WO2020057192A1

WO2020057192A1 - Nucleic acid amplification detection device and diagnostic analyzer

Info

Publication number: WO2020057192A1
Application number: PCT/CN2019/091417
Authority: WO
Inventors: 张中; 丁永军; 孙飞; 刘振宇; 张国秀; 高阳; 孙家振
Original assignee: 基蛋生物科技股份有限公司
Priority date: 2018-09-19
Filing date: 2019-06-14
Publication date: 2020-03-26
Also published as: CN109182117A

Abstract

The present application provides a nucleic acid amplification detection device and a diagnostic analyzer, pertaining to the field of analysis and detection equipment. The device comprises a microchip, a detection device, and a transfer assembly. The detection device comprises a thermal cycling system and a real-time signal detection system. The thermal cycling system is used to provide appropriate temperatures for nucleic acid amplification of a sample in the microchip. The real-time signal detection system is used to perform fluorescence detection on a sample having undergone nucleic acid amplification. The transfer assembly is used to grasp the microchip and transfer the microchip to a detection area of the detection device. The device is simple to operate and can perform nucleic acid amplification and fluorescence detection simultaneously, greatly facilitating the detection of samples to be used for PCR processing. The microchip is transferred to the detection device by means of the transfer assembly to perform amplification and detection, and the nucleic acid amplification detection device has a high degree of automation to facilitate improved detection efficiency.

Description

Nucleic acid amplification detection device and diagnostic analyzer

This application claims the priority of a Chinese patent application filed on September 19, 2018 with the Chinese Patent Office, application number 2018110938806, and invention name "Nucleic Acid Amplification Detection Device and Diagnostic Analyzer", the entire contents of which are incorporated herein by reference. In this application.

Technical field

The present application relates to the field of analysis and detection equipment, and in particular, to a nucleic acid amplification detection device and a diagnostic analyzer.

Background technique

The medical diagnostic industry is a key factor in the foundation of health care today. However, no matter what route, in vitro diagnostic analysis has become a bottleneck for patient care. There are several reasons for this. First, many diagnostic analyses are performed only with highly specialized equipment, which is expensive and can only be performed by trained clinicians. Such devices are found in only one location, often in only one in any given urban area. This means that most hospitals need to send samples to these locations for analysis, thus incurring transportation costs and delays, and may even be lost or improperly functioning. Second, the equipment in question is generally not available when needed, but runs in batches, so processing time is delayed for many samples because they have to wait for the machine to fill up before they can run.

Understanding that the sample stream is broken down into several key steps, what is desirable is an automated way. For example, once extracted from a patient, the biological sample must be placed in a form suitable for using a PCR processing protocol to amplify the vector of interest. Preparing samples for PCR is currently a time-consuming and labor-intensive step, although no one needs specialized skills. However, more and more automated extraction and detection devices are required.

Summary of the Invention

The purpose of the present application is to provide a nucleic acid amplification detection device that solves the problem of inconvenient detection of existing samples for PCR processing.

Another object of the present application is to provide a diagnostic analyzer that can be used for PCR-processed sample detection and is convenient to operate.

In order to achieve the foregoing objective, the technical solutions adopted in the embodiments of the present application are as follows:

A nucleic acid amplification detection device includes a microchip, which is used to hold a plurality of samples to be detected; a detection device, the detection device includes a thermal cycle system and a real-time signal detection system, and the thermal cycle system is used for the microchip Provide suitable temperature for nucleic acid amplification of samples; real-time signal detection system for fluorescence detection of samples after nucleic acid amplification; and transport components for grasping microchips and transferring microchips to detection Detection area of the device.

In a preferred embodiment of the present application, a plurality of channels are provided on the microchip, and each channel is used to accommodate a sample.

In a preferred embodiment of the present application, a wax seal is provided in the microchip. When the microchip is placed in a detection device for heating, the wax seal is automatically sealed.

In a preferred embodiment of the present application, the moving component includes a robot arm for grasping the microchip and a rotary arm for transferring the microchip to the detection area; the rotary arm is connected to the robot arm.

In a preferred embodiment of the present application, the manipulator includes a mounting plate, a first grabbing piece, and a second grabbing piece; the first grabbing piece and the second grabbing piece are disposed on opposite sides of the mounting plate, and the first grabbing piece and the second The grasping pieces can be close to or away from each other with respect to the mounting plate to grasp or loosen the microchip.

In a preferred embodiment of the present application, a first driving mechanism is provided on the mounting plate, and the first driving mechanism is drivingly connected to the first and second grasping pieces. The first driving mechanism is configured to drive the first grasping piece The film and the second gripper move relative to each other.

In a preferred embodiment of the present application, the rotating arm includes a first arm body and a second arm body; the first arm body has a first end and an opposite second end; and the second arm body is installed at the first end by a lifting component The second arm can move up and down relative to the first arm; the second end is provided with a second driving mechanism for driving the first arm to rotate.

In a preferred embodiment of the present application, a third driving mechanism is provided on the second arm body, and the manipulator is drivingly connected to the third driving mechanism; the third driving mechanism is configured to drive the manipulator to rotate.

In a preferred embodiment of the present application, the thermal cycle system includes a heating component and a heat dissipation component; the heating component and the heat dissipation component are both disposed below the detection area; the real-time signal detection system includes an optical emission system and an optical detector.

A diagnostic analyzer includes the nucleic acid amplification detection device as described above.

The beneficial effects of this application are:

A nucleic acid amplification and detection device provided in the present application includes a microchip, a detection device, and a transport component. The microchip is used for accommodating a plurality of samples to be detected. The detection device includes a thermal cycle system and a real-time signal detection system. The thermal cycle system is used to provide a suitable temperature for nucleic acid amplification of a sample in a microchip; the real-time signal detection system is used to perform fluorescence detection on a sample after nucleic acid amplification occurs. The transfer module is used to grasp the microchip and transfer the microchip to the detection area of the detection device. The device is simple to operate and can perform nucleic acid amplification and fluorescence detection at the same time, which greatly facilitates the detection of samples that need to be used for PCR processing. The microchip is transferred to a detection device for amplification and detection by transferring components. The nucleic acid amplification detection device has a high degree of automation and is conducive to improving detection efficiency.

A diagnostic analyzer provided in the present application includes the nucleic acid amplification detection device as described above. The diagnostic analyzer is provided with the above-mentioned nucleic acid amplification detection device, which greatly facilitates the detection of samples required for PCR processing.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to explain the technical solution of the embodiments of the present application more clearly, the drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present application, so It should be regarded as a limitation on the scope. For those of ordinary skill in the art, other related drawings can be obtained based on these drawings without paying creative work.

FIG. 1 is a schematic structural diagram of a nucleic acid amplification and detection device according to a first embodiment of the present application; FIG.

FIG. 2 is a schematic structural diagram of a microchip of a nucleic acid amplification and detection device according to a first embodiment of the present application; FIG.

FIG. 3 is a schematic structural diagram of a first perspective of a transport component of a nucleic acid amplification and detection device according to a first embodiment of the present application; FIG.

4 is a schematic structural diagram of a second perspective of a transport component of a nucleic acid amplification and detection device according to a second embodiment of the present application;

FIG. 5 is a schematic structural diagram of a manipulator of a nucleic acid amplification detection device according to a second embodiment of the present application.

Icon: 10-nucleic acid amplification detection device; 100-microchip; 110-channel; 120-wax seal; 130-sample well; 200-detection device; 210-thermal cycle system; 220-real-time signal detection system; 230- Detection area; 300-moving component; 310-manipulator; 311-mounting plate; 312-first grasping piece; 313-second grasping piece; 320-rotating arm; 330-first arm body; 331-first end; 332- second end; 340- second arm body; 341- lifting assembly; 343- linear guide; 350- second driving mechanism; 351- second motor; 352- second belt transmission assembly; 360- third driving mechanism 361-the third motor; 362-the third belt transmission assembly; 370-the first driving mechanism.

detailed description

In order to make the objectives, technical solutions, and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments These are part of the embodiments of the present application, but not all the embodiments. The components of embodiments of the present application, which are generally described and illustrated in the drawings herein, may be arranged and designed in a variety of different configurations.

Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative efforts shall fall within the protection scope of the present application.

It should be noted that similar reference numerals and letters indicate similar items in the following drawings, so once an item is defined in one drawing, it need not be further defined and explained in subsequent drawings.

In the description of the embodiments of the present application, it should be noted that the orientations or positional relationships indicated by the terms "up" and "inner" are based on the orientations or positional relationships shown in the drawings, or the products used in the invention are often placed The orientation or position relationship of the placement is only for the convenience of describing the application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, structure and operation in a specific orientation, so it cannot be understood as limit.

In the description of this application, it should also be noted that the terms “setup”, “installation”, “connected”, and “connected” should be understood in a broad sense, for example, fixed connections, unless otherwise specified and limited. It can also be detachable or integrally connected; it can be directly connected, or it can be indirectly connected through an intermediate medium, and it can be the internal communication of two elements. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood in specific situations.

First embodiment

Please refer to FIG. 1 to FIG. 5. This embodiment provides a nucleic acid amplification detection device 10, which includes a microchip 100, a detection device 200, and a transport module 300. The microchip 100 is used for accommodating a plurality of samples to be detected. The transfer module 300 can transfer the microchip 100 to the detection device 200 for amplification and detection, thereby greatly facilitating the detection of samples that need to be used for PCR processing. . The microchip 100 is transferred to the detection device 200 for amplification and detection by the transfer component 300. The nucleic acid amplification detection device 10 has a high degree of automation, which is beneficial to improve detection efficiency.

Further, a plurality of channels 110 are provided on the microchip 100, and each channel 110 is used for accommodating a sample for detection.

Further, in this embodiment, the nucleic acid amplification detection device 10 includes a plurality of microchips 100. The multiple microchips 100 are stacked together, so that continuous removal and detection can be realized, and the detection efficiency of the entire nucleic acid amplification detection device 10 can be improved.

Further, since a plurality of channels 110 are provided on each microchip 100, simultaneous detection of multiple samples can be achieved at the same time. This multi-channel detection method further improves the detection efficiency of the entire nucleic acid amplification detection device 10.

Specifically, in this embodiment, each of the above microchips 100 is provided with 48 channels 110, so that the simultaneous detection of 48 samples can be achieved at the same time.

It should be understood that, in other optional embodiments of the present application, other numbers of channels 110 may be selected and set on each microchip 100 described above according to actual needs.

Further, the microchip 100 is provided with a sample application hole 130 and a wax seal 120. After the sample is added from the sampling hole 130, the microchip 100 is made. When the microchip 100 is placed in the detection device 200 for heating, the wax seal 120 is automatically sealed.

By providing the wax seal 120 in the microchip 100 described above, the safety of the sample is further ensured. It should be understood that the principle of the automatic sealing of the wax seal 120 described above utilizes the properties of the wax itself, which is well known to those skilled in the art, and is not repeated here.

In other optional embodiments of the present application, the above-mentioned sealing of the microchip 100 may also choose to adopt other applicable sealing methods in the art.

Further, the moving component 300 is used for grasping and moving the microchip 100. As a result, the degree of automation of the entire nucleic acid amplification detection device 10 is greatly improved, which is beneficial to further improve the detection efficiency of the entire nucleic acid amplification detection device 10.

Further, the transfer assembly 300 includes a robot arm 310 for grasping the microchip 100 and a rotating arm 320 for transferring the microchip 100 to a detection area.

Further, the rotating arm 320 is connected to the robot hand 310. The rotating arm 320 can rotate within a certain range, thereby driving the robot arm 310 to rotate, and then rotating the robot arm 310 to the detection device 200, and placing the microchip 100 at the detection area 230 of the detection device 200.

Further, the rotating arm 320 includes a first arm body 330 and a second arm body 340.

Further, the first arm body 330 has a first end 331 and an opposite second end 332. A second driving mechanism 350 is provided at the second end 332 for driving the first arm body 330 to rotate.

Specifically, in this embodiment, the second driving mechanism 350 includes a second motor 351 and a second belt transmission assembly 352. The second motor 351 is drivingly connected to the second belt driving component 352, and the second belt driving component 352 is drivingly connected to the second end 332 of the first arm body 330. Therefore, when the second motor 351 rotates, it can drive the second belt transmission assembly 352 to move, and then drive the entire first arm 330 to rotate.

Further, the second arm body 340 is installed at the first end 331 through the lifting component 341, and the second arm body 340 can move up and down relative to the first arm body 330.

Specifically, in this embodiment, the lifting assembly 341 is a lead screw motor assembly. The linear guide rail 343 is disposed on the second arm body 340, and the lead screw motor assembly is drivingly connected to the linear guide rail 343. When the lead screw motor assembly is driven, the entire second arm body 340 is driven to move up and down along the linear guide rail 343, thereby conveniently removing the stacked microchip 100.

Further, the second arm body 340 is provided with a third driving mechanism 360, and the manipulator 310 is drivingly connected to the third driving mechanism 360. The third driving mechanism 360 is configured to drive the robot arm 310 to rotate. Furthermore, when the robotic hand 310 grips the microchip 100, the microchip 100 can rotate with the robotic hand 310, which is more convenient for the robotic hand 310 to grip and place the microchip 100 on the detection device 200.

Specifically, in this embodiment, the third driving mechanism 360 includes a third motor 361 and a third belt transmission assembly 362. The third motor 361 is drivingly connected to the third belt driving component 362, and the robot hand 310 is connected to the third belt driving component 362, so that when the third motor 361 rotates, the third belt driving component 362 is driven to move, thereby driving the robot 310 to rotate. Specifically, when the microchip 100 is gripped by the robot hand 310, the microchip 100 can be gripped more flexibly.

Further, the robot hand 310 includes a mounting plate 311, a first grasping piece 312, and a second grasping piece 313.

Further, the first grasping piece 312 and the second grasping piece 313 are disposed on opposite sides of the mounting plate 311, and the first grasping piece 312 and the second grasping piece 313 can be close to or away from each other with respect to the installation plate 311 to grasp or loosen Open microchip 100.

Specifically, the mounting plate 311 is further provided with a first driving mechanism 370. The first driving mechanism 370 is drivingly connected to the mounting plate 311. The first driving mechanism 370 is configured to drive the mounting plate 311 to rotate.

In this embodiment, the first driving mechanism 370 is a stepping motor. The first driving mechanism 370 is drivingly connected to the first grasping piece 312 and the second grasping piece 313. Therefore, when the first driving mechanism 370 rotates, the first grasping piece 312 and the second grasping piece 313 are driven to move relative to each other, so that the first grasping piece 312 and the second grasping piece 313 are close to each other or away from each other, thereby grasping or loosening the microscopic Chip 100.

Further, the detection device 200 includes a thermal cycling system 210 and a real-time signal detection system 220. The thermal cycling system 210 is used to provide a suitable temperature for nucleic acid amplification of a sample in the microchip 100. The real-time signal detection system 220 is configured to perform fluorescence detection on a sample after nucleic acid amplification occurs.

Further, the thermal cycle system 210 includes a heating component and a heat dissipation component; the heating component and the heat dissipation component are both disposed below the detection area.

Specifically, in this embodiment, the heating component is six semiconductor heating devices. The heat dissipation component includes a heat sink, a cooling fan, etc., and is used to achieve the temperature requirements during the expansion process.

The above-mentioned heating devices, radiators, and cooling fans are all common parts in the prior art, and are not repeated here.

Further, the real-time signal detection system 220 includes an optical transmission system and an optical detector.

Specifically, in this embodiment, it includes a special halogen light source for generating excitation light, five colors of filters, a special optical fiber for transmitting the emitted light beam, and high sensitivity for receiving the fluorescence signal of the sample. Detector.

The above-mentioned optical emission system and optical detector are also well known to those skilled in the art, and will not be repeated here.

Second embodiment

This embodiment provides a diagnostic analyzer, which includes the nucleic acid amplification detection device as described above. The diagnostic analyzer is provided with the above-mentioned nucleic acid amplification detection device, which greatly facilitates the detection of samples required for PCR processing.

The above description is only a preferred embodiment of the present application, and is not intended to limit the present application. For those skilled in the art, this application may have various modifications and changes. Any modification, equivalent replacement, or improvement made within the spirit and principle of this application shall be included in the protection scope of this application. It should be noted that similar reference numerals and letters indicate similar items in the following drawings, so once an item is defined in one drawing, it need not be further defined and explained in subsequent drawings.

Claims

A nucleic acid amplification detection device, comprising:

A microchip, which is used for accommodating a plurality of samples to be detected;

A detection device comprising a thermal cycling system and a real-time signal detection system, the thermal cycling system is used to provide a suitable temperature for nucleic acid amplification of the sample in the microchip; the real-time signal detection system is used for Performing fluorescence detection on the sample after the nucleic acid amplification has occurred; and

A moving component for grasping the microchip and transferring the microchip to a detection area of the detection device.
The nucleic acid amplification and detection device according to claim 1, wherein:

A plurality of channels are provided on the microchip, and each of the channels is used to receive one sample.
The nucleic acid amplification and detection device according to claim 2, wherein:

A wax seal is provided in the micro chip, and the wax seal is automatically sealed when the micro chip is placed in the detection device for heating.
The nucleic acid amplification and detection device according to claim 1, wherein:

The moving component includes a robot arm for grasping a microchip and a rotary arm for transferring the microchip to the detection area;

The rotating arm is connected to the robot hand.
The nucleic acid amplification and detection device according to claim 4, wherein:

The manipulator includes a mounting plate, a first grasping piece, and a second grasping piece;

The first grabbing piece and the second grabbing piece are disposed on opposite sides of the mounting plate, and the first grabbing piece and the second grabbing piece can be closer to or farther from each other with respect to the mounting plate, so as to Grasp or loosen the microchip.
The nucleic acid amplification and detection device according to claim 5, wherein:

A first driving mechanism is provided on the mounting plate, the first driving mechanism is drivingly connected to the first grasping piece and the second grasping piece, and the first driving mechanism is configured to drive the first A grasping piece and the second grasping piece are relatively moved.
The nucleic acid amplification and detection device according to claim 5, wherein:

The rotating arm includes a first arm body and a second arm body;

The first arm body has a first end and an opposite second end; the second arm body is installed at the first end by a lifting component, and the second arm body can be raised and lowered relative to the first arm body motion;

The second end is provided with a second driving mechanism for driving the first arm body to rotate.
The nucleic acid amplification and detection device according to claim 7, wherein:

A third driving mechanism is provided on the second arm body, and the manipulator is drivingly connected to the third driving mechanism;

The third driving mechanism is configured to drive the robot hand to rotate.
The nucleic acid amplification and detection device according to claim 1, wherein:

The thermal cycle system includes a heating component and a heat dissipation component; the heating component and the heat dissipation component are both disposed below the detection area;

The real-time signal detection system includes an optical transmission system and an optical detector.
A diagnostic analyzer, characterized in that the diagnostic analyzer comprises the nucleic acid amplification detection device according to any one of claims 1-9.