A molecular diagnostic system for food source ingredient authentication

Abstract

The application belongs to the technical field of food detection and molecular diagnosis, and particularly relates to a molecular diagnosis system for food source component identification. The system comprises a handheld shell, and an automatic sample processing unit, a molecular detection unit, a central control unit and a data transmission unit are integrated in the shell. The automatic sample processing unit comprises at least two processing modules and an automatic transfer mechanism, which are used for crushing, lysing and automatic transfer of a solid sample, and an in-situ cleaning and disinfecting assembly is integrated. The application realizes full-process automation, handholding and intelligence from a solid sample to a detection result, and provides an innovative solution for food safety on-site rapid detection and intelligent supervision.

Description

Technical Field

[0001] This invention belongs to the field of food testing and molecular diagnostic technology, specifically relating to a molecular diagnostic system for identifying food source components. Background Technology

[0002] Food safety is directly related to the health and safety of the people. Identification of food components, especially in areas such as meat adulteration, allergen detection, and species tracing, is a crucial aspect of food safety supervision. Traditional methods for food component detection mainly include microscopic observation, chemical analysis, and molecular biology methods based on polymerase chain reactions.

[0003] However, the existing technology has the following drawbacks: (1) Sample pretreatment is cumbersome and time-consuming: food samples (especially solid samples such as meat products) need to be manually ground, lysed, and nucleic acid extracted and purified, which usually takes 1-2 hours and requires high professional skills from operators; (2) Detection equipment is bulky and not portable: molecular diagnostic equipment such as fluorescence quantitative PCR instruments is bulky and difficult to achieve rapid on-site detection; (3) Detection process is fragmented: sample pretreatment and nucleic acid detection are separated, and samples need to be transferred between different devices, which can easily cause cross-contamination; (4) Detection cost is high: a single detection requires the consumption of a variety of reagents and consumables and depends on a professional laboratory environment; (5) Result interpretation is highly subjective: traditional methods rely on manual interpretation of amplification curves or gel electrophoresis results; (6) Data is difficult to trace: detection results are stored in isolation and lack correlation with sample traceability information.

[0004] To address the aforementioned issues, some portable molecular diagnostic devices have been attempted in the prior art. For example, related technologies disclose portable detection devices using isothermal amplification technology, but manual sample pretreatment is still required; other technologies disclose detection devices based on microfluidic chips, but these are only applicable to liquid samples and do not address the automation of solid sample pretreatment. None of these existing technologies have solved the problem of automating the entire process from sample introduction to detection results for solid samples.

[0005] Therefore, there is an urgent need to develop a handheld, highly sensitive molecular diagnostic system for the identification of food-derived components that can automate the entire process from solid sample introduction to results. This system has significant practical implications and application value. Summary of the Invention

[0006] To address the aforementioned technical problems, this invention provides a handheld, highly sensitive molecular diagnostic system for identifying food-derived components that enables fully automated solid sample introduction and result processing.

[0007] This invention provides a molecular diagnostic system for identifying food-derived components, comprising: A handheld housing; Integrated into the housing: An automated sample processing unit includes at least two alternating processing modules and an automated transfer mechanism. The processing modules are used to break and lyse food samples to release nucleic acid substances, and the automated transfer mechanism is used to transfer the nucleic acid-containing lysate to the detection area. The molecular detection unit includes a microfluidic chip, a temperature control component, and a signal acquisition component. The microfluidic chip is configured to receive the lysis buffer and amplify the target nucleic acid therein. The signal acquisition component is used to monitor the amplification reaction in real time and generate a detection signal. The central control unit is electrically connected to the automated sample processing unit and the molecular detection unit. It is configured to coordinate and control the automated operation of the automated sample processing unit and the molecular detection unit, and to interpret food composition information based on the detection signals. The data transmission unit is electrically connected to the central control unit and is configured to upload food ingredient information and related traceability data to the cloud management platform.

[0008] Preferably, the automated sample processing unit further includes a cleaning and disinfection assembly, which is fluidly connected to the processing module. Each processing module includes a reaction vessel, a crushing drive, and a heating element. The reaction vessel contains grinding media, the crushing drive drives the grinding media to crush the sample, and the heating element heats and lyses the crushed sample. The automated transfer mechanism is a multi-degree-of-freedom robotic arm with replaceable grippers and sampling elements at its end. The grippers are configured to grip solid samples and place them into the reaction vessel, and the sampling elements are configured to aspirate the lysate and add it to the microfluidic chip. The cleaning and disinfection assembly includes at least one cleaning solution reservoir, at least one disinfectant reservoir, and a waste liquid reservoir, as well as multiple micropumps and control valves, which, under the control of the central control unit, sequentially inject cleaning solution, disinfectant, and drying gas into the reaction vessel after sample processing to perform cleaning, disinfection, and drying procedures.

[0009] Preferably, the cleaning and disinfection components are configured to complete the entire cleaning and disinfection process on a single processing module in no more than 2 minutes.

[0010] Preferably, the handheld housing is provided with: a sample inlet, corresponding to the processing module of the automated sample processing unit; a chip slot for accommodating the microfluidic chip and forming an electrical and fluid connection with the molecular detection unit; a touch screen, electrically connected to the central control unit, for displaying operation guidance and detection results; and a chip ejection button, linked to the chip slot, for controlling the ejection of the microfluidic chip.

[0011] Preferably, the microfluidic chip is a disposable, fully enclosed chip, pre-packaged with lyophilized detection reagents; the detection reagents include specific nucleases, guide nucleic acids, and at least one hairpin probe; the microfluidic chip also has a single-molecule sensing unit, which is configured to detect the characteristic electrical signal generated when the reporter molecule produced after the hairpin probe is sheared passes through the nanoscale channel.

[0012] Preferably, the temperature control component includes a first temperature control element and a second temperature control element. The first temperature control element is disposed in the first functional area of ​​the microfluidic chip and is used to perform instantaneous high-temperature treatment on the sample lysis solution. The second temperature control element is disposed in the second functional area of ​​the microfluidic chip and is configured to use point heating mode, so that the reaction solution in the second functional area of ​​the microfluidic chip forms a temperature gradient and generates natural convection, thereby achieving isothermal amplification of nucleic acids.

[0013] Preferably, the temperature control component also includes a self-heating module, which encapsulates a heat-generating material composition that generates heat by triggering a chemical reaction, serving as a supplementary or alternative heat source for the first or second temperature control element.

[0014] Preferably, the central control unit includes a storage module and a processing module. The storage module stores a sample recognition model and a result analysis model. The processing module is configured to execute the recognition model to determine the sample type and match the corresponding processing procedure, and to execute the analysis model to process the detection signal and generate a detection report.

[0015] Preferably, the data transmission unit includes a wireless communication module and an encryption module. The wireless communication module supports wide area or local area wireless network communication, and the encryption module is configured to encrypt the uploaded data. The traceability data includes at least one of sample identification, detection time, spatial location, and operator information. The cloud management platform includes a distributed ledger evidence storage module for tamper-proof evidence storage of the received detection data.

[0016] Preferably, the following automated steps are also included: The food sample is placed into the first processing module through an automated transfer mechanism, and the crushing and pyrolysis process is initiated. During or after the lysis process in the first processing module, another food sample is placed into the second processing module, which has been cleaned and disinfected, via an automated transfer mechanism. After lysis is completed, the lysate is aspirated by an automated transfer mechanism and added to the microfluidic chip; The target nucleic acid is amplified within a microfluidic chip, and the detection signal is acquired in real time through a signal acquisition component. The central control unit analyzes the detection signals, interprets food composition information, and generates a test report. The test report and related traceability data are uploaded to the cloud management platform through the data transmission unit.

[0017] As a preferred option, it also includes: A cloud-based management platform is connected to a molecular diagnostic system used for the identification of food-derived components. It is configured to receive, store, and analyze detection data from the molecular diagnostic system used for the identification of food-derived components, and to conduct risk warning and traceability analysis. At least one monitoring terminal is connected to the cloud management platform and is configured to visually display the regional food safety situation and sample traceability information.

[0018] The beneficial effects of this invention are: (1) Through the alternating operation of dual processing modules and the collaboration of automated transfer mechanism, the entire process of solid food sample from injection, crushing, lysis to sample addition is automated for the first time in a handheld device without manual intervention; the integrated in-situ cleaning and disinfection component can automatically complete cleaning and disinfection within 2 minutes, effectively avoiding cross-contamination, realizing continuous detection, and shortening the detection time to 30-45 minutes.

[0019] (2) Combining the high specificity of specific nucleic acid cutting enzymes with the high sensitivity of single-molecule sensing, multiple detection of food components is achieved with a detection limit of ≤0.1% (w / w); point heating natural convection temperature expansion technology is adopted, eliminating the need for complex temperature control, greatly simplifying hardware and reducing power consumption; a chemical self-heating module is configured to provide a stable heat source in the absence of external power, enhancing on-site adaptability.

[0020] (3) The model automatically determines the sample type and matches the processing program, and the analysis model intelligently interprets the test results; combined with distributed ledger technology, the test data is tamper-proof and traceable throughout the process; the entire process of pre-processing, testing, analysis and uploading is integrated into the handheld shell (≤220×90×50mm, ≤450g), and more than 50 tests can be completed on a single charge, providing a complete solution for on-site food safety testing and intelligent supervision. Attached Figure Description

[0021] Figure 1 This is a perspective view of the handheld casing of the present invention; Figure 2 This is a flowchart of the system modules of the present invention; Figure 3 This is a schematic diagram of the material flow, signal flow, and data flow of the present invention.

[0022] Reference numerals: 100-Handheld housing, 101-Switch button, 102-Touch display, 103-Eject button, 104-Chip slot, 105-Sample inlet, 106-Water suction tube. Detailed Implementation

[0023] The present invention will be further described below with reference to the accompanying drawings and embodiments. Example

[0024] like Figure 1 and Figure 2 As shown, the molecular diagnostic system for identifying food source components includes a handheld housing 100. The housing 100 is equipped with a sample inlet 105, a chip slot 104, a touch display screen 102, a chip ejection button 103, and a power switch 101 for controlling the power supply of the device. The housing 100 integrates an automated sample processing unit, a molecular detection unit, a central control unit, and a data transmission unit. The automated sample processing unit includes at least two alternating processing modules and an automated transfer mechanism. The processing modules are used to break and lyse food samples to release nucleic acid substances, and the automated transfer mechanism is used to transfer the nucleic acid-containing lysate to the detection area. The molecular detection unit includes a microfluidic chip, a temperature control component, and a signal acquisition component. The microfluidic chip is configured to receive the lysate and amplify the target nucleic acid therein. The signal acquisition component is used to monitor the amplification reaction in real time and generate a detection signal. The central control unit is electrically connected to the automated sample processing unit and the molecular detection unit and is configured to coordinate and control the automated operation of the automated sample processing unit and the molecular detection unit, and to interpret food composition information based on the detection signal. The data transmission unit is electrically connected to the central control unit and is configured to upload food composition information and related traceability data to the cloud management platform.

[0025] Working principle: The user initiates the detection via the touchscreen display 102. The central control unit coordinates the automated sample processing unit to break down and lyse the solid food sample, releasing nucleic acid substances. An automated transfer mechanism then delivers the lysate to the molecular detection unit. The microfluidic chip in the molecular detection unit amplifies the target nucleic acid, while the signal acquisition component monitors this in real time and generates electrical signals. The central control unit interprets the food composition information based on these signals, generates a detection report, and displays it on the touchscreen display 102. Simultaneously, the data transmission unit encrypts and uploads the results to the cloud management platform. The entire process, from sample input to result output, is fully automated and requires no manual intervention. Example

[0026] like Figure 2 As shown, the automated sample processing unit also includes a cleaning and disinfection component, which is fluidly connected to the processing module. Each processing module includes a reaction vessel, a crushing drive, and a heating element. The reaction vessel contains grinding media (such as 0.5mm diameter stainless steel microspheres). The crushing drive is a miniature vibration motor (50Hz vibration frequency) used to drive the grinding media to crush the sample. The heating element is a PTC ceramic heating plate attached to the outer periphery of the reaction vessel for heating and lysing the crushed sample, capable of reaching 95°C. The automated transfer mechanism is a multi-degree-of-freedom robotic arm. The end of the robotic arm is equipped with replaceable grippers (e.g., clamps) and sampling devices (e.g., micro-absorption needles). The grippers are configured to grasp solid samples and place them into the reaction vessel, while the sampling devices are configured to aspirate the lysate and add it to the microfluidic chip. The cleaning and disinfection assembly includes at least one cleaning solution reservoir, at least one disinfectant reservoir, and a waste liquid reservoir, as well as multiple micro-pumps and control valves, connected to the reaction vessels of each processing module via fluid lines. One end of the suction pipe 106 is connected to either the cleaning solution reservoir or the disinfectant reservoir, and the other end extends to the cleaning position. The cleaning and disinfection components are configured to complete the entire cleaning and disinfection process on a single processing module in no more than 2 minutes.

[0027] Working Principle: The central control unit instructs the grasping component to pick up the first solid sample and place it into the reaction vessel of the first processing module. The first processing module then activates the crushing drive for 30 seconds of grinding and crushing, while the heating component performs instantaneous high-temperature pyrolysis at 95°C for 10 seconds. During the pyrolysis process in the first processing module, if continuous detection is required, the central control unit triggers the second processing module to execute a cleaning and disinfection procedure: the cleaning and disinfection component sequentially injects cleaning and disinfectant solutions into the reaction vessel of the second processing module through a micro-pump and control valve, and introduces drying gas to complete the cleaning, disinfection, and drying processes, which take no more than 2 minutes. After the pyrolysis is completed in the first processing module, the sampling component punctures the valve at the bottom of the reaction vessel, aspirates approximately 20 μL of lysate, and precisely adds it to the microfluidic chip inlet. Simultaneously, the grasping component picks up the second sample and places it into the cleaned and disinfected second processing module, initiating crushing and pyrolysis to achieve continuous detection. Example

[0028] like Figure 1 As shown, the handheld housing 100 is provided with: a sample inlet 105, which is correspondingly set with the processing module of the automated sample processing unit; a chip slot 104, which is used to accommodate the microfluidic chip and form an electrical and fluid connection with the molecular detection unit; a touch screen 102, which is electrically connected to the central control unit and is used to display operation guidance and detection results; and a chip ejection button 103, which is linked to the chip slot 104 and is used to control the ejection of the microfluidic chip.

[0029] Working principle: The user inserts a solid food sample through the sample inlet 105, inserts the microfluidic chip into the chip slot 104, and establishes a connection. The touch display screen 102 provides animated guidance and real-time status feedback. After the user clicks the "Start Detection" button on the screen, the system runs automatically. After the detection is completed, the touch display screen 102 displays the detection report. The user can press the eject button 103 to eject the used chip for easy replacement. Example

[0030] like Figure 2 and Figure 3 As shown, the microfluidic chip is a disposable, fully enclosed chip with a sample chamber, a reaction chamber, and a detection chamber inside. The chambers are connected by microchannels. The surface of the microchannels is treated with hydrophilic and hydrophobic properties to control the flow of liquid. A micro RFID tag is embedded at the tail of the chip, which contains the chip type, serial number, and expiration date. The chip is pre-packaged with lyophilized detection reagents, including specific nucleases (such as prokaryotic Argonaute proteins), guide nucleic acids, and at least one hairpin probe. Multiple hairpin probes can be designed for different detection targets to achieve multiplex detection (such as simultaneous detection of bovine, porcine, and chicken-derived components). The chip also includes a single-molecule sensing unit, comprising a nanoscale channel (a silicon nitride film with a pore size of approximately 50 nm) and a microelectrode pair (Ag / AgCl electrode), used to detect the characteristic electrical signal generated when the reporter molecule produced after the hairpin probe is sheared passes through the nanochannel.

[0031] Working Principle: The lysis buffer enters the chip sample chamber through the inlet and, guided by the microfluidic channel, enters the reaction chamber to reconstitute the lyophilized detection reagent. If the sample contains a specific target nucleic acid (such as a porcine-specific gene), the target nucleic acid specifically binds to the guide nucleic acid, triggering the release of the guide nucleic acid from the cleavage enzyme complex. The released guide nucleic acid activates a specific nuclease, which then specifically recognizes and cleaves the corresponding hairpin probe, generating a characteristic DNA reporter molecule fragment. The generated reporter molecule passes through a nanoscale channel driven by an electric field. When the reporter molecule passes through the nanopore, it causes a momentary blockage of the channel current, generating a characteristic electrical signal. Reporter molecules of different lengths and sequences generate current signals with different blocking depths and durations. The signal acquisition component acquires these electrical signals in real time and transmits them to the central control unit for analysis and interpretation. Example

[0032] like Figure 2As shown, the temperature control component includes a first temperature control element, a second temperature control element, and a self-heating module. The first temperature control element, located in the first functional area of ​​the microfluidic chip (corresponding to the sample chamber), is a PTC ceramic heating element used to perform instantaneous high-temperature treatment (95°C, 10 seconds) on the sample lysis buffer to ensure sufficient release of nucleic acids. The second temperature control element, located in the second functional area of ​​the microfluidic chip (corresponding to the reaction chamber), is also a PTC ceramic heating element, but configured for point heating—heating only a single area of ​​the reaction chamber, rather than uniformly heating the entire chamber.

[0033] Working principle: The point-heated natural convection amplification process is as follows: The second temperature control element points and heats the bottom or one side of the microfluidic chip's reaction chamber, raising the temperature of that area to 65°C (the temperature required for isothermal amplification). Due to localized heating, a stable temperature gradient is formed within the reaction chamber: the heated area has a higher temperature and lower liquid density, causing it to flow upwards; areas further away from the heated area have a lower temperature and higher liquid density, causing it to flow downwards. This density difference drives the reaction solution to form a stable natural convection circulation within the microcavity, allowing nucleic acid molecules to automatically traverse different temperature regions: denaturing in the high-temperature region and annealing and extending in the low-temperature region, thus achieving continuous nucleic acid amplification without the need for complex temperature control. Example

[0034] like Figure 2 As shown, the temperature control component also includes a self-heating module, which is an independently packaged unit containing a heating material composition (such as iron powder-activated carbon-salt composite powder, mass ratio 10:2:1) and a phase change material (such as paraffin wax, melting point 65°C). The self-heating module generates heat through a chemical reaction triggered by micro-needles, which is then conducted to the microfluidic chip through a thermally conductive copper sheet.

[0035] Working principle: When the device operates in an outdoor environment without external power, the central control unit triggers the self-heating module. A micro-needle punctures the water bladder, initiating an exothermic reaction. The heating material composition reacts to generate heat. The phase change material absorbs excess heat and releases it when the temperature drops to 65°C, achieving constant temperature control. The heat-conducting copper sheet transfers the heat to the reaction chamber of the microfluidic chip, maintaining the temperature required for isothermal amplification for approximately 25-30 minutes. The self-heating module can serve as a supplementary heat source (assisting heating in low-temperature environments) or a replacement heat source (operating independently in a completely power-free environment) for the first or second temperature control element. Example

[0036] like Figure 2 As shown, the central control unit includes a processing module (MCU microcontroller) and a storage module. The storage module stores sample recognition models and result analysis models, which are pre-trained using machine learning algorithms.

[0037] Working principle: The intelligent interpretation process is as follows: Step A: Sample Identification. When the user inserts the microfluidic chip, the central control unit obtains the chip type information via an RFID reader; simultaneously, if the device is equipped with an image acquisition device, it can also capture images of the sample's appearance via a camera. The processing module executes the sample identification model stored in the storage module, combining chip information and image information to automatically determine the sample type (e.g., meat products, grains, dairy products, etc.), and matches the corresponding crushing, pyrolysis, cleaning, and testing programs from the pre-stored program library based on the sample type.

[0038] Step B: Signal Acquisition. During the detection process, the signal acquisition component acquires the characteristic electrical signals generated by the nanopore sensing unit in real time, including characteristic parameters such as the depth, duration, and frequency of current interruption, and transmits this raw data to the processing module.

[0039] Step C: Signal Processing and Feature Extraction. The processing module performs preprocessing on the original electrical signal, including filtering, amplification, and baseline correction, and then extracts the feature parameters of each blocking event to form a feature vector.

[0040] Step D: Model Interpretation. The processing module executes the result analysis model in the storage module, inputs the extracted feature vectors into the model, and the model outputs the detection probability and confidence level of each target component (e.g., "Bovine component: detected, confidence level 99.5%; Porcine component: detected, confidence level 99.5%, content approximately 15%; Chicken component: not detected").

[0041] Step E: Report Generation. Based on the model's interpretation results, the processing module generates a structured testing report, including sample information, testing time, detected components, content estimation, confidence level, and detection limit, which is displayed on the touchscreen. Simultaneously, the report data is prepared for encrypted upload to the data transmission unit. Example

[0042] like Figure 2 As shown, the data transmission unit includes a wireless communication module and an encryption module. The wireless communication module supports wide area network (4G / 5G) or local area network (Wi-Fi / Bluetooth) communication. The encryption module uses national cryptographic algorithms or internationally recognized encryption algorithms to encrypt the uploaded data. The traceability data includes at least one of the following: sample identifier (which can be associated with the original sample), detection time, spatial location (obtained through the device's built-in GPS module), and operator information (obtained through the login account).

[0043] Working principle: The data upload and evidence storage process is as follows: Step A: Data Encapsulation. After the central control unit generates the test report, it encapsulates the report data and traceability data into a unified format data packet, adding a timestamp and digital signature.

[0044] Step B: Data Encryption. The encryption module encrypts the data packets to ensure data security during transmission.

[0045] Step C: Wireless Transmission. The wireless communication module automatically selects the optimal communication method based on the current network environment (prioritizing Wi-Fi, followed by 4G / 5G, and using Bluetooth for short-range data synchronization) and uploads the encrypted data packets to the cloud management platform. If the network is unavailable, the data is temporarily stored in local storage and will automatically resume transmission once the network is restored.

[0046] Step D: Distributed Ledger Notification. After receiving the encrypted data packet, the cloud management platform first decrypts and verifies its format. Then, it writes the key information of the detected data (including data hash value, timestamp, and digital signature) into the distributed ledger notification module. The distributed ledger is built using blockchain technology and maintained jointly by multiple nodes to ensure that the written data is immutable and fully traceable.

[0047] Step E: Data Distribution. The cloud management platform distributes the stored data to the data analysis module for subsequent big data analysis and risk warning; simultaneously, according to permission settings, the detection results are pushed to relevant regulatory terminals. Example

[0048] This embodiment uses the detection of whether beef balls contain pork components as an example to fully demonstrate the complete automated steps of a molecular diagnostic system for identifying food source components.

[0049] Step 1: Chip Insertion and Identification. The operator inserts the microfluidic chip for meat product testing into the chip slot 104. The device reads the chip information via RFID, and the touch screen 102 displays information such as chip type and expiration date, and prompts "Please insert sample".

[0050] Step 2: Sample addition and startup. The operator takes approximately 50 mg of sample from the beef meatball to be tested, places it into sample inlet 105, and clicks the "Start Testing" button on the touch display screen 102.

[0051] Step 3: The gripper of the automated transfer mechanism grabs the sample and places it into the reaction container of the first processing module.

[0052] Step 4: The first processing module starts grinding and crushing (30 seconds) and instantaneous high-temperature pyrolysis (95°C, 10 seconds).

[0053] Step 5: During the pyrolysis process in the first processing module, the automated transfer mechanism places another beef ball sample into the second processing module, which has been cleaned and disinfected, and starts the crushing and pyrolysis process.

[0054] Step 6: After the first processing module completes the lysis, the automated transfer mechanism switches to the sampling component, aspirates the lysate (approximately 20 μL), and precisely adds the sample to the microfluidic chip inlet.

[0055] Step 7: Amplification of the target nucleic acid within the microfluidic chip. Inside the chip, the lysate is reconstituted with lysed reagents, and the target nucleic acid (a porcine-specific gene) triggers the release of guide nucleic acid, activating specific nucleases to specifically cleave the corresponding hairpin probe, generating a characteristic reporter molecule. Simultaneously, the second temperature control element of the temperature control component heats the starting point (at a constant temperature of 65°C for 25 minutes), creating a temperature gradient and natural convection to achieve isothermal amplification.

[0056] Step 8: The signal acquisition component collects the characteristic electrical signals generated when the reporting molecules pass through the nanoscale channel in real time and transmits the raw data to the central control unit.

[0057] Step 9: The central control unit analyzes the characteristics of the electrical signal, executes the analysis model to automatically interpret the result as "detection of swine-derived components, confidence level 99.5%, content approximately 15%", and displays it on the touch screen 102.

[0058] Step 10: The data transmission unit encrypts the test report and uploads it to the distributed ledger evidence storage module of the cloud management platform via wireless network to ensure that the data cannot be tampered with.

[0059] After the test is completed, the user presses the eject button 103, and the used chip will automatically eject. Example

[0060] like Figure 3 As shown, a molecular diagnostic system for identifying food source components (deployed in farmers' markets, slaughterhouses, food processing enterprises, and grassroots regulatory offices), a cloud management platform, and at least one regulatory terminal (such as a computer-based management system, a mobile APP, or a large-screen command center) are included. The cloud management platform communicates with each identification system and is configured to receive, store, and analyze test data for risk warning and traceability analysis. The regulatory terminal communicates with the cloud management platform and is configured to visually display the regional food safety situation and sample traceability information.

[0061] Working principle: Data acquisition layer: After the molecular diagnostic system at each deployment site automatically completes the test, it encrypts and uploads the test results (including sample information, test time, geographical location, operator, test data, etc.) to the cloud management platform.

[0062] Data storage layer: The cloud management platform receives the test data uploaded by each device, first decrypts and verifies the format, and then writes the data hash value, timestamp, digital signature and other information into the distributed ledger storage module to ensure that the data is tamper-proof and traceable throughout the process.

[0063] Data Analysis Layer: The cloud management platform performs multi-dimensional analysis on the stored data: real-time monitoring of the large screen to statistically analyze the total number of tests, positive rate, and testing status in each region, generating a geographic heat map; the risk warning system sets anomaly threshold, automatically triggering an alarm when the positive rate in a certain area rises abnormally or the adulteration rate of a certain type of food exceeds the standard, notifying regulatory personnel via SMS, APP push, etc.; the traceability analysis system traces the supply chain of positive samples, associating production batches and circulation links through sample identification, generating a traceability chain map; the trend prediction model performs time series analysis based on historical data to predict regional food safety risk trends and generate risk profiles.

[0064] Regulatory Application Layer: Regulatory personnel can view the regional food safety situation in real time through regulatory terminals: the computer-based management system can perform data queries, report generation, access management, and statistical analysis; the mobile APP can receive real-time early warning messages, take photos on-site, scan codes for traceability, and execute task assignments; the large-screen command center displays an overview map of the regional food safety situation, supporting emergency command and decision support.

[0065] The molecular diagnostic system for identifying food-derived components of this invention achieves full automation from solid sample introduction to result output by integrating an automated sample processing unit, a molecular detection unit, a central control unit, and a data transmission unit. Its core workflow is as follows: User interaction: Users only need to put the solid sample into the sample inlet 105, insert the microfluidic chip into the chip slot 104, and click the "Start Detection" button on the touch screen 102, and the system will run automatically.

[0066] Sample pretreatment: The central control unit automatically identifies the sample type and matches the processing program based on the RFID chip information. An automated transfer mechanism picks up the sample and places it into the first processing module, which breaks down the sample using grinding media and releases nucleic acids through high-temperature lysis using a heating element. Simultaneously, the second processing module cleans and disinfects the sample, preparing it for the next sample, enabling continuous alternating operation of the two modules.

[0067] Molecular detection: The lysis buffer is transferred to a microfluidic chip, and the lyophilized reagents are reconstituted. The target nucleic acid triggers the release of guide nucleic acid, activating a specific nuclease to cleave the hairpin probe, generating a reporter molecule. The temperature control component uses point heating to create natural convection for isothermal amplification, while a single-molecule sensing unit acquires the characteristic electrical signals generated by the reporter molecule through nanochannels in real time.

[0068] Intelligent interpretation: The central control unit uses a machine learning model to analyze the characteristics of electrical signals, automatically interprets the types, contents and confidence levels of food ingredients, generates a structured test report and displays it on the touch screen.

[0069] Data Upload and Monitoring: The data transmission unit encrypts and uploads test reports and traceability data to the cloud management platform, ensuring data immutability through distributed ledger storage. The cloud platform combines big data analytics for risk warnings and supply chain traceability, while the monitoring terminal displays the regional food safety situation in real time.

[0070] This system condenses the complex molecular detection process into a handheld device, enabling on-site, real-time, and intelligent detection, and providing an innovative solution for smart food safety supervision.

Claims

1. A molecular diagnostic system for identifying food-derived components, characterized in that, include: A handheld housing (100); Integrated within the housing (100): An automated sample processing unit includes at least two alternating processing modules and an automated transfer mechanism. The processing modules are used to break and lyse food samples to release nucleic acid substances, and the automated transfer mechanism is used to transfer the nucleic acid-containing lysate to the detection area. A molecular detection unit, comprising a microfluidic chip, a temperature control component, and a signal acquisition component, wherein the microfluidic chip is configured to receive the lysis buffer and amplify the target nucleic acid therein, and the signal acquisition component is used to monitor the amplification reaction in real time and generate a detection signal; A central control unit, which is electrically connected to the automated sample processing unit and the molecular detection unit, is configured to coordinate and control the automated operation of the automated sample processing unit and the molecular detection unit, and to interpret food composition information based on the detection signal; The data transmission unit is electrically connected to the central control unit and is configured to upload the food ingredient information and related traceability data to the cloud management platform.

2. The molecular diagnostic system for identifying food-derived components according to claim 1, characterized in that, The automated sample processing unit further includes a cleaning and disinfection component, which is fluidly connected to the processing module. Each of the processing modules includes a reaction vessel, a crushing drive, and a heating element. The reaction vessel contains grinding media. The crushing drive is used to drive the grinding media to move to crush the sample. The heating element is used to heat and pyrolyze the crushed sample. The automated transfer mechanism is a multi-degree-of-freedom robotic arm. The end of the robotic arm is equipped with a replaceable gripper and a sampling component. The gripper is configured to grip a solid sample and place it into the reaction container. The sampling component is configured to aspirate the lysis solution and add the lysis solution to the microfluidic chip. The cleaning and disinfection assembly includes at least one cleaning solution reservoir, at least one disinfectant solution reservoir, and a waste liquid reservoir, as well as multiple micro pumps and control valves, which are used to sequentially inject cleaning solution, disinfectant solution, and drying gas into the reaction container after sample processing under the control of the central control unit to perform cleaning, disinfection, and drying procedures. The cleaning and disinfection component is configured to complete the entire cleaning and disinfection process on a single processing module in no more than 2 minutes.

3. The molecular diagnostic system for identifying food-derived components according to claim 1, characterized in that, The handheld housing (100) is provided with: Each sample entry point (105) is configured to correspond to the processing module of the automated sample processing unit; A chip slot (104) is used to accommodate the microfluidic chip and form an electrical and fluid connection with the molecular detection unit; A touch screen (102) is electrically connected to the central control unit and is used to display operation guidance and test results; An eject button (103) is linked to the chip slot (104) to control the ejection of the microfluidic chip.

4. The molecular diagnostic system for identifying food-derived components according to claim 1, characterized in that, The microfluidic chip is a disposable, fully enclosed chip, pre-packaged with lyophilized detection reagents; the detection reagents include specific nucleases, guide nucleic acids, and at least one hairpin probe. The microfluidic chip also includes a single-molecule sensing unit, which is configured to detect the characteristic electrical signal generated when the reporter molecule produced after the hairpin probe is sheared passes through the nanoscale channel.

5. The molecular diagnostic system for identifying food-derived components according to claim 1, characterized in that, The temperature control component includes a first temperature control element and a second temperature control element. The first temperature control element is disposed in the first functional area of ​​the microfluidic chip and is used to perform instantaneous high-temperature treatment on the sample lysis solution. The second temperature control element is disposed in the second functional area of ​​the microfluidic chip and is configured to use point heating mode, so that the reaction solution in the second functional area of ​​the microfluidic chip forms a temperature gradient and generates natural convection, thereby achieving isothermal amplification of nucleic acids.

6. The molecular diagnostic system for identifying food-derived components according to claim 5, characterized in that, The temperature control component also includes a self-heating module, which encapsulates a heat-generating material composition that generates heat by triggering a chemical reaction, serving as a supplementary or alternative heat source for the first or second temperature control element.

7. The molecular diagnostic system for identifying food-derived components according to claim 1, characterized in that, The central control unit includes a storage module and a processing module. The storage module stores a sample identification model and a result analysis model. The processing module is configured to execute the identification model to determine the sample type and match the corresponding processing program, and to execute the analysis model to process the detection signal and generate a detection report.

8. The molecular diagnostic system for identifying food-derived components according to claim 1, characterized in that, The data transmission unit includes a wireless communication module and an encryption module. The wireless communication module supports wide area or local area wireless network communication, and the encryption module is configured to encrypt the uploaded data. The traceability data includes at least one of sample identifier, detection time, spatial location, and operator information. The cloud management platform includes a distributed ledger evidence storage module for tamper-proof evidence storage of the received detection data.

9. The molecular diagnostic system for identifying food-derived components according to any one of claims 1-8, characterized in that, Includes the following automated steps: The food sample is placed into the first processing module through an automated transfer mechanism, and the crushing and pyrolysis process is initiated. During or after the pyrolysis process in the first processing module, another food sample is placed into the second processing module, which has been cleaned and disinfected, by the automated transfer mechanism. After lysis is completed, the lysate is aspirated by the automated transfer mechanism and added to the microfluidic chip; The target nucleic acid is amplified within the microfluidic chip, and the detection signal is acquired in real time by a signal acquisition component. The detection signal is analyzed by the central control unit to interpret food composition information and generate a detection report. The test report and related traceability data are uploaded to the cloud management platform through the data transmission unit.

10. The molecular diagnostic system for identifying food-derived components according to any one of claims 1-8, characterized in that, include: A cloud management platform is connected to the molecular diagnostic system for identifying food source components and is configured to receive, store and analyze detection data from the molecular diagnostic system for identifying food source components, and to perform risk warning and traceability analysis. At least one monitoring terminal is connected to the cloud management platform and is configured to visually display the regional food safety situation and sample traceability information.

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