TWM580591U - Nucleic acid analysis apparatus - Google Patents

Abstract

The nucleic acid analysis device includes a housing, a main frame, a fluid delivery unit, a temperature control unit, a drive unit, and an optical unit. The housing includes an upper housing and a lower housing. The main frame body is disposed in the lower casing and has a chamber for mounting the cassette therein. The fluid delivery unit is disposed in the lower housing and coupled to the main frame, and is adapted to transport reagents in the cassette for sample purification and/or nucleic acid extraction. The temperature control unit is disposed on the main frame and is adapted to provide a preset temperature for nucleic acid amplification. The driving unit is disposed in the lower casing and connected to the main frame body, and includes a motion control unit for applying pressure to the cassette during sample purification and/or nucleic acid extraction, and pre-nucleating during nucleic acid amplification and/or detection. Set the program to rotate the cassette. The optical unit is disposed on the main frame and includes a plurality of optical elements for detection.

Description

Nucleic acid analysis device

The present invention relates to a nucleic acid analysis device, and more particularly to a full-in-one nucleic acid analysis device.

The Point of Care (POC) test is an analytical method performed outside a central hospital or laboratory and is performed using a device that can interpret the results immediately. Because of the globalization trend, new or re-emerging infectious diseases have exploded, and their speed from epidemic-to-pandemic has been accelerated, and in the face of such threats, decentralization in front-line clinical disposal Diagnostic tests will help to implement early public health events to mitigate the severity of the incident. In developing countries, due to the lack of clinical laboratory infrastructure and financial constraints, the diagnosis is not easy to add to the burden of highly infectious diseases. If the POC test can be used, it will help to improve the situation.

In recent years, some POC devices have been developed for molecular diagnostics of nucleic acid amplification in an isothermal manner, using disposable cartridges that are installed in the device for fluid processing and can then be lifted and freely rotated to Perform amplification and multi-channel optical detection. In this design, the cassette is housed in the bottom slot of the device and the drive unit is mounted to the top slot. Since the drive unit utilizes a stepper motor with a high holding torque to achieve the predetermined actuation of the cassette, the overall cost, size, weight and power input of the device is increased. Furthermore, when the drive unit is mounted in the top trough, the device has top and bottom portions of nearly the same size, so that the heavy top may present a potential risk of device flipping during operation, and the user must be careful during the cassette installation Supporting the top of the ground is unacceptable in reality.

Therefore, in order to improve the lack of prior art, it is necessary to provide an improved POC device.

An object of an embodiment of the present invention is to provide a full-featured integrated nucleic acid analysis device, such that sample purification, nucleic acid extraction, nucleic acid amplification, and nucleic acid detection processes can be performed on the fully functional integrated device. Instant nucleic acid analysis.

Another object of an embodiment of the present invention is to provide a nucleic acid analysis device that can simultaneously detect a plurality of targets.

It is still another object of an embodiment of the present invention to provide a nucleic acid analysis device having a simplified structural design, improved heating efficiency, and smooth fluid handling.

To achieve the above object, the present invention provides a nucleic acid analysis device comprising a housing, a main frame, a fluid delivery unit, a temperature control unit, a drive unit and at least one optical unit. The housing includes an upper housing and a lower housing. The main frame body is disposed in the lower casing and has a chamber for mounting a card therein. The fluid delivery unit is disposed in the lower housing and connected to the main frame, and is adapted to transport reagents in the cassette for sample purification and/or nucleic acid extraction. The temperature control unit is disposed on the main frame of the lower casing and is adapted to provide a preset temperature for nucleic acid amplification. The driving unit is disposed in the lower casing and connected to the main frame body, and the driving unit includes a motion control unit, which can press the card during the purification and/or nucleic acid extraction of the sample, and perform nucleic acid amplification and/or detection. Rotate the cassette with a preset program during the period. The optical unit is disposed on the main frame of the lower casing and includes a plurality of optical components for detecting.

In an embodiment, the drive unit further includes a stepper motor that actuates the rotation of the motion control unit by gearing.

In an embodiment, the motion control unit includes at least one protrusion, the cassette includes at least one guide groove, and the protrusion is slidable in the guide groove.

In an embodiment, the guide groove includes a vertical groove and an inclined groove.

In one embodiment, the nucleic acid analysis device further includes a fluid connector disposed between the main frame and the fluid delivery unit, and a spring support member is mounted on the fluid connector.

In one embodiment, one of the motion control units is rotated forward so that the cassette is locked and in close contact with the fluid connector.

In one embodiment, one of the motion control units is rotated in a reverse direction such that the cassette is springed up by the spring support member and separated from the fluid connector and rotated according to a predetermined sequence.

In one embodiment, the motion control unit includes a plurality of balls that are received in an annular groove of the main frame.

In an embodiment, the nucleic acid analysis device further includes a sensor for recognizing the position of the cassette.

In one embodiment, the nucleic acid analysis device further includes an indicator that flashes when the cassette is depressed to the terminal to notify the user to release his hand.

In one embodiment, the cassette includes a reactive wafer and a cassette body, and the reactive wafer is disposed on one side of the cassette body.

In one embodiment, the reactive wafer is a planar fluid wafer comprising a plurality of detection grooves and at least one micro flow channel connecting the detection grooves.

In one embodiment, the shape of the reaction wafer is substantially a regular polygon, and each of the detection grooves has at least one plane.

In one embodiment, the main frame further includes at least one positioning member, and the reaction wafer includes at least one pair of bit grooves that are opposite to at least one of the positioning members on the main frame.

In one embodiment, the cassette body includes a plurality of slots for storing reagents for sample purification and nucleic acid extraction.

In one embodiment, the reactive wafer further includes at least one sample loading hole disposed on a top surface thereof for adding the sample to the cassette.

In one embodiment, the temperature control unit carries a reaction wafer thereon for heating.

In an embodiment, the optical unit includes a light source and a light detector.

In an embodiment, the nucleic acid analysis device includes a plurality of optical units, wherein each optical unit provides light of a unique wavelength to detect a plurality of targets.

In one embodiment, the nucleic acid analysis device further includes a touch screen disposed on the lower housing and having an adjustable operating angle.

Some embodiments embodying the features and advantages of the present invention are described in detail in the following description. It should be understood that the present invention is capable of various modifications in the various aspects of the present invention, and the description and drawings are intended to be illustrative, rather than limiting the present invention.

The present invention provides a full-in-one nucleic acid analysis device that integrates a fluid delivery unit, a temperature control unit, a driving unit, and at least one optical unit on a single device to facilitate sample purification and nucleic acid extraction. Processes such as nucleic acid amplification and nucleic acid detection can be performed on this fully functional integrated device for real-time nucleic acid analysis.

1 and 2 are schematic views of the nucleic acid analysis device of the embodiment of the present invention, wherein the nucleic acid analysis device of FIG. 1 is in an open state and the cassette is removed from the nucleic acid analysis device, and FIG. 2 removes the outer casing of the nucleic acid analysis device, and Other components such as wires, pipe connections, and PCBs are not shown to more clearly show the internal structure of the nucleic acid analysis device. As shown in FIGS. 1 and 2, the nucleic acid analysis device 10 includes a housing 1, a main housing 2, a fluid delivery unit 3, a temperature control unit 4, a driving unit 5, and at least one optical unit 6. The housing 1 includes an upper housing 11 and a lower housing 12, and the main housing 2, the fluid delivery unit 3, the temperature control unit 4, the driving unit 5, and at least one optical unit 6 are disposed in the lower housing 12. The main frame 2 has a chamber 21 which is specifically designed for mounting a cassette 7 therein. The fluid delivery unit 3 is coupled to the main housing 2 and is adapted to deliver reagents in the cartridge 7 for sample purification and/or nucleic acid extraction. The temperature control unit 4 is disposed on the main frame 2 and is adapted to provide a predetermined temperature for nucleic acid amplification. The driving unit 5 is connected to the main frame 2 and includes a motion control unit 52, wherein the motion control unit 52 can press the cassette 7 toward the fluid transport unit 3 during sample purification and/or nucleic acid extraction, and expand the nucleic acid The cassette 7 is rotated by a preset program during the addition and/or detection. At least one optical unit 6 is disposed on the main frame 2 and includes a plurality of optical elements for detecting, such as nucleic acid detection or sample reaction detection.

In one embodiment, the nucleic acid analysis device 10 further includes a controller, such as a micro control unit (MCU), to control the operation of the fluid delivery unit 3, the temperature control unit 4, the drive unit 5, and the optical unit 6.

In an embodiment, the upper casing 11 and the lower casing 12 are connected by a hinge, but are not limited thereto. The upper casing 11 can be opened such that the cassette 7 can be placed in the chamber 21 of the main casing 2, and when the upper casing 11 is closed, a closed space is formed in the casing 1.

Figures 3 and 4 show the cassettes at different angles. As shown in FIGS. 3 and 4, the cassette 7 includes a cassette body 71 and a reaction wafer 72, and the reaction wafer 72 is disposed on one side of the cassette body 71, such as the top of the cassette body 71. The reaction wafer 72 is a planar fluid wafer and includes a plurality of detection grooves 721 and at least one micro flow channel 722 connected to the detection groove 721. In one embodiment, the detection tank 721 has reagents for nucleic acid amplification and/or detection. For example, the detection slot 721 can be coated with reagents for nucleic acid amplification and/or detection, such as reagents comprising different fluorescent dyes.

The number of detection slots 721 is not limited, and can be as many as 40 or more slots, so the device of the present invention can perform nucleic acid analysis of multiplexing. In one embodiment, the shape of the reactive wafer 72 is substantially a regular polygon such that the reactive wafer 72 has a plurality of planar sides that are linearly aligned with the optical unit 6 to aid in light focusing. Of course, the shape of the reaction wafer 72 is not limited to a regular polygon, which may be circular or other shape, because the arrangement of the optical elements transmitted through the optical unit 6 may also focus the light on the sample in the detection groove 721.

In one embodiment, the reaction wafer 72 further includes at least one pair of bit grooves 723, and the main frame body 2 further includes at least one positioning member 22 (as shown in FIG. 5), and the positioning member 22 includes, for example, a positioning pin. When the cassette 7 is placed in the chamber 21 of the main frame 2, the alignment groove 723 of the cassette 7 is used to align the positioning member 22 of the main frame 2, which helps the cassette 7 to be more easily loaded and transmitted. In this alignment, the cassette 7 can be self-aligned with the fluid delivery unit 3, and each optical unit 6 is aligned with one of the detection slots 721. In an embodiment, each detection slot 721 has at least one plane. For example, the shape of the detecting groove 721 may be a rectangle, and during the nucleic acid detecting process, the detecting groove 721 has a plane and a linear detector of the optical unit 6 .

The cassette body 71 includes a plurality of slots 711 that store reagents for sample purification and/or nucleic acid extraction. The cassette body 71 also includes a plurality of flow channels that are coupled to the slots 711 for fluid delivery. In an embodiment, the cassette body 71 can be, but not limited to, a cylindrical body. The cassette body 71 further includes a plurality of openings 712 disposed on the bottom surface of the cassette body 71, and the opening 712 is communicated with the slot 711 through the flow path. The shape of the opening 712 can be, but is not limited to, a circle, a line, or other regular or irregular shape.

The reaction wafer 72 further includes at least one sample loading hole 724 disposed on the top surface of the reaction wafer 72, and the sample loading hole 724 is aligned and communicated with at least one groove 711 of the cassette body 71 for adding the sample to the sample. Card 7 in.

During operation, once the sample is loaded, the sample loading hole 724 is sealed, and the cassette 7 is placed in the chamber 21 of the nucleic acid analysis device 10 and is in close contact with the fluid delivery unit 3 to avoid leakage. . Fluid treatment is then carried out by the fluid delivery unit 3. The fluid transport unit 3 operates simultaneously with the cassette 7 for sample purification, nucleic acid extraction, and fluid transport to achieve a fully automated device. Fluid delivery may be via pneumatic, vacuum, plunger, chamber deformation, thermal-induced expansion, acoustics, centrifugal force, or the like. The method of completing the sample processing in the cassette body 71 is realized.

In one embodiment, the flow system is pneumatically driven via microchannels and holes. For example, the fluid delivery unit 3 is similar to the fluid integration module described in the Taiwan Patent Application No. 105123156 (Patent Publication No. I641823) filed on July 22, 2016, the entire contents of This is not disclosed here as a disclosure. Briefly, the fluid delivery unit 3 of the embodiment of the present invention includes the fluid manifold portion, the rotary valve stator, the rotary valve rotor, the rotary valve housing, and the fluid source described in Taiwan Patent Publication No. I641823. The fluid manifold has a plurality of microchannels that are connected to the slots 711 of the cassette 7 via the bottom opening 712 of the cassette 7. Since the rotary valve stator and the perforation and/or the groove on the rotary valve rotor have a corresponding alignment relationship when the rotary valve rotor rotates, when the rotary valve rotor rotates to different positions, the multiple fluid paths can be switched, and then Regulate the fluid operation of the cassette 7. Therefore, the reagent stored in the cassette 7 can be transported to the position to be transported by the aerodynamic force provided by the pump of the fluid transport unit 3, thereby automatically performing the sample purification and nucleic acid extraction processes. Of course, the fluid delivery unit is not limited to the above design, and any other form of fluid delivery unit can achieve the multiple fluid delivery and path switching functions in the cassette 7 without departing from the scope disclosed herein.

Fig. 5 is a view showing a part of the internal structure of the nucleic acid analyzing device, and Fig. 6 is a view showing the structure shown in Fig. 5 and the cassette attached thereto. As shown in FIGS. 5 and 6, the temperature control unit 4 is disposed on the main frame 2 and includes a heater 41 and a heat sink 42. In one embodiment, heater 41 is a metal heating element having a temperature control algorithm, and heat sink 42 includes a plurality of fins that are mounted on heater 41 and arranged in a ring to accelerate thermal energy dissipation. The heater 41 has a central hole, and the diameter of the central hole is slightly larger than the diameter of the cassette body 71 of the cassette 7, so that the cassette 7 can be easily installed therein. When the cassette 7 is mounted in the chamber 21, the temperature control unit 4 carries the reaction wafer 72 thereon, and the reaction wafer 72 is in contact with the heater 41 and surrounded by the heat sink 42. Since the reaction wafer 72 is in direct contact with the temperature control unit 4 and heated by contact heating, the nucleic acid analysis device 10 of the present invention has excellent heating efficiency and reduced heating time.

In one embodiment, the nucleic acid analysis device 10 of the present invention is designed for nucleic acid amplification in an isothermal manner, so that only a fixed temperature is required, and no thermal cycle control of three different temperature intervals is required, therefore, temperature control Unit 4 can be significantly simplified. Further, the chamber 21 of the nucleic acid analysis device 10 is designed to have good thermal insulation, which makes the internal temperature easy to maintain. Once the chamber 21 is in a uniform temperature environment, heat dissipation from the detection tank 721 and the sample flow to the environment can be minimized, and during the nucleic acid amplification and/or detection process, whether the cassette 7 is rotating Or at rest, the entire closed chamber 21 and the sample in each of the detection tanks 721 have substantially the same temperature.

The temperature control unit 4 is required to provide the temperature required inside the chamber 21 during operation, wherein the temperature control is not affected by the number and shape of the detecting grooves 721. In an embodiment, the temperature control unit 4 further includes at least one temperature sensor for controlling the accuracy of the temperature.

Figure 7 shows the structural relationship between the drive unit and the cassette. The driving unit 5 includes but is not limited to a motor, and may also be an electromagnetic device, a manual operation, a spring, a clockwork device or other components as long as it can clamp and rotate the cassette 7 at a preset angle and speed, and each Detector The slots 721 pass sequentially and are located in each optical unit 6. In an embodiment, the drive unit 5 includes a stepper motor 51 that can drive the rotation of the cassette 7 in different modes. The drive unit 5 further includes a motion control unit 52 adapted to clamp and rotate the cassette 7 during nucleic acid amplification and/or detection, and in the cassette 7 and fluid during sample purification and/or nucleic acid extraction. A good sealing effect is provided between the conveying units 3. In an embodiment, the motion control unit 52 is an annular motion control unit, and the motion control unit 52 has a central hole, and the diameter of the central hole is slightly larger than the diameter of the cassette body 71, so that the cassette 7 can be easily installed therein, and The cassette 7 can be rotated as required.

Motion control unit 52 may be actuated by stepper motor 51 via gears, belts, chains, racks, worms, or other mechanical transmission mechanisms. In one embodiment, the motion control unit 52 is a motion control gear, and the drive unit 5 further includes a driven gear 53 that is coupled to the stepper motor 51 via a shaft 54. The motion control unit 52 meshes with the driven gear 53, and the stepping motor 51 drives the rotation of the driven gear 53 and the motion control unit 52, thereby driving the movement and rotation of the cassette 7 held by the motion control unit 52.

Figures 8A and 8B show the configuration of the motion control unit on the main frame. The motion control unit 52 includes a plurality of balls 521 placed in corresponding circular holes having a defined diameter. Accordingly, the main frame body 2 has an annular groove 23 that accommodates the balls 521 of the motion control unit 52 and limits the trajectory of the motion control unit 52. When the motion control unit 52 is in operation, the ball 521 and the annular groove 23 on the main frame 2 allow the motion control unit 52 to accurately rotate concentrically according to the central axis. The balls 521 of the motion control unit 52 also minimize friction during operation and eliminate the use of bearings or other lubricants. In an embodiment, the motion control unit 52 and the cassette 7 are each designed to have two corresponding structures for controlling the movement of the cassette 7. For example, the motion control unit 52 further includes at least one protrusion 522, such as a positioning pin or the like, and the movement of the cassette 7 can be controlled by providing a corresponding groove-like structure on the cassette body 71.

As shown in FIG. 3, the cassette 7 includes at least one guide groove 73 provided on the outer surface of the cassette body 71, and the guide groove 73 can operate together with the protrusion 522 of the motion control unit 52 to control the cassette 7 motion. In one embodiment, the guide groove 73 includes a vertical groove 731 and a sloped groove 732, wherein the vertical groove 731 extends perpendicularly from the bottom of the cassette 7, and the inclined groove 732 is inclined and raised from the top end of the vertical groove 731. Extend the ground. The motion control unit 52 is initially located at a starting position that allows the cassette to be installed. When the cassette 7 is installed into the chamber 21 by the user, the vertical groove 731 cooperates with the protrusion 522 of the motion control unit 52 so that the cassette 7 can be slid to the end position, that is, the bottom surface of the cassette 7 and the fluid transport The location where unit 3 is in contact. Subsequently, the stepping motor 51 actuates the motion control unit 52 such that the protrusion 522 of the motion control unit 52 rotates along the inclined groove 732 on the cassette 7, thereby pressing down and locking the cassette 7.

In one embodiment, the motion control unit 52 includes two symmetric protrusions 522, and accordingly, the cassette 7 also includes two symmetric guide grooves 73. Of course, the number of the protrusions 522 and the guide grooves 73 is not limited to two.

Figures 9A through 9F show the workflow for completing a full-featured integrated detection based on isothermal amplification. For ease of explanation, only the main components are shown in the figure and some of the structure of the motion control unit is hidden. At the bottom of the chamber 21, a spring support member 81 is fitted over the fluid connector 82 between the main frame 2 and the fluid delivery unit 3. First, the user adds the collected sample to the cassette 7 and mounts the cassette in the chamber 21. At this time, the guide groove 73 of the cassette 7 is aligned with the protrusion 522 of the motion control unit 52 (as shown in FIG. 9A), and the protrusion 522 of the motion control unit 52 is movable along the vertical groove 731, so that the cassette 7 Swipe down to the terminal. After the cassette 7 is installed, the user presses the cassette 7 down until it contacts the fluid connector 82 (as shown in Figure 9B).

In one embodiment, the bottom of the chamber 21 can be embedded with a sensor to identify the position of the cassette 7, and provide feedback as long as the cassette 7 is depressed to contact the fluid connector 82. At this time, the protrusion 522 of the motion control unit 52 reaches the highest point of the vertical groove 731, that is, the cassette 7 is pressed to the terminal, and then the motion control unit 52 is activated to lock the cassette 7. In addition, an indicator, such as an LED, will flash to inform the user to release his hand. With this design, the cassette 7 is mounted by the user's hand, so that the drive motor torque can be minimized.

When the cassette 7 is depressed to the terminal, a signal is sent to the micro control unit, and then the step motor 51 is triggered so that the motion control unit 52 can be rotated forward and the protrusion 522 can be tilted along the cassette 7. The groove 732 slides (as shown in Fig. 9C). Therefore, the cassette 7 is further pressed downward, and the spring supporting member 81 is compressed (as shown in Fig. 9D). Accordingly, the cassette 7 is locked by the motion control unit 52 and slightly squeezed to ensure close contact with the fluid connector 82. Subsequently, sample preparation and nucleic acid extraction will be performed.

After the sample having the extracted nucleic acid is dispensed to the detecting groove 721 of the cassette 7 and heated to a predetermined temperature, the motion control unit 52 performs a reverse rotation, and the protrusion 522 moves rearward along the inclined groove 732 (Fig. 9E). Shown) until reaching the vertical ditch 731. When the projection 522 reaches the vertical groove 731, the cassette 7 will be bounced by the spring support member 81 and separated from the fluid connector 82 by a predetermined distance D (as shown in Fig. 9F). In an embodiment, the distance D may be 0.5-5 mm, and preferably 0.5-3 mm. Therefore, the friction between the interfaces is minimized, and the reaction wafer 72 of the cassette 7 is lifted above the positioning member 22, so that the cassette 7 can be freely rotated in the chamber 21 during nucleic acid amplification and detection. .

During the nucleic acid amplification and detection phase, since the cassette 7 is now constrained by the projection 522, further reverse rotation of the motion control unit 52 will drive the rotation of the cassette 7. Therefore, the cassette 7 can be rotated by the motion control unit 52 according to a predetermined program, so that the detecting slot 721 and each optical unit 6 are sequentially aligned for nucleic acid detection until the detection is completed.

In an embodiment, the nucleic acid analysis device 10 includes a plurality of optical units 6. The optical unit 6 includes optical elements such as a light source, a lens, a filter, and a photodetector to enable optical detection so that the sample can be detected instantaneously during nucleic acid amplification. The optical unit 6 can include at least one light source 61 and at least one light detector 62 (as shown in FIG. 1). In one embodiment, the light source 61 can be, but not limited to, a light emitting diode (LED), and the photodetector 62 can be, but not limited to, a photodiode. During operation, each light source 61 is aligned with one of the detection slots 721 to provide an effective light source for detection, and each of the light detectors 62 is aligned with one of the detection slots 721. To detect and obtain the analysis results. The rotation of the cassette 7 allows each detection slot 721 to sequentially pass through different optical units 6. In one embodiment, each optical unit 6 can provide a unique wavelength of light, thereby providing different colors of light for fluorescence detection, enabling the nucleic acid analysis device 10 to simultaneously detect multiple targets and achieve multiple detections. (multiplexing detection).

Due to the isothermal amplification mode, the temperature control unit 4 can be significantly simplified, and thus the nucleic acid analysis device 10 can be made compact, even smaller than a typical teacup. In one embodiment, the nucleic acid analysis device 10 has a height between 100 mm and 200 mm and a width between 80 mm and 120 mm. Since the nucleic acid analysis device 10 is a teacup size, it is quite portable and suitable for POC diagnosis.

Further, by reconfiguring the drive unit 5 and the motion control unit 52 to the lower casing 12, the size and weight of the top of the nucleic acid analysis device 10 are reduced. Figure 10 shows another schematic diagram of the nucleic acid analysis device. As shown in FIGS. 1 and 10, the nucleic acid analysis device 10 further includes a touch screen 13 disposed on the lower casing 12 for user operation and result display. Since the lower casing 12 is enlarged, the size of the touch screen 13 can also be increased. The touch screen 13 on the nucleic acid analysis device 10 of the present invention can be increased to a larger size than the conventional top-mounted touch screen. Moreover, the touch screen 13 is designed to have an adjustable operating angle for the user to view and operate.

In one embodiment, the nucleic acid analysis device 10 is designed for isothermal amplification and can be used to perform all isothermal amplification methods, such as nucleic acid sequence-based amplification (NASBA), chains. Strand displacement amplification (SDA), helicase-dependent amplification (HAD), loop-mediated isothermal amplification (LAMP), recombinase polymerase amplification Recombinase polymerase amplification (RPA), and nicking enzyme amplification reaction (NEAR).

In another embodiment, nucleic acid analysis device 10 can also be designed for PCR amplification. For example, the spring support member 81 can be configured with a heater therein to provide another temperature interval.

In summary, the embodiment of the present invention provides a full-featured integrated nucleic acid analysis device, which integrates a fluid delivery unit, a temperature control unit, a driving unit, and an optical unit on a single device to enable sample purification, nucleic acid extraction, and nucleic acid. Processes such as amplification and nucleic acid detection can be performed on this fully functional integrated device for real-time nucleic acid analysis. Therefore, the nucleic acid analysis device of the present invention provides a simple and rapid nucleic acid analysis. Moreover, since the temperature control unit is significantly simplified, the nucleic acid analysis device can be compactly designed, thus being portable and suitable for POC diagnosis. Also, since the cassette pressing system is operated by the user's hand, the nucleic acid analyzing device can reduce the motor size of the motion control unit. Furthermore, by reconfiguring the drive unit and the motion control unit to the lower housing, the size and weight of the top of the nucleic acid analysis device are reduced. Moreover, the touch screen disposed on the lower casing can be enlarged and has an adjustable operating angle for the user to view and operate.

Even though the present invention has been described in detail by the above-described embodiments, it can be modified by those skilled in the art, and is not intended to be protected by the scope of the appended claims.

10‧‧‧Nucleic acid analyzer

1‧‧‧shell

11‧‧‧Upper casing

12‧‧‧ Lower case

13‧‧‧Touch screen

2‧‧‧Main frame

21‧‧‧ chamber

22‧‧‧ Positioning parts

23‧‧‧ annular groove

3‧‧‧Fluid transport unit

4‧‧‧ Temperature Control Unit

41‧‧‧heater

42‧‧‧heatsink

5‧‧‧ drive unit

51‧‧‧Stepper motor

52‧‧‧Motion Control Unit

521‧‧‧ balls

522‧‧‧ protrusion

53‧‧‧ driven gear

54‧‧‧Axis

6‧‧‧ Optical unit

61‧‧‧Light source

62‧‧‧Photodetector

7‧‧‧Carmen

71‧‧‧ card body

711‧‧‧ slot

712‧‧‧ openings

72‧‧‧Reactive wafer

721‧‧‧Detection slot

722‧‧‧Microchannel

723‧‧‧ alignment slot

724‧‧‧Sample loading hole

73‧‧‧Guide

731‧‧‧ vertical ditch

732‧‧‧ inclined trench

81‧‧‧Spring support parts

82‧‧‧Fluid connector

D‧‧‧Distance

Fig. 1 and Fig. 2 are schematic views showing the nucleic acid analysis device of the embodiment of the present invention. Figures 3 and 4 show the cassettes at different angles. Fig. 5 is a view showing a part of the internal structure of the nucleic acid analysis device. Figure 6 shows the structure shown in Figure 5 and the cassette attached thereto. Figure 7 shows the structural relationship between the drive unit and the cassette. Figures 8A and 8B show the configuration of the motion control unit on the main frame. Figures 9A through 9F show the workflow for completing a full-featured integrated detection based on isothermal amplification. Figure 10 shows another schematic diagram of the nucleic acid analysis device.

Claims (20)

A nucleic acid analysis device comprising: a housing comprising an upper housing and a lower housing; a main frame disposed in the lower housing and having a chamber for mounting a latch therein: a fluid transport a unit, disposed in the lower casing and connected to the main frame, adapted to transport the reagent in the cassette for sample purification and/or nucleic acid extraction; a temperature control unit disposed in the lower casing The main frame is adapted to provide a preset temperature for nucleic acid amplification; a driving unit is disposed in the lower casing and connected to the main frame, the driving unit includes a motion control unit Pressing the cassette during sample purification and/or nucleic acid extraction, and rotating the cassette during a nucleic acid amplification and/or detection by a predetermined program; and at least one optical unit disposed in the lower housing The main frame body includes a plurality of optical components for detection. The nucleic acid analysis device of claim 1, wherein the driving unit further comprises a stepping motor that actuates rotation of the motion control unit by gear transmission. The nucleic acid analysis device of claim 2, wherein the motion control unit comprises at least one protrusion, the cassette includes at least one guide groove, and the protrusion is slidable in the guide groove. The nucleic acid analysis device according to claim 3, wherein the guide groove comprises a vertical groove and an inclined groove. The nucleic acid analysis device of claim 3, wherein the nucleic acid analysis device further comprises a fluid connector disposed between the main frame and the fluid transport unit, and a spring support member is mounted on the fluid connection On the device. The nucleic acid analysis device of claim 5, wherein one of the motion control units is rotated forward such that the cassette is locked and in close contact with the fluid connector. The nucleic acid analysis device according to claim 6, wherein one of the motion control units is reversely rotated such that the cassette is bounced by the spring support member, separated from the fluid connector, and rotated according to the predetermined program . The nucleic acid analysis device of claim 2, wherein the motion control unit comprises a plurality of balls housed in an annular groove of the main frame. The nucleic acid analysis device of claim 1, wherein the nucleic acid analysis device further comprises a sensor for recognizing the position of the cassette. The nucleic acid analysis device of claim 1, wherein the nucleic acid analysis device further comprises an indicator that blinks when the cassette is pressed down to the terminal to notify the user to release his hand. The nucleic acid analysis device of claim 1, wherein the cassette comprises a reaction wafer and a cassette body, and the reaction wafer is disposed on one side of the cassette body. The nucleic acid analysis device of claim 11, wherein the reaction wafer is a planar fluid wafer comprising a plurality of detection grooves and at least one micro flow channel connecting the detection grooves. The nucleic acid analysis device according to claim 12, wherein the reaction wafer has a shape of a substantially regular polygon, and each of the detection grooves has at least one plane. The nucleic acid analysis device of claim 11, wherein the main frame further comprises at least one positioning member, and the reaction wafer comprises at least one pair of bit grooves, and the at least one of the main frame bodies The positioning parts are opposite positions. The nucleic acid analysis device according to claim 11, wherein the cartridge body comprises a plurality of grooves for storing reagents for sample purification and nucleic acid extraction. The nucleic acid analysis device of claim 11, wherein the reaction wafer further comprises at least one sample loading hole disposed on a top surface thereof for adding a sample to the cassette. The nucleic acid analysis device according to claim 11, wherein the temperature control unit carries the reaction wafer thereon for heating. The nucleic acid analysis device of claim 1, wherein the optical unit comprises a light source and a photodetector. The nucleic acid analysis device of claim 1, wherein the nucleic acid analysis device comprises a plurality of optical units, wherein each optical unit provides light of a unique wavelength to detect a plurality of targets. The nucleic acid analysis device of claim 1, wherein the nucleic acid analysis device further comprises a touch screen disposed on the lower casing and having an adjustable operating angle.