JP2022115777A - Antigen test terminal and online infection test system using the same - Google Patents

Abstract

To provide an online infection test system that is cheaper (economical efficiency), faster (efficiency), and better in operability than PCR testing, and is network-compatible.SOLUTION: An online infection test system 10 according to the present invention includes an antigen test terminal 20, an external communication unit 30, an external communication terminal 35, and a network 40. The antigen test terminal 20 is a mobile terminal board of an immuno-chromatography reader and accommodates an input switch unit 21, an indicator unit 22, a communication unit 23, a microscopic imaging unit 24, a control and calculation unit 25, a light emitting unit 26, a power supply unit 27, and a sample unit 28 in a portable housing. A subject who performs a test for infection inserts an immuno-chromatography test kit after end of the test into the antigen test terminal 20. After a predetermined period of time, test results and status of presence or absence of infection are automatically transmitted to the external communication terminal 35, such as a mobile terminal owned by the subject.SELECTED DRAWING: Figure 1

Description

The present invention relates to a light source inspection terminal that can be used in an online infection inspection system using an immunochromatographic inspection kit. Furthermore, the present invention uses this light source inspection terminal device to automatically identify the source of infection in a sample collected from saliva or nasal mucosa after inserting an immunochromatography test kit. It relates to an online infection inspection system that includes systems and network systems.

Among various immunoassay methods based on antigen-antibody reactions, immunochromatography (immunochromatographic method) is economical, easy to operate, and has a short measurement time, making it easy to detect analytes. As a method, it is widely used in society as a whole, from the medical field to the public. An immunochromatographic test is performed using a test kit consisting of a long and narrow immunochromatographic test strip and a housing case containing it, and utilizes the antigen-antibody reaction that progresses in the immunochromatographic test strip during the process of sample liquid development. A typical test method involves dropping sample fluid extracted from saliva or nasal mucous fluid onto an immunochromatography test piece having an immunoreactive site with the test substance in the sample, allowing it to develop in the immunochromatography test piece, and obtaining the desired analyte. The test substance is specifically bound and captured by the immobilized antibody, and the color signal generated at the captured site is visually recognized to determine the test result.

Recently, an immunochromatographic test result determination device called an immunochromatographic reader that performs mechanical determination has been invented and marketed for the purpose of avoiding and automating the arbitrariness associated with human recognition (Patent Document 1- 4, Non-Patent Documents 1-5). The immunochromatographic reader is expected to be particularly useful for infectious disease testing POCT (Point Of Care Testing) at medical sites because of its high convenience and objective data. However, in the medical field of the new corona pandemic that began in the beginning of 2020 and covered the whole world, the current situation is that highly sensitive PCR tests are prioritized and immunochromatography methods and immunochromatography readers are hardly used.

In Japan under the novel coronavirus pandemic, immunochromatographic test kits for viral antigen tests themselves are not permitted to be used outside the medical field, and there are barriers to their use in the general public. However, the immunochromatographic method and the high potential of the immunochromatographic reader quickly identify the infection source POIS (Point Of Infection Source). As a means, rather, it should be widely and effectively used outside the medical field.

In particular, the mechanized immunochromatography method, which has been strengthened by the immunochromatography reader, has latent features such as individual independent testing, mass simultaneous testing, high-frequency testing, testing for all members of society, and rapid identification of the source of infection through objective judgment. It is considered to have the potential to become In the current testing environment, which relies on medical institutions for most of the infection testing, it is not possible to normalize society by quickly identifying the source of a large number of infections. As a trump card for preventing infection without restraining social activities, however, there are many technical issues that stand in the way of widely disseminating the potential of mechanized immunochromatography to the general public.

Japanese Patent No. 5554289 Japanese Patent No. 5543310 Japanese Patent No. 5603114 Japanese Patent No. 6761422 Utility Model Registration No. 3215815 Utility Model Registration No. 3217259 Japanese Patent No. 6579525

Fuji Dry Chem (Fujifilm), https://www.fujifilm.com/jp/en/healthcare/poct/immuno Immunochromato reader (Hamamatsu Photonics) https://www.hamamatsu.com/jp/en/product/life-science-and-medical-systems/immunochromato-reader/index.html Fluorescent immunochromatographic reader (Otsuka Electronics), https://www.otsukael.jp/product/detail/productid/110 Quick Navi Reader (Otsuka Pharmaceutical), https://www.otsuka-library.jp/pdf_viewer/index.html?f=/file/1072/qndbnotk.pdf Rapid Pier (Sekisui Medical), https://www.sekisuimedical.jp/business/diagnostics/poct/rapidpiaqf2bnotk.pdf Abott's new coronavirus antigen test kit https://dam.abbott.com/en-us/homepage/coronavirus/20-386051-ARDX-BinaxNOW-NAVICA-Infographic-v8.pdf

Infection prevention social tools that can be widely used by the public inside and outside the medical field are different from medical tools that identify patients with infectious diseases, such as PCR tests. It is a necessary requirement to have a function and performance that can grasp the situation as a routine. In consideration of this, the technical requirements and issues of the infection prevention social tool to which this application aspires are listed below.
1. Cheaper than PCR test (economical),
2. Faster than PCR test (efficiency)
3. Individuals can always carry (portability),
4, automation of operation (operability),
5, network support (online communication),
6. Identification of infection source (infection source specificity)
7. Authentication of infection source holder (infection source holder authenticity)
As one of the infection prevention measures to solve the devastating pandemic problem that covers the whole world, equipment and systems that simultaneously solve the above seven problems are essential. In other words, there is a need for a portable antigen test terminal that is inexpensive, compact, always portable, easy to operate at any time, and immediately aware of the test results via the network and aware of the possibility of infection at the site, and an online infection test system that supports this. is.

Below is a summary of the current technical background for the above seven issues.
Regarding task 1, immunochromatography + immunochromatography reader provides an alternative.
Regarding task 2, the immunochromatographic method + immunochromatographic reader provides an alternative.
Problem 3 can be handled by a portable device that is a mobile terminal of the immunochromato reader.
Problem 4 can be handled by a microprocessor embedded in a terminalized mobile device.
Problem 5 can be handled by the network communication function built into the terminalized mobile device.
Problem 6 can be dealt with by increasing the sensitivity of inspection using a microscope built into a terminalized mobile device.
Problem 7 can be handled by two-dimensional code authentication embedded in terminalized mobile devices.
Means for embodying the technical background outlined above will be described below.

The invention according to claim 1 is an antigen test terminal device that identifies an infection source (virus, etc.) using an immunochromatographic test kit containing an immunochromatographic test strip, wherein the immunochromatographic test kit is detachably inserted. A palm-sized portable housing having an insertion port, a sample unit for carrying the immunochromatography test kit inserted into the portable housing through the insertion port, and the immunochromatography test piece test a light emitting unit that emits visible light toward an inspection area including a region and a control area; an objective lens that magnifies the inspection area; an input switch unit that activates the antigen inspection terminal; and a power supply section for supplying power.

With the above configuration, the inspection area of the immunochromatographic inspection kit attached to the portable housing through the insertion port is irradiated with visible light emitted from the light emitting unit, and the inspection area can be expanded with the objective lens, making it easy to visually check. You will be able to

Further, according to the second aspect of the invention, there is provided a microscopic image pickup unit for microscopically photographing an image of an inspection area that has passed through the objective lens; a control/calculation unit, a communication unit that transmits the test results calculated by the control/calculation unit to the outside of the antigen test terminal, and a light source and a sound source that inform the outside of the operating state of the antigen test terminal. An indicator section, and a power supply section for supplying power to the microscopic imaging section, the control/calculation section, the communication section, and the indicator section are provided separately from the portable housing.

According to the above configuration, the control/calculation unit obtains the inspection results from the images of the two inspection machines that have passed through the objective lens and are photographed by the microscopic imaging unit, and the communication unit transmits the inspection results to the outside, The indicator part can notify the operating state by a light source or a sound source. In this invention, a set of configured elements is configured separately as an external device of a portable housing, and can be replaced by an external communication terminal such as a smartphone or tablet. . Moreover, it is possible to simplify the structure of the antigen test terminal.

The invention according to claim 3 is characterized by a microscopic image pickup unit for microscopically photographing an image of an inspection area that has passed through the objective lens, and a control unit for calculating and processing inspection results based on the microscopic image picked up by controlling the microscopic image pickup unit. a calculation unit, a communication unit for transmitting the test results calculated by the control/calculation unit to the outside of the antigen test terminal, and an indicator unit comprising a light source and a sound source for informing the outside of the operating state of the antigen test terminal. , the microscopic imaging unit, the control/calculation unit, the communication unit, and the power supply unit for supplying power to the indicator unit are provided in the portable housing.

According to this structure, it is possible to equip the portable housing with all the components described above, so that the result detected by the antigen test terminal can be rapidly communicated.

Moreover, it is preferable that the control/calculation unit calculates the evaluation index based on the following formulas (1) and (2).

[Background ratio]=[Signal channel statistic of background region]/[Background channel statistic of background region] (1)

R = [output image signal channel] - [output image background channel] x [background ratio] (2)

This evaluation index R is integrated in the direction perpendicular to the direction in which the sample liquid spreads on the test piece, and is expressed as a one-dimensional statistic by passing through a low-pass filter. Let Rv be the peak value in the vicinity of the target area, Rt be the peak value in the vicinity of the test area. Whether it is large or small determines the possibility of infection. In addition, in the present invention, instead of determining whether it is positive or negative for coronavirus as in the PCR test, for example, the Rt / Rv ratio of the specimen contained in saliva is used as an evaluation index R, and the saliva of the subject It is quantified as a standard for judging how much infectivity there is.

In the invention according to claim 4, it is preferable that the volume of the portable housing is smaller than 250 cubic centimeters.

In the invention according to claim 5, it is preferable that the light-emitting section includes a visible light LED.

In the invention according to claim 6, it is preferable that the microscopic imaging unit has a structure in which an objective lens and a mini digital camera are integrated to form a digital microscope.

In the invention according to claim 7, it is preferable that the control/calculation unit comprises a microprocessor for control and calculation.

In the eighth aspect of the invention, it is preferable that the communication unit includes a wireless LAN standard device or a short-range wireless communication standard device.

In the ninth aspect of the invention, it is preferable that the indicator unit includes an LED as a light source for informing various operational states of the antigen test terminal and a buzzer as a sound source for informing various operational states of the antigen test terminal.

In the invention according to claim 10, the power supply unit includes a battery for supplying power to various members installed in the light emitting unit, the microscopic imaging unit, the control/calculation unit, the communication unit, and the indicator unit, a booster circuit for increasing the battery voltage, and A charger for charging the battery is preferably provided.

Further, in the invention according to claim 11, any one of the antigen test terminals described above and, as an external environment of the antigen test terminal, the test results calculated by the control/calculation unit are received, stored, An external communication unit for transferring, an external communication terminal for receiving and displaying the test results, and a network for supporting communication between the antigen test terminal, the external communication unit, and the external communication terminal. That's what it is.

According to this configuration, the test result obtained by the antigen test terminal can be transmitted to the external communication terminal via a network or the like, so that the subject can be promptly notified of the test result.

According to a twelfth aspect of the present invention, the external communication unit comprises a server such as an application server or a database server.

According to a thirteenth aspect of the present invention, the external communication terminal is any one of a mobile terminal, a personal computer terminal, a tablet terminal, and the like.

According to the fourteenth aspect of the invention, the network comprises a wireless or wired LAN (Local Area Network), a wireless or wired WAN (Wide Area Network), a wireless or wired Internet, or a short-range wireless communication. be.

According to the fifteenth aspect of the invention, the immunochromatographic test kit is a modified immunochromatographic test kit to which a two-dimensional code for identifying a subject is added.

The invention according to claim 16 comprises a mobile platform installed at a place for entering/entering a facility, a support stand erected on the mobile platform, and a face recognition camera mounted on the upper part of the support platform. 1. An infection test stand for entry/entrance control, comprising at least a display for displaying face-authenticated data of a subject, and the above-described antigen test terminal provided on the support base.

The invention according to claim 17 is the above-described on-line infection test system comprising the antigen test terminal of the infection test stand for entry/entrance management.

According to the eighteenth aspect of the present invention, the above-described online infection detection method transfers the face image data acquired by the face authentication camera to the antigen inspection terminal, and transmits the result of inspection by the antigen inspection terminal to the external communication unit. inspection system.

In the nineteenth aspect of the invention, the face recognition camera has a body temperature detection function, and the face image data and body temperature data acquired by the face recognition camera are transferred to the antigen inspection terminal. It is the above-mentioned online infection inspection system that transmits to the external communication unit together with the inspection result by.

With the wide spread of the antigen test terminal and online infection test system of the present invention throughout society, the antigen test terminal holders can quickly recognize the possibility of infection anytime and anywhere, and make it a code of conduct. It will be possible to prevent the spread of infection and control pandemics as a society as a whole without relying excessively on medical care. Since the final determination of infection should be made at a medical institution, this system mechanically presents only the determination of the possibility of infection.

In addition, the infection test stand for entry/entrance management equipped with the antigen test terminal of the present invention allows the visitor to grasp his or her own condition, and thus has the effect of restricting the visitor who is suspected of being infected. .

FIG. 1 is a block diagram of an online infection inspection system according to the present invention. FIG. 2 is a schematic diagram of an antigen test terminal according to the present invention, where A is a schematic perspective view of the antigen test terminal, B is a side sectional view of an immunochromatographic test kit of the antigen test terminal, and C is an antigen test. A top plan view of the terminal, D is a battery side cross-sectional view of the antigen test terminal. FIG. 3 is a block diagram showing the network of the online infection inspection system of the present invention. FIG. 4 is a schematic diagram of a modified immunochromatography test kit to which a two-dimensional code is added. FIG. 5 is an inspection flow chart for carrying out an infection inspection in the basic form of the present invention. FIG. 6 shows Example 1 of the present invention, where A is a photograph of a normal immunochromatographic test kit, and B is a monitor screen of a mobile terminal for normal immunochromatographic test kit test photography by an antigen test terminal. is shown. FIG. 7 shows the screen display of the portable terminal of the results of the immunochromatography test kit test according to the present invention. FIG. 8 is a test flow chart for performing an infection test in an advanced form. FIG. 9 shows Example 2 of the present invention, where A is an actual photograph of a modified immunochromatography test kit with a two-dimensional code added, and B is a modified immunochromatography test kit with an antigen test terminal. It shows a monitor screen of a portable terminal for photographing a two-dimensional code. FIG. 10 shows the mobile terminal screen display of the modified immunochromatography test kit test results. FIG. 11 is an explanatory diagram showing an example of an infection test stunt for admission/entrance control according to the present invention.

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, embodiments of the present invention will be described with reference to the drawings. In addition, in each drawing, the same reference numerals are given to the same constituent elements, and detailed description thereof will be omitted as appropriate. Moreover, the present invention is not limited by the present embodiment.

(basic form)
As shown in FIG. 1, the present application connects an antigen test terminal 20, an external communication unit 30, and an external communication terminal 35, which is an extension of a portable smartphone microscope (Patent Documents 5 to 7) to an immunochromatographic method, via a network 40. An online infection inspection system 10 is shown.

As shown in FIG. 2, the antigen test terminal 20 comprises an input switch section 21, an indicator section 22, a communication section 23, a microscopic imaging section 24, a control/calculation section 25, a light emitting section 26, a power supply section 27, and a sample section 28. and integrated inside the portable enclosure 20a. The communication unit 23 is composed of a wireless LAN device, a short-range wireless communication device, or the like. The input switch section 21 is a power switch. The indicator unit 22 consists of an LED and a buzzer for notifying the operation of the antigen test terminal 20 . The microscopic imaging section 24 consists of an objective lens 24a and a mini digital camera 24b. The control/calculation unit 25 is composed of a mini digital camera control processor and an image analysis calculation processor. The light emitting part 26 is made up of a microscope illumination LED. The power supply unit 27 consists of a battery 27a and a charger 27b. The sample section 28 consists of a sample table 28a and a limit switch 28b.

First, an infection test using the immunochromatography test kit 50 is performed. In parallel, the power switch 21 of the antigen test terminal 20 is turned on to warm up. During warm-up, the illumination LED 26 is turned on, the control/calculation section 25 is activated, and the communication section 23 is ready. Next, the immunochromatography test kit 50 that has been tested is held by the end of the housing case 51 on the sample liquid addition side and inserted into the sample table 28a with guide through the test kit insertion port 53. FIG. If the limit switch 28b of the sample section 28 is touched during insertion, a buzzer sounds to inform the user that the insertion has been stopped. Immediately after the buzzer notification, microscopic imaging is performed by the mini digital camera 24b, image analysis of the obtained microscopic image proceeds in the control/calculation unit 25, and the analysis result of the inspection is sent from the communication unit 23 to the WiFi (registered trademark) card. For example, it is sent to the external communication terminal 35 via the server of the external communication unit 30 or directly by a Bluetooth (registered trademark) card or the like, and the inspection result is displayed. The test subject can quickly view the test results using the external communication terminal (portable terminal, etc.) held by the test subject, and the administrator can quickly view the test results using the external communication terminal (personal computer terminal, etc.) for the administrator.

The full automation of this application includes the control function of the microprocessor in microscopic image acquisition, the calculation function of the microprocessor in analysis and judgment, and the inspection results such as images and inspection judgments via WiFi (registered trademark) cards and Bluetooth (registered trademark) cards. It relies on the transmission function and the image display function of the external terminal that displays the inspection result data. The system of the present application is premised on the presence of an external device capable of receiving transmission data from a network and an antigen test terminal as an external environment for displaying test results. Although the network and the external device themselves are not included in the claims of the present application, their existence in the external environment is implied in the system of the present application and included in the claims of the present application.

3, the antigen test terminal 20 is claimed as an apparatus, and the antigen test terminal 20+external communication unit 30+external communication terminal 35+network 40 is claimed as an online system.

In the basic mode, test results are sent from the antigen test terminal 20 to the external communication terminal 35 via the network line 2 mainly via Bluetooth (registered trademark). The test result is first sent from the antigen test terminal 20 to the external communication unit 30 via the network line 1 , and then sent from the external communication unit 30 to the external communication terminal 35 via the network line 3 .

(Developed form)
The basic form assumes the use of a commercially available immunochromatography test kit. This is not too much or too little when the use of the test kit is limited to an individual basis, but it is inconvenient when used for admission control, for example, when authentication of the subject is required by a third party. In that case, it is necessary to devise ways to associate the test results with the subject himself/herself. Developments including automated authentication methods that address such authentication problems are described next.

A method of solving the authentication problem associated with image acquisition of the inspection area by the antigen inspection terminal 20 is considered to be the most rational in terms of speed and efficiency. For that purpose, it is necessary to modify the current immunochromatography test kit 50 and add image information necessary for authentication. An example of modification is shown in FIG.

In the example of the modified immunochromatography test kit 50a of FIG. 4, a two-dimensional code 54 for authentication is usually attached above the immunochromatography test piece inside the immunochromatography test kit 50 (see also FIGS. 2B and 2C). The two-dimensional code is preliminarily described with information linked to the holder of the immunochromatography test kit (that is, the subject), and is used for authentication. A two-dimensional code is a tag for identifying an individual.

As disclosed in the basic form, a microscopic image is automatically taken after the immunochromatography test kit is inserted into the antigen test terminal, but in the advanced form, the two-dimensional code 54 attached to the modified kit is also taken at the same time, and the image is taken. The two-dimensional code image is decoded by the analysis processor, and the decoded information is transmitted to the external communication unit 30 as subject information together with the inspection image analysis result.

Note that in an advanced form, the image analysis information, the infection possibility information, and the decoding information are the test results.

The decoded information transmitted to the external communication unit 30 such as a server is used for linking the examination result and the subject. Specifically, for example, it is used for admission management at various events, and according to the test result, it is sent to a specific subject linked to the result via the server to the communication terminal held by the subject. Then, whether or not they can enter the building is reported online. In addition, if necessary, the personally specified test result information is used as various social data, such as public health data, infection statistical data, and infection route tracing data, within the scope of personal information protection.

Since the main object of the present application is neither the immunochromatography method nor the immunochromatography test kit, the details of the immunochromatography method and the immunochromatography test kit applied to the present invention are omitted. However, the developed form includes modification of the immunochromatographic test kit, and inventions related thereto are also included, so the modified part of the immunochromatographic test kit will be described below.

As shown in FIGS. 2B, C and 4, the immunochromatographic test kit 50 is composed of an immunochromatographic test strip 52 and a housing case 51 containing it. , a reagent-containing member (conjugate pad) containing a reagent for labeling an analyte, a membrane for chromatography containing an inspection region, and an absorbent pad absorbing a chromatographic developing solution are connected in series in this order. Further, the housing case 51 protects the immunochromatographic test piece 52, has a sample droplet drop opening 51a, and guides the input of the sample liquid containing the test substance. When the sample liquid is added to the sample pad, capillary action causes the test substance to permeate and spread on the immunochromatographic test strip toward the absorbent pad. In this process, the capture of the analytes occurs in the detection zone, the test zone (test line 52a) and the control zone (control line 52b) of the chromatographic membrane, and the accompanying color reaction is detected.

Modification of the immunochromatography test kit 50, as seen in the schematic diagram of FIG. 4 and the example of FIG. A dimensional code 54 is inserted (in the example of FIG. 9A, a general-purpose QR code (registered trademark) is used as the two-dimensional code). The two-dimensional code to be inserted is approximately 5 mm square. Since the two-dimensional code is photographed at the same time as the inspection area, it is ideal to place it at the same height as the focus position of the inspection area in this application using a microscope method. be. In practice, the two-dimensional code is set slightly above the inspection area on the immunochromatographic test piece. This problem of positional deviation in the vertical direction was solved by setting the microscope magnification to a low magnification (10 times or less), and simultaneous focusing of the two-dimensional code and the inspection area was realized. This will be explained below.

In the example of FIG. 9A, the two-dimensional code is positioned about 0.3 mm above the immunochromatographic test strip 52, but the inspection area (test line 52a and control line 52b) and the two-dimensional code 54 are almost in focus. there were. Since the microscope used in this application has a low magnification of 10 times or less, the depth of focus of the objective lens is deep, and the distance between the lens and the object to be observed is set in advance so that both the inspection area and the two-dimensional code area are in focus at the same time. can. From the viewpoint of improving inspection sensitivity, it should be noted that even at this low magnification, the number of pixels of the light-receiving elements used for image analysis is sufficient to contribute to improving sensitivity through statistical averaging.

Immunochromatography test kits printed with two-dimensional codes are sold by Abbott in the United States (Non-Patent Document 6), but simultaneous imaging with the test area is not performed, and the purpose of using two-dimensional codes in this application is different.

An embodiment of the basic form will be described using the flow chart of FIG. 5 for using the online infection inspection system.
Step 1:
After turning on the input switch of the antigen test terminal 20, the subject drips the specimen liquid into the immunochromatography test kit 50 and waits for 15 minutes to complete the test.
Step 2:
Start inserting the test kit 50 into the antigen test terminal 20 after completion of the immunochromatographic test (an example of the immunochromatographic test kit after the end of the test is shown in FIG. 6A).
Step 3:
When the immunochromatography test kit reaches the limit switch, the buzzer sounds and the insertion is stopped (the indicator LED is also turned on).
Step 4:
The test piece inspection region of the immunochromatographic test kit 50 is photographed in the antigen test terminal 20, the image analysis of the microscopic image is performed, and the possibility of infection is automatically determined from the image analysis results (in the antigen test terminal 20 Although the photographed image is not displayed, an example of the photographed image separately monitored using a mobile terminal is shown in Fig. 6B.The image signals of the test line (left) and the control line (right) in the image are read, and the comparison determines the likelihood of infection).
Step 5:
The automatically determined test result data is transmitted to the external communication terminal via the communication unit 23, and the subject knows the test result (an example of the display of the transmitted test result is shown in FIG. 7. Red The upper part displaying two vertical lines corresponds to the test line and the control line shown in Fig. 6B, and is the result of image extraction by the red image filter. The signal is graphically displayed in the middle row, and the test line displays the specimen signal, whose strength is compared to an empirically-backed infection threshold strength to determine the presence or absence of infection mechanically. In the example shown in Fig. 6B, although weak, the subject signal above the baseline was obtained, the possibility of infection was determined, and the infection was reported in the lower row (the final determination of infection was made by the medical institution (Because it should be carried out in the Internet, infection determination is not performed.) The test result data is sent directly to mobile terminals, for example, via Bluetooth (registered trademark), and to PC terminals, for example, via WiFi (registered trademark). and sent via an external communication unit).
Step 6:
The subject takes out the immunochromatography test kit 50 from the antigen test terminal 20, and the test is completed.

Judgment of the possibility of infection by comparing the image signals of the test line 52a and the control line 52b in the inspection area on the immunochromatographic test piece is mechanization of visual judgment, but the calculation processing method is diversified. The following calculation method was adopted in the basic embodiment.

Three image areas, a test area, a background area, and a control area are specified in the image of the inspection area output from the light receiving element 24d of the mini digital camera 24b. The areas surrounded by rectangles on the immunochromatographic test piece shown in FIG. 6B correspond to the red, yellow, and red rectangular areas from the left. Based on the output values of the image signals of these regions, an evaluation index R representing the content of the test substance represented by the following formula is calculated for each light receiving element pixel. The pixel sensor output value corresponding to the coloration on the test piece due to the presence of the test substance is called the signal channel, and the pixel sensor output value corresponding to other colors is called the background channel.

[Background ratio]=[Signal channel statistic of background region]/[Background channel statistic of background region] (1)

R = [output image signal channel] - [output image background channel] x [background ratio] (2)

The evaluation index R calculated in the above formulas (1) and (2) is integrated in the direction perpendicular to the direction in which the sample liquid spreads on the test piece, and is expressed as a one-dimensional statistic by passing through a low-pass filter. Let Rv be the peak value in the vicinity of the target area, Rt be the peak value in the vicinity of the test area. Whether it is large or small determines the possibility of infection. In addition, in the present invention, instead of determining whether it is positive or negative for coronavirus as in the PCR test, for example, the Rt / Rv ratio of the specimen contained in saliva is used as an evaluation index R, and the saliva of the subject It is quantified as a standard for judging how much infectivity there is.

An example of an advanced form will be described using the flow chart of FIG. 8 for use of the online infection testing system.
Step 1:
After turning on the input switch of the antigen test terminal device 20, the subject drips the specimen liquid into the modified immunochromatography test kit 50a and waits for 15 minutes to complete the test.
Step 2:
Start inserting the test kit 50a into the antigen test terminal 20 after completion of the immunochromatographic test (an example of the immunochromatographic test kit after the end of the test is shown in FIG. 9).
Step 3:
When the test kit reaches the limit switch, the buzzer sounds and the insertion is stopped (the indicator LED is also turned on).
Step 4:
The antigen test terminal 20 captures an image of the test piece test area of the modified immunochromatography test kit 50a and the two-dimensional code, and performs image analysis of the test area microscopic image and two-dimensional code analysis (image captured by the antigen test terminal 2). is not displayed, but a display example of the two-dimensional code analysis on the monitor mobile terminal is shown in Fig. 9B (using QR code (registered trademark) as the two-dimensional code). And the QR code (registered trademark) in the QR code (registered trademark) image is analyzed, the decoding result is displayed as decoding information in the upper 12 digits of alphanumeric characters, and the modified immunochromatographic test kit shown in FIG. 9A subjects authenticated).
Step 5:
The inspection results of the image analysis and decode information are transmitted to the server of the external communication unit via the communication unit 23 and stored by the administrator (data of the inspection results are sent to the server, which is the external communication unit, via WiFi (registered trademark). Sent).
Step 6:
The administrator determines the possibility of infection based on the test result data, and transmits the determination result to the subject associated with the decoded information. The test subject knows the judgment result on his own communication terminal (an example of the display of the test result sent to the test subject's mobile terminal is shown in FIG. 10. The upper part displaying two red vertical lines is the test It corresponds to the line and the control line, and is the image analysis result obtained by applying the image calculation processing shown in formulas (1) and (2).Since colloidal gold showing red was used as the label of the test object, red The image is image-extracted.The signal obtained by further integrating the extracted image is displayed graphically in the middle row, and the test line shows the test line.The strength of this test-object signal is confirmed by experience. In this example, a weak infection signal above the baseline is obtained, and the possibility of infection is determined and entry is prohibited in the lower row. However, developments involving administrators can intervene in the determination of the presence or absence of infection and change the default infection threshold strength, for example to ensure flexible operation of admission control systems. First, it is sent to a server, which is an external communication unit, via WiFi (registered trademark), passes through the administrator's authentication system, and is sent to, for example, a mobile terminal of a subject authenticated by a QR code (registered trademark)).
Step 7:
The examiner takes out the modified immunochromatography test kit 50a from the antigen test terminal 20, and the test is completed.

The advanced form almost follows the calculation method of the basic form, but the advanced form has its own unique characteristics. Regarding the judgment of the possibility of infection based on the numerical data of image analysis, unlike the basic form of machine judgment that uses the specified values built into the antigen test terminal 20, the test result data is sent to an external communication unit such as a server. Since it is stored, there is still room for administrators to make numerical judgments for judging the possibility of infection based on the accumulated data. This provides a useful function in various infection prevention management systems that require fluid judgment.

[Configuration of each part of the online infection inspection system]
To complement the description of the embodiments, the configuration of each part of the online infection inspection system 10 will now be described in detail.

(Antigen test terminal 20)
Input switch unit 21 : A switch for activating the main power supply of the antigen test terminal 20 .
Indicator unit 22 : Consists of a plurality of LEDs for notifying the power-on state of various devices in the portable housing, and a plurality of buzzers for reporting the ON status of limit switches and the operation confirmation of the microprocessor. LEDs include those for main power supply, communication status display, and microprocessor operation display. The buzzer includes a limit switch ON notification when an immunochromatography test kit is inserted, an inspection end notification, and the like.
Communication unit 23 : Controls communication with the external communication unit 30 and the external communication terminal 35 via the network 40, and includes wireless LAN standard devices (such as WiFi cards) and short-range wireless communication standard devices (Bluetooth (registered trademark)). ) cards, etc.), communication ports, etc.
Microscopic imaging section 24 : Consists of an objective lens 24a and a mini digital camera 24b. The objective lens is a low-magnification single lens or a thin compound lens with a focal length of 10 to 30 mm. The mini digital camera is composed of a microlens 24c and a light receiving element 24d (CCD, CMOS, etc.). The microlens has a focal length of 2-5 mm. A digital microscope composed of an objective lens and a microlens of a mini-digital camera forms an infinite focal system, an object to be observed is placed at the focal position of the objective lens, and a light receiving element is placed at the focal position of the microlens. In this configuration, the distance between the objective lens and the microlens may be arbitrary, and the physical magnification on the light receiving element surface is defined by microlens focal length/objective lens focal length. In the configuration of the present application, the physical magnification is much smaller than 1 because microlens focal length > objective lens focal length. However, when the image is transferred from the surface of the light receiving element to the display screen of the terminal device, it is enlarged, and the final screen magnification is several times. When the microscope magnification is referred to in this application, it refers to the latter final screen magnification.
Control/Calculation Unit 25 : Consists of a microprocessor element CPU (Central Processing Unit), memory element ROM (Read Only Memory), RAM (Random Access Memory) and the like. The CPU calls a program stored in the ROM to a work memory area on the RAM, and drives and controls each device connected via the bus. Main controls include 1) inspection flow control, 2) mini digital camera control, 3) acquisition image calculation, and 4) communication unit control.
Light-emitting part 26 : Consists of LEDs for illuminating the inspection regions of the immunochromatographic inspection kits 50 and 50a. The LEDs are rectangular flat white LEDs (approximately 5 mm×30 mm), and it is desirable that two LEDs sandwich an objective lens and illuminate the inspection area obliquely. The relative positions of the objective lens and the immunochromatographic inspection kit are desirably such that the distance from the inspection area and the two-dimensional code site to the objective lens is approximately the same.
Power supply unit 27 : The power supply supplies electric power to all the electric parts inside the antigen test terminal 20, and is preferably composed of a rechargeable battery booster circuit in the 6V range and a charger.
Sample part 28 : It consists of a sample table 28a for guiding the inserted immunochromatography test kit 50 to a fixed position and a stopper switch 28b for notifying the correct insertion position. The sample stage 28a is detachable from the bottom portion of the antigen test terminal 20 below the microscopic imaging unit, and is custom-made according to the size and shape of various commercially available immunochromatography test kits. In order to fit the position of the immunochromatography test kit after insertion tightly to the fixed focus position of the digital microscope, it is necessary to provide an insertion guide on the sample stage. Immunochromatography test kits are generally elongated, measuring 2-4 cm long, 5-8 cm wide, and several millimeters thick. There is For that reason, it is detachable.

(External communication unit 30)
The external communication units are various servers such as application servers and database servers.
(External communication terminal 35)
Various communication terminals include mobile terminals, personal computer terminals, tablet terminals, and the like.
(Network 40)
It refers to a wireless or wired LAN (Local Area Network), a wireless or wired WAN (Wide Area Network), and the wireless or wired Internet. WiFi (registered trademark), which is a wireless LAN, also falls into this category. Bluetooth (registered trademark), which performs pairing between devices in short-range communication, is also classified here for convenience.

The infection test stand A for entrance/entrance management according to the third embodiment of the present invention includes a mobile trestle B installed at a place for entrance/entrance to facilities such as concert halls, movie theaters, art museums, and stadiums, and this A support stand C erected on a moving platform B, a face authentication camera D mounted on the upper part of the support stand C, a display E for displaying face-authenticated subject data, and provided on the support stand C It is configured at least by the antigen test terminal 20 .

In addition, the antigen test terminal 20 of the infection inspection stand A for entrance/entrance management constitutes a part of the online infection inspection system 10 described above.

In this embodiment 3, the face image data acquired by the face authentication camera D is transferred to the antigen test terminal 20 via a wireless communication system such as Bluetooth, and together with the test result by the antigen test terminal, It is transmitted to the external communication section 30 .

In addition, in this embodiment 3, the face authentication camera D has a body temperature detection function, and the face image data and body temperature data acquired by the face authentication camera D are transmitted to the antigen through the wireless communication system, for example. It is transferred to the inspection terminal and transmitted to the external communication unit together with the inspection result by the antigen inspection terminal.

As described above, in the online infection testing system 10 according to the third embodiment of the present invention as well, the effects described above can be obtained, and the face authentication data, body temperature data, etc. of visitors (subjects) can be grasped at the same time. It is possible.

By using the antigen test terminal and the on-line infection test system of the present invention, the antigen test terminal holder can quickly identify the possibility of infection of the holder himself/herself anytime, anywhere. Infected people are immediately self-restrained or quarantined, thereby preventing the spread of infection while allowing non-infected people to engage in free social activities with peace of mind. When the invention of the present application is widely implemented in society, it will be possible for society as a whole to achieve both prevention of the spread of infection and economy without excessive dependence on medical care.

10 Online infection test system 20 Antigen test terminal 20a Portable housing 21 Input switch unit 22 Indicator unit 22a Display LED
22b buzzer 23 communication unit 24 microscope imaging unit 24a objective lens 24b mini digital camera 24c microlens 24d light receiving element 25 control/calculation unit 26 light emitting unit 27 power supply unit 27a battery 27b charger 28 sample unit 28a sample stage 28b limit switch
30 External communication unit 35 External communication terminal 40 Network 50 Immunochromatographic test kit 50a Modified immunochromatographic test kit 51 Housing case 51a Specimen solution addition port 52 Immunochromatographic test piece 52a Test line 52b Control line 53 Immunochromatographic test kit insertion port 54 Two-dimensional code A Entrance・Infection test stand for entrance management B Mobile stand C Support stand D Face authentication camera E Display

TECHNICAL FIELD The present invention relates to an antigen test terminal that can be used in an online infection test system using an immunochromatography test kit. Furthermore, the present invention provides an apparatus, analysis method, and communication for automatically identifying the source of infection in a sample collected from saliva or nasal mucosa after inserting an immunochromatography test kit using this antigen test terminal. It relates to an online infection inspection system that includes systems and network systems.

Claims (19)

An antigen test terminal that identifies the source of infection (virus, etc.) using an immunochromatographic test kit containing an immunochromatographic test strip,
A palm-sized portable housing having an insertion port for detachably inserting the immunochromatography test kit,
a sample unit for carrying the immunochromatographic test kit inserted into the portable housing through the insertion port;
A light emitting unit that emits visible light toward an inspection area including a test area and a control area of the immunochromatographic test strip;
an objective lens for enlarging the inspection area;
an input switch unit for activating the antigen test terminal;
and a power supply unit that supplies power to the light emitting unit. a microscopic imaging unit for microscopically capturing an image of an inspection area that has passed through the objective lens;
a control/calculation unit that controls the microscopic imaging unit and performs calculation processing of inspection results based on the captured microscopic image;
a communication unit that transmits the test results calculated by the control/calculation unit to the outside of the antigen test terminal;
an indicator unit comprising a light source and a sound source for informing the outside of the operating state of the antigen test terminal;
2. The antigen according to claim 1, wherein said microscopic imaging unit, said control/calculation unit, said communication unit, and a power supply unit for supplying power to said indicator unit are provided separately from said portable housing. inspection terminal. a microscopic imaging unit for microscopically capturing an image of an inspection area that has passed through the objective lens;
a control/calculation unit that controls the microscopic imaging unit and performs calculation processing of inspection results based on the captured microscopic image;
a communication unit that transmits the test results calculated by the control/calculation unit to the outside of the antigen test terminal;
an indicator unit comprising a light source and a sound source for informing the outside of the operating state of the antigen test terminal;
2. The antigen test terminal according to claim 1, wherein said portable housing further comprises a power supply unit for supplying power to said microscopic imaging unit, said control/calculation unit, said communication unit, and said indicator unit. . The antigen test terminal according to any one of claims 1 to 3, wherein the portable housing has a volume smaller than 250 cubic centimeters. The antigen test terminal according to any one of claims 1 to 4, characterized in that said light emitting unit comprises a visible light LED. The terminal for antigen test according to any one of claims 1 to 5, wherein the microscopic imaging unit is configured such that an objective lens and a mini-digital camera are integrated to form a digital microscope. The antigen test terminal according to any one of claims 1 to 6, wherein said control/calculation unit comprises a microprocessor for control and calculation. The antigen test terminal according to any one of claims 1 to 7, wherein the communication unit includes a wireless LAN standard device or a short-range wireless communication standard device. 9. The indicator unit includes an LED as a light source for informing various operational states of the antigen test terminal, and a buzzer as a sound source for informing various operational states of the antigen test terminal. The antigen test terminal described in 1. The antigen test terminal according to any one of claims 1 to 9, wherein the power supply unit comprises a battery, a booster circuit for increasing battery voltage, and a charger for charging the battery. the antigen test terminal according to any one of claims 1 to 10;
an external communication unit that receives, stores, and transfers test results calculated by the control/calculation unit as an external environment of the antigen test terminal;
an external communication terminal that receives and displays the test results;
An on-line infection testing system comprising: the antigen testing terminal; the external communication unit; and a network supporting communication between the external communication terminal. 12. The online infection inspection system according to claim 11, wherein said external communication unit comprises a server such as an application server and a database server. 13. The online infection inspection system according to claim 11 or 12, wherein said external communication terminal device comprises any one of a mobile terminal, a personal computer terminal, a tablet terminal, and the like. The network of claims 11 to 13, wherein the network comprises a wireless or wired LAN (Local Area Network), a wireless or wired WAN (Wide Area Network), a wireless or wired Internet, a short-range wireless communication, or the like. The online infection inspection system according to any one of the above. The online infection test system according to any one of claims 11 to 14, wherein the immunochromatographic test kit is a modified immunochromatographic test kit added with a two-dimensional code for identifying a subject. A mobile stand installed at the place where you enter and enter the facility,
a support base erected on the movement platform;
a face authentication camera mounted on the upper part of the support;
a display that displays face-recognised subject data;
An infection test stand for entrance/entrance management, comprising at least the antigen test terminal according to any one of claims 1 to 10 provided on the support base. 16. The on-line infection testing system according to any one of claims 11 to 15, characterized by comprising the antigen testing terminal of the infection testing stand for entrance/entrance management according to claim 16. 18. The online infection according to claim 17, wherein the face image data acquired by said face authentication camera is transferred to said antigen test terminal, and transmitted to said external communication unit together with the test result by said antigen test terminal. inspection system. The face recognition camera has a body temperature detection function, and transfers the face image data and body temperature data acquired by the face recognition camera to the antigen test terminal, and together with the test result by the antigen test terminal, the external communication 18. The online infection inspection system according to claim 17, wherein the information is sent to a department.

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