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在载体和覆盖层之间具有中间层的毛细管活性测试元件

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CN1290195A
CN1290195A CN 98813487 CN98813487A CN1290195A CN 1290195 A CN1290195 A CN 1290195A CN 98813487 CN98813487 CN 98813487 CN 98813487 A CN98813487 A CN 98813487A CN 1290195 A CN1290195 A CN 1290195A
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V·兹默
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罗赫诊断器材股份有限公司
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Abstract

本发明涉及一种为分析元件收集液体试样样品的装置,其中通过毛细管活性孔道将试样从取样位置传输到测定位置。毛细管活性孔道基本上是由载体、覆盖层和位于覆盖层和载体之间的任选的中间层形成的,在分析测试元件的边缘上,在构成能传输液体的毛细管孔道的表面之一上,在形成加入试样开口的测试元件的边缘处有一个凹槽,以使形成施加试样开口的测试元件的边缘的一侧至少一部分是断开的,并露出对着凹槽表面。本发明还涉及借助于本发明的装置将液体试样吸入分析元件中的方法。

Description

在载体和覆盖层之间具有中间层的毛细管活性测试元件

本发明涉及为分析测试元件抽取分析试样样品的装置,其中在分析元件的毛细管活性孔道中将试样从施加试样的开口传输到试样的测定位置,其中毛细管的活性孔道基本上是由载体、覆盖层和在覆盖层与载体之间的任选的中间层形成的,此外,本发明还涉及借助于所述的装置将液体试样抽入分析元件的方法。

时常采用所谓的载体束缚测试来定性或定量地分析测定体液,特别是血液中的成分。在这些测试中,试剂被埋在与试样接触的相应的固态载体层中。如果有目标分析物存在,液体试样与试剂的反应会产生可检测的信号,特别是可用目视或借助于仪器测定的颜色变化,通常采用反射光度计测定。

测试元件或测试载体往往呈试条的形式,试条基本上由塑料材料制成的细长的载体层,和作为测试区施加到其上的检测层组成。然而,已知有方形或矩形小片状的测试载体。

采用目视或反射光度计测定的用于门诊诊断的测试元件,往往象电化学传感器和生物传感器那样,结构成施加试样区和检测区按竖直轴方向一个位于另一个之上。这种结构形式是有问题的。在必须将加上试样的试条插入仪器例如反射光度计进行测定时,可传染的试样物质能与仪器的部件发生接触,并可能污染这些部件。而且,特别是在未经训练的人员,例如糖尿病患者在自控血糖时使用试条的情况下,实现体积定量是有困难的。

最近可以买到一些具有毛细管孔道或间隙的测试元件,借助于这些测试元件,可以解决至少一些所述的问题。

英国专利-B-0 034 049涉及一种测试元件,其中将试样施加到中央的施加试样位置,例如覆盖层上的开口,试样由毛细管作用力传输到在空间上与试样施加位置分开的几个检测区。在这种情况下,值得注意的是,在英国专利-B-0 010 456中还叙述到施加试样的开口具有专门设计的几何形状,而且将这种专门设计看作是特别优选的。主张将顶视图中试样进口的正六边形应是开口中的试样液滴的中心。这能促进试样渗入与施加试样开口呈垂直的毛细管活性孔道。

在所述的毛细管孔隙测试元件中是通过测试元件中与毛细管孔隙垂直的开口施加试样,而在另一种设计中,将试样液体直接施加到与展开方向平行的毛细管间隙中。这能通过具有毛细管孔道终止边缘的测试元件,并用此边缘与试样液体直接接触,并通过能传输液体的毛细管孔道吸收试样来最简单地实现。

后一种测试元件经常出现的问题是,施加到毛细管孔隙施加试样开口上的液滴不能渗入间隙。这种现象可能有不同的原因。可以想象到,在这类测试元件的制造中,由于制造上的原因,开口达不到试样液滴进入毛细管孔道所要求的尺寸,例如因为在测试元件经截取、剪切或冲孔时,开口已被沾污或压扁。另一个原因可能是所用材料的疏水性,这些疏水性材料例如疏水性塑料常用于制造所述的测试元件,它削弱、延迟或阻止试样渗入毛细管孔隙。例如如果其内表面确实是亲水性的,但由于所用材料的剪切边缘是疏水性的,则液滴已经不能进入毛细管孔道内或只能非常缓慢地进入。

本发明的目的是要消除现有技术的缺点。

这一点是通过在本专利的权利要求中所表征的主题实现的。

本发明涉及为分析元件抽取液体试样的装置,其中在毛细管孔道中将试样从施加试样的开口传输到在分析元件中测定试样的位置,其中毛细管活性孔道基本上是由载体、覆盖层和在覆盖层与载体之间的任选的中间层形成的,该装置的特征在于,在形成能传输液体的毛细管孔道的一个表面上,在分析测试元件的形成施加试样的开口边缘处,有一凹槽,所以在该装置形成施加试样开口的边缘的一侧,至少有一部分被中断,露出对着凹槽的表面。

根据本发明的装置,特别优选包含一个这样的凹槽。然而,也可采用其它的设计形式,其中在一个表面上有几个、至少有二个凹槽一起存在,或错开在相反的面上。对凹槽的形状没有任何限制,只要形成施加试样开口的边缘的至少一部分被凹槽至少部分断开。因而三角形的或多边形的以及圆形的或椭圆形的都是可行的。也不排除不规则的形状。

在测试元件的边缘,在形成毛细管孔道的表面上的形成试样加入口的凹槽,用于确保试样液体能够进入毛细管孔道。这是使试样液滴在以凹槽断开的装置的最接近样品施加开口的边缘处直接施加到表面上实现的,该表面的伸展,形成毛细管的内表面。适当地选择凹槽的几何形状和尺寸,确保液滴与毛细管活性区发生接触的几率非常高,而且与投药的准确位置无关,又确保液滴易吸入毛细管内。例如,应当这样地选择露出表面的尺寸,使被施加到其上的液滴至少在一个位置与毛细管活性区发生接触。例如,应当如此地选择凹槽的一维尺寸,例如宽度,使液滴直径略大于凹槽所选的该维尺寸。已经证明,对于3μl的液滴,凹槽的宽度为1mm是适宜的。特别优选由凹槽露出区域是亲水性来将试样液滴吸入毛细管孔道,该区域至少在毛细管传输孔道方向上直接与毛细管活性区邻接。

在这种情况下,亲水性表面意是吸水的表面。水性试样,也包括血液,能在这类表面上很好地展开。此外,这类表面的特征还在于,置于其上的水滴,在界面上形成的边界角或接触角是锐角。相反地,在疏水性即斥水性的表面上,在水滴和表面之间的界面上形成的边界角是钝角。

由测试液体和被检测表面的表面张力形成的边界角,是表面亲水性的量度。例如水的表面张力为72mN/m。如果被观测表面的表面张力值比该值低很多,即大于20mN/m,则其润湿作用差,得到的边界角是钝角。这样的表面被称作疏水性表面。如果表面张力接近水的表面张力值,则其润湿性好,边界角是锐角。相反,如果表面张力等于或大于水的表面张力值,那么液滴就能渗开,所以液体会完全展开。因而不能再测定其边界角。以水滴形成的边界角是锐角的表面或在其上观测到水滴完全展开的表面,被称作亲水性表面。

毛细管吸收液体的能力,取决于液体对孔道表面的润湿性。对于水性试样,这意味着毛细管应由表面张力近达到72mN/m或超过该值的材料制造。

制造能迅速地吸收水性试样的毛细管的充分亲水性的材料是例如玻璃、金属或陶瓷。然而,这些材料不适合在测试载体中使用,因为它们有一些严重的缺点,例如玻璃或陶瓷有破碎的问题,而许多金属,其表面性质有随时间变化的危险。因此通常采用塑料薄膜或模制件制造测试元件。一般所用塑料的表面张力几乎不超过45mN/m。即使采用相对说来最亲水的塑料,例如聚甲基丙稀酸甲酯(PMMA)或聚酰胺(PA),如果采用它们,只能制造缓慢吸收的毛细管。由例如聚苯乙烯(PS)、聚丙烯(PP)或聚乙烯(PE)之类疏水性塑料制造的毛细管,基本上不吸收水性试样。因此,对于具有毛细管活性孔道的测试元件,必须赋予用作结构材料的塑料以亲水性,即使它们亲水化。

在根据本发明的分析测试元件优选的实施方案中,至少一个,但优选二个,特别优选二个相对的表面是亲水的,它们形成能够传输液体的毛细管孔道的内表面。非常优选至少对着凹槽的露出表面是亲水的。如果一个以上的表面是亲水性的,则这些表面可采用相同或不同的方法制成亲水性的。在形成毛细管活性孔道的材料,特别是载体本身是疏水性的或只有非常轻微的亲水性时,亲水化是特别必要的,因为它们是由例如非极性的塑料组成的。采用例如聚苯乙烯(PS)、聚乙烯(PE)、聚对本二酸乙烯酯(PET)或聚氯乙烯(PVC)之类的非极性塑料作为载体材料是有利的,因为它们不吸收被检测的液体,因此检测层能有效地利用试样体积。毛吸管孔道表面的亲水化,能使极性的,优选水性的试样液体易进入毛细管孔道,并迅速传输到试样测定位置。在这种情况下,为得到所要求的结果,测定位置被认为是在分析元件中应将试样传输到的位置或区域。如果分析元件是例如用光学或用光度计测定的测试载体,则试样的测定位置就是测试载体的检测区,其中具有颜色变化的反应是可观测的。如果分析元件是电化学传感器,则该试样测定位置就被认为是并入传感器中的电极,它能检测所要求的电化学检测反应。如果分析元件本身不用于检测试样中的被分析物,而是例如只用于体积配量或吸收一定量的试样材料,则试样的测定位置可以是分析元件上一个简单的记号,达到这个记号毛细管孔隙必定被充满,以便例如确定某个最小的试样体积。

在制造过程中,采用亲水性材料实现毛细管孔道表面的亲水化是理想的,然而,亲水性材料本身不能吸收试样液体,或只吸收到可忽略不计的程度。在不可能采用亲水性材料的情况下,可采用具有稳定的对试样液体是惰性的亲水层的适宜覆层,使疏水性的或只有微弱亲水性的表面亲水化,例如,通过施加含润湿剂的层,或借助于溶胶-凝胶技术采用毫微米复合物覆盖表面的方法,将光致反应的亲水性聚合物共价结合到塑料表面上。此外,通过表面的热、物理或化学处理来提高亲水性也是可行的。

特别优选采用氧化铝薄层进行亲水化。例如可通过给工件真空涂敷金属铝,然后氧化该金属,或采用用金属薄膜或覆金属的塑料膜制造测试载体,将这些层直接施加到所需的测试元件部件上,为了达到所需的亲水性,金属薄膜或覆金属的塑料也必须被氧化。在这种情况下,金属层的厚度为1-500nm是足够的。然后将金属层氧化成氧化的形式,对此,已经证明,除了电化学或阳极氧化方法以外,在水蒸气存在下或在水中煮沸进行上述所有的氧化是特别适宜的方法。以这种方法制备的氧化物层,视方法而定其厚度为0.1-500nm,优选10-100nm。在实践中,原则上可以得到层厚较大的金属层以及氧化物层,但没有任何附加的有利作用。

本发明的第二个主题涉及借助于根据本发明的装置抽取液体试样,特别是体液如血液、血浆、血清、尿、唾液和汗等的方法。在本方法中,首先使液体试样在被凹槽所断开的施加试样开口的边缘上与装置接触。通过能传输液体的毛细管孔道中的毛吸作用力将试样液体传输到装置的内部,使其能够达到它的测定位置。

通过图1和2以及下列实施例更详细地说明本发明。

图1示出根据本发明的装置的特别优选的实施方案。在图1A中示出根据本发明的装置的顶视示意图,图1B-1G分别示出沿线A-A′(1B)、B-B′(1C)、C-C′(1D和1G)、D-D′(1E)和E-E′(1F)的截面图。

图2示出根据本发明的装置的施加试样区的详细放大投影图。

图中的数字表示:1    载体2    检测元件3    毛细管孔道4    施加试样的开口5    施加试样的凹槽6    排气口7    覆盖层8    间隙覆盖薄膜9    中间层10   支撑薄膜在图1中用示意图示出根据本发明的装置特别优选实施方案的各个视图(图1A-1F)。试图通过所示的各个视图给出根据本发明装置的三维概念。中间层(9)例如以双面胶带的形式固定在惰性载体(1)上。中间层(9)在毛细管孔道(3)的区域内有一个凹槽,凹槽确定了孔道(3)的长度和宽度。孔道的高度是由中间层(9)的厚度给出的。在毛细管孔道(3)对着载体(1)的一侧上,覆盖层(7)例如塑料薄膜,与检测元件(2)例如浸渍试剂的膜邻接。为了确保检测元件和覆盖层之间毛细管的连续性,设有间隙覆盖薄膜(8)。该薄膜可被亲水化,以便能将试样从施加试样的开口(4)迅速传输到排气口(6),排气口(6)确定了毛细管孔道相对端。亲水化的另一个优点是,可将试样液滴直接施加到凹槽(5)的区域内亲水性的表面上,凹槽(5)在几个边界面上被毛细管活性区(3)所包围。这能使液滴迅速地渗入测试元件。

毛细管区(3)从施加试样的开口(4)伸展到检测元件(2)的相对端,因此,它能确保试样液体与检测元件(2)的整个区域接触,因而试样均匀地分布在检测元件(2)上。施加试样的开口(4)和排气口(6)在毛细管传输方向上界定了毛细管活性区(3)。

为了覆盖胶带露出的区域,图1G示出是如何用支撑薄膜(10)覆盖中间层(9)的。然而,排气口(6)不得被覆盖。

在采用所示的装置时,其施加试样的开口(4)例如与指尖上的血滴接触。在这种情况下,血滴是从上面即载体(1)的平面,还是从前面即从测试元件的包含的施加试样开口(4)正面与根据本发明的装置接触并不重要。这基本上消除了习惯于使用从上方投放试样的常规试条的用户所预计的施加试样的错误。在使用根据本发明的装置时,血滴通过载体(1)上的凹槽(5)与露出的任选的亲水性表面及同时与毛细管孔道(3)发生接触。毛细管孔道被试样填充,直至试样从施加试样的开口(4)填充到排气口(6)为止。然后将该装置从患者的手指上移开,该装置确保仅在毛细管孔道(3)中存在的试样能用于检测元件(2)。因此排除了试样的过量。被界定的毛细管孔道高度界定了在检测元件上的试样层厚度。

在图2示出根据本发明装置的测试元件特别优选的实施方案施加试样区的详细放大投影图。载体(1)上的凹槽(5),能促进试样液体从施加试样的开口(4)渗入毛细管活性区(3),在这种情况下,毛细管活性区(3)是由载体(1)、中间层(9)和覆盖层(7)形成的。除了所示的形状以外,凹槽还可具有用于根据本发明的目的所要求的任何其它形状。其中采用半圆形、三角形或多边形以及采用一个或几个紧挨着的或错开相对的凹槽是可行的。

以这种方法制得的测试元件具有长15mm、宽2mm和高0.1mm的毛细管孔道。该孔道可吸收3μl试样液体。由该试样润湿的检测膜面积为3mm×2mm。

将实施例1的测试元件的施加试样的一侧放在试样液滴上。测试元件的毛细管在2秒内自动地充满试样。如果在试样中有葡萄糖存在,在几秒钟后在检测膜上会看见颜色变化。在约30-35秒后达到反应终点。所得的颜色与试样的葡萄糖浓度有关,既可用目视也可用反射光度计测定。

Claims (8)

1.一种为分析元件抽取液体试样样品的装置,其中在毛细管活性孔道(3)中,使试样从取样位置传输到测定位置,其中毛细管活性孔道(3),基本上是由载体(1)、覆盖层(7)和在第二个覆盖层(7)和载体(1)之间任选的中间层(9)形成的,其特征在于,凹槽(5)位于形成能传输液体的毛细管孔道(3)的一个表面上,在分析测试元件的形成施加试样的开口(4)的边缘处,所以形成施加试样开口(4)的测试元件的边缘的一侧,至少一部分是断开的,露出对着凹槽(5)的表面。
2.权利要求1的装置,其特征在于,至少有二个互相紧挨着的凹槽。
3.权利要求1的装置,其特征在于,至少二个凹槽错开地排列在相对侧。
4.权利要求1-3任一项的装置,其特征在于,形成能传输液体的毛细管孔道内表面的至少一个表面是亲水性的。
5.权利要求4的装置,其特征在于,对着凹槽的表面是亲水性的。
6.权利要求4或5的装置,其特征在于,亲水化是通过采用亲水材料或采用亲水层覆盖亲水性差的材料达到的。
7.权利要求6的装置,其特征在于,亲水化采用氧化铝层。
8.一种借助于权利要求1-7任一项的装置将液体试样抽入分析元件中的方法,其中使液体试样在以凹槽断开的施加试样开口的边缘上与分析元件接触,并通过毛吸作用力传输到能传输液体的毛细管孔道中。
CN 98813487 1997-12-04 1998-12-03 在载体和覆盖层之间具有中间层的毛细管活性测试元件 CN1115198C (zh)

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WO1999029428A1 (de) 1999-06-17 application
JP3418173B2 (ja) 2003-06-16 grant
US7238534B1 (en) 2007-07-03 grant
CN1115198C (zh) 2003-07-23 grant
DE19753850A1 (de) 1999-06-10 application
CA2310762C (en) 2007-02-13 grant
JP2001525553A (ja) 2001-12-11 application
CA2310762A1 (en) 1999-06-17 application
EP1035920B1 (de) 2002-07-24 grant
ES2180229T3 (es) 2003-02-01 grant
US7799578B2 (en) 2010-09-21 grant
EP1035920A1 (de) 2000-09-20 application
KR20010032723A (ko) 2001-04-25 application

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