Immune quantitative detection device for tumor markers

Abstract

The invention discloses an immune quantitative detection device for tumor markers, relates to the technical field of medical detection, and aims to solve the problems of complicated operation, long detection period and poor portability in immune quantitative detection of tumor markers in the prior art. Comprising a shell, a disposable detection card, a multi-channel micro-fluidic chip, a high-sensitivity sensing system, a micro magnetic control incubation module, an AI auxiliary image recognition system and a wireless transmission module, the disposable detection card is used for accommodating the multi-channel micro-fluidic chip and a reaction reagent, and the multi-channel micro-fluidic chip is respectively aligned with the high-sensitivity sensing system and the micro magnetic control incubation module; the high-sensitivity sensing system is composed of a surface plasma resonance sensor and a quantum dot fluorescence labeling module, and the surface of a sensing chip of the surface plasma resonance sensor is modified with a tumor marker specific capture antibody. The method has the advantages of convenient detection and high efficiency and precision.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical detection, more particularly to an immune quantitative detection device for tumor markers. BACKGROUND

[0002] In the field of tumor diagnosis and treatment, quantitative detection of tumor markers is a core technical means to achieve early screening, efficacy evaluation and dynamic monitoring of tumors.

[0003] However, existing detection devices generally require multiple manual operations, including sample centrifugal separation (serum samples need to be centrifuged at 3000 rpm for 10-15 minutes), precise reagent sampling (requiring professional equipment such as a pipette), gradient dilution (for high-concentration samples), etc. For example, the ELISA method needs to go through more than 6 steps of "sample incubation-plate washing-enzyme-labeled antibody incubation-secondary plate washing-substrate reaction-signal reading", and the whole process needs to be operated by professional technicians, and each operation error (such as incomplete plate washing, deviation of sampling amount) will affect the accuracy of the detection result; at the same time, most devices are large in size and rely on fixed power supply and constant temperature laboratory environment. In view of this, we propose an immune quantitative detection device for tumor markers. SUMMARY

[0004] The purpose of the present application is to provide an immune quantitative detection device for tumor markers, which aims to solve the problems of complex operation, long detection period and poor portability in the prior art.

[0005] To solve the above technical problems, the present application provides the following technical scheme: an immune quantitative detection device for tumor markers, comprising a shell, a disposable detection card, a multi-channel microfluidic chip, a high-sensitivity sensing system, a micro magnetic control incubation module, an AI-assisted image recognition system and a wireless transmission module; The disposable detection card is used to embed the multi-channel microfluidic chip and reaction reagents, and the multi-channel microfluidic chip is aligned with the high-sensitivity sensing system and the micro magnetic control incubation module, respectively; The high-sensitivity sensing system is composed of a surface plasmon resonance sensor and a quantum dot fluorescent labeling module, the surface of the sensing chip of the surface plasmon resonance sensor is modified with tumor marker specific capture antibodies, and the quantum dot fluorescent labeling module is used to form quantum dot-antibody conjugates; The micro magnetic control incubation module, the AI-assisted image recognition system and the wireless transmission module are all integrated in the interior of the shell, the AI-assisted image recognition system is electrically connected with the high-sensitivity sensing system and the wireless transmission module through a data interface, realizing the collection, analysis and result transmission of the detection signal.

[0006] Preferably, the multi-channel microfluidic chip is provided with 3-6 independent micro-reaction cavities, each micro-reaction cavity has an effective volume of 1.5-3 muL, and each micro-reaction cavity is communicated with the sample inlet through an independent micro-channel, and the multi-channel microfluidic chip is suitable for fingertip blood and serum samples.

[0007] Preferably, the quantum dot fluorescence labeling module adopts CdSe / ZnS core-shell structure quantum dots, the particle size of the quantum dots is 2-8 nm, the emission wavelength is 520-650 nm, the quantum dots are connected with the detection antibody through amino-carboxyl coupling reaction to form quantum dot-antibody conjugates.

[0008] Preferably, the micro magnetic control incubation module comprises a micro electromagnetic array, a magnetic field controller, a temperature sensor and a semiconductor temperature control unit, the micro electromagnetic array is distributed below the micro-reaction cavity, the magnetic field controller adjusts the magnetic field strength in the range of 0.1-0.5T through pulse signal to realize the oscillation mixing of the reaction system, the temperature sensor monitors the temperature of the micro-reaction cavity in real time, and the semiconductor temperature control unit stably controls the reaction temperature at 37±0.5 DEG C.

[0009] Preferably, the AI-assisted image recognition system comprises an image acquisition unit, a signal preprocessing unit and an embedded quantitative analysis unit, the image acquisition unit is equipped with a high-power microscope lens, and the refractive index change image of the surface plasmon resonance sensor and the fluorescence image of the quantum dot fluorescence labeling module are synchronously acquired, the signal preprocessing unit carries out background noise reduction and signal enhancement processing on the acquired image, and the embedded quantitative analysis unit is provided with a tumor marker concentration calibration model, and the concentration of the tumor marker is calculated based on the preprocessed image signal.

[0010] Preferably, the wireless transmission module supports Bluetooth 5.0, 4G LTE and 5G NR transmission protocols, and is used for encrypting and transmitting the detection report containing the detection result and sample information to the cloud platform.

[0011] Preferably, the shell is made of ABS+PC alloy material, and the overall size is <20 cm³.

[0012] Preferably, the inner wall of the micro-channel of the microfluidic chip is subjected to hydrophilic treatment.

[0013] Compared with the prior art, the present application has the following advantages: 1、The shell in the application adopts ABS+PC alloy material, the overall size is <20cm³, the volume is small and portable, on the operation, the disposable detection card is adapted to 5-10 μL of fingertip blood or 3-5 μL of serum, the sample does not need pretreatment, the microchannel of the multichannel microfluidic chip is hydrophilic treated, the sample is automatically filled to the 1.5-3 μL microreaction cavity by capillary action, without external driving, on the detection cycle, the miniature magnetic control incubation module is used to oscillate and mix the reaction system with 0.1-0.5 T magnetic field, the semiconductor temperature control unit is used to stabilize the temperature at 37±0.5 DEG C to accelerate the reaction, the AI assisted image recognition system is used to quickly collect and analyze the signal, and the detection time is greatly shortened.

[0014] 2、In the application, tumor marker specific capture antibodies are modified on the surface of the core surface sheet of the surface plasmon resonance sensor, then CdSe / ZnS core-shell structure quantum dots are used, the particle size of the quantum dots is 2-8 nm, the emission wavelength is 520-650 nm, the quantum dots are coupled with detection antibodies through amino-carboxyl coupling, and the two cooperate to improve the detection capacity of low-concentration markers. BRIEF DESCRIPTION OF DRAWINGS

[0015] Figure 1 It is a structural schematic diagram of the application. DETAILED DESCRIPTION EMBODIMENT

[0016] The embodiment includes a shell (the shell is made of ABS+PC alloy material, and the overall size is <20cm³), a disposable detection card, a multichannel microfluidic chip, a high-sensitivity sensing system, a miniature magnetic control incubation module, an AI assisted image recognition system and a wireless transmission module. The disposable detection card is used for embedding the multichannel microfluidic chip and reaction reagents, the multichannel microfluidic chip is aligned with the high-sensitivity sensing system and the miniature magnetic control incubation module, the multichannel microfluidic chip is provided with 3-6 independent microreaction cavities, the effective volume of each microreaction cavity is 1.5-3 μL, each microreaction cavity is communicated with a sample inlet through an independent microchannel, the inner wall of the microchannel of the microfluidic chip is hydrophilic treated, the sample can be automatically filled to the microreaction cavity under capillary action, without an external driving device, and the multichannel microfluidic chip is adapted to fingertip blood (5-10 μL) and serum (3-5 μL) samples, the sample can be directly used without centrifugation, dilution and other pretreatment steps. The high-sensitivity sensing system is composed of a surface plasmon resonance sensor and a quantum dot fluorescent labeling module, the surface of the sensing chip of the surface plasmon resonance sensor is modified with tumor marker specific capture antibodies, the quantum dot fluorescent labeling module adopts CdSe / ZnS core-shell structure quantum dots, the particle size of the quantum dots is 2-8 nm, the emission wavelength is 520-650 nm, the quantum dots are connected with detection antibodies through amino-carboxyl coupling reaction to form quantum dot-antibody coupling. The miniature magnetic control incubation module, the AI-assisted image recognition system and the wireless transmission module are all integrated in the shell, the AI-assisted image recognition system is electrically connected with the high-sensitivity sensing system and the wireless transmission module through a data interface, and the collection, analysis and result transmission of detection signals are realized. Among them: The miniature magnetic control incubation module includes a miniature electromagnet array, a magnetic field controller, a temperature sensor and a semiconductor temperature control unit. The miniature electromagnet array is distributed below the micro-reaction cavity. The magnetic field controller adjusts the magnetic field strength in the range of 0.1-0.5T through pulse signals to realize the oscillation mixing of the reaction system. The temperature sensor monitors the temperature of the micro-reaction cavity in real time, and the semiconductor temperature control unit stably controls the reaction temperature at 37±0.5℃.

[0017] The AI-assisted image recognition system includes an image acquisition unit, a signal preprocessing unit and an embedded quantitative analysis unit. The image acquisition unit is equipped with a high-power microscope lens, which synchronously acquires the refractive index change image of the surface plasmon resonance sensor and the fluorescence image of the quantum dot fluorescence labeling module. The signal preprocessing unit processes the collected images by background noise reduction (using a Gaussian filtering algorithm) and signal enhancement (using a histogram equalization algorithm). The embedded quantitative analysis unit has a tumor marker concentration calibration model, and calculates the tumor marker concentration based on the preprocessed image signals. Among them: The formula used by the Gaussian filtering algorithm is: ; The formula used by the histogram equalization algorithm is: ; In the formula, is the weight value of the Gaussian filter kernel at the coordinate, is the standard deviation of the Gaussian function (the value range is 0.5-2.0), is the gray value after equalization, is the total number of image gray levels (the value is 256), is the total number of image pixels, is the number of pixels with a gray value of .

[0018] The wireless transmission module supports Bluetooth 5.0, 4G LTE and 5G NR transmission protocols, and is used for encrypted transmission of detection reports containing detection results and sample information to the cloud platform.

[0019] The shell made of ABS+PC alloy material in the embodiment has a volume less than 20 cm³, ensuring the portability of the device while having durability, the multi-channel microfluidic chip built in the disposable detection card is provided with 3-6 independent micro-reaction cavities, the effective volume of each micro-reaction cavity is 1.5-3 muL, and the inner wall of the micro-channel is hydrophilically treated, cooperating with the 5-10 muL of fingertip blood or 3-5 muL of serum sample, without external driving device, the sample can be automatically filled into the micro-reaction cavity by capillary action, without centrifugation, dilution and other pretreatment of the sample, greatly simplifying the sample processing process and improving the detection convenience.

[0020] In terms of detection accuracy, the high-sensitivity sensing system is composed of a surface plasmon resonance sensor and a quantum dot fluorescence labeling module, the former is surface-modified with tumor marker specific capture antibodies, and the latter uses 2-8 nm particle size, emission wavelength 520-650 nm CdSe / ZnS core-shell structure quantum dots and connects with detection antibodies through amino-carboxyl coupling reaction, enhancing the recognition and capture ability of tumor markers; The miniature magnetic control incubation module uses a miniature electromagnet array, a magnetic field controller, a temperature sensor and a semiconductor temperature control unit, which can realize the oscillation mixing of the reaction system through the magnetic field changing in the range of 0.1-0.5T, and can stably control the reaction temperature at 37±0.5℃, providing a stable and suitable environment for the reaction, further ensuring the detection accuracy.

[0021] In the signal processing and result transmission link, the AI-assisted image recognition system synchronously collects the refractive index change image and the fluorescence image through a high-power microscope lens, after background noise reduction by a Gaussian filter algorithm and signal enhancement processing by a histogram equalization algorithm, the embedded quantitative analysis unit with a tumor marker concentration calibration model is used to calculate the tumor marker concentration, ensuring the accurate quantization of the detection result, and meeting the needs of on-site rapid detection and remote data management, providing an efficient, accurate, convenient and safe solution for tumor marker detection.

[0022] The embodiments of the present application disclose the preferred embodiments, but are not limited thereto, and those skilled in the art can easily understand the spirit of the present application according to the above embodiments, and make different inferences and changes, as long as they do not deviate from the spirit of the present application, they are within the protection scope of the present application.

Claims

1. An immunoassay device for tumor markers, characterized in that, The device comprises a shell, a disposable detection card, a multi-channel microfluidic chip, a high-sensitivity sensing system, a miniature magnetic control incubation module, an AI-assisted image recognition system and a wireless transmission module. The disposable detection card is used for embedding the multi-channel microfluidic chip and reaction reagents, and the multi-channel microfluidic chip is respectively aligned with the high-sensitivity sensing system and the miniature magnetic control incubation module. The high-sensitivity sensing system is composed of a surface plasmon resonance sensor and a quantum dot fluorescent labeling module, the surface of the sensing chip of the surface plasmon resonance sensor is modified with tumor marker specific capture antibodies, and the quantum dot fluorescent labeling module is used to form quantum dot-antibody conjugates. The miniature magnetic control incubation module, the AI-assisted image recognition system and the wireless transmission module are all integrated in the shell, the AI-assisted image recognition system is electrically connected with the high-sensitivity sensing system and the wireless transmission module through a data interface, and the detection signal is collected, analyzed and transmitted.

2. The immunoassay device for quantitatively detecting a tumor marker according to claim 1, wherein The multi-channel microfluidic chip is provided with 3-6 independent micro-reaction cavities, the effective volume of each micro-reaction cavity is 1.5-3 μL, and each micro-reaction cavity is communicated with a sample inlet through an independent micro-channel, and the multi-channel microfluidic chip is suitable for fingertip blood and serum samples.

3. The immunoassay device for quantitatively detecting a tumor marker according to claim 1, wherein The quantum dot fluorescent labeling module adopts CdSe / ZnS core-shell structure quantum dots, the particle size of the quantum dots is 2-8 nm, the emission wavelength is 520-650 nm, the quantum dots are connected with detection antibodies through amino-carboxyl coupling reaction to form quantum dot-antibody conjugates.

4. The immunoassay device for quantitatively detecting a tumor marker according to claim 1, wherein The miniature magnetic control incubation module comprises a miniature electromagnet array, a magnetic field controller, a temperature sensor and a semiconductor temperature control unit, the miniature electromagnet array is distributed below the micro-reaction cavities, the magnetic field controller adjusts the magnetic field strength in the range of 0.1-0.5 T through pulse signals to realize the oscillation mixing of the reaction system, the temperature sensor monitors the temperature of the micro-reaction cavities in real time, and the semiconductor temperature control unit stably controls the reaction temperature at 37±0.5℃.

5. The immunoassay device for quantitatively detecting a tumor marker according to claim 1, wherein The AI-assisted image recognition system comprises an image acquisition unit, a signal preprocessing unit and an embedded quantitative analysis unit, the image acquisition unit is equipped with a high-power microscope lens, the refractive index change image of the surface plasmon resonance sensor and the fluorescence image of the quantum dot fluorescent labeling module are synchronously acquired, the signal preprocessing unit performs background noise reduction and signal enhancement processing on the acquired images, and the embedded quantitative analysis unit is provided with a tumor marker concentration calibration model, and the concentration of the tumor marker is calculated based on the preprocessed image signals.

6. The immunoassay device for quantitatively detecting a tumor marker according to claim 1, wherein The wireless transmission module supports Bluetooth 5.0, 4G LTE and 5G NR transmission protocols, and is used for encrypting and transmitting a detection report containing detection results and sample information to a cloud platform.

7. The immunoassay device for quantitatively detecting a tumor marker according to claim 1, wherein The shell is made of ABS+PC alloy material, and the overall size is <20 cm³.

8. The immunoassay device for quantitatively detecting a tumor marker according to claim 2, wherein The inner wall of the micro-channel of the microfluidic chip is subjected to hydrophilic treatment.

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