Continuous loadable module typed system for tests

Abstract

The present disclosure relates to a system for a test. More particularly, the present disclosure relates to a continuous loadable module-typed system for a test, a computer readable storage medium containing instructions to configure a processor to enable a continuous loadable module-typed system for a test, and a method for testing a sample. The exemplary embodiment of the presently disclosed system may be configured to support (i) single tests, (ii) batch tests, (iii) syndromic tests and / or (iv) combination tests. In addition, the exemplary embodiment of the presently disclosed system automatically processes and tests samples based on identification information, without requiring the user to classify and load the samples according to test type.

Description

CONTINUOUS LOADABLE MODULE TYPED SYSTEM FOR TESTS

[0001] The present disclosure relates to a system for a test. More particularly, the present disclosure relates to a continuous loadable module-typed system for a test, a computer readable storage medium containing instructions to configure a processor to enable a continuous loadable module-typed system for a test, and a method for testing a sample

[0002] Tests for detecting or analyzing a target molecule of interest in samples are used in a wide variety of fields. The test includes molecular diagnostics, immunological diagnostics, biochemical diagnostics, cell culture tests, forensic tests and environmental contamination tests.

[0003] Molecular diagnostics is a method of determining the presence or absence of diseases or infections by analyzing genetic information contained in a sample or biological markers contained in proteins using molecular biological techniques. Because of the characteristics of infectious disease diagnosis, when a particular infectious disease becomes prevalent, a large number of identical tests are required to be performed. Accordingly, a centralized testing model has primarily been adopted, in which specimens collected at local clinics or public health centers are rapidly transported to large-scale laboratories equipped with high-throughput testing systems for molecular diagnostic processing. In order to be applied to such centralized testing models, molecular diagnostic automation systems developed to date have been configured to process a large volume of samples simultaneously and to conduct assay reactions, However, automation systems that process large quantities of samples simultaneously and perform identical tests cannot be effectively applied to regions with low population density or to small- to medium-sized hospitals and clinics, because considerable time is required to collect a sufficient number of samples for large-scale testing. Furthermore, when no specific pathogen predominates and diagnostic testing is required for a wide variety of diseases, operational efficiency is significantly reduced.

[0004] To address these shortcomings, point-of-care testing (POCT) systems have been introduced. Such systems are advantageous in that a single cartridge incorporates both the reagents and the reaction chambers for sample processing and testing, and can be operated by connection to a simple external device, thereby enabling on-site testing. However, POCT systems are disadvantageous in that the cost per test is very high, and because they are closed systems limited to performing only predetermined tests on predetermined types of samples, the development of diverse test menus is difficult. In addition, since both sample processing and assay reactions are performed within a single cartridge, once a cartridge loaded with a sample is mounted on the testing device, no further sample processing can be performed until the assay reaction in the mounted cartridge is completed.

[0005] U.S. Pat. No. 12,292,454 discloses a method for operating a laboratory automation system. U.S. Pat. No. 9,834,748 discloses a modular automated system for sample processing and / or detection of microorganisms. U.S. Pat. No. 12,013,407 discloses a laboratory system for automatically processing at least one sample container containing a biological sample.

[0006] There is still a need for full automation testing systems with scale flexibility and operation flexibility. The full automation testing systems are required to be scalable in response to testing environment such as test volume, test capacity, area of testing room. The full automation testing systems are required to be operated for various test types such as (i) single tests, (ii) batch tests, (iii) syndromic tests and / or (iv) combination tests. Their operation should be automatically switchable between various test types.

[0007] Throughout this application, various patents and publications are referenced, and citations are provided in parentheses. The disclosure of these patents and publications in their entities are hereby incorporated by references into this application in order to more fully describe this invention and the state of the art to which this invention pertains.

[0008] It is an object of the present disclosure to provide a continuous loadable module-typed system for a test.

[0009] It is another object of the present disclosure to provide a method for testing a sample.

[0010] It is still another object of the present disclosure to provide a computer readable storage medium containing instructions to configure a processor to enable a continuous loadable module-typed system for a test to perform operations.

[0011] However, the present disclosure is not limited to the object described above and may be expanded in various ways without departing from the spirit and scope of the present invention

[0012] In order to achieve the object of the present disclosure described above, an aspect of the present disclosure is to provide a continuous loadable module-typed system for a test, comprising:

[0013] (a) a modular processing device configured to process a sample to provide a processed sample; wherein the sample is contained in a sample container labeled with an identification information; wherein the modular processing device is configured to be able to additionally process another sample simultaneously with the processing of the sample;

[0014] (b) a modular storage device for an assay reagent configured to accommodate a plurality of assay reagents for different tests; wherein the plurality of assay reagents are in at least one type selected from the group consisting of a liquid type, a freeze-dried type and combination thereof;

[0015] (c) a sample applicator configured to (i) receive the processed sample from the modular processing device, (ii) receive from the modular storage device a designated assay reagent specific for the sample among the plurality of assay reagents depending on the identification information labeled on a sample container containing the sample and (iii) apply the processed sample to the designated assay reagent, thereby providing a test reaction mixture in a reaction container;

[0016] (d) a transferring device comprising a first carrier configured to transfer the designated assay reagent among the plurality of assay reagents specific for the sample from the modular storage device to the sample applicator;

[0017] (e) at least one modular testing device configured to perform a designated test reaction specific for the sample depending on the identification information labeled on the sample container by using the test reaction mixture in the reaction container; and

[0018] (f) a controller configured to control (i) selecting the designated assay reagent specific for the sample among the plurality of assay reagents depending on the identification information labeled on the sample container and then transferring the designated assay reagent thus selected to the sample applicator, and (ii) selecting the modular testing device to perform the designated test reaction specific for the sample depending on the identification information labeled on the sample container and then transferring the test reaction mixture to the modular testing device thus selected.

[0019] Another aspect of the present disclosure is to provide a method for testing a sample, which comprises the steps of:

[0020] (a) loading the sample and reading an identification information labeled on a sample container containing the sample to receive a sample data corresponding to the identification information;

[0021] (b) based on the sample data, determining a sample processing protocol for the sample and processing the sample to provide a processed sample;

[0022] (c) based on the sample data, determining the type of the test for the sample;

[0023] (d) based on the type of the test for the sample, transferring a designated assay reagent specific for the sample among a plurality of assay reagents;

[0024] (e) based on the type of the test for the sample, providing a test reaction mixture containing the processed sample and the designated assay reagent by using a sample applicator; and

[0025] (f) based on the type of the test for the sample, automatically selecting a modular testing device to perform a designated test reaction specific for the sample, loading the test reaction mixture onto the modular testing device and performing the designated test reaction specific for the sample.

[0026] Still another aspect of the present disclosure is to provide a computer readable storage medium containing instructions to configure a processor to enable a continuous loadable module-typed system for a test to perform the following operations:

[0027] (a) upon receiving a sample, reading an identification information labeled on a sample container containing the sample and receiving a sample data corresponding to the identification information;

[0028] (b) based on the sample data, determining a sample processing protocol for the sample and controlling a modular processing device according to the sample processing protocol to provide a processed sample;

[0029] (c) based on the sample data, determining the type of the test for the sample;

[0030] (d) based on the type of the test for the sample, transferring a designated assay reagent specific for the sample among a plurality of assay reagents;

[0031] (e) based on the type of the test for the sample, controlling a sample applicator to provide a test reaction mixture containing the processed sample and the designated assay reagent;

[0032] (f) based on the type of the test for the sample, selecting a modular testing device to perform a designated test reaction specific for the sample and transferring the test reaction mixture to the modular testing device thus selected; and

[0033] (g) performing the designated test reaction according to a test reaction protocol specific for the type of the test.

[0034] The exemplary embodiment of the presently disclosed system is capable of receiving and processing new samples even while other samples are already being processed.

[0035] The exemplary embodiment of the presently disclosed system achieves a testing speed comparable to that of high-throughput systems, while also allowing samples to be introduced at any time. Accordingly, even in hospitals or clinics with relatively low testing volumes, patients can be tested without experiencing long waiting times for results.

[0036] The exemplary embodiment of the presently disclosed system can accommodate two or more types of reagents for sample processing, thereby enabling the handling of various types of samples. Furthermore, because there is no need to collect multiple samples of the same type for batch processing, rapid and immediate testing responses can be achieved.

[0037] The exemplary embodiment of the presently disclosed system may be configured to support (i) single tests, (ii) batch tests, (iii) syndromic tests and / or (iv) combination tests. In addition, the exemplary embodiment of the presently disclosed system automatically processes and tests samples based on identification information, without requiring the user to classify and load the samples according to test type.

[0038] The exemplary embodiment of the presently disclosed system is configured to utilize assay reagents that can be used both in the testing device of the presently disclosed system and in external stand-alone testing devices. Furthermore, the assay reagents exhibit substantially identical test results both in the testing device of the presently disclosed system and in external stand-alone testing devices. Thus, the development of diverse assay reagents used in the presently disclosed system can be achieved even with a stand-alone testing device and even without the presently disclosed system, thereby facilitating the development of testing products.

[0039] The exemplary embodiment of the presently disclosed system is an expandable system. Therefore, one or more modular devices can be added without substantial modification to the system. As such, the exemplary embodiment of the presently disclosed system can be flexibly configured in response to changing environments (e.g., test volume, test capacity and area of testing room).

[0040] It should be understood, however, that the advantages of the presently disclosed system are not limited to those described above, and may be variously extended within the scope and spirit of the present disclosure.

[0041] FIG. 1 is a block diagram describing an exemplary embodiment of the controller.

[0042] FIG. 2 is a schematic diagram of an exemplary embodiment of the presently disclosed system comprising modular devices and the transferring device between them.

[0043] FIG. 3A is a schematic diagram of an exemplary embodiment of the modular processing device used in the presently disclosed system.

[0044] FIG. 3B is a schematic illustration of an exemplary embodiment of a single nucleic acid extraction device used in the presently disclosed system.

[0045] FIG. 3C is a schematic illustration of an exemplary embodiment of a batch nucleic acid extraction device used in the presently disclosed system.

[0046] FIG. 4A is a schematic diagram of an exemplary embodiment of the modular storage device used in the presently disclosed system.

[0047] FIG. 4B is a schematic illustration of an exemplary embodiments of the modular storage device used in the presently disclosed system.

[0048] FIG. 4C is a schematic illustration of another exemplary embodiment of the modular storage device used in the presently disclosed system.

[0049] FIG. 4D is a schematic illustration of an inner part of a storage for liquid assay reagents.

[0050] FIG. 5A is a schematic diagram of an exemplary embodiment of the sample applicator used in the presently disclosed system.

[0051] FIG. 5B is a schematic illustration of another exemplary embodiment of the sample applicator used in the presently disclosed system.

[0052] FIG. 6A is a schematic diagram of an exemplary embodiment of the modular preparation device used in the presently disclosed system.

[0053] FIG. 6B is a schematic illustration of an exemplary embodiment of the modular preparation device used in the presently disclosed system.

[0054] FIG. 7A is a schematic diagram of an exemplary embodiment of the modular sample storage device used in the presently disclosed system.

[0055] FIG. 7B is a schematic illustration of an exemplary embodiment of the modular sample storage device used in the presently disclosed system.

[0056] FIG. 8A is a schematic diagram of an exemplary embodiment of the modular processed-sample storage device used in the presently disclosed system.

[0057] FIG. 8B is a schematic illustration of an exemplary embodiment of the modular processed-sample storage device used in the presently disclosed system.

[0058] FIG. 9 is a flow chart representing an embodiment of the presently disclosed test method by using the presently disclosed system.

[0059] FIG. 10 is a flow chart representing an embodiment of the sample processing procedure in the modular processing device .

[0060] FIG. 11 is a flow chart representing an embodiment of the application procedure of assay reagents in the sample applicator.

[0061] FIG. 12 is a flow chart showing an exemplary embodiment of a procedure for importing new assay reagent containers into the modular storage device.

[0062] FIG. 13 is a schematic illustration of another exemplary embodiment of of the presently disclosed system.

[0063] FIG. 14 is a flow chart representing another embodiment of the presently disclosed test method by using the presently disclosed system.

[0064] Hereinafter, a continuous loadable module-typed system for a test according to exemplary embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In the accompanying drawings, the same or similar reference numerals refer to the same or similar elements.

[0065] In present specification, specific structural and functional descriptions are merely exemplified for the purpose of explaining embodiments of the present disclosure, and the 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, but should be understood to include all modifications, equivalents, and substitutes included in the spirit and technical scope of the present invention. When a component is described as being "connected" or "in contact with" another component, it should be understood that it may be directly connected or in contact with the other component, but additional component may exist in between them. In addition, when a component is described as being "directly connected" or "in direct contact with" another component, it may be understood that there is no additional component in between them. Other expressions describing the relationship between components, such as "between" and "directly between" or "adjacent to" and "directly adjacent to", may be interpreted in the same way.

[0066] The terminology used in the present specification is for the purpose of describing embodiments only and is not intended to be limiting of the present disclosure. The singular expression includes the plural expression unless the context clearly indicates otherwise. In the present specification, it should be understood that the terms "comprise," "include," or "have" are intended to specify the presence of a feature, number, step, operation, component, part, or combination thereof, but do not exclude the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof. Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which this present invention belongs.

[0067] Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly defined in the present specification.

[0068] The terms first, second, and third may be used to describe various components, but these components are not limited by the terms. The terms are used for the purpose of distinguishing one component from another. For example, without departing from the scope of the present disclosure, the first component may be referred to as the second or third component, and similarly, the second or third component may be referred to interchangeably.

[0069]

[0070] I. Continuous Loadable Module-Typed System

[0071] In an aspect of the present disclosure, there is provided a continuous loadable module-typed system for a test, comprising:

[0072] (a) a modular processing device configured to process a sample to provide a processed sample; wherein the sample is contained in a sample container labeled with an identification information; wherein the modular processing device is configured to be able to additionally process another sample simultaneously with the processing of the sample;

[0073] (b) a modular storage device for an assay reagent configured to accommodate a plurality of assay reagents for different tests; wherein the plurality of assay reagents are in at least one type selected from the group consisting of a liquid type, a freeze-dried type and combination thereof;

[0074] (c) a sample applicator configured to (i) receive the processed sample from the modular processing device, (ii) receive from the modular storage device a designated assay reagent specific for the sample among the plurality of assay reagents depending on the identification information labeled on a sample container containing the sample and (iii) apply the processed sample to the designated assay reagent, thereby providing a test reaction mixture in a reaction container;

[0075] (d) a transferring device comprising a first carrier configured to transfer the designated assay reagent among the plurality of assay reagents specific for the sample from the modular storage device to the sample applicator;

[0076] (e) at least one modular testing device configured to perform a designated test reaction specific for the sample depending on the identification information labeled on the sample container by using the test reaction mixture in the reaction container; and

[0077] (f) a controller configured to control (i) selecting the designated assay reagent specific for the sample among the plurality of assay reagents depending on the identification information labeled on the sample container and then transferring the designated assay reagent thus selected to the sample applicator, and (ii) selecting the modular testing device to perform the designated test reaction specific for the sample depending on the identification information labeled on the sample container and then transferring the test reaction mixture to the modular testing device thus selected.

[0078]

[0079] The system of the present disclosure may be used in various tests.

[0080] The term used herein "test" in conjunction with the presently disclosed system refers to any test for analyzing any analyte [including pathogens (e.g., viruses, bacteria and fungi), target genes or sequences, chemicals, target proteins, antigens and antibodies] qualitatively or quantitatively. In an embodiment, the test may include molecular diagnostics, immunological diagnostics, biochemical diagnostics, cell culture tests, forensic tests and environmental contamination tests.

[0081] More specifically, the test may include molecular diagnostics. The term used herein "molecular diagnostics" or "MDx" means any diagnostics for analyzing DNA, RNA and their expression as proteins to identify genetic markers, detect pathogens and understand gene function in disease. The molecular diagnostics may be performed with gene amplification reactions such as PCR (polymerase chain reaction). Still more specifically, the test may be molecular diagnostics performed with a real-time PCR.

[0082] In an exemplary embodiment, the system of the present disclosure may be used in in vitro diagnostics (IVDs). The term used herein "in vitro diagnostics" refers to medical tests conducted outside the body on biological samples such as cell, tissue and fluid (e.g., blood) to detect diseases, conditions or infections.

[0083] The system of the present disclosure may be used in various tests for a sample. The term used herein "sample" refers to any material containing or suspected of containing an analyte. The sample may comprise a biological sample (e.g., cells, tissues and fluids from biological sources) and a non-biological sample (e.g., food, water and soil). The biological sample comprises, but not limited to, virus, bacteria, fungi, cell, tissue, blood (including whole blood, serum and plasma), lymph, spinal cord fluid (SCF), brain extracts (e.g., brain homogenates), sputum, swab (e.g., nasopharyngeal swab, cervical swab and vaginal swab), aspirate, bronchoalveolar lavage fluid, nasal lavage fluid, milk, urine, stool, ocular fluid, saliva, semen, appendix, spleen and tonsillar tissue extracts, ascitic fluid, amniotic fluid, liquid based cytology specimen and formalin-fixed paraffin-embedded (FFPE) sample.

[0084] The sample may comprise (i) natural-occurring nucleic acid molecules isolated from biological sources or synthetic nucleic acid molecules, (ii) proteins, antibodies or antigens and (iii) chemicals.

[0085] In an embodiment, the sample may further comprise materials for preservation, processing or detection of samples. For example, the sample may comprise supplementary materials such as amplification reaction reagent, detection reagent, preservative, distilled water, deionized water, saline, pH buffer, acidic and basic solution.

[0086] The presently disclosed system is a continuous loadable system. The term used herein "continuous loadable" or "continuous loading" in conjunction with the presently disclosed system means the capability of the system to accept and process additional samples without interrupting ongoing operations. More specifically, the term "continuous loadable" or "continuous loading" means the capability of the system to accept and process additional samples together with automatically providing additional reagents and consumables in line with introducing additional samples without interrupting ongoing operations.

[0087] The presently disclosed system is a module-typed system. The term used herein "module-typed" or "modular" in conjunction with the presently disclosed system means a system that comprises two or more self-contained modules, units or sections, each performing at least one defined function associated with testing, the modules being connectable, disconnectable, and replaceable to allow reconfiguration without substantial redesign of other modules. More specifically, the term used herein "module-typed" or "modular" in conjunction with the system means a system that comprises a modular processing device, a modular storage device a sample applicator, a transferring device and a modular testing device, each performing at least one defined function associated with testing, the modules being connectable, disconnectable, and replaceable to allow reconfiguration without substantial redesign of other modules. In an embodiment, the test capacity of the module-typed system is adjustable by additional connection or disconnection of at least one (more specifically two, still more specifically three) module selected from the group of consisting of the modular processing device, the modular storage device and the modular testing device. For example, additional modular testing devices may be installed into the module-typed system without substantial redesign of other modules and substantial change in a whole design of the system.

[0088] In addition, the devices (the processing device, the storage device and the testing device) in the presently disclosed system may be modular. The term used herein "modular" in conjunction with the devices means substantially the same as that for the presently disclosed system described above.

[0089]

[0090] [Modular Processing Device]

[0091] The presently disclosed system comprises a modular processing device.

[0092] As used herein, the term "processing" refers to any process to prepare a specimen (specifically, biological specimen) for analysis or test. More specifically, the term "processing" refers to any process to process or treat a sample (or primary sample) before performing a designated test reaction specific for the sample on a testing device. Still more specifically, the processing comprises a pretreatment process and / or a nucleic acid extraction process to provide an enriched, purified or isolated target analyte (specifically, nucleic acid molecule, protein, antibody, antigen or chemical) from the sample.

[0093] The processing device used in the presently disclosed system is modular. Accordingly, the processing device may comprise two or more self-contained devices, modules, units or sections, each performing a processing function, the modules being connectable, disconnectable, and replaceable to allow reconfiguration without substantial redesign of other modules.

[0094] In an exemplary embodiment, the modular processing device is a device that is structurally separated from the other devices including the modular storage device, the sample applicator and the modular testing device. The modular processing device may not be required to comprise an interlocking mechanism to connect to the other devices of the presently disclosed system. For example, the modular processing device may not be physically connected to the other devices of the presently disclosed system but operationally connected to the other devices of the presently disclosed system. In such case, the modular processing device may be placed at a location accessible by a transferring device (e.g., an articulated robot arm) configured to transfer sample containers and processing reagents.

[0095] When the processing device is a nucleic acid extraction device, the processing device may be configured to comprise (i) at least two single nucleic acid extraction devices, (ii) at least two batch nucleic acid extraction devices or (iii) at least one single nucleic acid extraction device and at least one batch nucleic acid extraction device. Alternatively, the processing device may be configured to comprise (i) at least two liquid-transfer nucleic acid extraction devices, (ii) at least two bead-transfer nucleic acid extraction devices or (iii) at least one liquid-transfer nucleic acid extraction device and at least one bead-transfer nucleic acid extraction device. Each of the nucleic acid extraction devices may be mounted on the presently disclosed system without substantial redesign of other nucleic acid extraction devices. Additional nucleic acid extraction devices may be installed on the presently disclosed system without substantial redesign of other nucleic acid extraction devices.

[0096] In an embodiment, the modular processing device comprises (i) a modular pretreatment device, (ii) a modular nucleic acid extraction device or (iii) a modular pretreatment device and a modular nucleic acid extraction device.

[0097] In an embodiment for molecular diagnostics, the modular processing device may comprise a modular nucleic acid extraction device, more specifically a modular pretreatment device and a modular nucleic acid extraction device. The modular nucleic acid extraction device may be classified into two types: a liquid transfer extraction device and a bead transfer extraction device. The liquid transfer extraction device comprises an automatic liquid handler with (i) pipette chancels to transfer samples and extraction reagents (including a magnetic bead, a lysis buffer, a binding buffer, a washing buffer and an elution buffer), (ii) a deck magnet and (iii) a deck heater and shaker. The bead transfer extraction device comprises magnetic rods covered by disposable tip-combs to carry, release and re-suspend magnetic beads as they pass through the binding, the washing and elution stages. The modular pretreatment device in conjunction with molecular diagnostics refers to a device that performs pre-analytic operations such as lysis / inactivation, proteolysis, mixing, physical or chemical disruption, separation / clarification, dilution and reagent conditioning, whereby a sample becomes suitable for nucleic acid purification and / or amplification. The modular pretreatment device may comprise at least one (specifically two, more specifically three, still more specifically four) selected from the group consisting of a centrifuge, a heater, a vortex mixer, a pipet channel and a decapper.

[0098] In an embodiment for immunological diagnostics, the modular processing device may comprise a modular pretreatment device. The modular pretreatment device in conjunction with immunological diagnostics refers to a device that conditions a sample before the actual immunoassay readout so that the target antigen / antibody can be measured accurately and reproducibly. The operations or functions of the modular pretreatment device include metering and mixing, dilution, chemical dissociation / unmasking of targets, blocking of interferences, cell / particle removal or phase separation, temperature-controlled incubation, magnetic capture and wash, plasma separation and hemolysis. The modular pretreatment device may comprise at least one (specifically two, more specifically three, still more specifically four) selected from the group consisting of a centrifuge, a heater, a vortex mixer, a pipette channel and a decapper.

[0099] In an embodiment for biochemical diagnostics, the modular processing device may comprise a modular pretreatment device. The modular pretreatment device in conjunction with biochemical diagnostics refers to a device that conditions a sample before analytical measurements so that the target analyte(s) can be quantified accurately and reproducibly. The operations or functions of the modular pretreatment device include metering and mixing, dilution, deproteinization, cell / particle removal or phase separation, temperature-controlled incubation, plasma separation and hemolysis. The modular pretreatment device may comprise at least one (specifically two, more specifically three, still more specifically four) selected from the group consisting of a centrifuge, a heater, a vortex mixer, a pipette channel and a decapper.

[0100] In an embodiment for cell culture tests, the modular processing device may comprise a modular pretreatment device. The modular pretreatment device in conjunction with cell culture tests refers to a device that conditions a sample before the analytical or cultivation step that follows. The operations or functions of the modular pretreatment device include metering and mixing, dilution, tissue dissociation to single cells, temperature-controlled incubation, centrifugal separation, plasma separation and hemolysis. The modular pretreatment device may comprise at least one (specifically two, more specifically three, still more specifically four) selected from the group consisting of a centrifuge, a heater, a vortex mixer, a pipette channel and a decapper.

[0101] The modular processing device is configured to process a sample to provide a processed sample. The term used herein "processed sample" refers to a sample being processed by the modular processing device, that contains a target analyte (specifically, a target nucleic acid molecule). In a specific embodiment, the processed sample is a sample being processed by (i) a pretreatment process, (ii) a nucleic acid extraction process or (iii) both a pretreatment process and a nucleic acid extraction process.

[0102] FIG. 3A is a schematic illustration of an exemplary embodiment of the modular processing device used in the presently disclosed system.

[0103] The modular processing device 200 may comprise a sample receiving part 210. The presently disclosed system may receive a sample through sample receiving part 210. The sample receiving part 210 may be equipped with a plurality of sample holders, each of which accommodates a respective sample container.

[0104] The modular processing device 200 may comprise a transferring module 270. The transferring module 270 transfers the sample container from a first sample carrier P1 to the sample receiving part 210 in the modular processing device 200. The transferring module 270 transfers the processed sample to a first processed sample carrier P4. The transferring module 270 may comprise a gripper, a lifting module or an articulated robot arm. Alternatively, the transferring device 900 such as an articulated robot arm located outside the modular processing device 200 may be used to load the sample into the modular processing device 200 and take out the processed sample from the modular processing device 200 as represented in FIGs. 13A and 13B.

[0105] The sample is contained in a sample container labeled with an identification information. The sample container may comprise any conventional sample container, tube, vessel or plate to receive, preserve / condition, identify or transport samples.

[0106] The sample container is labeled with an identification information (ID). The term used herein "identification information" refers to machine-readable data to identify samples distinctly from each other. The identification information may be numbers, letter, symbols or combinations thereof assigned uniquely to respective samples. The identification information may be in the form of bar code, QR code, other recognition patterns, RFID tag or NFC chip.

[0107] In an exemplary embodiment, the presently disclosed system or the modular processing device 200 may further comprise an identification information reader (ID reader) 240 capable of reading, scanning or decoding the identification information. The identification information reader 240 may include a bar code reader, QR code reader, camera and RFID reader. More specifically, the identification information reader 240 may be mounted on the modular processing device 200 such that the identification information reader 240 may read the identification information labeled on the sample container upon receiving the sample by the modular processing device 200.

[0108] According to an embodiment, the presently disclosed system or the modular processing device 200 is configured to read the identification information and receive a sample data corresponding to the identification information. The sample data may include the type of a sample, a sample identifier, the type of a test for a sample, information on a sample source (e.g., patient) and information on an assay reagent container for a sample. The type of the test may include a respiratory infection test, an MTB / NTM (Mycobacterium tuberculosis / nontuberculous Mycobacteria) test, a gastrointestinal infection test, HPV (human papilloma virus) infection test, a STI (sex-transmitted infection) test, a meningitis test, a mutation test, a SNP (single nucleotide polymorphism) test and a drug resistance test. The information on a sample source may include a patient identifier, and symptom, age, sex and underlying disease of a patient. The information on an assay reagent container for a sample may include the information on an assay reagent container containing a designated assay reagent for testing a sample.

[0109] According to an embodiment, the sample data comprises at least one (specifically two, more specifically three, still more specifically four) selected from the group consisting of the type of a sample, a sample identifier, the type of a test, information on a sample source (e.g., patient) and information on an assay reagent container for a sample.

[0110] The modular processing device 200 may comprise a sample processing part 220. The sample processing part 220 processes the sample received from the sample receiving part 210. The sample processing part 220 may aliquot the sample and then carry out the processing to provide the processed sample.

[0111] According to an embodiment, the modular processing device 200 may comprise a pipette module 250. The pipette module 250 is configured to dispense samples and reagents in the process of the processing. The pipette module 250 may comprise at least one pipette unit and motion unit. The pipette unit may include a pipette head and a pipette body. The pipette head may be equipped with a pipette tip and ensures aspiration and dispense of liquid. The pipette head may be vertically and moveably attached to the pipette body. The pipette body transmits power to the pipette head and controls the pipette head.

[0112] The pipette module 250 may comprise a motion unit to control movement of pipette units. The motion unit controls movement of the pipette module 250. Specifically, the motion unit allows for at least three motions among movements and rotations in x, y and z directions, enabling accurate movement of pipette units. The motion unit may be an articulated robot arm.

[0113] The modular processing device 200 is configured to be able to additionally process another sample simultaneously with the processing of the sample. Specifically, the modular processing device 200 may have the capability of accepting and processing additional samples without interrupting ongoing processing. The conventional high-volume full automation test systems generally process a plurality of samples simultaneously in a batch manner. The conventional POC (point-of-care) test systems in a cartridge type carry out processing and testing of a sample in a single cartridge and therefore a new test process may be carried out only after a sample test is completed.

[0114] In an exemplary embodiment, the modular processing device 200 is configured to provide a single processed sample from a single sample. The presently disclosed system 10 may apply the processed sample from a single sample to a plurality of assay reagents such that a plurality of tests may be performed. Therefore, for performing various tests by using a single sample, there is no need to provide a respective processed sample for each test.

[0115] When the modular processing device is a nucleic acid extraction device, it may be provided as either a single nucleic acid extraction device or a batch nucleic acid extraction device. More specifically, the nucleic acid extraction device used in the presently disclosed system comprises both a single nucleic acid extraction device or a batch nucleic acid extraction device.

[0116] FIG. 3B is a schematic illustration of an exemplary embodiment of a single nucleic acid extraction device used in the presently disclosed system. FIG. 3C is a schematic illustration of an exemplary embodiment of a batch nucleic acid extraction device used in the presently disclosed system.

[0117] In an exemplary embodiment, the modular processing device 200 is a single processing device configured to process a single sample to provide a single processed sample in the processing process. Alternatively, the modular processing device 200 is a batch processing device configured to process a plurality of samples simultaneously to provide a plurality of processed samples in the processing process. In an exemplary embodiment, the modular processing device 200 comprises both a single processing device and a batch processing device. The single processing device and the batch processing device may be modular.

[0118] In an exemplary embodiment, the modular processing device 200 comprises a nucleic acid extraction device, and the nucleic acid extraction device comprises two types of devices, one of two types of devices being a single nucleic acid extraction device configured to extract a nucleic acid molecule from a single sample individually in an extraction process and the other being a batch nucleic acid extraction device configured to extract nucleic acid molecules from a plurality of samples simultaneously in an extraction process. The single nucleic acid extraction device and the batch nucleic acid extraction device may be modular.

[0119] In an exemplary embodiment, the single nucleic acid extraction device comprises a pipette channel configured to extract the nucleic acid molecule from the single sample in a liquid transfer manner. The single nucleic acid extraction device may further comprise a deck magnet and a deck heater and shaker.

[0120] In an exemplary embodiment, the batch nucleic acid extraction device comprises a plurality of magnetic rods configured to extract the nucleic acid molecules from the plurality of samples simultaneously in a bead transfer manner.

[0121] According to an exemplary embodiment, processing reagents used in the modular processing device 200 may be bulk processing reagents. The bulk processing reagents are provided in such a manner that reagents in the amount enough to process at least two samples are contained a single vessel. In conventional processing systems to process individually samples as POC systems, a cartridge containing processing reagents for a single sample is used. Such systems do not need to aliquot and dispense processing reagents and therefore their structure may be relatively simplified, but they need a respective cartridge for each sample and thus their operation cost may be much higher. The modular processing device 200 may be configured to use bulk processing reagents for both the single processing device and the batch processing device, which contributes to reduction in the system operation cost. According to an exemplary embodiment, the modular processing device 200 comprises both the single processing device and the batch processing device configured to the same bulk processing reagents.

[0122] In an exemplary embodiment, the modular processing device 200 further comprises a bulk tank module 230 configured to accommodate bulk processing reagents for processing a plurality of samples. The bulk tank module 230 may comprise at least one processing reagent adaptor 231 configured to accommodate or attach a vessel containing bulk processing reagents.

[0123] In an exemplary embodiment, the modular processing device 200 may be configured to accommodate at least two types of processing reagents which are used for processing different types of samples. For example, the modular processing device 200 may be configured to accommodate both a processing reagent for processing viruses in sputum sample and a processing reagent for processing bacteria in stool sample.

[0124] According to an exemplary embodiment, the modular processing device 200 may be configured to select a designated processing reagent for the received sample among a plurality of processing reagents depending on the identification information labeled on the sample container, which allows the presently disclosed system to process and test a wide variety of samples.

[0125] According to an exemplary embodiment, the modular processing device 200 may comprise a storage for a processing reagent configured to accommodate a plurality of processing reagents and the control allows to control the storage for the processing reagent to selectively transfer a designated processing reagent for the sample among the plurality of processing reagents depending on the identification information labeled on the sample container.

[0126] The presently disclosed system 10 may further comprise additional device for processing samples besides the modular processing device 200.

[0127] According to an exemplary embodiment, the presently disclosed system 10 may further comprise a storage device for a processing reagent configured to provide the modular processing device 200 with the processing reagent. Specifically, the storage device is configured to retrieve the materials for processing the sample from the modular processing device 200 and then stores the materials thus retrieved.

[0128] In an exemplary embodiment, the presently disclosed system 10 may further comprise an automatic decapper for the sample container.

[0129] After processing the sample, the processed sample is generally added to a container. According to an exemplary embodiment, the presently disclosed system 10 may further comprise a capper 260 to cap a container containing the processed sample. The capper 260 may be mounted in the inner part of the modular processing device 200.

[0130]

[0131] FIG. 3B is a schematic illustration of an exemplary embodiment of a single nucleic acid extraction device used in the presently disclosed system, which shows a modular processing device to process samples by a single sample container. In FIG. 3B, the sample container may be a processing sample container S2.

[0132] The sample containers received on a sample receiving part 210 may be scanned by an identification information reader (ID reader) 240 and transferred in a one-by-one manner to a sample processing part 220. When necessary, a capper 260 may decap a cap of the sample container.

[0133] The modular processing device 200 may comprise a sample receiving part 210. The sample receiving part 210 is a region for stably loading and holding processing sample containers S2 which may have various shapes. The sample receiving part 210 may be configured in the form of a plurality of holders, slots and trays. The sample receiving part 210 may have a circular or rectangular mounting part. Alternatively, the sample receiving part 210 may be configured to accommodate a holder or tray containing a plurality of sample containers. The sample receiving part 210 may be equipped with a temperature-control module (e.g., peltier element, heat block, cooling fan and ice block) for preventing deterioration of samples or setting a certain reaction condition. In addition, the sample receiving part 210 may comprise a photo sensor, a proximity sensor or a pressure sensor to sense whether sample containers are loaded.

[0134] The processing sample containers S2 accommodated in sample receiving part 210 may be identified by the identification information reader 240. The identification information reader 240 is a device to read a bar code, QR code or RFID tag labeled on the processing sample containers S2 and identify a sample ID and the type and production batch (lot) information of an assay reagent to test the sample. The identification information reader 240 may be an optic scanner, an image scanner or a radio frequency scanner.

[0135] The capper 260 may be configured to decap and cap the sample container. In the exemplary embodiment, the capper 260 is a device to automatically open or close the top (e.g., cap, seal and stoper) of various containers such as the processing sample container S2. The capper 260 may be constructed in various forms. For example, the capper 260 may comprise a gripping part and a supporting part. The gripping part is configured to directly hold the sample container, including a mechanical clamp, a rubber pad and an adsorptive suction pad. The supporting part may comprise a holder or clamp for stably fixing a body of the sample container. The capper 260 may comprise an electric motor, a pneumatic cylinder or a linear actuator for operation of the gripping part and the supporting part. The capper 260 may further comprise a temporary storing part to store a cap used in recapping.

[0136] The decapped processing sample container S2 may be transferred to the sample processing part 220 by a transferring module 270. The transferring module 270 is a module to transfer (i) various types of sample containers such as the processing sample container S2 and a single-typed processing sample container S3, (ii) various processing reagents such as a bulk processing reagent container R1, (iv) consumables C1 and (v) reaction containers. The transferring module 270 may comprise a gripper, a lift or an articulated robot arm. For reliably sensing, gripping and transferring deliverables, the transferring module 270 may comprise a position sensor, an optic sensor, a pneumatic sensor or a camera-based vision module.

[0137] The sample processing part 220 is a region where the sample contained in the processing sample container S2 is processed. For example, the sample processing part 220 is a region where the sample contained in the processing sample container S2 is subject to pretreatment and nucleic acid extraction. The sample processing part 220 may comprise a station for correctly positioning various sample processing components, ensuring the exact approaching of a pipette module 250 or the transferring module 270. For example, the sample processing part 220 may comprise a station where the consumables C1 are placed and a station where single-typed processing sample containers S3. The sample processing part 220 may comprise a sample processing unit 221. The sample processing unit 221 may be plural. Each sample processing unit 221 may be configured to perform each step of a sample processing process. For example, the sample processing unit 221 may comprise a heater for heating samples. The sample processing unit 221 may comprise a magnetic capturing means to capture magnetic materials in samples. The sample processing unit 221 may comprise a spinning or agitating means for mixing samples and reagents. Following the completion of a certain step on a certain sample processing unit, the processing sample container S2 may be transferred to next sample processing unit by the transferring module 270. The sample finally processed is then added to the single-typed processing sample container S3 and transferred to the sample applicator 400.

[0138] According to an embodiment, the modular processing device 200 may comprise a pipette module 250. The pipette module 250 is configured to dispense samples and reagents in the process of the processing. The pipette module 250 may comprise at least one pipette unit and motion unit. The pipette unit may include a pipette head and a pipette body. The pipette head may be equipped with a pipette tip and ensures aspiration and dispense of liquid. The pipette head may be vertically and moveably attached to the pipette body. The pipette body transmits power to the pipette head and controls the pipette head.

[0139] The pipette module 250 may comprise a motion unit to control movement of pipette units. The motion unit controls movement of the pipette module 250. Specifically, the motion unit allows for at least three motions among movements and rotations in x, y and z directions, enabling accurate movement of pipette units. The motion unit may be an articulated robot arm.

[0140] In an exemplary embodiment, the modular processing device 200 further comprises a bulk tank module 230 configured to accommodate bulk processing reagents for processing a plurality of samples. The bulk processing reagents may be contained in the bulk processing reagent container R1. The bulk tank module 230 may comprise at least one processing reagent adaptor 231 configured to accommodate or attach a vessel containing bulk processing reagents. The bulk tank module 230 may comprise a level sensor, a pneumatic sensor or a flow sensor for sensing the residual amount of the bulk processing reagent in the bulk processing reagent container R1. The pipette module 250 may aliquot the bulk processing reagent in the bulk processing reagent container R1 and dispense into the processing sample container S2 mounted on the sample processing unit 221.

[0141] The waste box 280 is a region where used pipette tips, tubes, plates and liquid waste are collected. For example, the used pipette tips and liquid waste are transferred to the waste box 280. The inner part of the waste box 280 may be constructed as a closed-type cartridge which is replaceable, and may comprise adsorbent or activated carbon filter to prevent leakage of contaminants.

[0142] The single processing device 200a may be configured to process samples in a continuous manner. Therefore, the single processing device 200a allows for a continuous loading in which upon loading a sample into the presently disclosed system, the sample may be immediately processed without waiting for collection of samples. Where there is a plenty of samples to be processed, they may be processed all at once in the batch processing device 200b.

[0143] In an exemplary embodiment, the modular processing device 200 comprises either the single processing device 200a or the batch processing device 200b. In an exemplary embodiment, the modular processing device 200 comprises both the single processing device 200a and the batch processing device 200b.

[0144]

[0145] As another exemplary embodiment, FIG. 3C is a schematic illustration of a batch nucleic acid extraction device to perform an extraction process in a bead transfer manner.

[0146] Unlike FIG. 3B, the sample receiving part 210 is configured to accommodate not only the single-typed processing sample container S3 but also a batch-typed processing sample container S4 capable of simultaneously accommodating a plurality of samples. The batch-typed processing sample container S4 may be a multi-well plate or a deep-well plate to accommodate a plurality of samples in one container. As such, the batch nucleic acid extraction device may carry out effective nucleic acid extraction under situations requiring high-throughput analysis.

[0147] In FIG. 3C, the sample processing part 220 having an optimal construction for a batch processing may be configured to accommodate prefilled processing-reagent containers R2. The prefilled processing-reagent container R2 may comprise multi-wells prefilled with processing reagents for simultaneously processing a plurality of samples. The sample processing part 220 may be configured to be placed with a plurality of prefilled processing-reagent containers R2. Each of the prefilled processing-reagent containers R2 may be configured to perform each step of a sample processing process.

[0148] The sample processing part 220 of the batch processing device 200b may comprise a station for correctly positioning the batch-typed processing sample containers S4. The station may comprise a heater for heating the batch-typed processing sample containers S4.

[0149] The sample processing part 220 of the batch processing device 200b may comprise a magnetic rod module 255. The magnetic rod module 255 is used to isolate and purify a nucleic acid molecule in a bead transfer manner. The magnetic rod module 255 transfers magnetic beads contained in a prefilled processing-reagent containers R2 to another prefilled processing-reagent containers R2. The magnetic rod module 255 may comprise parallel-arranged magnetic rods. The magnetic rods may be a permanent magnet or electromagnet. The magnetic rod module 255 comprises a motion unit to control movement of the magnetic rod module 255. Specifically, the motion unit allows for at least three motions among movements and rotations in x, y and z directions, enabling accurate movement of the magnetic rod module 255. The motion unit may be an articulated robot arm.

[0150] The sample processing part 220 of the batch processing device 200b may comprise a seal remover 290. The prefilled processing-reagent containers R2 are provided with their top layer sealed and therefore required for seal removal before use. The seal remover 290 may comprise a gripper to peel off a sealing film or a punching means to punch a sealing film.

[0151]

[0152] The modular processing device 200 may be easily mounted in the presently disclosed system 10. For example, the modular processing device 200 may be mounted in the presently disclosed system 10 by placing, securing or fixing the modular processing device 200 on a location, specifically a specific location that the transferring module 270 (or the transferring device 900 such as an articulated robot arm) may be operationally connected to. In such case, sample containers and extraction reagents may be automatically transferred to the modular processing device 200. According to an embodiment, a plurality of the modular processing devices 200 may be mounted in the presently disclosed system 10 by placing separately the modular processing devices 200 on specific locations that one transferring module 270 (or one transferring device 900 such as an articulated robot arm) may be operationally connected to. In such case, there is no need for connection between the plurality of the modular processing devices 200.

[0153]

[0154] In describing other embodiments, the elements, parts or components same as those of the embodiment previously described are described with the same refence numbers as the embodiment previously described. The common descriptions between them are omitted in order to avoid undue redundancy leading to the complexity of this specification.

[0155]

[0156] [Assay Reagent, Assay Reagent Container and Reaction Container]

[0157] The plurality of assay reagents are used in the presently disclosed system 10 to test a variety of samples. The assay reagents are contained in assay reagent containers. The assay reagents may be in at least one type selected from the group consisting of a liquid type, a freeze-dried type and combination thereof.

[0158] The compositions of the assay reagents are determined depending on the type of samples and the type of tests.

[0159] When the presently disclosed system 10 is operated for molecular diagnostics, the compositions of the assay reagents may comprise primers, labeled probes, enzymes (e.g., DNA polymerase and reverse transcriptase) and buffers. When the presently disclosed system 10 is operated for immunological diagnostics, the compositions of the assay reagents may comprise buffers, protein stabilizers, chemiluminescent substrates, colorimetric substrates and antibodies.

[0160] In an exemplary embodiment, the assay reagents in the liquid type or the freeze-dried type comprises each at least two reagent components specific for each of the different tests. More specifically, the at least two reagent components specific for each of the different tests in the liquid type is contained in an individual assay reagent container. Still more specifically, the at least two reagent components specific for each of the different tests in the liquid type comprises (i) primers and probes in an oligonucleotide tube and (ii) enzymes in an enzyme tube used in a molecular diagnostic test.

[0161] In an exemplary embodiment, the at least two reagent components specific for each of the different tests in the freeze-dried type are pre-contained all in the reaction container. When freeze-dried reagent components are pre-contained in assay reagent containers, the assay reagent containers may also serve as a reaction container. More specifically, the at least two reagent components specific for each of the different tests in the freeze-dried type exist as (i) a single lyobead form containing primers, probes and enzymes or (ii) separate lyobeads one of which contains primers and probes and the other contains enzymes.

[0162] One of features and advantages of the presently disclosed system is that the presently disclosed system may be operated to selectively perform either a batch test or a single test depending on the identification information labeled on the sample container. More specifically, the presently disclosed system may be operated to perform selectively a test among a batch test, a single test and a syndromic test depending on the identification information labeled on the sample container. Still more specifically, the presently disclosed system may be operated to perform selectively a test among a batch test, a single test, a syndromic test and a combinatorial test depending on the identification information labeled on the sample container. The assay reagents, assay reagent containers and reaction containers used in the presently disclosed system may be prepared according to the type of test.

[0163] To my best knowledge, the presently disclosed system is the first test system allowing the type of tests to be automatically switched between a batch test and a single test (more specifically, a batch test, a single test and a syndromic test, still more specifically, a batch test, a single test, a syndromic test and a combinatorial test) depending on an identification information labeled on a sample container.

[0164] The term used herein "single test" means that one test is conducted for a single sample. For example, a single processed sample is added into a single well of a reaction container and then a test on the modular testing device is carried out. For example, a reaction container for the single test may have a single well for a processed sample. The reaction container for the single test may have wells for a positive control and a negative control. The single test may include a test for a target analyte by using a single sample in a single well of the reaction container (i.e., monoplex test) and a test for multiple target analytes in a single well of the reaction container (i.e., multiplex test). For example, the single test may include (i) a test for detecting SARS-CoV2 as a target analyte by using a single sample in a single well of the reaction container, or (ii) a respiratory infection test for detecting SARS-CoV2, Influenza virus and Respiratory syncytial virus as multiple target analytes by using a single sample in a single well of the reaction container.

[0165] The term used herein "batch test" means that one test is conducted for a plurality of samples. For example, a plurality of processed samples are added into different wells of a reaction container and then a test on the modular testing device is carried out. For example, a reaction container for the batch test may have a plurality of wells for processed samples. The plurality of wells comprise the same assay reagent for one test. For example, the batch test may include (i) a test for detecting SARS-CoV2 as a target analyte by using a plurality of samples in a plurality of wells of the reaction container, or (ii) a respiratory infection test for detecting SARS-CoV2, Influenza virus and Respiratory syncytial virus as multiple target analytes by using a plurality of samples in a plurality of wells of the reaction container.

[0166] The term used herein "syndromic test" refers to a test to simultaneously detect multiple analytes (e.g., pathogens) in one test run for identifying the cause of a specific symptom. Specifically, the syndromic test means that at least two types of tests in which the tests detect different analytes from each other are conducted in one reaction container for either a single sample or a plurality of samples in order to identify the cause of a specific symptom. For example, a single processed sample is added into different wells of a reaction container and then a test procedure on the modular testing device is carried out. For example, a reaction container for the syndromic test may have a plurality of wells for a processed sample. The plurality of wells comprise different assay reagents. For example, the syndromic test for a single sample may include (i) as a first test, a respiratory virus infection test to detect respiratory infection viruses (e.g., SARS-CoV2, Influenza virus and Respiratory syncytial virus) in a well of the reaction container, and (ii) as a second test, a respiratory bacteria infection test for detecting respiratory infection bacteria (e.g.,Mycoplasma pneumoniae,Streptococcus pneumoniaeandBordetella pertussis) in another well of the reaction container.

[0167] The term used herein "combinatorial test" refers to a test for a single sample to detect multiple analytes (e.g., pathogens) (specifically, in a simultaneous manner) for identifying the cause of a similar symptom. For example, pneumonia and tuberculosis show a similar symptom. The combinatorial test may be carried out to identify the cause of a similar symptom between pneumonia and tuberculosis. Specifically, the combinatorial test may be carried out by adding a single sample to at least two reaction containers which comprise different assay reagents.

[0168] According to an exemplary embodiment, the assay reagent container may comprise an identification information. The descriptions of the identification information labeled on the sample container may also be applied to the identification information of the assay reagent container. For example, the identification information labeled on the assay reagent container may be in the form of bar code, QR code, other recognition patterns, RFID tag or NFC chip.

[0169] When freeze-dried assay reagents are pre-contained in assay reagent containers, the assay reagent containers may serve as a reaction container. The assay reagent container for freeze-dried assay reagents may have at least one reaction site. The reaction site serves as a space where a mixture of assay reagents and a processed sample is located during a testing process on a testing device. The assay reagents pre-contained in the assay reagent container may be located in the reaction site. In such case, the assay reagent container may comprise no additional space to store the assay reagents pre-contained. Alternatively, at least a portion of the assay reagents may be stored in a region of the assay reagent container different from the reaction site and move to the reaction site upon introducing the processed sample. In such case, the assay reagent container may comprise additional storing space for the assay reagents pre-contained.

[0170] When freeze-dried assay reagents are pre-contained in assay reagent containers, the assay reagent containers serving as the reaction container may comprise at least one well (or chamber). The well is a recess structure configured to accommodate the assay reagent and the processed sample. The assay reagent may be located in the well. The well may also serve as a storing space.

[0171] When freeze-dried assay reagents are pre-contained in assay reagent containers, the assay reagent containers serving as the reaction container may comprise a plate-typed reaction container having a top layer that is film sealable. The plate-typed reaction container may comprise at least two wells aligned horizontally. The wells have openings at their top portion through which the processed samples are introduced. The openings are configured to be sealable with a cap or film.

[0172] When freeze-dried assay reagents are pre-contained in assay reagent containers, the assay reagent containers serving as the reaction container may require a two-time sealing process. For example, the assay reagent container is added with the assay reagent and then sealed, which is a first sealing. According to an exemplary embodiment, the sealed assay reagent container prefilled with the assay reagent may be provided. The sealing may be performed by using an optically transparent sealing film or a foil sealing film. Alternatively, the sealing may be performed by using a cap. In a testing process of the presently disclosed system for molecular diagnostics, the first sealing is removed or disrupted and then the assay reagent container is further added with the processed sample, followed by resealing (called as a second sealing) before placing the assay reagent container on the testing device. The sample applicator of the presently disclosed system may receive the sealed assay reagent container and then remove or punch then the first sealing and apply the processed sample to the opened assay reagent container. The assay reagent container with the processed sample may be resealed and transferred to the testing device. The second sealing may be performed by using an optically transparent sealing film or a cap. The film sealing may be conducted in a thermal welding manner or an adhesion manner using an adhesive.

[0173] When freeze-dried assay reagents are pre-contained in assay reagent containers, the assay reagent containers serving as the reaction container may have a top layer that is film sealable. According to an exemplary embodiment, the film-sealable top layer may comprise an extruded pattern for film sealing. For example, the extruded pattern may be formed around the opening of each well of the assay reagent container. The film adheres to the extruded pattern and then the sealing is substantially completed. The extruded pattern may be used for the second sealing.

[0174] When freeze-dried assay reagents are pre-contained in assay reagent containers, the assay reagent containers may be configured to serve as the reaction container in both the modular testing device and a stand-alone testing device. According to an exemplary embodiment, the assay reagent container may be configured to exhibit a substantially same test result in both the modular testing device and a stand-alone testing device. The modular testing device is a device assembled into the presently disclosed system and the stand-alone testing device is a device used alone without assembling into any system. When the assay reagent container is workable as the reaction container in both the modular testing device and a stand-alone testing device and exhibits a substantially same test result in both the modular testing device and a stand-alone testing device, an assay reagent container developed based on a stand-alone testing device may be used itself in the presently disclosed system. Such feature allows researchers to develop assay reagents for the presently disclosed system with no use of the presently disclosed system. The phrase "the assay reagent container is workable as the reaction container in both the modular testing device and a stand-alone testing device" also means that the assay reagent containerper semay be mounted on the stand-alone testing device, particularly the wells of the assay reagent container are arranged or aligned in such a manner that the well arrangement or alignment is fit into the stand-alone testing device. The wells thus arranged contain a mixture of the assay reagent and the processed sample, serving as the reaction site of the assay reagent container. According to an exemplary embodiment, the reaction sites of the assay reagent container are arranged in such a manner that they may be mounted on both the modular testing device and a stand-alone testing device. To this end, the reaction sites of the assay reagent container may have a shape same as a portion of standard reagent containers or reaction containers conventionally used in the art. Specifically, the wells of the assay reagent container may be substantially the same as the wells of conventional reagent containers or reaction containers in terms of shape, size and arrangement. According to an exemplary embodiment, the assay reagent container may be a container having a plurality of wells prefilled with assay reagents. The assay reagent container may at least two wells in its reaction site. The number of wells may be ranged from 2 to 100. Specifically, the number of wells may be at least 2, 4, 6 or 8. The number of wells may be less than 12, 16, 24, 32, 64 or 96. More specifically, the number of wells may be between 6 and 96.

[0175] According to an exemplary embodiment, when freeze-dried assay reagents are pre-contained in assay reagent containers serving as the reaction container, the presently disclosed system may be configured to use the assay reagent containers for a single test and the assay reagent containers for a batch test, more specifically, the assay reagent containers for a single test, the assay reagent containers for a batch test and the assay reagent containers for a syndromic test, still more specifically, the assay reagent containers for a single test, the assay reagent containers for a batch test, the assay reagent containers for a syndromic test and the assay reagent containers for a combinatorial test.

[0176]

[0177] [Modular Storage Device]

[0178] The presently disclosed system comprises the modular storage device for an assay reagent. The modular storage device for an assay reagent is configured to accommodate a plurality of assay reagents for different tests and release assay reagents to the sample applicator. The assay reagent is generally contained in a reagent container.

[0179] The storage device for assay reagents used in the presently disclosed system is modular. Accordingly, the storage device may comprise two or more self-contained devices, modules, units or sections, each performing a storage function (specifically, a storage function and a release function), the modules being connectable, disconnectable, and replaceable to allow reconfiguration without substantial redesign of other modules. For example, the modular storage device may be configured to comprise at least two storage devices. Each of the storage devices may be installed on the presently disclosed system without substantial redesign of other storage devices. One of the storage devices may be configured to store liquid-type assay reagents and the others may be configured to store freeze-dried type assay reagents. Additional storage devices may be installed on the presently disclosed system without substantial redesign of other storage devices.

[0180] In an exemplary embodiment, the modular storage device is a storage device that is structurally separated from the other devices including the modular processing device, the sample applicator and the modular testing device. More specifically, the modular storage device is detachable from the other devices without affecting them. The modular storage device may not be required to comprise an interlocking mechanism to connect to the other devices of the presently disclosed system. For example, the modular storage device may not be physically connected to the other devices of the presently disclosed system but operationally connected to the other devices of the presently disclosed system. In such case, the modular storage device may be placed at a location accessible by a transferring device (e.g., an articulated robot arm) configured to transfer sample containers and processing reagents.

[0181] The presently disclosed system obtains information on the test to be performed for the received sample from the identification information labeled on the sample container, and then controls the modular storage device to release an assay reagent for the test to the sample applicator.

[0182] FIGs. 4A and 4B are schematic illustrations of exemplary embodiments of the modular storage device 300 used in the presently disclosed system.

[0183] The modular storage device 300 comprises a reagent-container storing region 310 for storing reagent containers. In the container storing region 310, a plurality of reagent containers for different tests may be stored.

[0184] The modular storage device 300 may be configured such that a user may directly place reagent containers on the container storing region 310. Alternatively, the modular storage device 300 may comprise a reagent-container receiving part 340 for receiving reagent containers. Upon placing a tray loaded with reagent containers on the reagent-container receiving part 340, the modular storage device 300 may read an identification information labeled on the received reagent containers and then transfer the received reagent containers to the container storing region 310 for storage.

[0185] The modular storage device 300 may comprise a reagent-container transferring module 320 in its inner part. The reagent-container transferring module 320 may include a gripper, a lifting module or an articulated robot arm. The reagent-container transferring module 320 transfers reagent containers. The reagent-container transferring module 320 may transfer reagent containers received on the reagent-container receiving part 340 to the container storing region 310 in the modular storage device 300. The reagent-container transferring module 320 may select a reagent container of interest among reagent containers placed on the container storing region 310 and then transfer the selected reagent container to the transferring device 900 (specifically a first carrier P7) of the presently disclosed system. In an exemplary embodiment, the modular storage device 300 comprises a gripper to transfer selectively the designated assay reagent among the plurality of assay reagents to a location accessible to the first carrier P7 and then the first carrier transfers the designated assay to the sample applicator.

[0186] In an exemplary embodiment, the modular storage device 300 may comprise a means for identifying reagent containers containing assay reagents stored in the modular storage device 300. The means for identifying may be an identification information reader 330. The identification information reader 330 reads an identification information of reagent containers. Upon receiving a new reagent container, the identification information reader 330 reads its identification information and stores or transmits information on the type and storage location of the new reagent container. In addition, after selecting a reagent container to be transferred to the sample applicator, the identification information reader 330 reads an identification information of the selected reagent container to verify whether the selected reagent container is a reagent container to be transferred to the sample applicator. The identification information reader 330 may include a bar code reader, QR code reader, camera and RFID reader. The identification information reader 330 may be fixedly mounted inside the modular storage device 300. Alternatively, the identification information reader 330 may be configured to be attached to the reagent-container transferring module 320 and move together with the reagent-container transferring module 320.

[0187] The modular storage device 300 may comprise an internal temperature-control module. The internal temperature-control module allows to keep maintaining an internal temperature of the modular storage device at a predetermined temperature such that reagent containers may be stored at optimal temperature. The internal temperature-control module may be configured to adjust an internal humidity of the modular storage device depending on the type of assay reagents (i.e., a liquid type and a freeze-dried type).

[0188] In an exemplary embodiment, the modular storage device 300 may comprise at least two container storing regions 310 and temperatures of the at least two container storing regions are controlled independently from each other. In an exemplary embodiment, the modular storage device 300 may comprise two storages (e.g., container storing regions) combined or separated and temperatures of the two storages are controlled independently from each other. The modular storage device 300 may store reagent containers of which optimal storage temperatures are different from each other. For instance, the modular storage device 300 may store separately reagent containers for refrigeration and reagent containers for frozen storage in different container storing regions 310.

[0189]

[0190] FIG. 4C is a schematic illustration of another exemplary embodiment of the modular storage device 300 used in the presently disclosed system. The modular storage device 300 may comprise a room-temperature storage 300a for assay-reagent containers and a refrigerated or frozen storage 300b for liquid assay reagents. For example, freeze-dried assay reagents may be stored at room temperature. Liquid assay reagents usually need for a refrigerated storage and some liquid assay reagents such as enzymes need for a frozen storage. FIG. 4D schematically represents an inner part of a refrigerated or frozen storage 300b for liquid assay reagents.

[0191] The refrigerated or frozen storage 300b for liquid assay reagents may comprise a transferring module 320. The modular storage device 300 may be equipped with one transferring module 320 to transfer assay reagent containers stored both in the room-temperature storage 300a and in the refrigerated or frozen storage 300b. Alternatively, each of the room-temperature storage 300a and the refrigerated or frozen storage 300b is configured to comprise its respective transferring module 320.

[0192] The transferring module 320 of the refrigerated or frozen storage 300b may comprise a gripper, a lift or an articulated robot arm configured to transfer assay reagent containers stored both in a refrigerated region 300b1 and in a frozen region 300b2. The transferring module 320 of the refrigerated or frozen storage 300b may be configured to access to the refrigerated region 300b1 and the frozen region 300b2 and then transfer onto a taking-out part 350 assay reagent containers stored in the refrigerated region 300b1 and in the frozen region 300b2.

[0193] The refrigerated region 300b1 and the frozen region 300b2 may respectively comprise an opening configured to be opened and closed toward the outside. Alternatively, the refrigerated region 300b1 and the frozen region 300b2 may respectively comprise an opening configured to be opened and closed toward the interior of the refrigerated or frozen storage 300b, thereby allowing the transferring module 320 in the refrigerated or frozen storage 300b to access the refrigerated region 300b1 and the frozen region 300b2.

[0194] The refrigerated or frozen storage 300b may be configured to accommodate bulk assay reagent containers R3. The refrigerated or frozen storage 300b may be configured to accommodate reaction containers R5 prefilled with liquid assay reagents.

[0195]

[0196] According to an exemplary embodiment, when freeze-dried assay reagents are pre-contained in assay reagent containers serving as the reaction container, the modular storage device 300 is configured to accommodate the assay reagent containers for a single test and the assay reagent containers for a batch test, more specifically, the assay reagent containers for a single test, the assay reagent containers for a batch test and the assay reagent containers for a syndromic test, still more specifically, the assay reagent containers for a single test, the assay reagent containers for a batch test, the assay reagent containers for a syndromic test and the assay reagent containers for a combinatorial test.

[0197] According to an exemplary embodiment, the modular storage device 300 may be configured to accommodate at least two types of the assay reagent containers of which sizes are different from each other. For example, when freeze-dried assay reagents are pre-contained in assay reagent containers serving as the reaction container, the modular storage device 300 is configured to accommodate the assay reagent containers for a single test and the assay reagent containers for a batch test where the assay reagent containers for a batch test have a size bigger than the assay reagent containers for a single test.

[0198] According to an exemplary embodiment, the modular storage device 300 may comprise slots with different sizes in a single container storing region 310 for storing assay reagent containers. Alternatively, the modular storage device 300 may comprise trays for storage to accommodate assay reagent containers with different sizes. According to an exemplary embodiment, the reagent-container transferring module 320 may be configured to transfer assay reagent containers with different sizes.

[0199]

[0200] As described above, because the modular storage device 300 is modular, it may be flexibly expandable and adjustable in line with a test laboratory environment or capacity. For example, at least two modular storage devices may be connected to the presently disclosed system. The at least two modular storage devices may have different storage temperatures. In such case, the controller selects a modular storage device storing an assay reagent container of interest and then controls taking the assay reagent container of interest out of the selected modular storage device. The modular storage device may be replaced with another modular storage device with a different storage capacity. As described above, because the presently disclosed system is constructed with modular devices, the modular storage device may be added and replaced without change of other devices.

[0201] With referring to FIG. 12, a procedure for bringing new assay reagent containers into the modular storage device 300will be described hereunder. FIG. 12 is a flow chart showing an exemplary embodiment of a procedure for bringing new assay reagent containers into the modular storage device.

[0202] Upon receiving a new assay reagent container, the modular storage device 300 reads an identification information of the received assay reagent container and transmits the identification information to the controller (P100). The new assay reagent container is introduced into the modular storage device 300, the identification information reader 330 scans the identification information of the assay reagent container and then transmits the identification information to the controller.

[0203] Afterwards, based on the transmitted identification information and a storage status of the modular storage device 300, the controller determines a storage location of the received assay reagent container (P200). The controller identifies a location where the received assay reagent container may be stored based on a storage status of the modular storage device 300 and then determines a storage location of the received assay reagent container.

[0204] The assay reagent container is then stored at the determined storage location (P300). The controller controls the modular storage device 300 to store the received assay reagent container at the determined storage location by the reagent-container transferring module 320.

[0205] Then, after mapping the identification information of the assay reagent container with the storage location information, the storage status of the modular storage device 300 is updated (P400). Following the completion of storage of the received assay reagent container, the identification information of the assay reagent container is mapped with information on its storage location. When the assay reagent container is required for later test, the modular storage device 300 may take out the assay reagent container based on the information on the storage location.

[0206]

[0207] [Sample Applicator]

[0208] The presently disclosed system comprises the sample applicator. The sample applicator receives the processed sample from the modular processing device, receives from the modular storage device a designated assay reagent specific for the sample among the plurality of assay reagents depending on the identification information labeled on the sample container, and then applies the processed sample to the designated assay reagent, thereby providing a test reaction mixture in a reaction container.

[0209] FIG. 5A is a schematic illustration of an exemplary embodiment of the sample applicator used in the presently disclosed system. FIG. 5B is a schematic illustration of another exemplary embodiment of the sample applicator used in the presently disclosed system.

[0210] According to an exemplary embodiment, the sample applicator 400 may comprise a housing. The housing separates the inner part of the sample applicator 400 from external environment. In the housing of the sample applicator 400, the sample applicator 400 removes the seal of the assay reagent container and then applies the processed sample to the designated assay reagent to provide the test reaction mixture in the reaction container. Therefore, the housing may prevent contamination in the process of preparing the test reaction mixture and ensures accurate tests. The housing may have a first passage through which the processed sample is transferred into the housing of the sample applicator. The housing may have a second passage through which the reaction container containing the processed sample is transferred to the sealer or the testing device.

[0211] The sample applicator 400 may include an identification information reader 440 capable of reading, scanning or decoding an identification information. The identification information reader 440 may include a bar code reader, QR code reader, camera and RFID reader. An identification information labeled on a container containing the processed sample is read by the identification information reader 440, an assay reagent to test the processed sample is identified, and then an identification information labeled on an assay reagent container transferred from the modular storage device 300 is read to verify whether the transferred assay reagent container is the assay reagent to test the processed sample.

[0212] According to an exemplary embodiment, the sample applicator 400 may further comprise a decapper for the assay reagent container. According to an exemplary embodiment, the sample applicator 400 may further comprise a seal-removing means for a seal of the assay reagent container. The seal-removing means 460 punches or peels off a foil or film sealing the assay reagent container. The seal-removing means 460 may be a peeling-off type by use of a gripper or a punching type by use of a punching means.

[0213] According to an exemplary embodiment, the sample applicator 400 may comprise a pipette module 450 configured to dispense a designated assay reagent and the processed sample.

[0214] In an exemplary embodiment, the sample applicator 400is a liquid handler equipped with multi-pipette channels.

[0215] The pipette module 450 comprises at least one pipette unit and a motion unit to control movement of the pipette unit. The motion unit may be mounted in the housing of the sample applicator 400.

[0216] The details of the pipette module 450 may be described with reference to the details of pipette modules for the modular processing device 200 described above.

[0217] According to an exemplary embodiment, the sample applicator 400 may comprise an assay reagent-container transferring module 420. The assay reagent-container transferring module 420 transfers to a container region 410 assay reagent containers provided from the modular storage device 300. According to an exemplary embodiment, the assay reagent-container transferring module 420 may also transfer a reaction container to a sealer 470. According to an exemplary embodiment, the assay reagent-container transferring module 420 may also transfer the sealed reaction container to a transferring device 900, particularly a second carrier P8. The second carrier P8 may transfer reaction containers from the sample applicator 400 to a modular testing device 500. The assay reagent-container transferring module 420 may comprise a gripper, a lift or an articulated robot arm. In addition, the assay reagent-container transferring module 420 may comprise a position sensor, an optic sensor, a pneumatic sensor or a camera-based vision module in order to accurately recognize, grip and transfer deliverables.

[0218] The sample applicator 400 may comprise a deck 480. The deck 480 is a working region where processed samples, pipette tip adaptors, assay reagent containers and reaction containers are placed. The deck 480 is provided such that components of the sample applicator 400 may be mounted or attached.

[0219] The deck 480 comprises a container region 410. The container region is arranged such that the pipette module 450 dispenses the processed sample to a reaction container. Alternatively, when the plurality of assay reagents are in the freeze-dried type and the assay reagents are pre-contained in reaction containers, the reaction container region is arranged such that the pipette module 450 dispenses the processed sample to a reaction container prefilled with the designated assay reagent.

[0220] With reference to FIG. 5B, freeze-dried prefilled reaction containers R4 may be placed in the container region 410. The freeze-dried prefilled reaction container R4 comprises reagents for an assay (i.e., test). The assay reagent-container transferring module 420 places the freeze-dried prefilled reaction container R4 on the seal-removing means 460 for seal removal and then places the freeze-dried prefilled reaction container R4 thus unsealed on the container region 410. Afterwards, the pipette module 450 dispenses the processed sample to the freeze-dried prefilled reaction container R4 for test. The presently disclosed system may use a bulk assay reagent. In such case, a bulk assay reagent container R3 is placed in the container region 410 and an empty container region 410-1 for accommodating an empty assay container C2 in the deck 480 may be separately provided. The pipette module 450 aspirates assay reagents from the bulk assay reagent container R3 on the container region 410 and dispenses to an empty assay container C2 on the empty container region 410-1, and then dispenses the processed sample to the assay container C2 for test. When the freeze-dried prefilled reaction container R4 is used, a working time may be reduced but a test cost becomes higher than bulk assay reagents, and the waste of assay reagents may be caused if assay reagents contained the freeze-dried prefilled reaction container R4 are not fully used for the maximum number of samples. Unlikely, when a necessary amount of assay reagents is dispensed into the empty assay container C2 by using the bulk assay reagent container R3, the waste of assay reagents may become reduced and various combination of testes may be carried out in one assay container.

[0221]

[0222] In an exemplary embodiment, the sample applicator 400 is configured to accommodate at least two designated assay reagents, specifically at least two designated assay reagent containers.

[0223] In an exemplary embodiment, the sample applicator 400 is configured to apply the processed sample to the at least two designated assay reagents.

[0224] In the container region 410, a container holder may be placed to fixedly accommodate assay reagent containers and / or reaction containers. The assay reagent containers fixed at the container holder may be decapped or unsealed for dispensing.

[0225] A plurality of container holders may be placed in the container region 410. When one processed sample is applied to a plurality of assay containers as the combinatorial test, the plurality of assay containers are required to be fixed at the container holder.

[0226] According to an exemplary embodiment, the container holder may be configured to accommodate assay reagent containers or reaction containers of which sizes are different from each other. According to an exemplary embodiment, the sample applicator 400 may comprise a plurality of container holders for accommodate assay reagent containers or reaction containers of which sizes are different from each other.

[0227]

[0228] The deck 480 comprises a processed sample region 415 to accommodate processed samples transferred from the modular processing device 200. The processed sample is transferred by a transferring means from the modular processing device 200 to the sample applicator 400. The processed sample may be transferred to the sample applicator 400 as contained in a processed sample pallet capable of accommodating at least one processed sample. With reference to FIG. 5B, the processed sample region 415 of the sample applicator 400 may comprise a single-typed processed sample region 415a and a batch-typed processed sample region 415b. When the processed sample in the modular processing device 200 is transferred as contained in a single-typed processed sample container S3, the single-typed processed sample region 415a is configured to accommodate the single-typed processed sample container S3. When individual samples are processed in the liquid transfer manner, each of the processed samples is transferred to the single-typed processed sample container S3 (see FIG. 3B). When the processed samples in the modular processing device 200 are transferred as contained in a batch-typed processing sample container S4, the batch-typed processing sample region 415b is configured to accommodate the batch-typed processing sample container S4. When a multitude of samples are processed in the bead transfer manner, the processed samples are transferred to the batch-typed processing sample container S4 (see FIG. 3C). Since magnetic beads may be contained in the batch-typed processing sample container S4 containing the processed samples, the batch-typed processed sample region 415b where the batch-typed processing sample container S4 is placed may be equipped with a magnetic capturing means (not shown in Figures) for preventing magnetic beads from entering assay containers.

[0229]

[0230] The processed sample may be transferred to the processed sample region 415 of the sample applicator 400 as contained in a processed sample pallet. Alternatively, the processed sample may be transferred from the processed sample pallet into a separate rack located in the processed sample region 415.

[0231] After the application, a residual of the processed sample may be transferred to a modular processed-sample storage device 800. To this end, the housing of the sample applicator 400 may a third passage through which the residual of the processed sample after application may be transferred to a modular processed-sample storage device 800. Alternatively, the residual of the processed sample after application to assay reagents may be transferred to a modular processed-sample storage device 800 by the transfer device 900 configured as a mobile robotic arm type (see FIG. 13B).

[0232]

[0233] The deck 480 comprises a region for accommodating a pipette tip adaptor.

[0234] The pipette tip adaptor accommodates at least one pipette tip to be attached to a pipette head. The pipette tip attached to the pipette head may aspirate and dispense processed samples and assay reagents. According to an exemplary embodiment, the pipette tip adaptor may be plural to accommodate tips of various volumes such as 1 ml, 500 ul, 300 ul, 250 ul, 200 ul, 150 ul, 100 ul and 50 ul. Some tips may be piercing tips. According to an exemplary embodiment, the deck 480 may comprise a consumable storage at its lower part. A plurality of the pipette tip adaptors may be mounted in the consumable storage. The consumable storage may automatically supply the pipette tip adaptor to the top part of the deck 480.

[0235]

[0236] According to an exemplary embodiment, the sample applicator 400 may comprise a waste collection part 490. The waste collection part 490 comprises an opening formed on the deck 480. The waste collection part 490 may comprise a wall extended upwardly at a partial side around the opening. The wall structure may prevent residual liquid from　splashing during discarding pipette tips to the waste collection part 490. According to an exemplary embodiment, the waste collection part 490 may comprise a sliding door to open and close the opening. The sliding door may prevent unwanted contaminants by separating the inner part of the housing from a waste container. For example, the sliding door may be opened during the operation of the presently disclosed system and closed when the presently disclosed system is turned off.

[0237] The used pipette tips may be collected through the waste collection part 490. The used pipette tips are transferred to the waste container and collected. According to an exemplary embodiment, the waste container may be disposed below the location of the opening of the waste collection part 490.

[0238] The sample applicator 400 may provide a wide variety of test reaction mixtures in reaction containers by using various assay reagents, array reagent containers and reaction containers.

[0239] In an exemplary embodiment, when the plurality of assay reagents are in the liquid type and the assay reagents are contained in assay reagent containers, the sample applicator 400 transfers (i) the designated assay reagent contained in the assay reagent container and (ii) the processed sample to a reaction container, thereby providing the test reaction mixture.

[0240] In an exemplary embodiment, (i) when the plurality of assay reagents are in the freeze-dried type and the assay reagents are pre-contained in reaction containers, the sample applicator 400 transfers the processed sample to a reaction container prefilled with the designated assay reagent, or (ii) when the plurality of assay reagents are in the freeze-dried type and the assay reagents are contained in assay reagent containers, the sample applicator 400 transfers (ii-1) the designated assay reagent contained in the assay reagent container and (ii-2) the processed sample to a reaction container, thereby providing the test reaction mixture.

[0241] For the single test on the presently disclosed system 10, when the plurality of assay reagents are in the liquid type and the assay reagents are contained in assay reagent containers, the sample applicator 400 transfers (i) a designated assay reagent contained in an assay reagent container and (ii) a single processed sample to a reaction container, thereby providing the test reaction mixture. (i) When the plurality of assay reagents are in the freeze-dried type and the assay reagents are pre-contained in reaction containers, the sample applicator 400 transfers a single processed sample to a reaction container prefilled with the designated assay reagent, or (ii) when the plurality of assay reagents are in the freeze-dried type and the assay reagents are contained in assay reagent containers, the sample applicator 400 transfers (ii-1) the designated assay reagent contained in the assay reagent container and (ii-2) a single processed sample to a reaction container, thereby providing the test reaction mixture.

[0242] For the batch test on the presently disclosed system 10, when the plurality of assay reagents are in the liquid type and the assay reagents are contained in assay reagent containers, the sample applicator 400 transfers (i) a designated assay reagent contained in an assay reagent container and (ii) each of processed samples to each well of a reaction container containing a plurality of wells, thereby providing a plurality of test reaction mixtures. (i) When the plurality of assay reagents are in the freeze-dried type and the assay reagents are pre-contained in reaction containers, the sample applicator 400 transfers each of processed samples to each well of a reaction container containing a plurality of wells prefilled with the designated assay reagent, or (ii) when the plurality of assay reagents are in the freeze-dried type and the assay reagents are contained in assay reagent containers, the sample applicator 400 transfers (ii-1) the designated assay reagent contained in the assay reagent container and (ii-2) each of processed samples to each well of a reaction container containing a plurality of wells, thereby providing a plurality of test reaction mixtures.

[0243] For the syndromic test on the presently disclosed system 10, when the plurality of assay reagents are in the liquid type and the assay reagents are contained in assay reagent containers, the sample applicator 400 transfers (i) a plurality of designated assay reagents for the syndromic test contained in assay reagent containers and (ii) a single processed sample to each well of a reaction container containing a plurality of wells, thereby providing a plurality of test reaction mixtures. (i) When the plurality of assay reagents are in the freeze-dried type and the assay reagents are pre-contained in reaction containers, the sample applicator 400 transfers a single processed sample to each well of a reaction container containing a plurality of wells prefilled with a plurality of designated assay reagents for the syndromic test, or (ii) when the plurality of assay reagents are in the freeze-dried type and the assay reagents are contained in assay reagent containers, the sample applicator 400 transfers (ii-1) a plurality of designated assay reagents for the syndromic test contained in assay reagent containers and (ii-2) a single processed sample to each well of a reaction container containing a plurality of wells, thereby providing a plurality of test reaction mixtures.

[0244] For the combinatorial test on the presently disclosed system 10, when the plurality of assay reagents are in the liquid type and the assay reagents are contained in assay reagent containers, the sample applicator 400 transfers (i) each of a plurality of designated assay reagents for the combinatorial test contained in assay reagent containers and (ii) a single processed sample to each of reaction containers, thereby providing a plurality of test reaction mixtures. (i) When the plurality of assay reagents are in the freeze-dried type and the assay reagents are pre-contained in reaction containers, the sample applicator 400 transfers a single processed sample to each of reaction containers containing prefilled with a plurality of designated assay reagents for the combinatorial test, or (ii) when the plurality of assay reagents are in the freeze-dried type and the assay reagents are contained in assay reagent containers, the sample applicator 400 transfers (ii-1) each of a plurality of designated assay reagents for the combinatorial test contained in assay reagent containers and (ii-2) a single processed sample to each of reaction containers, thereby providing a plurality of test reaction mixtures.

[0245]

[0246] In an exemplary embodiment, the presently disclosed system 10 (specifically, the sample applicator 400) further comprises a sealer for sealing a reaction container containing a test reaction mixture. The sealer 470 may seal wells of the reaction container. The sealer 470 may prevent contamination by sealing the top layer of the reaction container. The sealer 470 may seal the reaction container by using a transparent film which may be provide as the roll type or sheet type. When the roll typed film is used, the sealer 470 may comprise a film cutter unit.

[0247] The sealer 470 may seal the reaction container in a thermal welding manner or an adhesion manner using an adhesive. When the thermal welding manner is used, the sealer 470 may comprise a heating unit.

[0248] According to an exemplary embodiment, the sealer 470 may be placed in the housing of the sample applicator 400. The sealer 470 may be fixedly mounted on the deck 480 or the housing of the sample applicator 400. For instance, the sealer 470 may be configured such that a portion of a transfer passage of a transferring device to transfer the reaction container from the sample applicator 400 to the modular testing device 500 is wrapped by the sealer in the tunnel form.

[0249] According to an exemplary embodiment, the sealer 470 may be configured to seals reaction containers of which sizes are different from each other. To this end, the sample applicator 400 may comprise a press unit to cover the top layer of the largest reaction container and a cutting unit to cut films in various sizes depending on the size of reaction containers.

[0250] According to an exemplary embodiment, the presently disclosed system 10 may comprise at least two sealers 470 capable of sealing reaction containers of which sizes are different from each other. In such case, at least two sealers 470 may be arranged in parallel with the transfer passage of the transferring device to transfer the reaction container from the sample applicator 400 to the modular testing device 500.

[0251] According to an exemplary embodiment, the sample applicator 400 may be modular. Accordingly, the sample applicator 400 may comprise two or more self-contained devices, modules, units or sections, each performing the sample application function, the modules being connectable, disconnectable, and replaceable to allow reconfiguration without substantial redesign of other modules. The details of modular properties of the sample applicator 400 may be described with reference to the details of the modular processing device 200 described above.

[0252]

[0253] [Transferring Device]

[0254] The presently disclosed system 10 comprises a transferring device 900. The transferring device 900 transfers samples, processed samples, assay reagent containers and / or reaction containers between devices of the presently disclosed system 10.

[0255] The transferring device 900 comprises a carrier. The carrier is a device transferring materials, including a lift, a conveyor or a robotic arm. The lift transfers samples, processed samples, assay reagent containers and / or reaction containers in a vertical direction. The conveyor transfers the materials in a horizontal direction or slope direction. The robotic arm transfers the materials in any direction. The carrier may be a lift, a conveyor, a robotic arm or combinations thereof.

[0256] The samples, processed samples, assay reagent containers and / or reaction containers may be transferred by the transferring device 900 as accommodated on a pallet. The pallet may be a tailor-made one for each of samples, processed samples, assay reagent containers and reaction containers. When the samples, processed samples, assay reagent containers or reaction containers are transferred as accommodated on a pallet, the accurate delivery positioning may be achieved. According to an exemplary embodiment, the presently disclosed system 10 may comprise at least one selecting from the group consisting of a sample pallet 960, a processed sample pallet 950, an assay reagent-container pallet 940 and a reaction container pallet.

[0257] FIG. 2 is a schematic diagram of an exemplary embodiment of the presently disclosed devices and the transferring device between them.

[0258] The transferring device 900 comprises a container carrier 910 to transfer assay reagent containers and reaction containers. The container carrier 910 may transfer assay reagent containers accommodated on the pallet.

[0259] The container carrier 910 may comprise a first container carrier P7, a second container carrier P8 or a third container carrier P9. The first container carrier P7 transfers assay reagent containers from the modular storage device 300 to the sample applicator 400. The second container carrier P8 transfers reaction containers from the sample applicator 400 to the modular testing device 500. After transferring reaction containers to the modular testing device 500, the empty pallet may be transferred to the modular storage device 300 through the third container carrier P9. In an exemplary embodiment, the transferring device 900 comprises a first carrier (i.e., the first container carrier P7) configured to transfer the designated assay reagent among the plurality of assay reagents specific for the sample from the modular storage device 300 to the sample applicator 400. In an exemplary embodiment, the transferring device 900 further comprises a second carrier (i.e., the second container carrier P8) configured to transfer the reaction container from the sample applicator 400 to the modular testing device 500.

[0260]

[0261] In an exemplary embodiment, the transferring device 900 further comprises a processed sample carrier 920. The processed sample carrier 920 transfers the processed sample, and in particular transfers the processed sample on a processed sample pallet.

[0262] The processed sample carrier 920 may comprise a first processed sample carrier P4, a second processed sample carrier P5 and a third processed sample carrier P6. The first processed sample carrier P4 transfers the processed sample from the modular processing device 200 to the sample applicator 400. The second processed sample carrier P5 transfers the processed sample from the sample applicator 400 to the modular processed-sample storage device 800. After transferring the processed sample to the modular processed-sample storage device 800, the empty pallet may be transferred to the modular processing device 200 through the third processed sample carrier P6.

[0263]

[0264] In an exemplary embodiment, the transferring device 900 further comprises a sample carrier 930 configured to transfer samples, specifically the sample on the sample pallet.

[0265] The sample carrier 930 may comprise a first sample carrier P1, a second sample carrier P2 and a third sample carrier P3. The first sample carrier P1 transfers the sample from the modular preparation device 600 to the modular processing device 200. The second sample carrier P2 transfers the sample from the modular processing device 200 to the modular sample storage device 700. After transferring the sample to the modular sample storage device 700, the empty pallet may be transferred to the modular preparation device 600 through the third sample carrier P3.

[0266]

[0267] [Modular Testing Device]

[0268] With reference to FIG. 2, the presently disclosed system 10 comprises a modular testing device 500. The modular testing device 500 is a device to analyze the processed sample contained in the reaction container.

[0269] The modular testing device is modular. Accordingly, the modular testing device may comprise two or more self-contained devices, modules, units or sections, each performing a testing function, the modules being connectable, disconnectable, and replaceable to allow reconfiguration without substantial redesign of other modules. For example, the modular testing device may be configured to comprise at least two testing devices. Each of the testing devices may be installed on the presently disclosed system without substantial redesign of other devices.

[0270] In an exemplary embodiment, the modular testing device is a testing device that is structurally separated from the other devices including the modular processing device, the sample applicator and the modular storage device. The modular testing device may not be required to comprise an interlocking mechanism to connect to the other devices of the presently disclosed system. For example, the modular storage device may not be physically connected to the other devices of the presently disclosed system but operationally connected to the other devices of the presently disclosed system. In such case, the modular testing device may be placed on a location that a loading device (e.g., an articulated robot arm) for mount a reaction container on the modular testing device may access to.

[0271] When the presently disclosed system 10 is a system for molecular diagnostics, the modular testing device 500 may comprise analysis devices for nucleic acid sequences [e.g., nucleic acid amplification devices (thermal cyclers), sequencing devices and DNA microarrays]. In an exemplary embodiment, the modular testing device 500 is a nucleic acid amplification device [specifically, a real-time PCR (polymerase chain reaction) cycler].

[0272] When the presently disclosed system 10 is a system for immunological diagnostics, the modular testing device 500 may comprise a microplate reader (ELISA reader), a CLIA analyzer,　immunoblotter or an immunofluorescence reader.

[0273] When the presently disclosed system 10 is a system for biochemical diagnostics, the modular testing device 500 may comprise a clinical chemistry analyzer, MALDI-TOF device, oxygen free radical biochemical analyzer, creatinine analyzer, bilirubin analyzer, urine microalbumin analyzer, hemoglobin analyzer or uric acid / glucose analyzer.

[0274] When the presently disclosed system 10 is a system for cell culture tests, the modular testing device 500 may comprise microscopes, cell counter, cell imaging analyzer or flow cytometer.

[0275] The nucleic acid amplification device as the modular testing device 500 comprises a reaction module and a detection module.

[0276] The reaction module accommodates the reaction container containing the processed sample. The reaction module permits a test reaction to occur in the reaction container. The reaction module may be configured to deliver a thermal energy, a magnetic field, an electrical energy, an ultrasonic energy, a mechanical kinetic energy or a combination thereof to the reagent container. According to an exemplary embodiment, the reaction container loaded on the reaction module is a sealed container.

[0277] The reaction module may be a thermal module. The thermal module controls the temperature of the reaction container, permitting a test reaction to occur in the reaction container. The thermal module may comprise a heat block to accommodate the reaction container. The thermal module may comprise at least one recess where each well of the reaction container is accommodated.

[0278] The detection module monitors the progress of the test reaction in the reaction container. The detection module detects a signal generated from each well of the reaction container.

[0279] The detection module may be an optic module. The optic module is a module to detect an optic signal generated from the test reaction. The detection module may comprise a detector configured to detect an optic signal generated from each well of the reaction container. The detection module may further comprise a light source to emit an optic signal by irradiating the reaction result of the processed sample and the designated assay reagent in reaction container.

[0280]

[0281] In an exemplary embodiment, the modular testing device 500 comprises at least two testing devices 500a, 500b, 500c. The controller determines a testing device to perform the designated test reaction specific for the sample (i.e., the processed sample in the reaction container) and then controls to transfer the test reaction mixture (i.e., the reaction container containing the processed sample and the designated assay reagent) to the selected testing device.

[0282] The term used herein "designated test reaction" refers to a test reaction predetermined by the controller based on (depending on) the identification information labeled on the sample container. For example, the designated test reaction may be as a respiratory infection test in a batch test manner.

[0283] In an exemplary embodiment, the at least two testing devices comprise testing devices, each of which is configured to accommodate a different reaction container in size.

[0284] In an exemplary embodiment, the at least two testing devices comprise testing devices, each of which is configured to be operated by an independent protocol. In such case, the at least two testing devices are configured to operate independently from each other. When the combinatorial test for one sample comprising at least two test reactions is performed by using different test reaction protocols, it cannot be carried out simultaneously on one testing device. When the presently disclosed system10comprises at least two testing devices operated independently from each other, the combinatorial test may be carried out simultaneously by using at least two reaction containers for the combinatorial test.

[0285]

[0286] The presently disclosed system 10 may comprise a loading device 510 to mount the reaction container on the modular testing device 500.

[0287] According to an exemplary embodiment, the reaction containers may be mounted on at least two testing devices by one loading device 510. The loading device 510 may comprise a gripper. The reaction container to be loaded on the modular testing device 500 by the loading device 510 may be identified by an identification information reader 520. The reaction container transferred through P8 is identified by reading its identification information and mounted on a designated modular testing device 500 by the gripper.

[0288] The loading device 510 may also unload the reaction container after test from the testing device. The unload reaction container may be transferred to a temporary storage or a waste collection box 530.

[0289] Since the modular testing device 500 is modular, it may be flexibly expandable and adjustable in line with a test laboratory environment or capacity. For example, at least two modular testing devices 500 may be connected to the presently disclosed system. The at least two modular testing devices 500 may be different in the maximum size of accommodable reaction containers. In such case, the controller selects a modular testing device 500 capable of accommodating a reaction container of interest and then controls undertaking a test reaction of interest in the reaction container. In the presently disclosed system 10, additional testing devices may be installed. The modular testing device may be replaced with another modular testing device with a different capacity. As described above, because the presently disclosed system is constructed with modular devices, the modular testing device may be added and replaced without change of other devices.

[0290]

[0291] As the modular testing device 500, commercially available testing devices (specifically, a real-time PCR cycler) may be used in the presently disclosed system 10. For example, at least one (specifically at least two, more specifically at least three, still more specifically at least four) of CFX96 (Bio-Rad), QuantStudio Real-Time PCR System (Thermo Fisher Scientific), LightCycler (Roche) and qTOWER (Analytik Jena) may be mounted as the modular testing device500.

[0292] The modular testing device 500 may be easily mounted in the presently disclosed system 10. For example, the modular testing device 500 may be mounted in the presently disclosed system 10 by placing, securing or fixing the modular testing device 500 on a location, specifically a specific location that the loading device 510 may access to. In such case, reaction containers may be automatically loaded by the loading device 510 on the modular testing device 500. According to an embodiment, a plurality of the modular testing devices 500 may be mounted in the presently disclosed system 10 by placing separately the modular testing devices 500 on specific locations that one loading device 510 may access to. In such case, there is no need for connection between the plurality of the modular testing devices 500.

[0293]

[0294] [Controller]

[0295] The presently disclosed system 10 comprises a controller. The controller refers to a device, system or its part to control at least one work, task or motion. The controller may be embodied in the form of hardware, firmware, software or combination thereof. The functions of the controller may be centralized or decentralized in a local or remote manner.

[0296] The controller 100 generates signals to control or operate the devices of the presently disclosed system 10. The controller 100 receives information from the devices of the presently disclosed system 10 and maps to other information.

[0297] FIG. 1 is a block diagram describing the controller 100.

[0298] Following the receipt of the sample, the modular processing device 200 or the modular preparation device 600 reads the identification information labeled on the sample container and then the controller 100 receives the identification information. Based on the received identification information, the controller 100 may determine what sample processing procedure is to be done by the modular processing device 200 and instruct the modular processing device 200 to perform the determined sample processing procedure. Based on the received identification information, the controller 100 may determine what sample pretreatment procedure is to be done by the modular preparation device 600 and instruct the modular preparation device 600 to perform the determined sample pretreatment procedure. Based on the received identification information, the controller 100 may select a designated assay reagent (i.e., an assay reagent container containing a designated assay reagent) specific for the sample among the plurality of assay reagents and then instruct the modular storage device 300 to take out the designated assay reagent. Based on the received identification information, the controller 100 may determine the type (or category) of a test for the received sample. The controller 100 may instruct the sample applicator 400 to apply the processed sample and the designated assay reagent to a reaction container in accordance with the type (or category) of the test. The controller 100 may instruct the sample applicator 400 to apply the processed sample to a reaction container prefilled with the designated assay reagent in accordance with the type (or category) of the test. The controller 100 may control the modular testing device 500 to perform a test reaction in accordance with a certain protocol. The controller 100 may receive data on the test reaction from the modular testing device 500. The controller 100 may receive information on storage location of imported samples from the modular sample storage device 700. The controller 100 may instruct the modular sample storage device 700 to export a certain sample. The controller 100 may receive information on storage location of imported processed-samples from the modular processed-sample storage device 800. The controller 100 may instruct the modular processed-sample storage device 800 to export a certain processed sample.

[0299] Based on (or depending on) the identification information labeled on the sample container, the controller 100 selects the designated assay reagent (i.e., an assay reagent container containing a designated assay reagent) specific for the sample among the plurality of assay reagents, controls to transfer the designated assay reagent to the sample applicator 400 to prepare a test reaction mixture containing the designated assay reagent and the processed sample, and then controls to transfer the test reaction mixture to the modular testing device 500.

[0300] In an exemplary embodiment, the controller 100 is configured to control performing selectively either a batch test or a single test depending on the identification information labeled on the sample container.

[0301] More specifically, when the controller 100 controls performing selectively the batch test, the controller 100 controls the sample applicator 400 (i) to transfer (i-1) the designated assay reagent in the liquid type contained in an assay reagent container and (i-2) a plurality of processed samples to a plurality of reaction chambers of the reaction container, thereby providing a plurality of test reaction mixtures; (ii) to transfer a plurality of processed samples to a plurality of reaction chambers of the reaction container prefilled with the designated assay reagent in the freeze-dried type, thereby providing a plurality of test reaction mixtures; or (iii) to transfer (iii-1) the designated assay reagent in the freeze-dried type contained in an assay reagent container and (iii-2) a plurality of processed samples to a plurality of reaction chambers of the reaction container, thereby providing a plurality of test reaction mixtures.

[0302] Still more specifically, the controller 100 controls (i) selecting at least one testing device (specifically, one testing device) for the batch test from the at least one modular testing device and (ii) transferring the plurality of test reaction mixtures to the at least one testing device thus selected.

[0303] More specifically, when the controller 100 controls performing selectively the single test, the controller controls the sample applicator 400 (i) to transfer (i-1) the designated assay reagent in the liquid type contained in the assay reagent container and (i-2) the processed sample to a reaction chamber of the reaction container, thereby providing a test reaction mixture; (ii) to transfer the processed sample to a reaction chamber of the reaction container prefilled with the designated assay reagent in the freeze-dried type, thereby providing a test reaction mixture; or (iii) to transfer (iii-1) the designated assay reagent in the freeze-dried type contained in an assay reagent container and (iii-2) the processed sample to a reaction chamber of the reaction container, thereby providing a test reaction mixture.

[0304] Still more specifically, the controller 100 controls (i) selecting a testing device for the single test from the at least one modular testing device and (ii) transferring the test reaction mixture to the testing device thus selected.

[0305] In an exemplary embodiment, the controller 100 is configured to control performing selectively a test among a batch test, a single test and a syndromic test depending on the identification information labeled on the sample container.

[0306] More specifically, when the controller 100 controls performing selectively the syndromic test, the controller controls the sample applicator 400 (i) to transfer (i-1) a plurality of designated assay reagents in the liquid type contained in assay reagent containers and (i-2) the processed sample to a plurality of reaction chambers of the reaction container, thereby providing a plurality of test reaction mixtures; (ii) to transfer the processed sample to a plurality of reaction chambers of the reaction container prefilled with a plurality of designated assay reagents in the freeze-dried type, thereby providing a plurality of test reaction mixtures; or (iii) to transfer (iii-1) a plurality of designated assay reagents in the freeze-dried type contained in assay reagent containers and (iii-2) the processed sample to a plurality of reaction chambers of the reaction container, thereby providing a plurality of test reaction mixtures.

[0307] Still more specifically, the controller 100 controls (i) selecting at least one testing device (specifically, one testing device) for the syndromic test from the at least one modular testing device and (ii) transferring the plurality of test reaction mixtures to the at least one testing device thus selected.

[0308] In an exemplary embodiment, the controller 100 is configured to control performing selectively a test among a batch test, a single test, a syndromic test and a combinatorial test depending on the identification information labeled on the sample container.

[0309] More specifically, when the controller 100 controls performing selectively the combinatorial test, the controller controls the sample applicator 400 (i) to transfer (i-1) a plurality of designated assay reagents in the liquid type contained in assay reagent containers and (i-2) the processed sample to a plurality of reaction containers, thereby providing a plurality of test reaction mixtures; (ii) to transfer the processed sample to a plurality of reaction containers prefilled with a plurality of designated assay reagents in the freeze-dried type, thereby providing a plurality of test reaction mixtures; or (iii) to transfer (iii-1) a plurality of designated assay reagents in the freeze-dried type contained in assay reagent containers and (iii-2) the processed sample to a plurality of reaction containers, thereby providing a plurality of test reaction mixtures.

[0310] Still more specifically, the controller 100 controls (i) selecting at least two testing devices for the combinatorial test from the at least one modular testing device and (ii) transferring the plurality of test reaction mixtures to the at least two testing devices thus selected.

[0311] When the presently disclosed system 10 comprises at least two modular testing device 500, the controller 100 may select at least one modular testing device 500 for test. According to an exemplary embodiment, the presently disclosed system 10 comprises at least two modular testing device 500. Based on the identification information labeled on the sample container, the controller 100 may determine the type (or category) of the test for the sample and then based on the type (or category) of the test, the controller 100 may control the sample applicator 400, after which the controller 100 may select at least one modular testing device 500 for the test and controls to transfer the reaction container to the at least one modular testing device 500.

[0312] Based on the identification information, the controller 100 may also select an operation protocol of the at least one modular testing device 500 and control the at least one modular testing device 500 to operate in accordance with the operation protocol. In an exemplary embodiment, the controller 100 selects an operation protocol of the modular testing device 500 for testing the processed sample depending on the identification information labeled on the sample container and then controls the modular testing device 500 to operate according to the operation protocol.

[0313] In an exemplary embodiment, the controller 100 integratively controls operations of the modular processing device 200, the modular storage device 300, the sample applicator 400 and the modular testing device 500 depending on the identification information labeled on the sample container.

[0314]

[0315] [Modular Processed-Sample Storage Device]

[0316] In an exemplary embodiment, the presently disclosed system 10 comprises a modular processed-sample storage device 800 to store processed samples.

[0317] The modular processed-sample storage device 800 is modular. Accordingly, the processed-sample storage device may comprise two or more self-contained devices, modules, units or sections, each performing a storage function (specifically, a storage function and a release function), the modules being connectable, disconnectable, and replaceable to allow reconfiguration without substantial redesign of other modules.

[0318] In an exemplary embodiment, the modular processed-sample storage device is a storage device that is structurally separated from the other devices including the modular processing device, the sample applicator and the modular testing device. More specifically, the modular processed-sample storage device is detachable from the other devices without affecting them.

[0319] The modular processed-sample storage device may not be required to comprise an interlocking mechanism to connect to the other devices of the presently disclosed system. For example, the modular processed-sample storage device may not be physically connected to the other devices of the presently disclosed system but operationally connected to the other devices of the presently disclosed system. In such case, the modular processed-sample storage device may be placed at a location accessible by a transferring device (e.g., an articulated robot arm) configured to transfer processed samples.

[0320] The details of modular properties of the modular processed-sample storage device 800 may be described with reference to the details of the modular storage device 300 described above.

[0321] FIGs. 8A and 8B are schematic illustrations of exemplary embodiments of the modular processed-sample storage device 800 used in the presently disclosed system. The modular processed-sample storage device 800 comprises a processed-sample storing region 810 for storing processed samples. The processed-sample storing region 810 may be configured to store a plurality of trays accommodating a plurality of single-typed processed sample containers S3. The processed-sample storing region 810 may be configured to store a batch-typed processed sample container S4. The processed-sample storing region 810 may be configured to accommodate processed sample containers with different shapes. The processed-sample storing region 810 may comprise a temperature-control means to maintain refrigerated temperatures or room temperature for storage stability of processed samples. The modular processed-sample storage device 800 may comprise a processed-sample transferring module 820 to transfer processed samples in an inner part of the modular processed-sample storage device 800. The processed-sample transferring module 820 may be configured to access to both the processed-sample storing region 810 and a processed-sample receiving part 840. The single-typed processed sample container S3 or the batch-typed processed sample container S4 received in the processed-sample receiving part 840 is scanned by an identification information reader 830 and stored at a certain location in the processed-sample storing region 810. The processed-sample transferring module 820 may comprise a gripper, a lift or an articulated robot arm. The identification information reader 830 may be a bar code reader, QR code reader, camera and RFID reader.

[0322] A certain amount of the processed sample may be applied to the reaction container by the sample applicator 400 and then a residual of the processed sample may be transferred to the modular processed-sample storage device 800 by a second processed-sample carrier P5. Alternatively, a residual of the processed sample may be transferred from the sample applicator 400 to the modular processed-sample storage device 800 by a transferring device 900. Specifically, the processed sample is transferred from the sample applicator 400 to the processed-sample receiving part 840. The identification information reader 830 reads the identification information labeled on the single-typed processed sample container S3 or the batch-typed processed sample container S4 containing the processed sample and then transmits the identification information to the controller 100. Based on the transmitted identification information and a list of processed-sample storage, the controller 100 may determine a storage location for the processed sample in the processed-sample storing region 810 and then transmits the determined information to the modular processed-sample storage device 800. According to an embodiment, the modular processed-sample storage device 800 may store the processed sample and then transmit to the controller 100 information on the processed sample including a storage location of the processed sample. The processed-sample transferring module 820 may transfer the processed sample to store at the location determined by the controller 100. Afterwards, the controller 100 may update a storage list of processed samples.

[0323] When retest or additional test for the processed sample is required, the controller 100 may control, with reference to the storage list of processed samples, to transfer to the sample applicator 400 the processed-sample stored in the modular processed-sample storage device 800. Accordingly, in the presently disclosed system, there is no need to recollect or reprocess a sample for a retest or additional test.

[0324]

[0325] [Modular Sample Storage Device]

[0326] In an exemplary embodiment, the presently disclosed system 10 comprises a modular sample storage device 700 to store samples.

[0327] The modular sample storage device 700 is modular. Accordingly, the modular sample storage device 700 may comprise two or more self-contained devices, modules, units or sections, each performing a storage function (specifically, a storage function and a release function), the modules being connectable, disconnectable, and replaceable to allow reconfiguration without substantial redesign of other modules.

[0328] In an exemplary embodiment, the modular sample storage device is a storage device that is structurally separated from the other devices including the modular processing device, the sample applicator and the modular testing device. More specifically, the modular sample storage device is detachable from the other devices without affecting them.

[0329] The modular sample storage device may not be required to comprise an interlocking mechanism to connect to the other devices of the presently disclosed system. For example, the modular sample storage device may not be physically connected to the other devices of the presently disclosed system but operationally connected to the other devices of the presently disclosed system. In such case, the modular sample storage device may be placed at a location accessible by a transferring device (e.g., an articulated robot arm) configured to transfer samples (e.g., an articulated robot arm).

[0330] The details of modular properties of the modular sample storage device 700 may be described with reference to the details of the modular storage device 300 described above.

[0331] FIGs. 7A and 7B are schematic illustrations of exemplary embodiments of the modular sample storage device 700 used in the presently disclosed system.

[0332] The modular sample storage device 700 is a device for storing primary samples, which are samples prior to processing. The primary samples may be provided at various stages. In FIG. 7A, the modular sample storage device 700 may store a sample container containing a residual of samples after processing in the modular processing device 200. In FIG. 7B, the modular sample storage device 700 may store a primary sample container S1 containing a residual of primary samples after aliquoting to the processing sample container S2 in the modular preparation device 600. In addition, the modular sample storage device 700 may receive and store the primary sample container S1 initially loaded into the presently disclosed system 10. As such, the modular sample storage device 700 may selectively provide the stored primary sample container S1 to the modular preparation device 600.

[0333]

[0334] The modular sample storage device 700 comprises a sample storing region 710 for storing samples. The sample storing region 710 may be configured to store a plurality of trays accommodating a plurality of primary sample containers S1. The sample storing region 710 may comprise a temperature-control means to maintain refrigerated temperatures or room temperature for storage stability of primary samples. The modular sample storage device 700 may comprise a sample transferring module 720 to transfer samples in an inner part of the modular sample storage device 700. The sample transferring module 720 may be configured to access to both the sample storing region 710 and a sample receiving part 740. The primary sample container S1 received in the sample receiving part 740 is scanned by an identification information reader 730 and stored at a certain location in the sample storing region 710. The sample transferring module 720 may comprise a gripper, a lift or an articulated robot arm. The identification information reader 730 may be a bar code reader, QR code reader, camera and RFID reader.

[0335] A certain amount of the sample may be aliquoted to process samples in the modular processing device 200 and then a residual of the sample may be transferred to the modular sample storage device 700 by a second sample carrier P2. Specifically, the sample is transferred to the sample receiving part 740. Alternatively, a residual of the primary sample after aliquoting to the processing sample container S2 in the modular preparation device 600 may be loaded onto the sample receiving part 740. The identification information reader 730 reads the identification information labeled on the primary sample container S1 containing the residual primary sample and then transmits the identification information to the controller 100. Based on the transmitted identification information and a list of sample storage, the controller 100 may determine a storage location for the sample in the sample storing region 710 and then transmits the determined information to the modular sample storage device 700. According to an embodiment, the modular sample storage device 700 may store the sample and then transmit to the controller 100 information on the sample including a storage location of the sample. The sample transferring module 720 may transfer the sample to store at the location determined by the controller 100. Afterwards, the controller 100 may update a storage list of samples.

[0336] When retest or additional test for the sample is required, the controller 100 may control, with reference to the storage list of samples, to transfer to either the modular processing device 200 or the modular preparation device 600 the primary sample container S1 stored in the modular sample storage device 700. As such, the presently disclosed system is not required to recollect samples for retest or additional test.

[0337] Alternatively, the modular sample storage device 700 may receive the primary sample container S1 loaded onto the presently disclosed system 10 and then store. The tray accommodating the primary sample container S1 is placed on the sample receiving part 740 and the identification information of the primary sample container S1 is read by the identification information reader 730 and then transmitted to the controller 100. Such identifying process may be automatically performed by the sample transferring module 720. Alternatively, the identifying process may be performed in such a manner that a user manually scans the tray accommodating the primary sample container S1. The controller 100 may determine a storage location for the primary sample container S1 and the sample transferring module 720 may transfer the primary sample container S1 to store at the determined location in the sample storing region 710. As such, the primary sample container S1 may be selectively transferred to the modular preparation device 600. In clinical laboratories, a multitude of samples may be simultaneously delivered for tests. It would be understood that a test order may be set more effectively by the presently disclosed system 10 than by users themselves. Specifically, the presently disclosed system 10 may scan all samples delivered, store the samples in the modular sample storage device 700, and then automatically generates the most effective test order. Depending on the most effective test order, the presently disclosed system 10 may permit samples to be timely exported and provided to the modular preparation device 600, thereby reducing the total test time. In addition, such feature of the presently disclosed system 10 may minimize hands-on-time to improve operation efficiency and reduce errors during a sample management.

[0338]

[0339] [Modular Preparation Device]

[0340] In an exemplary embodiment, the presently disclosed system 10 comprises a modular preparation device 600 to receive samples and prepare samples in the form suitable in processing samples in the modular processing device 200.

[0341] The modular preparation device 600 is modular. Accordingly, the modular preparation device 600 may comprise two or more self-contained devices, modules, units or sections, each performing a sample preparation function, the modules being connectable, disconnectable, and replaceable to allow reconfiguration without substantial redesign of other modules. The details of modular properties of the modular preparation device 600 may be described with reference to the details of the modular processing device 200 described above.

[0342] FIGs. 6A and 6B are schematic illustrations of exemplary embodiments of the modular preparation device 600 used in the presently disclosed system.

[0343] The modular preparation device 600 may comprise a sample receiving part 610 to receive samples. The sample received through the sample receiving part 610 may be a primary sample container S1. The sample receiving part 610 may be equipped with a plurality of sample holders each of which accommodates an individual sample. The sample receiving part 610 may be configured to accommodate a tray accommodating a plurality of primary sample containers S1. The sample receiving part 610 may be configured to enable a user to manually place the primary sample container S1 onto the sample receiving part 610. Alternatively, the sample receiving part 610 may be configured to receive the primary sample container S1 from the modular sample storage device 700. The sample receiving part 610 may comprise a sensor to detect landing of the primary sample container S1 onto the sample receiving part 610.

[0344]

[0345] The modular preparation device 600 may comprise a transferring module 670. The transferring module 670 transfers tubes containing samples to the sample receiving part 610 in an inner part of the modular preparation device 600. The transferring module 670 transfers prepared samples to a first sample carrier P1. The transferring module 670 may be configured to transfer prepared samples to the transferring device 900 or directly to the modular processing device 200 (see FIGs. 13A and 13B). The transferring module 670 may comprise a gripper, a lifting module or an articulated robot arm. According to another embodiment, the transferring module 670 may be configured to transfer the primary sample container S1 or the tray accommodating a plurality of primary sample containers S1 from the modular sample storage device 700 to the modular preparation device 600. For transferring the tray, the transferring module 670 may be configured to be equipped with a tray transferring unit 670a as a grip unit, and the modular preparation device 600 may comprise the tray transferring unit 670a.

[0346]

[0347] The modular preparation device 600 may comprise an identification information reader 630. The identification information reader 630 is a device to read a bar code, QR code or RFID tag labeled on sample or reagent containers and identify a unique ID of each sample and the type and production batch information of reagents. The identification information reader 630 may comprise an optic scanner such as a bar code reader and QR code reader, a radio frequency scanner or a camera.

[0348] The modular preparation device 600 may comprise a sample preparation part 620 configured to prepare samples received through the sample receiving part 610 into a form suitable for processing in the modular processing device 200. For instance, when a sample collection device is contained in a sample tube, it is taken out in the sample preparation part 620. When a solid contaminant is contained in a sample tube, it is taken out by filtering or centrifugation in the sample preparation part 620. The sample preparation part 620 may aliquot the received sample to a designated tube and then provide the designated tube to the modular processing device 200. The designated tube may be the processing sample container S2. The processing sample container S2 may be varied depending on a processing method in the modular processing device 200. For example, the processing sample container S2 may be a processing sample container with multi-wells useful in a batch-typed processing device. The processing sample container S2 may be a single tube-typed processing sample container usable in a single-typed processing device. The sample preparation part 620 may be configured to accommodate processing sample containers S2 with various shapes.

[0349] According to an exemplary embodiment, the modular preparation device 600 may comprise a pipette module 640. The pipette module 640 is configured to dispense samples in the process of sample preparation. The pipette module 640 may comprise at least one pipette unit and motion unit. The details of the pipette module 640 may be described with reference to the details of the modular processing device 200 described above.

[0350] According to an exemplary embodiment, the modular preparation device 600 may comprise a decapper 650 and capper 660. The decapper 650 removes a cap of primary sample containers for enabling the pipette module 640 to access samples in primary sample containers. The capper 660 attaches a cap to a sample container containing prepared sample, which is then transferred to the modular processing device 200. Alternatively, the decapper 650 may be configured to serve as both a decapper and a capper. The decapper 650 may be configured to handle caps of primary sample containers S1 and single tube-typed processing sample containers. The decapper 650 may comprise a temporary storage to store caps for reusage of removed caps.

[0351]

[0352] As described hereinabove, one embodiment of the presently disclosed system may be schematically represented with reference to FIG. 2, another embodiment of the presently disclosed system may be schematically represented with reference to FIGs. 13A and 13B. The main difference between two embodiment is the type of the transferring device 900.

[0353] In FIGs. 13A and 13B, the presently disclosed system 10 comprises (i) the modular sample storage device 700, (ii) the modular preparation device 600, (iii) the modular processing device 200 comprising the single nucleic acid extraction device 200a and the batch nucleic acid extraction device 200b, (iv) the articulated robot arm as the transferring device 900 for loading the sample into either the single nucleic acid extraction device 200a or the batch nucleic acid extraction device 200b, (v) the sample applicator 400, (vi) the modular testing device 500, (vii) the articulated robot arm as the loading device 510 to mount the reaction container on the modular testing device 500, (viii) the modular storage device 300 for an assay reagent, (ix) the articulated robot arm as the transferring device 900 for transferring assay reagent containers, (x) the modular processed-sample storage device 800, and (xi) the articulated robot arm as the transferring device 900 for transferring processed samples.

[0354] According to one embodiment of the presently disclosed system by using an articulated robot arm as a transferring device, the presently disclosed system comprises (i) a modular sample storage device, (ii) a modular preparation device, (iii) a modular processing device comprising a single nucleic acid extraction device and a batch nucleic acid extraction device, (iv) an articulated robot arm as a transferring device for loading a sample into either the single nucleic acid extraction device or the batch nucleic acid extraction device, (v) a sample applicator, (vi) a modular testing device, (vii) an articulated robot arm as a loading device to mount a reaction container on a modular testing device, (viii) a modular storage device for an assay reagent, (ix) an articulated robot arm as a transferring device for transferring assay reagent containers, (x) a modular processed-sample storage device, and (xi) an articulated robot arm as a transferring device for transferring processed samples.

[0355]

[0356] II. Testing Method

[0357] In another aspect of the present disclosure, there is provided a method for testing a sample, which comprises the steps of:

[0358] (a) loading the sample and reading an identification information labeled on a sample container containing the sample to receive a sample data corresponding to the identification information;

[0359] (b) based on the sample data, determining a sample processing protocol for the sample and processing the sample to provide a processed sample;

[0360] (c) based on the sample data, determining the type of the test for the sample;

[0361] (d) based on the type of the test for the sample, transferring a designated assay reagent specific for the sample among a plurality of assay reagents;

[0362] (e) based on the type of the test for the sample, providing a test reaction mixture containing the processed sample and the designated assay reagent by using a sample applicator; and

[0363] (f) based on the type of the test for the sample, automatically selecting a modular testing device to perform a designated test reaction specific for the sample, loading the test reaction mixture onto the modular testing device and performing the designated test reaction specific for the sample.

[0364]

[0365] Unless otherwise explicitly stated, the steps of the method recited herein, designated as (a), (b), (c), etc., are provided merely for ease of reference, and do not necessarily imply a required order of performance. The order of steps may be varied and certain steps may be performed simultaneously, without departing from the scope of the present disclosure.

[0366] Since the presently disclosed method follows in principle the first aspect of the present disclosure described above, the common descriptions between them are omitted in order to avoid undue redundancy leading to the complexity of this specification.

[0367]

[0368] With reference to FIG. 14, an embodiment of the presently disclosed test method by using the presently disclosed system10is described hereunder.

[0369] [Step (a): Loading Samples and Reading Identification Information]

[0370] In the step (a), the sample is loaded and an identification information labeled on a sample container containing the sample is read to receive a sample data corresponding to the identification information (S10).

[0371] The identification information may be read by the identification information reader 630 of the modular preparation device 600 or the identification information reader 730 of the modular preparation device 700. The identification information may be encoded in the form of a bar code, a QR code or RFID tag.

[0372] The information scanned or read may be connected to the sample data. The presently disclosed system may receive the corresponding sample data based on the identification information. The sample data may comprise the type of a sample, a sample identifier, the type of a test for a sample, information on a sample source (e.g., patient) and information on an assay reagent container for a sample.

[0373]

[0374] [Step (b): Determining Sample Processing Method and Processing Samples]

[0375] In the step (b), a sample processing method for the sample is determined based on the sample data and the sample is processed to provide a processed sample (S20).

[0376] The controller determines a sample processing method based on the sample data connected to the identification information. The sample processing method may be varied depending on the type of samples. For example, the sample processing method and sample processing reagent for viruses in sputum sample may be different from the sample processing method and sample processing reagent for microorganisms in stool sample.

[0377] According to the determined sample processing method, the modular processing device 200 processes the sample to provide the processed sample.

[0378]

[0379] [Step (c): Determining Type of Test]

[0380] In the step (c), the type of the test for the sample is determined based on the sample data (S30).

[0381] The controller determines the type of the test for the sample based on the sample data.

[0382] In an exemplary embodiment, the determination of the type of the test for the sample is to select a test between a batch test and a single test based on the sample data. More specifically, the determination of the type of the test for the sample is to select a test among a batch test, a single test and a syndromic test based on the sample data. Still more specifically, the determination of the type of the test for the sample is to select a test among a batch test, a single test, a syndromic test and a combinatorial test based on the sample data.

[0383] Depending on the determined type of the test, the type of assay reagents to be provided to the sample applicator and the procedure to provide a test reaction mixture are then determined.

[0384]

[0385] [Step (d): Transferring Designated Assay Reagent]

[0386] In the step (d), a designated assay reagent specific for the sample among a plurality of assay reagents is transferred based on the type of the test for the sample (S40).

[0387] Based on the type of the test for the sample, the controller controls to provide to the sample applicator a designated assay reagent specific for the sample among a plurality of assay reagents stored in the modular storage device.

[0388] The assay reagent may be varied depending on the type of the test for the sample. Specifically, depending on the test type selected from the group consisting of a batch test, a single test, a syndromic test and a combinatorial test, the assay reagents and the reaction containers may be varied.

[0389] Based on the type of the test for the sample, the controller may determine a assay reagent and a reaction container and then control to provide the determined assay reagent and reaction container to the sample applicator.

[0390]

[0391] [Step (e): Providing Test Reaction Mixture]

[0392] In the step (e), a test reaction mixture containing the processed sample and the designated assay reagent is provided by using a sample applicator based on the type of the test for the sample (S50).

[0393] The sample applicator mixes the processed sample and the assay reagent to provide the test reaction mixture. The control may determine a protocol for preparing a test reaction mixture depending on the test type and then control the sample applicator to prepare the test reaction mixture.

[0394] The protocol for preparing the test reaction mixture may be varied depending on the type of assay reagents.

[0395] In an exemplary embodiment, when the plurality of assay reagents are in the liquid type and the assay reagents are contained in assay reagent containers, (i) the designated assay reagent contained in the assay reagent container and (ii) the processed sample are transferred to a reaction container by the sample applicator, thereby providing the test reaction mixture.

[0396] In an exemplary embodiment, when the plurality of assay reagents are in the freeze-dried type and the assay reagents are pre-contained in reaction containers, the processed sample is transferred to a reaction container prefilled with the designated assay reagent the sample applicator, thereby providing the test reaction mixture.

[0397] In an exemplary embodiment, when the plurality of assay reagents are in the freeze-dried type and the assay reagents are contained in assay reagent containers, (i) the designated assay reagent contained in the assay reagent container and (ii) the processed sample are transferred to a reaction container by the sample applicator, thereby providing the test reaction mixture.

[0398] Furthermore, the protocol for preparing the test reaction mixture may be varied depending on the type of the test.

[0399] In an exemplary embodiment, when the batch test is selected as the type of the test for the sample, (i-1) the designated assay reagent in the liquid type contained in the assay reagent container and (i-2) a plurality of processed samples are transferred to a plurality of reaction chambers of the reaction container by the sample applicator, thereby providing a plurality of test reaction mixtures; (ii) a plurality of processed samples are transferred to a plurality of reaction chambers of the reaction container prefilled with the designated assay reagent in the freeze-dried type by the sample applicator, thereby providing a plurality of test reaction mixtures; or (iii-1) the designated assay reagent in the freeze-dried type contained in an assay reagent container and (iii-2) a plurality of processed samples are transferred to a plurality of reaction chambers of the reaction container by the sample applicator, thereby providing a plurality of test reaction mixtures.

[0400] In an exemplary embodiment, when the single test is selected as the type of the test for the sample, (i-1) the designated assay reagent in the liquid type contained in the assay reagent container and (i-2) the processed sample are transferred to a reaction chamber of the reaction container by the sample applicator, thereby providing the test reaction mixture; (ii) the processed sample is transferred to a reaction chamber of the reaction container prefilled with the designated assay reagent in the freeze-dried type, thereby providing the test reaction mixture; or (iii-1) the designated assay reagent in the freeze-dried type contained in an assay reagent container and (iii-2) the processed sample are transferred to a reaction chamber of the reaction container by the sample applicator, thereby providing a test reaction mixture.

[0401] In an exemplary embodiment, when the syndromic test is selected as the type of the test for the sample, (i-1) a plurality of designated assay reagents in the liquid type contained in the assay reagent container and (i-2) the processed sample are transferred to a plurality of reaction chambers of the reaction container by the sample applicator, thereby providing a plurality of test reaction mixtures; (ii) the processed sample is transferred to a plurality of reaction chambers of the reaction container prefilled with a plurality of designated assay reagents in the freeze-dried type by the sample applicator, thereby providing a plurality of test reaction mixtures; or (iii-1) a plurality of designated assay reagents in the freeze-dried type contained in assay reagent containers and (iii-2) the processed sample are transferred to a plurality of reaction chambers of the reaction container, thereby providing a plurality of test reaction mixtures.

[0402] In an exemplary embodiment, when the combinatorial test is selected as the type of the test for the sample, (i-1) a plurality of designated assay reagents in the liquid type contained in the assay reagent container and (i-2) the processed sample are transferred to a plurality of reaction chambers of the reaction container by the sample applicator, thereby providing a plurality of test reaction mixtures; (ii) the processed sample is transferred to a plurality of reaction chambers of the reaction container prefilled with a plurality of designated assay reagents in the freeze-dried type by the sample applicator, thereby providing a plurality of test reaction mixtures; or (iii-1) a plurality of designated assay reagents in the freeze-dried type contained in assay reagent containers and (iii-2) the processed sample are transferred to a plurality of reaction containers, thereby providing a plurality of test reaction mixtures.

[0403]

[0404] [Step (f): Selecting Testing Device, Loading Test Reaction Mixture and Performing Designated Test Reaction]

[0405] In the step (f), based on the type of the test for the sample, a modular testing device to perform a designated test reaction specific for the sample is automatically selected, the test reaction mixture is loaded onto the modular testing device and then the designated test reaction specific for the sample is performed (S60).

[0406] Finally, the designated test reaction specific for the sample is performed by using the test reaction mixture loaded onto the modular testing device. The controller determines the modular testing device for the test. The modular testing device for the test may be determined based on the type of the test and the size and type of the reaction container containing the test reaction mixture.

[0407]

[0408] In an exemplary embodiment, the method further comprises processing additionally another sample simultaneously with the processing of the sample.

[0409]

[0410] With reference to FIGs. 9 to 11, another embodiment of the presently disclosed test method by using the presently disclosed system 10 is described hereunder. FIG. 9 is a flow chart representing an embodiment of the presently disclosed test method by using the presently disclosed system 10. FIG. 10 is a flow chart representing an embodiment of the sample processing procedure in the modular processing device 200. FIG. 11 is a flow chart representing an embodiment of the application procedure of assay reagents in the sample applicator 400.

[0411] Upon receiving the sample, the identification information of the received sample is read or scanned and transmitted to the controller (S100). The information scanned or read is connected to the sample data such that information on the type of the sample and the type of the test for the sample is transmitted to the system.

[0412] Then, based on the transmitted identification information, (i) a sample processing protocol, (ii) the test category for the sample, (iii) a designated assay reagent for the test category, and (v) a testing device and its test reaction protocol are determined (S200).

[0413] The controller determines a sample processing method based on the sample data connected to the identification information. The sample processing method may be varied depending on the type of samples. For example, the sample processing method and sample processing reagent for viruses in sputum sample may be different from the sample processing method and sample processing reagent for microorganisms in stool sample.

[0414] Furthermore, the controller determines the test category for the sample. Based on the determined test category, the sample application protocol of the sample applicator is determined. Based on the determined test category, the designated assay reagent container is also determined and then the test reaction protocol is successively determined.

[0415] Following the sample processing, the processed sample is transferred to the sample applicator (S300).

[0416] The sample processing method is transmitted to the modular processing device 200. The container containing the processed sample is capped and then transferred to the sample applicator 400.

[0417] An embodiment of S300 step performed in the modular processing device 200 is described as follows: The sample processing method determined by the controller is received (S310). Then, a reagent for a sample processing and a sample processing protocol are prepared according to the determined sample processing method (S320). The sample is aliquoted and processed to generate a processed sample (S330). Afterwards, the identification information of the processed sample tube is mapped to the sample identification information (S340). The processed sample is capped and transferred to the sample applicator (S350). The remaining sample is capped and transferred to a sample storage device (S360).

[0418] Then, the designated assay reagent container is exported and transferred to the sample applicator (S400). The modular storage device 300 exports selectively the designated assay reagent container under control of the controller 100. The assay reagent transferring module 320 transfers the designated assay reagent container to the first container carrier P7 to allow the designated assay reagent container to be transferred to the sample applicator 400.

[0419] Afterwards, in accordance with the determined test category, the processed sample is applied to the transferred assay reagent container and then transferred to the modular testing device 500 (S500).

[0420] The test category is determined by the controller 100. The sample applicator 400 operates different application protocols depending on the test category. For example, when the test category is determined as a single test, the sample applicator 400 applies a single processed sample to a reaction container and then the resultant is sealed and transferred to the modular testing device 500. When the test category is determined as a batch test, the sample applicator 400 applies a plurality of processed samples to a reaction container and then the resultant is sealed and transferred to the modular testing device 500.

[0421] An embodiment of S500 step performed in the sample applicator 400 is described as follows: The test category for the sample as determined by the controller is received (S510). The designated assay reagent container exported from the modular storage device is retrieved and a sealing member is removed (S520). Then, in accordance with the determined test category, the processed sample is aliquoted and applied to the designated assay reagent container (S530). The identification information of the designated assay reagent container is mapped to the sample identification information (S540). Afterwards, the resultant of the sample application is sealed and transferred to the selected modular testing device (S550). The remaining processed sample is capped and transferred to the processed sample storage device (S560).

[0422]

[0423] Finally, the test reaction is performed, the test result information is then transmitted and the reagent container is discarded (S600).

[0424]

[0425] III. Computer Readable Storage Medium

[0426] In still another aspect of the present disclosure, there is provided a computer readable storage medium containing instructions to configure a processor to enable a continuous loadable module-typed system for a test to perform the following operations:

[0427] (a) upon receiving a sample, reading an identification information labeled on a sample container containing the sample and receiving a sample data corresponding to the identification information;

[0428] (b) based on the sample data, determining a sample processing protocol for the sample and controlling a modular processing device according to the sample processing protocol to provide a processed sample;

[0429] (c) based on the sample data, determining the type of the test for the sample;

[0430] (d) based on the type of the test for the sample, transferring a designated assay reagent specific for the sample among a plurality of assay reagents;

[0431] (e) based on the type of the test for the sample, controlling a sample applicator to provide a test reaction mixture containing the processed sample and the designated assay reagent;

[0432] (f) based on the type of the test for the sample, selecting a modular testing device to perform a designated test reaction specific for the sample and transferring the test reaction mixture to the modular testing device thus selected; and

[0433] (g) performing the designated test reaction according to a test reaction protocol specific for the type of the test.

[0434]

[0435] Since the storage medium are intended to perform the presently disclosed method in a computer, the common descriptions between them are omitted in order to avoid undue redundancy leading to the complexity of this specification.

[0436] In an exemplary embodiment, the operations further comprise processing additionally another sample simultaneously with the processing of the sample.

[0437] In an exemplary embodiment, the operations further comprise performing selectively either a batch test or a single test based on the sample data.

[0438] In an exemplary embodiment, the operations further comprise performing selectively a test among a batch test, a single test and a syndromic test based on the sample data.

[0439] In an exemplary embodiment, the operations further comprise performing selectively a test among a batch test, a single test, a syndromic test and a combinatorial test based on the sample data.

[0440] The program instructions are operative, when performed by the processor, to cause the processor to perform the present method described above. The program instructions may comprise an instruction to determine a sample processing protocol, determine the type of the test for the sample, select a modular testing device and perform the designated test reaction.

[0441] The present method described above is implemented in a processor, such as a processor in a stand-alone computer, a network attached computer or a data acquisition device.

[0442] The types of the computer readable storage medium include various storage medium such as CD-R, CD-ROM, DVD, flash memory, floppy disk, hard drive, portable HDD, USB, magnetic tape, MINIDISC, nonvolatile memory card, EEPROM, optical disk, optical storage medium, RAM, ROM, system memory and web server.

[0443] The data (e.g., identification information labeled on a sample container containing the sample) may be received through several mechanisms. For example, the data may be acquired by identification information readers. The data may be provided to the processor in real time as the data is being collected, or it may be stored in a memory unit or buffer and provided to the processor after the test has been completed. Similarly, the data set may be provided to a separate system such as a desktop computer system via a network connection (e.g., LAN, VPN, intranet and Internet) or direct connection (e.g.,USB or other direct wired or wireless connection) to the acquiring device, or provided on a portable medium such as a CD, DVD, floppy disk, portable HDD or the like to a stand-alone computer system. Similarly, the data set may be provided to a server system via a network connection (e.g., LAN, VPN, intranet, Internet and wireless communication network) to a client such as a notebook or a desktop computer system.

[0444] The instructions to configure the processor to perform the presently disclosed method may be included in a logic system. The instructions may be downloaded and stored in a memory module (e.g., hard drive or other memory such as a local or attached RAM or ROM), although the instructions can be provided on any software storage medium such as a portable HDD, USB, floppy disk, CD and DVD. A computer code for implementing the presently disclosed method may be implemented in a variety of coding languages such as C, C++, Java, Visual Basic, VBScript, JavaScript, Perl and XML. In addition, a variety of languages and protocols may be used in external and internal storage and transmission of data and commands according to the presently disclosed method.

[0445]

[0446] Having described a preferred embodiment of the present disclosure, it is to be understood that variants and modifications thereof falling within the spirit of the present disclosure may become apparent to those skilled in this art, and the scope of present disclosure is to be determined by appended claims and their equivalents.

Claims

A continuous loadable module-typed system for a test, comprising:(a) a modular processing device configured to process a sample to provide a processed sample; wherein the sample is contained in a sample container labeled with an identification information; wherein the modular processing device is configured to be able to additionally process another sample simultaneously with the processing of the sample;(b) a modular storage device for an assay reagent configured to accommodate a plurality of assay reagents for different tests; wherein the plurality of assay reagents are in at least one type selected from the group consisting of a liquid type, a freeze-dried type and combination thereof;(c) a sample applicator configured to (i) receive the processed sample from the modular processing device, (ii) receive from the modular storage device a designated assay reagent specific for the sample among the plurality of assay reagents depending on the identification information labeled on a sample container containing the sample and (iii) apply the processed sample to the designated assay reagent, thereby providing a test reaction mixture in a reaction container;(d) a transferring device comprising a first carrier configured to transfer the designated assay reagent among the plurality of assay reagents specific for the sample from the modular storage device to the sample applicator;(e) at least one modular testing device configured to perform a designated test reaction specific for the sample depending on the identification information labeled on the sample container by using the test reaction mixture in the reaction container; and(f) a controller configured to control (i) selecting the designated assay reagent specific for the sample among the plurality of assay reagents depending on the identification information labeled on the sample container and then transferring the designated assay reagent thus selected to the sample applicator, and (ii) selecting the modular testing device to perform the designated test reaction specific for the sample depending on the identification information labeled on the sample container and then transferring the test reaction mixture to the modular testing device thus selected.The system according to claim 1, wherein the test is molecular diagnostics, immunological diagnostics, biochemical diagnostics or cell culture tests.The system according to claim 1, wherein the modular processing device comprises (i) a modular pretreatment device, (ii) a modular nucleic acid extraction device or (iii) a modular pretreatment device and a modular nucleic acid extraction device.The system according to claim 1, wherein the modular processing device is a single processing device configured to process a single sample to provide a single processed sample in the processing process.The system according to claim 1, wherein the modular processing device is a batch processing device configured to process a plurality of samples simultaneously to provide a plurality of processed samples in the processing process.The system according to claim 4, wherein the modular processing device further comprises a batch processing device configured to process a plurality of samples simultaneously to provide a plurality of processed samples in the processing process.The system according to claim 1, wherein the modular processing device comprises a nucleic acid extraction device, and the nucleic acid extraction device comprises two types of devices, one of two types of devices being a single nucleic acid extraction device configured to extract a nucleic acid molecule from a single sample individually in an extraction process and the other being a batch nucleic acid extraction device configured to extract nucleic acid molecules from a plurality of samples simultaneously in an extraction process.The system according to claim 7, wherein the single nucleic acid extraction device comprises a pipette channel configured to extract the nucleic acid molecule from the single sample in a liquid transfer manner.The system according to claim 7, wherein the batch nucleic acid extraction device comprises a plurality of magnetic rods configured to extract the nucleic acid molecules from the plurality of samples simultaneously in a bead transfer manner.The system according to claim 1, wherein the modular processing device is configured to accommodate at least two types of processing reagents and select a designated processing reagent for the sample depending on the identification information labeled on the sample container.The system according to claim 1, wherein the modular processing device further comprises a bulk tank module configured to accommodate bulk processing reagents for processing a plurality of samples.The system according to claim 1, wherein the modular processing device further comprises an identification information reader (ID reader) to read the identification information labeled on the sample container.The system according to claim 1, wherein the system further comprises a decapper for the sample container.The system according to claim 1, wherein the modular storage device comprises two storages combined or separated and temperatures of the two storages are controlled independently from each other.The system according to claim 1, wherein the modular storage device comprises a means for identifying reagent containers containing assay reagents stored in the modular storage device.The system according to claim 1, wherein the modular storage device comprises two storages combined or separated, and one of the two storages is configured to store a plurality of assay reagents in the liquid type and the other is configured to store a plurality of assay reagents in the freeze-dried type.The system according to claim 1, wherein the modular storage device comprises a gripper to transfer selectively the designated assay reagent among the plurality of assay reagents to a location accessible to the first carrier and then the first carrier transfers the designated assay to the sample applicator.The system according to claim 1, wherein the modular storage device is a storage device that is structurally separated from the other devices including the modular processing device, the sample applicator, the modular testing device.The system according to claim 18, wherein the modular storage device is detachable from the other devices without affecting them.The system according to claim 1, wherein the sample applicator is configured to accommodate at least two designated assay reagents.The system according to claim 20, wherein the sample applicator is configured to apply the processed sample to the at least two designated assay reagents.The system according to claim 1, wherein the sample applicator is a liquid handler equipped with multi-pipette channels.The system according to claim 1, wherein when the plurality of assay reagents are in the liquid type and are contained in assay reagent containers, the sample applicator transfers (i) the designated assay reagent contained in the assay reagent container and (ii) the processed sample to a reaction container, thereby providing the test reaction mixture.The system according to claim 1, wherein (i) when the plurality of assay reagents are in the freeze-dried type and the assay reagents are pre-contained in reaction containers, the sample applicator transfers the processed sample to a reaction container prefilled with the designated assay reagent, or (ii) when the plurality of assay reagents are in the freeze-dried type and the assay reagents are contained in assay reagent containers, the sample applicator transfers (ii-1) the designated assay reagent contained in the assay reagent container and (ii-2) the processed sample to a reaction container, thereby providing the test reaction mixture.The system according to claim 1, wherein the modular testing device comprises at least two testing devices.The system according to claim 25, wherein the at least two testing devices comprise testing devices, each of which is configured to accommodate a different reaction container in size.The system according to claim 25, wherein the at least two testing devices comprise testing devices, each of which is configured to be operated by an independent protocol.The system according to claim 1, wherein the modular testing device comprises a real-time PCR (polymerase chain reaction) cycler.The system according to claim 1, wherein the transferring device further comprises a second carrier configured to transfer the reaction container from the modular sample applicator to the modular testing device.The system according to claim 1, wherein the transferring device further comprises a processed sample carrier configured to transfer the processed sample from the modular processing device the modular sample applicator.The system according to claim 1, wherein the controller is configured to control performing selectively either a batch test or a single test depending on the identification information labeled on the sample container.The system according to claim 31, wherein when the controller controls performing selectively the batch test, the controller controls the sample applicator (i) to transfer (i-1) the designated assay reagent in the liquid type contained in an assay reagent container and (i-2) a plurality of processed samples to a plurality of reaction chambers of the reaction container, thereby providing a plurality of test reaction mixtures; (ii) to transfer a plurality of processed samples to a plurality of reaction chambers of the reaction container prefilled with the designated assay reagent in the freeze-dried type, thereby providing a plurality of test reaction mixtures; or (iii) to transfer (iii-1) the designated assay reagent in the freeze-dried type contained in an assay reagent container and (iii-2) a plurality of processed samples to a plurality of reaction chambers of the reaction container, thereby providing a plurality of test reaction mixtures.The system according to claim 32, wherein the controller controls (i) selecting at least one testing device for the batch test from the at least one modular testing device and (ii) transferring the plurality of test reaction mixtures to the at least one testing device thus selected.The system according to claim 31, wherein when the controller controls performing selectively the single test, the controller controls the sample applicator (i) to transfer (i-1) the designated assay reagent in the liquid type contained in an assay reagent container and (i-2) the processed sample to a reaction chamber of the reaction container, thereby providing a test reaction mixture; (ii) to transfer the processed sample to a reaction chamber of the reaction container prefilled with the designated assay reagent in the freeze-dried type, thereby providing a test reaction mixture; or (iii) to transfer (iii-1) the designated assay reagent in the freeze-dried type contained in an assay reagent container and (iii-2) the processed sample to a reaction chamber of the reaction container, thereby providing a test reaction mixture.The system according to claim 34, wherein the controller controls (i) selecting a testing device for the single test from the at least one modular testing device and (ii) transferring the test reaction mixture to the testing device thus selected.The system according to claim 1, wherein the controller is configured to control performing selectively a test among a batch test, a single test and a syndromic test depending on the identification information labeled on the sample container.The system according to claim 1, wherein the controller is configured to control performing selectively a test among a batch test, a single test, a syndromic test and a combinatorial test depending on the identification information labeled on the sample container.The system according to claim 36, wherein when the controller controls performing selectively the syndromic test, the controller controls the sample applicator (i) to transfer (i-1) a plurality of designated assay reagents in the liquid type contained in assay reagent containers and (i-2) the processed sample to a plurality of reaction chambers of the reaction container, thereby providing a plurality of test reaction mixtures; (ii) to transfer the processed sample to a plurality of reaction chambers of the reaction container prefilled with a plurality of designated assay reagents in the freeze-dried type, thereby providing a plurality of test reaction mixtures; or (iii) to transfer (iii-1) a plurality of designated assay reagents in the freeze-dried type contained in assay reagent containers and (iii-2) the processed sample to a plurality of reaction chambers of the reaction container, thereby providing a plurality of test reaction mixtures.The system according to claim 38, wherein the controller controls (i) selecting at least one testing device for the syndromic test from the at least one modular testing device and (ii) transferring the plurality of test reaction mixtures to the at least one testing device thus selected.The system according to claim 37, wherein when the controller controls performing selectively the combinatorial test, the controller controls the sample applicator (i) to transfer (i-1) a plurality of designated assay reagents in the liquid type contained in assay reagent containers and (i-2) the processed sample to a plurality of reaction containers, thereby providing a plurality of test reaction mixtures; (ii) to transfer the processed sample to a plurality of reaction containers prefilled with a plurality of designated assay reagents in the freeze-dried type, thereby providing a plurality of test reaction mixtures; or (iii) to transfer (iii-1) a plurality of designated assay reagents in the freeze-dried type contained in assay reagent containers and (iii-2) the processed sample to a plurality of reaction containers, thereby providing a plurality of test reaction mixtures.The system according to claim 40, wherein the controller controls (i) selecting at least two testing devices for the combinatorial test from the at least one modular testing device and (ii) transferring the plurality of test reaction mixtures to the at least two testing devices thus selected.The system according to claim 1, wherein the controller integratively controls operations of the modular processing device, the modular storage device, the sample applicator and the modular testing device depending on the identification information labeled on the sample container.The system according to claim 1, wherein the controller selects an operation protocol of the modular testing device for testing the processed sample depending on the identification information labeled on the sample container and then controls the modular testing device to operate according to the operation protocol.The system according to claim 1, wherein the assay reagents in the liquid type or the freeze-dried type comprises each at least two reagent components specific for each of the different tests.The system according to claim 44, wherein the at least two reagent components specific for each of the different tests in the liquid type is contained in an individual assay reagent container.The system according to claim 45, wherein the at least two reagent components specific for each of the different tests in the liquid type comprises (i) primers and probes in an oligonucleotide tube and (ii) enzymes in an enzyme tube used in a molecular diagnostic test.The system according to claim 44, wherein the at least two reagent components specific for each of the different tests in the freeze-dried type are pre-contained all in the reaction container.The system according to claim 47, wherein the at least two reagent components specific for each of the different tests in the freeze-dried type exist as (i) a single lyobead form containing primers, probes and enzymes or (ii) separate lyobeads one of which contains primers and probes and the other contains enzymes.The system according to claim 1, wherein the reaction container comprises a plate-typed reaction container having a top layer that is film sealable.The system according to claim 1, wherein the system further comprises a sealer configured to seal the reaction container containing the test reaction mixture.The system according to claim 1, wherein the system further comprises a modular processed-sample storage device configured to store the processed sample.The system according to claim 51, wherein the modular processed-sample storage device receives and stores the processed sample and delivers to the controller information on the processed sample including a storage location of the processed sample.The system according to claim 1, wherein the system is an expandable system in which at least one modular device is additionally installed without affecting the other devices in the system.The system according to claim 1, wherein the system further comprises a storage device configured to store materials for processing the sample in the modular processing device.The system according to claim 54, wherein the storage device is configured to retrieve the materials for processing the sample from the modular processing device and then stores the materials thus retrieved.The system according to claim 1, wherein the test capacity of the module-typed system is adjustable by additional connection or disconnection of at least one module selected from the group of consisting of the modular processing device, the modular storage device and the modular testing device.A method for testing a sample, which comprises the steps of:(a) loading the sample and reading an identification information labeled on a sample container containing the sample to receive a sample data corresponding to the identification information;(b) based on the sample data, determining a sample processing protocol for the sample and processing the sample to provide a processed sample;(c) based on the sample data, determining the type of the test for the sample;(d) based on the type of the test for the sample, transferring a designated assay reagent specific for the sample among a plurality of assay reagents;(e) based on the type of the test for the sample, providing a test reaction mixture containing the processed sample and the designated assay reagent by using a sample applicator; and(f) based on the type of the test for the sample, automatically selecting a modular testing device to perform a designated test reaction specific for the sample, loading the test reaction mixture onto the modular testing device and performing the designated test reaction specific for the sample.The method according to claim 57, wherein the determination of the type of the test for the sample is to select a test between a batch test and a single test based on the sample data.The method according to claim 58, wherein when the batch test is selected as the type of the test for the sample, (i-1) the designated assay reagent in the liquid type contained in the assay reagent container and (i-2) a plurality of processed samples are transferred to a plurality of reaction chambers of the reaction container by the sample applicator, thereby providing a plurality of test reaction mixtures; (ii) a plurality of processed samples are transferred to a plurality of reaction chambers of the reaction container prefilled with the designated assay reagent in the freeze-dried type by the sample applicator, thereby providing a plurality of test reaction mixtures; or (iii-1) the designated assay reagent in the freeze-dried type contained in an assay reagent container and (iii-2) a plurality of processed samples are transferred to a plurality of reaction chambers of the reaction container by the sample applicator, thereby providing a plurality of test reaction mixtures.The method according to claim 58, wherein when the single test is selected as the type of the test for the sample, (i-1) the designated assay reagent in the liquid type contained in the assay reagent container and (i-2) the processed sample are transferred to a reaction chamber of the reaction container by the sample applicator, thereby providing the test reaction mixture; (ii) the processed sample is transferred to a reaction chamber of the reaction container prefilled with the designated assay reagent in the freeze-dried type, thereby providing the test reaction mixture; or (iii-1) the designated assay reagent in the freeze-dried type contained in an assay reagent container and (iii-2) the processed sample are transferred to a reaction chamber of the reaction container by the sample applicator, thereby providing a test reaction mixture.The method according to claim 57, wherein the determination of the type of the test for the sample is to select a test among a batch test, a single test and a syndromic test based on the sample data.The method according to claim 57, wherein the determination of the type of the test for the sample is to select a test among a batch test, a single test, a syndromic test and a combinatorial test based on the sample data.The method according to claim 61, wherein when the syndromic test is selected as the type of the test for the sample, (i-1) a plurality of designated assay reagents in the liquid type contained in the assay reagent container and (i-2) the processed sample are transferred to a plurality of reaction chambers of the reaction container by the sample applicator, thereby providing a plurality of test reaction mixtures; (ii) the processed sample is transferred to a plurality of reaction chambers of the reaction container prefilled with a plurality of designated assay reagents in the freeze-dried type by the sample applicator, thereby providing a plurality of test reaction mixtures; or (iii-1) a plurality of designated assay reagents in the freeze-dried type contained in assay reagent containers and (iii-2) the processed sample are transferred to a plurality of reaction chambers of the reaction container, thereby providing a plurality of test reaction mixtures.The method according to claim 62, wherein when the combinatorial test is selected as the type of the test for the sample, (i-1) a plurality of designated assay reagents in the liquid type contained in the assay reagent container and (i-2) the processed sample are transferred to a plurality of reaction chambers of the reaction container by the sample applicator, thereby providing a plurality of test reaction mixtures; (ii) the processed sample is transferred to a plurality of reaction chambers of the reaction container prefilled with a plurality of designated assay reagents in the freeze-dried type by the sample applicator, thereby providing a plurality of test reaction mixtures; or (iii-1) a plurality of designated assay reagents in the freeze-dried type contained in assay reagent containers and (iii-2) the processed sample are transferred to a plurality of reaction containers, thereby providing a plurality of test reaction mixtures.The method according to claim 57, wherein when the plurality of assay reagents are in the liquid type and the assay reagents are contained in assay reagent containers, (i) the designated assay reagent contained in the assay reagent container and (ii) the processed sample are transferred to a reaction container by the sample applicator, thereby providing the test reaction mixture.The method according to claim 57, wherein when the plurality of assay reagents are in the freeze-dried type and the assay reagents are pre-contained in reaction containers, the processed sample is transferred to a reaction container prefilled with the designated assay reagent the sample applicator, thereby providing the test reaction mixture.The method according to claim 57, wherein when the plurality of assay reagents are in the freeze-dried type and the assay reagents are contained in assay reagent containers, (i) the designated assay reagent contained in the assay reagent container and (ii) the processed sample are transferred to a reaction container by the sample applicator, thereby providing the test reaction mixture.The method according to claim 57, wherein the method further comprises processing additionally another sample simultaneously with the processing of the sample.A computer readable storage medium containing instructions to configure a processor to enable a continuous loadable module-typed system for a test to perform the following operations:(a) upon receiving a sample, reading an identification information labeled on a sample container containing the sample and receiving a sample data corresponding to the identification information;(b) based on the sample data, determining a sample processing protocol for the sample and controlling a modular processing device according to the sample processing protocol to provide a processed sample;(c) based on the sample data, determining the type of the test for the sample;(d) based on the type of the test for the sample, transferring a designated assay reagent specific for the sample among a plurality of assay reagents;(e) based on the type of the test for the sample, controlling a sample applicator to provide a test reaction mixture containing the processed sample and the designated assay reagent;(f) based on the type of the test for the sample, selecting a modular testing device to perform a designated test reaction specific for the sample and transferring the test reaction mixture to the modular testing device thus selected; and(g) performing the designated test reaction according to a test reaction protocol specific for the type of the test.The computer readable storage medium according to claim 69, wherein the operations further comprise processing additionally another sample simultaneously with the processing of the sample.The computer readable storage medium according to claim 69, wherein the operations further comprise performing selectively either a batch test or a single test based on the sample data.The computer readable storage medium according to claim 69, wherein the operations further comprise performing selectively a test among a batch test, a single test and a syndromic test based on the sample data.The computer readable storage medium according to claim 69, wherein the operations further comprise performing selectively a test among a batch test, a single test, a syndromic test and a combinatorial test based on the sample data.

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