WO2023092904A1 - 一种病毒提取保存一体化检测管及其应用方法 - Google Patents

一种病毒提取保存一体化检测管及其应用方法 Download PDF

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WO2023092904A1
WO2023092904A1 PCT/CN2022/081492 CN2022081492W WO2023092904A1 WO 2023092904 A1 WO2023092904 A1 WO 2023092904A1 CN 2022081492 W CN2022081492 W CN 2022081492W WO 2023092904 A1 WO2023092904 A1 WO 2023092904A1
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cavity
tube
lower cover
cover
integrated detection
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PCT/CN2022/081492
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English (en)
French (fr)
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张誉琳
张国锋
黄建国
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厦门宝太生物科技股份有限公司
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Publication of WO2023092904A1 publication Critical patent/WO2023092904A1/zh

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983—Viruses
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/5302—Apparatus specially adapted for immunological test procedures
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • the invention belongs to the field of virus detection, and in particular relates to an integrated detection tube for virus extraction and preservation and an application method thereof.
  • the above operation process is all realized by manual operation, the steps are cumbersome, and it is very easy to cause erroneous detection due to the introduction of external pollution due to misoperation, or due to improper prevention during operation, part transfer and recycling, virus leakage will cause secondary transmission or pollute the environment.
  • the present invention proposes an integrated detection tube and its application method to solve the problems of cumbersome and complicated manual operations, numerous parts and low biological safety in the prior art, and realize virus sampling, extraction, preservation, The purpose of integrating functional steps such as detection and traceability.
  • the present invention discloses a virus extraction and preservation integrated detection tube, the technical scheme is as follows:
  • An integrated detection tube for virus extraction and preservation comprising a tube body, an upper cover, a lower cover, a detection reagent strip and a rubber sealing gasket, the upper end of the tube body is installed with the upper cover, and the lower end of the tube body is installed with the lower cover.
  • Cover, the center of the lower cover is provided with a thimble structure, and the outside of the tube body is provided with a platform protruding from the circular tube wall, and traceability information is provided on the platform;
  • the inner parallel pipe wall of the pipe body is provided with a pair of cavity structures facing away from each other, which are the first cavity and the second cavity.
  • the upper port of the first cavity is closed, and the upper port of the first cavity is closed.
  • the lower port is provided with a tapered guide groove, and the first cavity is used to load the detection reagent cartridge from the lower port from bottom to top; the lower port of the second cavity is closed, and the upper port of the second cavity is closed.
  • the port is an opening, and the second cavity is used to fill the reagent liquid from the upper port from top to bottom;
  • the cavity structure of the first cavity and the second cavity is interfering with the inner wall of the pipe body through injection molding welding or a seal Cooperate with the inner wall of the tube body to form a sealing structure, and at the same time make the cavity structure of the first cavity and the second cavity fixed in the tube body, and the second cavity is centrally arranged in the tube body.
  • the outer wall at the opening of the upper end of the pipe body is a locking device
  • the upper cover is locked with the upper end of the pipe body through the locking device
  • the outer wall at the opening of the lower end of the pipe body is provided with
  • the upper cover is a cover structure, its inner wall is provided with a locking device, and its interior is provided with a lining tongue structure, which is used to extend into the interior of the pipe body and form an interference fit with the inner wall of the pipe body to achieve sealing Effect.
  • the lower cover is a cover structure, the inner side of the opening of the lower cover is provided with continuous or discontinuous convex edges along the ring wall, and one or more positioning slots.
  • the first cavity may be configured as a plurality of spaced cavities arranged around the periphery of the second cavity for installing multiple detection reagent strips.
  • two protruding structures are provided on the inner wall of the second cavity, and the lower port of the second cavity is closed by a diaphragm.
  • the top of the thimble structure of the lower cover is provided with a puncture device
  • the surface of the thimble structure is provided with a diversion groove
  • the middle part of the thimble structure is a platform
  • the bottom of the thimble structure is a supporting platform, so
  • the bottom of the thimble structure is also equipped with a rubber gasket.
  • the detection reagent cartridge is a lateral flow chromatography reagent cartridge, and the size and shape of the detection reagent cartridge match the space of the first cavity.
  • the upper opening of the rubber gasket is provided with a convex ring-shaped part, and the outside of the rubber gasket is provided with one or more ring-shaped sealing parts.
  • the present invention discloses an application method of an integrated detection tube for virus extraction and preservation, the method steps are as follows:
  • Step S1 the reagent liquid of the integrated detection tube is preloaded in the second cavity
  • Step S2 the swab extracts the sample, and after opening the upper cover, put the extraction swab into the second cavity, and the swab does not need to be taken out;
  • Step S3 screw back the upper cover, place the integrated detection tube upright and wait for the sample to be dissolved/lysed to obtain relevant biological components;
  • Step S4 after the relevant biological components are formed, rotate the lower cover so that the positioning sheath of the convex edge of the tube matches the position of the positioning groove of the lower cover, and then press the lower cover from bottom to top, and the positioning sheath will enter the positioning groove At the same time, the thimble structure of the lower cover will pierce the diaphragm of the second cavity, so that the reagent liquid will flow out with the relevant biological components, and automatically contact with the detection reagent cartridge to start the detection;
  • Step S5 after the detection is completed, you can choose to use the smart terminal to take pictures of the traceability information on the platform of the integrated detection tube body, and upload it to a specific digital platform;
  • Step S6 after all the detection actions are completed, the integrated detection tube is recovered as a whole.
  • the beneficial effect of the present invention is that: the present invention provides an integrated detection tube design, which integrates functional steps such as virus sampling, extraction, preservation, detection and traceability. Only by performing the steps of sample extraction and placing into the tube, the detection can be quickly started, without the need for traditional solutions such as parts sorting, sample addition, pipetting, and regular recovery. Due to the reliable sealing performance of the integrated detection tube of the present invention, the risk of leakage of biological pollutants can be reliably eliminated during and after the detection; secondly, the present invention simplifies the user's manual operation, reduces the number of parts, size, and space volume, and improves recovery. Convenience, biological safety, environmental protection of materials, traceability of test results and other key product performance, and guarantee the feasibility of lean manufacturing and automation.
  • Fig. 1 is the overall structural diagram of the integrated detection tube of the present invention
  • Fig. 2 is a schematic view of the tube body structure of the integrated detection tube of the present invention.
  • Fig. 3 is a side view of the tube body of the integrated detection tube of the present invention.
  • Fig. 4 is the rear view of the tube body of the integrated detection tube of the present invention.
  • Figure 5 is a detailed view of the inner wall of the second cavity of the integrated detection tube of the present invention.
  • FIG. 6 is a detailed view of the lower end of the second cavity of the integrated detection tube of the present invention.
  • Fig. 7 is a schematic diagram of the sealing structure of the cavity of the integrated detection tube of the present invention.
  • FIG. 8 is a schematic structural view of the upper cover of the integrated detection tube of the present invention.
  • FIG. 9 is a schematic structural view of the lower cover of the integrated detection tube of the present invention.
  • Fig. 10 is a schematic structural view of the detection reagent strip of the integrated detection tube of the present invention.
  • Fig. 11 is a schematic structural view of the rubber gasket of the integrated detection tube of the present invention.
  • the present invention discloses a virus extraction and preservation integrated detection tube, which specifically includes a tube body 1, an upper cover 2, a lower cover 3, a detection reagent strip 4 and a rubber sealing gasket 5, and the tube body 1
  • An upper cover 2 is installed on the upper end, and a lower cover 3 is installed on the lower end of the tube body 1.
  • a thimble structure is provided at the center of the lower cover 3, preferably a cylindrical thimble 3.1.
  • Platform 1.4 Platform 1.4 is used to deploy traceability information such as barcodes and characters. This platform 1.4 can be in any shape, such as rectangle or circle.
  • the traceability information is preferably a two-dimensional code.
  • the outer wall of the upper opening of the pipe body 1 is a locking device for the upper cover 2 to be installed and cooperated with it to achieve locking, specifically as the threaded device 1.1, the upper cover 2 is screwed into the pipe body 1 through the threaded device 1.1
  • the outer wall of the opening at the lower end of the pipe body 1 is provided with two vertically parallel adjacent convex edges of a specific shape that are continuously or discontinuously distributed along the outer pipe ring wall, preferably annular tapered convex edges 1.2, ring-shaped
  • the tapered convex edge 1.2 is used to cooperate with the lower cover 3 to form a staged interlocking mechanism.
  • One or more positioning sheaths 1.3 are arranged above the annular tapered convex edge 1.2, and the positioning sheaths 1.3 are used to cooperate with the lower cover 3 to limit the stroke of the lower cover 3 pressed into the tube body 1 in stages.
  • the upper cover 2 is a cover structure, and its inner wall can have a specific locking device, preferably a threaded screw cap, which is used to cooperate with the pipe body 1 to achieve locking.
  • a lining tongue structure 2.1 inside it, which is used to extend into the inside of the pipe body 1 and form an interference fit with the inner wall of the pipe body 1 to achieve a sealing effect.
  • the lower cover 3 is a cover structure, preferably a press-fit cover, and the inner side of the cover opening of the lower cover 3 is provided with a continuous or discontinuous distribution of specific shape convex edges along the ring wall, preferably at intervals or
  • the continuous tapered lip 3.4 is used to form an interlocking structure cooperating with the annular tapered lip 1.2 of the above-mentioned pipe body 1 .
  • One or more positioning grooves 3.5 are provided at the edge of the cover opening of the lower cover 3 to form a limit mechanism that cooperates with the positioning sheath body 1.3 to limit the stroke of the lower cover 3 being pressed into the tube body 1 .
  • a pair of cavity structures facing away from each other and isolated from each other are provided on the inside of the tube body 1 parallel to the tube wall, which are the first cavity 1.5 and the second cavity 1.6, wherein the upper port of the first cavity 1.5 is closed, and the upper port of the first cavity 1.5 is closed.
  • the lower port of the first cavity 1.5 is provided with a tapered guide groove, the first cavity 1.5 is used to load the detection reagent cartridge 4 from the bottom to the top, and the tapered guide groove is used to assist the detection reagent cartridge 4 Self-positioning and smooth loading.
  • the lower port of the second cavity 1.6 is closed, the upper port of the second cavity 1.6 is open, and the second cavity 1.6 is used to fill the reagent liquid from the upper port from top to bottom, and the second cavity 1.6 is in the tube body. 1 is set in the center to cooperate with the lower cover 3 to realize corresponding actions.
  • two protruding structures 1.6.1 are provided on the inner wall of the second cavity 1.6, which are used to scrape more samples from the swab head when the swab is put in.
  • a diaphragm 1.6.2 is located at the closing part of the lower port of the second cavity 1.6, which can be pierced by the cylindrical thimble 3.1 of the lower cover 3 during use to realize the diversion of the sample.
  • the cavity structure of the first cavity 1.5 and the second cavity 1.6 is welded or welded to the inner wall of the pipe by injection molding
  • the sealing member is interference fit to form a sealing structure, and at the same time, the cavity structure of the first cavity and the second cavity is fixed in the pipe body 1, and the second cavity is centrally arranged in the pipe body, wherein the sealing member is preferably The rubber ring; and the opening and closing openings of the first cavity 1.5 and the second cavity 1.6 are inverted, and the contents of the first cavity 1.5 and the second cavity 1.6 are isolated from each other and cannot be contacted.
  • the first cavity 1.5 can be expanded into multiple spaced cavities according to application requirements, and can be arranged around the periphery of the second cavity 1.6 for installing multiple detection reagent cartridges 4 to realize multiple detection items at the same time .
  • the top of the thimble structure is provided with a piercing device, preferably a cross-shaped wedge structure, which is used to puncture the diaphragm 1.6.2 of the second cavity 1.6 upward by pressing in use.
  • the thimble structure is preferably a cylindrical thimble 3.1.
  • a diversion groove is provided on the surface of the cylindrical thimble 3.1, and the diversion groove is preferably a concave channel, so that when the diaphragm 1.6.2 is broken, the reagent liquid contained in the second cavity 1.6 can flow out smoothly.
  • the middle part of the cylindrical thimble 3.1 is a pedestal, preferably a truncated cone 3.2, which is used to form a contact seal with the rubber gasket 5.
  • the bottom of the cylindrical thimble 3.1 is a support platform, preferably a knurled cylinder 3.3, which is used to support the loading of the rubber gasket 5; the cylindrical thimble is also covered with a rubber gasket 5.
  • the detection reagent strip 4 is a lateral flow chromatography reagent strip, or other detection components used to interact with liquids to achieve detection purposes, and the size and shape of the detection reagent strip 4 match the space of the first cavity 1.5.
  • the upper opening of the rubber gasket 5 of the present invention is provided with a convex ring-shaped part 5.1, which is used to cooperate with the frustum 3.2 to achieve sealing.
  • ring-shaped sealing parts on the outside of the rubber gasket 5, which are used to contact with the inner wall of the tube body 1 to achieve a sealing effect without causing excessive friction to hinder the smooth interaction between the lower cover 3 and the tube body 1 .
  • the present invention discloses an application method of an integrated detection tube for virus extraction and preservation, the method steps are as follows:
  • Step S1 the reagent liquid of the integrated detection tube is preloaded in the second cavity 1.6;
  • Step S2 extract the sample with the swab. After opening the upper cover 2, put the extracted swab into the second cavity 1.6, and the swab does not need to be taken out;
  • Step S3 turning back the upper cover 2, placing the integrated detection tube upright and waiting for the sample to be dissolved/lysed to obtain relevant biological components;
  • Step S4 after the relevant biological components are formed, rotate the lower cover 3 so that the positioning sheath body 1.3 of the annular tapered convex edge 1.2 of the tube body 1 matches the position of the positioning groove 3.5 of the lower cover 3, and then press down from the bottom up
  • the cover 3 the positioning sheath 1.3 will enter the positioning groove 3.5, and the cylindrical thimble 3.1 of the lower cover 3 will pierce the diaphragm 1.6.2 of the second cavity 1.6 at the same time, so that the reagent liquid will flow out with the relevant biological components, and the detection reagent card will be automatically connected Bar 4 contact, start detection;
  • Step S5 after the detection is completed, the user can choose to use a smart terminal, such as a smart phone, to take a photo of the QR code on the platform 1.4 of the tube body 1 of the integrated detection tube, and upload it to a specific digital platform. Since the two-dimensional code boss is designed to be coplanar with the detection reagent strip, the captured image can realize the digital identification of the detection result and the user's detection tube ID, anti-counterfeiting and collection;
  • a smart terminal such as a smart phone
  • Step S6 after all the detection actions are completed, the integrated detection tube is recovered as a whole.
  • the user only needs to perform the steps of sample extraction and placement into the tube, and the detection can be started quickly, without the need for parts sorting, sample addition, pipetting, regular recovery and other actions in the traditional solution. Since the integrated detection tube has reliable sealing performance, the risk of leakage of biological pollutants can be reliably eliminated during and after detection.

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Abstract

本发明公开了一种病毒提取保存一体化检测管及其应用方法，包括管体、上盖、下盖、检测试剂条以及橡胶密封垫，所述管体的上端安装所述上盖，所述管体的下端安装所述下盖，所述下盖的中心处设有顶针结构，所述管体的外部设有一凸起于圆形管壁的平台，所述平台上设有追溯性信息；所述管体的内部平行管壁设有一对背向相互隔离的腔体结构，为第一腔体和第二腔体，所述第一腔体的上端口封闭，所述第一腔体的下端口设有锥形导向槽，所述第二腔体的下端口封闭，所述第二腔体的上端口为开口。本发明将病毒采样、提取、保存、检测及追溯等功能步骤集成为一体。

Description

一种病毒提取保存一体化检测管及其应用方法 技术领域
本发明属于病毒检测领域，具体地涉及一种病毒提取保存一体化检测管及其应用方法。
背景技术
当前，在病毒快速/实时采集、检测应用中，普遍采用的是传统的手工加样、提取、检测、回收等典型人工操作流程。代表性的典型操作场景如病毒家庭自测中，用户需使用拭子获取病毒载体样品，加入独立提取液管中进行提取及稀释，而后再将稀释后样本注入检测设备中(如侧流层析试剂卡)进行反应及获取检测结果。检测结束后，用户需将检测过程中使用的一次性零部件、耗材和生物废料等统一归集到密封包装袋中进行回收。
以上操作过程均由人工操作实现，步骤繁琐，极易因误操作造成外部污染导入导致错误检测，或因操作及部品转移、回收过程中防范不当导致病毒外泄造成二次传播或污染环境。
发明内容
针对上述问题，本发明提出了一种一体化检测管及其应用方法，以达到解决现有技术中手工操作繁琐复杂、部品繁多、生物安全性低的问题，实现将病毒采样、提取、保存、检测及追溯等功能步骤集成为一体的目的。
为实现上述目的，一方面，本发明公开了一种病毒提取保存一体化检测管,技术方案如下：
一种病毒提取保存一体化检测管，包括管体、上盖、下盖、检测试剂条以及橡胶密封垫，所述管体的上端安装所述上盖，所述管体的下端安装所述下盖，所述下盖的中心处设有顶针结构，所述管体的外部设有一凸起于圆形管壁的平台，所述平台上设有追溯性信息；
所述管体的内部平行管壁设有一对背向相互隔离的腔体结构，为第一腔体和第二腔体，所述第一腔体的上端口封闭，所述第一腔体的下端口设有锥形导向槽，所述第一腔体用于从下端口由下往上装入检测试剂卡条；所述第二腔体的下端口封闭，所述第二腔体的上端口为开口，所述第二腔体用于从上端口由上往下装入试剂液体；
所述第一腔体和第二腔体的腔体结构，在其上方位置，通过所述第一腔体和 第二腔体的结合沿面，与管体的内壁通过注塑熔接或密封件过盈配合，与管体的内壁形成密封结构，同时使得所述第一腔体和第二腔体的腔体结构在管体内固定，且第二腔体在管体内居中设置。
进一步地，所述管体的上端开口处的外壁为锁附装置，所述上盖通过锁附装置与所述管体的上端进行锁附，所述管体的下端的开口处的外壁上设有两道上下平行相邻的沿外管环壁呈连续或断续分布的凸沿，所述凸沿的上方设有一个或多个定位鞘体。
进一步地，所述上盖为蒙盖结构，其内壁设有锁附装置，其内部设有一衬舌结构，用于伸入所述管体的内部，与管体的内壁形成过盈配合实现密封效果。
进一步地，所述下盖为蒙盖结构，所述下盖的盖口内侧设有沿环壁呈连续或断续分布的凸沿，所述下盖的盖口的边缘处设有一个或多个定位槽。
进一步地，所述第一腔体可以设置为多个间隔的腔体，以围绕第二腔体外周的方式排布，用于安装多个检测试剂卡条。
进一步地，所述第二腔体的内壁上设有两个凸出结构，所述第二腔体的下端口的封闭处为一隔膜。
进一步地，所述下盖的顶针结构的顶部设有穿刺装置，所述顶针结构的表面设有导流槽，所述顶针结构的中部为台体，所述顶针结构的底部为支撑台，所述顶针结构的底部还装有橡胶密封垫。
进一步地，所述检测试剂卡条为侧向层析试剂条，检测试剂卡条的尺寸大小外形与第一腔体的空间匹配。
进一步地，所述橡胶密封垫的上部开口处设有一凸状圈型件，所述橡胶密封垫的外部设有一个或多个圈型密封部件。
另一方面，本发明公开了一种病毒提取保存一体化检测管的应用方法，其方法步骤如下：
步骤S1，所述一体化检测管的试剂液体预装于第二腔体中；
步骤S2，拭子提取样本，打开上盖后，将提取拭子放入第二腔体中，拭子无需取出；
步骤S3，旋回上盖，将一体化检测管直立放置并等待样本溶解/裂解，以获得相关生物成分；
步骤S4，待相关生物成分形成后，将下盖进行旋转，使管体的凸沿的定位 鞘体与下盖的定位槽位置匹配，而后由下向上按压下盖，定位鞘体将进入定位槽中，同时下盖的顶针结构将刺破第二腔体的隔膜，使试剂液体携带相关生物成分流出，自动与检测试剂卡条接触，启动检测；
步骤S5，待检测完成后，可选择使用智能终端对所述一体化检测管管体的平台上的追溯性信息进行拍照，并上传至特定数字化平台；
步骤S6，全部检测动作完成后，将一体化检测管整体回收。
与现有技术相比，本发明的有益效果在于：本发明提供一种一体式检测管设计，将病毒采样、提取、保存、检测及追溯等功能步骤集成为一体，在检测进行检测时，用户仅执行样本提取及放置入管步骤，即可快速启动检测，而无需进行传统方案的部品整理，加样，移液，规整回收等动作。由于本发明一体化检测管具备可靠的密封性能，在检测中和检测后，能可靠消除生物污染物外泄风险；其次，本发明精简用户手工操作，缩减部品件数、尺寸、空间体积，改善回收便利性、生物安全性、材料环保性、检测结果可追溯性等关键产品效能，并保障制造精益及自动化可行性。
附图说明
图1为本发明一体化检测管的整体结构图；
图2为本发明一体化检测管的管体结构示意图；
图3为本发明一体化检测管的管体的侧视图；
图4为本发明一体化检测管的管体的后视图；
图5为本发明一体化检测管的第二腔体的内壁细节图
图6为本发明一体化检测管的第二腔体的下端细节图；
图7为本发明一体化检测管的腔体的密封结构示意图；
图8为本发明一体化检测管的上盖的结构示意图；
图9为本发明一体化检测管的下盖的结构示意图；
图10为本发明一体化检测管的检测试剂卡条的结构示意图；
图11为本发明一体化检测管的橡胶密封垫结构示意图；
附图标记：1、管体；1.1、螺纹装置；1.2、环形锥状凸沿；1.3、定位鞘体；1.4、平台；1.5、第一腔体；1.6、第二腔体；1.6.1、凸出结构；1.6.2、隔膜；1.6.3、密封结构；2、上盖；2.1、衬舌结构；3、下盖；3.1、圆柱顶针；3.2、锥台；3.3、滚花圆柱；3.4、锥状凸沿件；3.5、定位槽；4、检测试剂卡条；5、 橡胶密封垫；5.1、凸状圈型件；5.2、圈型密封部件。
具体实施方式
以下结合附图及具体实施例对本发明做进一步的详细解释。
如图1所示，本发明公开了一种病毒提取保存一体化检测管，具体包括管体1、上盖2、下盖3、检测试剂卡条4以及橡胶密封垫5，其管体1的上端安装上盖2，其管体1的下端安装下盖3，在下盖3的中心处设有顶针结构，优选圆柱顶针3.1，在其管体1的外部设有一凸起于圆形管壁的平台1.4，平台1.4用于部署条码及文字等追溯性信息，此平台1.4可为任意形状，如矩形或圆形等，追溯性信息优选为二维码。
如图2，其管体1的上端开口处的外壁为锁附装置，供上盖2装入并与之配合实现锁附，具体如螺纹装置1.1，上盖2通过螺纹装置1.1旋入管体1的上端，在管体1的下端的开口处的外壁上设有两道上下平行相邻的沿外管环壁呈连续或断续分布的特定形状凸沿，优选环形锥状凸沿1.2，环形锥状凸沿1.2用于配合下盖3形成阶段性互锁机构。在环形锥状凸沿1.2的上方设有一个或多个定位鞘体1.3，定位鞘体1.3用于用以配合下盖3阶段性限制下盖3压入管体1的行程。
如图8，其中上盖2为蒙盖结构，其内壁可带有特定锁附装置，优选为带螺纹旋盖，用于与管体1配合实现锁附。其内部还设有一衬舌结构2.1，用于伸入所述管体1的内部，与管体1的内壁形成过盈配合实现密封效果。
如图9，其中下盖3为蒙盖结构，优选为压入式蒙盖，下盖3的盖口内侧设有沿环壁呈连续或断续分布的特定形状凸沿，优选为相互间隔或连续的锥状凸沿件3.4，用于与上述管体1的环形锥状凸沿1.2形成相互配合的互锁结构。在下盖3的盖口的边缘处设有一个或多个定位槽3.5，用于与定位鞘体1.3形成相互配合的限位机构，限制下盖3压入管体1的行程。
如图3，在管体1的内部平行管壁设有一对背向相互隔离的腔体结构，为第一腔体1.5和第二腔体1.6，其中第一腔体1.5的上端口封闭，在第一腔体1.5的下端口设有锥形导向槽，第一腔体1.5用于从下端口由下往上装入检测试剂卡条4，锥形导向槽用于以辅助检测试剂卡条4的自定位及顺利装入。
其第二腔体1.6的下端口封闭，第二腔体1.6的上端口为开口，第二腔体1.6用于从上端口由上往下装入试剂液体，其第二腔体1.6在管体1内居中设置， 用以配合下盖3实现相应动作。如图4-5，在第二腔体1.6的内壁上设有两个凸出结构1.6.1，用于在拭子投入时，从拭子头部刮取更多样本。如图6，在第二腔体1.6的下端口的封闭处为一隔膜1.6.2，在使用时可被下盖3的圆柱顶针3.1刺破，实现样本的导流。
如图7，第一腔体1.5和第二腔体1.6的腔体结构，在其上方位置，通过第一腔体1.5和第二腔体1.6的结合沿面，与管体的内壁通过注塑熔接或密封件过盈配合，形成密封结构，同时使得所述第一腔体和第二腔体的腔体结构在管体1内固定，且第二腔体在管体内居中设置，其中密封件优选为橡胶圈；且其第一腔体1.5和第二腔体1.6的开闭口相互倒置，第一腔体1.5和第二腔体1.6的内容物被相互隔离，无法接触。第一腔体1.5根据应用需要，可以扩展为多个间隔的腔体，可以以围绕第二腔体1.6外周的方式排布，用于安装多个检测试剂卡条4，实现多检测项目同时进行。
其中顶针结构的顶部设有穿刺装置，优选为一十字形状的楔形结构，用于在使用中经按压朝上顶破第二腔体1.6的隔膜1.6.2，顶针结构优选为圆柱顶针3.1。在圆柱顶针3.1的表面设有导流槽，导流槽优选为凹形沟道，以利于在隔膜1.6.2被顶破时，第二腔体1.6内所含的试剂液体可顺利流出。圆柱顶针3.1的中部为台体，优选为锥台3.2，用于与橡胶密封垫5形成接触密封的作用。圆柱顶针3.1的底部为支撑台，优选为滚花圆柱3.3，用于支撑橡胶密封垫5的装入；圆柱顶针还套有橡胶密封垫5。
如图10，检测试剂卡条4为侧向层析试剂条，或其他用于与液体相互作用实现检测目的检测部件，检测试剂卡条4的尺寸大小外形与第一腔体1.5的空间匹配。
如图11，本发明的橡胶密封垫5的上部开口处设有一凸状圈型件5.1，用于与锥台3.2相互配合实现密封作用。在橡胶密封垫5的外部设有一个或多个圈型密封部件，用于与管体1内壁相互接触实现密封作用，而又不造成过度摩擦力阻碍下盖3与管体1的顺畅相互动作。
另一方面，本发明公开了一种病毒提取保存一体化检测管的应用方法，其方法步骤如下：
步骤S1，所述一体化检测管的试剂液体预装于第二腔体1.6中；
步骤S2，拭子提取样本，打开上盖2后，将提取拭子放入第二腔体1.6中， 拭子无需取出；
步骤S3，旋回上盖2，将一体化检测管直立放置并等待样本溶解/裂解，以获得相关生物成分；
步骤S4，待相关生物成分形成后，将下盖3进行旋转，使管体1的环形锥状凸沿1.2的定位鞘体1.3与下盖3的定位槽3.5位置匹配，而后由下向上按压下盖3，定位鞘体1.3将进入定位槽3.5中，同时下盖3的圆柱顶针3.1将刺破第二腔体1.6的隔膜1.6.2，使试剂液体携带相关生物成分流出，自动与检测试剂卡条4接触，启动检测；
步骤S5，待检测完成后，用户可选择使用智能终端，如智能手机等，对本一体化检测管的管体1的平台1.4上二维码进行拍照，并上传至特定数字化平台。由于二维码凸台被设计成与检测试剂条共面，所拍摄图像可实现检测结果与用户检测管ID的数字化识别，防伪与采集；
步骤S6，全部检测动作完成后，将一体化检测管整体回收。
本发明中，用户仅执行样本提取及放置入管步骤，即可快速启动检测，而无需进行传统方案的部品整理、加样、移液、规整回收等动作。由于本一体化检测管具备可靠的密封性能，在检测中和检测后，能可靠消除生物污染物外泄风险。
以上是对本发明较佳实施例进行了具体说明，但本发明创造并不限于所述实施例，熟悉本领域的技术人员在不违背本发明精神的前提下还可以做出种种的同等变换或替换，这些等同的变形或替换均包含在本申请权利要求的所限定的范围内。

Claims (10)

  1. 一种病毒提取保存一体化检测管，包括管体(1)、上盖(2)、下盖(3)、检测试剂卡条(4)以及橡胶密封垫(5)，所述管体(1)的上端安装所述上盖(2)，所述管体(1)的下端安装所述下盖(3)，其特征在于，所述下盖(3)的中心处设有顶针结构，所述管体(1)的外部设有一凸起于圆形管壁的平台(1.4)，所述平台(1.4)上设有追溯性信息；
    所述管体(1)的内部平行管壁设有一对背向相互隔离的腔体结构，为第一腔体(1.5)和第二腔体(1.6)，所述第一腔体(1.5)的上端口封闭，所述第一腔体(1.5)的下端口设有锥形导向槽，所述第一腔体(1.5)用于从下端口由下往上装入检测试剂卡条(4)；所述第二腔体(1.6)的下端口封闭，所述第二腔体(1.6)的上端口为开口，所述第二腔体(1.6)用于从上端口由上往下装入试剂液体；
    所述第一腔体(1.5)和第二腔体(1.6)的腔体结构，在其上方位置，通过所述第一腔体(1.5)和第二腔体(1.6)的结合沿面，与管体(1)的内壁通过注塑熔接或密封件过盈配合，与管体(1)的内壁形成密封结构(1.6.3)，同时使得所述第一腔体(1.5)和第二腔体(1.6)的腔体结构在管体(1)内固定，且第二腔体(1.6)在管体(1)内居中设置。
  2. 如权利要求1所述的一种病毒提取保存一体化检测管，其特征在于，所述管体(1)的上端开口处的外壁为锁附装置，所述上盖(2)通过锁附装置与所述管体(1)的上端进行锁附，所述管体(1)的下端的开口处的外壁上设有两道上下平行相邻的沿外管环壁呈连续或断续分布的凸沿，所述凸沿的上方设有一个或多个定位鞘体(1.3)。
  3. 如权利要求1所述的一种病毒提取保存一体化检测管，其特征在于，所述上盖(2)为蒙盖结构，其内壁设有锁附装置，其内部还设有一衬舌结构(2.1)，用于伸入所述管体(1)的内部，与管体(1)的内壁形成过盈配合实现密封效果。
  4. 如权利要求1所述的一种病毒提取保存一体化检测管，其特征在于，所述下盖(3)为蒙盖结构，所述下盖(3)的盖口内侧设有沿环壁呈连续或断续分布的凸沿，所述下盖(3)的盖口的边缘处设有一个或多个定位槽(3.5)。
  5. 如权利要求1所述的一种病毒提取保存一体化检测管，其特征在于，所述第一腔体(1.5)还可以设置为多个间隔的腔体，以围绕第二腔体(1.6)外周的方式排布，用于安装多个检测试剂卡条(4)。
  6. 如权利要求1所述的一种病毒提取保存一体化检测管，其特征在于，所述第二腔体(1.6)的内壁上设有两个凸出结构(1.6.1)，所述第二腔体(1.6)的下端口的封闭处为一隔膜(1.6.2)。
  7. 如权利要求1所述的一种病毒提取保存一体化检测管，其特征在于，所述下盖(3)的顶针结构的顶部设有穿刺装置，所述顶针结构的表面设有导流槽，所述顶针结构的中部为台体，所述顶针结构的底部为支撑台，所述顶针结构还套有所述橡胶密封垫(5)。
  8. 如权利要求1所述的一种病毒提取保存一体化检测管，其特征在于，所述检测试剂卡条(4)为侧向层析试剂条，检测试剂卡条(4)的尺寸大小外形与第一腔体(1.5)的空间匹配。
  9. 如权利要求1或7所述的一种病毒提取保存一体化检测管，其特征在于，所述橡胶密封垫(5)的上部开口处设有一凸状圈型件(5.1)，所述橡胶密封垫(5)的外部设有一个或多个圈型密封部件(5.2)。
  10. 如权利要求1-9任一项所述的一种病毒提取保存一体化检测管的应用方法，其特征在于，其方法步骤如下：
    步骤S1，所述一体化检测管的试剂液体预装于第二腔体(1.6)中；
    步骤S2，拭子提取样本，打开上盖(2)后，将提取拭子放入第二腔体(1.6)中，拭子无需取出；
    步骤S3，旋回上盖(2)，将一体化检测管直立放置并等待样本溶解/裂解，以获得相关生物成分；
    步骤S4，待相关生物成分形成后，将下盖(3)进行旋转，使管体(1)的凸沿的定位鞘体(1.3)与下盖(3)的定位槽(3.5)位置匹配，而后由下向上按压下盖(3)，定位鞘体(1.3)将进入定位槽(3.5)中，同时下盖(3)的顶针结构将刺破第二腔体(1.6)的隔膜(1.6.2)，使试剂液体携带相关生物成分流出，自动与检测试剂卡条(4)接触，启动检测；
    步骤S5，待检测完成后，可选择使用智能终端对所述一体化检测管管体(1)的平台(1.4)上的追溯性信息进行拍照，并上传至特定数字化平台；
    步骤S6，全部检测动作完成后，将一体化检测管整体回收。
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