Automated analysis system using individually operating biological devices, analysis method, and storage medium

Abstract

The present invention relates to an automated analytical system, an analytical method, and a storage medium using independently operated biological devices that can operate like an automated analytical system through the operational linkage of independently operated devices and can prepare and analyze analytical samples.

Description

[Technical Field]

[0001] The present invention relates to an automated analytical system that operates like a full automation system through the operational connection of independently operated devices, and relates to an automated analytical system including a device for preparing an analytical sample and a device for analyzing the sample, which operate independently, an analytical method, and a storage medium. [Background technology]

[0002] PCR testing for disease diagnosis involves testing processes such as nucleic acid extraction, PCR setup, amplification reaction, and reaction analysis, and various devices are used to perform each step.

[0003] For example, a nucleic acid extraction device for extracting nucleic acids from a specimen, a liquid dispensing device for preparing an analysis sample, a real-time PCR device for performing an amplification reaction and subsequent reaction analysis, etc. can be used.

[0004] These various devices are used in a stand-alone manner, with the user loading or transferring containers for reagents, specimens and / or analytical samples for each test step from one device to another.

[0005] External contamination may occur when specimen, reagent, and / or analytical sample containers are loaded into each device or transferred to other devices by the user, and human testing error may also occur.

[0006] Various devices have been developed to solve these problems, one example of which is the fully automated system.

[0007] Currently, a variety of fully automated systems are used in large medical institutions and laboratories, etc. Representative examples include Roche's Cobas 6800 / Cobas 8800, Hologic's Panther / Panther Fusion, Abbott's Alinity, and Qiagen's QIAsymphony.

[0008] Such devices may operate in a single step to provide results that integrate some or all of the various processes for the diagnostic tests described above.

[0009] However, conventional fully automated systems have been realized as a single system since the device was developed, and therefore cannot separately and individually perform nucleic acid extraction, PCR setup, amplification reaction, reaction analysis, and the like.

[0010] Furthermore, conventional automated systems are manufactured in a fairly large size to perform various processes for diagnostic testing within a single system, and the purchase cost is high. Therefore, it is difficult to introduce them into small and medium-sized hospitals and laboratories, which makes it difficult to develop various diagnostic reagents.

[0011] Conventional systems have low adaptability to the device, making it difficult to adapt to further developed diagnostic reagents. Furthermore, even if a partial error occurs in the device, it may be difficult to use the entire device.

[0012] Furthermore, in unusual circumstances where large-scale diagnostic testing is required, each testing device must be operated separately for rapid testing, but conventional systems do not allow each part to be used separately, and even if they could be used separately, it was impossible to separate the devices and use them separately.

[0013] When developing diagnostic reagents at diagnostic kit development companies or research institutes that have conventional systems, the entire system is used for development and experiments, making it difficult for small-scale diagnostic kit development companies or research institutes to develop reagents.

[0014] Even if the project is carried out by large-scale diagnostic kit development companies or research institutes, there is also the problem that the development of diagnostic reagents cannot be completed in a short period of time unless a large number of devices are installed. Summary of the Invention [Problem to be solved by the invention]

[0015] [Detailed Description of the Invention] [Technical issues] The present invention aims to enable modular combination of stand-alone biological devices for molecular diagnostic testing or research, which can be integrated into an automated analytical system.

[0016] Another object of the present invention is to integrate and operate separately operating biological devices into an integrated system that can be easily and quickly disassembled and re-operated separately as needed.

[0017] It is yet another object of the present invention to integrate and operate a biological device as an automated analytical system while minimizing structural modifications to the device.

[0018] It is yet another object of the present invention to allow a biological device integrated with an automated analytical system to use existing molecular diagnostic test reagents without modification.

[0019] Yet another object of the present invention is to integrate and operate independently operating biological devices into an automated analysis system through modular combination, while storing some or all of the devices to improve user convenience and reduce the space required.

[0020] It is yet another object of the present invention to provide an environmental control means within the enclosed structure for housing at least one or more individually operating biological devices so that the environment in which the devices operate is not altered.

[0021] It is yet another object of the present invention to form a defined passage through which reaction vessels commonly used by biological devices can be transported, thereby enabling easy transport of reaction vessels from one or more devices.

[0022] It is yet another object of the present invention to provide a robotic module for transporting reaction vessels so that the reaction vessels are easily transported through defined passages between biological devices.

[0023] It is yet another object of the present invention to provide a combination device that can combine two or more biological devices that operate independently so that they can be integrated into an automated analytical system.

[0024] It is yet another object of the present invention to modularly combine independently operating biological devices into an automated analytical system, and to perform tests using existing diagnostic reagents without changing the diagnostic reagents.

[0025] Another object of the present invention is to connect individually licensed biological devices to an automated analysis system so that they can be operated in an integrated manner without the need for new licenses for each device. [Means for solving the problem]

[0026] In order to achieve the object of the present invention, the present invention provides an automated analysis system, comprising: a preparation device for preparing an analytical sample in a reaction vessel; the preparation device being a stand-alone device; an analysis device for analyzing the analytical sample prepared in the reaction vessel; the analysis device being a stand-alone device; and a transport device and a closed structure for transporting the reaction vessel, wherein at least one device selected from the group consisting of the analysis device and the transport device is located inside the closed structure, the preparation device and the closed structure form a defined passage through which the reaction vessel is transported, the transport device transports the reaction vessel through the defined passage, and the independently driven device can operate independently when separated from the automated analysis system.

[0027] In order to achieve another object of the present invention, the present invention provides an analytical method using an automated analytical system, which comprises the steps of: The automated analysis system includes a preparation device, an analysis device, a transport device, a control module, and a closed structure, and the analysis method includes the steps of: the control module controlling the transport device so that a reaction vessel containing an analysis sample is transported from the preparation device to the analysis device; the preparation device and the analysis device are stand-alone devices; the control module controlling the analysis device so that the analysis sample is analyzed in the analysis device; and the control module controlling the transport device so that the reaction vessel, after analysis of the analysis sample, is removed from the analysis device; and at least one device selected from the group consisting of the analysis device and the transport device is located inside a closed structure, and the preparation device and the closed structure each include a defined passage through which the reaction vessel is transported, and the transport device transports the reaction vessel through the defined passage.

[0028] In order to achieve another object of the present invention, the present invention provides an automated analysis system including a memory, at least one processor configured to access the memory, and one or more programs stored in the memory and configured to be executed by the processor, The automated analytical system includes a preparation device, an analytical device, a transport device, a control module, and a closure structure, and the one or more programs include instructions that, when executed by the one or more processors, cause the system to perform the following steps: The control module controls the transport device so that a reaction vessel containing an analytical sample is transported from the preparation device to the analytical device; the preparation device and the analytical device are independently driven devices; the control module controls the analytical device so that the analytical sample is analyzed in the analytical device; and the control module controls the transport device so that the reaction vessel after analysis of the analytical sample is completed is removed from the analytical device; at least one device selected from the group consisting of the analytical device and the transport device is arranged inside an enclosure, and the preparation device and the closed structure each include a defined passage through which the reaction vessel is transported, and the one or more programs include instructions that cause the transport device to transport the reaction vessel through the defined passage.

[0029] In order to achieve another object of the present invention, the present invention provides a non-transitory computer-readable storage medium containing instructions, when executed by one or more processors, for performing an analytical method using an automated analytical system, the automated analytical system including a preparation device, an analytical device, a transport device, a control module, and a closing structure, the method including the steps of: the control module controlling the transport device so that a reaction vessel containing an analytical sample is transported from the preparation device to the analytical device; the preparation device and the analytical device are independently driven devices; the control module controlling the analytical device so that the analytical sample is analyzed in the analytical device; and the control module controlling the transport device so that the reaction vessel, after analysis of the analytical sample, is removed from the analytical device; wherein at least one device selected from the group consisting of the analysis device and the transport device is disposed within a closing structure, the preparation device and the closing structure each including a defined passage through which the reaction vessel is transported, and the instructions including instructions for causing the transport device to transport the reaction vessel through the defined passage.

[0030] In order to achieve another object of the present invention, the present invention provides a fan module control method to be performed in an automated analytical system, the automated analytical system including: a preparation device for preparing an analytical sample in a reaction container; an analytical device for analyzing the analytical sample prepared in the reaction container; a transport device for transporting the reaction container; a closing structure; an opening / closing unit for opening and closing the defined passage; and a fan module that operates to exhaust air in the internal space of the closed structure to the outside; at least one device selected from the group consisting of the analytical device and the transport device is located inside the closed structure; the preparation device and the closing structure each include a defined passage through which the reaction container is transported; the fan module control method includes the steps of opening the defined passage by the opening / closing unit; and stopping the operation of the fan module while the defined passage is opened by the opening / closing unit.

[0031] In order to achieve another object of the present invention, the present invention provides a method for manufacturing an assembly of an automated analysis system, the assembly including: an independently driven analysis device, a transport device, and an independently driven preparation device; the transport device transports a reaction vessel; the independently driven preparation device provides a reaction vessel containing a sample that can be analyzed by the independently driven analysis device; the independently driven analysis device analyzes the sample contained in the reaction vessel; the method includes the following steps: (a) a providing step of providing the independently driven analysis device and the independently driven preparation device to the transport device; and (b) an aligning step of aligning the independently driven analysis device, the transport device, and the independently driven preparation device; the alignment forms a movement pathway for the reaction vessel between the independently driven preparation device and the independently driven analysis device. [Effects of the Invention]

[0032] The features and advantages of the present invention can be summarized as follows: (1) The automated analytical system, analytical method, and storage medium of the present invention can facilitate operative connection between a preparation device and an analytical device that have been used separately for the analysis of analytical samples by providing a transport device that can provide a reaction vessel between the two devices.

[0033] (2) The automated analytical system, analytical method, and storage medium of the present invention have the advantage of being able to provide ease of use by operatively linking previously stand-alone biological devices so that they can be used like an automated analytical system.

[0034] (3) The automated analysis system, analysis method, and storage medium of the present invention can operatively connect multiple devices that have been used independently to operate and use them as an integrated automated analysis system, and can also be disassembled and used independently again if necessary.

[0035] (4) The automated analytical system, analytical method, and storage medium of the present invention combine biological devices that were previously used separately and can be connected without modifying the internal structure of the devices, thereby enabling the combined devices to be used without requiring additional licensing or approval.

[0036] (5) The automated analytical system, analytical method, and storage medium of the present invention can be combined so that additional licenses and permits are not required for biological devices integrated into the automated analytical system, and each device can be used without changing the reagents it previously used.

[0037] (6) The automated analysis system, analysis method, and storage medium of the present invention have the advantage of preventing human testing errors because the reaction vessels used by the biological devices connected to the automated analysis system can be provided to each device through a transport device.

[0038] (7) The automated analytical system, analytical method, and storage medium of the present invention have the advantage of being able to protect analytical samples from contamination of the external environment by combining a biological device with an automated analytical system and housing two or more devices.

[0039] (8) The automated analysis system, analysis method, and storage medium of the present invention can prevent the reaction vessel from coming into contact with external contamination by accommodating at least one of an analysis device and a transport device. [Brief explanation of the drawings]

[0040] [Figure 1] FIG. 1 is a front view showing an automated analysis system according to one embodiment of the present invention. [Figure 2] FIG. 2 is a right side view showing an automated analysis system according to one embodiment of the present invention. [Figure 3] FIG. 3 is an exemplary diagram showing the operational connections of an automated analysis system according to one embodiment of the present invention. [Figure 4] FIG. 4 is an internal front view showing an automated analysis system according to one embodiment of the present invention. [Figure 5] FIG. 5 is a perspective view of an independently driven preparation device according to one embodiment of the present invention. [Figure 6] FIG. 6 is a perspective view showing a closure structure according to one embodiment of the present invention. [Figure 7] FIG. 7 is an exemplary view showing the operation of a defined passage of a closed structure according to an embodiment of the present invention. [Figure 8] FIG. 8 is an internal perspective view showing the closure structure of an automated analysis system according to one embodiment of the present invention. [Figure 9] FIG. 9 is a perspective view showing a conveying device according to an embodiment of the present invention. [Figure 10] FIG. 10 is a perspective view showing a lifting module of a transport device according to an embodiment of the present invention. [Figure 11] FIG. 11 is a perspective view showing a crane module of a transport device according to an embodiment of the present invention. [Figure 12]FIG. 12 is a perspective view illustrating a rotational configuration of a crane module according to one embodiment of the present invention. [Figure 13] FIG. 13 is a perspective view of a stand-alone analytical device according to one embodiment of the present invention. [Figure 14] FIG. 14 is a perspective view showing an automatic sealer according to one embodiment of the present invention. [Figure 15] FIG. 15 is an exemplary view showing a conveyor for collecting reaction vessels according to one embodiment of the present invention. [Figure 16] FIG. 16 is a perspective view showing a solution recovery box according to one embodiment of the present invention. [Figure 17] FIG. 17 is a first exemplary view showing the horizontal extension movement of the lifting module in the closed structure according to an embodiment of the present invention. [Figure 18] FIG. 18 is a second exemplary view showing the horizontal extension movement of the lifting module in the closed structure according to an embodiment of the present invention. [Figure 19] FIG. 19 is a first exemplary view showing the reaction vessel transportation by the lifting module and the crane module according to an embodiment of the present invention. [Figure 20] FIG. 20 is a second exemplary view showing the reaction vessel transportation by the lifting module and the crane module according to an embodiment of the present invention. [Figure 21] FIG. 21 is an exemplary view showing an operation of loading a reaction container into an automatic sealer according to an embodiment of the present invention. [Figure 22] FIG. 22 is an exemplary view showing an operation of mounting a reaction vessel on an analyzer according to an embodiment of the present invention. [Figure 23] FIG. 23 is an exemplary diagram illustrating the operation of a lift module according to an embodiment of the present invention. [Figure 24] FIG. 24 is a perspective view illustrating horizontal extension movement of a lift module in a preparation apparatus according to one embodiment of the present invention. [Figure 25] FIG. 25 is an exemplary diagram showing a crane module according to an embodiment of the present invention transporting a reaction vessel on a lifting module. [Figure 26]FIG. 26 is an exemplary diagram showing a crane module loading a reaction vessel into an automatic sealer according to one embodiment of the present invention. [Figure 27] FIG. 27 is an exemplary diagram showing a crane module attaching a reaction vessel to an analytical device according to one embodiment of the present invention. [Figure 28] FIG. 28 is a first exemplary view showing an operation of recovering reaction vessels using a conveyor according to an embodiment of the present invention. [Figure 29] FIG. 29 is a second exemplary view showing the operation of recovering reaction vessels using a conveyor according to an embodiment of the present invention. [Figure 30] FIG. 30 is an interior plan view showing the interior of a closed structure according to one embodiment of the present invention. [Figure 31] FIG. 31 is an internal perspective view showing the inside of a closure structure according to one embodiment of the present invention. [Figure 32] FIG. 32 is an exemplary diagram showing an analytical device mounted in a closed structure using a positioning means according to one embodiment of the present invention. [Figure 33] FIG. 33 is a first exemplary view showing a positioning means according to an embodiment of the present invention. [Figure 34] FIG. 34 is a second exemplary view showing the positioning means according to an embodiment of the present invention. [Figure 35] FIG. 35 is a diagram showing a fan module, which is an environmental adjustment means within an enclosed structure according to one embodiment of the present invention. [Figure 36] Figure 36A is a diagram showing an independently driven preparation device according to one embodiment of the present invention installed in a conveying section, Figure 36B is a diagram for explaining that the independently driven preparation device is aligned with the conveying section, and Figure 36C is a diagram showing the internal structure of the housing of the independently driven preparation device. [Figure 37] Figure 37A shows an independently driven analytical device according to one embodiment of the present invention, and Figure 37B shows an independently driven analytical device according to one embodiment of the present invention mounted within a closed structure of a transport section. [Figure 38]FIG. 38 is a layout diagram showing the arrangement of components of a preparation apparatus on deck according to one embodiment of the present invention. [Figure 39] FIG. 39 is a flowchart illustrating a method of operation of an automated analysis system according to one embodiment of the present invention. [Figure 40] FIG. 40 is a conceptual diagram showing the configuration of an automated analysis system according to one embodiment of the present invention. [Figure 41] FIG. 41 is a block diagram conceptually showing the configuration of the HW section of the preparation device of the present invention. [Figure 42] FIG. 42 is a block diagram conceptually showing the configuration of a preparation device management unit included in the preparation device of the present invention. [Figure 43] FIG. 43 is a block diagram conceptually showing the configuration of the HW section of the analyzer of the present invention. [Figure 44] FIG. 44 is a block diagram conceptually showing the configuration of an analytical device management unit included in the analytical device of the present invention. [Figure 45] FIG. 45 is a diagram showing an example of a path along which a reaction vessel is transferred by a transport device in an automated analysis system according to one embodiment of the present invention. [Figure 46] FIG. 46 is a block diagram conceptually showing the configuration of the transfer module of the present invention. [Figure 47] FIG. 47 is a block diagram conceptually showing the configuration of the automatic sealer of the present invention. [Figure 48] FIG. 48 is a diagram illustrating an example of the direction of movement of a transport device in an automated analysis system according to one embodiment of the present invention. [Figure 49] FIG. 49 is a diagram illustrating the concept of controlling the operation of a fan module in accordance with the position and direction of movement of a transport device or the opening and closing of an opening in an automated analysis system according to one embodiment of the present invention. [Figure 50] FIG. 50 is a diagram illustrating the concept of controlling the operation of a fan module in accordance with the position and direction of movement of a transport device or the opening and closing of an opening in an automated analysis system according to one embodiment of the present invention. [Figure 51]FIG. 51 is a diagram illustrating the concept of controlling the operation of a fan module in accordance with the position and direction of movement of a transport device or the opening and closing of an opening in an automated analysis system according to one embodiment of the present invention. [Figure 52] FIG. 52 is a diagram illustrating the concept of controlling the operation of a fan module in accordance with the position and direction of movement of a transport device or the opening and closing of an opening in an automated analysis system according to one embodiment of the present invention. [Figure 53] FIG. 53 is a diagram illustrating the concept of controlling the operation of a fan module in accordance with the position and direction of movement of a transport device or the opening and closing of an opening in an automated analysis system according to one embodiment of the present invention. [Figure 54] FIG. 54 is a diagram illustrating the concept of controlling the operation of a fan module in accordance with the position and direction of movement of a transport device or the opening and closing of an opening in an automated analysis system according to one embodiment of the present invention. [Figure 55] FIG. 55 is a diagram illustrating the concept of controlling the operation of a fan module in accordance with the position and direction of movement of a transport device or the opening and closing of an opening in an automated analysis system according to one embodiment of the present invention. [Figure 56] FIG. 56 is a diagram illustrating the concept of controlling the operation of a fan module in accordance with the position and direction of movement of a transport device or the opening and closing of an opening in an automated analysis system according to one embodiment of the present invention. [Figure 57] FIG. 57 is a flowchart of a fan module control method that may be implemented in an automated analysis system according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0041] Specific embodiments for realizing the technical concept of the present invention will be described in detail below with reference to the accompanying drawings. These embodiments are merely for the purpose of explaining the present invention in more detail, and it will be obvious to those skilled in the art that the scope of the present invention is not limited to these embodiments according to the gist of the present invention.

[0042] Furthermore, in describing components of the present invention, terms such as first, second, A, B, (a), (b), (i), and (ii) may be used. These terms are used merely to distinguish the component from other components, and do not limit the nature, order, or sequence of the components. When a component is described as being "coupled," "coupled," or "connected" to another component, it should be understood that the component can be directly coupled, coupled, or connected to the other component, but other components may also be "coupled," "coupled," or "connected" between each component.

[0043] Automated Analysis System (Main: Common Content) The present inventors have endeavored to develop a system, method, etc. for interconnecting various devices that execute processors for amplifying and detecting target nucleic acids. As a result, the present inventors have constructed a system that enables a preparation device and an analysis device, which are stand-alone biological devices that operate independently and are used to detect target nucleic acids, to be interconnected and used. That is, the present inventors have developed an automated analysis system that enables a reaction vessel used in the preparation device and analysis device, which were previously operated independently, to be delivered from the preparation device to the analysis device using a delivery device.

[0044] As used herein, the term "automated analysis system" includes a preparation device that prepares an analysis sample that contains or is suspected to contain an analyte, and an analysis device that amplifies nucleic acids having a specific nucleotide sequence in the prepared analysis sample and detects the amplified nucleic acid. The preparation device and analysis device are independently operated devices that operate separately. The preparation device and analysis device can be applied to an automated analysis system while being licensed as independent devices. Alternatively, some modifications, such as a housing, can be made to the device for application to an automated analysis system, and partial license for the device can be obtained.

[0045] Therefore, the preparation and analysis devices can use approved reagents as they are for use in independently driven devices.

[0046] The automated analytical system includes one or more defined pathways and transport devices for operatively connecting the preparation device and the analytical device, respectively. The defined pathways can be openings.

[0047] As used herein, the term "sample" means a substance that contains or is suspected to contain an analyte.

[0048] "Sample" includes biological samples (eg, cells, tissues, and body fluids from biological sources) and non-biological samples (eg, food, water, and soil).

[0049] Biological samples may include, but are not limited to, viruses, bacteria, tissues, cells, blood (including whole blood, plasma, and serum), lymph, bone marrow fluid, sputum, smears, aspirates, bronchial washings, bronchoalveolar lavage fluid, nasal washings, milk, urine, feces, ocular fluid, saliva, semen, brain extracts, spinal fluid (SCF), synovial fluid, appendix, spleen, and tonsil tissue extracts, amniotic fluid, and ascites.

[0050] In addition, samples can include naturally occurring nucleic acid molecules isolated from biological sources as well as synthetic nucleic acid molecules.

[0051] In one embodiment, the term "sample" can include materials used to store, process, detect, etc. A "sample" can include additional substances such as, but not limited to, amplification reagents, detection reagents, preservatives, water, deionized water, saline, pH buffers, acidic solutions, basic solutions, etc.

[0052] As used herein, the term "raw sample" may be used to refer to a sample prior to use in an instrument that processes the sample for analysis.

[0053] As used herein, the term "raw sample" may be used to refer to a sample before it is processed in a preparation device for sample preparation.

[0054] As used herein, the term "analysis sample" may be used to refer to an analyte-containing intermediate prepared during some step in processing a sample for analysis.

[0055] It can be used to refer to a sample that is produced in the course of being processed in a preparatory device for sample preparation and an analytical device, and in particular to refer to a sample that is to be analyzed in an analytical device.

[0056] The term "specimen" as used herein may refer to a sample collected from food, soil, air, water, or a living organism as an object to be analyzed. Samples generally include saliva, blood, urine, stool, etc. A specimen container containing a specimen may contain a specimen collection composition and / or a specimen transport medium for collecting the specimen. The specimen transport medium functions to inactivate infectious pathogens by lysis and stabilize nucleic acid substances released from the lysed pathogens.

[0057] The term "analyte" may be used interchangeably with the term "sample." In particular, in one embodiment, the analyte is an antigen, an antibody, an enzyme, or a nucleic acid.

[0058] In a specific embodiment, the analyte is a nucleic acid. When the analyte to be analyzed herein is a nucleic acid molecule, the nucleic acid can be extracted from the sample using a nucleic acid extraction process known in the art (see Sambrook, J. et al., Molecular Cloning. A Laboratory Manual, 3rd ed. Cold Spring Harbor Press (2001)). The nucleic acid extraction process can vary depending on the type of sample. Furthermore, when the extracted nucleic acid is RNA, a reverse transcription process to synthesize cDNA can be further performed (see Sambrook, J. et al., Molecular Cloning. A Laboratory Manual, 3rd ed. Cold Spring Harbor Press (2001)).

[0059] One or more types of analytes can be contained in a sample, and multiple detection assay samples can be prepared to detect them.

[0060] As used herein, the term "preparation device" refers to a device used to prepare a sample for analysis. A preparation device is an independently operating, self-contained device.

[0061] In one embodiment of the present invention, the preparation device includes a housing, and the preparation device can be disposed within a separate hexahedron-shaped enclosure.

[0062] The preparation device can provide the analytical device with an internal reaction vessel. In one embodiment of the present invention, the preparation device can provide the reaction vessel therein to the analysis device through one or more openings formed in the housing.

[0063] In another embodiment of the present invention, the preparation device may form one or more defined passages (first defined passages) in the housing to provide the reaction vessels therein to the analysis device, and the defined passages may be openings.

[0064] In another embodiment of the present invention, when the preparation device is disposed inside the closed structure and the analysis device is disposed outside the closed structure, the closed structure can form one or more defined passages for providing the reaction vessels of the preparation device to the analysis device.

[0065] As used herein, the term "preparation device" is a device that prepares an analysis sample that contains or is suspected to contain an analyte.

[0066] The preparation device uses a microrobot to automatically perform the process of preparing a detection sample used to detect an analyte (e.g., a target nucleotide sequence), and the detection sample preparation process in the present invention includes nucleic acid extraction from a specimen, preparation of an amplification reaction solution (e.g., a reaction solution for PCR (polymerase chain reaction)), and a process of combining these to prepare a nucleic acid extraction and amplification reaction solution.

[0067] If the preparation device does not include a nucleic acid extraction module, nucleic acid extraction from the specimen can be performed using a separate device.

[0068] When the analyte to be analyzed herein is a nucleic acid, a nucleic acid extraction module can be used to extract the nucleic acid from the specimen.

[0069] That is, when the preparation task to be performed by the preparation device is a nucleic acid extraction task, a series of tasks for separating and purifying nucleic acids, including fractionating the sample in a container containing the sample, dispensing a cell lysis solution into the fractionated sample, heating, etc., must be performed, and finally, the separated nucleic acids must be collected. The nucleic acid extraction task can be performed by a nucleic acid extraction module included in the preparation device.

[0070] In one embodiment of the present invention, a magnetic bead-based method is commonly used to extract nucleic acids from a sample, which uses magnetic beads that can bind to nucleic acids and elute the bound nucleic acids. Magnetic bead-based automated nucleic acid extraction methods can be divided into a liquid transfer method and a bead transfer method depending on the type of process used to elute the nucleic acids bound to the magnetic beads.

[0071] In addition, the preparation device can perform a reaction mixture preparation operation for nucleic acid amplification. In one embodiment of the present invention, the preparation device can simultaneously perform a nucleic acid extract preparation operation and a reaction mixture preparation operation for nucleic acid amplification.

[0072] The preparation device performs a sample preparation process, including nucleic acid extraction from a specimen, preparation of an amplification reaction solution, and preparation of a sample by mixing these. The sample preparation process in the preparation device is realized by a control device (not shown) for controlling the preparation device, and the operation of each sample preparation process is performed by the control device controlling each component.

[0073] The control device can be configured to be incorporated into the preparation device, or can be provided as a separate device and connected to the preparation device via a network.

[0074] The control device according to the present invention is software-controlled. The control method of the preparation device can be controlled by software. The method realized by software or an algorithm can be stored in a computer-readable recording medium as computer-readable code or program instructions that can be executed on a processor.

[0075] Here, examples of computer-readable recording media include magnetic storage media (e.g., read-only memory (ROM), random access memory (RAM), floppy disks, hard disks, etc.) and optically readable media (e.g., CD-ROMs, DVDs, Digital Versatile Discs). The computer-readable recording media can be distributed among computer systems connected via a network, and computer-readable code can be stored and executed in a distributed manner. The medium is readable by a computer, can be stored in a memory, and can be executed by a processor.

[0076] The preparation apparatus according to the present invention is an automated liquid handling device that can automatically and programmatically aspirate and / or dispense desired amounts of reagents, samples, or other liquids from designated containers for automation in chemical or biochemical laboratories. Various configurations of automated liquid handling devices are known to those skilled in the art.

[0077] All components of the preparation device are designed as an integrated device and placed within the system housing.

[0078] In one embodiment of the present invention, the preparation device may be a product such as Hamilton's "Microlab VANTAGE," "Microlab STAR," "Microlab NIMBUS," or "Microlab Prep" (see https: / / www.hamiltoncompany.com / automated-liquid-handling / platforms).

[0079] As used herein, the term "analysis device" refers to a device used for the qualitative or quantitative analysis of an analyte.

[0080] Sample analysis involves detecting the presence or amount of an analyte. An analytical device can refer to an instrument that amplifies nucleic acids having specific nucleotide sequences and detects the amplified nucleic acids.

[0081] The analytical device may include an optical instrument including a light source and a light detector. The analytical device may include equipment capable of heating or cooling the analytical sample through temperature control.

[0082] The analytical device may include a nucleic acid amplifier that performs a nucleic acid amplification reaction by temperature control. The nucleic acid amplifier typically includes a thermal cycler.

[0083] In the analytical device, the nucleic acid can be amplified in a variety of ways. Examples of suitable amplification methods include ligase chain reaction (LCR, see Wiedmann M et al., "Ligase chain reaction (LCR) - overview and applications." PCR Methods and Applications 1994 Feb;3(4):S51-64), gap filling LCR (GLCR, see WO 90 / 01069, EP 439182, and WO 93 / 00447), Qbeta replicase amplification (Q-beta, see Cahill P et al., Clin Chem., 37(9):1482-5 (1991), U.S. Pat. No. 5,556,751), strand displacement amplification (SDA, see G.T. Walker et al., Nucleic Acids Res. 20(7):16911696 (1992), EP 497272), and nucleic acid sequence-based amplification (NAA). Sequence-based amplification (NASBA, see Compton, J. Nature 350(6313):912 (1991)), transcription-mediated amplification (TMA, see Hofmann WP et al., J. Clin Virol. 32(4):289-93 (2005); U.S. Pat. No. 5,888,779), or rolling circle amplification (RCA, see Hutchison CA et al., Proc. Natl. Acad. Sci. USA. 102:1733217336 (2005)).

[0084] The thermal cycler, which is a nucleic acid amplifier included in the analytical device of the present invention, is useful for PCR (polymerase chain reaction)-based nucleic acid amplification reactions. Various nucleic acid amplification methods based on PCR (polymerase chain reaction) are known, including quantitative PCR, digital PCR, asymmetric PCR, reverse transcriptase PCR (RT-PCR), differential display PCR (DDPCR), nested PCR, arbitrarily primed PCR (AP-PCR), multiplex PCR, and SNP genomic typing PCR.

[0085] For example, in the case of a thermal cycler, which is a nucleic acid amplifier of the present invention, an analytical device can perform a denaturing step, an annealing step, and an extension (or amplification) step to amplify DNA (deoxyribonucleic acid) having a specific nucleotide sequence.

[0086] The denaturation step involves heating a solution containing a sample containing double-stranded DNA (template nucleic acid) and reagents to a specific temperature, e.g., about 95°C, to separate the double-stranded DNA into single-stranded DNA. The annealing step involves providing an oligonucleotide primer with a nucleotide sequence complementary to that of the nucleic acid to be amplified, and cooling the isolated single-stranded DNA to a specific temperature, e.g., 60°C, to form a partial DNA-primer complex by binding the primer to a specific nucleotide sequence in the single-stranded DNA. The extension step involves maintaining the solution after the annealing step at a specific temperature, e.g., 72°C, and using DNA polymerase to form double-stranded DNA based on the primer in the partial DNA-primer complex.

[0087] As one example, the analytical device of the present invention can exponentially amplify DNA having the specific nucleotide sequence by repeating the above three steps, for example, 10 to 50 times.

[0088] In another embodiment, the analytical device of the present invention can simultaneously perform the annealing step and the extension step, in which case the analytical device can complete the first cycle by performing two steps consisting of the denaturation step and the annealing / extension step.

[0089] Meanwhile, the nucleic acid detecting device included in the analytical device of the present invention is a device for detecting target nucleic acids from a sample that has undergone polymerase chain reaction (PCR) via a nucleic acid amplifier, and includes an optical module that detects emission light emitted from a fluorescent substance in the target nucleic acid.

[0090] The optical module is an optics mechanism that analyzes (or monitors) the amplification reaction performed in the nucleic acid amplifier in real time. As an example, the optical module may be composed of components such as multiple light sources, optical filters, convex lenses, beam splitters, and photodetectors, and may detect fluorescence generated in the nucleic acid amplification reaction performed in the optical module in real time.

[0091] According to one embodiment of the present invention, the analytical device is a real-time detection device. According to one embodiment of the present invention, the analytical device is a real-time nucleic acid detection device.

[0092] According to one embodiment of the present invention, the analytical device is a real-time PCR device. The term "analytical device" as used herein refers to a device for analyzing an analytical sample. An analytical device is an independently operating, self-contained device.

[0093] In one embodiment of the present invention, the analytical device includes a housing for the analytical device, and the analytical device can be placed within a separate hexahedron-shaped enclosed structure.

[0094] The analytical device can receive a reaction vessel containing the analytical sample from the preparation device. The analysis device can receive the reaction vessel transported from the transport device, rather than receiving the reaction vessel directly from the preparation device.

[0095] The term "enclosure" as used herein is a housing-type structure formed from one or more enclosed spaces that can be environmentally / spatially separated from the outside.

[0096] In one embodiment of the present invention, the closed structure may be in the shape of a hexahedron.

[0097] In another embodiment of the present invention, the closed structure may have a shape in which a plurality of hexahedrons are connected, and the interior may be connected as one space or separated into a plurality of spaces.

[0098] In one embodiment of the present invention, the transport device can be located inside the closed structure, when the preparation device is located outside the closed structure and the analysis device is located inside the closed structure.

[0099] In another embodiment of the invention, the transport device can be located outside the closed structure, when the analytical device is located outside the closed structure and the preparation device is located inside.

[0100] In yet another embodiment of the present invention, when the preparation device and the analysis device are arranged inside the closed structure, the transport device can be arranged inside the closed structure.

[0101] The closure structure may be equipped with an automatic sealer.

[0102] The closed structure may include an environmental conditioning means therein to provide an environment in which the preparation device and / or the analysis device operate as an independently driven device when the preparation device and / or the analysis device are placed therein.

[0103] The environmental adjustment means is for adjusting the temperature, humidity, contamination, etc. inside the enclosed structure, and can be composed of a heating device, a cooling device, a humidity adjustment device, a fan module, a filter, etc.

[0104] The term "defined passage" as used herein refers to a configuration for connecting a preparation device and an analysis device that are environmentally / spatially separated. The defined passage is a passage through which a reaction vessel prepared in a preparation device is moved to an analysis device or an analysis device in a closed structure in order to spatially connect adjacently arranged preparation devices and analysis devices.

[0105] In one embodiment of the present invention, the defined passage may be an opening. In one embodiment of the present invention, the determined passage may be composed of a first determined passage formed in the preparation device and a second determined passage included in the closed structure.

[0106] In another embodiment of the present invention, the first and / or second determined passages may include a door device that can interrupt the spatial connection between them. The door device may be included in the first determined passage, the second determined passage, or both the first and second determined passages.

[0107] The defining passage is operable to open when the reaction vessel prepared in the preparation device is moved to the analytical device or to the analytical device in the closed structure, and to close after the movement is completed.

[0108] The first defined passage is formed in the lower part of the preparation device, preferably in the deck of the preparation device, and the first defined passage formed in the deck of the preparation device can provide the reaction vessel to the analysis device disposed in the lower part or to the analysis device disposed in the closed structure.

[0109] The second defined passage may be formed on the top, side, or bottom of the closed structure to accommodate the reaction vessels moving in the first defined passage of the preparation device.

[0110] Additionally, the closure structure may include a transport device for transporting the reaction vessel from the first defined passage through the second defined passage.

[0111] The term "transport device" as used herein refers to a device that can move reaction vessels used in an automated analytical system from a preparation device to an analytical device or an analytical device within a closed structure, and transport and attach them to each component within the closed structure.

[0112] In one embodiment of the present invention, the transport device for moving the reaction vessels from the preparation device to the analysis device may include at least one or more robot modules.

[0113] In one embodiment of the present invention, the robot module includes a lift module for moving the reaction vessel up and down, and can move the reaction vessel of the preparation device into the closed structure.

[0114] In another embodiment of the present invention, the robotic module includes a crane module that can transport and attach a reaction vessel moved into the enclosed structure to a component within the enclosed structure.

[0115] In yet another embodiment of the present invention, the robot module includes robot arms that can move the reaction vessel to a desired position via one or more articulations.

[0116] The robot module can move in up / down, forward / backward, and left / right directions, but in one embodiment of the present invention, the lifting module moves in up / down and left / right directions, and the crane module can move in up / down, forward / backward, and left / right directions and rotate.

[0117] The term "vessel" as used herein refers to a space that contains materials used in preparation and analysis devices. The materials generally contain solutions. A vessel can be used as a "sample vessel" or a "reaction vessel" that contains an analytical sample. Furthermore, the space that contains materials used in preparation and analysis devices can be used as a "container" or a "carrier" in this specification. No particular distinction is made between "vessel," "container," and "carrier." However, the terms can be used selectively depending on the device, form, or internal receptacle material used.

[0118] Furthermore, the term "container" refers to a container used for nucleic acid extraction, amplification reaction solution composition, and amplification reaction setup (e.g., PCR setup) performed in a preparation device. That is, a sample, one or more extraction reagents, one or more components for the reaction solution, an analysis sample (master mix) obtained by mixing extracted nucleic acid with the reaction solution, etc., are contained in a container, and the analysis sample to be reacted in the analysis device can be dispensed and contained in a reaction container. In one embodiment of the present invention, the container includes a tube, a tube strip, etc. In other embodiments of the present invention, the container includes a cartridge, a well plate, etc.

[0119] Various sizes of containers can be used depending on the materials to be stored, and various means for storing or housing the containers can be prepared according to the various sizes of containers. The means for housing the containers include carriers, racks, adapters, etc., and each means can store one or more containers inserted therein.

[0120] In one embodiment of the present invention, the container may include a cap. In another embodiment of the present invention, the container may be sealed with a film or the like.

[0121] The term "reaction vessel" as used herein refers to a sample vessel that can be accommodated in a sample holder of an analytical device. The reaction vessel accommodates a predetermined volume of an analytical sample containing or not containing a target nucleic acid, and can be accommodated in the sample holder and used for a reaction (e.g., amplification) or detection (e.g., fluorescent signal).

[0122] Although the reaction vessels described herein are tubes capable of containing analytical samples, various materials and shapes of reaction vessels can be used depending on the shape of the reaction region. The reaction vessels are inserted into wells formed in the reaction region to allow a reaction cycle of heating and cooling to occur. In other words, a "reaction vessel" refers to a closed space in which a reaction takes place.

[0123] A reaction vessel may contain one or more. A reaction vessel refers to a unit that can receive an analytical sample (e.g., an analyte or a reaction mixture). Test tubes, amplification tubes, strip tubes, well plates, and multi-well PCR plates are each examples of a reaction vessel that contains one or more.

[0124] In one embodiment of the present invention, one or more reaction vessels can be mounted on a sample holder.

[0125] In another embodiment of the present invention, one or more reaction vessels are contained in a multi-well plate (hereinafter referred to as a "well plate"). The well plate containing one or more reaction vessels can be attached to a sample holder.

[0126] In yet another embodiment of the present invention, the reaction vessel is a well plate capable of receiving an analytical sample in one or more wells. The well plate having received the analytical sample in one or more wells can be attached to a sample holder.

[0127] The above-described embodiments of the reaction vessel are merely examples of preferred embodiments of the present invention, and it is apparent that the reaction vessel can be embodied in various other ways.

[0128] As used herein, the term "reaction mixture" can refer to a solution that is mixed with an analyte to facilitate detection of the analyte. The reaction mixture can be configured to include one or more amplification reaction reagents.

[0129] Fig. 1 is a front view of an automated analytical system according to an embodiment of the present invention, and Fig. 2 is a right side view of the automated analytical system according to an embodiment of the present invention. As shown in Figs. 1 and 2, in one embodiment of the present invention, the automated analytical system 1000 includes a preparation device 1100 and an enclosure 1300.

[0130] In one embodiment of the present invention, the preparation device 1100 can be configured to be located on top of the closed structure 1300 .

[0131] In another embodiment of the present invention, the preparation device 1100 can be configured to be located to the side of the closed structure 1300.

[0132] In yet another embodiment of the present invention, the preparation device 1100 can be configured to be located at the rear of the closure structure 1300 .

[0133] In yet another embodiment of the present invention, the preparation device 1100 can be configured to be located in front of the closure structure 1300 .

[0134] In yet another embodiment of the present invention, the preparation device 1100 can be configured to be located inside an enclosed structure 1300 .

[0135] In yet another embodiment of the present invention, the preparation device 1100 can be configured to be located below the closed structure 1300 .

[0136] The closed structure 1300 is a closed space in the shape of a hexahedron. The enclosed structure 1300 can accommodate at least one of the following devices: a preparation device 1100 , an analysis device 1200 , and a transport device 1400 .

[0137] In one embodiment of the present invention, the enclosed structure 1300 can accommodate one or more analytical devices 1200 and a transport device 1400 .

[0138] In other embodiments of the present invention, the enclosed structure 1300 can house one or more analytical devices 1200 .

[0139] In yet another embodiment of the present invention, the closed structure 1300 can accommodate a carrier device 1400 .

[0140] In yet another embodiment of the present invention, the closed structure 1300 can accommodate the preparation device 1100 and the transport device 1400 .

[0141] In yet another embodiment of the present invention, the enclosed structure 1300 can house the preparation device 1100 .

[0142] The closure structure 1300 can provide an operative connection between one or more devices housed within and an externally located device.

[0143] In one embodiment of the present invention, the closure structure 1300 occupies a single space. When the closure structure 1300 occupies a single space, at least one of the preparation device 1100, the analysis device 1200, and the transport device 1400 can be arranged in the single space.

[0144] In another embodiment of the present invention, the closing structure 1300 closes a plurality of spaces. When the closing structure 1300 closes a plurality of spaces, at least one of the preparation device 1100, the analysis device 1200, and the transport device 1400 can be disposed in any one of the plurality of spaces, or in any two or more of the plurality of spaces.

[0145] For example, in a closed structure 1300 having a single space, the analysis device 1200 and the transport device 1400 may be arranged in the same space.

[0146] For example, in the closed structure 1300 having a plurality of spaces, the analysis device 1200 and the transport device 1400 may be arranged in different spaces.

[0147] In one embodiment of the present invention, the analytical device 1200 and the transport device 1400 can be disposed inside the closed structure 1300. In this case, the preparation device 1100 is located outside the closed structure 1300.

[0148] The closing structure 1300 is formed with a second passthrough cavity 1310, which is a defined passage through which a transport device 1400 moves to transport a reaction vessel 1500 provided from the preparation device 1100 to the analysis device 1200.

[0149] The second opening 1310 of the closure structure 1300 is a defined passage through which the reaction vessel 1500 is transported, and the transport device 1400 can provide the reaction vessel 1500 from the first opening 1130 of the preparation device 1100 to the analysis device 1200 through the second opening 1310 of the closure structure 1300.

[0150] The second opening 1310 of the closing structure 1300 may be located on any of the outer surfaces of the closing structure 1300. When the closing structure 1300 has a hexahedral shape as shown in FIG. 6, the second opening 1310 may be formed on the top surface of the closing structure 1300, but is not limited to this.

[0151] The transport device 1400 can be programmed to transport the reaction vessel 1500 through a path formed between the first opening (1st passthrough cavity) 1130 of the preparation device 1100 and the second opening 1310 of the closing structure 1300.

[0152] Therefore, it is preferable that each defined path is disposed at a distance within the range in which the transport device 1400 can move the reaction vessel 1500 .

[0153] The closed structure 1300 can be realized in the shape of a hexahedron-shaped cabinet, locker, box / case, etc. The closed structure 1300 is closed at the front / rear / left / right / top / bottom and has at least one closed structure door 1320. The closed structure doors 1320 are installed at the front / rear, left / right, etc. so that a user can access devices and components placed inside.

[0154] The closure structure 1300 is not sealed and an air vent 1370 may be formed.

[0155] The closed structure 1300 can be provided with at least one selected from the group consisting of the preparation device 1100, the analysis device 1200, and the transport device 1400.

[0156] Additionally, the closure structure 1300 may include an automatic sealer 1700 disposed therein for sealing the top face inlet of the reaction vessel 1500 .

[0157] Additionally, the closure structure 1300 may include a liquid waste collection bin 1330 for collecting various solutions used in the preparation of analytical samples in the preparation device 1100 .

[0158] In addition, a reaction vessel retrieval container 1360 may be disposed in the closed structure 1300 to retrieve the reaction vessel 1500 after the analysis performed by the analysis device 1200 has been completed.

[0159] In one embodiment of the present invention, reaction vessel collection box 1360 can be located inside enclosure structure 1300 .

[0160] 16B , when a reaction vessel collection box 1361 is placed inside the closed structure 1300, it can accommodate reaction vessels 1500 moved by the crane module 1430. The reaction vessel collection box 1361 placed inside may include a sensor that detects one or more of the number and weight of the reaction vessels 1500 accommodated therein.

[0161] In other embodiments of the present invention, the reaction vessel collection box 1360 can be located outside the closure structure 1300 .

[0162] Referring to Figures 15, 28, and 29, the reaction vessel recovery box 1360 located externally can recover the reaction vessel 1500 by transporting the reaction vessel 1500 from the inside to the outside through a retrieval passthrough cavity 1340 that connects the inside and outside of the closure structure 1300.

[0163] A conveyor 1350 may be installed and interconnected at a collection opening 1340 that connects the inside and outside of the enclosing structure 1300 for the movement of the reaction vessel 1500. When the transport device 1400 drops the reaction vessel 1500 onto the inner conveyor 1350 of the enclosing structure 1300, the reaction vessel 1500 may be moved by the conveyor 1350 and stored in a reaction vessel collection box 1360 arranged outside the enclosing structure 1300.

[0164] In one embodiment of the present invention, the conveyor 1350 forms an inclined surface that is lower on the outside than on the inside. The conveyor 1350 is provided with rollers on the inclined surface, so that the reaction vessels 1500 can be discharged to the outside of the closed structure 1300. The reaction vessels 1500 discharged to the outside can be collected in a reaction vessel collection box 1360.

[0165] In another embodiment of the present invention, the conveyor 1350 may be driven by a power source. The power source may rotate a belt or the like included in the conveyor 1350, thereby discharging the reaction vessels 1500 placed on the conveyor 1350 to the outside of the closed structure 1300. The reaction vessels 1500 discharged to the outside may be stored in a reaction vessel recovery box 1360.

[0166] The reaction vessel collection box 1360 can be emptied of one or more reaction vessels 1500 contained therein by a user.

[0167] The collection opening 1340, where the inside and outside of the enclosed structure 1300 are connected by the conveyor 1350, may include an opening / closing module (not shown). The opening / closing module can be opened when the reaction vessel 1500 is moved to the reaction vessel collection box 1360, and is preferably closed otherwise. The opening / closing module can protect the inside of the enclosed structure 1300 from external contamination.

[0168] In one embodiment of the present invention, the enclosed structure 1300 is not completely sealed but is embodied to be ventilated, and therefore the enclosed structure 1300 includes an environmental conditioning means, which may include a vent, an exhaust port, a fan, a temperature control means, a humidity control means, an air filter, etc.

[0169] 6 and 8 of the present invention show that the enclosed structure 1300 is provided with one or more air vents 1370 or exhaust vents 1370 for air circulation within the enclosed structure 1300, and / or one or more fans 1380 for exhausting the air therein.

[0170] 3 is an exemplary diagram showing the operational connections of an automated analysis system according to one embodiment of the present invention. As shown in FIG. 3, the preparation device 1100 is placed on top of a closed structure 1300.

[0171] The preparation device 1100 can be installed and operated independently for the preparation of analytical samples, and according to one embodiment of the present invention, can be operatively coupled to the closed structure 1300 and used as an automated analysis system 1000.

[0172] According to one embodiment of the present invention, when the preparation device 1100 is used as the automated analysis system 1000 in combination with the closed structure 1300, the preparation device 1100 can have a first opening 1130 so that the lifting module 1410 provided in the closed structure 1300 can move inside (see FIG. 5). The first opening 1130 is an empty space and a defined passage through which the reaction vessel 1500 is moved by the lifting module 1410.

[0173] When the lifting module 1410 is moved into the preparation device 1100, the preparation device 1100 loads a reaction vessel 1500 containing an analysis sample or a plate (not shown) containing the reaction vessel 1500 onto the lifting module 1410. The lifting module 1410 moves the loaded reaction vessel 1500 or plate into the enclosed structure 1300.

[0174] According to one embodiment of the present invention, when the preparation device 1100 is placed on top of the closing structure 1300, the preparation device 1100 and the closing structure 1300 can be coupled by a coupling mechanism (not shown).

[0175] In one embodiment of the present invention, when at least one of the preparation device 1100 and the analysis device 1200 is operatively connected to the closed structure 1300 and used as an automated analysis system 1000, the preparation device 1100 and the analysis device 1200 continue to use the power supply modules that were used as independently driven devices.

[0176] In one embodiment of the present invention, the preparation device and the analysis device may be powered by separate power sources.

[0177] In one embodiment of the present invention, when at least one of the independently driven preparation device 1100 and the independently driven analysis device 1200 are operatively connected to the closed structure 1300 and used as an automated analysis system 1000, the independently driven preparation device 1100 and the independently driven analysis device 1200 are devices that have already been commercialized and / or have already been approved as independently driven devices.

[0178] Therefore, when it is operatively connected to the closed structure 1300 and used as the automated analysis system 1000, no separate license is required or partial modifications may be required.

[0179] 4 is a front view showing the interior of the automated analytical system of the present invention. As shown in FIG. 4, analytical devices 1200-a and 1200-b are disposed in the lower part of a closed structure 1300.

[0180] The closure structure 1300 will now be described with reference to Figures 8, 30 and 31.

[0181] Figure 8 is an internal perspective view showing a closure structure of an automated analysis system according to one embodiment of the present invention. Figure 30 is an internal plan view showing the interior of a closure structure according to one embodiment of the present invention. Figure 31 is an internal perspective view showing the interior of a closure structure according to one embodiment of the present invention.

[0182] In one embodiment of the present invention, the closed structure 1300 includes a transport device 1400 for providing the reaction vessels 1500 prepared by the preparation device 1100 to the analysis devices 1200-a and 1200-b.

[0183] The transport device 1400 is a robot module, and is particularly composed of a lift module 1410 and a crane module 1430 .

[0184] In one embodiment of the present invention, transport apparatus 1400 is configured to include a lift module 1410 and a crane module 1430 .

[0185] In another embodiment of the present invention, the transport apparatus 1400 is configured to include a lift module 1410 .

[0186] In yet another embodiment of the present invention, the transport apparatus 1400 is configured to include a crane module 1430 .

[0187] In yet another embodiment of the present invention, the transport apparatus 1400 is configured to include a robotic arm (not shown).

[0188] In yet another embodiment of the present invention, the transport device 1400 can include a mechanical device capable of transporting the reaction vessel 1500 .

[0189] In one embodiment of the present invention, the lifting module 1410 and the crane module 1430 may be located inside the enclosed structure 1300 .

[0190] The lifting module 1410 and the crane module 1430 included in the closed structure 1300 are robot modules. The robot modules move the reaction vessels 1500 under the control of a control module 2500 (see FIG. 40) included in the automated analysis system 1000.

[0191] An automatic sealer 1700 for sealing the inlet of the reaction vessel 1500 may be disposed in the closure structure 1300 .

[0192] In the closed structure 1300, at least one or more analysis devices 1200-a, 1200-b for analyzing the analysis sample contained in the reaction vessel 1500 can be arranged.

[0193] A liquid waste collection bin 1330 may be arranged in the closed structure 1300 for collecting various solutions used in the preparation of analytical samples in the preparation device 1100 .

[0194] The closed structure 1300 may be provided with a reaction vessel retrieval container 1360 for retrieving the reaction vessel 1500 after the analysis performed by the analysis devices 1200-a and 1200-b has been completed.

[0195] The enclosed structure 1300 includes a control module 2500 (see FIG. 40) that transmits and / or receives data from multiple devices operatively coupled to the automated analysis system 1000 .

[0196] In one embodiment of the present invention, the control module can be connected via a communication channel to be operatively coupled to at least one of the preparation device 1100, the analysis device 1200, the transport device 1400, and / or the automatic sealer 1700. For example, the communication channel can be wireless and / or wired.

[0197] In one embodiment of the present invention, the control module can control the preparation device, the analysis device, and the transport device to operate in a timely manner. The control module controls the preparation device, the analysis device, and the transport device so that the preparation and analysis of an analytical sample are automatically performed using the preparation device and the analysis device of the present invention, which are independently driven devices. Specifically, when the preparation device completes the preparation of the analytical sample, the control module controls the transport device to transport the analytical sample to the analytical device. The control module also provides a signal to the analytical device to load the analytical sample onto the analytical device, causing the analytical device to load the analytical sample and start the analysis.

[0198] Furthermore, in one embodiment of the present invention, the control module can provide external signals necessary for the operation of the independently driven device, such as a signal to make the analyzer ready to receive an analysis sample, a signal to cause the analyzer to start analysis, or a signal to cause an automatic sealer to start a sealing operation.

[0199] In this way, the control module not only transmits signals between the independently driven devices to enable the transfer of analysis samples from the preparation device to the analysis device, but also provides signals that previously had to be manually input from outside by users in a timely manner so that the independently driven devices can independently perform unit tasks, thereby realizing a fully automated system.

[0200] In one embodiment of the present invention, the control module can receive a signal using the communication channel that the preparation device 1100 has completed preparation of the sample for analysis.

[0201] Also, a control signal for moving the reaction vessel 1500 of the preparation device 1100 to the analysis device 1200 can be provided to the transport device 1400 using the communication channel.

[0202] Additionally, the control module may receive a signal using the communication channel when the analytical device 1200 has completed analysis of the analytical sample.

[0203] The control module can also provide a control signal to the transport device 1400 using the communication channel to move the reaction vessel 1500 of the analysis device 1200 to the reaction vessel collection box 1360 .

[0204] The closing structure 1300 has a second defined passage 1310 formed on its upper surface through which the lifting module 1410 passes as it moves to the preparation device 1100 to receive the reaction vessel 1500 .

[0205] According to one embodiment of the present invention, the second determined passage 1310 can be described as follows with reference to Figures 6 and 7. Figure 6 is a perspective view showing a closure structure according to one embodiment of the present invention. Figure 7 is an exemplary view showing an operation state of the second opening of the closure structure according to one embodiment of the present invention. As shown in Figures 6 and 7, the second determined passage 1310 is formed on the upper surface of the closure structure 1300.

[0206] The second defined passage 1310 is formed to a size that allows a vertical motion guide 1413 and an analytical sample vessel rack 1416 included in the lifting module 1410 to pass through.

[0207] The second determined passage 1310 is formed to be vertically connected to the first determined passage 1130 formed on the deck 1110 of the preparation device 1100 .

[0208] In one embodiment of the present invention, the second defined passage 1310 is formed on the right side of the upper surface of the closed structure 1300, and the first defined passage 1130 is formed on the right side of the plane of the deck 1110.

[0209] In another embodiment of the present invention, the second defined passage 1310 may be formed on the left side of the upper surface of the closed structure 1300, and the first defined passage 1130 may be formed on the left side of the plane of the deck 1110.

[0210] In yet another embodiment of the present invention, the second defined passage 1310 may be formed on the upper surface of the upper surface of the closed structure 1300 , and the first defined passage 1130 may be formed on the upper surface of the plane of the deck 1110 .

[0211] In yet another embodiment of the present invention, the second defined passage 1310 may be formed on the underside of the upper surface of the closed structure 1300 , and the first defined passage 1130 may be formed on the underside of the plane of the deck 1110 .

[0212] In one embodiment of the present invention, the second defined passage 1310 is a passage through which a part of the lifting module 1410 located inside the closed structure 1300 moves to the inside of the preparation device 1100 (see FIG. 6). In another embodiment of the present invention, the second determined passage 1310 is an open passage for a part of the lifting module 1410 inside the closed structure 1300 to move into the preparation device 1100, and when a part of the lifting module 1410 does not move to the preparation device 1100, the opened second determined passage 1310 can be closed by an open / close module 1311 provided in the second determined passage 1310 (see FIG. 7). The opening and closing module 1311 is provided to keep out contaminants outside the enclosed structure 1300 .

[0213] In one embodiment of the present invention, the opening and closing module 1311 is realized in a hinge manner, and can be opened and closed above or below the top surface of the closing structure 1300 .

[0214] In another embodiment of the present invention, the opening and closing module 1311 is realized as a sliding type, and can be opened and closed by moving from the upper surface of the closing structure 1300 .

[0215] In still another embodiment of the present invention, the opening and closing module 1311 may be any type that can open and close the second determined passage 1310 using a method other than a hinge method or a slide method.

[0216] As shown in FIG. 7(a), when the lifting module 1410 is located inside the closed structure 1300, the opening / closing module 1311 of the second defined passage 1310 is closed.

[0217] 7(b), when the lifting module 1410 moves to the preparation device 1100, the opening / closing module 1311 of the second determined passage 1310 opens. Then, after the lifting module 1410 moves into the closed structure 1300, the opening / closing module 1311 of the second determined passage 1310 closes.

[0218] In one embodiment of the present invention, the lifting module 1410 can be described as follows with reference to Figures 9 and 10. Figure 9 is a perspective view of a transport apparatus according to one embodiment of the present invention, and Figure 10 is a perspective view of a lifting module of a transport apparatus according to one embodiment of the present invention.

[0219] The lifting module 1410 is configured to receive the reaction vessel 1500 at the preparation device 1100. The lifting module 1410 represents the operational form of an elevator that can rise to the preparation device 1100 at the top of the closed structure 1300 to receive the analysis sample from the preparation device 1100.

[0220] The lifting module 1410 includes a columnar vertical fixed guide 1411 fixed inside the closed structure 1300. The vertical fixed guide 1411 includes a fixed guide connector 1412 that moves up and down. The lifting module 1410 includes a vertical motion guide 1413 coupled to the fixed guide connector 1412 of the vertical fixed guide 1411.

[0221] The vertical motion guide 1413 includes a motion guide connector 1414 that moves up and down. The vertical motion guide 1413 includes a rack guide 1415 that couples to the motion guide connector 1414.

[0222] The lifting module 1410 includes an analytical sample vessel rack 1416 that receives sample vessels on top of rack guides 1415 .

[0223] The lift module 1410 includes an actuator 1417 that provides power to move the vertical motion guide 1413 up and down.

[0224] The vertical fixed guide 1411 is coupled to and fixed on at least one of the top, bottom, and / or side surfaces of the inside of the closure structure 1300. The vertical fixed guide 1411 is coupled to a fixed guide connector 1412. The vertical fixed guide 1414 can move the coupled fixed guide connector 1412 in the up and down directions.

[0225] The vertical fixed guide 1411 can use power provided by a drive unit 1417 to move the fixed guide connector 1412 up and down.

[0226] The size of the vertical fixed guide 1411 is equal to or smaller than the inner height of the closing structure 1300. As the fixed guide connector 1412 moves upward, the vertical fixed guide 1411 allows the vertical motion guide 1413 coupled to the fixed guide connector 1412 to move to the preparation device 1100 through the second defined passage 1310.

[0227] A fixed guide connector 1412 coupled to the vertical fixed guide 1411 couples a vertical motion guide 1413. The fixed guide connector 1412 moves the vertical motion guide 1413 in response to the up and down movement provided by the vertical fixed guide 1411.

[0228] The vertical motion guide 1413 can move up and down in response to the driving of the vertical fixed guide 1411 .

[0229] In one embodiment of the present invention, vertical motion guide 1413 is coupled to motion guide connector 1414. Vertical motion guide 1413 can move coupled motion guide connector 1414 in the up and down direction.

[0230] The vertical motion guide 1413 can use power provided by a drive unit 1417 to move the motion guide connector 1414 up and down.

[0231] In other embodiments of the present invention, vertical motion guide 1413 does not move motion guide connector 1414 and can be coupled in a fixed fashion.

[0232] In one embodiment of the present invention, a motion guide connector 1414 coupled to the vertical motion guide 1413 to provide up and down motion can be coupled to a rack guide 1415 .

[0233] A rack guide 1415 is connected to the upper part of the movement guide connector 1414, and when the vertical fixed guide 1411 moves the vertical movement guide 1413 upward and the vertical movement guide 1413 moves the rack guide 1415 upward, the rack guide 1415 is moved inside the preparation device 1100.

[0234] In another embodiment of the present invention, the motion guide connector 1414 can be coupled to a rack guide 1415 .

[0235] When the vertical fixed guide 1411 moves the fixed guide connector 1412 upward, the movement of the vertical motion guide 1413 and motion guide connector 1414 allows the rack guide 1415 to move into the interior of the preparation apparatus 1100.

[0236] The vertical movement guide 1413 uses power provided by a drive unit 1417 or a separate drive unit (not shown) to move the rack guide 1415 up and down.

[0237] The rack guide 1415 is coupled to the motion guide connector 1414 and can have a reaction vessel rack 1416 placed thereon on which the reaction vessel 1500 can be placed.

[0238] The reaction vessel rack 1416 is a space in which reaction vessels 1500 containing analysis samples are placed within the preparation device 1100. The reaction vessel rack 1416 can also be called a pedestal, cradle, holder, or the like as an alternative expression for a mounting table.

[0239] The reaction vessel rack 1416 can be moved into the preparation device 1100 by movement of the motion guide connector 1414 together with the rack guide 1415 to receive the reaction vessel 1500 .

[0240] The rack guide 1415 performs horizontal extension movement of the reaction vessel rack 1416 connected to the upper part.

[0241] The extension movement of the reaction vessel rack 1416 can be explained with reference to Figures 17, 18, 23, and 24. Figure 17 is a first exemplary view showing the horizontal extension movement of the lifting module in a closed structure according to an embodiment of the present invention. Figure 18 is a second exemplary view showing the horizontal extension movement of the lifting module in a closed structure according to an embodiment of the present invention. Figure 24 is a perspective view showing the horizontal extension movement of the lifting module in a preparation apparatus according to an embodiment of the present invention.

[0242] 17 and 18, the vertical fixed guide 1411 of the lifting module 1410 moves the fixed guide connector 1412 up and down using power provided by a drive device 1417. A part of the fixed guide connector 1412 is coupled to the vertical fixed guide 1411, and another part is coupled to a vertical motion guide 1413.

[0243] The vertical motion guide 1413 can move into the preparation device 1100 by the upward movement of the coupled fixed guide connector 1412. In addition, the vertical motion guide 1413 can move the motion guide connector 1414 coupled to the other side in the vertical direction. The motion guide connector 1414, which moves upward due to the operation of the vertical motion guide 1413, can move the rack guide 1415 connected to the upper part into the preparation device 1100.

[0244] When the rack guide 1415 moves into the preparation apparatus 1100, the rack guide 1415 can horizontally extend the reaction vessel rack 1416 located above it by a predetermined distance.

[0245] A transfer module (not shown) provided in the preparation device 1100 picks up and moves the prepared reaction vessel 1500 and places it on top of the horizontally extended reaction vessel rack 1416, thereby allowing the reaction vessel 1500 to be moved to the closed structure 1300.

[0246] When a reaction vessel 1500 is attached to the top of the reaction vessel rack 1416, the rack guide 1415 moves the reaction vessel rack 1416, which has been extended horizontally, back to its original position.

[0247] The vertical fixed guide 1411 and / or vertical motion guide 1413 move the coupled fixed guide connector 1412 and / or motion guide connector 1414 downward when the reaction vessel 1500 is ready to be moved into the closed structure 1300. The reaction vessel 1500 is moved into the closed structure 1300.

[0248] The reaction vessel rack 1416 includes a coupling guide (not shown) that corresponds to the reaction vessel 1500 attached to the top thereof. The coupling guide prevents the reaction vessel 1500 from coming off the reaction vessel rack 1416 during movement.

[0249] In one embodiment of the present invention, drive unit 1417 can provide power for horizontal movement of reaction vessel rack 1416 .

[0250] In other embodiments of the present invention, the rack guide 1415 can be powered by other driving devices for horizontal movement of the reaction vessel rack 1416.

[0251] The drive units 1417 can provide the power to move the lifting modules 1410 within the enclosed structure 1300. There can be one or more drive units 1417 and they can be located in one or more locations.

[0252] In one embodiment of the present invention, the drive unit 1417 may use a hydraulic motor. In another embodiment of the present invention, the drive unit 1417 may use an electric motor.

[0253] In yet another embodiment of the present invention, the drive unit 1417 may use a combination of hydraulic and electric motors.

[0254] In yet another embodiment of the present invention, the drive device 1417 can use any device capable of generating power other than a hydraulic motor and an electric motor.

[0255] In yet another embodiment of the present invention, the drive device 1417 can use a hydraulic motor, an electric motor, or any device capable of generating power.

[0256] The drive unit 1417 may be one or more and may provide power to at least one or more of the lift module 1410, the crane module 1430, and / or the reaction vessel racks 1416 within the enclosed structure 1300.

[0257] According to one embodiment of the present invention, the crane module 1430 can be described as follows with reference to FIGS. 9, 11-12, and 19-22. FIG. 11 is a perspective view showing a crane module of a transport device according to one embodiment of the present invention. FIG. 12 is a perspective view showing a rotational configuration of the crane module according to one embodiment of the present invention. FIG. 19 is a first exemplary view showing a reaction vessel transport by a lifting module and a crane module according to one embodiment of the present invention. FIG. 20 is a second exemplary view showing a reaction vessel transport by a lifting module and a crane module according to one embodiment of the present invention. FIG. 21 is an exemplary view showing an operation of loading a reaction vessel into an automatic plate sealer according to one embodiment of the present invention. FIG. 22 is an exemplary view showing an operation of loading a reaction vessel into an analyzer according to one embodiment of the present invention. FIG. 25 is an exemplary view showing a crane module according to one embodiment of the present invention transporting a reaction vessel on the lifting module. FIG. 26 is an exemplary view showing a crane module according to one embodiment of the present invention loading a reaction vessel into an automatic sealer. FIG. 27 is an exemplary view showing a crane module according to one embodiment of the present invention loading a reaction vessel into an analyzer.

[0258] As shown in Figures 9, 11 to 12, and 19 to 22, the crane module 1430 performs operations to move the reaction vessel 1500 received by the lifting module 1410 from the preparation apparatus 1100 to each component of the closed structure 1300.

[0259] In one embodiment of the present invention, the crane module 1430 includes a horizontal fixed guide 1431, a horizontal motion guide 1433, a gripper lift 1434, a gripper rotation module 1436, and a gripper 1437 at the top within the closed structure 1300, and each guide 1431, 1433 and the gripper rotation module 1436 allows the gripper 1437 to move and rotate in the X, Y, and Z axes.

[0260] In another embodiment of the present invention, the crane module 1430 includes a horizontal fixed guide 1431, a fixed guide connector 1432, a horizontal motion guide 1433, a gripper lift 1434, a gripper motion guide 1435, and a gripper 1437 at an upper portion within the closed structure 1300, and each of the guides 1431, 1433, and the gripper lift 1434 allows the gripper 1437 to move in the X, Y, and Z axes.

[0261] Horizontal fixed guide 1431 is coupled to horizontal motion guide 1433 by fixed guide connector 1432 .

[0262] The horizontal fixed guide 1431 may be provided in the form of one or more movable rails. The horizontal movement guide 1433 is coupled to the rail-like horizontal fixed guide 1431 via a fixed guide connector 1432 and is moved in the X-axis direction.

[0263] The horizontal fixed guide 1431 is provided in the form of two rails to stably move the horizontal movement guide 1433, and the horizontal movement guide 1433 is connected to the two rails so that it can move in the X-axis direction. Either of the two rails of the horizontal fixed guide 1431 can move the connected horizontal movement guide 1433 in the X-axis direction.

[0264] In one embodiment of the present invention, the power for the horizontal fixed guide 1431 to move the horizontal motion guide 1433 can be provided by the drive unit 1417 .

[0265] In another embodiment of the present invention, the power for the horizontal fixed guide 1431 to move the horizontal movement guide 1433 may be provided by a separately provided driving device (not shown).

[0266] The horizontal motion guide 1433 is coupled to a gripper lift 1434 . The horizontal motion guide 1433 is provided in a rail-like shape. The gripper lift 1434 is coupled to the rail-like horizontal motion guide 1433 and moved in the Y-axis direction. The horizontal motion guide 1433, which provides rail-like movement, can move the coupled gripper lift 1434 in the Y-axis direction.

[0267] In one embodiment of the present invention, the power for horizontal motion guide 1433 to move gripper lift 1434 can be provided by drive unit 1247 .

[0268] In another embodiment of the present invention, the power for the horizontal motion guide 1433 to move the gripper lift 1434 may be provided by a separately provided drive device (not shown).

[0269] The gripper lift 1434 is connected to a gripper motion guide 1435 and coupled to a gripper 1437. The gripper motion guide 1435 is coupled to the gripper lift 1434, which moves up and down, and moves in the Z-axis direction. The gripper list 1243 can move the coupled gripper 1437 in the Z-axis direction.

[0270] The gripper lift 1434 is a combination of two modules. One is a fixed module coupled to the horizontal motion guide 1433 and moves in the Y-axis direction, and the other is a moving module coupled to the gripper motion guide 1435 and moves the gripper 1437 up and down (see FIG. 12). The gripper motion guide 1435 is coupled to the gripper 1437, and the gripper 1437 moves in the Z-axis direction as the gripper lift 1434 moves up and down.

[0271] The gripper 1437 can move to the position of the reaction vessel 1500 by operation of the gripper lift 1434 and lift up the reaction vessel 1500. The gripper 1437 can sense the pressure with which it grips the reaction vessel 1500 using a pressure sensor or the like, and can grip the vessel so as not to damage the reaction vessel 1500.

[0272] In one embodiment of the present invention, the gripper 1437 can rotate the reaction vessel 1500 that is picked up.

[0273] 12, a gripper movement guide 1435 coupled to a gripper lift 1434 is coupled to a gripper 1437 and a gripper rotation module 1436. The gripper rotation module 1436 can rotate and move the gripper 1437, as shown in FIGS. 12(a) to 12(b). The gripper rotation module 1436 is composed of a rotation motor.

[0274] In one embodiment of the present invention, gripper rotation module 1436 is capable of rotating gripper 1437 through a 90 degree rotation angle.

[0275] In another embodiment of the present invention, the gripper rotation module 1436 can rotate the gripper 1437 through any rotation angle.

[0276] The drive unit or drives used in the lift module 1410 and / or crane module 1430 may operate using a variety of drive forces.

[0277] In one embodiment of the present invention, at least one of the drive devices may use a hydraulic motor.

[0278] In another embodiment of the invention, at least one of the drives may be an electric motor.

[0279] In yet another embodiment of the present invention, at least one of the drive devices may use a combination of a hydraulic motor and an electric motor.

[0280] In still another embodiment of the present invention, at least one of the drive devices may be a device capable of generating power other than a hydraulic motor or an electric motor.

[0281] In still another embodiment of the present invention, at least one of the drive devices may use a hydraulic motor, an electric motor, or a device capable of generating power.

[0282] 19 and 20, the crane module 1430 can move the gripper 1437 to a position above the reaction vessel rack 1416 of the lifting module 1410 to move the reaction vessel 1500. The crane module 1430 can lower the gripper 1437 located above the reaction vessel rack 1416 and then pick up the reaction vessel 1500.

[0283] In one embodiment of the present invention, the movement of the crane module 1430 to move the gripper 1437 to the top of the reaction vessel rack 1416 is performed according to pre-stored position coordinates.

[0284] The automated analysis system 1000 stores as coordinate information all positions to which the crane module 1430 can move within the enclosed structure 1300. The crane module 1430 can perform movement according to the coordinate information of the position to which it is moved.

[0285] In another embodiment of the present invention, the operation of the crane module 1430 to move the gripper 1437 to the top of the reaction vessel rack 1416 is performed according to pre-stored position coordinates, and the gripper 1437 can be stopped at a predetermined position by a position sensor module (not shown) provided in the closed structure 1300. The position sensor module transmits and receives signals between the gripper 1437 and the reaction vessel rack 1416 based on optical signals, and stops the gripper 1437 at a predetermined position.

[0286] The position sensor module can be provided in the reaction vessel rack 1416, the automatic sealer 1700, the analyzers 1200-a, 1200-b, the reaction vessel collection box 1360, or the conveyor 1350, which are components through which the gripper 1437 moves the reaction vessel 1500.

[0287] Of the transport device 1400 included in the closed structure 1300 , the lifting module 1410 and the crane module 1430 receive power for moving the reaction vessel 1500 .

[0288] The lift module 1410 receives power from a vertical fixed guide 1411 , a vertical motion guide 1413 , and / or a rack guide 1415 .

[0289] The crane module 1430 receives power from a horizontal fixed guide 1431 , a horizontal motion guide 1433 , a gripper lift 1434 and / or a gripper 1437 .

[0290] Each powered component in the lift module 1410 and crane module 1430 can perform its operation via the following drive schemes.

[0291] In one embodiment of the present invention, the lift module 1410 and / or the crane module 1430 can provide belt-type motion to move the reaction vessel 1500 .

[0292] In other embodiments of the present invention, the lift module 1410 and / or the crane module 1430 can provide a chain type of movement to move the reaction vessel 1500 .

[0293] In yet another embodiment of the present invention, the lifting module 1410 and / or the crane module 1430 can provide a screw-type or jackscrew-type movement to move the reaction vessel 1500 .

[0294] In yet another embodiment of the present invention, the lift module 1410 and / or the crane module 1430 can provide a cylinder type movement to move the reaction vessel 1500 .

[0295] In yet another embodiment of the present invention, the lift module 1410 and / or the crane module 1430 can provide hoist-type movement to move the reaction vessel 1500 .

[0296] In other embodiments of the present invention, the lifting module 1410 and / or the crane module 1430 may move the reaction vessel 1500 by a drive mechanism other than those described above.

[0297] 21, the crane module 1430 can move the reaction vessel 1500 picked up from the reaction vessel rack 1416 so that it can be attached to the automatic sealer 1700. The automatic sealer 1700 is a device for automatically sealing the top surface of the reaction vessel 1500.

[0298] The automatic sealer 1700 is described below with reference to FIG. 14 is a perspective view showing an automatic sealer according to one embodiment of the present invention. As shown in FIG. 14, the automatic sealer 1700 can seal the injection port of the reaction vessel 1500 containing the analysis sample, and can be realized in the following embodiments.

[0299] In one embodiment of the present invention, the reaction vessel 1500 is a multi-well plate having a plurality of wells each having a closed bottom, each of which contains an analysis sample.

[0300] The automatic sealer 1700 seals the upper surface of the reaction vessel 1500, which is a multi-well plate, to prevent the analysis samples from being mixed and contaminated from the outside.

[0301] In another embodiment of the present invention, the reaction vessel 1500 is a tube-shaped vessel that is inserted into each well of a multi-well plate, and multiple connected or individually separated tubes can be inserted into each well of the multi-well plate.

[0302] The automatic sealer 1700 can seal the top surface of one or more reaction vessels 1500 inserted into each well of a multi-well plate to prevent mixing of the assay samples and external contamination.

[0303] The automatic sealer 1700 can heat seal the inlet of the reaction vessel 1500 using a transparent film, or alternatively, can use an adhesive to seal the inlet.

[0304] In one embodiment of the present invention, the automatic sealer 1700 may use the Hamilton Plate Sealer product (see https: / / www.hamiltoncompany.com / automated-liquid-handling / small-devices / hamilton-plate-sealer).

[0305] The automatic sealer 1700 can be positioned in various ways within the closure structure 1300 . In one embodiment of the present invention, the automatic sealer 1700 can be positioned as shown in Figure 30. As shown in Figure 30, the automatic sealer 1700 can be positioned between the first analyzer 1200-a and the second analyzer 1200-b.

[0306] When the automatic sealer 1700 is located between the first analysis device 1200-a and the second analysis device 1200-b, the reaction vessel 1500 can be mounted on the automatic sealer 1700 by rotating it horizontally by 90 degrees.

[0307] The 90 degree horizontal rotation of the reaction vessel 1500 can be performed by the gripper rotation module 1436 of FIG.

[0308] The crane module 1430 uses the gripper rotation module 1436 to horizontally rotate the reaction vessel 1500 by 90 degrees in order to load the reaction vessel 1500 into the automatic sealer 1700 .

[0309] In other embodiments of the present invention, the automatic sealer 1700 can be implemented to be located elsewhere inside the closure structure 1300 .

[0310] In yet another embodiment of the present invention, an automatic sealer 1700 can be implemented to be located in the preparation device 1100 .

[0311] 22, the crane module 1430 can move the reaction vessel 1500 sealed by the automatic sealer 1700 so that it can be loaded into one of a plurality of analytical instruments 1200-a, 1200-b. The analytical instruments 1200-a, 1200-b are instruments for automatically analyzing one or more analytical samples contained in the reaction vessel 1500.

[0312] An analytical device 1200 according to one embodiment of the present invention can be described as follows with reference to Fig. 13. Fig. 13 is a perspective view showing an independently driven analytical device according to one embodiment of the present invention. As shown in Fig. 13, the analytical device 1200 is an independently driven device. That is, the analytical device 1200 can be installed and operated independently to analyze an analytical sample.

[0313] The analytical device 1200 is a device for automatically analyzing one or more analytical samples contained in a reaction vessel 1500 .

[0314] According to one embodiment of the present invention, the analytical device 1200 may be operatively coupled to the preparation device 1100 and / or the closure structure 1300 and used as an automated analytical system 1000 .

[0315] The analytical device 1200 may include a nucleic acid amplifier for amplifying nucleic acids and / or an optical module for detecting the amplified nucleic acids.

[0316] In one embodiment of the present invention, the analytical device 1200 includes a nucleic acid amplifier and an optical module.

[0317] In another embodiment of the present invention, the analytical device 1200 includes a nucleic acid amplifier. In yet another embodiment of the present invention, the analysis device 1200 includes an optical module.

[0318] In one embodiment of the present invention, one analytical device 1200 can be operatively connected to and applied to the automated analytical system 1000 .

[0319] In another embodiment of the present invention, multiple analytical devices 1200 can be operatively linked and applied to the automated analytical system 1000.

[0320] The analytical device 1200 can be equipped with a reaction vessel 1500 that contains the analytical sample prepared by the preparation device 1100 .

[0321] In one embodiment of the present invention, the analytical device 1200 can be fitted with a reaction vessel 1500 whose top surface is sealed by an automatic sealer 1700. To this end, the reaction vessel 1500 can be moved from the preparation device 1100 to the automatic sealer 1700, and after the sealing of the top surface is completed, the reaction vessel 1500 can be fitted to the analytical device 1200.

[0322] The analytical device 1200 is provided with a sample holder 1210 in which a reaction vessel 1500 is housed.

[0323] The analytical device 1200 may be provided with a sample holder and a lid 1220 for protecting the reaction vessel 1500 accommodated in the sample holder. The lid 1220 of the analytical device 1200 is opened before accommodating the reaction vessel 1500. The lid 1220 of the analytical device 1200 is closed after the reaction vessel 1500 is accommodated.

[0324] If the analytical device 1200 operates as an independently driven device, the lid 1220 can be opened and closed by command input from the user.

[0325] When operatively coupled with the automated analysis system 1000, the analysis device 1200 can open and close the lid 1220 via the control module of the automated analysis system 1000.

[0326] In one embodiment of the present invention, the reaction vessel 1500 can be provided in the form of an amplification multiwell plate containing multiple analytical samples to be analyzed in multiple wells. In this case, the sample holder can accommodate one amplification multiwell plate. If necessary, the well plate can contain n x m wells (n and m are natural numbers greater than or equal to 2). The well plate can be in the form of a rectangle with n x m wells arranged in rows and columns. For example, it represents 16 wells, 4 x 4. A well plate with n x m wells can be attached to the sample holder.

[0327] Various examples of well plates are as follows: Well plates can include 4 wells (2x2), 9 wells (3x3), 16 wells (4x4), 25 wells (5x5), 36 wells (6x6), 49 wells (7x7), or 64 wells (8x8), etc. Additionally, well plates can include 8 wells (2x4), 18 wells (3x6), 32 wells (4x8), 50 wells (5x10), 72 wells (6x12), 98 wells (7x14), or 128 wells (8x16), etc. Additionally, well plates can include 12 wells (2x6), 27 wells (3x9), 48 wells (4x12), 75 wells (5x15), 108 wells (6x18), 147 wells (7x21), or 192 wells (8x24), etc. Additionally, well plates can include 2x8 (16 wells), 3x12 (36 wells), 4x16 (64 wells), 5x20 (100 wells), 6x24 (144 wells), 7x28 (196 wells), or 8x32 (256 wells), etc. Additionally, well plates can include 8x12 (96 wells), 12x16 (192 wells), or 16x24 (384 wells), etc.

[0328] In another embodiment of the present invention, the reaction vessel may comprise one or more independent reaction vessels, in which case the sample holder may accommodate one or more of each reaction vessel.

[0329] In another embodiment of the present invention, the reaction vessel may be provided in the form of a strip tube to which two or more sample vessels are connected, and in this case, the sample holder may accommodate one or more strip tube-shaped reaction vessels.

[0330] In one embodiment of the present invention, at least one analytical device 1200 that receives the reaction vessel 1500 sealed by the automatic sealer 1700 may be provided within the closed structure 1300. That is, referring to Figure 4, two analytical devices 1200-a and 1200-b may be provided within the closed structure 1300.

[0331] In one embodiment of the present invention, when two analytical devices are configured in the closed structure 1300, the preparation device 1100 sequentially prepares analytical samples for analysis. When a first reaction vessel is prepared in the preparation device 1100, the first reaction vessel is moved so that one of the analytical devices in the closed structure 1300 performs the analysis of the first reaction vessel.

[0332] Once the second reaction vessel has been prepared in the preparation device 1100, the second reaction vessel is moved to another analytical device within the closed structure 1300 to perform an analysis on the second reaction vessel.

[0333] In another embodiment of the present invention, when two analytical devices are configured within the closed structure 1300, the preparation device 1100 prepares analytical samples for analysis simultaneously or sequentially. When a first reaction vessel and a second reaction vessel are prepared in the preparation device 1100, each reaction vessel 1500 is moved sequentially to the closed structure 1300, and when the first reaction vessel is attached to one of the analytical devices 1200-a, the second reaction vessel is attached to the other analytical device 1200-b.

[0334] 5 is a perspective view showing an independently driven preparation device according to one embodiment of the present invention. As shown in FIG. 5, the preparation device 1100 is an independently driven device. That is, the preparation device 1100 can be installed and operated independently to prepare an analytical sample.

[0335] According to one embodiment of the present invention, the preparation device 1100 may be operatively coupled to an analysis device 1200 and / or a closed structure 1300 and used as an automated analysis system 1000 .

[0336] The preparation device 1100 can include a nucleic acid extraction module and / or a liquid handling module for extracting nucleic acids from the analyte.

[0337] In one embodiment of the present invention, preparation device 1100 includes a nucleic acid extraction module and a liquid dispensing module.

[0338] In another embodiment of the present invention, the preparation device 1100 includes a nucleic acid extraction module. In yet another embodiment of the present invention, the preparation device 1100 includes a liquid dispensing module.

[0339] In the present invention, the nucleic acid extraction module and / or the liquid dispensing module included in the independently driven preparation device 1100 can be operatively connected to the automated analysis system 1000 without modification.

[0340] Furthermore, when the independently driven preparation device 1100 is operatively connected to the automated analysis system 1000, the preparation device 1100 can use tubular reagent containers that have already been used.

[0341] In one embodiment of the present invention, when the preparation device 1100 is used as the automated analysis system 1000, the first opening 1130 formed in the preparation device 1100 can be used as a defined passage through which the reaction vessel 1500 is transported by the transport device 1400. Therefore, in this specification, the terms "first opening" and "first defined passage" can be used interchangeably.

[0342] As shown in FIG. 5, the first determined passage 1130 is formed on the bottom surface of the preparation device 1100, but depending on the type of preparation device 1100, the first determined passage 1130 may be formed on the side (including front / rear / left / right) or may already be formed on the top surface.

[0343] In another embodiment of the present invention, when the preparation device 1100 is used as an automated analysis system 1000, the preparation device 1100 can form a first defined path 1130, which is a defined path along which reaction vessels can be transported by the transport device 1400.

[0344] The first defined passage of the preparation device 1100 may be formed on any of the top surface, bottom surface, or side surface (including front / back / left / right).

[0345] The first defined passage 1130 is formed to have a size that allows the reaction vessel 1500 and the transport device 1400 that transports the reaction vessel to move.

[0346] In one embodiment of the present invention, when one analytical device 1200 is used in the automated analytical system 1000, the preparation device 1100 can prepare the analytical samples one by one in sequence, and provide the prepared analytical samples after the analysis is completed by the analytical device 1200.

[0347] In another embodiment of the present invention, when multiple analytical devices 1200 are used in the automated analytical system 1000, the preparation device 1100 sequentially prepares each analytical sample to be provided to each analytical device and provides the prepared analytical sample to one of the analytical devices. Thereafter, the next analytical sample prepared by the preparation device can be provided to another analytical device.

[0348] In another embodiment of the present invention, when multiple analytical devices 1200 are used in the automated analytical system 1000, the preparation device 1100 prepares analytical samples for each analytical device equal to or less than the number of analytical devices, and then provides the prepared analytical samples to the corresponding analytical devices.

[0349] The preparation device 1100 includes a deck 1110 on which various types of instruments and containers for preparing analytical samples can be placed. The deck 1110 has a shape to which components included in the preparation device 1100 can be attached or fixed.

[0350] In one embodiment of the present invention, the deck 1110 provides guides that allow components of the preparation device 1100 to be slidably inserted into the preparation device 1100 and positioned on top of the deck 1110 .

[0351] The guide is one embodiment of the deck 1110 and may be provided in the form of other embodiments.

[0352] In one embodiment of the present invention, one or more components arranged on the deck 1110 can be fixed during operation of the preparation device 1100 by protrusions and / or grooves formed on the bottom of each component, etc.

[0353] The preparation apparatus 1100 may include a flat loading tray 1120 extending from the deck 1110. The loading tray 1120 is installed to extend from the deck 1110 so that components to be attached to the preparation apparatus 1100 can be easily moved inside the preparation apparatus 1100. The loading tray 1120 is formed with guides that extend or connect to the guides of the deck 1110. The guides of the deck 1110 and the loading tray 1120 allow components to be attached to the preparation apparatus 1100 to be easily moved and installed.

[0354] In one embodiment of the present invention, the preparation device 1100 includes a pipette module (not shown) that includes pipette arms for dispensing liquids and one or more pipetting channels connected to the pipette arms. The pipette module is configured on the upper side of the interior of the preparation device 1100.

[0355] In addition, a transfer module (not shown) for transporting various containers, including reaction containers, used for sample preparation in the preparation device 1100 is provided on one side inside the preparation device 1100.

[0356] In another embodiment of the present invention, the transfer module is configured on the top side inside the preparation device 1100 together with the pipette module.

[0357] In yet another embodiment of the present invention, the transfer module is realized by a pipetting channel of the pipette module and a gripper (not shown) coupled to the pipetting channel.

[0358] Each component located on deck 1110 of preparation device 1100 is positioned in a predetermined position for preparation of an analytical sample.

[0359] A first opening 1130 is formed in the deck 1110. The first opening 1130 is a space through which the transport device 1400 moves to receive the reaction vessel 1500 prepared by the preparation device 1100. The first opening 1130 is formed to a size that allows the transport device 1400 to receive the reaction vessel 1500 and move.

[0360] In one embodiment of the present invention, each component arranged on deck 1110 can be described as follows. The components described below are generally included in preparation device 1100 and used to prepare an analytical sample, but depending on the type of independently operated device, one or more of the components may not be included, or may be used as a separate device.

[0361] All components of the preparation device 1100 are designed as an integrated device. The preparation device 1100 includes a nucleic acid extraction module for extracting nucleic acids from a specimen and various components for amplification reaction setup (e.g., PCR setup).

[0362] The preparation apparatus 1100 according to one embodiment of the present invention may include a pipette tip adapter, a container carrier, a nucleic acid extraction module, a multi-well plate adapter, a scanner, a waste liquid inlet, a transfer module, and a pipette module, etc. Figure 38 is a layout diagram showing the components of the preparation apparatus according to one embodiment of the present invention arranged on a deck.

[0363] 1) The pipette tip adapter accommodates one or more pipette tips that are coupled to the pipetting channel and can aspirate and dispense solutions, such as samples or reagents, contained in containers.

[0364] The one or more pipette tips housed in the pipette tip adapter may be provided with different sizes and dispensing volumes depending on the preparation environment, such as the size of the container and the volume of the solution to be dispensed.

[0365] In one embodiment of the present invention, the preparation device may include a plurality of pipette tip adapters to accommodate tips of various volumes, such as 1 ml, 500 μl, 300 μl, 250 μl, 200 μl, 150 μl, 100 μl, and / or 50 μl, etc. Additionally, any one or more of the tips of various volumes may be a piercing tip.

[0366] Each pipette tip adapter can accommodate one or more pipette tips, and the pipette module positions the pipette channel on top of the pipette tip adapter and then moves it toward the pipette tip so that the pipette channel can mate with the pipette tip.

[0367] The number of pipette tip adapters and the capacities and sizes of the pipette tips accommodated in the pipette tip adapters may be modified or changed according to various embodiments of the present invention.

[0368] 2) The container carrier includes various containers containing various types of solutions used in the preparation device. The preparation device can prepare analytical samples containing nucleic acids extracted using the nucleic acid extraction module. Various types of containers are used in the operation of the preparation device, and containers other than well plates can be inserted into the container carrier.

[0369] The container carrier can be provided in various forms to allow easy insertion and securing of each container depending on the volume and / or size of the container to be inserted.

[0370] In one embodiment of the present invention, the containers to be inserted include a container containing a sample, a container containing an extraction reagent, a container containing a reaction reagent, etc. The container carrier can insert the containers in a line or in parallel.

[0371] The container carrier may have an opening formed in the side to expose an identification code printed or attached to the container, so that the exposed identification code can be recognized by a scanner located on deck 1110.

[0372] 3) The nucleic acid extraction module automatically performs the process of preparing a detection sample used to detect a target nucleotide sequence within the preparation device.

[0373] In the present invention, the detection sample preparation process includes the steps of extracting nucleic acids from a specimen, preparing a reaction solution for amplification, and preparing a detection sample by combining these.

[0374] If the preparation device does not include a nucleic acid extraction module, the sample may be nucleic acid obtained by previously performing a nucleic acid extraction process.

[0375] In another embodiment, nucleic acid extraction is frequently performed using a magnetic bead-based method that utilizes magnetic beads that can bind to nucleic acids and elute the bound nucleic acids. The magnetic bead-based automated nucleic acid extraction method can use a liquid transfer method or a bead transfer method depending on the type of process for eluting the nucleic acids bound to the magnetic beads.

[0376] 4) A multi-well plate adapter is a structure in which a reaction vessel containing a sample to be detected can be placed, and the reaction vessel can be attached to a sample holder of an analytical device.

[0377] The multiwell plate adapter can accommodate a reaction vessel (multiwell plate), and a sample for detection can be dispensed into the reaction vessel (multiwell plate) placed in the multiwell plate adapter. Two or more multiwell plates used in the preparation device can be placed in the multiwell plate adapter. In one embodiment of the present invention, the term "multiwell plate" can be used to refer to the reaction vessel adapter.

[0378] At this time, any one of the multiple multiwell plates mounted on the multiwell plate adapter can be moved to the starting position and used for preparing an analytical sample. The multiwell plate is moved to the starting position by the transfer module.

[0379] 5) Various containers can be attached to the fixed frame directly or via an adapter. The containers can contain analytical samples, extraction reagents, etc. The containers have caps, and the caps can be pierceable by a pipette tip. The piercing portion of the cap can be made of materials such as rubber, silicone, or plastic.

[0380] The pipette tip pierces the top of the cap by descending, aspirates or dispenses the solution, and then moves back up. As the pipette tip moves from the container to the top, the container can be lifted up together with the pipette tip inserted into the perforated part of the cap, so the container needs to be fixed. A fixing frame can fix the container so that the pierceable container does not move due to the pipette tip.

[0381] 6) The first opening 1130 is a defined path through which the transport device 1400 moves to the preparation device 1100 to receive the reaction vessel 1500 .

[0382] In one embodiment of the present invention, the first opening 1130 is an empty space. The transport device 1400 moves from the bottom of the preparation device 1100 to the inside of the preparation device 1100. Therefore, the first opening 1130, which is an empty space, is formed or preferably formed in the deck 1110, which is the bottom surface of the preparation device 1100.

[0383] In another embodiment of the present invention, the first opening 1130 includes an open / close module (not shown). The open / close module is provided to block the open space through which the transport device 1400 enters, which is the first opening 1130. The transport device 1400 is moved to the preparation device 1100 to receive reaction vessels prepared by the preparation device 1100. The preparation device 1100 can block the first opening 1130 using the open / close module to close the open space when the transport device 1400 is not moving.

[0384] 7) The waste unit includes a waste liquid inlet and / or a pipette tip collecting unit. The waste liquid inlet can be used to collect solutions used in preparing analytical samples for disposal, and the pipette tip collecting unit can be used to collect pipette tips used in preparing analytical samples for disposal.

[0385] In one embodiment of the present invention, the recovery solution inlet is connected to a separately arranged liquid waste collection bin (not shown). The waste solution of the preparation device 1100 is transferred to the liquid waste collection bin via the recovery solution inlet.

[0386] In addition, pipette tips collected via the pipette tip collection unit can be moved to and stored in a waste container. In one embodiment of the present invention, the waste container can be located on deck 1110 of preparation apparatus 1100. In another embodiment of the present invention, the waste container can be located on the bottom surface of preparation apparatus 1100. In yet another embodiment of the present invention, the waste container can be located outside preparation apparatus 1100.

[0387] When waste containers are placed on deck 1110, the waste containers can be separated from the area where analytical samples are prepared, such as by a partition.

[0388] 8) The transfer module is a gripper-like mechanical device for moving reaction vessels and the like within the preparation apparatus 1100. The transfer module is operated by the control device of the preparation apparatus 1100.

[0389] In one embodiment of the present invention, the transfer module is disposed on the inner rear surface of the preparation apparatus 1100. The transfer module is configured to be able to move reaction vessels and the like up and down, left and right, front and back, and rotate.

[0390] In another embodiment of the present invention, the transfer module is located inside the upper part of the preparation apparatus 1100. The transfer module is configured to move reaction vessels and the like up and down, left and right, front and back, and rotationally through an operating form similar to that of a pipette module.

[0391] In yet another embodiment of the present invention, the transfer module is configured to be able to move reaction vessels, etc. up and down, left and right, front and back, and rotationally using grippers coupled to at least two of the pipetting channels of the pipette module.

[0392] The transfer module can move components required for preparing analytical samples, such as reaction vessels, reagent vessels, adapters, cartridges, multi-well plates, etc., within the preparation device 1100 .

[0393] In one embodiment of the present invention, the transfer module can move the reaction vessel, for which the setup of the analysis sample has been completed, to the transport device 1400. The transport device 1400 is moved through the first opening 1130 of the preparation device 1100 to receive the reaction vessel for which the setup has been completed. The transfer module moves the reaction vessel to the transport device 1400, and the transport device 1400 can move the reaction vessel out of the preparation device 1100 through the first opening 1130.

[0394] 9) The scanner can read identifying codes displayed on specimens, reagents, reaction solutions, etc. Identifying codes are displays containing information such as barcodes and matrix codes. The scanner recognizes the identifying codes and can provide information such as the type and volume of the solution contained in the container.

[0395] In one embodiment of the present invention, a plurality of scanners may be provided, or any one of them may be configured as needed. Furthermore, the scanner may be configured as a barcode scanner and / or a 2D scanner. Such a configuration is preferably provided so as to be able to recognize different types of identification codes marked on reaction vessels, etc.

[0396] In one embodiment of the present invention, the scanner can recognize 1D and / or 2D barcodes. The scanner can recognize an identification code printed or attached to the side of a container to obtain information such as the type and / or volume of a solution contained in the container. The container includes a reaction vessel, a reagent vessel, a sample vessel, etc. used in a preparation device. The scanner can recognize the identification code of a container inserted into the deck 1110. The scanner can sequentially recognize the identification code of at least one or more containers inserted into the deck 1110. The scanner can move to a position where a container or a carrier containing the container is docked to the deck 1110 and recognize the identification code on the side of the container.

[0397] In another embodiment of the present invention, the scanner is a 2D barcode scanner (not shown) that can recognize matrix (two-dimensional) codes and can recognize identification codes printed or attached to the bottom of containers, including reaction vessels, reagent vessels, specimen vessels, and other containers used in the preparation device.

[0398] Thus, when a plate formed with an opening on all or part of the bottom surface of each well is attached to a scanner, the scanner can recognize the identification code printed or attached to the bottom surface of the container inserted into the plate, and the scanner can simultaneously recognize the codes of multiple containers inserted into the plate.

[0399] In one embodiment of the present invention, the flat surface of the scanner on which the container is attached is made of a transparent material. The scanner can recognize the identification code on the bottom of the container using an optical signal that passes through the transparent material. Furthermore, the scanner can recognize the identification code of the container by photographing the bottom of the container. The scanner is configured so that a multiwell plate can be placed on the scanner so that the scanner can recognize the identification code on the bottom of the container inserted in the multiwell plate.

[0400] A 2D scanner according to one embodiment of the present invention can use Hamilton's "easyCode Carrier" product (see https: / / www.hamiltoncompany.com / automated-liquid-handling / small-devices / easycode-carrier).

[0401] 10) The pipette module is not shown in the drawing, but is located inside the upper part of the preparation device 1100. The pipette module, which is a solution divider, includes a pipette arm and a pipetting channel, and the pipetting channel can be automatically moved up and down, left and right, and back and forth by a control device.

[0402] The pipette arm can include one or more pipetting channels that move independently or independently. In one embodiment, the ends of the pipetting channels can be coupled with pipette tips or needles that can be used to aspirate and dispense solutions.

[0403] In another embodiment, a gripper can be attached to the end of the pipetting channel, and the gripper can be used as a transfer module that can move containers (including reaction containers) used in the preparation device 1100, such as reaction containers.

[0404] The pipette arm can perform actions such as moving one or more included pipetting channels to a fractionating pipette tip, fixing the fractionating pipette tip to a pipetting channel, moving the pipette tip with the fixed pipetting channel to a certain location, and inserting the fractionating pipette tip into a container to a certain depth.

[0405] The pipette arm is located at the top inside the preparation device 1100, and the pipetting channels are operated by the pipette arm within the preparation device 1100. One or more pipetting channels couple pipette tips inserted into pipette tip adapters to the ends of the pipetting channels.

[0406] The pipette arm can be moved so that the pipetting channel is positioned above a container containing a solution to be dispensed. The pipetting channel descends from the moved position toward the container, fills the pipette tip with the solution, and then ascends again. The pipetting channel can be moved above another container to be dispensed by the pipette arm, descends to dispense the solution contained in the pipette tip, and then ascends again to complete the dispensing.

[0407] Multiple pipetting channels can operate simultaneously, and the number of pipetting channels determines the number of containers that can be dispensed simultaneously.

[0408] The pipette arm and pipetting channel can remove the pipette tip attached to the end after dispensing is completed, and the attached pipette tip can be removed by a pipette tip recovery unit that places the pipette tip in a waste unit and discarded in a waste container.

[0409] In one embodiment of the present invention, at least one of the preparation device 1100, the analysis device 1200, and / or the transport device 1400 must be precisely positioned in order for each device to be operatively coupled to the closure structure 1300. To this end, the closure structure 1300 and each device include positioning means.

[0410] Since the preparation device 1100, the analysis device 1200, and / or the transport device 1400 must be coupled to the closing structure 1300 without external deformation, it is preferable that the positioning means of each device uses components already formed in each device, as will be explained in Figures 32 to 34.

[0411] Fig. 32 is an exemplary view showing an analytical device mounted in a closed structure using a positioning means according to an embodiment of the present invention. Fig. 33 is a first exemplary view showing a positioning means according to an embodiment of the present invention. Fig. 34 is a second exemplary view showing a positioning means according to an embodiment of the present invention. As shown in Figs. 32 to 34, at least one of preparation device 1100, analytical device 1200, and / or transport device 1400 is spatially closed, and closed structure 1300 is used as a configuration for spatially closing them.

[0412] At least one or more of the preparation device 1100, the analysis device 1200, and / or the transport device 1400 are configured to be disposed within the closed structure 1300 for operatively connecting thereto.

[0413] 32 shows that, according to one embodiment of the present invention, analytical devices 1200-a and 1200-b are located in a closed structure 1300. At this time, a reaction vessel 1500 containing an analytical sample can be transferred to the analytical devices 1200-a and 1200-b from a preparation device 1100 located outside the closed structure 1300 via a transport device 1400.

[0414] In particular, the reaction vessel 1500 is provided to the analytical apparatuses 1200-a and 1200-b by a crane module 1430 of the transport apparatus 1400. The crane module 1430 can move to a position designated by the robot module, lift up the reaction vessel 1500, and lower the reaction vessel 1500 to a designated location.

[0415] If the positions of the analytical devices 1200-a and 1200-b are even slightly different from the predetermined positions, the reaction vessel 1500 will not be placed in the correct position and appropriate analysis will not be possible. Therefore, the analytical devices 1200-a and 1200-b must be accurately placed or coupled to the predetermined positions within the closure structure 1300. For this purpose, the closure structure 1300 provides a positioning means.

[0416] As shown in FIGS. 33 and 34, the positioning means can be located on the analytical device 1200 and on the closure structure 1300.

[0417] In one embodiment of the present invention, the first positioning means 1230 of the analytical device 1200 may be a fixing means located at the bottom, and the second positioning means 1390 of the closing structure 1300 may be a structure formed at the location where the analytical device 1200 is located.

[0418] The first positioning means 1230 and the second positioning means 1390 may have shapes that allow them to be coupled to each other.

[0419] According to one embodiment of the present invention, the first positioning means 1230 and the second positioning means 1390 can fix the analytical device 1200 at an accurate position in the closed structure 1300 without any separate fastening means.

[0420] According to another embodiment of the present invention, the first positioning means 1230 and the second positioning means 1390 are provided with mutual fastening means (not shown), and when the analytical device 1200 is fixed in a precise position in the closure structure 1300, the fastening means can be used to fasten each positioning means.

[0421] Figures 32 to 34 explain the positioning means between the analytical device 1200 and the closed structure 1300, but it is preferable that each device located inside the closed structure 1300, such as the conveying device 1400 and automatic sealer 1700 according to one embodiment of the present invention, also have a positioning means that matches the closed structure.

[0422] Figure 39 is a flowchart showing a method of operation of an automated analysis system according to one embodiment of the present invention. As shown in Figure 39, the automated analysis system of the present invention is composed of an enclosure including a preparation device, an analysis device, and / or a transport device. The preparation device and the analysis device included in the automated analysis system can each operate as individual devices (stand-alone).

[0423] The automated analysis system can arrange at least one device selected from the group consisting of a preparation device, an analysis device, and a transport device in a spatially closed structure.

[0424] In one embodiment of the present invention, the automated analytical system is configured such that the analytical device is located inside the enclosed structure and the preparation device is located above the enclosed structure.

[0425] The automated analysis system includes a control module that controls the preparation device to prepare an analysis sample, and the control module that controls the closure structure to analyze the prepared analysis sample.

[0426] The manner in which the control module of the automated analytical system controls the preparation device and closure structure to perform analytical sample preparation and analysis is as follows.

[0427] The control module controls the preparation device so that an analysis sample is prepared in a reaction vessel provided in the preparation device (S110).

[0428] The preparation device contains solutions such as specimens, nucleic acid extraction reagents, and amplification reaction reagents for preparing analytical samples, and prepares analytical samples using internal components.

[0429] In step S110, the control module is a preparation device that prepares the analytical sample.

[0430] The preparation device can perform at least one of the following steps: preparing the analysis sample by dispensing at least one of a specimen and a reagent; placing the analysis sample in the reaction vessel; or extracting nucleic acid from the specimen that is suspected to contain a pathogen.

[0431] The control module controls the lifting module in the closed structure so that the reaction vessel prepared by the preparation device is moved to the closed structure (S120).

[0432] In step S120, the lifting module moves into the preparation device through the second opening formed in the closed structure and the first opening formed in the deck of the preparation device, and the preparation device loads the reaction vessel onto the moved lifting module.

[0433] When the reaction vessel is attached to the lifting module, the control module controls the lifting module to move to the closed structure.

[0434] The first opening is a defined passage through which the reaction vessel can be transported.

[0435] In one embodiment of the present invention, the closed structure may comprise a plurality of analytical devices for analyzing analytical samples.

[0436] The control module controls the preparation devices so that analytical samples to be analyzed using a plurality of the provided analytical devices can be prepared simultaneously or sequentially.

[0437] The control module controls the lifting module so that the lifting module moves reaction vessels containing analytical samples to be simultaneously or sequentially prepared in the preparation device into the closed structure.

[0438] In step S120, when the lifting module is moved to the preparation device to receive the reaction container, the control module controls the lifting module to perform horizontal extension movement to easily receive the reaction container.

[0439] The control module controls the crane module so that the reaction vessel, which has been moved into the closed structure, is moved to a position where analysis is performed (S130).

[0440] The crane module can perform a moving operation to move the reaction vessel moved into the closed structure in the up / down / left / right / front / back directions, and a rotating operation to rotate the reaction vessel horizontally.

[0441] In one embodiment of the present invention, an automatic sealer is included within the closure structure. When an automatic sealer is provided in the closed structure, the control module controls the crane module to move the reaction vessel removed from the preparation device to the automatic sealer, which can seal the top surface of the reaction vessel.

[0442] The control module controls the crane module to move the reaction vessel sealed by the automatic sealer to a location where the analysis of the analytical sample is performed, which is an analytical instrument.

[0443] In another embodiment of the present invention, an automatic sealer can be included in the preparation device. When an automatic sealer is provided in the preparation device, the control module moves the reaction containers that have been prepared in the preparation device to the automatic sealer. The control module controls the automatic sealer so that the top surfaces of the moved reaction containers are sealed.

[0444] If an automatic sealer is provided in the preparation device, the lifting module can receive the reaction vessel after the sealing is completed in step S120.

[0445] In one embodiment of the present invention, when multiple analytical devices are provided and multiple reaction vessels are sequentially received in the preparation device, the control module controls the crane module to move each of the sequentially moved analytical sample vessels to the analytical device.

[0446] The control module controls the closed structure so that the analytical sample contained in the reaction vessel in the closed structure is analyzed (S140).

[0447] In step S140, the reaction vessel can be transferred by the crane module to an analytical instrument, which analyzes the analytical sample in the transferred reaction vessel and generates a result.

[0448] In step S140, the control module controls the closed structure so that analysis of the analytical sample is performed, the closed structure being an analysis device.

[0449] The analytical device can perform at least one of the following processes: a process of performing a polymerase chain reaction; and a process of analyzing the reaction results.

[0450] The analytical device is provided at the location where the analysis is to be performed. The analytical device includes a thermal cycler and an optics module. The process of performing a polymerase chain reaction in the analytical device uses the thermal cycler, and the process of measuring the reaction results uses the optics module.

[0451] The analytical device may be provided with a cover for analysis of the analytical sample. The control module may provide a control signal to the analytical device to open the cover of the analytical device to which the reaction vessel is transferred. Thereafter, when the crane module provides the reaction vessel to the analytical device, the control module may provide a control signal to close the cover of the analytical device.

[0452] The control module controls the crane module to remove the reaction vessel for which the analysis has been completed from the position where the analysis is performed (S150).

[0453] In step S150, the control module controls the crane module so that the reaction vessels for which the analysis has been completed can be moved to the reaction vessel collection box.

[0454] According to one aspect of the present invention, there is provided an automated analytical system including a memory, at least one processor configured to access the memory, and one or more programs stored in the memory and configured to be executed by the processors, the automated analytical system including a preparation device, an analysis device, a transport device, a control module, and a closure structure, the one or more programs including instructions that, when executed by the one or more processors, cause the one or more programs to perform the following steps: A control module controls a transport device so that a reaction vessel containing an analytical sample is transported from a preparation device to an analytical device; the preparation device and the analytical device are independently driven devices; the control module controls the analytical device so that the analytical sample is analyzed in the analytical device; and the control module controls the transport device so that the reaction vessel after analysis of the analytical sample is completed is removed from the analytical device; at least one device selected from the group consisting of the analytical device and the transport device is arranged inside an enclosure, the preparation device and the closed structure each include a defined passage through which the reaction vessel is transported, and the one or more programs include instructions that enable the transport device to transport the reaction vessel via the defined passage.

[0455] The components described in the embodiment of the present invention overlap with the description of the automated analysis system shown in FIGS. 1 to 39, and therefore the description thereof will be omitted.

[0456] According to one aspect of the present invention, a non-transitory computer-readable storage medium containing instructions, when executed by one or more processors, for performing an analytical method using an automated analytical system, the automated analytical system including a preparation device, an analytical device, a transport device, a control module, and a closing structure, the method including the steps of: the control module controlling the transport device so that a reaction vessel containing an analytical sample is transported from the preparation device to the analytical device; the preparation device and the analytical device being independently driven devices; the control module controlling the analytical device so that the analytical sample is analyzed in the analytical device; and the control module controlling the transport device so that the reaction vessel, after analysis of the analytical sample has been completed, is removed from the analytical device; at least one device selected from the group consisting of the analytical device and the transport device, is disposed within an enclosure, the preparation device and the closing structure each include a defined passage through which the reaction vessel is transported, and the instructions include instructions for causing the transport device to transport the reaction vessel through the defined passage.

[0457] The components described in the embodiment of the present invention overlap with the description of the automated analysis system shown in FIGS. 1 to 39, and therefore the description thereof will be omitted.

[0458] Fan module control and signaling An RT-PCR device is placed inside the automated analysis system, and this RT-PCR device generates heat during operation. This heat must be discharged from inside the automated analysis system to the outside. Therefore, this subject also includes technologies for discharging heat from inside the automated analysis system to the outside, such as temperature control technologies.

[0459] Furthermore, if the target nucleic acid in the sample is suspended in the air in the automated analysis system when the temperature control technique is performed, there is a risk that other samples may be contaminated. Therefore, a technique for preventing contamination between samples when performing such a temperature control technique is also included in the present invention.

[0460] An automated analytical system according to one embodiment includes a preparation device for preparing an analytical sample in a reaction container, an analytical device for analyzing the analytical sample prepared in the reaction container, a transport device for transporting the reaction container, a closing structure, an opening / closing unit for opening and closing the defined passage, a control module, and a fan module that operates to exhaust air in the internal space of the closing structure to the outside; at least one device selected from the group consisting of the analytical device and the transport device is arranged inside the closing structure; and the preparation device and the closing structure each include a defined passage through which the reaction container is transported.

[0461] The control module may include a control unit and a storage unit. Furthermore, the defined path can be opened while the transport device passes through the defined path.

[0462] Furthermore, the defined passage can be opened while the transport device is disposed in the preparation device.

[0463] Furthermore, the automated analysis system further includes a transport device that receives a predetermined unsealed reaction vessel from the preparation device and transfers the vessel to the analysis device, and the control unit can activate or stop the fan module depending on the position or movement direction of the transport device.

[0464] The control unit may also stop operation of the fan module while the transport device passes through the determined passage.

[0465] The control unit can also stop the operation of the fan module while the transport device is being placed on the preparation device.

[0466] Furthermore, the control unit can stop the operation of the fan module when the transport device in the internal space starts to move toward the confirmed passage.

[0467] The control unit can also stop the operation of the fan module while the transport device is moving toward the analyzer.

[0468] Furthermore, the control unit can resume operation of the fan module after the transport device arrives at the analyzer and completes transferring the container to the analyzer.

[0469] Furthermore, the automated analysis system further includes an automatic sealer that performs a sealing operation on the unsealed container, and the transport device receives the unsealed container from the preparation device and transfers it to the automatic sealer, receives the container after the sealing operation has been completed from the automatic sealer and transfers it to the analysis device, and the period during which the control unit stops the operation of the fan module can include the period from the time the transport device receives the unsealed container from the preparation device to the time the transport device completes the transfer of the container after the sealing operation has been completed to the analysis device.

[0470] In addition, the automated analysis system includes multiple fan modules, and the automated analysis system further includes a temperature measurement unit that measures the temperature of the internal space, and the control unit operates only some of the multiple fan modules and stops the remaining fan modules if the temperature measured by the temperature measurement unit is below a predetermined temperature, and operates all of the multiple fan modules if the measured temperature exceeds the predetermined temperature.

[0471] The automated analysis system further includes a temperature measurement unit that measures the temperature of the internal space, and the control unit can control the rotation speed of the fan included in the fan module according to the temperature measured by the temperature measurement unit when the fan module is operating.

[0472] The preparation device may include a preparation device management unit that manages the execution of the preparation work, and the analysis device may include an analysis device management unit that controls the execution of the detection work.

[0473] A fan module control method performed in an automated analysis system according to one embodiment, wherein the automated analysis system includes a preparation device that prepares an analytical sample in a reaction container, an analysis device that analyzes the analytical sample prepared in the reaction container, a transport device that transports the reaction container, a closing structure, an opening / closing unit that opens and closes the defined passage, and a fan module that operates to exhaust air in the internal space of the closed structure to the outside, wherein at least one device selected from the group consisting of the analysis device and the transport device is disposed inside the closed structure; the preparation device and the closing structure each include a defined passage through which the reaction container is transported; the fan module control method includes the steps of opening the defined passage by the opening / closing unit; and stopping the operation of the fan module while the defined passage is opened by the opening / closing unit.

[0474] Furthermore, in the opening step, the determined path can be opened while the transport device passes through the determined path.

[0475] Furthermore, in the opening step, the defined passage can be opened while the transport device is disposed in the preparation device.

[0476] Furthermore, the automated analysis system further includes a transport device that receives a predetermined unsealed reaction vessel from the preparation device and transfers the vessel to the analysis device, and the stopping step can activate or stop the fan module depending on the position or movement direction of the transport device.

[0477] Furthermore, the stopping step can stop the operation of the fan module while the transport device passes through the defined passage.

[0478] Furthermore, the stopping step can stop operation of the fan module while the transport device is placed on the preparation device.

[0479] The stopping step may stop the operation of the fan module when the transport device in the internal space starts to move toward the defined path.

[0480] Furthermore, the stopping step can stop operation of the fan module while the transport device is moving to the analyzer.

[0481] Furthermore, the method may further include the step of restarting operation of the fan module after the transport device has arrived at the analyzer and completed transferring the container to the analyzer.

[0482] Furthermore, the automated analysis system further includes an automatic sealer that performs a sealing operation on the unsealed container, and the transport device receives the unsealed container from the preparation device and transfers it to the automatic sealer, receives the container with the completed sealing operation from the automatic sealer and transfers it to the analysis device, and the period during which the operation of the fan module is stopped includes from the time the transport device receives the unsealed container from the preparation device to the time the container with the completed sealing operation is completely transferred to the analysis device.

[0483] Furthermore, the automated analysis system includes a plurality of fan modules, and the automated analysis system further includes a temperature measurement unit that measures the temperature of the internal space, and the fan module control method operates only some of the plurality of fan modules and stops the remaining fan modules when the temperature measured by the temperature measurement unit is below a predetermined temperature, and operates all of the plurality of fan modules when the measured temperature exceeds the predetermined temperature.

[0484] Furthermore, the fan module control method may further include a step of measuring the temperature of the internal space; and, when the fan module is operating, a step of controlling the rotation speed of the fan included in the fan module according to the temperature measured by the temperature measurement unit.

[0485] A computer-readable recording medium according to an embodiment includes a computer program, and the computer program can be programmed to include and execute each step included in the above-described method.

[0486] A computer program according to an embodiment may be stored in a computer-readable recording medium, and the computer program may be programmed to include and execute each step included in the above-described method.

[0487] According to one embodiment of the fan module control method of the present invention, the risk of pathogens that may be contained in a reaction vessel being released and dispersed into the air by the operation of the fan module can be reduced.

[0488] Furthermore, the possibility of mixing of the air in the preparation device where the preparation work for the detection of the target nucleic acid is performed with the air around the analysis device where the detection work of the target nucleic acid is performed can be reduced.

[0489] Figure 40 is a block diagram conceptually illustrating the configuration of an automated analysis system 2000 according to one embodiment. Referring to Figure 40, the automated analysis system 2000 includes a preparation device 2100, an analysis device 2200, a transport device 2300, an automatic sealer 2400, a control module 2500, a fan module 2600, and a container processing module 2800. However, the block diagram shown in Figure 40 is merely illustrative.

[0490] Here, the preparation device 2100 and the analysis device 2200 can be independently operable, i.e., stand-alone devices. Each device 2100, 2200 is provided with an API (application programming interface). Such an API can be used to externally control or monitor each device 2100, 2200, or each device 2100, 2200 can be used to monitor external conditions or control or monitor external devices.

[0491] Since these devices 2100 and 2200 are diagnostic or testing devices, they can only be used in certain countries after obtaining a license. Even after obtaining a license, if there is a change in the main function or structure or if a new feature is added, it may be necessary to obtain a license again.

[0492] From this point of view, since the API corresponds to the main function of these devices 2100 and 2200, there is a possibility that a situation will arise where approval must be obtained again when changing or adding the API.

[0493] Meanwhile, the automated analysis system 2000 not only includes the standalone preparation device 2100 and analysis device 2200 described above, but also includes a transport device 2300 for transporting and processing reaction vessels between them or for transmitting and receiving data between them, an automatic sealer 2400, a control module 2500, a fan module 2600, and a vessel processing module 2800. Furthermore, these devices 2100, 2200, 2300 and modules 2400 to 2600, 2800 can be connected to each other by assembly, thereby completing a molecular diagnostic system, and therefore the automated analysis system according to one embodiment can be called an "assembly type."

[0494] Meanwhile, according to one embodiment, the automated analysis system 2000 may further include components not shown in Figure 40, or may not include at least one of the components shown in Figure 40. Furthermore, each component of the automated analysis system 2000 may be connected differently from that shown in Figure 40. Each component will be described in detail below.

[0495] First, the preparation device 2100 is used for preparing an analytical sample, and in this respect, the preparation device 2100 can also be called a sample preparation device.

[0496] The analytical sample preparation work performed by the preparation device 2100 includes, but is not limited to, a nucleic acid extraction work and a nucleic acid amplification reaction mixture preparation work. For example, the analytical sample preparation work performed by the preparation device 2100 may not include a nucleic acid extraction work, depending on the embodiment. In this case, the nucleic acid extraction work described above may be performed by another configuration not shown in FIG. 40, rather than the preparation device 2100. However, the following description will be given on the assumption that the analytical sample preparation work performed by the preparation device 2100 includes a nucleic acid extraction work.

[0497] On the other hand, the above-mentioned nucleic acid extraction process and nucleic acid amplification reaction solution preparation process are themselves publicly known techniques, and therefore detailed explanations thereof will be omitted.

[0498] As shown in FIG. 40, the preparation device 2100 includes a preparation device HW (hardware) unit 2110 and a preparation device management unit 2120.

[0499] Here, the preparation device HW unit 2110 refers to a physically realized device or structure. The preparation device management unit 2120 generates commands for driving the preparation device HW unit 2110, drives the preparation device HW unit 2110 based on the generated commands, and outputs the driving results or various other messages and information as a log, as well as providing a predetermined API (application programming interface). The preparation device HW unit 2110 and the preparation device management unit 2120 themselves will be described below with reference to FIGS. 41 and 42.

[0500] Fig. 41 is a block diagram conceptually showing the configuration of the preparation device HW unit 2110 of the preparation device 2100. However, Fig. 41 is merely an example.

[0501] 41, the preparation device HW unit 2110 of the preparation device 2100 includes a pipette module 2111 and a transfer module 2112. Furthermore, according to an embodiment, the preparation device 2100 may further include a dedicated nucleic acid extraction module for nucleic acid extraction.

[0502] The pipette module 2111 is a module used for the nucleic acid extraction operation and nucleic acid amplification reaction solution preparation operation described above. The pipette module 2111 may include a pipette tip and an arm for moving the pipette tip. The pipette module 2111 may also be called a liquid handler.

[0503] Such a pipette module 2111 can automatically or programmatically aspirate and / or dispense desired amounts of reagents, analytical samples or other liquids from designated containers for chemical or biochemical laboratory automation.

[0504] The transfer module 2112 is a module that transfers a reaction vessel to the transport device 2300. An analysis sample may be contained in the reaction vessel transferred by the transfer module 2112. The analysis sample contained in the reaction vessel may be one for which the above-mentioned nucleic acid extraction operation and nucleic acid amplification reaction solution preparation operation have both been completed.

[0505] On the other hand, the transfer module 2112 can grip or release a reaction vessel, and can also move the reaction vessel while gripping it. In this respect, the transfer module 2112 can be called a gripper.

[0506] Meanwhile, although not shown in FIG. 41 , the pipette module 2111 and the transfer module 2112 or the dedicated nucleic acid extraction module may be arranged in a closed structure having an internal space. That is, the preparation device HW unit 2110 may include the above-described closed structure as a component. If the above-described nucleic acid extraction operation or nucleic acid amplification reaction solution preparation operation is performed inside the closed structure of the preparation device 2100, there is a risk that various substances that may be contained in the sample during this process, such as pathogens, may leak into the internal space of such a closed structure and become suspended within the internal space of such a closed structure. Therefore, according to one embodiment, a technique for reducing this risk is presented, which will be described below.

[0507] Here, since the components shown in FIG. 41 are already known, drawings and related detailed descriptions of these structures will be omitted.

[0508] Next, Fig. 42 is a block diagram conceptually showing the configuration of the preparation device manager 2120 of the preparation device 2100. However, Fig. 42 is merely an example.

[0509] 42, the preparation device management unit 2120 of the preparation device 2100 includes an instruction generation unit 2121, an API unit 2122, a log output unit 2123, and a file generation unit 2124. Here, the preparation device management unit 2120 and the components 2121 to 2124 included therein can be realized by a processor and a memory including instructions executable by such a processor.

[0510] Here, the instruction generation unit 2121 is realized to generate control instructions for controlling the components 2111 and 2112 shown in Fig. 41. Based on the control instructions generated in this way, the preparation device HW unit 2110 shown in Fig. 41 can be driven.

[0511] The API unit 2122 is implemented to provide a predetermined API. In some cases, the preparation device 2100 can monitor or control an external object using the API provided by the API unit 2122. Conversely, an external object can monitor or control the preparation device 2100 using the API provided by the API unit 2122.

[0512] In one embodiment, the API provided by the API unit 2122 does not support a function for connecting to the analysis device 2200 (described later). However, the API does support a function for creating a file with a specific file name and a function for writing the created file to a predetermined location. In this case, the file may contain predetermined content. Here, "content" includes, but is not limited to, text, images, or audio written in the file. An example of the predetermined location may be a file storage unit constituting the control module 2500 (described later), and the location may be a location previously agreed upon with the analysis device 2200.

[0513] The log output unit 2123 is realized to output various information including the status of the preparation device 2100 as a log. Examples of the output log may include, but are not limited to, status information indicating whether the preparation device 2100 is operating normally, abnormally, or stopped, a command to call the transport device 2300, a command to instruct the transport device 2300 to transport a reaction vessel, etc.

[0514] The file generator 2124 is implemented to generate a file containing instructions that the analytical device 2200 refers to when performing a detection operation on a target nucleic acid molecule.

[0515] Such instructions may include, but are not limited to, at least one of information regarding a plate having a plurality of wells, information regarding the specimen contained in each of the plurality of wells, information regarding the reagent contained in each of the plurality of wells, information regarding an optical scanning method used during the detection operation, and reaction conditions during the detection operation. The "reaction conditions" mentioned above may be, but are not limited to, a PCR protocol, for example.

[0516] The file generator 2124 may generate the above-described file based on the preparation work performed on the target nucleic acid molecule by the preparation device 2100. That is, the content of the above-described instructions may be determined based on which plate the pipette module 2111 of the preparation device 2100 performed the preparation work on, which specimen is contained in each of the multiple wells included in the plate, or which reagent has been dispensed into each of the multiple wells. The file generator 2124 may be responsible for determining the specific content of the instructions. To this end, the file generator 2124 may be provided with a table or the like that lists "what the instruction content should be when the content of the preparation work is performed." Alternatively, the entity that determines the specific content of the instructions may be an operator of the automated analysis system 2000 according to one embodiment.

[0517] Meanwhile, the file generated by the file generating unit 2124 can be recorded at a predetermined location by a function of writing a file to a predetermined location, among the API functions provided by the API unit 2122.

[0518] Furthermore, the file generation unit 2124 can record the file name of the above-mentioned file in a predetermined location using the API function provided by the API unit 2122. Here, the predetermined location where the file name is recorded can be the file information storage unit 2522 of the control module 2500, which will be described later.

[0519] Referring again to Figure 40, the analytical device 2200 will now be described. The analytical device 2200 is used for the qualitative or quantitative analysis of analytes. In this regard, the analytical device 2200 can be referred to as a sample analysis device.

[0520] More specifically, but not limited to, the analytical device 2200 performs a nucleic acid amplification operation to amplify a nucleic acid having a specific nucleotide sequence and a detection operation to detect the amplified nucleic acid.

[0521] Meanwhile, the nucleic acid amplification process and the amplified nucleic acid detection process are known techniques, and therefore further explanations thereof will be omitted.

[0522] As shown in FIG. 40, the analysis device 2200 includes an analysis device HW (hardware) unit 2210 and an analysis device management unit 2220.

[0523] Here, the analytical device HW unit 2210 refers to a physically realized device or structure. The analytical device management unit 2220 not only drives the analytical device HW unit 2210 and outputs the drive results and various other messages as logs, but also provides a predetermined API (application programming interface). The analytical device HW unit 2210 and analytical device management unit 2220 themselves will be described with reference to FIGS. 43 and 44.

[0524] Fig. 43 is a block diagram conceptually showing the configuration of the analysis device HW unit 2210 of the analysis device 2200. However, Fig. 43 is merely an example.

[0525] Referring to FIG. 43, the analyzer HW section 2210 of the analyzer 2200 includes a thermal cycler 2211 and an optical module 2212 .

[0526] The thermal cycler 2211 is implemented to perform nucleic acid amplification. Specifically, the thermal cycler 2211 is used for PCR (polymerase chain reaction)-based nucleic acid amplification reactions. More specifically, the thermal cycler 2211 can perform a denaturing step, an annealing step, and an extension (or amplification) step to amplify DNA (deoxyribonucleic acid) having a specific nucleotide sequence.

[0527] The denaturation step involves heating a solution containing a sample containing double-stranded DNA (template nucleic acid) and reagents to a specific temperature, e.g., about 95°C, to separate the double-stranded DNA into single-stranded DNA. The annealing step involves providing an oligonucleotide primer having a nucleotide sequence complementary to that of the nucleic acid to be amplified and cooling the solution together with the separated single-stranded DNA to a specific temperature, e.g., 60°C, to bind the primer to a specific nucleotide sequence in the single-stranded DNA to form a partial DNA-primer complex. The extension step involves maintaining the solution after the annealing step at a specific temperature, e.g., 72°C, to form double-stranded DNA based on the primer in the partial DNA-primer complex using DNA polymerase.

[0528] In one embodiment, the thermal cycler 2211 can exponentially amplify the DNA having the specific nucleotide sequence by repeating the above three steps, for example, 10 to 50 times.

[0529] In another embodiment, the thermal cycler 2211 can simultaneously perform the annealing step and the extension step, in which case the thermal cycler 2211 can complete one cycle by performing two steps: a denaturation step and an annealing / extension step.

[0530] The optical module 2212 is implemented to perform nucleic acid detection operations. Such an optical module 2212 can analyze (or monitor) in real time the amplification reaction performed in the thermal cycler 2211. As an example, such an optical module 2212 can include a plurality of light sources, optical filters, convex lenses, beam splitters, photodetectors, etc.

[0531] Next, Fig. 44 is a block diagram conceptually showing the configuration of the analytical device manager 2220 of the analytical device 2200. However, Fig. 44 is merely an example.

[0532] 44, the analysis device management unit 2220 of the analysis device 2200 includes a data output unit 2221, an API unit 2222, and a log output unit 2223. Here, the analysis device management unit 2220 and the components 2221 to 2223 included therein can be realized by a processor and a memory including instructions executable by such a processor.

[0533] Here, the data output unit 2221 outputs, as data, the results of detection or analysis by the optical module 2212 shown in Fig. 43. The output data includes, but is not limited to, the light intensity for each of multiple cycles.

[0534] The API unit 2222 is implemented to provide a predetermined API. In some cases, the analysis device 2200 can monitor or control an external object using the API provided by the API unit 2222. Conversely, an external object can monitor or control the analysis device 2200 using the API provided by the API unit 2222.

[0535] For example, the API provided by the API unit 2222 can be used to receive a run command for driving the analysis device 2200 from outside.

[0536] Furthermore, the above-mentioned API can be used to control the operation of a door (not shown) provided in the analytical device 2200. Specifically, the analytical device 2000 has a space in which reaction vessels are housed. Furthermore, this space can be opened and closed by the above-mentioned door. Here, the above-mentioned API can support the control function of such a door. Therefore, an external object, for example, the control module 2500, can open and close the above-mentioned door using the API provided by the API unit 2222.

[0537] Furthermore, the API may support a function for reading a file in a predetermined location, the file name, or the content described in the file. Here, "content" includes, but is not limited to, text, images, or audio described in the file. In one embodiment, the API unit 2222 reads a file name stored in the file information storage unit 2522 of the control module 2500. Then, the API unit 2222 can read a file having the read file name from among the files stored in the file storage unit 2521 of the control module 2500. The read object may include various objects. For example, the object may include a file generated by the preparation device management unit 2120 of the preparation device 2100, i.e., a file containing instructions referenced by the analysis device 2200 when performing detection operations.

[0538] The log output unit 2223 is realized to output the status of the analyzer 2200 and various other statuses as a log. Examples of the output log may include, but are not limited to, status information indicating whether the analyzer 2200 is operating normally, abnormally, or stopped, and an estimated time required for the analyzer 2200 to complete the nucleic acid amplification operation and / or nucleic acid detection operation currently in progress.

[0539] Referring again to FIG. 40 , the transport device 2300 will be described. The transport device 2300 is implemented to transport reaction vessels among the preparation device 2100, the analysis device 2200, the automatic sealer 2400, and the vessel processing module 2800. FIG. 45 shows the direction in which reaction vessels are transported by such a transport device 2300. Referring to FIG. 45 , the reaction vessels are transported from the preparation device 2100 to the transport device 2300, then from the transport device 2300 to the automatic sealer 2400, and then from the automatic sealer 2400 to the transport device 2300, and then from the transport device 2300 to the analysis device 2200. Furthermore, although not shown in FIG. 45 , the reaction vessels transported to the analysis device 2200 are transported to the sample processing module 2800 for disposal. Of course, the reaction vessel transport path shown in FIG. 45 is merely exemplary.

[0540] 46 shows a specific configuration of such a transport device 2300. Referring to FIG. 46, the transport device 2300 includes, but is not limited to, a transport module 2310, a position detection unit 2320, and a contact detection unit 2330.

[0541] The transport module 2310 is implemented to transport reaction vessels while moving between the preparation device 2100, the analysis device 2200, the automatic sealer 2400, and the vessel processing module 2800.

[0542] Such a transport module 2310 can be realized as a single module. For example, if the preparation device 2100, the analysis device 2200, and the automatic sealer 2400 are arranged on the same horizontal plane, the transport module 2310 can be realized as a single module that is movable on the horizontal plane.

[0543] Alternatively, the transport module 2310 may be implemented to include at least two configurations. For example, the transport module 2310 may include a vertically movable lift module 2311 and a horizontally movable crane module 2312. This will be described in more detail below.

[0544] The preparation device 2100 may be disposed relatively higher in the automated analysis system 2000, while the analysis device 2200, the automatic sealer 2400, and the container processing module 2800 may be disposed relatively lower in the automated analysis system 2000. The analysis device 2200, the automatic sealer 2400, and the container processing module 2800 may be disposed on the same horizontal plane. In this case, the lifting module 2311 may move vertically, for example, toward the upper part, to receive the reaction vessel from the preparation device 2100. The lifting module 2311 may also move vertically, for example, toward the lower part, while holding the reaction vessel transferred from the preparation device 2100.

[0545] When the lifting module 2311 has completed its vertical movement, for example, toward the bottom, while holding the reaction vessel transferred from the preparation device 2100, the crane module 2312 grips and acquires the reaction vessel from the lifting module 2311, and then moves horizontally. The automatic sealer 2400, the analysis device 2200, and the vessel processing module 2800 are arranged in the horizontal movement direction. This allows the crane module 2312 to transfer the reaction vessel to or retrieve it from each of these modules 2200, 2400, and 2800 while moving horizontally while holding the reaction vessel.

[0546] However, the above-described implementation or driving of the transfer module 2310 is merely an example, and the concept of the present invention is not limited thereto. For example, the transfer module 2310 can be implemented in any form that allows it to move while holding the reaction vessel.

[0547] The position detection unit 2320 is realized by a position detection sensor. Such a position detection unit 2320 detects the position of the transport module 2310. As a result of the detection, the position detection unit 2320 can detect and provide, for example, how far the transport module 2310 is from the preparation apparatus 2100 or the relative position of the transport module 2310 with respect to the preparation apparatus 2100.

[0548] The contact detection unit 2330 is realized by a contact detection sensor. Such a contact detection unit 2330 detects whether or not the transfer module 2310 and the reaction vessel are in contact with each other. As a result of the detection, the contact detection unit 2330 can detect and output, for example, whether or not the transfer module 2310 and the reaction vessel are in contact with each other.

[0549] Referring again to Figure 40, the automatic sealer 2400 will be described. The automatic sealer 2400 is implemented to seal the injection port, for example, the top surface, of a reaction vessel containing an analytical sample. Specifically, the automatic sealer 2400 seals the top surface when it receives the reaction vessel from the transport device 2300. Here, the surface to be sealed may be the side or bottom surface instead of the top surface, but the following description will be given assuming that it is the top surface.

[0550] A specific configuration of such an automatic sealer 2400 is shown in Fig. 47. Referring to Fig. 47, the automatic sealer 2400 includes, but is not limited to, a sealing unit 2410, an API unit 2420, and a log output unit 2430.

[0551] The sealing unit 2410 may seal the inlet (e.g., the top surface) of the reaction vessel containing the analysis sample as described above. To this end, the sealing unit 2410 may adhere a transparent film to the inlet of the reaction vessel. At this time, heat or an adhesive may be used for adhesion.

[0552] The API unit 2420 is implemented to provide a predetermined API, which may allow an external object to monitor or control the state of the seal unit 2410 using the API provided by the API unit 2420.

[0553] The log output unit 2430 is implemented to output a log of the status of the automatic sealer 2400. Examples of the log to be output include, but are not limited to, whether a sealing operation is currently in progress.

[0554] Referring again to Figure 40, the fan module 2600 is disposed in the automated analysis system 2000 and operates to exhaust the air inside the automated analysis system 2000 to the outside. At least one such fan module 2600 can be disposed in the automated analysis system 2000.

[0555] The location of the fan module 2600 within the internal structure of the automated analysis system 2000 and the operational control of such fan module 2600 will be described below.

[0556] The vessel processing module 2800 is configured to collect reaction vessels in which a detection operation for a target nucleic acid has been performed from the analysis device 2200. According to an embodiment, the transport device 2300 can collect reaction vessels in which a detection operation has been performed from the analysis device 2200 and transfer them to the vessel processing module 2800, but is not limited to this.

[0557] The control module 2500 will now be described. Referring to Fig. 40, the control module 2500 includes a control unit 2510 and a storage unit 2520. However, the control module 2500 is not limited to this. Here, the control module 2500 and the components 2510 to 2520 included therein can be realized by a processor and a memory that stores instructions executable by such a processor.

[0558] Various information can be stored in the memory unit 2520. For example, status information of the transport device 2300, status information of the preparation device 2100 or the analysis device 2200, or status information of the automatic sealer 2400 can be stored in the memory unit 2520.

[0559] The control unit 2510 controls the overall operation of the automated analysis system 2000. For example, the control unit 2510 controls the operation of the transport device 2300. The control unit 2510 may also control the automatic sealer 2400, the fan module 2600, or the container processing module 2800. Furthermore, the control unit 2510 allows files to be transferred between the preparation device 2100 and the analysis device 2200.

[0560] Next, we will explain the operation control of the transport device 2300 by the control unit 2510. Under the control of the control unit 2510, the transport device 2300 moves toward the preparation device 2100. Then, the transport device 2300 receives sample analysis containers from the preparation device 2100 that have not yet been sealed.

[0561] Furthermore, the conveying device 2300 moves from the preparation device 2100 to the automatic sealer 2400 under the control of the control unit 2510. Thereafter, the reaction containers are transferred to the automatic sealer 2400, where the sealing operation for the reaction containers is carried out.

[0562] Furthermore, the transport device 2300 carries the reaction vessel for which the sealing operation has been completed and moves it to the analysis device 2200 under the control of the control unit 2510. Thereafter, the reaction vessel is transferred to the analysis device 2200, where the operation of detecting the target nucleic acid is carried out.

[0563] The transport device 2300 carries the reaction vessel from the analyzer 2200 to the vessel processing module 2800 under the control of the control unit 2510. The reaction vessel is then collected in the vessel processing module 2800.

[0564] Next, we will explain the control of the fan module 2600 by the control unit 2510. First, we will explain where the fan module 2600 is placed in the automated analysis system 2000, how each component is placed in the automated analysis system 2000 at this time, and how the transport device 2300 moves, with reference to Figure 48.

[0565] Figure 48 shows the external appearance of an automated analysis system 2000 according to one embodiment and the devices or modules arranged therein. However, Figure 48 is merely an example, and the idea of ​​the present invention is not limited thereto.

[0566] 48, a preparation device 2100 is disposed on the top of the automated analysis system 2000. Furthermore, a closing structure 2700 is disposed on the bottom of the automated analysis system 2000. Of course, the location of the closing structure 2700 is not limited to the bottom of the preparation device 2100. For example, depending on the embodiment, the closing structure 2700 may be disposed on the top or side of the preparation device 2100. However, the following description will be given assuming that the closing structure 2700 is disposed on the bottom of the preparation device 2100.

[0567] The enclosed structure 2700 will now be described in detail. An internal space 2710 is provided inside the enclosed structure 2700. The analytical device 2200, the automatic sealer 2400, and the container processing module 2800 are disposed in the internal space 2710. Furthermore, the fan module 2600 can be disposed penetrating the enclosed structure 2700 so as to exhaust air from the internal space 2710 to the outside of the automated analytical system 2000.

[0568] Such an interior space 2710 can be sealed or isolated from the outside. To this end, the material of the closure structure 2700 can include an air-impermeable material. Furthermore, the closure structure 2700 can include a transparent or translucent material that allows viewing of the interior space 2710 from the outside.

[0569] The enclosed structure 2700 is provided with a determined passage 2730. This determined passage 2730 functions as a passage for connecting the internal space 2710 of the enclosed structure 2700 with other spaces. Referring to FIG. 48 , the internal space 2710 of the enclosed structure 2700 can be connected to the preparation device 2100 or the internal space of the preparation device 2100 via this determined passage 2730. That is, air can move between the internal space of the enclosed structure 2700 and the internal space of the preparation device 2100 via the determined passage 2730. Furthermore, the above-mentioned conveying device 2300 can move between the preparation device 2100 and the internal space 2720 via this determined passage 2730.

[0570] Such a determined passage 2730 is opened and closed by an opening / closing unit 2720. When the determined passage 2730 is closed by the opening / closing unit 2720, air cannot move between the internal space of the preparation device 2100 and the internal space 2710 of the closed structure 2700. On the other hand, when the determined passage 2730 is opened by the opening / closing unit 2720, air can move between the internal space of the preparation device 2100 and the internal space 2710 of the closed structure 2700.

[0571] The opening / closing unit 2720 can open and close the defined passage 2730 in various ways. For example, the opening / closing unit 2720 can be passively opened and closed by the movement of the conveying device 2300. More specifically, as the conveying device 2300, which was in the internal space 2710, passes through the defined passage 2730 and moves to the preparation device 2100, the conveying device 2300 moves while pushing the opening / closing unit 2720, thereby opening the opening / closing unit 2720. Thereafter, when the conveying device 2300 moves from the preparation device 2100 through the defined passage 2730 to the internal space 2710 of the closing structure 2700, the conveying device 2300 no longer pushes the opening / closing unit 2720, thereby closing the opening / closing unit 2720. To this end, the opening / closing unit 2720 can move in the direction of the arrow as shown in FIG. 48 and can be connected to the closing structure 2700 by a hinge.

[0572] Meanwhile, the opening / closing unit 2720 may also be controlled by the control unit 2510 shown in Fig. 40. For example, when the transport device 2300 in the internal space 2710 passes through the determination passage 2730, the control unit 2510 causes the opening / closing unit 2720 to open around the hinge. Thereafter, when the transport device 2300 moves from the preparation device 2100 through the determination passage 2730 into the internal space 2710 of the closing structure 2700, the control unit 2510 causes the opening / closing unit 2720 to close around the hinge.

[0573] The control unit 2510 stops the operation of the fan module 2600 when the determined passage 2730 is open. For example, while the transport device 2300 is passing through the determined passage 2730 or while the transport device 2300 is inside the preparation device 2100, the determined passage 2730 is open, and the control unit 2510 stops the operation of the fan module 2600 during this period.

[0574] More specifically, the transport device 2300 is normally stopped in the internal space 2710 of the closed structure 2700. At this time, the defined passage 2730 is closed by the opening / closing unit 2720. In this case, the fan module 2600 can be stopped or operating, and whether it is operating or stopped is determined by the control unit 2510.

[0575] Furthermore, the transport device 2300 can move from the internal space 2710 toward the inside of the preparation device 2100, and in the process can pass through the determined passage 2730. The control unit 2510 stops the operation of the fan module 2600 while the transport device 2300 passes through the determined passage 2730, i.e., while the transport device 2300 is passing through the determined passage 2730.

[0576] Furthermore, the transport device 2300, which has passed through the determined passage 2730, accesses the preparation device 2100, receives the reaction container therefrom, and then passes through the determined passage 2730 again to return to the internal space 2710. During this period, the determined passage 2730 is open, and the control unit 2510 stops the operation of the fan module 2600 during this period.

[0577] That is, according to one embodiment, the operation of the fan module 2600 is stopped while the defined passage 2730 is open. Therefore, since the fan module 2600 does not operate despite the defined passage 2730 being open, the possibility of air being exchanged between the internal space of the preparation device 2100 and the internal space 2710 of the closed structure 2700 of the analysis device 2200 is reduced.

[0578] Generally, there should be no air exchange between the interior space of the preparation device 2100 and the interior space 2710 in which the analysis device 2200 is located, because air exchange could result in the transfer of pathogens or other contaminants that may be contained in the air from one space to the other, potentially causing contamination or infection.

[0579] In one embodiment, a situation may occur in which the determined passage 2730 is open, and if the fan module 2600 operates in this situation, there is a high possibility that air will be exchanged between the internal space of the preparation device 2100 and the internal space 2710 in which the analysis device 2200 is located. Therefore, in one embodiment, by having the control unit 2510 stop the operation of the fan module 2600 in the above situation, the possibility of the above-mentioned contamination or infection can be reduced.

[0580] Meanwhile, the situation in which the control unit 2510 stops the operation of the fan module 2600 may include not only when the determination passage 2730 is opened but also when it is closed, as will be described in more detail below.

[0581] The control unit 2510 stops the operation of the fan module 2600 while the transporting device 2300 is moving with an unsealed reaction container, even if the determination path 2730 is closed. For example, after the transporting device 2300 receives an unsealed reaction container from the preparation device 2100 and passes through the determination path 2730, the control unit 2510 can stop the operation of the fan module 2600 while the transporting device 2300 is in the internal space 2720. That is, the control unit 2510 can stop the operation of the fan module 2600 from the time the transporting device 2300 passes through the determination path 2730 with an unsealed reaction container until the automatic sealer 2400 is reached and the sealing operation is completed. Thereafter, once the sealing operation is completed, the control unit 2510 can resume the operation of the fan module 2600.

[0582] Meanwhile, the control unit 2510 can stop the operation of the fan module 2600 from when the transport device 2300 passes through the determination path 2730 with an unsealed reaction container until the reaction container is transferred to the analysis device 2200 via the automatic sealer 2400. After that, when the transfer of the reaction container to the analysis device 2200 is completed, the control unit 2510 can resume the operation of the fan module 2600.

[0583] That is, according to one embodiment, operation of fan module 2600 can be stopped while an unsealed reaction vessel is placed in interior space 2710 or for a longer period of time, thereby reducing the spread of various substances, such as pathogens, contained within the unsealed reaction vessel into the air in interior space 2710.

[0584] Normally, pathogens and the like may be contained in an unsealed reaction vessel, and these can escape into the air, particularly into the internal space 2710. If the fan module 2600 operates in such a situation, air will be discharged from the internal space 2710 to the outside of the automated analysis system 2000, and depending on the situation, there is a risk that the pathogens and the like will be mixed in with the air and discharged to the outside.

[0585] Therefore, in one embodiment, when an unsealed reaction vessel is placed in the internal space 2710, the fan module 2600 is prevented from operating, thereby preventing the aforementioned pathogens and the like from being expelled from the inside to the outside of the automated analysis system 2000.

[0586] Hereinafter, the control of the above-mentioned fan module will be described with reference to FIGS. 49 to 56 together with FIG. 48, using examples.

[0587] 49 to 56, the positions of the transport device 2300 are indicated by (1) to (8), respectively.

[0588] 49, the transport device 2300 is in position (1). This position is called the "home" position. When the automated analysis system 2000 is not driven and is in an idle state, or when the automated analysis system 2000 has completed one analysis of a reaction vessel and is waiting for its next turn, the transport device 2300 will be located in this position.

[0589] At this time, the fixed passage 2730 is closed by the opening / closing part 2720. Furthermore, the fan module 2600 can be operating (ON) or stopped (OFF) depending on the temperature of the internal space 2710, as shown in Fig. 49. The following description will be given on the assumption that the fan module 2600 is operating (ON).

[0590] FIG. 50 shows the time when the transport device 2300 starts moving from its home position (1) toward the preparation device 2100. (2) in FIG. 50 shows an example of a position to which the transport device 2300 has moved from (1). This position (2) is before the transport device 2300 has passed through the determined passage 2730. At this time, the determined passage 2730 is still closed by the opening / closing unit 2720. Also, the fan module 2600 changes from ON to OFF as shown in FIG. 50.

[0591] FIG. 51 shows a time when the transport device 2300 has passed through the determined passage 2730 and is positioned in (the internal space of) the preparation device 2100. (3) in FIG. 51 shows an example of a position where the transport device 2300 is positioned in the preparation device 2100. Referring to FIG. 51, the determined passage 2730 is in an open state by the opening / closing unit 2720. In this case, air may move between the internal space of the preparation device 2100 and the internal space 2710 of the closed structure 2700 of the analysis device 2200. At this time, the operation of the fan module 2600 is stopped by the control unit 2510. Therefore, the possibility of air moving between the internal space of the preparation device 2100 and the internal space 2710 of the closed structure 2700 of the analysis device 2200 can be reduced compared to when the fan module 2600 is operating, and even if air moves, the amount of air may be less than when the fan module 2600 is operating.

[0592] In FIG. 51, a transport device 2300 can receive unsealed reaction vessels from the preparation device 2100 .

[0593] Figure 52 shows the point at which the transport device 2300 passes through the defined passage 2730 in the internal space of the preparation device 2100 and returns to the internal space 2710 of the closed structure 2700 of the analysis device 2200. (4) in Figure 52 shows an example of the point at which the transport device 2300 is located in the internal space 2710.

[0594] 52, the determined passage 2730 is closed by the opening and closing part 2720. In this case, there is no possibility of air moving between the internal space of the preparation device 2100 and the internal space 2710 of the closing structure 2700 of the analysis device 2200.

[0595] However, the transport device 2300 may be in the internal space 2710 with an unsealed reaction vessel transferred from the preparation device 2100. At this time, the fan module 2600 is stopped by the control unit 2510.

[0596] Therefore, the possibility that pathogens that may be contained in the reaction vessel will leak into the internal space 2710 can be reduced compared to when the fan module 2600 is operating.

[0597] Figure 53 shows the point in time when the transport device 2300 has completed its movement to the automatic sealer 2400. (5) in Figure 53 shows the position of the transport device 2300 at this time. Referring to Figure 53, the determined passage 2730 is closed by the opening / closing section 2720. In this case, there is no possibility of air moving between the internal space of the preparation device 2100 and the internal space 2710 of the closing structure 2700 of the analysis device 2200. Furthermore, the fan module 2600 is also stopped.

[0598] In FIG. 53, an automatic sealer 2400 receives unsealed reaction vessels from the transport device 2300 and performs a sealing operation on them.

[0599] Figure 54 shows the point in time when the transport device 2300 has completed its movement from the automatic sealer 2400 to the analysis device 2200. (6) in Figure 54 shows the position of the transport device 2300 at that time.

[0600] 54, the determined passage 2730 is closed by the opening and closing part 2720. In this case, there is no possibility of air moving between the internal space of the preparation device 2100 and the internal space 2710 of the closing structure 2700 of the analysis device 2200.

[0601] 54, the analyzer 2200 receives the sealed reaction vessel from the transporter 2300, and performs a detection operation on the target nucleic acid in the reaction vessel. Heat is generated in the analyzer 2200 during this process.

[0602] 54, when the reaction vessel is transferred to the analyzer 2200, the control unit 2510 resumes operation of the fan module 2600. As a result, heat generated by the operation of the analyzer 2200 is discharged from the internal space 2710 to the outside of the automated analysis system 2000.

[0603] Figure 55 shows the time when the transport device 2300 has completed its movement from the analysis device 2200 to the container processing module 2800. (7) in Figure 55 shows the position of the transport device 2300 at that time.

[0604] 55, the determined passage 2730 is closed by the opening and closing part 2720. In this case, there is no possibility of air moving between the internal space of the preparation device 2100 and the internal space 2710 of the closing structure 2700 of the analysis device 2200.

[0605] 55, the transport device 2300 transfers the reaction vessel transferred from the analysis device 2200 to the vessel processing module 2800. When this happens, the reaction vessel is collected.

[0606] Figure 56 shows a state in which the transfer device 2300 has completed its movement from the container processing module 2800 to its home position. (8) in Figure 56 shows the position of the transfer device 2300 at this time.

[0607] 56, the determined passage 2730 is closed by the opening / closing part 2720. In this case, there is no possibility of air moving between the internal space of the preparation device 2100 and the internal space 2710 of the closed structure 2700 of the analysis device 2200. Furthermore, the fan module 2600 is in an operating (ON) state.

[0608] Meanwhile, the control unit 2510 can also control the rotation speed of the fan in the fan module 2600. For example, the control unit 2510 can control the rotation speed of the fan in the fan module 2600 to be faster or slower depending on the internal temperature of the automated analysis system 2000. To this end, the automated analysis system 2000 can include a temperature measurement unit (not shown) for measuring the temperature of the internal space 2710.

[0609] Meanwhile, at least one of the fan modules 2600 described above may be provided in the automated analysis system 2000. Some of these fan modules 2600 may be driven when the analysis device 2200 is in operation, the determined passage 2730 is closed, and the temperature of the internal space 2710 is below or above the reference value, while other fan modules 2600 may be driven only when the analysis device 2200 is in operation, the determined passage 2730 is closed, and the temperature of the internal space 2710 is above the reference value. The control of these fan modules 2600 may be performed by the control unit 2510.

[0610] 57 is a flowchart of a fan module control method that can be executed in the automated analysis system 2000 according to one embodiment. However, FIG. 57 is merely an example, and the concept of the present invention is not limited to what is shown in FIG.

[0611] Referring to FIG. 57, the fan module control method includes a step of opening the defined passage 2730 of the closed structure 2700 of the analyzer 2200 by the opening / closing unit 2720 (S100).

[0612] In this case, the control unit 2510 performs a step of stopping the operation of the fan module 2600 while the determined passage 2730 is being opened by the opening / closing unit 2720 in S100 (S200).

[0613] Hereinafter, such a fan module control method is performed in the automated analysis system 2000, and the detailed content of the method will be referred to in the description of the automated analysis system 2000.

[0614] On the other hand, the methods shown in Figure 57 can be realized by a computer-readable recording medium storing a computer program programmed to execute the steps included in each of the methods, or can be realized in the form of a computer program programmed to execute each step included in the method and stored in a computer-readable recording medium.

[0615] As described above, according to one embodiment, the risk of pathogens that may be contained in the reaction vessel being released and dispersed into the air by the operation of the fan module can be reduced.

[0616] Furthermore, it is possible to reduce the possibility that the air in the preparation device where the preparation work for detecting the target nucleic acid is performed will mix with the air around the analysis device where the detection work for the target nucleic acid is performed.

[0617] Assembly method Next, a method for assembling the automated analysis system will be described.

[0618] This is a technology for assembling three types of devices: an independently driven analytical device used for sample preparation and analysis for molecular diagnostics, an independently driven preparation device, and a transport unit that transports reaction vessels between the two devices, allowing the entire process from sample preparation to analysis to be carried out in one go.

[0619] The present inventors have endeavored to develop a method for assembling an independently operated device approved for existing molecular diagnostics, while maintaining the independence of each device, and ensuring user convenience and safety. As a result, the present inventors have developed a method for assembling an independently operated analysis device and an independently operated preparation device, in which a transfer path for a reaction vessel between them is formed using a transfer unit without compromising the independence of the independently operated analysis device and the independently operated preparation device.

[0620] The present invention provides a method for manufacturing an assembly of a molecular diagnostic device. According to one aspect of the present invention, there is provided a method for manufacturing an assembly of a molecular diagnostic device, the assembly including: a stand-alone analyzer, a transport device, and an independently driven preparation device; the transport device transports a reaction vessel; the independently driven preparation device provides a reaction vessel containing a sample that can be analyzed by the independently driven analyzer; the independently driven analyzer analyzes the sample contained in the reaction vessel; the method includes the following steps: (a) a providing step of providing the independently driven analyzer and the independently driven preparation device to the transport device; and (b) an aligning step of aligning the independently driven analyzer, the transport device, and the independently driven preparation device; the alignment forming a movement pathway for the reaction vessel between the independently driven preparation device and the independently driven analyzer.

[0621] Molecular diagnostics refers to the application of molecular biology techniques to medical testing, analyzing genetic information contained in samples or biological markers contained in proteins, to obtain desired information. The biological marker refers to a target analyte, and can be, for example, a target nucleic acid sequence or amino acid sequence. The desired information can be information about the presence, absence, or amount of the biological marker.

[0622] A molecular diagnostic device refers to a device that can be used for such molecular diagnosis. Molecular diagnostic devices include analytical devices that identify genetic information (e.g., nucleic acid amplification devices, sequencing devices, DNA chip systems) and analytical devices that identify amino acid sequence information (e.g., antibody-based analytical devices). Molecular diagnostic devices also include preparation devices (e.g., extraction devices, PCR setup devices) that prepare samples in a state that allows the analytical device that identifies the genetic or amino acid information to carry out the identification process. The object to be identified is called an analyte or target analyte.

[0623] According to one embodiment of the present invention, the molecular diagnostic device may be a stand-alone device, which is a device designed to perform its own function independently without the involvement of other devices.

[0624] The analytical device of the present invention is an independently driven analytical device, and the preparation device of the present invention is an independently driven preparation device. Thus, according to one embodiment of the present invention, the independently driven analytical device and / or the independently driven preparation device of the present invention may be a molecular diagnostic device.

[0625] According to one embodiment of the present invention, the independently operated analytical device may be a pre-certified analytical device, and the independently operated preparation device may be a pre-certified preparation device. The authorization may be authorization to use the device for the purpose of molecular diagnosis. Specifically, the authorization may be authorization to use the device for in-vitro diagnostics (IVD). An in-vitro diagnostic medical device is a device containing reagents used as a medical device outside the body to test substances in a sample derived from the human body and provide information such as disease diagnosis, prognosis, and observation, and blood or tissue compatibility determination.

[0626] Therefore, in this invention, a preparation device or an analysis device that has already been approved includes the preparation device or the analysis device itself that has been approved as an in vitro diagnostic medical device, and even if the use of the preparation device or the analysis device is approved when a kit for diagnosing a specific disease or infectious disease is approved as an in vitro diagnostic medical device, the preparation device or the analysis device is included in the preparation device or the analysis device that has already been approved.

[0627] The authorization may be authorization granted by a national health authority, and the country may be South Korea, the United States, or Europe.

[0628] The term "assembly" as used herein refers to a structure in which two or more devices are combined. At least one of the two or more devices constituting the assembly may be an independently operated device. According to one embodiment of the present invention, at least one of the devices constituting the assembly is a device that has already been approved as an in vitro diagnostic medical device, and the approved device, even if included in the assembly of the present invention, can be used independently as an in vitro diagnostic medical device without receiving a separate approval.

[0629] In other words, while existing fully automated molecular diagnostic systems include multiple modules that are manufactured for the purpose of the fully automated molecular diagnostic system, and the fully automated molecular diagnostic system itself is a single device that performs various functions, the assembly of the present invention is not a single device per se, but rather a collection of multiple devices that are intricately connected together and can perform specific functions.

[0630] According to one embodiment of the present invention, the assembly may be the automated analysis system 1000 described above.

[0631] The assembly of the present invention includes a preparation device for preparing an analysis sample containing or suspected of containing an analyte. As used herein, the terms "preparation device" and "sample preparation device" are interchangeable and may be used interchangeably.

[0632] A preparation device is a device that prepares or pre-treats a sample in a state that allows an analytical device to proceed with the identification process. For example, the preparation device may be an extraction device that separates nucleic acids or polypeptides from a sample, or a setup device that mixes the separated nucleic acids or polypeptides with reagents and the like required for the analysis so that the analytical device can perform the desired analysis.

[0633] The assembly of the present invention also includes an analytical device. The analytical device analyzes the sample contained in the reaction vessel. Specifically, the analytical device analyzes the sample to provide information regarding the presence or amount of an analyte in the sample. The analytical device can include analytical devices that identify genetic information (e.g., nucleic acid amplification devices, sequencing devices, DNA chip systems) and analytical devices that identify amino acid sequence information (e.g., antibody-based analytical devices).

[0634] As used herein, the terms "analytical device" and "sample analysis device" refer equally to devices used for the qualitative or quantitative analysis of analytes and can be used interchangeably.

[0635] Sample analysis involves detecting the presence or amount of an analyte. According to one embodiment, the sample analysis device is a real-time detection device. According to one embodiment, the sample analysis device is a real-time nucleic acid detection device. According to one embodiment, the sample analysis device is a real-time PCR device.

[0636] The assembly of the present invention also includes a transport section, which transports the reaction vessel, and which includes a transport device and a closing structure, and which includes a lifting module and a crane module.

[0637] According to one embodiment of the present invention, the transport section includes at least one closing structure, and the closing structure may include a second confirmation passage through which the reaction vessel passes.

[0638] The closed structure may house the independently driven analytical device or the independently driven preparation device.

[0639] According to one embodiment of the present invention, the closing structure may include a positioning means for alignment. In this specification, the terms "positioning means" and "positioning means" have the same meaning and may be used interchangeably. The positioning means allows the analytical device or preparation device housed in the closing structure to be positioned at a predetermined location. The positioning means may be, for example, a fastening means for fixing the lower part of the analytical device or preparation device, or a groove, protruding structure, or fastening portion formed on the inner surface of the closing structure with which the analytical device or preparation device comes into contact. The positioning means allows the analytical device or preparation device to be positioned at a predetermined location inside the closing structure to form a movement path for the reaction vessel.

[0640] The closed structure includes a second defined passage through which the reaction vessel passes. The reaction vessel enters and exits through the second defined passage. Therefore, the formed movement path of the reaction vessel may be formed to pass through the second defined passage.

[0641] According to one embodiment of the present invention, the second determined passage may include a door device that is operable to open when the reaction vessel moves through the second determined passage and to close after the movement is completed.

[0642] The location of the second confirmation passage is not particularly limited, and may be located at the top, bottom, or side of the closed structure. According to one embodiment of the present invention, the second confirmation passage may be located at the top of the closed structure.

[0643] According to one embodiment of the present invention, the transport unit of the present invention may include an environment adjusting unit, which adjusts the internal environment of the closed structure of the transport unit.

[0644] The environmental adjustment means adjusts the internal environment of the closed structure of the transport section to the same environment as when an independently driven device (e.g., an independently driven analysis device or an independently driven preparation device) located inside the closed structure is used alone and not included in the assembly of the present invention. This allows the independently driven device located in the closed structure to perform the same as when used alone. The modules of existing fully automated molecular diagnostic systems are not used alone but are designed from the beginning to operate in the environment provided by the system. Therefore, existing fully automated molecular diagnostic systems do not need to be equipped with means for adjusting the environment to the same as when each module is used alone.

[0645] The environmental adjustment means of the present invention can include a ventilation fan, an air conditioner, a heating / cooling device such as a heating wire or a lamp, and a controller for controlling the same.

[0646] Furthermore, the environmental adjustment unit of the transport unit of the present invention can be controlled in conjunction with the operation of other parts of the transport unit. According to one embodiment of the present invention, the environmental adjustment unit of the present invention can be a motion-linked environmental adjustment unit. The motion-linked environmental adjustment unit can operate in conjunction with the operation of other parts of the transport unit.

[0647] The closed structure of the transport section of the present invention can accommodate either an independently driven analytical device or an independently driven preparation device. However, an independently driven preparation device generally includes a shielding means for separating the inside from the outside. This is because, even when used alone, a means for separating the inside from the outside of the preparation device is necessary to prevent contamination of the samples, reaction vessels, and various reagents contained within the preparation device. However, the independently driven analytical device does not include a means for shielding itself. Therefore, according to one embodiment of the present invention, the independently driven analytical device can be disposed in the closed structure of the transport section.

[0648] The transport unit of the present invention transports the reaction vessels. Therefore, according to one embodiment of the present invention, the transport unit can include one or more transport modules.

[0649] According to an embodiment of the present invention, the transport unit may include a lifting module and a crane module.

[0650] According to one embodiment of the present invention, the lifting module may be configured to transport the reaction vessel through the second defined passage of the transport unit, and the crane module may be configured to transport the reaction vessel within the closed structure of the transport unit. This minimizes the size of the second defined passage of the closed structure, and allows a reaction vessel movement path to be established between the preparation device and the analysis device while maintaining the mutual isolation effect between the two devices. In order to achieve both three-dimensional movement within the closed structure of the transport unit and transportation of the reaction vessel through the second defined passage with a single transport module, an expensive articulated device is required.

[0651] According to one embodiment of the present invention, the independently driven analytical device may be located in the closed structure of the transport section, in which case the lifting module transports a reaction vessel from inside the independently driven preparation device to inside the closed structure of the transport section, and the crane module transports the reaction vessel within the closed structure of the transport section.

[0652] According to one embodiment of the present invention, the transport unit of the present invention may include two transport modules, and the independently driven preparation device and the independently driven analyzer are aligned with different transport modules. The assembly of the present invention allows for the construction of a one-step molecular diagnostic process by using an existing, independently used preparation device or analyzer in the assembly configuration. This eliminates the need to discard a previously used molecular diagnostic device and build a new, expensive, fully automated molecular diagnostic system. The transport unit must be able to form a reaction vessel movement path between the preparation device and the analyzer, which were designed and manufactured without considering the transfer of reaction vessels between them. To this end, the transport unit of the present invention includes a lifting module and a crane module, and the independently driven preparation device and the independently driven analyzer are aligned with different transport modules. As a result, in the construction of the assembly of the present invention, the independently driven preparation device and the independently driven analyzer can be selected independently. That is, the assembly and its manufacturing method of the present invention do not limit the selection of an independently driven preparation device by using a specific independently driven analyzer, and the selection of an independently driven analyzer by using a specific independently driven preparation device does not limit the selection of an independently driven analyzer.

[0653] The method for manufacturing the assembly of the molecular diagnostic device of the present invention comprises the following steps.

[0654] (a) providing an independently driven analysis device and an independently driven preparation device to a transport unit; and (b) an alignment step of aligning the independently driven analytical device, the transport unit, and the independently driven preparation device; the alignment forms a movement pathway for reaction vessels between the independently driven preparation device and the independently driven analytical device.

[0655] In the step (a), an independently driven analysis device and an independently driven preparation device are provided to the transport unit.

[0656] As described above, the transport unit includes at least one closing structure, and the closing structure may include a second defined passage through which the reaction vessel passes. According to one embodiment of the present invention, providing the independently driven analytical device to the transport unit may include disposing the independently driven analytical device in the closing structure of the transport unit.

[0657] Furthermore, the closed structure may include a positioning means for alignment, and providing the independently driven analytical device and the transport unit in step (a) may include the step of placing the independently driven analytical device on the positioning means.

[0658] 34 is a diagram illustrating the provision of an independently driven analytical device 1200 to the closing structure 1300 of the transport unit 1050 according to one embodiment of the present invention. As shown in FIG. 6, in the providing step of the present invention, the independently driven analytical device 1200 is placed in the closing structure 1300 of the transport unit 1050. The closing structure 1300 may have a second positioning means 1390 at a predetermined position for the independently driven analytical device 1200. The second positioning means 1390 may be, for example, a fastening means for fixing the lower part of the analytical device or preparation device, or a groove, protruding structure, or fastening portion formed on the inner surface of the closing structure with which the analytical device or preparation device comes into contact.

[0659] The step (a) also includes providing the independently driven preparation device to the transport section.

[0660] Providing the independently driven preparation device means disposing the independently driven preparation device relative to the transport unit so that the moving path of the analysis device and the reaction vessel can be completed.

[0661] According to one embodiment of the present invention, the independently driven preparation device includes a first determined passage through which the reaction vessel can pass, and the providing step may include a step of arranging the second determined passage of the conveying unit so that the first determined passage faces the second determined passage.

[0662] In the manufacturing method of the present invention, the independently driven preparation device can be arranged so that an opening (first determined passage) of the independently driven preparation device and an opening (second determined passage) of the closing structure are closely opposed to each other. The reaction vessel enters and leaves the independently driven preparation device via the first determined passage, and the reaction vessel enters and leaves the closing structure via the second determined passage.

[0663] Therefore, when the independently driven preparation device is arranged so that the first determining passage faces closely to the second determining passage, exposure of the reaction vessel to the outside during the movement of the reaction vessel can be blocked or minimized.

[0664] Referring to Fig. 6, a second defined passage 1310 is formed on the upper surface of the closing structure 1300 of the conveying section 1050. Also, a third positioning means 1395 is formed for positioning the independently driven preparation device 1100 provided in the conveying section 1050. Fig. 17 shows the conveying section 1050 in a state where the lifting module 1410 is exposed. Fig. 36 is a diagram for explaining the provision of the preparation device 1100 to the conveying section 1050.

[0665] The first defined passage 1130 and the second defined passage 1310 of the closing structure 1300 are arranged opposite each other so that the lifting module 1410 can move into the preparation device 1100 through the first defined passage 1130 of the preparation device 1100 (see Figures 36C and 6).

[0666] To facilitate such provision, a third positioning means 1395 is configured on the upper surface of the closure structure 1300 for positioning the independently driven preparation device 1100 provided in the transport section 1050 (see Figure 6).

[0667] This allows a reaction vessel movement path to be formed from the preparation device 1100 to the analysis device 1200. According to one embodiment of the present invention, in the manufacturing method of the present invention, the reaction vessel movement path can be formed via the second determined path and the first determined path.

[0668] In the step (b), the independently driven analysis device, the transport unit, and the independently driven preparation device are aligned.

[0669] The aligning step forms a reaction vessel movement path between the independently driven preparation device and the independently driven analysis device.

[0670] The alignment may specifically include a first alignment step of forming a reaction vessel movement path between the independently driven preparation device and the transport unit, and a second alignment step of forming a reaction vessel movement path between the independently driven analysis device and the transport unit.

[0671] The manufacturing method of the present invention is a method for constructing an assembly capable of realizing a one-step molecular diagnostic process using an independently driven preparation device and an independently driven analyzer that are manufactured independently without considering the formation of a reaction container movement path. Therefore, the independently driven preparation device and the independently driven analyzer used in the present invention do not always have a structure that allows them to be directly aligned with each other to form a reaction container movement path. Therefore, the present invention uses a conveying unit to form a reaction container movement path between the independently driven preparation device and the independently driven analyzer. Specifically, the method of the present invention may include a first alignment step for forming a reaction container movement path between the independently driven preparation device and the conveying unit, and a second alignment step for providing a reaction container movement path between the independently driven analyzer and the conveying unit. Thus, the manufacturing method of the present invention can assemble an assembly capable of realizing a one-step molecular diagnostic process using an independently driven preparation device and an independently driven analyzer that are manufactured independently without considering the formation of a reaction container movement path.

[0672] In addition, the transport unit of the present invention may include at least two transport modules, and the independently driven preparation device and the independently driven analysis device may be aligned with different transport modules, respectively, thereby making it much easier to form a reaction vessel movement path than when one transport module is aligned with each of the preparation device and the analysis device.

[0673] Specifically, the transport unit may include a lifting module and a crane module. According to one embodiment of the present invention, the aligning step may include: (c1) aligning the lifting module with the independently driven preparation device; and (c2) aligning the crane module with the independently driven analysis device.

[0674] As described above, the transport unit of the present invention includes a lifting module and a crane module, and the lifting module is configured to transport the reaction vessel through the second defined passage of the transport unit, and the crane module is configured to transport the reaction vessel within the closed structure of the transport unit. The above embodiment relates to a case where the independently driven analysis device is disposed inside the closed structure of the transport unit, and the independently driven preparation device is located outside the closed structure.

[0675] The lifting module, which transports the reaction vessel through the second defined passage of the transporting unit, aligns with the independently driven preparation device and transports the reaction vessel prepared by the independently driven preparation device into the enclosed structure via the lifting module. Inside the enclosed structure, the lifting module transfers the reaction vessel it is holding to the crane module. The crane module, which transports the reaction vessel inside the enclosed structure of the transporting unit, aligns with the analysis device located inside the enclosed structure and places the received reaction vessel at a predetermined position on the analysis device. This forms a movement pathway for the reaction vessel between the independently driven preparation device and the independently driven analysis device.

[0676] 36, the lifting module 1410 and the preparation apparatus 1100 are aligned so that the lifting module 1410 can pass through the first defined passage 1130 of the preparation apparatus 1100. Specifically, the lifting module 1410 may be aligned to adjust its protruding height (see FIG. 36B) so that the preparation apparatus 1100 can deliver reaction vessels to the lifting module, and the preparation apparatus 1100 may be aligned to adjust its position so that the lifting module 1410 can pass through the first defined passage 1130, and may be aligned to adjust the position of the preparation apparatus 1100 so that a third transport module (not shown) of the preparation apparatus can deliver reaction vessels to the reaction vessel rack 1416 of the lifting module 1410.

[0677] According to one embodiment of the present invention, the method may include a step in which the transport unit learns the position of the independently driven analyzer.

[0678] According to one embodiment of the present invention, the method may include the step of the independently driven preparation device learning the position of the transport.

[0679] When the independently driven preparation device and the independently driven analysis device are placed on the transport section by the aligning step, their relative positions are mechanically adjusted to form a movement path for the reaction vessel.

[0680] In addition to the alignment step, the manufacturing method of the present invention may include a step of fine-tuning the movement of the lifting module, crane module, or pipette module of the preparation device, which are transport modules of the transport unit, by software, to ensure accurate transfer of reaction vessels between devices. This step is called a teaching step, and is performed as the final step after the mechanical positioning of each device is completed. The teaching step may involve a method in which a moving module of one device learns the specific position of another device.

[0681] The manufacturing method of the present invention may include a step in which the transport unit learns the position of the independently driven analyzer, which may be performed by a transport module of the transport unit touching a reaction vessel previously accommodated in the independently driven analyzer to store the position.

[0682] The manufacturing method of the present invention may also include a step in which the preparation device learns the position of the transport unit, which may be performed by a method in which a pipette module of the preparation device touches a reaction vessel previously stored in a transport module to memorize the position.

[0683] In this way, the manufacturing method of the present invention can transport a reaction vessel to the reaction vessel storage portion of the analysis device in the transport module for an analysis device that does not have a module for transporting reaction vessels. For a preparation device in which a pipette module can transport a reaction vessel, the preparation device can learn the position of the transport module and transport the reaction vessel to the transport module. In order for the transport module to lift a reaction vessel in the preparation device, the transport module must be designed to be able to enter the workspace inside the preparation device. In this case, the mechanical structure of the transport module may restrict the movement of the pipette module of the preparation device, and structural modifications to the main parts of the preparation device may be necessary to resolve this. However, if the pipette module of the preparation device transfers the reaction vessel to the location where the transport module is located, the space occupied by the mechanical structure of the transport module inside the preparation device can be minimized, and the pipette module can proceed with the sample preparation process without interference from the transport module, even without structural modifications to the main parts of the preparation device.

[0684] 21 and 22 illustrate how the transport unit 1050 learns the position of the independently driven analyzer 1200. Specifically, the position learning of the analyzer 1200 can be performed by the crane module 1430 of the transport unit 1050. As shown in FIG. 22, a reaction vessel 1500 is placed in the sample holder of the analyzer 1200, and the gripper 1437 of the crane module 1430 is brought into contact with the sample holder 1500 to learn the position of the analyzer 1200. This allows the transport unit 1050 to memorize the position of the analyzer 1200, which allows the movement of the crane module 1430 to be adjusted more accurately.

[0685] According to one embodiment of the present invention, the learning of the crane module 1430 can proceed not only with respect to the analytical device 1200 but also with respect to other components inside the closed structure 1300. Referring to Figure 21, an automatic sealer 1700 can be disposed inside the closed structure 1300, and the crane module 1430 can also learn the position of the automatic sealer 1700.

[0686] According to one embodiment of the present invention, the independently driven preparation device 1100 may include a step of learning the position of the transport unit 1050. The learning may involve the independently driven preparation device 1100 learning the position of the lifting module of the transport unit, specifically, learning the position of the reaction vessel 1500 accommodated in the reaction vessel rack 1416 when the reaction vessel rack 1416 of the lifting module 1410 is extended as far as possible in the horizontal direction to receive the reaction vessel 1500.

[0687] After the mechanical alignment between the lifting module 1410 and the independently driven analysis device 1200 described above is completed, the gripper of the third transport module (not shown) of the preparation device 1100 can learn the position of the reaction vessel 1500 contained in the reaction vessel rack 1416 with the reaction vessel rack 1416 of the lifting module 1410 fully extended as shown in Figure 24(a).

[0688] FIG. 6 shows a closure structure according to one embodiment of the present invention. The transport section 1050 includes an enclosed structure 1300 and a transport device 1400. The transport device 1400 includes a lifting module 1410 and a crane module 1430.

[0689] The closed structure 1300 is used to spatially isolate the molecular diagnostic device provided in the transport unit 1050, and may take the form of a cabinet, locker, box, case, or the like. The closed structure 1300 may be a table that is closed at the front, back, left, right, and bottom and has at least one door. The closed structure may be a form that completely blocks the ingress and egress of air or substances, or may be a form that allows the ingress and egress of air in a controlled manner via ventilation holes.

[0690] The enclosed structure 1300 can contain components for sample analysis inside. The enclosed structure 1300 is provided with at least one door for component maintenance. The doors may be installed at the front / rear, left / right, etc., to allow users to access each component.

[0691] The closed structure 1300 includes a second defined passage 1310 through which the reaction vessels pass. A lifting module 1410 transports the reaction vessels through the second defined passage 1310.

[0692] The closure structure 1300 has a second defined passage 1310 formed on its upper surface through which the lifting module 1410 passes as it moves to the analysis device 1200 to receive the reaction vessel 1500 .

[0693] 7(b) is a perspective view showing an opening and closing device of the second determined passage 1310 according to an embodiment of the present invention. In FIG. 6, the opening and closing module 1311 of the second determined passage 1310 is shown in a closed state.

[0694] The second defined passage 1310 may be formed on the upper surface of the closure structure 1300 . The second defined passage 1310 is formed to a size that allows a vertical motion guide 1413 included in the lifting module 1410 and a reaction vessel rack 1416 that can accommodate reaction vessels 1500 to pass through.

[0695] The second determined passage 1310 may be formed to be vertically connected to the first determined passage 1130 formed in the independently driven preparation device 1100 located at the top of the closed structure 1300 (see FIG. 36). In one embodiment of the present invention, the second defined passage 1310 is a passage for the lifting module 1410 to move into the preparation device 1100 .

[0696] In another embodiment of the present invention, the second determined passage 1310 is a passage that is opened so that the lifting module 1410 can move into the preparation device 1100, and when the lifting module 1410 does not move into the preparation device 1100, the opened second determined passage 1310 can be closed via the opening / closing module 1311 provided in the second determined passage 1310.

[0697] The opening and closing module 1311 is provided to maximize prevention of uncontrolled transfer of substances between the closed structure 1300 and the preparation device 1100. The analysis device 1200 can be placed inside the closed structure 1300, and the analysis device 1200 can produce a high concentration of an analyte during the analysis process. If such an analyte diffuses into the preparation device 1100 via the second determination passage 1310 and the first determination passage 1130, an error in the diagnostic result may occur. The opening and closing module 1311 provided in the second determination passage 1310 can prevent the occurrence of errors due to such contamination.

[0698] FIG. 35 shows the interior of a closed structure 1300 equipped with a fan 1380, which is an example of an environmental adjustment means according to one embodiment of the present invention. The environmental adjustment means 1380 adjusts the internal environment of the closed structure 1300 for the transport section. The environmental adjustment means 1380 adjusts the internal environment of the closed structure 1300 for the transport section to the same environment as when an independently driven analytical device located inside the closed structure 1300 is used alone and not included in the assembly of the present invention. This allows the independently driven device located in the closed structure 1300 to perform the same as when used alone. According to one embodiment, the environmental adjustment means may include heating and cooling devices such as fans, air conditioners, heating elements, and lamps, as well as controllers for controlling them. FIG. 35 shows a closed structure 1300 equipped with four fans 1380-a, 1380-b, 1380-c, and 1380-d as environmental adjustment means. The four fans can be configured to be turned on and off as a whole by a single power source. Alternatively, the four fans may be configured to selectively operate only some of the fans in response to changes in the internal environment.

[0699] According to one embodiment, a duct for guiding the air discharged by the fan may be further provided, thereby preventing the air discharged by the fan from approaching the preparation device located at the top of the closed structure.

[0700] Fig. 37A is a perspective view showing an analytical device 1200 according to one embodiment of the present invention. As shown in Fig. 37B, at least one analytical device 1200 that receives a reaction vessel 1500 sealed by an automatic sealer 1700 can be provided within a closing structure 1300. That is, referring to Fig. 37B, two analytical devices 1200-a and 1200-b can be provided within the closing structure 1300 of the transport section 1050.

[0701] In one embodiment of the present invention, when two analytical devices are configured within the closed structure 1300, the preparation device 1100 sequentially prepares analytical samples for analysis. When a first reaction vessel is prepared in the preparation device 1100, the first reaction vessel can be moved to one of the analytical devices within the closed structure 1300 for analysis. Thereafter, when a second reaction vessel is prepared in the preparation device 1100, the second reaction vessel can be moved to the other analytical device within the closed structure 1300 for analysis.

[0702] Therefore, according to one embodiment of the present invention, the method of the present invention may include a step in which, in the case of a plurality of analytical devices 1200, the transport unit 1050 learns the positions of the analytical devices 1200 respectively.

[0703] The preparation device 1100 is a sample preparation device for preparing samples for analysis. Figure 36 shows an independently driven preparation device 1100 of the present invention and the alignment of said preparation device 1100 with the transport section 1050.

[0704] The preparation device 1100 includes a deck 1110 on which various types of instruments and containers for preparing analytical samples can be placed. The deck 1110 has a shape on which components included in the preparation device 1100 can be attached and fixed.

[0705] In one embodiment of the present invention, the deck 1110 provides guides that allow components of the preparation device 1100 to be slidably inserted into the preparation device 1100 and positioned on top of the deck 1110 .

[0706] The preparation device 1100 includes a housing 1190. The housing 1190 isolates the inside of the preparation device 1100 from the outside. The housing 1190 is disposed on the top, bottom, and rear of the preparation device. The housing 1190 may be disposed on the front of the preparation device 1100. The front housing may have an openable door for storing samples, etc. The housing 1190 may be disposed on the left or right side of the preparation device 1100.

[0707] According to one embodiment, a first defining passage 1130 is disposed on the underside of the housing 1190 .

[0708] The first determined passage 1130 is a space through which the lifting module 1410 moves from the closed structure 1300. The first determined passage 1130 is formed to vertically correspond to the second determined passage 1310 of the closed structure 1300. The first determined passage 1130 is formed to a size that allows the vertical movement guide 1413 of the lifting module 1410 and the reaction vessel rack 1416 to move.

[0709] 4 shows an assembly according to one embodiment of the present invention. As described above, in the assembly manufactured by the manufacturing method of providing and aligning the independently driven preparation device 1100 and the independently driven analysis device 1200 in the transport unit 1050 of the present invention, a movement path for reaction vessels can be formed between the independently driven preparation device 1100 and the independently driven analysis device 1200.

[0710] Specifically, the reaction vessel movement path may include the following steps: (1) Transfer of the reaction vessel 1500 from the preparation device 1100 to the lifting module 1410; (2) transporting the reaction vessel 1500 from the interior of the preparation device 1100 to the interior of the closure structure 1300 by the lifting module 1410; (3) The reaction vessel 1500 is transported from the lifting module 1410 to the independently driven analytical device 1200 by the crane module.

[0711] According to one embodiment, the transport step (3) may involve transporting the reaction vessel 1500 to the analysis device 1200 via an automatic sealer 1700 .

[0712] In addition, the manufacturing method of the present invention can isolate the independently driven analytical device 1200 from the independently driven preparation device 1100 by positioning the independently driven analytical device 1200 in the closed structure 1300 of the conveying section 1050, thereby eliminating the risk of analytical errors due to contamination.

Claims

1. An automated analysis system, comprising: a preparation device for preparing an analytical sample in a reaction vessel, the preparation device being a stand-alone device; an analysis device for analyzing the analysis sample prepared in the reaction vessel, the analysis device being an independently driven device; a transport device for transporting the reaction vessel and a closure structure; at least one device selected from the group consisting of the analytical device and the transport device is located within an enclosure; the preparation device and the closure structure each include a defined passage through which the reaction vessel is transported; the conveying device conveys the reaction vessel through the defined passage; the independently driven device is capable of operating independently when separated from the automated analytical system; An automated analysis system, wherein the transport device comprises a crane module, the crane module configured to provide the reaction vessel to the analysis device, the analysis device including a nucleic acid amplifier and an optical module.

2. The automated analysis system comprises: The automated analysis system according to claim 1, wherein the closed structure is closed as a single space, and the analysis device and the transport device are disposed in the single space.

3. The conveying device is The automated analysis system according to claim 1, wherein the automated analysis system is disposed inside the closed structure.

4. The preparation device and / or the analysis device, 10. The automated analytical system of claim 1, operatively connected to said closure structure.

5. The closure structure comprises:

5. The automated analysis system according to claim 4, further comprising positioning means capable of determining the position of said preparation device and / or said analysis device in order to be operatively connected.

6. The automated analysis system of claim 1 further comprising a control module capable of controlling the transport device.

7. The control module 7. The automated analysis system according to claim 6, wherein the preparation device, the analysis device, and the transport device are connected to a communication channel.

8. The control module The automated analysis system according to claim 7, wherein the preparation device, the analysis device, and the transport device are controlled so as to operate in a timely manner.

9. The control module The automated analysis system according to claim 7, further comprising: a means for providing external signals necessary for the operation of said independently driven devices;

10. The control module receiving a signal using the communication channel that the sample preparation device has completed preparation of the analytical sample; and providing a control signal to the transport device using the communication channel to cause the preparation device to transport the reaction vessel to the analytical device; 8. The automated analysis system according to claim 7, wherein the reaction vessel is transported from the preparation device to the analysis device.

11. The conveying device is 2. The automated analysis system according to claim 1, further comprising at least one robotic module for transporting the reaction vessel from the preparation device to the analysis device.

12. The preparation device comprises:

10. The automated analysis system of claim 1, wherein the defined passage is provided by a pre-formed opening.

13. The determined path is 2. The automated analysis system according to claim 1, wherein the reaction vessel is provided with an opening and closing part that is opened when the reaction vessel is transported.

14. The preparation device comprises: The automated analysis system according to claim 1 , wherein the analysis device is located above and below the analysis device.

15. The preparation device and the analysis device 2. The automated analysis system according to claim 1, wherein each of the components is supplied with power from a separate power source.

16. 10. The automated analysis system of claim 1, further comprising an automatic sealer for sealing the upper surface of the reaction vessel.

17. The automated analytical system of claim 16, wherein the automatic sealer is disposed in the closed structure.

18. the transport device includes a lifting module and a crane module; 2. The automated analysis system according to claim 1, wherein the lifting module is moved upward to the preparation device to move the reaction vessel to the analysis device.

19. The lifting module includes:

19. The automated analytical system of claim 18, wherein the preparation device has horizontal extension movement for receiving the reaction vessel within the preparation device.

20. The crane module includes: The automated analysis system according to claim 18, further comprising the operation of horizontally rotating the reaction vessel.

21. The automated analysis system comprises: an opening / closing unit that opens and closes the defined passage; and The automated analysis system according to claim 6, further comprising a fan module that operates to exhaust air from the interior space of the closed structure to the outside.

22. The automated analysis system comprises: further comprising an automatic sealer for sealing unsealed reaction vessels; the transport device receives the unsealed reaction vessel from the preparation device and transfers it to the automatic sealer, receives the reaction vessel whose sealing operation has been completed from the automatic sealer and transfers it to the analysis device; The automated analysis system of claim 21, wherein the control module stops operation of the fan module from the time the transport device receives the unsealed reaction vessel from the preparation device until the transport device completes transferring the reaction vessel whose sealing operation has been completed to the analysis device.

23. The automated analysis system includes a plurality of fan modules, The automated analysis system further includes a temperature measurement unit that measures the temperature of the internal space, The control module The automated analysis system of claim 21, wherein when the temperature measured by the temperature measurement unit is below a predetermined temperature, only some of the plurality of fan modules are operated and the remaining fan modules are stopped, and when the measured temperature exceeds the predetermined temperature, all of the plurality of fan modules are operated.

24. An analytical method using an automated analytical system, comprising: The automated analytical system includes a preparation device, an analytical device, a transport device, a control module, and a closure structure; The analysis method includes: the control module includes a step of controlling the transport device so that a reaction vessel containing an analysis sample is transported from the preparation device to the analysis device, the preparation device and the analysis device being independently driven devices; the control module controls the analytical device to analyze the analytical sample; the control module controls the transport device so that the reaction vessel in which the analysis sample has been analyzed is removed from the analysis device; The analytical device comprises a nucleic acid amplifier and an optical module; at least one device selected from the group consisting of the analytical device and the transport device is located within an enclosure; the preparation device and the closure structure each include a defined passage through which the reaction vessel is transported; the transport device comprises a crane module, the crane module configured to provide the reaction vessel to the analytical device; An analysis method using an automated analysis system, wherein the transport device transports the reaction vessel through the defined path.

25. before the step of controlling the transport device so that the reaction vessel is transported to the analysis device, 25. The method of claim 24, further comprising the step of the control module receiving a signal indicating that preparation of the analytical sample in the preparation device is complete.

26. before the step of controlling the transport device to remove the reaction vessel, 25. The method of claim 24, further comprising the step of the control module receiving a signal indicating that analysis of the analytical sample has been completed in the analytical device.

27. The closed structure is closed in a single space, a step in which the control module controls a transport device so that the reaction vessel is transported from the preparation device to the analysis device; 25. The analytical method using the automated analytical system according to claim 24, wherein the transport device located inside the closed structure transports the reaction vessel to the analytical device located in the same space.

28. The preparation device and / or the analysis device for carrying out the steps, The analytical method using the automated analytical system of claim 24, operatively connected to the closure structure.

29. the control module is connected to the preparation device, the analysis device, and the transport device via a communication channel; In the step of controlling the transport device so that the reaction vessel is transported to the analysis device, The control module receiving a signal over the communication channel indicating that the sample preparation device has completed the preparation of the sample for analysis; and providing a control signal to a transport device using the communication channel to cause the preparation device to transport the reaction vessel to the analytical device; 25. The analytical method using an automated analytical system according to claim 24, wherein the reaction vessel is transported from the preparation device to the analytical device.

30. The transport device includes a lifting module, and the step of controlling the transport device so that the reaction vessel is transported from the preparation device to the analysis device includes:

25. The analytical method using the automated analytical system of claim 24, further comprising a step of controlling the lift module so that when the lift module moves into the preparation device, the lift module makes a horizontal extension movement to receive the reaction vessel.

31. The transport device includes a crane module, and the step of controlling the transport device so that the reaction vessel is transported from the preparation device to the analysis device includes: The crane module:

25. The analytical method using an automated analytical system according to claim 24, further comprising the step of controlling the crane module to horizontally rotate the reaction vessel.

32. Memory and at least one processor configured to access the memory; and one or more programs stored in the memory and configured to be executed by the processor, The automated analytical system includes a preparation device, an analytical device, a transport device, a control module, and a closure structure; The one or more programs, when executed by the one or more processors, the control module includes instructions for executing a step of controlling the transport device so that a reaction vessel containing an analytical sample is transported from the preparation device to the analysis device, the preparation device and the analysis device being independently driven devices; the control module includes instructions for controlling the analytical device to analyze the analytical sample; the control module includes instructions for executing a step of controlling the transport device so that the reaction vessel in which the analysis of the analysis sample has been completed is removed from the analysis device; the analytical device comprises a nucleic acid amplifier and an optical module; at least one device selected from the group consisting of the analytical device and the transport device is disposed within an enclosure; the preparation device and the closure structure each include a defined passage through which the reaction vessel is conveyed; the transport device comprises a crane module, the crane module configured to provide the reaction vessel to the analytical device; the one or more programs include instructions that cause the transport device to transport the reaction vessel through the defined path. Automated analysis system.

33. A non-transitory computer-readable storage medium containing instructions that, when executed by one or more processors, cause an analytical method using an automated analytical system to be performed, the instructions comprising: The automated analytical system includes a preparation device, an analytical device, a transport device, a control module, and a closure structure; The method comprises: the control module includes a step of controlling the transport device so that a reaction vessel containing an analysis sample is transported from the preparation device to the analysis device, the preparation device and the analysis device being independently driven devices; the control module controls the analytical device to analyze the analytical sample; the control module controls the transport device so that the reaction vessel in which the analysis sample has been analyzed is removed from the analysis device; at least one device selected from the group consisting of the analytical device and the transport device is disposed within an enclosure; the analytical device comprises a nucleic acid amplifier and an optical module; the preparation device and the closure structure each include a defined passage through which the reaction vessel is conveyed; the transport device comprises a crane module, the crane module configured to provide the reaction vessel to the analytical device; the instructions include instructions for causing the transport device to transport the reaction vessel through the defined path. Non-transitory computer-readable storage medium.

34. 1. A fan module control method performed in an automated analysis system, the automated analysis system comprising: a preparation device for preparing an analytical sample in a reaction vessel; an analytical device for analyzing the analytical sample prepared in the reaction vessel, the analytical device including a nucleic acid amplifier and an optical module; a transport device for transporting the reaction vessel, the transport device including a crane module configured to provide the reaction vessel to the analytical device; The automated analysis system further comprises a closed structure, wherein the preparation device and the closed structure each include a defined path through which the reaction vessel is transported. an opening / closing unit that opens and closes the defined passage; and a fan module that operates to exhaust air from the interior space of the closed structure to the outside; at least one device selected from the group consisting of the analytical device and the transport device is located within an enclosure; The fan module control method includes: a step of opening the determined passage by the opening / closing unit; stopping operation of the fan module while the defined passage is opened by the opening and closing unit, Fan module control method.

35. The stopping step includes: The fan module control method according to claim 34, wherein the fan module is operated or stopped depending on the position or the moving direction of the transport device.

36. The stopping step includes: The method of claim 35, further comprising stopping operation of the fan module while the transport device is being placed on the preparation device.

37. The automated analysis system comprises: further comprising an automatic sealer for sealing unsealed reaction vessels; the transport device receives the unsealed reaction vessel from the preparation device and transfers it to the automatic sealer, receives the vessel whose sealing operation has been completed from the automatic sealer and transfers it to the analysis device; The operation of the fan module is The fan module control method of claim 35, wherein the transport device is stopped from the time it receives the unsealed reaction vessel from the preparation device until it has completely transferred the reaction vessel whose sealing operation has been completed to the analysis device.

38. The automated analysis system includes a plurality of fan modules; The automated analysis system further includes a temperature measurement unit that measures the temperature of the internal space, The fan module control method includes:

35. The fan module control method of claim 34, wherein when the temperature measured by the temperature measurement unit is equal to or lower than a predetermined temperature, only some of the fan modules are operated and the other fan modules are stopped, and when the measured temperature exceeds the predetermined temperature, all of the fan modules are operated.

39. A method for manufacturing an assembly of a molecular diagnostic device, comprising: the assembly includes a stand-alone analyzer, a transporter, and an independently driven preparation device; the transport device transports a reaction vessel, the transport device includes a crane module, the crane module is configured to provide the reaction vessel to the analytical device; the independently operated preparation device provides a reaction vessel containing a sample that can be analyzed by the independently operated analysis device; the analytical device includes a nucleic acid amplifier and an optical module; The independently driven analytical device analyzes the sample contained in the reaction vessel; The method comprises: (a) providing an independently driven analytical device and an independently driven preparation device to a transport device; (b) aligning the independently driven analytical device, the transport device, and the independently driven preparation device. The alignment forms a movement pathway for the reaction vessel between the independently driven preparation device and the independently driven analysis device. Method for manufacturing an assembly of a molecular diagnostic device.

40. 40. The method of claim 39, wherein the transport device includes at least one closure structure, the closure structure including a second defined passageway through which the reaction vessel passes.

41. 41. The method of claim 40, wherein the independently driven preparation device includes a first defined path through which the reaction vessel can pass, and the providing step includes a step of arranging the transport device so that the first defined path and the second defined path face each other.

42. The method 40. The method of claim 39, further comprising the step of the transport device learning the location of the independently driven analytical device.

43. The method 40. The method of claim 39, including the step of the independently driven preparation device learning the position of the transport device.

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