Intelligent disposable detection system and method

Abstract

The present application relates to intelligent disposable detection system and method. The intelligent disposable detection system comprises an intelligent mobile terminal and a disposable detection device; the detection device comprises a shell and a spectrum sensing chip, and the spectrum sensing chip has a unique identification code; a test strip or a test cabin is arranged in the shell; the spectrum sensing chip has a photosensitive receiving unit; the photosensitive receiving unit faces the shell; an excitation light source is arranged in the shell; a data output end of the spectrum sensing chip is connected with the intelligent mobile terminal through a connecting cable; the intelligent mobile terminal has an identity authentication module, a detection device control module, a detection data processing module, a data binding module and a data uploading module. The present application can be used for self-detection, and the whole process is closed loop in the detection process, without manual intervention, and has sufficient identity traceability and detection result authenticity proof strength.

Description

TECHNICAL FIELD

[0001] The present application relates to an intelligent one-time detection system and method, belonging to the technical field of medical detection. BACKGROUND

[0002] According to the applicant's understanding, at present, whether in network medical treatment or in epidemic control management, people generally need a device that can detect some medical indicators at home by themselves, and this demand is becoming stronger and stronger. The current related technical means are mainly one-way chromatographic immunization test strips, which can meet the needs of self-detection, but cannot achieve sufficient identity tracing and detection result authenticity. For example, someone shows a photo of a test strip after self-detection, but it cannot prove that it is his own detection result, nor can it prove that it is an immediate detection result. If the complete evidence chain is saved for the above identity tracing and detection result authenticity, it will be too cumbersome to lose the convenience of self-detection at home. This leads to the fact that although people can achieve self-detection, they still need to go to a hospital or an authoritative detection institution for detection again to give a detection result with proof. It is urgent to develop a technical means that can be used for self-detection at home and has a certain degree of identity tracing and detection result authenticity.

[0003] The applicant is committed to the research and development of detection reagents and devices, and holds an invention patent "Test strip for quantitative detection of compounds and detection method of lateral immunization chromatography" (CN107037211B). The application discloses a test strip for quantitative detection of compounds, which comprises a layer of NC film, a layer of sample pad located at the front end of the NC film, a layer of marker pad located inside the sample pad, a detection zone located behind the marker pad, and a first control zone located behind the detection zone. A second control zone is further provided behind the first control zone. The marker pad contains monoclonal antibody coupled Eu microspheres and the first antibody coupled Eu microspheres of the compound to be detected. The detection zone contains the second antibody or the antigen of the compound to be detected. The first control zone contains the third antibody. The second control zone contains the fourth antibody which does not react with the detection compound, the second antibody and the third antibody. The fourth antibody only reacts with the first antibody. The application can improve the detection precision of the detection compound.

[0004] Through retrieval, it is found that the invention patent application with application number CN201610864221.2 and publication number CN106404783A discloses a test paper detection method, which comprises: obtaining a first image of a test paper to be detected, wherein the test paper to be detected has added a sample to be detected and a sensitizing agent; analyzing the first image to obtain a detection index analysis result.

[0005] The patent application with the application number CN201580081403.6 and the publication number CN108139387A discloses a method for collecting test data from a disposable test kit, comprising the following steps: a code reader scans a unique test identifier provided on the disposable test kit; an identification module identifies the type of test performed by the disposable test kit from the scanned unique test identifier; the code reader scans a patient identifier; the identification module identifies the patient who used the disposable test kit from the scanned patient identifier; a display and selection module automatically displays each of all possible specific results associated with the identified test on a display screen as selectable options; the user selects one of all possible specific results displayed as test data for collection; an association module automatically associates the test data with the patient; and the user activates the test data to be stored to a data storage.

[0006] The patent application with the application number CN202010901063.X and the publication number CN111999288A discloses a pathogen and antibody detection system for a mobile terminal, comprising: a detection device for detecting pathogens and antibodies; an identity creation module for creating a unique identity for the detection device and creating an operator role or a subject role with the unique identity according to user information; a binding module for binding the detection device, the operator role and the subject role to the detection activity according to the detection activity to be performed; a detection information processing module for obtaining the detection result of the detection device and judging the accuracy of the detection result; and an intelligent mobile terminal module for identifying the unique identity of the detection device, the operator role or the subject role, and for obtaining the data of the detection activity for the operator role or the subject role.

[0007] However, the prior art represented by the above technical solutions more or less needs manual intervention in the process of detecting and obtaining data, for example, some need manual scanning or manual input of detection device identification code to realize binding, some need manual photographing to upload detection results, some need manual comparison to obtain detection conclusions, etc. It is difficult to achieve a full closed loop without manual intervention, and it is difficult to achieve sufficient identity traceability and detection result authenticity when used for home self-detection which needs to upload and report real-time detection results. SUMMARY

[0008] The main purpose of the present application is to overcome the problems existing in the prior art, provide an intelligent disposable detection system which can be used for home self-detection and has a full closed loop in the detection process without manual intervention, and has sufficient identity traceability and detection result authenticity; and also provide a corresponding control method.

[0009] The technical solution of the present application to solve its technical problems is as follows:

[0010] An intelligent disposable detection system comprises an intelligent mobile terminal and a disposable detection device, the detection device is connected with the intelligent mobile terminal through a plug-in connection cable; characterized in that the detection device comprises a shell and a spectrum sensing chip, the spectrum sensing chip has a unique identification code; the shell is provided with a test strip or test cabin, the test strip or test cabin has a sample adding area, the shell is provided with a sample adding hole corresponding to the sample adding area; the spectrum sensing chip has a light receiving unit; the light receiving unit faces the shell and is used to receive light in the shell; the shell is provided with an excitation light source, a controlled end of the excitation light source is connected with a control end of the spectrum sensing chip; a data output end of the spectrum sensing chip is connected with the intelligent mobile terminal through the connection cable; the spectrum sensing chip and the excitation light source are powered by the intelligent mobile terminal;

[0011] The intelligent mobile terminal has:

[0012] An identity authentication module is used to perform real-name authentication on the user's identity and identity recognition on the current user;

[0013] A detection device control module is used to confirm whether the detection device is connected with the intelligent mobile terminal, identify and record the unique identification code of the spectrum sensing chip, and issue a start self-checking or detection instruction to the spectrum sensing chip;

[0014] A detection data processing module is used to receive detection data sent by the spectrum sensing chip, judge whether the self-checking of the detection device is normal according to the detection data, and process the detection data into detection result data;

[0015] A data binding module is used to bind the detection result data, the unique identification code and the current user's identity information and generate upload data;

[0016] A data upload module is used to upload the upload data to a cloud server.

[0017] The system completes real-name authentication of the user on the intelligent mobile terminal in advance before use; during use, the intelligent mobile terminal identifies the current user (such as fingerprint identification, face recognition, etc.), performs self-checking after connecting the detection device to confirm that the detection device has not been used, and then starts the detection device to begin detection; the user adds the user's own sample to the sample adding area through the sample adding hole of the detection device, and the test strip or test cabin completes the test; the light source is excited to irradiate the test strip or test cabin, the fluorescence generated by excitation enters the photosensitive receiving unit to generate a photoelectric signal, which is then processed by the spectral sensing chip to generate detection data and sent to the intelligent mobile terminal; the intelligent mobile terminal processes the detection data into a detection result, and binds it with the unique identification code and the current user's identity information, and finally uploads it to the cloud server. The detection is a closed loop, and sample detection, data processing, identity binding and result uploading are all automatically completed without human intervention, ensuring the authenticity of the results, and at the same time, the detection device is used only once and the unique identification code of the spectral sensing chip is recorded and uploaded to ensure the uniqueness of the detection device, thereby having sufficient identity traceability and detection result authenticity.

[0018] The further improved technical solutions of the present application are as follows:

[0019] Preferably, the excitation light source is located at the top of the shell; the photosensitive receiving unit is located at the top of the shell; and the shell is provided with a light shielding member to cut off the interfering light.

[0020] More preferably, the excitation light source is a single-wavelength LED lamp.

[0021] Preferably, the test strip is located at the lower part of the shell; the test strip is a fluorescent immunochromatographic test strip, and the test strip has a detection zone and a control zone, and the detection zone and the control zone respectively contain antibodies or antigens; the detection zone and the control zone respectively emit fluorescence under the irradiation of the excitation light source after reaction, and the fluorescence is within the recognition and detection spectral range of the photosensitive receiving unit. After the sample is added to the sample adding area, it successively passes through the detection zone and the control zone under the action of chromatographic flow and generates a fluorescent immunoreaction.

[0022] Preferably, the excitation light source includes a detection zone excitation light source and a control zone excitation light source.

[0023] Preferably, the photosensitive receiving unit is located between the detection zone excitation light source and the control zone excitation light source, and between the detection zone and the control zone of the test strip.

[0024] More preferably, the light shielding member comprises a first upper shielding member and a second upper shielding member respectively arranged on the upper part of the housing; the first upper shielding member is located between the detection area excitation light source and the light receiving unit, and is used to shield the light directly emitted from the detection area excitation light source to the control area of the test strip; the second upper shielding member is located between the light receiving unit and the control area excitation light source, and is used to shield the light directly emitted from the control area excitation light source to the detection area of the test strip.

[0025] Preferably, the detection area comprises a first detection area and a second detection area, and the control area comprises a first control area and a second control area; the first detection area, the second detection area, the first control area and the second control area are arranged in sequence along the chromatographic flow direction.

[0026] Preferably, the light receiving unit comprises a first light receiving area and a second light receiving area, the first light receiving area and the second light receiving area are located between the second detection area and the first control area, the first light receiving area is located between the first upper shielding member and the second light receiving area, and the second light receiving area is located between the first light receiving area and the second upper shielding member.

[0027] Preferably, the light shielding member comprises a third middle shielding member and a fourth middle shielding member respectively arranged in the middle part of the housing and located below the light receiving unit; the third middle shielding member is used to shield the fluorescent light emitted from the first detection area to the second light receiving area, and to shield the fluorescent light emitted from the second detection area to the first light receiving area; the fourth middle shielding member is used to shield the fluorescent light emitted from the first control area to the second light receiving area, and to shield the fluorescent light emitted from the second control area to the first light receiving area.

[0028] More preferably, the cross section of the third middle shielding member comprises at least one line segment that shields both the fluorescent light emitted from the first detection area to the second light receiving area and the fluorescent light emitted from the second detection area to the first light receiving area; the upper edge or upper end of the cross section of the third middle shielding member leaves or forms a light path from the first detection area to the first light receiving area, a light path from the first control area to the first light receiving area, and a light path from the second detection area to the second light receiving area between the first light receiving area or the second light receiving area; the lower edge or lower end of the cross section of the third middle shielding member leaves or forms a light path from the detection area excitation light source to the first detection area, and a light path from the detection area excitation light source to the second detection area between the first detection area or the second detection area.

[0029] The fourth middle shielding piece has a cross section comprising at least one line segment that shields both fluorescent light emitted by the first control region towards the second photosensitive region and fluorescent light emitted by the second control region towards the first photosensitive region; an upper edge or upper end of the cross section of the fourth middle shielding piece leaves or forms a light path for the first control region to the first photosensitive region, a light path for the second control region to the second photosensitive region, and a light path for the second detection region to the second photosensitive region; a lower edge or lower end of the cross section of the fourth middle shielding piece leaves or forms a light path for the control region excitation light source to the first control region and a light path for the control region excitation light source to the second control region.

[0030] Preferably, the light shielding member comprises a fifth lower shielding piece arranged at the lower part of the shell, the fifth lower shielding piece is located between the first photosensitive region and the second photosensitive region and between the second detection region and the first control region, and is used to shield fluorescent light emitted by the first detection region and the second detection region towards the second upper shielding piece, and to shield fluorescent light emitted by the first control region and the second control region towards the first upper shielding piece.

[0031] With the above preferred scheme, the specific structural features of the detection device when using the test strip can be further optimized.

[0032] Preferably, the number of excitation light sources, detection regions, and control regions is one respectively; the light shielding member comprises a first shielding piece and a second shielding piece; the photosensitive receiving unit is located between the detection region and the control region; the photosensitive receiving unit comprises a first photosensitive region and a second photosensitive region; the first shielding piece is located at the upper part of the shell and between the excitation light source and the first photosensitive region; the first photosensitive region is located between the first shielding piece and the second photosensitive region; the second shielding piece is located at the upper part or middle part of the shell and between the first photosensitive region and the second photosensitive region, and is used to shield fluorescent light emitted by the detection region towards the second photosensitive region and to shield fluorescent light emitted by the control region towards the first photosensitive region.

[0033] With the above preferred scheme, the simplified structure of the detection device when using the test strip can be provided, and the cost can be further reduced.

[0034] Preferably, the test strip further has a sample pad, a conjugate pad, and a water absorption pad, the sample pad is located at the sample adding region; the detection region has three, which are a first detection region, a second detection region, and a third detection region; the control region has one; the sample pad, the conjugate pad, the first detection region, the second detection region, the third detection region, the control region, and the water absorption pad are sequentially arranged along the chromatographic direction.

[0035] The conjugate pad is provided with a fluorescently labeled monoclonal first antibody against a novel coronavirus antigen, a fluorescently labeled monoclonal second antibody against an influenza A virus antigen, and a fluorescently labeled monoclonal third antibody against an influenza B virus antigen.

[0036] The first detection area is provided with a fourth antibody against the novel coronavirus antigen, the second detection area is provided with a fifth antibody against the influenza A virus antigen, and the third detection area is provided with a sixth antibody against the influenza B virus antigen.

[0037] The control area is provided with an antibody against a fluorescently labeled monoclonal first antibody, an antibody against a fluorescently labeled monoclonal second antibody, and an antibody against a fluorescently labeled monoclonal third antibody.

[0038] After the preferred scheme is adopted, the specific structural features of the test strip can be optimized. By comparing the fluorescence intensity of the first detection area, the fluorescence intensity of the second detection area, the fluorescence intensity of the third detection area, and the fluorescence intensity of the control area, the novel coronavirus antigen, the influenza A virus antigen, and the influenza B virus antigen in the sample can be quantitatively detected.

[0039] Preferably, the test strip further has a sample pad, a conjugate pad, and a water absorption pad, the sample pad is located in the sample adding area; the detection area has one; the control area has two, which are a first control area and a second control area; the sample pad, the conjugate pad, the detection area, the first control area, the second control area, and the water absorption pad are sequentially arranged in the chromatographic direction.

[0040] The conjugate pad is provided with a fluorescently labeled first antibody and a fluorescently labeled monoclonal second antibody against the novel coronavirus antigen.

[0041] The detection area is provided with a third antibody against the novel coronavirus antigen.

[0042] The first control area is provided with a fourth antibody against the fluorescently labeled monoclonal second antibody, and the second control area is provided with a fifth antibody against the fluorescently labeled first antibody.

[0043] After the preferred scheme is adopted, the specific structural features of the test strip can be optimized. By comparing the fluorescence intensity of the detection area and the second control area, the novel coronavirus antigen in the sample can be quantitatively detected with high precision.

[0044] Preferably, the test strip further has a sample pad, a conjugate pad, and a water absorption pad, the sample pad is located in the sample adding area; the detection area and the control area each have one; the sample pad, the conjugate pad, the detection area, the control area, and the water absorption pad are sequentially arranged in the chromatographic direction.

[0045] The conjugate pad is provided with a fluorescently labeled monoclonal first antibody against the novel coronavirus antigen.

[0046] The detection area is provided with a second antibody against the novel coronavirus antigen.

[0047] The control area is provided with a third antibody against a fluorescently labeled monoclonal first antibody.

[0048] By adopting the preferred solution, the specific structural features of the test strip can be optimized, and the novel coronavirus antigens in the sample can be quantitatively detected by comparing the fluorescence intensities of the detection area and the control area.

[0049] Preferably, the test strip further has a sample pad, a conjugate pad, and a water absorption pad, the sample pad is located in the sample adding area; the detection area and the control area are each one; the sample pad, the conjugate pad, the detection area, the control area, and the water absorption pad are sequentially arranged along the chromatographic direction; the optical spectrum sensing chip has at least two wavelength channels;

[0050] The conjugate pad is provided with a fluorescently labeled first antibody and a fluorescently labeled monoclonal second antibody against the novel coronavirus antigen; the fluorescently labeled first antibody has a first fluorescent label, and the fluorescently labeled monoclonal second antibody has a second fluorescent label, the wavelength of the first fluorescent label excited to emit fluorescence is different from the wavelength of the second fluorescent label excited to emit fluorescence, and the wavelength of the first fluorescent label excited to emit fluorescence and the wavelength of the second fluorescent label excited to emit fluorescence respectively match the corresponding wavelength channels of the optical spectrum sensing chip;

[0051] The detection area is provided with a third antibody against the novel coronavirus antigen;

[0052] The control area is provided with a fourth antibody against the fluorescently labeled first antibody and a fifth antibody against the fluorescently labeled monoclonal second antibody.

[0053] By adopting the preferred solution, the specific structural features of the test strip can be optimized, and the novel coronavirus antigens in the sample can be quantitatively detected by comparing the intensities of the second fluorescent label excited to emit fluorescence in the detection area and the intensities of the first fluorescent label excited to emit fluorescence in the control area; and the intensities of the first fluorescent label and the second fluorescent label excited to emit fluorescence in the control area are used to determine the detection effectiveness.

[0054] As can be seen from the above preferred solutions of the specific structural features of the test strip, by using the multi-channel characteristics of the optical spectrum sensing chip, the specific structure is set, so that one or more markers required to be detected can be set according to the actual situation, and single detection or multiplex detection can be realized.

[0055] Preferably, the test cabin is located at the lower part of the shell and below the light receiving unit; the sample adding area of the test cabin is a nucleic acid processing area; the test cabin includes an amplification reaction area, the amplification reaction area is provided with a transparent reaction cabin, the reaction cabin is communicated with the sample adding area; and the reaction reagent is arranged in the reaction cabin. After the sample is added to the sample adding area, the sample enters the test cabin for temperature control amplification reaction.

[0056] More preferably, the amplification product obtained after the amplification reaction by the reaction reagent emits detection fluorescence and control fluorescence with different wavelength characteristics under the irradiation of the excitation light source in the reaction chamber; the detection fluorescence and the control fluorescence are respectively within the recognition and detection spectral range of the light receiving unit.

[0057] More preferably, the optical spectrum sensing chip has at least two wavelength channels, the light receiving unit has a light receiving area array composed of at least two light receiving areas, the reaction chamber has a marking area array composed of at least two marking areas, the marking areas and the light receiving areas correspond to the wavelength channels one by one; the marking areas are respectively provided with a binding substance capable of specifically binding to the amplification product, the binding substance includes but is not limited to nucleic acid fragments, peptide segments, biotin, and each marking area binds to at least one amplification product; the amplification product includes a detection product or a control product; the detection product and the control product each have at least one fluorescent label, each fluorescent label is excited to emit fluorescence with different wavelength characteristics, and is within the recognition and detection spectral range of the light receiving unit.

[0058] More preferably, the light shielding member includes an upper shielding member arranged on the upper part of the housing and located between the light receiving unit and the excitation light source; the reaction chamber is a transparent real-time fluorescent PCR temperature control reaction chamber or a transparent fluorescent isothermal amplification temperature control reaction chamber.

[0059] After the above preferred scheme is adopted, the specific structural features of the detection device when the test chamber is used can be further optimized. When the light receiving area array and the marking area array are used, the real-time fluorescent PCR detection or real-time isothermal amplification detection of multiple detection products and control products can be better performed, so that multiple markers required for detection can be set according to actual conditions.

[0060] The application also provides:

[0061] A control method of an intelligent disposable detection system, characterized in that the intelligent disposable detection system is used, and the control method comprises:

[0062] In the first step, the identity authentication module of the intelligent mobile terminal determines whether the current user has been real-name authenticated through identity recognition, and if not, performs real-name authentication on the current user, and if yes, records the identity information of the current user;

[0063] In the second step, the detection device control module of the intelligent mobile terminal determines whether the detection device is connected with the intelligent mobile terminal, and if yes, identifies and records the unique identification code of the optical spectrum sensing chip;

[0064] Third step, the detection device control module of the intelligent mobile terminal issues a start self-checking instruction to the spectrum sensing chip; the detection data processing module of the intelligent mobile terminal judges whether the current detection device has been used according to the detection data sent by the spectrum sensing chip, if yes, prompts to replace the unused detection device and returns to the first step or the second step, if not, prompts that the self-checking is passed and prompts the user to add a sample;

[0065] Fourth step, the detection device control module of the intelligent mobile terminal issues a start detection instruction to the spectrum sensing chip; the detection data processing module of the intelligent mobile terminal processes the detection data sent by the spectrum sensing chip into detection result data;

[0066] Fifth step, the data binding module of the intelligent mobile terminal binds the detection result data with the unique identification code and the current user identity information and generates upload data;

[0067] Sixth step, the data upload module of the intelligent mobile terminal uploads the upload data to the cloud server.

[0068] The control method realizes the full-closed loop and automatic completion through a series of processes such as identity recognition and real-name authentication, obtaining a unique identification code, detection device self-checking, detection after sample addition, data processing to obtain a result, binding of result data with identity information and unique identification code and uploading, and has sufficient identity traceability and detection result authenticity proof strength.

[0069] The further improved technical solutions of the present application are as follows:

[0070] Preferably, in the first step, the identity recognition includes fingerprint recognition and / or face recognition.

[0071] Preferably, in the detection device, a test strip is adopted, the test strip is a fluorescent immunoassay test strip, the test strip has a detection zone and a control zone, and the detection zone and the control zone respectively contain antibodies or antigens; the excitation light source is located at the top of the shell, and the excitation light source includes a detection zone excitation light source and a control zone excitation light source; the light receiving unit is located at the top of the shell, between the detection zone excitation light source and the control zone excitation light source, and between the detection zone and the control zone of the test strip; and the test strip is located at the lower part of the shell.

[0072] After the spectrum sensing chip receives the start self-checking or detection instruction, the following steps are performed:

[0073] S1, the spectrum sensing chip turns on the detection zone excitation light source, and keeps the control zone excitation light source off; the light receiving unit receives the fluorescent light emitted by the detection zone of the test strip, and the spectrum sensing chip generates detection data of the detection zone according to the photoelectric signal of the light receiving unit;

[0074] S2, the spectrum sensing chip opens the control area of the test strip and the excitation light source, and keeps the detection area of the test strip closed; the photosensitive receiving unit receives the fluorescent light emitted by the control area of the test strip; the spectrum sensing chip generates the detection data of the control area according to the photoelectric signal of the photosensitive receiving unit;

[0075] S3, the spectrum sensing chip sends the detection data of the detection area and the control area to the intelligent mobile terminal.

[0076] Preferably, in the detection device, a test strip is used, the test strip is a fluorescent immunochromatography test strip, the test strip has a detection area and a control area, the detection area and the control area respectively contain an antibody or an antigen; the excitation light source is located at the top of the shell; the photosensitive receiving unit is located at the top of the shell and between the detection area and the control area of the test strip; the test strip is located at the lower part of the shell.

[0077] After receiving the start self-detection or detection instruction, the spectrum sensing chip performs the following steps:

[0078] S1, the spectrum sensing chip opens the excitation light source; the photosensitive receiving unit respectively receives the fluorescent light emitted by the detection area and the control area of the test strip; the spectrum sensing chip generates the detection data according to the photoelectric signal of the photosensitive receiving unit.

[0079] S2, the spectrum sensing chip sends the detection data to the intelligent mobile terminal.

[0080] Preferably, in the detection device, a test cabin is used, the test cabin includes an amplification reaction area, the amplification reaction area is provided with a transparent reaction cabin; the test cabin is provided with a reaction reagent; the excitation light source is located at the top of the shell; the photosensitive receiving unit is located at the top of the shell; the test cabin is located at the lower part of the shell and below the photosensitive receiving unit.

[0081] After receiving the start self-detection or detection instruction, the spectrum sensing chip performs the following steps:

[0082] S1, the spectrum sensing chip opens the excitation light source; the photosensitive receiving unit receives the fluorescent light emitted by the test cabin, the fluorescent light includes detection fluorescent light and control fluorescent light with different wavelength characteristics; the spectrum sensing chip generates the detection data according to the photoelectric signal of the photosensitive receiving unit.

[0083] S2, the spectrum sensing chip sends the detection data to the intelligent mobile terminal.

[0084] After the above preferred scheme is used, the specific details of the control method can be further optimized.

[0085] Compared with the prior art, the application can be used for self-detection, and is closed-loop in the whole detection process without manual intervention, and has sufficient identity traceability and detection result authenticity proof strength. BRIEF DESCRIPTION OF DRAWINGS

[0086] Figure 1 It is a schematic diagram of the overall structure of embodiment 1 of the application.

[0087] Figure 2 It is a schematic diagram of the overall structure of the disposable detection device of embodiment 1 of the application.

[0088] Figure 3 It is a schematic diagram of the cross section of the disposable detection device of embodiment 1 of the application.

[0089] Figure 4 It is an exploded structural diagram of the disposable detection device of embodiment 1 of the application. The arrow in the diagram is the chromatography direction.

[0090] Figure 5 It is a schematic diagram of the third and fourth shielding members of embodiment 1 of the application.

[0091] Figure 6 It is a schematic diagram of the cross section of the disposable detection device of embodiment 2 of the application.

[0092] Figure 7 It is a schematic diagram of the overall structure of embodiment 3 of the application.

[0093] Figure 8 It is a schematic diagram of the cross section of the disposable detection device of embodiment 3 of the application.

[0094] Figure 9 It is an exploded structural diagram of the disposable detection device of embodiment 3 of the application. The arrow in the diagram is the nucleic acid movement direction.

[0095] Figure 10 It is an exploded structural diagram of a specific implementation example of the disposable detection device of embodiment 3 of the application. The arrow in the diagram is the nucleic acid movement direction. DETAILED DESCRIPTION

[0096] The application will be further described in detail below with reference to the accompanying drawings and in conjunction with the embodiments. However, the application is not limited to the examples given.

[0097] Embodiment 1

[0098] As Figures 1 to 4As shown, the intelligent one-time detection system of the embodiment includes an intelligent mobile terminal and a one-time detection device, and the detection device is connected with the intelligent mobile terminal through a plug-in connecting cable; the detection device includes a shell 01 and a spectrum sensing chip, and the spectrum sensing chip has a unique identification code; a test strip 02 is arranged in the shell 01, the test strip 02 has a sample adding area 03, and the shell 01 is provided with a sample adding hole 04 corresponding to the sample adding area 03; the spectrum sensing chip has a light receiving unit; the light receiving unit faces the inside of the shell 01 and is used to receive light in the shell 01; an excitation light source is arranged in the shell 01, and a controlled end of the excitation light source is connected with a control end of the spectrum sensing chip; a data output end of the spectrum sensing chip is connected with the intelligent mobile terminal through the connecting cable; the spectrum sensing chip and the excitation light source are powered by the intelligent mobile terminal.

[0099] The intelligent mobile terminal has: an identity authentication module, which is used to perform real-name authentication on the identity of a user and identity recognition on a current user; a detection device control module, which is used to confirm whether the detection device is connected with the intelligent mobile terminal, identify and record the unique identification code of the spectrum sensing chip, and issue a start self-checking or detection instruction to the spectrum sensing chip; a detection data processing module, which is used to receive detection data sent by the spectrum sensing chip, judge whether the self-checking of the detection device is normal according to the detection data, and process the detection data into detection result data; a data binding module, which is used to bind the detection result data, the unique identification code and the identity information of the current user and generate upload data; and a data upload module, which is used to upload the upload data to a cloud server.

[0100] Specifically, the test strip is located at the lower part of the shell; the test strip is a fluorescent immunoassay test strip, and the test strip has a sample adding area, a detection area and a control area, and the detection area and the control area respectively contain antibodies or antigens; the detection area and the control area respectively emit fluorescence under the irradiation of the excitation light source after reaction, and the fluorescence is within the recognition and detection spectrum range of the light receiving unit. The excitation light source is located at the top of the shell; the excitation light source includes a detection area excitation light source 121 and a control area excitation light source 122. The excitation light source adopts a single-wavelength LED lamp. A light shielding member is arranged in the shell to cut off the interference light.

[0101] The light receiving unit is located at the top of the shell, between the detection area excitation light source 121 and the control area excitation light source 122, and between the detection area and the control area of the test strip.

[0102] The light shielding member includes a first upper shielding member 131 and a second upper shielding member 132 respectively arranged on the upper part of the housing; the first upper shielding member 131 is located between the detection area excitation light source 121 and the light receiving unit, and is used to shield the light directly irradiated from the detection area excitation light source 121 to the test strip control area; the second upper shielding member 132 is located between the light receiving unit and the control area excitation light source 122, and is used to shield the light directly irradiated from the control area excitation light source 122 to the test strip detection area.

[0103] The detection area includes a first detection area 211 and a second detection area 212, and the control area includes a first control area 213 and a second control area 214; the first detection area 211, the second detection area 212, the first control area 213 and the second control area 214 are arranged in order along the chromatographic flow direction.

[0104] The light receiving unit includes a first light receiving area 110a and a second light receiving area 110b; the first light receiving area 110a and the second light receiving area 110b are located between the second detection area 212 and the first control area 213; the first light receiving area 110a is located between the first upper shielding member 131 and the second light receiving area 110b; and the second light receiving area 110b is located between the first light receiving area 110a and the second upper shielding member 132.

[0105] The light shielding member includes a third middle shielding member 133 and a fourth middle shielding member 134 respectively arranged in the middle part of the housing and located below the light receiving unit; the third middle shielding member 133 is used to shield the fluorescent light emitted from the first detection area 211 to the second light receiving area 110b, and to shield the fluorescent light emitted from the second detection area 212 to the first light receiving area 110a; and the fourth middle shielding member 134 is used to shield the fluorescent light emitted from the first control area 213 to the second light receiving area 110b, and to shield the fluorescent light emitted from the second control area 214 to the first light receiving area 110a.

[0106] Among them, the cross-sectional shape of the third middle shielding member 133 and the fourth middle shielding member 134 is as shown in the following figure: Figure 5

[0107] ​The third middle shielding member 133 has a cross section including at least one line segment (i.e. the line segment A1B1 in the figure) that shields both the fluorescent light emitted by the first detection area 211 toward the second light-sensing area 110b and the fluorescent light emitted by the second detection area 212 toward the first light-sensing area 110a. The upper edge or upper end of the cross section of the third middle shielding member 133 leaves or forms a light path for the first detection area 211 to the first light-sensing area 110a, a light path for the first control area 213 to the first light-sensing area 110a, and a light path for the second detection area 212 to the second light-sensing area 110b, between the first light-sensing area 110a or the second light-sensing area 110b. The lower edge or lower end of the cross section of the third middle shielding member 133 leaves or forms a light path for the detection area excitation light source to the first detection area 211 and a light path for the detection area excitation light source to the second detection area 212, between the first detection area 211 or the second detection area 212. In the embodiment, the upper edge or upper end of the cross section of the third middle shielding member 133 is located in the shadow range above the line segment A1B1, and the lower edge or lower end of the cross section of the third middle shielding member 133 is located in the shadow range below the line segment A1B1, which can meet the above conditions.

[0108] The fourth middle shielding member 134 has a cross section including at least one line segment (i.e. the line segment A2B2 in the figure) that shields both the fluorescent light emitted by the first control area 213 toward the second light-sensing area 110b and the fluorescent light emitted by the second control area 214 toward the first light-sensing area 110a. The upper edge or upper end of the cross section of the fourth middle shielding member 134 leaves or forms a light path for the first control area 213 to the first light-sensing area 110a, a light path for the second control area 214 to the second light-sensing area 110b, and a light path for the second detection area 212 to the second light-sensing area 110b, between the first light-sensing area 110a or the second light-sensing area 110b. The lower edge or lower end of the cross section of the fourth middle shielding member 134 leaves or forms a light path for the control area excitation light source to the first control area 213 and a light path for the control area excitation light source to the second control area 214, between the first control area 213 or the second control area 214. In the embodiment, the upper edge or upper end of the cross section of the fourth middle shielding member 134 is located in the shadow range above the line segment A2B2, and the lower edge or lower end of the cross section of the fourth middle shielding member 134 is located in the shadow range below the line segment A2B2, which can meet the above conditions.

[0109] The light shielding member includes a fifth lower shielding member 221 arranged at the lower part of the housing. The fifth lower shielding member 221 is located between the first light-sensing area 110a and the second light-sensing area 110b and between the second detection area 212 and the first control area 213, and is used to shield the fluorescent light emitted by the first detection area 211 and the second detection area 212 toward the second upper shielding member 132, and to shield the fluorescent light emitted by the first control area 213 and the second control area 214 toward the first upper shielding member 131.

[0110] The control method of the intelligent one-time detection system comprises the following steps:

[0111] In the first step, the identity authentication module of the intelligent mobile terminal determines whether the current user has completed real-name authentication through identity recognition. If not, the current user is prompted to complete real-name authentication. If yes, the identity information of the current user is recorded.

[0112] In the second step, the detection device control module of the intelligent mobile terminal determines whether the detection device is connected to the intelligent mobile terminal. If yes, the unique identification code of the spectrum sensing chip is identified and recorded.

[0113] In the third step, the detection device control module of the intelligent mobile terminal sends a start self-checking instruction to the spectrum sensing chip. The detection data processing module of the intelligent mobile terminal determines whether the current detection device has been used according to the detection data sent by the spectrum sensing chip. If yes, the user is prompted to replace the unused detection device and return to the first step or the second step. If no, the user is prompted to add a sample.

[0114] In the fourth step, the detection device control module of the intelligent mobile terminal sends a start detection instruction to the spectrum sensing chip. The detection data processing module of the intelligent mobile terminal processes the detection data sent by the spectrum sensing chip into detection result data.

[0115] In the fifth step, the data binding module of the intelligent mobile terminal binds the detection result data, the unique identification code, and the current user's identity information, and generates upload data.

[0116] In the sixth step, the data upload module of the intelligent mobile terminal uploads the upload data to the cloud server.

[0117] In the first step, the identity recognition includes fingerprint recognition and / or face recognition.

[0118] After receiving the start self-checking or detection instruction, the spectrum sensing chip performs the following steps:

[0119] S1, the spectrum sensing chip turns on the detection zone excitation light source 121 and keeps the control zone excitation light source 122 off. The photosensitive receiving unit receives the fluorescent light emitted by the test strip under excitation. The spectrum sensing chip generates detection data of the detection zone according to the photoelectric signal processing of the photosensitive receiving unit.

[0120] S2, the spectrum sensing chip turns on the control zone excitation light source 122 and keeps the detection zone excitation light source 121 off. The photosensitive receiving unit receives the fluorescent light emitted by the test strip under excitation. The spectrum sensing chip generates detection data of the control zone according to the photoelectric signal processing of the photosensitive receiving unit.

[0121] S3, the spectrum sensing chip sends the detection data of the detection zone and the control zone to the intelligent mobile terminal.

[0122] Example 2

[0123] The intelligent disposable detection system in this embodiment has the same basic structure as that in Embodiment 1, except that:

[0124] like Figure 6 As shown, there is one excitation light source, one detection area, and one control area. The light-shielding component includes a first shielding member 131 and a second shielding member 132. The photosensitive receiving unit is located between the detection area 211 and the control area 213. The photosensitive receiving unit includes a first photosensitive area 110a and a second photosensitive area 110b. The first shielding member 131 is located on the upper part of the housing and between the excitation light source 121 and the first photosensitive area 110a. The first photosensitive area 110a is located between the first shielding member 131 and the second photosensitive area 110b. The second shielding member 132 is located on the upper or middle part of the housing and between the first photosensitive area 110a and the second photosensitive area 110b, and is used to block the fluorescent light emitted from the detection area 211 to the second photosensitive area 110b, and to block the fluorescent light emitted from the control area 213 to the first photosensitive area 110a.

[0125] The control method of the intelligent disposable detection system in this embodiment is basically the same as that in embodiment 1, except that:

[0126] After receiving a start self-test or detection command, the spectral sensor chip will proceed as follows:

[0127] S1. The spectral sensing chip turns on the excitation light source 121; the photosensitive receiving unit receives the fluorescent light emitted by the detection area 211 and control area 213 of the test strip respectively; the spectral sensing chip generates detection data based on the photoelectric signal processing of the photosensitive receiving unit.

[0128] S2, the spectral sensing chip sends the detection data to the smart mobile terminal.

[0129] Example 3

[0130] like Figures 7 to 9 As shown, the intelligent disposable detection system in this embodiment has the same basic structure as that in Embodiment 1, except that:

[0131] The housing of the detection device is provided with a test cabin 10; the test cabin 10 has a sample adding area 03 (i.e. a nucleic acid processing area). The test cabin 10 is located at the lower part of the housing and below the light receiving unit 110; the test cabin 10 includes an amplification reaction area 08, which is provided with a transparent reaction cabin 411, the reaction cabin 411 is in communication with the sample adding area 03, and the reaction cabin 411 is a transparent real-time fluorescent PCR temperature control reaction cabin or a transparent fluorescent isothermal amplification temperature control reaction cabin; the reaction reagent is arranged in the reaction cabin 411. In the reaction cabin 411, the amplification product obtained after the amplification reaction of the reaction reagent emits detection fluorescence and control fluorescence with different wavelength characteristics under the irradiation of the excitation light source 321; the detection fluorescence and the control fluorescence are respectively within the recognition and detection spectral range of the light receiving unit. The light shielding member includes an upper shielding piece 331, which is arranged at the upper part of the housing and between the light receiving unit 110 and the excitation light source 321. In this embodiment, the light receiving unit 110 can also include a first light receiving area 110a and a second light receiving area 110b. Figure 9

[0132] As a preferred specific embodiment, the spectral sensing chip has at least two wavelength channels, the light receiving unit has a light receiving area array composed of at least two light receiving areas, the reaction cabin has a marking area array composed of at least two marking areas, and the marking areas and the light receiving areas correspond to the wavelength channels one by one; the marking areas are respectively provided with a binding substance capable of specifically binding to the amplification product, and the binding substance includes but is not limited to a nucleic acid fragment, a peptide segment, and biotin; each marking area binds at least one amplification product; the amplification product includes a detection product or a control product; the detection product and the control product each have at least one fluorescent label, each fluorescent label is excited to emit fluorescence with different wavelength characteristics, and is within the recognition and detection spectral range of the light receiving unit. For example, as shown in Figure 10 the light receiving area array includes light receiving areas 110a and 110b, and the marking area array includes marking areas 411a and 411b. This example uses a light receiving area array and a marking area array to better perform real-time fluorescent PCR detection or real-time isothermal amplification detection of multiple detection products and control products, so that multiple markers required for detection can be set according to actual conditions.

[0133] This embodiment can provide same-pipe detection of multiple markers.

[0134] The control method based on the intelligent disposable detection system of this embodiment is basically the same as that of embodiment 1, except that:

[0135] After receiving the start self-checking or detection instruction, the spectral sensing chip performs the following steps:

[0136] ​S1, the spectrum sensing chip starts the excitation light source 321, the photosensitive receiving unit 110 receives the fluorescent light emitted by the test cabin 10, and the fluorescent light includes detection fluorescence and control fluorescence with different wavelength characteristics, and the spectrum sensing chip generates detection data according to the photoelectric signal processing of the photosensitive receiving unit 110;

[0137] S2, the spectrum sensing chip sends the detection data to the intelligent mobile terminal.

[0138] As a specific implementation example, the intelligent disposable detection system of the above embodiments can be used for household self-testing of novel coronavirus nucleic acid or antigen.

[0139] As a specific implementation example, the above embodiments use a low-cost spectrum sensing chip (such as AMS's 11-channel AS7341), which can make the detection device suitable for one-time use and disposal, eliminating the need for maintenance equipment, and thus enabling commercialization in the household field.

[0140] As a specific implementation example, the spectrum sensing chip of each embodiment has multiple channels, which can correspond to collect different wavelength fluorescence channels respectively, and realize fluorescence intensity analysis of multiple markers in PCR reaction.

[0141] As a specific implementation example, the unique identification code of the spectrum sensing chip in the above embodiments belongs to the chip identification information that the spectrum sensing chip comes with, and has uniqueness.

[0142] As a specific implementation example, the test strip used in embodiments 1 and 2 uses the technical solution described in the invention patent “Test strip for quantitative detection of compounds and lateral flow immunochromatographic detection method” (CN107037211B) held by the applicant, to ensure accurate detection and maintain low production process quality control cost. Note: as shown in the figure, the sample addition area 03 of the test strip 02 is a sample pad, and the test strip 02 is also provided with a combination pad 06 and a water absorption pad 07. Figure 4

[0143] As a preferred specific implementation example, based on embodiment 1, by changing or detailing some specific structural features, single detection or multiple detection of novel coronavirus can be realized, for example:

[0144] ​(1) The test strip also has a sample pad, a conjugate pad, and a water absorption pad, the sample pad is located in the sample adding area; the detection area has three, which are the first detection area, the second detection area, and the third detection area; the control area has one; the sample pad, the conjugate pad, the first detection area, the second detection area, the third detection area, the control area, and the water absorption pad are sequentially arranged along the chromatographic direction; the conjugate pad is provided with a fluorescently labeled monoclonal first antibody against the novel coronavirus antigen, a fluorescently labeled monoclonal second antibody against the influenza A virus antigen, and a fluorescently labeled monoclonal third antibody against the influenza B virus antigen; the first detection area is provided with a fourth antibody against the novel coronavirus antigen, the second detection area is provided with a fifth antibody against the influenza A virus antigen, and the third detection area is provided with a sixth antibody against the influenza B virus antigen; the control area is provided with an antibody against the fluorescently labeled monoclonal first antibody, an antibody against the fluorescently labeled monoclonal second antibody, and an antibody against the fluorescently labeled monoclonal third antibody.

[0145] The present example can quantitatively detect the novel coronavirus antigen, the influenza A virus antigen, and the influenza B virus antigen in the sample by comparing the fluorescence intensity of the first detection area, the fluorescence intensity of the second detection area, the fluorescence intensity of the third detection area, and the fluorescence intensity of the control area.

[0146] (2) The test strip also has a sample pad, a conjugate pad, and a water absorption pad, the sample pad is located in the sample adding area; the detection area has one; the control area has two, which are the first control area and the second control area; the sample pad, the conjugate pad, the detection area, the first control area, the second control area, and the water absorption pad are sequentially arranged along the chromatographic direction; the conjugate pad is provided with a fluorescently labeled first antibody and a fluorescently labeled monoclonal second antibody against the novel coronavirus antigen; the detection area is provided with a third antibody against the novel coronavirus antigen; the first control area is provided with a fourth antibody against the fluorescently labeled monoclonal second antibody, and the second control area is provided with a fifth antibody against the fluorescently labeled first antibody.

[0147] The present example can quantitatively detect the novel coronavirus antigen in the sample with high precision by comparing the fluorescence intensity of the detection area and the second control area.

[0148] (3) The test strip also has a sample pad, a conjugate pad, and a water absorption pad, the sample pad is located in the sample adding area; the detection area and the control area each have one; the sample pad, the conjugate pad, the detection area, the control area, and the water absorption pad are sequentially arranged along the chromatographic direction; the conjugate pad is provided with a fluorescently labeled monoclonal first antibody against the novel coronavirus antigen; the detection area is provided with a second antibody against the novel coronavirus antigen; and the control area is provided with a third antibody against the fluorescently labeled monoclonal first antibody.

[0149] The present example can quantitatively detect the novel coronavirus antigen in the sample by comparing the fluorescence intensity of the detection area and the control area.

[0150] (4) The test strip further has a sample pad, a combination pad, and a water absorption pad, the sample pad is located in the sample adding area; there is one detection area and one control area respectively; the sample pad, the combination pad, the detection area, the control area, and the water absorption pad are sequentially arranged along the chromatographic direction; the spectral sensing chip has at least two wavelength channels; the combination pad is provided with a fluorescently labeled first antibody and a fluorescently labeled monoclonal second antibody against the novel coronavirus antigen; the fluorescently labeled first antibody has a first fluorescent label, the fluorescently labeled monoclonal second antibody has a second fluorescent label, the wavelength of the fluorescent light emitted by the first fluorescent label under excitation is different from the wavelength of the fluorescent light emitted by the second fluorescent label under excitation, and the wavelength of the fluorescent light emitted by the first fluorescent label under excitation and the wavelength of the fluorescent light emitted by the second fluorescent label under excitation respectively match the corresponding wavelength channels of the spectral sensing chip; the detection area is provided with a third antibody against the novel coronavirus antigen; and the control area is provided with a fourth antibody against the fluorescently labeled first antibody and a fifth antibody against the fluorescently labeled monoclonal second antibody.

[0151] The present example can quantitatively detect the novel coronavirus antigen in the sample by comparing the intensity of the fluorescent light emitted by the second fluorescent label under excitation in the detection area with the intensity of the fluorescent light emitted by the first fluorescent label under excitation in the control area; and the intensity of the fluorescent light emitted by the first fluorescent label and the intensity of the fluorescent light emitted by the second fluorescent label under excitation in the control area are used to determine the validity of the detection.

[0152] As a specific implementation example, the above embodiment uses an existing USB data line as the connection cable, which can not only meet the power supply demand of the intelligent mobile terminal to the detection device, but also meet the demand of command / data interaction between the two. Note: as shown in Figure 2 、 Figure 4 、 Figure 9 The plug-in port 05 for plugging in the connection cable is a USB interface.

[0153] As a specific implementation example, the above embodiment uses a disposable detection device that can only be connected to an intelligent mobile terminal to obtain power supply, and uses initial self-checking as a measure to ensure that the detection device has not been used, which can better ensure the authenticity of the detection result and the accuracy of the detection time.

[0154] As a specific implementation example, the above embodiment uses an intelligent mobile terminal to realize the functions of detection device operation control, information storage, detection data processing binding upload, power supply to the detection device, etc., which can reduce the integration of devices related to the operation of the spectral sensing chip in the disposable detection device, thereby reducing the production cost.

[0155] In addition to the above embodiments, the present application can also have other implementation manners. Any technical solution formed by equivalent replacement or equivalent transformation falls within the protection scope required by the present application.

Claims

1. An intelligent disposable detection system, comprising an intelligent mobile terminal and a disposable detection device, the detection device being connected with the intelligent mobile terminal through a plug-in connection cable; characterized in that, The detection device comprises a shell and a spectrum sensing chip, the spectrum sensing chip has a unique identification code; the shell is provided with a test strip or test cabin, the test strip or test cabin has a sample adding area, the shell is provided with a sample adding hole corresponding to the sample adding area; the spectrum sensing chip has a light receiving unit; the light receiving unit faces the shell, and is used for receiving light in the shell; the shell is provided with an excitation light source, a controlled end of the excitation light source is connected with a control end of the spectrum sensing chip; a data output end of the spectrum sensing chip is connected with a smart mobile terminal through a connecting cable; the spectrum sensing chip and the excitation light source are powered by the smart mobile terminal; The smart mobile terminal has: an identity authentication module, which is used for real-name authentication of the user's identity and identity recognition of the current user; A detection device control module is used to confirm whether the detection device is connected with the smart mobile terminal, identify and record the unique identification code of the spectrum sensing chip, and issue a start self-checking or detection instruction to the spectrum sensing chip; A detection data processing module is used to receive detection data sent by the spectrum sensing chip, judge whether the self-checking of the detection device is normal according to the detection data, and process the detection data into detection result data; A data binding module is used to bind the detection result data, the unique identification code and the current user's identity information, and generate upload data; A data upload module is used to upload the upload data to a cloud server; The excitation light source is located at the top of the shell; the light receiving unit is located at the top of the shell; the shell is provided with a light shielding member to cut off the interfering light; The test strip is located at the lower part of the shell; the test strip is a fluorescent immunoassay test strip, the test strip has a detection area and a control area, the detection area and the control area respectively contain antibodies or antigens; the detection area and the control area respectively emit fluorescence under the irradiation of the excitation light source after reaction, and the fluorescence is within the recognition and detection spectrum range of the light receiving unit; The excitation light source comprises a detection area excitation light source and a control area excitation light source; the light receiving unit is located between the detection area excitation light source and the control area excitation light source, and between the detection area and the control area of the test strip; The light shielding member comprises a first upper shielding member and a second upper shielding member arranged on the upper part of the shell; the first upper shielding member is located between the detection area excitation light source and the light receiving unit, and is used to shield the light directly irradiated from the detection area excitation light source to the control area of the test strip; the second upper shielding member is located between the light receiving unit and the control area excitation light source, and is used to shield the light directly irradiated from the control area excitation light source to the detection area of the test strip; The detection area includes a first detection area and a second detection area, and the control area includes a first control area and a second control area; the first detection area, the second detection area, the first control area and the second control area are arranged in sequence according to the chromatographic flow direction; the light-receiving unit includes a first light-receiving area and a second light-receiving area, the first light-receiving area and the second light-receiving area are located between the second detection area and the first control area, the first light-receiving area is located between the first upper shielding member and the second light-receiving area, and the second light-receiving area is located between the first light-receiving area and the second upper shielding member; The light-shielding member further includes a third middle shielding member and a fourth middle shielding member located below the light-receiving unit in the middle of the shell; the third middle shielding member is used to shield the fluorescent light emitted by the first detection area to the second light-receiving area and the fluorescent light emitted by the second detection area to the first light-receiving area; the fourth middle shielding member is used to shield the fluorescent light emitted by the first control area to the second light-receiving area and the fluorescent light emitted by the second control area to the first light-receiving area; The cross section of the third middle shielding member includes at least one line segment that shields both the fluorescent light emitted by the first detection area to the second light-receiving area and the fluorescent light emitted by the second detection area to the first light-receiving area; the upper edge or upper end of the cross section of the third middle shielding member leaves or forms a light path of the first detection area to the first light-receiving area, a light path of the first control area to the first light-receiving area and a light path of the second detection area to the second light-receiving area between the first light-receiving area or the second light-receiving area; the lower edge or lower end of the cross section of the third middle shielding member leaves or forms a light path of the detection area excitation light source to the first detection area and a light path of the detection area excitation light source to the second detection area between the first detection area or the second detection area; The cross section of the fourth middle shielding member includes at least one line segment that shields both the fluorescent light emitted by the first control area to the second light-receiving area and the fluorescent light emitted by the second control area to the first light-receiving area; the upper edge or upper end of the cross section of the fourth middle shielding member leaves or forms a light path of the first control area to the first light-receiving area, a light path of the second control area to the second light-receiving area and a light path of the second detection area to the second light-receiving area between the first light-receiving area or the second light-receiving area; the lower edge or lower end of the cross section of the fourth middle shielding member leaves or forms a light path of the control area excitation light source to the first control area and a light path of the control area excitation light source to the second control area between the first control area or the second control area.

2. The intelligent disposable test system of claim 1, wherein, The excitation light source adopts a single-wavelength LED lamp.

3. The intelligent disposable test system of claim 1, wherein, The light-shielding member includes a fifth lower shielding member arranged in the lower part of the shell, the fifth lower shielding member is located between the first light-receiving area and the second light-receiving area and between the second detection area and the first control area, and is used to shield the fluorescent light emitted by the first detection area and the second detection area to the second upper shielding member and the fluorescent light emitted by the first control area and the second control area to the first upper shielding member.

4. The intelligent disposable test system of claim 1, wherein, The excitation light source, the detection area, and the control area are one in number respectively; the light shielding member comprises a first shielding piece and a second shielding piece; the photosensitive receiving unit is located between the detection area and the control area; the photosensitive receiving unit comprises a first photosensitive area and a second photosensitive area; the first shielding piece is located on the upper part of the shell and between the excitation light source and the first photosensitive area; the first photosensitive area is located between the first shielding piece and the second photosensitive area; the second shielding piece is located on the upper part or the middle part of the shell and between the first photosensitive area and the second photosensitive area, so as to shield the fluorescent light emitted by the detection area to the second photosensitive area and shield the fluorescent light emitted by the control area to the first photosensitive area.

5. The intelligent disposable test system of claim 1, wherein, The test strip further has a sample pad, a conjugate pad, and a water absorption pad, the sample pad is located in the sample adding area; the detection area has three, which are a first detection area, a second detection area, and a third detection area; the control area has one; the sample pad, the conjugate pad, the first detection area, the second detection area, the third detection area, the control area, and the water absorption pad are sequentially arranged in the chromatographic direction; The conjugate pad is provided with a fluorescently labeled monoclonal first antibody against a novel coronavirus antigen, a fluorescently labeled monoclonal second antibody against an influenza A virus antigen, and a fluorescently labeled monoclonal third antibody against an influenza B virus antigen; The first detection area is provided with a fourth antibody against a novel coronavirus antigen, the second detection area is provided with a fifth antibody against an influenza A virus antigen, and the third detection area is provided with a sixth antibody against an influenza B virus antigen; The control area is provided with an antibody against the fluorescently labeled monoclonal first antibody, an antibody against the fluorescently labeled monoclonal second antibody, and an antibody against the fluorescently labeled monoclonal third antibody.

6. The intelligent disposable test system of claim 1, wherein, The test strip further has a sample pad, a conjugate pad, and a water absorption pad, the sample pad is located in the sample adding area; the detection area has one; the control area has two, which are a first control area and a second control area; the sample pad, the conjugate pad, the detection area, the first control area, the second control area, and the water absorption pad are sequentially arranged in the chromatographic direction; The conjugate pad is provided with a fluorescently labeled first antibody and a fluorescently labeled monoclonal second antibody against a novel coronavirus antigen; The detection area is provided with a third antibody against a novel coronavirus antigen; The first control area is provided with a fourth antibody against the fluorescently labeled monoclonal second antibody, and the second control area is provided with a fifth antibody against the fluorescently labeled first antibody.

7. The intelligent disposable test system of claim 1, wherein, The test strip further has a sample pad, a conjugate pad, and a water absorption pad, the sample pad is located in the sample adding area; the detection area and the control area each have one; the sample pad, the conjugate pad, the detection area, the control area, and the water absorption pad are sequentially arranged in the chromatographic direction; The conjugate pad is provided with a fluorescently labeled monoclonal first antibody against a novel coronavirus antigen; The detection area is provided with a second antibody against a novel coronavirus antigen; The control area is provided with a third antibody against the fluorescently labeled monoclonal first antibody.

8. The intelligent disposable test system of claim 1, wherein, The test strip also has a sample pad, a combination pad, and a water absorption pad, the sample pad is located in the sample adding area; the detection area and the control area are one respectively; the sample pad, the combination pad, the detection area, the control area, and the water absorption pad are sequentially arranged along the chromatographic direction; the spectral response chip has at least two wavelength channels; The combination pad is provided with a fluorescently labeled first antibody and a fluorescently labeled monoclonal second antibody against the novel coronavirus antigen; the fluorescently labeled first antibody has a first fluorescent label, the fluorescently labeled monoclonal second antibody has a second fluorescent label, the wavelength of the fluorescently labeled first antibody excited to emit fluorescence is different from the wavelength of the fluorescently labeled second antibody excited to emit fluorescence, and the wavelength of the fluorescently labeled first antibody excited to emit fluorescence and the wavelength of the fluorescently labeled second antibody excited to emit fluorescence respectively match the corresponding wavelength channels of the spectral response chip; The detection area is provided with a third antibody against the novel coronavirus antigen; The control area is provided with a fourth antibody against the fluorescently labeled first antibody and a fifth antibody against the fluorescently labeled monoclonal second antibody.

9. The intelligent disposable test system of claim 1, wherein, The test cabin is located below the shell and below the light receiving unit; the sample adding area of the test cabin is a nucleic acid processing area; the test cabin includes an amplification reaction area, the amplification reaction area is provided with a transparent reaction cabin, the reaction cabin is communicated with the sample adding area; the reaction cabin is provided with a reaction reagent.

10. The intelligent disposable test system of claim 9, wherein, In the reaction cabin, after the amplification reaction of the reaction reagent, the amplification product obtained emits detection fluorescence and control fluorescence with different wavelength characteristics under the irradiation of the excitation light source; the detection fluorescence and the control fluorescence are respectively within the recognition and detection spectral range of the light receiving unit.

11. The intelligent disposable test system of claim 10, wherein, The spectral response chip has at least two wavelength channels, the light receiving unit has a light receiving area array composed of at least two light receiving areas, the reaction cabin has a marking area array composed of at least two marking areas, the marking areas and the light receiving areas respectively correspond to the wavelength channels one by one; the marking areas are respectively provided with a binding substance capable of specifically binding to the amplification product, the binding substance includes but is not limited to a nucleic acid fragment, a peptide segment, and biotin, and each marking area binds at least one amplification product; the amplification product includes a detection product or a control product; the detection product and the control product respectively have at least one fluorescent label, each fluorescent label is excited to emit fluorescence with different wavelength characteristics, and is within the recognition and detection spectral range of the light receiving unit.

12. The intelligent disposable test system of claim 9, wherein, The light shielding member includes an upper shielding member, the upper shielding member is arranged on the upper part of the shell and between the light receiving unit and the excitation light source; the reaction cabin is a transparent real-time fluorescent PCR temperature control reaction cabin or a transparent fluorescent isothermal amplification temperature control reaction cabin.

13. A control method of an intelligent disposable detection system, characterized in that, The control method comprises: In the first step, the identity authentication module of the intelligent mobile terminal judges whether the current user has been real-name authenticated through identity recognition, if not, the current user is real-name authenticated, if yes, the identity information of the current user is recorded; In the second step, the detection device control module of the intelligent mobile terminal judges whether the detection device is connected with the intelligent mobile terminal, if yes, the unique identification code of the spectral response chip is identified and recorded. Third step, the detection device control module of the intelligent mobile terminal issues a start self-checking instruction to the spectrum sensing chip; the detection data processing module of the intelligent mobile terminal judges whether the current detection device has been used according to the detection data sent by the spectrum sensing chip, if yes, it prompts to replace the unused detection device and returns to the first step or the second step, if not, it prompts that the self-checking is passed and prompts the user to add a sample; Fourth step, the detection device control module of the intelligent mobile terminal issues a start detection instruction to the spectrum sensing chip; the detection data processing module of the intelligent mobile terminal processes the detection data sent by the spectrum sensing chip into detection result data; Fifth step, the data binding module of the intelligent mobile terminal binds the detection result data with the unique identification code and the current user identity information and generates upload data; Sixth step, the data upload module of the intelligent mobile terminal uploads the upload data to the cloud server.

14. The control method according to claim 13, characterized by, In the first step, the identity recognition includes fingerprint recognition and / or face recognition.

15. The control method according to claim 13, characterized by, In the detection device, a test strip is used, the test strip is a fluorescent immunoassay test strip, the test strip has a detection zone and a control zone, the detection zone and the control zone respectively contain antibodies or antigens; the excitation light source is located at the top of the shell, the excitation light source includes a detection zone excitation light source and a control zone excitation light source; the light receiving unit is located at the top of the shell, between the detection zone excitation light source and the control zone excitation light source, and between the detection zone and the control zone of the test strip; the test strip is located at the lower part of the shell; After receiving the start self-checking or detection instruction, the spectrum sensing chip performs the following steps: S1, the spectrum sensing chip turns on the detection zone excitation light source, and keeps the control zone excitation light source off; the light receiving unit receives the fluorescent light emitted by the detection zone of the test strip under excitation, and the spectrum sensing chip generates detection data of the detection zone according to the photoelectric signal of the light receiving unit; S2, the spectrum sensing chip turns on the control zone excitation light source, and keeps the detection zone excitation light source off; the light receiving unit receives the fluorescent light emitted by the control zone of the test strip under excitation, and the spectrum sensing chip generates detection data of the control zone according to the photoelectric signal of the light receiving unit; S3, the spectrum sensing chip sends the detection data of the detection zone and the control zone to the intelligent mobile terminal.

16. The control method according to claim 13, wherein In the detection device, a test strip is used, the test strip is a fluorescent immunoassay test strip, the test strip has a detection zone and a control zone, the detection zone and the control zone respectively contain antibodies or antigens; the excitation light source is located at the top of the shell; the light receiving unit is located at the top of the shell, and between the detection zone and the control zone of the test strip; the test strip is located at the lower part of the shell; After receiving the start self-checking or detection instruction, the spectrum sensing chip performs the following steps: S1, the spectrum sensing chip turns on the excitation light source; the light receiving unit respectively receives the fluorescent light emitted by the detection zone and the control zone of the test strip under excitation, and the spectrum sensing chip generates detection data according to the photoelectric signal of the light receiving unit; S2, the spectrum sensing chip sends the detection data to the intelligent mobile terminal.

17. The control method according to claim 13, wherein In the detection device, a test cabin is used, which comprises an amplification reaction area provided with a transparent reaction cabin; reaction reagents are arranged in the test cabin; the excitation light source is located at the top of the shell; the light receiving unit is located at the top of the shell; the test cabin is located at the lower part of the shell and below the light receiving unit; After receiving the start self-checking or detection instruction, the spectrum sensing chip performs the following steps: S1, the spectrum sensing chip starts the excitation light source, and the light receiving unit receives the fluorescent light emitted by the test cabin under excitation, which includes detection fluorescent light and control fluorescent light with different wavelength characteristics, and the spectrum sensing chip generates detection data according to the photoelectric signal of the light receiving unit; S2, the spectrum sensing chip sends the detection data to the intelligent mobile terminal.

18. Use of the intelligent disposable detection system of any one of claims 1 to 12 for preparing a detection product for household self-testing of novel coronavirus nucleic acid or antigen.

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