CN114878806A - Integrated antigen detection device and quality control method for antigen detection process thereof - Google Patents

Integrated antigen detection device and quality control method for antigen detection process thereof Download PDF

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CN114878806A
CN114878806A CN202210507046.7A CN202210507046A CN114878806A CN 114878806 A CN114878806 A CN 114878806A CN 202210507046 A CN202210507046 A CN 202210507046A CN 114878806 A CN114878806 A CN 114878806A
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孙非
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Shanghai Jedicare Medical Technology Co ltd
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    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983—Viruses

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Abstract

The invention belongs to the technical field of antigen detection, and particularly relates to an integrated antigen detection device and an antigen detection process quality control method thereof, wherein the method comprises the following steps: acquiring a first image of a nasal swab inserted into a nasal cavity; the invention solves the problem that the infected person cannot be found in time due to the fact that the self-testing process of the examined person is not standardized, misoperation or intentional cheating occurs in the prior art, and has the advantages of standardizing the self-testing process of the examined person, effectively preventing misoperation or intentional cheating during the use of the examined person and effectively finding the infected person in time.

Description

Integrated antigen detection device and quality control method for antigen detection process thereof
Technical Field
The invention belongs to the technical field of antigen detection, and particularly relates to an integrated antigen detection device and an antigen detection process quality control method thereof.
Background
The antigen self-test can obtain the test result in about 15 minutes, and the cost is relatively low, the examinee can automatically complete the test, and the test method is low in cost, convenient and fast and easy to popularize; however, if the examinee is screened in a large scale by requiring the examinee to perform self-check and report by using the existing antigen detection kit, the examinee may have the situations of irregular self-check process, misoperation or intentional cheating, such as irregular sampling, confusion of collected samples among households, confusion of samples collected at different times and the like, so that an infected person cannot be found in time, and therefore, a technical means is urgently needed to ensure the quality of the examinee antigen self-check and ensure the true and reliable result of the examinee antigen self-check; another disadvantage of antigen detection versus nucleic acid detection is the low sensitivity, corresponding to false negatives in the detection results, resulting in a failure to identify infected patients in time; on the premise that the performance of the test paper is fully explored, how to obtain the number of antigen samples to the maximum extent and improve the detection sensitivity is another technical challenge;
the prior art has the problems that the self-test process of a detected person is not standard, misoperation or intentional cheating occurs, so that an infected person cannot be found in time.
Disclosure of Invention
The invention provides an integrated antigen detection device and an antigen detection process quality control method thereof, which aim to solve the problem that an infected person cannot be found in time due to the fact that the self-test process of a detected person is not standard, misoperation or intentional cheating exists in the prior art.
The technical problem solved by the invention is realized by adopting the following technical scheme: an integrated antigen detection device comprises a detection functional area and an optical space positioning identification area, wherein the detection functional area comprises a nose wiper part, a detection part and an extraction pipe part, and the above structures are combined into the integrated device at one or more stages of an antigen detection process.
Further, the detection part is provided with a sealing protection device, and an optical space positioning identification area is arranged on the sealing protection device.
Further, the nose swab part adopts a non-transparent color which is obviously distinguished from the skin color and the color of the detection part.
Further, the detection part comprises an optical anti-counterfeiting interpretation window, the optical anti-counterfeiting interpretation window comprises an anti-counterfeiting substrate and/or an anti-counterfeiting window body, the anti-counterfeiting substrate adopts a color and/or stripe substrate, and the anti-counterfeiting window body adopts a lens, a prism, color transparent paper or a non-linear frame.
Meanwhile, the invention also provides an antigen detection process quality control method based on the integrated antigen detection device, and the method comprises the following steps:
acquiring a first image of a nasal swab inserted into a nasal cavity;
performing first judgment based on the first image, and judging whether the sample sampling of the detected person is qualified;
if the first judgment result is qualified, entering a second stage, and acquiring a second image of the state that the nasal swab part is inserted into the extraction tube;
performing second judgment based on the second image, and judging whether the sample extraction operation of the detected person is qualified;
if the second judgment result is qualified, entering a third stage, and acquiring a third image of the sample detection result displayed by the interpretation window;
performing third judgment based on the acquisition time interval of the third image and the second image, and judging whether the time interval of the detected person is qualified;
and if the third judgment result is qualified, judging the detection result based on the third image to obtain an antigen detection result.
Further, the quality control method further comprises: identifying the brand and/or model of the integrated antigen detection device according to the first image based on information in a product database; the product database stores spatial structure characteristics and/or optical characteristics of detection functional regions and optical spatial positioning identification regions of integrated antigen detection devices of different brands and/or different models.
Further, the quality control method further comprises an image space pre-calibration method, and the image space calibration method comprises the following steps: based on the pose of the characteristic pattern of the optical space positioning identification part in the imaging system and the relative relation between the feature pattern of the optical space positioning identification part and the functional area to be identified in the space structure characteristic, the image area corresponding to the functional area to be identified is obtained through coordinate transformation.
Further, the quality control method further includes an image color pre-correction method, the image color correction method including: and adjusting the brightness and/or contrast of preset parameters through the image area to be identified to obtain the corrected color.
Further, the first discrimination includes: and judging whether the nose swab part is inserted into the preset depth of the nasal cavity or not and which side of the nasal cavity the nose swab part enters according to the first image based on the fact that the first image determined by the recognizable face and the recognizable optical space positioning marking area exist in the obtained image, and judging that the sample sampling of the detected person is qualified if the nose swab part is inserted in place and the nose swab part enter the nasal cavity.
Further, the second determination includes: and based on a second image determined after the nasal swab rod is kept in the state of the antigen extracting solution stored in the extracting tube, judging whether the extracting tube part is completely combined with the detection part or not according to the second image, if so, further judging whether the nasal swab is immersed in the antigen extracting solution stored in the extracting tube, and if still yes, judging that the sample extracting operation of the detected person is qualified.
Further, the third discrimination includes: and determining whether the interval between the second image acquisition time and the third image acquisition time is greater than the detection preset time and less than the longest detection time, and if so, judging that the time is qualified.
Further, the quality control method further comprises invalid event discrimination:
identifying whether an abnormal detection result is displayed in an interpretation window area of the integrated antigen detection device in the first image and/or the second image, if so, generating an invalid event, and giving a corresponding prompt;
and/or;
and identifying the optical space positioning identifier in the second image and/or the third image, if the optical space positioning identifier in the second image and/or the third image is inconsistent with the optical space positioning identifier in the first image, generating an invalid event, and giving a corresponding prompt.
Further, the first discrimination further includes: based on the range of the nasal swab, if the characteristic color area of the nasal swab is smaller than the minimum area threshold value of the characteristic color, the nasal swab is determined to be completely inserted into the nasal cavity, and otherwise, the nasal swab is determined not to be completely inserted into the nasal cavity.
Further, the second determination further includes: based on the area range of the nasal swab and the intermediate body in the extraction tube, if the change degree of the characteristic color of the identified nasal swab rod and/or the intermediate body relative to the unoccluded time value stored in the database is consistent with the preset range, the nasal swab is determined to be immersed in the stored antigen extracting solution in the extraction tube, and the intermediate body is completely covered by the extraction tube, namely the extraction tube is completely combined with the detection part.
Further, the quality control method further includes a face recognition method implemented based on the first image, the face recognition method including:
the identity information of the detected person is obtained by comparing the face information in the image with the known information in the identity information database, and the antigen detection result of the detected person at this time is associated with the record of the detected person.
Further, the quality control method also comprises the following steps of judging the anatomical position of the nasal swab in the first stage, which is blocked by the nostril, through the identification of the human face organ in the image:
if the nasal swab is positioned on the left side of the midline of the human body, the antigen detection process of the detected person is determined as sampling of the left nostril;
if the nasal swab is positioned at the right side of the midline of the human body, the antigen detection process of the detected person is determined as sampling of the nostril at the right side;
the midline of the human body is a straight line connecting the midpoint of the line connecting the eyes and the nose tip.
The beneficial technical effects are as follows:
the device comprises a detection function area, wherein the detection function area is used for connecting a nose swab with a detection part, simultaneously connecting an extraction tube with the nose swab and the detection part into a whole, a sealed extraction solution channel is established in a connecting part, an extraction solution with a detection sample is directly sent to a sample pad of a detection test paper, simultaneously, an integrated structure consisting of an extraction tube, the detection part and an interpretation window is used for integrally sealing the detection sample in the detection device, an optical space positioning identification area is used for sealing the upper surface of the antigen detection device, the detection part which is at a specific distance from a rod part of the nose swab part and an interpretation window is provided with a pattern which can be used for optical identification, preferably a two-dimensional code, is based on the effective identification of different operation steps of the same optical identification, is the core invention point of the invention, and is based on the position basis of the optical identification, the color state of the structure at a position away from the optical identifier by a certain distance on the detection device can be quickly and accurately identified by software, and whether the detection device is correctly used or not can be supervised; meanwhile, the integrity of the optical identification is used as an evaluation mode for judging whether the detection device is damaged or not, so that the detection result can be conveniently ensured not to be artificially modified in the detection process, such as replacing a detection test paper, dropping an extracting solution of a non-user and the like, and in one or more stages of the antigen detection process, such as a sample sampling stage (a first stage of first judgment is carried out on a first image), a sample extraction stage (a second stage of second judgment is carried out on a second image), and a sample detection stage (a third stage of third judgment is carried out on an acquisition time interval of a third image and a second image) are combined into an integrated device based on the above structure.
This patent simultaneously provides an antigen testing process quality control method based on integration antigen detection device, namely (1) the first stage (sample sampling judgement): based on the integrated antigen detection device, in a sample sampling stage, acquiring a first image of the depth of inserting the nasal swab part into the nasal cavity, judging whether the sample sampling of the detected person is qualified or not by a first image judging method based on the first image, and if the sample sampling is unqualified, judging that the antigen detection process of the detected person is invalid; (2) second stage (sample extraction judgment): if the sample sampling is qualified, acquiring a second image of the state that the nasal swab part is inserted into the extraction tube after the sample sampling in a sample extraction stage, judging whether the sample extraction operation of the detected person is qualified or not by a second image judgment method based on the second image, and if the sample extraction operation is carried out, judging that the antigen detection process of the detected person is invalid; (3) third stage (sample detection judgment): if the sample extraction operation is qualified, acquiring a third image of the sample detection displayed by the optical anti-counterfeiting interpretation window after the sample extraction operation in a sample detection stage, judging whether the sample detection operation of the detected person is qualified or not by a third image judging method based on the third image, if the sample detection operation is qualified, judging that the antigen detection process of the detected person is effective, otherwise, judging that the antigen detection process of the detected person is effective if the sample detection operation is unqualified; and finally, if the antigen detection process of the detected person is effective, determining that the antigen detection result of the detected person is negative if the sample detection displayed by the optical anti-counterfeiting interpretation window in the third image is negative, or determining that the antigen detection result of the detected person is positive if the sample detection displayed by the optical anti-counterfeiting interpretation window in the third image is positive.
In summary, based on an integrated antigen detection device, the quality control method of the original detection process through the sequential processes from the first stage (sample sampling judgment) to the second stage (sample extraction judgment) and from the second stage (sample extraction judgment) to the third stage (sample detection judgment) standardizes the self-test process of the examinee, effectively prevents the misoperation or intentional cheating behavior of the examinee in use, and thereby effectively and timely discovers the infected person.
Drawings
FIG. 1 is a schematic view of the structure of an antigen detection device according to the present invention;
FIG. 2 is a flow chart of the use of the antigen detection device of the present invention;
FIG. 3 is a schematic diagram of an application of the antigen detection device of the present invention;
FIG. 4 is a schematic flow chart of a quality control method in the antigen detection process according to the present invention;
FIG. 5 is a flow chart of an embodiment of the quality control method of the antigen detection process according to the present invention;
FIG. 6 is a flow chart illustrating the quality control method of the antigen detection process according to the present invention;
FIG. 7 is a structural diagram of an internal optical anti-counterfeiting interpretation window of the antigen detection device of the present invention;
FIG. 8 is a schematic diagram of an image space calibration method of the quality control method of the antigen detection process of the present invention.
Detailed Description
The invention is further described below with reference to the accompanying drawings:
in the figure:
1-detection functional area, 2-optical space positioning identification area, 3-nasal swab part, 4-detection part and 5-extraction tube part;
s101, acquiring a first image of a nasal swab inserted into a nasal cavity;
s102, judging whether the sample sampling of the detected person is qualified or not;
s103, acquiring a second image of the state that the nasal swab part is inserted into the extraction tube;
s104, judging whether the sample extraction operation of the detected person is qualified or not;
s105, acquiring a third image of the interpretation window displaying the detection result of the sample;
s106, judging whether the time interval of the detected person is qualified or not;
s107, judging the detection result based on the third image to obtain an antigen detection result;
s201, judging whether a nose swab part is inserted into a preset depth of a nasal cavity or not according to a first image determined by an identifiable face and an identifiable optical space positioning marking area based on the fact that the identifiable face and the identifiable optical space positioning marking area exist in the obtained image at the same time, and if the nose swab part is inserted in the preset depth of the nasal cavity, judging that the sample sampling of a detected person is qualified;
s202, based on a second image determined after the nasal swab rod keeps the state of the internal storage antigen extracting solution inserted into the extracting tube, judging whether the extracting tube part is completely combined with the detection part or not according to the second image, if so, further judging whether the nasal swab is immersed into the internal storage antigen extracting solution of the extracting tube, and if still yes, judging that the sample extracting operation of the detected person is qualified;
s203, determining whether the interval between the second image acquisition time and the third image acquisition time is greater than the detection preset time and less than the longest detection time, and if so, judging that the time is qualified;
s301, based on the range of the nasal swab, if the characteristic color area of the nasal swab is smaller than the minimum area threshold of the characteristic color, determining that the nasal swab is completely inserted into the nasal cavity, and otherwise, determining that the nasal swab is not completely inserted into the nasal cavity;
s302-based on the area range of the nasal swab and the intermediate body in the extraction tube, if the change degree of the identified characteristic color of the nasal swab rod and/or the intermediate body relative to the unoccluded time value stored in the database is consistent with the preset range, the nasal swab is determined to be immersed in the stored antigen extracting solution in the extraction tube, and the intermediate body is completely covered by the extraction tube, namely the extraction tube is completely combined with the detection part.
The first embodiment is as follows:
as shown in fig. 1, 2 and 3, an integrated antigen detection device comprises a detection functional region 1 and an optical spatial orientation mark region 2, wherein the detection functional region 1 comprises a nasal swab portion 3, a detection portion 4 and an extraction tube portion 5, and the above structures are combined into an integrated device at one or more stages of an antigen detection process.
Because a detection functional area and an optical space positioning identification area are adopted, wherein the detection functional area comprises the nasal swab part, the detection part and the extraction tube part, the above structures are combined into an integrated device at one or more stages of the antigen detection process; the device comprises a detection function area, wherein the detection function area is used for connecting the nasal swab with the detection part and simultaneously connecting the extraction tube with the nasal swab and the detection part into a whole, a sealed extraction solution channel is established in the connection part, the extraction solution with the detection sample is directly conveyed to a sample pad of the detection test paper, and meanwhile, the detection sample is completely sealed in the detection device by an integrated structure consisting of the extraction tube, the detection part and an optical anti-counterfeiting structure on an interpretation window; the optical space positioning identification area is arranged on the upper surface of the antigen detection device, more specifically, the detection part is arranged at a specific distance from the stem part of the nasal swab part and the interpretation window, and the surface of the detection part is provided with a pattern for optical recognition, preferably a two-dimensional code. The method is characterized in that effective identification is carried out on the basis of different operation steps of the same optical identification, and based on the position basis of the optical identification, software can quickly and accurately identify the color state of a structure at a position away from the optical identification by a specific distance on a detection device and supervise whether the detection device is correctly used or not; information such as the brand, the model or the product ID of the integrated antigen detection device can be obtained by identifying the optical identifier; meanwhile, the integrity of the optical identification is used as an evaluation mode for judging whether the detection device is damaged or not, so that the detection result can be conveniently and surely not modified artificially in the detection process, such as replacing detection test paper, dropping non-self extracting solution and the like, and the sample sampling stage (the first stage of first judgment is carried out on the first image), the sample extracting stage (the second stage of second judgment is carried out on the second image) and the sample detection stage (the third stage of third judgment is carried out on the acquisition time interval of the third image and the second image) are combined into an integrated device based on the structure in one or more stages of the antigen detection process.
The detection part 4 is provided with a sealing protection device, and the sealing protection device is provided with an optical space positioning identification area 2.
Since the detection portion is provided with the seal protection device on which the optical space positioning identification area is provided, the optical space positioning identification area is actually an optically recognized pattern, preferably a two-dimensional code, and more preferably a two-dimensional code printed on the seal protection tape of the antigen detection device. The sealing protective belt can be damaged when the detection device is disassembled, and the two-dimensional code pattern can be damaged simultaneously; the optical mark is traditionally used for industrial detection or space positioning when a robot moves, and the optical mark is used for monitoring the use process of an antigen reagent for the first time. Meanwhile, in different using steps, the detection device changes the external color characteristics, such as the shielding of partial color after being inserted into a nasal cavity, the change of color brightness after being connected with an extraction liquid bottle, different optical stripes of different detection results displayed by test paper and the like, and based on the position basis of the optical identifier, software can quickly and accurately identify the color state of a structure at a position away from the optical identifier and at a specific distance on the detection device, and supervise whether the detection device is correctly used or not; meanwhile, the integrity of the optical identification is used as an evaluation mode for judging whether the detection device is damaged or not, so that the detection result can be conveniently ensured not to be artificially modified in the detection process, such as replacing detection test paper, dropping non-self extracting solution and the like, and the dual functions of positioning and identification are realized.
The nose swab part 3 is non-transparent and is obviously distinguished from skin color and the color of the detection part 4.
Because the nose swab part adopts the color which is non-transparent and is obviously distinguished from the skin color and the detection part, the nose swab part has the color which is distinguished from the skin of human and the detection part, and the best specificity can be obtained in the software interpretation process.
The detection part 4 comprises an optical anti-counterfeiting interpretation window, the optical anti-counterfeiting interpretation window comprises an anti-counterfeiting substrate and/or an anti-counterfeiting window body, the anti-counterfeiting substrate adopts a colored and/or stripe substrate, and the anti-counterfeiting window body adopts a lens, a prism, colored transparent paper or a non-linear frame.
As shown in fig. 7, the detection portion includes an optical anti-counterfeiting interpretation window, the optical anti-counterfeiting interpretation window includes an anti-counterfeiting substrate and/or an anti-counterfeiting window body, the anti-counterfeiting substrate adopts a color and/or stripe substrate, the anti-counterfeiting window body adopts a lens, a prism, a color transparent paper or a non-linear frame, and since the interpretation window is provided with an optical anti-counterfeiting component, a single detection result of adding a straight line to a white substrate is changed on the premise of not changing the structure of the test paper. The straight line can be changed into a curve or a broken line by using a prism or a convex-concave lens, and the white bottom can be changed into the colored bottom by using colored transparent paper, so that the difficulty of counterfeiting results and cheating identification software is increased. The corresponding change method is stored in a database corresponding to the kit in advance, and after the software recognizes the result pattern, the result is compared with the database to judge whether the result is credible; meanwhile, the optical anti-counterfeiting structure can be prismatic or arc-shaped glass, and can change the detection result (dark color strips displayed at the detection line and the quality control line) into a graph difficult to imitate or change along with the observation angle. Compared with the prior art, the detection result can be prevented from being artificially altered.
As shown in fig. 4, the present invention also provides a method for controlling quality of an antigen detection process based on an integrated antigen detection device, which uses the integrated antigen detection device, and the method comprises:
acquiring a first image S101 of the nasal swab 3 inserted into the nasal cavity;
performing first judgment based on the first image, and judging whether the sample sampling of the detected person is qualified or not S102;
if the first judgment result is qualified, entering a second stage, and acquiring a second image of the nasal swab part 3 inserted into the extraction tube S103;
performing a second judgment based on the second image, and judging whether the sample extraction operation of the detected person is qualified or not S104;
if the second judgment result is qualified, entering a third stage, and acquiring a third image of the sample detection result displayed by the interpretation window S105;
performing third judgment based on the acquisition time intervals of the third image and the second image, and judging whether the time interval of the detected person is qualified or not S106;
and if the third judgment result is qualified, judging the detection result based on the third image to obtain an antigen detection result S107.
The quality control method for the antigen detection process based on the integrated antigen detection device comprises the steps of acquiring a first image of the nasal swab part inserted into the nasal cavity by using the integrated antigen detection device; performing first judgment based on the first image, and judging whether the sample sampling of the detected person is qualified; if the first judgment result is qualified, entering a second stage, and acquiring a second image of the state that the nasal swab part is inserted into the extraction tube; performing second judgment based on the second image, and judging whether the sample extraction operation of the detected person is qualified; if the second judgment result is qualified, entering a third stage, and acquiring a third image of the sample detection result displayed by the interpretation window; performing third judgment based on the acquisition time interval of the third image and the second image, and judging whether the time interval of the detected person is qualified; if the third judgment result is qualified, judging the detection result based on the third image to obtain an antigen detection result; because the method comprises three stages in total, namely (1) a first stage (sample sampling judgment): based on the integrated antigen detection device, in a sample sampling stage, acquiring a first image of the depth of inserting the nasal swab part into the nasal cavity, judging whether the sample sampling of the detected person is qualified or not by a first image judging method based on the first image, and if the sample sampling is unqualified, judging that the antigen detection process of the detected person is invalid; (2) second stage (sample extraction judgment): if the sample sampling is qualified, acquiring a second image of the state that the nasal swab part is inserted into the extraction tube after the sample sampling in a sample extraction stage, judging whether the sample extraction operation of the detected person is qualified or not by a second image judgment method based on the second image, and if the sample extraction operation is carried out, judging that the antigen detection process of the detected person is invalid; (3) third stage (sample detection judgment): if the sample extraction operation is qualified, acquiring a third image of the sample detection displayed by the optical anti-counterfeiting interpretation window after the sample extraction operation in a sample detection stage, judging whether the sample detection operation of the detected person is qualified or not by a third image judging method based on the third image, if the sample detection operation is qualified, judging that the antigen detection process of the detected person is effective, otherwise, judging that the antigen detection process of the detected person is effective if the sample detection operation is unqualified; and finally, if the antigen detection process of the detected person is effective, determining that the antigen detection result of the detected person is negative if the sample detection displayed by the optical anti-counterfeiting interpretation window in the third image is negative, or determining that the antigen detection result of the detected person is positive if the sample detection displayed by the optical anti-counterfeiting interpretation window in the third image is positive.
The above three-stage work overall workflow can be summarized as follows: acquiring a first image shot by a detector when sampling by using a sampling swab; judging whether the sampling operation of the examiner is qualified or not (the swab rod is completely inserted into the nasal cavity) according to the first image; acquiring a second image when the examiner completely inserts the sampling swab into the extraction liquid accommodating part of the antigen detection device, and confirming that the sampling swab is completely inserted into the extraction liquid; acquiring a third image shot when the interpretation window displays the detection result; judging whether the detection result interpretation time is qualified or not according to the shooting interval time of the second image and the third image; and obtaining a negative, positive or invalid detection result according to the third image.
In summary, the quality control method of the original detection process from the first stage (sample sampling judgment) to the second stage (sample extraction judgment) and from the second stage (sample extraction judgment) to the third stage (sample detection judgment) is adopted, so that the self-test process of the examinee is standardized, the misoperation or intentional cheating behavior of the examinee in use is effectively prevented, and the infected person is effectively and timely found.
The quality control method further comprises: identifying the brand and/or model of the integrated antigen detection device according to the first image based on information in a product database; the product database stores the spatial structure characteristics and/or optical characteristics of the detection functional area 1 and the optical spatial positioning identification area 2 of the integrated antigen detection device with different brands and/or different models.
The quality control method also comprises the following steps: identifying the brand and/or model of the integrated antigen detection device according to the first image based on information in a product database; the product database stores spatial structure characteristics and/or optical characteristics of a detection function area and an optical spatial positioning identification area of the integrated antigen detection device with different brands and/or different models, and can record product information used in the detection according to information such as brands and models of the first image identification product, and also can respectively adopt different specific processing schemes according to product characteristics of different brands and models.
The quality control method further comprises an image space pre-calibration method, and the image space calibration method comprises the following steps: based on the pose of the characteristic pattern of the optical space positioning identification part in the imaging system and the relative relation between the feature pattern of the optical space positioning identification part and the functional area 1 to be identified in the space structure characteristic, an image area corresponding to the functional area 1 to be identified is obtained through coordinate transformation.
Due to the adoption of the image space calibration method before sample sampling judgment, the image space calibration method comprises the following steps: based on the pose of the characteristic pattern of the optical space positioning identification part in the imaging system and the relative relation between the characteristic pattern and the functional area to be identified and detected in the space structure characteristic, the image area corresponding to the functional area to be identified and detected is obtained through coordinate transformation, and whether the depth of the swab inserted into the nostril meets the requirement (1-1.5 cm) or not is judged according to the first image, and the specific image identification mode can be as follows: (1) identifying a two-dimensional code in an image; (2) obtaining information contained in the two-dimensional code based on the identified two-dimensional code, wherein the information comprises A. the pose of the two-dimensional code, namely the coordinate and normal direction of the plane where the two-dimensional code is located in the camera space, and the coordinate and direction of the two-dimensional code in the camera space; B. comparing the product model or the structural information contained in the two-dimensional code with the product model stored in the database or directly reading the structural information to obtain a characteristic pattern to be recognized, such as the distance between the nose swab rod part and the detection test paper interpretation window relative to the two-dimensional code; (3) based on the space coordinates of the two-dimensional code in the camera coordinate system, the coordinates and normal angles of the plane and the relative distance of the characteristic pattern to be recognized, which are obtained in the previous step, the target area coordinate range of the pattern to be recognized in the camera coordinate system and the pattern deformation caused by the angle of the pattern relative to the camera can be obtained through simple geometric calculation; therefore, this pattern deformation is used as a reference for image space calibration.
The following describes the image space calibration method (the flow of two-dimensional code calibration):
as shown in fig. 8:
1. storing in a local or remote database, in advance, absolute coordinates of a coordinate system of the kit with origin corresponding to two-dimensional code center points of nasal swab regions and detection window regions corresponding to kits of different specifications and models based on actual sizes, such as four vertices S of a quadrangle for defining the nasal swab regions 1 ，...，S 4 W which defines the detection window area 1 ，...，W 4 Coordinate position information of the line (C-line) area and the result line (T-line) area is controlled. This algorithm can be extended to a three-dimensional database.
2. The database stores the two-dimensional code size information of the kit with the specification and model, and the color and area information of the nasal swab, the extraction tube, the detection window, the C line and the T line.
3. And at different stages, shooting the two-dimension code area by using different cameras (such as a front camera used in stage 1 and a rear camera used in stages 2 and 3) of the mobile phone, identifying the two-dimension code, and obtaining position and posture information of the two-dimension code. Different two-dimensional code coding rules all have methods for positioning two-dimensional code patterns, such as 3 squares in QRCode types, solid line and dotted line borders in Datamatrix, and the like, and in the following, by taking QRCode as an example, two-dimensional coordinates of the 3 squares in a camera imaging plane are identified based on a computer pattern processing algorithm, so that a transformation matrix of the two-dimensional code plane relative to a camera coordinate system is obtained through calculation. And determining the pose of the two-dimensional code by taking the corner points of the 3 squares as characteristic points. And coordinates in the world coordinate system are consistent with a two-dimensional code coordinate system stored in the database. Therefore, from the pinhole camera imaging model, the following relationship can be obtained:
x i ＝K[R，t]p i
where K is the reference matrix of the camera, [ R, t [ ]]Is a reference matrix of the camera, p i Denotes the homogeneous coordinate, x, of the ith feature point in the world coordinate system i And the homogeneous coordinate of the ith characteristic point in an image coordinate system is shown. 3 squares have 12 corner points as feature points, so we have 12 of the above relations. Here we consider the camera to have completed calibration, i.e. the internal reference matrix K is known. Then only the external parameter [ R, t ] is in the above relation]Is unknown and comprises 3 translation components and 3 rotation components, and has 6 degrees of freedom. The problem is a least squares problem and is a non-linear optimization problem, defining an objective function as:
Figure BDA0003637804930000101
where K is the internal reference matrix of the camera, [ R, t [ ]]Is a reference matrix of the camera, p i Denotes the homogeneous coordinate, x, of the ith feature point in the world coordinate system i And the homogeneous coordinate of the ith characteristic point in an image coordinate system is shown. The Levenberg-Marquardt algorithm can be used toSolving the nonlinear optimization problem to obtain external parameters [ R, t ] of the camera]And obtaining the posture of the two-dimensional code.
4. And reading the two-dimensional code coding information, finding the specification model of the corresponding kit, and obtaining the size and color information of the target structure corresponding to the specification model.
5. And applying the transformation matrix to the vertex coordinates of the area to be detected to obtain the transformed position of the imaging plane of the area to be detected. The following relationship can be obtained from the pinhole camera imaging model:
Figure BDA0003637804930000102
where K is the internal reference matrix of the camera, [ R, t [ ]]Is the external reference matrix of the camera, s i The four vertices of the quadrilateral representing the nasal swab region are at homogeneous coordinates of the image coordinate system,
Figure BDA0003637804930000103
the four vertices of the quadrilateral representing the nasal swab region are homogeneous coordinates in the world coordinate system.
The position of the nasal swab region in the world coordinate system can thus be determined. And similarly, detecting the position of the window area in the world coordinate system.
6. Method 1 for interpreting the degree of occlusion of a nasal swab by a nostril: and searching whether the corresponding specific color area exists in the database in the nose swab area after coordinate transformation. As defined by the nasal swab area in the database as 75mm 2 And according to the actual size of the two-dimensional code and the imaging resolution of the camera, the corresponding area of each pixel point in the current image is known to be 0.3mm 2 Then, the number of white pixels in the region to be detected is interpreted, and the degree of the blocked nasal swab is obtained according to the ratio of the number of pixels to 75/0.3, which corresponds to the complete nasal swab, of 250.
7. Method 2 for interpreting the degree of occlusion of the nasal swab by the nostril: and (3) for the nose swab area after coordinate transformation, finding a continuous white color band with the width of 10 pixels along the Y axis, wherein the length of the identified white color band is the length of the uncovered nose swab.
8. A method of determining whether a nasal swab is occluded by an extraction fluid:
(a) identifying whether an extraction tube exists: for the extraction tube area after coordinate transformation, similar to the nasal swab recognition algorithm 1, whether an extraction tube area exists is found, and one possible method is to carry out brightness and contrast transformation on an original image of the extraction tube area according to preset values of transparency of extraction tubes of different models stored in a database to obtain the optimal color distinguishing contrast of the extraction tubes relative to different environments. Another possible method is to select the extraction tube material as a color transparent tube, and confirm whether the extraction tube is contained in the image or not through the extraction of a specific color area;
(b) identifying whether there is a nasal swab: when the extraction tube is confirmed to exist in the image, whether the nasal swab exists is further judged. The possible methods comprise: 1. carrying out brightness and contrast transformation according to preset values of transparency of extraction tubes of different models stored in a database, selecting a combination of the color of the nasal swab and the color of the extraction tube with the maximum brightness contrast, and searching whether an area which accords with the color and the shape of the nasal swab exists in an extraction tube area; 2. whether the image contains a nose swab region of a specific color is confirmed by the color difference between the nose swab and the extraction tube.
9. And judging whether the detection window area is qualified or not.
10. Interpreting the detection result;
the quality control method also comprises an image color pre-correction method before sample sampling judgment, and the image color correction method comprises the following steps: and adjusting the brightness and/or contrast of preset parameters through the image area to be identified to obtain the corrected color.
Because the quality control method also comprises an image color correction method before sample sampling judgment, the image color correction method comprises the following steps: the brightness and/or contrast adjustment of preset parameters is carried out through an image area to be identified to obtain the corrected color, and the contrast adjustment method comprises the following steps:
assuming that the contrast correction parameter of the extraction tube region of brand A is preset to be C in the range from 0 to 1 a Nose, noseThe initial color R, G, B component of the swab is denoted as R 0 ,G 0 ,B 0 Then, when the nasal swab is in the extraction tube, its corrected new RGB components are denoted as R 1 ,G 1 ,B 1 Then, then
R 1 ＝R 0 *C a ；G 1 ＝G 0 *C a ；B 1 ＝B 0 *C a
A brightness adjusting method comprises the following steps:
assuming that the contrast correction parameter of the extraction tube region of the brand A is preset to be B from 0 to 1 a The nasal swab initial color R, G, B component is denoted as R 0 ,G 0 ,B 0 Then, when the nasal swab is in the extraction tube, its corrected new RGB components are denoted as R 1 ,G 1 ,B 1 Then the treatment is carried out according to the following steps
1. R is to be 0 G 0 B 0 Conversion to HSL value H 0 S 0 L 0
2.L 1 ＝L 0 *Ba
3. H is to be 0 S 0 L 1 Conversion to R 1 G 1 B 1
If (4) the pattern collected in the target coordinate area is subjected to correlation matching with the target pattern stored in the system after angular deformation, the target pattern is proved to be identified after a correlation threshold value is reached, if the position where the nasal swab rod should exist does not identify the characteristic color larger than the minimum area threshold value, the nasal swab is proved to be completely inserted into the nasal cavity, and the insertion depth is proved to be insufficient by the anti-regularities; if the reagent color development strip is identified at the position of the detection test paper interpretation window, the sampling test paper is proved to be polluted, the detection is invalid, and the like, the image color correction is realized by the method.
As shown in fig. 5, the first discrimination includes: based on the fact that the recognizable face and the first image determined by the recognizable optical space positioning marking area exist in the obtained image at the same time, whether the nose swab part is inserted into the preset depth of the nasal cavity or not is judged according to the first image, and or which side of the nasal cavity the nose swab part enters is judged, and if the nose swab part is inserted in place or the nose swab part enters the nasal cavities on both sides, the sample sampling of the detected person is judged to be qualified S201.
The first discrimination is adopted to include: based on the fact that the recognizable face and the first image determined by the recognizable optical space positioning marking area exist in the obtained image at the same time, whether the nose swab part is inserted into the preset depth of the nasal cavity or not is judged according to the first image, and whether the nose swab part enters the nasal cavity on the certain side or not is judged, if the nose swab part is inserted in place or whether the nose swab part enters the nasal cavity on the certain side or not is judged, the sample sampling of the detected person is qualified, and the first image shot when the detected person uses the sampling swab to sample is obtained; judging whether the sampling operation of the examiner is qualified or not (the swab rod is completely inserted into the nasal cavity) according to the first image; in the first discrimination, two processes of image pickup and image discrimination are included, wherein the image pickup is the basis of the image discrimination, the determination of the first image needs to sense the recognizable human face and the recognizable optical space positioning mark area as the pickup condition at the same time, after the image is picked up, the picked-up image is discriminated, whether the swab rod is inserted into the nasal cavity is judged, and finally the conclusion whether the sample sampling is qualified is given.
The second determination includes: based on a second image determined after the status of the nasal swab shaft holding the stored antigen extract in the extraction tube is confirmed, it is determined whether or not the extraction tube portion 5 is completely combined with the detection portion 4 based on the second image, and if so, it is further determined whether or not the nasal swab is immersed in the stored antigen extract in the extraction tube, and if still so, it is determined that the sample extraction operation of the subject is acceptable S202.
The second judgment comprises the following steps: and judging whether the extraction tube part is completely combined with the detection part or not according to a second image determined after the nasal swab rod keeps the state of the antigen extraction solution stored in the extraction tube, if so, further judging whether the nasal swab is immersed in the antigen extraction solution stored in the extraction tube, if still yes, judging that the sample extraction operation of the detected person is qualified, and if so, entering a third stage.
The third discrimination includes: and determining whether the interval between the second image acquisition time and the third image acquisition time is greater than the detection preset time and less than the longest detection time, and if so, judging that the time is qualified S203.
The third determination includes: and determining whether the interval between the second image acquisition time and the third image acquisition time is greater than the detection preset time and less than the longest detection time. The preset time for inspection is the time from adding the extracting solution to flowing through the T/C line of the whole extracting solution, which is set by an antigen manufacturer according to product performance, and is generally at least 15 minutes and at most 20 minutes. If so, judging the interpretation time to be qualified, and judging whether the interpretation time of the detection result is qualified or not according to the shooting interval time of the second image and the third image.
The quality control method also comprises invalid event discrimination:
identifying whether an abnormal detection result is displayed in an interpretation window area of the integrated antigen detection device in the first image and/or the second image, if so, generating an invalid event, and giving a corresponding prompt;
and/or;
and identifying the optical space positioning identifier in the second image and/or the third image, if the optical space positioning identifier in the second image and/or the third image is inconsistent with the optical space positioning identifier in the first image, generating an invalid event, and giving a corresponding prompt.
The quality control method also comprises invalid event judgment: identifying whether an abnormal detection result is displayed in an interpretation window area of the integrated antigen detection device in the first image and/or the second image, if so, generating an invalid event, and giving a corresponding prompt; and/or; identifying the optical space positioning identification in the second image and/or the third image, if the optical space positioning identification in the second image and/or the third image is inconsistent with the optical space positioning identification in the first image, generating an invalid event, and giving a corresponding prompt; when any unexpected pattern appears outside the non-third image in the detection window and a pattern which does not accord with the standard line and is modulated by the optical anti-counterfeiting structure appears in the third image, the detection can be judged to be invalid, and if the position of the line C of the interpretation window displays a dark strip, the detection result is negative; if the line C of the window is judged and read, the position of the line T respectively shows two dark color strips, and the detection result is positive. The other results are invalid results; if the reagent color development strip is identified at the position of the test paper interpretation window, the sample test paper is proved to be polluted, the detection is invalid, and the like.
As shown in fig. 6, the first determination further includes: based on the range of the nasal swab, if the characteristic color area of the nasal swab is smaller than the characteristic color minimum area threshold, determining that the nasal swab is fully inserted into the nasal cavity, otherwise determining that the nasal swab is not fully inserted into the nasal cavity S301.
The first discrimination is adopted to further include: based on the range of the nasal swab, if the characteristic color area of the nasal swab is smaller than the minimum area threshold of the characteristic color, the nasal swab is determined to be completely inserted into the nasal cavity, otherwise, the nasal swab is determined to be not completely inserted into the nasal cavity, and the characteristic color larger than the minimum area threshold is not identified in the position where the nasal swab rod should exist, so that the nasal swab is proved to be completely inserted into the nasal cavity, and the insertion depth is proved to be insufficient in an anti-regular mode.
The second determination further includes: based on the area range of the nasal swab and the intermediate body in the extraction tube, if the change degree of the identified characteristic color of the nasal swab rod and/or the intermediate body relative to the un-occluded time value stored in the database is consistent with the preset range, it is determined that the nasal swab is immersed in the stored antigen extracting solution in the extraction tube, and the intermediate body is completely covered by the extraction tube, that is, the extraction tube is completely combined with the detection part 4S 302.
The second judgment further includes: based on the area range of the nasal swab and the intermediate body in the extraction tube, if the change degree of the characteristic color of the identified nasal swab rod and/or the intermediate body relative to the un-shielded time value stored in the database is consistent with the preset range, the nasal swab is determined to be immersed in the stored antigen extracting solution in the extraction tube, and the intermediate body is completely covered by the extraction tube, namely the extraction tube is completely combined with the detection part. Furthermore, the current detection device can be judged to be in the positive state or the negative state according to the color difference between the part, shielded and the part, not shielded, of the extracting solution, wherein the part, shielded and the part, not shielded, of the nose swab are shielded.
The intermediate not only plays a role in connecting the nasal swab with the detection part, but also plays a role in connecting the extracting solution with the nasal swab and the detection part into a whole, and authenticity and replaceability of detection results are ensured. Meanwhile, a sealed extracting solution channel is established in the connecting part, and the extracting solution with the detection sample is directly conveyed to the sample pad of the detection test paper. Ensuring the accurate source of the detected sample.
The quality control method further comprises a face recognition method implemented based on the first image, and the face recognition method comprises the following steps:
the identity information of the detected person is obtained by comparing the face information in the image with the known information in the identity information database, and the antigen detection result of the detected person at this time is associated with the record of the detected person.
Because the quality control method also comprises a face recognition method realized based on the first image, the face recognition method comprises the following steps: the identity information of the detected person is obtained by comparing the face information in the image with the known information in the identity information database, the antigen detection result of the detected person at this time is associated with the record of the detected person, and the identity information of the detected person is obtained due to face recognition, so that the detection result at this time is associated with the detected person.
The quality control method also comprises the following steps of judging the anatomical position of a nose swab blocked by the nostril in the first stage through the recognition of the human face organ in the image:
if the nasal swab is positioned on the left side of the midline of the human body, the antigen detection process of the detected person is determined as sampling of the left nostril;
if the nasal swab is positioned at the right side of the midline of the human body, the antigen detection process of the detected person is determined as sampling of the nostril at the right side;
the human body midline is a straight line connecting the midpoint of the connecting line of the two eyes and the nose tip.
Because the quality control method further comprises the step of judging the anatomical position of the nasal swab blocked by the nostril in the first stage through the human face organ recognition in the image: if the nasal swab is positioned on the left side of the midline of the human body, the antigen detection process of the detected person is determined as sampling of the left nostril; if the nasal swab is positioned at the right side of the midline of the human body, the antigen detection process of the detected person is determined as sampling of the nostril at the right side; the human body midline is a straight line connecting the midpoint of the connecting line of the two eyes and the tip of the nose, and the positions of the two eyes and the nose are obtained due to face recognition. And connecting the midpoint of the connecting line of the two eyes with the tip of the nose to obtain the midline of the human body. The interpretation is based on the fact that the nasal swab rod part obtained in the step 3 is positioned on the left or right of the midline of the human body, so that the sampling confirmation process of the nostrils on both sides under the supervision of software is realized.
As shown in fig. 2, the kit is exemplified in step 1 in a state after completion of nasal cavity insertion and before insertion of the kit into the extraction liquid. And a gray dotted line partially shielded by the two-dimensional code is the position of the detection test paper. Step 2 is a state that the nasal swab is immersed in the extracting solution, and the connecting part is tightly connected with the extracting solution. At this point, a second image acquisition may begin and timing begins. And step 3, inverting the reagent kit, guiding the extracting solution to the water guide hole by using gravity, and gradually extruding the extracting solution into the reagent kit by extruding the wall of the extracting tube to be contacted with the sample pad.
Example two:
in the sample sampling stage (first stage of first discrimination of the first image):
identifying whether there is a nasal swab: when the extraction tube is confirmed to exist in the image, whether the nasal swab exists is further judged. The possible methods comprise: 1. carrying out brightness and contrast transformation according to preset values of transparency of extraction tubes of different models stored in a database, selecting a combination of the color of the nasal swab and the color of the extraction tube with the maximum brightness contrast, and searching whether an area which accords with the color and the shape of the nasal swab exists in an extraction tube area; 2. confirming whether the image contains a nose swab area with a specific color according to the color difference between the nose swab and the extraction tube;
in the sample sampling stage (first stage of first discrimination of the first image):
method 1 for interpreting the degree of occlusion of a nasal swab by a nostril: and searching whether the corresponding specific color area exists in the database in the nose swab area after the coordinate transformation. As defined by the nasal swab area in the database as 75mm 2 And according to the actual size of the two-dimensional code and the imaging resolution of the camera, the corresponding area of each pixel point in the current image is known to be 0.3mm 2 Judging the number of white pixels in the area to be detected, and obtaining the shielded degree of the nose swab according to the ratio of the number of the pixels to 75/0.3 (250) corresponding to the complete nose swab
Sample extraction stage (second stage of second discrimination for second image):
a method of determining whether a nasal swab is occluded by an extraction fluid:
identifying whether an extraction tube exists: for an extraction tube area after coordinate transformation, similar to the nose swab recognition algorithm 1, whether an extraction tube area exists is searched, and one possible method is to carry out brightness and contrast transformation on an original image of the extraction tube area according to preset values of the transparency of extraction tubes of different types stored in a database so as to obtain the optimal color distinguishing contrast of the extraction tubes relative to different environments. Another possible method is to select the extraction tube material as a color transparent tube, and confirm whether the extraction tube is contained in the image or not through the extraction of a specific color area;
a result interpretation stage (interpretation of the detection result is performed based on the third image to obtain an antigen detection result):
judging whether the detection window area is qualified:
a) detecting whether the color of the window area is consistent with the database:
if the color anti-counterfeiting detection window is used by the detection box, judging whether the color corresponding to the single color with the largest area acquired in the detection window area is consistent with the color stored in the database.
b) Whether the preset control line C shape is consistent with the database:
if the detection box uses a prism anti-counterfeiting detection window, judging whether the contour shape corresponding to the single color with the largest area acquired in the C line area is consistent with the shape stored in the database or not.
Interpretation of the detection results:
in the preset detection line T line area, whether the area of the pixel of the color of the non-preset detection test paper pad, which is larger than the preset area (such as 2mm2), can be detected, if so, the detection result is defined as abnormal, otherwise, the detection result is normal (negative result).
Example three:
in the sample sampling stage (first stage of first discrimination of the first image):
method 2 for interpreting the degree of occlusion of the nasal swab by the nostril: and (3) for the nose swab area after coordinate transformation, finding a continuous white color band with the width of 10 pixels along the Y axis, wherein the length of the identified white color band is the length of the uncovered nose swab.
The working principle is as follows:
the detection functional area and the optical space positioning identification area are adopted, wherein the detection functional area comprises a nose wiper part, a detection part and an extraction tube part, and the above structures are combined into an integrated device at one or more stages of an antigen detection process; the device comprises a detection function area which is used for connecting a nose swab with a detection part and connecting an extraction tube with the nose swab and the detection part into a whole, a sealed extraction solution channel is established in the connecting part, the extraction solution from which a detection sample is extracted is directly sent to a sample pad of the detection test paper, meanwhile, an integrated structure consisting of an optical anti-counterfeiting structure on the extraction tube, the detection part and an interpretation window completely seals the detection sample in the detection device, an optical space positioning identification area is used for sealing the upper surface of the antigen detection device, the detection part which is at a specific distance from a rod part of the nose swab part and an interpretation window is provided with a pattern, preferably a two-dimensional code, which can be used for optical identification on the detection device quickly and accurately by software based on the position basis of optical identification, the color state of the structure at a specific distance from the optical identifier supervises whether the detection device is used correctly; meanwhile, the integrity of the optical identification is used as an evaluation mode for judging whether the detection device is damaged or not, so that the detection result can be conveniently ensured not to be artificially modified in the detection process, such as replacing a detection test paper, dropping an extracting solution of a non-user and the like, and in one or more stages of the antigen detection process, such as a sample sampling stage (a first stage of first judgment is carried out on a first image), a sample extraction stage (a second stage of second judgment is carried out on a second image), and a sample detection stage (a third stage of third judgment is carried out on an acquisition time interval of a third image and a second image) are combined into an integrated device based on the above structure.
Acquiring a first image of the nasal swab inserted into the nasal cavity by using the integrated antigen detection device; performing first judgment based on the first image, and judging whether the sample sampling of the detected person is qualified; if the first judgment result is qualified, entering a second stage, and acquiring a second image of the state that the nasal swab part is inserted into the extraction tube; performing second judgment based on the second image, and judging whether the sample extraction operation of the detected person is qualified; if the second judgment result is qualified, entering a third stage, and acquiring a third image of the sample detection result displayed by the interpretation window; performing third judgment based on the acquisition time interval of the third image and the second image, and judging whether the time interval of the detected person is qualified; if the third judgment result is qualified, judging the detection result based on the third image to obtain an antigen detection result; because the method comprises three stages in total, namely (1) the first stage (sample sampling judgment): based on the integrated antigen detection device, in a sample sampling stage, acquiring a first image of the depth of inserting the nasal swab part into the nasal cavity, judging whether the sample sampling of the detected person is qualified or not by a first image judging method based on the first image, and if the sample sampling is unqualified, judging that the antigen detection process of the detected person is invalid; (2) second stage (sample extraction judgment): if the sample sampling is qualified, acquiring a second image of the state that the nasal swab part is inserted into the extraction tube after the sample sampling in a sample extraction stage, judging whether the sample extraction operation of the detected person is qualified or not by a second image judgment method based on the second image, and if the sample extraction operation is carried out, judging that the antigen detection process of the detected person is invalid; (3) third stage (sample detection judgment): if the sample extraction operation is qualified, acquiring a third image of the sample detection displayed by the optical anti-counterfeiting interpretation window after the sample extraction operation in a sample detection stage, judging whether the sample detection operation of the detected person is qualified or not by a third image judging method based on the third image, if the sample detection operation is qualified, judging that the antigen detection process of the detected person is effective, otherwise, judging that the antigen detection process of the detected person is effective if the sample detection operation is unqualified; and finally, if the antigen detection process of the detected person is effective, determining that the antigen detection result of the detected person is negative if the sample detection displayed by the optical anti-counterfeiting interpretation window in the third image is negative, or determining that the antigen detection result of the detected person is positive if the sample detection displayed by the optical anti-counterfeiting interpretation window in the third image is positive.
The above three-stage work overall workflow can be summarized as follows: acquiring a first image shot by a detector when sampling by using a sampling swab; judging whether the sampling operation of the examiner is qualified or not (the swab rod is completely inserted into the nasal cavity) according to the first image; acquiring a second image when the examiner completely inserts the sampling swab into the extraction liquid accommodating part of the antigen detection device, and confirming that the sampling swab is completely inserted into the extraction liquid; acquiring a third image shot when the interpretation window displays the detection result; judging whether the detection result interpretation time is qualified or not according to the shooting interval time of the second image and the third image; and obtaining a negative, positive or invalid detection result according to the third image.
The invention solves the problem that the infected person can not be found in time due to the fact that the self-test process of the examinee is not standard, misoperation or intentional cheating exists in the prior art, and has the beneficial technical effects of standardizing the self-test process of the examinee, effectively preventing misoperation or intentional cheating of the examinee in use and effectively finding the infected person in time.
The technical solutions of the present invention or similar technical solutions designed by those skilled in the art based on the teachings of the technical solutions of the present invention are all within the scope of the present invention to achieve the above technical effects.

Claims (16)

1. An integrated antigen detection device is characterized by comprising a detection functional area and an optical space positioning identification area, wherein the detection functional area comprises a nose wiping part, a detection part and an extraction pipe part, and the above structures are combined into the integrated device at one or more stages of an antigen detection process.
2. The integrated antigen detecting device of claim 1, wherein the detecting portion is provided with a sealing protector, and the sealing protector is provided with an optical space positioning identification area.
3. The integrated antigen detection device of claim 1, wherein the nasal swab portion is opaque and visibly distinguishable from skin color and color of the detection portion.
4. The integrated antigen detecting device of claim 1, wherein the detecting portion comprises an optical anti-counterfeiting interpretation window, the optical anti-counterfeiting interpretation window comprises an anti-counterfeiting substrate and/or an anti-counterfeiting window body, the anti-counterfeiting substrate adopts a colored and/or striped substrate, and the anti-counterfeiting window body adopts a lens, a prism, colored transparent paper or a non-linear frame.
5. An antigen detection process quality control method based on an integrated antigen detection device, which is characterized by using the integrated antigen detection device of claim 1, and comprises the following steps:
acquiring a first image of a nasal swab inserted into a nasal cavity;
performing first judgment based on the first image, and judging whether the sample sampling of the detected person is qualified;
if the first judgment result is qualified, entering a second stage, and acquiring a second image of the state that the nasal swab part is inserted into the extraction tube;
performing second judgment based on the second image, and judging whether the sample extraction operation of the detected person is qualified;
if the second judgment result is qualified, entering a third stage, and acquiring a third image of the sample detection result displayed by the interpretation window;
performing third judgment based on the acquisition time interval of the third image and the second image, and judging whether the time interval of the detected person is qualified;
and if the third judgment result is qualified, judging the detection result based on the third image to obtain an antigen detection result.
6. The quality control method for the antigen detection process according to claim 5, wherein the quality control method further comprises: identifying the brand and/or model of the integrated antigen detection device according to the first image based on information in a product database; the product database stores spatial structure characteristics and/or optical characteristics of detection functional regions and/or optical spatial positioning identification regions of integrated antigen detection devices of different brands and/or different models.
7. The antigen detection process quality control method of claim 5, wherein the quality control method further comprises an image space pre-calibration method, the image space calibration method comprising: based on the pose of the characteristic pattern of the optical space positioning identification part in the imaging system and the relative relation between the feature pattern of the optical space positioning identification part and the functional area to be identified in the space structure characteristic, the image area corresponding to the functional area to be identified is obtained through coordinate transformation.
8. The antigen detection process quality control method of claim 5, wherein the quality control method further comprises an image color pre-correction method, the image color correction method comprising: and adjusting the brightness and/or contrast of preset parameters through the image area to be identified to obtain the corrected color.
9. The method of claim 5, wherein the first determining comprises: and judging whether the nose swab part is inserted into the preset depth of the nasal cavity or not and which side of the nasal cavity the nose swab part enters according to the first image based on the fact that the first image determined by the recognizable face and the recognizable optical space positioning marking area exist in the obtained image, and judging that the sample sampling of the detected person is qualified if the nose swab part is inserted in place and the nose swab part enter the nasal cavity.
10. The method for controlling the quality of an antigen detection process according to claim 5, wherein the second determination includes: and based on a second image determined after the status of the internal storage antigen extracting solution inserted into the extracting tube is kept by the nasal swab rod, judging whether the extracting tube part is completely combined with the detection part or not according to the second image, if so, further judging whether the nasal swab is immersed into the internal storage antigen extracting solution of the extracting tube, and if still yes, judging that the sample extracting operation of the detected person is qualified.
11. The method of claim 5, wherein the third determination comprises: and determining whether the interval between the second image acquisition time and the third image acquisition time is greater than the detection preset time and less than the longest detection time, and if so, judging that the time is qualified.
12. The method of claim 5, further comprising the step of identifying an invalid event:
identifying whether an abnormal detection result is displayed in an interpretation window area of the integrated antigen detection device in the first image and/or the second image, if so, generating an invalid event, and giving a corresponding prompt;
and/or the presence of a gas in the gas,
and identifying the optical space positioning identifier in the second image and/or the third image, if the optical space positioning identifier in the second image and/or the third image is inconsistent with the optical space positioning identifier in the first image, generating an invalid event, and giving a corresponding prompt.
13. The method of claim 9, wherein the first determining further comprises: based on the range of the nasal swab, if the characteristic color area of the nasal swab is smaller than the minimum area threshold value of the characteristic color, the nasal swab is determined to be completely inserted into the nasal cavity, and otherwise, the nasal swab is determined not to be completely inserted into the nasal cavity.
14. The method for controlling the quality of an antigen detection process according to claim 10, wherein the second determination further comprises: based on the area range of the nasal swab and the intermediate body in the extraction tube, if the change degree of the characteristic color of the identified nasal swab rod and/or the intermediate body relative to the unoccluded time value stored in the database is consistent with the preset range, the nasal swab is determined to be immersed in the stored antigen extracting solution in the extraction tube, and the intermediate body is completely covered by the extraction tube, namely the extraction tube is completely combined with the detection part.
15. The quality control method for the antigen detection process according to claim 5, wherein the quality control method further comprises a face recognition method implemented based on the first image, the face recognition method comprising:
the identity information of the detected person is obtained by comparing the face information in the image with the known information in the identity information database, and the antigen detection result of the detected person at this time is associated with the record of the detected person.
16. The quality control method for the antigen detection process of claim 5, wherein the quality control method further comprises the following steps of determining the anatomical position of the nasal swab blocked by the nostril in the first stage through the identification of the human face organ in the image:
if the nasal swab is positioned at the left side of the midline of the human body, the antigen detection process of the detected person is determined as sampling of the left nostril;
if the nasal swab is positioned at the right side of the midline of the human body, the antigen detection process of the detected person is determined as sampling of the nostril at the right side;
the human body midline is a straight line connecting the midpoint of the connecting line of the two eyes and the nose tip.
CN202210507046.7A 2022-05-11 2022-05-11 Integrated antigen detection device and quality control method for antigen detection process thereof Pending CN114878806A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115661728A (en) * 2022-12-29 2023-01-31 北京正大创新医药有限公司 Virus sampling in-place judgment method based on image recognition and virus sampling system

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115661728A (en) * 2022-12-29 2023-01-31 北京正大创新医药有限公司 Virus sampling in-place judgment method based on image recognition and virus sampling system

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