CN1712969A - 用于制造具有绑定能力的试剂载体的方法和设备 - Google Patents

用于制造具有绑定能力的试剂载体的方法和设备 Download PDF

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CN1712969A
CN1712969A CNA2005100795762A CN200510079576A CN1712969A CN 1712969 A CN1712969 A CN 1712969A CN A2005100795762 A CNA2005100795762 A CN A2005100795762A CN 200510079576 A CN200510079576 A CN 200510079576A CN 1712969 A CN1712969 A CN 1712969A
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H·霍尔瑙尔
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Abstract

本发明涉及一种用于制造具有绑定能力的适于检测液体中的分析物的试剂载体的方法，其中该方法包括处理相应预制试剂载体主体(4)的至少一个步骤，尤其是通过在制备设备中在处理设备(12)和试剂载体主体(4)之间传送物料，其中，该处理步骤发生：在所述试剂载体主体在制备设备中输送的期间在所述移动试剂载体主体上或在制备设备中处理设备(12a；12b)相对于试剂载体主体(4)的移动期间。

Description

用于制造具有绑定能力的试剂载体的方法和设备
技术领域
本发明涉及制造试剂载体的方法，所述载体具有绑定能力，适用于测定液体中的分析物，其中所述方法包括至少一个步骤，所述步骤就是，特别地通过在制备设备中在处理设备和试剂载体主体之间传送物料，从而处理特定的试剂载体主体。
本发明涉及试剂载体的经济制造或制备，所述载体用于液体特别是体液中的分析物的定性或定量测定。在反应(“化验”)中，这些已知的试剂载体可以从试样液体中将分析物分子绑定在载体表面，其中绑定活动可以通过测量技术检测到，例如通过荧光现象的光学检测。为了例如制造用于绑定反应的选择性局部检测的生物芯片，这种类型的试剂载体可以例如通过本发明的方法用微阵列结构制备好。
但是，本发明并不限于制造带微阵列的生物芯片，还可以适于制造两维带涂层的载体，例如微量滴定盘或微量滴定带。
技术背景
在制造这里考虑的类型的试剂载体时，之前制备的试剂载体主体的独立表面区域在定义好的时间次序与一种液体或多种液体相接触。具有用于液体的控制容量的增加的技术设备的制备设备用于制备试剂载体。另外，可使用具有从载体主体的表面去除之前增加的液体或去除弱绑定或诱陷分子或颗粒的设备的制备设备。此外，洗涤设备，干燥设备等也可以当作处理设备使用。
通常制备设备包括用于控制处理步骤的预定时间次序的控制设备。通过等待允许反应进行所需要的时间，处理步骤的次序可以中断。为此目的，试剂载体主体可以输送到位于制备设备内或制备设备外部的过渡存放位置。所述过渡存放位置可以安装有用于试剂载体主体的温度控制设备，振荡器等。
在制造或制备试剂载体的传统系统中，特定的试剂载体主体输送到处理设备，并在静止状态下在那里接收处理步骤。处理后试剂载体主体从处理区域移走，并可选择地传送到另外的处理设备。一般这个传统程序仅达到制备好的试剂载体相对较低的每时间单元产出。已经有提议在一个制备设备中并行允许几个处理设备。虽然这样在试剂载体的制备中有较高的产出量，但是产生的问题是由于各个处理设备之间存在变化，使得在各个试剂载体主体的处理产生不同的结果。因此，需要更多努力去保证在并行处理通道之间的充分一致性能，并通过测试去确定这一点。
某些情况下，在几个试剂载体主体上并行运行处理步骤是不实际的。这样的一个例子是在微阵列的制造中液滴的精确定位沉积。在这种情况下，因为不同区域与试样液体的成分发生不同的特定的反应，为了在后面化验的同一次运作中可以同时检测试样液体的几种不同成分，目的是在试剂载体主体的表面不同区域上加上不同的液体。在出版物“Kuhn et al./BIOforum Int.，p.30 ff，2000-1”中描述了每天最多产出5000个载体的高产出量系统。
还公知的是在制造检测条的情况下，载体纸可以从存储卷卷放出来，然后在后续过程中条带穿过浸没池或用测试物质喷洒。但是，在喷涂过程后，接着是设备制造的一个非常繁重的过程，其中将条带切成型，并且切下的条带要费时地装进一个个夹具中以及装配好以便形成易处理的元件。
发明内容
本发明的目的是提供一种方法，其使用简单的设备，使得具有绑定能力的试剂载体的制造具有很高的生产率，所述试剂载体适于用预制的试剂载体主体去检测液体中的分析物。本发明的另一个目的是还提供使用该方法的设备。
制造适于检测液体中的分析物并具有绑定能力的试剂载体的本发明的方法包括，处理相应预制试剂载体主体的至少一个步骤，尤其是通过在制备设备中在处理设备和试剂载体主体之间传送物料，其特征在于，所述的至少一个处理步骤发生：
-在所述试剂载体主体在制备设备中输送的期间在所述移动试剂载体主体上或
-在制备设备中处理设备相对于试剂载体主体的移动期间。
在第一种情况下，即当试剂载体主体在制备设备中输送的时候处理试剂载体主体，而省略了每个试剂载体主体在处理设备的处理区域的固定定位。从而试剂载体主体在其继续通过相关的处理区域的期间承受处理步骤。因此将载体主体放置在处理区域和将载体主体输送出处理区域的减速时间和加速时间可以废弃，这样就在试剂载体的成套制备中节省了大量的时间。
本发明的一个基本概念是要设计处理的次序，从而在“停止的机械状态下进行处理过程”的传统系统中实行的原则在尽可能多的处理步骤中省去了，取而代之的是在每个连续的试剂载体主体的输送运动过程中进行处理步骤。
当采用上述的第二种方法控制的时候，即在制备设备中处理设备相对于试剂载体主体的移动期间进行至少一个处理步骤的情况下，同样可以达到时间上的优点。这种方法控制可以例如包括将多个试剂载体主体组引入进处理区域，然后在此基础上处理设备移动横过试剂载体主体以便进行相关的处理步骤。之后处理后的试剂载体主体可以自动输送走，而可以在处理区域中提供新的试剂载体主体组。
根据本发明方法的优选实施例，在试剂载体主体在制备设备中的输送期间在移动的试剂载体主体上进行所述至少一个处理步骤，由此在处理区域的范围内所述处理设备执行同步移动或相对于移动的试剂载体主体的移动。
如果为了制备试剂载体而需要进行几步快速处理步骤，那么尽可能多的这些步骤应该在移动试剂载体主体上或/和在移动处理设备内进行，以便执行最少的可能的启动/停止操作或停留或/和定位过程。然而，在适当的情况下，在传统方式下进行几项处理步骤以执行这些处理步骤中的一些也可能是真正合适的，例如，根据前述的并行运行独立的处理步骤的原则。
根据本发明方法需要在之前提供的独立的试剂载体主体进行的处理步骤和为此而需要的处理设备上进行的处理步骤可以是具有各种变化的类型。因此，例如第一处理步骤可以包括用一种物质例如是液体，通过计量设备将所述物质的量定的量加到试剂载体主体，从而完全覆盖试剂载体主体的相应反应表面。
另一个处理步骤可以是为了形成微阵列，在试剂载体主体的特定表面区域的预定位置上沉积液滴。所述液滴由液滴产生器释出，该液滴产生器可以例如根据从喷墨打印机知道的喷墨原理运作。根据本发明，试剂载体主体和液滴产生器相互移动，并不会因液滴的释出而停止。
另一个处理步骤可以是通过吸盘设备从试剂载体主体将物质例如是液体除去。
另一个处理步骤可以例如是替换试剂载体主体上的溶液。这可以例如是漂洗步骤或冲洗步骤。在这种情况下根据本发明的目的也是基本上避免在制备设备中的开始/停止过程而进行所述步骤。
根据本发明的方法可以特别用来制造用于绑定化验的局部限定的固态，其基本原理在例如EP0939319A2或EP1380839A1中公开了。因此本发明的方法可以用来将多层涂层加到固体的非多孔的试剂载体主体上，其中在连续的处理步骤中，在最好是连续移动的试剂载体主体上，一个预涂层加到试剂载体主体的试剂区域，用含水的液体冲洗所述预涂的试剂载体主体，在试剂区域上以空间限定区域的方式将第二涂层加到预涂的试剂载体主体，其中第二涂层包括可以绑定到预涂层的受体分子。在这种情况下，预涂层可以加到固体试剂载体主体的试剂区域的整个范围的部分上的全部区域或者是以点的形式。预涂层优选是加到全部区域。典型地预涂层从水溶液加到载体上。它可以包含能实现第二涂层的绑定的任何分子。预涂层优选是包括具有高亲和力绑定对的第一配对，例如抗生蛋白链菌素，抗生物素蛋白或维生素H，或者所述物质或抗体的相似物，衍生物或配对物。然而也可能加上对第二涂层可实现共价绑定的分子作预涂层，例如是带胺、亚硫酸盐或甲硅烷基组的分子。在带预涂层的试剂载体主体冲洗之后，受体分子就以小液滴的形式加到水溶液中的预涂层。受体分子可以从所述溶液扩散到所述预涂层并绑定在其上。因此根据本发明的过程可以实现具有多种分析物的载体的制造，所述载体在适当的预涂层上并具有多种分析物涂层。例如在EP0939319A2或EP1380839A1中描述的载体基本上可以用本发明的过程制造。
因此，根据本发明的过程还可以例如用于制造试剂载体，其中将具有受体分子的涂层溶液加到试剂载体主体的预定有限区域(点)上，所述受体分子绑定在空间限定的区域，使涂层溶液变干并在后续步骤中将重新加载的溶液加到移动试剂载体。
在EP0939319A2和EP1380839A1中给传统过程控制说明了这些方法步骤，本申请结合了其中揭露的内容。
因此，根据本发明的方法可以用于制造或制备涂链霉抗生物素蛋白的载体，HBc抗原载体或多分析物载体。但是，这仍然没有穷述可能的应用。
本发明还涉及用于检测液体分析物的通过本发明方法制造的试剂载体。
为了执行本发明的方法，建议了制备设备，其特征是：包括至少一个用于处理试剂载体主体的处理设备，用于输送连续的试剂载体主体通过处理设备的处理区域的输送设备，以及用于处理设备和输送设备的时间协调控制的控制设备，从而在各种情况下，在对应的试剂载体主体的输送移动期间，当试剂载体主体通过处理步骤时，在试剂载体主体上执行至少一个预定的处理步骤。
用于执行本发明的方法的另一个制备设备的特征是：包括用于处理试剂载体主体的至少一个处理设备，用于从处理区域输送试剂载体主体或将试剂载体主体输送到该区域的输送设备，以及用于控制处理设备和可选地控制输送设备的控制设备，其中在控制设备的控制下，处理设备可以相对处理区域移动并还可以在运动过程中被启动而执行至少一个预定的处理步骤，以便在处理区域中处理试剂载体主体。
在所述制备设备中，处理设备最好具有释放设备，用于将至少一种物质尤其是液体可控计量地释放在试剂载体主体上面。根据本发明的制备设备的进一步扩展，所述释放设备可包括用于液滴在试剂载体主体上位置选择沉积的设备。
另外或可选地，处理设备可具有移除设备，用于从试剂载体主体移除至少一种物质尤其是液体。通过结合释放设备和移除设备，可以同步在试剂载体主体上交换液体。
处理设备优选还包括用于试剂载体主体的漂洗设备。另外，处理设备可包括干燥设备。
另外或可选地，处理设备可包括照射装置或光学监视装置，用于制备设备中的试剂载体主体。
参照附图，下面更详细地描述本发明的实施例。
附图说明
图1概略地示出了本发明的制备设备的部分区域，其中保持固定的多液滴产生器当作通过处理区域的处理设备使用，其中的连续的试剂载体主体是移动的。
图2概略地示出了本发明的制备设备，其中试剂载体主体和处理设备在处理区域范围内运动。
具体实施方式
图1示出了传送带2的部分的立体图，所述传送带用于试剂载体主体4的输送设备的部分。试剂载体主体4是预制的反应容器，可例如是聚苯乙烯或其他类似材料的注塑模制件。在图1示出的例子的情况下，通过输送设备2将独立的试剂载体主体4成组地输送过处理区域6，试剂载体主体例如是通过连接带8连接起来，之后可以容易地移除。在本发明的其他实施例中，预制的试剂载体主体4可没有连接带而在传送设备2上输送，也是各自分开的。
试剂载体主体4的上侧掏空成槽状形状，其中槽的底部具有将要处理的试剂载体主体4的表面10。在具体示例中试剂载体主体4的外尺寸是大约22mm×7mm×3mm。当然试剂载体的其他尺寸和设计也是可能的。
在图1中概略地示出了当作处理设备的液滴产生器12，该产生器是根据喷墨原理运作并由电子控制单元(未示出)控制。液滴产生器12用来将液滴沉积在试剂载体主体4的区域10上的预定位置。图1的示例中，液滴产生器12包括8个液滴释出喷嘴14，从流体容器供应某些液体给该喷嘴，然后该液体释放成滴状在试剂载体主体4的上面。液滴16滴在对应的试剂载体主体的表面10上，该试剂载体主体在几毫米的距离处正自由移动通过处理区域6。优选但不是必须的是以恒定的速度连续输送试剂载体主体4以及通过液滴产生器12以恒定的频率产生液滴。
控制设备的监视装置保证了液滴产生器12释放的液滴和试剂载体主体4的输送相互配合成这样的形式：液滴16仅可以预定的方式达到试剂载体主体4的表面区域10。图1的安排可以用来容易地以高循环速率制造几个同样的区域(复制品)。在图1中试剂载体主体4已经被处理过的情况下，用同样的灰度表示复制品，而不同的反应物则用不同的灰度标识。用这种方式制备试剂载体主体4，其具有在化验时有不同反应的区域。
如果需要的话，图1的安排允许过程控制，其中试剂载体主体4和液滴产生器12之间的相对运动发生在恒定的速度，单独的液滴产生器(喷嘴14)以恒定的时间频率运作，但是每个喷嘴14之间的频率有一点不同。这样导致了相应复制品之间具有单独的距离的样式，这在化验中可以用来区分液滴类型或分析物类型。
在测试进行时，试剂载体主体4以大约10cm/s的前进速度传送通过处理区域6。为了以大约每种液体25个复制品的速度制备试剂载体样品，液滴产生器14以500Hz的频率运作。可达到的生产能力是大于每小时50000个样品。通过优化措施可以显著地提高产出性能。
图2以概略的俯视图示出了本发明结构的另一个实施例，该结构考虑了试剂载体主体4的处理过程中试剂载体主体4和处理设备12b的连续运动。
输送设备沿路径3b一个接一个地输送试剂载体主体4。在此过程中试剂载体主体4通过处理区域6b并在该区域通过处理设备2b处理。在这个示例中，处理设备12b包括围绕着共同中心20旋转的8个处理头14b，所述处理头从共同的中心20放射状地向外突出并以相等的角向距离相互隔开。用箭头15b指出了处理设备12b的旋转方向，并且在电子控制设备(未示出)的控制下其旋转速度与试剂载体主体4的移动相配成这样子，使得通过处理区域6b的试剂载体主体4在预定的角度范围22内由独立分配的处理头14b伴随着，从而被处理。在图2的示例中，在各种情况下，在试剂载体主体4和处理设备12的共同移动中同步处理3个试剂载体主体4。图2实施例示例中的处理设备12b可例如是液体喷洒设备，可通过每个处理头14b将液体以计量的方式喷洒在试剂载体主体4的上面。在很高生产率的情况下，释放时间选择成这样是合适的，使得在相应的试剂载体主体4定位在出口喷嘴下面之前液体已经喷出。
控制设备的监视装置优选用来同步液体转换的触发和试剂载体的移动。该监视装置可以例如是光栅，图象录影设备例如是CCD传感器等。
另外，将供应液体到试剂载体主体的过程分级进行是有利的，这样从N个通道来的液体以几个剂量而不是一个剂量加到试剂载体主体4上，所述通道由共同的存储罐供应。
在图2概述的原理的情况下，处理头14b可以以不同于试剂载体主体4通过处理区域6b的速度运动，从而每个试剂载体主体4可以连续通过几个处理头14b依次处理，以便例如连续执行吸取步骤，液体供应步骤和可选地照射步骤。
对于本领域的技术人员，适当的液体喷射设备、吸取设备、漂洗和冲洗设备的功能和结构系统是已知的，因此，为了在制备具有绑定能力的试剂载体时在试剂载体主体4的操作中尽可能避免启动和停止过程，可以根据他的判断力来决定根据本发明的方式在在此考虑的类型的制备设备中使用一个或多个这些设备，并且执行本发明的过程，
应该指出的是在图中示出的试剂载体主体4仅是象征例子。本发明当然可以用其他形状的试剂载体主体来实现。

Claims (12)

1.用于制造具有绑定能力的适于检测液体中的分析物的试剂载体的方法，该方法包括处理相应预制试剂载体主体(4)的至少一个步骤，尤其是通过在制备设备中在处理设备(12；12a；12b)和试剂载体主体(4)之间传送物料，其特征在于，所述的至少一个处理步骤发生：
-在试剂载体主体(4)在制备设备中输送的期间在所述移动试剂载体主体上或
-在制备设备中处理设备(12a；12b)相对于试剂载体主体(4)的移动期间。
2.根据权利要求1所述的用于制造试剂载体的方法，其特征在于，在执行处理步骤时，所述试剂载体主体(4)和处理设备(12b)是移动的。
3.根据权利要求1或2所述的用于制造试剂载体的方法，其特征在于，处理步骤包括传送至少一种物质尤其是液体到试剂载体主体(4)。
4.根据权利要求1，2或3所述的用于制造试剂载体的方法，其特征在于，处理步骤包括将至少一个物质尤其是液体从试剂载体主体(4)上移除。
5.根据前述的任一项权利要求所述的用于制造试剂载体的方法，其特征在于，其用来制造
-链霉抗生物素蛋白的载体或
-HBc抗原载体或
-多分析物载体。
6.通过前述任一项权利要求的方法制造的试剂载体用来测定液体中的分析物的使用。
7.用于执行权利要求1到5任一项要求保护的方法的制备设备，其特征在于，包括用于处理所述试剂载体主体的至少一个处理设备(12；12b)，用输送连续的试剂载体主体(4)通过处理设备(12；12b)的处理区域(6；6b)的输送设备(2；2b)，和用于处理设备(12；12b)和输送设备(2；2b)的时间协调控制的控制设备，从而在试剂载体主体(4)的输送移动期间通过处理区域(6；6b)的时候，在各种情况下处理设备(12；12b)在试剂载体主体(4)上执行至少一个预定的处理步骤，
8.用于执行权利要求1到5任一项要求保护的方法的制备设备，其特征在于，包括用于处理试剂载体主体(4)的至少一个处理设备(12；12b)，用从处理区域(6a；6b)输送试剂载体主体(4)或将所述试剂载体主体输送到所述处理区域的输送设备(2a；2b)，和用于控制处理设备(12a；12b)和可选地所述输送设备的控制设备，其中在所述控制设备的控制下，处理设备(12a；12b)可以相对于处理区域(6a；6b)移动，还可以在移动期间被启动来执行至少一个预定的处理步骤，以便在处理区域(6a；6b)中处理试剂载体主体(4)。
9.根据权利要求7或8所述的制备设备，其特征在于，所述处理设备具有分发设备(12)，用于将至少一种物质尤其是液体具体控制计量地释放在试剂载体主体(4)上面。
10.根据权利要求9所述的制备设备，其特征在于，分发设备(12)具有用于液滴在试剂载体主体(4)上的位置选择沉积的装置。
11.根据权利要求7到10中任一项所述的制备设备，其特征在于，所述处理设备具有从所述试剂载体主体中将至少一种物质尤其是液体移除的移除设备。
12.根据权利要求7到11中任一项所述的制备设备，其特征在于，所述处理设备具有用于试剂载体主体的漂洗设备。
CNA2005100795762A 2004-06-21 2005-06-21 用于制造具有绑定能力的试剂载体的方法和设备 Pending CN1712969A (zh)

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