WO2022007453A1 - 一种单向动线可移动病原体核酸检测实验室系统 - Google Patents

一种单向动线可移动病原体核酸检测实验室系统 Download PDF

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WO2022007453A1
WO2022007453A1 PCT/CN2021/086559 CN2021086559W WO2022007453A1 WO 2022007453 A1 WO2022007453 A1 WO 2022007453A1 CN 2021086559 W CN2021086559 W CN 2021086559W WO 2022007453 A1 WO2022007453 A1 WO 2022007453A1
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room
buffer room
movable structure
pressure value
preparation
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PCT/CN2021/086559
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English (en)
French (fr)
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谢孝民
李丹
谢正华
熊磊
陈才夫
孙祎
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上海思路迪生物医学科技有限公司
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Publication of WO2022007453A1 publication Critical patent/WO2022007453A1/zh

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    • E—FIXED CONSTRUCTIONS
    • E04—BUILDING
    • E04H—BUILDINGS OR LIKE STRUCTURES FOR PARTICULAR PURPOSES; SWIMMING OR SPLASH BATHS OR POOLS; MASTS; FENCING; TENTS OR CANOPIES, IN GENERAL
    • E04H1/00—Buildings or groups of buildings for dwelling or office purposes; General layout, e.g. modular co-ordination or staggered storeys
    • E04H1/12—Small buildings or other erections for limited occupation, erected in the open air or arranged in buildings, e.g. kiosks, waiting shelters for bus stops or for filling stations, roofs for railway platforms, watchmen's huts or dressing cubicles
    • E04H1/1205—Small buildings erected in the open air

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  • the present invention relates to the technical field of pathogen detection equipment, in particular to a laboratory system for detecting nucleic acid of pathogens with unidirectional moving lines.
  • the novel coronavirus is an airborne pathogen with strong infectious and pathogenic characteristics. It often presents explosive spread infection in community populations, posing an extremely serious threat to the lives and health of the people.
  • nucleic acid detection method is a screening method with high accuracy and reliable results.
  • nucleic acid detection generally needs to be performed in a testing laboratory that meets the requirements, the number of testing laboratories is insufficient to meet the huge testing needs. , which seriously restricts the efficiency of nucleic acid detection, and many patients delay the best time for treatment while waiting for nucleic acid detection, resulting in aggravation of the disease. Therefore, there is an urgent need for a mobile nucleic acid detection laboratory system that meets the standards of biosafety laboratories.
  • the present invention proposes a laboratory system for nucleic acid detection of unidirectional moving lines for pathogens.
  • the isolation requirements between the three steps in the nucleic acid detection process are realized.
  • the three movable structures can be quickly moved and deployed to any required position and deployed to form a fully functional pathogen nucleic acid detection laboratory. , to implement on-site testing at key prevention and control locations to avoid centralized transfer of high-risk groups.
  • the technical scheme adopted in the present invention includes:
  • a unidirectional moving line movable pathogen nucleic acid detection laboratory system characterized in that it includes any one of a movable structure for reagent storage and preparation, a movable structure for sample preparation, and a movable structure for amplification and product analysis, which are isolated and independent from each other.
  • a movable structure or a combination of any kind of movable structure, and the number of any single kind of movable structure in the system is one or more;
  • the movable structure for reagent storage and preparation includes a first inlet buffer room, a reagent preparation room maintaining a positive pressure environment, a first waste disposal room and a first outlet buffer room, which are sequentially airtightly connected, forming a one-way relative to the external environment.
  • Airtight personnel passage, and at least one airtight transfer window is arranged on the side wall of the reagent preparation chamber;
  • the movable structure for sample preparation includes a second inlet buffer room, a sample processing chamber for maintaining a negative pressure environment, a second waste disposal room and a second outlet buffer room, which are sequentially airtightly connected to form a one-way airtightness relative to the external environment.
  • a personnel passage, and at least two mutually independent airtight transfer windows are arranged on the side wall of the sample processing chamber;
  • the movable structure for amplification and product analysis includes a third inlet buffer room airtightly connected in sequence, an amplification analysis room for maintaining a negative pressure environment, a third waste disposal room and a third outlet buffer room, forming a relative environment to the external environment.
  • One-way air-tight personnel passage, and at least one air-tight transmission window is arranged on the side wall of the amplification and analysis chamber.
  • the air-tight transfer windows provided in the movable structure for reagent storage and preparation, the movable structure for sample preparation, and the movable structure for amplification and analysis are communicated through a detachable and air-tightly connected conveying pipeline for air-tight transmission of items. .
  • a positive pressure environment is maintained between the first inlet buffer room and the first outlet buffer room, and the positive pressure environment pressure value between the first inlet buffer room and the first outlet buffer room is lower than the positive pressure of the reagent preparation chamber Ambient pressure value; the second inlet buffer room and the second outlet buffer room and the third inlet buffer room and the third outlet buffer room maintain a negative pressure environment, and the second inlet buffer room and the second outlet buffer room maintain a negative pressure environment.
  • the negative pressure ambient pressure value is higher than the negative pressure ambient pressure value of the sample processing chamber, and the negative pressure ambient pressure value between the third inlet buffer and the third outlet buffer is higher than the negative pressure ambient pressure value of the amplification analysis chamber .
  • the first sewage treatment room maintains a positive pressure environment
  • the positive pressure environment pressure value of the first sewage treatment room is lower than the positive pressure environment pressure value of the reagent preparation chamber and higher than the first sewage treatment room.
  • the negative pressure ambient pressure value of the analytical chamber is simultaneously lower than the negative pressure ambient pressure value of the third outlet buffer room.
  • the pressure value of the reagent preparation chamber is 30Pa, the pressure value between the first inlet buffer room and the first outlet buffer room is 10Pa, and the pressure value of the first waste disposal room is 20Pa;
  • the sample processing The pressure value of the chamber is -30Pa, the pressure value between the second inlet buffer room and the second outlet buffer room is -10Pa, the pressure value of the second sewage disposal room is -20Pa;
  • the pressure value of the amplification analysis chamber is is -25Pa, the pressure value between the third inlet buffer room and the third outlet buffer room is -10Pa, and the pressure value of the third waste disposal room is -15Pa.
  • the movable structure for reagent storage and preparation, the movable structure for sample preparation and the movable structure for amplification and product analysis are respectively connected to mains power supply through detachable cables.
  • the movable structure for amplification and product analysis further includes a generator set; the generator set is connected to the movable structure for reagent storage and preparation, movable structure for sample preparation and/or amplification and products through a detachable cable. Analyze movable structures and provide electrical energy.
  • the generator set is movably accommodated in the third outlet buffer room and moves out of the third outlet buffer room to re-determine the placement position when electric power is supplied.
  • the mobile platform provided with the movable structure includes a van, a box trailer or a container whose cab is airtightly isolated.
  • the movable structures for reagent storage and preparation, movable structures for sample preparation, and/or movable structures for amplification and product analysis are arranged on a mobile platform in any combination, or are arranged in a plurality of mutually independent mobile structures in any combination. on the platform.
  • the unidirectional moving line movable pathogen nucleic acid detection laboratory system of the present invention by using three movable structures isolated from each other to carry different steps in the nucleic acid detection process respectively, different operating environments can be adjusted in a targeted manner: for For reagent preparation steps that require high environmental cleanliness, a positive pressure environment is used to ensure that the internal air is not polluted by the outside world; for sample processing steps involving pathogen contact, a negative pressure environment is used to prevent accidental leakage of pathogens, ensure safety, and prevent secondary transmission.
  • the three independently isolated movable structures of the present invention all meet the design of one-way movement lines for personnel and items, form a complete airtight isolation protection, avoid the spread of pollutants, and fully meet the requirements of national mandatory standards.
  • the nucleic acid detection capability can be quickly mobilized to the hotspot demand area, and the detection capability can be rapidly formed without time-consuming laboratory construction.
  • the function of quick cross-regional deployment of capabilities makes up for the sudden shortage of testing capabilities in specific regions; at the same time, mobile testing capabilities can effectively avoid the centralized transfer and aggregation of a large number of high-risk groups, which is conducive to the orderly development of large-scale nucleic acid testing.
  • FIG. 1 is a schematic diagram of a first embodiment of the present invention.
  • FIG. 2 is a schematic diagram of a second embodiment of the present invention.
  • pathogen nucleic acid detection laboratories are generally set up in fixed facilities such as hospitals or related research institutes, and the detection samples need to be collected and sent to the detection laboratory for detection.
  • Such laboratory setup is inconvenient for the short-term expansion of detection capabilities and the rational allocation of detection capabilities.
  • detection capabilities in key areas and a large number of idle and wasteful detection capabilities in non-hot areas, which do not meet the practical needs of fighting the epidemic.
  • FIG. 1 is a schematic diagram of the first embodiment of the laboratory system for unidirectional movement of mobile pathogen nucleic acid detection according to the present invention.
  • the movable structure 3 is composed of three parts.
  • Reagent storage and preparation Movable structure 1 corresponds to the reagent storage and preparation area in the nucleic acid detection laboratory, and is responsible for the preparation of storage reagents, the sub-packaging of reagents and the preparation of amplification reaction mixture, as well as consumables such as centrifuge tubes and tips storage and preparation;
  • the specimen preparation movable structure 2 corresponds to the specimen preparation area in the nucleic acid detection laboratory, and is responsible for nucleic acid (RNA, DNA) extraction, storage and addition to the amplification reaction tube, especially when the specimen preparation is movable Structure 2 will involve the operation of clinical samples, which should meet the requirements of biosafety secondary laboratory protective equipment, personal protection and operation specifications;
  • the movable structure 3 for amplification and product analysis corresponds to the amplification area and amplification area
  • the amplification product analysis area is responsible for cDNA synthesis, DNA amplification and detection, as well as further analysis and determination of amplified fragments, such as hybridization, enzyme digestion electrophoresis, denaturing high performance liquid phase analysis, sequencing, etc.
  • the movable structure 1 for reagent storage and preparation includes a first inlet buffer room 12, a reagent preparation room 11 for maintaining a positive pressure environment, a first waste disposal room 13 and a first outlet buffer room 14, which are sequentially airtightly connected, forming a relatively One-way air-tight personnel passage of the external environment, and at least one air-tight transmission window 4 is provided on the side wall of the reagent preparation chamber 11 .
  • the movable structure 2 for sample preparation includes a second inlet buffer room 22, a sample processing room 21 for maintaining a negative pressure environment, a second waste disposal room 23 and a second outlet buffer room 24, which are sequentially airtightly connected to form a relatively external environment.
  • a one-way airtight passage for personnel is provided, and at least two airtight transfer windows 4 independent of each other are provided on the side wall of the sample processing chamber 21 .
  • the sample processing chamber 21 may be provided with functional components such as a sample inactivation component, a sample nucleic acid extraction component, a nucleic acid sample adding component, and a reagent sealing component to be detected.
  • the movable structure 3 for amplification and product analysis includes a third inlet buffer room 32 airtightly connected in sequence, an amplification analysis room 31 maintaining a negative pressure environment, a third waste disposal room 33 and a third outlet buffer room 34, A one-way air-tight personnel passage is formed relative to the external environment, and at least one air-tight transfer window 4 is provided on the side wall of the amplification and analysis chamber 31, and the third outlet buffer room 34 preferably also accommodates a movable generator set 343.
  • the above-mentioned first sewage disposal room 13, second sewage disposal room 23 and third sewage disposal room 33 provide extra buffer space for experimenters before leaving the contaminated area, so that wastes can be disposed of in the sewage disposal room. Then leave through the outlet buffer to avoid secondary pollution caused by the waste generated in the nucleic acid detection process.
  • the first sewage treatment room 13, the second sewage treatment room 23 and the third sewage treatment room 33 can preferably be equipped with harmless treatment equipment such as high temperature and high pressure treatment equipment, incineration equipment, and airtight waste. Staging devices, etc.
  • the three movable structures can be moved separately without interfering with each other, and can be quickly deployed at the desired location to form a nucleic acid detection laboratory.
  • the reagent storage and preparation movable structure 1 , the sample preparation movable structure 2 , and the amplification and product analysis movable structure 3 are deployed at a designated site in a first embodiment.
  • the movable structure 1 for reagent storage and preparation, the movable structure 2 for sample preparation and the movable structure 3 for amplification and product analysis are unfolded side by side in sequence to form a natural buffer; the movable structure 1 for reagent storage and preparation An air-tight transfer window 4 is provided on the right side of the sample preparation movable structure 2; an air-tight transfer window 4 is provided on the left and right sides of the sample preparation movable structure 2, and the air-tight transfer window 4 on the left side faces the reagent
  • the storage and preparation movable structure 1 is convenient for the transfer of items with the reagent storage and preparation movable structure 1, and the air-tight transfer window 4 arranged on the right side faces the amplification and product analysis movable structure 3, and is connected with the above-mentioned each through the conveying pipeline 7.
  • the airtight transfer window 4 forms a completely airtight article transfer channel.
  • the movable structure 1 for reagent storage and preparation, the movable structure 2 for sample preparation, and the movable structure 3 for amplification and product analysis are all connected to the mains power supply 5 through a detachable cable 6 .
  • FIG. 2 is a schematic diagram of the second embodiment of the present invention. Similar to the first embodiment, it is also developed for a designated site, but different from the first embodiment, in the second embodiment, in order to cope with the inconvenience of accessing the commercial power
  • the generator set 343 provided on the movable structure 3 for amplification and product analysis supplies power to the movable structure 1 for reagent storage and preparation, the movable structure for sample preparation 2 and the movable structure for amplification and product analysis 3,
  • the single connection length of the detachable cable 6 should be no more than 10 meters to ensure the safety of power supply.
  • the generator set 343 is stored in the third outlet buffer room 34 when it is not activated; when activated, it is moved to the external environment and the placement position of the generator set 343 is freely selected according to the setting positions of the three movable structures, which is convenient for detachable cable arrangement connect.
  • the generator set 343 may preferably use a power supply device that can continuously output stable voltage, such as a diesel generator.
  • the generator set 343 can also preferably be directly connected and powered with the movable structure 3 for amplification and product analysis only through the detachable cable 6 , while the movable structure 3 for amplification and product analysis is further connected to the specimen through the detachable cable 6
  • the preparation movable structure 2 and the reagent storage and preparation movable structures are connected in sequence to form a series power supply structure. Due to the serially connected power supply structure, the restriction on the placement position of the generator set 343 is further reduced, and a longer distance power supply to the movable structure can be realized without considering the length limitation of a single detachable cable 6 connecting the generator set 343 .
  • the movable structure 1 for reagent storage and preparation, the movable structure 2 for sample preparation, and the movable structure 3 for amplification and product analysis described in the present invention can be used in combination as shown in Example 1 and Example 2, or they can be used together. They can be used individually or in any combination; at the same time, in order to balance the processing capacity of different steps, multiple movable structures of the same type can also be included in one system, for example, two reagent storage and preparation can be set in one system. Movable structure 1, one movable structure for sample preparation 2 and two movable structures for amplification and product analysis 3 to give full play to the processing capacity of each movable structure.
  • the airtight transfer window 4 of the present invention may include a first airtight door and a second airtight door that are not opened at the same time. By sequentially opening the first airtight door and the second airtight door, the structural airtightness during the article transfer process is ensured. tightness.
  • the conveying pipe 7 of the present invention may preferably be an inclined air-tight pipe that supports disassembly and connection, so that the articles can move in the pipe by their own gravity, or an air-tight pipe with an active conveying power source can be selected.
  • the first inlet buffer room 12 and the first outlet buffer room 14 maintain a positive pressure environment, and the positive pressure environment pressure value of the first inlet buffer room 12 and the first outlet buffer room 14 is lower than the reagent
  • the pressure value is also higher than the positive pressure ambient pressure value of the first outlet buffer room 14; the second inlet buffer room 22 and the second outlet buffer room 24 and the third inlet buffer room 32 and the third outlet buffer room 34 are both
  • the negative pressure environment is maintained, and the negative pressure environment pressure value of the second inlet buffer room 22 and the second outlet buffer room 24 is higher than the negative pressure environment pressure value of the sample processing chamber 21 , and the third inlet buffer room 32 is different from the negative pressure environment pressure value of the sample processing chamber 21 .
  • the negative pressure environment pressure value of the third outlet buffer room 34 is higher than the negative pressure environment pressure value of the amplification analysis chamber 31 ; the second sewage treatment room 23 maintains a negative pressure environment, and the second sewage treatment room
  • the negative pressure environment pressure value of 23 is higher than the negative pressure environment pressure value of the sample processing chamber 21 and lower than the negative pressure environment pressure value of the second outlet buffer room 24; the third sewage treatment room 33 maintains negative pressure environment, and the negative pressure environment pressure value of the third waste disposal room 33 is higher than the negative pressure environment pressure value of the amplification analysis chamber 31 and lower than the negative pressure environment pressure value of the third outlet buffer room 34 .
  • the pressure value of the reagent preparation chamber 11 is 30Pa
  • the pressure value of the first inlet buffer room 12 and the first outlet buffer room 14 are both 10Pa
  • the first The pressure value of the sewage disposal room 13 is 20Pa
  • the pressure value of the sample processing chamber 21 is -30Pa
  • the pressure value of the second inlet buffer room 22 and the second outlet buffer room 24 are both -10Pa
  • the pressure value of the amplification analysis chamber 31 is -25Pa
  • the pressure value of the third inlet buffer room 32 and the third outlet buffer room 34 is -10Pa
  • the pressure value of the third waste disposal room 33 is -15Pa.
  • the connecting doors adjacent to the above-mentioned areas can be selected as rotary airtight doors that are rotated and opened to the side with higher environmental pressure, so that personnel can feel the appropriate resistance formed by the large environmental pressure when opening the connecting door, and can also be used. Use the pressure difference between the environment to push the connecting door to rotate and close by itself.
  • the first inlet buffer room 12 and the first outlet buffer room 14, the second inlet buffer room 22 and the second outlet buffer room 24, and the third inlet buffer room 32 and the third outlet buffer room 34 are not only provided with the necessary personnel to change clothes In addition to functions such as , disinfection, etc., you can also preferably set the rest function of the testing personnel, such as toilets, bathrooms, etc.

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Abstract

本发明涉及一种单向动线可移动病原体核酸检测实验室系统，通过将核酸检测过程所涉及的试剂储存和准备、标本制备、扩增及产物分析三个主要步骤分别独立的设置在三个可移动结构中，实现核酸检测过程中对于三个步骤之间的隔离要求，同时依照国家标准设计了严格的人员、物品单向动线，符合安全要求；同时三个可移动结构可以快速移动部署至任意需求位置并展开形成一个具有完整功能的病原体核酸检测实验室，实现重点防控位置就地执行检测，避免高危人群集中转移。

Description

一种单向动线可移动病原体核酸检测实验室系统 技术领域
本发明涉及病原体检测设备技术领域，尤其涉及一种单向动线可移动病原体核酸检测实验室系统。
背景技术
新型冠状病原体是一种具有强传染性、强致病性特点的空气传播型病原体，其在社区人群中往往会呈现出爆发式的扩散感染，对人民群众生命健康构成了极其严重的威胁。
由于目前针对新型冠状病原体所引起的肺炎等疾病尚不存在针对性特效药，对于感染人群的尽早发现及隔离就成为了防治新型冠状病原体的最有效手段。当前最普遍使用的核酸检测方法是公然准确性高、结果可靠的筛查手段，但由于进行核酸检测一般需要在符合要求的检测实验室中操作，导致检测实验室数量不足以满足庞大的检测需求，严重制约了核酸检测效率，很多患者在等待核酸检测过程中延误了最佳治疗时机致使病情加重。因此，急需一种满足生物安全实验室标准的可移动核酸检测实验室系统。
发明内容
为解决现有技术的不足，本发明提出一种单向动线可移动病原体核酸检测实验室系统，通过将核酸检测过程所涉及的试剂制备、样本处理、样本分析三个主要步骤分别独立的设置在三个可移动结构中，实现核酸检测过程中对于三个步骤之间的隔离要求，同时三个可移动结构可以快速移动部署至任意需求位置并展开形成一个具有完整功能的病原体核酸检测实验室，实现重点防控位置就地执行检测，避免高危人群集中转移。
为实现以上目的，本发明所采用的技术方案包括：
一种单向动线可移动病原体核酸检测实验室系统，其特征在于，包括相互 隔离独立的试剂储存和准备可移动结构、标本制备可移动结构和扩增及产物分析可移动结构中的任意一种可移动结构或任意多种可移动结构的组合，且所述系统中的任意单一种类可移动结构数量为一个或多个；
所述试剂储存和准备可移动结构包括依次气密连接的第一入口缓冲间、维持正压环境的试剂准备室、第一污物处置间和第一出口缓冲间，形成相对外部环境的单向气密人员通道，且所述试剂准备室侧壁至少设置一个气密传递窗；
所述标本制备可移动结构包括依次气密连接的第二入口缓冲间、维持负压环境的样本处理室、第二污物处置间和第二出口缓冲间，形成相对外部环境的单向气密人员通道，且所述样本处理室侧壁至少设置两个相互独立的气密传递窗；
所述扩增及产物分析可移动结构包括依次气密连接的第三入口缓冲间、维持负压环境的扩增分析室、第三污物处置间和第三出口缓冲间，形成相对外部环境的单向气密人员通道，且所述扩增分析室侧壁至少设置一个气密传递窗。
进一步地，所述试剂储存和准备可移动结构、标本制备可移动结构和扩增及分析可移动结构所设置的气密传递窗之间通过可拆卸气密连接的输送管道连通进行物品气密传递。
进一步地，所述第一入口缓冲间与第一出口缓冲间维持正压环境，且所述第一入口缓冲间与第一出口缓冲间的正压环境压力值低于所述试剂准备室正压环境压力值；所述第二入口缓冲间与第二出口缓冲间和第三入口缓冲间与第三出口缓冲间均维持负压环境，且所述第二入口缓冲间与第二出口缓冲间的负压环境压力值高于所述样本处理室负压环境压力值，所述第三入口缓冲间与第三出口缓冲间的负压环境压力值高于所述扩增分析室负压环境压力值。
进一步地，所述第一污物处置间维持正压环境，且所述第一污物处置间的正压环境压力值低于所述试剂准备室正压环境压力值同时高于所述第一出口缓冲间的正压环境压力值；所述第二污物处置间维持负压环境，且所述第二污物处置间的负压环境压力值高于所述样本处理室负压环境压力值同时低于所述第二出口缓冲间的负压环境压力值；所述第三污物处置间维持负压环境，且所述第三污物处置间的负压环境压力值高于所述扩增分析室负压环境压力值同时低于所述第三出口缓冲间的负压环境压力值。
进一步地，所述试剂准备室压力值为30Pa，所述第一入口缓冲间与第一出 口缓冲间的压力值均为10Pa，所述第一污物处置间压力值为20Pa；所述样本处理室压力值为-30Pa，所述第二入口缓冲间与第二出口缓冲间的压力值均为-10Pa，所述第二污物处置间压力值为-20Pa；所述扩增分析室压力值为-25Pa，所述第三入口缓冲间与第三出口缓冲间的压力值均为-10Pa，所述第三污物处置间压力值为-15Pa。
进一步地，所述试剂储存和准备可移动结构、所述标本制备可移动结构和扩增及产物分析可移动结构分别通过可拆卸线缆连接市电供电。
进一步地，所述扩增及产物分析可移动结构还包括发电机组；所述发电机组通过可拆卸线缆连接所述试剂储存和准备可移动结构、标本制备可移动结构和/或扩增及产物分析可移动结构并提供电能。
进一步地，所述发电机组可移动的收纳在所述第三出口缓冲间内并在提供电能时移出所述第三出口缓冲间重新确定放置位置。
进一步地，设置有所述可移动结构的移动平台包括驾驶室气密隔离的厢式货车、箱式拖挂车或集装箱。
进一步地，所述试剂储存和准备可移动结构、标本制备可移动结构和/或扩增及产物分析可移动结构任意组合设置在一个移动平台上，或，任意组合设置在多个相互独立的移动平台上。
本发明的有益效果为：
采用本发明所述单向动线可移动病原体核酸检测实验室系统，通过采用三个相互独立隔离的可移动结构分别承载执行核酸检测过程中的不同步骤，能够针对性的调整不同操作环境：对于环境洁净度要求高的试剂配制步骤，采用正压环境，保证内部空气不被外界污染；对于涉及病原体接触的样本处理步骤，采用负压环境以免病原体意外外泄，保证安全，防止二次传播。在此基础上，本发明所述三个相互独立隔离的可移动结构均满足人员、物品单向动线设计，形成完整的气密隔离保护，避免污染物扩散，完全符合国家强制标准要求。通过应用本发明所述单向动线可移动病原体核酸检测实验室系统即可快速调动核酸检测能力至热点需求地区，迅速形成检测能力，而无需耗时进行实验室建设，通过赋予现有核酸检测能力快捷跨区域调配的功能弥补特定区域突发性的检测能力短缺；同时移动检测能力能够有效避免大量高危人群集中转运以及聚集， 有助于大规模核酸检测事宜的有序开展。
附图说明
图1为本发明第一实施例示意图。
图2为本发明第二实施例示意图。
附图编号说明：1-试剂储存和准备可移动结构、11-试剂准备室、12-第一入口缓冲间、13-第一污物处置间、14-第一出口缓冲间、2-标本制备可移动结构、21-样本处理室、22-第二入口缓冲间、23-第二污物处置间、24-第二出口缓冲间、3-扩增及产物分析可移动结构、31-扩增分析室、32-第三入口缓冲间、33-第三污物处置间、34-第三出口缓冲间、343-发电机组、4-气密传递窗、5-市电供电、6-可拆卸线缆、7-输送管道。
具体实施方式
为了更清楚的理解本发明的内容，将结合附图和实施例详细说明。
目前病原体核酸检测实验室一般设置在医院或相关研究所等固定设施中，需要将检测样本采集后集中送至检测实验室进行检测。这样的实验室设置方式不便于检测能力的短期扩展以及检测能力的合理配置，经常会出现重点地区检测能力严重不足的同时非热点地区检测能力大量闲置浪费，不符合抗击疫情的切实需要。
现有技术中也提出过一些可移动的实验室设计，但大多为采用大型客车底盘设计的一体式结构，不利于各区域之间的相互隔离，对于传染性强的病原体检测适用能力差。
如图1所示为本发明单向动线可移动病原体核酸检测实验室系统第一实施例示意图，优选的由相互隔离独立的试剂储存和准备可移动结构1、标本制备可移动结构2和扩增及产物分析可移动结构3三部分组成。其中试剂储存和准备可移动结构1对应核酸检测实验室中的试剂储存和准备区，负责进行贮存试剂的制备、试剂的分装和扩增反应混合液的准备，以及离心管、吸头等消耗品的贮存和准备；标本制备可移动结构2对应核酸检测实验室中的标本制备区，负责进行核酸(RNA、DNA)提取、贮存及其加入至扩增反应管，尤其在所述标 本制备可移动结构2中会涉及临床样本的操作，应符合生物安全二级实验室防护设备、个人防护和操作规范的要求；扩增及产物分析可移动结构3对应核酸检测实验室中的扩增区和扩增产物分析区，负责进行cDNA合成、DNA扩增及检测，以及扩增片段的进一步分析测定，如杂交、酶切电泳、变性高效液相分析、测序等。所述试剂储存和准备可移动结构1包括依次气密连接的第一入口缓冲间12、维持正压环境的试剂准备室11、第一污物处置间13和第一出口缓冲间14，形成相对外部环境的单向气密人员通道，且所述试剂准备室11侧壁至少设置一个气密传递窗4。根据需要，所述试剂准备室11内可以设置有核酸检测试剂配制组件、核酸检测试剂分装组件与核酸检测试剂保存组件等功能组件。所述标本制备可移动结构2包括依次气密连接的第二入口缓冲间22、维持负压环境的样本处理室21、第二污物处置间23和第二出口缓冲间24，形成相对外部环境的单向气密人员通道，且所述样本处理室21侧壁至少设置两个相互独立的气密传递窗4。根据需要，所述样本处理室21可以设置有样本灭活组件、样本核酸提取组件、核酸加样组件和待检测试剂封口组件等功能组件。所述扩增及产物分析可移动结构3包括依次气密连接的第三入口缓冲间32、维持负压环境的扩增分析室31、第三污物处置间33和第三出口缓冲间34，形成相对外部环境的单向气密人员通道，且所述扩增分析室31侧壁至少设置一个气密传递窗4，同时优选的所述第三出口缓冲间34还收纳有可移动的发电机组343。
上述第一污物处置间13、第二污物处置间23和第三污物处置间33的设置使实验人员离开污染区前具有额外的缓冲空间，可以在污物处置间内处理废弃物，再经出口缓冲间离开，避免核酸检测过程产生的废弃物造成二次污染。所述第一污物处置间13、第二污物处置间23和第三污物处置间33内可以优选的设置如高温高压处理设备、焚烧设备等无害化处理设备以及气密的废弃物暂存设备等。
三个可移动结构之间优选的可分别移动互不干涉，并在所需地点快速展开组成核酸检测实验室。如图1所示为所述试剂储存和准备可移动结构1、标本制备可移动结构2和扩增及产物分析可移动结构3于指定场地展开的第一实施例。在第一实施例中，试剂储存和准备可移动结构1、标本制备可移动结构2和扩增及产物分析可移动结构3并排依次展开，形成天然的缓冲区；试剂储存和准备可移动结构1的右侧设置一个朝向标本制备可移动结构2的气密传递窗4；标本 制备可移动结构2左右两侧各设置一个气密传递窗4，其中设置在左侧的气密传递窗4朝向试剂储存和准备可移动结构1便于与试剂储存和准备可移动结构1进行物品传递，设置在右侧的气密传递窗4朝向扩增及产物分析可移动结构3，并通过输送管道7连接上述各气密传递窗4，形成完全气密的物品传送通道。在实施例1中，试剂储存和准备可移动结构1、标本制备可移动结构2和扩增及产物分析可移动结构3均通过可拆卸线缆6连接市电供电5。
如图2所示为本发明的第二实施例示意图，类似于第一实施例也同样为指定场地展开，但不同于第一实施例，在第二实施例中为了应对不便于接入市电供电5的情况，由扩增及产物分析可移动结构3上设置的发电机组343对试剂储存和准备可移动结构1、标本制备可移动结构2和扩增及产物分析可移动结构3进行供电，在使用发电机组343供电的情况下，可拆卸线缆6的单根连接长度应不大于10米以保证供电安全。发电机组343在不启用的情况下收纳在第三出口缓冲间34内；启用时移动到外部环境中并根据三个可移动结构的设置位置自由选择发电机组343的放置位置，方便可拆卸电缆布置连接。所述的发电机组343可以优选的使用柴油发电机等能够连续输出稳定电压的供电装置。
当然，发电机组343也可以优选的仅通过可拆卸线缆6与扩增及产物分析可移动结构3直接连接并供电，同时扩增及产物分析可移动结构3进一步通过可拆卸线缆6与标本制备可移动结构2和试剂储存和准备可移动结构依次连接形成串联供电结构。由于采用了依次连接的串联供电结构，发电机组343的放置位置限制进一步减小，可以实现对可移动结构的较远距离供电，而无需考虑连接发电机组343的单根可拆卸电缆6长度限制。
本发明所述的试剂储存和准备可移动结构1、标本制备可移动结构2和扩增及产物分析可移动结构3既可以如实施例1、实施例2中所示组合在一起使用，也可以分别单独使用或任意两两组合使用；同时，为了平衡不同步骤的处理能力，在一个系统中还可以包括有多个同一种类的可移动结构，例如可以在一个系统中设置两个试剂储存和准备可移动结构1、一个标本制备可移动结构2和两个扩增及产物分析可移动结构3，以充分发挥各可移动结构的处理能力。
本发明所述的气密传递窗4可以包括不同时开启的第一气密门和第二气密门，通过依次开启第一气密门和第二气密门保证物品传递过程中的结构气密性。当然除此以外的其他气密传递窗设计也可以应用在本发明中以实现相同的技术 效果。本发明所述的输送管道7可以优选为支持拆卸连接的倾斜气密管道，使物品可以依靠自身重力在管道中移动，也可以选用具备主动输送动力源的气密管道。
为了进一步满足实验室安全需要，尤其是要杜绝空气传播型病毒污染外部环境的可能，本发明所述的可移动结构内不同位置采用了不同的环境压力值，形成压力梯度设计，保证污染区空气不会泄露至外部环境。优选的，所述第一入口缓冲间12与第一出口缓冲间14维持正压环境，且所述第一入口缓冲间12与第一出口缓冲间14的正压环境压力值低于所述试剂准备室11正压环境压力值；所述第一污物处置间13维持正压环境，且所述第一污物处置间13的正压环境压力值低于所述试剂准备室11正压环境压力值同时高于所述第一出口缓冲间14的正压环境压力值；所述第二入口缓冲间22与第二出口缓冲间24和第三入口缓冲间32与第三出口缓冲间34均维持负压环境，且所述第二入口缓冲间22与第二出口缓冲间24的负压环境压力值高于所述样本处理室21负压环境压力值，所述第三入口缓冲间32与第三出口缓冲间34的负压环境压力值高于所述扩增分析室31负压环境压力值；所述第二污物处置间23维持负压环境，且所述第二污物处置间23的负压环境压力值高于所述样本处理室21负压环境压力值同时低于所述第二出口缓冲间24的负压环境压力值；所述第三污物处置间33维持负压环境，且所述第三污物处置间33的负压环境压力值高于所述扩增分析室31负压环境压力值同时低于所述第三出口缓冲间34的负压环境压力值。具体的，上述各区域可以采用以下环境压力设置实现较好的防护效果：试剂准备室11压力值为30Pa，第一入口缓冲间12与第一出口缓冲间14的压力值均为10Pa，第一污物处置间13压力值为20Pa；样本处理室21压力值为-30Pa，第二入口缓冲间22与第二出口缓冲间24的压力值均为-10Pa，第二污物处置间23压力值为-20Pa；扩增分析室31压力值为-25Pa，第三入口缓冲间32与第三出口缓冲间34的压力值均为-10Pa，第三污物处置间33压力值为-15Pa。
进一步优选的，上述各区域相邻的连接门可以选用向环境压力较高一侧旋转开启的旋转气密门，使人员开启连接门时能够感受到较大环境压力形成的适当阻力，同时也可利用环境之间压力差推动连接门自行旋转闭合。
所述的第一入口缓冲间12与第一出口缓冲间14、第二入口缓冲间22与第二出口缓冲间24和第三入口缓冲间32与第三出口缓冲间34除了提供必要的人 员更衣、消毒等功能外，还可以优选的设置检测人员休息功能，如洗手间、浴室等。
以上所述仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到的变化或替换等都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应该以权利要求书的保护范围为准。

Claims (10)

  1. 一种单向动线可移动病原体核酸检测实验室系统，其特征在于，包括相互隔离独立的试剂储存和准备可移动结构、标本制备可移动结构和扩增及产物分析可移动结构中的任意一种可移动结构或任意多种可移动结构的组合，且所述系统中的任意单一种类可移动结构数量为一个或多个；
    所述试剂储存和准备可移动结构包括依次气密连接的第一入口缓冲间、维持正压环境的试剂准备室、第一污物处置间和第一出口缓冲间，形成相对外部环境的单向气密人员通道，且所述试剂准备室侧壁至少设置一个气密传递窗；
    所述标本制备可移动结构包括依次气密连接的第二入口缓冲间、维持负压环境的样本处理室、第二污物处置间和第二出口缓冲间，形成相对外部环境的单向气密人员通道，且所述样本处理室侧壁至少设置两个相互独立的气密传递窗；
    所述扩增及产物分析可移动结构包括依次气密连接的第三入口缓冲间、维持负压环境的扩增分析室、第三污物处置间和第三出口缓冲间，形成相对外部环境的单向气密人员通道，且所述扩增分析室侧壁至少设置一个气密传递窗。
  2. 如权利要求1所述的系统，其特征在于，所述试剂储存和准备可移动结构、标本制备可移动结构和扩增及分析可移动结构所设置的气密传递窗之间通过可拆卸气密连接的输送管道连通进行物品气密传递。
  3. 如权利要求1所述的系统，其特征在于，所述第一入口缓冲间与第一出口缓冲间维持正压环境，且所述第一入口缓冲间与第一出口缓冲间的正压环境压力值低于所述试剂准备室正压环境压力值；所述第二入口缓冲间与第二出口缓冲间和第三入口缓冲间与第三出口缓冲间均维持负压环境，且所述第二入口缓冲间与第二出口缓冲间的负压环境压力值高于所述样本处理室负压环境压力值，所述第三入口缓冲间与第三出口缓冲间的负压环境压力值高于所述扩增分析室负压环境压力值。
  4. 如权利要求3所述的系统，其特征在于，所述第一污物处置间维持正压环境，且所述第一污物处置间的正压环境压力值低于所述试剂准备室正压环境压力值同时高于所述第一出口缓冲间的正压环境压力值；所述第二污物处置间维持负压环境，且所述第二污物处置间的负压环境压力值高于所述样本处理室负压环境压力值同时低于所述第二出口缓冲间的负压环境压力值；所述第三污 物处置间维持负压环境，且所述第三污物处置间的负压环境压力值高于所述扩增分析室负压环境压力值同时低于所述第三出口缓冲间的负压环境压力值。
  5. 如权利要求4所述的系统，其特征在于，所述试剂准备室压力值为30Pa，所述第一入口缓冲间与第一出口缓冲间的压力值均为10Pa，所述第一污物处置间压力值为20Pa；所述样本处理室压力值为-30Pa，所述第二入口缓冲间与第二出口缓冲间的压力值均为-10Pa，所述第二污物处置间压力值为-20Pa；所述扩增分析室压力值为-25Pa，所述第三入口缓冲间与第三出口缓冲间的压力值均为-10Pa，所述第三污物处置间压力值为-15Pa。
  6. 如权利要求1所述的系统，其特征在于，所述试剂储存和准备可移动结构、所述标本制备可移动结构和扩增及产物分析可移动结构分别通过可拆卸线缆连接市电供电。
  7. 如权利要求1所述的系统，其特征在于，所述扩增及产物分析可移动结构还包括发电机组；所述发电机组通过可拆卸线缆连接所述试剂储存和准备可移动结构、标本制备可移动结构和/或扩增及产物分析可移动结构并提供电能。
  8. 如权利要求7所述的系统，其特征在于，所述发电机组可移动的收纳在所述第三出口缓冲间内并在提供电能时移出所述第三出口缓冲间重新确定放置位置。
  9. 如权利要求1至8任一项所述的系统，其特征在于，设置有所述可移动结构的移动平台包括驾驶室气密隔离的厢式货车、箱式拖挂车或集装箱。
  10. 如权利要求9所述的系统，其特征在于，所述试剂储存和准备可移动结构、标本制备可移动结构和/或扩增及产物分析可移动结构任意组合设置在一个移动平台上，或，任意组合设置在多个相互独立的移动平台上。
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