Storage device and fully automated diagnostic testing system including the same

Abstract

The present disclosure relates to a storage device for an automated diagnostic testing system and an automated diagnostic testing system including the same. More particularly, the storage device includes a storage area configured to store materials, an identification information reader, a material dispensing interface configured to interact with a transfer device of the automated diagnostic testing system, and a controller configured to control the storage device, wherein the controller determines, based on identification information of a sample loaded in the automated diagnostic testing system, materials to be supplied to a functional device, and controls the storage device such that the determined materials are supplied to the functional device.

Description

STORAGE DEVICE AND FULLY AUTOMATED DIAGNOSTIC TESTING SYSTEM INCLUDING THE SAME

[0001] The present disclosure relates to a storage device and a fully automated diagnostic testing system including the same. More particularly, the present disclosure relates to a storage device that is spatially separated from a functional device of an automated diagnostic testing system and supplies materials to the functional device, and a fully automated diagnostic testing system including the same.

[0002] A diagnostic test is a test for determining a state of a subject or confirming the presence or absence of contamination or infection by analyzing a specific substance, marker, or biological, chemical, or physical property. The diagnostic test is not limited to a specimen derived from a human body (e.g., blood, serum, plasma, urine, saliva, sputum, tissue, a swab sample, etc.), and may also be performed on various samples such as food, animals, plants, soil, and water (e.g., drinking water, river water, wastewater, etc.). Such a diagnostic test may include various methods such as immunological analysis, biochemical analysis, and molecular biological analysis depending on an application field and a purpose of the test, and may be expanded to qualitative and / or quantitative analysis and multi-item analysis. Molecular diagnosis is a method of determining the presence or absence of a disease or infection by analyzing genetic information contained in a sample or a biological marker contained in a protein using molecular biological technology.

[0003] In particular, in a situation in which high-throughput processing is required, such as an outbreak of an infectious disease, reinforcement of monitoring for food and environmental safety, or a rapid increase in demand for a specific test, it is often necessary to repeatedly perform the same or similar test protocol for a plurality of samples, and to stably process a large number of tests within a short period of time. However, the entire process of the diagnostic test may be configured with a plurality of steps such as management of reagents and consumables, sample pretreatment, performing a reaction, detection, and result generation, and in many cases, a high level of proficiency and repetitive work are required for each step, thereby causing a problem in that test time and consumption of human resources increase. A fully automated diagnostic testing system addresses these issues to reduce dependency on manpower and enable more stable test operation.

[0004] An unattended laboratory refers to a test environment that is operated completely automatically without human intervention for a predetermined period of time (e.g., 48 hours). In order to realize an unattended laboratory using a fully automated diagnostic testing system, a system capable of stably supplying reagents and consumables that are continuously used during the diagnostic testing process is essential. However, a conventional laboratory is operated in a manner in which personnel directly replenishes reagents and consumables, and this is one of the major factors that makes continuous automatic operation of an unattended laboratory difficult. Therefore, there is a need for a storage device that automatically stores and supplies materials so that the fully automated diagnostic testing system can operate without interruption for a predetermined period of time.

[0005] In a conventional testing system, each functional device that processes a sample includes a storage module for storing reagents and consumables. This approach may causes various problems in test efficiency and continuous operation due to various structural limitations. First, a problem arises in that personnel has to individually replenish reagents and consumables for each of the plurality of functional devices. That is, when a reagent of a specific functional device is exhausted during the diagnostic testing process, an operator has to directly access the functional device to replenish the reagent, and this causes problems such as an increase in workload, a time delay, and an increase in manpower dependency. In addition, the storage module included in each functional device cannot store a large amount of reagents due to spatial limitations. As the test volume increases, the consumption rate of reagents and consumables also increases, and if storage capacity is limited, frequent replenishment is required.

[0006] Accordingly, there is a need to develop a storage device capable of storing reagents and consumables required for diagnostic testing for a predetermined period of time and automatically supplying the reagents and consumables.

[0007]

[0008] An object of the present disclosure is to provide a storage device for an automated diagnostic testing system.

[0009] Another object of the present disclosure is to provide an automated diagnostic testing system including a plurality of functional devices and a storage device that supplies materials to the plurality of functional devices.

[0010] However, the present disclosure is not limited by the above-described objects, and may be variously expanded without departing from the spirit and scope of the present disclosure.

[0011] In order to achieve the above-described object of the present disclosure, a storage device for an automated diagnostic testing system is provided according to exemplary embodiments of the present disclosure. The storage device is a storage device for an automated diagnostic testing system, wherein the storage device is configured to supply materials to a functional device of the automated diagnostic testing system, wherein the storage device is spatially separated from the functional device, and wherein the storage device comprises at least one storage area for storing materials, a material release interface configured to interact with a transfer device of the automated diagnostic testing system, and a local controller configured to communicate with a main controller of the automated diagnostic testing system, wherein the local controller exchanges information with the main controller, and controls the storage device in response to instructions received from the main controller, such that materials for a loaded sample, determined based on identification information of the sample loaded in the automated diagnostic testing system, are supplied to the functional device.

[0012] In exemplary embodiments, the storage device may comprise an identification information reader for identifying identification information of the materials.

[0013] In exemplary embodiments, the storage device may comprise a release module configured to transfer materials within the storage area.

[0014] In exemplary embodiments, the storage device may comprise two or more storage areas, wherein at least one of the storage areas may be independently temperature-controllable.

[0015] In exemplary embodiments, the two or more storage areas may be configured to store different types of materials.

[0016] In exemplary embodiments, the storage device may comprise two or more storage areas, wherein at least one of the storage areas may be isolated from the other storage areas and configured to store a biological substance.

[0017] In exemplary embodiments, the storage device may be configured to be expandable, and the release module may be configured to access the expanded storage area.

[0018] In exemplary embodiments, the storage device may be configured in a modular manner so as to be addable without changes to the automated diagnostic testing system.

[0019] In exemplary embodiments, the automated diagnostic testing system may comprise (i) a sample processing unit comprising a plurality of functional devices; (ii) a testing device that receives a processed sample from the sample processing unit and performs a diagnostic test; and (iii) a transfer device that transfers samples and materials between the functional device and the storage device.

[0020] In exemplary embodiments, the local controller periodically may update inventory information of materials stored in the storage device, generate an inventory message, and transmit the inventory message to the main controller.

[0021] In exemplary embodiments, the main controller may generate, based on the updated inventory information, a material replenishment list of materials to be replenished such that an amount of materials greater than an amount of materials used until a next inventory information update time point is stored in the storage device, and the local controller may control the storage device based on information on the material replenishment list received from the main controller.

[0022] In exemplary embodiments, when the next inventory information update time point is changed by a user, the main controller may generate a new material replenishment list based on the changed inventory information update time point, and the local controller may control the storage device based on information on the new material replenishment list received from the main controller.

[0023] In exemplary embodiments, the storage device may be configured to store residual materials received from the functional device.

[0024] In exemplary embodiments, the residual materials received from the functional device may be configured to be stored in a storage area different from a storage area in which the materials were stored before being initially released to the functional device.

[0025] In exemplary embodiments, the storage device may comprise a residual material storage area configured to store the received residual materials without contamination.

[0026] In exemplary embodiments, the main controller may determine, based on identification information of a first sample loaded in the automated diagnostic testing system, a material list of materials to be supplied to the functional device for processing the first sample, and the local controller may control the storage device such that, among materials already supplied to the functional device, materials not listed in the material list are stored in the residual material storage area of the storage device.

[0027] In exemplary embodiments, the storage device may be configured to receive and store a sample from the functional device.

[0028] In exemplary embodiments, the storage area may be configured to accommodate a plurality of trays.

[0029] In exemplary embodiments, the trays may be configured to store a plurality of materials.

[0030] In exemplary embodiments, the storage device may comprise a housing, wherein the release module may be configured to be coupled to the housing.

[0031] In exemplary embodiments, the storage area may comprise a storage module for storing materials, and the storage module may be configured to be movably mounted to the housing.

[0032] In exemplary embodiments, the storage module may be configured to be aligned with respect to the release module when mounted to the housing, such that materials contained in the storage module are transferred by the release module.

[0033] In exemplary embodiments, when the local controller detects mounting of the storage module, the local controller may be configured to transmit, to the main controller, material identification information and / or storage module identification information obtained from the identification information reader, and the main controller may be configured to automatically register materials contained in the storage module and update inventory information based on the material identification information and / or the storage module identification information.

[0034] In exemplary embodiments, the storage device may comprise at least one selected from the group consisting of a decapper, a seal remover unit, a reagent set holder, a tip container opener, and a self-cleaning system.

[0035] In order to achieve the above-described object of the present disclosure, a storage device for an automated diagnostic testing system is provided according to another exemplary embodiments of the present disclosure. The storage device is a storage device for an automated diagnostic testing system, wherein the storage device is configured to supply materials to a functional device of the automated diagnostic testing system, wherein the storage device is spatially separated from the functional device, and wherein the storage device comprises a storage area for storing materials, and an identification information reader for identifying identification information of the materials, wherein the storage area is configured to store unused materials and residual materials received from the functional device.

[0036] In exemplary embodiments, the storage area may comprise an unused material storage area for storing the unused materials and a residual material storage area for storing the residual materials received from the functional device.

[0037] In exemplary embodiments, the storage device may comprise a local controller configured to communicate with a main controller of the automated diagnostic testing system, wherein the local controller may exchange information with the main controller and control the storage device in response to instructions received from the main controller, such that, based on a material list of materials to be supplied to the functional device for processing a first sample, the material list being determined by the main controller based on identification information of the first sample loaded in the automated diagnostic testing system, among materials already supplied to the functional device, materials not listed in the material list are recovered into the storage device.

[0038] In exemplary embodiments, the local controller may control the storage device such that, among materials listed in the material list, excluding materials already supplied to the functional device, the materials are supplied to the functional device.

[0039] In order to achieve the above-described another object of the present disclosure, an automated diagnostic testing system is provided according to exemplary embodiments of the present disclosure. The automated diagnostic testing system comprises (i) a sample processing unit comprising a plurality of functional devices, the sample processing unit being configured to perform sample processing for a diagnostic test of a sample loaded in the automated diagnostic testing system; (ii) one or more storage devices configured to supply materials to the plurality of functional devices, the storage devices being spatially separated from the plurality of functional devices; (iii) a testing device configured to receive a processed sample from the sample processing unit and perform a diagnostic test reaction; (iv) a transfer device configured to transfer samples and materials between the functional devices and the storage devices; and (v) a controller, wherein the controller controls the storage devices such that materials for the diagnostic test of the loaded sample are supplied to a functional device that processes the loaded sample.

[0040] In exemplary embodiments, the one or more storage devices may comprise a functionally compatible material release interface.

[0041] In exemplary embodiments, the controller may determine, based on identification information of the loaded sample, materials to be supplied to each of at least two functional devices, and control the one or more storage devices such that the determined materials are supplied to the at least two functional devices.

[0042] In exemplary embodiments, the one or more storage devices may be configured to be non-integrated with any of the plurality of functional devices.

[0043] In exemplary embodiments, the controller periodically may update inventory information of materials stored in the storage devices and generate an inventory message.

[0044] In exemplary embodiments, the controller may generate, based on the updated inventory information, a material replenishment list of materials to be replenished such that an amount of materials greater than an amount of materials used until a next inventory information update time point is stored in the storage devices.

[0045] In exemplary embodiments, when the next inventory information update time point is changed by a user, the controller may generate a new material replenishment list based on the changed inventory information update time point.

[0046] In exemplary embodiments, at least one of the one or more storage devices may comprise (i) a housing; (ii) a storage module configured to store materials and configured to be movably mounted to the housing; and (iii) an identification information reader for identifying material identification information and / or storage module identification information.

[0047] In exemplary embodiments, when the controller detects mounting of the storage module, the controller may be configured to automatically register materials contained in the storage module and update inventory information based on material identification information and / or storage module identification information obtained from the identification information reader.

[0048] In exemplary embodiments, the sample processing unit may comprise a first functional device and a second functional device, and the first functional device and the second functional device may be configured to perform different steps of sample processing.

[0049] In exemplary embodiments, the one or more storage devices may comprise a first storage device and a second storage device, wherein the first storage device may supply materials to the first functional device, and wherein the second storage device may supply materials to the second functional device.

[0050] In exemplary embodiments, the sample processing unit may comprise two or more first functional devices, and the first storage device may be configured to supply materials to the two or more first functional devices.

[0051] In exemplary embodiments, the first storage device may be configured to supply different materials to the two or more first functional devices.

[0052] In exemplary embodiments, the one or more storage devices may comprise a third storage device, and wherein the third storage device may be configured to supply materials to the first functional device and the second functional device.

[0053] In exemplary embodiments, the one or more storage devices may comprise a fourth storage device and a fifth storage device, and wherein the fourth storage device and the fifth storage device may be configured to supply materials to the first functional device.

[0054] In exemplary embodiments, the storage devices may be configured to receive and store residual materials from the functional devices.

[0055] In exemplary embodiments, the controller may determines, based on identification information of a first sample loaded in the automated diagnostic testing system, a material list of materials to be supplied to the functional device for processing the first sample, and control the storage devices such that, among materials already supplied to the functional device, materials not listed in the material list are recovered into the storage devices.

[0056] In exemplary embodiments, the controller may control the storage devices such that, among materials listed in the material list, excluding materials already supplied to the functional device, are supplied to the functional device.

[0057] In exemplary embodiments, the storage devices may be configured to receive and store samples from the functional devices.

[0058] In exemplary embodiments, the transfer device may comprise a material transfer module and a sample transfer module.

[0059] In exemplary embodiments, the materials may comprise consumables or reagents.

[0060] In exemplary embodiments, the storage devices may be configured to be replaceable with other storage devices having different shapes or structures.

[0061] In exemplary embodiments, the automated diagnostic testing system may be an expandable system configured to add one or more storage devices without changes to the system.

[0062]

[0063] The storage device according to exemplary embodiments of the present disclosure is spatially separated from a functional device, and thus the storage device can supply materials to a plurality of functional devices. Accordingly, a need for an operator to directly access each functional device to replenish materials is reduced, thereby reducing manpower dependency of the automated diagnostic testing system and enabling an operation suitable for unattended operation.

[0064] The storage device according to exemplary embodiments of the present disclosure may selectively supply, to each functional device, materials required based on information on a sample loaded in a testing system. Accordingly, the automated diagnostic testing system is not limited to automatically performing a single predetermined test, but may automatically perform various tests on various samples without intervention of an operator.

[0065] The storage device according to exemplary embodiments of the present disclosure is spatially separated from a functional device, and thus can store sufficient materials for operating the automated diagnostic testing system for a long time. In addition, since the storage device is connected to the automated diagnostic testing system in a modular manner, flexible operation is possible by replacing the storage device with another storage device having a different shape and size according to the situation of a laboratory. In other words, the automated diagnostic testing system according to exemplary embodiments of the present disclosure is an expandable system capable of adding or changing one or more storage devices without changes to the system. Accordingly, the system can be flexibly configured according to changes in the environment.

[0066] A conventional automation system stores reagents and consumables by providing a limited storage space inside a functional device, and thus a user has to intervene periodically. The storage device according to exemplary embodiments of the present disclosure is spatially separated from a functional device, and thus can be continuously automatically operated for a long period of time and is suitable for operation of an unattended laboratory.

[0067] The storage device according to exemplary embodiments of the present disclosure may include a residual material storage area. Accordingly, materials arranged in a functional device may be automatically replaced according to a sample, and residual materials may be recovered and reused. This can optimize utilization of reagents and consumables and can enable operation of an unattended laboratory.

[0068] The storage device according to exemplary embodiments of the present disclosure may include a sample storage area. Accordingly, a sample for which a test has been completed can be safely stored even in an unattended operation environment, and can be utilized for post-analytical verification or retesting if necessary.

[0069] However, effects of the present disclosure are not limited to the above-described effects, and may be variously expanded without departing from the spirit and scope of the present disclosure.

[0070]

[0071] FIG. 1 is a perspective view illustrating an automated diagnostic testing system according to exemplary embodiments of the present disclosure.

[0072] FIG. 2 is a plan view for describing an automated diagnostic testing system according to exemplary embodiments of the present disclosure.

[0073] FIG. 3 is a plan view for describing a storage device according to exemplary embodiments of the present disclosure.

[0074] FIG. 4 is a plan view for describing an automated diagnostic testing system according to other exemplary embodiments of the present disclosure.

[0075] FIG. 5 is a plan view for describing an operation of a storage device according to exemplary embodiments of the present disclosure.

[0076] FIG. 6 is a plan view for describing an operation of a storage device according to other exemplary embodiments of the present disclosure.

[0077] FIG. 7 is a plan view for describing an operation of a storage device according to still other exemplary embodiments of the present disclosure.

[0078] FIG. 8 is a plan view for describing an operation of a storage device according to still other exemplary embodiments of the present disclosure.

[0079] FIG. 9 is a block diagram illustrating a controller included in an automated diagnostic testing system according to exemplary embodiments of the present disclosure.

[0080] FIG. 10 is a plan view for describing expansion of a storage device according to exemplary embodiments of the present disclosure.

[0081] FIG. 11 is a flowchart for describing a process of rearranging materials of a functional device according to a type of a loaded sample, according to exemplary embodiments of the present disclosure.

[0082] FIG. 12 is a block diagram illustrating a communication relationship between a main controller and a local controller according to exemplary embodiments of the present disclosure.

[0083] FIG. 13 is a perspective view illustrating an arrangement structure of a housing, a storage module, and a tray of a storage device according to exemplary embodiments of the present disclosure.

[0084]

[0085] Hereinafter, with reference to the accompanying drawings, a fully automated diagnostic testing system according to exemplary embodiments of the present disclosure will be described in detail. In the accompanying drawings, the same or similar components are denoted by the same or similar reference numerals.

[0086] In the present specification, specific structural and / or functional descriptions are illustrated only for the purpose of describing embodiments of the present disclosure, and embodiments of the present disclosure may be implemented in various forms and are not construed as being limited to the embodiments described in the present specification, and it should be understood that the present disclosure includes all modifications, equivalents, and / or alternatives falling within the spirit and scope of the present disclosure. When it is described that any component is "connected to" or "in contact with" another component, it should be understood that any component may be directly connected to or in contact with another component, or one or more intervening components may be present therebetween. In addition, when it is described that any component is "directly connected to" or "directly in contact with" another component, it may be understood that no other component exists therebetween. Other expressions describing relationships between components, for example, "between" and "directly between" or "adjacent to" and "directly adjacent to," may be interpreted similarly.

[0087] Terms used in the present specification are used only to describe exemplary embodiments and are not intended to limit the present disclosure. A singular expression includes the plural unless the context clearly indicates otherwise. In the present specification, terms such as "include," "comprise," or "have" are intended to specify that features, numbers, steps, operations, components, parts, or combinations thereof are present, and should be understood not to exclude the presence or addition possibility of one or more other features, numbers, steps, operations, components, parts, or combinations thereof. Unless otherwise defined, all terms used herein including technical and scientific terms have the same meaning as commonly understood by a person having ordinary skill in the art to which the present disclosure belongs.

[0088] Terms such as those defined in generally used dictionaries should be interpreted as having meanings consistent with their meanings in the context of the related art, and unless explicitly defined in the present application, they are not interpreted in an idealized or overly formal sense.

[0089] Terms such as first, second, and third may be used to describe various components, but the components are not limited by the terms. The terms are used for the purpose of distinguishing one component from another component. For example, without departing from the scope of the present disclosure, a first component may be named a second component or a third component, and similarly, a second component or a third component may be interchangeably named.

[0090]

[0091] In the present specification, an "automated diagnostic testing system" may mean a system configured to automatically perform at least a part of a series of processes from loading of a sample to pretreatment, sample processing, target detection, result generation, and / or storage in order to perform a diagnostic test on the sample. The automated diagnostic testing system may include one or more functional devices 310, a testing device 500, a transfer device 400, and a controller 800, and may include a storage device 20 for storing and supplying reagents 740 and consumables 730. In addition, the automated diagnostic testing system may be configured to minimize user intervention, and may be configured to selectively supply required materials 700 and schedule operations of devices based on sample identification information and / or test protocol information.

[0092] A "diagnostic test" performed by the automated diagnostic testing system may be implemented in various ways depending on an application field and a purpose. For example, the diagnostic test may include molecular diagnostic testing (e.g., PCR, RT-PCR, isothermal amplification, nucleic acid hybridization-based detection, etc.), immunodiagnostic testing (e.g., qualitative / quantitative analysis using an antigen-antibody reaction, immunofluorescence, immunoluminescence, ELISA-based analysis, etc.), biochemical testing (e.g., enzyme reaction-based analysis, substrate / metabolite analysis, etc.), hematological testing (e.g., blood cell analysis, coagulation analysis, etc.), microbiological testing (e.g., culture and identification, antibiotic susceptibility analysis, etc.), or a combination thereof, and is not limited thereto.

[0093] Molecular diagnostic testing refers to a testing method of identifying genes, proteins, or other molecules that may be an indication of a specific disease or condition in a sample using a molecular biological technique. In other words, molecular diagnostic testing refers to acquiring desired information by applying molecular biological techniques to analyze genetic information contained in a sample or a biological marker contained in a protein. A biological marker means a target analyte, and for example, may be a target nucleic acid sequence or an amino acid sequence. The desired information may be information on the presence, absence, or an amount of the biological marker.

[0094] Immunodiagnostic testing refers to a testing method of identifying an analyte that may be an indication of a specific disease or condition in a sample by using a specific binding reaction between an antigen and an antibody. In other words, immunodiagnostic testing refers to acquiring desired information by applying a detection technology combined with an antigen-antibody reaction to analyze a protein, peptide, hormone, antigen, antibody, or other immunological marker contained in a sample. An immunological marker means a target analyte, and for example, may be a pathogen-derived antigen, a patient-derived antibody, a cytokine, a tumor marker, or a specific protein. The desired information may be information on the presence, absence, or an amount of the immunological marker, and detection may be performed based on, for example, fluorescence, luminescence, absorbance (colorimetry), an electrochemical signal, or a particle agglutination signal.

[0095] Biochemical testing refers to a testing method of obtaining information on a disease or a physiological state by measuring a specific chemical component or a biochemical reaction in a sample. In other words, biochemical testing refers to acquiring desired information by applying a measurement technique combined with a chemical reaction or an enzyme reaction to analyze a metabolite, electrolyte, substrate, enzyme activity, lipid, sugar, or other chemical and / or biochemical marker contained in a sample. A biochemical marker means a target analyte, and for example, may be glucose, cholesterol, creatinine, urea nitrogen, a liver enzyme (AST / ALT, etc.), an electrolyte (Na+, K+, etc.), or a pH-related component. The desired information may be information on a concentration, activity, rate of change, or deviation from a reference range of the marker, and measurement may be performed by, for example, absorbance / reflectance-based optical measurement, fluorescence / luminescence measurement, electrochemical measurement, or titration / ion-selective electrode measurement.

[0096] Hematological testing refers to a testing method of obtaining information on a disease or a physiological state by measuring blood cell components and related indices in blood or a blood-derived sample. In other words, hematological testing refers to acquiring desired information by analyzing a number, size, distribution, and / or morphological characteristics of a blood cell component such as a red blood cell, a white blood cell, and a platelet contained in a sample, or by measuring a hematological marker such as hemoglobin. A hematological marker may be, for example, a white blood cell differential, a red blood cell index (MCV, MCH, etc.), a platelet index, a reticulocyte, or a hemoglobin concentration. The desired information may be information on the presence, absence, a numerical value (e.g., a cell count or a concentration), a fraction ratio, or presence or absence of a morphological abnormality of the marker, and measurement may be performed based on, for example, electrical impedance, flow cytometry (scattered light / fluorescence), image-based analysis, or a chemical staining reaction.

[0097] Microbiological testing refers to a testing method of obtaining information on infection and a causative organism by confirming presence or absence of a microorganism (e.g., bacteria, fungi, etc.) in a sample, or by evaluating identification and / or antimicrobial susceptibility. In other words, microbiological testing refers to acquiring desired information by culturing a microorganism from a sample to observe growth characteristics, or by identifying the microorganism using a biochemical reaction pattern, an immunological reaction, or physical and / or chemical characteristics. A microbiological marker may be, for example, growth (colony formation) of a specific microorganism, a metabolic reaction pattern, a surface antigen, an enzyme activity, or a specific community characteristic. The desired information may be information on the presence, absence, an identification result (species / genus), or susceptibility / resistance to an antimicrobial agent, and analysis may be performed by, for example, culture-based measurement, turbidity / color change measurement, immunological detection, spectroscopic analysis such as MALDI-TOF, or other identification techniques.

[0098] A sample refers to a substance that includes or is presumed to include an analyte. The sample includes a biological sample (e.g., cells, tissues, and bodily fluids from a biological source) and a non-biological sample (e.g., food, water, and soil). The biological sample may include, but is not limited to, a virus, bacteria, tissue, cells, blood (including whole blood, plasma, and serum), lymph, bone marrow fluid, sputum, a swab, aspiration, bronchial lavage fluid, bronchoalveolar lavage fluid, nasal lavage fluid, milk, urine, feces, ocular fluid, saliva, semen, a brain extract, cerebrospinal fluid (CSF), synovial fluid, appendix, spleen and tonsil tissue extract, amniotic fluid, and ascites. In addition, the sample may include naturally occurring nucleic acid molecules and synthetic nucleic acid molecules isolated from a biological source. In one embodiment, the sample may include materials used for storage, processing, detection, and the like of the sample. The sample may include, but is not limited to, an amplification reagent, a detection reagent, a preservative, water, deionized water, saline, a pH buffer, an acidic solution, and an alkaline solution. In addition, pretreatment, dispensing, mixing, washing, separation, concentration, reaction, and detection processes of the sample may be variously changed according to a testing method.

[0099] Hereinafter, in order to help understanding of the present disclosure, a fully automated molecular diagnostic testing system, which is one of various implementation forms of an automated diagnostic testing system, will be described as an exemplary embodiment with focus on respective configurations and operations. However, this is for convenience of description, and the technical spirit of the present disclosure is not limited to a molecular diagnostic testing system and may be equally applied to the automated diagnostic testing system defined above.

[0100]

[0101]

[0102] Automated diagnostic testing system

[0103] According to one aspect of the present disclosure, an automated diagnostic testing system including the following is provided: (i) a sample processing unit 300 comprising a plurality of functional devices 310, the sample processing unit 300 being configured to perform sample processing for a diagnostic test of a sample loaded in the automated diagnostic testing system; (ii) one or more storage devices 20 configured to supply materials 700 to the plurality of functional devices 310, the storage devices 20 being spatially separated from the plurality of functional devices 310; (iii) a testing device 500 configured to receive a processed sample 610 from the sample processing unit 300 and perform a diagnostic test reaction; (iv) a transfer device 400 configured to transfer samples 600 and materials 700 between the functional devices 310 and the storage devices 20; and (v) a controller 800, wherein the controller 800 controls the storage devices 20 such that materials 700 for the diagnostic test of the loaded sample are supplied to a functional device 310 that processes the loaded sample.

[0104] FIG. 1 is a perspective view illustrating an automated diagnostic testing system according to exemplary embodiments of the present disclosure. FIG. 2 is a plan view for describing an automated diagnostic testing system according to exemplary embodiments of the present disclosure. For example, the automated diagnostic testing system may implement an automated diagnostic testing system capable of automatically performing various tests while minimizing intervention of an operator. In the automated diagnostic testing system, a first direction D1, a second direction D2, a third direction D3, a fourth direction D4, and a fifth direction D5 may be defined. For example, the first direction D1 and the second direction D2 are substantially opposite directions to each other, and the third direction D3 and the fourth direction D4 are substantially opposite directions to each other. In addition, the first and second directions D1 and D2 may cross the third and fourth directions D3 and D4, and may be substantially orthogonal thereto. Further, the fifth direction D5 may be a direction substantially perpendicular to the first to fourth directions D1, D2, D3, and D4.

[0105] Referring to FIGS. 1 and 2, the automated diagnostic testing system may include a sample processing unit 300, a transfer device 400, a testing device 500, and a controller 800. In addition, the automated diagnostic testing system may include a storage device 20. The sample processing unit 300 may perform sample processing for a diagnostic test of a sample loaded in the automated diagnostic testing system 10. The sample processing unit 300 may include a plurality of functional devices 310. The testing device 500 is a device in which a test for a sample 600 processed in the sample processing unit 300 is performed. The test may include at least one of molecular diagnostic testing, immunodiagnostic testing, biochemical testing, hematological testing, or microbiological testing, but is not limited thereto. Specifically, the test may be molecular diagnostic testing. The storage device 20 may supply materials 700 to the plurality of functional devices 310. The transfer device 400 may transfer samples 600 and materials 700 between the functional devices 310 and the storage device 20. Specifically, the transfer device 400 may transfer samples 600 and materials 700 between the functional devices 310, the storage device 20, and the testing device 500.

[0106] The sample processing unit 300 may perform sample processing for a diagnostic test of a sample loaded in the automated diagnostic testing system 10.

[0107] The sample processing unit 300 may include a plurality of functional devices 310. The functional device 310 may mean a device that performs a preparation function for performing a diagnostic test, such as sample pretreatment, dispensing, mixing, reaction, washing, separation, concentration, and / or preparation for detection, and the like, and two or more functional devices 310 may be included. Examples of the functional device 310 may include a sample dispensing device, a mixing device, a nucleic acid extraction device, a washing device, a reagent dispensing device, a reaction incubator, a centrifugation device, a filtration device, a magnetic separation device, and a loading device for the testing device 500. The plurality of functional devices 310 may process the sample 600 so that a diagnostic test reaction can be performed in the testing device 500 and may provide the processed sample 610. The functional device 310 may be, for example, an extraction device that extracts and purifies a target analyte such as nucleic acid. The functional device 310 may be, for example, a diagnostic test setup device that prepares a mixture of a reaction reagent and a processed sample so that a test reaction can proceed in the testing device 500. The functional device 310 may be, for example, a pretreatment device that performs a pretreatment process such as removing solids of the sample 600 or concentrating the sample 600 before extracting and purifying the target analyte from the sample 600. The functional device 310 may be, for example, a dispensing device that performs a process of transferring a predetermined amount of a sample into a standard tube so that samples loaded in various containers can be handled in the automated diagnostic testing system.

[0108] The functional device 310 may include a sample interface 315A for exchanging a sample 600 with the transfer device 400. The transfer device 400 may place the sample 600 at the sample interface 315A. A moving unit 316 of the functional device 310 may carry the sample 600 positioned at the sample interface 315A to a specific location within the functional device 310 to perform sample processing. When sample processing is completed in the functional device 310, the moving unit 316 may place the processed sample at the sample interface 315A, and the transfer device 400 may transport the processed sample to a next functional device 310. Alternatively, the transfer device 400 may transport the processed sample to the testing device 500. The sample interface 315A may be a location at which the sample 600 is first positioned in the functional device 310. The sample interface 315A may be formed at a position accessible to the transfer device 400 or the moving unit 316 of the functional device 310.

[0109] The functional device 310 may include a material interface 315B for receiving, from the transfer device 400, materials 700 required for sample processing. The moving unit 316 of the functional device 310 may carry materials located at the material interface 315B to a specific position within the functional device 310 and may use the materials for sample processing. The material interface 315B may be formed at a position accessible to the transfer device 400 or the moving unit 316 of the functional device 310.

[0110] The functional device 310 may include the moving unit 316 therein. The moving unit 316 may be configured to transfer samples 600 and materials 700 within the functional device 310. The moving unit 316 may transport various testing materials such as a sample tube, a reagent container, and a tip to a specific position within the functional device 310, so that a diagnostic testing process can smoothly proceed. For example, the moving unit 316 may be an articulated robot unit or an orthogonally movable gripper.

[0111] The testing device 500 is a device in which a test for a sample 600 processed in the sample processing unit 300 is performed. The testing device 500 may be implemented in various forms according to various diagnostic methods. For example, the testing device 500 may include a molecular diagnostic device, an immunodiagnostic device, and a clinical chemistry diagnostic device. For example, the testing device 500 may be a PCR testing device, an RT-PCR testing device, an NGS device, an ELISA-based diagnostic device, an immunofluorescence analysis device, an electrochemical immunodiagnostic device, a blood biochemical analyzer, a blood gas analyzer, or an immunochemical biochemical analyzer. The testing device may also include an interface 315. At the interface 315 of the testing device, a processed sample prepared for testing, a test reagent, or a mixture thereof may be positioned by the transfer device 400.

[0112] The transfer device 400 may transfer samples 600 and materials 700 between the functional devices 310 and the storage device 20. Alternatively, the transfer device 400 may be configured to transfer samples 600 and materials 700 between the functional devices 310, the storage device 20, and the testing device 500. The transfer device 400 is a device for moving samples and / or materials between the functional devices 310, the storage device 20, and the testing device 500. The transfer device 400 may include a robot arm, a gantry robot, a conveyor, a linear motor track, a shuttle, a rotary table, an elevator, or a combination thereof. The transfer device 400 may include a transfer module 410. The transfer module 410 may transfer materials 700 and / or samples 600. The transfer module 410 may be a material transfer module 411 or a sample transfer module 412. Alternatively, one transfer module 410 may be configured to transfer both materials 700 and samples 600. Alternatively, according to one embodiment, the transfer device 400 may include a material transfer module 411 and a sample transfer module 412.

[0113] The sample transfer module 412 may be configured to transfer samples 600. The sample transfer module 412 may transfer a sample 600 from one functional device 310 to another functional device 310, or may transfer a sample 600 from the functional device 310 to the testing device 500. The material transfer module 411 may be configured to transfer materials700. The material transfer module 411 may transfer materials 700 between the storage device 20 and the functional device 310.

[0114] The transfer module 410 may include a gripper-type carrier and a driving mechanism that moves the carrier to the functional devices 310, the storage device 20, and the testing device 500. Alternatively, the transfer module 410 may include a pallet-type carrier and a conveyor that moves the carrier to the functional devices 310, the storage device 20, and the testing device 500.

[0115] The transfer device 400 may include a transport module 430. The transport module 430 may be disposed adjacent to each functional device 310 or the testing device 500. The transport module 430 may deliver a sample 600 or material 700 delivered by the transfer module 410 to a position accessible to the functional device 310. The transport module 430 may deliver a sample 600 to a position at which the testing device 500 can receive the sample 600. According to one embodiment, the transport module 430 may deliver a sample 600 or material 700 to the interface 315, 315A, or 315B. For example, the transport module 430 may be an articulated robot unit or an orthogonally movable gripper.

[0116] The transfer device 400 may include a communicable station 440. The communicable station 440 may be disposed adjacent to each transport module 430. For example, the transport module 430 may be disposed between the functional device 310 and the communicable station 440, and the communicable station 440 may be disposed between the transfer module 410 and the transport module 430. The communicable station 440 may control delivery of a sample or material between the transfer module 410 and the transport module 430 so as to be smoothly performed. The communicable station 440 may include an area in which a sample or material can be temporarily placed. The area in which the sample or material can be temporarily placed may be defined as an input area 450 and / or an output area 460. The communicable station 440 may include a sensor 441 capable of sensing whether a sample or material is placed in the area. According to one embodiment, the sensor 441 may sense identification information of the sample or material. For example, the sensor 441 may include a character recognition sensor that detects a QR code or a barcode, a weight detection sensor that detects weight, a laser detection sensor that detects an object, and the like.

[0117] The input area 450 may be an area in which a sample 600 or material 700 transferred for loading into the functional device 310 or the testing device 500 is located. The transfer module 410 may transfer a sample or material and place the sample or material in the input area 450, and when the sensor 441 senses the placement, the transport module 430 in charge of the corresponding functional device 310 or testing device 500 may load the sample 600 or material 700 located in the input area 450 into the functional device 310 or the testing device 500. The output area 460 may be an area in which a sample processed in the functional device 310 or a sample for which a test is completed is located. The transport module 430 may transfer the processed sample or the sample for which a test is completed and place the sample in the output area 460, and the sensor 441 senses this, and the transfer module 410 may transfer the sample located in the output area 460. According to identification information of a sample located in the output area 460 sensed by the sensor 441, the transfer module 410 may transfer the sample located in the output area 460 to a predetermined device or place. A processed sample from the functional device 310 may be transferred to another functional device 310 for subsequent processing, or may be transferred to the testing device 500 for testing. According to one embodiment, a processed sample from the functional device 310 may be transferred to the storage device 20 for storage. A sample for which testing is completed from the testing device 500 may be transferred to a disposal unit (not shown) for disposal.

[0118] According to one embodiment, the transport module 430 may place a residual material (a reagent or a consumable) from the functional device 310 in the output area 460. When the functional device 310 replaces materials for performing a different type of function, or when the functional device 310 processes all samples using the residual material, the residual material may be stored in the storage device 20 without contamination. For this, the transport module 430 may place residual material (a reagent or a consumable) from the functional device 310 in the output area 460. Referring to FIG. 3, the residual material 710 located in the output area 460 may be transferred to the storage device 20 by the transfer module 410 and stored in the residual material storage area 2130.

[0119] According to one embodiment, the transfer device 400 may include an identification device 470. The identification device 470 may move together with the transfer module 410. The identification device 470 may recognize a sample or material loaded in the transfer module 410 so that the loaded sample or material can be transferred to a correct device or area. The identification device 470 may be a character recognition sensor that detects a QR code or a barcode.

[0120] According to one embodiment, at least one of one or more storage devices 20 of the automated diagnostic testing system may include: (i) a housing 2400; (ii) a storage module 2410 configured to store materials 700 and configured to be movably mounted to the housing 2400; and (iii) an identification information reader 2200 for identifying material identification information and / or storage module identification information. According to one embodiment, when the controller 800 detects mounting of the storage module 2410, the controller 800 may be configured to automatically register materials contained in the storage module 2410 and update inventory information based on material identification information and / or storage module identification information obtained from the identification information reader 2200. The housing 2400 may be a structure that supports and protects internal components of the storage device 20. The storage module 2410 is a module for accommodating and storing materials 700 or samples 600 in the storage device 20. The storage module 2410 may be detachably mounted to the housing 2400 so that replacement or addition is possible. When the controller 800 determines that the storage module 2410 is mounted, the controller 800 may read storage module identification information and / or material identification information of materials 700 contained in the storage module 2410 through the identification information reader 2200, and may be configured to automatically register a type, quantity, location, and / or expiration date of materials contained in the storage module 2410 based on the read information, and update inventory information. The specific structure and arrangement of the housing 2400, the storage module 2410, and the identification information reader 2200, a method of movably mounting the storage module 2410, and a method of reading reading identification information will be described in more detail in the description of the storage device below.

[0121] The controller 800 controls the sample processing unit 300, the storage device 20, the testing device 500, and the transfer device 400 of the automated diagnostic testing system 10. The controller 800 refers to any device, system, or a part thereof that controls at least one operation. The controller 800 may be implemented as hardware, firmware, or software, or a combination of at least two thereof. FIG. 9 is a block diagram illustrating a controller included in an automated diagnostic testing system according to exemplary embodiments of the present disclosure. FIG. 12 is a block diagram illustrating a communication relationship between a main controller and a local controller according to exemplary embodiments of the present disclosure. The controller 800 may control each functional device 310 of the sample processing unit 300 to process a sample. The controller 800 may control the transfer module 410 of the transfer device 400 to transfer samples and materials. The controller 800 may control the transport module 430 of the transfer device 400 to deliver a sample or material delivered by the transfer device 400 to the functional device 310 or the testing device 500. The controller 800 may control the transport module 430 of the transfer device 400 to deliver a sample or material delivered from the functional device 310 or the testing device 500 to the transfer module 410. The controller 800 may receive a signal from the sensor 441 of the communicable station 440 of the transfer device 400, and may control the transfer module 410 or the transport module 430 to transfer a sample or material located in the communicable station 440. The controller 800 may control the storage device 20 such that materials for a diagnostic test of a sample loaded in the automated diagnostic testing system 10 are supplied to the functional device 310 that processes the loaded sample.

[0122] The controller 800 may also control the storage area 2100 of the storage device 20 as shown in FIG. 9. The controller 800 may control temperature and / or humidity of the storage device 20 to be maintained at a constant state. The controller 800 may control the identification information reader 2200 of the storage device 20. The controller 800 may control the identification information reader 2200 to recognize identification information of materials and samples carried into and / or released from the storage device 20. The controller 800 may control the recognized identification information to be delivered to the controller 800. The controller 800 may control the material release interface 2300 of the storage device 20. When materials are located at the material release interface 2300, the controller 800 may control the material release interface 2300 to deliver information thereof to the controller 800. The controller 800 may control the transport module 430 to pick up the materials 700 located at the material release interface 2300 and transport the materials to a desired functional device 310. The controller 800 may control the release module 2500 of the storage device 20. The controller 800 may control the release module 2500 to find materials 700 to be supplied to the functional device 310 in the storage area 2100 and transfer the materials to the material release interface 2300. The controller 800 may control the storage device accessory 900 of the storage device 20. The controller 800 may control the storage device accessory 900 such that a decapper that handles a cap of a tube and the like in order to use a reagent or consumable, a seal remover unit that removes a seal of a reagent cartridge and the like, and a tip container opener that makes a tip box and the like usable operate.

[0123] According to another embodiment, the controller 800 may include a main controller 810 and a local controller 820. As shown in FIG. 12, the main controller 810 may control components of the functional device 310 of the sample processing unit 300, the transfer device 400, and the testing device 500, excluding the storage device 20. The local controller 820 communicates with the main controller 810 to transmit and receive necessary information, and may control components of the storage device 20, including the storage area 2100, the identification information reader 2200, the material release interface 2300, the release module 2500, and the storage device accessory 900. According to one embodiment, the storage device 20 may include a local controller 820 configured to communicate with the main controller 810 of the automated diagnostic testing system, and the local controller 820 exchanges information with the main controller 810 and controls the storage device 20 in response to instructions received from the main controller 810, such that materials for the loaded sample, determined based on identification information of the sample loaded in the automated diagnostic testing system 10, are supplied to the functional device 310.

[0124]

[0125] Storage device

[0126] According to one aspect of the present disclosure, there is provided a storage device for an automated diagnostic testing system, wherein the storage device is configured to supply materials to a functional device of the automated diagnostic testing system, wherein the storage device is spatially separated from the functional device, and wherein the storage device includes at least one storage area for storing materials, a material release interface configured to interact with a transfer device of the automated diagnostic testing system, and a local controller configured to communicate with a main controller of the automated diagnostic testing system, wherein the local controller exchanges information with the main controller and controls the storage device in response to instructions received from the main controller, such that materials for a loaded sample, determined based on identification information of the sample loaded in the automated diagnostic testing system, are supplied to the functional device.

[0127] FIG. 3 is a plan view for describing a storage device according to exemplary embodiments of the present disclosure. FIGS. 5 to 8 are plan views for describing operation of a storage device according to exemplary embodiments of the present disclosure. FIG. 13 is a conceptual diagram of a storage device including a storage module configured to accommodate a plurality of trays according to exemplary embodiments of the present disclosure.

[0128] The storage device 20 is configured to supply materials 700 to the functional device 310 of the automated diagnostic testing system 10. The storage device 20 according to one embodiment of the present disclosure may be spatially separated from the functional device 310. In other words, the storage device 20 may be configured to be non-integrated with any functional device 310 included in the automated diagnostic testing system 10. The storage device 20 performs a role of supplying materials 700 required for the functional device 310, but may be designed not to be configured integrally with the functional device 310 and to be disposed in a separate independent space. That is, the storage device 20 does not exist as an internal module directly connected to the functional device 310, but may be disposed at a position separated from the functional device 310 by a predetermined distance or more, and may include a separate frame, cabinet, or independent structure. The storage device 20 may be installed in the same work space as the functional device 310, or may be installed as a separate zone or an external device separated from a main body of the automated diagnostic testing system 10 by a predetermined distance, in consideration of overall space utilization of the automated diagnostic testing system 10. Accordingly, when the automated diagnostic testing system 10 is installed in a limited space, arrangement flexibility can be maximized. In addition, when the storage device 20 is spatially separated from the functional device 310, reagents and consumables can be replenished independently in the storage device 20 even while a specific operation is performed in the functional device 310, and continuous operation is possible without stopping operation of the functional device 310. When the storage device 20 is spatially separated from the functional device 310, the sample processing unit 300 and the testing device 500 may be operated together or respectively in a state isolated from the outside, and an operator's access to the sample processing unit 300 and the testing device 500 can be minimized. Minimizing an operator's access to the sample processing unit 300 is desirable not only in terms of preventing contamination of the sample but also in terms of safety of the operator.

[0129] The storage device 20 includes the storage area 2100 for storing materials. The storage area 2100 is an area that stores materials 700. The storage area 2100 may be formed such that materials 700 stored therein are easily identified and transferred to enable efficient preservation of the materials 700 and rapid transfer of the materials 700 to a determined functional device under instructions of the controller 800 or under control of the local controller 820 performed in response to instructions received from the main controller 810.

[0130] The materials 700 may refer to items required for the automated diagnostic testing system 10 to process and test a sample. The materials 700 may include consumables 730 and reagents 740. The consumables 730 may be, for example, a tubes for sample processing or a pipette tips. The reagents 740 may be, for example, a pretreatment reagent, an extraction reagent, or a PCR reaction reagent. The pretreatment reagent may be used in a pretreatment device among the functional devices 310, the extraction reagent may be used in an extraction device among the functional devices 310, and a diagnostic reagent may be used in a diagnostic setup device among the functional devices 310. In addition, types of the pretreatment reagent, the extraction reagent, and the diagnostic reagent may vary depending on a type of a sample and a type of a test. The storage device 20 of the automated diagnostic testing system 10 according to one embodiment of the present disclosure can store various types of pretreatment reagents, extraction reagents, and diagnostic reagents, and supplies, to each functional device, materials determined by the controller 800 based on identification information of a sample loaded in the automated diagnostic testing system 10.

[0131] According to one embodiment, the storage device 20 may include two or more storage areas independently temperature-controllable. According to one embodiment, the storage device 20 may include two or more storage areas 2100, and at least one of the two or more storage areas 2100 may be configured to be independently temperature-controllable. Here, the two or more storage areas 2100 may mean a plurality of storage spaces partitioned from each other to store materials 700 in the storage device 20, and each storage area 2100 may be separated from each other by a partition wall, a heat insulating portion, a cover, a door, or a separate chamber structure. According to one embodiment, the two or more storage areas may be configured to store different types of materials. Referring to FIG. 3, the storage device 20 may include the reagent storage area 2110 and the consumable storage area 2120. The consumable storage area 2120 may be an area that stores consumables 730. The consumable storage area 2120 may have temperature controlled to room temperature. The reagent storage area 2110 may be an area that stores reagents 740. The reagent storage area 2110 may have temperature adjusted to match types of stored reagents 740. For example, for refrigerated reagents 740, the reagent storage area 2110 may be controlled to 4 degrees Celsius. Alternatively, for frozen reagents 740, the reagent storage area 2110 may be controlled to -20 degrees Celsius. As shown in FIG. 3, in order to satisfy storage conditions of various reagents, the storage device 20 may include a plurality of reagent storage areas 2110A and 2110B, and these may be independently temperature-controllable. In the present specification, independent temperature control may mean that at least one storage area 2100 can be controlled to maintain a target temperature or temperature range different from that of another storage area 2100. Temperature control may include cooling and / or heating, and for this, the storage area 2100 may include a cooling unit (e.g., a Peltier element, a cooling coil, etc.), a heating unit (e.g., a heater), and an air circulation unit (e.g., a fan, a duct). In addition, each storage area 2100 may include a temperature sensor (e.g., a thermistor, an RTD, etc.), and the local controller 820 or the controller 800 may control the temperature of the storage area 2100 to be maintained at a target value or target range by driving the cooling / heating unit based on temperature information received from the sensor.

[0132] According to one embodiment, the storage area 2100 may be configured to accommodate a plurality of trays 2420. Here, a tray 2420 may mean a carrier or an accommodating part that accommodates materials 700 by loading and aligning the materials 700 in a standardized form, and the tray 2420 may be implemented in a form of a rack, a cassette, a drawer, a magazine, a slot-type holder, or a container, but is not limited thereto. The storage area 2100 may include one or more tray accommodating parts, shelves, slots, rails, guides, or stoppers such that the plurality of trays 2420 are stacked or arranged. For example, the storage area 2100 may include a rail or slide structure such that the tray 2420 is drawable in a horizontal direction, or may include a stacking frame or magazine structure such that the plurality of trays 2420 are stacked in multiple layers in a vertical direction. In addition, according to one embodiment, the tray 2420 may be configured to store a plurality of materials 700. That is, one tray 2420 may include a plurality of accommodating holes (e.g., a holes, a wells, a slots, or a pockets) or partitions to accommodate a plurality of materials 700 of the same type, or may include a plurality of partitions such that different types of materials 700 are stacked together. For example, the tray 2420 may be configured to accommodate a plurality of consumables 730 (e.g., pipette tips, tubes, cartridges, etc.) in a predetermined arrangement, or may be configured to accommodate a plurality of reagents 740 in a predetermined arrangement. A partition structure of the tray 2420 may be varied depending on the shape, specifications, and usage scenario of the materials 700. The tray 2420 may include tray identification information for identification and automatic management of the materials 700. For example, a barcode, a QR code, an RFID tag, or a memory tag may be attached to the tray 2420, and the identification information reader 2200 may read the identification information to confirm information on a type of the tray 2420, a type of materials 700 in the tray 2420, a position, a lot, an expiration date, and / or a remaining amount. The controller 800 may update the arrangement and inventory information of the tray 2420 in the storage area 2100 based on the reading result, and may control the storage device 20 or the release module 2500 to select and release a tray 2420 accommodating required materials 700 according to identification information of a loaded sample 600 and a test protocol.

[0133] According to one embodiment, the storage device 20 may include a housing 2400. The housing 2400 may mean a structure that forms an outer shape of the storage device 20 and supports and protects internal components. For example, referring to FIG. 13, the housing 2400 may provide an internal space to accommodate the storage module 2410, the release module 2500, the material release interface 2300, and the identification information reader 2200. The housing 2400 may include a guide, a support part, a coupling part, or a fastening part such that these components are arranged at predetermined positions. The housing 2400 may include a door or a cover in order to reduce introduction of dust, impact, and fluid from the outside, and may include a locking part, an opening / closing detection sensor, and / or a user access restriction structure for unattended operation or safe operation. A material of the housing 2400 may be metal, plastic, a composite material, or a combination thereof, and a shape and size of the housing 2400 may be variously changed according to capacity of the storage device 20, an installation environment, and a coupling method. The housing 2400 may include one or more mounting parts (e.g., a rail, a slide, a latch, a hook, or a key-keyhole structure) such that the storage module 2410 is detachably mounted. When the storage module 2410 is mounted to the housing 2400, the housing 2400 may provide a reference surface, a stopper, a tapered guide, an alignment pin, or a magnetic alignment structure such that the storage module 2410 is aligned with respect to the release module 2500 and / or the material release interface 2300.

[0134] According to one embodiment, the storage device 20 may include one or more storage modules 2410. The storage module 2410 is a component for accommodating and storing materials 700 or samples 600 in the storage device 20. According to one embodiment, the storage area 2100 may include the storage module 2410 for storing materials. For example, the reagent storage area 2110, the consumable storage area 2120, and the residual material storage area 2130 may each include a separate storage module 2410. In addition, the storage module 2410 may be configured to be movably mounted to the housing 2400. In other words, the storage module 2410 may be a component detachably mounted to the housing 2400 so that replacement or addition is possible. According to one embodiment, the storage module 2410 may be configured to be aligned with respect to the release module 2500 when mounted to the housing 2400. Alternatively, according to one embodiment, the storage module 2410 may be configured to be aligned with respect to the release module 2500 and the material release interface 2300 when mounted to the housing 2400. Accordingly, materials contained in the storage module 2410 may be transferred by the release module 2500. For example, the storage module 2410 may include a corresponding structure that engages with a guide rail, a key-keyhole, a tapered guide, a stopper, or an alignment pin of the housing 2400, and at a mounting completion position, a drawing position of the tray 2420 or the materials 700 may be arranged to match or correspond to an access path of the release module 2500 and / or a delivery path of the material release interface 2300.

[0135] In addition, the storage module 2410 may include module identification information. For example, the storage module 2410 may provide storage module identification information by including a barcode, a QR code, an RFID, or a memory tag and / or the like, and may be configured such that the identification information reader 2200 reads the storage module identification information and / or material identification information of materials 700 contained in the storage module 2410. The controller 800 may automatically register information on a type, a lot, an expiration date, a remaining amount, and / or storage conditions of materials accommodated in the storage module 2410, or may update inventory information based on the read identification information. According to one embodiment, when the local controller 820 detects mounting of the storage module 2410, the local controller 820 is configured to transmit, to the main controller 810, material identification information and / or storage module identification information obtained from the identification information reader 2200, and the main controller 810 may be configured to automatically register materials contained in the storage module 2410 and update inventory information based on the material identification information and / or the storage module identification information. The storage module 2410 may further include a structure for maintaining storage conditions. For example, the storage module 2410 may include a heat insulating portion, an airtight portion (a gasket), a condensation prevention structure, or a temperature sensor mounting part, and may be coupled with a temperature control configuration of the housing 2400 to allow independent temperature control for each storage area 2100. In addition, the storage module 2410 may include a fixing part, a partition wall, and a support part for preventing the materials from dropping or moving. The storage module 2410 may be entirely integrated, or may be divided into a plurality of sub-modules corresponding to different material groups (e.g., reagents, consumables, residual materials, and samples), and a shape and capacity of the storage module 2410 may be variously changed according to an installation environment, required throughput, and an operation time of the storage device 20.

[0136] According to one embodiment, the storage device 20 may include a release module 2500 configured to transfer materials 700 in the storage area 2100. In the present specification, "release" may refer to an operation of outputting a material or a sample from a storage device to a transfer device and / or a functional device, or moving the material or the sample to a handoff position (for example, a material release interface) such that the transfer device can receive the material or the sample. The release may be an operation involving movement of the material or the sample, and may include an operation of placing or exposing the material or the sample at a position at which the transfer device can receive the material or the sample. The release module 2500 may be configured to transfer materials 700 inside the storage device 20. The release module 2500 transports various materials 700 such as a reagent, a tube, and a tip for sample processing and testing, or a tray 2420 configured to accommodate the materials 700, to a specific position so that the transfer device 400 can transfer the materials 700 to a desired device. For example, the release module 2500 may be an articulated robot unit or a gripper of an orthogonal movement method. The specific position may be the material release interface 2300. According to one embodiment, the release module 2500 may be configured to be coupled to the housing 2400. The release module 2500 may be fixedly disposed inside the housing 2400 or on one side of the housing 2400, and may include a bracket, a fastening part (a bolt / a screw), a rail, a pin coupling, a latch, or an insertion-coupling structure for coupling with the housing 2400. As the release module 2500 is coupled to the housing 2400, the release module 2500 may be aligned to have a predetermined reference position with respect to a placement position of the storage module 2410 and / or the tray 2420. The release module 2500 may be implemented in various structures depending on a shape and a supply method of the materials 700. For example, the release module 2500 may include a pusher that pushes out the tray 2420, a lift that lifts or lowers the tray 2420, a slider that slidably draws out the tray 2420, a gripper that directly grips the materials, a suction / vacuum grip, a rotary arm or link structure, or a combination thereof. The release module 2500 may include one or more driving parts (e.g., a motor, a linear actuator, a solenoid, etc.) and a guide part (e.g., a rail, a guide shaft, etc.), and may be configured to move the materials 700 toward the material release interface 2300 or place the materials 700 at a height and a position accessible by the transfer device 400. The release module 2500 may include a vertical movement axis and sequentially access trays 2420 arranged in multiple layers, and may further include a horizontal movement axis or a rotation axis to correspond to a plurality of tray positions or a plurality of storage modules 2410. Operation of the release module 2500 may be controlled by the controller 800, particularly the local controller 820 of the storage device 20.

[0137] The material release interface 2300 is a component for exchanging materials between the release module 2500 and the transport module 430. The controller 800 controls the storage device 20 such that materials 700 to be supplied to the functional device 310 are released. The release module 2500 may find materials 700 to be supplied to the functional device 310 in the storage area 2100 and transfer the materials to the material release interface 2300. The release module 2500 or the material release interface 2300 may deliver, to the controller 800, a signal indicating that the materials 700 to be supplied to the functional device 310 are located at the material release interface 2300. The controller 800 may control the transport module 430 to pick up the materials 700 located at the material release interface 2300 and transport the materials to a desired functional device 310. According to one embodiment, the storage device 20 may further include the identification information reader 2200. The identification information reader 2200 may be a barcode reader, a QR code reader, or a camera for recognizing identification information, or an RFID reader. The identification information reader 2200 may be configured to read identification information of all materials and samples entering and leaving the storage device 20. The read information may be delivered to the controller 800. Accordingly, the controller 800 can identify, in real time, a type and an amount of materials 700 stored in the storage device 20. In addition, it is possible to monitor whether correct materials 700 are released to the functional device 310.

[0138] According to one embodiment, the material release interface 2300 may be configured to interact with the transfer device 400 of the automated diagnostic testing system. In the present specification, "interaction with the transfer device 400" may refer to an operation in which, to allow the transfer device 400 to take over materials 700 from the storage device 20 or to allow the storage device 20 to hand over materials 700 to the transfer device 400, the material release interface 2300 provides the materials 700 at a predetermined position and, when necessary, assists gripping / takeover operation of the transfer device 400. For example, the material release interface 2300 may interact with the transfer device 400 by providing an accessible pickup position (transfer point) for the transfer device 400 even without being physically coupled to or in contact with the sample transfer module 412 or the material transfer module 411 of the transfer device 400.

[0139] Referring to FIG. 13, the material release interface 2300 may be configured to accommodate materials 700 handed over from the release module 2500 or the tray 2420 within the housing 2400 and then provide the materials 700 to outside of the housing 2400 such that the transfer device 400 can take over the materials 700. For example, the material release interface 2300 may include a horizontal transfer structure that receives the materials 700 inside the housing 2400 and moves the materials 700 toward an opening of the housing 2400. The horizontal transfer structure may be a conveyor, a belt, a chain, a roller, a slider, a pusher, or a transfer mechanism based on a linear actuator, and when the materials 700 reach a predetermined handover position (pickup position), the transfer device 400 may be configured to grip and take over the materials 700. Alternatively, the material release interface 2300 may include a vertical lifting structure that, after receiving the materials 700 inside the housing 2400, moves the materials 700 in a vertical direction and exposes the materials 700 to the outside through an upper surface or an upper opening of the housing 2400. For example, the material release interface 2300 may include a lift, an elevator, a scissor lift, a lead screw-based lifting unit, or a linear actuator-based lifting unit, and when the lifting unit raises the materials 700 or the tray 2420 up to a predetermined height and exposes the materials 700 on the upper surface of the housing 2400, the transfer device 400 may be configured to grip and take over the materials 700.

[0140] In order to increase reliability of seating and handover of the materials 700, the material release interface 2300 may include a guide wall, a stopper, an alignment part, a drop-prevention lip, and / or a sensor (e.g., an optical sensor) that detects presence or absence of the materials 700, and the controller 800 may control an operation of the material release interface 2300 and the takeover operation of the transfer device 400 based on the sensor signal.

[0141] According to one embodiment, the storage device 20 may be configured such that the storage area 2100 is expandable. In this case, the release module 2500 may be configured to access the expanded storage area 2100. When an amount of samples to be processed per unit time increases, the storage area 2100 may be expanded. In the automated diagnostic testing system 10 according to one embodiment of the present disclosure, since the functional device 310 and the storage device 20 are spatially separated, the storage area 2100 of the storage device 20 may be expandable without changing other components of the automated diagnostic testing system 10. As used herein, "expandable" with respect to the storage area 2100 means that the storage area 2100 can be increased in capacity and / or usable volume by adding, attaching, extending, or rearranging one or more storage structures (e.g., a storage module 2410 or a tray 2420). In addition, expansion of the storage area 2100 is preferably performed in an area accessible by the release module 2500 of the storage device 20. In this case, the capacity of the storage device 20 can be expanded only by expansion of the storage area 2100 without replacement or modification of the release module 2500. FIG. 10 is a plan view for describing expansion of a storage device according to exemplary embodiments of the present disclosure. When the release module 2500 includes a gripper having a structure expandable in a horizontal direction, expansion of the storage area 2100 may be performed in the third direction D3 as shown in FIG. 10B. Accordingly, the capacity of the storage device 20 may be expanded without modification or replacement of the release module 2500. When the release module 2500 is movable in the fifth direction D5, the storage area 2100 may be expanded by forming a plurality of layers in the fifth direction D5.

[0142] According to one embodiment, the storage device 20 may be configured in a modular manner. Specifically, the storage device 20 may be added without changes to the automated diagnostic testing system 10. In addition, the storage device 20 may be replaceable with another storage device having a different shape or structure, that is, a storage device having a different shape and size. In other words, the automated diagnostic testing system 10 according to one embodiment may be an expandable testing system 10 capable of adding one or more storage devices 20 without changes to the testing system 10. As used herein, "expandable" with respect to the testing system 10 and / or the storage device 20 means that the system 10 and / or the storage capacity can be extended by adding, replacing, or rearranging one or more storage devices 20 and / or storage modules 2410. The expandable includes a meaning of scalable, i.e., enabling stepwise (modular) increase or decrease of storage capacity and / or operating capability according to demand. Here, that the storage device 20 can be added without changes to the testing system 10 may mean that one or more storage devices 20 can be coupled to and operated in the system without structural change or hardware replacement of the functional device 310, the testing device 500, the transfer device 400, and / or the main controller 810 of the automated diagnostic testing system 10. For example, the storage device 20 may be connected to the system through a common mechanical coupling structure and / or an electrical connection structure (e.g., power, a communication port), and the material release interface 2300 may be configured to provide a standardized transfer point at which the transfer device 400 can take over materials. Accordingly, even when the storage device 20 is added or replaced, the transfer device 400 can take over the materials according to the same takeover operation or predefined calibration parameters, and a basic operation sequence of the system can be maintained. In addition, when the storage device 20 is added, the main controller 810 and / or the local controller 820 may automatically recognize the presence and / or identification information of the added storage device 20, and may integrally manage inventory information and storage condition information of materials 700 stored in the storage device 20.

[0143] For example, one or more storage devices 20 may be added according to needs of the automated diagnostic testing system 10. When the type or amount of materials 700 to be supplied to the functional device 310 increases, the system may respond by expanding an existing storage device 20, and flexible operation of the testing system is possible. In addition, even during maintenance or upgrade of the system, it is possible to introduce a new storage device 20 or replace the existing storage device 20 without overall structural change. For this, the storage device 20 may be configured to be spatially separated from the functional device 310. In addition, the storage device 20 may be configured to exchange materials and the like with the transfer device 400 using a standard interface such as the material release interface 2300. Furthermore, since the storage device 20 is designed separately from the automated diagnostic testing system 10, a size, a form factor, and a storage method may be differently configured to match a purpose of storing specific materials 700. For example, a storage device 20 for reagents requiring refrigerated storage may include a temperature control function, and a storage device 20 for storing consumables such as tips or tubes may provide a separate sterile environment.

[0144]

[0145] Storage device for unattended laboratory

[0146] An unattended laboratory refers to a test environment operated fully automatically without human intervention for a predetermined period (e.g., 48 hours). A predetermined period operated fully automatically without human intervention may be defined as an operation session. Correspondingly, a period in which operations such as replenishing consumables and reagents and disposing waste are performed after one operation session ends and before a next operation session starts may be defined as a maintenance period. An unattended laboratory is designed such that all processes including loading of a sample, replenishing reagents and consumables, sample pretreatment, and performing a test are automated in the functional device 310 and the testing device 500 in which a test proceeds, so that tests can be continuously performed even without a human staying. In order to apply the automated diagnostic testing system 10 of the present disclosure to an unattended laboratory, the storage device 20 needs to have unique functions. For example, the storage device 20 should calculate and store reagents 740 and consumables 730 to be used in a laboratory during an operation session. In addition, the storage device 20 should be able to supply materials 700 corresponding to the sample 600 to the functional device 310 so as to process various samples without user intervention. In addition, the storage device 20 should be able to store, as needed, a used sample, a processed sample, or residual materials 710 again.

[0147] According to one embodiment of the present disclosure, the storage device 20 includes a controller 800 that communicates with the automated diagnostic testing system 10 and controls the storage device 20. FIG. 9 is a block diagram illustrating a controller included in an automated diagnostic testing system according to exemplary embodiments of the present disclosure. The controller 800 may determine materials to be supplied to the functional device 310 based on identification information of a sample loaded in the automated diagnostic testing system 10, and may control the storage device 20 such that the determined materials are supplied to the functional device 310.

[0148] According to one embodiment of the present disclosure, the controller 800 may periodically update inventory information of materials 700 stored in the storage device 20 and generate an inventory message. Specifically, the local controller 820 may periodically update inventory information of materials 700 stored in the storage device 20, generate an inventory message, and transmit the inventory message to the main controller 810. In the present specification, inventory information may mean status information on materials 700 stored in the storage device 20. The inventory information may be information on a quantity and / or a remaining amount of the materials 700. In addition, the inventory information may further include information indicating identification, position, availability, and storage status of the materials 700, and may be data used by the controller 800, the main controller 810, and / or the local controller 820 to control operation of the storage device 20 and plan material replenishment. The inventory information may be managed for each material unit (e.g., an individual tube / cartridge), or may be aggregated and managed in units of the tray 2420, the storage module 2410, the storage area 2100, or the storage device 20. In addition, the inventory information of materials 700 stored in the storage device 20 is inventory information indicating a state of materials 700 loaded in the storage device 20, and may include, for example, at least one of the following: (1) material identification information such as a material ID, a material name, a specification, a manufacturer, a lot / batch number, and kit configuration information, (2) position information such as a storage device 20 number, storage area identification, storage module 2410 identification, tray 2420 identification, and a slot / coordinate in the tray, (3) quantity and remaining amount information such as a number, a volume, an estimated remaining amount, a number of uses, and an unused / opened / residual material state, (4) availability information such as availability, expiration, open-time, a reusable time window of residual material 710, and quality status, and (5) usage history information such as when and by which sample 600 the material were used, in which functional device 310 the material were used, a consumption amount record, and a carry-out / carry-in (recovery) time.

[0149] Inventory information may be generated or updated when identification information assigned to the materials 700, the tray 2420, and / or the storage module 2410 is read by the identification information reader 2200. For example, when a user stocks (replenishes) the materials 700 into the storage device 20, when the release module 2500 releases the materials, or when residual materials 710 are carried into the storage device 20 from the functional device 310, the identification information reader 2200 reads the identification information, and the local controller 820 may update the inventory information by linking the reading result with a state of the storage device 20 (e.g., a position or a storage area). In addition, a quantity and / or a remaining amount of the inventory information may be calculated by (i) counting in units of stocking / releasing, (ii) calculating a consumption amount according to a use protocol (calculation-based consumption estimation), (iii) sensor-based measurement, or (iv) a combination thereof.

[0150] A generation period (or interval) of the inventory message may be equal to or longer than a length of the operation session during which the automated diagnostic testing system 10 is operated without user intervention. In other words, the controller 800 or the local controller 820 may update inventory information of materials 700 stored in the storage device 20 and generate an inventory message when one operation session is completed. Such periodic generation of an inventory message is a concept entirely different from a message that notifies that a specific material is depleted in a general automation system. Since an existing automation system is designed based on an assumption that personnel for replenishing materials in the system can access the system frequently, the existing automation system generates a message indicating that the material is depleted or will soon be depleted when a specific material is depleted or close to depletion.

[0151] In contrast, generation of the inventory message according to one embodiment of the present disclosure is intended to replenish a necessary amount for the next operation session by determining whether remaining materials are sufficient to operate the next operation session, even when a material is not depleted or almost depleted. Therefore, even materials for which a certain amount of inventory still remains can be reported by determining their state. In particular, it is possible to notify not only that replenishment of a specific material is required, but also the material item to be replenished and the amount to be replenished so as to complete the next operation session without additional user intervention.

[0152] An inventory message is data indicating a current holding amount of materials 700 in the storage device 20, and may be generated by the controller 800 or the local controller 820. This message may serve to help a system operator monitor a state of the storage device 20 in real time and replenish materials at an appropriate time. The inventory message may include unique identification information and / or a name of materials stored in the storage device 20 and a current stock level. In addition, the inventory message generated by the controller 800 or the local controller 820 may include a minimum stock level indicating a minimum holding amount that the automated diagnostic testing system 10 needs to maintain in order to complete the next operation session. In addition, the inventory message generated by the controller 800 or the local controller 820 may include, for each material, whether restock is required and a material replenishment quantity. In addition, the material replenishment quantity may be calculated according to a criterion such as "estimated consumption amount until the next update time point + safety stock - current stock." The safety stock may be variably set according to unattended operation time, laboratory operation policy, fluctuation in device throughput, or material lead time. The inventory message may be reported directly to a user. Alternatively, the inventory message may be transmitted to a separate material supply system such that materials 700 are automatically stocked (replenished) into the storage device 20. In addition, based on the material replenishment list received from the main controller 810, the local controller 820 may be configured to automatically update the inventory information by confirming identification information of replenished materials 700 through the identification information reader 2200 during a replenishment process by a user and reporting a replenishment result (whether replenishment is completed, a replenishment amount, a position, and a time) to the main controller 810.

[0153] In addition, according to one embodiment of the present disclosure, the controller 800 may generate, based on the updated inventory information, a material replenishment list of materials to be replenished such that an amount of materials to be stored in the storage device 20 exceeds an amount of materials 700 expected to be used until a next inventory information update time point. Specifically, the main controller 810 may generate, based on the updated inventory information, a material replenishment list so that an amount of materials to be stored in the storage device 20 exceeds an amount of materials expected to be used until the next inventory information update time point, and the local controller 820 may control the storage device 20 based on information on the material replenishment list received from the main controller 810. The material replenishment list may include, for each material, whether restock is required and a material replenishment quantity.

[0154] In addition, according to one embodiment of the present disclosure, when the next inventory information update time point is changed by a user, the controller 800 may generate a new material replenishment list based on the changed inventory information update time point. Specifically, the new material replenishment list may be generated by the main controller 810, and the local controller 820 may control the storage device 20 based on information on the material replenishment list received from the main controller 810. For example, when a previous inventory update cycle is 24 hours but a user changes the cycle to 48 hours, the controller 800 may recalculate an amount of materials to be consumed for 48 hours and may newly prepare a list of materials to be replenished accordingly.

[0155] According to one embodiment of the present disclosure, the storage device 20 may be configured to store residual materials carried into the storage device 20 from the functional device 310. The residual materials 710 mean materials 700 used in the functional device 310 during an operation session. The residual materials 710 include materials 700 that remain without being fully consumed at an end time point of an operation session, but are not limited thereto. The storage device 20 of the present disclosure may be configured to receive and store residual materials from the functional device 310 when necessary even while an operation session is in progress, and to release other materials and supply the other materials to the functional device 310.

[0156] In a general automated testing system, a user directly mounts a sample and reagents required therefor in the system before a test, and, even during the test progress, when a new sample type is loaded, the user must manually replace processing reagents and testing reagents suitable therefor. Such a method requires continuous user intervention, and periodic monitoring is required to maintain appropriate reagents even during a test. However, in an automation system for an unattended laboratory, a test must proceed continuously without user intervention after an operation session starts. During an operation session, it is not possible to accurately predict in advance which type of sample will be loaded and which test will be requested, and thus it is impossible for a user to directly mount reagents as in the existing method. Therefore, in an unattended laboratory, the system itself needs to have a capability of managing and replacing reagents so as to respond to various types of samples. In particular, in a diagnostic test, reagents used in a pretreatment process vary depending on characteristics of a sample. However, there is a physical limitation on types and quantities of reagents that can be simultaneously stored in the functional device 310. Accordingly, an automation system for an unattended laboratory needs to be capable of automatically removing existing reagents in the functional device 310 and automatically mounting new reagents suitable for the sample, according to a type of the loaded sample. To make this possible, the storage device 20 may be designed to temporarily store residual materials recovered from the functional device 310. For example, when unused reagents remain in the functional device 310, instead of immediately disposing of the reagents, the unused reagents may be carried into and stored in the storage device 20, and the unused reagents may be configured to be reusable later when the same reagents are required again. Such a method not only minimizes waste of reagents, but also is an important factor supporting long-term stable operation of an unattended laboratory. Therefore, the automation system for an unattended laboratory according to the present disclosure includes the storage device 20 so as to automatically remove reagents of the functional device 310 and mount required reagents according to a sample type, and thereby can quickly and flexibly respond to various test demands even in an unattended environment.

[0157] According to another embodiment of the present disclosure, residual materials 710 carried into the storage device 20 from the functional device 310 may be configured to be stored in a storage area different from a storage area in which the residual materials were stored before being initially released to the functional device 310. Referring to FIG. 3, the storage device 20 may include the residual material storage area 2130. The storage area 2100 of the storage device 20 may include an unused material storage area for storing unused materials and the residual material storage area for storing residual materials received from the functional device 310. The residual material storage area 2130 may mean an area for recovering and storing materials that were temporarily placed in the functional device 310 and remain after use or materials reusable. The storage device 20 may include a separate residual material storage area 2130 distinguished from the reagent storage area 2110 and the consumable storage area 2120 storing unused materials 700, and may store residual materials 710 recovered from the functional device 310 in the residual material storage area 2130. By configuring an independent storage area as described above, unused unopened reagents and consumables and opened residual materials can be physically separated and stored.

[0158] According to another embodiment of the present disclosure, the storage device 20 may include the residual material storage area 2130 configured to store the carried-in residual materials 710 without contamination. Reagents or consumables recovered from the functional device 310 are likely to be in an opened state, and when the reagents or consumables are stored in an open environment, there is a risk of contamination by external dust, microorganisms, chemical contaminants, and the like. Such contamination may cause errors in test results, and thus an appropriate storage environment that can store the residual materials 710 in a clean state is required. The residual material storage area 2130 may be configured such that the residual materials 710 are stored in a state that does not directly contact outside air. The residual material storage area 2130 may include a separate temperature and / or humidity control unit in order to prevent denaturation of opened reagents. The residual material storage area 2130 may include a material release interface 2300 separate from the reagent storage area 2110 and the consumable storage area 2120. According to one embodiment, the controller 800 may automatically identify and manage the type, availability, expiration date of the residual materials 710 recovered from the functional device 310.

[0159] According to another embodiment of the present disclosure, the controller 800 may determine, based on identification information of a first sample loaded in the automated diagnostic testing system 10, a material list of materials to be supplied to the functional device 310 for processing the first sample, and may control the automated diagnostic system 10 such that, among materials already supplied to the functional device 310, materials not listed in the material list are recovered into or stored in the residual material storage area 2130 of the storage device 20.

[0160] In other words, the controller 800 may control the storage device such that, among materials 700 listed in the material list, materials other than materials 700 already supplied to the functional device 310, are supplied to the functional device 310. According to an embodiment in which the controller 800 includes the main controller 810 and the local controller 820, the main controller 810 determines, based on identification information of the first sample loaded in the automated diagnostic testing system, a material list of materials to be supplied to the functional device for processing the first sample, and the local controller 820 controls the storage device such that, among materials already supplied to the functional device, materials not listed in the material list are recovered into or stored in the residual material storage area of the storage device. The local controller 820 may be configured to communicate with the main controller 810, exchange information with the main controller 810, and control the storage device 20 in response to instructions received from the main controller 810. In addition, the local controller 820 may control the storage device 20 such that, among materials 700 listed in the material list, excluding materials 700 already supplied to the functional device 310, the materials are supplied to the functional device 310.

[0161] FIG. 11 is a flowchart for describing a material rearrangement process of a functional device according to a loaded sample type according to exemplary embodiments of the present disclosure. In general, various reagents and consumables used in a previous operation may remain in the functional device 310. However, in an unattended laboratory, different types of samples are continuously loaded, and thus reagents and consumables being used in the functional device 310 need to be recovered, and reagents and consumables corresponding to the loaded first sample need to be supplied. However, before starting processing for a different type of sample in the functional device 310, it is not necessary to recover all reagents and consumables. Rather, it is necessary to check whether materials remaining in the functional device 310 are suitable for processing the newly loaded first sample.

[0162] The controller 800 may, when a first sample is loaded (P100), check information of the first sample. Specifically, the controller 800 may read identification information of the first sample to check a sample type of the first sample and a test requested for the first sample (P200). Subsequently, the controller 800 may determine a functional device 310 that will process the first sample (P300). For example, among a plurality of pretreatment devices, the controller 800 may select a pretreatment device that can start processing the first sample earliest. Alternatively, among the plurality of pretreatment devices, the controller 800 may select a device that is processing the same type of sample as the first sample, or a device that is performing processing for the same type of test. When the functional device for processing the first sample is determined, the controller 800 generates a material list for processing the first sample (a first list) (P401), and may check previous task information of the functional device 310 determined to process the first sample and generate a list of residual materials remaining in the determined functional device 310 (a second list) (P402). In step P500, the first list and the second list may be compared to classify material items into three groups. First, among materials already mounted in the functional device 310, materials usable for processing the first sample may be materials that are common items listed in both the first list and the second list. These items may be classified as group 1. Next, materials required for processing the first sample but not present in the functional device 310 may be classified as group 2. Group 2 may be items included only in the first list but not included in the second list. Finally, materials that are not required for processing the first sample but remain in the functional device 310 may be classified as group 3. The group 3 may be items not included in the first list and included only in the second list. Finally, the controller 800 may control the storage device 20 to recover materials unnecessary for processing the first sample and supply new materials. First, through the comparison, materials not required for processing the first sample (materials corresponding to group 3) may be controlled to be recovered into the residual material storage area 2130 of the storage device 20 (P603). However, among materials remaining in the functional device 310, materials usable as they are for processing the first sample (materials corresponding to group 1) may be maintained (P601), thereby minimizing unnecessary material replacement. Instead of the recovered materials, new materials required for processing the first sample (materials corresponding to group 2) may be automatically supplied from the storage device 20 to the functional device 310 (P602). Accordingly, the functional device 310 may be maintained to include materials optimized for a currently loaded sample.

[0163] According to one embodiment of the present disclosure, the storage device 20 may be configured to receive and store a sample 600 from the functional device 310. According to one embodiment of the present disclosure, for sample storage, the storage device 20 may include a storage area isolated from other storage areas 2100 and configured to store a biological substance. In general, in an existing automated testing system, since a user can recover a tested sample at any time a sample storage issue does not become significant. However, in an unattended laboratory, even after a test on a sample loaded during an operation session is completed, it is necessary to safely store the sample until the user recovers the sample. For this, the storage device 20 of the present disclosure may include a dedicated storage area for sample storage. As such a dedicated storage area, the storage device 20 may include the sample storage area 2140. The sample storage area 2140 may mean an area for storing a tested sample or a sample being processed. This sample storage area 2140 may have a structure physically isolated from other storage areas 2100. Accordingly, according to one embodiment, the storage device 20 may include two or more storage areas 2100, and at least one of the two or more storage areas 2100 may be isolated from the other storage areas 2100 and may be configured to store a biological substance. Here, isolation may mean a structure in which the storage area is physically partitioned from the other storage area 2100 such that direct air flow, contact, or contamination transfer is limited. For example, the isolation may be implemented by a partition wall, a separate chamber, a door / cover, a gasket, an air blocking part, or a separate opening, and the isolated storage area may have an independent access path from the other storage areas. In addition, the isolated storage area may include a lock, an interlock, an opening / closing detection sensor, and the like such that user access is restricted in an unattended operation environment. The biological substance may include a sample 600, a processed sample 610, a tested sample, or materials requiring biological safety management (e.g., potentially infectious materials, pathogen-derived materials), but is not limited thereto. The isolated storage area may include a ventilation structure including a HEPA filter and a negative pressure maintaining structure in order to safely store the biological substance. The isolated storage area may be the sample storage area 2140. The sample storage area 2140 may include a separate temperature and / or humidity control unit. The sample storage area 2140 may include the sample interface 2141 separate from the reagent storage area 2110 and the consumable storage area 2120. According to one embodiment, the controller 800 may automatically identify a type, availability, and the like of the sample 600 recovered from the functional device 310 and record and manage a storage location thereof. For this, a separate identification information reader may be disposed in the sample storage area 2140. When additional tests are required for a specific sample being stored, the storage device 20 of the present disclosure may send the specific sample to the functional device 310 to perform processing for the additional tests.

[0164] The sample storage area 2140 may be configured such that a raw sample before a sample processing process proceeds is stored. Alternatively, the sample storage area 2140 may be configured such that a processed sample 610 for which the sample processing process is completed is stored. By integrally managing reagents, consumables, and samples in a single storage device 20, a frequency of user intervention may be reduced. During periodic maintenance, samples and consumables may be recovered and replenished together in a single storage device 20, thereby enabling efficient maintenance. In addition, since a dedicated sample storage device does not need to be separately installed in the unattended laboratory, laboratory space may be utilized more efficiently. Further, by performing sample storage and management of reagents and consumables in a single system, costs required to operate a separate sample storage device and a separate management system may be reduced.

[0165] According to one embodiment, the sample storage area 2140 may include the storage module 2410 configured to accommodate a plurality of trays 2420. According to one embodiment, the storage module 2410 included in the sample storage area 2140 may be configured to accommodate the sample 600 or the processed sample 610 in units of the trays 2420 in a standardized format. For example, the tray 2420 may include a plurality of receiving holes or slots that accommodate a plurality of sample containers in a predetermined arrangement. In addition, tray identification information (e.g., a barcode, a QR code, RFID, and the like) may be assigned to the tray 2420, and the controller 800 may automatically map, record, and manage a sample storage position (e.g., a tray number, a slot number) based on the tray identification information and / or sample identification information in the tray.

[0166] In addition, according to one embodiment, the storage module 2410 disposed in the sample storage area 2140 may be configured to be separable from the storage device 20 even while the automated diagnostic testing system 10 is in operation. The storage module 2410 disposed in the storage area 2100 may be configured to be separable from the storage device 20 even while the automated diagnostic testing system 10 is in operation. In particular, the storage module 2410 disposed in the sample storage area 2140 is for storing samples for which a test has been completed. Therefore, by periodically replacing the storage module 2410 disposed in the sample storage area 2140 with an empty storage module 2410, the automated diagnostic testing system 10 can be continuously operated without interruption by continuously loading new samples.

[0167] As used herein, "separable during operation" may mean that, even while the automated diagnostic testing system 10 performs sample processing and testing operations, at least some storage modules 2410 are configured to be detachably mounted to the storage device 20 such that the at least some storage modules 2410 can be attached to or detached from the storage device 20. For example, the storage device 20 may include a plurality of storage modules 2410, and the controller 800 may, after switching a specific storage module 2410 to a detachable state, guide a user to detach the specific storage module 2410. In this case, other storage modules 2410 or other storage areas (e.g., the reagent storage area 2110 and the consumable storage area 2120) may be maintained to remain available, and thus sample recovery or module replacement may be possible without stopping the entire system.

[0168] According to one embodiment of the present disclosure, the storage device 20 may include a decapper, a seal remover unit, a reagent set holder, or a tip container opener. According to one embodiment, the storage device 20 may include a self-cleaning system. FIG. 8 illustrates an automated diagnostic testing system 10 in which a single storage device 20 is configured to supply materials to a plurality of same-type functional devices 310A and 310B. A storage device accessory 900 such as a decapper that handles a cap of a tube or the like for using reagents or consumables, a seal remover unit that removes a seal of a reagent cartridge or the like, and a tip container opener that makes a tip box and the like usable may be required. When these accessory units 900 are provided in a functional device 310 that uses the corresponding reagents and consumables, the accessory unit 900 needs to be provided in each functional device 310. However, when such an accessory unit is provided in the storage device 20, it is not necessary to dispose a device having the same function for each functional device 310, thereby reducing a system construction cost and improving space utilization of a laboratory. A reagent set holder serves to configure and hold a reagent set required for a specific test and to store and supply the reagent set. It may be inefficient and time-consuming to deliver reagents one by one to the functional device 310 for sample processing and / or test setup. The reagent set holder enables transfer of a plurality of reagents at one time. In addition, the reagent set holder allows reagents to be disposed at predetermined positions, and thus settings for operation of the functional device 310 according to a sample type or a test type can be standardized. The reagent set holder may include identification information such as a barcode. The tip container opener is a device that automatically opens a tip container including pipette tips. In a diagnostic system, pipette tips are used in large quantities, and a function of automatically replacing a new tip box is required. The tip container opener may automatically open the tip container such that the functional device 310 can immediately use pipette tips. The self-cleaning system performs a function of automatically cleaning and disinfecting the storage device 20 and internal components. This is a function for preventing contamination and minimizing maintenance of an automation system in an unattended laboratory environment. For example, storage regions such as a reagent storage area 2110 within the storage device 20 may be automatically cleaned to remove residual reagents and contaminants. In particular, after samples stored in the sample storage area are recovered by a user during a maintenance period after an operation session ends, automatic periodic cleaning and disinfection may be performed. The disinfection may include ultraviolet disinfection and / or chemical disinfection.

[0169] The storage device 20 of the present disclosure may include various functions that, beyond simply storing reagents or consumables, automate a test process and enable continuous operation of the system, thereby ultimately enabling an unattended laboratory. Specifically, the storage device 20 according to an embodiment of the present disclosure may, in order to establish an unattended testing environment, (i) supply materials required for a functional device according to a sample, (ii) recover and store residual materials used in the functional device according to a loaded sample, and (iii) store samples on which tests have been performed during an operation session such that a user can retrieve the samples during a maintenance period.

[0170] According to one embodiment of the present disclosure, the present disclosure provides a storage device for an automated diagnostic testing system, wherein the storage device is configured to supply materials to a functional device of the automated diagnostic testing system, wherein the storage device is spatially separated from the functional device, wherein the storage device includes a storage area configured to store materials and an identification information reader configured to identify identification information of the materials, and wherein the storage area is configured to store unused materials and residual materials received from the functional device. According to one embodiment, the storage area may include a storage area configured to store unused materials and a storage area configured to store residual materials received from the functional device.

[0171] FIG. 4 is a plan view for describing an automated diagnostic testing system according to other exemplary embodiments of the present disclosure. The storage device 20 may be spatially separated from the functional device 310. Referring to FIG. 4, the storage device 20 may include reagent storage areas 2110A and 2110B configured to store unused reagents 740, and a consumable storage area 2120 configured to store consumables 730. In addition, the storage device 20 may include a residual material storage area 2130 configured to store residual materials 710 received from the functional device 310. As shown in FIG. 4, one transfer module 410 may transfer both materials and samples. In addition, the transport module 430 of the transfer device 400 that transfers samples to each functional device 310 may directly access the reagent storage area 2110A and 2110B, the consumable storage area 2120, and the residual material storage area 2130 of the storage device 20, and may retrieve the materials and provide the materials to the functional device 310. In this case, the material release interface 2300 for releasing materials may not be included.

[0172]

[0173] Material supply method between the storage device and the functional device

[0174] According to one embodiment of the present disclosure, the present disclosure provides an automated diagnostic testing system including: (i) a sample processing unit including a plurality of functional devices, wherein the sample processing unit performs sample processing for a diagnostic test of a sample loaded in the automated diagnostic testing system; (ii) one or more storage devices configured to supply materials to the plurality of functional devices, wherein the storage devices are spatially separated from the plurality of functional devices; (iii) a testing device that receives a processed sample from the sample processing unit and performs a diagnostic test reaction; (iv) a transfer device that transfers samples and materials between the functional devices and the storage devices; and (v) a controller, wherein the controller controls the storage devices such that materials for the diagnostic test of the loaded sample are supplied to a functional device that is selected to process the loaded sample. FIG. 1 is a perspective view illustrating an automated diagnostic testing system according to exemplary embodiments of the present disclosure. FIG. 2 is a plan view for describing an automated diagnostic testing system according to exemplary embodiments of the present disclosure.

[0175] According to one embodiment of the present disclosure, the one or more storage devices 20 may include material release interfaces 2300 that are functionally compatible with each other. As used herein, the term "functionally compatible" may mean that, even when a plurality of storage devices 20 are provided, the corresponding material release interfaces 2300 are configured to interact with the transfer device 400 in a common or consistent manner. The material release interface 2300 may be a configuration for exchanging materials between the release module 2500 and the transport module 430. The controller 800 controls the storage device 20 to release materials 700 to be supplied to the functional device 310. The release module 2500 may locate materials 700 to be supplied to the functional device 310 in the storage area 2100 and may transfer the materials to the material release interface 2300. The release module 2500 or the material release interface 2300 may transmit, to the controller 800, a signal indicating that materials 700 to be supplied to the functional device 310 are positioned at the material release interface 2300. The controller 800 may control the transport module 430 such that transport module 430 picks up materials 700 positioned at the material release interface 2300 and transports the materials to a desired functional device 310.

[0176] For example, the material release interfaces 2300 of the storage devices 20 may have the same physical standard and / or mechanical interface, or may include a common reference feature that allows the transfer device 400 to record and calibrate a position of the material release interface 2300. Alternatively, the material release interfaces 2300 may be configured to interact with the transfer device 400 in the same takeover sequence. Alternatively, the material release interfaces 2300 may be configured to deliver, to the controller 800, a presence signal indicating whether materials are present at the material release interface 2300 in the same manner. When the storage device 20 includes a functionally compatible material release interface 2300 as described above, even when the storage device 20 is replaced, added, or repositioned within the system, a procedure for configuring (or reconfiguring) interaction between the storage device 20 and the transfer device 400 and / or the controller 800 can be performed more easily and, in some cases, automatically.

[0177] According to one embodiment of the present disclosure, the controller 800 may determine, based on identification information of a loaded sample, materials to be supplied to each of at least two functional devices 310, and may control the one or more storage devices such that the determined materials are supplied to the at least two functional devices. Referring to FIG. 2, before a loaded sample is transferred by the sample transfer module 412, identification device 470 reads identification information of the loaded sample, and the controller 800 may receive, based on the read identification information, information about a type of the loaded sample and a type of a test requested for the sample is received based on the read identification information. Depending on the sample type and the test type, the types of reagents to be used in the functional device 310, for example, pretreatment reagents, extraction reagents, and diagnostic reagents, may vary. The controller 800 may determine two or more functional devices 310 that are to be used to process the loaded sample, and may control the material transfer module 411 such that the materials are supplied to the respective functional devices 310.

[0178] FIG. 5 is a plan view for describing operation of a storage device according to exemplary embodiments of the present disclosure. Referring to FIG. 5, the automated diagnostic testing system 10 according to one embodiment of the present disclosure may include two or more functional devices 310. In addition, the two or more functional devices 310 may be configured to perform different steps of sample processing. That is, the sample processing unit 300 may include a first functional device 310A and a second functional device 310B, and the first functional device 310A and the second functional device 310B may be configured to perform different steps of sample processing. For example, the first functional device 310A may be a pretreatment device that preprocesses a sample, and the second functional device 310B may be an extraction device that receives the pretreated sample and extracts nucleic acids. The first functional device 310A and the second functional device 310B require different materials for sample processing. The automated diagnostic testing system 10 according to one embodiment of the present disclosure may include a first storage device 20A and a second storage device 20B, wherein the first storage device 20A is configured to supply materials to the first functional device 310A, and the second storage device 20B is configured to supply materials to the second functional device 310B. When one storage device 20 is assigned to one functional device 310 to supply materials in this manner, the storage device 20 may be disposed adjacent to the functional device 310, and rapid supply of materials may be possible.

[0179] FIG. 8 is a plan view for describing operation of a storage device according to other exemplary embodiments of the present disclosure. According to one embodiment of the present disclosure, the sample processing unit 300 may include two or more first functional devices 310A, and the storage device 20 may be configured to supply materials to the two or more first functional devices 310A. In addition, storage device 20 may be configured to supply different materials to the two or more first functional devices 310A and 310B.

[0180] The automated diagnostic testing system 10 according to one embodiment of the present disclosure may include two or more functional devices that perform the same processing step. For example, two or more pretreatment devices 310A may be included. Alternatively, two or more extraction devices 310B may be included. By operating functional devices 310 in parallel, sample throughput per unit time may be increased. When there are many test requests, multiple functional devices 310 may operate simultaneously to maximize processing speed. In addition, workload for the same processing step may be distributed.

[0181] For example, when two or more pretreatment devices 310A are included, sample pretreatment may be performed simultaneously using the same reagents and consumables. Even when a particular functional device is temporarily unavailable due to inspection or maintenance, continuous testing may be performed using another functional device. In addition, when two or more extraction devices 310B are included, different types of samples may be individually processed. For example, one extraction device 310B may be set to process a blood sample, and another extraction device 310B may be set to process a saliva sample. Accordingly, the automated diagnostic testing system 10 may provide flexibility to simultaneously perform various types of tests within the same system 10. In order to supply materials to two or more functional devices 310 of the same processing step, the transfer device 400 may include a plurality of transfer modules 410. One transfer module 410A may be disposed to supply materials to each of a plurality of functional devices 310A of the same processing step. Another transfer module 410B may be disposed to supply materials to each functional device 310B of a different processing step. Another transfer module 410 may be disposed to receive materials from storage device 20 and to deliver the materials to transfer modules 410A and 410B assigned to the functional devices of each step, respectively.

[0182] FIG. 6 is a plan view for describing operation of a storage device according to other exemplary embodiments of the present disclosure. According to one embodiment of the present disclosure, the automated diagnostic testing system 10 according to one embodiment of the present disclosure includes a third storage device 20C, and the third storage device 20C may be configured to supply materials to a first functional device 310A and a second functional device 310B. Referring to FIG. 6, one storage device 20C may supply materials to the functional devices 310A and 310B that perform different processing steps. One material transfer module 411 may release materials from storage device 20C and may provide the materials to the first functional device 310A or the second functional device 310B. The controller 800 may control supply of depleted materials by monitoring remaining amounts of materials in the first functional device 310A and the second functional device 310B during an operation session. The third storage device 20C may release materials through the material release interface 2300 thereof. The first functional device 310A and the second functional device 310B may receive the materials delivered by the material transfer module 411 through a material interface 315B provided in each functional device. When one storage device 20C is configured to supply materials to the functional devices 310A and 310B that perform different processing steps in this manner, a user may replenish materials for a next operation session by supplying the materials only to the one storage device 20C during a maintenance period, which is a period in which operations such as replenishing consumables and reagents and discarding waste are performed after one operation session ends and before the next operation session begins. Accordingly, material replenishment during the maintenance period can be conveniently and quickly performed.

[0183] FIG. 7 is a plan view for describing operation of a storage device according to other exemplary embodiments of the present disclosure. According to one embodiment of the present disclosure, the automated diagnostic testing system 10 includes a fourth storage device 20D and a fifth storage device 20E, and the fourth storage device 20D and the fifth storage device 20E may be configured to supply materials to a first functional device 310A. Referring to FIG. 7, two or more storage devices 20D and 20E may be configured to supply materials to a single functional device 310A. According to one embodiment, the storage device 20D for storing reagents 740 and the storage device 20E for storing consumables 730 may be separately provided. Consumables 730 and reagents 740 may have different optimal storage environments. For example, the reagents 740 may include reagents that require refrigerated storage or frozen storage, whereas the consumables 730 may be suitable for room-temperature storage. When these are managed in the same space, it may be difficult to optimize storage conditions, and system configuration may be complicated. Accordingly, when a storage device for storing reagents and a storage device for storing consumables are separately configured, the configuration of each storage device may be simplified.

[0184] According to one embodiment, the fourth storage device 20D and the fifth storage device 20E may be configured to supply materials to the first functional device 310A and may also be configured to supply materials to a second functional device 310B. The first functional device 310A may be a pretreatment device, and the second functional device 310B may be an extraction device. Accordingly, according to one embodiment, the fourth storage device 20D may be a reagent storage device and may be configured to supply reagents 740 to all of the functional devices 310 of the automated diagnostic testing system 10. In addition, the fifth storage device 20E may be a consumable storage device and may be configured to supply consumables 730 to all of the functional devices 310 of the automated diagnostic testing system 10.

[0185] The controller 800 may control supply of depleted materials by monitoring remaining amounts of materials in the first functional device 310A and the second functional device 310B during an operation session. In this case, when the depleted material 700 is a consumable 730, the controller 800 may control the fifth storage device 20E such that the fifth storage device 20E supplies the depleted consumable 730 to the corresponding functional device 310. In addition, when the depleted material 700 is a reagent 740, the controller 800 may control the fourth storage device 20D such that the fourth storage device 20D supplies the depleted reagent 740 to the corresponding functional device 310. The fourth storage device 20D or the fifth storage device 20E may release materials through the material release interface 2300 thereof. The first functional device 310A and the second functional device 310B may receive the materials delivered by the material transfer module 411 through a material interface 315B provided in each functional device.

[0186]

[0187] Although the exemplary embodiments of the present disclosure have been described with reference to the above embodiments, those skilled in the art will appreciate that various modifications and variations may be made without departing from the spirit and scope of the present disclosure as set forth in the appended claims.

[0188]

[0189] <Cross-Reference to Related Application>

[0190] The application claims priority to Korean Patent Application No. 10-2025-0022112, filed in the Korean Intellectual Property Office on February 20, 2025, the entire disclosure of which is incorporated herein by reference in its entirety.

[0191]

[0192] <List of Reference Signs>

[0193] 10: automated diagnostic testing system

[0194] 20: storage device

[0195] 20A, 20B, 20C, 20D, 20E: first to fifth storage devices

[0196] 2100: storage area

[0197] 2110: reagent storage area

[0198] 2120: consumable storage area

[0199] 2130: residual material storage area

[0200] 2140: sample storage area

[0201] 2141: sample interface

[0202] 2200: identification information reader

[0203] 2300: material release interface

[0204] 2400: housing

[0205] 2410: storage module

[0206] 2420: tray

[0207] 2500: release module

[0208] 300: sample processing unit

[0209] 310: functional device

[0210] 310A, 310B: first and second functional devices

[0211] 315: interface

[0212] 315A: sample interface, 315B: material interface

[0213] 316: moving unit

[0214] 400: transfer device

[0215] 410: transfer module

[0216] 411: material transfer module, 412: sample transfer module

[0217] 430: transport module

[0218] 440: communicable station

[0219] 441: sensor

[0220] 450: input area, 460: output area

[0221] 470: identification device

[0222] 500: testing device

[0223] 600: sample

[0224] 610: processed sample

[0225] 601: first sample

[0226] 602: second sample

[0227] 700: material

[0228] 710: residual material

[0229] 730: consumable, 740: reagent

[0230] 800: controller

[0231] 810: main controller

[0232] 820: local controller

[0233] 900: storage device accessory

Claims

1.A storage device for an automated diagnostic testing system,wherein the storage device is configured to supply materials to a functional device of the automated diagnostic testing system,wherein the storage device is spatially separated from the functional device,the storage device comprising:at least one storage area for storing materials,a material release interface configured to interact with a transfer device of the automated diagnostic testing system, anda local controller configured to communicate with a main controller of the automated diagnostic testing system,wherein the local controller exchanges information with the main controller, and controls the storage device in response to instructions received from the main controller, such that materials for a loaded sample, determined based on identification information of the sample loaded in the automated diagnostic testing system, are supplied to the functional device.2.The storage device of claim 1, further comprising an identification information reader for identifying identification information of the materials.3.The storage device of claim 2, comprising a release module configured to transfer materials within the storage area.4.The storage device of claim 1, comprising two or more storage areas, wherein at least one of the storage areas is independently temperature-controllable.5.The storage device of claim 4, wherein the two or more storage areas are configured to store different types of materials.6.The storage device of claim 1, comprising two or more storage areas, wherein at least one of the storage areas is isolated from the other storage areas and is configured to store a biological substance.7.The storage device of claim 3,wherein the storage area is configured to be expandable, andwherein the release module is configured to access the expanded storage area.8.The storage device of claim 1, wherein the storage device is configured in a modular manner so as to be addable without changes to the automated diagnostic testing system.9.The storage device of claim 1, wherein the automated diagnostic testing system comprises:(i) a sample processing unit comprising a plurality of functional devices;(ii) a testing device that receives a processed sample from the sample processing unit and performs a diagnostic test; and(iii) a transfer device that transfers samples and materials between the functional device and the storage device.10.The storage device of claim 1, wherein the local controller periodically updates inventory information of materials stored in the storage device, generates an inventory message, and transmits the inventory message to the main controller.11.The storage device of claim 10,wherein the main controller generates, based on the updated inventory information, a material replenishment list of materials to be replenished such that an amount of materials greater than an amount of materials used until a next inventory information update time point is stored in the storage device, andwherein the local controller controls the storage device based on information on the material replenishment list received from the main controller.12.The storage device of claim 11, wherein, when the next inventory information update time point is changed by a user, the main controller generates a new material replenishment list based on the changed inventory information update time point, and the local controller controls the storage device based on information on the new material replenishment list received from the main controller.13.The storage device of claim 1, wherein the storage device is configured to store residual materials received from the functional device.14.The storage device of claim 13, wherein the residual materials received from the functional device are configured to be stored in a storage area different from a storage area in which the materials were stored before being initially released to the functional device.15.The storage device of claim 13, comprising a residual material storage area configured to store the received residual materials without contamination.16.The storage device of claim 15,wherein the main controller determines, based on identification information of a first sample loaded in the automated diagnostic testing system, a material list of materials to be supplied to the functional device for processing the first sample, andthe local controller controls the storage device such that, among materials already supplied to the functional device, materials not listed in the material list are stored in the residual material storage area of the storage device.17.The storage device of claim 1, wherein the storage device is configured to receive and store a sample from the functional device.18.The storage device of claim 1, wherein the storage area is configured to accommodate a plurality of trays.19.The storage device of claim 18, wherein the trays are configured to store a plurality of materials.20.The storage device of claim 3, further comprising a housing, wherein the release module is configured to be coupled to the housing.21.The storage device of claim 20, wherein the storage area comprises a storage module for storing materials, and the storage module is configured to be movably mounted to the housing.22.The storage device of claim 21, wherein, the storage module is configured to be aligned with respect to the release module when mounted to the housing, such that materials contained in the storage module are transferred by the release module.23.The storage device of claim 21, wherein, when the local controller detects mounting of the storage module, the local controller is configured to transmit, to the main controller, material identification information and / or storage module identification information obtained from the identification information reader, and the main controller is configured to automatically register materials contained in the storage module and update inventory information based on the material identification information and / or the storage module identification information.24.The storage device of claim 1, wherein the storage device comprises at least one selected from the group consisting of:a decapper, a seal remover unit, a reagent set holder, a tip container opener, and a self-cleaning system.25.A storage device for an automated diagnostic testing system,wherein the storage device is configured to supply materials to a functional device of the automated diagnostic testing system,wherein the storage device is spatially separated from the functional device,the storage device comprising:a storage area for storing materials, andan identification information reader for identifying identification information of the materials,wherein the storage area is configured to store unused materials and residual materials received from the functional device.26.The storage device of claim 25, wherein the storage area comprises an unused material storage area for storing the unused materials and a residual material storage area for storing the residual materials received from the functional device.27.The storage device of claim 25, further comprising a local controller configured to communicate with a main controller of the automated diagnostic testing system,wherein the local controller exchanges information with the main controller and controls the storage device in response to instructions received from the main controller,such that, based on a material list of materials to be supplied to the functional device for processing a first sample, the material list being determined by the main controller based on identification information of the first sample loaded in the automated diagnostic testing system,among materials already supplied to the functional device, materials not listed in the material list are recovered into the storage device.28.The storage device of claim 27, wherein the local controller controls the storage device such that, among materials listed in the material list, excluding materials already supplied to the functional device, the materials are supplied to the functional device.29.An automated diagnostic testing system comprising:(i) a sample processing unit comprising a plurality of functional devices, the sample processing unit being configured to perform sample processing for a diagnostic test of a sample loaded in the automated diagnostic testing system;(ii) one or more storage devices configured to supply materials to the plurality of functional devices, the storage devices being spatially separated from the plurality of functional devices;(iii) a testing device configured to receive a processed sample from the sample processing unit and perform a diagnostic test reaction;(iv) a transfer device configured to transfer samples and materials between the functional devices and the storage devices; and(v) a controller,wherein the controller controls the storage devices such that materials for the diagnostic test of the loaded sample are supplied to a functional device that processes the loaded sample.30.The system of claim 29, wherein the one or more storage devices comprise a functionally compatible material release interface.31.The system of claim 29, wherein the controller determines, based on identification information of the loaded sample, materials to be supplied to each of at least two functional devices, and controls the one or more storage devices such that the determined materials are supplied to the at least two functional devices.32.The system of claim 29, wherein the one or more storage devices are configured to be non-integrated with any of the plurality of functional devices.33.The system of claim 29, wherein the controller periodically updates inventory information of materials stored in the storage devices and generates an inventory message.34.The system of claim 33, wherein the controller generates, based on the updated inventory information, a material replenishment list of materials to be replenished such that an amount of materials greater than an amount of materials used until a next inventory information update time point is stored in the storage devices.35.The system of claim 34, wherein, when the next inventory information update time point is changed by a user, the controller generates a new material replenishment list based on the changed inventory information update time point.36.The system of claim 29,wherein at least one of the one or more storage devices comprises:(i) a housing;(ii) a storage module configured to store materials and configured to be movably mounted to the housing; and(iii) an identification information reader for identifying material identification information and / or storage module identification information.37.The system of claim 36, wherein, when the controller detects mounting of the storage module, the controller is configured to automatically register materials contained in the storage module and update inventory information based on material identification information and / or storage module identification information obtained from the identification information reader.38.The system of claim 29, wherein the sample processing unit comprises a first functional device and a second functional device, and the first functional device and the second functional device are configured to perform different steps of sample processing.39.The system of claim 38, wherein the one or more storage devices comprise a first storage device and a second storage device, wherein the first storage device supplies materials to the first functional device, and wherein the second storage device supplies materials to the second functional device.40.The system of claim 39, wherein the sample processing unit comprises two or more first functional devices, and the first storage device is configured to supply materials to the two or more first functional devices.41.The system of claim 40, wherein the first storage device is configured to supply different materials to the two or more first functional devices.42.The system of claim 38, wherein the one or more storage devices comprise a third storage device, and wherein the third storage device is configured to supply materials to the first functional device and the second functional device.43.The system of claim 38, wherein the one or more storage devices comprise a fourth storage device and a fifth storage device, and wherein the fourth storage device and the fifth storage device are configured to supply materials to the first functional device.44.The system of claim 29, wherein the storage devices are configured to receive and store residual materials from the functional devices.45.The system of claim 44, wherein the controller determines, based on identification information of a first sample loaded in the automated diagnostic testing system, a material list of materials to be supplied to the functional device for processing the first sample, and controls the storage devices such that, among materials already supplied to the functional device, materials not listed in the material list are recovered into the storage devices.46.The system of claim 45, wherein the controller controls the storage devices such that, among materials listed in the material list, excluding materials already supplied to the functional device, are supplied to the functional device.47.The system of claim 29, wherein the storage devices are configured to receive and store samples from the functional devices.48.The system of claim 47, wherein the transfer device comprises a material transfer module and a sample transfer module.49.The system of claim 29, wherein the materials comprise consumables or reagents.50.The system of claim 29, wherein the storage devices are configured to be replaceable with other storage devices having different shapes or structures.51.The system of claim 29, wherein the system is an expandable system configured to add one or more storage devices without changes to the system.

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