Genome amplification module with a branching space adjacent to the extract inlet.

Abstract

The present invention relates to a genome amplification module having a branch space adjacent to an inlet through which an extract flows, and provides a genome amplification module in which a branch space that is wider and deeper than the extract flow passage is formed adjacent to the inlet, and after the branch space is filled with extract, the extract can be simultaneously injected along each extract flow passage.

Description

Technical Field

[0001] The present invention relates to a genome amplification module having a branch space adjacent to an inlet into which an extract flows.

Background Art

[0002] In recent years, with the development of biotechnology, it has become possible to interpret the causes of diseases at the gene level. As a result, the requirements for the manipulation of biological samples and biochemical analysis for the treatment or prevention of human diseases have been gradually increasing.

[0003] In addition to disease diagnosis, techniques for extracting and analyzing nucleic acids from samples containing biological samples or cells are required in various fields such as new drug development, pre-examination for the presence or absence of viral or bacterial infections, and forensic medicine.

[0004] On the other hand, as an apparatus developed by the present applicant, Patent Document 5 discloses an extraction apparatus that pretreats an input sample to prepare an extract containing a genome. The extract generated through the extraction apparatus moves to an amplification module connected to the extraction apparatus, and the extract introduced into the storage unit of the amplification module is amplified through a nucleic acid amplification reaction. Since a probe that specifically binds to a target sequence and contains a fluorescent substance is stored in the storage unit, fluorescence can be observed through a nucleic acid amplification reaction when the target sequence is contained in the genome of the extract. Then, the presence or absence of diseases / viral infections of the individual from whom the sample was collected can be confirmed based on the presence or absence of fluorescence observation.

[0005] On the other hand, in the case of an amplification module having a plurality of storage units, primers / probes or the like for detecting different targets may be stored in each storage unit. When the extracts introduced into the storage units are mixed with each other during the injection / amplification process, inaccurate detection results will be obtained. Also, although relatively uniform results can be ensured only when the same amount of extract is injected into each storage unit, in the case of existing genome amplification modules, there has been a problem that more extract is injected into storage units that are less affected by gravity.

[0006] In response to this, the inventors focused on and completed the present invention in order to solve the problems of conventional genome amplification modules. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] Korean Registered Patent Publication No. 10-2346703 [Patent Document 2] Korean Registered Patent Publication No. 10-2416335 [Patent Document 3] Korean Registered Patent Publication No. 10-2293717 [Patent Document 4] Korean Registered Patent Publication No. 10-2375252 [Patent Document 5] Korean Registered Patent Publication No. 10-2362853 [Overview of the Initiative] [Problems that the invention aims to solve]

[0008] The present invention aims to provide a genome extraction apparatus that solves the problem of reagents contained in a single chamber leaking out of conventional genome extraction apparatuses by providing an inner chamber containing reagents necessary for genome extraction separately from the outer chamber, and by sealing the upper and lower parts of the inner chamber.

[0009] Furthermore, the objective is to provide a genome extraction device that includes safety clips to prevent the sealing members that seal the upper and lower openings of the inner chamber from being perforated by the protruding members formed on the cover and outer chamber, due to the movement of the inner chamber up and down caused by vibrations that occur during the production and distribution process of the product.

[0010] Furthermore, the objective is to provide a genome extraction device that solves the problem of cross-contamination between reagents due to capillary action occurring through the space between the double chambers, through a unique inner chamber design (lower inner chamber).

[0011] Furthermore, the objective is to provide a genome extraction device that solves the problem of preventing capillary action by designing a unique inner chamber (upper inner chamber) to prevent reagents from leaking out to the outside.

[0012] Furthermore, the configuration of the first protruding member formed on the bottom surface of the outer chamber allows the sealing member to be torn with little force, the perforated portion to expand, and the goal is to provide a genome extraction device that allows the reagent contained inside the inner chamber to flow out smoothly to the outside.

[0013] Furthermore, the objective is to provide a genome extraction device in which a slanted portion is formed around the discharge port through which the reagent is discharged, allowing the reagent to be discharged smoothly through the discharge port.

[0014] Furthermore, by arranging a double-layered flow cover-pad between the outer chamber and the base plate, the aim is to provide a genome extraction device that offers improved manufacturing convenience compared to conventional genome extraction devices that only have one pad, and solves the problem of unintentionally narrowing the flow path.

[0015] Furthermore, the objective is to provide a genome extraction device in which a sealed channel is formed without the phenomenon of leakage from the intermediates during the process of reagent movement, by achieving a strong bond between the base plate, flow cover, pad, and outer chamber.

[0016] Furthermore, the bead chamber, which contains the beads necessary for genome extraction and amplification, has a double-chamber structure consisting of an outer chamber and a bead chamber. This aims to provide a genome extraction device that can maintain the performance of moisture-sensitive beads for extended periods.

[0017] Another object is to provide a genomic extraction device that can maintain the performance of beads by a dehumidifying unit located above the bead chamber even when the bead chamber is opened.

[0018] Another object is to provide a genomic extraction device to which an amplification module is applied, in which the air remaining inside the housing can be easily discharged when a pre-treated extraction solution is introduced, so that an extraction solution with a sufficient volume can be introduced.

[0019] Another object is to provide a genomic extraction device in which the amplification module has a plurality of housing parts, primers and probes for different genomic amplifications are stored in each housing part, and several types of disease diagnoses are possible through one genomic extraction.

[0020] Another object is to provide a genomic amplification module in which a plurality of extraction solution transfer passages have the same volume (volume) as each other, the extraction solution can be simultaneously injected into all the housing parts, and the same amount of extraction solution can be injected.

[0021] Another object is to provide a genomic amplification module in which a branch space that is wider and deeper than the extraction solution transfer passage is formed in a portion adjacent to the inlet, and after the branch space is filled with the extraction solution, the extraction solution can be simultaneously injected along each extraction solution transfer passage.

[0022] Another object is to provide a genomic amplification module in which a branch space is formed at a first end adjacent to the inlet, a housing part is provided at a second end far from the first end, and it is possible to prevent a phenomenon in which the amplification product in each housing part is pushed out into the transfer passage according to the heating temperature or flows back to other housing parts during the amplification process.

[0023] Another object is to provide a genomic amplification module in which a space that is wider and deeper than other parts is formed at the connection point of the housing part of the gas transfer passage, and even if bubbles are generated, it does not affect the housing part, so the detection accuracy is improved.

[0024] It is also an object of the present invention to provide a genome amplification module in which the width and depth of the gas transfer passage are minimized to minimize the extract discharged through the gas transfer passage.

[0025] Another object of the present invention is to provide a genome extraction method using the above-described genome extraction device.

Means for Solving the Problems

[0026] One embodiment of the present invention for solving the above problems includes a body, an inlet formed in the body through which an extract flows in, a plurality of storage portions connected to the inlet and accommodating the extract flowing in, a first branch space communicating with the inlet, a plurality of extract transfer passages branching from the branch space and connecting the inlet and the plurality of storage portions to each other, an outlet formed in the body through which gas is discharged, and a plurality of gas transfer passages connecting the outlet and the plurality of storage portions to each other, and provides an amplification module.

[0027] In one embodiment, the first branch space may include a first through portion that penetrates the body while being connected to the inlet, and a first recess portion formed between the first through portion and the plurality of extract transfer passages and recessed in one surface of the body.

[0028] In one embodiment, one or more of the width and depth of the first branch space may be wider or deeper than the width and depth of the extract transfer passage.

[0029] In one embodiment, the volumes of the plurality of extract transfer passages may be the same as each other.

[0030] In one embodiment, the first branch space may be formed at a first end portion in the width direction of the amplification module, and the plurality of storage portions may be formed at a second end portion opposite to the first end portion in the width direction of the amplification module.

[0031] In one embodiment, the second branch space is further formed between the outlet and the plurality of gas transport passages, and the second branch space may include a second penetration portion that penetrates the body while being connected to the outlet, and a second recessed portion formed between the second penetration portion and the plurality of gas transport passages and recessed into the other side of the body.

[0032] In one embodiment, the first recessed portion and the second recessed portion may have portions that partially overlap in the width direction of the body, and may be formed as recesses in the body.

[0033] In one embodiment, the body may further include a sealing member that adheres to one surface and the opposite surface of the body and seals the plurality of housing sections, the first branch space, the second branch space, the extractant transport passage, and the gas transport passage from the outside space.

[0034] In one embodiment, the space between the first recessed portion and the sealing member and the space between the second recessed portion and the sealing member may be independent spaces that do not communicate with each other.

[0035] In one embodiment, the gas transfer passage is connected to the upper part of the containment section, and a space wider and deeper than other parts may be formed at the connection point.

[0036] In one embodiment, one or more of the width and depth of the gas transport passage may be narrower or lower than the width and depth of the extract transport passage.

[0037] In one embodiment, the gas transport passage may be formed through one or more combinations of a first gas transport passage having a first width and a first depth, a second gas transport passage having a second width greater than the first width and the first depth, and a third gas transport passage having a third width greater than the second width and a second depth greater than the first depth.

[0038] In one embodiment, a number of columns may be formed protruding from the gas transport passage.

[0039] In one embodiment, the gas transfer passages connected to the plurality of storage sections can all have the same volume.

[0040] In one embodiment, one of the plurality of storage compartments may store a probe and primer for amplifying a first target substance, while another storage compartment may store a probe and primer for amplifying a second target substance different from the first target substance. [Effects of the Invention]

[0041] The genome extraction apparatus according to the present invention is equipped with an inner chamber containing reagents necessary for genome extraction, separate from the outer chamber, and the upper and lower parts of the inner chamber are sealed, thereby solving the problem in conventional genome extraction apparatuses where reagents contained in a single chamber leak out.

[0042] Furthermore, vibrations generated during the production and distribution process of the product cause the inner chamber to move up and down, preventing the sealing members that seal the upper and lower openings of the inner chamber from being perforated by the protruding members formed on the cover and outer chamber.

[0043] Furthermore, the problem of cross-contamination between reagents is resolved by the capillary action that occurs through the space between the double chambers.

[0044] Furthermore, the structure designed to prevent capillary action prevents reagents from leaking out.

[0045] Furthermore, the configuration of the first protruding member formed on the bottom surface of the outer chamber allows the sealing member to be torn with little force, the perforated portion expands, and the reagent contained inside the inner chamber flows out smoothly to the outside.

[0046] Furthermore, an inclined section is formed around the discharge port through which the reagent is discharged, allowing the reagent to be discharged smoothly through the port.

[0047] Furthermore, the placement of a double-layered flow cover-pad between the outer chamber and the base plate improves manufacturing convenience and solves the problem of unintentionally narrowing the flow path compared to conventional genome extraction devices that only have one pad.

[0048] Furthermore, the strong bond between the base plate, flow cover, pad, and outer chamber creates a sealed channel without the phenomenon of leakage during the reagent's movement.

[0049] Furthermore, the bead chamber, which contains the beads necessary for genome extraction and amplification, has a double-chamber structure consisting of an outer chamber and a bead chamber, making it possible to maintain the performance of the moisture-sensitive beads for extended periods.

[0050] Furthermore, even when the bead chamber is opened, the performance of the bead is maintained by the dehumidifying unit located at the top of the bead chamber.

[0051] Furthermore, by introducing the pre-treated extract, residual air inside the containment section is easily removed, ensuring that a sufficient volume of extract is supplied to the amplification module.

[0052] Furthermore, the amplification module has multiple storage compartments, each containing different primers and probes for genome amplification, allowing for the diagnosis of several diseases through a single genome extraction.

[0053] Furthermore, multiple extractant transport passages have the same volume, allowing extractant to be injected into all containment sections simultaneously, and the same amount of extractant to be injected.

[0054] Furthermore, a branched space is formed adjacent to the inlet, which is wider and deeper than the extract transport passage. After the branched space is filled with extract, the extract can be simultaneously injected along each extract transport passage.

[0055] Furthermore, a branching space is formed at the first end adjacent to the inlet, and a housing section is provided at the second end far from the first end, making it possible to prevent the amplification product in each housing section from being pushed out into the moving passage or flowing back into other housing sections due to the heating temperature during the amplification process.

[0056] Furthermore, a wider and deeper space is formed at the connection point of the gas transport passage's containment section compared to other sections. Even if bubbles are generated, they do not affect the containment section, improving detection accuracy.

[0057] Furthermore, the width and depth of the gas transport passage are minimized, and the amount of extract discharged through the gas transport passage can be minimized. [Brief explanation of the drawing]

[0058] [Figure 1] This is a perspective view showing the overall configuration of a genome extraction apparatus according to an embodiment of the present invention. [Figure 2] Figure 1 is a perspective view of the genome extraction device from another side. [Figure 3] Figure 1 is an exploded perspective view. [Figure 4] This is a diagram illustrating the coupling relationship between the outer chamber and the inner chamber. [Figure 5] This is a diagram illustrating the connection between the inner chamber and the safety clip. [Figure 6] This is a plan view of the outer chamber. [Figure 7] This is a cross-sectional view illustrating the coupling relationship between the inner and outer chambers. [Figure 8] This is an enlarged drawing illustrating the second protruding member formed on the bottom surface of the outer chamber. [Figure 9] This is a diagram to explain the inner chamber in more detail. [Figure 10] This is a bottom perspective view to provide a more detailed explanation of the cover. [Figure 11]This is an exploded perspective view to more specifically explain the flow cover and pad located between the base plate and the outer chamber. [Figure 12] This is an exploded perspective view to specifically explain the piston's configuration. [Figure 13] This is a bottom perspective view of the flow cover. [Figure 14] This is a perspective view to provide a more detailed explanation of the base plate. [Figure 15] This is a cross-sectional view illustrating a genome extraction device according to an embodiment of the present invention. [Figure 16] This is another cross-sectional view for specifically illustrating a genome extraction device according to an embodiment of the present invention. [Figure 17] This is a diagram illustrating an amplification module according to a first embodiment of the present invention. [Figure 18] This is a diagram illustrating an amplification module according to a first embodiment of the present invention. [Figure 19] This is a diagram illustrating an amplification module according to a first embodiment of the present invention. [Figure 20] This is a diagram illustrating an amplification module according to a first embodiment of the present invention. [Figure 21] This is a diagram illustrating an amplification module according to a second embodiment of the present invention. [Figure 22] This is a diagram illustrating an amplification module according to a second embodiment of the present invention. [Figure 23] This is a diagram illustrating an amplification module according to a second embodiment of the present invention. [Figure 24] This is a diagram illustrating an amplification module according to a third embodiment of the present invention. [Figure 25] This is a diagram illustrating an amplification module according to a third embodiment of the present invention. [Figure 26] This is a diagram illustrating an amplification module according to a third embodiment of the present invention. [Figure 27] This is a diagram illustrating an amplification module according to a fourth embodiment of the present invention. [Figure 28]This is a diagram illustrating an amplification module according to a fourth embodiment of the present invention. [Figure 29] This is a diagram illustrating an amplification module according to a fourth embodiment of the present invention. [Figure 30] This is a plan view of the bead chamber. [Figure 31] This is a perspective view to explain the bead chamber configuration in more detail. [Figure 32] This is a perspective view to explain the bead chamber configuration in more detail. [Figure 33] Figure 31 is a cross-sectional view of the bead chamber. [Figure 34] Figure 31 is a longitudinal cross-sectional view of the bead chamber, illustrating the structure connected to the outer chamber. [Modes for carrying out the invention]

[0059] In some cases, known structures and devices may be omitted or shown in the form of block diagrams focusing on the core function of each structure and device, in order to avoid obscuring the concept of the present invention.

[0060] Throughout the specification, when a part "comprising" or "including" a component, this means, unless otherwise stated, that it does not exclude other components, but rather that it may further include other components. Furthermore, terms such as "...part," "...machine," and "module" as used in the specification mean a unit that processes at least one function or operation, which can be embodied in hardware, software, or a combination of hardware and software. Also, "1 (a or an)," "one," "the," and similar related terms may be used in the context describing the invention (particularly in the context of the following claims) to include both singular and plural meanings, unless otherwise specifically indicated herein or clearly contradicted by the context.

[0061] In describing embodiments of the present invention, if a specific description of a known function or configuration is deemed to unnecessarily obscure the gist of the invention, such detailed description will be omitted. Furthermore, the terms used hereafter are defined in consideration of the functions in embodiments of the present invention, and these may change depending on the intent or conventions of the user or operator. Therefore, their definitions should be based on the content throughout this specification.

[0062] The present invention will be described in detail below with reference to the attached drawings.

[0063] Referring to Figures 1-3, the genome extraction apparatus 1000 according to an embodiment of the present invention includes an outer chamber 100, an inner chamber 200, a cover 300, a base plate 400, a safety clip 500, an amplification module 600, a piston 700, a drive unit 800, and a bead chamber 900.

[0064] The outer chamber 100 is divided into a plurality of first spaces 101, 102, 103, 104, 105, 106, and 107 by the outer chamber partition wall. That is, the plurality of first spaces 101, 102, 103, 104, 105, 106, and 107 may be spaces that are independent of each other.

[0065] Multiple first spaces 101, 102, 103, 104, 105, 106, and 107 may be provided in a form where the upper part is open and the lower part is closed. On the other hand, first discharge holes 121, 122, 123, 124, and 125 are formed through the bottom surfaces of the multiple first spaces 101, 102, 103, 104, and 105, and are formed along the circumferential direction while being separated by a first distance from the center of the outer chamber 100. Second discharge holes 126 and 127 are formed through the bottom surfaces of the remaining first spaces 106 and 107, and are formed along the circumferential direction while being separated by a second distance from the center of the outer chamber 100. In addition, discharge holes 128 and 129 that communicate with the amplification module 600 are formed through the bottom surface of the space between the first spaces 106 and 107. Here, the first distance may be shorter than the second distance, but in other embodiments, the first distance may be longer than the second distance.

[0066] Multiple first spaces 101, 102, 103, 104, and 105 are filled with reagents stored in the inner chamber 200, which will be described later, while the remaining multiple first spaces 106 and 107 are filled with beads stored in the bead chamber 900.

[0067] In the center of each of the multiple first spaces 101, 102, 103, 104, 105, 106, and 107, a piston insertion section 108 is formed vertically through which a piston 700 is inserted. When the piston 700 is inserted into the piston insertion section 108, and the drive unit of the diagnostic device (not shown) is coupled to the piston 700 to raise and lower the piston 700, the reagent (fluid) in the first spaces 101, 102, 103, 104, 105, 106, and 107 can enter and exit the fluid storage section 701 inside the piston 700. More specific details will be described later.

[0068] Referring to Figure 4, the upper outer surface 100a of the outer chamber 100 is recessed toward the center while being connected to the upper part of the lower outer surface 100b. The safety clip 500 is coupled to the upper outer surface 100a of the outer chamber 100, and the boundary between the upper outer surface 100a and the lower outer surface 100b acts as a short jaw of the safety clip 500 so that the coupling position of the safety clip 500 can be maintained after it has been coupled to the upper outer surface 100a. The safety clip 500 has a length that encloses at least a portion of the upper outer surface 100a of the outer chamber 100 and includes an extending outer chamber coupling portion 510 and a handle 520 formed on one side of the outer chamber coupling portion 510.

[0069] The safety clip 500 engages with the outer chamber 100, which pressurizes the inner chamber 200 engaged with the outer chamber 100, preventing the upper and lower openings of the inner chamber 200 from opening. The user can grasp the handle 520 and remove the safety clip 500 from the outer chamber 100 before starting the extraction process. In other words, when the safety clip 500 is engaged with the outer chamber 100, the reagent in the inner chamber 200 cannot be introduced into the outer chamber 100, and only after the safety clip 500 is removed from the outer chamber 100 can the reagent in the inner chamber 200 be introduced into the outer chamber 100.

[0070] Refer to Figures 3-5 for a more detailed explanation of the 500 safety clip configuration.

[0071] The safety clip 500 includes an outer chamber coupling 510, a handle 520, an upper extension 530, and a side extension 540.

[0072] The outer chamber coupling portion 510 engages with the outer chamber 100, enclosing at least a portion of its outer surface (specifically, the upper outer surface 100a). More specifically, the outer chamber coupling portion 510 engages with the outer chamber 100 so as to enclose four of its outer surfaces, although the extended ends of the outer chamber coupling portion 510 are configured to be separated from each other. As shown in Figure 1, when the safety clip 500 engages with the outer chamber 100, the extended ends of the outer chamber coupling portion 510 grip any one of the outer surfaces of the outer chamber 100, and the safety clip 500 can only be separated from the outer chamber 100 when a user grasps the safety clip 500 and applies an external force in one direction.

[0073] The handle 520 is the portion that extends outward from the outer chamber coupling portion 510 and is the portion that is grasped by the user in order to separate the safety clip 500 from the outer chamber 100.

[0074] The upper extension 530 extends upward on one side of the outer chamber coupling 510, and the side extension 540 extends from the upper extension 530 toward the center of the outer chamber 100.

[0075] The safety clip 500 according to an embodiment of the present invention is characterized in that a cover support member 541 is formed to protrude from the upper surface of the side extension 540, and an inner chamber connecting portion 542 is formed to protrude from the extended end of the side extension 540.

[0076] When the safety clip 500 is engaged with the outer chamber 100, the cover support member 541 plays a role in preventing the protruding members 311, 312, 313, 314, 315, 316, and 317 formed on the bottom surface of the cover 300 from tearing (perforating) the first sealing member S1 that seals the upper openings of the multiple second spaces 201, 202, 203, 204, and 205 of the inner chamber 200 and the third sealing member S3 that seals the upper opening of the bead chamber 900.

[0077] As shown in Figure 15, when the safety clip 500 is engaged with the outer chamber 100 and the inner chamber 200, the protruding members 311, 312, 313, 314, 315, 316, and 317 are prevented from contacting the first sealing member S1 and the third sealing member S3. Therefore, when the safety clip 500 is engaged with the outer chamber 100 and the inner chamber 200, puncture of the inner chamber 200 and the bead chamber 900 is prevented, thereby preventing the reagent contained in the inner chamber 200 and the bead contained in the bead chamber 900 from flowing out into the outer chamber 100.

[0078] The inner chamber coupling portion 542 is the portion that connects to the fixing portion 230 of the inner chamber 200 when the safety clip 500 is engaged with the outer chamber 100. When the inner chamber coupling portion 542 is connected to the fixing portion 230, the bottom surface of the inner chamber 200 is positioned at a predetermined distance from the bottom surface of the outer chamber 100, and thus the lower openings of the multiple second spaces 201, 202, 203, 204, 205 are sealed. sealing The member S2 is prevented from tearing by the protruding members 111, 112, 113, 114, and 115 formed on the bottom surface of the outer chamber 100 (see Figure 15).

[0079] In the attached drawings, the inner chamber coupling portion 542 is shown in the form of an engaging projection and the fixing portion 230 is shown in the form of a coupling groove that connects to the engaging projection. However, in other embodiments, the inner chamber coupling portion 542 may be provided in the form of a coupling groove and the fixing portion 230 may be provided in the form of an engaging projection that connects to the coupling groove.

[0080] The outer chamber 100 (more specifically, the outer chamber partition wall) has a recessed attachment portion 109 that provides a space for the fixing portion 230 of the inner chamber 200 to be securely attached. The inner chamber 200 is fixed at a predetermined distance from the bottom surface of the outer chamber 100 through a coupling structure with a safety clip 500, but the fixing force is further improved by the secure attachment and support of the fixing portion 230 of the inner chamber 200 to the attachment portion 109.

[0081] Referring to Figure 7, an insertion space 130 is formed as a recess on the upper side of the inner wall of the outer chamber 100, and the coupling hook 240 of the inner chamber 200 may be coupled to the insertion space 130. A stopper 131 is formed above the insertion space 130, protruding toward the inside of the outer chamber 100. Therefore, when the inner chamber 200 is not pressurized by the cover 300, the coupling hook 240 of the inner chamber 200 is located on the stopper 131, but when the inner chamber 200 is pressurized by the cover 300, the coupling hook 240 is inserted into the insertion space 130 via the stopper 131.

[0082] Referring to Figure 15, the coupling relationship between the outer chamber and the inner chamber according to another embodiment of the present invention will be described. In Figure 7, instead of the coupling hook 240 formed on the inner chamber 200, a locking projection 250 is provided that protrudes outward from the outer wall of the inner chamber 200, and the locking projection 250 engages with a stopper 131 formed on the inner wall of the outer chamber 100, partially restricting the downward movement of the inner chamber 200. When the safety clip 500 is removed from the outer chamber 100 and the inner chamber 200 is pressurized by the cover 300, the locking projection 250 is inserted into the insertion space 130 via the stopper 131, thereby perforating a second sealing member S2 that seals multiple second spaces in the inner chamber 200 by a protruding member formed on the outer chamber 100.

[0083] The inner chamber 200 is divided into multiple second spaces 201, 202, 203, 204, and 205 by the partition walls of the inner chamber. That is, the multiple second spaces 201, 202, 203, 204, and 205 may be independent spaces from one another.

[0084] The upper and lower ends of the multiple second spaces 201, 202, 203, 204, and 205 are open (i.e., the multiple second spaces have an upper opening and a lower opening), the upper end is sealed by the first sealing member S1 and the lower end is sealed by the second sealing member S2. The first sealing member S1 and the second sealing member S2 may be, for example, a film, but are not limited to this, and a film made of any material that does not allow fluid to pass through may be used.

[0085] Different reagents are placed in each of the multiple second spaces 201, 202, 203, 204, and 205. First, the second sealing member S2 seals the lower parts of the multiple second spaces before the reagents are placed in, and then the first sealing member S1 seals the upper parts of the multiple second spaces, thereby completing the placement of reagents into the inner chamber 200.

[0086] Referring to Figure 4, the inner chamber 200 includes an upper inner chamber 210 and a lower inner chamber 220.

[0087] The upper inner chamber 210 is formed as a single unit and is configured to be in close contact with the inner wall of the outer chamber 100 when connected to it.

[0088] The lower inner chamber 220 is connected to the upper inner chamber 210 and includes a portion that is bent (towards the inside in the radius direction) so as to separate from the inner wall of the outer chamber 100 when connected to the outer chamber 100.

[0089] In this invention, a double-chamber structure consisting of an inner chamber and an outer chamber is used, so there may be a risk of cross-contamination between reagents in the inner chamber 200 during operation. Cross-contamination can occur due to capillary action through the microspace between the inner chamber and the outer chamber, but in this invention, in order to prevent the aforementioned problem of cross-contamination, a structure is adopted in which the inner chamber 200 is bent so as to be sufficiently separated from the inner wall of the outer chamber 100, thereby preventing capillary action.

[0090] Furthermore, in order to prevent capillary action, the outer chamber 100 and the inner chamber 200 are separated, and to prevent reagents from leaking out through the separated portion, the upper inner chamber 210 is configured to be in close contact with the inner wall of the outer chamber 100.

[0091] On the other hand, first protruding members 111, 112, 113, 114, and 115 are formed on the bottom surfaces of the multiple first spaces 101, 102, 103, 104, and 105, which are formed by tearing the second sealing member S2 of the inner chamber 200, thereby allowing the reagent contained in the inner chamber 200 to flow out into the multiple first spaces 101, 102, 103, 104, and 105.

[0092] Each of the first protruding members 111, 112, 113, 114, and 115 is arranged to correspond one-to-one with a plurality of first spaces 101, 102, 103, 104, and 105. For example, the first protruding member corresponding to reference numeral 111 will tear the second sealing member S2 that seals the upper part of the first space corresponding to reference numeral 101, and the first protruding member corresponding to reference numeral 115 will tear the second sealing member S2 that seals the upper part of the first space corresponding to reference numeral 105.

[0093] The first protruding members 111, 112, 113, 114, 115 include protruding portions 111a, 112a, 113a, 114a, 115a that protrude by a first height (h1) from the bottom surface of a plurality of first spaces 101, 102, 103, 104, 105, and wing portions 111b, 112b, 113b, 114b, 115b that extend from the protruding portions 111a, 112a, 113a, 114a, 115a and protrude by a second height (h2) lower than the first height (h1) from the bottom surface. Here, the wing portions 111b, 112b, 113b, 114b, 115b may have a structure that extends in both left and right directions from the protruding portions 111a, 112a, 113a, 114a, 115a.

[0094] The protruding portion performs the role of perforating the second sealing member S2, and the wing portion performs the role of expanding the perforated portion of the second sealing member S2. In this invention, since the height of the protruding portion is higher than that of the wing portion, point contact (point-cont) between the second sealing member S2 that seals the lower part of the inner chamber 200 and the protruding portion. ac t) is performed, which has the effect of minimizing the pressure when the second sealing member S2 is torn through point contact. Therefore, the second sealing member S2 can be torn with less force.

[0095] When the second sealing member S2 is ruptured by the protruding members 111, 112, 113, 114, and 115, the reagents stored in the multiple second spaces 201, 202, 203, 204, and 205 of the inner chamber 200 flow out into the multiple first spaces 101, 102, 103, 104, and 105 of the outer chamber 100. The flowed-out reagents are then discharged through the first discharge holes 121, 122, 123, 124, and 125 formed on the bottom surface of the first spaces 101, 102, 103, 104, and 105. To facilitate the outflow of reagents to the first discharge holes 121, 122, 123, 124, and 125, there are portions around the first discharge holes 121, 122, 123, 124, and 125 that are inclined downward toward the first discharge holes 121, 122, 123, 124, and 125. These inclined portions can have an angle of 3 to 10 degrees, which facilitates the process by which reagents that have flowed into the first spaces 101, 102, 103, 104, and 105 escape to the first discharge holes 121, 122, 123, 124, and 125.

[0096] The cover 300 is coupled to the top of the outer chamber 100 and is configured to cover the tops of both the outer chamber 100 and the inner chamber 200.

[0097] Referring to Figure 10, the cover 300 includes a cover body 301 and a lid 302.

[0098] The cover body 301 has a first insertion hole 307 aligned with the piston insertion portion 108 and a first sample insertion hole 309 through which a sample is inserted. The bottom surface of the cover body 301 has protruding second protruding members 311, 312, 313, 314, and 315 for tearing the first sealing member S1 and third protruding members 316 and 317 for tearing the third sealing member S3.

[0099] The second protruding members 311, 312, 313, 314, and 315 are arranged in a one-to-one correspondence with a plurality of first spaces 101, 102, 103, 104, 105, 106, and 107, and the third protruding members 316 and 317 are arranged in a one-to-one correspondence with a plurality of third spaces 910 and 920. For example, the second protruding member corresponding to reference numeral 311 will tear the first sealing member S1 that seals the upper part of the first space corresponding to reference numeral 101, and the second protruding member corresponding to reference numeral 315 will tear the first sealing member S1 that seals the upper part of the first space corresponding to reference numeral 105.

[0100] A separation member 320 is formed on the bottom surface of the cover body 301 along the periphery of the first insertion hole 307. The separation member 320 is the portion that separates the first protruding member and the first sealing member from each other when the safety clip 500 is engaged with the outer chamber 100. That is, the cover 300 is separated from the inner chamber 100 by a predetermined distance as the separation member 320 is supported by the cover support member 541.

[0101] The lid 302 is hinged to one side of the cover body 301 so as to be rotatable. A second insertion hole 308 is formed through the center of the lid 302, aligned with the first insertion hole 307.

[0102] With the cover 300 engaged with the outer chamber 100, after separating the safety clip 500 from the outer chamber 100, pressurizing the cover 300 downwards causes the inner chamber 200, which is engaged with the outer chamber 100, to descend along the inner wall of the outer chamber 100. First protruding members 111, 112, 113, 114, 115, 116, and 117 are formed on the bottom surface of the outer chamber 100, and second protruding members 311, 312, 313, 314, and 315 and third protruding members 316 and 317 are formed on the bottom surface of the cover 300. The protruding members cause the first sealing member S1 and second sealing member S2, which seal the upper and lower openings of the inner chamber 200, and the third sealing member S3, which seals the upper opening of the bead chamber 900, to tear. Therefore, the reagent contained in the inner chamber 200 flows out into the multiple first spaces 101, 102, 103, 104, and 105 of the outer chamber 100, and the second sealing member S2 that seals the upper opening of the inner chamber 200 ruptures, acting as an air vent to allow the reagent to be sufficiently discharged into the first spaces.

[0103] The base plate 400 is coupled to the lower part of the outer chamber 100 and includes multiple flow channels that guide the reagent's path between the first spaces 101, 102, 103, 104, 105, 106, 107 of the outer chamber 100 and the fluid reservoir of the piston 700.

[0104] According to one embodiment of the present invention, the base plate 400 may have a liquid channel through which liquid can move and an air channel through which air can move. Between the outer chamber 100 and the base plate 400, a flow cover 410 and a pad 420 may be further included, which are placed on the upper surface of the base plate 400 to prevent liquid leakage when the base plate 400 is connected to the outer chamber 100. When the base plate 400, flow cover 410, and pad 420 are connected, the upper surfaces of the liquid channel and air channel of the base plate 400 are blocked by the flow cover 410 and pad 420, forming a space and completing a complete flow channel.

[0105] The liquid flow path is connected to the flow cover 410, pad 420, and outer chamber 100, providing a space in which samples and reagents can move and mix.

[0106] The air passage connects the vacuum control section of the amplification module 600 and the piston 700, controlling the vacuum that may be generated when the genome extracted from the amplification module 600 moves, and preventing contamination of the amplification product that may be generated during genome amplification.

[0107] Multiple flow channels 401, 402, 403, 404, 405, 406, 407, 408, and 409 are formed on the upper part of the base plate 400. Each flow channel is formed so as not to intersect with others and to extend from the center of the base plate 400 to the outer edge. Here, the liquid flow channels correspond to the configurations shown in the drawings, 401 to 408, and the air flow channel corresponds to the configuration shown in the drawings, 409.

[0108] Referring to Figure 14, some of the channels in the multiple channels may have one end positioned on the same circumference, and the other ends of each channel may also be positioned on the same circumference.

[0109] A piston drive unit insertion hole 400a is formed through the center of the base plate 400 so that a piston drive unit 800, which rotates the piston 700, is connected to it.

[0110] A flow cover 410 is placed in the anchoring space on top of the base plate 400. The flow cover 410 can be manufactured from, for example, plastic and ultrasonically fused to the top of the base plate 400, thereby being integrally fitted with the base plate 400.

[0111] The flow cover 410 has a first through hole 410a aligned with the piston drive insertion hole 400a, a plurality of first flow cover holes 411a, 412a, 413a, 414a, 415a, 416a, 417a, and 418a formed through the first flow cover hole 411a, a plurality of second flow cover holes 411b, 412b, 413b, 414b, and 415b formed through the second flow cover hole 411b, 412b, 413b, 414b, and 415b formed through the second flow cover hole 411b, a plurality of third flow cover holes 416b, 417b, and 418b formed through the third flow cover hole 416b, 417b, and 418b formed through the third flow cover hole 416b, 417b, and 418b formed through the third flow cover hole 419a, which communicate with one end and the other end of the air passage 409. Here, the first flow cover hole is aligned with one inner end of the flow path formed in the body plate 400, the second and third flow cover holes are aligned with the other outer end of the flow path, and the fourth flow cover hole communicates with one end and the other end of the air flow path. The second distance may be longer than the first distance or shorter than the third distance.

[0112] Referring to Figure 11, a first engaging projection 410b may be further formed on the outer circumference of the first through-hole 410a, projecting upward and downward.

[0113] Furthermore, the bottom surface of the flow cover 410 may have molten projections 410c formed along the edges of the multiple flow channels of the base plate 400 (see Figure 12). When ultrasonic welding is performed after the flow cover 410 is installed on the upper surface of the base plate 400, the molten projections 410c melt and become integrated with the base plate 400. Through this, a tight bond between the base plate 400 and the flow cover 410 is possible.

[0114] A pad 420 is placed on top of the flow cover 410. The pad 420 may be made of, for example, silicone, but is not limited to any material having a certain elastic force.

[0115] Multiple second engaging protrusions 410d are formed protruding from the upper surface of the flow cover 410, and a strong connection is made between the flow cover 410 and the pad 420 by coupling the second engaging protrusions 410d into the coupling grooves 420c of the pad 420. In addition, a strong connection can be made between the two components by inserting and coupling the first engaging protrusion 410b of the flow cover 410 into the second through hole 420a of the pad 420.

[0116] The pad 420 has a second through-hole 420a aligned with the first through-hole 410a, and a plurality of first pad holes 421a, 422a, 423a, 424a, 425a, 426a, 427a, and 428a are formed through the pad on a first circumference at a first distance from the second through-hole 420a, a plurality of second pad holes 421b, 422b, 423b, 424b, and 425b are formed through the pad on a second circumference at a second distance from the second through-hole 420a, a plurality of third pad holes 426b, 427b, and 428b are formed through the pad on a third circumference at a third distance from the second through-hole 420a, and fourth pad holes 429a and 429b are formed through the pad, communicating with one end and the other end of the air passage 409. Here, the first pad hole aligns with the first flow cover hole, the second pad hole aligns with the second flow cover hole, the third pad hole aligns with the third flow cover hole, and the fourth pad hole aligns with the fourth flow cover hole.

[0117] On the upper surface of the pad 420, a protrusion is further formed that extends from the portion where multiple second pad holes 421b, 422b, 423b, 424b, 425b, multiple third pad holes 426b, 427b, 428b, and a fourth pad hole 429b communicating with the other end of the air passage are formed, and which narrows towards the top. By forming this protrusion, the problem of the diameter of the pad holes decreasing unintended even when the pad 420 is in close contact with the outer chamber 100 and the base plate 400 can be solved.

[0118] The amplification module 600 is engaged with the outer chamber 100 and configured to contain a pre-treated sample. Pre-treated sample means that the genome, such as DNA or RNA, contained in the sample has been eluted (lysis) into the reagent. When the genome extraction device 1000 according to the present invention is coupled to a diagnostic instrument (not shown), an amplification process (such as PCR) is performed on the genome contained in the amplification module 600.

[0119] Referring to Figures 1 and 2, the amplification module 600 is engaged with the outer chamber 100 in the vertical direction. In other words, the upper part 631 of the housing 630 of the amplification module 600 is engaged with the outer chamber 100 such that it is further away from the ground than the lower part 632.

[0120] Referring to Figures 17-29, the amplification module 600 includes a body 610, an inlet 621, an outlet 622, a housing 630, a gas transport passage 640, and an extractant transport passage 650.

[0121] The body 610 is the outer shape of the amplification module 600, and an inlet 621 and an outlet 622 are formed at the first end 613 of the body 610, which are connected to the discharge holes 128 and 129 of the outer chamber 100.

[0122] The inlet 621 is connected to the discharge port 129 and serves as an inlet for the extract liquid discharged from the discharge port 128 to be introduced into the containment section 630, while the outlet 622 is connected to the discharge port 128 and serves as an outlet for the internal air to be discharged into the air passage of the extraction device 1000 as the extract liquid is introduced into the amplification module 600.

[0123] That is, with the amplification module 600 connected to the extraction device 1000, the inlet 621 communicates with the liquid flow path 408, and the outlet 622 communicates with the air flow path 409.

[0124] A storage section 630 is formed at a location far from the extraction device 1000, relative to the body 610, the second end 614, the inlet 621 and the outlet 622, and which is a space for containing the extract that flows in through the inlet 621.

[0125] In one example, the housing section 630 is manufactured in such a way that it penetrates both one side of the body 610 and the opposite side of that side, but in other examples, it may be manufactured in such a way that it penetrates only one side and not the opposite side. Both embodiments are the same in that the open portion is sealed by sealing members S4 and S5. Therefore, the extract and air are introduced into or discharged from the housing section 630 only through the gas transport passage 640 and the extract transport passage 650.

[0126] One or more housing units 630 according to the embodiment of the present invention can be provided within a single amplification module 600. Figures 17 to 23 show an amplification module equipped with three housing units, and Figures 24 to 29 show an amplification module equipped with four housing units.

[0127] The storage section 630 may have a substantially trapezoidal shape, and more specifically, it is preferable that it has a trapezoidal shape with rounded edges.

[0128] Here, "trapezoidal" refers to a shape in which the width narrows as it moves away from the gas transport passage 640 and the extract transport passage 650. The presence of this shape in the containment section 630 solves the problem of bubbles forming when the extract is injected through the extract transport passage 650. If bubbles remain in the amplification module 600, particularly in the containment section 630, it can lead to low analytical accuracy in the fluorescence detection process after the amplification process. This problem can be solved through the shape of the containment section 630. In this invention, the amplification process may include isothermal amplification (Lamp) and real-time nucleic acid amplification reactions (Real-time Polymerase Chain Reaction), but is not particularly limited to any process that amplifies a genome.

[0129] The containment section 630 stores primers and probes necessary for genome amplification. Although the amplification module 600 according to the embodiment of the present invention is equipped with one or more containment sections 630, each containment section 630 may be equipped with primers and probes targeting different substances. Therefore, it is possible to simultaneously detect several types of viruses / diseases in a genome extracted from a single sample. For example, one containment section 630 may be equipped with primers and probes for coronavirus amplification, and another containment section 630 may be equipped with primers and probes for influenza virus amplification, making it possible to simultaneously detect different viruses / diseases in a single amplification process within one amplification module 600.

[0130] The gas transport passage 640 is formed on one surface 611 of the body 610 and is configured to connect the outlet 622 with the upper part 631 of the housing 630. Conversely, the extractant transport passage 650 is formed on the opposite surface 612, opposite to the aforementioned surface 611, and is configured to connect the inlet 621 with the lower part 632 of the housing 630.

[0131] First, the extract transport passage 650 will be described with reference to Figures 20, 23, 26, and 29. As mentioned above, the extract transport passage 650 serves as a passage through which the extract pretreated by the genome extraction device 1000 moves.

[0132] In the embodiments of the present invention, the number of extractant transport passages 650 is the same as the number of storage sections 630. In other words, in the case of an amplification module 600 equipped with three storage sections 630 as shown in Figure 20, there are three extractant transport passages 650, and in the case of an amplification module 600 equipped with four storage sections 630 as shown in Figure 29, there are four extractant transport passages 650.

[0133] Each extract transport passage 650 is configured to have the same volume. For example, each extract transport passage 650 may have the same length, width, and depth, or even if one or more of the depth, width, and height differ, the volume of each passage is configured to be the same. Therefore, the extract that unfolds along the extract transport passage 650 reaches the storage section 630 simultaneously, filling all the storage sections 630 with extract.

[0134] On the other hand, in order to minimize the phenomenon of bubbles being generated during the process of the extract being spread through the extract transport passage 650, the extract transport passage 650 is equipped with curved connecting sections without any angular parts to minimize bubble generation.

[0135] A first branch space 660 is formed between the extract transport passage 650 and the inlet 621. The first branch space 660 allows the inlet 621 and the extract transport passage 650 to communicate with each other.

[0136] Referring to Figure 20, the first branch space 660 includes the first penetration portion 661 and the first recessed portion 662.

[0137] The first penetration portion 661 is configured to penetrate the body 610 while being connected to the inlet 621, and the first recessed portion 662 is formed between the first penetration portion 661 and the extractant transport passage 650, and does not penetrate the body 610, but is formed as a recess on one surface 611. As will be described later, a second recessed portion 672 is also formed on the opposite surface 612 of the body 610, but the first recessed portion 662 and the second recessed portion 672 are formed in positions where a portion of them overlaps in the width direction. However, the space between the first recessed portion 662 and the sealing member, and the space between the second recessed portion 672 and the sealing member, overlap a portion of each other so that they are independent spaces that do not communicate with each other. If the first recessed portion 662 and the second recessed portion 672 are configured to penetrate the body 610, the extractant that flows into the extractant transport passage 650 through the inlet 621 may also flow into the gas transport passage 640, and conversely, the air discharged from the containment portion 630 toward the outlet 622 may also flow into the extractant transport passage 650, which can cause problems. Therefore, in the present invention, the first recessed portion 662 and the second recessed portion 672 are configured as recesses rather than through-partitions. On the other hand, the first and second through-partitions, which do not overlap each other in the width direction, do not cause interference problems even if they are formed as through-partitions.

[0138] Each extract transport passage 650 extends from the first recessed section 662 to the storage section 630, bending at least once along the way.

[0139] The width and depth of the first penetration 661 and the first recessed portion 662 are greater than the width and depth of the extract transport passage 650. Therefore, assuming that the extract transport passage 650, the first penetration 661, and the first recessed portion 662 have the same length, the volume of the first penetration 661 and the first recessed portion 662 is greater than that of the extract transport passage 650.

[0140] In other words, the rate at which the extract injected through the inlet 621 is deployed is even slower in the first branch space 660 compared to the extract transport passage 650, resulting in a kind of stagnation. After the first branch space 660 is completely filled with extract, the extract is deployed into the extract transport passage 650, which has the advantage of allowing the extract to be deployed into each extract transport passage 650 simultaneously, compared to the case where the first branch space 660 is not present (in the case of an amplification module without a first branch space, the extract is injected first into the extract transport passage located at the bottom due to gravity).

[0141] On the other hand, it is preferable that the first branch space 660 is formed at the first end 613 in the width direction of the amplification module 600, and the housing portion 630 is formed at the second end 614 opposite to the first end 613. In other words, it is preferable that the housing portion 630 and the first branch space 660 are far apart from each other in the width direction.

[0142] The extract is introduced into and contained in the containment section 630, and the heating / cooling device is placed in close proximity to or in contact with it to carry out the amplification reaction. In order to prevent the amplification product in each containment section 630 from being pushed out into the moving passages 640 and 650 or flowing back into other containment sections 630 due to the heating temperature during the amplification process, the first branch space 660 and the second branch space 670, which will be described later, are located at the first end 613 adjacent to the inlet 621 and outlet 622.

[0143] The gas transfer passage 640 serves as a passage through which gas (e.g., air) moves within the containment section 630. The flow path of the amplification module 600 is connected to the flow path of the genome extraction device 1000 and generally has the characteristics of a closed flow path. Since the containment section 630 is filled with air before the extraction solution is injected, when the extraction solution is injected, an appropriate volume of air must be discharged to the outside. In this invention, the air inside the amplification module 600 is discharged through the gas transfer passage 640 to the air flow path 409 via the outlet 622, thereby preventing an excessive increase in pressure inside the containment section 630 caused by the injection of the extraction solution and solving the problem of bubbles generated by residual air inside. It is preferable that the gas transfer passage 640, like the containment section 630, has no angular parts and the connection part of the passage is curved to minimize the generation of bubbles.

[0144] Gases are lighter than liquids such as extractants, and in this invention, multiple gas transport passages 640 are connected to the upper end 631 of the containment section 630. At the connection point of the gas transport passages 640 to the containment section 630, there is a bubble containment section 633 that is wider and deeper than a part of the other gas transport passages 640. When the extractant is injected, bubbles are generated inside, but the bubbles are contained in the wide and deep bubble containment section 633, and therefore the bubbles do not affect the containment section 630.

[0145] Figure 25 shows a first embodiment of an amplification module equipped with four housing units 630, and Figure 28 shows a second embodiment of an amplification module equipped with four housing units 630.

[0146] Both embodiments are characterized by minimizing the width and depth of the gas transport passage 640, thereby minimizing liquid inflow into the gas transport passage 640 and allowing only air to pass through.

[0147] The gas transfer passage 640 of the amplification module 600 according to the first embodiment is composed of a combination of a first gas transfer passage 641 having a first width and a first depth, a second gas transfer passage 642 having a second width greater than the first width and a first depth, and a third gas transfer passage 643 having a third width greater than the second width and a second depth deeper than the first depth. Specifically, the amplification module 600 according to the first embodiment is configured such that the volume of each gas transfer passage 640 is all the same.

[0148] On the other hand, the first gas transfer passage 641, which is the narrowest and shallowest of the gas transfer passages 640 of the amplification module 600 according to the first embodiment, may have a width of 0.135 mm to 0.165 mm, more specifically 0.14 mm to 0.16 mm, even more specifically 0.145 mm to 0.155 mm, preferably 0.15 mm, and a depth of 0.045 mm to 0.055 mm, more specifically 0.0475 mm to 0.0525 mm, preferably 0.05 mm.

[0149] Furthermore, the gas transport passage 640 of the amplification module 600 according to the second embodiment may have a constant width and depth along its length, but its width may be 0.45 mm to 0.55 mm, more specifically 0.475 mm to 0.525 mm, even more specifically 0.49 mm to 0.51 mm, preferably 0.5 mm, and its depth may be 0.045 mm to 0.055 mm, more specifically 0.0475 mm to 0.0575 mm, even more specifically 0.049 mm to 0.051 mm, preferably 0.05 mm. In addition, the gas transport passage 640 of the amplification module 600 according to the second embodiment is provided with a number of columns (r) formed by a laser pattern processing method in a protruding form. Therefore, the width and depth of the gas transport passage 640 are further minimized, liquid inflow is minimized, and only air can pass through. Similar to the first embodiment, the amplification module 600 according to the second embodiment is also configured such that the volume of each gas transfer passage 640 is the same.

[0150] In embodiments of the present invention, the number of gas transfer passages 640 is the same as the number of storage sections 630. In other words, in the case of an amplification module 600 equipped with three storage sections 630 as shown in Figures 19 and 22, there are three gas transfer passages 640, and in the case of an amplification module 600 equipped with four storage sections 630 as shown in Figures 25 and 28, there are four gas transfer passages 640.

[0151] The piston 700 is inserted into the piston insertion section 108 of the outer chamber 100 and is configured to draw in reagents contained in the outer chamber 100 or discharge reagents drawn into the outer chamber 100 or the amplification module 600 by moving up and down.

[0152] Referring to Figures 3 and 12, the piston 700 includes an upper piston 710 and a lower piston 720.

[0153] The upper piston 710 is open at the top, and a fluid reservoir 701 is formed inside to contain the inhaled fluid. A sealing portion 711 is installed inside the upper piston 710. The outer surface of the sealing portion 711 is in close contact with the inner surface of the upper piston 710, making it impossible for fluid to enter or exit through the space between the outer surface of the sealing portion 711 and the inner surface of the upper piston 710. A recessed drive unit mounting portion 711a is formed in the center of the sealing portion 711, to which the drive unit (not shown) of the diagnostic device is connected. The drive unit (not shown) of the diagnostic device is connected to the drive unit mounting portion 711a, and by raising and lowering the sealing portion 711 inside the upper piston 710, fluid is drawn into the fluid reservoir 701, and the fluid contained in the fluid reservoir 701 is discharged to the outside.

[0154] A coupling structure that engages with the lower piston 720 is formed on the bottom surface of the upper piston 710, and a first hole 712 that connects to the liquid port of the lower piston 720 and a second hole 713 that connects to the filter port of the lower piston 720 are formed through it. The second hole 713 may be formed to have a smaller diameter than the filter mounting space of the filter port in order to prevent the support structure and the filter from becoming detached.

[0155] The lower piston 720 is fixed by engaging with a coupling structure formed on the bottom surface of the upper piston 710.

[0156] The lower piston 720 may include a disc-shaped body 721, a shaft 722 formed to protrude outward from the center of the body 721, and liquid ports 723 and filter ports 724 arranged at the same distance from the center of the body 721.

[0157] The liquid port 723 is used to draw in, mix, and discharge samples and reagents into the piston 700, while the filter port 724 is used to wash the genome collection filter or to separate genomes from the genome collection filter.

[0158] Furthermore, a groove recessed toward the center may be formed on the outer circumference of the body 721 of the lower piston 720. This groove serves to remove any vacuum that may be generated during liquid movement inside the extraction device.

[0159] The liquid port 723 and the filter port 724 are positioned on the same circumference, separated from each other at a certain angle. For example, the filter port 724 and the liquid port 723 may be positioned 18 to 36 degrees apart from each other, or more specifically, they may be positioned with a distance of 22.5 degrees between them. When using a stepper motor that rotates in 16 steps, the positions of the liquid port 723 and the filter port 724 can be changed with a single drive.

[0160] The filter port 724 of the lower piston 720 may include a filter mounting space 725, in which a filter and a support structure can be placed. The filter for genome collection may be a fiberglass filter or mold fixture of various particle sizes, and the support structure serves to fix the filter for genome collection.

[0161] The support structure can be made of a porous plastic material with a certain particle size to prevent the filter from detaching during fluid discharge and to maintain a constant pressure.

[0162] The drive unit 800 is connected to the drive unit (not shown) of the diagnostic equipment and acts as a mediator, rotating the piston (700) at a constant angle.

[0163] The drive unit 800 may include an engagement groove formed in the center of one surface to engage with the shaft 722, and a drive groove formed on the other surface to engage with the drive unit (not shown) of a diagnostic device.

[0164] The drive unit 800, in conjunction with the piston 700, positions the liquid port 723 and the filter port 724 at the appropriate location of the first discharge port of the outer chamber 100 so that various chemical reactions required in the genome extraction stage can be carried out within a single device.

[0165] The liquid port 723 and the filter port 724 are separated by a certain angle, and the drive unit 800 rotates the ports to positions suitable for each stage during genome extraction.

[0166] The bead chamber 900 includes a first bead chamber 910, a second bead chamber 920, and a dehumidifying chamber 930, which are partitioned by a first bead chamber partition wall 901 and a second bead chamber partition wall 902. The first bead chamber 910 is inserted into the first space 106 of the outer chamber 100, and the second bead chamber 920 is inserted into the first space 107 of the outer chamber 100.

[0167] Similar to the inner chamber 200, the upper opening of the bead chamber 900 is also sealed by a third sealing member S3, which is perforated by third protruding members 316, 317 formed on the bottom surface of the cover 300 when the cover 300 engages with the outer chamber 100. The opening of the upper opening of the bead chamber 900 by the third protruding members 316, 317 allows a corresponding amount of air to be discharged through the perforated portion even when fluid is subsequently introduced into the first bead chamber 910 and the second bead chamber 920.

[0168] The lower opening of the bead chamber 900 is provided in an open form without being sealed by a separate sealing member. Dry beads (more specifically, freeze-dried beads) are stored in the bead chamber 900, but dry beads are susceptible to moisture. In the genome extraction apparatus according to the present invention, the lower opening of the bead chamber 900, the first space of the outer chamber 100, the flow cover 410, the flow channels of the pad 420 and the base plate 400, and the flow channels of the amplification module 600 are in communication with each other but form a closed flow channel that is not exposed to the outside air, thereby minimizing the inflow of moisture into the bead chamber 900.

[0169] The first bead chamber 910 may store several dried beads (b1) necessary for genome extraction, and the second bead chamber 920 may store several dried beads (b2) necessary for genome amplification.

[0170] A first bead holder 911 is installed at the upper opening of the first bead chamber 910, configured to keep the dried bead (b1) inside without being discharged to the outside, and a first dehumidification unit 912 is installed in the dehumidification chamber 930 for dehumidifying the internal space of the first bead chamber 910. Here, the dried bead necessary for genome amplification is provided in the form of a capsule, for example, but is not limited to this.

[0171] A second bead holder 921 is installed at the upper opening of the second bead chamber 920, configured to keep the dry bead (b2) inside without being discharged to the outside. A second dehumidifying unit 922 is installed above the second bead holder 921 to dehumidify the inside of the second bead chamber 920. The third sealing member S3 seals the second bead chamber 920 so that it does not communicate with the dehumidifying chamber 930 and the first bead chamber 910, but seals the first bead chamber 910 and the dehumidifying chamber 930 so that they communicate with each other. This will be explained in detail with reference to Figures 30 and 31.

[0172] The aforementioned effects are achieved through the configuration of the height difference between the first bead chamber partition 901 and the second bead chamber partition 902. Referring to Figures 30 and 31, the second bead chamber partition 902, which separates the second bead chamber 920 and the dehumidification chamber 930, has a greater height than the first bead chamber partition 901, which separates the first bead chamber 910 and the dehumidification chamber 930.

[0173] In other words, the upper part of the second bead chamber partition 902 extends to the same height as the upper part of the outer partition forming the second bead chamber 920, while the upper part of the first bead chamber partition 901 extends to a height lower than the upper part of the outer partition forming the first bead chamber 910.

[0174] Therefore, even if the upper opening of the bead chamber 900 is sealed by the third sealing member S3, the first bead chamber 910 and the dehumidification chamber 930 can communicate with each other through the space between the first bead chamber partition wall 901 and the third sealing member S3. Consequently, the first bead chamber 910 is dehumidified by the second dehumidification unit 922 installed inside the dehumidification chamber 930.

[0175] The lower opening 914 of the first bead chamber 910 (i.e., the outlet of the first bead chamber) and the lower opening 924 of the second bead chamber 920 (i.e., the outlet of the second bead chamber) are formed at the ends of the discharge passages 913 and 923, which narrow as they move from the bead chamber 900 toward the base plate 400.

[0176] Dry beads may be contained inside the discharge passages 913 and 923, and bead holders can be installed above the discharge passages 913 and 923 to prevent the beads contained in the discharge passages 913 and 923 from flowing out to the outside.

[0177] The discharge passages 913 and 923 may have a so-called tapered shape, becoming narrower towards the base plate 400. The diameters of the lower openings 914 and 924 located at the ends of the discharge passages 913 and 923 are smaller than the diameter of the dry bead, so that the bead is not discharged to the outside through the lower openings 914 and 924. Fluid flows into the interior of the discharge passages 913 and 923 through the lower openings 914 and 942, the incoming fluid melts the dry bead, and is discharged only in the form of fluid to the fluid reservoir of the external piston or amplification module through the lower openings 914 and 924.

[0178] Here, the discharge passage 913 of the first bead chamber 910, where the dried beads necessary for genome amplification are stored, may have a wider diameter than the discharge passage 923 of the second bead chamber 920, and may narrow towards the base plate 400.

[0179] The first bead chamber 910 is configured to receive the final fluid before the pre-treated extract is fed into the amplification module 600. Accurate detection results can only be obtained if the fluid fed into the first bead chamber 910 does not remain in the first bead chamber 910 to the maximum extent and is fed into the housing section 630 of the amplification module 600. Therefore, in this invention, the amount of fluid remaining in the first bead chamber 910 is minimized by having a wider diameter and narrower discharge passage 913 of the first bead chamber 910 than the discharge passage 923 of the second bead chamber 920.

[0180] Furthermore, the bead chamber 900 according to the present invention has first locking projections 903, 904 extending from the bottom surface of the outer partition wall of the first bead chamber 910 and the second bead chamber 920. As shown in Figures 32 and 34, the first locking projections 903, 904 may be formed in a structure that extends toward the base plate 400 and then protrudes outward.

[0181] The outer chamber 100, which is connected to the bead chamber 900, has a second locking projection 109a formed on one side of the outer chamber partition wall that divides a plurality of first spaces. When force is applied to the bead chamber 900 toward the base plate 400, the first locking projections 903 and 904 are connected to each other via the second locking projection 109a, thereby creating a strong connection between the two components. When the first locking projections 903 and 904 are connected to the second locking projection 109a, the relative position of the bead chamber 900 with respect to the outer chamber 100 is fixed.

[0182] The extraction method according to the embodiment of the present invention will be described in detail below.

[0183] First, (a) the inner chamber is coupled to the outer chamber through the upper openings of a plurality of first spaces in the outer chamber. Here, it is preferable that the fixing portion of the inner chamber is coupled to the outer chamber while coupled to the inner chamber coupling portion of the safety clip.

[0184] Next, (b) the cover is attached to the outer chamber, and (c) the safety clip is removed from the outer chamber.

[0185] Next, (d) the cover is pressurized and the first sealing member that seals the upper opening of the inner chamber is torn by the first protruding member formed on the bottom surface of the cover, and the second sealing member that seals the lower opening of the inner chamber is torn by the second protruding members formed on the bottom surfaces of the plurality of first spaces of the outer chamber, causing the reagent contained in the inner chamber to flow out into the plurality of first spaces, and (e) the drive unit is driven, causing the reagent that has flowed out into the plurality of first spaces to be drawn into and mixed in the fluid containment section inside the upper piston, and then the mixed reagent is discharged to the amplification module.

[0186] Step (e) may be carried out in multiple stages. Step (e) will be described in more detail below.

[0187] First, the sample to be analyzed is introduced into one of the multiple first spaces of the outer chamber through the sample input hole in the cover (e1).

[0188] Next, (e2) the piston installed in the piston housing of the outer chamber rotates, and the liquid port of the piston communicates with the first discharge hole formed in the bottom surface of one of the first spaces into which the sample to be analyzed is introduced.

[0189] Next, (e3) the sealing portion installed in the internal space of the piston rises, and the sample to be analyzed, contained in one of the first spaces, is drawn into the fluid containment portion inside the outer chamber.

[0190] Next, (e4) the piston rotates, and the liquid port of the piston communicates with the first discharge hole formed in the bottom surface of the other first space.

[0191] Next, (e5) the contact portion rises, and the first reagent contained in the other first space is drawn into the fluid containment portion inside the outer chamber, thereby mixing the sample to be analyzed with the first reagent in the fluid containment portion.

[0192] Next, (e6) the piston rotates, and the liquid port of the piston communicates with the first discharge hole formed in the bottom surface of another first space.

[0193] Next, (e7) the contact portion rises and the second reagent contained in the other first space is drawn into the fluid containment portion inside the outer chamber, thereby mixing the sample to be analyzed with the first reagent and the second reagent.

[0194] Next, (e8) the piston rotates, and the filter port of the piston communicates with the first discharge hole formed in the bottom surface of the other first space.

[0195] Next, (e9) the sealing portion descends and the mixed liquid contained in the fluid containment portion passes through the genome collection filter installed in the filter port and is discharged into the other first space.

[0196] Next, (e10) the piston rotates, and the liquid port of the piston communicates with the first discharge hole formed in the bottom of the first space, which contains the first reagent and the second reagent, which are different reagents.

[0197] Next, (e11) the contact portion rises, and other reagents are drawn into and mixed in the fluid containment portion.

[0198] Next, (e12) the piston rotates, and the filter port of the piston communicates with the first discharge hole formed at the bottom of the first space containing the other reagents.

[0199] Next, (e13) the sealing section descends, and the mixed solution contained in the fluid containment section passes through the genome collection filter and is discharged into the first space containing the other reagents.

[0200] Next, (e14) the piston rotates, and the liquid port of the piston communicates with the first discharge hole formed in the bottom of the first space containing the eluent.

[0201] Next, (e15) the contact area rises and the eluent is drawn into the fluid containment section.

[0202] Next, (e16) the piston rotates, and the filter port of the piston communicates with the second discharge port formed at the bottom of the first space containing the beads necessary for genome amplification.

[0203] Next, (e17) the contact portion descends, and the eluent contained in the fluid containment portion passes through the genome collection filter and is discharged into the first space containing the beads necessary for genome amplification. In this step, the genome collected in the genome collection filter is separated from the genome collection filter and discharged together into the first space.

[0204] Next, the (e18) piston rotates, and the liquid port of the piston communicates with the second discharge port formed at the bottom of the first space containing the genome.

[0205] Next, (e19) the contact section rises and the extract containing the genome is drawn into the fluid containment section.

[0206] Next, the (e20) piston rotates, and the piston's liquid port communicates with the amplification module.

[0207] Next, (e21) the contact section descends, and the extract containing the genome contained in the fluid containment section is discharged to the amplification module.

[0208] Next, (e22) the extract is introduced into the housing of the amplification module through the extract transport passage of the amplification module.

[0209] Next, (e23) the remaining air in the containment section is discharged to the outside of the amplification module through the gas transport passage of the amplification module.

[0210] Next, (e24) the amplification device applies heat above a predetermined temperature to the housing to amplify the genome.

[0211] Next, (e25) based on the fluorescence intensity of the amplified genome product, the presence or absence of disease infection in the sample to be analyzed is determined.

[0212] Although this specification has described the present invention with reference to the embodiments shown in the drawings so that those skilled in the art can easily understand and reproduce it, these are merely illustrative examples, and those skilled in the art will understand that a variety of modifications and equivalent other embodiments are possible from the embodiments of the present invention. Therefore, the scope of protection of the present invention must be defined by the claims. [Explanation of Symbols]

[0213] S1: First sealing member S2: Second sealing member S3: Third sealing member S4, S5: Sealing material 100: Outer chamber 100a: Upper outer surface 100b: Lower outer surface 101,102,103,104,105,106,107: 1st space 108: Piston insertion section 109: Safe Placement Department 109a: Second locking protrusion 111,112,113,114,115: First protruding member 111a, 112a, 113a, 114a, 115a: Protrusion 111b, 112b, 113b, 114b, 115b: Wing section 119:Second locking protrusion 121,122,123,124,125: 1st discharge hole 126,127,129:Second discharge hole 128: Air vent 130: Insertion space 131: Stopper 200: Inner Chamber 201,202,203,204,205:Second space 210: Upper inner chamber 220: Lower inner chamber 230: Fixed part 300: Cover 301: Cover body 302: Lid 307: First insertion hole 308: Second insertion hole 311, 312, 313, 314, 315: Second protruding member 316,317: Third protruding member 320: Separation member 400: Base plate 400a: Piston drive unit insertion hole 401, 402, 403, 404, 405, 406, 407, 408: Liquid flow path 409: Airflow channel 410: Flow Cover 410a: 1st through hole 410b: 1st engagement protrusion 410c: Melting protrusion 410d: Second engagement protrusion 411a, 412a, 413a, 414a, 415a, 416a, 417a, 418a: First flow cover hole 411b, 412b, 413b, 414b, 415b: Second flow cover hole 416b, 417b, 418b: Third flow cover hole 419a, 419b: Fourth flow cover hole 420: Pad 420a: 2nd through hole 421a, 422a, 423a, 424a, 425a, 426a, 427a, 428a: First pad hole 421b, 422b, 423b, 424b, 425b: Second pad hole 426b, 427b, 428b: Third pad hole 429a, 429b: Fourth pad hole 420c: Binding groove 500: Safety clip 510: Outer chamber joint 520: Handle 530: Upper extension 540: Side extension 541: Cover support member 542: Inner chamber joint 600: Amplifier Module 610: Body 611: One side 612: Opposite side 613: First end 614:Second end 621:Inlet 622: Outlet 630: Containment Unit 631: Top 632: Lower part 633: Bubble containment section 640: Gas transport passage 641: First gas transport passage 642: Second gas transport passage 643: Third gas transport passage 650:Extract liquid transfer passage 660: First branch space 661: First penetration section 662: First sinkhole 670: Second branch space 671: Second penetration section 672: Second sinkhole 700: Piston 701: Fluid containment section 710: Upper Snapshot 711: Close-up section 711a: Drive unit mounting section 712: Hall 1 713: Second Hall 720: Lower piston 721: Torso 722: Shaft 723: Liquid port 724: Filter port 800: Drive unit 900: Bead Chamber 910: First bead chamber 911: First bead holder 912: 1st dehumidification section 913: Discharge passage 914: Lower opening 920: Second bead chamber 921: Second bead holder 922:Second dehumidification section 923: Discharge passage 924: Lower opening 930: Dehumidifying Chamber 1000: Genome extraction device

Claims

1. body; An inlet formed in the body through which the extract flows in; Multiple containment sections connected to the aforementioned inlet, which contain the inflow of the extracted liquid; A first branch space communicating with the aforementioned inlet; Multiple extractant transport passages that branch off from the aforementioned branching space and connect the inlet and the multiple containment sections to one another; An outlet formed in the body from which gas is discharged; and An amplification module comprising: a plurality of gas transfer passages connecting the discharge port and the plurality of storage sections to each other; The first branch space is, A first penetrating portion that penetrates the body while being connected to the inlet; and An amplification module comprising: a first recess formed between the first penetration and the plurality of extractant transport passages, and recessed into one surface of the body;

2. The amplification module according to claim 1, wherein one or more of the width and depth of the first branch space is wider or deeper than the width and depth of the extractant transport passage.

3. The amplification module according to claim 1, wherein the volumes of the plurality of extractant transport passages are the same as those of the others.

4. The first branch space is formed at the first end in the width direction of the amplification module, The amplification module according to claim 1, wherein the plurality of housing portions are formed at the second end opposite to the first end in the width direction of the amplification module.

5. The system further includes a second branching space formed between the aforementioned outlet and the plurality of gas transfer passages, The aforementioned second branch space is, A second penetrating portion that penetrates the body while being connected to the aforementioned discharge port; and The amplification module according to claim 1, comprising: a second recess formed between the second penetration and the plurality of gas transport passages and recessed into the other side of the body;

6. The amplification module according to claim 5, wherein the first recessed portion and the second recessed portion have portions that partially overlap in the width direction of the body, and are formed as recesses in the body.

7. The amplification module according to claim 6, further comprising a sealing member attached to one surface of the body and the opposite surface of the body, which seals the plurality of housings, the first branch space, the second branch space, the extractant transport passage, and the gas transport passage from the external space.

8. The amplification module according to claim 7, wherein the space between the first recessed portion and the sealing member and the space between the second recessed portion and the sealing member are independent spaces that do not communicate with each other.

9. The amplification module according to claim 1, wherein the gas transport passage is connected to the upper part of the housing, and a space wider and deeper than the other parts is formed at the connection point.

10. The amplification module according to claim 1, wherein one or more of the width and depth of the gas transport passage is narrower or lower than the width and depth of the extract transport passage.

11. The aforementioned gas transport passage is A first gas transport passage having a first width and a first depth; A second gas transport passage having a second width greater than the first width and the first depth; and The amplification module according to claim 10, formed by one or more combinations of a third gas transport passage having a third width greater than the second width and a second depth greater than the first depth.

12. The amplification module according to claim 10, wherein a number of columns are formed to protrude from the gas transport passage.

13. The amplification module according to claim 11 or 12, wherein the gas transport passages connected to the plurality of storage sections all have the same volume.

14. The amplification module according to claim 1, wherein one of the plurality of storage compartments stores a probe and primer for amplifying a first target substance, and another storage compartment stores a probe and primer for amplifying a second target substance different from the first target substance.

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