are fixedly connected to the linkage collar block 10, and the outer wall of the first guide slide 14 is horizontally slidably connected to the inner wall of the transparent reagent kit body 1. This allows the linkage collar block 10 to drive multiple first guide slides 14 to move to the right along the inner wall of the transparent reagent kit body 1, thus guiding the slides to the right and ensuring stable movement of the first guide slides 14. A second guide slide 14 is provided between each two adjacent linkage extrusion blocks 6, fixedly connected to the outer wall of the threaded sleeve push block 5. The outer walls of the guide slide 16 and multiple second guide slides 16 are horizontally slidably connected to the inner wall of the transparent reagent kit 1. A rotating ring 15 is fixedly connected to the outer wall of the linkage screw 3 and located on one side of the short-sized threaded groove 9, so that the threaded sleeve push block 5 can drive the multiple second guide slides 16 to move to the right along the inner wall of the transparent reagent kit 1, ensuring that the threaded sleeve push block 5 can move to the right stably. The linkage screw 3 drives the rotating ring 15 to rotate at the end of the transparent positioning cylinder 2, increasing the vertical cross-sectional area of ​​the linkage screw 3 and stabilizing the rotation.

[0031] In some embodiments, as shown in the appendix Figure 2-5As shown, the insertion guide assembly includes an insertion tip 12 installed inside the collar insertion frame 11, and the insertion tip 12 is connected to the predictive reagent container soft cylinder 8. A positioning container groove 20 is equidistantly embedded in one side of the transparent positioning rotating cylinder 2 in a circular pattern. A silicone septum 13 is fixedly connected to the inner wall of the positioning container groove 20. A silicone thin pad 17 and a compression support block 18 are arranged sequentially from right to left on the inner wall of the insertion tip 12. Multiple linkage blocks 19, fixedly connected to the inner wall of the insertion tip 12, are distributed in a circular pattern on the outer wall of the compression support block 18. A connecting needle tube 21 for horizontal insertion of the silicone thin pad 17 is installed on one side of the silicone septum 13. A compression ring 22, a fixed collar bracket 23, and a linkage spring 24 are arranged sequentially from left to right on the outer wall of the connecting needle tube 21. The outer wall of the connecting needle tube 21 is connected to the fixed collar bracket... The two parts are horizontally slidably connected, and a linkage pull ring 25 is provided at one end of the linkage spring 24. The inner wall of the linkage pull ring 25 is provided with a docking needle tube 26 that communicates with the docking connecting needle tube 21. Multiple cutting blades 27 are fixedly connected in a circular pattern near one end of the outer wall of the docking needle tube 26. A silicone spacer 28 is provided on one side of the cutting blade 27 and is fixedly connected to the inner wall of the transparent positioning cylinder 2. The outer wall of the fixing collar bracket 23 is fixedly connected to the transparent positioning cylinder 2 to which the positioning support groove 20 belongs. The linkage spring 24 is fixedly connected to the fixing collar bracket 23 and the linkage pull ring 25 respectively. The docking connecting needle tube 21 and the linkage pull ring 25 are both welded to the docking needle tube 26. The tip of the docking connecting needle tube 21 and the tip of the docking needle tube 26 are symmetrically arranged. One corner line of each cutting blade 27 is chamfered.

[0032] In some embodiments, as shown in the appendix Figure 1-7As shown, the specimen quantitative diversion assembly includes a three-hole rubber ring 29 fixedly installed on the outer wall of the transparent positioning rotating cylinder 2. A specimen guide hopper 30 with a top inner wall diameter smaller than its bottom inner wall diameter is fixedly connected to the top of the outer wall of the transparent reagent kit 1. A reagent color reference rotating ring 31 is rotatably connected to the outer wall of the transparent reagent kit 1 on one side of the specimen guide hopper 30. Limiting rings 32 are fixedly connected to both sides of the reagent color reference rotating ring 31 on the outer wall of the transparent reagent kit 1. Both limiting rings 32 are fixedly connected to the transparent reagent kit 1. An end extending to the transparent reagent kit is fixedly connected to the inner wall of the transparent positioning rotating cylinder 2 at its center point. The transparent reagent kit 1 has a rotating shaft 33 on its exterior. One end of the rotating shaft 33 is welded with a rotating cap 36 with a vertical cross-section of hexagonal shape. A collar pointer 34 is fixedly connected to the outer wall of the rotating shaft 33 near the rotating cap 36. Above the collar pointer 34 is a check pointer 35 fixedly connected to the transparent reagent kit 1. The three-hole rubber ring 29 and the outer wall of the rotating shaft 33 are both connected to the inner wall of the transparent reagent kit 1. The bottom tip of the check pointer 35 and the top tip of the collar pointer 34 are on the same vertical line. The collar pointer 34 is rotatably connected to the transparent reagent kit 1, and there is a gap between the collar pointer 34 and the check pointer 35.

[0033] The working principle of the reagent kit for predicting the efficacy of immunotherapy in this invention is as follows:

[0034] When quantitatively discharging the specimen, the prepared predictive specimen solution is poured into the specimen guide hopper 30. Rotating the rotating cap 36 drives the rotating shaft 33 to rotate, which in turn drives the transparent positioning rotating cylinder 2 to rotate the three-hole rubber ring 29. The three-hole rubber ring 29 is located on the inner wall of the transparent reagent kit 1. When the positioning receiving groove 20 is connected to the specimen guide hopper 30, the specimen detection liquid inside the specimen guide hopper 30 is quantitatively discharged into the gap formed between the positioning receiving groove 20 and the silicone spacer 28. Then, the rotating cap 36 is rotated again... The rotating cap 36 drives the rotating shaft 33 to continue rotating the transparent positioning cylinder 2. Another positioning receiving groove 20 can also be quantitatively connected to the specimen guide hopper 30. The third positioning receiving groove 20 continues to rotate and docks with the specimen guide hopper 30. The rotating shaft 33 drives the collar pointer 34 to rotate 360 ​​degrees below the checking pointer 35, so that the gap formed by the three silicone spacers 28 and the positioning receiving groove 20 can quantitatively hold the specimen detection solution, and the silicone spacers 28 can also act as a separator for the specimen detection solution.

[0035] During quantitative synchronous detection, rotating the linkage screw 3 causes the long threaded groove 4 to rotate. The long threaded groove 4 causes the threaded sleeve push block 5 to move to the right under the action of the thread. At the same time, the linkage screw 3 causes the short threaded groove 9 to cause the linkage collar block 10 to move to the right under the action of the thread. The threaded sleeve push block 5 causes multiple second guide slides 16 to move to the right along the inner wall of the transparent reagent kit 1. The linkage collar block 10 causes multiple first guide slides 14 to move to the right along the inner wall of the transparent reagent kit 1. The linkage screw 3 also causes the rotating ring 15 to rotate at the end of the transparent positioning cylinder 2. Since the spacing length of the long threaded groove 4 is greater than the thread spacing length of the short threaded groove 9, the threaded sleeve push block 5 moves to the right by a certain amount during the rotation of the linkage screw 3. When the distance is greater than the rightward movement distance of the linkage collar block 10, the linkage collar block 10 drives the predictive reagent container soft cylinder 8 to move the collar plug frame 11 to the right. The collar plug frame 11 drives the plug tip 12 to move to the right, and the plug tip 12 is inserted into the position of the silicone septum 13, thereby stretching the silicone septum 13 to align with the docking connecting needle tube 21. The docking connecting needle tube 21 can be inserted into the silicone septum 13 and penetrate into the silicone thin pad 17. In this way, the docking connecting needle tube 21 and the plug tip 12 are docked and connected. The PD-L1 detection reagent inside the predictive reagent container soft cylinder 8 enters the docking connecting needle tube 21 and is poured into the position inside the transparent positioning rotating cylinder 2. The PD-L1 detection reagent inside the three plug tips 12 simultaneously enters the multiple positioning container slots 20.

[0036] When the flow is connected, as the insertion tip 12 continues to move to the right, the insertion tip 12 drives multiple linkage blocks 19 to move the squeezing support block 18 to the right. The squeezing support block 18 squeezes the left end of the connecting needle tube 21, while the end of the insertion tip 12 squeezes the left side of the squeezing ring 22. The connecting needle tube 21 and the squeezing ring 22 move to the right. The connecting needle tube 21 moves to the right along the inner wall of the fixed collar bracket 23, and the connecting needle tube 21 drives the connecting needle tube 26 to move to the right. The connecting needle tube 26 drives the linkage pull ring 25 to stretch the linkage spring 24 on the fixed collar bracket 23. The connecting needle tube 26 drives multiple cutting blades 27 to move to the right. The cutting blades 27 cut the silicone spacer 28 on the right side, and the connecting needle tube 26 can cut the middle of the silicone spacer 28, allowing the three predictive reagent containers inside the soft cylinder 8 to be connected. The PD-L1 detection reagent and the specimen detection solution inside the three positioning tanks 20 are used to achieve quantitative detection simultaneously. After staining and detecting the specimen detection solution, the colors of the three sets of detection reagents in the transparent positioning cylinder 2 inside the transparent kit 1 are viewed by rotating the reagent color reference ring 31 and observing the various colors outside the reagent color reference ring 31. This helps to determine whether the predicted immunotherapy effect is effective. Brown: usually used to describe the color of PD-L1 staining positive areas. Yellow: in some cases, yellow may appear in the staining results, which usually indicates moderate staining. Pink: in some staining results, pink staining areas are seen, which usually indicates low-intensity staining. Red: in the staining results, red staining areas may be seen, which usually indicates high-intensity staining. This is used to determine whether the kit predicts the effectiveness of the treatment effect.

[0037] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A reagent kit for predicting the efficacy of immunotherapy, comprising a transparent reagent kit body (1), wherein a transparent positioning rotating cylinder (2) is installed inside the transparent reagent kit body (1), characterized in that: A quantitative synchronous detection mechanism is provided on one side of the transparent positioning rotary cylinder (2); The quantitative synchronous detection mechanism includes a linkage screw (3) set on one side of the transparent positioning rotary cylinder (2), and the outer wall of the linkage screw (3) is provided with a long threaded groove (4). The outer wall of the long threaded groove (4) is threadedly connected to a threaded sleeve push block (5). Multiple linkage extrusion blocks (6) are fixedly connected in a circular and equidistant manner on the outer wall of the threaded sleeve push block (5). An extrusion plate (7) is welded to one end of each linkage extrusion block (6). A PD-L1 is provided on one side of the extrusion plate (7). The predictive reagent container (8) of the test reagent is provided with a short thread groove (9) on the outer wall of the linkage screw (3) and located on one side of the long thread groove (4). A linkage collar block (10) is threadedly connected to the outer wall of the short thread groove (9). The outer wall of the linkage collar block (10) is provided with a plurality of collar insertion frames (11) distributed in a circular pattern at equal intervals. An insertion guide assembly is installed inside the collar insertion frame (11). The specimen quantitative guide assembly is located on the outer wall of the transparent positioning rotating cylinder (2).

2. The kit for predicting the efficacy of immunotherapy according to claim 1, characterized in that: One end of the linkage screw (3) penetrates the inner wall of the transparent reagent kit (1) and extends to the outer position of the transparent reagent kit (1). The linkage screw (3) is rotatably connected to the transparent reagent kit (1), and the vertical cross-sectional area of ​​one end of the linkage screw (3) is smaller than the vertical cross-sectional area of ​​the other end.

3. The kit for predicting the efficacy of immunotherapy according to claim 1, characterized in that: Each of the two adjacent collar connectors (11) is provided with a first guide slide (14), and multiple first guide slides (14) are fixedly connected to the linkage collar block (10), and the outer wall of the first guide slide (14) is horizontally slidably connected to the inner wall of the transparent reagent kit (1).

4. The kit for predicting the efficacy of immunotherapy according to claim 1, characterized in that: A second guide slide (16) is provided between two adjacent linkage extrusion blocks (6) and is fixedly connected to the outer wall of the threaded sleeve push block (5). The outer walls of multiple second guide slides (16) are horizontally slidably connected to the inner wall of the transparent reagent kit (1). A rotating ring (15) is fixedly connected to the outer wall of the linkage screw (3) and located on one side of the short-size threaded groove (9).

5. The kit for predicting the efficacy of immunotherapy according to claim 1, characterized in that: The insertion guide assembly includes an insertion tip (12) installed inside the collar insertion frame (11), and the insertion tip (12) is connected to the predictive reagent container soft cylinder (8). The transparent positioning rotating cylinder (2) has a positioning container groove (20) embedded in a ring at equal intervals on one side. A silicone septum (13) is fixedly connected to the inner wall of the positioning container groove (20). The inner wall of the insertion tip (12) is provided with a silicone thin pad (17) and a compression support block (18) from right to left. Multiple linkage blocks (19) fixedly connected to the inner wall of the insertion tip (12) are distributed in a ring at equal intervals on the outer wall of the compression support block (18). A side of the silicone septum (13) is equipped with a tool for horizontal insertion of the silicone thin pad (17). The docking and connecting needle tube (21) has a compression ring (22), a fixed collar bracket (23), and a linkage spring (24) arranged sequentially from left to right on the outer wall of the docking and connecting needle tube (21). The outer wall of the docking and connecting needle tube (21) and the fixed collar bracket (23) are horizontally slidably connected. A linkage pull ring (25) is provided at one end of the linkage spring (24). The inner wall of the linkage pull ring (25) is provided with a docking needle tube (26) that communicates with the docking and connecting needle tube (21). Multiple cutting blades (27) are fixedly connected in a circular pattern near one end of the outer wall of the docking needle tube (26). A silicone spacer (28) is fixedly connected to the inner wall of the transparent positioning rotating cylinder (2) on one side of the cutting blade (27).

6. A kit for predicting the efficacy of immunotherapy according to claim 5, characterized in that: The outer wall of the fixed collar bracket (23) is fixedly connected to the transparent positioning rotary cylinder (2) to which the positioning mounting groove (20) belongs, and the linkage spring (24) is fixedly connected to the fixed collar bracket (23) and the linkage pull ring (25) respectively.

7. The kit for predicting the efficacy of immunotherapy according to claim 5, characterized in that: The docking connecting needle tube (21) and the linkage pull ring (25) are both welded to the docking needle tube (26). The tip of the docking connecting needle tube (21) and the tip of the docking needle tube (26) are symmetrically arranged. One corner line of each cutting blade (27) is chamfered.

8. The kit for predicting the efficacy of immunotherapy according to claim 1, characterized in that: The specimen quantitative diversion assembly includes a three-hole rubber ring (29) fixedly installed on the outer wall of the transparent positioning rotating cylinder (2). The top of the outer wall of the transparent reagent kit (1) is fixedly connected to a specimen guide hopper (30) with a top inner wall diameter smaller than its bottom inner wall diameter. A reagent color reference rotating ring (31) is rotatably connected to the outer wall of the transparent reagent kit (1) on one side of the specimen guide hopper (30). Limiting rings (32) are fixedly connected to both sides of the outer wall of the transparent reagent kit (1) on both sides of the reagent color reference rotating ring (31). All rings (32) are fixedly connected to the transparent reagent kit body (1). A rotating shaft (33) with an end extending to the outside of the transparent reagent kit body (1) is fixedly connected to the inner wall of the transparent positioning rotating cylinder (2) at its center point. A rotating cap (36) with a vertical cross-section of hexagon is welded to one end of the rotating shaft (33). A collar pointer (34) is fixedly connected to the outer wall of the rotating shaft (33) near the rotating cap (36). A check pointer (35) fixedly connected to the transparent reagent kit body (1) is provided above the collar pointer (34).

9. A kit for predicting the efficacy of immunotherapy according to claim 8, characterized in that: The outer walls of the three-hole rubber ring (29) and the rotating shaft (33) are connected to the inner wall of the transparent reagent kit (1), and the bottom tip of the checking pointer (35) and the top tip of the collar pointer (34) are on the same vertical line.

10. A kit for predicting the efficacy of immunotherapy according to claim 8, characterized in that: The collar pointer (34) is rotatably connected to the transparent reagent kit body (1), and there is a gap between the collar pointer (34) and the verification pointer (35).

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