WO2021138902A1 - Point-of-care testing system for immunochromatographic strip - Google Patents

Point-of-care testing system for immunochromatographic strip Download PDF

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Publication number
WO2021138902A1
WO2021138902A1 PCT/CN2020/071459 CN2020071459W WO2021138902A1 WO 2021138902 A1 WO2021138902 A1 WO 2021138902A1 CN 2020071459 W CN2020071459 W CN 2020071459W WO 2021138902 A1 WO2021138902 A1 WO 2021138902A1
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WIPO (PCT)
Prior art keywords
luminescence
test strip
probe
temperature
information
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PCT/CN2020/071459
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French (fr)
Chinese (zh)
Inventor
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/CN2020/071459 priority Critical patent/WO2021138902A1/en
Publication of WO2021138902A1 publication Critical patent/WO2021138902A1/en

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558Immunoassay; 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 an instant detection system and an instant detection method for 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. Immunochromatography technology is one of the most important means of real-time detection. The immunochromatography technique detects the fluorescence or afterglow generated by excitation on the test strip, and quantitatively detects the markers on the test strip.
  • 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 luminescent combination with the luminescent probe will act on the nitric acid made from the strip fiber by means of capillary action. Migration on the cellulose membrane.
  • the luminescent conjugate of the antigen substance to be detected binds to the specific antibody on the above-mentioned zone, and a specific immune response occurs.
  • the zone displays a certain color, or emits a certain intensity of fluorescence or afterglow under the excitation of the excitation light, thereby realizing qualitative or quantitative specific immunodiagnosis.
  • the detection instruments used for 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 luminescent probe on the test strip, and the fluorescence generated by the excitation of the luminescent 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 volume, 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.
  • ambient temperature is one of the most important parameters of immune response, and the immune calibration curve at each ambient temperature is different.
  • the detector in the industry only stores the calibration curve at 37°C, which requires incubating the test environment temperature to 37°C, otherwise the concentration of the luminescent probe obtained by the test will be inaccurate.
  • the incubation unit needs to be incubated for nearly half an hour. The incubation unit additionally increases the size and weight of the detector, the operation steps, and the time for each sample measurement.
  • One of the objectives of the present disclosure is to provide an instant detection system for immunochromatographic test strips that can overcome at least one defect in the prior art.
  • a real-time detection system for immunochromatographic test strips in which:
  • the immunochromatographic test strip instant detection system includes an information collection device and a computing device that are separated from each other, the test strip includes a light-emitting area, and the test strip and/or the information collection device includes a temperature sensing pattern;
  • the information collection device includes a collection component and a first communication component.
  • the collection component sends excitation light to the test strip, collects luminescence information and temperature sensing pattern information of the light-emitting area of the test strip, and the first communication component collects Sending the luminescence information and the temperature sensing pattern information of the luminous area of the test strip to the computing device, where the luminescence information includes the luminous intensity of the luminous area of the test strip;
  • the computing device includes a control module, a storage module, a second communication module, and an output module.
  • the storage module stores the corresponding relationship between the temperature sensing pattern information and the ambient temperature, and the luminous intensity of the luminescent probe at a plurality of preset temperatures. Needle concentration calibration curve, and the second communication module and the first communication component communicate with each other in a wireless or wired manner,
  • control module obtains the light-emitting information and temperature-sensing pattern information of the light-emitting area of the test strip through the communication between the first communication component and the second communication module, and the control module retrieves the temperature-sensing pattern information and the ambient temperature from the storage module. To obtain the ambient temperature T0 around the test strip, and the control module determines whether the ambient temperature T0 is equal to one of the plurality of preset temperatures:
  • the control module retrieves the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at the ambient temperature T0 from the storage module;
  • the control module selects the preset temperature T1 and the preset temperature T2 adjacent to the ambient temperature T0, and retrieves the preset temperature from the storage module Set the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L1 at the temperature T1 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2, and the control module passes the luminescence at the preset temperature T1 Probe luminescence intensity-luminescence probe concentration calibration curve L1 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 simulates the luminescence probe luminescence intensity-luminescence probe concentration calibration at ambient temperature T0 Curve L0;
  • the control module fits and obtains the luminescence probe concentration value of the luminescence area of the test strip according to the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 under the ambient temperature T0 and the obtained luminescence information of the luminescence area of the test strip, And output the luminescence probe concentration value of the luminescence area of the test strip through the output module.
  • the control module uses the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L1 at the preset temperature T1 to obtain n at the preset temperature T1
  • the n luminescence probe luminescence intensity values corresponding to each luminescence probe concentration value are obtained by using the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 to obtain the n luminescence probes at the preset temperature T2.
  • the n luminescence probe luminescence intensity value corresponding to the needle concentration value selects the n luminescence probe concentration values at the preset temperature T1 and the corresponding n luminescence probe luminescence intensity values, and the luminescence intensity values at the preset temperature T2.
  • the concentration values of the n luminescent probes and the corresponding luminescence intensity values of the n luminescence probes are linearly interpolated to obtain the concentration values of the n luminescence probes and the corresponding luminescence intensity values of the luminescence probe at the ambient temperature T0 , Where n is an integer greater than 1.
  • control module calculates the concentration values of the n luminescent probes and the corresponding luminescence intensity values of the luminescent probes under the ambient temperature T0, by using The logit-log4p model or the Spline function of the spline curve simulates the calibration curve L0 of luminescence probe luminescence intensity-luminescence probe concentration at ambient temperature T0.
  • thermosensitive pattern is made of temperature-sensitive color-changing ink.
  • thermochromatographic test strips according to clause 4, wherein: the temperature-sensitive color-changing ink includes a cholesteric liquid crystal temperature-sensitive ink.
  • thermosensitive pattern includes a plurality of adjacent small blocks, and each small block is different due to the material ratio of the temperature-sensitive color-changing ink. Discoloration at critical temperature.
  • the luminescence information includes the luminescence intensity of the fluorescence emitted by the fluorescent probe on the test strip.
  • the luminescence information includes the luminescence intensity of the afterglow emitted by the long afterglow luminescence probe on the test strip.
  • the collection component is configured to also collect identification code information of the test strip
  • the control module recognizes the traceability data of the test strip from the identification code information.
  • the identification code is a two-dimensional code or a barcode.
  • 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 is configured Take a color photo of the test strip through the filter.
  • the information collection device includes an upper housing and a lower housing, and the upper housing and the lower housing 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 groove
  • the test strip receiving groove is fixed to the upper housing or the lower housing, 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 mobile terminal where the detection program is installed.
  • the other part of the terminal is set in a server connected to the mobile terminal.
  • test strip includes a card housing and a nitrocellulose membrane arranged in the card housing, and the card housing has axially spaced apart The sample port and the display port, and the display port is the light-emitting area.
  • a method for instant detection of test strips using an immunochromatographic test strip instant detection system wherein the method includes the following steps:
  • the information collection device sends excitation light to the test strip, and collects luminescence information and temperature sensing pattern information of the light-emitting area of the test strip, the light-emitting information including the luminous intensity of the light-emitting area of the test strip;
  • the computing device obtains the luminescence information and the temperature sensing pattern information of the luminous area of the test strip through wireless or wired communication between the information collection device and the computing device;
  • the computing device obtains the ambient temperature T0 around the test strip based on the preset corresponding relationship between the temperature sensing pattern information and the ambient temperature, and the computing device determines whether the ambient temperature T0 is equal to one of the plurality of preset temperatures:
  • the computing device retrieves the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at the ambient temperature T0;
  • the computing device selects the preset temperature T1 and the preset temperature T2 adjacent to the ambient temperature T0, and calls the preset temperature T1
  • the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L1 under the preset temperature T2 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 and the calculation device emits light through the luminescence probe at the preset temperature T1
  • the intensity-luminescence probe concentration calibration curve L1 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 simulates the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at ambient temperature T0;
  • the calculation device fits the luminescence probe concentration value of the luminescence area of the test strip according to the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at ambient temperature T0 and the obtained luminescence information of the luminescence area of the test strip, And output the luminescence probe concentration value of the luminescence area of the test strip.
  • the ambient temperature T0 around the test strip is obtained, and it is determined whether the ambient temperature T0 is equal to one of the plurality of preset temperatures:
  • the ambient temperature T0 is equal to one of the plurality of preset temperatures, call the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at the preset ambient temperature T0;
  • the ambient temperature T0 is not equal to any one of the plurality of preset temperatures
  • select the preset temperature T1 and the preset temperature T2 adjacent to the ambient temperature T0 and call the preset temperature T1 Luminescence probe luminescence intensity-luminescence probe concentration calibration curve L1, and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2, through the luminescence probe luminescence intensity-luminescence probe luminescence intensity at the preset temperature T1
  • the needle concentration calibration curve L1 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 simulate the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at ambient temperature T0;
  • the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at ambient temperature T0 and the obtained luminescence information of the luminescence area of the test strip the luminescence probe concentration value of the luminescence area of the test strip is fitted, and the The concentration value of the luminescence probe in the luminescence area of the test strip is output.
  • Luminescence intensity values of the luminescence probes using the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 to obtain n luminescence corresponding to the n luminescence probe concentration values at the preset temperature T2
  • the probe luminescence intensity value from the n luminescence probe concentration values and the corresponding luminescence probe luminescence intensity values at the preset temperature T1, and the n luminescence probe concentration values and the corresponding luminescence probe concentration values at the preset temperature T2
  • the luminescence intensity value of the luminescence probe is obtained by linear interpolation to obtain the concentration value of the n luminescence probe and the corresponding luminescence intensity value of the luminescence probe under the ambient temperature T0, where n is an integer greater than 1.
  • 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 28-31.
  • 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 computing device executes, the one or more computing devices are caused to perform the method described in any one of clauses 28-31.
  • An information collection device for instant detection of immunochromatographic test strips wherein the information collection device includes:
  • An upper shell and a lower shell, the upper shell and the lower shell cooperate to form a light-proof cavity inside;
  • test strip receiving groove is located in the light-proof cavity, and is configured to open on the upper shell or the lower shell to receive the inserted test strip, the test strip includes a long afterglow luminous probe The light-emitting area of the needle;
  • the collection component is located in the light-proof cavity and includes a light source for sending excitation light to the inserted test strip, a filter, and a camera for photographing the test strip.
  • the filter includes an infrared cut-off filter A dual-filter switcher composed of a full-spectrum optical glass, and the dual-filter switch can switch between an infrared cut filter and a full-spectrum optical glass,
  • the dual filter switcher is configured to switch the filter to the infrared cut filter during the excitation period of the long afterglow luminescence probe to filter out high-intensity excitation light, and the camera can pass through the infrared cut filter Take color photos of the test strip; and switch the filter to the full-spectrum optical glass during the afterglow period of the long-lasting luminescence probe, so that the camera can take color photos of the test strip through the full-spectrum optical glass.
  • test strip receiving slot is arranged to be opposite to the camera and the filter, and the light source is arranged to be offset from the camera and the filter, and the test strip receiving slot is opposite to each other. path.
  • the information collection device further comprises a communication component located in a light-proof cavity, the communication component being configured to send the captured color photo to the information A computing device separated from the collection device.
  • thermochromic ink includes a cholesteric liquid crystal thermochromic ink.
  • test strip for testing specimen samples, wherein the test strip includes a card shell, and the card shell is provided with a temperature sensing pattern capable of collecting the ambient temperature around the test strip.
  • test strip according to clause 49 wherein the temperature-sensitive pattern is made of temperature-sensitive color-changing ink.
  • thermochromic ink includes a cholesteric liquid crystal temperature sensitive ink.
  • the temperature-sensitive pattern includes a plurality of small blocks, and each small block changes color at a different critical temperature due to a different material ratio of the temperature-sensitive color-changing ink.
  • test strip according to clause 52 wherein: the plurality of small pieces are arranged in the order of the critical temperature.
  • test strip according to clause 53 wherein: the temperature-sensitive pattern is rectangular, and the plurality of small blocks are arranged in a manner of multiple rows and multiple columns.
  • test strip according to clause 53 wherein: the temperature-sensitive pattern is in a straight shape, and the plurality of small blocks are arranged in a row.
  • test strip according to clause 53 wherein: the temperature sensing pattern is in a ring shape, and the plurality of small pieces are arranged in a ring shape.
  • test strip according to clause 49 wherein the temperature-sensitive pattern is set on the card shell by printing or pasting.
  • test strip according to any one of clauses 49-57, wherein: the card housing is also provided with an identification code adjacent to the temperature sensing pattern, and the identification code contains traceability data bound to the specimen sample .
  • the identification code is a two-dimensional code or a barcode.
  • test strip according to clause 58, wherein: the identification code is set on the card housing by printing or pasting.
  • test strip according to any one of clauses 49-57, wherein: the test strip further comprises a nitrocellulose membrane located in the card housing, and the test strip has an axially spaced sample loading port and a display mouth.
  • test strip according to clause 61 wherein: the temperature sensing pattern is provided on the card housing on the side of the display port away from the sample loading port.
  • test strip according to Clause 61, wherein: the display port includes a nitrocellulose film exposed in the display port area and T-line and C-line for testing.
  • Fig. 1 shows a schematic diagram of an instant detection system for immunochromatographic test strips according to an embodiment of the present disclosure
  • FIG. 2 shows a front view of a test strip to be detected by the immunochromatographic 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 of the immunochromatographic test strip of FIG. 1;
  • Figure 5 shows the luminescence characteristic curve of the long afterglow luminescence probe
  • Figure 6 shows a perspective view of the IR-Cut camera from different angles
  • FIG. 7 shows a flow chart of the detection method of the instant detection system for immunochromatographic test strips 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 an 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, temperature-sensing pattern 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 the concentration of luminescent probes, 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 luminescent 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 luminescent conjugate of the substance to be detected is produced by combining the antigen with the antibody coupled to the surface of the luminescent probe.
  • the display port 44 includes the nitrocellulose membrane 42 exposed in the display port area and the T-line and C-line 45 for testing, and an immune response occurs when the delivered substance to be detected and its luminescent conjugate reach the T-line and C-line 45 It is fixed by coupling.
  • the display port 44 serves as a light-emitting area for the information collecting device 2 to collect light-emitting information.
  • the display port 44 contains a luminescent probe, such as a fluorescent probe or a long-lasting luminescent probe.
  • the fluorescent probe generates fluorescence during excitation by the excitation light; while the long-lasting luminescence probe generates afterglow after being excited by the excitation light. After the excitation light is turned off, the afterglow emission can last for more than 100 ms, for example.
  • the luminescence information may be information about the fluorescence emitted by the fluorescent probe (e.g., luminescence intensity), or may be information about the afterglow (e.g., luminescence intensity) emitted by the long-lasting luminescence probe.
  • 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 temperature-sensitive pattern 47 is provided on the card housing 41 (for example, by printing or pasting), and serves as an area where the information collecting device 2 collects the temperature-sensitive pattern information.
  • the temperature sensing pattern 47 may be located on the card housing 41 on the side of the display port 44 away from the sample loading port 43 and adjacent to the identification code 46.
  • the temperature-sensitive pattern 47 is made of a temperature-sensitive color-changing ink, such as a cholesteric liquid crystal temperature-sensitive ink.
  • the thermochromic ink has high sensitivity in the test temperature range of the test strip 4, and displays different colors at different test temperatures. For example, a temperature change of 1° C. is sufficient to produce a recognizable color difference.
  • the temperature sensing pattern 47 is provided as a plurality of small blocks. Each small block changes color at different critical temperatures due to the different material ratio of the thermochromic ink, so it can be arranged in the order of the height of the critical temperature.
  • the temperature-sensitive pattern 47 may be rectangular, and multiple small blocks are arranged in multiple rows and multiple columns; the temperature-sensitive pattern 47 may be in a line shape, and multiple small blocks are arranged in a row; the temperature-sensitive pattern 47 can be in a ring shape, and a plurality of small pieces are arranged in a ring shape.
  • the temperature sensing pattern 47 may be provided on the information collection device 2 (for example, on the support frame or lower housing of the information collection device 2 as detailed below) instead of the test strip 4.
  • 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 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 collection component 24 sends excitation light to the test strip 4, and collects various information (such as luminescence information, temperature sensing pattern information, identification code information, etc.) of the test strip 4 during and/or after the excitation.
  • the luminescence information includes the fluorescence intensity information of the fluorescent probe or the long afterglow luminescence intensity information of the long-lasting luminescence probe.
  • the luminescence information includes the fluorescence intensity information of the fluorescent probe, the light source is turned on during the fluorescence intensity test, and the collection device collects fluorescence intensity information + temperature sensing pattern information + identification code information, preferably divided into multiple Three kinds of information are obtained in the second collection, and more preferably three kinds of information are obtained at the same time at one time.
  • the luminescence information includes the long-lasting luminescence intensity information of the long-lasting luminescence probe.
  • the temperature sensing pattern information + identification code information is collected while the excitation light is excited, and the long-lasting luminescence intensity is collected after the light source is turned off. information.
  • 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 background light and scattered light.
  • the camera 243 collects light-emitting information of the light-emitting area, temperature-sensing pattern information and identification code information 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 filter 242 may include a dual filter switch composed of an infrared cut filter and a full-spectrum optical glass, and the dual filter switch The filter can be switched back and forth between the infrared cut filter and the full-spectrum optical glass.
  • the long-lasting luminescence probe excitation is divided into two stages. The first stage is the excitation period when the light source 241 is turned on to send excitation light to the long-lasting luminescence probe, and the second stage is the long-lasting luminescence after the light source 241 is turned off. The probe emits an afterglow period of afterglow.
  • the dual filter switcher switches the filter 242 to the infrared cut filter to attenuate or filter out the high-intensity excitation light, thereby protecting the detector of the camera 243, and collecting identification code information and temperature sensing Pattern information.
  • the long afterglow luminescence probe emits afterglow
  • the dual filter switcher switches the filter 242 to the full-spectrum optical glass to collect the afterglow information from the long afterglow luminescence probe.
  • the combination of the filter 242 with the dual filter switch and the camera 243 may be the IR-Cut camera shown in FIG. 6.
  • the IR-Cut camera is a finished lens sold on the market, and the price is only a dozen yuan. Compared with the high-precision camera used for short afterglow collection in existing instruments, the cost is reduced by hundreds to thousands of times.
  • 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 (such as WIFI, Bluetooth, etc.) or a wired communication device (such as through a USB port) used in conjunction with the communication component on the computing device 3.
  • the power supply component 27 is used to supply power to the collection component 24, the communication component 25, 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 storage module 32 stores the corresponding relationship between the temperature sensing pattern information and the ambient temperature T0, and stores a plurality of calibration curves L of the luminescence intensity of the luminescence probe and the concentration of the luminescence probe at a preset temperature.
  • 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 temperature-sensing pattern information and light-emitting information through the communication between the communication module 34 and the communication component 25.
  • the control module 31 retrieves the corresponding relationship between the temperature sensing pattern information and the ambient temperature from the storage module 32 to obtain the ambient temperature T0 around the test strip 4.
  • the control module 31 retrieves one or more calibration curves L of the luminescence probe luminescence intensity-luminescence probe concentration at the preset temperature from the storage module 32 according to the ambient temperature T0. Based on the above-mentioned calibration curve L, the control module 31 obtains the luminescence probe concentration of the test strip 4 from the luminescence intensity in the luminescence information.
  • the control module 32 outputs the luminescence 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.
  • FIG. 7 shows a flow chart of the detection method of the instant detection system 1 for 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 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 during the excitation period.
  • the filter 242 includes a dual filter switch composed of an infrared cut filter and a full-spectrum optical glass.
  • the dual filter switcher switches the filter 242 to the infrared cut filter to protect the detector of the camera 243 and take the first color photo of the test strip 4; in the afterglow period, the long The afterglow luminous probe emits afterglow, and the dual filter switcher switches the filter 242 to the full-spectrum optical glass to take a second color photo of the test strip 4.
  • the first color photo captures the temperature sensing pattern information and identification code information on the test strip 4, and the second color photo captures the light-emitting information of the display port 44 of the test strip 4.
  • the color photos are converted into electrical signals by photoelectric signals, and the temperature sensing pattern information, identification code information, and luminescence information are 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 S3 the control module 31 identifies the traceability data of the test strip 4 from the collected identification code information, and outputs the traceability data to the storage module 32.
  • step S4 the control module 31 retrieves the corresponding relationship between the temperature sensing pattern information and the ambient temperature from the storage module 32, and recognizes the ambient temperature T0 around the test strip 4 from the collected temperature sensing pattern information.
  • the control module 31 includes a temperature calibration function. The control module 31 determines whether the ambient temperature T0 is equal to the preset temperature corresponding to the calibration curve L. If the ambient temperature T0 is equal to one of the plurality of preset temperatures, the control module 31 retrieves the calibration curve L0 of the luminescence probe luminescence intensity-the luminescence probe concentration at the ambient temperature T0 from the storage module 32.
  • the control module 31 selects two preset temperatures T1 and T2 adjacent to the ambient temperature T0, and retrieves the preset temperature T1 from the storage module 32
  • the control module 31 uses the calibration curve L1 to obtain n (n is an integer greater than 1, for example, at least 5) luminescence probe luminescence intensity values corresponding to the preset temperature T1, and uses the calibration curve L2 to obtain the preset temperature T1.
  • the control module 31 uses a certain algorithm (such as linear interpolation) to obtain the n luminescence probe concentration values at the preset temperature T1 and T2 and the corresponding luminescence probe luminescence intensity value to obtain n luminescence probes at the ambient temperature T0.
  • the needle concentration value and the corresponding luminescence probe luminescence intensity value thereby simulating the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at ambient temperature T0, for example, by linear simulation software, such as using a logit-log4p model Or the spline curve Spline function.
  • the control module 31 fits and obtains the luminescence probe concentration according to the calibration curve L0 of the luminescence probe luminescence intensity-the luminescence probe concentration under the ambient temperature T0 and the measured luminescence probe luminescence intensity.
  • step S5 the output module 33 outputs the luminescent probe concentration and/or traceability data, for example, to display on the display screen of the computing device 3.
  • the preset temperature may include 10°C, 20°C, 25°C, 30°C, 35°C, 37°C, 39°C, 42°C, and so on. Measure the luminescence intensity of the luminescence probe at the concentration of at least 5 luminescence probes at the above preset temperature, and simulate the measured points with linear simulation software to obtain the above preset temperature (for example, including 10°C, 20°C, 25°C). , 30°C, 35°C, 37°C, 39°C, 39°C, and 42°C) and store the calibration curve L of the luminescence probe luminescence intensity-luminescence probe concentration at the storage module 32. After that, as shown in FIG.
  • the control module 31 retrieves the environment temperature corresponding to the temperature sensing pattern information from the storage module 32, and obtains that the environment temperature is 27°C.
  • the ambient temperature of 27°C is not equal to any of the preset temperatures. Therefore, the control module 31 selects the preset temperatures of 25°C and 30°C, which are adjacent to the ambient temperature of 27°C, and retrieves the preset temperature of 25°C from the storage module 32 Lower luminescent probe luminescence intensity-luminescence probe concentration calibration curve L1, luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at a preset temperature of 30°C.
  • the control module 31 uses the calibration curve L1 to obtain the luminescence intensities of the 6 luminescent probes corresponding to the 6 luminescent probe concentrations at a preset temperature of 25°C, and uses the calibration curve L2 to obtain the 6 luminescence probe concentrations corresponding to the 6 luminescent probe concentrations at the preset temperature of 30°C.
  • the luminescence intensity of a luminescent probe uses the linear interpolation method to calculate the luminescence intensity of the 6 luminescence probes corresponding to the concentration of the 6 luminescence probes at 27°C from the above data, and simulates 27 through the logit-log4p model or the spline function.
  • the control module 31 fits and obtains the concentration of the luminescence probe according to the calibration curve L0 and the measured luminescence intensity of the luminescence probe.
  • the output module 33 displays the luminescent probe concentration and/or traceability data on the display screen of the computing device 3.
  • the instant detection system for immunochromatographic test strips according to the embodiments of the present disclosure has fast measurement speed and relatively accurate measurement.
  • the information collection device of the instant detection system for immunochromatographic test strips eliminates the need for a processor and scanning device that occupies a large space, and the device can be only palm-sized, greatly increasing its convenience Sex.
  • the processing work is handed over 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.
  • thermochromic ink to measure the ambient temperature.
  • Thermochromic inks are more sensitive to temperature (the temperature resolution is less than 1°C), and temperature identification can be carried out in a true, effective and repeatable manner.
  • the thermochromic ink can be conveniently printed on the test strip, and the process of collecting the temperature-sensitive pattern information can be carried out at the same time as the process of collecting the luminous information.
  • the instant detection system for immunochromatographic test strips prestores calibration curves of luminescence probe luminescence intensity-luminescence probe concentration of the test strips to be tested at preset temperatures, and adopts linear interpolation and The linear simulation software obtains the calibration curve at ambient temperature. According to actual comparative experiments, the present disclosure has significantly improved the accuracy of luminescent probe concentration measurement.

Abstract

A point-of-care testing system (1) for an immunochromatographic strip. The testing system (1) comprises an information collection device (2) and a computation device (3) that are separated from each other; the information collection device (2) comprises a collection assembly (24) and a first communication assembly (25); and the computation device (2) comprises a control module (31), a storage module (32), a second communication module (34), and an output module (33). The testing system (1) performs simulation to obtain a calibration curve at an actual ambient temperature, thereby significantly improving the accuracy of the concentration measurement of a light-emitting probe.

Description

免疫层析试纸条即时检测***Real-time detection system for immunochromatographic test strips 技术领域Technical field
本公开涉及医疗器械体外诊断的技术领域,特别涉及一种免疫层析试纸条即时检测***和即时检测方法。The present disclosure relates to the technical field of in vitro diagnosis of medical devices, and in particular to an instant detection system and an instant detection method for immunochromatographic test strips.
背景技术Background technique
即时检测是指非专业检测人员利用便携式仪器快速诊断分析患者的标本样品,具有携带方便、操作简单、现场检验等特点。免疫层析技术是即时检测最为重要的手段之一。免疫层析技术通过检测试纸条上激发产生的荧光或余辉,定量检测试纸条上的标志物。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. Immunochromatography technology is one of the most important means of real-time detection. The immunochromatography technique detects the fluorescence or afterglow generated by excitation on the test strip, and quantitatively detects the markers on the test strip.
具体来说,免疫层析技术将特异抗体固定于硝酸纤维素膜的某一区带(例如T线和C线)。当干燥的硝酸纤维素膜一端浸入或滴加样品(尿液或血清)时,样品中的待检测抗原物质及其与发光探针的发光结合物借助于毛细作用在条状纤维制成的硝酸纤维素膜上泳动。待检测抗原物质的发光结合物与上述区带上的特异抗体结合,发生特异性免疫反应。由此,该区带显示一定的颜色、或者在激发光激发下发出一定强度的荧光或余辉,从而实现定性或定量特异性免疫诊断。Specifically, immunochromatography technology fixes specific antibodies on a certain zone (such as T-line and C-line) of the nitrocellulose membrane. When one end of the dry nitrocellulose membrane is immersed or dripped with a sample (urine or serum), the antigenic substance to be detected in the sample and its luminescent combination with the luminescent probe will act on the nitric acid made from the strip fiber by means of capillary action. Migration on the cellulose membrane. The luminescent conjugate of the antigen substance to be detected binds to the specific antibody on the above-mentioned zone, and a specific immune response occurs. As a result, the zone displays a certain color, or emits a certain intensity of fluorescence or afterglow under the excitation of the excitation light, thereby realizing qualitative or quantitative specific immunodiagnosis.
目前用于免疫层析技术的检测仪器主要有扫描型检测仪和成像型检测仪。扫描型检测仪由光学模块与机械扫描结构组成。光学模块的激发二极管激发试纸条上的发光探针,发光探针激发所产生的荧光经汇聚后被光电二极管等探测器接收。探测器一次只能探测试纸条局部的荧光,因此需要使用传动机构带动光学模块或试纸条托盘对整个试纸条进行“扫描式”探测,经过十几秒后得到荧光曲线,并推算样品含量。扫描型检测仪操作简单,但测量速度慢,并且测得的样品含量与实际值存在较大偏差。At present, the detection instruments used for 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 luminescent probe on the test strip, and the fluorescence generated by the excitation of the luminescent 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.
成像型检测仪利用荧光成像相机对试纸条进行一次抓拍成像,然后对图像进行处理。成像型检测仪对操作主机、成像相机和发光二极管光源等硬件性能要求较高,且具有体积大、标本鉴定复杂、操作繁杂、专业人员操作等特点。该类仪器多用于实验室场合,鲜见于日常临床检验场合。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 volume, 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.
另外众所周知的是,环境温度是免疫反应最为重要的参数之一,各环境温度下的免疫校准曲线是不一样的。目前,行业内的检测仪只存入37℃时的校准曲线,这就需要把测试的环境温度温育至37℃,否则将导致测试得到的发光探针浓度不准确。在 对实测环境温度不是37℃的试纸条进行温育时,需要温育单元温育将近半小时。温育单元额外增加了检测仪的尺寸和重量、操作步骤、以及每个样品测量的时间。In addition, it is well known that ambient temperature is one of the most important parameters of immune response, and the immune calibration curve at each ambient temperature is different. At present, the detector in the industry only stores the calibration curve at 37°C, which requires incubating the test environment temperature to 37°C, otherwise the concentration of the luminescent probe obtained by the test will be inaccurate. When incubating the test strips whose measured ambient temperature is not 37°C, the incubation unit needs to be incubated for nearly half an hour. The incubation unit additionally increases the size and weight of the detector, the operation steps, and the time for each sample measurement.
发明内容Summary of the invention
本公开的目的之一是提供一种能够克服现有技术中至少一个缺陷的免疫层析试纸条即时检测***。One of the objectives of the present disclosure is to provide an instant detection system for immunochromatographic test strips that can overcome at least one defect in the prior art.
根据下面描述的各方面说明了本公开的主题技术。为方便起见,将主题技术的各方面的各种示例描述为标号的条款(1、2、3等)。这些条款是作为示例提供的,而非限制本公开的主题技术。The subject technology of the present disclosure is explained in terms of various aspects described below. For convenience, various examples of various aspects of the subject technology are described as labeled terms (1, 2, 3, etc.). These terms are provided as examples, rather than limiting the subject technology of the present disclosure.
1、一种免疫层析试纸条即时检测***,其中:1. A real-time detection system for immunochromatographic test strips, in which:
所述免疫层析试纸条即时检测***包括彼此分离开的信息采集装置和计算装置,试纸条包括发光区域,试纸条和/或信息采集装置包括感温图案;The immunochromatographic test strip instant detection system includes an information collection device and a computing device that are separated from each other, the test strip includes a light-emitting area, and the test strip and/or the information collection device includes a temperature sensing pattern;
信息采集装置包括采集组件和第一通信组件,所述采集组件对试纸条发送激发光,采集试纸条的发光区域的发光信息和感温图案信息,并且所述第一通信组件将采集到的试纸条的发光区域的发光信息和感温图案信息发送至计算装置,所述发光信息包括试纸条的发光区域的发光强度;The information collection device includes a collection component and a first communication component. The collection component sends excitation light to the test strip, collects luminescence information and temperature sensing pattern information of the light-emitting area of the test strip, and the first communication component collects Sending the luminescence information and the temperature sensing pattern information of the luminous area of the test strip to the computing device, where the luminescence information includes the luminous intensity of the luminous area of the test strip;
计算装置包括控制模块、存储模块、第二通信模块和输出模块,所述存储模块储存感温图案信息和环境温度之间的对应关系、以及多个预设温度下发光探针发光强度-发光探针浓度校准曲线,并且所述第二通信模块和第一通信组件以无线方式或有线方式彼此连通,The computing device includes a control module, a storage module, a second communication module, and an output module. The storage module stores the corresponding relationship between the temperature sensing pattern information and the ambient temperature, and the luminous intensity of the luminescent probe at a plurality of preset temperatures. Needle concentration calibration curve, and the second communication module and the first communication component communicate with each other in a wireless or wired manner,
其中,控制模块通过第一通信组件和第二通信模块之间的连通获得试纸条的发光区域的发光信息和感温图案信息,控制模块从存储模块调取感温图案信息和环境温度之间的对应关系,以得到试纸条周围的环境温度T0,并且控制模块判断环境温度T0与所述多个预设温度之一是否相等:Wherein, the control module obtains the light-emitting information and temperature-sensing pattern information of the light-emitting area of the test strip through the communication between the first communication component and the second communication module, and the control module retrieves the temperature-sensing pattern information and the ambient temperature from the storage module. To obtain the ambient temperature T0 around the test strip, and the control module determines whether the ambient temperature T0 is equal to one of the plurality of preset temperatures:
在环境温度T0与所述多个预设温度之一相等的情况下,控制模块从存储模块调取环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0;In the case where the ambient temperature T0 is equal to one of the plurality of preset temperatures, the control module retrieves the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at the ambient temperature T0 from the storage module;
在环境温度T0与所述多个预设温度中任一个均不相等的情况下,控制模块选择 与环境温度T0上下相邻的预设温度T1与预设温度T2,并从储存模块调取预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1、以及预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2,控制模块通过预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1和预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2模拟出环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0;In the case that the ambient temperature T0 is not equal to any one of the plurality of preset temperatures, the control module selects the preset temperature T1 and the preset temperature T2 adjacent to the ambient temperature T0, and retrieves the preset temperature from the storage module Set the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L1 at the temperature T1 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2, and the control module passes the luminescence at the preset temperature T1 Probe luminescence intensity-luminescence probe concentration calibration curve L1 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 simulates the luminescence probe luminescence intensity-luminescence probe concentration calibration at ambient temperature T0 Curve L0;
控制模块根据环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0和获得的试纸条的发光区域的发光信息,拟合得到试纸条的发光区域的发光探针浓度值,并通过输出模块将试纸条的发光区域的发光探针浓度值输出。The control module fits and obtains the luminescence probe concentration value of the luminescence area of the test strip according to the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 under the ambient temperature T0 and the obtained luminescence information of the luminescence area of the test strip, And output the luminescence probe concentration value of the luminescence area of the test strip through the output module.
2、根据条款1所述的免疫层析试纸条即时检测***,其中:控制模块利用预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1、得到预设温度T1下n个发光探针浓度值对应的n个发光探针发光强度值,利用预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2、得到预设温度T2下所述n个发光探针浓度值对应的n发光探针发光强度值,控制模块从预设温度T1下的所述n个发光探针浓度值和对应的n个发光探针发光强度值、和预设温度T2下的所述n个发光探针浓度值和对应的n个发光探针发光强度值,通过线性内插法得到环境温度T0下的所述n个发光探针浓度值和对应的发光探针发光强度值,其中,n为大于1的整数。2. The immunochromatographic test strip real-time detection system according to clause 1, wherein: the control module uses the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L1 at the preset temperature T1 to obtain n at the preset temperature T1 The n luminescence probe luminescence intensity values corresponding to each luminescence probe concentration value are obtained by using the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 to obtain the n luminescence probes at the preset temperature T2. The n luminescence probe luminescence intensity value corresponding to the needle concentration value, the control module selects the n luminescence probe concentration values at the preset temperature T1 and the corresponding n luminescence probe luminescence intensity values, and the luminescence intensity values at the preset temperature T2. The concentration values of the n luminescent probes and the corresponding luminescence intensity values of the n luminescence probes are linearly interpolated to obtain the concentration values of the n luminescence probes and the corresponding luminescence intensity values of the luminescence probe at the ambient temperature T0 , Where n is an integer greater than 1.
3、根据条款2所述的免疫层析试纸条即时检测***,其中:控制模块从环境温度T0下的所述n个发光探针浓度值和对应的发光探针发光强度值,通过使用对数logit-log4p模型或样条曲线Spline函数模拟出环境温度T0下的发光探针发光强度-发光探针浓度的校准曲线L0。3. The instant detection system for immunochromatographic test strips according to clause 2, wherein: the control module calculates the concentration values of the n luminescent probes and the corresponding luminescence intensity values of the luminescent probes under the ambient temperature T0, by using The logit-log4p model or the Spline function of the spline curve simulates the calibration curve L0 of luminescence probe luminescence intensity-luminescence probe concentration at ambient temperature T0.
4、根据条款1所述的免疫层析试纸条即时检测***,其中:感温图案由感温变色油墨制成。4. The instant detection system for immunochromatographic test strips according to clause 1, wherein: the temperature-sensitive pattern is made of temperature-sensitive color-changing ink.
5、根据条款4所述的免疫层析试纸条即时检测***,其中:感温变色油墨包括胆甾型液晶感温油墨。5. The instant detection system for immunochromatographic test strips according to clause 4, wherein: the temperature-sensitive color-changing ink includes a cholesteric liquid crystal temperature-sensitive ink.
6、根据条款4所述的免疫层析试纸条即时检测***,其中:感温图案包括多个邻接的小块,每个小块因感温变色油墨的材料配比不同而在各自不同的临界温度变 色。6. The instant detection system for immunochromatographic test strips according to clause 4, wherein: the temperature-sensitive pattern includes a plurality of adjacent small blocks, and each small block is different due to the material ratio of the temperature-sensitive color-changing ink. Discoloration at critical temperature.
7、根据条款1所述的免疫层析试纸条即时检测***,其中:发光信息包括试纸条上的荧光探针发出的荧光的发光强度。7. The instant detection system for immunochromatographic test strips according to clause 1, wherein: the luminescence information includes the luminescence intensity of the fluorescence emitted by the fluorescent probe on the test strip.
8、根据条款1所述的免疫层析试纸条即时检测***,其中:发光信息包括试纸条上的长余辉发光探针发出的余辉的发光强度。8. The instant detection system for immunochromatographic test strips according to clause 1, wherein: the luminescence information includes the luminescence intensity of the afterglow emitted by the long afterglow luminescence probe on the test strip.
9、根据条款1-8中任一项所述的免疫层析试纸条即时检测***,其中:试纸条的卡壳设有识别码,所述识别码包含与标本样品绑定的溯源数据。9. The instant detection system for immunochromatographic test strips according to any one of clauses 1-8, wherein: the card shell of the test strip is provided with an identification code, and the identification code contains traceability data bound to the specimen sample.
10、根据条款9所述的免疫层析试纸条即时检测***,其中:采集组件构造成还采集试纸条的识别码信息,并且控制模块从识别码信息识别试纸条的溯源数据。10. The immunochromatographic test strip instant detection system according to clause 9, wherein: the collection component is configured to also collect identification code information of the test strip, and the control module recognizes the traceability data of the test strip from the identification code information.
11、根据条款9所述的免疫层析试纸条即时检测***,其中:识别码是二维码或者条形码。11. The instant detection system for immunochromatographic test strips according to clause 9, wherein: the identification code is a two-dimensional code or a barcode.
12、根据条款1-8中任一项所述的免疫层析试纸条即时检测***,其中:第一通信组件和第二通信模块是配合使用的无线通信器件或者有线通信器件。12. The immunochromatographic test strip instant detection system according to any one of clauses 1-8, wherein: the first communication component and the second communication module are wireless communication devices or wired communication devices that are used in conjunction.
13、根据条款1-8中任一项所述的免疫层析试纸条即时检测***,其中:采集组件包括光源、滤波片和摄像头,光源构造成对试纸条发送激发光,并且摄像头构造成透过滤波片对试纸条拍摄彩色照片。13. The immunochromatographic test strip instant detection system according to any one of clauses 1-8, wherein: 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, and the camera is configured Take a color photo of the test strip through the filter.
14、根据条款13所述的荧光免疫层析试纸条即时检测***,其中:试纸条放置成与摄像头和滤波片相对,并且光源设置成偏离摄像头和滤波片、以及试纸条之间的彼此相对的路径。14. The fluorescence immunochromatographic test strip instant detection system according to clause 13, wherein: the 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 strip Paths opposite to each other.
15、根据条款13所述的免疫层析试纸条即时检测***,其中:光源为带有光阑的LED灯。15. The instant detection system for immunochromatographic test strips according to clause 13, wherein: the light source is an LED lamp with a diaphragm.
16、根据条款13所述的免疫层析试纸条即时检测***,其中:摄像头为广角数字摄像头。16. The instant detection system for immunochromatographic test strips according to clause 13, wherein: the camera is a wide-angle digital camera.
17.根据条款1-8中任一项所述的免疫层析试纸条即时检测***,其中:信息采集装置包括上壳体和下壳体,上壳体和下壳体配合在一起以在内部形成避光的空腔。17. The instant detection system for immunochromatographic test strips according to any one of clauses 1-8, wherein: the information collection device includes an upper housing and a lower housing, and the upper housing and the lower housing cooperate to A light-proof cavity is formed inside.
18、根据条款17所述的免疫层析试纸条即时检测***,其中:避光空腔内设置 有支撑架,并且支撑架固定在下壳体上。18. The instant detection system for immunochromatographic test strips according to clause 17, wherein: a support frame is provided in the light-proof cavity, and the support frame is fixed on the lower shell.
19、根据条款18所述的免疫层析试纸条即时检测***,其中:支撑架包括多个隔层,所述多个隔层构造成支撑信息采集装置的多个零件。19. The instant detection system for immunochromatographic test strips according to clause 18, wherein: the support frame includes a plurality of compartments configured to support a plurality of parts of the information collection device.
20.根据条款17所述的荧光免疫层析试纸条即时检测***,其中:信息采集装置包括试纸条接收槽,所述试纸条接收槽固定至上壳体或下壳体,并且在相应壳体上开口,以接收***的试纸条。20. The instant detection system for fluorescence immunochromatographic test strips according to clause 17, wherein: the information collection device includes a test strip receiving groove, the test strip receiving groove is fixed to the upper housing or the lower housing, and in the corresponding The shell has an opening to receive the inserted test strip.
21.根据条款1-8中任一项所述的荧光免疫层析试纸条即时检测***,其中:信息采集装置包括电源组件,所述电源组件对信息采集装置供电。21. The instant detection system for fluorescence immunochromatographic test strips according to any one of clauses 1-8, wherein: the information collection device includes a power supply component, and the power supply component supplies power to the information collection device.
22、根据条款1-8中任一项所述的免疫层析试纸条即时检测***,其中:信息采集装置的长度不大于10cm,宽度不大于8cm,高度不大于10cm。22. The instant detection system for immunochromatographic test strips according to any one of clauses 1-8, wherein: the length of the information collection device is not greater than 10cm, the width is not greater than 8cm, and the height is not greater than 10cm.
23、根据条款1-8中任一项所述的免疫层析试纸条即时检测***,其中:计算装置是安装有检测程序的移动终端,或者计算装置的一部分设置在安装有检测程序的移动终端中、另一部分设置在与移动终端连通的服务器中。23. The instant detection system for immunochromatographic test strips according to any one of clauses 1-8, wherein: the computing device is a mobile terminal installed with a detection program, or a part of the computing device is installed in a mobile terminal where the detection program is installed. The other part of the terminal is set in a server connected to the mobile terminal.
24、根据条款1-8中任一项所述的免疫层析试纸条即时检测***,其中:试纸条包括卡壳和设置在卡壳内的硝酸纤维素膜,卡壳具有沿轴向间隔开的上样口和显示口,显示口为所述发光区域。24. The instant detection system for immunochromatographic test strips according to any one of clauses 1-8, wherein: the test strip includes a card housing and a nitrocellulose membrane arranged in the card housing, and the card housing has axially spaced apart The sample port and the display port, and the display port is the light-emitting area.
25、一种利用免疫层析试纸条即时检测***对试纸条进行即时检测方法,其中,所述方法包括以下步骤:25. A method for instant detection of test strips using an immunochromatographic test strip instant detection system, wherein the method includes the following steps:
将试纸条***信息采集装置中,并且在计算装置中开启检测命令;Insert the test strip into the information collection device, and start the detection command in the computing device;
信息采集装置对试纸条发送激发光,并采集试纸条的发光区域的发光信息和感温图案信息,所述发光信息包括试纸条的发光区域的发光强度;The information collection device sends excitation light to the test strip, and collects luminescence information and temperature sensing pattern information of the light-emitting area of the test strip, the light-emitting information including the luminous intensity of the light-emitting area of the test strip;
计算装置通过信息采集装置和计算装置之间的无线方式连通或有线方式连通获得试纸条的发光区域的发光信息和感温图案信息;The computing device obtains the luminescence information and the temperature sensing pattern information of the luminous area of the test strip through wireless or wired communication between the information collection device and the computing device;
计算装置基于预设的感温图案信息和环境温度之间的对应关系,得到试纸条周围的环境温度T0,并且计算装置判断环境温度T0与所述多个预设温度之一是否相等:The computing device obtains the ambient temperature T0 around the test strip based on the preset corresponding relationship between the temperature sensing pattern information and the ambient temperature, and the computing device determines whether the ambient temperature T0 is equal to one of the plurality of preset temperatures:
在环境温度T0与所述多个预设温度之一相等的情况下,计算装置调取环境温度 T0下的发光探针发光强度-发光探针浓度校准曲线L0;In the case that the ambient temperature T0 is equal to one of the plurality of preset temperatures, the computing device retrieves the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at the ambient temperature T0;
在环境温度T0与所述多个预设温度中任一个均不相等的情况下,计算装置选择与环境温度T0上下相邻的预设温度T1与预设温度T2,并调取预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1、以及预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2,计算装置通过预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1和预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2模拟出环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0;In the case that the ambient temperature T0 is not equal to any one of the plurality of preset temperatures, the computing device selects the preset temperature T1 and the preset temperature T2 adjacent to the ambient temperature T0, and calls the preset temperature T1 The luminescence probe luminescence intensity-luminescence probe concentration calibration curve L1 under the preset temperature T2 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2, and the calculation device emits light through the luminescence probe at the preset temperature T1 The intensity-luminescence probe concentration calibration curve L1 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 simulates the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at ambient temperature T0;
计算装置根据环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0和获得的试纸条的发光区域的发光信息,拟合得到试纸条的发光区域的发光探针浓度值,并将试纸条的发光区域的发光探针浓度值输出。The calculation device fits the luminescence probe concentration value of the luminescence area of the test strip according to the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at ambient temperature T0 and the obtained luminescence information of the luminescence area of the test strip, And output the luminescence probe concentration value of the luminescence area of the test strip.
26、根据条款25所述的检测方法,其中:信息采集装置在发送激发光期间采集试纸条的识别码信息,并且计算装置从识别码信息识别试纸条的溯源数据,并将试纸条的溯源数据输出。26. The detection method according to Clause 25, wherein: the information collection device collects the identification code information of the test strip during the period of sending the excitation light, and the computing device identifies the traceability data of the test strip from the identification code information, and combines the test strip The output of traceable data.
27、根据条款25或26所述的检测方法,其中:所述免疫层析试纸条即时检测***是根据条款1-24中任一项所述的免疫层析试纸条即时检测***。27. The detection method according to clause 25 or 26, wherein: the immunochromatographic test strip instant detection system is the immunochromatographic test strip instant detection system according to any one of clauses 1-24.
28、一种免疫层析试纸条即时检测方法,其中,所述方法包括以下步骤:28. An instant detection method for immunochromatographic test strips, wherein the method includes the following steps:
接收试纸条的发光区域的发光信息和感温图案信息;Receiving the light-emitting information and temperature-sensing pattern information of the light-emitting area of the test strip;
基于预设的感温图案信息和环境温度之间的对应关系,得到试纸条周围的环境温度T0,并且判断环境温度T0与多个预设温度之一是否相等:Based on the corresponding relationship between the preset temperature sensing pattern information and the ambient temperature, the ambient temperature T0 around the test strip is obtained, and it is determined whether the ambient temperature T0 is equal to one of the plurality of preset temperatures:
在环境温度T0与所述多个预设温度之一相等的情况下,调取预设的环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0;In the case that the ambient temperature T0 is equal to one of the plurality of preset temperatures, call the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at the preset ambient temperature T0;
在环境温度T0与所述多个预设温度中任一个均不相等的情况下,选择与环境温度T0上下相邻的预设温度T1与预设温度T2,并调取预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1、以及预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2,通过预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1和预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2模拟出环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0;In the case that the ambient temperature T0 is not equal to any one of the plurality of preset temperatures, select the preset temperature T1 and the preset temperature T2 adjacent to the ambient temperature T0, and call the preset temperature T1 Luminescence probe luminescence intensity-luminescence probe concentration calibration curve L1, and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2, through the luminescence probe luminescence intensity-luminescence probe luminescence intensity at the preset temperature T1 The needle concentration calibration curve L1 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 simulate the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at ambient temperature T0;
根据环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0和获得的试纸条的发光区域的发光信息,拟合得到试纸条的发光区域的发光探针浓度值,并将试纸条的发光区域的发光探针浓度值输出。According to the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at ambient temperature T0 and the obtained luminescence information of the luminescence area of the test strip, the luminescence probe concentration value of the luminescence area of the test strip is fitted, and the The concentration value of the luminescence probe in the luminescence area of the test strip is output.
29、根据条款28所述的检测方法,其中:利用预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1、得到预设温度T1下n个发光探针浓度值对应的n个发光探针发光强度值,利用利用预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2、得到预设温度T2下所述n个发光探针浓度值对应的n个发光探针发光强度值,从预设温度T1下的所述n个发光探针浓度值和对应的发光探针发光强度值、和预设温度T2下的所述n个发光探针浓度值和对应的发光探针发光强度值,通过线性内插法得到环境温度T0下的所述n个发光探针浓度值和对应的发光探针发光强度值,其中,n为大于1的整数。29. The detection method according to clause 28, wherein: using the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L1 at the preset temperature T1, the n corresponding to the n luminescence probe concentration values at the preset temperature T1 is obtained. Luminescence intensity values of the luminescence probes, using the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 to obtain n luminescence corresponding to the n luminescence probe concentration values at the preset temperature T2 The probe luminescence intensity value, from the n luminescence probe concentration values and the corresponding luminescence probe luminescence intensity values at the preset temperature T1, and the n luminescence probe concentration values and the corresponding luminescence probe concentration values at the preset temperature T2 The luminescence intensity value of the luminescence probe is obtained by linear interpolation to obtain the concentration value of the n luminescence probe and the corresponding luminescence intensity value of the luminescence probe under the ambient temperature T0, where n is an integer greater than 1.
30、根据条款28所述的检测方法,其中:从环境温度T0下的所述n个发光探针浓度值和对应的n个发光探针发光强度值,通过使用对数logit-log4p模型或样条曲线Spline函数模拟出环境温度T0下的发光探针发光强度-发光探针浓度的校准曲线L0。30. The detection method according to clause 28, wherein: from the n luminescent probe concentration values and the corresponding n luminescent probe luminescence intensity values at ambient temperature T0, by using a logit-log4p model or sample The curve Spline function simulates the calibration curve L0 of luminescence probe luminescence intensity-luminescence probe concentration at ambient temperature T0.
31、根据条款28-30中任一项所述的检测方法,其中:接收试纸条的识别码信息,并且从识别码信息识别试纸条的溯源数据,并将试纸条的溯源数据输出。31. The detection method according to any one of clauses 28-30, wherein: the identification code information of the test strip is received, and the traceability data of the test strip is identified from the identification code information, and the traceability data of the test strip is output .
32、一种计算装置,其中,所述计算装置包括:32. A computing device, wherein the computing device includes:
一个或多个处理器;以及One or more processors; and
一个或多个存储模块,所述一个或多个存储模块被配置为存储一系列计算机可执行的指令以及与所述一系列计算机可执行的指令相关联的计算机可访问的数据,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,
其中,当所述一系列计算机可执行的指令被所述一个或多个处理器执行时,使得所述一个或多个处理器进行如条款28-31中任一项所述的方法。Wherein, when the series of computer-executable instructions are executed by the one or more processors, the one or more processors are caused to perform the method according to any one of clauses 28-31.
33、一种非临时性计算机可读存储介质,其中,所述非临时性计算机可读存储介质上存储有一系列计算机可执行的指令,当所述一系列计算机可执行的指令被一个或多个计算装置执行时,使得所述一个或多个计算装置进行如条款28-31中任一项所述的方法。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. When the computing device executes, the one or more computing devices are caused to perform the method described in any one of clauses 28-31.
34、一种用于免疫层析试纸条即时检测的信息采集装置,其中,所述信息采集装置包括:34. An information collection device for instant detection of immunochromatographic test strips, wherein the information collection device includes:
上壳体和下壳体,所述上壳体和下壳体配合在一起以在内部形成避光空腔;An upper shell and a lower shell, the upper shell and the lower shell cooperate to form a light-proof cavity inside;
试纸条接收槽,所述试纸条接收槽位于避光空腔内,并且构造成在上壳体或下壳 体上开口以接收***的试纸条,试纸条包括具有长余辉发光探针的发光区域;和The test strip receiving groove, the test strip receiving groove is located in the light-proof cavity, and is configured to open on the upper shell or the lower shell to receive the inserted test strip, the test strip includes a long afterglow luminous probe The light-emitting area of the needle; and
采集组件,所述采集组件位于避光空腔内,并且包括对***的试纸条发送激发光的光源、滤波片、和对试纸条进行拍摄的摄像头,滤波片包括由红外截止滤光片和全光谱光学玻璃构成的双滤光片切换器,并且双滤光片切换器能够在红外截止滤光片和全光谱光学玻璃之间切换,The collection component is located in the light-proof cavity and includes a light source for sending excitation light to the inserted test strip, a filter, and a camera for photographing the test strip. The filter includes an infrared cut-off filter A dual-filter switcher composed of a full-spectrum optical glass, and the dual-filter switch can switch between an infrared cut filter and a full-spectrum optical glass,
其中,双滤光片切换器构造成在长余辉发光探针的激发期将滤波片切换到红外截止滤光片,以将高强度的激发光过滤掉,并且摄像头能够透过红外截止滤光片对试纸条拍摄彩色照片;并且在长余辉发光探针的余辉期将滤波片切换到全光谱光学玻璃,从而摄像头能够透过全光谱光学玻璃对试纸条拍摄彩色照片。Among them, the dual filter switcher is configured to switch the filter to the infrared cut filter during the excitation period of the long afterglow luminescence probe to filter out high-intensity excitation light, and the camera can pass through the infrared cut filter Take color photos of the test strip; and switch the filter to the full-spectrum optical glass during the afterglow period of the long-lasting luminescence probe, so that the camera can take color photos of the test strip through the full-spectrum optical glass.
35、根据条款34所述的信息采集装置,其中,试纸条接收槽设置成与摄像头和滤波片相对,并且光源设置成偏离摄像头和滤波片、以及试纸条接收槽之间的彼此相对的路径。35. The information collection device according to clause 34, wherein the test strip receiving slot is arranged to be opposite to the camera and the filter, and the light source is arranged to be offset from the camera and the filter, and the test strip receiving slot is opposite to each other. path.
36、根据条款34所述的信息采集装置,其中,光源是带有光阑的LED灯。36. The information collection device according to clause 34, wherein the light source is an LED lamp with a diaphragm.
37、根据条款34所述的信息采集装置,其中,摄像头是广角数字摄像头。37. The information collection device according to clause 34, wherein the camera is a wide-angle digital camera.
38、根据条款34所述的信息采集装置,其中,滤波片和摄像头的组合为IR-Cut摄像头。38. The information collection device according to clause 34, wherein the combination of the filter and the camera is an IR-Cut camera.
39、根据条款34-38中任一项所述的信息采集装置,其中,信息采集装置还包括位于避光空腔内的通信组件,所述通信组件构造成将拍摄的彩色照片发送至与信息采集装置分离开的计算装置。39. The information collection device according to any one of clauses 34-38, wherein the information collection device further comprises a communication component located in a light-proof cavity, the communication component being configured to send the captured color photo to the information A computing device separated from the collection device.
40、根据条款39所述的信息采集装置,其中,通信组件是无线通信组件或有线通信组件。40. The information collection device according to clause 39, wherein the communication component is a wireless communication component or a wired communication component.
41、根据条款34-38中任一项所述的信息采集装置,其中,信息采集装置还包括对其供电的电源组件。41. The information collection device according to any one of clauses 34-38, wherein the information collection device further includes a power supply component for powering it.
42、根据条款34-38中任一项所述的信息采集装置,其中,信息采集装置还包括支撑架,所述支撑架位于避光空腔内,并且固定在下壳体上。42. The information collection device according to any one of clauses 34-38, wherein the information collection device further comprises a support frame, the support frame being located in the light-proof cavity and fixed on the lower housing.
43、根据条款42所述的信息采集装置,其中,支撑架包括多个隔层,所述多个隔层构造成支撑采集组件。43. The information collection device according to clause 42, wherein the support frame includes a plurality of compartments configured to support the collection assembly.
44、根据条款34-38中任一项所述的信息采集装置,其中,信息采集装置还包括感温图案,所述感温图案设置在下壳体上或者下壳体的支撑架上,并且能够被摄像头拍摄彩色照片。44. The information collection device according to any one of clauses 34-38, wherein the information collection device further comprises a temperature-sensitive pattern, which is arranged on the lower housing or on the support frame of the lower housing, and can Color photos taken by the camera.
45、根据条款44所述的信息采集装置,其中:感温图案由感温变色油墨制成。45. The information collection device according to clause 44, wherein: the temperature-sensitive pattern is made of temperature-sensitive color-changing ink.
46、根据条款45所述的信息采集装置,其中:感温变色油墨包括胆甾型液晶感温油墨。46. The information collection device according to clause 45, wherein: the thermochromic ink includes a cholesteric liquid crystal thermochromic ink.
47、根据条款44所述的信息采集装置,其中:感温图案设置为多个邻接的小块,每个小块因感温变色油墨的材料配比不同而在各自不同的临界温度变色。47. The information collection device according to clause 44, wherein the temperature-sensitive pattern is arranged as a plurality of adjacent small blocks, and each small block changes color at a different critical temperature due to a different material ratio of the temperature-sensitive color-changing ink.
48、根据条款34-38中任一项所述的信息采集装置,其中,信息采集装置的长度不大于10cm,宽度不大于8cm,高度不大于10cm。48. The information collection device according to any one of clauses 34-38, wherein the length of the information collection device is not greater than 10 cm, the width is not greater than 8 cm, and the height is not greater than 10 cm.
49、一种用于测试标本样品的试纸条,其中,所述试纸条包括卡壳,所述卡壳上设有能够采集试纸条周围的环境温度的感温图案。49. A test strip for testing specimen samples, wherein the test strip includes a card shell, and the card shell is provided with a temperature sensing pattern capable of collecting the ambient temperature around the test strip.
50、根据条款49所述的试纸条,其中,感温图案由感温变色油墨制成。50. The test strip according to clause 49, wherein the temperature-sensitive pattern is made of temperature-sensitive color-changing ink.
51、根据条款50所述的试纸条,其中:感温变色油墨包括胆甾型液晶感温油墨。51. The test strip according to Clause 50, wherein: the thermochromic ink includes a cholesteric liquid crystal temperature sensitive ink.
52、根据条款50所述的试纸条,其中:感温图案包括多个小块,每个小块因感温变色油墨的材料配比不同而在各自不同的临界温度变色。52. The test strip according to clause 50, wherein: the temperature-sensitive pattern includes a plurality of small blocks, and each small block changes color at a different critical temperature due to a different material ratio of the temperature-sensitive color-changing ink.
53、根据条款52所述的试纸条,其中:所述多个小块按照临界温度的高低顺序进行排列。53. The test strip according to clause 52, wherein: the plurality of small pieces are arranged in the order of the critical temperature.
54、根据条款53所述的试纸条,其中:感温图案为矩形,并且所述多个小块按照多行多列的方式进行排列。54. The test strip according to clause 53, wherein: the temperature-sensitive pattern is rectangular, and the plurality of small blocks are arranged in a manner of multiple rows and multiple columns.
55、根据条款53所述的试纸条,其中:感温图案为一字型,并且所述多个小块按照一行的方式进行排列。55. The test strip according to clause 53, wherein: the temperature-sensitive pattern is in a straight shape, and the plurality of small blocks are arranged in a row.
56、根据条款53所述的试纸条,其中:感温图案为环形,并且所述多个小块排列成环形。56. The test strip according to clause 53, wherein: the temperature sensing pattern is in a ring shape, and the plurality of small pieces are arranged in a ring shape.
57、根据条款49所述的试纸条,其中:感温图案通过印刷或粘贴设置在卡壳上。57. The test strip according to clause 49, wherein the temperature-sensitive pattern is set on the card shell by printing or pasting.
58、根据条款49-57中任一项所述的试纸条,其中:所述卡壳上还设有与感温图案相邻的识别码,所述识别码包含与标本样品绑定的溯源数据。58. The test strip according to any one of clauses 49-57, wherein: the card housing is also provided with an identification code adjacent to the temperature sensing pattern, and the identification code contains traceability data bound to the specimen sample .
59、根据条款58所述的试纸条,其中:识别码是二维码或者条形码。59. The test strip according to clause 58, wherein: the identification code is a two-dimensional code or a barcode.
60、根据条款58所述的试纸条,其中:识别码通过印刷或粘贴设置在卡壳上。60. The test strip according to clause 58, wherein: the identification code is set on the card housing by printing or pasting.
61、根据条款49-57中任一项所述的试纸条,其中:试纸条还包括位于卡壳内的硝酸纤维素膜,并且试纸条具有沿轴向间隔开的上样口和显示口。61. The test strip according to any one of clauses 49-57, wherein: the test strip further comprises a nitrocellulose membrane located in the card housing, and the test strip has an axially spaced sample loading port and a display mouth.
62、根据条款61所述的试纸条,其中:感温图案设置在卡壳上位于显示口远离 上样口的一侧。62. The test strip according to clause 61, wherein: the temperature sensing pattern is provided on the card housing on the side of the display port away from the sample loading port.
63、根据条款61所述的试纸条,其中:显示口包括在显示口区域中露出的硝酸纤维素膜和测试用的T线和C线。63. The test strip according to Clause 61, wherein: the display port includes a nitrocellulose film exposed in the display port area and T-line and C-line for testing.
本公开的主题技术的其它特征和优点将在下面的描述中阐述,并且部分地将从所述描述显而易见,或者可以通过实践本公开的主题技术来学习。通过在书面说明书及其权利要求书以及附图中特别指出的结构,将实现和获得本公开的主题技术的优点。Other features and advantages of the subject technology of the present disclosure will be set forth in the following description, and will be partially obvious from the description, or can be learned by practicing the subject technology of the present disclosure. The advantages of the subject technology of the present disclosure will be realized and obtained through the structures particularly pointed out in the written description and its claims as well as the drawings.
应当理解,前述一般性描述和以下详细描述都是示例性和说明性的,并且旨在提供对要求保护的本公开的主题技术的进一步说明。It should be understood that the foregoing general description and the following detailed description are both exemplary and illustrative, and are intended to provide a further explanation of the subject technology of the claimed disclosure.
附图说明Description of the drawings
在结合附图阅读下文的具体实施方式后,将更好地理解本公开的多个方面,在附图中:After reading the following specific embodiments in conjunction with the accompanying drawings, you will better understand multiple aspects of the present disclosure. In the accompanying drawings:
图1示出根据本公开实施例的免疫层析试纸条即时检测***的示意图;Fig. 1 shows a schematic diagram of an instant detection system for immunochromatographic test strips according to an embodiment of the present disclosure;
图2示出待由图1的免疫层析试纸条即时检测***检测的试纸条的正视图;FIG. 2 shows a front view of a test strip to be detected by the immunochromatographic test strip instant detection system of FIG. 1;
图3和4示出图1的免疫层析试纸条即时检测***信息采集装置的分解立体图和组装立体图;3 and 4 show an exploded perspective view and an assembled perspective view of the information acquisition device of the instant detection system of the immunochromatographic test strip of FIG. 1;
图5示出长余辉发光探针的发光特性曲线图;Figure 5 shows the luminescence characteristic curve of the long afterglow luminescence probe;
图6示出IR-Cut摄像头的不同角度的立体图;和Figure 6 shows a perspective view of the IR-Cut camera from different angles; and
图7示出图的1的免疫层析试纸条即时检测***的检测方法的流程图。FIG. 7 shows a flow chart of the detection method of the instant detection system for immunochromatographic test strips of FIG. 1.
具体实施方式Detailed ways
以下将参照附图描述本公开,其中的附图示出了本公开的若干实施例。然而应当理解的是,本公开可以以多种不同的方式呈现出来,并不局限于下文描述的实施例;事实上,下文描述的实施例旨在使本公开的公开更为完整,并向本领域技术人员充分说明本公开的保护范围。还应当理解的是,本文公开的实施例能够以各种方式进行组合,从而提供更多额外的实施例。The present disclosure will be described below with reference to the accompanying drawings, which illustrate several embodiments of the present disclosure. However, it should be understood that the present disclosure can be presented in a variety of different ways, and is not limited to the embodiments described below; in fact, the embodiments described below are intended to make the disclosure of the present disclosure more complete, and to contribute to the present disclosure. Those skilled in the art fully explain the protection scope of the present disclosure. It should also be understood that the embodiments disclosed herein can be combined in various ways to provide more additional embodiments.
应当理解的是,在所有附图中,相同的附图标记表示相同的元件。在附图中,为清楚起见,某些特征的尺寸可以进行变形。It should be understood that in all the drawings, the same reference numerals denote the same elements. In the drawings, the dimensions of certain features may be deformed for clarity.
应当理解的是,说明书中的用辞仅用于描述特定的实施例,并不旨在限定本公开。说明书使用的所有术语(包括技术术语和科学术语)除非另外定义,均具有本领域技 术人员通常理解的含义。为简明和/或清楚起见,公知的功能或结构可以不再详细说明。It should be understood that the terms in the specification are only used to describe specific embodiments and are not intended to limit the present disclosure. Unless otherwise defined, all terms (including technical terms and scientific terms) used in the specification have the meanings commonly understood by those skilled in the art. For conciseness and/or clarity, well-known functions or structures may not be described in detail.
说明书使用的单数形式“一”、“所述”和“该”除非清楚指明,均包含复数形式。说明书使用的用辞“包括”、“包含”和“含有”表示存在所声称的特征,但并不排斥存在一个或多个其它特征。说明书使用的用辞“和/或”包括相关列出项中的一个或多个的任意和全部组合。说明书使用的用辞“在X和Y之间”和“在大约X和Y之间”应当解释为包括X和Y。本说明书使用的用辞“在大约X和Y之间”的意思是“在大约X和大约Y之间”,并且本说明书使用的用辞“从大约X至Y”的意思是“从大约X至大约Y”。The singular forms "a", "the" and "the" used in the specification include plural forms unless clearly indicated. The terms "including", "including" and "containing" used in the specification indicate the presence of the claimed feature, but do not exclude the presence of one or more other features. The term "and/or" used in the specification includes any and all combinations of one or more of the related listed items. The terms "between X and Y" and "between about X and Y" used in the specification should be interpreted as including X and Y. The term "between about X and Y" used in this specification means "between about X and about Y", and the term "from about X to Y" used in this specification means "from about X To about Y".
在说明书中,称一个元件位于另一元件“上”、“附接”至另一元件、“连接”至另一元件、“耦合”至另一元件、或“接触”另一元件等时,该元件可以直接位于另一元件上、附接至另一元件、连接至另一元件、联接至另一元件或接触另一元件,或者可以存在中间元件。相对照的是,称一个元件“直接”位于另一元件“上”、“直接附接”至另一元件、“直接连接”至另一元件、“直接耦合”至另一元件或、或“直接接触”另一元件时,将不存在中间元件。在说明书中,一个特征布置成与另一特征“相邻”,可以指一个特征具有与相邻特征重叠的部分或者位于相邻特征上方或下方的部分。In the specification, 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. In the specification, 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.
在说明书中,诸如“上”、“下”、“左”、“右”、“前”、“后”、“高”、“低”等的空间关系用辞可以说明一个特征与另一特征在附图中的关系。应当理解的是,空间关系用辞除了包含附图所示的方位之外,还包含装置在使用或操作中的不同方位。例如,在附图中的装置倒转时,原先描述为在其它特征“下方”的特征,此时可以描述为在其它特征的“上方”。装置还可以以其它方式定向(旋转90度或在其它方位),此时将相应地解释相对空间关系。In the specification, terms such as "up", "down", "left", "right", "front", "rear", "high", "low", etc. can describe one feature and another feature. The relationship in the drawing. It should be understood that, in addition to the orientation shown in the drawings, the terms of the spatial relationship also include different orientations of the device in use or operation. For example, when the device in the drawings is turned upside down, features that were originally described as being "below" other features may now be described as being "above" other features. The device can also be oriented in other ways (rotated by 90 degrees or in other orientations), at which point the relative spatial relationship will be explained accordingly.
本说明书描述的***还可利用一个或多个控制模块来接收信息并变换所接收的信息以生成输出。该控制模块可包括任意类型的计算装置、计算电路或者任意类型的处理器或能够执行存储在存储模块中的一系列指令的处理电路。该控制模块可包括多个处理器和/或多核中央处理单元(CPU)并且可包括任意类型的处理器,诸如微处理器、数字信号处理器、微控制模块等。该控制模块还可包括存储模块以存储数据和/或算法以执行一系列指令。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.
本说明书描述的任意方法、程序、算法或编码可以转换成或表达为编程语言或计 算机程序。“编程语言”和“计算机程序”是用以将指令指定给计算机的任意语言,并且包括(但不限于)这些语言和它们的派生物:汇编语言、Basic、批处理文件、BCPL、C、C+、C++、Delphi、Fortran、Java、JavaScript、机器代码、操作***命令语言、Pascal、Perl、PL1、脚本语言、Visual Basic、其自身指定程序的元语言,以及第一代、第二代、第三代、***和第五代计算机语言。同样包括的是数据库和其他数据模式,以及任意其他元语言。为了这种定义的目的,不在被解译、编译的语言之间或者是使用编译和解译这两种方法的语言之间进行区分。为了这种定义的目的,不在程序的编译版本和源版本之间进行区分。因此,参考编程语言可存在于一个以上状态(诸如源状态、编译状态、对象状态或链接状态)中的程序是参考任意和所有这种状态。该定义还包含有效指令和这些指令的意图。Any method, program, algorithm, or code described in this specification can be converted or expressed as a programming language or computer program. "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. For the purpose of this definition, no distinction is made between languages that are interpreted and compiled, or languages that use the two methods of compilation and interpretation. For the purpose of this definition, no distinction is made between the compiled version and the source version of the program. Therefore, a reference to a program in which a programming language can exist in more than one state (such as a source state, a compiled state, an object state, or a link state) refers to any and all such states. The definition also contains valid instructions and the intent of these instructions.
本说明书描述的任意方法、程序、算法或代码可包含在一个或多个机器可读媒介或存储模块上。术语“存储模块”可包括提供(例如,存储和/或传送)以由诸如处理器、计算机或数字处理设备的机器可读格式的信息的机构。例如,存储模块可包括只读存储模块(ROM)、随机存取存储模块(RAM)、磁盘存储介质、光学存储介质、闪存设备或任意其他易失性或非易失性存储设备。包含在其上的代码或指令可由载波信号、红外信号、数字信号和其他相似的信号表示。Any method, program, algorithm, or code described in this specification can be contained on one or more machine-readable media or storage modules. 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. For example, 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. The codes or instructions contained on it can be represented by carrier signals, infrared signals, digital signals and other similar signals.
图1示出根据本公开实施例的免疫层析试纸条即时检测***1的示意图。如图所示,检测***1包括单独的信息采集装置2和计算装置3。信息采集装置2和计算装置3分离开,并且通过无线方式或有线方式彼此连通。信息采集装置2从试纸条4采集各种信息(例如发光信息、感温图案信息、识别码信息等),并将采集到的信息发送给计算装置3。计算装置3对接收到的信息进行处理,并将处理结果(例如发光探针浓度、样品溯源数据等)输出。Fig. 1 shows a schematic diagram of an immunochromatographic test strip instant detection system 1 according to an embodiment of the present disclosure. As shown in the figure, 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, temperature-sensing pattern 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 the concentration of luminescent probes, sample traceability data, etc.).
检测***1检测的试纸条4是接收完标本样品进行测试后的试纸条。如图2所示,试纸条4可以包括卡壳41和设置在卡壳41内的硝酸纤维素膜42。试纸条4具有沿轴向间隔开的上样口43和显示口44。上样口43用于接收样品(例如尿液、血清等),并且样品中的待检测物质及其发光结合物通过硝酸纤维素膜42的毛细作用传递至显示口44。在一些实施例中,试纸条4上免疫反应的待检测物质为抗原,并且待检测物质的发光结合物是所述抗原与发光探针表面偶联的抗体相结合而产生的。The test strip 4 detected by the detection system 1 is the test strip after receiving the sample for testing. As shown in FIG. 2, 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 luminescent combination in the sample are transferred to the display port 44 through the capillary action of the nitrocellulose membrane 42. In some embodiments, the immunoreactive substance to be detected on the test strip 4 is an antigen, and the luminescent conjugate of the substance to be detected is produced by combining the antigen with the antibody coupled to the surface of the luminescent probe.
显示口44包括在显示口区域中露出的硝酸纤维素膜42和测试用的T线和C线45,并且传递过来的待检测物质及其发光结合物到达T线和C线45时发生免疫反应而被 偶联固定。显示口44作为信息采集装置2采集发光信息的发光区域。显示口44包含发光探针,例如荧光探针或者长余辉发光探针。荧光探针在受到激发光激发期间产生荧光;而长余辉发光探针在受到激发光激发后产生余辉,激发光关闭后余辉发光可持续例如100ms以上。发光信息可以是荧光探针发出的荧光的信息(例如发光强度),也可以是长余辉发光探针发出的余辉的信息(例如发光强度)。The display port 44 includes the nitrocellulose membrane 42 exposed in the display port area and the T-line and C-line 45 for testing, and an immune response occurs when the delivered substance to be detected and its luminescent conjugate reach the T-line and C-line 45 It is fixed by coupling. The display port 44 serves as a light-emitting area for the information collecting device 2 to collect light-emitting information. The display port 44 contains a luminescent probe, such as a fluorescent probe or a long-lasting luminescent probe. The fluorescent probe generates fluorescence during excitation by the excitation light; while the long-lasting luminescence probe generates afterglow after being excited by the excitation light. After the excitation light is turned off, the afterglow emission can last for more than 100 ms, for example. The luminescence information may be information about the fluorescence emitted by the fluorescent probe (e.g., luminescence intensity), or may be information about the afterglow (e.g., luminescence intensity) emitted by the long-lasting luminescence probe.
识别码46设置在卡壳41上(例如通过印刷或粘贴),并且作为信息采集装置2采集识别码信息的区域。在一些实施例中,识别码46可以在卡壳41上位于显示口44远离上样口43的一侧。在一些实施例中,识别码46可以是二维码或者条形码。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. In some embodiments, 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. In some embodiments, the identification code 46 may be a two-dimensional code or a barcode.
感温图案47设置在卡壳41上(例如通过印刷或粘贴),并且作为信息采集装置2采集感温图案信息的区域。在一些实施例中,感温图案47可以在卡壳41上位于显示口44远离上样口43的一侧,并且与识别码46相邻。在一些实施例中,感温图案47由感温变色油墨制成,例如胆甾型液晶感温油墨。感温变色油墨在试纸条4测试温度范围内具有较高灵敏度,并且在不同的测试温度下显示不同的颜色,例如1℃的温度变化足以产生能够识别的颜色差异。在一些实施例中,感温图案47设置为多个小块。每个小块因感温变色油墨的材料配比不同而在不同临界温度变色,因此可以按临界温度的高度顺序进行排列。例如,感温图案47可以为矩形,并且多个小块按照多行多列的方式进行排列;感温图案47可以为一字型,并且多个小块按照一行的方式进行排列;感温图案47可以为环形,并且多个小块排列成环形。在一些实施例中,感温图案47可以设置在信息采集装置2(例如在信息采集装置2的如下详述的支撑架上或下壳体)上、而非试纸条4上。The temperature-sensitive pattern 47 is provided on the card housing 41 (for example, by printing or pasting), and serves as an area where the information collecting device 2 collects the temperature-sensitive pattern information. In some embodiments, the temperature sensing pattern 47 may be located on the card housing 41 on the side of the display port 44 away from the sample loading port 43 and adjacent to the identification code 46. In some embodiments, the temperature-sensitive pattern 47 is made of a temperature-sensitive color-changing ink, such as a cholesteric liquid crystal temperature-sensitive ink. The thermochromic ink has high sensitivity in the test temperature range of the test strip 4, and displays different colors at different test temperatures. For example, a temperature change of 1° C. is sufficient to produce a recognizable color difference. In some embodiments, the temperature sensing pattern 47 is provided as a plurality of small blocks. Each small block changes color at different critical temperatures due to the different material ratio of the thermochromic ink, so it can be arranged in the order of the height of the critical temperature. For example, the temperature-sensitive pattern 47 may be rectangular, and multiple small blocks are arranged in multiple rows and multiple columns; the temperature-sensitive pattern 47 may be in a line shape, and multiple small blocks are arranged in a row; the temperature-sensitive pattern 47 can be in a ring shape, and a plurality of small pieces are arranged in a ring shape. In some embodiments, the temperature sensing pattern 47 may be provided on the information collection device 2 (for example, on the support frame or lower housing of the information collection device 2 as detailed below) instead of the test strip 4.
图3和4示出信息采集装置2的分解立体图和组装立体图(已除去上壳体)。如图所示,信息采集装置2包括上壳体21和下壳体22,上壳体21和下壳体22配合在一起以在内部形成避光的空腔。支撑架23位于避光的空腔内,并且固定在下壳体22上。支撑架23包括多个隔层,以用于支撑采集组件24、通信组件25、电源组件27、和/或试纸条接收槽28中的一个或多个零件。试纸条接收槽28用于接收***的试纸条4。采集组件24对试纸条4发送激发光,并在激发期间和/或激发后采集试纸条4的各种信息(例如发光信息、感温图案信息、识别码信息等)。发光信息分别包括荧光探针的荧光强度信息或长余辉发光探针的长余辉发光强度信息。在一种实施例中,发光信息包括荧光探针的荧光强度信息,荧光强度测试时光源处于开启状态,采集装置采集到的是荧光强度信息+感温图案信息+识别码信息,优选地分多次采集分别获得 三种信息,更优选地一次同时获得三种信息。在另一种实施例中,发光信息包括长余辉发光探针的长余辉发光强度信息,优选地在激发光激发的同时采集感温图案信息+识别码信息,待光源关闭之后采集长余辉发光强度信息。通信组件25将采集到的信息发送至计算装置3。电源组件27用于对信息采集装置2供电。3 and 4 show an exploded perspective view and an assembled perspective view of the information collecting device 2 (with the upper casing removed). As shown in the figure, 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 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 collection component 24 sends excitation light to the test strip 4, and collects various information (such as luminescence information, temperature sensing pattern information, identification code information, etc.) of the test strip 4 during and/or after the excitation. The luminescence information includes the fluorescence intensity information of the fluorescent probe or the long afterglow luminescence intensity information of the long-lasting luminescence probe. In an embodiment, the luminescence information includes the fluorescence intensity information of the fluorescent probe, the light source is turned on during the fluorescence intensity test, and the collection device collects fluorescence intensity information + temperature sensing pattern information + identification code information, preferably divided into multiple Three kinds of information are obtained in the second collection, and more preferably three kinds of information are obtained at the same time at one time. In another embodiment, the luminescence information includes the long-lasting luminescence intensity information of the long-lasting luminescence probe. Preferably, the temperature sensing pattern information + identification code information is collected while the excitation light is excited, and the long-lasting luminescence intensity is collected after the light source is turned off. information. 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.
采集组件24包括光源241、滤波片242和摄像头243。光源241用于对试纸条4发送激发光。滤波片242用于过滤背景光和散射光。摄像头243通过拍摄彩色照片来采集发光区域的发光信息、试纸条4上的感温图案信息和识别码信息等。在一些实施例中,试纸条接收槽28可以设置成与摄像头243和滤波片242彼此相对;光源241可以设置成偏离摄像头243和滤波片242、以及试纸条接收槽28之间的彼此相对的路径。在一些实施例中,光源241、滤波片242和摄像头243均放置在支撑架23上。在一些实施例中,光源241可以是带有光阑的LED灯。在一些实施例中,摄像头243可以是广角数字摄像头,例如CCD摄像头或者CMOS摄像头等。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 background light and scattered light. The camera 243 collects light-emitting information of the light-emitting area, temperature-sensing pattern information and identification code information on the test strip 4 by taking color photos. In some embodiments, 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. In some embodiments, the light source 241, the filter 242, and the camera 243 are all placed on the support frame 23. In some embodiments, the light source 241 may be an LED lamp with a diaphragm. In some embodiments, the camera 243 may be a wide-angle digital camera, such as a CCD camera or a CMOS camera.
在一些实施例中,当显示口44包含长余辉发光探针时,滤波片242可以包括由红外截止滤光片和全光谱光学玻璃构成的双滤光片切换器,并且该双滤光片切换器可以在红外截止滤光片和全光谱光学玻璃之间来回切换。如图5所示,长余辉发光探针激发分为两个阶段,第一阶段是光源241打开以向长余辉发光探针发送激发光的激发期,第二阶段是光源241关闭后长余辉发光探针发出余辉的余辉期。在激发期,双滤光片切换器将滤波片242切换到红外截止滤光片,以将高强度的激发光衰减或过滤掉,从而保护摄像头243的探测器,并且采集识别码信息和感温图案信息。在余辉期,长余辉发光探针发出余辉,并且双滤光片切换器将滤波片242切换到全光谱光学玻璃,以采集长余辉发光探针发出的余辉信息。在一些实施例中,带有双滤光片切换器的滤波片242和摄像头243的组合可以为图6所示的IR-Cut摄像头。IR-Cut摄像头为市场出售的成品镜头,售价仅有十几元,相对现有仪器中对于较短余辉收集使用的高精度摄像头,成本降低了几百至几千倍。In some embodiments, when the display port 44 contains a long-lasting luminescence probe, the filter 242 may include a dual filter switch composed of an infrared cut filter and a full-spectrum optical glass, and the dual filter switch The filter can be switched back and forth between the infrared cut filter and the full-spectrum optical glass. As shown in Figure 5, the long-lasting luminescence probe excitation is divided into two stages. The first stage is the excitation period when the light source 241 is turned on to send excitation light to the long-lasting luminescence probe, and the second stage is the long-lasting luminescence after the light source 241 is turned off. The probe emits an afterglow period of afterglow. During the excitation period, the dual filter switcher switches the filter 242 to the infrared cut filter to attenuate or filter out the high-intensity excitation light, thereby protecting the detector of the camera 243, and collecting identification code information and temperature sensing Pattern information. In the afterglow period, the long afterglow luminescence probe emits afterglow, and the dual filter switcher switches the filter 242 to the full-spectrum optical glass to collect the afterglow information from the long afterglow luminescence probe. In some embodiments, the combination of the filter 242 with the dual filter switch and the camera 243 may be the IR-Cut camera shown in FIG. 6. The IR-Cut camera is a finished lens sold on the market, and the price is only a dozen yuan. Compared with the high-precision camera used for short afterglow collection in existing instruments, the cost is reduced by hundreds to thousands of times.
返回图3和图4,通信组件25将采集组件24采集到的信息发送至计算装置3。通信组件25可以是与计算装置3上的通信组件配合使用的无线通信器件(例如WIFI、蓝牙等)或者有线通信器件(例如通过USB口)。Returning to FIG. 3 and FIG. 4, 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 (such as WIFI, Bluetooth, etc.) or a wired communication device (such as through a USB port) used in conjunction with the communication component on the computing device 3.
电源组件27用于对采集组件24、通信组件25等进行供电。电源组件27可以包括内置电源(包括充电板、锂电池等),和/或外置电源(例如通过USB口)。The power supply component 27 is used to supply power to the collection component 24, the communication component 25, 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).
试纸条接收槽28固定至上壳体21或下壳体22,并且在相应壳体上开口,以用于 接收***的试纸条4。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.
在一些实施例中,信息采集装置2的长度可以不大于10cm,宽度可以不大于8cm,高度可以不大于10cm。In some embodiments, 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.
返回图1,计算装置3包括控制模块31、存储模块32、输出模块33和通信模块34。存储模块32存储有感温图案信息和环境温度T0之间的对应关系,并且存储有多个预设温度下发光探针发光强度-发光探针浓度的校准曲线L。通信模块34为与通信组件25相配合的无线通信模块或有线通信模块。控制模块31通过通信模块34和通信组件25的连通获取感温图案信息和发光信息。控制模块31从存储模块32调取感温图案信息和环境温度之间的对应关系,以得到试纸条4周围的环境温度T0。控制模块31根据环境温度T0从存储模块32调取一个或多个预设温度下发光探针发光强度-发光探针浓度的校准曲线L。控制模块31基于上述校准曲线L,通过发光信息中的发光强度得到试纸条4的发光探针浓度。控制模块32将试纸条4的发光探针浓度通过输出模块33输出。Returning to FIG. 1, the computing device 3 includes a control module 31, a storage module 32, an output module 33 and a communication module 34. The storage module 32 stores the corresponding relationship between the temperature sensing pattern information and the ambient temperature T0, and stores a plurality of calibration curves L of the luminescence intensity of the luminescence probe and the concentration of the luminescence probe at a preset temperature. 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 temperature-sensing pattern information and light-emitting information through the communication between the communication module 34 and the communication component 25. The control module 31 retrieves the corresponding relationship between the temperature sensing pattern information and the ambient temperature from the storage module 32 to obtain the ambient temperature T0 around the test strip 4. The control module 31 retrieves one or more calibration curves L of the luminescence probe luminescence intensity-luminescence probe concentration at the preset temperature from the storage module 32 according to the ambient temperature T0. Based on the above-mentioned calibration curve L, the control module 31 obtains the luminescence probe concentration of the test strip 4 from the luminescence intensity in the luminescence information. The control module 32 outputs the luminescence probe concentration of the test strip 4 through the output module 33.
在一些实施例中,计算装置3可以是安装有检测程序的移动终端(例如手机、平板电脑等),或者计算装置3的一部分设置在安装有检测程序的移动终端中、另一部分设置在与移动终端连通的服务器中。In some embodiments, 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.
在一些实施例中,控制模块31还通过通信模块34和通信组件25的连通获取识别码信息,识别出试纸条4的溯源数据,并将溯源数据存储至存储模块32。输出模块33可以将存储的试纸条4的溯源数据输出。In some embodiments, the 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.
图7示出了免疫层析试纸条即时检测***1的检测方法的流程图。如图所示,在S1步骤,将试纸条4***信息采集装置2的试纸条接收槽28中,并且在计算装置3的检测程序中开启检测命令。FIG. 7 shows a flow chart of the detection method of the instant detection system 1 for immunochromatographic test strips. As shown in the figure, in 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.
在S2步骤,计算装置3的控制模块31通过通信模块34和通信组件25之间的连通将检测开启命令发送至信息采集装置2的采集组件24。采集组件24的光源241打开,并为试纸条4提供激发光。在显示口44含有荧光探针的情况下,摄像头243在激发期间对试纸条4拍摄彩色照片。在显示口44含有长余辉发光探针的情况下,滤波片242包括由红外截止滤光片和全光谱光学玻璃构成的双滤光片切换器。由此,在激发期,双滤光片切换器将滤波片242切换到红外截止滤光片,以保护摄像头243的探测器,并对试纸条4拍摄第一彩色照片;在余辉期,长余辉发光探针发出余辉,并且双滤光片切换器将滤波片242切换到全光谱光学玻璃,以对试纸条4拍摄第二彩色 照片。第一彩色照片采集试纸条4上的感温图案信息和识别码信息,并且第二彩色照片采集试纸条4的显示口44的发光信息。彩色照片经光电信号转化后得到电信号,并通过通信模块34和通信组件25之间的连通将感温图案信息和识别码信息、以及发光信息输出至计算装置3的控制模块31。In step S2, 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. In the case where the display port 44 contains a fluorescent probe, the camera 243 takes a color photo of the test strip 4 during the excitation period. In the case that the display port 44 contains a long-lasting luminescence probe, the filter 242 includes a dual filter switch composed of an infrared cut filter and a full-spectrum optical glass. Therefore, in the excitation period, the dual filter switcher switches the filter 242 to the infrared cut filter to protect the detector of the camera 243 and take the first color photo of the test strip 4; in the afterglow period, the long The afterglow luminous probe emits afterglow, and the dual filter switcher switches the filter 242 to the full-spectrum optical glass to take a second color photo of the test strip 4. The first color photo captures the temperature sensing pattern information and identification code information on the test strip 4, and the second color photo captures the light-emitting information of the display port 44 of the test strip 4. The color photos are converted into electrical signals by photoelectric signals, and the temperature sensing pattern information, identification code information, and luminescence information are output to the control module 31 of the computing device 3 through the communication between the communication module 34 and the communication component 25.
在S3步骤,控制模块31从采集的识别码信息识别试纸条4的溯源数据,并将溯源数据输出至存储模块32。In step S3, the control module 31 identifies the traceability data of the test strip 4 from the collected identification code information, and outputs the traceability data to the storage module 32.
在S4步骤,控制模块31从存储模块32调取感温图案信息和环境温度之间的对应关系,并且从采集的感温图案信息识别试纸条4周围的环境温度T0。控制模块31包括温度校准的功能。控制模块31判断该环境温度T0与校准曲线L对应的预设温度是否相等。如果环境温度T0与多个预设温度之一相等,则控制模块31从储存模块32调取环境温度T0下发光探针发光强度-发光探针浓度的校准曲线L0。如果环境温度T0与所有预设温度均不相等,则控制模块31选择与环境温度T0上下相邻的两个预设温度T1与预设温度T2,并从储存模块32调取预设温度T1下发光探针发光强度-发光探针浓度的校准曲线L1、以及预设温度T2下发光探针发光强度-发光探针浓度的校准曲线L2。控制模块31利用校准曲线L1、得到预设温度T1下n个(n为大于1的整数,例如至少5个)发光探针浓度值对应的发光探针发光强度值,利用校准曲线L2、得到预设温度T2下n个发光探针浓度值对应的发光探针发光强度值。控制模块31利用一定的算法(例如线性内插法)从预设温度T1和T2下的n个发光探针浓度值和对应的发光探针发光强度值,得到环境温度T0下的n个发光探针浓度值和对应的发光探针发光强度值,由此模拟出环境温度T0下发光探针发光强度-发光探针浓度的校准曲线L0,例如通过线性模拟软件,诸如使用对数logit-log4p模型或样条曲线Spline函数。In step S4, the control module 31 retrieves the corresponding relationship between the temperature sensing pattern information and the ambient temperature from the storage module 32, and recognizes the ambient temperature T0 around the test strip 4 from the collected temperature sensing pattern information. The control module 31 includes a temperature calibration function. The control module 31 determines whether the ambient temperature T0 is equal to the preset temperature corresponding to the calibration curve L. If the ambient temperature T0 is equal to one of the plurality of preset temperatures, the control module 31 retrieves the calibration curve L0 of the luminescence probe luminescence intensity-the luminescence probe concentration at the ambient temperature T0 from the storage module 32. If the ambient temperature T0 is not equal to all preset temperatures, the control module 31 selects two preset temperatures T1 and T2 adjacent to the ambient temperature T0, and retrieves the preset temperature T1 from the storage module 32 The calibration curve L1 of luminescence probe luminescence intensity-luminescence probe concentration and the calibration curve L2 of luminescence probe luminescence intensity-luminescence probe concentration at the preset temperature T2. The control module 31 uses the calibration curve L1 to obtain n (n is an integer greater than 1, for example, at least 5) luminescence probe luminescence intensity values corresponding to the preset temperature T1, and uses the calibration curve L2 to obtain the preset temperature T1. Suppose the luminescence intensity value of the luminescence probe corresponding to the n luminescence probe concentration values at the temperature T2. The control module 31 uses a certain algorithm (such as linear interpolation) to obtain the n luminescence probe concentration values at the preset temperature T1 and T2 and the corresponding luminescence probe luminescence intensity value to obtain n luminescence probes at the ambient temperature T0. The needle concentration value and the corresponding luminescence probe luminescence intensity value, thereby simulating the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at ambient temperature T0, for example, by linear simulation software, such as using a logit-log4p model Or the spline curve Spline function.
控制模块31根据环境温度T0下发光探针发光强度-发光探针浓度的校准曲线L0和测得的发光探针发光强度,拟合得到发光探针浓度。The control module 31 fits and obtains the luminescence probe concentration according to the calibration curve L0 of the luminescence probe luminescence intensity-the luminescence probe concentration under the ambient temperature T0 and the measured luminescence probe luminescence intensity.
在S5步骤,输出模块33将发光探针浓度和/或溯源数据输出,例如显示在计算装置3的显示屏上。In step S5, the output module 33 outputs the luminescent probe concentration and/or traceability data, for example, to display on the display screen of the computing device 3.
举例说明,预设温度可以例如包括10℃、20℃、25℃、30℃、35℃、37℃、39℃与42℃等。在如上预设温度下分别测量至少5个发光探针浓度下的发光探针发光强度,将测得的点通过线性模拟软件模拟,得到如上预设温度(例如包括10℃、20℃、25℃、30℃、35℃、37℃、39℃与42℃)下发光探针发光强度-发光探针浓度的校准曲线L, 并储存在储存模块32中。之后,如图6所示,控制模块31从储存模块32调取与感温图案信息对应的环境温度,并且得到环境温度为27℃。环境温度27℃与任一个预设温度都不相等,因此,控制模块31选择与环境温度27℃上下相邻的预设温度25℃和30℃,并从储存模块32调取预设温度25℃下发光探针发光强度-发光探针浓度的校准曲线L1、预设温度30℃下发光探针发光强度-发光探针浓度的校准曲线L2。控制模块31利用校准曲线L1得到预设温度25℃下6个发光探针浓度对应的6个发光探针发光强度,利用校准曲线L2得到预设温度30℃下6个发光探针浓度对应的6个发光探针发光强度。控制模块31从上述数据利用线性内插法计算得到27℃度下6个发光探针浓度对应的6个发光探针发光强度,并通过对数logit-log4p模型或样条曲线Spline函数模拟出27℃下发光探针发光强度-发光探针浓度的校准曲线L0。控制模块31根据校准曲线L0和测得的发光探针发光强度,拟合得到发光探针浓度。输出模块33将发光探针浓度和/或溯源数据显示在计算装置3的显示屏上。For example, the preset temperature may include 10°C, 20°C, 25°C, 30°C, 35°C, 37°C, 39°C, 42°C, and so on. Measure the luminescence intensity of the luminescence probe at the concentration of at least 5 luminescence probes at the above preset temperature, and simulate the measured points with linear simulation software to obtain the above preset temperature (for example, including 10℃, 20℃, 25℃). , 30°C, 35°C, 37°C, 39°C, 39°C, and 42°C) and store the calibration curve L of the luminescence probe luminescence intensity-luminescence probe concentration at the storage module 32. After that, as shown in FIG. 6, the control module 31 retrieves the environment temperature corresponding to the temperature sensing pattern information from the storage module 32, and obtains that the environment temperature is 27°C. The ambient temperature of 27°C is not equal to any of the preset temperatures. Therefore, the control module 31 selects the preset temperatures of 25°C and 30°C, which are adjacent to the ambient temperature of 27°C, and retrieves the preset temperature of 25°C from the storage module 32 Lower luminescent probe luminescence intensity-luminescence probe concentration calibration curve L1, luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at a preset temperature of 30°C. The control module 31 uses the calibration curve L1 to obtain the luminescence intensities of the 6 luminescent probes corresponding to the 6 luminescent probe concentrations at a preset temperature of 25°C, and uses the calibration curve L2 to obtain the 6 luminescence probe concentrations corresponding to the 6 luminescent probe concentrations at the preset temperature of 30°C. The luminescence intensity of a luminescent probe. The control module 31 uses the linear interpolation method to calculate the luminescence intensity of the 6 luminescence probes corresponding to the concentration of the 6 luminescence probes at 27°C from the above data, and simulates 27 through the logit-log4p model or the spline function. The calibration curve L0 of luminescence probe luminescence intensity-luminescence probe concentration at ℃. The control module 31 fits and obtains the concentration of the luminescence probe according to the calibration curve L0 and the measured luminescence intensity of the luminescence probe. The output module 33 displays the luminescent probe concentration and/or traceability data on the display screen of the computing device 3.
根据本公开实施例的免疫层析试纸条即时检测***测量速度快,并且测量较为精确。The instant detection system for immunochromatographic test strips according to the embodiments of the present disclosure has fast measurement speed and relatively accurate measurement.
根据本公开实施例的免疫层析试纸条即时检测***的信息采集装置省去了占用空间较大的处理器和扫描装置,可以将装置做到仅有手掌大小,极大程度地增加其便利性。The information collection device of the instant detection system for immunochromatographic test strips according to the embodiments of the present disclosure eliminates the need for a processor and scanning device that occupies a large space, and the device can be only palm-sized, greatly increasing its convenience Sex.
根据本公开实施例的免疫层析试纸条即时检测***将处理工作交由手机中的处理器来完成。手机也是5G、大数据和人工智能等未来通讯、网络和信息处理核心技术的终端,采用该类型终端有利于将免疫检测数据直接与这些技术对接。According to the instant detection system for immunochromatographic test strips according to the embodiment of the present disclosure, the processing work is handed over 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.
根据本公开实施例的免疫层析试纸条即时检测***采用感温变色油墨测量环境温度。感温变色油墨对温度较为敏感(温度分辨率小于1℃),可以真实、有效与可重复地进行温度辨识。感温变色油墨可以便捷地印刷在试纸条上,并且采集感温图案信息的过程可以与采集发光信息的过程同时进行。The instant detection system for immunochromatographic test strips according to the embodiments of the present disclosure uses thermochromic ink to measure the ambient temperature. Thermochromic inks are more sensitive to temperature (the temperature resolution is less than 1°C), and temperature identification can be carried out in a true, effective and repeatable manner. The thermochromic ink can be conveniently printed on the test strip, and the process of collecting the temperature-sensitive pattern information can be carried out at the same time as the process of collecting the luminous information.
根据本公开实施例的免疫层析试纸条即时检测***预存了多个预设温度下待检试纸条的发光探针发光强度-发光探针浓度的校准曲线,并且采用线性内插法和线性模拟软件得到环境温度下的校准曲线。根据实际的对比试验,本公开在发光探针浓度测量的准确度上得到了显著提高。The instant detection system for immunochromatographic test strips according to the embodiments of the present disclosure prestores calibration curves of luminescence probe luminescence intensity-luminescence probe concentration of the test strips to be tested at preset temperatures, and adopts linear interpolation and The linear simulation software obtains the calibration curve at ambient temperature. According to actual comparative experiments, the present disclosure has significantly improved the accuracy of luminescent probe concentration measurement.
虽然已经描述了本公开的示范实施例,但是本领域技术人员应当理解的是,在本质上不脱离本公开的精神和范围的情况下能够对本公开的示范实施例进行多种变化 和改变。因此,所有变化和改变均包含在权利要求所限定的本公开的保护范围内。本公开由附加的权利要求限定,并且这些权利要求的等同物也包含在内。Although the exemplary embodiments of the present disclosure have been described, those skilled in the art should understand that various changes and changes can be made to the exemplary embodiments of the present disclosure without substantially departing from the spirit and scope of the present disclosure. Therefore, all changes and changes are included in the protection scope of the present disclosure defined by the claims. The present disclosure is defined by the appended claims, and equivalents of these claims are also included.

Claims (25)

  1. 一种免疫层析试纸条即时检测***,其特征在于:A real-time detection system for immunochromatographic test strips, which is characterized in:
    所述免疫层析试纸条即时检测***包括彼此分离开的信息采集装置和计算装置,试纸条包括发光区域,试纸条和/或信息采集装置包括感温图案;The immunochromatographic test strip instant detection system includes an information collection device and a computing device that are separated from each other, the test strip includes a light-emitting area, and the test strip and/or the information collection device includes a temperature sensing pattern;
    信息采集装置包括采集组件和第一通信组件,所述采集组件对试纸条发送激发光,采集试纸条的发光区域的发光信息和感温图案信息,并且所述第一通信组件将采集到的试纸条的发光区域的发光信息和感温图案信息发送至计算装置,所述发光信息包括试纸条的发光区域的发光强度;The information collection device includes a collection component and a first communication component. The collection component sends excitation light to the test strip, collects luminescence information and temperature sensing pattern information of the light-emitting area of the test strip, and the first communication component collects Sending the luminescence information and the temperature sensing pattern information of the luminous area of the test strip to the computing device, where the luminescence information includes the luminous intensity of the luminous area of the test strip;
    计算装置包括控制模块、存储模块、第二通信模块和输出模块,所述存储模块储存感温图案信息和环境温度之间的对应关系、以及多个预设温度下发光探针发光强度-发光探针浓度校准曲线,并且所述第二通信模块和第一通信组件以无线方式或有线方式彼此连通,The computing device includes a control module, a storage module, a second communication module, and an output module. The storage module stores the corresponding relationship between the temperature sensing pattern information and the ambient temperature, and the luminous intensity of the luminescent probe at a plurality of preset temperatures. Needle concentration calibration curve, and the second communication module and the first communication component communicate with each other in a wireless or wired manner,
    其中,控制模块通过第一通信组件和第二通信模块之间的连通获得试纸条的发光区域的发光信息和感温图案信息,控制模块从存储模块调取感温图案信息和环境温度之间的对应关系,以得到试纸条周围的环境温度T0,并且控制模块判断环境温度T0与所述多个预设温度之一是否相等:Wherein, the control module obtains the light-emitting information and temperature-sensing pattern information of the light-emitting area of the test strip through the communication between the first communication component and the second communication module, and the control module retrieves the temperature-sensing pattern information and the ambient temperature from the storage module. To obtain the ambient temperature T0 around the test strip, and the control module determines whether the ambient temperature T0 is equal to one of the plurality of preset temperatures:
    在环境温度T0与所述多个预设温度之一相等的情况下,控制模块从存储模块调取环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0;In the case where the ambient temperature T0 is equal to one of the plurality of preset temperatures, the control module retrieves the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at the ambient temperature T0 from the storage module;
    在环境温度T0与所述多个预设温度中任一个均不相等的情况下,控制模块选择与环境温度T0上下相邻的预设温度T1与预设温度T2,并从储存模块调取预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1、以及预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2,控制模块通过预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1和预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2模拟出环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0;In the case that the ambient temperature T0 is not equal to any one of the plurality of preset temperatures, the control module selects the preset temperature T1 and the preset temperature T2 adjacent to the ambient temperature T0, and retrieves the preset temperature from the storage module Set the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L1 at temperature T1 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2, and the control module passes the luminescence at the preset temperature T1 Probe luminescence intensity-luminescence probe concentration calibration curve L1 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 simulates the luminescence probe luminescence intensity-luminescence probe concentration calibration at ambient temperature T0 Curve L0;
    控制模块根据环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0和获得的试纸条的发光区域的发光信息,拟合得到试纸条的发光区域的发光探针浓度值,并通过输出模块将试纸条的发光区域的发光探针浓度值输出。The control module fits and obtains the luminescence probe concentration value of the luminescence area of the test strip according to the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 under the ambient temperature T0 and the obtained luminescence information of the luminescence area of the test strip, And output the luminescence probe concentration value of the luminescence area of the test strip through the output module.
  2. 根据权利要求1所述的免疫层析试纸条即时检测***,其特征在于:控制模块利用预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1、得到预设温度T1下n个发光探针浓度值对应的n个发光探针发光强度值,利用预设温度T2下的发 光探针发光强度-发光探针浓度校准曲线L2、得到预设温度T2下所述n个发光探针浓度值对应的n发光探针发光强度值,控制模块从预设温度T1下的所述n个发光探针浓度值和对应的n个发光探针发光强度值、和预设温度T2下的所述n个发光探针浓度值和对应的n个发光探针发光强度值,通过线性内插法得到环境温度T0下的所述n个发光探针浓度值和对应的发光探针发光强度值,其中,n为大于1的整数。The immunochromatographic test strip real-time detection system according to claim 1, wherein the control module uses the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L1 at the preset temperature T1 to obtain the calibration curve L1 at the preset temperature T1. n luminescence probe luminescence intensity values corresponding to n luminescence probe concentration values, use the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 to obtain the n luminescence at the preset temperature T2 The n luminescence probe luminescence intensity value corresponding to the probe concentration value, and the control module starts from the n luminescence probe concentration values at the preset temperature T1 and the corresponding n luminescence probe luminescence intensity values, and the preset temperature T2 The concentration values of the n luminescent probes and the corresponding luminescence intensity values of the n luminescence probes are obtained by linear interpolation to obtain the concentration values of the n luminescence probes and the corresponding luminescence probe luminescence intensity at the ambient temperature T0 Value, where n is an integer greater than 1.
  3. 根据权利要求2所述的免疫层析试纸条即时检测***,其特征在于:控制模块从环境温度T0下的所述n个发光探针浓度值和对应的发光探针发光强度值,通过使用对数logit-log4p模型或样条曲线Spline函数模拟出环境温度T0下的发光探针发光强度-发光探针浓度的校准曲线L0。The immunochromatographic test strip instant detection system according to claim 2, wherein the control module obtains the concentration values of the n luminescence probes and the corresponding luminescence intensity values of the luminescence probes at ambient temperature T0 by using The logit-log4p model or the Spline function of the spline curve simulates the calibration curve L0 of the luminescence intensity of the luminescence probe-the concentration of the luminescence probe under the ambient temperature T0.
  4. 根据权利要求1所述的免疫层析试纸条即时检测***,其特征在于:感温图案由感温变色油墨制成。The instant detection system for immunochromatographic test strips according to claim 1, wherein the temperature-sensitive pattern is made of temperature-sensitive color-changing ink.
  5. 根据权利要求4所述的免疫层析试纸条即时检测***,其特征在于:感温变色油墨包括胆甾型液晶感温油墨。The instant detection system for immunochromatographic test strips according to claim 4, wherein the temperature-sensitive color-changing ink comprises a cholesteric liquid crystal temperature-sensitive ink.
  6. 根据权利要求4所述的免疫层析试纸条即时检测***,其特征在于:感温图案包括多个邻接的小块,每个小块因感温变色油墨的材料配比不同而在各自不同的临界温度变色。The instant detection system for immunochromatographic test strips according to claim 4, wherein the temperature sensing pattern includes a plurality of adjacent small blocks, and each small block is different due to the different material ratio of the temperature-sensitive color-changing ink. Discoloration at the critical temperature.
  7. 根据权利要求1所述的免疫层析试纸条即时检测***,其特征在于:发光信息包括试纸条上的荧光探针发出的荧光的发光强度。The instant detection system for immunochromatographic test strips according to claim 1, wherein the luminescence information includes the luminescence intensity of the fluorescence emitted by the fluorescent probes on the test strips.
  8. 根据权利要求1所述的免疫层析试纸条即时检测***,其特征在于:发光信息包括试纸条上的长余辉发光探针发出的余辉的发光强度。The instant detection system for immunochromatographic test strips according to claim 1, wherein the luminescence information includes the luminescence intensity of the afterglow emitted by the long afterglow luminescence probe on the test strip.
  9. 根据权利要求1-8中任一项所述的免疫层析试纸条即时检测***,其特征在于:试纸条的卡壳设有识别码,所述识别码包含与标本样品绑定的溯源数据;The instant detection system for immunochromatographic test strips according to any one of claims 1-8, wherein the card shell of the test strip is provided with an identification code, and the identification code contains traceability data bound to the specimen sample ;
    和/或,采集组件构造成还采集试纸条的识别码信息,并且控制模块从识别码信息识别试纸条的溯源数据;And/or, the collection component is configured to also collect the identification code information of the test strip, and the control module identifies the traceability data of the test strip from the identification code information;
    和/或,识别码是二维码或者条形码。And/or, the identification code is a two-dimensional code or a barcode.
  10. 根据权利要求1-8中任一项所述的免疫层析试纸条即时检测***,其特征在于:第一通信组件和第二通信模块是配合使用的无线通信器件或者有线通信器件。The instant detection system for immunochromatographic test strips according to any one of claims 1-8, wherein the first communication component and the second communication module are wireless communication devices or wired communication devices that are used in conjunction.
  11. 根据权利要求1-8中任一项所述的免疫层析试纸条即时检测***,其特征在于:采集组件包括光源、滤波片和摄像头,光源构造成对试纸条发送激发光,并且摄像头构造成透过滤波片对试纸条拍摄彩色照片;The immunochromatographic test strip instant detection system according to any one of claims 1-8, wherein the collection component includes a light source, a filter and a camera, the light source is configured to send excitation light to the test strip, and the camera Structured to take a color photo of the test strip through the filter;
    和/或,试纸条放置成与摄像头和滤波片相对,并且光源设置成偏离摄像头和滤 波片、以及试纸条之间的彼此相对的路径;And/or, the test strip is placed opposite to the camera and the filter, and the light source is set to deviate from the path between the camera, the filter, and the test strip opposite to each other;
    和/或,光源为带有光阑的LED灯;And/or, the light source is an LED lamp with a diaphragm;
    和/或,摄像头为广角数字摄像头。And/or, the camera is a wide-angle digital camera.
  12. 根据权利要求1-8中任一项所述的免疫层析试纸条即时检测***,其特征在于:信息采集装置包括上壳体和下壳体,上壳体和下壳体配合在一起以在内部形成避光的空腔;The instant detection system for immunochromatographic test strips according to any one of claims 1-8, wherein the information collection device comprises an upper housing and a lower housing, and the upper housing and the lower housing cooperate to A light-proof cavity is formed inside;
    和/或,避光空腔内设置有支撑架,并且支撑架固定在下壳体上;And/or, a support frame is arranged in the light-proof cavity, and the support frame is fixed on the lower shell;
    和/或,支撑架包括多个隔层,所述多个隔层构造成支撑信息采集装置的多个零件;And/or, the support frame includes a plurality of compartments configured to support a plurality of parts of the information collection device;
    和/或,信息采集装置包括试纸条接收槽,所述试纸条接收槽固定至上壳体或下壳体,并且在相应壳体上开口,以接收***的试纸条。And/or, the information collection device includes a test strip receiving groove, the test strip receiving groove is fixed to the upper casing or the lower casing and opens on the corresponding casing to receive the inserted test strip.
  13. 根据权利要求1-8中任一项所述的荧光免疫层析试纸条即时检测***,其特征在于:信息采集装置包括电源组件,所述电源组件对信息采集装置供电。The instant detection system for fluorescence immunochromatographic test strips according to any one of claims 1-8, wherein the information collection device comprises a power supply component, and the power supply component supplies power to the information collection device.
  14. 根据权利要求1-8中任一项所述的免疫层析试纸条即时检测***,其特征在于:信息采集装置的长度不大于10cm,宽度不大于8cm,高度不大于10cm。The instant detection system for immunochromatographic test strips according to any one of claims 1-8, wherein the length of the information collection device is not greater than 10 cm, the width is not greater than 8 cm, and the height is not greater than 10 cm.
  15. 根据权利要求1-8中任一项所述的免疫层析试纸条即时检测***,其特征在于:计算装置是安装有检测程序的移动终端,或者计算装置的一部分设置在安装有检测程序的移动终端中、另一部分设置在与移动终端连通的服务器中。The instant detection system for immunochromatographic test strips according to any one of claims 1-8, wherein the computing device is a mobile terminal installed with a detection program, or a part of the computing device is installed in a device where the detection program is installed. The other part of the mobile terminal is set in a server connected to the mobile terminal.
  16. 根据权利要求1-8中任一项所述的免疫层析试纸条即时检测***,其特征在于:试纸条包括卡壳和设置在卡壳内的硝酸纤维素膜,卡壳具有沿轴向间隔开的上样口和显示口,显示口为所述发光区域。The instant detection system for immunochromatographic test strips according to any one of claims 1-8, wherein the test strip comprises a card housing and a nitrocellulose membrane arranged in the card housing, and the card housing has axially spaced apart The sample loading port and display port of, the display port is the light-emitting area.
  17. 一种利用免疫层析试纸条即时检测***对试纸条进行即时检测方法,其特征在于,所述方法包括以下步骤:A method for instant detection of test strips using an immunochromatographic test strip instant detection system, characterized in that the method includes the following steps:
    将试纸条***信息采集装置中,并且在计算装置中开启检测命令;Insert the test strip into the information collection device, and start the detection command in the computing device;
    信息采集装置对试纸条发送激发光,并采集试纸条的发光区域的发光信息和感温图案信息,所述发光信息包括试纸条的发光区域的发光强度;The information collection device sends excitation light to the test strip, and collects luminescence information and temperature sensing pattern information of the light-emitting area of the test strip, the light-emitting information including the luminous intensity of the light-emitting area of the test strip;
    计算装置通过信息采集装置和计算装置之间的无线方式连通或有线方式连通获得试纸条的发光区域的发光信息和感温图案信息;The computing device obtains the luminescence information and the temperature sensing pattern information of the luminous area of the test strip through wireless or wired communication between the information collection device and the computing device;
    计算装置基于预设的感温图案信息和环境温度之间的对应关系,得到试纸条周围的环境温度T0,并且计算装置判断环境温度T0与所述多个预设温度之一是否相等:The computing device obtains the ambient temperature T0 around the test strip based on the preset corresponding relationship between the temperature sensing pattern information and the ambient temperature, and the computing device determines whether the ambient temperature T0 is equal to one of the plurality of preset temperatures:
    在环境温度T0与所述多个预设温度之一相等的情况下,计算装置调取环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0;In the case that the ambient temperature T0 is equal to one of the plurality of preset temperatures, the calculation device retrieves the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at the ambient temperature T0;
    在环境温度T0与所述多个预设温度中任一个均不相等的情况下,计算装置选择与环境温度T0上下相邻的预设温度T1与预设温度T2,并调取预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1、以及预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2,计算装置通过预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1和预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2模拟出环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0;In the case that the ambient temperature T0 is not equal to any one of the plurality of preset temperatures, the computing device selects the preset temperature T1 and the preset temperature T2 adjacent to the ambient temperature T0, and calls the preset temperature T1 The luminescence probe luminescence intensity-luminescence probe concentration calibration curve L1 under the preset temperature T2 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2, and the calculation device emits light through the luminescence probe at the preset temperature T1 The intensity-luminescence probe concentration calibration curve L1 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 simulates the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at ambient temperature T0;
    计算装置根据环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0和获得的试纸条的发光区域的发光信息,拟合得到试纸条的发光区域的发光探针浓度值,并将试纸条的发光区域的发光探针浓度值输出。The calculation device fits the luminescence probe concentration value of the luminescence area of the test strip according to the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at ambient temperature T0 and the obtained luminescence information of the luminescence area of the test strip, And output the luminescence probe concentration value of the luminescence area of the test strip.
  18. 根据权利要求17所述的检测方法,其特征在于:信息采集装置在发送激发光期间采集试纸条的识别码信息,并且计算装置从识别码信息识别试纸条的溯源数据,并将试纸条的溯源数据输出。The detection method according to claim 17, wherein the information collecting device collects the identification code information of the test strip during the period of sending the excitation light, and the computing device recognizes the traceability data of the test strip from the identification code information, and integrates the test strip The traceability data output of the article.
  19. 根据权利要求17或18所述的检测方法,其特征在于:所述免疫层析试纸条即时检测***是根据权利要求1-24中任一项所述的免疫层析试纸条即时检测***。The detection method according to claim 17 or 18, wherein the instant detection system for immunochromatography test strips is the instant detection system for immunochromatography test strips according to any one of claims 1-24 .
  20. 一种免疫层析试纸条即时检测方法,其特征在于,所述方法包括以下步骤:An instant detection method for immunochromatographic test strips, characterized in that the method comprises the following steps:
    接收试纸条的发光区域的发光信息和感温图案信息;Receiving the light-emitting information and temperature-sensing pattern information of the light-emitting area of the test strip;
    基于预设的感温图案信息和环境温度之间的对应关系,得到试纸条周围的环境温度T0,并且判断环境温度T0与多个预设温度之一是否相等:Based on the corresponding relationship between the preset temperature sensing pattern information and the ambient temperature, the ambient temperature T0 around the test strip is obtained, and it is determined whether the ambient temperature T0 is equal to one of the plurality of preset temperatures:
    在环境温度T0与所述多个预设温度之一相等的情况下,调取预设的环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0;In the case that the ambient temperature T0 is equal to one of the plurality of preset temperatures, call the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at the preset ambient temperature T0;
    在环境温度T0与所述多个预设温度中任一个均不相等的情况下,选择与环境温度T0上下相邻的预设温度T1与预设温度T2,并调取预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1、以及预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2,通过预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1和预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2模拟出环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0;In the case that the ambient temperature T0 is not equal to any one of the plurality of preset temperatures, select the preset temperature T1 and the preset temperature T2 adjacent to the ambient temperature T0, and call the preset temperature T1 Luminescence probe luminescence intensity-luminescence probe concentration calibration curve L1, and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2, through the luminescence probe luminescence intensity-luminescence probe luminescence intensity at the preset temperature T1 The needle concentration calibration curve L1 and the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 simulate the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at ambient temperature T0;
    根据环境温度T0下的发光探针发光强度-发光探针浓度校准曲线L0和获得的试纸条的发光区域的发光信息,拟合得到试纸条的发光区域的发光探针浓度值,并将试 纸条的发光区域的发光探针浓度值输出。According to the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L0 at ambient temperature T0 and the obtained luminescence information of the luminescence area of the test strip, the luminescence probe concentration value of the luminescence area of the test strip is fitted, and the The concentration value of the luminescence probe in the luminescence area of the test strip is output.
  21. 根据权利要求20所述的检测方法,其特征在于:利用预设温度T1下的发光探针发光强度-发光探针浓度校准曲线L1、得到预设温度T1下n个发光探针浓度值对应的n个发光探针发光强度值,利用利用预设温度T2下的发光探针发光强度-发光探针浓度校准曲线L2、得到预设温度T2下所述n个发光探针浓度值对应的n个发光探针发光强度值,从预设温度T1下的所述n个发光探针浓度值和对应的发光探针发光强度值、和预设温度T2下的所述n个发光探针浓度值和对应的发光探针发光强度值,通过线性内插法得到环境温度T0下的所述n个发光探针浓度值和对应的发光探针发光强度值,其中,n为大于1的整数。The detection method according to claim 20, characterized in that: using the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L1 at a preset temperature T1 to obtain n luminescence probe concentration values corresponding to the preset temperature T1 n luminescence probe luminescence intensity values, using the luminescence probe luminescence intensity-luminescence probe concentration calibration curve L2 at the preset temperature T2 to obtain n corresponding to the n luminescence probe concentration values at the preset temperature T2 The luminescence intensity value of the luminescence probe is calculated from the n luminescence probe concentration values and the corresponding luminescence probe luminescence intensity values at the preset temperature T1, and the n luminescence probe concentration values at the preset temperature T2 and The corresponding luminescence probe luminescence intensity value is obtained by linear interpolation to obtain the n luminescence probe concentration values and the corresponding luminescence probe luminescence intensity value at ambient temperature T0, where n is an integer greater than 1.
  22. 根据权利要求20所述的检测方法,其特征在于:从环境温度T0下的所述n个发光探针浓度值和对应的n个发光探针发光强度值,通过使用对数logit-log4p模型或样条曲线Spline函数模拟出环境温度T0下的发光探针发光强度-发光探针浓度的校准曲线L0。The detection method according to claim 20, characterized in that: from the n luminescent probe concentration values and the corresponding n luminescent probe luminescence intensity values at ambient temperature T0, by using a logit-log4p model or The Spline function of the spline curve simulates the calibration curve L0 of the luminescence intensity of the luminescence probe-the concentration of the luminescence probe under the ambient temperature T0.
  23. 根据权利要求20-22中任一项所述的检测方法,其特征在于:接收试纸条的识别码信息,并且从识别码信息识别试纸条的溯源数据,并将试纸条的溯源数据输出。The detection method according to any one of claims 20-22, wherein the identification code information of the test strip is received, and the traceability data of the test strip is identified from the identification code information, and the traceability data of the test strip is identified Output.
  24. 一种计算装置,其特征在于,所述计算装置包括:A computing device, characterized in that the computing device includes:
    一个或多个处理器;以及One or more processors; and
    一个或多个存储模块,所述一个或多个存储模块被配置为存储一系列计算机可执行的指令以及与所述一系列计算机可执行的指令相关联的计算机可访问的数据,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,
    其中,当所述一系列计算机可执行的指令被所述一个或多个处理器执行时,使得所述一个或多个处理器进行如权利要求20-23中任一项所述的方法。Wherein, when the series of computer-executable instructions are executed by the one or more processors, the one or more processors are caused to perform the method according to any one of claims 20-23.
  25. 一种非临时性计算机可读存储介质,其特征在于,所述非临时性计算机可读存储介质上存储有一系列计算机可执行的指令,当所述一系列计算机可执行的指令被一个或多个计算装置执行时,使得所述一个或多个计算装置进行如权利要求20-23中任一项所述的方法。A non-transitory computer-readable storage medium, characterized in that a series of computer-executable instructions are stored on the non-transitory computer-readable storage medium, and when the series of computer-executable instructions is replaced by one or more When executed by the computing device, the one or more computing devices are caused to perform the method according to any one of claims 20-23.
PCT/CN2020/071459 2020-01-10 2020-01-10 Point-of-care testing system for immunochromatographic strip WO2021138902A1 (en)

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CN208833768U (en) * 2018-06-29 2019-05-07 江苏达骏生物科技有限公司 Optical signal detecting device and system
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US5972715A (en) * 1996-12-23 1999-10-26 Bayer Corporation Use of thermochromic liquid crystals in reflectometry based diagnostic methods
CN101743467A (en) * 2007-06-04 2010-06-16 马里兰大学生物技术研究所 Fluorescence microscope in a microwave cavity
CN103091486A (en) * 2011-11-01 2013-05-08 马义才 Test strip detection system
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