Reader for rapid diagnostic kit

Abstract

The present invention relates to a rapid diagnostic kit reader, wherein the rapid diagnostic reader comprises: a measurement module into which a rapid diagnostic kit is inserted; and a smart terminal seated on the measurement module, which photographs the membrane of the rapid diagnostic kit inserted in the measurement module and analyzes the image of the membrane to determine the diagnostic result of the rapid diagnostic kit.

Description

Technology Field

[0001] The present invention relates to a rapid diagnostic kit reader. Background Technology

[0002] Rapid diagnostic kits are field diagnostic tools that perform diagnosis through the simple action of inserting a sample at the site where diagnosis is required. Rapid diagnostic kits are designed to rapidly confirm the presence or absence of a target biomaterial in the sample if the target biomaterial is present. Target biomaterials are primarily pathogenic microorganisms or proteins. In rapid diagnostic kits, antibodies or antigens capable of selectively binding to the target biomaterial are installed at specific locations to trigger a selective antigen-antibody reaction, allowing the result of the reaction to be confirmed as a band-like pattern via a marker.

[0003] Various nanomaterials and fluorescent materials are used as markers.

[0004] In the case of a gold nanoparticle-based rapid diagnostic kit that is visible to the naked eye, a band-shaped signal may appear weak when the amount of the target biomaterial in the sample is small. In this case, it is difficult for the user to visually distinguish the signal and may make an incorrect judgment.

[0005] In the case of rapid diagnostic kits containing fluorescent materials, visual identification is generally difficult, and it is necessary to irradiate them with light of a specific wavelength to excite the fluorescence.

[0006] Due to the potential for errors in visual inspection and the necessity of luminescent tools, there is a need for readers capable of quantitatively determining the diagnostic results of rapid diagnostic kits. Furthermore, the expansion of the digital healthcare market and the resulting increase in demand for on-site diagnostics are driving the need for miniaturized and low-cost readers.

[0007] Conventional rapid diagnostic kit readers are implemented as devices that digitize the signal lines of the kit; however, because the reader itself is equipped with optical components, sensors, displays, and control boards, it is expensive and bulky.

[0008] In addition, conventional rapid diagnostic kit readers were implemented as separate devices for measuring colorimetric rapid diagnostic kits that can be visually identified and fluorescence rapid diagnostic kits that require an excitation light source.

[0009] Furthermore, conventional rapid diagnostic kit readers find it practically difficult to accommodate variations in the external size, shape, and number of signal lines of various rapid diagnostic kits.

[0010] In addition, conventional rapid diagnostic kit readers had a problem of reduced measurement accuracy because they did not measure the amount of light irradiated to control and stabilize the intensity of the light source.

[0011] The background technology of the present invention is disclosed in Korean Published Patent Application No. 10-2020-0134405 (December 2, 2020). The problem to be solved

[0012] The technical problem that the present invention aims to solve is to provide a rapid diagnostic kit reader capable of simultaneously measuring fluorescence and rapid diagnostic kit occurrence. means of solving the problem

[0013] According to one aspect of the present invention, the present invention provides a rapid diagnostic kit reader comprising a smart terminal, wherein the smart terminal comprises: a user interface unit; a camera for photographing a membrane of a rapid diagnostic kit inserted inside a measurement module; and a processor for determining a diagnostic result of the rapid diagnostic kit based on an image of the membrane and displaying it through the user interface unit, wherein the smart terminal is mounted on the measurement module.

[0014] In the present invention, the processor is characterized by receiving measurement variables through the user interface and transmitting them to the measurement module.

[0015] In the present invention, the measurement variable is characterized by including at least one of the type of the rapid diagnostic kit, the type of light source that irradiates light inside the measurement module, the intensity of the light source, and a signal processing variable for determining the diagnostic result of the rapid diagnostic kit.

[0016] In the present invention, the processor processes the RGB signals of an image of the membrane to obtain a quantitative numerical value for each signal line of the rapid diagnostic kit, and compares the quantitative numerical value with a preset positive judgment criterion value, a negative judgment criterion value, and a re-test judgment criterion value, respectively, and determines the reaction result as positive, negative, or re-test according to the comparison result.

[0017] In the present invention, the processor extracts the number of pixels on the X-axis and Y-axis of the data acquisition area within the membrane from an image of the membrane, calculates pixel information for each pixel by applying an RGB weighting value set for each RGB for each pixel, calculates horizontal line data by averaging NY horizontal lines based on the pixel information, calculates a maximum value for signal selection by subtracting a baseline value without a signal from the data acquisition area from the horizontal line data, calculates a numerical area for signal selection based on the maximum value for signal selection, and then calculates a representative value of the numerical area.

[0018] According to one aspect of the present invention, the present invention provides a rapid diagnostic kit reader comprising: a slot that allows a rapid diagnostic kit to be inserted into or discharged from a housing; a shooting aid that enables a camera of a smart terminal to photograph the rapid diagnostic kit inserted into the housing; a light source that illuminates the rapid diagnostic kit inserted into the housing; and a control board that controls the light source to illuminate the rapid diagnostic kit so that the camera of the smart terminal can photograph the rapid diagnostic kit inserted into the housing.

[0019] The present invention is characterized by further including a smart terminal mounting portion formed in the housing and mounting the smart terminal in the housing.

[0020] In the present invention, the shooting assistance part is characterized by being a transparent window formed transparently at a position corresponding to the camera of the smart terminal.

[0021] In the present invention, the transparent window is characterized by having an optical filter additionally installed or replaced depending on the fluorescence used in the rapid diagnostic kit.

[0022] In the present invention, the light source is characterized by including at least one of a white LED (Light Emitting Diode) that emits white light and a UV (Ultraviolet ray) LED that emits ultraviolet light.

[0023] The present invention further includes a light intensity measuring unit for measuring the amount of light inside the housing, and the control board controls the light source according to the amount of light inside the housing measured by the light intensity measuring unit to adjust the amount of light inside the housing.

[0024] The present invention is characterized by further including a light path adjustment unit that ensures the light from the light source is uniformly irradiated onto the surface of the membrane of the rapid diagnostic kit.

[0025] In the present invention, the control board is characterized by receiving measurement variables from the smart terminal and controlling the light source according to the measurement variables.

[0026] In the present invention, the measurement variable is characterized by including at least one of the type of the rapid diagnostic kit, the type of the light source, the intensity of the light source, and a signal processing variable for determining the diagnostic result of the rapid diagnostic kit.

[0027] According to another aspect of the present invention, the present invention provides a rapid diagnostic kit reader comprising: a measurement module into which a rapid diagnostic kit is inserted; and a smart terminal seated on the measurement module, which photographs a membrane of the rapid diagnostic kit inserted in the measurement module and analyzes the image of the photographed membrane to determine a diagnostic result of the rapid diagnostic kit.

[0028] In the present invention, the smart terminal comprises: a user interface unit; a camera that photographs the membrane of the rapid diagnostic kit inserted inside the measurement module; and a processor that determines the diagnostic result of the rapid diagnostic kit based on the image of the photographed membrane and displays it through the user interface unit.

[0029] In the present invention, the processor processes the RGB signals of an image of the membrane to obtain a quantitative numerical value for each signal line of the rapid diagnostic kit, and compares the quantitative numerical value with a preset positive judgment criterion value, a negative judgment criterion value, and a re-test judgment criterion value, respectively, and determines the reaction result as positive, negative, or re-test according to the comparison result.

[0030] In the present invention, the processor extracts the number of pixels on the X-axis and Y-axis of the data acquisition area within the membrane from an image of the membrane, calculates pixel information for each pixel by applying an RGB weighting value set for each RGB for each pixel, calculates horizontal line data by averaging NY horizontal lines based on the pixel information, calculates a maximum value for signal selection by subtracting a baseline value without a signal from the data acquisition area from the horizontal line data, calculates a numerical area for signal selection based on the maximum value for signal selection, and then calculates a representative value of the numerical area.

[0031] In the present invention, the measurement module comprises: a smart terminal mounting portion formed in a housing to mount the smart terminal in the housing; a slot to allow the rapid diagnostic kit to be inserted into or ejected from the housing; a shooting assist portion to allow the camera of the smart terminal to photograph the rapid diagnostic kit inserted into the housing; a light source to illuminate the rapid diagnostic kit inserted into the housing; a light intensity measuring portion to measure the amount of light inside the housing; and a control board to control the light source according to the amount of light inside the housing measured by the light intensity measuring portion to illuminate the rapid diagnostic kit.

[0032] In the present invention, the light source is characterized by including at least one of a white LED that irradiates white light and a UV LED that irradiates ultraviolet light. Effects of the invention

[0033] According to one aspect of the present invention, a rapid diagnostic kit reader can measure both fluorescence and the occurrence of a rapid diagnostic kit.

[0034] According to another aspect of the present invention, a rapid diagnostic kit reader reduces the possibility of human visual discrimination errors and quantitatively determines the diagnostic result of the rapid diagnostic kit.

[0035] According to another aspect of the present invention, a rapid diagnostic kit reader can implement various functions based on a smart terminal, thereby enabling miniaturization and low cost.

[0036] According to another aspect of the present invention, a rapid diagnostic kit reader can measure rapid diagnostic kits of various shapes and can increase universality and measurement reproducibility. Brief explanation of the drawing

[0037] FIG. 1 is a drawing showing the form of a rapid diagnostic kit according to one embodiment of the present invention. FIG. 2 is a configuration diagram of a rapid diagnostic kit diagnostic device according to one embodiment of the present invention. FIG. 3 is a drawing showing a kit tray according to one embodiment of the present invention. FIG. 4 is a block diagram of a smart terminal according to one embodiment of the present invention. FIG. 5 is a flowchart illustrating the operation process of a rapid diagnostic kit reader according to one embodiment of the present invention. FIG. 6 is a diagram showing the signal of a rapid diagnostic kit according to one embodiment of the present invention. FIG. 7 is a flowchart illustrating the signal processing process of a rapid diagnostic kit reader according to one embodiment of the present invention. FIG. 8 is a diagram showing the functions of a smart terminal and a measurement module according to an embodiment of the present invention. FIG. 9 is a diagram exemplarily illustrating a communication method of a rapid diagnostic kit reader according to one embodiment of the present invention. Specific details for implementing the invention

[0038] Hereinafter, an embodiment of a rapid diagnostic kit reader according to an embodiment of the present invention is described. In this process, the thickness of lines or the size of components shown in the drawings may be exaggerated for clarity and convenience of explanation. Furthermore, the terms described below are defined considering their functions in the present invention, and these may vary depending on the intention or convention of the user or operator. Therefore, the definitions of these terms should be based on the content throughout this specification.

[0039] Embodiments of the present invention are described below with reference to the attached drawings so that those skilled in the art can easily implement them. However, the present invention may be embodied in various different forms and is not limited to the embodiments described herein. Furthermore, in order to clearly explain the present invention in the drawings, parts unrelated to the explanation have been omitted, and similar parts throughout the specification are denoted by similar reference numerals.

[0040] Throughout the specification, when a part is described as "including" a certain component, this means that, unless specifically stated otherwise, it does not exclude other components but may include additional components.

[0041] The implementations described herein may be implemented, for example, as methods or processes, devices, software programs, data streams, or signals. Even if discussed only in the context of a single form of implementation (e.g., discussed only as a method), the implementation of the discussed features may also be implemented in other forms (e.g., devices or programs). Devices may be implemented in appropriate hardware, software, and firmware, etc. Methods may be implemented in devices such as processors, which generally refer to processing devices including, for example, computers, microprocessors, integrated circuits, or programmable logic devices.

[0042] FIG. 1 is a drawing showing the form of a rapid diagnostic kit according to one embodiment of the present invention.

[0043] Referring to FIG. 1(a), the rapid diagnostic kit (400) is equipped with a membrane (420) and a sample inlet (440). A data acquisition area (450) is formed in the membrane (420).

[0044] A sample is introduced into the sample inlet (440). The sample introduced into the sample inlet (440) flows from right to left by capillary flow.

[0045] After a set amount of time has elapsed, one or more signal lines (410) appear on the membrane (420).

[0046] Referring to FIG. 1(b), the signal line (410) is divided into a test signal line (410-2, 410-3) and a control signal line (410-1). Generally, the control signal line (410-1) is positioned downstream of the test signal lines (410-2, 410-3).

[0047] The test signal lines (410-2, 410-3) indicate the presence and amount of the target biomaterial to be measured in the sample. The number of test signal lines (410-2, 410-3) may be formed in multiple numbers, for example, 1 to 3, depending on the number of measurement markers.

[0048] The control signal line (410-1) is formed to determine an error in the rapid diagnostic kit (400). The control signal line (410-1) appears when a normal test without errors is performed, and, for example, one may be formed.

[0049] Multiple membranes (420), sample inlet (440), and data acquisition area (450) may each be arranged.

[0050] Referring to Fig. 1(c), two or more membranes (420) may be installed in a single rapid diagnostic kit (400) as needed, and accordingly, two or more sample inlets (440) and data acquisition areas (450) may also be installed.

[0051] The rapid diagnostic kit reader (500) analyzes the RGB data of an image extracted from a data acquisition area (450) within a membrane (420) to quantify and determine the intensity of the signal line (410).

[0052] As illustrated in FIG. 1, the rapid diagnostic kit reader (500) can respond to various changes in the number of signal lines (410), the number of membranes (420), and the external size of the rapid diagnostic kit (400).

[0053] FIG. 2 is a configuration diagram of a rapid diagnostic kit reader according to one embodiment of the present invention, and FIG. 3 is a diagram showing a kit tray according to one embodiment of the present invention.

[0054] Referring to FIG. 2, a rapid diagnostic kit reader (400) according to one embodiment of the present invention includes a smart terminal (100) and a measurement module (600).

[0055] The measurement module (600) and the smart terminal (100) can be combined or separated from each other.

[0056] The measurement module (600) is illuminated so that the rapid diagnostic kit (400) is inserted inside and the rapid diagnostic kit (400) can be photographed.

[0057] The measurement module (600) includes a smart terminal mounting part (240), a shooting assistance part (250), a control board (300), a battery (350), a tray fixing part (220), a light path adjustment part (260), a light quantity measuring part (340), a light source (310, 320), and a slot (230).

[0058] The smart terminal mounting portion (240) is formed in the housing (200) of the measurement module (600) to mount the smart terminal (100) on the measurement module (600).

[0059] The smart terminal mounting portion (240) can be installed at various locations on the housing (200) depending on the mounting position of the smart terminal (100). For example, the smart terminal mounting portion (240) can be formed on the upper part of the measurement module (600).

[0060] The smart terminal mounting portion (240) can be installed to correspond to the size and shape of the smart terminal (100) so that the smart terminal (100) can be mounted.

[0061] The smart terminal mounting portion (240) may include at least one of a pinch fixing mechanism, a spring fixing mechanism, and a magnetic fixing mechanism, and the method of mounting the smart terminal on the smart terminal mounting portion (240) is not particularly limited.

[0062] The shooting assistance unit (250) enables the smart terminal (100) to obtain an image of the rapid diagnostic kit (100) inside the housing (200) when the smart terminal (100) is placed on the measurement module (600).

[0063] To this end, the shooting aid (250) may be a transparent window formed transparently at a position corresponding to the camera (110) of the smart terminal (100). For example, the shooting aid (250) may be a transparent glass window or a transparent plastic window. Alternatively, the shooting aid (250) may be a perforation.

[0064] Furthermore, the imaging aid (250) can acquire images within a specific wavelength range according to the fluorescence used in the rapid diagnostic kit (400). To this end, the imaging aid (250) may have an optical filter additionally installed or replaced. For convenience in replacing the optical filter, the imaging aid (250) may further be equipped with a mechanism for attaching and detaching the optical filter.

[0065] A light source (310, 320), a light intensity measuring unit (340), and a communication unit (330) are installed in the control board (300).

[0066] The control board (300) controls the amount of light from the light source (310, 320).

[0067] The control board (300) controls the light intensity of the white LED (310) or UV LED (320) according to the light intensity of the white LED (Light Emitting Diode) (310) or UV LED (320) measured by the light intensity measuring unit (340). That is, the control board (300) measures the light intensity inside the housing (200) using the light intensity measuring unit (340) and controls the current supplied to the white LED (310) or UV LED (320), thereby causing a preset amount of light to be emitted from the white LED (310) or UV LED (320).

[0068] The control board (300) can perform wireless communication with the smart terminal (100) through the communication unit (330).

[0069] For example, the control board (300) transmits various signals to the smart terminal (100) via Bluetooth communication.

[0070] In addition, the control board (300) can receive measurement variables from the smart terminal (100) through the communication unit (330).

[0071] The measurement variables may include, but are not specifically limited to, the type of rapid diagnostic kit (400), the type of light source (310, 320), the intensity of the light source (310, 320), and signal processing variables for determining the diagnosis result of the rapid diagnostic kit (400). The measurement variables may be stored as optimized values ​​in the application of the smart terminal (100) for each rapid diagnostic kit (400).

[0072] The control board (300) controls the light source (310, 320), the light intensity measuring unit (340), and the battery (350) according to the measurement variables. For example, the control board (300) can supply power to the light source (310, 320), the light intensity measuring unit (340), or the communication unit (330) through the battery (350). The control board (300) can adjust the light intensity of the light source (310, 320). The control board (300) can measure the light intensity through the light intensity measuring unit (340). The control board (300) can perform wired or wireless communication through the communication unit (330). In this case, the control board (300) receives measurement variables from the smart terminal (100) through the communication unit (330) and can control at least one of the light source (310, 320), light quantity measuring unit (340), and battery (350) according to these measurement variables.

[0073] The light source (310, 320) illuminates the rapid diagnostic kit (400).

[0074] The light source (310, 320) may include a white LED (310) or a UV LED (320), but is not specifically limited, and a light source that emits various light may be employed depending on the type of rapid diagnostic kit (400).

[0075] A white LED (310) is installed at the bottom of the control board (300) and emits white light toward the rapid diagnostic kit (400). Multiple white LEDs (310) may be installed, and the number of installations is not particularly limited.

[0076] A white LED (310) can be used in a colorimetric rapid diagnostic kit (400) in which a signal line (410) appears as a colored line.

[0077] A UV LED (320) is installed at the bottom of the control board (300) and irradiates ultraviolet light toward the rapid diagnostic kit (400). Multiple UV LEDs (320) may be installed, and the number of installations is not particularly limited.

[0078] A UV LED (320) can be used in a fluorescent rapid diagnostic kit (400) in which a signal line (410) appears as a fluorescent line.

[0079] Meanwhile, the white LED (310) and UV LED (320) can be installed in an array symmetrically with respect to the rapid diagnostic kit (400), and the control board (300) on which they are installed can be installed at a certain angle.

[0080] In this way, the rapid diagnostic kit reader (500) according to an embodiment of the present invention is equipped with both a white LED (310) and a UV LED (320), so that it can be used universally for a colorimetric rapid diagnostic kit (400) and a fluorescent rapid diagnostic kit (400).

[0081] The light intensity measuring unit (340) is installed at the bottom of the control board (300) and measures the amount of light irradiated from light sources (310, 320), such as a white LED (310) and a UV LED (320).

[0082] The light intensity measuring unit (340) may be a photodiode, but is not specifically limited to one.

[0083] The amount of light emitted from the white LED (310) and UV LED (320) can be set via the smart terminal (100). This will be described later.

[0084] The communication unit (330) performs wireless communication of the smart terminal (100) through various communication networks. The communication unit (330) receives measurement variables set in the smart terminal (100) and transmits them to the control board (300), and transmits control results for the battery (350), white LED (310), UV LED (320), and light intensity measuring unit (340) of the control board (300) to the smart terminal (100).

[0085] The communication unit (330) can perform wireless communication with the smart terminal (100) via Bluetooth or Wi-Fi (Wireless Fidelity), but the communication method is not particularly limited.

[0086] The battery (350) supplies power to the measurement module (600). The battery (350) may be a rechargeable battery, and a connector (not shown) for charging the battery may be installed on one side of the housing (200). Accordingly, the measurement module (600) is portable and can be easily used in various locations.

[0087] The kit tray (430) places the rapid diagnostic kit (400) on its upper surface. A fixing groove is formed in the kit tray (430) to correspond to the shape of the rapid diagnostic kit (400), and the rapid diagnostic kit (400) is placed in this fixing groove.

[0088] Referring to FIG. 3, the external shape and size of the kit tray (430) can be formed differently depending on the type of rapid diagnostic kit (400). In addition, the size and structure of the fixing groove formed in the kit tray (430) can also be varied depending on the type of rapid diagnostic kit (400).

[0089] Referring to FIG. 2, the tray fixing part (220) allows the rapid diagnostic kit (400) to be fixed at a certain position below the camera (110) when the kit tray (430) is inserted into the measurement module (600). For example, the kit tray (430) and the tray fixing part (220) can be fixed to each other by a magnetic force mechanism or a spring mechanism.

[0090] A slot (230) is formed in the housing (200) of the measurement module (600) to allow the kit tray (430) to be inserted into or discharged from the interior of the measurement module (600).

[0091] The light path adjustment unit (260) allows the light from the white LED (310) and UV LED (320) to be uniformly irradiated onto the surface of the membrane (420) of the rapid diagnostic kit (400).

[0092] For example, the optical path adjustment unit (260) may be equipped with a blocking diaphragm, a reflective mirror, and an optical diffuser.

[0093] Unexplained code 210 is a darkroom.

[0094] FIG. 4 is a block diagram of a smart terminal according to one embodiment of the present invention.

[0095] The smart terminal (100) photographs the membrane of the rapid diagnostic kit (400) inserted into the measurement module (600) and analyzes the photographed image to determine the diagnosis result of the rapid diagnostic kit (400).

[0096] Referring to FIG. 4, the smart terminal (100) includes a camera (110), a user interface unit (120), a communication element (140), and a processor (130).

[0097] The camera (110) photographs the membrane (420) of the rapid diagnostic kit (400) through the shooting aid (250) and transmits the acquired image to the processor (130).

[0098] The communication element (140) performs wireless communication with the measurement module (600). The communication element (140) can transmit measurement variables to the measurement module (600) or receive control results from the measurement module (600).

[0099] Additionally, the communication device (140) can transmit the analysis results of the rapid diagnostic kit (400) to a server (800) or a terminal (700) via a communication network.

[0100] Communication networks such as 3GPP (3rd Generation Partnership Project), LTE (Long Term Evolution), 5G (Generation), WIMAX (World Interoperability for Microwave Access), wired and wireless internet (Internet), LAN (Local Area Network), Wireless LAN (Wireless Local Area Network), WAN (Wide Area Network), PAN (Personal Area Network), Bluetooth, and Wifi (Wireless Fidelity) may be adopted, but are not specifically limited.

[0101] The user interface section (120) provides a user interface.

[0102] The user interface unit (120) can receive various control commands from the user and output the operation results of the processor (130). For example, the user interface unit (120) can receive measurement variables from the user. The user interface unit (120) can display the control results of the measurement module (600). The user interface unit (120) can output the analysis results for the rapid diagnostic kit (100).

[0103] The user interface section (120) may be provided as a user interface such as a touchpad, touchscreen, electronic pen, or touch button. Additionally, the user interface section (120) may include a printer, a display, etc. to output data. Here, the display may be implemented as, for example, a TFT-LCD (thin film transistor-liquid crystal display) panel, an LED (light emitting diode) panel, an OLED (organic LED) panel, an AMOLED (active matrix OLED) panel, or a flexible panel.

[0104] The processor (130) is equipped with an application for analyzing a rapid diagnostic kit. The processor (130) executes the application according to a user control command input from the user interface unit (120). In this case, the processor (130) provides the user with various menus for analyzing the rapid diagnostic kit and performs the analysis of the rapid diagnostic kit step by step.

[0105] To explain in more detail, the processor (130) transmits the measurement variable to the measurement module (600). At this time, the control board (300) irradiates light onto the rapid diagnostic kit (400) through the white LED (310) or UV LED (320) according to the measurement variable, and can control the current of the white LED (310) or UV LED (320) according to the amount of light measured through the light amount measuring unit (340). Afterward, when the set amount of light is reached and stabilized, the control board (300) requests the smart terminal (100) to start image measurement.

[0106] Upon receiving a request from the control board (300) to start image measurement, the processor (130) waits for a preset response time so that a response can be sufficiently performed in the rapid diagnostic kit (400). At this time, the processor (130) lights up a white LED (310) through the control board (300) and captures an image of the membrane (420) in real time using the camera (110) and displays it through the user interface section (120), thereby allowing the user to check the progress of the response during the response time.

[0107] When the response time has elapsed, the processor (130) photographs the membrane (420) through the camera (110). The processor (130) can photograph the membrane (420) repeatedly several times.

[0108] The processor (130) analyzes an image of the membrane (420) to quantitatively determine the diagnosis result for the rapid diagnostic kit (400). That is, the processor (130) processes the RGB signals of the image of the membrane (420) to obtain a quantitative numerical value for each signal line (410) of the rapid diagnostic kit (400). Here, the quantitative numerical value may be a representative value of the numerical area for each signal line. The representative value of the numerical area for each signal line will be described later.

[0109] The processor (130) compares the quantitative numerical value with a preset positive threshold, negative threshold, and retest threshold, respectively, and determines the reaction result as positive, negative, or retest based on the comparison result. The process of the processor (130) analyzing the image of the membrane (420) is described in detail with reference to FIGS. 6 and FIGS. 7.

[0110] The processor (130) stores the derived quantitative numerical value and the judgment result in memory and transmits them to a server (800) or terminal (700) through a communication element (140).

[0111] The processor (130) receives measurement variables from the user interface unit (120) and transmits them to the measurement module (600) through the communication element (140).

[0112] The processor (130) receives the control result of the measurement module (600) through the communication element (140) and displays it through the user interface unit (120).

[0113] The processor (130) may be connected to a memory that stores various commands for rapid diagnostic kit analysis. The commands may include commands for executing an application according to control commands of the user interface unit (120), providing various menus for rapid diagnostic kit analysis to the user, performing rapid diagnostic kit analysis step by step, and storing and transmitting rapid diagnostic kit analysis results.

[0114] Memory may include magnetic storage media or flash storage media in addition to volatile storage devices that require power to maintain stored information, but the scope of the present invention is not limited thereto.

[0115] The processor (130) may be configured to perform each function separately at the hardware, software, or logic level. In this case, dedicated hardware may be used to perform each function. To this end, the processor (130) may be implemented as or include at least one of an ASIC (Application Specific Integrated Circuit), DSP (Digital Signal Processor), PLD (Programmable Logic Devices), FPGAs (Field Programmable Gate Arrays), CPU (Central Processing Unit), microcontrollers, and / or microprocessors.

[0116] FIG. 5 is a flowchart illustrating the operation process of a rapid diagnostic kit reader according to one embodiment of the present invention.

[0117] Referring to FIG. 5, first, the user mounts the smart terminal (100) onto the measurement module (600) through the smart terminal mounting portion (240).

[0118] The user executes a measurement application through the user interface unit (120) (S100).

[0119] The processor (130) can receive measurement variables through the user interface unit (120). In this case, the processor (130) can receive at least one of the type of rapid diagnostic kit (400), the type of light source (310, 320), the intensity of the light source (310, 320), and signal processing variables.

[0120] At this time, in addition to receiving measurement variables directly from the user as described above, the processor (130) can store optimized measurement variables in advance in the application of the smart terminal (100) for each rapid diagnostic kit (400) and retrieve the stored measurement variables.

[0121] The user mounts the rapid diagnostic kit (400) onto the kit tray (430) (S300) and inserts a measurement sample into the sample inlet (440).

[0122] The user inserts the kit tray (430), on which the rapid diagnostic kit (400) is fixed, into the measurement module (600) through the slot (230) of the measurement module (600) so that the kit tray (430) is fixed by the tray fixing part (220).

[0123] Next, the processor (130) receives input from the user by displaying a measurement start button of the measurement application through the user interface section (120) (S400).

[0124] In this case, the processor (130) may wait for a preset response time so that a reaction can be performed in the rapid diagnostic kit (400). At this time, the processor (130) lights up the white LED (310), captures the membrane (420) through the camera (110), and displays the captured image in real time through the user interface unit (120).

[0125] The processor (130) transmits the measurement variable set as described above to the measurement module (600) through the communication element (140).

[0126] The control board (300) of the measurement module (600) controls the white LED (310) or UV LED (320) according to the measurement variable received from the processor (130) to irradiate light onto the rapid diagnostic kit (400). In this case, the processor (130) measures the amount of light through the light amount measuring unit (340) and controls the current of the white LED (310) or UV LED (320) according to the measured amount of light to adjust the amount of light (S500).

[0127] When the light irradiated from the white LED (310) or UV LED (320) reaches a set amount of light and stabilizes, the control board (300) requests the smart terminal (100) to start image measurement.

[0128] In response to the image measurement time request from the control board (300), the processor (130) captures an image of the membrane (420) through the camera (110) (S600). The processor (130) may measure repeatedly several times and average the results if necessary.

[0129] The processor (130) analyzes an image of the membrane (420) and outputs the analysis result (S700). That is, the processor (130) processes the RGB signal of the image of the membrane (420) to obtain a quantitative numerical value for each signal line (410) of the rapid diagnostic kit (400). The processor (130) compares the quantitative numerical value with a preset positive threshold, negative threshold, and retest threshold, respectively, and determines the reaction result as positive, negative, or retest based on the comparison result.

[0130] The processor (130) stores the derived quantitative numerical value and the judgment result in memory and transmits it to the server (800) or terminal (700) via a communication network (S800).

[0131] Afterwards, the user separates the rapid diagnostic kit (400) from the rapid diagnostic kit reader (500) and completes the measurement.

[0132] Next, the process of analyzing an image of the membrane (420) and outputting the analysis result is explained in detail with reference to FIGS. 6 and FIGS. 7.

[0133] FIG. 6 is a diagram showing a signal of a rapid diagnostic kit according to one embodiment of the present invention, and FIG. 7 is a flowchart illustrating the signal processing process of a rapid diagnostic kit reader according to one embodiment of the present invention.

[0134] Referring to FIGS. 6 and FIGS. 7, one or more signal lines (410) appear on the membrane (420), and a data acquisition area (450) including the entire signal line (410) is set.

[0135] The processor (130) extracts pixel information of the data acquisition area (450) from an image of the membrane (420).

[0136] Each pixel has R (Red), G (Green), and B (Blue) stored as values ​​in the range of 0 to 255.

[0137] The method of quantifying the signal line (410) within the data acquisition area (450) can be applied in various ways as needed, such as changing the number of signal lines (410).

[0138] First, the processor (130) extracts the number of pixels in the data acquisition area (450) (S710). Here, the number of pixels on the X-axis is denoted as NX, and the number of pixels on the Y-axis is denoted as NY.

[0139] The processor (130) calculates pixel information for each pixel as follows by applying a preset RGB weighting value to each RGB for each pixel (S720).

[0140] V(i, j) = a×R(i, j) + b×G(i, j) + c×B(i, j)(i=1~NX, j=1~NY, a+b+c=1)

[0141] Here, V(i, j) is pixel information. a, b, and c are the weighted values ​​for RGB, respectively. R, G, and B are the R, G, and B values, ranging from 0 to 255. i,j are the pixel coordinates of the horizontal and vertical lines.

[0142] The processor (130) averages NY horizontal lines to calculate horizontal line data as follows (S730).

[0143] Va(i) = ΣV(i,j) / NY (i=1~NX, j=1~NY)

[0144] Here, Va(i) is horizontal line data.

[0145] The processor (130) calculates the baseline value as follows (S740). The baseline value is the average value of the no-signal portion (left horizontal portion, i=1~10) of the data acquisition area (450).

[0146] BaseV= ΣVa(i) / 10 (i=1~10)

[0147] The processor (130) subtracts the baseline value from the horizontal line data as follows (S750).

[0148] VMB(i) = Va(i) - BaseV (i=1~NX)

[0149] The processor (130) extracts the maximum value for each signal line (410) from the values ​​obtained by subtracting the baseline value from the horizontal line data (S760). That is, the processor (130) compares the values ​​obtained by subtracting the baseline value from the horizontal line data with each other to calculate the maximum value VCMax of the left control signal and the maximum value VTMax of the right test signal (S760). Here, the maximum value VCMax of the left control signal is the maximum value of VMB(i) in the left signal. The maximum value VTMax of the right test signal is the maximum value of VMB(i) in the right signal.

[0150] The processor (130) calculates the representative value of the numerical area for each signal line (410) (S770).

[0151] That is, the processor (130) finds a range (i1~i2) in the left control signal that satisfies the condition VMB(i) > e×VCMax.

[0152] Here, e is a constant value and can be arbitrarily set within the range of 0 to 0.99. For example, when e is 0.1, it can be applied when a signal area of ​​10% or more of the maximum value (the maximum value of the left control signal, VCMax) is set as a numerical area. When e is 0.9, it can be applied when a signal area of ​​90% or more of the maximum value (the maximum value of the left control signal, VCMax) is set as a numerical area. For reference, in FIG. 6, the case where e is 0.4 is illustrated as an example.

[0153] Additionally, the processor (130) finds a section (i3~i4) in the right test signal that satisfies the condition VMB(i) > e × VTMax. Here, e is a constant value and can be arbitrarily set within the range of 0 to 0.99. For reference, in FIG. 6, the case where e is 0.4 is illustrated as an example.

[0154] The processor (130) calculates representative values ​​for each numerical region calculated as described above.

[0155] The processor (130) calculates the representative value of the numerical area of ​​the control signal as follows.

[0156] Control = ΣVMB(i) / (i2-i1+1) (i=i1~i2)

[0157] Here, Control is the representative value of the numerical domain of the control signal.

[0158] The processor (130) calculates the representative value of the numerical area of ​​the test signal as follows.

[0159] Test = ΣVMB(i) / (i4-i3+1) (i=i3~i4)

[0160] Here, Test is the representative value of the numerical domain of the test signal.

[0161] The processor (130) displays the representative value of the numerical area of ​​the control signal and the representative value of the numerical area of ​​the test signal through the user interface unit (120) (S780).

[0162] FIG. 8 is a diagram showing the functions of a smart terminal and a measurement module according to an embodiment of the present invention.

[0163] Referring to FIG. 8, the measurement module (600) performs a power supply function, a light source control function, a light intensity measurement function, a rapid diagnostic kit (400) mounting function, a smart terminal mounting function, and a Bluetooth communication function.

[0164] The smart terminal (100) performs display functions, application (app) operation functions, measurement variable setting functions, camera image measurement functions, signal processing functions, measurement result storage functions, Bluetooth communication functions, and internet communication functions through the application of the smart terminal (100). Meanwhile, the application of the smart terminal (100) can display a real-time measurement window, a measurement variable setting window, and a measurement result storage communication window.

[0165] In this way, by having the smart terminal (100) perform various functions for diagnosing the rapid diagnostic kit (400), a low-cost rapid diagnostic kit reader (500) with a miniaturized measurement module (600) can be provided.

[0166] FIG. 9 is a diagram exemplarily illustrating a communication method of a rapid diagnostic kit reader according to one embodiment of the present invention.

[0167] Referring to FIG. 9, measurement variables set in the smart terminal (100) are transmitted to the measurement module (600), and the measurement module (600) transmits measurement operation information to the smart terminal (100). This process can be performed via Bluetooth wireless communication. If necessary, the smart terminal (100) and the measurement module (600) can also be connected via a wire.

[0168] Meanwhile, the analysis result derived from the rapid diagnostic kit reader (500) can be stored in the memory of the smart terminal (100) via a communication network and transmitted to the terminal (700) and server (800) at the site.

[0169] In addition, previous measurement information stored in the terminal (700) and server (800) can be transmitted back to the smart terminal (100).

[0170] Here, the communication method between the smart terminal (100) and the measurement module (600), and the communication method between them and the terminal (700) and the server (800) are not particularly limited.

[0171] In this way, the rapid diagnostic kit reader according to one embodiment of the present invention can measure both fluorescence and the generated rapid diagnostic kit.

[0172] In addition, a rapid diagnostic kit reader according to one embodiment of the present invention reduces the possibility of human visual discrimination errors and quantitatively determines the diagnostic result of the rapid diagnostic kit.

[0173] In addition, the rapid diagnostic kit reader according to one embodiment of the present invention can implement various functions based on a smart terminal, thereby enabling miniaturization and low cost.

[0174] In addition, a rapid diagnostic kit reader according to one embodiment of the present invention can measure rapid diagnostic kits of various shapes and can improve universality and measurement reproducibility.

[0175] Although the present invention has been described with reference to embodiments illustrated in the drawings, this is merely illustrative, and those skilled in the art will understand that various modifications and equivalent alternative embodiments are possible therefrom.

[0176] Therefore, the technical scope of protection of the present invention should be determined by the following patent claims. Explanation of the symbols

[0177] 100: Smart device 110: Camera 120: User interface section 200: Housing 210: Darkroom 220: Tray Fixing Part 230: Slot 240: Smart terminal fixing part 250: Window 260: Optical path control unit 300: Control board 310: White LED 320: UV LED 140, 330: Communication unit 340: Light intensity measuring unit 350: Battery 400: Rapid diagnostic kit 410: Signal line 420: Membrane 430: Kit Tray 440: Sample inlet 450: Data acquisition area 500: Rapid diagnostic kit reader 600: Measurement module 700: Terminal 800: Server

Claims

Claim 1 It includes a smart terminal, wherein the smart terminal comprises: a user interface unit; and a camera for photographing the membrane of a rapid diagnostic kit inserted inside a measurement module; A rapid diagnostic kit reader comprising a processor that determines the diagnostic result of the rapid diagnostic kit based on an image of the membrane and displays it through the user interface unit, wherein the smart terminal is mounted on the measurement module, and the processor processes the RGB signal of the image of the membrane to obtain a quantitative numerical value for each signal line of the rapid diagnostic kit, wherein the processor extracts the number of pixels on the X-axis and Y-axis of the data acquisition area within the membrane from the image of the membrane, calculates pixel information for each pixel by applying an RGB weighting value set for each RGB for each pixel, calculates horizontal line data by averaging NY horizontal lines based on the pixel information, calculates a maximum value for signal selection by subtracting a baseline value where there is no signal in the data acquisition area from the horizontal line data, calculates a numerical area for the signal selection based on the maximum value for signal selection, and then calculates a representative value for the numerical area. Claim 2 A rapid diagnostic kit reader according to claim 1, characterized in that the processor receives measurement variables through the user interface and transmits them to the measurement module. Claim 3 A rapid diagnostic kit reader according to paragraph 2, characterized in that the measurement variable includes at least one of the type of the rapid diagnostic kit, the type of light source that irradiates light inside the measurement module, the intensity of the light source, and a signal processing variable for determining the diagnostic result of the rapid diagnostic kit. Claim 4 A rapid diagnostic kit reader according to claim 1, wherein the processor compares the quantitative numerical value with a preset positive judgment criterion value, a negative judgment criterion value, and a re-test judgment criterion value, respectively, and determines the reaction result as positive, negative, or re-test based on the comparison result. Claim 5 delete Claim 6 A smart terminal; and a measurement module, wherein the measurement module includes a slot that allows a rapid diagnostic kit to be inserted into or discharged from the housing; a shooting assist unit that enables a camera of the smart terminal to photograph the rapid diagnostic kit inserted into the housing; and a light source that illuminates the rapid diagnostic kit inserted into the housing. A rapid diagnostic kit reader comprising a control board that controls a light source to illuminate the rapid diagnostic kit so that the camera of the smart terminal can photograph the rapid diagnostic kit inserted inside the housing, wherein the smart terminal processes the RGB signals of an image of the membrane of the rapid diagnostic kit to obtain quantitative numerical values ​​for each signal line of the rapid diagnostic kit, and the smart terminal extracts the number of pixels on the X-axis and Y-axis of the data acquisition area within the membrane from the image of the membrane, calculates pixel information for each pixel by applying an RGB weighting value set for each RGB for each pixel, calculates horizontal line data by averaging NY horizontal lines based on the pixel information, calculates a maximum value for signal selection by subtracting a baseline value where there is no signal in the data acquisition area from the horizontal line data, calculates a numerical area for the signal selection based on the maximum value for signal selection, and then calculates a representative value for the numerical area. Claim 7 A rapid diagnostic kit reader according to claim 6, characterized in that the measurement module further includes a smart terminal mounting portion formed in the housing to mount the smart terminal in the housing. Claim 8 A rapid diagnostic kit reader according to claim 6, wherein the above-mentioned shooting aid is a transparent window formed transparently at a position corresponding to the camera of the smart terminal. Claim 9 A rapid diagnostic kit reader according to claim 8, wherein the transparent window is characterized by having an optical filter additionally installed or replaced depending on the fluorescence used in the rapid diagnostic kit. Claim 10 A rapid diagnostic kit reader according to claim 6, characterized in that the light source comprises at least one of a white LED (Light Emitting Diode) that emits white light and a UV (Ultraviolet ray) LED that emits ultraviolet light. Claim 11 A rapid diagnostic kit reader according to claim 10, wherein the measurement module further includes a light intensity measuring unit for measuring the amount of light inside the housing, and the control board controls the light source according to the amount of light inside the housing measured by the light intensity measuring unit to adjust the amount of light inside the housing. Claim 12 A rapid diagnostic kit reader according to claim 6, wherein the measurement module further comprises a light path adjustment unit that causes the light of the light source to be uniformly irradiated onto the surface of the membrane of the rapid diagnostic kit. Claim 13 A rapid diagnostic kit reader according to claim 6, wherein the control board receives measurement variables from the smart terminal and controls the light source according to the measurement variables. Claim 14 A rapid diagnostic kit reader according to claim 13, wherein the measurement variable comprises at least one of the type of the rapid diagnostic kit, the type of the light source, the intensity of the light source, and a signal processing variable for determining the diagnostic result of the rapid diagnostic kit. Claim 15 A measurement module into which a rapid diagnostic kit is inserted; The apparatus includes a smart terminal that is mounted on the measurement module and photographs the membrane of the rapid diagnostic kit inserted into the measurement module, and analyzes the image of the photographed membrane to determine the diagnostic result of the rapid diagnostic kit; the smart terminal includes a processor that determines the diagnostic result of the rapid diagnostic kit based on the image of the photographed membrane; the processor processes the RGB signals of the image of the photographed membrane to obtain quantitative numerical values ​​for each signal line of the rapid diagnostic kit; the processor extracts the number of pixels on the X-axis and Y-axis of the data acquisition area within the membrane from the image of the photographed membrane, calculates pixel information for each pixel by applying RGB weighting values ​​set for each RGB for each pixel, calculates horizontal line data by averaging NY horizontal lines based on the pixel information, calculates a maximum value for signal selection by subtracting a baseline value where there is no signal in the data acquisition area from the horizontal line data, calculates a numerical area for signal selection based on the maximum value for signal selection, and then calculates the numerical area of ​​the numerical area A rapid diagnostic kit reader characterized by calculating a representative value. Claim 16 In claim 15, the smart terminal comprises: a user interface unit for displaying the diagnosis result of the rapid diagnostic key; and a camera for photographing the membrane of the rapid diagnostic kit inserted inside the measurement module. more A rapid diagnostic kit reader characterized by including Claim 17 A rapid diagnostic kit reader according to claim 15, wherein the processor compares the quantitative numerical value with a preset positive judgment criterion value, a negative judgment criterion value, and a re-test judgment criterion value, respectively, and determines the reaction result as positive, negative, or re-test based on the comparison result. Claim 18 delete Claim 19 A rapid diagnostic kit reader according to claim 15, wherein the measurement module comprises: a smart terminal mounting portion formed in a housing for mounting the smart terminal in the housing; a slot for allowing the rapid diagnostic kit to be inserted into or discharged from the housing; a shooting assist portion for enabling the camera of the smart terminal to photograph the rapid diagnostic kit inserted into the housing; a light source for illuminating the rapid diagnostic kit inserted into the housing; a light intensity measuring portion for measuring the amount of light inside the housing; and a control board for controlling the light source according to the amount of light inside the housing measured by the light intensity measuring portion to illuminate the rapid diagnostic kit. Claim 20 A rapid diagnostic kit reader according to claim 19, characterized in that the light source comprises at least one of a white LED that emits white light and a UV LED that emits ultraviolet light.

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