CN102621295A - 用于检测样本的装置和使用该装置的方法 - Google Patents

用于检测样本的装置和使用该装置的方法 Download PDF

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CN102621295A
CN102621295A CN2012100221787A CN201210022178A CN102621295A CN 102621295 A CN102621295 A CN 102621295A CN 2012100221787 A CN2012100221787 A CN 2012100221787A CN 201210022178 A CN201210022178 A CN 201210022178A CN 102621295 A CN102621295 A CN 102621295A
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G·梁
梁亚红
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    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
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    • B01L2400/00Moving or stopping fluids
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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    • B01L2400/06Valves, specific forms thereof
    • B01L2400/0677Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
    • B01L2400/0683Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers mechanically breaking a wall or membrane within a channel or chamber
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
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    • YGENERAL 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
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    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/25Chemistry: analytical and immunological testing including sample preparation
    • Y10T436/2575Volumetric liquid transfer

Abstract

提供了用于快速检测固体、半固体或液体样本如粪便、血液、尿液、唾液或子宫颈、尿道、鼻腔和咽喉的分泌物样本,以及用于环境检测的方法和装置。

Description

用于检测样本的装置和使用该装置的方法
本申请是申请号为200780006542.8、申请日为2007年1月23日、发明名称为“快速检测装置”的中国发明专利申请的分案申请。
相关申请的交叉引用
本申请要求由Greg Liang和Yahong Liang于2006年1月23日递交的标题为Rapid Test Apparatus(快速检测装置)的美国临时申请No.60/761580的优先权,该申请通过参考而整体地在此引用和合并。
技术领域
本发明通常涉及用于快速检测固体、半固体或液体样本(如粪便、血液、尿液、唾液或子宫颈、尿道、鼻腔和咽喉的分泌物样本(swab specimen))的方法和装置,以及用于快速检测环境样本的方法和装置。
背景技术
固体、半固体或液体样本(如粪便、血液、尿液、唾液或子宫颈、尿道、鼻腔和咽喉的分泌物样本)以及环境样本(如食品、土壤或灰尘)的检测通常需要用检测缓冲液预处理。预处理样本有助于稀释样本,从样本中提取被测物质,或者改变样本或物质。通过预处理得到一种更适合于检测被测物质的新样本溶液。通常,收集好的样本与检测缓冲液在容器中预混合,该容器独立于检测装置,该检测装置用于检测特定测试物质的存在。在多数检测方案中,部分得到的样本溶液被转移到第二检测地点与试剂反应来获得检测结果,该结果表明样本中检测物质的存在或数量。例如,在大便隐血检查中,使用塑料管将粪便样本悬浮到检测缓冲液中,所述检测缓冲液溶解样本中的血液成分。然后将所述塑料管的易碎部分切断,并且将一部分样本溶液从管中释放到第二装置中,所述第二装置用于进行免疫血色素检测。在检测装置的检测区域中读取检测结果。
用于切断样本处理管和将样本溶液从样本处理管中转移到检测装置的过程由于需要多个步骤使检测方法变得复杂。由于需要转移样本,工作区域可能因为样本泄露而被污染。同样,转移样本溶液会因为转移的检测体积可能不准确而导致结果不准确。这些方法不便于未经实验训练的使用者现场检测。所需的是一种更简单、安全和精确的固体、半固体或液体样本的检测方法。
发明内容
本发明提供了用于处理和检测样本的更简单、使用更安全且更精确的装置和方法。在本发明的某些实施方式中提供了检测组件,所述检测组件可用于固体、半固体或液体样本的快速检测。在一个非限制实施方式中提供了一种用于检测大便隐血的存在的快速检测装置。在本发明的该实施方式中,粪便样本的收集、处理和检测都在一个装置中完成。例如,检测缓冲液预先存储在所述装置的样本接收腔中,以及至少一条用于测定血色素的快速侧流检测条存放在独立的检测腔中,即检测腔。取样棒连接到装置的上部盖,用于粪便样本的收集,然后利用取样棒将粪便样本转移到检测缓冲液腔。然后摇动该装置使粪便样本分散到缓冲液中,然后拧紧位于该装置底部的盖子开始检测,允许样本溶液接触侧流检测条。可视化检测结果可以在大约5分钟内从该侧流检测条上读取。
在一种实施方式中提供了包括检测组件的检测装置,其中该检测组件(例如纵向地)可以具有:上端,下端,在所述检测组件的所述上端具有开口的样本接收腔,在所述检测组件的所述下端具有开口的并且能从所述开口中接收试剂件的检测腔,能够连接到所述检测腔的所述开口并且用所述检测腔内的试剂件密封所述检测组件的所述下端的基座,和当所述基座连接到所述检测组件时用于使所述样本接收腔与所述检测腔液体连通的装置;所述检测组件包括所述检测腔内的试剂件。用于样本收集和检测的所述检测组件可以为具有各种适当尺寸的任意形状,例如为杯子或者管子形状。本发明的检测装置(如检测组件)可由任意适当材料制成,包括如塑料,该塑料例如选自包括聚乙烯、聚丙烯、聚苯乙烯、乙烯聚合物和丙烯腈β-优卡因苯乙烯的组。
还公开了一种诊断检测装置,该装置包括:具有上端、下端的纵向检测组件;在所述检测组件的所述上端具有开口的样本接收腔;在所述检测组件的所述下端具有开口并且能从所述开口中接收试剂件的检测腔;在所述检测腔内的试剂件;连接到所述检测腔的所述开口的基座,其中所述基座通过所述检测腔内的试剂件密封所述检测组件的下端;以及用于使所述样本接收腔与所述检测腔液体连通的装置。
使用所述检测组件制造诊断检测装置的方法包括:将从试剂件所述检测组件的下端导入所述检测腔中,该试剂件能够与化验样本反应,并能够产生指示所述化验样本中被分析物的存在或数量的信号;以及将所述基座连接到所述检测腔的下端。
使用本发明的检测装置的方法包括:将样本溶液导入至所述样本接收腔,启用使得样本从所述样本接收腔到所述检测腔连通的装置,以及读取所述试剂件的检测结果。
本发明的检测装置可以被用于例如检测分析物,所述分析物选自但不限于包括滥用药品、激素、肿瘤标记物、心脏标记物、传染性病原及环境污染物的分析物组。所述检测样本溶液为溶液,该溶液可能包括某些数量级的分析物。该样本溶液选自包括体液(包括尿液、唾液、血浆或血清)、血液及脊髓液的溶液组。该样本溶液也可以包括处理溶液,如蒸馏水、PH或蛋白质缓冲液。例如,可能包括毒品、爆炸物或传染物的灰尘或粉末。
附图说明
图1为本发明的装置的侧视图。
图2为图1所示的装置的分解图。
图3为本发明的检测组件的顶视图。
图4为图3所示的部件的底视图。
图5为本发明的另一装置的升高透视图。
图6为图5所示的装置的分解图。
图7为图5所示的装置处于检测位置时的升高透视图。
图8为本发明的装置的透视图。
图9为图8所示的装置的分解图。
具体实施方式
图1(结合图2至图4)描述了本发明的一种装置。样本收集和检测装置包括检测组件110和基座120。
所述检测组件110为纵向地具有外壁111、上端112、下端113和将所述检测组件内部分隔为两个腔(样本接收腔115和检测腔116)的隔膜壁114。所述隔膜壁具有弯离所述外壁111的底部117和连接到所述外壁111的顶部118。所述隔膜壁的底部117包括孔119,所述样本接收腔的底部开孔。所述外壁在底端的内侧具有螺纹109。
所述基座120包括手柄部分121、具有螺纹123的插入部分122和用于密封所述样本接收腔底部开孔的塞子125。橡胶O型环124作为密封物包围所述插入部分122。
在这种实施方式中,试剂件140包括芯部141和包括化验试剂143的检测区域142。当样本溶液接触所述试剂件的芯部时,所述样本溶液从芯部吸到所述检测区域并与试剂反应。因而,测定出样本溶液中的检测物质的存在或数量。
橡胶O型环126被设置为密闭所述孔119的密封物。
可选的盖130包括手柄131和取样针132。
随着化验试剂件140插入所述检测腔116,所述基座能够紧密安装到所述检测组件的底端,密封所述检测组件的底端,所述塞子125和所述O型环126能够密封所述样本接收腔的底部开孔。
当样本溶液被导入所述样本接收腔时,松开所述基座120,从所述孔119上打开所述塞子125和所述O型环126,允许所述样本溶液流过所述孔119并接触所述检测腔116的试剂件140。在化验试剂件140上,通过所述检测腔部分的外壁111能够读取所述样本溶液的化验结果。
对于这种装置有多种选择以适应特殊的需要。首先,随着所述试剂件插入所述检测腔中,所述基座安装到所述检测组件的底端,且所述塞子125密封所述样本接收腔的底部开孔,样本溶液能被保存或储存在样本接收腔内以用于以后的检测。因此,稍后可以准备样本溶液并进行检测操作。例如,病人可以获得样本,然后所述装置被送至实验室技术人员或其他受过训练的人员以进行其检测并解释结果。作为一种选择,在样本导入所述样本接收腔之前,可以将用于处理或稀释检测样本的缓冲溶液保存在样本接收腔内。第二,所述基座120的所述塞子125或O型环能够从装置中省略或者所述基座保持松开,以使所述样本接收腔和检测腔之间的通道保持开放。当样本溶液导入样本接收腔时,一定体积的溶液通过所述样本通道或位于所述检测组件底部的孔,自动地从所述样本接收腔流入所述检测腔。
可选的盖130密封样本接收腔的顶部开孔。该盖130的可选的取样针能够采集液体或非液体样本并将样本导入所述样本接收腔。液体样本包括但不限于例如血液、尿液、唾液、水、粘液或其他流体样本。非液体样本包括例如粉末、粪便、排泄物、灰尘及其他干的或半干的样本。
允许从样本接收腔到检测腔的液体交换的其他方法也可使用在该装置上。例如,在一种实施方式中,对图1的装置简单的修改为本发明的检测组件,其中所述孔119被密封或塞住,该检测组件包括连接到基座的顶面的针或其他锋利边缘或突起物,当基座相对于检测组件被旋转或挤压时所述针或其他锋利边缘或突起物能够破坏密封或除去塞子。在这个实施方式中,一旦密封被破坏或塞子被除去,样本溶液就会穿过所述孔流动,或者在另一种实施方式中,密封被破坏或塞子被除去之后,溶液会穿过所述孔流动。在这种实施方式中,例如,当所述盖子被松弛安装时所述孔被密封,当所述盖子被盖紧时所述孔未密封,用所述针破坏该密封。
图5(结合图6和图7)描述了本发明的另一实施方式。装置200包括检测组件201、样本接收腔204和检测腔206。所述检测组件201包括上端202和下端203,所述样本接收腔204包括检测缓冲液205,所述检测腔206包括试剂件207。底部208闭合所述检测组件201的下端,盖子209闭合所述检测组件的上端,并设置一种装置(例如针盖210)用于使得液体能够从所述样本接收腔204流入所述检测腔206。所述检测组件201包括塑料管状结构,该塑料管状结构包括在颈部227连接在一起的管状内壁211和外壁212。该双层侧壁形成了内部的样本接收腔204和检测腔206。易碎密封件213密封所述内壁211的下端开孔。与所述检测组件的下端尺寸相适应的所述底部208从下端密封所述检测组件206。所述底部208包括上端214和下端215、用于与所述检测组件下端内部配合的侧壁216、以及在所述下端214处通过易碎密封件218密封的通孔217。所述针盖210包括杆219,所述杆219的尺寸适于安装到底部的通孔217,并且当所述杆219从通孔下端推入所述通孔时,所述杆219能够破坏所述易碎密封件218和213。
所述盖子209包括手柄部分220和尺寸适合于所述检测组件上部开孔202的插入部分221,且所述盖子209密闭该组件的上端。
所述试剂件207包括上端222和下端223、接近所述上端222的检测区域224和接近所述下端223的芯部225。所述检测区域包括至少一种试剂226。与所述芯部225接触的液体能够通过所述芯部吸至所述检测区域224并接触试剂226。所述试剂件设置在检测腔内部,且试剂件的上端朝向所述检测组件上端,试剂件的下端朝向所述检测组件下端。
所述检测组件的易碎密封件为选自包括塑料、橡胶和金属薄片的组的疏水隔离物,所述易碎密封件连接到所述样本接收腔的侧壁。用于破坏所述易碎密封件的密封破坏装置包括当所述装置处于检测位置时能够穿透、撕裂或除去易碎密封件一部分的任何装置。在本发明的一种实施方式中,密封破坏装置为从所述样本接收腔上端插入并能够破坏密封件的棍。在示例性的实施方式中,所述棍设计为清洁的,也就是不污染样本或样本溶液。在本发明的另一种实施方式中,密封破坏装置为一种连接到检测组件容器上的结构,该结构能从所述样本接收腔下端破坏该密封件。
图8(结合图9)描述了本发明另一实施方式的一种装置。装置300包括组件310,所述组件310包括具有外壁或侧壁312的杯状透明部分311、上部开孔313、下部开孔314和隔膜315。所述隔膜315连接到所述侧壁312并将杯子内部分割成上部316和下部317,所述两部分通过通孔318连接。隔膜包括相对侧壁成一角度的一个部分319和向上弯曲以与侧壁形成口袋321(试剂件容器)的另一部分320。所述试剂件容器321包括试剂件、包括芯部331的吸收检测条、和包括试剂333的检测区域332。底部340尺寸适合于所述杯子部分的下部开孔,且试剂件位于试剂件容器内部。排气孔341为所述底部340的通孔。空气能够透过但是样本溶液不能透过的多孔塞342填充在所述通孔341中。可选的盖350尺寸完全适合于所述上部开孔313。
所述多孔塞包括所需性质(可透空气但不可透样本溶液)的多孔材料。现有技术中的这些基本技术与被用于形成多孔塑料塞的材料相似,例如但不限于聚乙烯和聚四氟乙烯。在多孔塑料塞中,中间孔尺寸从3微米到由塞子材料的疏水性决定的上限之间变化。多孔塞的空气和水的通透性取决于孔的尺寸和多孔材料的表面特性。为达到上述特性,所述塞子的孔的尺寸通常小于30微米,例如10到20微米。达到所需特性的另一种途径是在多孔材料表面涂敷一层能够融化并在与样本溶液相接触时形成凝胶体的涂层。这种凝胶体形成材料选自包括树脂、凝胶、长链多糖(long change polysaccharides)和蛋白质的材料的组。
所述试剂件可以包括用于在所述样本溶液中检测多于一种检测物质的多于一种的检测试剂。例如,所述装置300可以包括多于一个吸收检测条,每一个吸收检测条用来检测一种不同的检测物(如滥用药品)。当样本溶液(如尿液样本)从上部开孔导入所述装置时,所述样本流入所述装置的下部并与试剂反应。因此,多种检测物(如滥用药品)能被同时检测出来。当处于所述装置下部的液面到达多孔塞时,空气通过多孔塞排出。另外的从上部流向下部的液体流停止。这种设置形成了对流入所述检测腔的液体体积的自动控制。
例如,本发明的装置可用于检测体液样本、环境样本、粪便和其他样本。可以使用本发明的装置来检测的物质包括滥用药品、治疗药品、传染性病原体、抗体、血液成分、环境污染物(如微生物)、爆炸物和毒药。本发明的装置适于检测的样本例如选自包括粪便、血液、尿液和唾液,微生物培养基,动物表面(如子宫颈、尿道、鼻腔和咽喉)分泌物样本以及环境样本(如食品、土壤和灰尘样本)的组。动物代表任何活的或死的动物,例如包括哺乳动物,例如人类。这些样本中的被测物质包括但不限于大便隐血成分、血红蛋白-结合珠蛋白复合物、抗体、细菌、病毒、酶、蛋白质、药物、滥用物质、过敏原、杀虫剂和污染物。
所述试剂件可为液态或干态。在本发明的一个实施方式中,所述装置的试剂件为包括试剂的液体溶液,所述试剂能够与被测样本溶液的分析物反应并产生指示所述样本溶液的至少一种分析物的存在或数量的化验信号。在本发明的另一实施方式中,所述化验试剂为包括试剂的干试剂,所述试剂能够与被测样本溶液的分析物反应并产生指示所述样本溶液的至少一种分析物的存在或数量的化验信号。干试剂(风干或冻干)具有比液体试剂长的保存期。优选的干态化验试剂例如但不限于干试剂垫、含有干化验试剂的多孔基体。这种干试剂用于多种检测物,如尿液葡萄糖、pH、肌氨酸酐和酒精检测。另一种优选的干试剂件示例为侧流检测试条。试剂件为干试剂(如检测条),相关技术领域人员可以理解的是,所述检测组件可以包含多于一个试剂件,例如每个试剂件含有用于不同分析物测试化验的试剂。例如,用于大便隐血检测的装置可以包括检测血色素的试剂件和检测血红蛋白-结合珠蛋白复合物的另一试剂件。
本发明还提供了用于检测固体、半固体或液体样本检测物的套件。例如,提供的套件包括本发明的装置。所述套件还可以包括用于检测样本中某种物质存在的说明书,以及还可以包括获得样本的说明书。所述套件还可以包括使检测结果与样本相比较的参考样本。
实施例1:用于大便隐血检测的检测腔装置
大便隐血检测是一种用于测定大便样本中血液的基于免疫分析的检测方法。粪便中存在血色素并结合出血现象能够表示胃肠道情况,如结肠直肠癌、结肠息肉、克罗恩病和溃疡性结肠炎。当前实施例提供了一种二合一样本准备和检测装置,所述装置不需要进行吸液操作或进行样本或样本溶液的转移。使用大便收集探针(或样本棍)收集并准备大便样本,以进行测试,所述大便收集探针(或样本棍)连接到本发明的检测组件的盖子上。所述收集探针插入大便样本的不同点中。剩余的样本用有吸收性的棉纸轻轻从棍上擦去。所述探针再插入管中,并且将所述盖子牢固地盖紧。剧烈摇晃所述管以获得液体悬浮样本。保持管竖直,将腔组件的底部松开大约1圈(360°)。这样允许所述样本接收腔内的样本溶液流入所述检测腔。所述装置保持竖直位置5分钟,之后可以读取结果。等待超过10分钟后可能引起数据读取不准确。当一条淡粉红色带出现在控制区域时表示为阴性,意味着粪便样本不含有可检测等级的人类血色素。当两条粉红色带出现时,一条在在检测(T)区及一条在控制(C)区,表示为阳性。阳性结果说明样本携带人类血色素。如果五分钟后没有出现带,或者检测区域出现带而控制区域未出现带,则表示为无效结果。
在这里所涉及到的每一专利、专利申请、公布及文件的全部作为参考,并通过参考而在此合并。引用以上专利、专利申请、公布及文件不是承认前述任何内容属于相关的现有技术,也不构成对这些公开或文件的内容或时间的任何承认。
单数形式“一”、“一种”和“该”包括复数含义,除非内容明确指出以外。因此,例如,涉及“一子集”包括多个子集,涉及“一核酸”包括一个或多个核酸以及相关技术领域人员所理解的等价物,等等。词语“或”并不意味着唯一一个或词语所指明的。例如,所用的“A或B”结构的短语可单独表示A、单独表示B、或者A和B一起。
除非不同地加以限定,这里所用的所有技术术语和科学术语与本领域所属领域的普通技术人员通常理解的含义相同。尽管与这里描述的一些相似或相同于的方法和系统能被用于实践或本发明的检测,但方法、装置和材料仍被描述。这里提及的所有出版物通过参考而在此合并,以实现描述和公开在该出版物中所记载的并与本发明可能相关的步骤、系统和方法。此处的任何内容都不构成对本发明因被现有技术提前公开而不得授权的承认。
在不违背本发明基本方面的情况下可对前述内容做出修改。尽管本发明已经根据一个或多个具体实施方式做了充分细致的描述,但相关领域的普通技术人员可以认识到对本申请中所具体公开的实施方式做出修改,然而这些修改和改进应该落在本发明的范围和实质内。此处描述的本发明在缺少此处未具体说明的一些元件时可能适合实践。因此,例如在每个实例中任一词语“包括”、“本质上由…组成”和“由…组成”可被任何其他两个代替。因此,所使用的词语和表述是描述性的而不是限制性的,并不排除所显示和描述的特征及其部分的等价物,可以认识到在本发明的范围内可以做出各种修改。在接下来的权利要求中提出本发明的实施方式。

Claims (12)

1.一种用于检测样本的装置,该装置包括:检测组件,所述检测组件包括:
i)样本接收腔;
ii)检测腔;
iii)隔膜壁,该隔膜壁分隔所述样本接收腔和所述检测腔;
iv)孔,该孔形成于所述隔膜壁中以使得所述样本接收腔与检测腔能够形成液体连通;
v)试剂件,该试剂件位于所述检测腔中,所述试剂件具有芯部和检测区域,该检测区域包括至少一种化验试剂;
vi)易碎密封件,该易碎密封件用于防止样本溶液从所述样本接收腔流至所述检测腔;和
vii)用于破坏所述易碎密封件的装置,以允许所述样本从所述样本接收腔流到所述检测腔。
2.根据权利要求1所述的装置,其中所述样本接收腔包括检测缓冲液。
3.根据权利要求1所述的装置,其中用于破坏所述易碎密封件的所述装置连接于所述样本接收腔的下端。
4.根据权利要求1所述的装置,其中所述检测组件由塑料制成,该塑料选自包括聚乙烯、聚丙烯、聚苯乙烯、乙烯聚合物和丙烯腈β-优卡因苯乙烯的组。
5.根据权利要求1所述的装置,其中该装置还包括盖子,该盖子包括手柄和插入部分,该插入部分的尺寸适合安装于所述检测组件的上端内。
6.根据权利要求1所述的装置,其中所述试剂件为侧流检测试条。
7.根据权利要求1所述的装置,其中所述装置包括至少2个试剂件。
8.根据权利要求1所述的装置,其中所述装置包括3到5个试剂件。
9.根据权利要求1所述的装置,其中所述化验试剂用于检测血色素。
10.根据权利要求1所述的装置,其中所述化验试剂用于血红蛋白-结合珠蛋白复合物。
11.使用根据权利要求1所述的装置的方法,该方法包括:
将样本溶液导入至所述样本接收腔中;
在所述样本接收腔中混合所述样本和缓冲液;
破坏所述密封件;
通过所述孔将所述样本导入所述检测腔中;和
使所述样本与位于所述检测腔内的所述试剂件的化验试剂反应。
12.根据权利要求11所述的方法,其中所述装置还包括盖子,该盖子包括手柄和插入部分,该插入部分的尺寸适合安装于所述检测组件的上端内,该方法还包括:
使所述手柄下降,使得所述插入部分得以插入到所述检测组件中,以移动所述破坏所述易碎密封件的装置,从而破坏所述易碎密封件。
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CN104792567A (zh) * 2015-04-30 2015-07-22 珠海市银科医学工程有限公司 一种新型采便及快速免疫检测装置及其操作方法
WO2016188362A1 (zh) * 2015-05-28 2016-12-01 万华普曼生物工程有限公司 带有防误装结构的采集检测一体装置
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EP1979468A2 (en) 2008-10-15
AU2007208334A1 (en) 2007-08-02
US7871568B2 (en) 2011-01-18
US20070275475A1 (en) 2007-11-29
CN102621295B (zh) 2018-04-27
CA2639957A1 (en) 2007-08-02
AU2007208334B2 (en) 2012-06-07
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