CN114965995A - Immunochromatography analysis detection system and method - Google Patents

Immunochromatography analysis detection system and method Download PDF

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CN114965995A
CN114965995A CN202210560647.4A CN202210560647A CN114965995A CN 114965995 A CN114965995 A CN 114965995A CN 202210560647 A CN202210560647 A CN 202210560647A CN 114965995 A CN114965995 A CN 114965995A
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CN114965995B (en
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张玉芹
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Henan Shenyou Medical Laboratory Co ltd
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Beijing Hezicheng Technology Co ltd
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    • 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
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Abstract

The invention discloses an immunochromatographic analysis detection system and method, which relate to the field of immunochromatographic analysis and comprise a box body, wherein a plurality of detection channels are arranged in the box body, a driving module is arranged on the upper side of the box body, a moving module and a separating module are arranged in each of the plurality of detection channels, and the separating module divides the corresponding detection channel into a channel I and a channel II; the driving module comprises a plurality of output ends extending to the interior of the corresponding detection channel, and the plurality of output ends are provided with detection position modules; the detection position modules are used for driving the detection test paper to contact with the sample and move along the corresponding detection channels. According to the invention, different spaces can be formed in a single detection channel through the separation module in continuous detection, and two groups of spaces have disinfection functions, so that the problem of detection errors caused by pollution can be avoided in continuous detection.

Description

Immunochromatography analysis detection system and method
Technical Field
The invention relates to the field of immunochromatography, in particular to an immunochromatography analysis detection system and method.
Background
Immunochromatography is a commonly used rapid diagnostic technique, and generally, one end of a test strip is dipped into a sample, after the end is dipped into the sample, the sample moves forwards along the membrane due to capillary action, when the test strip moves to a region where an antibody is fixed, a corresponding antigen in the sample is specifically combined with the antibody, and if immune colloidal gold is used, the region can show a certain color.
Through retrieval, the Chinese patent discloses a multichannel synchronous immunochromatographic detection system and a detection method (publication number: CN109490535B), the patent comprises a box body and a test strip, the box body is provided with a first sample adding hole and a plurality of observation windows, and a second sample adding hole is arranged between the first sample adding hole and each observation window; a plurality of percolation channels are arranged on the test strip, and the percolation channels pass through the first sample adding hole, the observation window and the lower part of the second sample adding hole; the device also comprises a motion mechanism, a photoelectric detector and a control computer, wherein the motion mechanism is used for driving the box body to do linear motion; the photoelectric detector outputs the detection result to the control computer in the form of an electric signal; and the control computer receives the detection result transmitted by the photoelectric detector to obtain the detection result of each detected sample on the test strip.
In the prior art, when a plurality of groups of samples are detected, multiple channels are generally adopted to synchronously detect the samples, but when the plurality of groups of samples are continuously detected synchronously, the problem of pollution among the samples or the channels is easily caused, and the detection result is influenced.
Disclosure of Invention
In order to solve the above technical problems, the present invention provides an immunochromatographic assay detection system comprising:
the box body is used for loading each component and module in the system, a plurality of detection channels are arranged in the box body, and the upper side of the box body is provided with a driving module;
the detection device comprises detection channels, wherein a plurality of detection channels are internally provided with a moving module and a separating module, the moving module is used for driving the separating module to move at two sides of the corresponding detection channel, and when the separating module moves to two sides of the detection channel, the corresponding detection channel is divided into a channel I and a channel II;
the driving module is provided with a plurality of output ends, the output ends respectively extend into the detection channels, and each output end of the driving module is provided with a detection position module;
the detection position modules move synchronously and are used for driving the detection test paper to contact with the sample and driving the detection test paper to move along the corresponding detection channel;
the image detection module moves synchronously with the detection position module, generates image information corresponding to the detection position module and the detection test paper in the detection position module, and transmits the image information to the processing module;
and the processing module is used for receiving and analyzing the image information to obtain detection data.
Preferably: the sample storage module is arranged inside the box body, the clamping mechanism and the first disinfection module are arranged inside the sample storage module, the clamping mechanism is used for fixing a sample, and the first disinfection module is used for disinfecting the inner space of the sample storage module when the sample is replaced, so that subsequent samples are prevented from being polluted.
Preferably: the detection device comprises a detection position module, a processing module and a control module, wherein the detection position module comprises a radio frequency identification unit and is used for identifying information corresponding to detection test paper to obtain information of detection personnel, and the information of the detection personnel is matched with detection data and then is conveyed to the processing module;
the processing module classifies and stores the information of the detection personnel and is used for assisting the detection result and the detection personnel to carry out overall planning, so that whether the detection result is related to the relevant information of the detection personnel or not is conveniently identified.
Preferably: the separation module comprises a plurality of second disinfection units which are symmetrically arranged at two sides of the separation module and are respectively marked as an X1 part and an X2 part;
the inner walls of the two sides of the channel module are divided into a part marked as A1 and a part marked as A2, the two sides corresponding to the separation module are respectively marked as B1 and B2, and the use method of the separation module comprises the following steps:
y1: the part B1 of the separation module is attached to the part A1 of the corresponding channel module, the space between the part B2 of the separation module and the part A2 of the corresponding channel module is a channel I, and the part X1 of the second disinfection unit is positioned between the part A1 and the part B1 and disinfects the inner space of the second disinfection unit;
y2: the B2 position of separating the module and the A2 position laminating that corresponds the passageway module, and the space between the B1 position of separating the module and the A1 that corresponds the passageway module is passageway II, the X2 part of second disinfection unit is located between A2 position and B2 position, and disinfects its inner space.
Preferably: the detection bit module comprises:
the clamping unit is used for clamping the test paper, driving the test paper to move, and keeping the test paper in a stable state when the test paper moves, namely the clamping unit does not move relative to the test paper;
the rotation unit, the rotation unit is used for driving the centre gripping unit and rotates for carry out the rotation of first direction and second direction respectively with test paper, when test paper carries out the rotation of first direction, contact with the sample, and when test paper carries out the rotation of second direction, with the one end perk of test paper and sample contact, avoid the sample to drip to the box body in, cause the pollution to it.
Preferably, the following components: the image detection module includes:
the image recognition unit is used for recognizing an antibody region of the detection test paper, generating image information I and image information II, transmitting the image information I to the processing module and transmitting the image information II to the gray level conversion unit;
the gray level conversion unit is used for receiving the image information II, then carrying out gray level processing on the image information to obtain gray level image information and transmitting the gray level image information to the processing module;
the processing module is provided with preset analysis data, and after receiving the image information I and the gray level image information, the processing module compares the image information I and the gray level image information with the preset analysis data to obtain detection data.
Preferably: the method for recognizing the antibody region by the image recognition unit comprises the following steps:
z1: establishing a first coordinate system in advance, establishing edge simulation information of the detection test paper according to the size information of the detection test paper, matching any end of the edge simulation information with the origin of coordinates of the first coordinate system, generating position information by surrounding the rest end points of the edge simulation information with the origin of coordinates of the first coordinate system, marking one end of the edge simulation information matched with the origin of the first coordinate system as H1, and marking an antibody area of the detection test paper in the first coordinate system according to the edge simulation information as K1;
z2: after the detection test paper to be detected and the detection position module are assembled, the image recognition unit recognizes the edge information of the detection test paper to be detected and generates edge information I to be recognized, then the edge information I to be recognized is compared with edge simulation information to obtain end point information H2 matched with a first coordinate system, meanwhile, based on the end point information H2, H2 and H1 are overlapped, the edge information I to be recognized is matched with the first coordinate system, after the matching, each coordinate point of the edge information I to be recognized on the first coordinate system is coincided with the coordinate point of the corresponding part in the edge simulation information, and meanwhile, the edge information I to be recognized generates an antibody region to be recognized marked as K2 based on the K1 region,
z3: after the detection test paper to be detected is contacted with a sample, the color of the antibody area changes, the image recognition unit recognizes the corresponding image information I in the K2 area, and the image information I is copied to obtain image information II.
The invention also discloses an immunochromatographic assay detection method, which comprises the following steps:
the method comprises the following steps: installing a plurality of groups of samples into a box body, and installing the detection test paper into each detection position module based on the classification sequence of the plurality of groups of samples;
step two: the image detection module identifies the antibody region of each detection test paper, starts the moving module in each detection channel, and moves the separation module to form a corresponding channel I or channel II;
step three: the driving module and the detection position module drive the detection test paper to incline and then contact with the sample, the detection test paper is separated from the sample after the contact, the detection test paper is kept to incline at the same angle, the holding time is S, the value range of S is 0.5-3.5S, the value of S is based on the fluidity of the sample, the higher the fluidity of the sample is, the larger the value of S is, and then the detection position module drives the detection test paper to incline in the opposite direction;
step four: the image detection module and the detection test paper rotate at the same angle, and the identified image information is transmitted to the processing module;
step five: the processing module obtains detection data based on the image information.
The invention has the technical effects and advantages that:
the detection channels are arranged in the box body, so that a plurality of samples can be detected at the same time, and in the detection process, the detection result can be matched with corresponding information based on various information of the samples, so that the relevant relevance information can be obtained while the detection is carried out;
in addition, each detection channel can form different spaces in a single detection channel through the separation module during continuous detection, and the two groups of spaces have the disinfection function, so that the problem of detection errors caused by pollution can be avoided during continuous detection;
on the other hand, the image detection module mainly identifies the antibody part region of the detection test paper when identifying the detection test paper, thereby avoiding the influence of other parts of the detection test paper on image identification, and also producing a gray image when carrying out image identification, thereby further improving the accuracy of the image identification.
Drawings
FIG. 1 is a system diagram of an immunochromatographic assay detection system of the present invention.
The present invention will be described in further detail with reference to the accompanying drawings and specific embodiments. The embodiments of the present invention have been presented for purposes of illustration and description, and are not intended to be exhaustive or limited to the invention in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art. The embodiment was chosen and described in order to best explain the principles of the invention and the practical application, and to enable others of ordinary skill in the art to understand the invention for various embodiments with various modifications as are suited to the particular use contemplated.
Detailed Description
The following examples are included:
example 1
Referring to fig. 1, an immunochromatographic assay detection system includes a cartridge, a detection channel, a driving module, a detection position module, an image detection module, and a processing module;
the box body is used for each component and the module in the loading system, the inside a plurality of detection channel that is provided with of box body, and the drive module is installed to the upside of box body, the inside of box body is provided with sample storage module, inside fixture and the first disinfection module of being provided with of sample storage module, fixture is used for fixing the sample, first disinfection module is used for when changing the sample, disinfects the inner space of sample storage module, avoids follow-up sample to be contaminated.
The mobile modules are used for driving the separation modules to move at two sides of the corresponding detection channels, and when the separation modules move to two sides of the detection channels, the interiors of the corresponding detection channels are respectively divided into a channel I and a channel II;
the driving module is provided with a plurality of output ends which respectively extend into each detection channel, and each output end of the driving module is provided with a detection position module;
the detection position modules move synchronously, and the detection position modules are used for driving the detection test paper to contact with the sample and driving the detection test paper to move along the corresponding detection channel;
the image detection module and the detection position module move synchronously, generate image information corresponding to the detection position module and the detection test paper in the detection position module, and transmit the image information to the processing module;
the processing module is used for receiving and analyzing the image information to obtain detection data.
The detection device comprises a detection position module, a processing module and a display module, wherein the sample is classified according to any one group or combination of multiple groups of region information, occupation information, age information and gender information, a radio frequency module is installed in the detection test paper and used for recording any one group or combination of multiple groups of region information, occupation information, age information and gender information, when in detection, the corresponding detection test paper is selected according to various information of the sample, and the detection position module comprises a radio frequency identification unit and is used for identifying the information of the corresponding detection test paper to obtain the information of detection personnel, and the information of the detection personnel is matched with the detection data and then is transmitted to the processing module;
the processing module classifies and stores the information of the detection personnel and is used for assisting the detection result and the detection personnel to carry out overall planning, so that whether the detection result is related to the relevant information of the detection personnel or not is conveniently identified.
The separation module comprises a plurality of second disinfection units which are symmetrically arranged at two sides of the separation module and are respectively marked as an X1 part and an X2 part.
The inner walls of the two sides of the channel module are divided into a part marked as A1 and a part marked as A2, the two sides of the corresponding separation module are respectively marked as B1 and B2, and the use method of the separation module comprises the following steps:
y1: the B1 part of the separation module is attached to the A1 part of the corresponding channel module, the space between the B2 part of the separation module and the A2 part of the corresponding channel module is a channel I, and the X1 part of the second disinfection unit is positioned between the A1 part and the B1 part and disinfects the channel I;
y2: the B2 part of the separation module is attached to the A2 part of the corresponding channel module, the space between the B1 part of the separation module and the A1 part of the corresponding channel module is a channel II, and the X2 part of the second disinfection unit is positioned between the A2 part and the B2 part and disinfects the channel II.
The detection position module comprises:
the clamping unit is used for clamping the detection test paper, driving the detection test paper to move, and keeping the detection test paper in a stable state when the detection test paper moves, namely the clamping unit does not move relative to the detection test paper;
the rotation unit, the rotation unit is used for driving the centre gripping unit and rotates for carry out the rotation of first direction and second direction respectively with test paper, when test paper carries out the rotation of first direction, contact with the sample, and when test paper carries out the rotation of second direction, with the one end perk of test paper and sample contact, avoid the sample to drip to the box body in, cause the pollution to it.
The image detection module includes:
the image recognition unit is used for recognizing an antibody region of the detection test paper, generating image information I and image information II, transmitting the image information I to the processing module and transmitting the image information II to the gray level conversion unit;
the gray level conversion unit is used for receiving the image information II, then carrying out gray level processing on the image information to obtain gray level image information and transmitting the gray level image information to the processing module;
the processing module is provided with preset analysis data, and after the processing module receives the image information I and the gray image information, the image information I and the gray image information are compared with the preset analysis data to obtain detection data.
A method for recognizing an antibody region by an image recognition unit, comprising the steps of:
z1: establishing a first coordinate system in advance, establishing edge simulation information of the detection test paper according to the size information of the detection test paper, matching any end of the edge simulation information with the origin of coordinates of the first coordinate system, generating position information in the first coordinate system, marking an end of the edge simulation information matched with the origin of the first coordinate system as H1, and marking an antibody area of the detection test paper in the first coordinate system as K1 according to the edge simulation information;
z2: after the detection test paper to be detected and the detection position module are assembled, the image recognition unit recognizes the edge information of the detection test paper to be detected and generates edge information I to be recognized, then the edge information I to be recognized is compared with edge simulation information to obtain end point information H2 matched with a first coordinate system, meanwhile, based on the end point information H2, H2 and H1 are overlapped, the edge information I to be recognized is matched with the first coordinate system, after the matching, each coordinate point of the edge information I to be recognized on the first coordinate system is coincided with the coordinate point of the corresponding part in the edge simulation information, and meanwhile, the edge information I to be recognized generates an antibody region to be recognized marked as K2 based on the K1 region,
z3: after the detection test paper to be detected contacts with the sample, the antibody area generates color change, the image recognition unit recognizes the corresponding image information I in the K2 area, and copies the image information I to obtain image information II.
The working principle is as follows:
installing a plurality of groups of samples into a sample receiving module of a box body, sterilizing the sample receiving module and an installation area thereof through a first sterilizing module before installation to prevent the samples from being polluted, then installing detection test paper into each detection position module based on the classification sequence of the plurality of groups of samples, selecting edge simulation information corresponding to the detection test paper according to the neutralization size of the detection test paper, and combining the edge simulation information with a first coordinate system;
the image detection module identifies antibody regions of all detection test paper, K2 regions to be identified are obtained by identifying edges of the detection test paper to be detected and comparing the edges with edge simulation information in a first coordinate system, then the moving module in each detection channel is started, the separation module is moved to form a corresponding channel I or channel II, after a channel for pair is formed, an X1 part or an X2 part of a second disinfection module in the channel which is not used is started, and the detection channel, the side wall of the separation module and the space between the side wall of the detection channel and the side wall of the separation module are disinfected;
the driving module drives the detection position module and the detection test paper to move to the upper side of the corresponding sample, the rotating unit in the detection position module drives the detection test paper to incline towards the sample direction, the detection test paper is contacted with the sample, the detection test paper is separated from the sample after the contact, the detection test paper is kept to incline at the same angle, the keeping time is S, the S is preferably 3S, and then the detection position module drives the detection test paper to incline towards the opposite direction, so that the sample is prevented from dropping in the box body;
when the rotation unit drives the detection test paper to rotate, the image detection module and the detection test paper rotate at the same angle, the image identification is kept stable, the identified image information is transmitted to the processing module, a sample flows to an antibody area of the detection test paper based on capillary action, the color change occurs in the antibody area, meanwhile, the image detection module detects that the color change occurs in a K2 area, image information I is generated and copied to obtain image information II, meanwhile, based on the image information II, the gray level conversion unit converts the image information II into gray level image information, and then the image information I and the gray level image information are transmitted to the processing module;
and the processing module identifies the K2 area based on the image information I and the gray image information to obtain detection data.
The concrete case is as follows:
when the epidemic disease is detected in a certain area, classifying patients by age and gender, wherein a male aged 0-18 is C1, a male aged 18-60 is C2, a male aged 60 or more is C3, a female aged 0-18 is N1, a female aged 18-60 is N2, and a female aged 60 or more is N3, and respectively obtaining six samples;
during detection, six groups of samples are circularly arranged according to the sequence of C1, C2, C3, N1, N2 and N3, and detection test paper provided with corresponding radio frequency units is sequentially arranged in corresponding detection position modules and used for enabling detection data to correspond to the age of the region;
during detection, a worker starts the moving module, moves the separation module, uses the channel after each detection channel is disinfected, then starts the detection system, and displays the image information I and the gray image information normally through observation;
after the detection data of each sample is obtained, it is observed that the probability of acquiring a disease of C1 is 0.03%, the probability of acquiring a disease of C2 is 0.133%, the probability of acquiring a disease of C3 is 0.12%, the probability of acquiring a disease of N1 is 0.025%, the probability of acquiring a disease of N2 is 0.098%, and the probability of acquiring a disease of N3 is 0.105%, and it can be guessed that the prevalence rate of the epidemic disease is high in the adult and the elderly population, and the male probability is greater than that of the female.
It is to be understood that the described embodiments are merely a few embodiments of the invention, and not all embodiments. All other embodiments, which can be derived by one of ordinary skill in the art and related arts based on the embodiments of the present invention without any creative effort, shall fall within the protection scope of the present invention. Structures, devices, and methods of operation not specifically described or illustrated herein are generally practiced in the art without specific recitation or limitation.

Claims (8)

1. An immunochromatographic assay detection system, comprising:
the detection device comprises a box body, a detection module and a control module, wherein a plurality of detection channels are arranged in the box body, and the upper side of the box body is provided with a driving module;
the detection device comprises detection channels, wherein a plurality of detection channels are internally provided with a moving module and a separating module, and the moving module is used for driving the separating module to move at two sides of the corresponding detection channel, so that the corresponding detection channel is divided into a channel I and a channel II;
the driving module comprises a plurality of output ends extending to the interior of the corresponding detection channel, and the plurality of output ends are provided with detection position modules;
the detection position modules are used for driving the detection test paper to be in contact with the sample and move along the corresponding detection channels;
the image detection module moves synchronously with the detection position module, generates image information corresponding to the detection test paper and transmits the image information to the processing module;
and the processing module is used for receiving and analyzing the image information to obtain detection data.
2. The immunochromatographic assay detection system of claim 1, wherein a radio frequency module is installed in the detection test paper, and the radio frequency module is used for recording any one or combination of multiple groups of regional information, occupational information, age information and sex information of the sample;
the detection position module comprises a radio frequency identification unit for identifying information corresponding to the detection test paper.
3. The immunochromatographic assay test system of claim 1, wherein the partition module comprises a plurality of second sterilizing units, the plurality of second sterilizing units are symmetrically disposed on both sides of the partition module and are respectively labeled as X1 part and X2 part, and X1 part and X2 part are used for sterilizing corresponding channel I or channel II.
4. The immunochromatographic assay detection system of claim 1, wherein the detection site module comprises:
the clamping unit is used for clamping the test paper and driving the test paper to move;
and the rotating unit is used for driving the clamping unit to rotate and is used for contacting and separating the detection test paper with the sample.
5. The immunochromatographic assay detection system of claim 1, wherein the image detection module comprises:
the image recognition unit is used for recognizing an antibody region of the detection test paper, generating image information I and image information II, transmitting the image information I to the processing module and transmitting the image information II to the gray level conversion unit;
and the gray level conversion unit is used for receiving the image information II, then carrying out gray level processing on the image information to obtain gray level image information and transmitting the gray level image information to the processing module.
6. The immunochromatographic assay detection system of claim 5, wherein the image recognition unit recognizes the antibody region by the method comprising the steps of:
z1: establishing a first coordinate system in advance, establishing edge simulation information of the detection test paper according to the size information of the detection test paper, matching any end of the edge simulation information with the origin of coordinates of the first coordinate system, generating position information in the first coordinate system, marking an end of the edge simulation information matched with the origin of the first coordinate system as H1, and marking an antibody area of the detection test paper in the first coordinate system as K1 according to the edge simulation information;
z2: identifying the edge information of the test paper to be detected, generating edge information I to be identified, comparing the edge information I to be identified with edge simulation information to obtain end point information H2 matched with a first coordinate system, simultaneously matching the edge information I to be identified with the first coordinate system based on the end point information H2, generating an antibody area to be identified marked as K2 based on a K1 area,
z3: the image recognition unit recognizes the corresponding image information i in the K2 area, and copies the image information i to obtain image information ii.
7. The method of claim 1, comprising the steps of:
the method comprises the following steps: installing a plurality of groups of samples into a box body, and installing the detection test paper into each detection position module based on the classification sequence of the plurality of groups of samples;
step two: the image detection module identifies the antibody region of each detection test paper, starts the moving module in each detection channel, and moves the separation module to form a corresponding channel I or channel II;
step three: the driving module and the detection position module drive the detection test paper to incline and then contact with the sample, the detection test paper is separated from the sample after the contact, the detection test paper is kept to incline at the same angle for S, and then the detection position module drives the detection test paper to incline in the opposite direction;
step four: the image detection module and the detection test paper rotate at the same angle, and the identified image information is transmitted to the processing module;
step five: the processing module obtains detection data based on the image information.
8. The detection method of the immunochromatographic assay detection system according to claim 7, wherein the value of S in the third step is based on the fluidity of a sample, and the value of S ranges from 0.5S to 3.5S.
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