A gene analysis cartridge and gene analysis device including the same

Abstract

The present invention relates to a cartridge for gene analysis and a gene analysis device including the same. Specifically, it relates to an analysis tool that can be manufactured with a 3D printer and can accommodate a gene amplification reaction and a solution for the same, and a device that can analyze genes on-site and transmit the analysis results to the outside.

Description

Technology Field

[0001] The present invention relates to a cartridge for gene analysis and a gene analysis device including the same. Specifically, it relates to an analysis tool that can be manufactured with a 3D printer and can accommodate a gene amplification reaction and a solution for the same, and a device that can analyze genes on-site and transmit the analysis results to the outside. Background Technology

[0002] The World Health Organization (WHO) has reported 762.79 million confirmed cases of COVID-19 and more than 6.9 million deaths since the outbreak began in December 2019.

[0003] Despite the remarkable speed of mRNA vaccine development, concerns have been raised regarding the efficacy of existing vaccinations due to a recent surge in infection cases caused by the Omicron variant in the vaccinated population.

[0004] The protective efficacy of currently available vaccines against infections and symptomatic diseases caused by the Omicron variant has been shown to be inferior compared to previous variants, and the rate of decline in this efficacy after vaccination is rapid.

[0005] Therefore, rapid diagnostic testing is still considered essential for protection against COVID-19.

[0006] While it is understandable that a global shortage of medical materials occurred during the early stages of the pandemic due to an unprecedented increase in testing demand, we are still experiencing supply shortages of medical equipment and analytical tools as regional lockdowns and social distancing policies in some countries have disrupted global manufacturing and trade.

[0007] Furthermore, the current standard for COVID-19 diagnostic systems approved by the U.S. Centers for Disease Control and Prevention (CDC) requires sophisticated real-time fluorescence thermocycling and biological analysis based on quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR).

[0008] Although qRT-PCR is widely used in molecular diagnostics due to its high sensitivity and excellent specificity, it requires various expensive equipment and trained analysts, and there are problems such as the analysis time usually taking 4 to 6 hours and the time required to inform the patient of the analysis results taking more than 24 hours. Prior art literature

[0009] KR 10-2023-0049323(Published 2023.04.13) The problem to be solved

[0010] The objective of the present invention is to provide an analysis tool that can be manufactured with a 3D printer and can accommodate a gene amplification reaction and a solution for the same, and a device that can analyze genes on-site and transmit the analysis results to the outside. means of solving the problem

[0011] To achieve the above objective, the present invention may include a chamber block coupled to a microfluidic chip and having a plurality of chambers formed therein; a syringe tube installed in the chamber block and communicating with the chambers; and a rotary valve communicating with the chambers or the microfluidic chip.

[0012] To achieve the above other objectives, the present invention may include a cartridge coupled with a microfluidic chip; a fluid flow unit for flowing fluid between the microfluidic chip and the cartridge; and a magnetic body rotation unit for rotating a magnetic body and positioning it on the side of the cartridge.

[0013] In the present invention, the microfluidic chip and cartridge can be manufactured using a 3D printer.

[0014] In the present invention, the cartridge may include a chamber block coupled with a microfluidic chip and having a plurality of chambers formed therein; a syringe tube installed in the chamber block and communicating with the chambers; and a rotary valve communicating with the chambers or the microfluidic chip.

[0015] In the present invention, a slide groove is formed on the side of the chamber block along the height direction of the chamber block so that the side end of the microfluidic chip can be coupled.

[0016] In the present invention, a valve coupling groove is formed at the bottom of the chamber block along the height direction of the chamber block, and a plurality of cartridge flow paths are formed inside the chamber block and can communicate with the valve coupling groove.

[0017] In the present invention, the cartridge flow paths can be arranged on the inner circumference of the valve coupling groove, spaced apart from each other by 60 degrees along the circumference of the valve coupling groove with respect to the center of the valve coupling groove.

[0018] In the present invention, the cartridge can communicate with the cartridge flow path formed inside the rotary valve.

[0019] In the present invention, the valve passage may include a chamber connecting passage formed at the upper part of the rotary valve; and an air exhaust passage formed at the lower part of the rotary valve.

[0020] In the present invention, the chamber connecting passage may include a combined passage formed extending a certain length from the upper surface of the rotary valve along the longitudinal direction of the rotary valve; and a pair of branched passages branched from the combined passage and formed extending to the outer surface of the rotary valve along the diametrical direction of the rotary valve.

[0021] In the present invention, the angle between the branch channels can be formed at 150 degrees.

[0022] In the present invention, the fluid flow section may include a valve rotation section that rotates the rotary valve by being coupled with a rotary valve; and a plunger transfer section that linearly moves the plunger along the longitudinal direction of the syringe tube, wherein a plunger inserted into the syringe tube is installed.

[0023] The present invention may further include a heater positioned opposite the microfluidic chip; and a cooling fan positioned opposite the heater.

[0024] The present invention may further include an image sensor positioned opposite the microfluidic chip and generating image information by photographing the microfluidic chip at regular time intervals; and a control unit that analyzes a fluorescence signal generated from the microfluidic chip based on the image information and transmits it externally. Effects of the invention

[0025] The gene analysis device according to the present invention uses magnetic beads to perform RNA extraction of a solution in which a virus sample is dissolved in a cartridge, and a microfluidic chip coupled to the cartridge can perform a gene amplification reaction of the solution in which RNA has been extracted.

[0026] In addition, the gene analysis device automatically measures and processes fluorescence signals generated in the reaction chamber of the microfluidic chip, and based on IoT technology, can transmit analysis results to a smartphone in real time via wireless networks such as the Internet and Wi-Fi, thereby enabling accurate and rapid diagnosis on-site.

[0027] In addition, microfluidic chips and cartridges can be manufactured using 3D printers, so a stable supply can be ensured. Brief explanation of the drawing

[0028] FIG. 1 (a) is a perspective view showing a state in which a cartridge is separated in a gene analysis device according to one embodiment of the present invention. Figure 1(b) is a perspective view showing the state in which a cartridge is coupled to the gene analysis device shown in Figure 1(a). Figure 2 is an exploded view of the gene analysis device shown in Figure 1 (b). Figure 3(a) is an exploded perspective view showing a product made with an actual 3D printer of the microfluidic chip and cartridge shown in Figure 2. Figure 3(b) is a perspective view showing a product made with an actual 3D printer of the microfluidic chip and cartridge shown in Figure 2. FIG. 4 is a one-sided perspective view of the internal configuration housed in the housing shown in FIG. 2. FIG. 5 is a second perspective view of the internal configuration housed in the housing shown in FIG. 2. FIG. 6 is a perspective view showing the state in which the cartridge is separated from the fluid flow section illustrated in FIG. 4 and 5. Figure 7 is a conceptual diagram showing the connection relationship between the gene analysis device and the smartphone illustrated in Figure 1 (b). Figure 8 is a plan view of the microfluidic chip shown in Figure 6. Fig. 9 is a perspective view of the cartridge shown in Fig. 6. Figure 10 is a BB section diagram shown in Figure 9. Figure 11 (a) is a plan view of the cartridge shown in Figure 9. Figure 11 (b) is a bottom view of the cartridge shown in Figure 9. FIG. 12 is an exploded view of the cartridge shown in FIG. 9. FIG. 13 is a schematic diagram of the valve coupling groove shown in FIG. 11 (b). Fig. 14 is a section of the AA diagram shown in Fig. 9. FIG. 15 is a perspective view of the rotary valve shown in FIG. 12. Fig. 16 is a plan view of the rotary valve shown in Fig. 12. Fig. 17 is a CC section diagram shown in Fig. 9. Figure 18 (a) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Figure 13, showing the state in which fluid flows from the dissolution chamber to the mixing chamber. Figure 18 (b) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Figure 13, showing the state in which fluid flows from the mixing chamber to the dissolution chamber. FIG. 19 is a side view of the cartridge shown in FIG. 9, showing a state in which a magnetic body is rotated and placed on or separated from the side of the cartridge. Figure 20 (a) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Figure 13, showing the state in which fluid flows from the first washing chamber to the mixing chamber. Figure 20 (b) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Figure 13, showing the state in which fluid flows from the mixing chamber to the first washing chamber. Figure 21 (a) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Figure 13, showing the state in which fluid flows from the second washing chamber to the mixing chamber. Figure 21 (b) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Figure 13, showing the state in which fluid flows from the mixing chamber to the second washing chamber. FIG. 22 is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in FIG. 13, and shows the state in which fluid flows from the elution chamber to the mixing chamber. Figure 23 (a) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Figure 13, showing the state in which fluid flows from the mixing chamber to the reagent chamber. Figure 23 (b) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Figure 13, showing the state in which fluid flows from the reagent chamber to the mixing chamber. FIG. 24 is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in FIG. 13, and shows the state in which fluid flows from the mixing chamber to the microfluidic tip through the solution outflow path. Figure 25A is a figure showing the RNA concentration extracted according to sample concentration using the gene analysis device shown in Figure 1(a). Figure 25B is a figure showing a fluorescence image generated during the amplification reaction in the microfluidic chip shown in Figure 1(a). Figure 25C is a figure showing the display illustrated in Figure 7. Figure 25D is a figure comparing the critical time for each sample concentration using the gene analyzer shown in Figure 1(a) with the critical time for each sample concentration using a standard thermal cycler. Figure 26A is a figure showing the results of 19 clinical sample tests using the gene analysis device shown in Figure 1. Figure 26B is a diagram showing the decision tree of the gene analysis device illustrated in Figure 1. Figure 26C is a figure showing the identification status of a sample based on the decision tree shown in Figure 26B. D of FIG. 26 is a conceptual diagram showing the state in which data derived from the gene analysis device shown in FIG. 1 is transmitted via email and output to a smartphone. Specific details for implementing the invention

[0029] In order to provide a detailed explanation sufficient for a person skilled in the art to easily implement the technical concept of the present invention, the most preferred embodiment of the present invention will be described with reference to the accompanying drawings.

[0030] First, it should be noted that when assigning reference numerals to the components of each drawing, the same components are assigned the same numeral whenever possible, even if they are shown on different drawings.

[0031] In addition, in describing the present invention, if it is determined that a detailed description of related known components or functions may obscure the essence of the invention, such detailed description is omitted.

[0032] Hereinafter, a gene analysis device according to an embodiment of the present invention will be described with reference to FIGS. 1 to 26.

[0033] FIG. 1(a) is a perspective view showing a state in which a cartridge is separated in a gene analysis device according to an embodiment of the present invention, FIG. 1(b) is a perspective view showing a state in which a cartridge is coupled to the gene analysis device shown in FIG. 1(a), and FIG. 2 is an exploded perspective view of the gene analysis device shown in FIG. 1(b).

[0034] Referring to FIG. 1 (a) to FIG. 2, the gene analysis device (100) may include a housing (110), a cover (111), a sealing plate (112), a battery (113), a microfluidic chip (200), a cartridge (300), a fluid flow section (120), and a magnetic rotating section (140).

[0035] The housing (110) is in the form of a polyhedron with a hollow interior, such as a cuboid or a cylinder, and an opening (110a) is formed on the upper surface of the housing (110), a fluid flow section (120) is arranged inside, and a cover (111) can be hinge-connected to the top of the housing (110).

[0036] The finishing plate (112) can be placed in the opening (110a) to finish the upper part of the housing (110) and can be fixed to the inner surface of the housing (110) via known fastening members such as bolts, screws, pieces, clamps, or known adhesive members such as adhesive.

[0037] Hereinafter, the fixation between the components of the gene analysis device (100) described below can also be achieved through a fixing member and an adhesive member, so a detailed description will be omitted.

[0038] The battery (113) is a lithium-ion battery and is placed inside the housing (110) and can supply power to the components forming the gene analysis device (100).

[0039] The end plate (112) has a cartridge insertion hole (112a) formed therein, and a cartridge (300) can be inserted through the cartridge insertion hole (112a) and combined with the fluid flow part (120).

[0040] FIG. 3(a) is an exploded perspective view showing a product made with an actual 3D printer of the microfluidic chip and cartridge shown in FIG. 2, and FIG. 3(b) is a perspective view showing a product made with an actual 3D printer of the microfluidic chip and cartridge shown in FIG. 2.

[0041] Referring to FIG. 3 (a) and (b), the microfluidic chip (200), cartridge (300), and rotary valve (330) included in the cartridge (300) can be manufactured with a 3D printer so that a stable supply can be achieved.

[0042] The dimensions of the finished cartridge are width, length, and height of 30X25X40mm, and the width of the cartridge (300) including the microfluidic chip (200) when the microfluidic chip (200) is combined with the cartridge (300) is 45mm, so it can be made in a compact size.

[0043] The genetic analysis device (100) can be manufactured using known materials having a certain rigidity, such as steel or synthetic resin, for the remaining components excluding the microfluidic chip (200) and cartridge (300).

[0044] FIG. 4 is a first perspective view of an internal configuration housed in a housing shown in FIG. 2, FIG. 5 is a second perspective view of an internal configuration housed in a housing shown in FIG. 2, and FIG. 6 is a perspective view showing a state in which a cartridge is separated from a fluid flow section shown in FIG. 4 and 5.

[0045] Referring to FIGS. 4 to 6, the fluid flow section (120) is configured to flow fluid between the microfluidic chip (200) and the cartridge (300), and can be fixed by being placed inside the housing (110) via a mounting bracket (114).

[0046] The mounting bracket (114) is a frame on which components disposed inside the housing (110), including the fluid flow section (120), are mounted and fixed, and can be fixed to the inner surface of the housing (110).

[0047] The fluid flow section (120) includes a valve rotation section (121) and a plunger transfer section (123), and the valve rotation section (121) is a motor, and the rotation shaft (121a) of the motor can be coupled to the rotary valve (330) of the cartridge (300).

[0048] That is, the motor rotates the rotary valve (330) in the forward or reverse direction so that a plurality of chambers formed inside the cartridge (300) can be selectively connected.

[0049] The plunger transfer unit (123) may include a plunger (123a), a push bar, a rack bar (123b), and a motor (123c).

[0050] The plunger (123a) is fixed to the end of the push bar, and the push bar and the rack bar (123b) are arranged parallel to each other and fixed, and the rotation axis of the motor (123c) can be engaged with the rack bar (123b).

[0051] That is, the rotational force of the motor (123c) is converted into linear motion by the rack bar (123b), and in synchronization with this, the push rod is raised and lowered so that the plunger (123a) can move linearly inside the cartridge (300).

[0052] The magnetic body rotation part (140) includes a magnetic body (130), a rotation rod (142), and a motor (141), and one end of the rotation rod (142) is fixed to the rotation axis of the motor (141), and the magnetic body (130) can be fixed to the other end of the rotation rod (142).

[0053] That is, the motor (141) rotates the pivot rod (142) so that the magnetic body (130) can be placed on or separated from the outer surface of the cartridge (300).

[0054] When a magnetic body (130) is placed on the outer surface of a cartridge (300), the magnetic force of the magnetic body (130) reacts with magnetic beads contained in the solution, so that the magnetic beads can be attached to the inner surface of the cartridge (300).

[0055] The gene analysis device (100) may further include a heater (151), a cooling fan (152), an image sensor (160), and a control unit (170).

[0056] The heater (151) is a plate-shaped resistance heater and is positioned opposite one side of the microfluidic chip (200), and applies heat to the microfluidic chip (200). The heat temperature applied to the microfluidic chip (200) can be controlled by PID control during gene amplification reaction analysis using an Arduino Nano and a thermistor.

[0057] A cooling fan (152) is positioned opposite the heater (151) to cool the heater (151) and the microfluid chip (200).

[0058] An image sensor (160) is positioned opposite to the other side of the microfluidic chip (200), and a CMOS sensor combined with a 520 nm bandpass filter and a 488 nm LED may be used to measure a fluorescent signal coming from the reaction chamber (220) of the cartridge (300).

[0059] An incident hole (115) is formed at the top of the stand (114), and a light beam of a certain light range output from an LED can pass through the incident hole (115) and be irradiated onto the reaction chamber of the microfluidic chip (200), and the fluorescence intensity generated in the reaction chamber during the gene amplification reaction is strengthened by the light beam, making it easier to perform gene analysis.

[0060] The image sensor (160) can generate image information by photographing the reaction chamber of the microfluidic chip (200) at regular intervals.

[0061] The control unit (170) can be mounted on a printed circuit board and can diagnose pathogens by analyzing the fluorescent signal generated from the microfluidic chip (200) based on image information.

[0062] Figure 7 is a conceptual diagram showing the connection relationship between the gene analysis device and the smartphone illustrated in Figure 1 (b).

[0063] Referring to FIG. 7, the gene analysis device (100) further includes a display (180), the display (180) is a 3-inch touchscreen and is installed on the upper surface of the cover (111) so that image information or an analysis value of a fluorescent signal can be displayed.

[0064] The control unit can control the operation of the components forming the gene analysis device (100), including the valve rotation unit, based on preset values ​​input to the display (180).

[0065] The control unit automatically measures and processes the fluorescence signal generated from the microfluidic chip (200), and in addition to the display (180), can transmit the analysis results in real time to the smartphone (1) of the patient or the person involved in the analysis via a wireless network such as the internet or Wi-Fi, so that accurate diagnosis and on-site rapid diagnosis can be achieved simultaneously.

[0066] Figure 8 is a plan view of the microfluidic chip shown in Figure 6.

[0067] Referring to FIG. 8, the microfluidic chip (200) may include a flow plate (210), a reaction chamber (220), a waste chamber (230), and a passive valve (240).

[0068] A solution inlet pipe (211) and an air outlet pipe (212) are formed protrudingly on one side of the fluid plate (210), and the solution inlet pipe (211) and the air outlet pipe (212) are combined with a cartridge so that the microfluid chip (200) and the cartridge can communicate with each other.

[0069] The reaction chamber (220) is composed of multiple chambers spaced apart from each other and formed on the other side of the flow plate (210), and the inner surface may be coated with a primer capable of reacting with target RNA.

[0070] A solution inlet channel (213) is formed in the flow plate (210) to allow the solution inlet pipe (211) and the reaction chamber (220) to communicate with each other, and an air outlet channel (214) is formed to allow the reaction chamber (220) and the air outlet pipe (212) to communicate with each other.

[0071] The solution inlet channel (213) may include a solution flow channel (213a) and a solution dispensing channel (213b).

[0072] One end of the solution flow channel (213a) is connected to the solution inlet pipe (211), one end of the solution dispensing channel (213b) is connected to the other end of the solution flow channel (213a), and the other end of the solution dispensing channel (213b) can be connected to each reaction chamber (220).

[0073] The air outlet channel (214) includes an air flow channel (214a) and an air dispensing channel (214b), and one end of the air flow channel (214a) is in communication with the air outlet pipe (212), and one end of the air dispensing channel (214b) is in communication with the other end of the air flow channel (214a), and the other end can be in communication with the reaction chamber (220).

[0074] The waste chamber (230) is formed in the air flow channel (214a) and can receive and accommodate excess solution that the reaction chamber (220) has not been able to accommodate.

[0075] In the microfluidic chip (200), a solution introduced from the cartridge (300) flows through the solution inlet pipe (211) along the solution inlet channel (213) and is divided and received in a plurality of reaction chambers (220), and a gene amplification reaction can occur by heat applied from the heater (151).

[0076] The passive valve (240) is a channel section coated with hydrophobic material, which means a section where the hydrophilic solution does not flow when suction force is not applied by the plunger conveyor (123, shown in FIG. 6).

[0077] That is, by forming a passive valve (240) in the air dispensing channel (214b), a gene amplification reaction can be performed with the solution contained in the reaction chamber (220).

[0078] FIG. 9 is a perspective view of the cartridge shown in FIG. 6, FIG. 10 is a BB section view shown in FIG. 9, FIG. 11 (a) is a top view of the cartridge shown in FIG. 9, and FIG. 11 (b) is a bottom view of the cartridge shown in FIG. 9.

[0079] Referring to (b) of FIGS. 9 to 11, the cartridge (300) may include a chamber block (310), a syringe tube (320), and a rotary valve (330).

[0080] The chamber block (310) may be formed as a polyhedron including a cuboid, and may be formed with partitions including a dissolution chamber (312), a mixing chamber (311), a first washing chamber (313), a second washing chamber (314), an elution chamber (315), and a reagent chamber (316).

[0081] Injection holes (310a) are formed on the upper surface of each chamber of the chamber block (310) so that a solution, magnetic beads (10), etc. can be injected.

[0082] A slide groove (310b) is formed along the height direction of the chamber block (310) on the side of the chamber block (310) so that the side end of the microfluid chip (200) can be slidably connected.

[0083] An air inlet (317) and a solution outlet (318) may be formed at the bottom of the slide groove (310b).

[0084] The air outlet pipe (212, illustrated in FIG. 8) of the microfluidic chip (200) is inserted into the air inlet (317), and the solution inlet pipe (211, illustrated in FIG. 8) of the microfluidic chip (200) is inserted into the solution outlet (318), so that the cartridge (300) and the microfluidic chip (200) can communicate with each other.

[0085] FIG. 12 is an exploded view of the cartridge shown in FIG. 9, and FIG. 13 is a schematic diagram of the valve coupling groove shown in FIG. 11 (b).

[0086] Referring to FIGS. 12 and 13, a valve coupling groove (319) is formed along the height direction of the chamber block (310) at the bottom of the chamber block (310) so that a rotary valve (330) can be inserted.

[0087] The rotary valve (330) and the valve coupling groove (319) are formed to correspond to each other in a cylindrical shape, and an axial coupling groove (331) is formed on the lower surface of the rotary valve (330) so that the rotation shaft (121a, shown in FIG. 6) of the valve rotation part (121) can be inserted.

[0088] In order for the rotational force of the rotation shaft (121a, illustrated in FIG. 6) to be transmitted to the rotary valve (330), the shaft coupling groove (331) and the end of the rotation shaft (121a) may be formed to correspond to each other in the shape of a polyhedron, including a triangular prism.

[0089] A cartridge flow path (340) is formed inside the chamber block (310) so that the valve coupling groove (319), the dissolution chamber (312), the mixing chamber (311), the first washing chamber (313), the second washing chamber (314), the elution chamber (315), the reagent chamber (316), and the microfluid chip can be interconnected.

[0090] The cartridge path (340) may include a mixing chamber path (341), a dissolution chamber path (342), a first washing chamber path (343), a second washing chamber path (344), an elution chamber path (345), a reagent chamber path (346), and a solution outflow path (347).

[0091] The mixing chamber passage (341) is connected to the upper surface of the valve coupling groove (319) and the mixing chamber (311), and the dissolving chamber passage (342) is connected to the inner surface of the valve coupling groove (319) and the dissolving chamber (312).

[0092] The first washing chamber passage (343) is connected to the inner surface of the valve coupling groove (319) and the first washing chamber (313), and the second washing chamber passage (344) is connected to the inner surface of the valve coupling groove (319) and the second washing chamber (314).

[0093] The elution chamber passage (345) is connected to the inner surface of the valve coupling groove (319) and the elution chamber (315), and the reagent chamber passage (346) is connected to the inner surface of the valve coupling groove (319) and the reagent chamber (316).

[0094] The solution outflow channel (347) can be connected to the inner surface of the valve coupling groove (319) and the solution outlet (318, shown in FIG. 11 (a)).

[0095] That is, the mixing chamber passage (341), the dissolution chamber passage (342), the first washing chamber passage (343), the second washing chamber passage (344), the elution chamber passage (345), and the reagent chamber passage (346) can be arranged on the inner circumference of the valve coupling groove (319) at a distance of 60 degrees (θ2) along the circumference of the valve coupling groove (319) with respect to the center of the valve coupling groove (319).

[0096] Fig. 14 is a section of the AA diagram shown in Fig. 9.

[0097] Referring to FIG. 14, the syringe tube (320) may be formed integrally with the chamber block (310) or may be separately fixed to the chamber block (310).

[0098] One end of the syringe tube (320) has a through hole (321) formed therein, and the syringe tube (320) and the mixing chamber (311) can be interconnected through a flow path (322) formed between the syringe tube (320) and the mixing chamber (311).

[0099] And, a plunger (123a, illustrated in FIG. 6) can be inserted and positioned inside the syringe tube (320) through the other end of the syringe tube (320).

[0100] That is, as the plunger (123a, illustrated in FIG. 6) moves linearly, a positive or negative pressure is formed inside the mixing chamber (311), so that the fluid contained inside the mixing chamber (311) may flow out of the mixing chamber (311) or flow into the mixing chamber (311).

[0101] FIG. 15 is a perspective view of the rotary valve shown in FIG. 12, FIG. 16 is a plan view of the rotary valve shown in FIG. 12, and FIG. 17 is a CC section view shown in FIG. 9.

[0102] Referring to FIGS. 15 to 17, the rotary valve (330) may be in communication with at least one of the dissolution chamber (312), mixing chamber (311), first washing chamber (313), second washing chamber (314), elution chamber (315), amplification reagent chamber (316), and microfluidic chip (200) shown in FIG. 13.

[0103] To this end, a valve passage (350) is formed inside the rotary valve (330) and can communicate with the cartridge passage (340, shown in FIG. 13).

[0104] The valve passage (350) includes a chamber connection passage (351) and an air discharge passage (352), the chamber connection passage (351) may be formed at the upper part of the rotary valve (330), and the air discharge passage (352) may be formed at the lower part of the rotary valve (330).

[0105] The chamber connecting channel (351) is a 3-way channel and may include a laminated channel (351a) and a branched channel (351b).

[0106] The composite flow path (351a) communicates with the mixing chamber flow path (341, shown in FIG. 13) and can be formed to extend a certain length from the upper surface of the rotary valve (330) along the longitudinal direction of the rotary valve (330).

[0107] The branching channel (351b) is formed as a pair and branches off from the end of the branching channel (351a) and extends along the diameter direction of the rotary valve (330) to the outer surface of the rotary valve (330), and can be connected to at least one of the dissolution chamber channel (342), the first washing chamber channel (343), the second washing chamber channel (344), the elution chamber channel (345), the reagent chamber channel (346), and the solution outflow channel (347) shown in FIG. 13.

[0108] The angle (θ1) between the branch passages (351b) can be formed at 150 degrees, and as described above, the mixing chamber passage (341), dissolution chamber passage (342), first washing chamber passage (343), second washing chamber passage (344), elution chamber passage (345), and reagent chamber passage (346) shown in FIG. 13 can be spaced apart from each other by 60 degrees (θ2) along the circumference of the valve coupling groove (319) and arranged on the inner circumference of the valve coupling groove (319).

[0109] That is, while the mixing chamber passage (341) and the bonding passage (351a) are connected, the rotary valve (330) rotates so that one side of the branch passage (351b) can be connected to any one of the mixing chamber passage (341), the dissolution chamber passage (342), the first washing chamber passage (343), the second washing chamber passage (344), the elution chamber passage (345), the reagent chamber passage, and the solution outflow passage (347).

[0110] In addition, the other side of the branch passage (351b) is sealed by contacting the inner surface of the valve coupling groove (319), thereby maintaining airtightness.

[0111] Since the branch passage (351b) is formed as a pair, the amount of rotation of the rotary valve (330) is reduced compared to when there is only one branch passage (351b), thereby reducing the fatigue of the valve rotation part (121).

[0112] The cartridge path (340) further includes an air inlet path (348), and the air inlet path (348) may be spaced apart from the solution outlet path (347) along the height direction of the chamber block (310) and positioned on the inner circumference of the valve coupling groove (319).

[0113] The air discharge passage (352) is a 1-way and is formed between the outer surface of the rotary valve (330) and the lower surface of the rotary valve (330), that is, between the shaft coupling groove (331), and can be connected to the air inlet passage (348).

[0114] An air discharge groove (332, shown in FIG. 15) may be formed between the outer surface of the rotary valve (330) and the inner surface of the shaft coupling groove (331).

[0115] That is, the internal air of the cartridge (300) flows along the air discharge passage (352) and the air inlet passage (348) and is discharged into the shaft coupling groove (331), and then can be discharged from the rotary valve (330) through the air discharge groove (332).

[0116] Hereinafter, the flow process of the solution contained in the cartridge will be explained with reference to FIG. 18 (a) to FIG. 24.

[0117] Figure 18 (a) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Figure 13, showing the state in which fluid flows from the dissolution chamber to the mixing chamber.

[0118] And, Fig. 18 (b) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Fig. 13, showing the state in which fluid flows from the mixing chamber to the dissolution chamber.

[0119] And, FIG. 19 is a side view of the cartridge shown in FIG. 9, showing the state in which a magnetic body is rotated and placed on or separated from the side of the cartridge.

[0120] Referring to FIGS. 18(a) to FIGS. 19, first, the volumes of the dissolution chamber (312), the first washing chamber (313), the second washing chamber (314), the elution chamber (315), and the reagent chamber (316) are 1200 μL, 1200 μL, 1200 μL, 600 μL, 600 μL, and 1000 μL, respectively, and a designated solution is injected into each chamber.

[0121] Then, magnetic beads are injected into a dissolution chamber (312) to prepare, and a sample is collected with a cotton swab to make a virus sample solution.

[0122] After injecting 150 μL of virus sample solution into the dissolution chamber (312) with a pipette, the cartridge (300) combined with the microfluidic chip (200) as shown in FIG. 2 is inserted into the cartridge insertion hole (112a) and connected to the fluid flow section (120).

[0123] Afterwards, the rotary valve (330) rotates so that the branch passage (351b) communicates with the dissolution chamber passage (342), and the plunger (123a, shown in FIG. 6) descends so that the solution contained in the dissolution chamber (312) flows into the mixing chamber (311).

[0124] With the solution contained in the dissolution chamber (312), the magnetic body (130) is rotated and placed on the outer surface of the mixing chamber (311), and as the solution flows from the dissolution chamber (312) to the mixing chamber (311) and is contained in the mixing chamber (311), the magnetic bead (10) can be attached to the inner surface of the mixing chamber (311) as shown in FIG. 19.

[0125] At this time, after waiting for 30 seconds so that the magnetic bead (10) can be adhered to the inner surface of the mixing chamber (311), the solution contained in the mixing chamber (311) flows back into the dissolution chamber (312).

[0126] Afterwards, as the plunger (123a, illustrated in FIG. 6) rises, the solution contained in the mixing chamber (311) flows back into the dissolution chamber (312), thereby improving the dissolution efficiency of the virus and the RNA capture effect on the magnetic beads (10).

[0127] Hereinafter, redundant descriptions regarding the rotation of the rotary valve (330), the lifting and lowering of the plunger, and the rotation of the magnetic body (130) will be omitted.

[0128] Figure 20 (a) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Figure 13, showing the state in which fluid flows from the first washing chamber to the mixing chamber.

[0129] And, Fig. 20 (b) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Fig. 13, showing the state in which fluid flows from the mixing chamber to the first washing chamber.

[0130] Referring to FIG. 20 (a) and (b), subsequently, the branch channel (351b) is connected to the first washing chamber channel (343), and at the same time, the magnetic body (130, shown in FIG. 19) is separated from the outer surface of the mixing chamber (311).

[0131] Then, the solution contained in the first washing chamber (313) flows into the mixing chamber (311) and then flows back into the first washing chamber (313), and the washing of the magnetic beads (10) can be performed by repeating this flow three times.

[0132] Afterwards, the magnetic body (130) is placed on the outer surface of the mixing chamber (311) and the magnetic bead (10) is in close contact with the inner surface of the mixing chamber (311) and remains in the mixing chamber (311), and the solution contained in the mixing chamber (311) flows into the first washing chamber (313).

[0133] Figure 21 (a) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Figure 13, showing the state in which fluid flows from the second washing chamber to the mixing chamber.

[0134] And, Fig. 21 (b) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Fig. 13, showing the state in which fluid flows from the mixing chamber to the second washing chamber.

[0135] Referring to Figures 21 (a) and (b), the secondary cleaning of the magnetic bead (10) is the same as the primary cleaning performed.

[0136] That is, the branch channel (351b) is connected to the second washing chamber channel (344), and at the same time, the magnetic body (130) is separated from the outer surface of the mixing chamber (311).

[0137] Then, the solution contained in the second washing chamber (314) flows into the mixing chamber (311) and then flows back into the second washing chamber (314), and this flow is performed three times.

[0138] Afterwards, the magnetic body (130, illustrated in FIG. 19) is placed on the outer surface of the mixing chamber (311) and the magnetic bead (10) is in close contact with the inner surface of the mixing chamber (311) and remains in the mixing chamber (311), and the solution contained in the mixing chamber (311) flows into the second washing chamber (314).

[0139] FIG. 22 is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in FIG. 13, and shows the state in which fluid flows from the elution chamber to the mixing chamber.

[0140] Referring to FIG. 22, thereafter, the branch channel (351b) is connected to the elution chamber channel (345), and the solution contained in the elution chamber (315) flows into the mixing chamber (311).

[0141] The solution contained in the elution chamber (315) is water free of nuclease, and RNA captured by the magnetic beads (10) can be dispersed in the solution to form an RNA solution, and to enhance this dispersion effect, the flow of the solution between the elution chamber (315) and the mixing chamber (311) is repeated several times.

[0142] After repeated flow, with the solution finally contained in the mixing chamber (311), the magnetic body (130) is placed on the outer surface of the mixing chamber (311) and the magnetic bead (10) is attached to the inner surface of the mixing chamber (311).

[0143] Figure 23 (a) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Figure 13, showing the state in which fluid flows from the mixing chamber to the reagent chamber.

[0144] And, Fig. 23 (b) is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in Fig. 13, showing the state in which fluid flows from the reagent chamber to the mixing chamber.

[0145] Referring to FIG. 23 (a) and (b), thereafter, the branch channel (351b) is connected to the reagent chamber channel (346), and the solution contained in the mixing chamber (311) flows into the reagent chamber (316) and is mixed with the reagent solution already contained in the reagent chamber (316) to form an amplification reaction mixture.

[0146] Afterwards, the solution contained in the reagent chamber (316) flows into the mixing chamber (311).

[0147] FIG. 24 is a schematic diagram showing the state in which a rotary valve is coupled to the valve coupling groove shown in FIG. 13, and shows the state in which fluid flows from the mixing chamber to the microfluidic tip through the solution outflow path.

[0148] Referring to FIG. 24, the branch channel (351b) may be connected to the solution outflow channel (347), and as shown in FIG. 17, the air discharge channel (352) may be connected to the air inflow channel (348).

[0149] That is, the solution contained in the mixing chamber (311) can flow along the solution outflow path (347) and be introduced into the solution inflow channel (213) through the solution inflow pipe (211) of the microfluidic chip (200) as shown in FIG. 8.

[0150] And, air can be discharged from the air outlet channel (214) of the microfluidic chip (200) and flow along the air inlet channel (348) and the air outlet channel (352) as shown in FIG. 17 to be discharged to the outside of the cartridge (300).

[0151] As described above, the solution introduced into the microfluidic chip is received in the reaction chamber to perform a gene amplification reaction, and the fluorescence signal generated in the reaction chamber is measured to diagnose pathogens.

[0152] Figure 25A is a figure showing the RNA concentration extracted according to sample concentration using the gene analysis device shown in Figure 1(a).

[0153] Figure 25B is a figure showing a fluorescence image generated during the amplification reaction in the microfluidic chip shown in Figure 1(a).

[0154] Figure 25C is a figure showing the display illustrated in Figure 7.

[0155] Figure 25D is a figure comparing the critical time for each sample concentration using the gene analyzer shown in Figure 1(a) with the critical time for each sample concentration using a standard thermal cycler.

[0156] Referring to FIGS. 25A to FIGS. 25D, the diagnostic performance of the gene analysis device of the present invention was evaluated by sensitivity testing, specificity testing, clinical sample testing, and comparison testing with a standard thermal cycler.

[0157] The limit of detection (LOD) is an important indicator in genetic diagnosis, and to determine the LOD of the gene analysis device of the present invention, an LOD test was performed using a heat-inactivated SARS-CoV-2 sample purchased from ATCC.

[0158] Dilute the stock sample by 1 χ 10 -2 from 1x10 3 A series of concentrations ranging from genome copies / μL were prepared, and 150μL of sample was used for each test.

[0159] In genetic diagnosis, the sample pretreatment step is crucial for the successful and sensitive detection of target pathogens; to verify RNA extraction by sample pretreatment, aliquots of the extracted RNA were collected before transfer to the microfluidic chip, and their concentrations were measured using a Nanodrop One spectrophotometer.

[0160] The extraction result within the cartridge is 1X10 -1 It was demonstrated that purified RNA could be effectively recovered from viral samples at a concentration of copies / μL, and the concentration of the extracted RNA was measured to be 0.52±0.12 ng / μL (Figure A in Fig. 25).

[0161] After successfully recovering purified RNA from the virus sample, four amplification reactions were performed using the reaction chamber of the microfluidic chip.

[0162] This facilitated the amplification and detection of target genes of viral RNA to further confirm the presence of the virus in the sample, and 1X10 to demonstrate real-time fluorescence monitoring of gene amplification on a microfluidic chip 2 Amplification analysis was performed using an input sample concentration of genome copy / μL, and fluorescence intensity was monitored throughout the entire process.

[0163] Fluorescence images of the reaction chamber captured by the image sensor during the amplification reaction are shown in Fig. 25B, and the results show that the fluorescence intensity of the reaction chamber containing a set of primers targeting 18S rRNA, As1e, and N genes increased during the reaction process, while the negative control remained unchanged.

[0164] As part of the data processing, fluorescence images of four reaction chambers are captured every minute, and the fluorescence intensity is calculated and displayed on the display. As shown in Fig. 25 C, the analysis results of the gene amplification curve after the test are displayed as a screenshot, and the 5-parameter log-logistic (5PLL) fitting fluorescence intensity of each reaction chamber is presented to show the progress of amplification.

[0165] The calculated threshold time of the amplification curve is displayed at the bottom of the display, and the final diagnostic result is shown, which can provide a comprehensive analysis of the amplification response.

[0166] In a comparative test with a standard thermal cycler, serially diluted samples of inactivated SARS-CoV-2 were utilized in both the gene analysis device of the present invention and the standard thermal cycler.

[0167] The standard heat cycle test was performed as follows.

[0168] First, RNA was extracted from the sample using a cartridge-based method, and after the elution step, the extracted RNA was pipetted in a thermal cycler for use in the amplification reaction.

[0169] Each reaction consisted of 5 μL of amplification reaction mixture (RM), 0.4 μL of enzyme mixture (EM), 0.4 μL of SYBR green, 2.4 μL of primer mixture, 0.8 μL of nuclease-free water, and 1 μL of RNA sample.

[0170] The amplification reaction was carried out at 65 degrees for 1 hour, and the fluorescence intensity of the amplification mixture was measured at 1-minute intervals.

[0171] In contrast, tests for the gene analysis device of the present invention were performed on cartridges and microfluidic chips, ranging from sample pretreatment to amplification analysis.

[0172] Through this, the accuracy, sensitivity, and specificity of the gene analysis device could be compared with a standard thermal cycler.

[0173] Integrating all steps into a single cartridge can significantly simplify the test process and improve the speed and user-friendliness of analysis, and reduce the risk of contamination and human error because there are fewer steps requiring manual pipetting and sample transfer.

[0174] In addition, the compact size of the cartridge and the IoT-based gene analyzer make it easier to use in various gene analyzers and field test applications.

[0175] Fig. 25D shows that the gene analysis device of the present invention analyzes the As1e and N genes of SARS-CoV-2 with an LOD of 1×10 -1 It is shown that high-sensitivity identification of COVID-19 is possible by detection at genome copy / μL, which corresponds to 15 genome copies (150μL volume) per sample.

[0176] In addition, as a result of comparing the critical time between the BioRad CFX Connect, a standard thermal cycler, and the gene analyzer of the present invention, it was revealed that the molecular diagnostic performance of the gene analyzer of the present invention is similar to that of the standard thermal cycler, thereby proving that it is a reliable and accurate diagnostic tool for SARS-CoV-2 detection.

[0177] FIG. 26A is a diagram showing the results of 19 clinical sample tests using the gene analysis device shown in FIG. 1, FIG. 26B is a diagram showing the decision tree of the gene analysis device shown in FIG. 1, FIG. 26C is a diagram showing the identification status of the sample based on the decision tree shown in FIG. 26B, and FIG. 26D is a conceptual diagram showing the state in which data derived from the gene analysis device shown in FIG. 1 is transmitted via email and displayed on a smartphone.

[0178] Referring to FIGS. 26A to FIGS. 26D, clinical samples were also tested to demonstrate the actual application of the gene analysis device of the present invention.

[0179] Virus samples were obtained from 5 patients infected with COVID-19, 14 patients infected with other respiratory viruses, 3 positive control samples (commercial virus samples from ATCC), and 5 negative control samples.

[0180] As shown in Fig. 26A, real-time fluorescence detection was performed in the reaction chamber, and the threshold time of the target gene in each sample was determined based on the fluorescence threshold, and three genes (SARS-CoV-2 As1e and N genes and human 18S rRNA gene) were successfully detected in both SARS-CoV-2 patient samples and positive control samples.

[0181] Samples from patients infected with other respiratory viruses and negative controls were amplified only by the 18S rRNA gene, whereas other negative controls containing only water showed no signs of amplification.

[0182] For SARS-CoV-2 samples, the critical time is shortest for the 18S rRNA gene and longest for the As1e gene due to the abundance of it in human cells.

[0183] The total diagnostic time was 70 minutes, including 10 minutes for sample pretreatment and 60 minutes for the amplification reaction through real-time analysis of the fluorescence signal.

[0184] As illustrated in Fig. 26B, after obtaining diagnostic data from the gene analysis device of the present invention, a final decision can be determined using a decision tree based on possible situations.

[0185] First, the threshold of a positive control chamber containing 18S rRNA as a template is examined, and if a negative result is obtained, it indicates that the sample does not contain housekeeping RNA, which suggests that the sample was improperly collected, whereas if the result is positive, the threshold of a negative control chamber is examined.

[0186] The negative control chamber is designed to check for cross-contamination issues between reaction chambers or primer-dimer occurrence, and if the negative control shows a positive result, it indicates a false positive result.

[0187] If the negative control correctly shows a negative result, it tests for the presence of the SARS-CoV-2 gene (As1e and N genes); if both show a positive result, it indicates that the sample is positive for COVID-19.

[0188] Conversely, if both show negative results, it suggests that the patient's sample is not infected with COVID-19.

[0189] Based on this decision-making process, the gene analyzer of the present invention proposed was able to automatically and accurately identify contaminated samples regardless of the presence or absence of SARS-CoV-2 by taking into account all issues related to appropriate sample collection or chip operation. (See Figure 26C)

[0190] In addition, as described above, an IoT function is integrated to enable the gene analysis device of the present invention to communicate with a computer or smartphone via the Internet (D in FIG. 26).

[0191] In other words, once the genetic diagnosis is complete, the genetic analyzer can compile the raw data, analyze the results, record other metadata such as time, location, and notes, and send them to a designated email address.

[0192] These measures will enable scientists and technicians at the Centers for Health and Disease Control to easily collect and audit data, which is expected to be very useful for continuously tracking the early stages of an infectious disease recurrence, such as COVID-19, in real time to suppress it in advance.

[0193] Optimal embodiments have been disclosed in the drawings and specification as described above. Specific terms have been used herein, but they are used only for the purpose of describing the invention and are not intended to limit the meaning or the scope of the invention as described in the claims. Therefore, those skilled in the art will understand that various modifications and equivalent alternative embodiments are possible therefrom. Accordingly, the true technical scope of protection of the invention should be determined by the technical spirit of the appended claims. Explanation of the symbols

[0194] 100 : Gene analyzer 110 : Housing 111 : Cover 110a : Open hole 112: Finish plate 112a: Cartridge insertion hole 113 : Battery 114 : Stand 115 : Entry worker 120: Fluid flow section 121: Valve rotation section 121a: Rotating shaft 123: Plunger feed section 123a: Plunger 130: Magnetic material 123b : Rack bar 123c : Motor 140: Magnetic rotating part 141: Motor 142 : Rotating rod 151 : Heater 152 : Cooling fan 160 : Image sensor 170 : Control unit 180 : Display 200: Microfluidic chip 210: Flow plate 211: Solution inlet pipe 212: Air outlet pipe 213: Solution inlet channel 213a: Solution flow channel 213b: Solution dispensing channel 214: Air outflow channel 214a: Air flow channel 214b: Air dispensing channel 220: Reaction Chamber 230: Waste Chamber 240: Passive valve 300: Cartridge 310 : Chamber block 311 : Mixing chamber 310a: Injection port 312: Dissolution chamber 310b : Slide groove 313 : First cleaning chamber 314: Second washing chamber 315: Elution chamber 316: Reagent Chamber 317: Air Inlet 318: Solution outlet 319: Valve coupling groove 320 : Syringe tube 321 : Passage 322 : Euro 330 : Rotary valve 331: Shaft coupling groove 332: Air exhaust groove 340: Cartridge Euro 341: Mixing Chamber Euro 342: Dissolution Chamber Flow Path 343: First Washing Chamber Flow Path 344: Second washing chamber flow path 345: Elution chamber flow path 346: Reagent chamber flow path 347: Solution outflow flow path 348 : Air intake path 350 : Valve path 351: Chamber connection channel 351a: Lamination channel 351b: Branch passage 352: Air exhaust passage 10 : Magnetic bead 1 : Smartphone

Claims

Claim 1 delete Claim 2 A cartridge coupled to a microfluidic chip; a fluid flow unit for flowing fluid between the microfluidic chip and the cartridge; and a magnetic body rotation unit for rotating a magnetic body and positioning it on the side of the cartridge; wherein the cartridge comprises: a chamber block coupled to the microfluidic chip and having a plurality of chambers formed therein for injecting a solution and a plurality of magnetic beads; a syringe tube installed in the chamber block and communicating with the chambers; and a rotary valve installed in the chamber block and communicating with the chambers or the microfluidic chip; wherein a plunger is inserted inside the syringe tube, and the plunger moves linearly along the length of the syringe tube to form positive or negative pressure inside the chambers; and the magnetic body rotation unit comprises a motor; A gene analysis device comprising: a rotating rod having one end fixed to the rotating shaft of the motor and the other end fixed to the magnetic body; wherein the motor rotates the rotating rod so that the magnetic body is disposed on the outer surface of the chamber block or separated from the outer surface of the chamber block, and when the magnetic body is disposed on the outer surface of the chamber block, the magnetic bead adheres to the inner surface of the chamber block. Claim 3 In claim 2, the microfluidic chip and cartridge are a gene analysis device manufactured by a 3D printer. Claim 4 delete Claim 5 In claim 2, the cartridge is a gene analysis device in which a slide groove is formed along the height direction of the chamber block on the side of the chamber block, and the side end of the microfluidic chip is coupled thereto. Claim 6 In claim 2, the cartridge is a gene analysis device having a valve coupling groove formed at the bottom of the chamber block along the height direction of the chamber block, and a plurality of cartridge flow paths formed inside the chamber block and communicating with the valve coupling groove. Claim 7 In claim 6, the cartridge flow path is a gene analysis device disposed on the inner circumference of the valve coupling groove, spaced apart from each other by 60 degrees along the circumference of the valve coupling groove with respect to the center of the valve coupling groove. Claim 8 In claim 6, the cartridge is a gene analysis device in which a valve passage is formed inside the rotary valve and communicates with the cartridge passage. Claim 9 In claim 8, the valve passage comprises: a chamber connection passage formed at the upper part of the rotary valve; and an air discharge passage formed at the lower part of the rotary valve; a gene analysis device. Claim 10 In claim 9, the chamber connecting passage comprises: a combined passage formed extending a certain length from the upper surface of the rotary valve along the longitudinal direction of the rotary valve; and a pair of branched passages branched from the combined passage and formed extending to the outer surface of the rotary valve along the diametric direction of the rotary valve. Claim 11 A gene analysis device according to claim 10, wherein the angle between the branching channels is formed at 150 degrees. Claim 12 In claim 2, the fluid flow section comprises: a valve rotating section that rotates the rotary valve in conjunction with the rotary valve; and a plunger transfer section that linearly moves the plunger along the longitudinal direction of the syringe tube, wherein a plunger inserted into the syringe tube is installed. Claim 13 A gene analysis device according to claim 2, further comprising: a heater disposed opposite to the microfluidic chip; and a cooling fan disposed opposite to the heater. Claim 14 A gene analysis device according to claim 2, further comprising: an image sensor disposed opposite to the microfluidic chip and generating image information by photographing the microfluidic chip at regular time intervals; and a control unit that analyzes a fluorescence signal generated from the microfluidic chip based on the image information and transmits it externally.

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