Immunodetection kit and detection method thereof

Abstract

The invention discloses an immunodetection kit and a detection method thereof.The kit comprises a kit shell, a cleaning liquid box, a waste liquid box, an immunoreagent box, a sample inlet, a control switch and a displayer are connected to the kit shell in an embedded mode, and a reagent pump, a reaction chamber, a detection chamber, a data processing module, a microcontroller, a battery and a cleaning pump are connected to the interior of the kit shell; the cleaning liquid box is connected with the reaction chamber and the detection chamber through a cleaning pump, the immunoreagent box is connected with the reaction chamber through a reagent pump, the reaction chamber is connected with the sample inlet through a pipeline, the reaction chamber is connected with the detection chamber through a micropump, the detection chamber is connected with the waste liquid box through a micropump, and the reaction chamber and the detection chamber are internally connected with a sterilizing lamp and a heating plate. An optical sensor and an electrochemical sensor are connected in the detection chamber; the method comprises the following steps: sample preparation, reagent addition, reaction process, product conveying, detection process, data processing, result display and transmission, and cleaning process. The system has the advantages of high efficiency, intellectualization, portability, accuracy and multifunctionality.

Description

Technical Field

[0001] The present invention relates to the technical field of immunoassay, and particularly relates to an immunoassay kit and a detection method thereof. Background Art

[0002] In many fields such as modern medicine, food safety detection, environmental monitoring, and biological research, immunoassay technology plays a crucial role. It can accurately identify and measure specific biomolecules in samples, providing key evidence for disease diagnosis, quality control, and scientific research. However, there are many problems to be solved in the current mainstream immunoassay methods.

[0003] Traditional ELISA technology, as a classic method of immunoassay, although widely used in clinical diagnosis and scientific research, its operation process is extremely cumbersome. Before detection, samples need to go through complex pretreatment steps such as centrifugation, filtration, etc. to remove impurities and obtain pure target components. The sample addition process not only requires operators to have high technical precision, but also multiple sample additions are prone to introducing errors. During the incubation stage, the temperature and time need to be strictly controlled to ensure sufficient binding of antigens and antibodies, which often takes a long time, usually several hours or even overnight. The washing step is also crucial and requires multiple repeated operations to remove unbound substances. A slight carelessness will affect the accuracy of the detection result. The color development step relies on a professional microplate reader for reading. Such equipment is expensive, has high maintenance costs, and is large in size, making it difficult to be used on-site or in environments with limited resources.

[0004] Although immunochromatography technology has been applied in some scenarios due to its simple and rapid operation characteristics, its detection sensitivity and accuracy have obvious shortcomings. This technology mainly detects based on the specific binding of antigens and antibodies and the chromatography principle. For low-concentration target substances, due to weak signals, it is extremely easy to miss detection or misdetection. At the same time, the quality of immunochromatography test strips varies, and there may be differences between different batches, further affecting the reliability of the detection results.

[0005] Existing portable detection kits have improved the convenience of detection to a certain extent and can meet some needs of on-site rapid detection. However, their detection efficiency still needs to be improved. There may be unnecessary waiting time in the detection process and they cannot truly achieve instant results. In terms of intelligence, most portable kits lack effective data processing and analysis functions and only rely on simple color changes or visual observation to judge results, making it difficult to provide accurate quantitative information. Moreover, in the face of complex samples, such as biological samples or environmental samples containing various interfering substances, their detection accuracy will drop significantly and cannot meet the increasing demand for detection precision.

[0006] In summary, developing an immunoassay kit and its detection method that combines speed, accuracy, intelligence, and portability is of great practical significance and urgency for promoting the development of immunoassay technology and meeting the actual application needs in different fields. Summary of the Invention

[0007] To solve the above problems, especially the deficiencies of the existing technology, the present invention provides an immunoassay kit and its detection method that can solve the above problems.

[0008] To achieve the above object, the present invention adopts the following technical means:

[0009] An immunoassay kit, comprising a kit housing, a cleaning solution tank is inlaid and connected to the top of the kit housing, a waste liquid tank is inlaid and connected to the bottom of the kit housing, an immunoassay reagent tank is inlaid and connected to one side of the kit housing horizontally, a sample inlet is inlaid and connected to one side of the kit housing longitudinally, a control switch and a display are inlaid and connected to the other side of the kit housing longitudinally, a reagent pump, a reaction chamber, a detection chamber, a data processing module, a microcontroller, a battery, and a cleaning pump are connected inside the kit housing, the cleaning solution tank is connected to the reaction chamber and the detection chamber respectively through the cleaning pump, the immunoassay reagent tank is connected to the reaction chamber through the reagent pump, the reaction chamber is connected to the sample inlet through a pipeline, the reaction chamber is connected to the detection chamber through a micropump, the detection chamber is connected to the waste liquid tank through a micropump, a disinfection lamp and a heating plate are respectively connected inside the reaction chamber and the detection chamber, and an optical sensor and an electrochemical sensor are connected inside the detection chamber;

[0010] The reagent pump, the disinfection lamp, the heating plate, the micropump, the optical sensor, the electrochemical sensor, the data processing module, the microcontroller, the cleaning pump, and the display are respectively connected to the battery, the reagent pump, the disinfection lamp, the heating plate, the micropump, the data processing module, the cleaning pump, the control switch, and the display are respectively connected to the microcontroller, and the optical sensor and the electrochemical sensor are respectively connected to the data processing module.

[0011] A further scheme of the present invention is that the kit housing is made of ABS plastic products.

[0012] A further scheme of the present invention is that a handle is connected to the other side of the kit housing horizontally.

[0013] A further scheme of the present invention is that a charging module connected to the battery is provided inside the kit housing, and the charging port of the charging module is inserted into the kit housing.

[0014] A further scheme of the present invention is that the cleaning solution tank, the immunoassay reagent tank, and the waste liquid tank are all made of transparent products.

[0015] A further solution of the present invention is that the data processing module includes a microprocessor, a memory, and a wireless transmission module. The optical sensor, the electrochemical sensor, the microcontroller, and the battery are respectively connected to the microprocessor. The microprocessor is an ARM Cortex-M series processor, which is used for data acquisition and preliminary processing. The memory is used for storing detection data and algorithms. The wireless transmission module is used for transmitting data to an external intelligent terminal.

[0016] A further solution of the present invention is that the microcontroller is an STM32 series microcontroller.

[0017] A further solution of the present invention is that a plugging head is inserted into the sample inlet.

[0018] A further solution of the present invention is that the plugging head has a T-shaped structure, and the plugging head is connected to the kit housing through a connecting rod.

[0019] A detection method for an immunoassay kit is as follows:

[0020] Sample preparation: Open the plugging head at the sample inlet, and inject the biological sample to be detected into the reaction chamber through the sample inlet.

[0021] Reagent addition: Start the microcontroller through the control switch, and the microcontroller controls the reagent pump to extract an appropriate amount of immunoassay reagent from the immunoassay reagent box and inject it into the reaction chamber.

[0022] Reaction process: The microcontroller controls the heating plate to heat the reaction chamber, so that the sample and the immunoassay reagent react fully at an appropriate temperature. At the same time, the disinfection lamp can be controlled according to needs to disinfect the reaction environment.

[0023] Product transportation: After the reaction is completed, the microcontroller controls the micropump to transport the reaction product from the reaction chamber to the detection chamber.

[0024] Detection process: The optical sensor and the electrochemical sensor perform optical and electrochemical signal detection on the reaction product in the detection chamber, and the detected signals are transmitted to the data processing module.

[0025] Data processing: The microprocessor in the data processing module collects and preliminarily processes the signals transmitted by the sensors, and then further analyzes the data in combination with the algorithms stored in the memory to obtain the detection result.

[0026] Result display and transmission: The detection result is displayed on the display on the one hand, and transmitted to the external intelligent terminal through the wireless transmission module on the other hand.

[0027] Cleaning process: After the detection is completed, the microcontroller controls the cleaning pump to extract cleaning liquid from the cleaning liquid tank, and cleans the reaction chamber and the detection chamber. The waste liquid after cleaning is discharged into the waste liquid tank through the micropump.

[0028] Advantages of the present invention:

[0029] 1. The present invention has high efficiency. By optimizing the detection process, unnecessary operation steps are reduced, and the detection time is significantly shortened. It is easy to operate. Only simple sample injection and starting the detection program are required, which is suitable for on-site rapid detection and can provide results for users in a short time.

[0030] 2. The present invention has intelligence. It integrates optical and electrochemical intelligent sensing technologies, as well as a data processing module. The sensor accurately detects the signal of the reaction product, and the data processing module quickly and accurately analyzes and processes the data. The result is displayed on the display in real time and can also be transmitted to an external intelligent terminal to provide comprehensive and timely detection information.

[0031] 3. The present invention has portability. It is small in size and light in weight, and is equipped with a handle for easy carrying. The overall structure is compact, and the internal components are reasonably arranged, meeting the portable requirements of on-site detection in different scenarios.

[0032] 4. The present invention has accuracy. Based on microfluidic technology, the liquid flow is precisely controlled by a micropump, combined with intelligent sensing technology, to accurately detect the target molecules in the sample and improve the detection accuracy. At the same time, the heating plate and disinfection lamp provide a stable and suitable environment for the reaction, further ensuring the accuracy of the detection result.

[0033] 5. The present invention has versatility. It is applicable to various biological samples such as blood, urine, and saliva, can detect multiple target molecules, has a wide range of applications, and can meet the immunoassay requirements in different fields. Description of the Drawings

[0034] Figure 1 is a schematic structure of the present invention Figure 1 ;

[0035] Figure 2 is a schematic structure of the present invention Figure 2 ;

[0036] Figure 3 is an inner view of the outer shell of the kit of the present invention;

[0037] Reference Numerals:

[0038] Outer shell of the kit 1, Cleaning solution tank 2, Immune reagent tank 3, Reagent pump 4, Reaction chamber 5, Disinfection lamp 6, Heating plate 7, Micropump 8, Detection chamber 9, Optical sensor 10, Electrochemical sensor 11, Data processing module 12, Waste liquid tank 13, Microcontroller 14, Charging module 15, Battery 16, Handle 17, Sample inlet 18, Plug 19, Connecting rod 20, Cleaning pump 21, Control switch 22, Display 23. Detailed Embodiments

[0039] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of them. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative work belong to the scope of protection of the present invention.

[0040] Example 1

[0041] As Figures 1 to 3 shown, an immunoassay kit includes a kit housing 1. A cleaning solution tank 2 is inlaid and connected to the top of the kit housing 1. A waste liquid tank 13 is inlaid and connected to the bottom of the kit housing 1. An immunoassay reagent tank 3 is inlaid and connected to one side of the kit housing 1 horizontally. A sample inlet 18 is inlaid and connected to one side of the kit housing 1 longitudinally. A control switch 22 and a display 23 are inlaid and connected to the other side of the kit housing 1 longitudinally. A reagent pump 4, a reaction chamber 5, a detection chamber 9, a data processing module 12, a microcontroller 14, a battery 16, and a cleaning pump 21 are connected inside the kit housing 1. The cleaning solution tank 2 is connected to the reaction chamber 5 and the detection chamber 9 respectively through the cleaning pump 21. The immunoassay reagent tank 3 is connected to the reaction chamber 5 through the reagent pump 4. The reaction chamber 5 is connected to the sample inlet 18 through a pipeline. The reaction chamber 5 is connected to the detection chamber 9 through a micropump 8. The detection chamber 9 is connected to the waste liquid tank 13 through the micropump 8. A disinfection lamp 6 and a heating plate 7 are respectively connected inside the reaction chamber 5 and the detection chamber 9. An optical sensor 10 and an electrochemical sensor 11 are connected inside the detection chamber 9.

[0042] The reagent pump 4, the disinfection lamp 6, the heating plate 7, the micropump 8, the optical sensor 10, the electrochemical sensor 11, the data processing module 12, the microcontroller 14, the cleaning pump 21, and the display 23 are respectively connected to the battery 16. The reagent pump 4, the disinfection lamp 6, the heating plate 7, the micropump 8, the data processing module 12, the cleaning pump 21, the control switch 22, and the display 23 are respectively connected to the microcontroller 14. The optical sensor 10 and the electrochemical sensor 11 are respectively connected to the data processing module 12.

[0043] Working principle

[0044] Sample and reagent mixing reaction: The biological sample to be detected is injected into the reaction chamber 5 from the sample inlet 18. The microcontroller 14 controls the reagent pump 4 to extract the immunoassay reagent from the immunoassay reagent tank 3 and inject it into the reaction chamber 5. The target antigen or antibody in the sample specifically binds to the corresponding antibody or antigen in the immunoassay reagent to form an antigen-antibody complex. During this process, the heating plate 7 can heat the reaction chamber 5 according to the detection requirements to create a suitable temperature condition for the antigen-antibody binding. The disinfection lamp 6 ensures a sterile reaction environment and reduces interference factors.

[0045] Product transportation and detection: After the reaction ends, the microcontroller 14 controls the micro pump 8 to transport the reaction product from the reaction chamber 5 to the detection chamber 9. The optical sensor 10 and the electrochemical sensor 11 in the detection chamber 9 detect signals of the reaction product from the perspectives of optical characteristics and electrochemical characteristics respectively. For example, the optical sensor 10 can judge the existence and content of the antigen-antibody complex by detecting the changes in characteristics such as the absorption and scattering of specific wavelength light by the reaction product; the electrochemical sensor 11 obtains relevant detection information by detecting the changes in electrical signals caused by the reaction product, such as current and potential.

[0046] Data processing and result presentation: The optical and electrochemical signals detected by the sensors are transmitted to the data processing module 12. The data processing module 12 collects the signals and conducts preliminary processing, and then further analyzes the data to obtain accurate detection results. On the one hand, the results are intuitively presented to the user through the display 23. On the other hand, the data processing module 12 can also transmit the detection results to an external intelligent terminal for the user to view remotely and further analyze.

[0047] Cleaning and maintenance: After the detection is completed, to ensure the accuracy of the next detection of the kit, the microcontroller 14 controls the cleaning pump 21 to extract the cleaning liquid from the cleaning liquid tank 2 to clean the reaction chamber 5 and the detection chamber 9, removing the residual samples, reagents, reaction products, etc. The waste liquid after cleaning is discharged into the waste liquid tank 13 through the micro pump 8 to ensure the cleanliness of the internal environment of the kit and prepare for the next detection.

[0048] Example 2

[0049] As Figures 1 to 3 shown, an immunoassay kit includes a kit housing 1. A cleaning liquid tank 2 is inlaid and connected to the top of the kit housing 1. A waste liquid tank 13 is inlaid and connected to the bottom of the kit housing 1. An immunoassay reagent box 3 is inlaid and connected to one side of the kit housing 1 horizontally. A sample inlet 18 is inlaid and connected to one side of the kit housing 1 longitudinally. A control switch 22 and a display 23 are inlaid and connected to the other side of the kit housing 1 longitudinally. A reagent pump 4, a reaction chamber 5, a detection chamber 9, a data processing module 12, a microcontroller 14, a battery 16, and a cleaning pump 21 are connected inside the kit housing 1. The cleaning liquid tank 2 is connected to the reaction chamber 5 and the detection chamber 9 respectively through the cleaning pump 21. The immunoassay reagent box 3 is connected to the reaction chamber 5 through the reagent pump 4. The reaction chamber 5 is connected to the sample inlet 18 through a pipeline. The reaction chamber 5 is connected to the detection chamber 9 through the micro pump 8. The detection chamber 9 is connected to the waste liquid tank 13 through the micro pump 8. A disinfection lamp 6 and a heating plate 7 are respectively connected inside the reaction chamber 5 and the detection chamber 9. An optical sensor 10 and an electrochemical sensor 11 are connected inside the detection chamber 9;

[0050] The reagent pump 4, disinfection lamp 6, heating plate 7, micropump 8, optical sensor 10, electrochemical sensor 11, data processing module 12, microcontroller 14, cleaning pump 21, and display 23 are respectively connected to the battery 16. The reagent pump 4, disinfection lamp 6, heating plate 7, micropump 8, data processing module 12, cleaning pump 21, control switch 22, and display 23 are respectively connected to the microcontroller 14. The optical sensor 10 and electrochemical sensor 11 are respectively connected to the data processing module 12.

[0051] The kit housing 1 is made of ABS plastic product.

[0052] The advantages of the above settings are as follows:

[0053] Good mechanical properties: ABS plastic has relatively high strength and hardness, and can effectively resist external forces such as collisions and squeezes that may be encountered during daily use, providing reliable physical protection for precision components such as the internal cleaning liquid tank 2, immune reagent tank 3, reaction chamber 5, and detection chamber 9, reducing the risk of internal components being damaged due to shell damage, and extending the overall service life of the kit.

[0054] Excellent corrosion resistance: During the immunoassay process, the kit may come into contact with various chemical reagents such as cleaning liquid and immune reagents. ABS plastic has good tolerance to a variety of chemical substances and is not easily corroded by these reagents, ensuring that the shell will not deform or crack due to chemical erosion during long-term use, maintaining the integrity of the kit structure, and guaranteeing the stable progress of the detection work.

[0055] Good processing performance: ABS plastic is easy to process and form, and can be precisely manufactured into complex shapes that meet the design requirements through various common plastic processing techniques such as injection molding and extrusion, meeting the diverse needs of the kit housing in terms of structural design, achieving precise inlay connections at parts such as the top with the cleaning liquid tank 2, the bottom with the waste liquid tank 13, and the side with the immune reagent tank 3, as well as the reasonable installation layout of components such as the sample inlet 18, control switch 22, and display 23.

[0056] Excellent insulation performance: The kit internally integrates various electronic components such as the reagent pump 4, microcontroller 14, and data processing module 12. The insulation characteristics of ABS plastic can effectively prevent current leakage, avoid affecting the normal operation of the kit due to problems such as circuit short circuits, ensure the operation safety of users, and at the same time provide a stable working environment for electronic components, improving the accuracy and reliability of detection results.

[0057] Cost - benefit advantage: ABS plastic is widely supplied in the market and its price is relatively affordable. Using ABS plastic as the material for the kit shell can effectively control the production cost while ensuring the product performance, making the product more price - competitive in the market competition, which is conducive to the large - scale production and popularization of the product.

[0058] On the other lateral side of the kit shell 1 in the horizontal direction, a handle 17 is connected.

[0059] The advantages of the above - mentioned setting are as follows:

[0060] Convenient to carry: The setting of the handle 17 makes the kit easy to hold and carry. Whether it is transferred inside the laboratory or transported between different locations, it allows users to pick up the kit more easily, reducing the burden on the hands and avoiding hand fatigue or the kit slipping due to directly holding the shell.

[0061] Convenient for operation: During the use of the kit, the handle 17 can serve as a stable holding point, facilitating users to better fix the kit when performing operations such as adding samples, mixing reagents, and observing test results, making the operation more accurate and stable, and helping to improve the accuracy and reliability of the detection.

[0062] Inside the kit shell 1, a charging module 15 connected to the battery 16 is provided, and the charging port of the charging module 15 is plugged into the kit shell 1.

[0063] The advantages of the above - mentioned setting are as follows:

[0064] Convenient charging: The charging module 15 is connected to the battery 16, and the charging port is plugged into the kit shell 1, which means that users can directly charge the battery inside the kit. There is no need to, like the traditional way, possibly disassemble the battery for separate charging, simplifying the charging process and saving time and energy. For example, during emergency outdoor detection, a power source can be quickly found to charge the kit to ensure the continuous progress of the detection work.

[0065] Flexible power supply: Having a built - in charging module 15 means that the kit does not rely on disposable batteries. This has significant advantages in some remote areas or places where it is difficult to obtain specific battery models. As long as there is a suitable power source, the kit can be charged at any time, ensuring that the detection work is not restricted by battery supply and improving the applicability of the kit in different environments.

[0066] The cleaning solution tank 2, the immunological reagent tank 3, and the waste liquid tank 13 are all made of transparent materials.

[0067] The advantages of the above - mentioned setting are as follows:

[0068] Easy to observe the remaining amount: The transparent design allows users to intuitively see the remaining amount of liquid in the box. During the immunoassay process, the remaining amount of cleaning liquid and immunoreagent can be timely understood so that preparations can be made in advance to avoid interrupting the testing process due to insufficient reagents. For the waste liquid tank, its fullness can be observed and cleaned in time to prevent waste liquid overflow and pollution.

[0069] Convenient quality inspection: Through the transparent box wall, users can check the quality of cleaning liquid and immune reagents at any time, such as whether there are abnormal phenomena such as precipitation, discoloration, turbidity, etc., which helps to timely discover the deterioration of reagents and ensure the accuracy of test results. At the same time, it can also observe the state of waste liquid, judge whether the test process is normal, and whether there are abnormal substances mixed in the waste liquid.

[0070] Easy to maintain: The transparent material makes it easy for staff to check whether there is dirt residue on the inner wall of the box, whether there is liquid leakage, etc. during daily maintenance, so as to carry out cleaning and maintenance in time to ensure the normal function of each box and extend its service life.

[0071] Improve operational efficiency: When preparing for testing or conducting experimental operations, you can quickly understand the internal situation without opening the box, saving inspection time and improving overall operational efficiency. Especially in batch testing or time-sensitive situations, this intuitive observation method can help operators make quick judgments and decisions.

[0072] Example 3

[0073] like Figures 1 to 3 As shown, an immunoassay kit comprises a kit housing 1, a cleaning liquid tank 2 is inlaid and connected to the top of the kit housing 1, a waste liquid tank 13 is inlaid and connected to the bottom of the kit housing 1, an immune reagent box 3 is inlaid and connected to one side of the kit housing 1 in a horizontal direction, a sample inlet 18 is inlaid and connected to one side of the kit housing 1 in a longitudinal direction, a control switch 22 and a display 23 are inlaid and connected to the other side of the kit housing 1 in a longitudinal direction, a reagent pump 4, a reaction chamber 5, a detection chamber 9, a data processing module 12, a microcontroller 14, a battery 16, and a cleaning pump 21 are connected to the kit housing 1, the cleaning liquid tank 2 is connected to the reaction chamber 5 and the detection chamber 9 respectively through the cleaning pump 21, the immune reagent box 3 is connected to the reaction chamber 5 through the reagent pump 4, the reaction chamber 5 is connected to the sample inlet 18 through a pipeline, the reaction chamber 5 is connected to the detection chamber 9 through a micropump 8, the detection chamber 9 is connected to the waste liquid tank 13 through the micropump 8, the reaction chamber 5 and the detection chamber 9 are respectively connected to a disinfection lamp 6 and a heating plate 7, and the detection chamber 9 is connected to an optical sensor 10 and an electrochemical sensor 11;

[0074] The reagent pump 4, disinfection lamp 6, heating plate 7, micropump 8, optical sensor 10, electrochemical sensor 11, data processing module 12, microcontroller 14, cleaning pump 21, and display 23 are respectively connected to the battery 16. The reagent pump 4, disinfection lamp 6, heating plate 7, micropump 8, data processing module 12, cleaning pump 21, control switch 22, and display 23 are respectively connected to the microcontroller 14. The optical sensor 10 and electrochemical sensor 11 are respectively connected to the data processing module 12.

[0075] The data processing module 12 includes a microprocessor 121, a memory 122, and a wireless transmission module 123. The optical sensor 10, electrochemical sensor 11, microcontroller 14, and battery 16 are respectively connected to the microprocessor 121. The microprocessor 121 is an ARM Cortex-M series processor, which is used for data acquisition and preliminary processing. The memory 122 is used to store detection data and algorithms. The wireless transmission module 123 is used to transmit data to an external intelligent terminal.

[0076] The advantages of the above settings are as follows:

[0077] Powerful data processing capabilities: The ARM Cortex-M series processor is selected as the microprocessor 121. This series of processors features high performance and low power consumption. It can quickly collect a large number of complex signals detected by the optical sensor 10 and electrochemical sensor 11, and perform preliminary processing on this data, such as operations like filtering, amplification, and digital conversion, to improve the quality and usability of the data, laying a foundation for subsequent precise analysis.

[0078] High computing speed: The ARM Cortex-M series processors have a relatively high clock frequency and an optimized instruction set architecture, enabling complex mathematical operations and logical judgments to be completed in a short time. In immunoassay, it can quickly calculate key information such as the concentration and content of the target substance based on sensor data, greatly shortening the detection time, improving the detection efficiency, and meeting the requirements of on-site rapid detection.

[0079] Good compatibility and expandability: This series of processors has rich peripheral interfaces, facilitating convenient connection and communication with other components such as the optical sensor 10, electrochemical sensor 11, microcontroller 14, and battery 16. At the same time, it is also convenient for future functional expansion and upgrade of the test kit, such as adding new detection items or improving algorithms.

[0080] Data storage security: The memory 122 can stably store detection data and algorithms. Detection data is an important record of immunoassay results and is of great significance for subsequent diagnosis, research, and quality control. By storing the data in the memory, data loss or damage can be prevented, ensuring the traceability and reliability of the detection results.

[0081] Algorithm Optimization and Update: The stored algorithm is crucial for analyzing and interpreting the detection data. With the continuous development of immunoassay technology and in-depth research, the algorithm needs to be continuously optimized and updated. The memory provides space for the storage and update of the algorithm, enabling the kit to continuously improve the accuracy and sensitivity of detection.

[0082] Real-time Data Sharing: The wireless transmission module 123 can transmit the detection data to external intelligent terminals in real time, such as mobile phones, tablets, etc. This enables medical staff, researchers, or relevant personnel to obtain the detection results in a timely manner for remote diagnosis and analysis. In some emergency situations, decisions can be made quickly, improving the efficiency of medical treatment.

[0083] Facilitate Data Analysis and Management: External intelligent terminals usually have more powerful data processing and analysis capabilities, as well as rich software applications. By transmitting the data to the intelligent terminal, professional data analysis software can be used to further process and mine the detection data, generating detailed reports and statistical charts for comprehensive analysis and management of the detection results.

[0084] Remote Monitoring and Quality Control: The wireless transmission function also supports remote monitoring and quality control of the kit. The manufacturer or regulatory department can understand information such as the usage of the kit and the accuracy of the detection data in real time through the intelligent terminal, promptly discover and solve potential problems, and ensure the product quality and consistency of the detection results.

[0085] The microcontroller 14 is of the STM32 series.

[0086] The advantages of the above settings are as follows:

[0087] Efficient Data Processing: STM32 series microcontrollers are usually based on the ARM Cortex-M core, with a relatively high clock frequency and a rich instruction set. This enables it to quickly process a large amount of data transmitted from components such as the optical sensor 10 and the electrochemical sensor 11, collect, analyze, and process the detection signals in a timely manner, ensuring that the detection results can be obtained quickly and accurately, meeting the requirements of immunoassay for timeliness.

[0088] Complex Task Management: During the immunoassay process, it is necessary to coordinate and control the operation of multiple components such as the reagent pump 4, the disinfection lamp 6, the heating plate 7, the micropump 8, and the cleaning pump 21 simultaneously. The STM32 series microcontroller has multitasking capabilities and can efficiently manage these complex tasks, ensuring that each component works in coordination according to the preset program and time sequence, realizing the automation and precision of the detection process.

[0089] Extended battery life: Immunoassay kits usually need to be portable and may be powered by batteries. STM32 series microcontrollers feature low power consumption, which can effectively reduce power consumption while ensuring high-performance processing, thus extending the usage time of battery 16. This enables the kit to perform more detection operations after a single charge, enhancing its practicality and reliability in scenarios such as on-site detection.

[0090] A plugging head 19 is inserted into the sample inlet 18.

[0091] The advantages of the above settings are as follows:

[0092] Prevention of contamination: When the kit is not in use, the plugging head can effectively prevent external dust, impurities, microorganisms, etc. from entering the interior of the kit, avoiding contamination of the sample inlet and the internal detection system and ensuring the accuracy of the detection results.

[0093] Protection of samples: Before detection, it can prevent the sample from accidentally splashing out or being interfered by external factors during the preparation process, ensuring the integrity and originality of the sample; after detection, it can prevent the residual sample from leaking and avoid biological contamination of the environment and personnel.

[0094] Maintenance of airtightness: Good plugging can maintain a relatively closed environment inside the kit, which helps to maintain the stability of the internal reagents, prevent the reagents from volatilizing or getting damp, and extend the service life of the kit.

[0095] The plugging head 19 has a T-shaped structure and is connected to the kit housing 1 through a connecting rod 20.

[0096] The advantages of the above settings are as follows:

[0097] Convenient operation: The plugging head with a T-shaped structure has a relatively large holding area, which is convenient for users to pinch with their fingers and facilitates the plugging and unplugging operations. Especially when it is necessary to quickly open or close the sample inlet 18, it allows users to operate more easily, improving the convenience of use.

[0098] Prevention of loss: Connected to the kit housing through a connecting rod, it can prevent the plugging head from being accidentally lost during use. During the detection process, users do not need to worry about misplacing the plugging head and not being able to find it, ensuring that the plugging head is always available for closing the sample inlet and maintaining the integrity and airtightness of the kit.

[0099] Stable plugging: The T-shaped structure design enables the plugging head to better fit the sample inlet, providing a more stable plugging effect. The T-shaped head can cover a relatively large area around the sample inlet, effectively preventing liquid leakage and the entry of external impurities during plugging. Compared with plugging heads of other shapes, the sealing performance may be better, which helps to ensure the accuracy of the detection results.

[0100] Protective connecting rod: The plugging head with a T-shaped structure can play a certain protective role for the connecting rod. Since the T-shaped head is relatively large, when the kit is collided or squeezed, the T-shaped head can disperse part of the external force, reducing the possibility of the external force acting directly on the connecting rod, thereby reducing the risk of damage to the connecting rod and extending the service life of the connection structure between the plugging head and the kit.

[0101] Example 4

[0102] A detection method for an immunoassay kit, the specific steps are as follows:

[0103] Sample preparation: Open the plugging head 19 of the sample inlet 18, and inject the biological sample to be detected into the reaction chamber 5 through the sample inlet 18;

[0104] Reagent addition: Start the microcontroller 14 through the control switch 22, and the microcontroller 14 controls the reagent pump 4 to extract an appropriate amount of immunoassay reagent from the immunoassay reagent box 3 and inject it into the reaction chamber 5;

[0105] Reaction process: The microcontroller 14 controls the heating plate 7 to heat the reaction chamber 5, so that the sample and the immunoassay reagent react fully at an appropriate temperature. At the same time, the disinfection lamp 6 can be controlled according to needs to disinfect the reaction environment;

[0106] Product transportation: After the reaction is completed, the microcontroller 14 controls the micropump 8 to transport the reaction product from the reaction chamber 5 to the detection chamber 9;

[0107] Detection process: The optical sensor 10 and the electrochemical sensor 11 perform optical and electrochemical signal detection on the reaction product in the detection chamber 9, and the detected signals are transmitted to the data processing module 12;

[0108] Data processing: The microprocessor 121 in the data processing module 12 collects and preliminarily processes the signals transmitted by the sensors, and then further analyzes the data in combination with the algorithms stored in the memory 122 to obtain the detection result;

[0109] Result display and transmission: The detection result is displayed on the display 23 on the one hand, and transmitted to an external intelligent terminal through the wireless transmission module 123 on the other hand;

[0110] Cleaning process: After the detection is completed, the microcontroller 14 controls the cleaning pump 21 to extract the cleaning liquid from the cleaning liquid tank 2, and clean the reaction chamber 5 and the detection chamber 9. The waste liquid after cleaning is discharged into the waste liquid tank 13 through the micropump 8.

[0111] Example 5

[0112] Influenza virus antigen detection

[0113] Sample collection and preparation: During the high-incidence season of influenza, a patient with influenza symptoms goes to the community health center. Medical staff use a special throat swab to collect the patient's throat sample, put the throat swab into a sampling tube containing sample preservation solution, and stir well to mix the sample evenly with the preservation solution.

[0114] Detection operation: Medical staff place the test kit on a stable table, open the plug 19 of the sample inlet 18, use a pipette to aspirate an appropriate amount of the processed sample, and slowly inject it into the reaction chamber 5. Press the control switch 22, and the microcontroller 14 starts the reagent pump 4 to draw the immunoassay reagent against the influenza virus antigen from the immunoassay reagent box 3 and inject it into the reaction chamber 5. The microcontroller 14 controls the heating plate 7 to raise the temperature in the reaction chamber 5 to 37 °C and maintain it for 10 minutes to allow the sample to react fully with the immunoassay reagent. At the same time, the disinfection lamp 6 is turned on to disinfect the reaction environment.

[0115] Result acquisition: After the reaction ends, the microcontroller 14 controls the micropump 8 to transport the reaction product to the detection chamber 9. The optical sensor 10 and the electrochemical sensor 11 detect the product in the detection chamber 9 and transmit the detection signal to the data processing module 12. The data processing module 12 processes and analyzes the signal, and displays the detection result on the display 23, indicating that the influenza virus antigen is detected positive in the patient's sample. At the same time, the detection result is sent to the hospital's information management system through the wireless transmission module 123 for the doctor to consult and for subsequent diagnosis.

[0116] Subsequent processing: After the detection is completed, the microcontroller 14 controls the cleaning pump 21 to draw the cleaning solution from the cleaning solution tank 2 to clean the reaction chamber 5 and the detection chamber 9. The waste liquid after cleaning is discharged into the waste liquid tank 13. Medical staff process the waste liquid in the waste liquid tank 13 according to the medical waste treatment specifications, and after simply cleaning the test kit, prepare it for the next detection.

[0117] Example 6

[0118] Detection of melamine in milk

[0119] Sample processing: A food testing agency conducts melamine detection on milk products in the market. The staff takes an appropriate amount of milk sample, first removes impurities by centrifugation, and then transfers the supernatant to a clean test tube for standby.

[0120] Kit detection process: Place the kit on the detection table, open the sample inlet 18, and use a pipette to inject the processed milk sample into the reaction chamber 5. Operate the control switch 22, and the microcontroller 14 controls the reagent pump 4 to extract the immunoassay reagent for melamine and inject it into the reaction chamber 5. The microcontroller 14 sets the temperature of the heating plate 7 to 35 °C and the reaction time to 15 minutes, while the disinfection lamp 6 is working. After the reaction is completed, the micropump 8 transports the product to the detection chamber 9, and the optical sensor 10 and the electrochemical sensor 11 detect the product and transmit the signals to the data processing module 12.

[0121] Analysis of detection results: The data processing module 12 analyzes the detection data according to the built-in algorithm, and the content of melamine in the milk sample is shown as not detected on the display 23. The detection results are simultaneously sent to the database of the institution through the wireless transmission module 123 for recording and archiving.

[0122] Kit maintenance: After the detection is completed, start the cleaning program. The cleaning pump 21 extracts the cleaning solution from the cleaning solution tank 2 to clean the reaction chamber 5 and the detection chamber 9, and the waste liquid after cleaning is discharged into the waste liquid tank 13. The staff regularly checks the remaining amounts of the cleaning solution tank 2 and the immunoassay reagent tank 3, and replenishes the reagents in a timely manner to ensure that the kit can be used for the next detection task at any time.

[0123] Example 7

[0124] Detection of Escherichia coli in environmental water samples

[0125] Water sample collection and pretreatment: Environmental monitoring personnel collect water samples at a sampling point in a certain river and bring the water samples back to the laboratory. In the laboratory, first filter the water samples to remove large particulate impurities, and then take an appropriate amount of the filtered water samples for concentration treatment to improve the detection sensitivity.

[0126] Detection using the kit: Place the kit on the experimental table, open the plug 19 of the sample inlet 18, and inject the concentrated water sample into the reaction chamber 5. Press the control switch 22, and the microcontroller 14 controls the reagent pump 4 to extract the immunoassay reagent for Escherichia coli from the immunoassay reagent tank 3 and inject it into the reaction chamber 5. The microcontroller 14 controls the heating plate 7 to heat the reaction chamber 5 to keep the temperature at 38 °C, and the reaction time is 20 minutes. The disinfection lamp 6 is turned on synchronously. After the reaction is completed, the micropump 8 transports the reaction product to the detection chamber 9.

[0127] Obtaining and applying the results: The optical sensor 10 and the electrochemical sensor 11 detect the product in the detection chamber 9, and the detection signals are transmitted to the data processing module 12. The data processing module 12 analyzes and obtains the concentration of Escherichia coli in the water sample and displays it on the display 23. The detection results are sent to the platform of the environmental monitoring center through the wireless transmission module 123, and the monitoring personnel evaluate the pollution status of the river according to the detection results to provide data support for subsequent environmental governance.

[0128] Kit Cleaning and Storage: After the detection is completed, the microcontroller 14 controls the cleaning pump 21 to clean the reaction chamber 5 and the detection chamber 9, and the waste liquid is discharged into the waste liquid tank 13. After cleaning, place the kit in a dry and cool place for storage, and regularly perform performance detection and maintenance on the kit to ensure its accurate operation in subsequent environmental detection work.

[0129] The examples given in the present invention are illustrative rather than restrictive of the embodiments. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to enumerate all the embodiments here, and the obvious changes or modifications derived therefrom are still within the protection scope of the present invention.

Claims

1. An immunoassay kit, characterized in that: The invention comprises a reagent box shell (1), wherein the top of the reagent box shell (1) is inlaid with a cleaning liquid tank (2), the bottom of the reagent box shell (1) is inlaid with a waste liquid tank (13), one side of the reagent box shell (1) is inlaid with an immune reagent box (3), one side of the reagent box shell (1) is inlaid with a sample inlet (18), the other side of the reagent box shell (1) is inlaid with a control switch (22) and a display (23), and the reagent box shell (1) is connected with a reagent pump (4), a reaction chamber (5), a detection chamber (9), a data processing module (12), a microcontroller (14), and a battery (13). 6), a cleaning pump (21), the cleaning liquid tank (2) is connected to the reaction chamber (5) and the detection chamber (9) respectively through the cleaning pump (21), the immune reagent box (3) is connected to the reaction chamber (5) through the reagent pump (4), the reaction chamber (5) is connected to the sample inlet (18) through a pipeline, the reaction chamber (5) is connected to the detection chamber (9) through a micro pump (8), the detection chamber (9) is connected to the waste liquid tank (13) through the micro pump (8), the reaction chamber (5) and the detection chamber (9) are respectively connected to a disinfection lamp (6) and a heating plate (7), and the detection chamber (9) is connected to an optical sensor (10) and an electrochemical sensor (11); The reagent pump (4), the disinfection lamp (6), the heating plate (7), the micro pump (8), the optical sensor (10), the electrochemical sensor (11), the data processing module (12), the micro controller (14), the cleaning pump (21), and the display (23) are respectively connected to the battery (16); the reagent pump (4), the disinfection lamp (6), the heating plate (7), the micro pump (8), the data processing module (12), the cleaning pump (21), the control switch (22), and the display (23) are respectively connected to the micro controller (14); and the optical sensor (10) and the electrochemical sensor (11) are respectively connected to the data processing module (12).

2. An immunoassay kit according to claim 1, characterized in that: The reagent kit housing (1) is made of ABS plastic.

3. An immunoassay kit according to claim 2, characterized in that: A handle (17) is connected to the other lateral side of the reagent kit housing (1).

4. An immunoassay kit according to claim 3, characterized in that: A charging module (15) connected to a battery (16) is provided inside the reagent kit housing (1), and a charging port of the charging module (15) is plugged into the reagent kit housing (1).

5. An immunoassay kit according to claim 1, characterized in that: The cleaning liquid tank (2), the immune reagent tank (3) and the waste liquid tank (13) are all transparent products.

6. An immunoassay kit according to claim 1, characterized in that: The data processing module (12) comprises a microprocessor (121), a memory (122) and a wireless transmission module (123); the optical sensor (10), the electrochemical sensor (11), the microcontroller (14) and the battery (16) are respectively connected to the microprocessor (121); the microprocessor (121) is an ARM Cortex-M series processor; the microprocessor (121) is used for data acquisition and preliminary processing; the memory (122) is used for storing detection data and algorithms; and the wireless transmission module (123) is used for transmitting data to an external intelligent terminal.

7. An immunoassay kit according to claim 1, characterized in that: The microcontroller (14) is an STM32 series microcontroller.

8. An immunoassay kit according to claim 1, characterized in that: The sample inlet (18) is plugged with a plugging head (19).

9. An immunoassay kit according to claim 8, characterized in that: The plugging head (19) is of a T-shaped structure, and the plugging head (19) is connected to the reagent box housing (1) via a connecting rod (20).

10. A detection method based on the immunoassay kit according to any one of claims 1 to 9, characterized in that: The specific steps are as follows: Sample preparation: opening the plug (19) of the sample inlet (18), and injecting the biological sample to be tested into the reaction chamber (5) through the sample inlet (18); Adding reagents: The microcontroller (14) is activated by the control switch (22), and the microcontroller (14) controls the reagent pump (4) to extract an appropriate amount of immune reagent from the immune reagent box (3) and inject it into the reaction chamber (5); Reaction process: the microcontroller (14) controls the heating plate (7) to heat the reaction chamber (5) so that the sample and the immune reagent react fully at a suitable temperature, and at the same time controls the disinfection lamp (6) to disinfect the reaction environment as needed; Product delivery: After the reaction is completed, the microcontroller (14) controls the micropump (8) to deliver the product from the reaction chamber (5) to the detection chamber (9); Detection process: the optical sensor (10) and the electrochemical sensor (11) perform optical and electrochemical signal detection on the reaction products in the detection chamber (9), and the detected signals are transmitted to the data processing module (12); Data processing: The microprocessor (121) in the data processing module (12) collects and preliminarily processes the signals transmitted by the sensor, and then further analyzes the data in combination with the algorithm stored in the memory (122) to obtain the detection results; Result display and transmission: The test results are displayed on the display (23) and transmitted to an external intelligent terminal via a wireless transmission module (123); Cleaning process: After the detection is completed, the microcontroller (14) controls the cleaning pump (21) to extract cleaning liquid from the cleaning liquid tank (2) to clean the reaction chamber (5) and the detection chamber (9), and the waste liquid after cleaning is discharged into the waste liquid tank (13) through the micropump (8).

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