CN104471384A - 临床诊断系统 - Google Patents
临床诊断系统 Download PDFInfo
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- CN104471384A CN104471384A CN201380037617.4A CN201380037617A CN104471384A CN 104471384 A CN104471384 A CN 104471384A CN 201380037617 A CN201380037617 A CN 201380037617A CN 104471384 A CN104471384 A CN 104471384A
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Abstract
本文提供了一种诊断系统,该诊断系统包括仪器,该仪器包括电化学发光(ECL)检测器;和容器,该容器被构造成嵌合在该仪器的一部分内,其中,该容器包括至少一种试剂,该至少一种试剂包括ECL标记;以及血液采集保持器。本文还提供了一种系统,该系统包括:诊断仪器,该诊断仪器包括:泵;ECL检测器;培育器;磁体;以及输出装置;以及容器,该容器被构造成嵌合在该诊断仪器的一部分内;样品保持器,该样品保持器被构造成被嵌合在该容器内;以及封闭流体回路,当该容器嵌合在该诊断仪器的一部分内时该封闭流体回路在该诊断仪器与该容器之间,其中,该容器被构造成容纳来自该样品保持器的样品并且经由该封闭流体回路将该样品设置成与该诊断仪器流体连通。
Description
相关申请的交叉引用
本申请要求下列申请的优先权:2012年5月15日提交的美国临时申请NO.61/647,272;2012年11月29日提交的国际PCT申请NO.PCT/US2012/067041;2013年3月15日提交的美国专利申请NO.13/844,450;2013年3月15日提交的美国专利申请NO.13/844,527;以及2013年5月15日提交的题为“CLINICAL DIAGNOSTICSYSTEM INCLUDING INSTRUMENT AND CARTRIDGE”的国际PCT申请,该申请的代理人案号是20108.1-PCT,发明人是R.Cook、S.Cho、C.Davis、K.Dorsey、J.Harley、J.Leland、R.Matikyan、S.Otten、J.Peterman、B.Thomas且转让的申请序号是PCT/US2013/041252,此处以引证的方式并入上述各个申请的全部内容。
背景技术
在医疗行业中,诊断测试对正确诊断医疗问题至关重要。为了提供正确的诊断,需要精确性和准确性。为了提供精确性和准确性,已经创建了诊断系统,来分析实验室、诊所、医院、医师办公室等中的样品。
提供临床医疗点(point-of-care)诊断系统以及其它诊断系统还需要易用性和故障保护机制,以降低用户错误的频率和强度,这可能导致不准确的诊断。
此外,诊断系统的大小和规模也很重要。为了能够在某些环境下使用诊断系统,还可能需要紧凑性。为此,系统可以包括仪器和用来向诊断系统中的仪器提供样品的单独的容器(cartridge)。容器可能还需要被设计成协助仪器的紧凑性。
另外,被用来将样品提供给诊断系统的容器的设计也可能被设计成需要较少的用于测试的生物样品,以及被设计成具有易用性和故障保护机制,以进一步协助诊断的准确性。
发明内容
本文提供了包括仪器和关联容器的诊断系统。诊断系统可以提供准确性和精确性、易用性、故障保护机制以及规模的紧凑性。
如本文所公开的,诊断系统的实施方式可以包括临床诊断仪器,临床诊断仪器可以被构造成经由容器接受样品、处理容器内的样品、在将样品保留在容器内的同时对样品进行测试、以及提供诊断结果。
本文也公开了诊断系统的实施方式可以是自包含的(self-contained)诊断系统,因为可以使用仪器与包含样品的容器之间的封闭流体回路。通过提供自包含的诊断系统,可以通过将容器的内容物放回容器中来维护仪器,这样可以将仪器准备用于另一容器和测试。
此外,如本文所公开的,诊断系统的实施方式可以包括电化学发光(ECL)检测器,以准确地且精确地分析经由容器提供的样品。ECL检测器可以包括与用于美国专利5,700,427、5,296,191和5,624,637(此处以引证的方式并入各个申请)的检测器相似的检测器。
在本文所公开的实施方式中,提供了一种体外诊断系统,该体外诊断系统被设计用于医疗点(POC)设置。示例性实施方式可以为各种临床上重要的分析物提供快速、实时的测试结果。示例性实施方式还可以使用基于ECL的检测技术执行免疫测定。在示例性实施方式中,测定可以用于单次使用的一次性容器,这些容器可以包含用于执行测试所需的所有试剂。在示例性实施方式中,在执行测试之前,可以没有样品处理。例如,在不经任何处理(例如,离心分离)的情况下可以将血液采集保持器(诸如,标准血液管路)直接插入到示例性容器中,并且可以将容器以及血液采集保持器放入仪器中进行处理。根据容器中所运行的测试数量,15分钟内可以提供结果。
在本文所公开的实施方式中,示例性诊断系统可以在易于使用的低成本系统中提供中心实验室质量结果。
在示例性实施方式中,提供一种诊断系统,该诊断系统具有包括ECL检测器的仪器;以及容器,该容器被构造成嵌合在仪器的一部分内。在示例性实施方式中,容器可以包括具有ECL标签的至少一种试剂;以及血液采集保持器。
在示例性实施方式中,提供一种系统,该系统具有诊断仪器,该诊断仪器包括:泵;ECL检测器;培育器;磁体;以及输出装置。另外,系统还可以具有容器,该容器被构造成嵌合在诊断仪器的一部分内;样品保持器,该样品保持器被构造成嵌合在容器内;以及封闭流体回路,在容器嵌合在诊断仪器的一部分内时该封闭流体回路在诊断仪器与容器之间,其中,容器被构造成从样品保持器接受样品并且经由封闭流体回路将样品设置成与诊断仪器流体连通。
在示例性实施方式中,提供一种提供POC服务的方法,该方法可以包括以下步骤:提供生物样品;将生物样品引入到容器;将容器提供给包括ECL检测器的诊断仪器;在容器中将生物样品与试剂混合以形成生物样品-试剂混合物;使用ECL检测器分析生物样品-试剂混合物;以及输出来自分析步骤的结果。
附图说明
附图被并入并构成本说明书的一部分,附图例示了本发明的实施方式。在附图中:
图1为示例性诊断系统的概述例示图;
图2为可以使用示例性诊断系统的示例性方法的概述例示图;
图3为诊断系统的实施方式的例示图;
图4为诊断系统中处理生物样品的示例性方法的概述例示图;
图5为示例性过滤模块的例示图;
图6为在容器内被分成多个体积的测试样品的示例的例示图;
图7为用于混合容器内的测试样品与试剂的组件的例示图;
图8为位于示例性仪器内的示例性培育器上的示例性容器的例示图;
图9为设置有用于示例性清洗步骤的磁体的示例性容器的例示图;
图10A为可以用于样品分析的示例性仪器的一部分的例示图;
图10B为诊断系统中的示例性ECL检测装置的截面的例示图;
图11为可以用于保持样品测试的废品的示例性容器的一部分的例示图;
图12为可以由示例性诊断系统提供的示例性输出的例示图;
图13为示例性诊断系统的示例性仪器与示例性容器之间的流体通路的例示图;
图14A为诊断系统的容器的示例性主体和盖的分解立体图的例示图;
图14B为诊断系统的示例性容器的分解立体图的例示图;
图15A为诊断系统的容器盖的前面和后面的示例的立体图的例示图;
图15B为诊断系统的容器盖的一部分的示例的立体图的例示图;
图16为用于示例性仪器驱动的工作流程的流程图;
图17为诊断仪器与容器之间的示例性封闭流体路径的概述例示图;以及
图18为内部标准(internal standard,IS)、非ECL检测装置的示例的例示图。
具体实施方式
以下详细的描述涉及附图。在不同的附图中的相同的附图标记可以识别相同或相似的元件。此外,以下详细的描述描述了本发明的实施方式,并且不旨在限制本发明。相反,本发明的范围由所附权利要求书和等同物来定义。
A.概述
本文提供一种临床诊断系统,该临床诊断系统包括容器和仪器。临床诊断系统可以提供测试结果的准确性和精确性、系统的易用性(包括故障保护机制)、以及在规模方面的紧致性。通过提供采用ECL技术的具有有效且准确的仪器和容器的健全系统,可以用很少的培训或设置确保系统的用户准确的结果。
在本文所公开的实施方式中,临床诊断系统可以为各种临床上重要的分析物提供快速、实时的测试结果。示例性临床诊断系统实施方式可以使用基于ECL的检测技术执行免疫测定,测定可用于一次性容器,该容器可以包含执行测试所需的所有试剂。
B.定义
以下是与一般诊断系统有关的术语的定义。
本文所使用的术语“测定架构”意思是包括进行无论手动或自动测定的逐步处理。测定架构可以涉及实验室操作,诸如,移液、配药、计量、标本抽样、清洗、自由结合分离、透析、过滤、收集、分馏、稀释、混合、培育、处理等。
本文所使用的术语“测定合成物”意思是包括用于组合时的测定的必需试剂或物质的完整集合或子集。测定合成物可以包括测定架构之前的初始合成物、启动测定架构不久以后的合成物、测定架构之后的最终混合物、或在测定架构的任何中间步骤的合成物。
本文所使用的术语“珠子”意思是包括显微粒子,例如,超顺磁性粒子、磁性微粒子、磁性纳米粒子,或显微粒径的其它粒子。珠子可以是球形,然而形状不受限制并且可以包括其它形状,例如,椭球体、不规则的粒子、立方体、不规则的立方体和圆盘。大小范围可以从1纳米覆盖到10微米宽。
本文所使用的术语“封闭回路控制”意思是包括具有一个或更多个传感器以调制诊断系统响应的控制模块。术语“开放回路控制”与“封闭回路控制”相反,并且“开放回路控制”包括不提供反馈信号以调制系统响应的模块。
本文所使用的术语“死体积”意思是包括受限在指定的隔室(诸如,样品保持器或储液槽)内的液体的体积,其可能是不可恢复的。
本文所使用的术语“一次性用品”意图包括物品,诸如,单次使用的容器,其可以在初次使用后即可丢弃,并且可以包含在丢弃容器之前足以用于测试单个生物样品的一些试剂。
本文所使用的术语“流体元件”意思是包括保持、携带或允许流体输送的结构。流体元件可以包括管子、通道、井、储液槽、管道、阀、通风口、流动路径、分配器、移液管、漏斗、过滤器和/或过道。
本文所使用的术语“流体连通”意思是包括在经由通道、过道、通路、管道、流动路径或其它流体元件连接流体元件时可以与其它流体元件流体连通的流体元件。此外,如果流体元件由例如移液管或其它转移构件连接或转移,则流体元件也可以流体连通。此外,液体可以由移液管在一个流体元件与另一个流体元件之间或从一个流体元件到另一个流体元件分配或转移的相邻的或附近的流体元件可以流体连通。
本文所使用的术语“荧光”意思是包括任何电磁辐射(包括紫外光或可见光)的发射,该发射通过入射辐射的吸收在物质中被刺激并且只要继续刺激辐射,就持续。
本文所使用的术语“荧光团”指的是发荧光的物质。
本文所使用的术语“荧光标记”意思是包括用于荧光的检测或测量的荧光团。发荧光的但由其它检测方法(诸如,ECL)检测的物质不是荧光标记。荧光标记在测量荧光时可操作。荧光珠子意思是包括荧光标记的珠子。
本文所使用的术语“医疗点(point of care)”意思是包括地方或人,包括实验室、诊所、医院、医师办公室等,以及医护人员、临床医师,或可以提供医疗保健产品和服务的其它人。
本文所使用的术语“精确的”意思是包括特征的再现性和重复性可能发生的情况。本文所使用的术语“高度精确的”意思是包括对特征的许多观测上特征变化很小的情况。
本文所使用的术语“处理过的”意思是包括可能已从其原始的或未使用的状态(相对于诊断系统)改变的材料,诸如,例如与其它材料、试剂、样品或其组合而组合或混合。
本文所使用的术语“标准化的量”意思是包括已知量的物质,其中,量可能是质量、浓度、体积、数量或其它物理量。已知量可以被确定或可以追溯至参考方法、规范的标准、美国国家标准与技术研究院(NIST)可溯源标准或其它方法或标准。也可以通过比较分析结果与校准器来确定已知量的物质。
C.诊断系统
图1为示例性诊断系统100的概述例示图。如图1中所示,诊断系统100可以包括仪器112、容器114和容器114内的样品保持器116。示例性仪器112可以被构造成接受示例性容器114。示例性仪器112可以包括ECL检测技术,以检测样品中的分析物。示例性容器114可以被构造成接受样品保持器。仪器112和容器114的进一步讨论将遵循如下。
图2为可以使用示例性诊断系统100的示例性方法200的概述例示图。如图2中所示,方法200可以包括收集生物样品的步骤210。用于收集生物样品的示例性过程210可以包括可用于收集生物样品的任何方法,例如,静脉穿刺、指刺、踵刺、动脉抽血插管等。例如,可以将生物样品收集到管形瓶(vial)、管、血液采集管和例如中。
收集生物样品的步骤210还可以包括验证样品-患者标识。可以通过比较样品标识与患者标识来确认验证。例如,可以通过比较放置在样品保持器上的标记与患者识别卡或腕带来执行标识。
方法200可以包括选择诊断测试的步骤220。用于选择诊断测试的示例性过程220可以包括识别设置在样品上的关于诊断测试信息的访问选择的所需测试或其它处理的信息。例如,样品瓶可以具有代码或指令,其指示在该样品上应进行哪些测试,并且仪器112的操作员可以自动或手动地直接识别和选择诊断测试的选择。
方法200可以包括将样品引入到容器中的步骤300。用于将样品引入到容器中的示例性过程300可以包括可用于将样品引入到容器中的任何方法,例如,将血液采集管插入容器的预构造区域中。在下面进一步讨论的实施方式中,可以如图1中所示提供将样品引入到容器中300,其中,样品保持器116被构造成嵌合在容器114的预构造部分内。作为示例,预构造部分包括用于安装样品保持器的装置,诸如,样品保持器针。
方法200可以包括将容器引入到仪器中的步骤350。用于将容器引入到仪器中的示例性过程350可以包括可用于将容器引入到仪器中的任何方法,例如,将容器插入仪器的预构造区域中。在下面进一步讨论的实施方式中,可以如图1中所示提供将容器引入到仪器中350,其中,容器114被构造成嵌合在仪器112的预构造部分内。例如,如图3中所示,可以将容器114插入系统100的仪器112中的缝隙113中。
方法200可以包括处理样品的步骤400。用于处理样品的示例性过程400可以包括任何一系列的子步骤,这些子步骤被设计成建构测定、分析样品以及提供关于样品的信息。在下面进一步讨论的实施方式中,可以如图4中所示提供处理样品400。
在图4中,处理样品的步骤400的实施方式可以包括若干个子步骤404至414,其中,各个步骤是可选的并且可以包括本文可能未讨论的附加子步骤。
处理样品的步骤400可以包括过滤生物样品以产生测试样品的子步骤404。用于过滤生物样品的示例性过程404可以包括从另一部分中分离样品的一部分。例如,过滤全血生物样品可以包括从全血中分离血浆。
如图5中所示,可以设置过滤模块510,以过滤生物样品。如图5中所示,生物样品流动路径520可以流过过滤模块510。在示例性实施方式中,过滤模块510可以包括一个或更多个过滤器530,其中,生物样品流动路径520被一个或更多个过滤器530分成测试样品540和废品550。测试样品540可以被收集到测试样品缓存器545中。废品可以被收集到废品收集器555中。可以想到的是,过滤模块510可以被构造成在各个过滤器530内具有一个或更多个过滤层,其中,过滤层530的数量和类型可以取决于一个或更多个目标过滤因素,以及结构完整性因素。例如,过滤层的数量和类型可以取决于容器和/或诊断系统的目标过滤、设计和构造。另外,过滤层可以包括相同的过滤材料或不同的过滤材料的若干层。
诊断系统110的一些实施方式想到过滤模块510可以置于容器114内。进一步想到的是,过滤模块510可以适合于嵌合在容器114内。例如,通过在容器114内设置过滤模块510,例如可以收集测试样品540(例如,血浆)而不需要对样品400的离心分离。过滤模块510的进一步讨论可以见于PCT/US2012/067041中,此处以引证的方式并入其全部内容。
处理样品的步骤400可以包括将测试样品540分成等分部分的子步骤406。在测试样品540处于使用所需的形式(例如,过滤的血浆)时,可以将测试样品540分成多个体积,以便进一步处理。
在进行一组(panel)测定时或在进行重复测量时可以期望将测试样品540等分成多个体积。诊断系统110的各种实施方式想到将测试样品540在容器114内分成相等上非相等体积,以便进一步处理。
图6例示被分成容器114内的相等体积的测试样品540(阴影)的示例。划分测试样品540的示例性方法可以涉及使用泵(未示出)。例如,泵可以被提供为诊断仪器112的组件以协助控制使测试样品540移动到容器114内的等分体积610中。例如,泵可以在容器114的一部分内产生真空,其可以将测试样品540驱使到等分体积610中。在实施方式中,想到的是,可以选择特定泵以控制将测试样品540分成等分部分的准确性和精确性。
进一步想到的是,传感器(未示出)(诸如,光学传感器)可以与泵结合使用,以将测试样品540准确地定位在容器114内。传感器可以是诊断仪器112的组件并且可以以传感器可检测测试样品540在容器114内的位置的方式来定位。例如,传感器可以用于检测流体(例如,测试样品540或任何其它流体)的存在相比空气的存在或缺乏流体的存在之间的转换。另外,进一步想到的是,来自光学传感器的反馈可以转化为告诉泵停止或进一步移动样品的指示。
处理样品的步骤400可以包括混合测试样品与试剂的子步骤408。如图7中所例示,诊断系统110的各种实施方式想到容器114内的一部分可以保持和存储试剂710以进行特定诊断测试。
图7为用于混合容器114内的测试样品540与试剂710的组件的例示图。根据诊断测试的想到目的或目标,试剂710可以被选择并测量到适量。试剂710的预先测量的体积可以位于容器114的各指定部分中(例如,在隔室、井和通道中)用于存储和使用。
试剂710可以包括测定合成物、珠子、抗体、结合搭档(binding partner)、配位体、受体或检测标记。在将试剂710与测试样品540混合时,可以形成测试样品-试剂混合物730。
示例性测定合成物可以包括可以附着到目标分析物的生物标志物。例如,5-氟尿嘧啶(5-FU)广泛用于癌症患者来治疗肿瘤,包括(但不限于)肠癌、头颈癌、胃癌和乳腺癌。5-FU最经常是全身给药,但也适用于局部治疗某些形式的癌前期与癌变的皮肤疾病。在5-FU过量的情况下,可以提供具有专门设计为附着到5-FU的生物标志物的试剂。用于5-FU的生物标志物的进一步讨论可以见于PCT申请号PCT/US12/67353中,此处以引证的方式并入其全部内容。
在泵的协助下,试剂710可以与测试样品540组合在容器114内。例如,如图7中所示,可以沿着混合流动路径720将测试样品540的等分体积610移动到保持了试剂710的容器114的一部分(例如,混合井或通道)中。在保持试剂710的容器114的该部分内,可以输送测试样品540的等分体积610,使得测试样品-试剂混合物730内的试剂710和测试样品540可以正确地相互作用,以为诊断测试分析做准备。
测试样品-试剂混合物730可以可选地包括试剂反应后的测试样品,或可检测的复合物740、未反应的测试样品750,以及未反应的试剂760。可检测的复合物740可以形成在混合子步骤408和/或培育子步骤410中。可检测的复合物740可以具有直接或间接地附着到固相介质(例如,珠子)的标记分析物。可检测的复合物740可以包括可以读取用于分析诊断测试的检测标记。例如,诊断系统110中的ECL检测单元可以通过检测附着到分析物的检测单元来检测关于可检测的复合物740的信息。未反应的测试样品750和未反应的试剂760保留在测试样品-试剂混合物540中,直到被去除或反应为止。
在本文的实施方式中,优选地充分混合测试样品540和试剂710,以产生同质测试样品-试剂混合物730,以实现诊断测试准确性。同质测试样品-试剂混合物730可以指的是测试样品-试剂混合物730,该测试样品-试剂混合物730在被结合到试剂710的测试样品540中包括最大量的分析物或抗原,使得形成最大量的可检测的复合物740。可以设置泵,该泵通过创建运动(例如,来回)协助在容器114内搅拌组合的测试样品-试剂混合物730,以产生同质测试样品-试剂混合物730。
处理样品的步骤400可以包括培育测试样品-试剂混合物的子步骤410。诊断系统110的各种实施方式想到在实现同质测试样品-试剂混合物730时培育测试样品-试剂混合物730。测试样品-试剂混合物730可以由培育器培育,以允许可检测的复合物740由未反应的样品750和未反应的试剂760形成在测试样品-试剂混合物730内。测试样品-试剂混合物730可以由培育器装置培育,培育器装置可以是诊断仪器112的组件。
图8为位于示例性仪器112内的示例性培育器810上的示例性容器114的例示图。如图所例示的,包括同质测试样品-试剂混合物730的容器114可以位于仪器112内的培育器810附近。例如,容器114可以放置在培育器810上,使得容器114的下部区域可以邻近培育器810。
同质测试样品-试剂混合物730的培育可以帮助提供针对抗原和试剂的最适温度以彼此反应和/或结合。培育器810可以包括一个或更多个传感器以提供样品-试剂混合物730的温度测量,以确保维持预定温度。培育器810还可以包括一个或更多个加热和/或冷却元件以确保可以调整温度,以维持预定温度。例如,培育器810可以使用加热元件、冷却元件和传感器的组合以提供最适温度。在本文的实施方式中,最适温度可以在范围内(例如,从约25℃至约42℃)或在特定温度(例如,约37℃)。想到的是,依赖于所运行的诊断测试,以及所使用的试剂和样品,可以调整预定温度。依赖于所使用的诊断测试、试剂和样品,也可以调整培育的时间。
另外,培育器810可以具有多个加热和/或冷却区以加热和/或冷却容器112的各个部分。例如,可以设置单独的加热器以同时或连续加热几个区。作为另一示例,如果容器在仪器112内移动,则可以将容器112的部分移动到培育器810内的加热区。
处理样品的步骤400可以包括清洗测试样品-试剂混合物的子步骤412。诊断系统110的各种实施方式想到清洗测试样品-试剂混合物730,以隔离可检测的复合物740。例如,清洗子步骤412可以从测试样品-试剂混合物730去除任何未反应的测试样品760和任何未反应的试剂760,以隔离可检测的复合物740。
通过从测试样品-试剂混合物730洗掉未反应的测试样品750和未反应的试剂760,可以提高诊断测试内的分析物或抗原(即,可检测的复合物740)的检测和分析的灵敏性和准确性。例如,因为背景噪声可以通过清洗(例如,去除未反应的测试样品750和未反应的试剂760,这两个都导致背景噪声)而基本上降低,所以可以提高准确性。想到的是,可以洗掉大致所有的未反应的测试样品750和未反应的试剂760。本文的示例提供未反应的测试样品750和未反应的试剂760可以被收集和包括在容器114内,使得可以将清洗的样品引入到诊断仪器112的检测装置中,由此降低诊断测试之间污染的可能性。
在一些实施方式中,想到的是,试剂710包括可以具有顺磁质量的固相介质。通过提供可以具有顺磁质量的固相介质,磁体可以与固相介质结合使用以在清洗区内磁性固定可检测的复合物740,同时可以提供冲洗液(诸如缓冲液)以去除不需要的组分并且留下可检测的复合物740。
图9为设置有用于示例性清洗子步骤412的磁体910的示例性容器114的例示图。图9包括具有磁体910的容器114,磁体910将可检测的复合物740保持在容器114内的适当位置。还提供冲洗液920以从测试样品-试剂混合物730洗掉任何未反应的测试样品760和任何未反应的试剂760,以露出可检测的复合物740。
磁体910可以是诊断仪器112的组件并且可以位于诊断仪器112内,使得磁体910和容器114可以靠得很近。
诊断仪器112的泵(未示出)可以协助清洗子步骤412。泵可以在容器114内移动测试样品-试剂混合物730并且可以在存储在容器114上引入附加的流体以协助冲洗。传感器(未示出)还可以协助在容器114内移位和定位流体。还想到的是,在清洗测试样品-试剂混合物730期间,还可能发生培育。例如,培育器810可以位于容器114与磁体910之间或邻近容器114和磁体910。
处理样品的步骤400可以包括分析至少一个检测装置中的可检测的复合物的子步骤414。分析可检测的复合物可以通过使用ECL技术检测可检测的复合物740来完成。
图10A例示诊断仪器112内的检测装置1010。检测装置1010可以经由流体通路1020连接到容器114。在示例性实施方式中,如通过子步骤404至步骤412制备在容器114中的可检测的复合物740可以经由通路1020从容器114行进到检测装置1010。
想到的是,可以在诊断仪器112中或诊断系统110内有超过一个检测装置1010。在示例性诊断系统110中,检测装置1010可以被构造成满足不同需要的检测和分析目标并且适应所运行的诊断测试。检测和分析的类型也可以根据许多因素变化,这些因素包括(但不限于)所运行的诊断测试,以及所检测的组件的所需特异性和灵敏度。检测装置可以使用许多不同类型的检测,包括ECL检测、化学发光检测、荧光检测、时间分辨荧光检测、荧光偏振检测、放射性标记检测、电化学检测、磁性标记检测、酶联免疫吸附试验检测等。
在以下美国专利中详细描述了ECL:5,714,089、6,165,729、6,316,607、6,312,896、6,808,939、6,881,589、6,881,536和7,553,448,此处以引证的方式并入上述各个专利。图10B为诊断系统110中的示例性ECL检测装置1010的截面的例示图。ECL检测装置1010可以包括由垫片1016分开的至少两个电极1012、1014,垫片1016包含在可以与顶部1020匹配的底座1018内。ECL检测可能发生的测量隔离区1015可以部分地由垫片1016和至少两个电极1012、1014的结构来形成。ECL检测装置1010可以是流动池,该流动池还包括引入用于检测的流体的流体端口和协助检测样品内的目标分析物的光源。
通常,ECL可以操作为流动池,因此有必要引入流体并从测量隔离区1015提取流体,以建立ECL反应并且冲洗掉ECL试剂。测量隔离区1015可以是具有至少两个流体端口的密封体积,流体端口可以允许流体被抽入和推出密封体积。
想到的是,可检测的复合物740可以包括结合到磁珠子的ECL标记,并且ECL标记的存在可以由ECL检测。想到的是,可以使用ECL检测器来检测ECL标记的数量和/或ECL标记在生物样品-试剂混合物内的存在或不存在。
可以由ECL标记与基板之间的氧化还原反应产生ECL信号。在某些实施方式中,ECL标记可以是含钌试剂。适合的ECL标记的一个示例是三(联吡啶)钌(II)(Tris(bypyridine)ruthenium(II))[Ru(bipy)3]2+,也被称为TAG。在某些其它实施方式中,基板可以是三丙胺(tripropylamine)(TPA)。使用基于ECL的测定的方法的一些优点是它们快速且灵敏。想到的是,对于其它检测方法,检测标记和试剂可以在必要时变化以满足检测方法的要求。
再次参看图2,方法200可以包括丢弃样品的步骤500。用于丢弃样品的部分(即,未反应的测试样品和冲洗液)的示例性过程500可以包括丢弃容器114的一部分内的样品500的部分。图11例示示例性实施方式容器114,其可以包括丢弃储液槽1110以经由流体通道1120接受被丢弃的未反应的测试样品和冲洗液。
方法200可以包括输出结果的步骤600。用于输出结果的示例性过程600可以包括从步骤400收集处理样品结果并且经由诊断仪器112输出结果。图12例示示例性诊断仪器,其可以包括用于输出结果的各种设备。如图12中所示,诊断仪器112可以包括用于显示结果的显示面板1210、用于连接到外部媒体的端口1220(诸如,通用串行总线(USB)端口、火线端口等)、经由电子方式将结果发送到另一位置的有线或无线电子连接器1230(例如,无线互联网发射机、以太网电缆等)、打印出结果的打印设备1240(诸如,打印机)、或创建媒体格式的媒体写入设备1250(诸如,致密盘(CD))。
G.实施方式
图13为诊断系统110的例示图,诊断系统110具有通过流体通路134流体连接到容器114的诊断仪器112。箭头指示穿过诊断系统110的材料的大致单方向流动的示例。在一些实施方式中,由于流体在诊断测试中遵循的大致单方向流动,所以处理材料的处置可以返回到容器,而没有运行在诊断仪器上的测试之间的交叉污染。
诊断系统110可以包括自包含且紧凑的容器114。诊断系统110的各种实施方式想到可以将样品引入到容器114中,其中,可以在诊断测试期间在容器114内处理样品。可以将容器114引入到诊断仪器112中,诊断仪器112具有运行诊断测试并且使用包含在诊断仪器112内的检测技术来检测结果所必需的机械和电气组件。在下面的公开中将更详细地描述与容器114相关联的组件和方法。
容器114可以被构造成在诊断系统110以及诊断系统110的诊断仪器112内完全执行诊断测试的步骤。例如,容器114可以存储和保持执行特定诊断测试(诸如,测定)所必需的所有必要的试剂和材料。容器114还可以被构造成将试剂和材料存储在单独的隔室中,并且提供可以协助诊断测试功能的气密和液密密封,这将在下面的公开中进一步详细地描述。
容器114也可以被构造成接收生物样品以在诊断测试期间进行处理和分析。在样品被收集并引入到容器114中时,通过与诊断仪器112的合作机制,可以在诊断系统110内完全制备和处理生物样品,而没有终端用户输入的要求。在下面的公开中还将进一步详细地描述诊断系统的容器与诊断仪器之间的合作机制。
容器114还可以被构造成在完成诊断测试时,保留和收集用于诊断测试中进行处置的大致所有处理过的样品、试剂和材料。这不仅提供附加的独立便利性,而且防止和/或减少运行在相同的诊断仪器上的不同的诊断测试之间的交叉或污染。在下面的公开中还将进一步详细地描述涉及收集用过的材料的机制。
容器114的某些实施方式的示例公开在共同待决的美国外观设计申请号29/420,961和29/420,967中,这两个申请都在2012年5月15日提交,并且此处以引证的方式并入其全部内容。包含在那些公开内的图像规定诊断系统的示例性诊断容器及其设计,这提供了功能和形式,以及产品、用户与环境之间的连接。这样的图像仅代表示例性容器、诊断系统,并且本公开不限于这些特定设计。
图14A例示诊断系统110的容器114的主体和盖的立体图。容器114的各种实施方式想到具有配合在一起以形成容器114的盖420和主体422。
图14B例示诊断系统110的容器114的实施方式的示例的立体图。盖420可以具有至少一个固定特征件424以促进将盖420连接到主体422。例如,至少一个固定特征件424可以在盖420的一端或两端上包括滑入配合。
图15A和图15B例示至少一个固定特征件424,并且还示出盖420的示例,盖420可以在盖420的各端上具有上拉以确保与主体422的紧固嵌合。想到的是,本领域中已知的附加固定特征可以被设计并包括在盖420中以协助将盖420紧固到主体422,这些固定特征包括(但不限于)压配合、拉环、弹簧锁和过模制的磁体。
容器114的各种实施方式想到盖420可以具有平坦的区域,该平坦区域接触并覆盖主体422,有效地覆盖和保护主体422的组件。在盖420与容器114的其余部分之间不需要液密或气密密封。光学机器可读标记118可以位于如先前所讨论的用于识别的盖420的平坦的区域的一部分上,并且作为并入诊断系统110的许多故障保护机制中的一个的一部分。
盖420还可以使容器114作为一个整体看起来更美观。盖420可以由各种坚固的材料注射成型出来,例如,聚(甲基丙烯酸甲酯)(PMMA)、聚碳酸酯(PC)、聚碳酸酯/丙烯腈-丁二烯-苯乙烯(PC/ABS)混合物。想到的是,根据一次性容器114的所需的规格和制造目标,可以使用其它材料来形成盖420,诸如,例如聚碳酸酯/丙烯腈-丁二烯-苯乙烯(诸如,GE Cycoloy HC 1204HF)、聚碳酸酯(诸如,Sabic Lexan(PC)EXL9134)、聚对苯二甲酸乙二醇酯(PET)、聚丙烯(PP)、聚氯乙烯(PVC)和聚四氟乙烯。想到的是,可以采用形成盖420的其它已知的方法,包括(但不限于)铸造、旋转成型、热成型、压缩成型和注射成型。
参照图14B,盖420在功能上可以协助将样品保持器(未示出)(例如,可商购获得的样品保持器)引导到至少一个针428上,至少一个针428集成到主体422中并且在处理诊断测试期间被使用。盖420还用于保护操作员不受至少一个针428的尖点伤害。
容器114的各种实施方式想到具有结构和功能特征,其可用于样品的过滤、测定处理区域(各区域也被称为容器测定复制或CAR)、探针清洗区、填充有ECL读取缓冲剂的吸取储液槽(也可以被称为填充有读取缓冲剂的试剂处理站(RHS))、以及填充有泵存储流体的RHS。某些实施方式想到容器114的一些组件可以附着到主体422,包括例如盖420、过滤模块330、至少一个针428和多个密封件。
容器114可以包括样品安装座。容器114的各种实施方式想到具有样品安装座430并且具有样品保持器116。例如,主体422可以被构造成适应行业标准样品保持器(即,)或相似的样品保持器116(样品保持器116可以连接到诊断系统110的流体通路)的安装。如前所述,样品可以是诸如血液、血浆、尿液或痰等的生物样品。
在某些实施方式中,样品安装座430可以被构造成将样品保持器116引导到至少一个针428上,以建立例如与诊断仪器112的流体连通。引导特征件434也可以通过物理限制样品保持器116的径向运动来促进穿透样品保持器的隔膜438的期望部分。至少一个针428可以安装在框架432上以促进其插入样品保持器116的隔膜438中,这将从而帮助、建立和保持至少一个针428与诊断仪器112之间的流体连接。
诊断系统110的各种实施方式想到具有过滤模块530,例如先前在方法400中所描述并且在图5中所描绘的过滤模块,以与样品保持器116和容器114流体连通。诊断系统110的各种实施方式也想到使用过滤模块530在容器114内过滤样品的方法。适合的过滤模块和过滤方法的示例描述在‘253申请和‘041PCT申请中。过滤模块530可以被设计成使得其维持容器114的紧凑尺寸和独立性质。
图16为示例性仪器驱动的工作流程的流程图的例示图。用户或操作员可以使用标准的做法将血液吸入血液管路中。在仪器驱动的模式中,用户或操作员(按任一顺序)可以将血液管路插入容器中并且可以将患者ID和操作员ID输入到诊断仪器中。诊断仪器在从容器读取面板信息之后可以询问操作员以确认面板。用户或操作员可以将容器插入诊断仪器中。诊断仪器或分析器在从容器读取面板信息之后可以询问用户以确认面板。此后,处理样品并且例如在大约15分钟内呈现结果。
图17为诊断系统110的诊断仪器112与容器114之间的封闭流体路径710(参见例如710a、710b、710c)的概述例示图。诊断仪器112的各种实施方式想到具有机械和电气组件,这些机械和电气组件通过封闭流体路径710流体连接到容器114。例如,封闭流体路径710可以经由第一探针712沿着封闭流体路径710将容器114流体连接到可选特征,例如,经由路径710a连接到非ECL检测模块910,经由路径710b连接到至少一个ECL检测装置1010、泵810,并且经由路径710c和第二探针714返回到容器114。封闭流体路径710提供通路,诊断材料(例如,生物样品以及干燥和液体试剂)可以通过通路从容器114中被取出,并且可以穿过诊断仪器112。在处理之后,可以使用大致单方向流动(由箭头指示)使处理过的试剂和其它废料返回到容器114。
图18为可以提供的内部标准(internal standard,IS)非ECL检测装置910的示例的例示图。诊断系统110的各种实施方式可以想到非ECL检测装置910用作故障保护机制以确保诊断系统110的精确和准确的功能。在一些实施方式中,对于诊断系统110,一个这样的故障保护机制可以包括内部标准(IS)非ECL检测装置910。IS可以是能够以恒量添加到样品的物质和测定或分析的校准标准。IS可以是与样品中感兴趣的物质非常相似但不完全相同的物质。IS的测定架构的效果应与感兴趣的物质相同。
非ECL检测装置910可以包括内部具有管总成920的壳体912,该壳体912可以携带要分析的样品。当样品穿过壳体912时,激光924可以被引导穿过过滤器926并且激光可以被反射穿过样品。在样品流过非ECL检测装置910时,反射光可以用于检测样品内的特定分析物的存在。例如,在检测分析内可以使用IS。
IS的一个目的可以是识别在测定架构期间可能发生的故障。由此可见,实施IS的方法操作为故障保护机制。IS的另一目的是校正测定结构的正常变化。由此可见,实施IS的方法操作为提高精确性和准确性的方法。关于IS和故障保护机制的进一步讨论可以见于2013年5月15日提交的题为“CLINICAL DIAGNOSTIC SYSTEMSINCLUDING INSTRUMENT AND CARTRIDGE”的相关申请国际PCT专利申请中,该申请的代理人案号是20108.1-PCT,此处以引证的方式并入。
尽管已参照优选实施方式详细地描述了本发明,但是对于本领域技术人员将显而易见的是,在不脱离所附权利要求书的范围的情况下,可以进行变型和修改并且使用等效物。
Claims (28)
1.一种诊断系统,该诊断系统包括:
仪器,该仪器包括电化学发光(ECL)检测器;以及
容器,该容器被构造成嵌合在所述仪器的一部分内,其中,所述容器包括:
至少一种试剂,该至少一种试剂包括ECL标记;以及
血液采集保持器。
2.根据权利要求1所述的诊断系统,其中,所述仪器还包括泵、培育器、传感器、磁体和输出装置。
3.根据权利要求1所述的诊断系统,其中,所述容器还包括至少一个血液采集保持器针、血液采集保持器结构、以及在所述血液采集保持器与所述仪器之间的封闭流体通路。
4.根据权利要求1所述的诊断系统,其中,所述容器还包括过滤器或丢弃储液槽,
其中,所述过滤器如果存在则所述过滤器从全血中过滤血浆,并且
其中,所述丢弃储液槽如果存在则所述丢弃储液槽从所述血液采集保持器收集包括所述ECL标记在内的所述至少一种试剂和内容物。
5.根据权利要求1所述的诊断系统,其中,所述血液采集保持器包括血液采集管。
6.一种系统,该系统包括:
诊断仪器,该诊断仪器包括:
泵;
电化学发光(ECL)检测器;
培育器;
磁体;以及
输出装置;以及
容器,该容器被构造成嵌合在所述诊断仪器的一部分内;
样品保持器,该样品保持器被构造成嵌合在所述容器内;以及
封闭流体回路,在所述容器嵌合在所述诊断仪器的一部分内时该封闭流体回路在所述诊断仪器与所述容器之间,其中,所述容器被构造成从所述样品保持器接受样品并且经由所述封闭流体回路将所述样品设置成与所述诊断仪器流体连通。
7.根据权利要求6所述的系统,其中,所述ECL检测器包括:
至少两个电极;以及
垫片,其中,所述垫片分开所述至少两个电极,并且其中,由所述垫片和所述至少两个电极形成测量隔离区,并且其中,所述ECL检测器测量所述测量隔离区内的ECL标记。
8.根据权利要求6所述的系统,其中,所述培育器包括:
一个或更多个传感器;以及
一个或更多个加热和/或冷却元件,其中,所述一个或更多个传感器和所述一个或更多个加热和/或冷却元件向所述容器内的封闭流体通道的一部分提供预定温度。
9.根据权利要求6所述的系统,其中,所述容器进一步包括:
至少一个样品保持器针;以及
样品保持器结构,其中,所述样品保持器嵌合在所述样品保持器结构内,并且所述样品经由所述至少一个样品保持器针能够接入到所述封闭流体回路。
10.根据权利要求6所述的系统,其中,所述容器还包括具有生物标志物的至少一种试剂,所述生物标志物被设计成检测所述封闭流体回路内的5-氟尿嘧啶(5-FU)。
11.根据权利要求6所述的系统,其中,所述容器还包括所述封闭流体回路内的过滤器,其中,所述过滤器被构造成分离所述样品的部分。
12.根据权利要求6所述的系统,其中,所述容器还包括所述封闭流体回路内的丢弃储液槽,其中,所述丢弃储液槽被构造成保持所述封闭流体回路的内容物,并且其中,所述系统为自包含的诊断系统。
13.一种提供医疗点(POC)服务的方法,该方法包括以下步骤:
提供生物样品;
将所述生物样品引入到容器;
将所述容器提供到包括电化学发光(ECL)检测器的诊断仪器;
在所述容器中将所述生物样品与试剂混合以形成生物样品-试剂混合物;
使用所述ECL检测器分析所述生物样品-试剂混合物;以及
输出来自所述分析步骤的结果。
14.根据权利要求13所述的方法,其中,将所述生物样品引入到容器的步骤包括:
将包含所述生物样品的血液采集保持器插入所述容器的预构造的区域中;以及
使来自所述血液采集保持器的所述生物样品可到达所述容器内的流体通道。
15.根据权利要求14所述的方法,其中,将所述血液采集保持器插入所述容器的所述预构造的区域中的步骤包括将所述血液采集保持器插入血液采集安装座中,该血液采集安装座包括至少一个血液采集针,该血液采集针使所述生物样品可到达所述容器内的流体通道。
16.根据权利要求13所述的方法,其中,将所述容器提供给包括ECL检测器的诊断仪器的步骤包括:
将所述容器嵌合到所述诊断仪器的预构造的区域中,其中,所述诊断仪器的所述预构造的区域是所述诊断仪器中的专门被成形用于所述容器的槽。
17.根据权利要求13所述的方法,其中,在所述容器中将所述生物样品与试剂混合以形成生物样品-试剂混合物的步骤包括:
将所述生物样品与所述试剂混合,其中,该混合操作使所述生物样品与所述试剂一起在流体通道内移动,以在所述生物样品-试剂混合物内形成能够检测的复合物。
18.根据权利要求13所述的方法,其中,使用所述ECL检测器分析所述生物样品-试剂混合物的步骤包括:
将所述生物样品-试剂混合物引入到所述ECL检测器中;
将光源施加到所述ECL检测器的测量隔离区内的所述生物样品-试剂混合物;以及
使用所述ECL检测器来检测所述生物样品-试剂混合物内的ECL标记的数量。
19.根据权利要求13所述的方法,其中,输出来自所述分析步骤的结果的步骤包括:
收集来自所述分析步骤的结果;以及
将结果输出到所述诊断仪器,以为用户提供所述结果。
20.根据权利要求13所述的方法,还包括通过以下步骤过滤所述生物样品的步骤:
使所述生物样品流过所述容器内的过滤模块,以将所述生物样品分成测试样品和废品。
21.根据权利要求20所述的方法,其中,使所述生物样品流过过滤模块的步骤包括使所述生物样品流过一个或更多个过滤层。
22.根据权利要求20所述的方法,所述方法还包括收集所述容器内的测试样品缓存器中的所述测试样品的步骤。
23.根据权利要求20所述的方法,所述方法还包括收集所述容器内的废品收集器中的所述废品的步骤。
24.根据权利要求13所述的方法,所述方法还包括通过以下步骤培育所述生物样品-试剂混合物的步骤:
使用一个或更多个加热和/或冷却元件加热和/或冷却所述生物样品-试剂混合物;
使用一个或更多个传感器感测所述生物样品-试剂混合物的温度;以及
将所述培育器的温度调整到预定温度。
25.根据权利要求13所述的方法,所述方法还包括通过以下步骤清洗所述生物样品-试剂混合物的步骤:
将所述生物样品-试剂混合物定位在所述容器的所述诊断仪器的磁体的电磁场内的一部分内;
将所述生物样品-试剂混合物的第一部分磁吸引到所述磁体;以及
使用冲洗液洗掉所述生物样品-试剂混合物的第二部分,以露出所述能够检测的复合物进行分析。
26.根据权利要求13所述的方法,其中,提供所述生物样品的步骤包括从血液采集管内提供血液,并且其中,在所述容器中将所述生物样品与试剂混合以形成生物样品-试剂混合物的步骤包括将来自所述血液采集管内的所述血液与被设计成检测5-氟尿嘧啶(5-FU)的生物标志物混合。
27.根据权利要求13所述的方法,所述方法还包括使用内部标准(IS)检测器分析所述生物样品-试剂混合物的步骤。
28.根据权利要求27所述的方法,所述方法还包括通过将由所述IS检测器对所述生物样品-试剂混合物进行分析的结果与由所述ECL检测器对所述生物样品-试剂混合物进行分析的结果比较,提供故障保护机制。
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AU2013262816B2 (en) | 2016-06-23 |
EP2849632A4 (en) | 2016-01-20 |
JP2015522801A (ja) | 2015-08-06 |
CA2873457A1 (en) | 2013-11-21 |
US9081001B2 (en) | 2015-07-14 |
WO2013173524A2 (en) | 2013-11-21 |
JP2015516583A (ja) | 2015-06-11 |
WO2013173524A9 (en) | 2014-01-09 |
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