CN111808731A - A nucleic acid amplification tube and a fully enclosed nucleic acid detection system - Google Patents
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- 150000007523 nucleic acids Chemical class 0.000 title claims abstract description 189
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- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
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- B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
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Abstract
本发明提供了一种核酸扩增管及全封闭核酸检测系统,该核酸扩增管上设置有温度显示区域。采用该技术方案,当处于某些贫困或者是落后区域,无法及时获得恒温设备进行核酸扩增反应时,可以直接将核酸扩增管放置于保温容器中,加入热水和凉水,并通过温度显示区域显示的温度,调节热水或凉水的量,调节至合适的反应温度,无需额外的恒温水浴设备,即可当场进行核酸扩增反应,即时检测。
The present invention provides a nucleic acid amplification tube and a fully enclosed nucleic acid detection system. The nucleic acid amplification tube is provided with a temperature display area. With this technical solution, when you are in some poor or backward areas and cannot obtain constant temperature equipment for nucleic acid amplification reaction in time, you can directly place the nucleic acid amplification tube in the heat preservation container, add hot water and cold water, and display the temperature through the temperature display. The temperature displayed in the area, adjust the amount of hot or cold water, and adjust to the appropriate reaction temperature, without the need for additional constant temperature water bath equipment, the nucleic acid amplification reaction can be carried out on the spot for instant detection.
Description
技术领域technical field
本发明涉及检测领域,具体涉及一种核酸扩增管及全封闭核酸检测系统。The invention relates to the field of detection, in particular to a nucleic acid amplification tube and a fully enclosed nucleic acid detection system.
背景技术Background technique
核酸诊断是未来IVD(体外诊断)行业中最具活力的细分领域之一。我国传染病防治力度的加大、血筛核酸检测的推广以及个体化医疗的发展是国内核酸诊断发展的主要动力。在这些因素的推动下,国内核酸诊断未来增速将在25-30%之间,明显超越国内IVD行业平均增速。核酸诊断一方面造福于大型医疗中心,实现病原体、基因病等早期、快速、特异、高通量的检测。Nucleic acid diagnosis is one of the most dynamic segments in the future IVD (in vitro diagnostic) industry. The increase in the prevention and control of infectious diseases in my country, the promotion of nucleic acid detection by blood screening, and the development of individualized medicine are the main driving forces for the development of domestic nucleic acid diagnosis. Driven by these factors, the future growth rate of domestic nucleic acid diagnosis will be between 25-30%, significantly exceeding the average growth rate of the domestic IVD industry. On the one hand, nucleic acid diagnosis benefits large medical centers and realizes early, rapid, specific, and high-throughput detection of pathogens and genetic diseases.
POCT(point-of-care testing),中文为“即时检验”,是体外诊断(IVD)的一个新兴细分行业,是在采样现场即刻进行分析,省去标本在实验室检验时的复杂处理程序,快速得到检验结果的一类新方法。POCT的主要标准是不需要固定的检测场所,试剂和仪器是便携式的,并且可及时操作。POCT承担了实验室的职能但又无需传统的医院实验室设备,可以不受时间、地点限制、24小时全方位为病人服务。POCT (point-of-care testing), Chinese for "point-of-care testing", is an emerging sub-industry of in vitro diagnosis (IVD). , a new class of methods to get test results quickly. The main criteria of POCT are that no fixed testing site is required, reagents and instruments are portable, and can be operated in a timely manner. POCT undertakes the functions of a laboratory but does not require traditional hospital laboratory equipment, and can serve patients 24 hours a day regardless of time and location.
特别是针对某些贫困或者是落后区域,由于贫困、卫生条件差、卫生意识低、营养不良等原因,一直是传染病肆虐的重灾区。传染病发病率高,病死率高,高昂的治疗费用一般家庭难以负担。但是在这些地区,先进的传染病检验方法却无法普及,主要原因在于大部分地区供电困难,无法运转大型仪器;无法负担大型医学设备费用以及相应的维护设备费用;场地限制;患者也无法承担高昂的检查费用等等。而核酸扩增管内的扩增反应需要在特定的温度区间内进行,并且需要在特定的密闭实验室内进行,避免样品泄漏,污染环境,而在上述区域检测人员可能很难获取温度恒温设备及密闭实验室,不能当场检测,限制了核酸检测的即时性。Especially for some poor or backward areas, due to poverty, poor sanitary conditions, low hygiene awareness, malnutrition and other reasons, they have always been the hardest hit areas by infectious diseases. The incidence of infectious diseases is high, the mortality rate is high, and the high cost of treatment is unaffordable for ordinary families. However, in these areas, advanced infectious disease testing methods cannot be popularized, mainly due to the difficulty of power supply in most areas and the inability to operate large-scale instruments; the cost of large-scale medical equipment and the corresponding maintenance equipment costs cannot be afforded; site restrictions; patients cannot afford the high cost inspection fees, etc. The amplification reaction in the nucleic acid amplification tube needs to be carried out in a specific temperature range, and it needs to be carried out in a specific closed laboratory to avoid sample leakage and pollution of the environment. The closed laboratory cannot detect on the spot, which limits the immediacy of nucleic acid detection.
因此,提供一种可即时进行核酸检测的方法,成为本领域亟待解决的问题。Therefore, it is an urgent problem to be solved in the art to provide a method that can perform nucleic acid detection in real time.
发明内容SUMMARY OF THE INVENTION
本发明的目的在于解决现有技术中不能当场进行核酸检测的问题。为了解决上述问题,本发明公开了一种全新结构的核酸扩增管及全封闭核酸检测系统,通过该核酸扩增管及检测系统可以随时进行核酸检测,极大推进核酸检测在贫困或者是落后区域应用。The purpose of the present invention is to solve the problem that nucleic acid detection cannot be performed on the spot in the prior art. In order to solve the above problems, the present invention discloses a nucleic acid amplification tube with a new structure and a fully enclosed nucleic acid detection system, through which nucleic acid amplification tube and detection system can be used for nucleic acid detection at any time, which greatly promotes nucleic acid detection in poverty or backwardness. Regional application.
本发明中公开了一种核酸扩增管,包括核酸扩增管本体和核酸扩增管盖,核酸扩增管本体下端密封,上端开口,核酸扩增管盖密封核酸扩增管本体的开口,形成封闭的核酸溶液存放腔,核酸扩增管上设置有温度显示区域。The invention discloses a nucleic acid amplification tube, comprising a nucleic acid amplification tube body and a nucleic acid amplification tube cover. The nucleic acid amplification tube body is sealed at the lower end and opened at the upper end. The nucleic acid amplification tube cover seals the opening of the nucleic acid amplification tube body. A closed nucleic acid solution storage cavity is formed, and a temperature display area is arranged on the nucleic acid amplification tube.
采用该技术方案,当处于某些贫困或者是落后区域,无法及时获得恒温设备进行核酸扩增反应时,可以直接将核酸扩增管放置于容器中,加入热水和凉水,温度显示区域会显示当前核酸扩增管的温度,通过温度显示区域显示的温度,调节热水或凉水的量至合适的核酸扩增反应温度,无需额外的恒温水浴设备,核酸扩增管内的核酸溶液即可当场进行核酸扩增反应,待反应完成后,可即时进行检测。With this technical solution, when you are in some poor or backward areas and cannot obtain constant temperature equipment for nucleic acid amplification reaction in time, you can directly place the nucleic acid amplification tube in the container, add hot and cold water, and the temperature display area will display The current temperature of the nucleic acid amplification tube, through the temperature displayed in the temperature display area, adjust the amount of hot or cold water to the appropriate nucleic acid amplification reaction temperature, without the need for additional constant temperature water bath equipment, the nucleic acid solution in the nucleic acid amplification tube can be carried out on the spot The nucleic acid amplification reaction can be detected immediately after the reaction is completed.
根据本发明的另一具体实施方式,温度显示区域包括可逆温度试纸。According to another specific embodiment of the present invention, the temperature display area includes a reversible temperature test paper.
根据本发明的另一具体实施方式,温度显示区域包括第一温度显示区域和第二温度显示区域,第一温度显示区域和第二温度显示区域分别涂覆有变色温度不同的可逆温敏变色材料。According to another specific embodiment of the present invention, the temperature display area includes a first temperature display area and a second temperature display area, and the first temperature display area and the second temperature display area are respectively coated with reversible thermochromic materials with different color changing temperatures .
根据本发明的另一具体实施方式,温度显示区域设置在管盖上,或温度显示区域设置在侧管壁上。According to another specific embodiment of the present invention, the temperature display area is arranged on the tube cover, or the temperature display area is arranged on the side wall of the tube.
本发明中还公开了一种全封闭核酸检测系统,包括外壳和前述任一种核酸扩增管,外壳内设有空腔,外壳上表面设有核酸溶液添加区域,The invention also discloses a fully enclosed nucleic acid detection system, comprising a casing and any of the aforementioned nucleic acid amplification tubes, a cavity is arranged in the casing, and a nucleic acid solution adding area is arranged on the upper surface of the casing,
核酸溶液添加区域下方的空腔内从下到上依次设有层析试纸和刺破机构,核酸溶液添加区域被设置成用于供核酸扩增管插入,且在核酸扩增管插入核酸溶液添加区域后,空腔密封,刺破机构刺破核酸扩增管,核酸溶液流入空腔。The cavity below the nucleic acid solution addition area is provided with a chromatography test paper and a puncturing mechanism in sequence from bottom to top, and the nucleic acid solution addition area is set for the insertion of the nucleic acid amplification tube, and the nucleic acid solution is inserted into the nucleic acid amplification tube to add After the area, the cavity is sealed, the piercing mechanism pierces the nucleic acid amplification tube, and the nucleic acid solution flows into the cavity.
根据本发明的另一具体实施方式,空腔内还设有破坏液储存部,破坏液储存部可打开,使破坏液流入空腔内。According to another specific embodiment of the present invention, a destruction liquid storage part is further provided in the cavity, and the destruction liquid storage part can be opened to allow the destruction liquid to flow into the cavity.
附图说明Description of drawings
下面结合附图和具体实施方式对本发明作进一步详细地说明:Below in conjunction with the accompanying drawings and specific embodiments, the present invention will be described in further detail:
图1是本发明提供的一种核酸扩增管的剖视图;1 is a cross-sectional view of a nucleic acid amplification tube provided by the present invention;
图2是本发明提供的一种核酸扩增管的结构示意图;2 is a schematic structural diagram of a nucleic acid amplification tube provided by the present invention;
图3是本发明提供的核酸扩增管和检测系统一种配合状态下的剖视图;3 is a cross-sectional view of the nucleic acid amplification tube provided by the present invention and the detection system in a matched state;
图4是本发明提供的核酸扩增管和检测系统另一种配合状态下的剖视图;4 is a cross-sectional view of the nucleic acid amplification tube and the detection system provided by the present invention in another state of cooperation;
图5是本发明提供的核酸扩增管和检测系统一种配合状态下的结构示意图;5 is a schematic structural diagram of the nucleic acid amplification tube provided by the present invention and the detection system in a coordinated state;
图6是本发明提供的核酸扩增管和检测系统爆炸示意图;6 is a schematic diagram of an explosion of a nucleic acid amplification tube and a detection system provided by the present invention;
图7是本发明提供的刺破机构的结构示意图;Fig. 7 is the structural representation of the puncturing mechanism provided by the present invention;
图8是本发明提供的刺破机构的结构示意图。FIG. 8 is a schematic structural diagram of the puncturing mechanism provided by the present invention.
附图标记:Reference number:
核酸扩增管 100Nucleic
侧管壁 110
第一凸部 111
下管壁 120Down Tube
凹部 121
管盖 130Tube
核酸溶液存放腔 140Nucleic acid
密封环 150
温度显示区域 160
外壳 200Shell 200
空腔 210
破坏液储存部 220Destruction Fluid Storage 220
液体密封件 230Liquid Seals 230
层析试纸 240
刺破机构 250
定位部 251
第四限位部 2511
第三凸部 2512The
刺穿部 252Pierced 252
流体通道 253
核酸溶液添加区域 260Nucleic acid
第一凹槽 261
第三限位部 262The
检测结果观察区域 270Test
弹性下压结构 280Elastic press down
具体实施方式Detailed ways
以下由特定的具体实施例说明本发明的实施方式,本领域技术人员可由本说明书所揭示的内容轻易地了解本发明的其他优点及功效。虽然本发明的描述将结合较佳实施例一起介绍,但这并不代表此发明的特征仅限于该实施方式。恰恰相反,结合实施方式作发明介绍的目的是为了覆盖基于本发明的权利要求而有可能延伸出的其它选择或改造。为了提供对本发明的深度了解,以下描述中将包含许多具体的细节。本发明也可以不使用这些细节实施。此外,为了避免混乱或模糊本发明的重点,有些具体细节将在描述中被省略。需要说明的是,在不冲突的情况下,本发明中的实施例及实施例中的特征可以相互组合。The embodiments of the present invention are described below by specific embodiments, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. Although the description of the invention will be presented in conjunction with the preferred embodiment, this does not mean that the features of the invention are limited to this embodiment. On the contrary, the purpose of introducing the invention in conjunction with the embodiments is to cover other options or modifications that may be extended based on the claims of the invention. The following description will contain numerous specific details in order to provide a thorough understanding of the present invention. The invention may also be practiced without these details. Furthermore, some specific details will be omitted from the description in order to avoid obscuring or obscuring the gist of the present invention. It should be noted that the embodiments of the present invention and the features of the embodiments may be combined with each other under the condition of no conflict.
在本实施例的描述中,需要说明的是,术语“上”、“下”、“内”、“底”等指示的方位或位置关系为基于附图所示的方位或位置关系,或者是该发明产品使用时惯常摆放的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。In the description of this embodiment, it should be noted that the orientations or positional relationships indicated by the terms "upper", "lower", "inside", "bottom", etc. are based on the orientations or positional relationships shown in the drawings, or are The orientation or positional relationship that the product of the invention is usually placed in use is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, Therefore, it should not be construed as a limitation of the present invention.
术语“第一”、“第二”、“第三”等仅用于区分描述,而不能理解为指示或暗示相对重要性。The terms "first", "second", "third", etc. are only used to differentiate the description and should not be construed as indicating or implying relative importance.
在本实施例的描述中,还需要说明的是,除非另有明确的规定和限定,术语“设置”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通。对于本领域的普通技术人员而言,可以具体情况理解上述术语在本实施例中的具体含义。In the description of this embodiment, it should also be noted that, unless otherwise expressly specified and limited, the terms "arranged", "connected" and "connected" should be understood in a broad sense, for example, it may be a fixed connection or a Removable connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two components. For those of ordinary skill in the art, the specific meanings of the above terms in this embodiment can be understood in specific situations.
为使本发明的目的、技术方案和优点更加清楚,下面将结合附图对本发明的实施方式作进一步地详细描述。In order to make the objectives, technical solutions and advantages of the present invention clearer, the embodiments of the present invention will be further described in detail below with reference to the accompanying drawings.
如图1和图2所示,本发明中公开了一种核酸扩增管100,包括核酸扩增管本体和核酸扩增管盖130,核酸扩增管本体下端密封,上端开口,核酸扩增管本体包括侧管壁110和下管壁120,核酸扩增管盖130密封核酸扩增管本体的开口,形成封闭的核酸溶液存放腔140,且核酸扩增管本体上还设置有温度显示区域160。As shown in FIG. 1 and FIG. 2, the present invention discloses a nucleic
采用该技术方案,当处于某些贫困或者是落后区域,无法及时获得恒温设备进行核酸扩增反应时,可以直接将核酸扩增管放置于保温容器中,加入热水和凉水,并通过温度显示区域160显示的温度,调节热水或凉水的量,调节至合适的反应温度,无需额外的恒温水浴设备,即可当场进行核酸扩增反应。With this technical solution, when you are in some poor or backward areas and cannot obtain constant temperature equipment for nucleic acid amplification reaction in time, you can directly place the nucleic acid amplification tube in the heat preservation container, add hot water and cold water, and display the temperature through the temperature display. The temperature displayed in the
根据本发明的另一具体实施方式,本发明中的核酸扩增管100为特制的核酸扩增管,核酸扩增管100的侧管壁110可由一系列材料组成,其优选为导热性好,强度高,流动性好的材料制成,如金属、合金、导热塑料以及有机复合材料,高度1-3cm,优选2cm,大致形状可以类似普通核酸扩增管,但有所区别。According to another specific embodiment of the present invention, the nucleic
根据本发明的另一具体实施方式,温度显示区域160可以为可逆温度试纸。可以根据核酸扩增反应的温度选择合适的可逆温度试纸。例如,当核酸扩增反应的温度为38度时,可以选择THERMAX的0~50℃的可逆温度试纸;若核酸扩增反应需要63度时,则可以选择THERMAX的50~100℃的可逆温度试纸。此外,还可以根据实际情况向供应商定制特殊温度试纸。According to another specific embodiment of the present invention, the
根据本发明的另一具体实施方式,温度显示区域160包括第一温度显示区域和第二温度显示区域,第一温度显示区域和第二温度显示区域分别涂覆有变色温度不同的可逆温敏变色材料。温敏变色材料的变色温度可以根据实际情况需要设定,具体的可逆温敏变色材料可采用市售产品。针对某一种扩增反应,若需要反应温度在第一温度T1和第二温度T2之间时,可以选择在核酸扩增管100表涂覆两种温敏变色材料,第一种温敏变色材料的变色温度为第一温度T1,第二种温敏变色材料的变色温度为第二温度T2。这样在进行该种扩增反应时,当第一温敏材料变色而第二温敏材料未变色时,表明该温度正适于核酸扩增管100内扩增反应进行。这样的话,可以直接将核酸扩增管100放入暖水瓶内,调节冷热水的量控制暖水瓶内的水的温度,即可维持扩增反应的进行,不需要恒温设备,可以随时随地对样品进行检测。According to another specific embodiment of the present invention, the
举例来说,如最佳反应温度在38度左右,温敏涂料针对的温度可以选用2种,分别大于38和小于38,优选为37和39度,如果最佳反应温度在63度,那么温敏涂料可以选为62和64,温敏涂料涂抹的形状可以任意,但是优选为与温度对应的阿拉伯数字,如38度变色的温敏材料,显示为“38”。这样可以更直接的反应核酸扩增管100的温度。For example, if the optimal reaction temperature is around 38 degrees, two temperature-sensitive coatings can be used, which are greater than 38 and less than 38 degrees, preferably 37 and 39 degrees. If the optimal reaction temperature is 63 degrees, then the temperature The temperature-sensitive paint can be selected as 62 and 64, and the shape of the temperature-sensitive paint can be arbitrary, but it is preferably an Arabic numeral corresponding to the temperature, such as a temperature-sensitive material with a color change of 38 degrees, which is displayed as "38". In this way, the temperature of the nucleic
进一步地,核酸扩增管100若是用于多种温度不同的扩增反应体系时,可以设置多种温敏变色材料。Further, if the nucleic
根据本发明的另一具体实施方式,为了便于核酸扩增管100在插入全封闭核酸检测系统后被刺破机构250刺破,可以在核酸扩增管100的下管壁120上设有切痕,在刺破机构250刺向核酸扩增管100的下管壁120时,核酸扩增管100下管壁120沿切痕所在的位置破裂;或者相对于核酸扩增管100的其他部位,可以将下管壁120设置得较薄,便于刺破机构250刺破核酸扩增管100。According to another specific embodiment of the present invention, in order to facilitate the nucleic
进一步地,由于核酸扩增管100的下管壁120上设置有切痕或者将下管壁120设置得较薄,核酸扩增管100在插入全封闭核酸检测系统之前,在取放过程中就可能会沿切痕或者是较薄的位置破损。因此,根据本发明的另一具体实施方式,将核酸扩增管100的下管壁120设置有一个向管盖130方向凹陷的凹部121,将切痕设置在凹部121内;或者是仅凹部121内的核酸扩增管100管壁较薄,优选至少核酸扩增管100下管壁120中心位置处较薄,这样可以有效的避免取放过程中核酸扩增管100破损。Further, since the
根据本发明的另一具体实施方式,一般的核酸扩增管100都是开盖结构,即管盖130是一个可开合的盖子,将需要扩增的样品和与扩增反应体系相关的试剂放入核酸扩增管100后,在盖上盖子,实现密封。此外,核酸扩增管100上部也可以直接是密闭结构,即管盖130和侧管壁110固定相连,甚至直接一体成型,不可打开。使用时带细针的注射器穿破核酸扩增管100的管盖130,注射反应体系,然后以封口膜或者较高熔点的蜡滴密封破口,以此可以更好的实现核酸扩增管100的密封。According to another specific embodiment of the present invention, the general nucleic
根据本发明的另一具体实施方式,从便于观察的角度出发,温度显示区域160设置在管盖上,或温度显示区域160设置在侧管壁上。According to another specific embodiment of the present invention, from the viewpoint of easy observation, the
根据本发明的另一具体实施方式,侧管壁110的外表面上设有一个或多个第一凸部111,如果是多个第一凸部111,则多个第一凸部111可以位于侧管壁110的同一横截面上,至少部分侧管壁110为圆柱形侧管壁,圆柱形侧管壁的外表面上设有外螺纹(图中未示出),外螺纹位于第一凸部111的下方。According to another specific embodiment of the present invention, one or more
其中,第一凸部111的结构没有特殊的限定,只要能够配合第一凹槽261,在轴向方向上限制核酸扩增管100相对于圆柱形通道的位置即可,第一凸部111可以是一个凸点,也可以是沿周向延伸的凸条,或者是一个完整的圆形凸环。从更有效且更稳定的限制核酸扩增管100沿的轴向方向的位置的角度出发,优选第一凸部111为一个完整的圆形凸环,或者多个沿侧管壁110周向均匀分布的凸点或者是凸条。The structure of the first
根据本发明的另一具体实施方式,如图1和图2所示,核酸扩增管100侧管壁110上的第一凸部111为圆形凸环,第一凸部111下方的核酸扩增管100侧管壁110为圆柱形侧管壁,该圆柱形侧管壁上设置有与刺破机构250的定位部251的内螺纹配合的外螺纹。According to another specific embodiment of the present invention, as shown in FIG. 1 and FIG. 2 , the first
进一步地,如图3至图6所示,本发明中还公开了一种全封闭核酸检测系统,包括外壳200和前述任一种核酸扩增管100,外壳200内设有空腔210,外壳200上表面设有核酸溶液添加区域260,Further, as shown in FIG. 3 to FIG. 6 , a fully enclosed nucleic acid detection system is also disclosed in the present invention, which includes a
核酸溶液添加区域260下方的空腔内从下到上依次设有层析试纸240和刺破机构250,核酸溶液添加区域260被设置成用于供核酸扩增管100插入,且在核酸扩增管100插入核酸溶液添加区域260后,空腔210密封,刺破机构250刺破核酸扩增管100的下管壁130,核酸溶液流入空腔210。The
在某些贫困或者是落后区域,采用本发明提供的核酸扩增管100,可以即时完成核酸扩增反应,随后可以将该核酸扩增管100插入核酸溶液添加区域260,即可快速的完成核酸检测,并且由于核酸扩增管100和核酸溶液添加区域260之间是密封连接,可以有效的避免样品挥发到空气中,污染环境,无需将待测核酸样本运送至专门的封闭型实验室进行检测,可即时检测。In some poor or backward areas, using the nucleic
根据本发明的另一具体实施方式,空腔210内还设有破坏液储存部220,破坏液储存部220可打开,使破坏液流入空腔210内。采用核酸破坏试剂去除全封闭核酸检测系统中残留的核酸,进一步避免和后继过程中可能的污染。According to another specific embodiment of the present invention, the
根据本发明的另一具体实施方式,外壳200内设有空腔210,空腔210内从下到上依次设有破坏液储存部220、层析试纸240和刺破机构250,破坏液储存部220上表面设有开口,且开口由液体密封件230密封,液体密封件230可打开,破坏液储存部220内可以储存有核酸破坏试剂,例如次氯酸钠溶液或者是商用DNA去污剂等。According to another specific embodiment of the present invention, the
外壳200上表面设有核酸溶液添加区域260和检测结果观察区域270,核酸溶液添加区域260包括圆柱形通道,圆柱形通道包括插入端和非插入端,插入端被设置成用于供核酸扩增管100插入,且插入端的形状与核酸扩增管100相配合,以密封空腔210,圆柱形通道的插入端设有环形的第一凹槽261,当核酸扩增管100插入圆柱形通道内,第一凸部111和第一凹槽261相互配合限制核酸扩增管100相对于圆柱形通道在轴向上移动,The upper surface of the
如图7和图8所示,刺破机构250包括圆筒形的定位部251、位于定位部251中轴线上的刺穿部252,刺破机构250还设有流体通道253,圆柱形通道的非插入端设有第三限位部262,定位部251上设有第四限位部2511,第三限位部262和第四限位部2511相互配合限制刺破机构250以定位部251的中心轴为转轴旋转,定位部251内表面上设有内螺纹(图中未示出),核酸扩增管100的外表面上设有与内螺纹配合的外螺纹。As shown in FIG. 7 and FIG. 8 , the piercing
当将核酸扩增管100插入圆柱形通道内并旋转核酸扩增管100时,如图3所示,由于第一凸部111和环形的第一凹槽261配合,核酸扩增管100只能旋转,而不能够相对于圆柱形通道向内插入。并且随着核酸扩增管100旋转,由于核酸扩增管100侧管壁110上的外螺纹与定位部251上的内螺纹相配合,定位部251会带动刺穿部252向核酸扩增管100移动至图4所示的位置(图4中液体密封件230已经打开,但在检测未完成前液体密封件230不能打开,此处仅用图4来展示刺破机构250和核酸扩增管100的相对位置关系),刺破核酸扩增管100,核酸溶液从流体通道253流入空腔210内。空腔210内的层析试纸240就可以对样品进行检测,检测人员可以通过检测结果观察区域270域观察检测结果。When the nucleic
采用上述技术方案,在检测过程中,空腔210始终保持密封,避免了扩增产物向外泄露。更进一步地,在记录检测结果后,如图4所示,可以打开液体密封件230,层析试纸240就可以和核酸破坏试剂反应,完全去除全封闭核酸检测系统中残留的核酸。这样即使在后继过程中,核酸扩增管100不慎脱落,或者是全封闭核酸检测系统破损,造成内部暴露,也不会造成任何污染。By adopting the above technical solution, during the detection process, the
除此之外,在现有技术中向下插入核酸扩增管100,而刺破机构250维持不动的方式中,由于外壳200内的气体受到压缩,可能会有扩增产物从核酸扩增管100和外壳200连接的缝隙里泄漏,造成污染。而通过本发明提供的全新结构的封闭的全封闭核酸检测系统,该装置允许核酸扩增管100在轴向上保持不动,而是通过旋转使刺破机构250向上移动来刺破核酸扩增管100,在刺破过程中,外壳200内的气压不变,扩增产物的气溶胶并不会向外界泄漏,可以更好的避免污染。并且核酸扩增管100和外壳200通过螺纹连接,连接结构更稳定,不易脱落,进一步避免扩增产物暴露,造成污染的可能。并且最终采用核酸破坏试剂去除全封闭核酸检测系统中残留的核酸,进一步避免和后继过程中可能的污染。In addition, in the prior art in which the nucleic
根据本发明的另一具体实施方式,第三限位部262为沿轴向延伸的第二凹槽,第四限位部2511为第二凸部。第二凸部可以是凸点,也可以是沿轴向延伸的凸条;并且第二凹槽的长度要允许刺破机构250向上移动至刺破核酸扩增管100的位置。在核酸扩增管100插入定位部251内并开始旋转前,第二凸部位于第二凹槽的最下端,随着核酸扩增管100旋转,整个刺破机构250向上移动,第二凸部沿第二凹槽向上移动,直至刺破机构250刺穿核酸扩增管100下管壁120。According to another specific embodiment of the present invention, the third limiting
进一步地,从更可靠的角度出发,还可以设有多个第二凸部和与之配合的沿轴向延伸的第二凹槽,优选,多个第二凸部和与之配合的沿轴向延伸的第二凹槽沿圆柱形通道的周向均匀分布。Further, from a more reliable point of view, a plurality of second protrusions and a second groove extending along the axial direction can be provided. Preferably, a plurality of second protrusions and a matching groove along the axis The second extending grooves are evenly distributed along the circumference of the cylindrical channel.
很容易可以想到的是,也可以将第三限位部262设置为第二凸部,第四限位部2511设置为沿轴向延伸的第二凹槽。It is easily conceivable that the third limiting
根据本发明的另一具体实施方式,如图3至图6所示,外壳200上设有通孔,液体密封件230通过通孔穿设在外壳200上,液体密封件230包括位于外壳200外的操作部和位于外壳200内的密封部,密封部密封破坏液储存部220上表面,且液体密封件230具有第一位置和第二位置,当检测系统未使用时,液体密封件230位于图3所示的第一位置,通过操作部,可以将液体密封件230移动至图4所示的第二位置,打开破坏液储存部220,在整个过程中,液体密封件230与外壳200始终密封连接,空腔210始终处于密封状态,扩增产物不会泄露。According to another specific embodiment of the present invention, as shown in FIG. 3 to FIG. 6 , the
根据本发明的另一具体实施方式,定位部251下端设有第三凸部2512,液体密封件230上设有对应的第三凹槽。刺破机构250未向上移动之前,第三凸部2512设置在第三凹槽内。由于第三凸部2512和第三凹槽的配合,液体密封件230始终处于第一位置,不能够被移动至第二位置,在核酸扩增管100插入定位部251并旋转提升刺破机构250后,第三凸部2512也随之向上移动,从第三凹槽内脱离。此时,检测人员可以通过操作部将液体密封件230从第一位置移动至第二位置,打开破坏液储存部220,层析试纸240可以和破坏液储存部220内的破坏液体接触。According to another specific embodiment of the present invention, the lower end of the
根据本发明的另一具体实施方式,层析试纸240上方设置有弹性下压结构280,当液体密封件230打开后,弹性下压结构280将至少部分层析试纸240压入破坏液储存部220。弹性下压结构280没有特殊的限定,可以是弹簧也可以是一个弹片。According to another specific embodiment of the present invention, an
进一步地,实现空腔210密封的具体结构可以参照现有技中已有的任何方式,本发明中不在赘述,例如核酸溶液添加区域260可以通过将形状设置得与核酸扩增管100相匹配,在核酸扩增管100插入核酸溶液添加区域260后,二者的表面相贴合,实现空腔210的密封。根据本发明的另一具体实施方式,为了更有效的避免扩展产物泄露到空气中,还可以在圆柱形通道的插入端设有由弹性体制成的密封环140,或核酸扩增管100的侧管壁110外设有弹性体制成的密封环140。Further, the specific structure for realizing the sealing of the
根据本发明的另一具体实施方式,检测结果观察区域270由透明材料制成。According to another specific embodiment of the present invention, the detection
虽然通过参照本发明的某些优选实施方式,已经对本发明进行了图示和描述,但本领域的普通技术人员应该明白,以上内容是结合具体的实施方式对本发明所作的进一步详细说明,不能认定本发明的具体实施只局限于这些说明。本领域技术人员可以在形式上和细节上对其作各种改变,包括做出若干简单推演或替换,而不偏离本发明的精神和范围。Although the present invention has been illustrated and described by referring to some preferred embodiments of the present invention, those of ordinary skill in the art should understand that the above content is a further detailed description of the present invention in conjunction with specific embodiments, and it cannot be assumed that Embodiments of the present invention are limited only by these descriptions. Those skilled in the art may make various changes in form and details, including making several simple deductions or substitutions, without departing from the spirit and scope of the present invention.
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