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CN211292270U - A storage tube for quality control analytes - Google Patents

A storage tube for quality control analytes Download PDF

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CN211292270U
CN211292270U CN201921464852.0U CN201921464852U CN211292270U CN 211292270 U CN211292270 U CN 211292270U CN 201921464852 U CN201921464852 U CN 201921464852U CN 211292270 U CN211292270 U CN 211292270U
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storage tube
quality control
nozzle
cavity
wall
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尚雪松
徐晶
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Beijing Huashi Novi Medical Technology Co ltd
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Jinyu Runze Beijing Technology Co ltd
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/18Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/28Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/38Diluting, dispersing or mixing samples

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  • Mechanical Engineering (AREA)
  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Analytical Chemistry (AREA)
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  • General Health & Medical Sciences (AREA)
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Abstract

The utility model provides a storage tube for quality control analytes, which comprises a tube orifice 1, an upper tube body 2 and a lower base 4 which are connected in sequence from top to bottom; the pipe orifice 1 is formed by surrounding a pipe wall, and the thickness of the pipe wall is gradually reduced from the upper pipe body 2 to the pipe orifice 1; the upper pipe body 2 is formed by surrounding a pipe wall, a middle cavity 3 is formed inside the upper pipe body 2, the upper part of the middle cavity 3 is communicated with the outside, the lower part of the middle cavity 3 is contacted with the lower base 4, and the middle cavity 3 is used for storing quality control products; the lower base 4 is of a round table-shaped structure with a wide upper part and a narrow lower part, and the inner part of the lower base is a cylindrical bottom cavity 5; the upper end of the bottom cavity 5 is in contact with the outer wall of the lower base 4, and the lower end of the bottom cavity 5 is communicated with the outside.

Description

一种质控分析物的储存管A storage tube for quality control analytes

技术领域technical field

本实用新型涉及生化检测技术领域,尤其涉及应用于质控分析物的的储存管。The utility model relates to the technical field of biochemical detection, in particular to a storage tube used for quality control analytes.

背景技术Background technique

目前的自动质控,没有可供参考的文献和资料,一直处于探索阶段,ISO15189与CLSI中没有明确基于某个项目给出个性化定制的控制规则,只有一个相对简单的要求,要求指出:每天每个项目至少运行一次质控,每个项目不少于两个水平。The current automatic quality control has no literature and materials for reference, and has been in the exploratory stage. ISO15189 and CLSI do not clearly provide customized control rules based on a certain project. There is only a relatively simple requirement, which requires that: every day Run at least one quality control for each item, with no less than two levels for each item.

现有的生化检测流水线的结构:主机----储存箱---传送带上的机械臂、取样器、分析仪、封盖器----冰箱等等。流水线本身的用途是进行生化分析,也即自动对大量病人的血样进行各种检测,整个过程是自动化的,目前有很多厂商如雅培等都有生化检测流水线。The structure of the existing biochemical detection line: main engine ---- storage box --- mechanical arm on the conveyor belt, sampler, analyzer, capping device ---- refrigerator, etc. The purpose of the assembly line itself is to perform biochemical analysis, that is, to automatically perform various tests on blood samples from a large number of patients. The entire process is automated. At present, many manufacturers such as Abbott have biochemical test lines.

具体地,生化检测的过程例如下:Specifically, the process of biochemical detection is as follows:

流水线上,机械臂从冰箱里抓出储存管(初始时储存管有盖,里边装的是病人血液),然后进入开盖模块,开盖完成;下一步进入分析单元即生化分析仪,吸样完成;下一步进入盖帽模块,盖帽完成;下一步进入冰箱。储存管进入冰箱完成后,等待10分到15分钟以后,完成生化分析。On the assembly line, the robotic arm grabs the storage tube from the refrigerator (initially, the storage tube has a cover, which contains the patient's blood), and then enters the cap-opening module, and the cap-opening is completed; the next step is to enter the analysis unit, the biochemical analyzer, to aspirate the sample. Done; the next step is to enter the capping module, the capping is completed; the next step is to enter the refrigerator. After the storage tube enters the refrigerator, wait for 10 to 15 minutes to complete the biochemical analysis.

病人血样储存管的材质是塑料和玻璃纤维的混合物(医院给病人抽血后存血用的管),管口有盖子,初始一般是螺纹拧紧的盖子,流水线第一次取样时会把盖子拧掉,取样完成后在管口封上一个膜,膜的材料一般是铝箔等软性金属材质,并且表面有胶,流水线是靠下压力把膜粘在管口的。下一次取样时,需要把这个膜揭掉。对于病人样本检测而言,封膜、揭膜一般来说只需要进行一次或两次,之后样本储存管就会被丢弃。The material of the patient's blood sample storage tube is a mixture of plastic and glass fiber (the tube used by the hospital to store blood after the patient draws blood). After the sampling is completed, seal a film on the nozzle. The material of the film is generally a soft metal material such as aluminum foil, and there is glue on the surface. The assembly line uses the downward pressure to stick the film to the nozzle. The membrane needs to be removed for the next sampling. For patient sample testing, sealing and peeling the film generally only needs to be performed once or twice, and then the sample storage tube will be discarded.

根据流水线的结构发现,流水线可以用于进行生化检测的质量控制,也即自动质控。只需要一套自动质控软件程序改变流水线的一些流程即可进行质控。According to the structure of the assembly line, the assembly line can be used for quality control of biochemical detection, that is, automatic quality control. Only a set of automatic quality control software programs are required to change some processes of the pipeline to perform quality control.

质控与病人样本检测最主要的区别是,质控需要周期性的进行,也就是上述流程需要每周执行几次,甚至每天执行几次。因此就会频繁的对储存管进行封膜、揭膜。现有的储存管的设计不适合进行多次封膜、揭膜。The main difference between quality control and patient sample testing is that quality control needs to be performed periodically, that is, the above process needs to be performed several times a week, or even several times a day. Therefore, the storage tube is frequently sealed and uncovered. The design of the existing storage tube is not suitable for sealing and peeling the film multiple times.

CN305142959S提供一种末梢血样管,用于医疗机构末梢血样的采集、转运和保存,也可用于其他已采集血样的转移、运输和保存,存储管的管壁厚度也就是管口截面的宽度比较大。因此与膜的接触面积比较大,封膜的时候容易粘上,但是揭膜时可能会揭不下来,尤其是多次揭膜时更容易出现揭不下来的情况(揭不干净),在封膜时就会出现问题。CN305142959S provides a peripheral blood sample tube, which is used for the collection, transportation and preservation of peripheral blood samples in medical institutions, and can also be used for the transfer, transportation and preservation of other collected blood samples. . Therefore, the contact area with the film is relatively large, and it is easy to stick when the film is sealed, but it may not be peeled off when the film is peeled off, especially when the film is peeled off multiple times. The problem occurs when the membrane is used.

因此,有针对性地对生化检测技术领域提供一种质控分析物的储存管,是亟待解决的技术问题。Therefore, it is an urgent technical problem to provide a storage tube for quality control analytes in the field of biochemical detection technology.

实用新型内容Utility model content

本实用新型的目的在于提供一种质控分析物的储存管,实现对储存管的多次贴膜封装,以解决传统血样管在质控流程中的不足之处。The purpose of the utility model is to provide a storage tube for quality control analyte, which can realize multiple film packaging of the storage tube, so as to solve the deficiencies of the traditional blood sample tube in the quality control process.

为达到上述目的,本实用新型的解决方法是提供一种质控分析物的储存管,包括由上至下依次连接的管口(1)、上部管体(2)和下部底座(4);In order to achieve the above object, the solution of the present invention is to provide a quality control analyte storage tube, comprising a nozzle (1), an upper tube body (2) and a lower base (4) sequentially connected from top to bottom;

所述管口(1),由管壁环绕而成,从所述上部管体(2)到所述管口(1),管壁的厚度逐渐变薄;The nozzle (1) is surrounded by a pipe wall, and the thickness of the pipe wall gradually becomes thinner from the upper pipe body (2) to the nozzle (1);

所述上部管体(2),由管壁环绕而成,在所述上部管体(2)内部形成中部腔体(3),所述中部腔体(3)上部与外界连通,所述中部腔体(3)下部与所述下部底座(4)接触,所述中部腔体(3)用于存放质控品;The upper pipe body (2) is surrounded by a pipe wall, a middle cavity (3) is formed inside the upper pipe body (2), the upper part of the middle cavity (3) is communicated with the outside world, and the middle The lower part of the cavity (3) is in contact with the lower base (4), and the middle cavity (3) is used for storing quality control products;

所述下部底座(4),外部为上宽下窄的圆台形结构,内部为圆柱形的底部腔体(5);所述底部腔体(5)上端与所述下部底座(4)的外壁接触,所述底部腔体(5)下端与外界联通。The lower base (4) has a circular truncated structure with a wide top and a narrow bottom on the outside, and a cylindrical bottom cavity (5) on the inside; the upper end of the bottom cavity (5) and the outer wall of the lower base (4) contact, the lower end of the bottom cavity (5) communicates with the outside world.

可选地,所述管口(1)的内壁均匀分布有多个加强筋(6),用于加固管口 (1)。Optionally, a plurality of reinforcing ribs (6) are evenly distributed on the inner wall of the nozzle (1) for reinforcing the nozzle (1).

可选地,所述储存管的管体材料中含有玻璃纤维。Optionally, the tube body material of the storage tube contains glass fibers.

可选地,在所述管口(1)的上部添加盖或者膜。Optionally, a cap or membrane is added to the top of the spout (1).

可选地,所述中部腔体(3)内设有磁力混匀珠,用于对其中的质控品进行搅拌混匀。Optionally, magnetic mixing beads are provided in the middle cavity (3) for stirring and mixing the quality control product therein.

可选地,所述管口(1)的外壁均匀分布有多个加强筋(6),所述管口(1) 外壁由下至上逐渐向内收缩,保持布置有所述加强筋(6)的位置与所述上部管体(2)的中部直径一致。Optionally, the outer wall of the nozzle (1) is evenly distributed with a plurality of reinforcing ribs (6), the outer wall of the nozzle (1) gradually shrinks inward from bottom to top, and the reinforcing ribs (6) are kept arranged. The position of is consistent with the middle diameter of the upper pipe body (2).

可选地,所述底部腔体(5)中设置有填充体(7),用于配合流水线上用于安放所述储存管的底座的顶针将所述储存管从所述底座中顶起。Optionally, the bottom cavity (5) is provided with a filling body (7), which is used to push up the storage tube from the base in cooperation with a thimble on the base for placing the storage tube on the assembly line.

可选地,所述填充体(7)为短柱,所述短柱上部与所述底部腔体(5) 的上端中心连接,所述短柱半径小于所述底部腔体(5)的半径。Optionally, the packing body (7) is a short column, the upper part of the short column is connected to the center of the upper end of the bottom cavity (5), and the radius of the short column is smaller than the radius of the bottom cavity (5). .

可选地,所述填充体(7)包括马达、电池和电磁开关,所述电磁开关用于响应流水线上的启动信号,在接收到所述启动信号时使所述马达运动,从而带动所述储存管运动以对其中的质控品进行混匀。Optionally, the filling body (7) includes a motor, a battery and an electromagnetic switch, and the electromagnetic switch is used to respond to a start-up signal on the assembly line, and when the start-up signal is received, the motor is moved, thereby driving the The storage tube is moved to mix the controls in it.

可选地,所述下部底座(4)与所述上部管体(2)之间为可拆卸连接。Optionally, the lower base (4) and the upper pipe body (2) are detachably connected.

本实用新型有如下优点:The utility model has the following advantages:

1.现有的储存管,由于管口与管体整体薄厚一致,因此,当管口封膜后,再次取下时容易产生残留。本实用新型在管口处做了改进,管口部分设计为逐渐变薄的结构,这使得本实用新型在实际使用过程中,由于管口与封膜接触面积小,易于操作,不会产生残留,更加适用于质控流程;1. In the existing storage tube, since the mouth of the tube and the overall thickness of the tube body are the same, after the mouth of the tube is sealed, it is easy to leave residues when it is taken off again. The nozzle of the utility model is improved at the nozzle, and the nozzle part is designed as a gradually thinner structure, which makes the utility model in the actual use process, because the nozzle and the sealing film contact area is small, easy to operate, and will not produce residues , more suitable for quality control process;

2.现有的储存管均为单一腔体,这种结构由于底部为实心,会导致加工过程中管体变形,次品率较高。本实用新型通过将储存管内部设计成上、下的双腔体结构,以应对流水线对储存管规格的限制,底部腔体能够提高加工成品率。2. The existing storage tubes are all of a single cavity. Because the bottom of this structure is solid, the tube body will be deformed during the processing, and the defective rate is high. In the utility model, the interior of the storage tube is designed as an upper and lower double-cavity structure, so as to cope with the limitation of the specification of the storage tube by the assembly line, and the bottom cavity can improve the processing yield.

附图说明Description of drawings

图1是本实用新型提供的一种质控分析物的储存管的主视图;1 is a front view of a storage tube for a quality control analyte provided by the present invention;

图2是本实用新型提供的一种质控分析物的储存管的俯视图;2 is a top view of a storage tube for a quality control analyte provided by the present invention;

图3是本实用新型提供的管口局部示意图;Fig. 3 is the partial schematic diagram of the nozzle provided by the present invention;

图4是本实用新型提供的一种质控分析物的储存管的优选方案示意图;4 is a schematic diagram of a preferred solution for a storage tube for a quality control analyte provided by the present invention;

图5示出了本实用新型实施例的临床医疗体液检测系统的结构示意图;5 shows a schematic structural diagram of a clinical medical body fluid detection system according to an embodiment of the present invention;

图6示出了本实用新型实施例的临床医疗体液检测质控方法的示意图;6 shows a schematic diagram of a quality control method for clinical medical body fluid detection according to an embodiment of the present invention;

1-管口,2-上部管体,3-中部腔体,4-下部底座,5-底部腔体,6-加强筋, 7-填充体。1-Nozzle, 2-Upper body, 3-Middle cavity, 4-Lower base, 5-Bottom cavity, 6-Reinforcing rib, 7-Filling body.

具体实施方式Detailed ways

为使本实用新型实施例的目的、技术方案和优点更加清楚,下面将结合本实用新型实施例中的附图,对本实用新型实施例中的技术方案进行清楚、完整地描述。In order to make the purposes, technical solutions and advantages of the embodiments of the present utility model more clear, the technical solutions in the embodiments of the present utility model will be described clearly and completely below with reference to the accompanying drawings in the embodiments of the present utility model.

如图1和图2所示,一种质控分析物的储存管,包括由上至下依次连接的管口1、上部管体2和下部底座4;所述管口1、上部管体2和下部底座4;所述管口1,由管壁环绕而成,从所述上部管体2到所述管口1,管壁的厚度逐渐变薄。优选地,所述上部管体2和所述管口1与所述上部管体2连接处的管壁厚度为0.8mm,所述管口1的顶部的管壁厚度为0.1mm,所述管口1的长度为6mm,所述管口1的半径为12mm,在所述管口1的上部可以添加盖或者膜,使其在出厂时符合医疗领域对无菌环境的要求。As shown in Figures 1 and 2, a storage tube for quality control analytes includes a nozzle 1, an upper tube body 2 and a lower base 4 sequentially connected from top to bottom; the nozzle 1, the upper tube body 2 and the lower base 4; the nozzle 1 is surrounded by a pipe wall, and from the upper pipe body 2 to the nozzle 1, the thickness of the pipe wall gradually becomes thinner. Preferably, the thickness of the pipe wall at the connection between the upper pipe body 2 and the nozzle 1 and the upper pipe body 2 is 0.8 mm, and the thickness of the pipe wall at the top of the nozzle 1 is 0.1 mm. The length of the mouth 1 is 6 mm, and the radius of the mouth 1 is 12 mm. A cover or film can be added to the upper part of the mouth 1 to make it meet the requirements of the medical field for sterile environment when it leaves the factory.

所述上部管体2,由管壁环绕而成,在所述上部管体2内部形成中部腔体3,所述中部腔体3上部与外界连通,所述中部腔体3下部与所述下部底座4接触,所述中部腔体3用于存放质控品。优选地,在中部腔体3内部添加一个或多个磁力混匀珠,使其在流水线上能够进行磁力混匀;所述上部管体2的管壁厚度为0.8mm,所述上部管体2的长度为75mm或者100mm。所述下部底座4,外部为上宽下窄的圆台形结构,内部为圆柱形的底部腔体5;所述底部腔体5上端与所述下部底座4的外壁接触,所述底部腔体5下端与外界联通。The upper pipe body 2 is surrounded by a pipe wall, a middle cavity 3 is formed inside the upper pipe body 2, the upper part of the middle cavity 3 is communicated with the outside world, and the lower part of the middle cavity 3 is connected to the lower part. The base 4 is in contact, and the middle cavity 3 is used to store quality control products. Preferably, one or more magnetic mixing beads are added inside the middle cavity 3 to enable magnetic mixing on the assembly line; the thickness of the pipe wall of the upper pipe body 2 is 0.8 mm, and the upper pipe body 2 The length is 75mm or 100mm. The lower base 4 has a circular truncated structure with a wide top and a narrow bottom, and a cylindrical bottom cavity 5 inside; the upper end of the bottom cavity 5 is in contact with the outer wall of the lower base 4, and the bottom cavity 5 The lower end communicates with the outside world.

如图3所示,所述管口1的内壁均匀分布有四个加强筋6,使管口1不易损坏。具体地,流水线封膜时会对管口1施加一个下压力,由于本实施例中的管口1厚度很薄,这有可能在受到下压力的时候变形或破碎,为了加固管口1使其不被流水线的封膜装置损坏,而可以在管口1处设置若干加强筋。在其他实施例中,加强筋也可以设置在管口1的外壁上。因为一些应用场景下,所述储存管有盖子,所述加强筋6在内壁上会导致不能加塞子或者密封不严,因此加强筋优选为设置在外壁上。As shown in FIG. 3 , four reinforcing ribs 6 are evenly distributed on the inner wall of the nozzle 1, so that the nozzle 1 is not easily damaged. Specifically, a downward pressure will be applied to the nozzle 1 during film sealing. Since the nozzle 1 in this embodiment is very thin, it may be deformed or broken when subjected to the down pressure. In order to strengthen the nozzle 1 to make it Instead of being damaged by the film sealing device of the assembly line, several reinforcing ribs can be provided at the nozzle 1. In other embodiments, the reinforcing ribs can also be arranged on the outer wall of the nozzle 1 . Because in some application scenarios, the storage tube has a cover, and the reinforcing rib 6 on the inner wall may result in the inability to add a plug or the sealing is not strict, so the reinforcing rib is preferably arranged on the outer wall.

进一步地,所述储存管的材料中含有玻璃纤维,能够使管体变硬,不易在受到下压力时变形。Further, the material of the storage tube contains glass fibers, which can make the tube body hard and not easily deformed when subjected to down pressure.

图4同时提供了三种优选方案,所述底部腔体5中设置有填充体7,某些品牌的流水线上的安置所述储存管的底座,在检测过程中需要把所述储存管从所述底座上顶起来,如果所述底部腔体5内为空心,那么所述底座上的顶针就无法将所述储存管顶起,因此需要在所述底部腔体5中设置有所述填充体7,使得所述底座的顶针能把整个所述储存管顶起来。Fig. 4 also provides three preferred solutions, the bottom cavity 5 is provided with a filler 7, and some brands of the assembly line are installed on the base of the storage tube, during the detection process, the storage tube needs to be removed from all If the bottom cavity 5 is hollow, the ejector pin on the base cannot lift the storage tube, so the filler body needs to be provided in the bottom cavity 5 7, so that the ejector pin of the base can push up the entire storage tube.

第一种可选方案,所述填充体7为短柱,所述短柱上部与所述底部腔体5的上端中心连接,所述短柱半径小于所述底部腔体5半径,所述短柱用途是配合自动生化检测流水线。In the first alternative, the packing body 7 is a short column, the upper part of the short column is connected to the center of the upper end of the bottom cavity 5 , the radius of the short column is smaller than the radius of the bottom cavity 5 , and the short column is The purpose of the column is to cooperate with the automatic biochemical detection pipeline.

第二种可选方案,所述填充体7由电池、电磁开关和马达组成。这种设置是为了使所述储存管能够震动或晃动,从而对所述储存管内质控分析物进行混匀。具体是在流水线上设置一个相应的磁力开关,当所述储存管经过开关时(可响应到流水线的磁力开关发出的信号),触发所述填充体7 中的所述电磁开关,使得所述马达短暂地运转,使所述储存管随之短暂震动,从而实现混匀操作。可选的,所述底部腔体5和所述中部腔体3分体设置,所述下部底座4和所述上部管体2之间用插接或螺纹连接等可拆卸地连接,这样使带有所述马达的所述下部底座4可以被反复使用,所述上部管体2使用后可以废弃。In the second option, the filling body 7 is composed of a battery, an electromagnetic switch and a motor. This setting is to enable the storage tube to be shaken or shaken to mix the quality control analyte in the storage tube. Specifically, a corresponding magnetic switch is set on the assembly line. When the storage tube passes through the switch (which can respond to the signal sent by the magnetic switch of the assembly line), the electromagnetic switch in the filling body 7 is triggered, so that the motor Run briefly, causing the storage tube to vibrate briefly, so as to realize the mixing operation. Optionally, the bottom cavity 5 and the middle cavity 3 are provided separately, and the lower base 4 and the upper pipe The lower base 4 with the motor can be used repeatedly, and the upper tubular body 2 can be discarded after use.

第三种可选方案,管口1外壁由下至上逐渐向内收缩,保持布置有所述加强筋6的地方与所述上部管体2的中部直径一致。The third option is that the outer wall of the nozzle 1 gradually shrinks inward from bottom to top, and the place where the reinforcing rib 6 is arranged is kept consistent with the diameter of the middle of the upper pipe body 2 .

具体实施过程:储存管从冰箱进入到流水线,流水线上设置一个相应的磁力开关,当所述储存管经过所述磁力开关时,触发所述填充体7中的所述电磁开关,使得所述马达短暂地运转,使所述储存管随之短暂震动,从而实现混匀操作;然后进入开盖模块,所述管口1有盖子,初始是螺纹拧紧的盖子,流水线第一次取样时会把盖子拧掉;然后进入分析模块,流水线底座上的顶针顶入所述底部腔体5内与所述填充体7接触,将所述储存管顶起,由取样针伸如中部腔体3,供分析仪进行质控分析;取样完成后进入封膜模块,在所述管口1封上一个膜,膜的材料一般是铝箔等软性金属材质,并且表面有胶,流水线靠下压力把膜粘在所述管口1上;最后封膜后的储存管回到冰箱中。The specific implementation process: the storage tube enters the assembly line from the refrigerator, and a corresponding magnetic switch is arranged on the assembly line. When the storage tube passes through the magnetic switch, the electromagnetic switch in the filling body 7 is triggered to make the motor Run for a short time to make the storage tube vibrate for a short time, so as to realize the mixing operation; then enter the cap opening module, the nozzle 1 has a cap, and the cap is screwed at the beginning. Unscrew it; then enter the analysis module, the ejector pin on the assembly line base is pushed into the bottom cavity 5 to contact with the filling body 7, the storage tube is pushed up, and the sampling needle extends into the middle cavity 3 for analysis After the sampling is completed, it enters the film sealing module, and a film is sealed on the nozzle 1. The material of the film is generally a soft metal material such as aluminum foil, and there is glue on the surface. On the nozzle 1; the storage tube after the final sealing film is returned to the refrigerator.

质控需要周期性的进行,也就是上述流程需要每周执行几次,甚至每天执行几次。因此就会频繁的对所述储存管进行封膜、揭膜。所述管口1 的顶部管壁厚度仅为0.1mm,因此与膜的接触面积较小,在频繁操作中封膜也不会存在揭不下来的情况。Quality control needs to be performed periodically, that is, the above process needs to be performed several times a week, or even several times a day. Therefore, the storage tube is frequently sealed and uncovered. The thickness of the top tube wall of the nozzle 1 is only 0.1 mm, so the contact area with the film is small, and the sealing film will not be unable to be peeled off during frequent operations.

为了清楚地说明储存管的用途,本实用新型实施例介绍一种临床医疗体液检测质控方法,该质控方法基于临床医疗体液检测系统自动执行质控操作。如图5所示,临床医疗体液检测系统(相当于上述实施例中的流水线)包括检测系统10和数据管理系统20,据管理系统可以为计算机或服务器。检测系统10包括轨道传传输模块111以及依次连接在轨道传传输模块 111上的进样模块11、识别模块12、离心模块13、去盖模块14、去膜模块 15、至少一台分析仪器16、封膜模块17、回盖模块18、出样模块19、存储模块112。上述实施例中所述流水线上的磁力开关可以设置在分析仪器 16之前的任何一个模块处,使储存管在到达分析仪器16之前完成混匀。In order to clearly illustrate the purpose of the storage tube, the embodiment of the present invention introduces a quality control method for clinical medical body fluid detection, which automatically performs quality control operations based on a clinical medical body fluid detection system. As shown in FIG. 5 , the clinical medical body fluid detection system (equivalent to the pipeline in the above embodiment) includes a detection system 10 and a data management system 20, and the data management system can be a computer or a server. The detection system 10 includes an orbital transmission module 111, a sample injection module 11, an identification module 12, a centrifugation module 13, a cap removal module 14, a membrane removal module 15, at least one analytical instrument 16, Film sealing module 17 , capping module 18 , sampling module 19 , storage module 112 . The magnetic switch on the assembly line in the above embodiment can be set at any module before the analyzer 16, so that the storage tube can be mixed before reaching the analyzer 16.

数据管理系统20与检测系统10进行连接通信,在数据管理系统20中安装有管理系统软件,利用数据管理系统20中的管理系统软件控制操控检测系统工作。The data management system 20 is connected and communicated with the detection system 10 , management system software is installed in the data management system 20 , and the management system software in the data management system 20 is used to control and control the operation of the detection system.

进样模块11将体液样本送入轨道传传输模块111,轨道传传输模块111 将体液样本转移至分析仪,分析仪对体液样本进行抽样检测,分析仪与数据管理系统20连接,分析仪将采集的数据传输至数据管理系统20,数据管理系统20对分析仪采集的数据进行分析处理。The sampling module 11 sends the bodily fluid samples into the orbital transmission module 111, and the orbital transmission and transmission module 111 transfers the bodily fluid samples to the analyzer, and the analyzer samples and detects the bodily fluid samples. The data is transmitted to the data management system 20, and the data management system 20 analyzes and processes the data collected by the analyzer.

检测系统含有至少一个进样模块11和至少一个出样模块19。进样模块 11和出样模块19通过可配置的在轨道输送模块上装载和卸载体液样本试管。其中,进样模块11和出样模块19可以为机械手或者其他用于装载和卸载体液样本其他装置。The detection system includes at least one sampling module 11 and at least one sampling module 19 . The sample inlet module 11 and the sample outlet module 19 are loaded and unloaded with bodily fluid sample cuvettes on the rail transport module configurable. Wherein, the sample injection module 11 and the sample output module 19 may be a manipulator or other devices for loading and unloading body fluid samples.

离心模块13可以对体液样本进行自动离心分离,去盖模块14可以拆开主样本试管的塑料螺旋盖和压力封盖,去膜摸块可以去除被封膜模块17 密封的样本试管密封膜,分杯模块可以通过现有主样本试管产生辅助样本试管。The centrifuge module 13 can automatically centrifuge the body fluid samples, the cap removal module 14 can disassemble the plastic screw cap and the pressure seal of the main sample test tube, and the membrane removal module can remove the sealing film of the sample test tube sealed by the sealing module 17. The cup module can generate auxiliary sample tubes from existing main sample tubes.

封膜模块17使用密封门口密封试管。将密封膜切割,然后热封到每个塑料样本试管上。回盖摸块可以将旋盖放在分杯模块产生的辅助样本试管上。储存模块将密封的样本试管保存在温度受控的环境中,它可以包括存储工作台和自动冷冻机。The sealing module 17 seals the test tube using the sealing door. The sealing film was cut and heat sealed to each plastic sample tube. The capping module can place the screw cap on the auxiliary sample tube generated by the cupping module. Storage modules store sealed sample tubes in a temperature-controlled environment and can include storage benches and automated freezers.

下面将结合临床医疗体液检测系统的各个模块对临床医疗检测系统的工作过程进行描述,体液样本盛放在试管中,试管上设置有用于标志该体液样本信息标签,具体的该标签可以为识别码例如二维码或电子标签等,首先,对体液样本进行检测时,由进样模块11将体液样本放置在轨道传传输模块111上,由识别模块12识别试管上的标签,识别完成后,如需离心,则进入离心模块13进行自动离心,之后进入去盖模块14或去膜模块15,具体的可以根据试管上密封物进行选择,在完成去盖或去膜后,由轨道传传输模块111将样本输送至分析仪,分析仪可以通过试管上的标签识别体液样本信息,分析仪对样本进行吸样分析,之后进入封膜模块17进行封膜,封膜完成后,由轨道传传输模块111将体液样本传输至存储模块112,出样模块19将体液样本放回储存模块进行储存。The working process of the clinical medical body fluid detection system will be described below in conjunction with each module of the clinical medical body fluid detection system. The body fluid sample is placed in a test tube, and the test tube is provided with an information label for marking the body fluid sample. The specific label can be an identification code. For example, a two-dimensional code or an electronic label, etc., first, when the body fluid sample is detected, the sample injection module 11 places the body fluid sample on the rail transmission module 111, and the identification module 12 identifies the label on the test tube. After the identification is completed, such as If centrifugation is required, enter the centrifuge module 13 for automatic centrifugation, and then enter the capping module 14 or the membrane stripping module 15. The specific selection can be made according to the sealing material on the test tube. After the capping or membrane stripping is completed, the rail transfer module 111 The sample is transported to the analyzer, the analyzer can identify the body fluid sample information through the label on the test tube, the analyzer performs suction analysis on the sample, and then enters the film sealing module 17 for film sealing. After the film sealing is completed, the rail transmission module 111 The body fluid sample is transferred to the storage module 112, and the sample output module 19 returns the body fluid sample to the storage module for storage.

基于图5所示的临床医学体液检测系统,本实用新型实施例提供的临床医疗体液检测质控方法如图6所示,该质控方法可以包括如下步骤:Based on the clinical medical body fluid detection system shown in FIG. 5 , the quality control method for clinical medical body fluid detection provided by the embodiment of the present invention is shown in FIG. 6 , and the quality control method may include the following steps:

S10,获取体液样本的至少一个检测项目的检测数据。在本实施例中,体液样本可以包括血液、尿液、组织液。检测项目可以包括体液中的各种酶的检测。例如谷丙转氨酶、丙氨酸转移酶等,以及各种离子的检测,例如,钾、钙、钠等离子。或者其他检测项目,例如,白蛋白,球蛋白等检测项目。示例性的所称的检测数据为患者的检测项目的检测结果。S10: Acquire detection data of at least one detection item of the body fluid sample. In this embodiment, the body fluid sample may include blood, urine, and tissue fluid. Test items can include the detection of various enzymes in body fluids. For example, alanine aminotransferase, alanine transferase, etc., and detection of various ions, such as potassium, calcium, sodium, etc. Or other testing items, such as albumin, globulin and other testing items. Exemplary so-called test data are test results of test items of a patient.

S20,对检测数据进行移动均值计算,得到检测项目的移动均值。作为示例性的实施例,移动均值的计算可以采用如下方法:若依次得到测定值为 (x1,x2,x3,…,xn)时,按顺序取一定个数所做的全部算术平均值。例如

Figure BDA0002191760770000101
可以得到移动平均值。当然,在本实施例中,也可以采用按照顺序取两个数据做平均值。作为示例性的实施例,在本实施例中,可以采用一次移动平均法或二次移动平均法。S20: Perform moving average calculation on the detection data to obtain a moving average of the detection items. As an exemplary embodiment, the calculation of the moving average may adopt the following method: if the measured values (x 1 , x 2 , x 3 , . average value. E.g
Figure BDA0002191760770000101
A moving average can be obtained. Of course, in this embodiment, two pieces of data can also be taken in order as an average value. As an exemplary embodiment, in this embodiment, a first-order moving average method or a second-order moving average method may be adopted.

S30,判断检测项目的移动均值是否超过预设阈值。作为示例性的实施例,预设阈值可以根据医院检测样本的检测结果确定预设阈值,在本实施例中,预设阈值可以根据检测得到的检测数据随时变动,可以根据检测移动均值可以按时间顺序对移动均值进行描点,在移动均值的点落入预设阈值内,则认为检测项目的检测数据正常,在移动均值点落入预设阈值外时,则认为该检测项目的检测结果可能存在问题。S30: Determine whether the moving average of the detected items exceeds a preset threshold. As an exemplary embodiment, the preset threshold may be determined according to the detection results of the hospital detection samples. In this embodiment, the preset threshold may be changed at any time according to the detection data obtained by the detection, and may be determined by time according to the detection moving average. Sequentially trace the moving average. When the moving average point falls within the preset threshold, the detection data of the test item is considered to be normal. When the moving average point falls outside the preset threshold, it is considered that the test result of the test item may exist. question.

为了避免出现随机现象,例如,分析仪在吸取试管中的体液样本时,吸取到气泡等,导致检测数据出现较大的漂移,在示例性的实施例中,在确认移动均值是否超过预设阈值时,可以连续检测多个移动均值是否均超过预设阈值,或者连续检测多个预设阈值中是否存在多个移动均值超过预设阈值的情况,即较短时间内间隔性的出现多个移动均值超过预设阈值的情况。In order to avoid random phenomena, for example, when the analyzer absorbs the body fluid sample in the test tube, it absorbs air bubbles, etc., resulting in a large drift in the detection data. In an exemplary embodiment, it is confirmed whether the moving average exceeds a preset threshold value. , it can continuously detect whether multiple moving averages exceed the preset threshold, or continuously detect whether there are multiple moving averages exceeding the preset threshold among the multiple preset thresholds, that is, multiple movements occur at intervals in a relatively short period of time. When the mean exceeds a preset threshold.

具体的,判断多个连续体液样本中的检测项目的移动均值超过预设阈值的个数是否大于预设个数;当连续多个体液样本中的移动均值超过预设阈值的个数大于预设个数时,确认移动均值是否超过预设阈值。作为示例性的说明,在出现移动均值超过预设阈值时,为避免出现随机情况,可以在第一个出现超过预设阈值的移动均值开始,可以连续观测后续的两个或三个移动均值是否均超出预设阈值,如果从第一个超出预设阈值的移动均值开始连续出现了两个或三个移动均值超出预设阈值的状况,可以确认当前检测项目的移动均值超标,输出提示信息。例如可以在临床医疗体液检测的操作屏幕上显示某一项目的检测可能存在某种问题,或者输出语音提示等。Specifically, it is determined whether the moving average of the detection items in the multiple consecutive body fluid samples exceeds the preset threshold is greater than the preset number; when the moving average of the multiple consecutive body fluid samples exceeds the preset threshold The number of When the number is reached, confirm whether the moving average exceeds the preset threshold. As an exemplary illustration, when the moving average exceeds the preset threshold, in order to avoid random situations, starting from the first moving average that exceeds the preset threshold, it is possible to continuously observe whether the subsequent two or three moving averages are If two or three moving averages exceed the preset threshold continuously from the first moving average that exceeds the preset threshold, it can be confirmed that the moving average of the current detection item exceeds the standard, and a prompt message is output. For example, it can be displayed on the operation screen of clinical medical body fluid detection that there may be some problems in the detection of a certain item, or output voice prompts and so on.

作为另一可选的实施例,在第一个出现超过预设阈值的移动均值开始,连续观测后续的五个移动均值中是否有超过两个超出预设阈值的移动均值,在超过两个时,确认当前检测项目的移动均值超标,输出提示信息。本领域技术人员应当明白上述实施例中的移动均值的个数只是为了方便说明而进行的举例,其他个数的移动均值也在本实施例的保护范围内。当检测项目的移动均值超过预设阈值时,进入步骤S40,当检测项目的移动均值在预设范围内,返回步骤S10。As another optional embodiment, starting from the first occurrence of a moving average that exceeds a preset threshold, continuously observe whether there are more than two moving averages that exceed the preset threshold in the following five moving averages, and when more than two , confirm that the moving average of the current test item exceeds the standard, and output a prompt message. Those skilled in the art should understand that the number of moving averages in the above embodiment is only an example for convenience of description, and other numbers of moving averages are also within the protection scope of this embodiment. When the moving average value of the detection item exceeds the preset threshold, the process goes to step S40, and when the moving average value of the detection item is within the preset range, the process returns to step S10.

S40,控制临床医疗体液检测系统对检测项目进行质控。具体地,预先在临床医疗体液检测系统中的储存模块中放置质控品(质控分析物),在检测项目的移动均值超过预设阈值后,控制出样模块19在储存模块中取出质控品,放在轨道传传输模块111上进入分析仪,进行移动均值超出预设阈值的对应的检测项目的质控分析。S40, controlling the clinical medical body fluid detection system to perform quality control on the detection items. Specifically, the quality control substance (quality control analyte) is placed in the storage module in the clinical medical body fluid detection system in advance, and after the moving average value of the detection item exceeds the preset threshold, the sample extraction module 19 is controlled to take out the quality control material in the storage module. The product is placed on the track transmission module 111 to enter the analyzer, and the quality control analysis of the corresponding test items whose moving average exceeds the preset threshold is performed.

作为示例性的实施例,如图5所示,轨道传传输模块111可以包括急诊通道113,在检测项目的移动均值超过预设阈值时,可以控制质控品进入急诊通道113优先进入分析仪进行质控,以在最短的时间内完成当前检测项目的质控。As an exemplary embodiment, as shown in FIG. 5 , the rail transmission module 111 may include an emergency channel 113 , and when the moving average value of the detection item exceeds a preset threshold, the quality control product may be controlled to enter the emergency channel 113 and enter the analyzer preferentially. Quality control to complete the quality control of the current testing items in the shortest time.

作为示例性的实施例,当检测项目的移动均值超过预设阈值时,继续对体液样本进行检测,并将确认移动均值失控时具有检测项目的后续体液样本标注待查标签。具体的,可以将该待查标签与体液样本的识别标签关联。由于移动均值超出预设阈值时,并不能完全确认该检测项目失控,因此,可以先继续对样本进行正常检测,以免影响检测效率。As an exemplary embodiment, when the moving average value of the detection item exceeds a preset threshold, the body fluid sample continues to be detected, and the subsequent body fluid sample with the detection item when it is confirmed that the moving average value is out of control is marked with an unchecked label. Specifically, the to-be-checked label can be associated with the identification label of the body fluid sample. Since when the moving average exceeds the preset threshold, it cannot be completely confirmed that the detection item is out of control. Therefore, normal detection of the sample can be continued to avoid affecting the detection efficiency.

作为另一示例性的实施例,当检测项目的移动均值超过预设阈值时,控制临床医疗体液检测系统对检测项目下线,所称的检测项目下线可以为停止当前的分析仪进样。具体的,可以停止具有该检测项目的体液样本进入当前的分析仪。在本实施例中,在停止进入当前分析仪后,将具有该检测项目的体液样本输送至其他在线的分析仪继续进行吸样检测。As another exemplary embodiment, when the moving average value of the detection item exceeds a preset threshold, the clinical medical body fluid detection system is controlled to offline the detection item, and the detection item offline may be stopping the current analyzer injection. Specifically, the body fluid sample with the detection item can be stopped from entering the current analyzer. In this embodiment, after stopping entering the current analyzer, the body fluid sample with the detection item is transported to other online analyzers to continue sampling detection.

作为示例性的实施例,在某一检测项目的移动均值超过预设阈值时,质控品通过急诊通道113进入该检测项目对应的分析仪后,控制分析仪器16按预设质控规则在质控品中采集与该检测项目相应的室内质控数据,并对室内质控数据进行分析。具体的,不同的检测项目对应的质控规则是根据实际情况可以在六西格玛sigma规则中选择至少一个规则进行质控,其中质控规则可以包括:13s、22s、232s、r4s、6x、8x、9x、10x、15s等。As an exemplary embodiment, when the moving average of a certain test item exceeds a preset threshold, after the quality control product enters the analyzer corresponding to the test item through the emergency channel 113, the analyzer 16 is controlled in the quality control according to the preset quality control rules. The indoor quality control data corresponding to the test item is collected from the control product, and the indoor quality control data is analyzed. Specifically, the quality control rules corresponding to different test items are based on the actual situation. At least one rule can be selected from the Six Sigma sigma rules for quality control, and the quality control rules can include: 13s, 22s, 232s, r4s, 6x, 8x, 9x , 10x, 15s, etc.

控制规则以13s为例,在室内质控数据超过质控规则13s时,判定质控结果为失控,在质控结果为失控时,对当前检测项目的体液样本进行复检,具体的,如果在检测项目的移动均值超过预设阈值时,分析仪继续进样检测,则可以对具有待查标签的体液样本进行复检。由于在移动均值第一次超过预设阈值时,为防止出现随机事件,在连续多个体液样本中的移动均值超过预设阈值的个数大于预设个数时,才对后续的样本进行标注,因此,只对带有待查标签的体液样本进行复检,可能会出现遗漏,所以也需要对出现移动均值超过预设阈值的体液样本之前的几个样本也进行复检。具体的,对移动均值第一次超过预设阈值时的样本至通过采用质控品进行质控,并得到质控结果为失控时之间的所有样本都进行复检。The control rule takes 13s as an example. When the indoor quality control data exceeds the quality control rule for 13s, the quality control result is determined to be out of control. When the quality control result is out of control, the body fluid sample of the current test item is re-examined. When the moving average of the detected items exceeds the preset threshold, the analyzer continues to inject and detect, and the body fluid sample with the label to be checked can be re-checked. Because when the moving average exceeds the preset threshold for the first time, in order to prevent random events from occurring, the subsequent samples will be marked only when the number of consecutive moving averages exceeding the preset threshold is greater than the preset number. , therefore, only the body fluid samples with labels to be checked are rechecked, and omissions may occur, so it is also necessary to recheck several samples before the body fluid samples whose moving average exceeds the preset threshold. Specifically, all samples from the time when the moving average exceeds the preset threshold for the first time to the time when the quality control product is used for quality control and the quality control result is out of control are rechecked.

显然,上述实施例仅仅是为清楚地说明所作的举例,而并非对实施方式的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本实用新型创造的保护范围之中。Obviously, the above-mentioned embodiments are only examples for clear description, and are not intended to limit the implementation manner. For those of ordinary skill in the art, changes or modifications in other different forms can also be made on the basis of the above description. There is no need and cannot be exhaustive of all implementations here. And the obvious changes or changes derived from this are still within the protection scope of the present invention.

Claims (10)

1.一种质控分析物的储存管,其特征在于,包括由上至下依次连接的管口(1)、上部管体(2)和下部底座(4);1. A storage tube for a quality control analyte, characterized in that it comprises a nozzle (1), an upper tube body (2) and a lower base (4) sequentially connected from top to bottom; 所述管口(1),由管壁环绕而成,从所述上部管体(2)到所述管口(1),管壁的厚度逐渐变薄;The nozzle (1) is surrounded by a pipe wall, and the thickness of the pipe wall gradually becomes thinner from the upper pipe body (2) to the nozzle (1); 所述上部管体(2),由管壁环绕而成,在所述上部管体(2)内部形成中部腔体(3),所述中部腔体(3)上部与外界连通,所述中部腔体(3)下部与所述下部底座(4)接触,所述中部腔体(3)用于存放质控品;The upper pipe body (2) is surrounded by a pipe wall, a middle cavity (3) is formed inside the upper pipe body (2), the upper part of the middle cavity (3) is communicated with the outside world, and the middle The lower part of the cavity (3) is in contact with the lower base (4), and the middle cavity (3) is used for storing quality control products; 所述下部底座(4),外部为上宽下窄的圆台形结构,内部为圆柱形的底部腔体(5);所述底部腔体(5)上端与所述下部底座(4)的外壁接触,所述底部腔体(5)下端与外界联通。The lower base (4) has a circular truncated structure with a wide top and a narrow bottom on the outside, and a cylindrical bottom cavity (5) on the inside; the upper end of the bottom cavity (5) and the outer wall of the lower base (4) contact, the lower end of the bottom cavity (5) communicates with the outside world. 2.根据权利要求1所述的储存管,其特征在于,所述管口(1)的内壁均匀分布有多个加强筋(6),用于加固管口(1)。2 . The storage tube according to claim 1 , wherein a plurality of reinforcing ribs ( 6 ) are evenly distributed on the inner wall of the nozzle ( 1 ) for reinforcing the nozzle ( 1 ). 3 . 3.根据权利要求1所述的储存管,其特征在于,所述储存管的管体材料中含有玻璃纤维。3 . The storage tube according to claim 1 , wherein the tube body material of the storage tube contains glass fibers. 4 . 4.根据权利要求1所述的储存管,其特征在于,在所述管口(1)的上部添加盖或者膜。4. The storage tube according to claim 1, characterized in that a cap or film is added to the upper part of the nozzle (1). 5.根据权利要求1所述的储存管,其特征在于,所述中部腔体(3)内设有磁力混匀珠,用于对其中的质控品进行搅拌混匀。5 . The storage tube according to claim 1 , characterized in that, magnetic mixing beads are arranged in the middle cavity ( 3 ) for stirring and mixing the quality control product therein. 6 . 6.根据权利要求1所述的储存管,其特征在于,所述管口(1)的外壁均匀分布有多个加强筋(6),所述管口(1)外壁由下至上逐渐向内收缩,保持布置有所述加强筋(6)的位置与所述上部管体(2)的中部直径一致。6 . The storage tube according to claim 1 , wherein a plurality of reinforcing ribs ( 6 ) are evenly distributed on the outer wall of the nozzle ( 1 ), and the outer wall of the nozzle ( 1 ) gradually inwards from bottom to top By shrinking, the position where the reinforcing rib (6) is arranged is kept consistent with the middle diameter of the upper pipe body (2). 7.根据权利要求1所述的储存管,其特征在于,所述底部腔体(5)中设置有填充体(7),用于配合流水线上用于安放所述储存管的底座的顶针将所述储存管从所述底座中顶起。7. The storage tube according to claim 1, wherein a filling body (7) is provided in the bottom cavity (5) for cooperating with a thimble on the assembly line for placing the base of the storage tube to The storage tube is jacked up from the base. 8.根据权利要求7所述的储存管,其特征在于,所述填充体(7)为短柱,所述短柱上部与所述底部腔体(5)的上端中心连接,所述短柱半径小于所述底部腔体(5)的半径。8 . The storage tube according to claim 7 , wherein the filling body ( 7 ) is a short column, the upper part of the short column is connected to the center of the upper end of the bottom cavity ( 5 ), and the short column The radius is smaller than the radius of the bottom cavity (5). 9.根据权利要求7所述的储存管,其特征在于,所述填充体(7)包括马达、电池和电磁开关,所述电磁开关用于响应流水线上的启动信号,在接收到所述启动信号时使所述马达运动,从而带动所述储存管运动以对其中的质控品进行混匀。9. The storage tube according to claim 7, characterized in that, the filling body (7) comprises a motor, a battery and an electromagnetic switch, the electromagnetic switch is used to respond to a start signal on the assembly line, and the start-up signal is received after the start-up signal is received. When the signal is received, the motor is moved, so as to drive the storage tube to move to mix the quality control substance therein. 10.根据权利要求9所述的储存管,其特征在于,所述下部底座(4)与所述上部管体(2)之间为可拆卸连接。10. The storage tube according to claim 9, wherein the lower base (4) and the upper tube body (2) are detachably connected.
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