CN1341210A - 具有整体的试剂/血液隔离层的一次性试条 - Google Patents

具有整体的试剂/血液隔离层的一次性试条 Download PDF

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CN1341210A
CN1341210A CN00804294A CN00804294A CN1341210A CN 1341210 A CN1341210 A CN 1341210A CN 00804294 A CN00804294 A CN 00804294A CN 00804294 A CN00804294 A CN 00804294A CN 1341210 A CN1341210 A CN 1341210A
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J·F·麦克阿莱
D·斯科特
G·霍尔
M·阿尔瓦雷斯-伊卡萨
E·V·普洛特金
O·W·H·戴维斯
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Abstract

一种改进的用于测量计的一次性葡萄糖试条,该测量计的类型是接受一次性试条和病人的血液样品,并用非导电性整体试剂/血液隔离层(17)进行电化学分析,该隔离层含有一种填料、一种可有效氧化葡萄糖的酶(如葡萄糖氧化酶)和能有效从酶传递电子的媒质。将该整体层的制剂印刷在导电碳元件(16)上,形成工作电极。选择具有疏水性平衡的填料(如二氧化硅填料),使其在干燥时在导电元件表面能形成二维网络。该试条的响应基本上在相关温度范围内与温度无关,而且对病人的红细胞压积基本上不敏感。

Description

具有整体的试剂/血液隔离层的一次性试条
发明背景
本申请涉及用于电化学测定血液分析物如葡萄糖的一次性试条和用于制造这种试条的方法和组合物。
葡萄糖监测是糖尿病病人日常生活中的一项测量，这种监测的准确性能精确的表明生命和死亡之间的区别。为了使正常的生活方式适应经常监测葡萄糖水平的需要，现在已有许多种葡萄糖测量计，使病人只用少量血液就能测量其中的葡萄糖水平。
这些测量计许多用电化学方法测量血样中的葡萄糖，都是通过用酶(如葡萄糖氧化酶)作为可弃置的一次性使用的电极系统的部分来测量血液葡萄糖的氧化。这类装置的例子公开于欧洲专利号0 127 958与美国专利号5,141,868、5,286,636和5,437,999中，在此为了那些允许引用的国家方便，引用于本发明中。
一般说，现存的用在电化学测量计中的葡萄糖试条包括一块衬底、在衬底表面形成的工作电极和参比电极、以及在这些电极和测量计之间形成通路的装置。用能氧化葡萄糖的酶和一种当存在葡萄糖时能将电子从酶传递给电极，产生可测量的电流的媒质化合物涂布在工作电极上。代表性的媒质化合物包括氰铁酸盐，茂金属化合物如二茂铁，醌，吩嗪鎓盐(phenazinium salt)，氧化还原指示剂DCPIP和咪唑取代的锇化合物。
已用许多方法配制了这类工作电极。例如，已将导电性碳、葡萄糖氧化酶和一种媒质的混合物配制成糊或浆液，涂在衬底上，EP 0 127 958和US 5,286,362。就一次性葡萄糖试条而言，用丝网印刷来涂上，以便获得适用于小型平面试条。然而使用丝网印刷给电极操作带来了问题。
和在测量时能基本保持完整的较厚的碳糊电极不同，由碳糊或碳的浆液形成的丝网印刷电极在与样品接触时容易破碎。这种破碎引起的后果是双重的。第一，电极制剂的组分会释放到溶液中。一旦这些组分从其下面的导电层移动超过一个扩散长度时，它们不再对测量起作用，而是通过消耗内向扩散的分析物来减少响应。第二，丝网印刷电极的破碎意味着有效电极面积随时间变小。
这两种作用共同的结果，会导致电流的瞬变，即电流从最初的峰值随测量时间而迅速下降，并大大提高氧的敏感性，因为氧会迅速与媒质竞争酶。在血样中测量到的电流比血浆样品或其它水相媒质测量到的电流低得多，清楚的证实了上述事实，而且还会导致错误的读数。另一个后果是因为电极会以无秩序的方式破碎，这种电流的瞬变常常是“差异很大”。差异很大的电流瞬变导致错误的读数，或不合格试条的增加，两者都是不能接受的。
除了丝网印刷的碳基电极容易破碎外，一次性葡萄糖试条中使用的已知电极已由动力学控制，即电流由酶转化葡萄糖的速率所控制。因为仪器测量出的该响应反映了酶和媒质、酶和葡萄糖、以及酶和氧反应之间的平衡，而且因为这些反应都具有其自身对温度的依赖性，所以动力学控制的试条的响应对样品温度非常敏感。因此，所测葡萄糖值中的巨大差异可以是样品处理中的差异造成的。
电化学葡萄糖测量传感器面临的另一个挑战是由样品中存在的血细胞的干扰引起的。在红细胞压积读数中反映了红血细胞水平。通常，高红细胞压积样品会使读数比真实值低，而低红细胞压积样品导致读数高于真实值，因为血细胞会弄脏电极表面从而限制电子转移。与红血细胞的血红蛋白结合的氧还与媒质竞争还原的酶，从而进一步减少了对葡萄糖的响应。已尝试通过添加膜来滤去血液组分，来限制红细胞压积作用(见美国专利号5,658,444，为了那些允许引用的国家方便，引用于此。)，但这在制造过程中加入了一个额外的步骤，引起成本增加，而且常常在其它方面如精确度上带来不利影响。
因为获得准确的葡萄糖读数对于使用葡萄糖测量计和一次性试条的病人健康很重要，非常理想的是有一种葡萄糖试条，它没有这些缺点，因而不论实际条件如何都能提供较为稳定和可靠的实际血液葡萄糖值。因此，本发明的一个目的是提供一次性葡萄糖试条，它能提供基本上与样品的红细胞压积无关的葡萄糖读数，包括一层整体的试剂/血液隔离层。
本发明的另一个目的是提供制造一次性葡萄糖试条的改进方法。
发明简述
本发明提供了一种测量计中用的改进的一次性试条，该测量计接受一次性试条和来自病人的血样，对血液分析物(如样品中的葡萄糖)的量进行电化学分析。试条包括：
(a)一块衬底；
(b)置于衬底上的第一导电元件；
(c)置于衬底上的第二导电元件，它和第一导电元件足够近，使得当血样置于试条上时第一和第二导电元件之间形成电流环路；
(d)置于第一导电元件上的一层非导电性整体的试剂/血液隔离层；
(e)在第一、第二导电元件和测量计之间形成电气连接的接点。整体的试剂/血液隔离层含有用于分析物电化学测量的，分散在非导电性基质中的试剂，该基质能将血细胞与第一导电元件表面隔离，而同时允许可溶性电活性物质能到达第一导电元件。在本发明的一个实施例中，形成了带有整体的试剂/血液隔离层的葡萄糖试条，该隔离层含有一种同时具有疏水和亲水的表面区域的填料、有效氧化葡萄糖的酶(如葡萄糖氧化酶)和能将电子从酶有效转移到导电元件的媒质。所选的填料在疏水性和亲水性之间有一个平衡，从而在整体的试剂/血液隔离层干燥时在导电元件表面形成二维网络。优选整体的试剂/血液隔离层包含非导电性二氧化硅填料以及羟乙基纤维素(HEC)等材料。二氧化硅和HEC形成能排除红血细胞的二维网络，从而使试条对病人的红细胞压积基本上不敏感。
在本发明的一个优选例中，制备的试条具有至少置于第一导电元件上的一绝缘层。该绝缘层中有一个形成的孔，与第一导电元件的一部分对齐，将整体的试剂/血液隔离层安置成通过该孔与第一导电元件接触。
附图简述
图1A和1B显示一种本发明用于一次性试条的电极结构；
图2显示本发明的试条；
图3A-3C显示对于三种不同红细胞压积水平，测出的电流与葡萄糖浓度的关系；
图4显示测出的电流与葡萄糖浓度的依赖性关系，随红细胞压积的变化；
图5A-5C显示对于三种不同导电元件，在血液和一种对照溶液中测出的电流与葡萄糖的关系；
图6A和6B显示在两种不同温度下测出的电流与葡萄糖的关系；
图7显示本发明葡萄糖试条的另一个实施例；
图8A和8B显示用本发明的试条和一种商品碳基试条测出的电流瞬变过程。
图9A-C显示制造本发明试条的三步过程；和
图10A-10G显示本发明试条的制造。
发明详述
图1A和1B显示用于本发明的一次性试条的电极。如图所示，在衬底10上形成了电极。在衬底10上放置两个导电元件14’和16，它们藉导线14和15与导电性接点11、12和13连接。然后形成一个绝缘罩18，它仅使导电元件14’和16的一部分，以及接头11、12和13露出来。然后将非导电的整体试剂/血液隔离层17加到绝缘罩18上，与导电元件16接触。
当与测量计连接时，图1所示的组件提供了测量血液分析物的全功能组件。然而有利的是，本发明的电极试条是通过将一层尼龙或聚酯筛网21加在加样区上完成的，该加样区由电极组件22整体的试剂/血液隔离层17的位置所限定，然后加上顶盖23，防止血样溅出(图2)。聚酯筛网的作用是将血样引到参比电极(导电元件14’)，从而触发装置开始测试过程。
非导电性整体试剂/血液隔离层的使用与利用含试剂的导电性浆液印刷试剂的已知试条相比，是一个重要的特点，而且是个优点。在后一种系统中，印刷的浆液变成电极的一个功能部分，在试剂层的外表面上会发生电荷转移。如果试剂和血液直接接触，即其间没有隔离层时，样品中存在的红血细胞和白血细胞、脂肪和蛋白质可与试剂层相互作用，干涉样品中分析物的测量。
相反，本发明中整体的试剂/血液隔离层是不导电的，因此在结构上和功能上都不是电极的一部分。除非电活性物质通过整体的试剂/血液隔离层的开口/孔到达下面的导电元件，否则不发生电荷转移。因此，整体的试剂/血液隔离层提供了干扰物质(如细胞和高分子)通过达到导电元件的屏障，得到在制造上更简便，性能更卓越的装置。
为了达到这个结果，特别理想的是将整体的试剂/血液隔离层沉积在加样区中时，导电元件16没有一部分直接和样品接触。上述方法(其中利用了具有一些孔的绝缘层，这些孔提供了到达导电元件14’和16的入口)特别适合于实现这个结果。因此，如图9A-C所示，该方法仅用三步就能形成试条。在第一步中(图9A)，将两个导电元件14’和16，以及有关导线和触点沉积在衬底上。在第二步中(图9B)，将一层绝缘材料沉积在导电元件上。该绝缘材料具有两个孔94和96，分别和导电元件14’和16对准。在第三步中(图9C)，整体的试剂/血液隔离层17沉积在孔96上，由于使得沉积的隔离层17的尺寸比孔96大，因此试剂层完全覆盖着下面的导电元件，从而使试剂层不直接与血样接触，提供了有效的与血液的隔离。
导电元件16被完全覆盖还克服了另一个误差来源，该误差可能是电化学氧化存在于样品中的小分子(如抗坏血酸、尿酸和乙酰氨基苯)造成的。这些分子存在时，它在电极表面的氧化导致电流假性升高，从而使所要进行的分析物(如葡萄糖)测量不准确。本发明整体的试剂/血液隔离层一般不隔离这些分子，因为它们比观察到的孔尺寸小。然而，在整体的试剂/血液隔离层中加入pH缓冲剂，可以将电极表面的局部pH提高到一定水平，此时这些物质的电化学势提高。因此，例如使用pH被缓冲到大约5的整体的试剂/血液隔离层，就能大大减小这些干扰物质的影响。然而为了使该缓冲作用最大化，必须覆盖整个导电元件，因为即使(未缓冲)的电极表面很小的区域外露，也会导致大的干扰电流。
本发明的试条不仅因为将导电元件和血样隔开得到了性能上的益处，而且还不会产生其它误差。例如，在测试期间，试剂可从原沉积位置侧向扩散。如果试剂层直接放在导电元件上，这些试剂将继续对测量的信号起作用。因此，各次测试之间对流扩散的任何差异(例如由于温度差异或设备处理差异引起的)将表现为信号的不可重复性。然而如果试剂层重叠在印刷的绝缘层上，其从孔的侧向不会对信号起作用，因此不会引起信号的变化。
除了提供具有有益性能的试条外，图9A-9C概述的方法还提供了制造方面的几个优点。第一，如果试剂层直接印在导电元件上，试剂层的面积就是“活性面积”。因此，试剂层印刷的精度就决定了测量精度。与此不同，首先沉积一个在试剂层和下面导电元件之间形成接触区的开孔绝缘层，则由该绝缘层中孔的尺寸确定了活性区。由于绝缘层通常是用细丝网印刷的，可实现更好的边缘分辨力，因此能实现更高的装置精度。因此，导电元件16和整体试剂/血液隔离层对于完成的试条的性能特征都不是关键的。可以用比在其它方法中使用的精度较低的技术施加导电元件和整体的试剂/血液隔离层。
本领域技术人员将会明白，虽然两个导电元件必须能与放置在加样区中的样品中的电活性物质接触，绝缘罩的重要作用是提供一个孔，用于构成导电元件16和整体的试剂/血液隔离层17之间的接触区。因此在极限情况下，仅需在绝缘层中有一个孔。可将第二导电元件与绝缘层边缘接触，也可将其放置在一面对的表面上呈折叠的电极结构。
用于制备本发明试条的衬底10可以是任何不导电、尺寸上稳定、并适合插入葡萄糖测量计中的材料。合适的材料包括聚酯薄膜，如330微米的聚酯薄膜，还有其它绝缘衬底材料如聚氯乙烯(PVC)和聚碳酸酯。
导电元件和连接的导线及触点可用基本上任何导电材料(包括银、Ag/AgCl、金或铂/碳)形成，但并不需要都用相同的材料。导电元件16优选用导电碳。优选的导电碳是ERCON ERC1、ERCON ERC2和Acheson Carbon Electrodag 423。这些牌号的碳可从Ercon Inc.(Waltham，Massachusetts，USA)或AchesonColloids，(Princes Rock，Plymouth，England)购得。导电元件16与工作电极轨15接触，并与置于参比电极轨14末端的导电元件14’接近，但不接触。
可用聚酯基的可印刷电介质材料(如ERCON R488-B(HV)-B2 Blue)构成绝缘层18。顶盖23适合由聚酯条或“热熔性”涂层塑料构成。
本发明的试条不需要形成独立的出口，在样品进入电极室时让空气从装置流出之用，而是以沿着筛网所有边缘分布的出口起这种作用。随着样品液沿网眼吸入，空气在顶层下面环绕整个装置的筛网边缘逸出。而样品液体不会渗出，因为绝缘层赋予筛网该部分显著的疏水性。因此，液体样品仍然留在中央的亲水区域中。
用本发明实现其功能的关键在于整体试剂/血液隔离层17的本性。可用含有填料(同时具有疏水和亲水表面区)、可氧化葡萄糖的酶(就葡萄糖试条而言)、以及可将电子从酶转移到下面的导电元件层16的媒质的混合物形成该层。可配制一种浆液(它含有在合适载体中的填料、酶和媒质)，合适的形成该层，并用该浆液将层17印刷到装置上。
用于层17的优选填料是二氧化硅。有各种级别的和各种表面修饰的二氧化硅。虽然所有试验用的二氧化硅化合物得到可在一定条件下测量葡萄糖的产品，如果使用经表面修饰从而具有部分疏水性的二氧化硅，能获得本发明葡萄糖试条的优越性能。这类材料包括Cab-O-Sil TS610，一种用甲基二氯硅烷部分表面处理的二氧化硅；Cab-o-Sil 530，一种用六甲基二硅氮烷完全表面处理的二氧化硅；用4条碳链表面修饰的Spherisorb C4二氧化硅；还有其它类似的经表面修饰的二氧化硅；或它们的组合。应避免使用疏水性太强的表面修饰的二氧化硅。例如，已观察到C-18修饰的二氧化硅疏水性太强，不能形成可印刷的浆液。
在制造本发明浆液的过程中，匀浆破碎二氧化硅颗粒，暴露出颗粒的亲水性内部。因此，浆液中存在的实际颗粒同时具有亲水区和疏水区。亲水区互相之间，亲水区和水形成氢键。
当将该二氧化硅材料如下文实施例1中所述配制成浆液，并用丝网印刷印到导电元件16上时，该材料的双重性质就使它形成蜂窝状的二维网络层，这在显微镜检查时清晰可见。在再次水化后，该层不破碎，而是在下面的导电元件附近膨胀形成胶凝的反应区。反应物如酶、媒质和葡萄糖在该区中可自由迁移，但干扰物质，如含有氧化血红蛋白的红血细胞会排除。这样就得到一种装置，其对应给定葡萄糖量产生的电流量在红细胞压积范围从40-60％内的改变小于10％，因此对样品的红细胞压积基本不敏感，而且实际上在血液中和在无细胞的对照溶液中是一样的(图3A-C，图4和图5A-5C)。
另外，胶凝反应区代表了血液分析物(如葡萄糖)进入的更大屏障，从而使装置是扩散限制的，而不是动力学限制的。这得到了一种装置，其在温度从20℃变到37℃时，测出的电流变化小于10％，因此基本上是不受温度影响的(图6A和6B)。
当制造葡萄糖试条时，最好用含有2-10％重量，优选4-10％重量和更优选约4.5％重量的粘合剂(如羟乙基纤维素或羟乙基纤维素和藻酸盐或其它增稠剂的混合物)；3-10％重量，优选3-5％重量，更优选约4％重量二氧化硅；8-20％重量，优选14-18％重量和更优选约16％重量媒质(如氰铁酸盐)；和0.4-2％重量，优选1-2％重量和更优选约1.6％重量的酶(如葡萄糖氧化酶，假设其比活性是约250单位/毫克，或约1000-5000单位/克浆液制剂)形成整体的试剂/血液隔离层。
整体的试剂/血液隔离层还在不违背本发明的范围情况下可包含其它成分。例如，非导电层可包括一种防沫剂。另外，非导电层配制时可用一种缓冲剂来控制反应区的pH。pH可维持在pH3到pH10的范围内。在本发明的一个实施例中，特别实用的是将装置pH维持在大于8的水平上，因为在该pH，与血红蛋白结合的氧不会释放。另外在该pH，葡萄糖氧化酶与氧的反应速率非常小。因此，选择合适的pH能进一步稳定试条的性能，使其不受变化的红细胞压积的影响。在本发明的另一个实施例中，优选维持低pH(pH在5.5以下，是葡萄糖氧化酶与氧反应的最佳pH)。例如，如果主要关注的是要消除干扰物质(如抗坏血酸、尿酸或对乙酰氨基酚)氧化产生的电化学影响，那么将pH维持在5左右更好，因为这些化合物在较低的pH下更难氧化。
虽然本发明的优选例是如上所述的葡萄糖试条，但本发明的试条不限于测量葡萄糖。例如，一条果糖胺试条可在导电元件上置有两层。下面的第一层是含有碳酸盐缓冲剂(pH＞10)的二氧化硅混合物(基本如实施例7所述，但不含酶、媒质或柠檬酸缓冲剂)的浆液形成的。上面的第二层是由还含有氰铁酸盐等氧化剂的浆液形成的。
图7显示本发明的另一个实施例。在该实施例中，将第二个非导电层71置于整体试剂/血液隔离层17上面。该层与第一整体试剂/血液隔离层相同，但不含酶或不含酶和媒质。该层还使导电元件16和携带氧的红血细胞隔离，不致接触，从而减少了氧的影响。另外，就酶在测量过程中会从电极表面扩散开来而言，含有媒质的这个层可提供扩大的区域，其中具有能传递电子用的媒质。
实施例1
如下制备了一种用于制备整体的试剂/血液隔离层17的非导电性制剂。通过加入0.1M柠檬酸，将100毫升水相20mM柠檬酸三钠水溶液调节到pH6。加入6g羟乙基纤维素(HEC)，并匀浆混合。混合物放置过夜，并让空气冒泡分散，然后用作涂层组合物的储藏溶液。
在50克HEC溶液中手工逐渐加入2克Cab-o-Sil二氧化硅和0.1克DowCorning防沫剂化合物，直到加入总量的4/5为止。一边匀浆混合，一边加入剩下的。然后在冰箱中冷却该混合物10分钟。然后加入8g六氰基铁酸(III)钾，混合直到完全溶解。最后，加入0.8克葡萄糖氧化酶制剂(250单位/毫克)，然后完全混合直至溶解。得到的制剂可用于印刷或冷藏。
实施例2
为了用实施例1的浆液制剂制备葡萄糖试条，在330微米聚酯衬底(Melinex329)上以一系列图案进行丝网印刷。第一步是印刷上碳垫。用EC2碳(Ercon)对聚酯衬底进行印刷，在其表面上形成10×50的碳垫阵列。然后使该印刷好的衬底通过加热干燥器，还可以在高温(如70℃)下固化1-3周。
接着，用ERCON R-414(DPM-68)1.25生物电极传感器涂层材料在该衬底上印刷出银/氯化银连接轨和接点的阵列，并干燥。对此阵列中的每块碳垫，印刷出一条与碳垫接触的工作轨和一条参比轨。
然后用ERCON R488-B(HV)-B2蓝印刷电介质层。用电介质层印上的图案几乎覆盖着每个装置的全部，仅露出接点、参比电极的头和碳垫。
在电介质层顶部用实施例1的浆液，形成覆盖每块导电碳垫顶部的整体试剂/血液隔离层。
然后在衬底上成行的放置一些聚酯筛网条(Scrynel PET230 HC)，覆盖电介质中窗口所露出的反应区。然后将5毫米宽的聚酯条(50微米厚)加到筛条上面，并加热密封电极边缘。最后，将衬底切开，得到50个独立电极，例如每个宽5.5毫米，长30毫米。
实施例3
将用实施例1的浆液，以实施例2的方式制造的试条置于测量计中，加上500mV的电压，用于测试不同葡萄糖浓度、红细胞压积在40％-60％之间的血液样品。图3A-3C显示了加上电压25秒后测得的电流与葡萄糖浓度的关系，而图4是葡萄糖响应的斜率作为红细胞压积的函数作图。可以看到，结果是电流的重现性很好，基本上与红细胞压积无关。
实施例4
根据实施例2制备了本发明的葡萄糖试条，除了用7克Spherisorb C4和1克Cab-o-Sil TS610形成了非导电层。该制剂铺在下列三种不同的含碳导电元件上：
A：Ercon EC1
B：Ercon EC2
C：Ercon EC2在Acheson Carbon(Electrodag 423 SS)的顶部。
用这些试条在425mV的电压下测定了含有溶于惰性溶液的葡萄糖的对照溶液(One Touch Control Solution，Lifescan Inc.)或血液中的不同葡萄糖浓度。测量了加上电压25秒后观察到的电流。图5A-5C显了三种制剂A、B和C获得的结果。在所有的情况下，显示测量计对不同葡萄糖浓度的响应的线的斜率基本是相同的，不论是在血液还是在对照溶液中进行测量。因此，这进一步证明本发明的试条不受样品含氧量和红细胞压积的影响，也不受使用各种材料作为导电元件的能力的影响。
实施例5
在两种不同样品温度，即37℃和20℃，在425mV电压下测量了实施例2的试条。图6A和6B显示了加上电压25秒后，测得的电流与葡萄糖的关系。如所见，两条线的斜率基本相同(20℃时0.1068，37℃时0.1009)，因此证明试条在环境温度到生理温度下的温度范围内，其行为基本上不依赖于温度。
实施例6
测量了根据实施例2制备的试条和用含碳浆液制备的商品试条的电流瞬变过程。图8A和8B显示了结果。如图所示，本发明的试条(图8A)是一个非常平坦的电流瞬变过程，在试条开始响应后大于25秒的时间内仍维持大于峰值电流的50％。与此不同，碳基电极的电流几乎立即显示衰减，在试条开始响应后最初的1-2秒内就由峰值电流下降了50％。如果要测量峰电流值，这就难于抓住测量的时间，或者如果要在发生了基本衰减后必须测量电流，就降低了测量计的动态范围。因此，本发明的试条具有对于给定量的葡萄糖响应产生的电流在峰值电流产生5秒内衰减小于50％的优点。
实施例7
根据本发明如下配制了印刷葡萄糖试条用的浆液：
67.8克20mM柠檬酸缓冲液，pH6
0.68克聚乙烯醇(分子量85,000-146,000，88％水解)
0.68克聚乙烯吡咯烷-乙酸乙烯酯
0.42克Dow Corning DC1500防沫剂
3.4克羟乙基纤维素(Natrosol 250G，Hercules)
5.5克表面修饰的二氧化硅(Cabo-Sil TS 610，Cabot)
1.5克葡萄糖氧化酶
20.0克氰铁酸钾
实施例8
图10A-I显示了本发明试条的分步制备。将该试条和图1试条比较可以明白，在试条上电极的确切安排不是关键性的。另外，制备试条中可使用不同的材料。
制备试剂条的第一步是沉积衬底100上的银轨101、102。衬底优选是500微米厚的聚酯膜，它是以商品名ValoxTM出售的。可通过丝网印刷，用实施例2中配制的浆液组合物形成这些银电极。
在银电极沉积好后，进行第二次印刷，形成图10B中所示的碳导电元件103、104和105。形成的导电元件103与银轨101接触，并将在制成的试条中构成工作电极。碳垫104和105与银轨101和102的两端通电连接，并在试条和测量计之间形成通路。可用上述实施例中所述的导电碳浆液制剂进行丝网印刷，形成碳导电元件。
制造过程的下一步是通过例如丝网印刷绝缘浆液(如实施例2的电介质浆液)沉积出绝缘层106(图10C)。如图所示，该绝缘层含有三个窗口107、108和109。窗口108位于碳导电元件103的末端。窗口107位于银轨102的末端，提供与参比电极的接触。第三个窗口109是用来让绝缘材料从第二绝缘涂层通过筛网层的，但这个窗口不是必需的。
图10D显示了过程中的下一步，即制备整体的试剂/血液隔离层110。该层沉积在108窗口上，并在窗口108四个边上延伸越过绝缘层106。印刷整体的试剂/血液隔离层110用的合适制剂(其缓冲的pH约为6)具有下列组分：
成分  量
分析纯水  3升
柠檬酸三钠  15.75克
Nat 250G  6.3克
聚乙烯醇  30克
DC 1500脱泡剂  15毫升
Cabosil  225克
葡萄糖氧化酶  48克
Potassium Hex/60299  660克
PVPVA  30克
在整体的试剂/血液隔离层110形成后，在试条的样品收集区上沉积一层筛网111(图10E)。筛网111优选是尼龙的，它预先用丙酮和Fluorad 170C表面活性剂处理，使其具有亲水性。筛网111的作用是将液体样品均匀的传送通过工作电极和参比电极之间的区域。
然后用稍有柔性的绝缘浆液(ERCON Insulayer 820202)进行第二次绝缘印刷112，用来限定样品收集区(图10F)。然后如实施例2所述将带状覆盖物113加到试条顶部，形成完成的试条(图10G)。

Claims (23)

1.一种用于测量计的一次性试条，该测量计的类型是接受一次性试条和血液样品，并对样品中血液分析物的量进行电化学分析，其特征在于，该试条包括：
(a)一块衬底；
(b)置于衬底上的第一导电元件；
(c)置于衬底上的第二导电元件，它和第一导电元件足够近，使得当血样置于试条上时第一和第二导电元件之间形成电流环路；
(d)置于第一导电元件上的一层非导电性的整体的试剂/血液隔离层，所述整体的试剂/血液隔离层含有电化学测量分析物用的试剂，所述试剂分散在非导电性基质中，所述基质能将血细胞与第一导电元件表面有效隔离，而允许可溶性电活性物质与第一导电物质接触；
(e)在第一、第二导电元件和测量计之间形成电气连接的接点；和
(f)置于至少第一导电元件上的一个绝缘层，所述绝缘层具有与第一导电元件对齐的第一个孔，其中非导电整体试剂/血液隔离层与第一导电元件通过绝缘层中的所述孔接触，其中形成的非导电性整体试剂/血液隔离层覆盖着整个第一个孔，从而使第一导电元件没有一部分与加到试剂条上的样品直接接触。
2.如权利要求1所述的试条，其特征在于，所述整体的试剂/血液隔离层包含一种氧化葡萄糖的酶和一种氧化还原媒质，所述氧化还原媒质有效的将电子从酶转移到第一导电元件上。
3.如权利要求2所述的试条，其特征在于，所述基质是同时具有疏水表面和亲水表面的二氧化硅。
4.如权利要求3所述的试条，其特征在于，第一和第二导电元件含有导电性碳。
5.如权利要求4所述的试条，其特征在于，所述酶是葡萄糖氧化酶。
6.如权利要求5所述的试条，其特征在于，所述氧化还原媒质是氰铁酸盐。
7.如权利要求3所述的试条，其特征在于，用一种水相组合物形成整体的试剂/血液隔离层，该组合物含有2-10％重量的粘合剂；3-10％重量的二氧化硅；8-20％重量的氧化还原媒质；和每克水相组合物1000-5000单位的酶。
8.如权利要求7所述的试条，其特征在于，所述第一和第二导电元件包含导电碳。
9.如权利要求7所述的试条，其特征在于，所述酶是葡萄糖氧化酶。
10.如权利要求9所述的试条，其特征在于，所述氧化还原媒质是氰铁酸盐。
11.一种形成用于测量计的一次性试条的方法，该测量计的类型是接受一次性试条和血液样品，并进行样品中血液分析物的量的电化学分析，其特征在于，该方法包括：
(a)在衬底上形成第一和第二导电元件；
(b)形成覆盖第一导电元件的一层绝缘层，所述绝缘层具有第一个孔，它与加样区中的第一导电元件的一部分对齐；和
(c)在绝缘层上形成一试剂层，并使其与第一导电元件通过绝缘层中的第一个孔接触，所述整体的试剂/血液隔离层含有用于电化学测量葡萄糖的试剂，所述试剂分散在非导电性基质中，所述基质能将血细胞与第一导电元件表面有效隔离，而允许可溶性电活性物质能达到第一导电元件，从而避免第一导电元件与置于试条上的样品直接接触。
12.如权利要求11所述的方法，其特征在于，所述试剂层是非导电性整体试剂/血液隔离层。
13.如权利要求12所述的方法，其特征在于，形成的非导电性整体试剂/血液隔离层覆盖着整个第一个孔，从而避免第一导电元件的任何一部分与加到试条上的样品直接接触。
14.如权利要求13所述的方法，其特征在于，整体的试剂/血液隔离层含有一种氧化葡萄糖的酶和一种氧化还原媒质，所述媒质能有效的将电子从酶转移到第一导电元件上。
15.如权利要求14所述的方法，其特征在于，所述基质是由同时具有疏水和亲水表面的二氧化硅形成的。
16.如权利要求15所述的方法，其特征在于，第一和第二导电元件含有导电性碳。
17.如权利要求16所述的方法，其特征在于，所述酶是葡萄糖氧化酶。
18.如权利要求17所述的方法，其特征在于，所述氧化还原媒质是氰铁酸盐。
19.如权利要求13所述的方法，其特征在于，用一种水相组合物形成整体的试剂/血液隔离层，该组合物含有2-10％重量的粘合剂；3-10％重量的二氧化硅；8-20％重量的氧化还原媒质；和每克水相组合物1000-5000单位的酶。
20.如权利要求19所述的方法，其特征在于，所述第一和第二导电元件包含导电碳。
21.如权利要求19所述的方法，其特征在于，所述酶是葡萄糖氧化酶。
22.如权利要求21所述的方法，其特征在于，所述氧化还原媒质是氰铁酸盐。
23.如权利要求13所述的方法，其特征在于，在第一和第二导电元件上都形成绝缘层，而且所述绝缘层具有与第二个导电元件对齐的第二个孔。
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CN100439913C (zh) * 2003-01-13 2008-12-03 厚美德生物科技股份有限公司 用于分析样品的试条
CN103305590A (zh) * 2004-12-13 2013-09-18 拜尔保健有限公司 用于测量生物液体中的分析物的自我限定大小的组合物和检验设备
CN102788875A (zh) * 2005-10-25 2012-11-21 霍夫曼-拉罗奇有限公司 用于对测试元件上的试样进行分析的分析仪器
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CN104880503A (zh) * 2011-02-28 2015-09-02 卢奥克西斯诊断股份有限公司 用于测量氧化还原电位的装置、测试条、方法和系统
CN104880503B (zh) * 2011-02-28 2019-04-19 艾图生物科学股份有限公司 用于测量氧化还原电位的装置、测试条、方法和系统
CN103175872A (zh) * 2011-12-23 2013-06-26 长沙中生众捷生物技术有限公司 便携式电化学检测试纸条及其制备方法
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AU763723B2 (en) 2003-07-31
ES2339122T3 (es) 2010-05-17
BR0008615A (pt) 2001-10-16
EP1593959A3 (en) 2006-07-05
EP1155310B1 (en) 2006-01-04
EP1593958A3 (en) 2006-07-12
DK1155310T3 (da) 2006-03-06
AU2847900A (en) 2000-08-01
DE60043905D1 (de) 2010-04-08
CA2358464C (en) 2008-08-26
EP1593959A2 (en) 2005-11-09
EP1155310A4 (en) 2002-11-04
US6241862B1 (en) 2001-06-05
HK1043832B (zh) 2006-09-29
EP1593958A2 (en) 2005-11-09
DE60025334T2 (de) 2006-08-10
ATE458996T1 (de) 2010-03-15
HK1043832A1 (en) 2002-09-27
EP1155310A1 (en) 2001-11-21
EP1612548A3 (en) 2006-07-12
CN1241012C (zh) 2006-02-08
EP1612548A2 (en) 2006-01-04
WO2000042422A1 (en) 2000-07-20
DE60025334D1 (de) 2006-03-30
BR0008615B1 (pt) 2012-09-04
EP1593958B1 (en) 2010-02-24
ES2255980T3 (es) 2006-07-16
CA2358464A1 (en) 2000-07-20
ATE315223T1 (de) 2006-02-15

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