CN1240027A - 被校准的分析物化验系统 - Google Patents

被校准的分析物化验系统 Download PDF

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CN1240027A
CN1240027A CN97180526A CN97180526A CN1240027A CN 1240027 A CN1240027 A CN 1240027A CN 97180526 A CN97180526 A CN 97180526A CN 97180526 A CN97180526 A CN 97180526A CN 1240027 A CN1240027 A CN 1240027A
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equipment
chemical examination
band
chip
sampling
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乔尔·S·道格拉斯
卡伦·R·德克斯勒
杰弗里·N·罗
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Mercury Diagnostics Inc
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Abstract

一种分析物检测系统设有标定信息，标定信息专用于一组涂了取样的化验带。标定信息可存于化验设备的永久性存储器中，从而在成套器件中所有化验带用完后就把设备丢弃，或者把标定信息存入标定芯片中，标定芯片伴随着一组最好的化验带并与之配套，由此可对不同组化验带及其相应的标定芯片重复使用化验设备。

Description

被校准的分析物化验系统
发明背景
发明领域
本发明涉及了一种检测设备，用于确定在取样中分析物或生物物质的存在或浓度，尤其是，本发明涉及了一种系统，它采用化验设备来测量分析物对浸渍适当试剂的化验带的作用。
有关技术的描述
由于在护理时刻进行化验已普遍地逐渐增多，增加了用简便方法确定体液中化学和生物成分的需求。通常的使用方式是由糖尿病患者自行检测血糖浓度。这些患者常常根据化验结果来服用胰岛素或采取其它治疗手段。因为一般推荐每天要作多次化验，并可在任何位置状态下进行化验，所以需要一种使用方便和花钱不多的方法来完成这项工作。对于许多糖尿病患者来说，化验的费用很重要，这对靠固定收入的老年患者和不能由医疗保险计划偿付的人员来说更是如此。
除了对慢性疾病的监测，在其它应用中也希望在护理时刻具有简便价廉的化验方法。例如，许多医生认为：如果在治疗过程中能检测到药物的流通量，这从治疗效果和从费用观点来说，均能使某些药物的服用更加有效。一般说，如果分析物或生物物质的量非常显著，则患者需要去诊所或化验室并接受静脉注射，因而化验将在昂贵的临床设备上进行。能够在医生办公室或在家庭中花费不多地检查患者可以提高疗效。由于目前对改进保健费用有效性的迫切程度，以花钱少、易使用的方法来替代昂贵的化验方法将会受到欢迎。
国家卫生研究院进行了大规模的研究来评价长期严格控制糖尿病患者血糖的好处。该研究称为DCCT，它证明了：对患者血糖量的长期严格控制与患者的健康有直接关系。医务人员监督患者控制的一种途径是由患者使用血糖检测系统，该系统有一个存储装置来记录血糖量和其它数据，如日期和时间。
许多糖尿病患者目前采用了在Phillips等的美国专利号5,304,468中所述的化验方法。该系统包括一个电子测量设备和一个一次性的试剂带。测量设备判读出试剂带的颜色变化，该变化与涂到试剂带上的取样中的分析物浓度有关。测量设备是一个昂贵和复杂的设备，它采用多光源或检测器来把试剂颜色变化从取样颜色中分离出去。使用者必须选择测量设备的标定代码来与化验带的标定代码相匹配。这样，测量设备要容纳范围很广的化验带的性能值。
Garcia等的美国专利号4,637,403描述了一个综合的系统，它提供一种方法，由此患者可刺破手指来得到血样，然后由系统设备来判读出血样中的分析物量。该系统采用复杂的光反射系统来判读出血样中的分析物量。
Anderson等的美国专利号5,279,294描述了一个可装在衬衫口袋中的手持设备，用于定量地测出生物液中的葡萄糖或分析物。设备具有复杂的电子系统和一个组装在一个设备内的取样系统，用于确定体液取样内的分析物数量。
Matzinger等的美国专利号5,515,170描述了保持试剂带支承和光学系统清洁的难度和对光学系统正确地提供化验带的需求。
BI Hill等的欧洲专利说明书0 351 891 B1描述了一个电化学系统和电极，它们适用于在玻璃器皿内确定血糖量。该系统需要采用昂贵的电极和复杂的读数器来确定血糖量。
Shults等的美国专利号4,994,167描述了一个测量设备，它采用电化学方法来确定生物液中物质的存在和数量。该系统需要一个复杂的仪器和方法，由患者确定定量的结果。
Allen等的美国专利号5,580,794描述了一个单独使用的一次性测量设备，采用光反射方法来确定生物液中物质的存在和数量。该系统利用了光学和电子组件包，它们配合在单独的平面内。
已设计了单独使用的一次性设备来分析体液中的分析物。Mast等的美国专利号3,298,789描述了一个系统，其中整个血液涂在试剂带上。在使用者精确计时的时间间隔之后，必须由使用者擦去血液。一个酶系统与取样中的葡萄糖起反应而产生颜色变化，它与取样中葡萄糖量成比例。与印刷的颜色强度标盘作比较或在电子设备中，用目视方式对试剂带进行读数。
Kiser等的美国专利号5,418,142描述了一个单独使用的设备，它不需要擦去血液或作颜色的匹配。它以半定量的方式判读出取样中存在的分析物量。
Macho等的美国专利号5,451,350描述了一个单独使用的系统，用于确定生物取样中的分析物。
Neel等的美国专利号5,522,255描述了医疗设备中一个液体剂量、流量和凝固量的传感器，它采用了在系统中不挥发的电子标定设备，以检查试剂带的标定值。
Keiser等的美国专利号5,053,199描述了一个用于医疗设备的用电子方式判读出信息的载体。
White等的美国专利号5,366,609描述了具有可插入存储键的双敏感测量设备。该设备采用了可插入存储键。用于控制测量设备的操作。
Brown等的美国专利号5,307,263描述了根据模块式微处理器作出的一个健康状况监测系统，它设计成可从健康检测化验系统，如血糖监测仪收集数据。
虽然已作了许多改进，在生物取样中测量分析物量的费用和复杂程度仍是患者和保健系统的一个重要问题。甚至得到支付血糖监测费用的患者仍往往必须购买测量设备并期待着偿付。要求在使用中把测量设备和试剂带或电极的标定值作匹配会导致性能上的误差，并增加了制造厂家的成本和复杂性。对于定期检测生物液体的成分，如血液中的葡萄糖，能得到一种低廉而简便的定量化验系统将使化验工作更加贴近患者，并将改进他们的健康状况和降低他们的护理费用。
目前，现有的标定技术需要装入标定芯片和标定化验带，输入标定代码或在化验带上采用机械可读的技术，以修改测量设备对反应结果的分析。如果对一批化验带采用了错误的标定装置，或者对一批化验带输入了错误的标定代码，这些方法会造成被化验的分析物的判读误差。
此外，需要较小液体取样的系统对许多患者是有吸引力的。虽然已经有了朝着较小取样尺寸发展的趋势，但大多数设备仍需要约10微升的血液。许多患者难以定期地对化验带或电极涂以适当的取样。不适当的取样可能引起错误的结果，或者需要使用者丢弃昂贵的化验带再重复涂覆取样的程序。
另外一个的问题是对测量设备采用了过期的化验带。目前开封后的截止日期和到期天数是打印在化验带的包装盒上。如果患者没有看到包装盒上的日期信息，则就有了问题。化验带可造成判读错误，这可能引起患者的错误理解和治疗。
发明概述
本发明克服了先前技术中的缺陷，提供了一种低廉的化验设备和单独使用的化验带，能够判读小尺寸的取样，如3微升的取样，并可确定小取样中的分析物量。化验设备的低廉特性可容许把化验设备和化验带作成一个包装，建立一个可用于进行特定化验次数的校准系统。可向使用者提供化验设备而无额外费用，由于对所购买的每包新的化验带具有一个新的设备，使用者得到了好处。这消除了需要患者花钱买化验设备来监测特定的状态或治疗。
在一个可替代的形式中，设备可作为包括取样器和化验带的成套包装的一部分。如果希望化验设备有较长的寿命，可单独购买供置换的化验带而不包括设备或取样器。例如，引入诸如数据管理能力的附加特性可能要增加费用，但它对延长化验设备的使用寿命有利。
化验设备含有由一个或几个通路组成的模制透镜光学系统，以及一个简单电子组件，它包括发光二极管(LFD)，模数转换的电子线路，处理器，只读存储器和数字显示系统。化验设备外壳上有一个定位系统，定位系统与化验带对接，以便为化验带内的试剂化验垫和光学系统建立可靠的定位和对准。
所涂的体液与浸透在化验带内化验垫中的试剂起反应，并且所产生的颜色变化由光学系统作判读。其信号被转换，并作为取样中的分析物浓度显示在数字显示装置上。
本发明的一个有利特性是采用了小的取样尺寸，如3微升左右，它是大多数血糖化验所需体积的几分之一，更容易由患者得到。
本发明的另一个有利特性是提供了简单低廉的化验设备，以及一条免费赠送的试剂化验带。
本发明的另一个有利特性是采用了对化验设备作了标定的试剂化验带，以及/或者采用了一个标定装置，每个标定装置是只可读一次的装置，消除了可能对一组不正确的化验带再次使用标定装置的问题。
本发明的另一个有利特性是化验设备对一批试剂化验带作预先标定或校准，消除了需要使用者来匹配或输入标定信息。
本发明的另一个有利特性是该系统针对预定数目的化验结果进行设计，尽量减少了诸如清洁或置换电池之类的维护工作。
本发明的另一个有利特性是消除了需要一个单独的化验带支承件，简化了化验系统的一次性使用部分与重复使用的化验设备之间的接口关系。
本发明的另一个有利特性是把信息放在单独使用的标定芯片上，消除了需要患者来为化验带标定测量设备或需要经常留意截止日期。
附图简述
结合附图阅读本说明，对熟悉本技术的人员来说本发明的许多优点将很明显，附图中同一编号用于同一零件，其中：
图1是化验带的一个实施例的透视图，化验带包括用于体液分析的化验垫和支承件；
图2是具有化验垫和支承件的化验设备透视图；
图3说明了与化验带连接的化验设备；
图4是化验设备电子组件和用于判读化验带的光学组件的方框图；
图5A和图5B表示了保证化验垫湿润的方法和开始化验设备计时的触点；
图6表示了系统的成套器件，包括化验设备和化验带；
图7表示了系统的成套器件，包括化验设备、化验带和取样装置；
图8表示了在一个光学系统中采用两个检测器和两个发射器。
优选实施例描述
图1是一个透视图，表示了与本发明检测设备一起使用的化验带11。化验带11包括用于分析体液16的化验垫12和支承件13。化验带11提供一个使患者握住带11的手柄14。手柄的作用象一根灯芯，可把体液16传送到化验垫12，并为此设有通道10。化验垫12可由吸水基材制成，它已浸以包括酶、指示剂和血液分离剂的试剂系统。
化验带11上装有一个对准装置，它可包括位于化验带11底部15上的凹口17和凸起18。按以下说明把凹口17和凸起18与化验设备的相应部分配合，其作用是保证化验带11相对于本发明化验设备21的确定位置和方向。当然可以设想到，对本发明系统可采用其它形式的化验带，而在专利上不偏离本发明的精神和范围。
图2是化验设备21的透视图，它用于按照本发明来判读化验带11。化验设备21具有外壳22，外壳上具有一个光学视窗23和一个结合区37，结合区37与化验带上的对准凹口17和凸起18相配合。结合区37可包括设在保持夹19中的槽20，用于引导化验带11的手柄14定位，还包括一个凹口24，它与化验带11的凸起18相配合。由此保证了为了精确判读所需的正确对准，如图3所示，表示了处于工作位置的化验设备21，它与化验带连通。
在化验设备21上还设有一个敏感器45，用于测量取样16中的分析物浓度，以及设有一个用于显示结果的显示器49。敏感器45可以是光学性质的，并且如图8所示，可包括成对的发光器和检测器。特别是，一个发光二极管(LED)50和一个光检测器51测量来自含有取样的化验垫12的反射光。该反射光与取样中分析物的量成比例，它显示了取样/分析物与化验垫12上试剂的反应程度。化验带11和化验设备21设计成可阻挡外界的光线，尽量减小由不利于反射判读的外界光线引起的误差。这种设计包括适当限制视窗23的尺寸，同时选择极不透明的材料来制作设有视窗的外壳22。根据本发明对正确对准的保证，也可使外界光线的不利影响减到最小。
按照本发明，可采用许多种光学系统方案，包括采用透射光而不是反射光，许多对LED/检测器以及它们的各种布局。也可设想到，与所说明的1比1情形不同，可采用各种光源与光检测器的比。
按照本发明，还可装有一个LED 53并相应于光检测器52。可选择光检测器51和52在不同的光强值下工作，从而由一个光检测器来测量低于或等于预定光强界限值的光线，而由另一个光检测器来测量高于界限值的光线。也可以是，用一个检测器来测量特殊颜色成分的反射率，而用另一个检测器来测量不同颜色成分的反射率，或者用一个检测器测量总光强，而用其它检测器测量一个颜色成分。此外，可采用一个参考检测器(图中未示)来补偿整个时间上LED光强的退化。在一种供替代的布局中，可采用一个检测器的测量来提供对血液血球容量或氧含量的补偿。现有的通常技术之一可实现许多改变并仍在本发明范围之内。
本发明的光学装置还设有一个模制的塑料透镜系统48，它把向着和来自取样的光线聚焦在化验垫12上。这种装置提供了向着和来自小反射面积的光线聚焦能力，减少了化验垫12的尺寸和实现化验程序所需的取样量。由此产生的好处包括：减少了所用基材的尺寸/费用和所需昂贵试剂的用量。
本发明的光学装置可包括用于优化测量的适当光学过滤器，或者可采用电子过滤和屏蔽技术来改进信号噪声比的量级。如果要进行血液分析，本发明的光学过滤方案包括采用含阻塞填充剂的现有薄膜材料，以形成一种不透明的薄膜，阻挡来自血细胞的干扰，并可协助把红血细胞从比较透明的液体中分离出来。
另一种光学装置采用了多个成对的LED和光检测器。采用第一对来确定主要的分析物。采用第二对来监测化验的开始和定量确定血红蛋白和血球容量。采用其次的一对来检测淋巴和黄疸取样的原有颜色效应。结合化验带中的添加化学成分，采用附加的一对光学装置来专门确定可能存在的干扰因素，如pH、比重等，以及专门确定附加的分析物，如胆固醇、甘油三酯等。这种分析可采用不同的波长，给出的明显好处是可以克服来自取样和环境的干扰影响。选择与化验的检测成分相协调的一对波长，可以分离和定量确定在化验中的分析物、血球容量和红血细胞成分。根据本发明，分离出干扰的影响和采用多个光学系统来独立监测每个干扰，可把环境的干扰减到最小。通过检测和定量化，可从分析物测量结果中除去对测量的个别影响。随着计算功率费用的日益降低，以及在极低成本下构成多光学系统的特殊性，本发明的方式易适合于家庭诊断使用。
化验带11包括位于化验垫支承件13内的化验垫12。支承件除了提供阻挡外界光线影响分析的方法，也提供了化验垫12相对于敏感器45的精确定位方法。化验垫12被浸渍以适当的化学物质，以容许对所化验的分析物作比色分析，因而它提供了稳定的吸收基底。
本发明的化验带11在许多方面与当前的化验带不同。对于当前的化验带，无孔的支承为患者提供了一个手柄[Jina等的美国专利号5,526,120]，以及/或者提供了一种对准在带支承件中化验带的方法[Matzinger等的美国专利号5,515,170]。本发明的化验带为化验垫提供了一种支承。化验带可靠地位于化验设备上，保证了合适的对准。它也缩小了外界光线和血污染引起的光学区域。因此它提供了常规反射系统的化验带和化验带支承件的所有功能。化验带提供的附加好处是在每次化验后可以除去，并且如果需要的话，有助于进入光学区域进行清洁。采用这种组合的零件，系统的总成本可进一步减少。当化验带11插入检测设备21时，它的接触形成了使设备通电的电路。除去化验带则可使设备断电。这消除了需要单独的开/关线路或需要由患者来开关化验设备。
浸在化验垫基材中的信号产生系统可由不同的指示剂系统形成，如3甲基-2苯并恶唑啉酮-腙(MBTH)和8苯胺-1萘磺酸盐(ANS)[Yu的美国专利号5,453,360]，MBTH和3-二甲氨基苯甲酸(DMAB)[Phillips等的美国专利号5,049,487]，3-甲基-2苯并噁唑啉酮-腙磺化钠盐(MBTH-SO4)和ANS[Douglas等的美国专利号08/628,794]，MBTH-SO4和N-(3-磺丙基)苯胺(HALPS)[Maeda等的美国专利号4,396,714和Douglas等的美国专利申请号08/628,794]，MBTH-SO4和N-乙基-N-(3-磺丙基)苯胺ALPS[Maeda等的美国专利号4,396,714和Douglas等的美国专利申请号08/628,794]。对该技术熟悉的人员可以设计出其它替代的指示剂系统。包含在试剂垫中的氧化酶系统产生过氧化氢，它在作为催化剂的过氧化酶协助下，用于转换指示剂。
在大多数优选实施例中，把干燥的薄膜浸泡在试剂溶液中，使试剂浸入多孔的薄膜内。从薄膜表面擦去多余的液体，并在炉中使薄膜缓慢地干燥。此时，可进行后续的浸泡和干燥。对两种浸泡方法的优选实施例为：MBTH-SO4和ALPS配方A浸泡液                            最后浓度
在柠檬酸缓冲剂中，pH7            0.1M
A浸泡液原料
    EDTA                         0.08％
    甘露糖酸                     0.19％
    Gantrez-S95                  0.53％
    Klucel 99-EF                 20uM
    巴豆毒蛋白                   7.45％
酶试剂
    葡萄糖氧化酶                 0.92％
    过氧化酶                     0.54％B浸泡液
在70％乙醇中
    MBTH-SO4                    0.66％
    ALPS                         2.00％
    SOS                          0.20％
系统的全套器件包括一个化验设备和规定数目的被校准的化验带，用于化验专门的分析物，该全套器件可提供简便和费用合理的化验方法和程序。
图4是一个方框图，表示了本发明的操作过程。化验设备21包括了控制化验设备21操作的微处理器41。化验设备21由开关机构启动，开关机构可包括一个机械的ON按钮34和触点30-33，当压下按钮34时触点闭合成适当的电路。电路的闭合触发了设备的工作，通知微处理器41将进行对已就位化验带11的测量读数。化验带可以是成组的许多化验带中一个，并有一个计数器对它们作跟踪。作为替代方式，可采用化验取样的液体连接来闭合电路，触点30和31作为与化验带11的化验垫12进行接触的探头，由此启动化验设备21来检测已适当定位的化验带11上的取样。
图5A和5B说明了确保化验垫12的湿润来启动化验设备的方法。图5B的化验带11作成在其化验垫12上设置了触点52和54的形式。触点52和54隔开一个有限的距离，仅依靠取样形成的液体接触才形成电连通。取样16涂在化验带11上，湿润了化验垫12和触点54和55。触点54和55与化验设备21上的触点30和31连通，因此当湿润时，它形成了一条电路，启动化验设备21并开始取样分析。当然，本发明也可利用其它的启动方案。这两种方案可以是在结合区37中化验带11的光学或机械检测。
随着化验设备启动，采用光学敏感器45对取样与化验带11上试剂的反应进行测量。当然，敏感器本身不一定要用光学类型，其它合适的方法，如电化学检测方法，也在本发明范围之内。从包括电-光装置50和52的敏感器45，微处理器获得一个电信号，并对它作处理而产生一个检测信号，指示出所化验取样中的分析物浓度。一个ASIC(专用集成电路)和一个存储器，如RAM(随机存取存储器)42或ROM(只读存储器)，可用于与微处理器41连接，同时采用LCD显示器49来显示测量的结果。结果也可存储在RAM 42中作为以后查阅或处理之用。采用化验设备21本身，或者采用被载入测量结果的其它装置，可进行后续的处理。本发明的一个可能方式是采用电话线与远距处理器作调制和解调方式的连接。也可把信息存入互联网地址或电子布告牌用于以后的检索和处理或医务人员的检查。
本发明的一个特征是采用如图4所示的标定芯片40。标定芯片可拆卸地与化验设备21连接，与微处理器41电连通。它可以是永久性或非永久性的存储器形式，包括单独使用的微处理器EPROM或EEPROM。标定芯片40含有标定的信息，它专用于一组配有标定芯片的特定化验带11上设置的试剂。这样，采用所需的信息和技术，可补偿各批试剂间的差别，而同时避免了需要使用者来输入和提供这种信息。这尽量减小了误差，并大大促进了本发明化验设备21的应用和精确性。
在试剂化验垫上涂了体液后形成的颜色与采样16中的分析物量成比例。通过敏感器45和微处理器41，化验设备21测量出反射率的变化，这变化是因化验带11上试剂显现的规定颜色而引起。它可作为输入，用作把反射率与分析物量联系起来的函数，或用作把反射率与分析物量联系起来的表格。函数或表格必须存储在系统内，以便在显示器49上产生和显示出取样16中的分析物量的读数。尽管目前应用的大多数测量设备采用了函数形式来把反射率读数转换成分析物浓度，这种方法需要函数是稳定而易于了解。采用检索表格容许存储特定的反射率值及其相应的分析物量级。化验设备采用这种表格并在表格值之间作插入，可得到比较精确的读数。在本发明所述的系统中这是可以实现的，因为对所生产的每批试剂可快速形成表格。
在优选实施例中，根据一批特定的化验带所产生的反应来进行标定。在此情形下，不需要预先选择和测试LED 50和53，大大降低了敏感器45的成本。此外，这种在生产中的标定步骤使得设备可对反射系统中通常发现的很大的变动范围作补偿。对于随化验设备一起提供的化验带11，其特定的标定数据可存储在设备的只读存储器(图中未示)内。作为替代方式，可提供一条主化验带来确定一批化验带的标定信息，主化验带可与这批化验带一起配套。可提供一个计数器来限制化验设备21只进行特定的化验次数，这个次数与随设备一起提供的化验带11数量有关。可建立其它的限制，例如属于一批特定化验带11的截止日期信息，该信息包含在化验设备的ROM或标定芯片40内，或者在主化验带内。
也可以采取更传统的标定方法。如果化验设备具有较长的设计寿命并准备用于多组化验带，则把标定的算法，如果需要还可带有几个设定值，作为程序编入系统中。
如果把微处理器用于标定芯片，则芯片可设有自己的电源来保持存储信息。如果把EPROM或其它存储装置用作标定芯片，为了防止再次使用，可采用一个供选用的机械锁44来消除标定芯片第二次与化验设备21联结的能力。相似地，如果采用微处理器或EEPROM或者其它的存储装置，则标定芯片可改写它的数据，或者可在其使用后由微处理器41写入一个指示数，用于防止再次使用。因此可把存储在标定芯片40中的标定信息载入处理器的存储器42，并使标定芯片报废，防止它再次使用。标定信息包含了要进行的化验带分析的容许次数，该次数与整套器件中化验带的数目相应。然后可去除标定芯片本身。
作为替代方式，可在标定芯片中设有一个计数器(图中未示)，每次判读芯片时计数器递减。这样，仅可进行有限的判读次数，这个次数与配备标定芯片的化验带11的数目相应。也可以设想到，标定信息可提供截止日期，防止在此日期后使用标定芯片和/或相应的化验带，或者可测量出一个时间段，在此之后不可使用芯片和/或相应的化验带。该时间段可从打开装有全套器件的包装开始，或者从其它任何相似的时间，如从首次使用标定芯片40的时间开始。一般的熟练技术人员将找到许多可实现的变化形式而不偏离本发明的精神和范围。
把化验设备从包装中取出并放置在固定的表面上，患者就可使用这个系统。下一步骤是取出化验带并把它插入化验设备中。插入化验带就启动了设备，而不需要采用接通/断开电源的按钮或开关。然后患者采用全套器件中一个取样器60(图7)，或者采用单独购买的取样器，来抽取微血管中的取样。全套器件也可包括一个取样装置62。把取样涂在化验带上，开始计时程序，在适当时间之后化验设备显示出结果。作为替代方式，患者可先把血样涂在化验带上，然后把化验带插入化验设备，来启动化验过程并读出化验结果。
本发明在几个方面提供了对目前使用的现有技术的改进。本发明的优选实施例消除了要求患者购买费钱的系统来进行体液的日常化验。它也消除了现在要依靠使用者来维护化验设备和对不同试剂批次作监测和补偿。本发明引入了先进的透镜光学器件和低廉的现代电子线路，为诸如血糖的分析物提供了这种易于使用的方式。应用透镜光学器件容许系统在小的反应区域上聚焦，减少了化验垫的尺寸。这种小的化验垫降低了所用基材的成本和昂贵的试剂量，为了采用氧化酶和过氧化酶化学物质来进行精确的化验，这种试剂是必需用的。由于化验垫较小，可适用较少的取样容量。系统保存了所用的能量，并尽量减小了为确定颜色变化而系统所需的光量。可在化验设备制造期间标定光学模块。
本发明的一个重要特征是针对已在厂内匹配的专门数量的化验带11，来制造和标定化验设备21。这限制了标定代码的需要，并尽量减少了患者所需的维护工作，如清洁、电池置换和标定代码的改变。因为化验设备只与一定的化验带作校准，这也提高了系统提供长期精确结果的能力。一旦这些化验带被用过后，就采用完全新的全套器件，其中化验设备对这些化验带作了专门的标定。这就消除了在当前产品中发现的在系统性能上许多不得不妥协的现象，这些产品工作时不得不采用在很大范围的生产条件和输入状态下制造出的化验带。
以上是实现本发明的举例，但并不意味着受此限制。对于熟悉本技术的人员来说，显然可对此作出修改而不背离以下权利要求中规定的本发明精神和范围。

Claims (34)

1.一种被校准的检测设备，它根据取样与试剂的实际可测的反应，用于检测取样中分析物的存在，设备包括：
一组化验带，每条化验带包含着放在其中的试剂，每组化验带至少包含一条化验带；
一个标定装置，它相应于一组化验带并包含对一组化验带中试剂所特有的标定信息；
一个外壳，它至少具有与一条化验带配合的结合区；
一个敏感器，它至少部分地设置在外壳内并适于产生一个电信号，以响应取样与试剂的反应；以及
一个处理器，它部分地设置在外壳内并适于按照标定装置进行工作，以产生一个表示取样中分析物存在的检测信号。
2.权利要求1的设备，其中，检测设备使用次数为相应于一组化验带数目的预定次数，由处理器把预定次数制成表格，在预定次数之后处理器使检测设备不能工作。
3.权利要求1的设备，其中，处理器适于使检测设备在预定日期之后不能工作。
4.权利要求1的设备，其中，标定装置包括一个芯片，芯片含有把电信号与检测信号联系起来的相关信息。
5.权利要求4的设备，其中，检测设备适用于许多个上述芯片，每个芯片相应于相关的一组化验带，并适于与外壳作可拆的连接。
6.权利要求4的设备，其中，相关的信息是根据一个预定的数学函数。
7.权利要求4的设备，其中，相关的信息是根据一个检索表格。
8.权利要求5的设备，其中，每个芯片使用次数为相应于相关一组化验带的数目的预定次数，由处理器把预定次数制成表格，在预定次数之后处理器使芯片不能工作。
9.权利要求5的设备，其中，每个芯片使用到预定的日期，在预定日期之后处理器使芯片不能工作。
10.权利要求1的设备，其中，标定装置从一组化验带中的主带获得相关的信息。
11.权利要求1的设备，其中，结合区适于把化验带正确定位在相对于敏感器的预定位置。
12.权利要求11的设备，其中，结合区适于采用配合销和相应的孔来配合化验带，使得只有成功的配合才能达到预定的位置。
13.权利要求1的设备，其中，敏感器至少包括一个LED和相应的光检测器。
14.权利要求13的设备，其中，敏感器包括适于在低于辐射强度界限下工作的第一LED和适于在高于辐射强度界限下工作的第二LED。
15.权利要求13的设备，其中，敏感器包括适于检测反应产生的总反射率的第一LED和适于测量预定颜色成分反射率的第二LED。
16.权利要求13的设备，其中，敏感器至少设置一个用于光线聚焦的模制透镜光学系统。
17.权利要求1的设备，还包括一个存储检测信号的存储器。
18.权利要求17的设备，还包括一个调制和解调器，用于把信号从存储器载入远离检测设备的地方。
19.权利要求18的设备，其中，调制和解调器设置在一个通信组件上，它可拆地与检测设备连通配合，并与远处存储设备相连通。
20.权利要求1的设备，其中，检测设备由机电开关来启动，开关由结合区内化验带的存在来触发。
21.权利要求1的设备，其中，检测设备由光学开关来启动，开关由在结合区内化验带的存在来触发。
22.权利要求1的设备，其中，检测设备由一对电极来启动，电极敏感到结合区内化验带上取样的存在。
23.权利要求1的设备，其中，敏感器包括一对与取样电连通的电极。
24.权利要求13的设备，其中，光检测器对外界辐射屏蔽。
25.权利要求1的设备，其中，随检测设备提供一组取样器，取样器的数目相应于化验带的数目。
26.权利要求1的设备，其中，检测信号显示在位于外壳上的显示器中。
27.权利要求26的设备，其中，显示器是一种LCD装置。
28.权利要求4的设备还包括一个存储器，从芯片载入相关的信息并存入存储器中。
29.权利要求28的设备，其中，芯片在载入后不能工作。
30.权利要求28的设备，还包括防止重复载入的机械锁。
31.权利要求4的设备，其中，芯片中设有一个计数器，以相应于相关一组化验带数目的预定次数，处理器判读有关的信息，每读一次计数器递减一次。
32.权利要求1的设备，其中，处理器在预定时间段之后防止使用标定装置。
33.权利要求1的设备，其中，随检测设备提供一个取样装置。
34.权利要求25的设备，其中，随检测设备提供一个取样装置。
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