Detailed Description
The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative work belong to the protection scope of the present invention.
It will be understood that when an element is referred to as being "secured to" another element, it can be directly on the other element or intervening elements may also be present. When a component is referred to as being "connected" to another component, it can be directly connected to the other component or intervening components may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only.
The system embodiments described below are merely illustrative, and the division of the modules or circuits is merely a logical division, and other divisions may be realized in practice. Furthermore, it is obvious that the word "comprising" does not exclude other elements or steps, and the singular does not exclude the plural. Several units or mechanisms recited in the system claims may also be implemented by one and the same unit or mechanism in software or hardware. The terms first, second, etc. are used to denote names, but not any particular order.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
Referring to fig. 1, an integrated intelligent nucleic acid detecting system 100 according to an embodiment of the present invention is used for detecting a nucleic acid sample, and is particularly applied to detecting a new coronavirus nucleic acid sample, and includes a laboratory, where the laboratory includes a reagent preparing unit 12, a sample transmitting device 13, a reagent transmitting device 14, a sample processing unit 15, a sample detecting transmitting device 16, a sample detecting unit 17, an information management unit 18, and an environment control unit 11.
The reagent preparation unit 12 is used to store necessary detection reagents. The reagent preparation unit 12 specifically includes a storage device 121 and a clean bench 122, the storage device 121 is used for storing the detection-related reagent, and the clean bench 122 is used for performing a reagent preparation operation.
In the present embodiment, the reagent preparation unit 12 may further include necessary devices such as a pipette set, a small centrifuge, and a vortex mixer.
The sample processing unit 15 is used for extracting a sample to be detected to obtain a nucleic acid sample, and specifically includes a sample processing device 151.
In the present embodiment, the detection reagent is transferred from the reagent preparation unit 12 to the sample processing unit 15 by the reagent transfer device 14. The sample to be tested is received by the sample transfer device 13.
In this embodiment, the sample processing device 151 is used to extract a nucleic acid sample from a sample to be detected. The sample processing device 151 is specifically a nucleic acid extraction device (e.g., an RT-PCR instrument) and is mainly used for extraction of RNA. The method can specifically adopt but not limited to a high-throughput automatic sample preparation system (model: MGISP-960, 192 cases/8 h-576 cases/24 h of theoretical flux, or MGISP-100B, 192 cases/8 h-576 cases/24 h of theoretical flux) developed by Shenzhen Huazhi Dazhi science and technology Limited. High-flux nucleic acid extraction can be realized, and the detection efficiency is greatly improved; the method can automatically complete the steps from the extraction of the nucleic acid sample to the configuration of an RT-PCR reaction system, and only needs a small amount of conventional auxiliary equipment; integrates multiple functions, occupies a floor area of less than 0.5m3(ii) a The suction head with the filter element is used, so that cross contamination is prevented, the pipetting range is as low as 2 mu L, and better extraction efficiency can be ensured by good pipetting precision. The kit is compatible with an RT-PCR system and a third magnetic bead method RNA extraction kit (MGIEasy nucleic acid extraction kit), has good extraction stability and high nucleic acid recovery rate, and can ensure the extraction success rate of low-concentration samples.
In another embodiment, the sample processing unit 15 further includes at least one sample dispensing device 152, the sample dispensing device 152 is mainly used for automatically dispensing the sample to be detected, and the dispensed sample to be detected enters the sample processing device 151 for nucleic acid extraction. The method can be particularly used for automatically extracting the high-flux samples by adopting a full-automatic cup separation processing system (MGISTP-7000, 192 cases/40 min) developed by Shenzhen Hua Dazhi science and technology industries, Ltd. The full-automatic cup separation processing system can be adapted to the high-throughput automatic sample preparation system. The sample subpackaging device 152 can realize the operations of automatic uncovering, automatic scanning, automatic subpackaging, automatic cover screwing and the like, and the whole input of an original pipe, so that the automatic feeding and discharging of samples and consumables and the automatic storage of finished products are realized, the subpackaging efficiency can be greatly improved, and the efficiency can be improved by 7 times compared with the manual operation efficiency by adopting the sample subpackaging device 152; the detection flux can be greatly improved, and the labor and field investment is saved. The full-automatic treatment can avoid the contact of experimenters and virus samples; and meanwhile, a HEPA negative pressure filtering system and an ultraviolet disinfection system are arranged, so that the risk of pollution leakage is effectively prevented. The full-automatic cup separating processing system reduces the manual intervention time, simplifies and standardizes the complex operation, liberates the manpower, reduces the misoperation and the biological pollution and reduces the production cost.
The sample detection unit 17 receives the nucleic acid sample from the sample processing unit 15 by the sample transfer device 16, and the nucleic acid sample processed by the sample processing device 151 in the sample processing unit 15 can be transferred to the sample detection unit 17 by the sample transfer device 16.
In this embodiment, the sample detection unit 17 includes at least one detection device 171.
In this embodiment, the detection device 171 is used to perform an amplification reaction on the extracted RNA sample to obtain a detection result. In particular, in this embodiment, the detection device 171 is a fluorescence quantitative PCR instrument, and the fluorescence quantitative PCR instrument is herein an RT-PCR instrument, wherein the conventional fluorescence quantitative PCR instrument can be compatible with the high-throughput automated sample preparation system and the fully automatic cup processing system.
The information management unit 18 is in communication connection with the reagent preparation unit 12, the sample processing unit 15, the sample detection unit 17 and the environment control unit 11 through a wired or wireless network, so as to realize information management and process management of each link.
Referring to fig. 2, in the present embodiment, the information management unit 18 mainly includes two parts, a first part is sample information management, and a second part is detection flow management.
The first part is sample information management, which mainly aims at the entry management of sample information at each stage, and specifically, information entry devices (such as bar code scanners) are arranged in the reagent preparation unit 12, the sample processing unit 15 and the sample detection unit 17, and are used for collecting sample information at each stage and transmitting the information to the information management unit 18, so that the whole-process informatization management is realized.
The method specifically comprises the following steps:
and in the sample collection stage, the information of the detected person and the submitted sample is imported.
And a sample preparation stage, wherein package unpacking and sample counting condition recording are carried out.
And in the sample detection stage, checking the information of the sample tube to be detected and binding the external sample bar code with the internal sample bar code.
And in the sample collection stage, the warehousing of the samples and the inventory management of the ex-warehouse samples.
And in the sample detection stage, the detection result is audited and a detection report is issued.
Specifically, the corresponding bar codes are attached to the containers for containing the samples, and the bar codes of the corresponding samples in the corresponding stages are output to the information management unit 18 through the bar code scanning device, so that the time for data entry and information check of a large number of samples can be reduced, the problem of sample mixing is reduced, the sample storage management and sample tracing are facilitated, meanwhile, the report result can be assisted to be examined, and the time for manual report checking is reduced.
In the second part, the detection process management mainly implements informatization management for each detection process, and specifically, the information management unit 18 is respectively bound with the sample processing device 151, the sample dispensing device 152 and the detection device 171, so as to implement remote monitoring of the above devices.
The method specifically comprises the following steps:
in the sample processing stage, the sample layout and the sample transfer operation into the deep hole plate are monitored.
In the sample processing stage, the relationship between the deep hole plate of the sample dispensing device 152 and the nucleic acid extraction plate of the sample processing device 151 is bound, so that the monitoring of the sample to be detected is automatically transferred from the sample dispensing device 152 to the sample processing device 151, and the running state of the nucleic acid extraction device is monitored.
And in the sample detection stage, the relation between the nucleic acid extraction plate of the sample processing device 151 and the RT-PCR plate of the detection device 171 is bound, so that the nucleic acid sample on the nucleic acid extraction plate is transferred to the RT-PCR plate for amplification reaction, and meanwhile, the detection value is automatically captured.
And a sample detection stage, wherein the RT-PCR detection result is confirmed, and the confirmed RT-PCR detection result enters the first sample information management step for checking and detecting the detection result, including outputting.
The system adopts information remote information and process management, can collect and summarize production and equipment information in real time, realizes information visualization and transparence, monitors production capacity, equipment running condition, equipment performance and saturation, and provides data basis for decision making, thereby improving management efficiency and realizing capacity maximization. The information management unit 18 can specifically adopt a laboratory information management unit (huada ZLIMS system) developed by shenzhen hua maozi science and technology limited company to perform information management in the whole detection process, and the huada ZLIMS system serves as an information management platform special for life science instruments and can record experimental process data, monitor the real-time states of the instruments and samples, schedule offline data to be stored, integrate an information analysis platform, start automatic analysis, and form an end-to-end complete solution from sample entry to final report.
The environment control unit 11 is mainly used for controlling the environmental temperature, the environmental pressure, the environmental humidity, the environmental atmosphere, the laboratory water supply and drainage and the laboratory power supply of the whole laboratory.
In the present embodiment, the environment control unit 11 mainly includes a ventilation device 111, a water supply and drainage device 112, a power supply device 113, and a central management station 114.
The ventilation device 111 is used for controlling environmental factors such as experiment temperature, humidity, pressure, atmosphere, etc., the water supply and drainage device 112 is used for supplying and draining water for the whole laboratory, the power supply device 113 is used for supplying power for the whole laboratory, and the central management station 114 is used for managing network communication of the real laboratory.
Referring to fig. 3, the present invention provides an integrated intelligent nucleic acid detecting system 200, which includes a box 21, and an air conditioning and electromechanical chamber 22, a reagent preparing chamber 23, a first dressing chamber 24, a sample processing chamber 25, a buffer chamber 26, a sample detecting chamber 27, and a second dressing chamber 28 sequentially arranged in the box 21. The reagent preparation unit 12 is provided in the reagent preparation chamber 23, the sample processing unit 15 is provided in the sample processing chamber 25, and the sample detection unit 17 is provided in the sample detection chamber 27.
This box 21 is the box (for example the carriage of vehicle) of cuboid structure approximately, adopts the rain-proof design of excellent heat preservation, and overall structure satisfies engineering structure mechanics requirement, can satisfy the requirement of long distance transportation load and long-time transportation. The floor within the cabinet 21 and the laboratory bench are all sterilizable materials.
Two ends of the box body 21 are provided with a sealed door 211, one sealed door 211 is communicated with the first dressing room 24, and the other sealed door 211 is communicated with the second dressing room 28.
The first dressing room 24 is located between the reagent preparation room 23 and the sample processing room 25, and a first decontamination basin 241 is provided therein for an operator to enter the laboratory for cleaning. Two airtight doors 211 are provided in the first dressing room 24 to allow access to the reagent preparation room 23 and the sample processing room 25, respectively.
The second changing room 28 is located at the side of the sample testing room 27 far from the sample processing room 25, and the second changing room 28 is communicated with the sample testing room 27 through another two sealed doors 211 for performing the corresponding washing operation when the operator leaves the laboratory. An autoclave 281 and a second decontamination basin 282 are arranged in the second dressing room 28, the autoclave 281 is used for autoclave sterilization of the personal laboratory supplies, and the second decontamination basin 282 is used for personal decontamination of the operators.
The reagent preparation unit 12 is disposed in the reagent preparation chamber 23, the clean bench 122 is disposed on one side of the reagent preparation chamber 23, the storage device 121 is disposed on the same side, the storage device 121 is used for storing relevant reagents for detection, and the clean bench 122 is used for reagent preparation operation. The side opposite to the storage device 121 is provided with a reagent transferring device 14, wherein the reagent transferring device 14 is used for transferring a reagent into the sample processing chamber 25, a transferring channel and windows arranged at two sides of the transferring channel are arranged in the reagent transferring device 14, wherein an illuminating lamp and an ultraviolet sterilizer are arranged in the transferring channel, and the reagent transferring device 14 can conveniently and quickly transfer the reagent into the sample processing chamber 25.
Referring to fig. 3 and 4, the sample processing unit 15 is disposed in the sample processing chamber 25, and the sample processing device 151 can be, but not limited to, an automatic sample preparation system (MGISP-100B, 192/8 h-576/24 h theoretical flux), an automatic high-flux sample preparation system (model: MGISP-960, 192/8 h-576/24 h theoretical flux) or a nucleic acid extractor (model: NE384) developed by shenzhen hua maozheng science and technology limited.
Wherein the sample processing chamber 25 communicates with the outside through the sample transfer device 13 and receives a sample to be tested. The sample transfer device 13 is provided with a transfer channel and window bodies arranged at two sides of the transfer channel, wherein the transfer channel is internally provided with an illuminating lamp and an ultraviolet sterilizer, and the sample transfer device 13 can conveniently and rapidly transfer the sample to the sample processing chamber 25.
Referring to fig. 5, in another embodiment, the sample processing unit 15 further includes a sample dispensing device 152, wherein the sample dispensing device 152 is disposed at one side of the sample processing chamber 25 and is used for dispensing the sample to be detected, and a high-throughput full-automatic cup dispensing processing system (MGISTP-7000, 192 cases/40 min) developed by shenzhen hua wisdom manufacturing science and technology limited company can be specifically used, but the system has a large throughput, can significantly improve the detection efficiency, and is helpful for realizing high-throughput detection in a laboratory.
Referring to fig. 3 to 5, the sample detecting unit 17 is disposed in the sample detecting chamber 27, the sample detecting chamber 27 is communicated with the sample processing chamber 25 through the sample transferring device 16, and the detecting device 171 is used for PCR amplification of the nucleic acid sample, wherein a plurality of detecting devices 171 (e.g., RT-PCR instruments) are disposed in the sample detecting chamber 27, so as to improve the detection efficiency.
In this embodiment, the airtight doors 211 are all dedicated airtight doors, and are equipped with a hollow glass observation window, a door lock, a handle, a door closer, a lifting seal, an electronic interlock, and the like.
Referring to fig. 1, in addition, the integrated intelligent nucleic acid detecting system 200 further includes a ventilation device 111, wherein, in order to ensure the safety of the experiment and the personnel, the whole production line adopts a full fresh air and full exhaust direct current air conditioning system, the ventilation frequency is greater than 12 times/h, the cleaning grade is one hundred thousand grade, the indoor temperature is 18-26 ℃, the humidity is less than 75-75%, and the noise is less than 60 dB. The indoor pressure is integral negative pressure and is unidirectional airflow; the air feeding and exhausting mode is upward feeding and downward returning; the air port is reasonable in position design, and air flow of the biological safety cabinet is not influenced. The laboratory air outlet is provided with a P3 laboratory-level double-in-situ efficient exhaust filtering device, the side wall is installed, and the upper part of the device is provided with an electric biological airtight valve to prevent indoor polluted air from being exhausted outdoors.
Referring to fig. 1, the integrated intelligent nucleic acid detecting system 200 further includes a water supply and drainage device 112, which can be connected to domestic tap water and hot water, and is provided with a clean tap water outlet tank. The protective clothing is worn with a hand sterilizer, and the first and second dressing rooms 24 and 28 are provided with stainless steel hand washing basins, automatic induction taps, soap dispenser, spray hand sterilizer and hand dryer. PP experiment water tanks are arranged in the sample processing chamber 25 and the sample detection chamber 27, a single-port cold-hot water experiment faucet and a double-port eye washer are arranged, and the upper water and the lower water in the two chambers are closed and are not used when a new crown epidemic situation is processed. And floor drains are not arranged in all rooms of the laboratory. The water drained is used for washing hands, and a sewage treatment device is not arranged in the laboratory for storage, disinfection and sterilization and is directly drained into a nearby sewage well. A small-sized wastewater treatment system can be optionally installed.
Referring to fig. 1, the integrated intelligent nucleic acid detecting system 200 further includes a power supply device 113, a 380V-63A industrial connector (a male and female set) is reserved on the side of the casing of the box 21 for power distribution connection, and a 380V-40KW power supply is led to the laboratory electromechanical cabin from the owner. The illumination and entrance guard security device is provided with a UPS power supply, and the power supply time is not less than 15 min. The designed illumination is considered in each experimental area as follows: the air conditioning and electromechanical room 22 is 100lx, the first changing room 24, the second changing room 28 and the buffer room 26 are 200lx, and the reagent preparation room 23, the sample processing room 25 and the sample detection room 27 are 300 lx. Except for normal illumination, all the laboratory rooms are provided with ultraviolet germicidal lamps and the first and second dressing rooms 24 and 28 are separately controlled by delay switches. All lamps and lanterns all adopt clean lamps and lanterns, and all light sources all adopt the LED light source. The light switch is controlled individually for each room.
Referring to fig. 1, the integrated intelligent nucleic acid detecting system 200 further includes a central management station 114, the air-conditioning and mechatronic room 22 is provided with four external network interfaces, one for telephone, two for network, one for security reservation, 8 switches in the warehouse, and information points in the laboratory are reserved to ensure smooth transmission of experimental data information. The hospital is responsible for the access of external weak wires and can be optionally provided with a 5G wireless communication card. All the airtight doors 211 are provided with access control devices, the room is provided with a monitoring camera, and a memory is arranged in the weak current box. An independent automatic control system is arranged in the air conditioner and electromechanical room 22, and is used for configuration, programming, fault diagnosis and the like of the system, centralized operation is realized for managers, effective and accurate data are provided, and all equipment in a laboratory forms effective and reasonable operation order so as to achieve effective energy conservation. A touch operation screen is arranged on the wall of the first dressing room 24, and pressure difference sensors with display are arranged in the sample processing room 25 and the sample detection room 27 of the second dressing room 28.
The application provides an integrated form intelligence nucleic acid detecting system 100, can make up the multiunit laboratory according to the user demand of difference and assemble, specifically, this application provides three kinds of design, is high throughput scheme, basic scheme and emergent scheme respectively.
Referring to fig. 3, the integrated intelligent nucleic acid detecting system 200 according to the present embodiment is a single-compartment basic scheme: theoretical flux: 700/8h to 2100/24h, and the sample processing chamber 25 is equipped with a sample processing device 151, and a high-throughput automated sample preparation system (model: MGISP-960, MGISP-100B) and a nucleic acid extractor (model: NE384), the laboratory management system employed was the ZLIMS system manufactured by huada.
Referring to fig. 4, the integrated intelligent nucleic acid detecting system 300 according to the present embodiment is a dual-chamber high-throughput scheme: the two integrated intelligent nucleic acid detection systems 200 provided by the basic scheme are combined to realize high-flux detection, and the two groups are communicated with each other through the sample transfer device 13 to realize interaction of samples to be detected, wherein the two sample processing chambers 25 are communicated with each other.
Referring to fig. 5, the integrated intelligent nucleic acid detecting system 400 according to the present embodiment is a single-chamber high-throughput scheme: theoretical flux: 192/8h to 576/24h, a sample processing chamber 25 was equipped with a sample dispensing device 152 (model: MGISTP-7000) and a sample processing device 151 (model: MGISP-100B), and the laboratory management system used was a ZLIMS system manufactured by Huada.
The application provides an integrated form intelligence nucleic acid detecting system 100 can be along with the car quick travel, satisfies the nucleic acid testing of anytime and anywhere, examines the measurement 1000 people daily, and one-stop form nucleic acid detects and can shorten virus nucleic acid extraction time by a wide margin, satisfies medical staff and draws the demand of in-process nimble, quick automation and safe prevention and control to the flux at the virus nucleic acid. The main application scenarios include: customs and entry ports in various places, airports, train stations, long-distance bus stations, etc., schools, exhibition halls, shopping malls, commercial buildings, and government and commercial external assistance.
The integrated intelligent nucleic acid detection system 100 provided by the application can be applied to detection of new coronavirus, and accords with technical guidelines (third edition) for detecting pneumonia infected by the new coronavirus in laboratory, clinical gene amplification inspection laboratory management methods 2010 and GB11489-2008 laboratory biological safety general requirements, WS-233-: the building design specification of an infectious disease hospital, T-CECS 662-.
In addition, various other changes and modifications can be made by those skilled in the art according to the technical idea of the present invention, and all such changes and modifications should fall within the protective scope of the claims of the present invention.