WO2021138900A1 - Système de détection en temps réel de bandelette réactive d'immunochromatographie de fluorescence - Google Patents

Système de détection en temps réel de bandelette réactive d'immunochromatographie de fluorescence Download PDF

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Publication number
WO2021138900A1
WO2021138900A1 PCT/CN2020/071425 CN2020071425W WO2021138900A1 WO 2021138900 A1 WO2021138900 A1 WO 2021138900A1 CN 2020071425 W CN2020071425 W CN 2020071425W WO 2021138900 A1 WO2021138900 A1 WO 2021138900A1
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Prior art keywords
fluorescent
test strip
area
fluorescent area
element signal
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PCT/CN2020/071425
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English (en)
Chinese (zh)
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吴勇
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上海泰辉生物科技有限公司
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Priority to PCT/CN2020/071425 priority Critical patent/WO2021138900A1/fr
Publication of WO2021138900A1 publication Critical patent/WO2021138900A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01D—MEASURING NOT SPECIALLY ADAPTED FOR A SPECIFIC VARIABLE; ARRANGEMENTS FOR MEASURING TWO OR MORE VARIABLES NOT COVERED IN A SINGLE OTHER SUBCLASS; TARIFF METERING APPARATUS; MEASURING OR TESTING NOT OTHERWISE PROVIDED FOR
    • G01D21/00—Measuring or testing not otherwise provided for
    • G01D21/02—Measuring two or more variables by means not covered by a single other subclass
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64—Fluorescence; Phosphorescence
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody

Definitions

  • the present disclosure relates to the technical field of in vitro diagnosis of medical devices, and in particular to a real-time detection system and a real-time detection method for fluorescent immunochromatographic test strips.
  • Real-time testing refers to the use of portable instruments by non-professional testing personnel to quickly diagnose and analyze patients' specimen samples. It has the characteristics of convenient carrying, simple operation and on-site inspection. Fluorescence immunochromatography technology is one of the most important means of real-time detection. Fluorescence immunochromatography technology quantitatively detects the markers on the test strip by detecting the excited fluorescence on the test strip.
  • fluorescence immunochromatography technology fixes specific antibodies on a certain zone (such as T-line and C-line) of the nitrocellulose membrane.
  • a certain zone such as T-line and C-line
  • the antigenic substance to be detected in the sample and its fluorescent combination with the fluorescent probe will act on the nitric acid made from the strip fiber by means of capillary action. Migration on the cellulose membrane.
  • the fluorescent conjugate of the antigen substance to be detected binds to the specific antibody on the above-mentioned zone, and a specific immune reaction occurs. Therefore, the zone displays a certain color or emits a certain intensity of fluorescence under excitation light, thereby realizing qualitative or quantitative specific immunodiagnosis.
  • the detection instruments used for fluorescence immunochromatography technology mainly include scanning-type detectors and imaging-type detectors.
  • the scanning detector is composed of an optical module and a mechanical scanning structure.
  • the excitation diode of the optical module excites the fluorescent probe on the test strip, and the fluorescence generated by the excitation of the fluorescent probe is collected by the photodiode and other detectors.
  • the detector can only detect the local fluorescence of the test strip at a time, so it is necessary to use the transmission mechanism to drive the optical module or the test strip tray to perform "scanning" detection of the entire test strip. After more than ten seconds, the fluorescence curve is obtained and the sample is calculated. content. Scanning detectors are simple to operate, but the measurement speed is slow, and the measured sample content has a large deviation from the actual value.
  • the imaging detector uses a fluorescent imaging camera to take a snapshot of the test strip and then process the image.
  • the imaging detector has high requirements on the hardware performance of the operating host, imaging camera and light-emitting diode light source, and has the characteristics of large individual, complicated specimen identification, complicated operation, and professional operation. This type of instrument is mostly used in laboratory occasions and is rarely seen in daily clinical examination occasions.
  • the image "noise reduction" algorithm of imaging detectors generally uses the grayscale signal of a black-and-white camera or the luminous intensity value of a certain single-color signal of a color camera to subtract a uniform "baseline" value. Such processing is easy to lose weak signal information, and the detection of weak signal information determines the sensitivity of the system.
  • One of the objectives of the present disclosure is to provide an instant detection system for fluorescence immunochromatographic test strips that can overcome at least one defect in the prior art.
  • test strip has a fluorescent area containing fluorescent probes and a non-fluorescent area not containing fluorescent probes, wherein:
  • the instant detection system for fluorescence immunochromatographic test strips includes an information collection device and a computing device that are separated from each other;
  • the information collection device includes a collection component and a first communication component, the collection component sends excitation light to the test strip, and collects the luminescence information of the fluorescent area and the non-fluorescence area of the test strip, and the first communication component connects The collected luminescence information of the fluorescent area of the test strip and the luminescence information of the non-fluorescent area are sent to the computing device;
  • the computing device includes a control module, a storage module, a second communication module, and an output module.
  • the storage module stores the fluorescent probe luminescence intensity-fluorescence probe concentration calibration curve of the test strip, and the second communication module communicates with the first communication module.
  • the components are connected to each other wirelessly or wiredly,
  • the control module obtains the luminescence information of the fluorescent area and the luminescence information of the non-fluorescent area of the test strip through the communication between the first communication component and the second communication module, and uses the luminescence information of the non-fluorescent area to compare the luminescence information of the fluorescent area. Perform noise reduction algorithm processing to obtain the luminous intensity value of the fluorescent probe in the fluorescent area; the control module retrieves the preset fluorescent probe luminous intensity-fluorescent probe concentration calibration curve from the storage module, and passes the fluorescent probe in the fluorescent area. The luminescence intensity value is fitted to obtain the fluorescent probe concentration value in the fluorescent area, and the fluorescent probe concentration value in the fluorescent area is output through the output module.
  • the luminescence information of the fluorescent area includes the total luminous intensity of the first single-color element signal in the fluorescent area and the second single-color element signal in the fluorescent area
  • the total luminous intensity of the non-fluorescent area and the luminous information of the non-fluorescent area includes the total luminous intensity of the first single-color element signal in the non-fluorescent area and the total luminous intensity of the second single-color element signal in the non-fluorescent area.
  • the fluorescent probe in the fluorescent area emits The fluorescence of is the first single-color element signal, and the first single-color element signal is different from the second single-color element signal.
  • R is the luminescence intensity of the fluorescent probe in the fluorescent region
  • Rt is the total luminous intensity of the first single-color element signal in the fluorescent area
  • Gy is the total luminous intensity of the second single-color element signal in the fluorescent area
  • Rf is the total luminous intensity of the first single-color element signal in the non-fluorescent region
  • Gf is the total luminous intensity of the second single-color element signal in the non-fluorescent region.
  • the acquisition component includes a light source, a filter, and a camera
  • the light source is configured to send excitation light to the test strip
  • the camera It is configured to take color photos of the fluorescent area and the non-fluorescent area of the test strip through the filter.
  • test strip is placed opposite to the camera and the filter, and the light source is set to deviate from the camera and the filter, and between the test strips Paths opposite to each other.
  • the incubation component includes a heater, a refrigerator, a temperature controller, and a temperature sensor, and the heater, the refrigerator, and the temperature sensor are arranged in close proximity to the test strip.
  • the temperature controller is configured to control the heater and/or the refrigerator to heat and/or cool the test strip according to the temperature of the test strip measured by the temperature sensor.
  • the information collection device includes an upper casing and a lower casing, and the upper casing and the lower casing cooperate to A light-proof cavity is formed inside.
  • the support frame includes a plurality of compartments configured to support a plurality of parts of the information collection device.
  • the information collection device includes a test strip receiving slot
  • the test strip receiving slot is fixed to the upper shell or the lower shell, and in the corresponding The shell has an opening to receive the inserted test strip.
  • the computing device is a mobile terminal installed with a detection program, or a part of the computing device is installed in a device with a detection program installed.
  • the other part of the mobile terminal is set in a server connected to the mobile terminal.
  • test strip includes a card shell and a nitrocellulose membrane arranged in the card shell, and the test strip has an axial direction
  • the sample loading port and the display port are spaced apart.
  • the display port includes the T line and C line for testing exposed in the display port area and the blank nitrocellulose membrane except the T line and C line.
  • a real-time detection method for test strips using a fluorescence immunochromatographic test strip real-time detection system wherein the method includes the following steps:
  • the information collection device sends excitation light to the fluorescent area containing the fluorescent probe and the non-fluorescent area not containing the fluorescent probe of the test strip, and collects the luminescence information of the fluorescent area and the non-fluorescent area of the test strip;
  • the computing device obtains the luminescence information of the fluorescent area and the luminescence information of the non-fluorescent area of the test strip through the wireless or wired connection between the information collection device and the computing device, and uses the luminescence information of the non-fluorescent area to illuminate the fluorescent area
  • the information is processed by noise reduction algorithm to obtain the luminous intensity value of the fluorescent probe in the fluorescent area;
  • the calculation device is based on a preset calibration curve of fluorescence probe luminescence intensity-fluorescence probe concentration, and obtains the fluorescence probe concentration value in the fluorescence area through the luminescence intensity value of the fluorescence probe in the fluorescence area, and calculates the concentration value of the fluorescence probe in the fluorescence area Output.
  • the luminescence intensity value of the fluorescent probe in the fluorescent area is used to obtain the fluorescent probe concentration value in the fluorescent area, and the fluorescent probe concentration value in the fluorescent area is output.
  • the luminescence information of the fluorescent area includes the total luminous intensity of the first single-color element signal of the fluorescent area and the total luminous intensity of the second single-color element signal of the fluorescent area, and is non-fluorescent
  • the luminescence information of the area includes the total luminous intensity of the first single-color element signal in the non-fluorescent area and the total luminous intensity of the second single-color element signal in the non-fluorescent area.
  • the fluorescence emitted by the fluorescent probe in the fluorescent area is the first single-color element. Signal, and the first single-color element signal is different from the second single-color element signal.
  • the first single-color element signal and the second single-color element signal are any one of a red element signal, a blue element signal, and a green element signal.
  • R is the luminous intensity emitted by the fluorescent probe in the fluorescent area
  • Rt is the total luminous intensity of the first single-color element signal in the fluorescent area
  • Gy is the total luminous intensity of the second single-color element signal in the fluorescent area
  • Rf is the total luminous intensity of the first single-color element signal in the non-fluorescent region
  • Gf is the total luminous intensity of the second single-color element signal in the non-fluorescent region.
  • a computing device wherein the computing device includes:
  • One or more processors are One or more processors.
  • One or more storage modules configured to store a series of computer-executable instructions and computer-accessible data associated with the series of computer-executable instructions
  • the one or more processors are caused to perform the method according to any one of clauses 29-33.
  • a non-transitory computer-readable storage medium wherein a series of computer-executable instructions are stored on the non-transitory computer-readable storage medium.
  • the one or more computing devices are caused to perform the method described in any one of clauses 29-33.
  • Fig. 1 shows a schematic diagram of an instant detection system for a fluorescence immunochromatographic test strip according to an embodiment of the present disclosure
  • FIG. 2 shows a front view of a test strip to be detected by the fluorescence immunochromatography test strip instant detection system of FIG. 1;
  • FIG. 3 and 4 show an exploded perspective view and an assembled perspective view of the information acquisition device of the instant detection system for the fluorescence immunochromatographic test strip of Figure 1;
  • Fig. 5 shows a flow chart of the detection method of the instant detection system for the fluorescence immunochromatographic test strip of Fig. 1.
  • an element when an element is referred to as being “on”, “attached” to another element, “connected” to another element, “coupled” to another element, or “contacting” another element, etc., The element may be directly on another element, attached to another element, connected to another element, coupled to another element, or contacting another element, or an intermediate element may be present. In contrast, it is said that an element is “directly on” another element, “directly attached” to another element, “directly connected” to another element, “directly coupled” to another element, or, or “ When directly contacting another element, there will be no intermediate element.
  • a feature when a feature is arranged “adjacent” to another feature, it may mean that a feature has a portion overlapping with an adjacent feature or a portion located above or below the adjacent feature.
  • the system described in this specification can also utilize one or more control modules to receive information and transform the received information to generate output.
  • the control module may include any type of computing device, computing circuit, or any type of processor or processing circuit capable of executing a series of instructions stored in the storage module.
  • the control module may include multiple processors and/or a multi-core central processing unit (CPU) and may include any type of processor, such as a microprocessor, a digital signal processor, a micro-control module, and so on.
  • the control module may also include a storage module to store data and/or algorithms to execute a series of instructions.
  • Programming language and “computer program” are any language used to assign instructions to a computer, and include (but are not limited to) these languages and their derivatives: assembly language, Basic, batch files, BCPL, C, C+ , C++, Delphi, Fortran, Java, JavaScript, machine code, operating system command language, Pascal, Perl, PL1, scripting language, Visual Basic, the metalanguage of its own designated program, and the first, second, and third generation 1st, 4th and 5th generation computer languages. Also included are databases and other data schemas, as well as any other metalanguage.
  • the term "storage module” may include a mechanism for providing (eg, storing and/or transmitting) information in a format readable by a machine such as a processor, computer, or digital processing device.
  • the storage module may include a read-only storage module (ROM), a random access storage module (RAM), a magnetic disk storage medium, an optical storage medium, a flash memory device, or any other volatile or non-volatile storage device.
  • Fig. 1 shows a schematic diagram of a fluorescence immunochromatographic test strip instant detection system 1 according to an embodiment of the present disclosure.
  • the detection system 1 includes a separate information collection device 2 and a computing device 3.
  • the information collection device 2 and the computing device 3 are separated and communicate with each other in a wireless or wired manner.
  • the information collection device 2 collects various information (such as luminescence information, identification code information, etc.) from the test strip 4, and sends the collected information to the computing device 3.
  • the computing device 3 processes the received information and outputs the processing results (such as fluorescent probe concentration, sample traceability data, etc.).
  • the test strip 4 detected by the detection system 1 is the test strip after receiving the sample for testing.
  • the test strip 4 may include a card housing 41 and a nitrocellulose membrane 42 arranged in the card housing 41.
  • the test strip 4 has a sample loading port 43 and a display port 44 spaced apart in the axial direction.
  • the sample loading port 43 is used to receive a sample (such as urine, serum, etc.), and the substance to be detected and its fluorescent combination in the sample are transferred to the display port 44 through the capillary action of the nitrocellulose membrane 42.
  • the immunoreactive substance to be detected on the test strip 4 is an antigen
  • the fluorescent conjugate of the substance to be detected is produced by combining the antigen with the antibody coupled to the surface of the fluorescent probe.
  • the display port 44 includes the blank nitrocellulose membrane 421 exposed in the display port area and the T-line and C-line 45 used for testing, and an immune response occurs when the transferred substance to be detected and its fluorescent conjugate reach the T-line and C-line 45. It is fixed by coupling.
  • the test strip after the effective test, the T line and the C line 45 in the display port 44 contain fluorescent probes, and are used as the fluorescent area for the information collection device 2 to collect luminescence information.
  • the fluorescent areas in the present disclosure are the T line and the C line 45 is located. Fluorescent probes produce fluorescence during excitation by excitation light.
  • the blank nitrocellulose film 421 exposed in the display port 44 does not contain fluorescent probes or contains fewer fluorescent probes in some parts, and serves as a non-fluorescent area where the information collection device 2 collects luminescence information.
  • the non-fluorescent area may be the blank nitrocellulose membrane 421 on the side of the T-line and C-line 45 away from the loading port 43 in the display port area.
  • the blank nitrocellulose membrane 421 does not contain or contains more Fluorescent probes with less capillary action can ensure the accuracy of information collection such as background light signals.
  • the identification code 46 is provided on the card housing 41 (for example, by printing or pasting), and serves as an area where the information collection device 2 collects identification code information.
  • the identification code 46 may be located on the card housing 41 on the side of the display port 44 away from the sample loading port 43.
  • the identification code 46 may be a two-dimensional code or a barcode.
  • the information collection device 2 includes an upper housing 21 and a lower housing 22, and the upper housing 21 and the lower housing 22 cooperate to form a light-proof cavity inside.
  • the support frame 23 is located in a light-proof cavity and fixed on the lower housing 22.
  • the support frame 23 includes a plurality of compartments for supporting one or more parts in the collection assembly 24, the communication assembly 25, the incubation assembly 26, the power supply assembly 27, and/or the test strip receiving slot 28.
  • the test strip receiving slot 28 is used to receive the inserted test strip 4.
  • the incubation component 26 is used to maintain the inserted test strip 4 at a constant preset temperature.
  • the collection component 24 sends excitation light to the test strip 4, and collects various information (such as luminescence information, identification code information, etc.) of the test strip 4 during the excitation.
  • the communication component 25 sends the collected information to the computing device 3.
  • the power supply component 27 is used to supply power to the information collection device 2.
  • the collection component 24 includes a light source 241, a filter 242, and a camera 243.
  • the light source 241 is used to send excitation light to the test strip 4.
  • the filter 242 is used to filter the light scattered by the background light and excitation light irradiating the nitrocellulose film 42.
  • the camera 243 collects the luminescence information of the fluorescent area and the non-fluorescent area, and the identification code on the test strip 4 by taking color photos.
  • the test strip receiving groove 28 may be arranged to be opposite to the camera 243 and the filter 242; the light source 241 may be arranged to deviate from the camera 243 and the filter 242, and the test strip receiving groove 28 is opposite to each other. route of.
  • the light source 241, the filter 242, and the camera 243 are all placed on the support frame 23.
  • the light source 241 may be an LED lamp with a diaphragm;
  • the camera 243 may be a wide-angle digital camera, such as a CCD camera or a CMOS camera.
  • the communication component 25 sends the information collected by the collection component 24 to the computing device 3.
  • the communication component 25 may be a wireless communication device (for example, WIFI, Bluetooth, etc.) or a wired communication device (for example, through a USB port) used in conjunction with the communication module on the computing device 3.
  • the incubation component 26 maintains the test strip 4 in the test strip receiving groove 28 at a predetermined temperature (for example, 37° C.).
  • the incubation assembly 26 includes a heater 261, a refrigerator 262, a temperature controller 263 and a temperature sensor 264.
  • the heater 261, the refrigerator 262, and the temperature sensor 264 are arranged in close proximity to the test strip 4.
  • the temperature controller 263 controls the heater 261 and/or the refrigerator 262 to heat and/or cool the test strip 4 according to the temperature of the test strip 4 measured by the temperature sensor 264 to maintain the test strip 4 at a constant preset temperature.
  • the power supply component 27 is used to supply power to the collection component 24, the communication component 25, the incubation component 26, and the like.
  • the power supply component 27 may include a built-in power supply (including a charging board, a lithium battery, etc.), and/or an external power supply (for example, through a USB port).
  • the test strip receiving groove 28 is fixed to the upper casing 21 or the lower casing 22, and is opened on the corresponding casing for receiving the inserted test strip 4.
  • the length of the information collection device 2 may not be greater than 10 cm, the width may not be greater than 8 cm, and the height may not be greater than 10 cm.
  • the computing device 3 includes a control module 31, a storage module 32, an output module 33 and a communication module 34.
  • the communication module 34 is a wireless communication module or a wired communication module that cooperates with the communication component 25.
  • the control module 31 obtains light-emitting information and the like through the communication between the communication module 34 and the communication component 25.
  • the control module 31 performs noise reduction processing on the luminescence information, calculates and obtains the luminescence intensity of the fluorescent probe in the fluorescent area of the test strip 4.
  • the storage module 32 stores a calibration curve of fluorescence probe luminescence intensity-fluorescence probe concentration.
  • the control module 31 retrieves the calibration curve from the storage module 32, and obtains the fluorescent probe concentration of the test strip 4 through the obtained fluorescent probe luminescence intensity.
  • the control module 32 outputs the fluorescent probe concentration of the test strip 4 through the output module 33.
  • the computing device 3 may be a mobile terminal (such as a mobile phone, a tablet computer, etc.) installed with a detection program, or a part of the computing device 3 is installed in a mobile terminal installed with a detection program, and another part is installed in a mobile terminal with a detection program.
  • the terminal connected to the server.
  • control module 31 also obtains identification code information through the communication between the communication module 34 and the communication component 25, identifies the traceability data of the test strip 4, and stores the traceability data in the storage module 32.
  • the output module 33 can output the stored traceability data of the test strip 4.
  • the light source 241 sends excitation light to the test strip 4
  • the fluorescent probes in the fluorescent area are excited to generate fluorescence.
  • the light of the fluorescent area captured by the camera 243 includes not only the fluorescence emitted by the fluorescent probe, but also the scattered light generated by the excitation light not filtered by the filter 242 irradiating the nitrocellulose film 42 and the background light. These scattered light and background light will interfere with the detection sensitivity of fluorescent luminescence intensity, thereby affecting the measured value of the fluorescent probe concentration. Therefore, it is necessary to perform noise reduction processing on the luminescence information of the photographed fluorescent area.
  • the fluorescent probe used in the immunodetection chromatography test strip usually has a specific fluorescence emission peak, and the fluorescence emission peak covers one of the three elements of blue, green and red or two adjacent ones (such as emission Blue-green element fluorescence signal, green-red element fluorescence signal). More preferably, depending on the material design of the fluorescent probe and the choice of excitation light, the fluorescence emitted by the fluorescent probe in the fluorescent area may be any one of a red element signal, a blue element signal, and a green element signal.
  • the present disclosure sets the fluorescence emitted by the fluorescent probe in the fluorescent area as the red element signal, uses the red element signal as the main signal, and uses other color signals (such as the green element signal) different from the red element signal as the parameter. Than signal.
  • the camera 243 simultaneously collects the luminescence information of the fluorescent area and the luminescence information of the non-fluorescent area.
  • the luminescence information of the fluorescent area includes the luminescence intensity of the red element signal and the luminescence intensity of the green element information.
  • the red element signal in the luminescence information of the fluorescent area includes both the red element signal emitted by fluorescence (as set above), as well as the red element signal emitted by scattered light and background light, where the red element signal emitted by scattered light and background light is The noise signal to be eliminated from the red element signal emitted by the fluorescence.
  • the green element signal in the luminescence information of the fluorescent area only includes the green element signal emitted by the scattered light and the background light.
  • the luminescence information of the non-fluorescent area includes the luminescence intensity of the red element signal and the luminescence intensity of the green element information.
  • the red element signal in the luminescence information of the non-fluorescent area includes the red element signal from the scattered light and the background light; and the green element signal in the luminescence information of the fluorescent area includes the green element signal from the scattered light and the background light.
  • the ratio of the luminous intensity of the red element signal and the green element signal in the scattered light and the background light is fixed whether in the fluorescent area or in the non-fluorescent area. Therefore, by measuring the luminous intensity of the scattered light in the non-fluorescent area and the red element signal and the green element signal in the background light, and the luminous intensity of the scattered light in the fluorescent area and the green element signal in the background light, the scattering of the fluorescent area can be obtained.
  • the luminous intensity of the red element signal in the light and the background light that is, the luminous intensity of the noise signal.
  • the total luminous intensity of the red element signal in the luminescence information of the fluorescent area subtracts the luminous intensity of the scattered light in the fluorescent area and the red element signal in the background light to obtain the luminous intensity of the fluorescent red element signal emitted by the fluorescent probe. According to the preset calibration curve of fluorescence probe luminescence intensity-fluorescence probe concentration, the fluorescence probe concentration can be obtained.
  • the noise reduction formula is as follows:
  • Rn is the luminous intensity of the red noise signal in the fluorescent area
  • Gy is the total luminous intensity of the green element signal in the fluorescent area
  • Rf is the total luminous intensity of the red element signal in the non-fluorescent area
  • Gf is the green element signal in the non-fluorescent area
  • R is the luminescence intensity of the red element signal emitted by the fluorescent probe in the fluorescent area
  • Rt is the total luminescence intensity of the red element signal in the fluorescent area.
  • Gy ⁇ (Rf/Gf) on the right side of formula (3) can increase the correction coefficient. According to experience, the correction factor is close to 1.
  • FIG. 5 shows a flow chart of the detection method of the instant detection system 1 for fluorescence immunochromatographic test strips.
  • step S1 the test strip 4 is inserted into the test strip receiving slot 28 of the information collection device 2, and the detection command is activated in the detection program of the computing device 3.
  • step S2 the control module 31 of the computing device 3 sends a detection start command to the incubation component 26 of the information collection device 2 through the communication between the communication module 34 and the communication component 25.
  • the temperature controller 263 of the incubation component 26 controls the heater 261 and/or the refrigerator 262 to heat and/or cool the test strip 4 for 5-30 minutes according to the temperature near the test strip 4 measured by the temperature sensor 264.
  • the test strip 4 is maintained at a constant preset temperature (for example, 37°C).
  • step S3 the control module 31 of the computing device 3 sends a detection start command to the collection component 24 of the information collection device 2 through the communication between the communication module 34 and the communication component 25.
  • the light source 241 of the collection component 24 is turned on and provides excitation light for the test strip 4.
  • the camera 243 takes a color photo of the test strip 4 to collect the luminescence information of the fluorescent area and the luminescence information of the non-fluorescence area on the test strip 4, and the identification code information.
  • the color photos are converted into electrical signals by photoelectric signals, and the identification code information and light-emitting information are respectively output to the control module 31 of the computing device 3 through the communication between the communication module 34 and the communication component 25.
  • step S4 the control module 31 identifies the traceability data of the test strip 4 from the identification code information, and outputs the traceability data to the storage module 32.
  • step S5 the control module 31 processes the received luminescence information of the fluorescent area and the luminescence information of the non-fluorescent area through the noise reduction algorithm described above to obtain the luminescence intensity of the fluorescent probe in the fluorescent area.
  • the control module 31 retrieves a pre-stored calibration curve of fluorescent probe luminescence intensity-fluorescent probe concentration from the storage module 32, and fits the calibration curve to obtain the corresponding fluorescent probe concentration.
  • step S6 the output module 33 outputs the fluorescent probe concentration and/or traceability data, for example, to display on the display screen of the computing device.
  • the instant detection system for the fluorescence immunochromatographic test strip according to the embodiment of the present disclosure has fast measurement speed and relatively accurate measurement.
  • the information acquisition device of the fluorescence immunochromatographic test strip instant detection system eliminates the need for a processor and a scanning device that takes up a large space, and the device can be only the size of a palm, greatly increasing its size. Convenience.
  • the real-time detection system for fluorescence immunochromatographic test strips hand over the processing work to the processor in the mobile phone to complete.
  • Mobile phones are also terminals for future communication, network, and information processing core technologies such as 5G, big data, and artificial intelligence.
  • the use of this type of terminal is conducive to directly connecting immune detection data with these technologies.
  • the instant detection system for fluorescence immunochromatographic test strips adopts an improved noise reduction algorithm, which improves the sensitivity of system detection.

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  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)

Abstract

L'invention concerne un système de détection en temps réel de bandelette réactive d'immunochromatographie de fluorescence (1), une bandelette réactive (4) étant pourvue d'une zone de fluorescence comprenant une sonde fluorescente et une zone de non-fluorescence ne comprenant pas de sonde fluorescente. Le système de détection (1) comprend un dispositif de collecte de signal (2) et un dispositif informatique (3) séparés l'un de l'autre. Le dispositif de collecte de signal (2) comprend un composant de collecte (24) et un premier composant de communication (25). Le dispositif informatique (3) comprend : un module de commande (31), un module mémoire (32), un second module de communication (34) et un module de sortie (33). Le système de détection (1) utilise un algorithme de réduction de bruit amélioré et augmente la sensibilité de détection. Le dispositif de collecte d'informations (2) du système de détection (1) a la taille d'une paume de main seulement, augmentant ainsi son degré de commodité.
PCT/CN2020/071425 2020-01-10 2020-01-10 Système de détection en temps réel de bandelette réactive d'immunochromatographie de fluorescence WO2021138900A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050109951A1 (en) * 2001-12-27 2005-05-26 Falk Fish Novel device, system and method for fluorescence detection
CN102253015A (zh) * 2011-03-23 2011-11-23 中国科学院上海光学精密机械研究所 嵌入式免疫层析荧光检测系统及检测方法
CN103499699A (zh) * 2013-09-27 2014-01-08 南昌大学 一种结合物联网数据传输系统的荧光微球免疫层析定量检测仪
CN208818644U (zh) * 2018-07-27 2019-05-03 黄光文 一种手持智能多功能快速分析仪系统

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050109951A1 (en) * 2001-12-27 2005-05-26 Falk Fish Novel device, system and method for fluorescence detection
CN102253015A (zh) * 2011-03-23 2011-11-23 中国科学院上海光学精密机械研究所 嵌入式免疫层析荧光检测系统及检测方法
CN103499699A (zh) * 2013-09-27 2014-01-08 南昌大学 一种结合物联网数据传输系统的荧光微球免疫层析定量检测仪
CN208818644U (zh) * 2018-07-27 2019-05-03 黄光文 一种手持智能多功能快速分析仪系统

Non-Patent Citations (6)

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Title
HOU, YAFEI: "Smartphone-based Dual-modality Imaging System for Quantitative Detection of Color Or Fluorescent Lateral Flow Immunochromatographic Strips", CHINESE MASTER’S THESES FULL-TEXT DATABASE, 15 September 2019 (2019-09-15), pages 1 - 72, XP055827865 *
LI, PENGFEI: "Research on Rapid Diagnosis Method and Device Based on Smart Phone", CHINA SCIENCE PERIODICAL DATABASE OF WANFANG, 8 October 2019 (2019-10-08), pages 1 - 93, XP055827843 *
XU XIAOHAN: "Design and Algorithm Research of Fluorescence Immunoassay Strip Imaging System", CHINESE MASTER’S THESES FULL-TEXT DATABASE, 15 February 2019 (2019-02-15), pages 1 - 75, XP055827789 *
XU XIAOHAN: "Design of Imaging Detection System for Fluorescent Immune-Chromatographic Test Strip", CHINESE JOURNAL OF LASERS, vol. 45, no. 4, 30 April 2018 (2018-04-30), Oxford, UK, pages 287 - 294, XP055827870 *
XU, XIAOHAN: "Design and Algorithm Research of Fluorescence Immunoassay Strip Imaging System", CHINESE MASTER’S THESES FULL-TEXT DATABASE, 15 February 2019 (2019-02-15), pages 1 - 75, XP055827789 *
XU, XIAOHAN: "Design of Imaging Detection System for Fluorescent Immune-Chromatographic Test Strip", CHINESE JOURNAL OF LASERS, vol. 45, no. 4, 30 April 2018 (2018-04-30), pages 287 - 294, XP055827870 *

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