KR102034352B1 - In-vitro diagnostic system comprising attaching type-optical device using mobile device - Google Patents

Abstract

The present invention relates to an in vitro diagnostic system having an attachable optical system using a mobile device, and more specifically, to a strip sensor for detecting a biomaterial; An attachment optical system including a support for supporting the strip sensor, a fluorescent filter, a lens, and a light source disposed on the support; And a camera, and a mobile device having an application for determining the biomaterial from an image of the strip sensor photographed by the camera, and capable of wireless communication with the attached optical system.
According to the present invention, it is possible to measure the fluorescence signal of the LFA strip with a small and simple structure and low power, and effectively utilizes the wireless Internet function of the mobile device together with information such as location information, date and time, etc. It can be transmitted, it is possible to implement the optimal personalized mobile mobile field-tested virus diagnostic device and system. In addition, it is suitable for rapid low-cost inspection based on LFA strip, and the reader is composed of a small LOP strip reader, a small attachment optical system attached to the mobile device camera without hardware / software, and a low cost system can be realized. It is easy to link the results of the LFA test diagnosis to the server accurately.

Description

In-vitro diagnostic system comprising attaching type-optical device using mobile device}

The present invention relates to an in vitro diagnostic system having an attachable optical system using a mobile device, and more particularly to an in vitro diagnostic system including an attachable optical system using a mobile device for virus diagnosis.

Conventional biodiagnostic technology, particularly acute viral immunodiagnostic sensor technology, is a portable strip reader consisting of a lateral flow assay based immunodiagnostic strip and a separate optical system for reading the results thereof for rapid on-site diagnosis. It consists of. Since the measured value of the reader is stored in the memory of the device and then the measurement result is transmitted by using a storage device or wired / wireless communication, a separate gateway or communication module is used, which is a disadvantage to apply to emergency response and central control through on-site diagnosis. there was.

When biomaterial test results such as acute viruses or infectious and seasonal diseases cause bacteria are automatically stored in the central server, such as the frequency and region of occurrence through central control, the expected expectation effect of health care such as emergency response is high, but conventional portable The device has a disadvantage in that it is difficult to cope.

In addition, a low cost system implementation is required in that an LFA strip reader must be used.

On the other hand, as a prior art, Korean Patent Laid-Open Publication No. 2004-0102726 (name of the invention: a mobile diagnostic method and system using a PD and a biosignal measuring device), a biosignal detecting means for detecting a patient's biosignal and transmitting it wirelessly And, the present invention discloses a personal handheld information terminal for displaying a treatment method according to a bio-signal from the bio-signal detecting means and a predetermined rule-based diagnosis. However, the bio-signal measured by the prior patent includes blood pressure, blood sugar level, With respect to pulse rate, body temperature, electrocardiogram, etc., a configuration in which an immunodiagnostic strip based on a lateral flow assay (LFA) is applied to a mobile diagnostic device is not disclosed.

Republic of Korea Patent Publication 2004-0102726 (2004.12.08)

Therefore, an object of the present invention comprises a hardware / program of the mobile device, and the optical device attached to the mobile device is equipped with an optical system using a mobile device that can effectively transmit the fluorescence signal measurement results of the LFA strip with a small and simple structure and low power To provide an in vitro diagnostic system.

In addition, another object of the present invention is to use a small attachment type optical system attached to a separate mobile device camera and the reader to the mobile device in vitro having an attached optical system using a mobile device that can implement a small low-cost system without an LFA strip reader To provide a diagnostic system.

In order to achieve the above object, in vitro diagnostic system having an attached optical system using a mobile device of the present invention, a strip sensor for detecting a biological material; An attachment optical system including a support for supporting the strip sensor, a fluorescent filter, a lens, and a light source disposed on the support; And a camera, and a mobile device having an application for determining the biomaterial from an image of the strip sensor photographed by the camera, and capable of wireless communication with the attached optical system.

In addition, the in-vitro diagnostic system having an attachable optical system using a mobile device of the present invention, the attachable optical system includes a support for supporting the strip sensor; A fluorescent filter disposed above the center of the strip sensor window; A lens disposed on the fluorescent filter; And a light source spaced apart from the left and right sides of the fluorescent filter.

In addition, in an in vitro diagnostic system having an attached optical system using the mobile device of the present invention, the attached optical system includes a black-out sheet on the upper surface of the strip sensor.

In addition, in the in vitro diagnostic system having an attached optical system using a mobile device of the present invention, the wireless communication is characterized in that the Bluetooth communication.

In addition, in vitro diagnostic system having an attached optical system using a mobile device of the present invention, the mobile device, the application execution unit for executing the application; A controller for controlling and turning on a light source of the optical system in a state where the application is executed; An image capturing and processing unit for photographing the strip sensor continuously or step by step using a camera provided in the mobile device while the application is executed; An image analyzing and determining unit analyzing the photographed image to determine a biomarker concentration; And a determination information display unit displaying the determination result of the image analysis and determination unit.

In addition, in an in-vitro diagnostic system including an attachable optical system using a mobile device of the present invention, the attachable optical system further includes a driving circuit unit in the light source.

In addition, in the in vitro diagnostic system having an attached optical system using a mobile device of the present invention, in order to perform in vitro diagnostics through an in vitro diagnostic system having an attached optical system using the mobile device, the application of the mobile device is Applying power to the light source and controlling the amount of light through the driving circuit unit of the attached optical system, the image capturing and processing unit continuously or step-by-step the strip sensor using a camera provided in the mobile device while the application is running And the image analysis and determination unit determines the biomarker by analyzing the photographed image.

In addition, in the in vitro diagnostic system having an attached optical system using a mobile device of the present invention, the strip sensor is characterized in that the acute virus diagnostic or acute myocardial infarction diagnostic strip.

In addition, in the in vitro diagnostic system having an attached optical system using a mobile device of the present invention, the strip sensor is characterized in that the LFA strip using a fluorescent material as a label.

In addition, in the in vitro diagnostic system having an attached optical system using a mobile device of the present invention, the light source of the optical system is disposed on both sides or four directions of the strip sensor window to uniformly irradiate the window of the strip sensor. It is done.

The in vitro diagnostic system having an attachable optical system using a mobile device according to the present invention comprises a mobile device camera, a hardware / program of the mobile device, and an attachable optical system for a mobile device. It is possible to measure and transmit the diagnosis results to the central control server with the location information, date and time, etc., which can be effectively transmitted using the wireless internet function of the mobile device. System implementation is possible.

In addition, the attached optical system attached to the front of the mobile device camera is composed of an LED light source suitable for LFA fluorescence measurement, an optical system composed of a lens and a filter, a jig fixing the position of the LFA, and a driving circuit for driving the LED light source. It is suitable for quick low-cost inspection based on the system, and the reader is composed of a separate LFA strip reader, a small attachment optical system attached to the mobile device camera without hardware / software, and a mobile device, which enables the implementation of a small low-cost system and enables quick and accurate LFA inspection. The ease of linking the diagnosis result to the server is excellent.

In addition, the LFA reader, which consists of a mobile device camera, an attached optical system, and a mobile application program, is a good example of a small, low-cost system, and is an application program that controls the camera of a mobile device. Since no instrument configuration is required), an analytical instrument system can be implemented.

1 is a block diagram of a mobile device based LFA strip sensor reader system according to the present invention (consists of an LFA strip, an attached optical system, a mobile device, and a driving program, and the optical system includes a circuit for driving an LED light source).
2 is a structural diagram of an attachable optical system according to the present invention.
3 is a photograph showing an improvement effect of a measured image by a built-in treatment of a black-out sheet in the attachable optical system according to the present invention.
4 is an operation algorithm of a mobile device based LFA strip reader system according to the present invention.
5 is a mobile device image analysis program operation algorithm and image processing results according to the present invention.
6 is an embodiment showing a configuration of a mobile device application program GUI according to the present invention.
Figure 7 is an embodiment showing the LFA strip reading result image and analysis results using a dengue virus sample according to the present invention.

Hereinafter, embodiments of the present disclosure will be described in detail with reference to the accompanying drawings, and the same or similar components are denoted by the same reference numerals regardless of the reference numerals, and redundant description thereof will be omitted. The suffixes "module" and "unit" for components used in the following description are given or used in consideration of ease of specification, and do not have distinct meanings or roles from each other. In addition, in describing the embodiments disclosed herein, when it is determined that the detailed description of the related known technology may obscure the gist of the embodiments disclosed herein, the detailed description thereof will be omitted. In addition, the accompanying drawings are intended to facilitate understanding of the embodiments disclosed herein, but are not limited to the technical spirit disclosed herein by the accompanying drawings, all changes included in the spirit and scope of the present invention. It should be understood to include equivalents and substitutes.

Terms including ordinal numbers such as first and second may be used to describe various components, but the components are not limited by the terms. The terms are used only for the purpose of distinguishing one component from another.

When a component is referred to as being "connected" or "connected" to another component, it may be directly connected to or connected to that other component, but it may be understood that other components may be present in between. Should be. On the other hand, when a component is said to be "directly connected" or "directly connected" to another component, it should be understood that there is no other component in between.

Singular expressions include plural expressions unless the context clearly indicates otherwise.

In this application, the terms "comprises" or "having" are intended to indicate that there is a feature, number, step, operation, component, part, or combination thereof described in the specification, and one or more other features. It is to be understood that the present invention does not exclude the possibility of the presence or the addition of numbers, steps, operations, components, components, or a combination thereof.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. It is apparent to those skilled in the art that the present invention can be embodied in other specific forms without departing from the spirit and essential features of the present invention.

In vitro diagnostic system having an attached optical system using a mobile device of the present invention, the strip sensor for detecting a biological material; An attachment optical system including a support for supporting the strip sensor, a fluorescent filter, a lens, and a light source disposed on the support; And a camera, and a mobile device having an application for determining the biomaterial from an image of the strip sensor photographed by the camera, and capable of wireless communication with the attached optical system.

Here, the attachment optical system, the support for supporting the strip sensor; A fluorescent filter disposed above the center of the strip sensor window; A lens disposed on the fluorescent filter; And a light source spaced apart from the left and right sides of the fluorescent filter. In this case, the light source further includes a driving circuit unit. Preferably, the light source of the optical system is disposed on both sides or four directions of the strip sensor window, characterized in that to uniformly irradiate the window of the strip sensor.

In addition, the attachment optical system includes a black-out sheet on an upper surface of the strip sensor.

In addition, the wireless communication is characterized in that the Bluetooth communication.

In addition, the mobile device, the application execution unit for executing the application; A controller for controlling and turning on a light source of the optical system in a state where the application is executed; An image capturing and processing unit for photographing the strip sensor continuously or step by step using a camera provided in the mobile device while the application is executed; An image analyzing and determining unit analyzing the photographed image to determine a biomarker concentration; And a determination information display unit displaying the determination result of the image analysis and determination unit.

Referring to Figure 1, the configuration of the mobile device-based on-site diagnostic virus measurement system provided in the present invention is an LFA strip sensor, a mobile device and mobile device built-in application program, the attachment optical system attached to the camera unit of the mobile device It consists of. As shown in FIG. 2, the attachable optical system may include a lens, a fluorescent filter, a light source LED, an LFA strip, and a light fixture structure supporting the position thereof. In this case, the camera optical side of the mobile device and the lens optical axis of the attachable optical system may be positioned on the same line. The method or device for attaching to the mobile device is not particularly limited and includes all those well known in the art.

In addition, the top surface of the LFA strip consists of a black-out sheet layer and an interior treated surface that dramatically reduces photoreflection in all areas except the measurement window. In FIG. 2, the outer case of the attachable optical system is omitted. As shown in FIG. 3, it can be seen that the use of a black-out sheet on the upper surface of the LFA strip has the advantage of significantly improving the contrast of the fluorescent image of the LFA strip. The black-out sheet is a plastic component composed of a polymer material having a property of blocking light transmission, and blackout blind (trade name) is preferable.

Meanwhile, in an in vitro diagnostic system having an attached optical system using a mobile device of the present invention, the application of the mobile device may be performed to perform an in vitro diagnosis through an in vitro diagnostic system having an attached optical system using the mobile device. Applying power to the light source and controlling the amount of light through the driving circuit unit of the attached optical system, the image capturing and processing unit continuously or step-by-step the strip sensor using a camera provided in the mobile device while the application is running And the image analysis and determination unit determines the biomarker by analyzing the photographed image.

In this case, the strip sensor is preferably a strip for diagnosing acute virus or acute myocardial infarction. In addition, the strip sensor may be an LFA strip using a fluorescent material as a label.

Referring to FIG. 4, FIG. 4 illustrates an operation algorithm of an entire program for controlling an application program implemented in a mobile device and a circuit for controlling an LED light source of an attached optical system. The mobile device and the LED driving circuit show an example of operating by interworking with wireless communication using Bluetooth low energy (BLE), and can also be controlled by a serial connection using a cable. The main operation sequence of the application program is low power Bluetooth (BLE), which starts to interlock with the LED circuit, controls the camera of the mobile device to complete the setting, transmits the LED light quantity information and on / off control information to the circuit, and confirms the operation. Is taken in order of shooting and analyzing and storing it.

5 illustrates an algorithm for operating and obtaining an image by operating a camera of a mobile device. This is achieved by taking three pictures in succession, cropping them into the desired window area, eliminating unnecessary parts, reducing image processing burden, and converting them into gray information to merge them into a single image. The Sobel algorithm uses the virus detection immune response on the LFA strip to automatically analyze the position of the line from which the fluorescence signal is derived. Since the control region has a large fluorescence signal, the image is clearly implemented so that the contrast ratio can be easily analyzed, so the position of the actual test region can be known based on its position. Since the test area is very low, the physical spacing information between the control and test lines is used for image analysis when manufacturing LFA strips. In the production of LFA strips the spacing between two lines can be made constant.

By calculating the ratio of the fluorescence signal values in the two areas of the control and test lines, the concentration can be converted into the concentration of the target substance by comparing with the quantitative curve data, which is the input calibration value, and transmitted to the central server using the internet connection function of the mobile device. Process.

6 is an embodiment showing a configuration of a mobile device application program GUI according to the present invention. Figure 7 is an embodiment showing the LFA strip reading result image and analysis results using a dengue virus sample according to the present invention. Referring to FIG. 7, even when the virus sample was diluted 1.6-fold or 3.2-fold, the LFA strip diagnosis according to the present invention showed a significant result compared to the control without the virus (negative sample of FIG. 7).

The in vitro diagnostic system having an attachable optical system using a mobile device according to the present invention comprises hardware and programs such as a camera of a personal mobile device and a mobile device, and performs diagnosis of a self-diagnosis or a point of care (POC) strip sensor. It is possible to read the results, such as GPS information, test location and date and time inherent in the mobile device automatically to the central control data server through the communication function of the mobile device to effectively determine the location and frequency.

In addition, the system equipment can be used semi-permanently by only replacing the membrane strip, which is suitable for self-diagnosis apparatus for biological samples.

On the other hand, the above detailed description should not be construed as limited in every respect and should be considered as illustrative. The scope of the invention should be determined by reasonable interpretation of the appended claims, and all changes within the equivalent scope of the invention are included in the scope of the invention.

Claims (10)

A strip sensor for detecting a biomaterial;
An attachable optical system including a support for supporting the strip sensor, a fluorescent filter, a lens, and a light source disposed on the support; And
A mobile device having a camera and an application for discriminating the biomaterial from an image of the strip sensor photographed by the camera and capable of wireless communication with the attached optical system;
Including,
The mobile device,
An application execution unit that executes the application;
A controller for controlling and turning on a light source of the optical system in a state where the application is executed;
An image capturing and processing unit for photographing the strip sensor continuously or step by step using a camera provided in the mobile device while the application is executed;
An image analyzing and determining unit analyzing the photographed image to determine a biomarker concentration; And
And a determination information display unit which displays the determination result of the image analysis and determination unit.
The strip sensor is characterized in that the LFA strip using a fluorescent material as a label,
The image analysis and determination unit may determine an analysis position using a Sobel algorithm for analyzing the position of the line from which the fluorescence signal is derived, and use the physical interval information between the control line and the test line of the strip sensor to test the test line. Attachment type optical system using a mobile device to determine the position of, and to calculate the ratio of the fluorescence signal value on the two areas of the control line and the test line to compare with the input quantitative curve data converted into the concentration of the biomarker In vitro diagnostic system comprising a.
The optical system of claim 1, wherein
A support for supporting the strip sensor;
A fluorescent filter disposed above the center of the strip sensor window;
A lens disposed on the fluorescent filter; And
A light source spaced apart from the left and right sides of the fluorescent filter;
In vitro diagnostic system having an attachable optical system using a mobile device comprising a.
The optical system of claim 1, wherein
In-vitro diagnostic system having an attached optical system using a mobile device, characterized in that it comprises a black-out sheet (black-out sheet) on the upper surface of the strip sensor.
The method of claim 1,
The wireless communication is an in vitro diagnostic system having an attached optical system using a mobile device, characterized in that the Bluetooth communication.
delete The method of claim 1,
The attachable optical system includes an attachable optical system using a mobile device, further comprising a driving circuit unit in a light source.
The method of claim 6,
In order to perform in vitro diagnosis through an in vitro diagnostic system having an attached optical system using the mobile device,
Application of the mobile device is to apply power to the light source and control the amount of light through the drive circuit of the attached optical system
The image capturing and processing unit photographs the strip sensor continuously or step by step using a camera provided in the mobile device while the application is executed,
And the image analyzing and determining unit analyzes the photographed image to determine a biomarker.
The method of claim 1,
The strip sensor is an in vitro diagnostic system having an attached optical system using a mobile device, characterized in that the strip for acute virus diagnosis or acute myocardial infarction.
delete The method of claim 1,
The light source of the optical system is disposed on both sides or four directions of the strip sensor window, the in-vitro diagnostic system having an attached optical system using a mobile device, characterized in that to irradiate the window of the strip sensor uniformly.

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