Apparatus and method of aalergies in vitro diagnostic

Abstract

An in vitro diagnostic device for allergy testing is disclosed, comprising: a strip mounting unit for mounting a first strip that has absorbed a sample; a reagent spraying unit for spraying a reagent onto the first strip; a photographing unit for photographing the first strip onto which the reagent has been sprayed; and a processor for acquiring an image of the first strip and analyzing an allergic reaction to the sample, wherein the processor controls the strip mounting unit so that, when the spraying of the reagent is completed, the first strip is moved to allow a second strip to be mounted continuously.

Description

Technology Field

[0001] The present disclosure relates to an in vitro diagnostic device and method. More specifically, it relates to an in vitro diagnostic device and method for allergy testing. Background Technology

[0002] An allergic reaction refers to a condition in which the body exhibits a very rapid hypersensitivity reaction to foreign substances entering the body from the outside, causing abnormalities. In South Korea, it is reported that about 20% of the entire population suffers from allergy symptoms.

[0003] Therefore, medical care is provided to test for and manage specific allergic reactions in each individual. Recently in Korea, the AdvanSure Allergy Screen, a protein chip capable of simultaneously diagnosing 60 types of allergies with a single drop of blood, has been developed. This is a test reagent that utilizes immunoblotting technology to quantitatively analyze allergen-specific IgE antibodies present in human serum or plasma. Specifically, various types of allergens are immobilized on different lines of an allergen-coated membrane, and allergen-specific IgE antibodies contained in the sample bind to each allergen antigen. The attached IgE antibodies bind to biotin-conjugated anti-phosphorus IgE antibodies, which in turn bind to enzyme-conjugated streptavidin. Finally, when a chromogenic reagent is added, color development occurs via the enzyme, and the result is analyzed using a colorimetric analyzer.

[0004] Meanwhile, measurement equipment for clinical immunoassay analysis is large-scale equipment with a relatively high price, and since specialized knowledge is required for the measurement method, it has been accessible only to a limited number of experts, such as doctors and clinical pathologists. Prior art literature

[0005] Registered Patent 10-2152629 (2020.09.07) The problem to be solved

[0006] The embodiments disclosed in this disclosure are intended to provide an in vitro diagnostic apparatus and method for allergy testing that processes sample strips in parallel so as to enable the equipment to be miniaturized.

[0007] The problems that this disclosure aims to solve are not limited to those mentioned above, and other unmentioned problems will be clearly understood by a person skilled in the art from the description below. means of solving the problem

[0008] An apparatus according to the present disclosure for achieving the above-described technical problem comprises: a strip mounting unit for mounting a first strip that has absorbed a sample; a reagent spraying unit for spraying a reagent onto the first strip; a photographing unit for photographing the first strip onto which the reagent has been sprayed; and a processor for acquiring an image of the first strip and analyzing an allergic reaction to the sample, wherein the processor controls the strip mounting unit so that, when the spraying of the reagent is completed, the first strip is moved to allow a second strip to be mounted continuously.

[0009] Meanwhile, the strip mounting portion can move the first strip so that reagent spraying, washing, imaging, and disposal of the first strip can proceed sequentially.

[0010] In addition, the reagent spraying unit sprays a plurality of reagents sequentially according to a predetermined step, and the strip mounting unit can move the first strip to a position where the reagent according to the next order among the plurality of reagents is sprayed when the spraying of any one of the plurality of reagents is completed with respect to the first strip.

[0011] In addition, the strip mounting portion can move the first strip downward when the spraying of any one of the plurality of reagents on the first strip is completed.

[0012] In addition, the strip mounting portion may be configured so that a plurality of strips that have absorbed different sample specimens can be mounted simultaneously.

[0013] In addition, the processor can monitor the reagent spraying status at the reagent spraying unit to predict the amount of reagent sprayed once, and provide the predicted amount of reagent sprayed once to the manager's mobile terminal so that the reagent can be managed according to the predicted amount of reagent sprayed once.

[0014] In addition, the processor can calculate the intensity of the allergic reaction based on the color intensity of the strip.

[0015] In addition, the processor can generate an allergy reaction result for the sample, including a reaction grade for each allergen, and provide it to the user's mobile terminal.

[0016] Meanwhile, the method according to the present disclosure is an in vitro diagnostic method for allergy testing performed by an in vitro diagnostic device for allergy testing that diagnoses an allergic reaction to a sample, comprising: a step of mounting a first strip that has absorbed a sample; a step of spraying a reagent onto the first strip; a step of photographing the first strip onto which the reagent has been sprayed; and a step of acquiring an image of the first strip and analyzing an allergic reaction to the sample. The step of spraying a reagent onto the first strip comprises: a step of moving the first strip when the spraying of the reagent onto the first strip is completed; and a step of mounting a second strip at the position where the first strip has been moved and spraying the reagent.

[0017] Meanwhile, the step of spraying a reagent onto the first strip may include: a first reaction induction step of detecting a protein from the sample as an antibody through an allergen antigen coated on the membrane of the first strip; a second reaction induction step of spraying the reagent containing antigen-antibody binding magnetic particles to bind the protein detected in the first reaction with the magnetic particles; and a luminescence reaction induction step of spraying a color-developing solution onto the magnetic particles to generate a luminescence reaction in the first strip.

[0018] In addition to this, a computer program stored on a computer-readable recording medium for executing the present disclosure may be further provided.

[0019] In addition, a computer-readable recording medium for recording a computer program for executing a method for implementing the present disclosure may be further provided. Effects of the invention

[0020] According to the means for solving the problem described above in the present disclosure, by continuously mounting a plurality of strips that have absorbed different specimen samples and controlling the injection of reagents for each strip to be carried out in parallel, it is possible to expect an improvement in diagnostic efficiency, achieve miniaturization of the device, and enable an efficient diagnostic process even in small hospitals where there are limitations in collecting the number of specimen samples.

[0021] In addition, in in vitro diagnostic methods, including an immunoblotting method using magnetic particles can improve detection sensitivity and allow for a reduction in time.

[0022] The effects of the present disclosure are not limited to those mentioned above, and other unmentioned effects will be clearly understood by a person skilled in the art from the description below. Brief explanation of the drawing

[0023] FIG. 1 is a conceptual diagram of an in vitro diagnostic device for allergy testing according to one embodiment of the present disclosure. FIGS. 2 and FIGS. 3 are drawings showing an example of the main body part illustrated in FIGS. 1. FIG. 4 is a drawing showing an example of a state in which a strip is mounted on the strip mounting portion disclosed in FIG. 3. FIG. 5 is a flowchart of an in vitro diagnostic method for allergy testing according to one embodiment of the present invention. Figure 6 is a detailed flowchart of the reagent injection step (S300) illustrated in Figure 5. Specific details for implementing the invention

[0024] Throughout this disclosure, the same reference numerals denote the same components. This disclosure does not describe all elements of the embodiments, and general content in the art to which this disclosure pertains or content that overlaps between embodiments is omitted. The terms 'part, module, component, block' as used in the specification may be implemented in software or hardware, and depending on the embodiments, a plurality of 'parts, modules, components, blocks' may be implemented as a single component, or a single 'part, module, component, block' may include a plurality of components.

[0025] Throughout the specification, when a part is described as being "connected" to another part, this includes not only cases where they are directly connected but also cases where they are indirectly connected, and indirect connections include connections made via a wireless communication network.

[0026] Furthermore, when it is stated that a part "includes" a certain component, this means that, unless specifically stated otherwise, it does not exclude other components but may include additional components.

[0027] Throughout the specification, when it is stated that a component is located "on" another component, this includes not only cases where a component is in contact with another component, but also cases where another component exists between the two components.

[0028] The terms first, second, etc. are used to distinguish one component from another, and the components are not limited by the aforementioned terms.

[0029] Singular expressions include plural expressions unless there is an obvious exception in the context.

[0030] In each step, identification codes are used for convenience of explanation and do not describe the order of the steps; the steps may be performed differently from the specified order unless a specific order is clearly indicated in the context.

[0031] The operating principles and embodiments of the present disclosure will be described below with reference to the attached drawings.

[0032] In this specification, the term "device according to the present disclosure" includes all various devices capable of performing computational processing and providing results to a user. For example, the device according to the present disclosure may include all of a computer, a server device, and a portable terminal, or may be in the form of any one of these.

[0033] Here, the computer may include, for example, a notebook, desktop, laptop, tablet PC, slate PC, etc. equipped with a web browser.

[0034] The above server device is a server that processes information by communicating with an external device, and may include an application server, a computing server, a database server, a file server, a game server, a mail server, a proxy server, and a web server.

[0035] The above portable terminal may include, for example, all types of handheld-based wireless communication devices such as PCS (Personal Communication System), GSM (Global System for Mobile communications), PDC (Personal Digital Cellular), PHS (Personal Handyphone System), PDA (Personal Digital Assistant), IMT (International Mobile Telecommunication)-2000, CDMA (Code Division Multiple Access)-2000, W-CDMA (W-Code Division Multiple Access), WiBro (Wireless Broadband Internet) terminals, smartphones, etc., as well as wearable devices such as watches, rings, bracelets, anklets, necklaces, glasses, contact lenses, or head-mounted devices (HMDs).

[0036] Functions related to artificial intelligence according to the present disclosure are operated through a processor and memory. The processor may be composed of one or more processors. In this case, the one or more processors may be general-purpose processors such as CPUs, APs, and DSPs (Digital Signal Processors), graphics-dedicated processors such as GPUs and VPUs (Vision Processing Units), or artificial intelligence-dedicated processors such as NPUs. The one or more processors control the processing of input data according to predefined operation rules or artificial intelligence models stored in memory. Alternatively, if the one or more processors are artificial intelligence-dedicated processors, the artificial intelligence-dedicated processors may be designed with a hardware structure specialized for processing a specific artificial intelligence model.

[0037] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the attached drawings.

[0039] FIG. 1 is a conceptual diagram of an in vitro diagnostic device for allergy testing according to one embodiment of the present disclosure.

[0040] Referring to FIG. 1, an in vitro diagnostic device (1) for allergy testing according to one embodiment of the present disclosure may include a main body (10), a processor (110), a communication module (120), and a memory (130).

[0041] The main body (10) can perform in vitro diagnosis on a specimen sample derived from a person or animal and provide diagnostic result information.

[0042] For example, in this embodiment, the main body (10) can diagnose an allergic reaction of a sample using a strip coated with a membrane containing an allergen antigen. The configuration of the main body (10) for this purpose will be described later with reference to FIG. 2 and below.

[0043] The processor (110) can perform an allergy testing process according to the present disclosure.

[0044] The processor (110) may be implemented as a memory that stores data for an algorithm or a program that reproduces the algorithm for controlling the operation of components within the main body (10), and at least one processor (not shown) that performs the aforementioned operation using the data stored in the memory. In this case, the memory and the processor may each be implemented as separate chips. Alternatively, the memory and the processor may be implemented as a single chip.

[0045] In addition, the processor (110) may control one or more of the components described above in combination to implement various embodiments according to the present disclosure described in the drawings below on the device.

[0046] The communication module (120) may include one or more components that enable communication with an external device, and may include, for example, at least one of a wired communication module, a wireless communication module, a short-range communication module, and a location information module.

[0047] The wired communication module may include various wired communication modules such as a Local Area Network (LAN) module, a Wide Area Network (WAN) module, or a Value Added Network (VAN) module, as well as various cable communication modules such as USB (Universal Serial Bus), HDMI (High Definition Multimedia Interface), DVI (Digital Visual Interface), RS-232 (recommended standard 232), power line communication, or POTS (plain old telephone service).

[0048] In addition to Wi-Fi modules and WiBro (Wireless broadband) modules, the wireless communication module may include wireless communication modules that support various wireless communication methods such as GSM (global System for Mobile Communication), CDMA (Code Division Multiple Access), WCDMA (Wideband Code Division Multiple Access), UMTS (universal mobile telecommunications system), TDMA (Time Division Multiple Access), LTE (Long Term Evolution), 4G, 5G, and 6G.

[0049] The wireless communication module may include a wireless communication interface comprising an antenna and a transmitter that transmit a mobile communication signal. Additionally, the wireless communication module may further include a signal conversion module that modulates a digital control signal output from the processor (110) through the wireless communication interface into an analog wireless signal under the control of the processor (110).

[0050] A short-range communication module is for short-range communication and can support short-range communication by using at least one of Bluetooth™, RFID (Radio Frequency Identification), Infrared Data Association (IrDA), UWB (Ultra Wideband), ZigBee, NFC (Near Field Communication), Wi-Fi (Wireless-Fidelity), Wi-Fi Direct, and Wireless USB (Wireless Universal Serial Bus) technologies.

[0051] The location information module is a module for obtaining the location (or current location) of the device according to the present disclosure, and representative examples thereof include a Global Positioning System (GPS) module or a Wireless Fidelity (WiFi) module. For example, if a GPS module is utilized, the location of the device can be obtained using signals sent from GPS satellites. As another example, if a Wi-Fi module is utilized, the location of the device can be obtained based on information from a Wireless Access Point (AP) that transmits or receives wireless signals from the Wi-Fi module. If necessary, the location information module may perform any of the functions of other modules of the communication unit to obtain data regarding the location of the device, either substituted or additionally. The location information module is a module used to obtain the location (or current location) of the device, and is not limited to a module that directly calculates or obtains the location of the device.

[0052] The memory (130) can store data supporting various functions of the device and programs for the operation of the processor (110), and can store input / output data, and can store a number of application programs (or applications) running on the device, data for the operation of the device, and instructions. At least some of these application programs can be downloaded from an external server via wireless communication.

[0053] Such memory (130) may include at least one type of storage medium among flash memory type, hard disk type, SSD type (Solid State Disk type), SSD type (Silicon Disk Drive type), multimedia card micro type, card type memory (e.g., SD or XD memory, etc.), RAM (random access memory; RAM), SRAM (static random access memory), ROM (read-only memory; ROM), EEPROM (electrically erasable programmable read-only memory), PROM (programmable read-only memory), magnetic memory, magnetic disk, and optical disk. Additionally, the memory (130) may be a database that is separated from the device but connected via wired or wireless connection.

[0055] FIGS. 2 and FIGS. 3 are drawings showing an example of the main body portion illustrated in FIGS. 1, and FIGS. 4 is a drawing showing an example of a state in which a strip is mounted on the strip mounting portion disclosed in FIGS. 3.

[0056] Referring to FIGS. 2 and FIGS. 3, a main body (10) according to one embodiment of the present disclosure may include a housing (11) that forms the outer shape of the main body (10), a sample mounting part (13) for mounting a sample, a strip mounting part (15) for mounting a strip, a reagent spraying part (17) for mounting and spraying a reagent, and a shooting part (19) for photographing the strip.

[0057] The housing (11) forms the outer shape of the main body (10) and can form an internal space to provide an installation space for components of the main body (10), including a sample mounting part (13), a strip mounting part (15), a reagent spraying part (17), and a shooting part (19).

[0058] The housing (11) may include a door (11a) and a reagent holder (11b).

[0059] A door (11a) may be provided to open and close the internal space of the housing (11). For example, the door (11a) may close the internal space of the housing (11) to prevent contamination of the sample mounted on the sample mounting part (13) and the strip mounted on the strip mounting part (15).

[0060] The reagent holder (11b) may be formed extending from the outer surface of the housing (11). For example, the reagent holder (11b) may be formed in the shape of a plate of a predetermined thickness and may be formed extending horizontally from the front of the housing (11) to the ground.

[0061] The reagent holder (11b) can provide a space for holding at least one reagent (17a), distilled water (17c), and a washing solution (17d).

[0062] The sample mounting portion (13) can be provided in the internal space formed by the housing (11) and can mount a sample container containing a sample sample.

[0063] The specimen sample may include at least one of blood, serum, plasma, urine, saliva, and tissue cells derived from a human or animal. In this embodiment, the specimen sample is described as either serum or plasma. Here, in the case of plasma, it may be in a state obtained by treatment with heparin or citrate, and the specimen sample may be in a state diluted by a sample reagent.

[0064] Meanwhile, the sample can be obtained through a centrifuge provided separately from the device. Alternatively, the main body (10) may incorporate a centrifuge for obtaining the sample. However, the main body (10) may incorporate a centrifuge for obtaining the sample within a range that does not impair the appearance or the bonding state with other components, and does not cause an increase in size.

[0065] The strip mounting portion (15) can be provided in the internal space formed by the housing (11) and can mount a strip.

[0066] The strip can absorb a specimen sample and display a diagnostic result. For example, the strip may be formed in a shape having a short side width and a long side length, and may include a specimen pad that absorbs the specimen sample, a membrane that displays the detection result, and an absorbent pad that absorbs the developing liquid of the specimen. In this embodiment, the strip includes a nitrocellulose transfer membrane, and a plurality of strips may be configured as a set to be coated with a total of 108 allergen antigens, thereby allowing the application of an immune blotting method in in vitro diagnosis.

[0067] The strip mounting portion (15) can be configured to allow multiple strips (5) that have absorbed different sample samples to be mounted simultaneously, as shown in FIG. 4. For example, in this embodiment, the strip mounting portion (15) can be configured to allow mounting of multiple strips (5) that have absorbed up to three sample samples so as to achieve miniaturization of the device.

[0068] Meanwhile, the strip mounting part (15) can move the strip (5) in a conveyor manner so that a series of in vitro diagnostic processes for the strip (5) can proceed sequentially.

[0069] For example, the strip mounting unit (15) can move the strip (5) to a location where each step is performed according to the in vitro diagnostic process of mounting the strip (5), spraying a reagent onto the strip (5), capturing an image of the strip (5), and disposing of the strip (5). To this end, the strip mounting unit (15) may include members for guiding the transport direction of various moving elements, a combination of multiple panels, or guide members for guiding the movement direction of moving elements, and is not limited to a specific structure or shape. As an example, the strip mounting unit (15) may include an electric motor that provides driving force via an endless track type belt, an encoder, and a position detection sensor for position control, and can move the mounted strip (5) to a predetermined location according to the rotation direction of the electric motor.

[0070] The reagent spraying unit (17) can be provided in the internal space formed by the housing (11) and can spray the reagent (17a) with the strip (5) mounted on the strip mounting unit (15).

[0071] In this embodiment, the reagent (17a) may include Sample (DIL), Antibody (SOLN), Enzyme (SOLN), Substrate (SOLN), and Wash (CONC 20X), and may be sprayed sequentially by the reagent spray unit (17). Here, the Sample reagent is for diluting the sample, the Antibody reagent is an antibody solution containing a biotinylated antibody, the Enzyme reagent is an enzyme solution containing an alkaline phosphate, the Substrate is a chromogenic solution containing a chromogenic substrate, and the Wash may be a washing solution. At this time, the secondary enzyme, the Enzyme reagent (17a), is a reagent widely used in various immunodiagnostics including the Chemiluminescent Enzyme Immunotherapy (CLEIA) method, and plays a role in removing phosphate groups in various biological reactions to react with the chemiluminescent substrate. As such, according to this embodiment, the Chemiluminescent Enzyme Immunotherapy (CLEIA) method can be used in parallel, so the effect of improving reaction sensitivity can be expected. For example, in the sample dilution step, the Sample reagent is sprayed, in the antibody reaction step against the protein due to immunoblotting, the Antibody reagent and Enzyme reagent are sprayed, in the washing step, the Wash reagent is sprayed onto the strip (5), and in the color development reaction step, the Substrate reagent is sprayed.

[0072] In this embodiment, the secondary enzyme reagent may include antigen (or antibody)-binding magnetic particles. When magnetic particles are used, the antigen can be stably attached to the surface of the magnetic particles by utilizing chemical bonding and physical adsorption, thereby enabling the capture of antibodies (target substances). For example, the azide group (-N3) is a chemical functional group used to immobilize antigens on the surface of magnetic particles, and is frequently used in photochemical bonding. It selectively binds to alkyne functional groups of other substrates through a photoreaction, thereby enabling the immobilization of antigens or proteins on the magnetic particles. That is, according to this embodiment, in an in vitro diagnostic method, detection sensitivity can be improved and a time reduction effect can be expected by including an immunoblotting method using magnetic particles.

[0073] For example, the reagent injection unit (17) may include a storage container for storing a reagent (17a), a tube (17d) providing a passage for moving the reagent (17a) from the storage container, a motor that operates according to a control signal from a processor (110), an injection pump that pumps the reagent (17a) supplied from the storage container at a constant pressure by the operation of the motor and moves it through the tube (17d), and a nozzle that has one end connected to the tube (17d) and the other end positioned toward the strip mounting unit (15) to inject the reagent (17a) pumped by the injection pump into the strip (5).

[0074] Meanwhile, the reagent spraying unit (17) can spray not only multiple reagents (17a) but also distilled water (17c), washing solution (17d), etc., onto the strip (5) in the same manner as the reagent (17a) according to a series of in vitro diagnostic processes.

[0075] Meanwhile, the reagent spraying unit (17) sprays a plurality of reagents sequentially according to a predetermined step as described above, and may be configured to spray each reagent at a different location for each step within the housing (11). For example, the reagent spraying unit (17) may be configured to include spraying spaces formed in multiple stages in the vertical direction within the internal space of the housing (11), and may adopt a structure in which nozzles connected to different storage containers are arranged in each spraying space so that reagents (17a) contained in different storage containers are sprayed in each spraying space. At this time, the reagent spraying unit (17) may be configured so that a plurality of reagents are sprayed sequentially from the upper spraying space to the lower spraying space according to a predetermined step.

[0076] The strip mounting section (15) can move the first strip to a position where the next reagent is sprayed when the spraying of any one of the multiple reagents on the first strip is completed. To this end, the strip mounting section (15) may include a fixed plate on which the strip (5) is fixedly installed, an inlet formed through the housing (11) to allow the insertion of the fixed plate, a downward conveyor that transports the fixed plate downward from the inlet along the spraying space of the reagent spraying section (17) within the internal space of the housing (11), a first horizontal conveyor that transports the fixed plate horizontally in the lowest spraying space of the reagent spraying section (17), a rising conveyor connected to the first horizontal conveyor to transport the fixed plate upward, a second horizontal conveyor connected to the rising conveyor to transport the fixed plate horizontally toward the discharge port, and an outlet formed through the housing (11) to allow the discharge of the fixed plate.

[0077] For example, the strip mounting unit (15) can move the first strip downward via a descending conveyor and place it in the lower spraying space where the second stage of reagent is sprayed, when the first stage of reagent spraying for the first strip is completed while the first strip is inserted through the inlet and placed in the uppermost spraying space of the reagent spraying unit (17). Then, as the first strip is placed in the lower spraying space, the strip mounting unit (15) continuously inserts the second strip inserted through the inlet into the uppermost spraying space of the reagent spraying unit (17) so that reagent spraying for the second strip is performed. Then, when the final stage of reagent spraying for the first strip is completed in the lowermost spraying space, the strip mounting unit (15) can transport the first strip to the discharge side via an ascending conveyor, and at this time, a photographing unit (19) is formed in the transport path to the discharge, so that the first strip, after the previous stage of reagent spraying is completed, can be photographed and the first strip can be discharged and discarded.

[0078] In this way, the strip mounting unit (15) according to the present embodiment is configured so that a plurality of strips that have absorbed different specimen samples are mounted in succession, and by moving the plurality of strips mounted in succession, each step of reagent spraying is performed simultaneously at different locations, thereby enabling diagnosis of the plurality of strips to be performed in parallel and simultaneously, thus achieving miniaturization of the device and enabling an efficient diagnostic process to be carried out even in small hospitals, etc., where there are limitations in collecting the number of specimen samples.

[0079] The imaging unit (19) can be provided in the internal space formed by the housing (11) and can obtain an image of the strip after the reagent spraying by the reagent spraying unit (17) is completed.

[0080] For example, the shooting unit (19) can be composed of a CCD camera.

[0081] Meanwhile, referring to FIG. 2, the main body (10) may further include a tubing washing tray (12).

[0082] For example, the tubing cleaning tray (12) may be formed in the shape of a box with an open top surface, provided on a reagent holder (11b), capable of containing cleaning liquid in its internal space, and at least one tube (17d) of a reagent spray unit (17) may be inserted through the top surface. Briefly describing a tube cleaning method using such a tubing cleaning tray (12), the inside of the tube (17d) can be cleaned by operating a spray pump while at least one tube (17d) is inserted into the tubing cleaning tray (12) to inject cleaning liquid into the tube (17d).

[0083] Meanwhile, referring to FIG. 3, the main body (10) may further include a waste liquid container (18) on the outer surface of the housing (11).

[0084] Meanwhile, the processor (110) illustrated in FIG. 1 can control the strip mounting part (15) so that when the spraying of the reagent is completed, the first strip is moved so that the second strip can be mounted continuously.

[0085] Additionally, the processor (110) monitors the reagent injection state at the reagent injection unit (17) to predict the amount of reagent injected once, and can provide the predicted amount of reagent injected once to the manager's mobile terminal so that the reagent can be managed according to the predicted amount of reagent injected once.

[0086] Additionally, the processor (110) can calculate the intensity of the allergic reaction based on the color intensity of the strip.

[0087] Additionally, the processor (110) can generate an allergy reaction result for the sample, including a reaction grade for each allergen, and provide it to the user's mobile terminal.

[0089] FIG. 5 is a flowchart of an in vitro diagnostic method for allergy testing according to one embodiment of the present invention.

[0090] Referring to FIG. 5, an in vitro diagnostic method for allergy testing according to one embodiment of the present invention may be performed by an in vitro diagnostic device (1) for allergy testing shown in FIGS. 1 to 4, and may include a step of mounting a sample (S100), a step of mounting a strip (S200), a step of spraying a reagent onto the strip (S300), a step of photographing the strip (S400), a step of analyzing an allergy reaction (S500), and a step of providing an allergy reaction analysis result (S600).

[0091] The sample mounting part (13) can mount a sample (S100). In this embodiment, the sample mounting part (13) may mount multiple sample samples simultaneously.

[0092] The strip mounting portion (15) can mount a strip (S200). The strip can absorb a sample and display a diagnostic result.

[0093] The reagent spraying unit (17) can spray a reagent with a strip mounted on the strip mounting unit (15) (S300).

[0094] For example, the reagent spraying unit (17) can sequentially spray a plurality of reagents onto a strip according to a predetermined diagnostic process, and at this time, the reagent spraying can be controlled by the processor (110).

[0095] For example, the diagnostic process according to the present embodiment may comprise a first reaction induction step in which a protein is detected as an antibody from a sample through an allergen antigen coated on the membrane of a strip, a second reaction induction step in which a reagent containing antigen-antibody conjugated magnetic particles is sprayed to bind the protein detected in the first reaction with the magnetic particles, a strip washing step, and a luminescence reaction induction step in which a chromogenic solution is sprayed onto the magnetic particles to induce a luminescence reaction in the strip.

[0096] Here, the first reaction induction step may utilize an immunoblotting technique. For example, proteins can be extracted from a sample and separated via SDS-PAGE, after which the separated proteins can be transferred to and fixed on the membrane of a strip. At this time, specific IgE binding of the protein, such as slgE or tlgE within the sample, can bind to the allergen antigen on the membrane. Then, an Antibody (SOLN) reagent is sprayed onto the strip to allow the biotinylated mouse monoclonal anti-human IgE antibody to attach.

[0097] The second reaction induction step is treated by spraying an Enzyme (SOLN) reagent containing antigen-antibody binding magnetic particles onto a strip, and the washing step can eliminate non-specific reactions.

[0098] The luminescence reaction induction step can produce a purple insoluble precipitate by spraying a chromogenic reagent onto a strip to induce a luminescence reaction between magnetic particles and a chromogenic substrate. In this case, the concentration of slgE or tlgE in the sample can be measured based on the color intensity appearing on the strip.

[0099] The imaging unit (19) can photograph a strip in which a plurality of reagent sprays have been completed according to a predetermined diagnostic process (S400).

[0100] The processor (110) can analyze the allergic reaction to the sample by analyzing the strip imaging (S500).

[0101] For example, the processor (110) can identify the coating location of the allergen antigen in the strip imaging, analyze the color intensity appearing for each identified location, and calculate the intensity of a specific allergic reaction as a grade from 0 to 6 based on the color intensity. At this time, the processor (110) can determine that the allergic reaction is positive if the slgE concentration calculated based on the color intensity is 0.35 IU / mL or higher. This strip fluorescence analysis technique is a widely applied technology in the field of in vitro diagnostics, so a detailed description will be omitted.

[0102] The processor (110) can provide the results of the analysis of an allergic reaction to a sample to the user's mobile terminal. Here, the results of the analysis of the allergic reaction may include reaction grades for each allergen.

[0103] Figure 6 is a detailed flowchart of the reagent injection step (S300) illustrated in Figure 5.

[0104] Referring to FIG. 6, the reagent injection step (S300) may include, when the first reagent injection with the first strip is completed (S310), the step of moving the first strip to a second reagent injection position (S320), the step of mounting the second strip (S330), and the step of injecting the first reagent with the second strip (S340).

[0105] The processor (110) detects whether the first reagent injection to the first strip is completed, and if it is confirmed that the first reagent injection to the first strip is completed, it can control the strip mounting part (15) to move the first strip to the second reagent injection position. Then, when the first strip is moved to the second reagent injection position, the processor (110) can control the reagent injection part (17) so that the second reagent is injected to the first strip.

[0106] The processor (110) can detect whether the second strip is mounted on the strip mounting portion (15), and if the second strip is mounted on the strip mounting portion (15), the processor can control the strip mounting portion (15) so that the second strip can be moved to the first reagent injection position. And, if the second strip is moved to the first reagent injection position, the processor (110) can control the reagent injection portion (17) so that the first reagent is injected into the second strip.

[0107] In this way, the processor (110) can expect improved diagnostic efficiency by controlling the continuous loading of multiple strips that have absorbed different sample specimens and the parallel injection of reagents for each strip.

[0109] Meanwhile, the disclosed embodiments may be implemented in the form of a recording medium that stores instructions executable by a computer. The instructions may be stored in the form of program code and, when executed by a processor, may generate a program module to perform the operation of the disclosed embodiments. The recording medium may be implemented as a computer-readable recording medium.

[0110] Computer-readable recording media include all types of recording media that store instructions that can be decoded by a computer. Examples include ROM (Read Only Memory), RAM (Random Access Memory), magnetic tape, magnetic disk, flash memory, optical data storage devices, etc.

[0111] As described above, the disclosed embodiments have been explained with reference to the attached drawings. Those skilled in the art will understand that the present disclosure may be practiced in forms different from the disclosed embodiments without changing the technical spirit or essential features of the present disclosure. The disclosed embodiments are illustrative and should not be interpreted restrictively. Explanation of the symbols

[0113] 1: In Vitro Diagnostic Device for Allergy Testing 10: Main body 110: Processor 120: Communication module 130: Memory

Claims

Claim 1 An in vitro diagnostic device for allergy testing, comprising: a strip mounting unit for mounting a first strip that has absorbed a sample; a reagent spraying unit for spraying a reagent onto the first strip; a photographing unit for photographing the first strip onto which the reagent has been sprayed; and a processor for acquiring an image of the first strip and analyzing an allergic reaction to the sample, wherein the processor controls the strip mounting unit so that, when the spraying of the reagent is completed, the first strip is moved to allow a second strip to be mounted continuously. Claim 2 An in vitro diagnostic device for allergy testing according to claim 1, wherein the strip mounting portion moves the first strip so that reagent spraying, washing, imaging, and disposal of the first strip can proceed sequentially. Claim 3 An in vitro diagnostic device for allergy testing according to claim 1, wherein the reagent spraying unit sprays a plurality of reagents sequentially according to a predetermined step, and the strip mounting unit moves the first strip to a position where the reagent according to the next order among the plurality of reagents is sprayed when the spraying of any one of the plurality of reagents is completed on the first strip. Claim 4 In paragraph 3, the strip mounting portion moves the first strip downward when the spraying of any one of the plurality of reagents on the first strip is completed, an allergy test in vitro diagnostic device. Claim 5 An in vitro diagnostic device for allergy testing according to claim 1, wherein the strip mounting portion is configured to allow a plurality of strips that have absorbed different specimen samples to be mounted simultaneously. Claim 6 An in vitro diagnostic device for allergy testing according to claim 1, wherein the processor monitors the reagent spraying status at the reagent spraying unit to predict the single spray amount of the reagent, and provides the predicted single spray amount of the reagent to a manager's mobile terminal so that the reagent can be managed according to the predicted single spray amount of the reagent. Claim 7 In claim 1, the processor is an in vitro diagnostic device for allergy testing that calculates the intensity of an allergic reaction based on the color intensity of the strip. Claim 8 In claim 1, the processor generates an allergy reaction result for the sample, including a reaction grade for each allergen, and provides it to a user's mobile terminal. Claim 9 A method for in vitro diagnostic of allergy testing performed by an in vitro diagnostic device for diagnosing an allergic reaction to a specimen sample, comprising: a step of mounting a first strip that has absorbed a specimen sample; a step of spraying a reagent onto the first strip; a step of photographing the first strip onto which the reagent has been sprayed; and a step of acquiring an image of the first strip and analyzing the allergic reaction to the specimen sample; wherein the step of spraying a reagent onto the first strip comprises: a step of moving the first strip when the spraying of the reagent onto the first strip is completed; and a step of mounting a second strip at the position where the first strip has been moved and spraying the reagent. Claim 10 In claim 9, the step of spraying a reagent onto the first strip comprises: a first reaction induction step of detecting a protein from the specimen sample as an antibody through an allergen antigen coated on the membrane of the first strip; a second reaction induction step of spraying the reagent containing antigen-antibody binding magnetic particles to bind the protein detected in the first reaction with the magnetic particles; and a luminescence reaction induction step of spraying a color-developing solution onto the magnetic particles to generate a luminescence reaction in the first strip; an in vitro diagnostic method for allergy testing.

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