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CN1394280A - 用于测定血球比率校正的分析物浓度的电化学方法及装置 - Google Patents

用于测定血球比率校正的分析物浓度的电化学方法及装置 Download PDF

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CN1394280A
CN1394280A CN 01803437 CN01803437A CN1394280A CN 1394280 A CN1394280 A CN 1394280A CN 01803437 CN01803437 CN 01803437 CN 01803437 A CN01803437 A CN 01803437A CN 1394280 A CN1394280 A CN 1394280A
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CN1193228C (zh )
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T·J·奥哈拉
M·Z·凯尔马尼
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生命扫描有限公司
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    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • G01N27/28Electrolytic cell components
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    • G01N27/327Biochemical electrodes electrical and mechanical details of in vitro measurements
    • G01N27/3271Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3274Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration

Abstract

提供了一种在生理样品中确定分析物浓度的方法和装置。在本发明方法中,将生理样品引入具有工作电极和参比电极的电化学电池中。给电池施加第一电势,测定一段时间内产生的电池电流,以确定第一时间-电流瞬变值。然后给电池施加极性相反的第二电势,以确定第二时间-电流瞬变值。然后从第一和/或第二时间-电流瞬变值计算分析物的初始浓度。分析物的初始浓度扣除本底值然后乘以血球比率校正因子,得到样品中分析物的浓度,其中该血球比率校正因子是分析物初始浓度和电化学电池的变量γ的函数。本发明方法和装置适用于测定许多种样品中的许多种分析物,尤其适于测定全血样或其衍生物中的分析物,其中特别感兴趣的分析物是葡萄糖。

Description

用于测定血球比率校正的分析 物浓度的电化学方法及装置

发明领域本发明的领域是测定物分析,特别是电化学测定物分析,尤其是电化学测定血液分析物。

一种用作分析物检测的方法是电化学方法。在该方法中,将含水液体样品置入包括两极,即参比电极和工作电极的电化学电池反应区中,所述电极具有阻抗使之适于测定电流。使待分析的成分与电极直接反应,或与氧化还原剂直接或间接反应,形成与待分析成分(即分析物)浓度对应量的可氧化(或可还原)的物质。然后用电化学方法估测可氧化(或可还原)物质存在的量,该量与初始样品中存在的分析物的量相关联。

当化验的生理样品是全血或其衍生物时,样品的血球比率是分析物最终浓度测定中的分析误差源。例如,由观测到的时间-电流瞬变值得到分析物浓度的电化学测定方法中,血球比率可以减缓电化学电池中的化学平衡,和/或通过增加池中样品粘度而减缓酶动力学平衡,因而降低了时间-电流响应造成分析误差。

由此,建立至少使血球比率所引起分析误差最小化的方法已引起了极大兴趣。有些方法用血滤膜去除红血细胞,因此使血球比率效应最小化。由于需要增加样品体积和延长试验时间,因此这些特定方法不能令人满意。其它方法着重于确定毛细管充满时间。然而,这些方法增加了分析试片及用于读数装置的复杂性。还有一些其它的具体实施方案,用两个附加的电极单独测定血球比率,这些方法也使分析试片及装置变得更复杂和更昂贵。

由此,建立新的测定生理样品中分析物浓度的电化学方法,一直令人感兴趣,该方法可使样品的血球比率带来的分析误差最小化。相关文献有关专利文献包括:5,942,102和WO97/18465。

在进一步描述本发明之前,应该理解,本发明不限于如下所述的具体实施方案,这些具体实施方案的变化仍落入本发明附加的权利要求的范围。还应理解,所用的术语是为了描述具体实施方案,而非对其限制。反之,本发明的范围由所附的权利要求定义。

在说明书和所附权利要求书中,单数标记包括复数,除非在上下文中清楚地另有说明。除另有定义,用于本发明的所有技术和科学术语与本发明所属技术领域的普通技术人员通常所理解的意义相同。方法如上概述,本发明提供了一种在生理样品中测定血球比率校正的分析物浓度的方法。通过血球比率校正的分析物浓度意味着用本发明方法确定的分析物浓度值已调整或改变,以基本上去除血球比率对浓度值带来的所有影响。换言之,用本发明方法测定的浓度值已被调整,去除了不用本发明方法时,样品血球比率对浓度值带来的任何影响。由此,在本发明方法中,血球比率信号从分析物信号中去除,在最终血球比率校正的分析物浓度中仅有分析物信号。

本发明方法的第一步是将一定量的待测生理样品引入到电化学电池中,该电池包括空间分隔的工作和参比电极及氧化还原剂系统。生理样品可以改变,但许多具体实施方案通常所用的是全血或其衍生物或血成分,其中在许多具体实施方案中,优选全血样。引入到检测试片反应区中的生理样品如血的量可以变化,但一般范围为约0.1-10μL,通常为约0.9-1.6μL。可用任何便利的方法将样品引入到反应区中,如可将样品注射进入反应区,也可由毛细作用将样品带入反应区等方便的方法。

当使用本发明方法时,原则上用任何类型的空间分隔的工作和参比电极及氧化还原剂系统的电化学电池,在许多具体实施方案中,本发明方法使用电化学试片(test strip)。用于本发明这些具体实施方案的电化学试片由两个相对的被一薄的间隔层分隔的金属电极组成,其中这些部件构成了其中具有氧化还原剂系统的反应区或区域。

在这些电化学试片的某些具体实施方案中,该工作和参比电极通常是拉伸的矩形带状。典型地,电极长度为约1.9-4.5cm,通常为约2.0-2.8cm。电极宽度为约0.38-0.76cm,通常为约0.51-0.67cm。典型的参比电极的厚度为约10-100nm,通常为约10-20nm。在某些具体实施方案中,一个电极的长度比另一个短,典型的约短0.32cm。较短的电极可以是工作电极或参比电极。

工作电极和参比电极进一步的特征是,至少在试片中电极朝向反应区一侧的表面是金属的,其中所述金属包括钯、金、铂、银、铱、碳、掺杂的锡氧化物、不锈钢等。许多具体实施方案中金属是金或钯。虽然原则上整个电极可由金属制备,但每个电极一般由惰性支撑材料构成,其表面有电极金属成分的薄层。在这些更普通的具体实施方案中,惰性材料的厚度通常为约51-356μm,一般为约102-153μm,而金属层的厚度通常为约10-100nm,一般为约10-40nm,如为喷镀金属层。本发明电极中可使用任何便利的惰性支撑材料,通常是能够给电极提供结构支撑的刚性材料,而使电化学试片成为一个整体。可用作支撑基底的合适材料包括塑料,如PET、PETG、聚酰亚胺、聚碳酸酯、聚苯乙烯、硅、陶瓷、玻璃等。

在本发明方法的这些具体实施方案中所用的电化学试片的一个特征是上述工作和参比电极彼此面对,且仅由一短距离分隔,因此在电化学试片反应区域或区中工作和参比电极间的距离极小。这种在本发明试片上最小化的工作和参比电极间距是由于在工作和参比电极之间存在定位的或夹有的薄间隔层的结果。此间隔层的厚度一般应小于或等于500μm,通常为约102-153μm。此间隔层被切开以提供一反应区域或反应区,所述反应区至少有一入口进入该区域,也通常有一离开反应区域的出口。间隔层可以有一个圆形的反应区,侧面有入口或出口孔或口,或其它结构如正方形、三角形、矩形、不规则形反应区等。间隔层可以用任何方便的材料制成,其中有代表性的合适材料包括PET、PETG、聚酰亚胺、聚碳酸酯等,其中处理间隔层的表面以使其对于各自电极具有粘合性,因此保持电化学试片的结构。特别优选的是用一种裂口双面粘性试片作为间隔层。

本发明中这些具体实施方案中所用的电化学试片包括由工作电极、参比电极和间隔层定义的一个反应区域或区,这些元件前面已描述。具体地说,该工作和参比电极限定了反应区的顶部和底部,而间隔层限定了反应区的壁。反应区的体积至少为约0.1μL,通常至少约1μL,更常用至少约1.5μL,如体积可大至10μL或更大。如上所述,反应区通常包括至少一个入口,在许多具体实施方案也包括一个出口。入口和出口的横截面可以改变,只要其足够大可提供来自反应区液体的进出,但通常为约9×10-4~5×10-3cm2,通常为约1.3×10-3~2.5×10-3cm2。

反应区中是一个氧化还原剂系统,该系统提供可由电极测定的物种,因此可用于测定生理样品中分析物的浓度。反应区中的氧化还原剂系统通常包括至少一种酶和一种介质。在许多具体实施方案中,氧化还原剂系统中的酶是一种酶或可协同氧化所述分析物的多种酶。换言之,氧化还原剂系统的酶组分由单一的分析物氧化酶或可协同氧化所述分析物的两种或多种酶的组合组成。所述的酶包括氧化酶、脱氢酶、脂肪酶、激酶、二磷酸酶(diphorases)、醌蛋白酶等。

反应区中具体酶的选择取决于电化学试片要检测的具体分析物,代表性的酶包括葡萄糖氧化酶、葡萄糖脱氢酶、胆固醇酯酶、胆固醇氧化酶、脂蛋白脂肪酶、甘油激酶、甘油3-磷酸氧化酶、乳酸酯氧化酶、乳酸酯脱氢酶、丙酮酸酯氧化酶、醇氧化酶、胆红素氧化酶、尿酸酶等。在许多优选具体实施方案中所述分析物是葡萄糖,氧化还原剂系统中的酶组分是葡萄糖氧化酶,如葡萄糖氧化酶或葡萄糖脱氢酶。

氧化还原剂系统的第二种部分是介质部分,其由一种或多种介质组成。可使用本领域熟知的多种不同的介质,包括:铁氰化物、吩嗪乙氧硫酸酯(phenazine ethosulphate)、吩嗪甲氧硫酸酯(phenazinemethosulfate)、苯二胺(pheylenediamine)、1-甲氧-吩嗪甲氧硫酸酯、2,6-二甲基-1,4-苯醌、2,5-二氯-1,4-苯醌、二茂铁衍生物、锇双吡啶络合物、钌络合物等。在所述分析物是葡萄糖的具体实施方案中,酶成分是葡萄糖氧化酶或葡萄糖脱氢酶,所述具体介质是铁氰化物等。

反应区中可能存在的其它试剂包括缓冲剂,如柠康酸盐、柠檬酸盐、苹果酸、马来酸、磷酸盐、“Good”缓冲剂等。但也可以有其它缓冲剂,包括:二价阳离子如氯化钙、氯化镁;吡咯并喹啉醌;表面活性剂类如Triton、Macol、Tetronic、Silwet、Zonyl及Pluronic;稳定剂如铝、蔗糖、海藻糖、甘露醇及乳糖。

氧化还原剂系统通常以干燥形式存在。各种组分的量可以改变,其中酶的典型用量为约1-100mg/mL,通常为约5-80mg/mL;介质的典型用量为约5-1000mM,通常为约90-900mM。

引入样品后,得到第一和第二时间-电流瞬变值。第一和第二时间-电流瞬变值通过如下方法获得,给电池施加恒定电势,并观测电池在一定时间内电流的变化。换句话说,通过给电池施加第一和第二脉冲,观测所产生的时间-电流瞬变值。由此,通过第一时间-电流瞬变值由如下方法获得,给电池例如工作和参比电极之间施加恒定的电势或第一脉冲,并观测一定时间后两极间电流的改变,即电池中电流的改变,从而获得第一时间-电流瞬变值。所施加的第一电势的大小为约0~-0.6V,通常为约-0.2~-0.4V。为获得第一时间-电流瞬变值,典型的观测两极间电流时间的长短为约3-20秒,通常为约4-10秒。

第二时间电流通过如下方法获得,给电极施加第二恒定电势或第二脉冲,典型的是与第一恒定电势极性相反的电势,并观测第二时间段内两极间电流的改变。典型的第二电势的大小为约0~+0.6V,通常为约+0.2~+0.4V,在许多具体实施方案中,第二电势的大小与第一电势相等。典型的第二时间段约1-10秒,通常为约2-4秒。通过观测第二时间段内两极间电流的改变可确定电池的第二时间-电流瞬变值。

在某些具体实施方案中,获得必要的上述第一和第二时间-电流瞬变值所需的总时间段相对短一些。在这些具体实施方案中,获得第一和第二时间-电流瞬变值所需的总时间小于30秒,通常约小于20秒,更通常约小于14秒。

本发明方法的下一步骤是用如上所述观察到的第一和第二时间-电流瞬变值测定:(a)在本发明方法中使用的电化学电池的变量γ;及(b)样品中所述分析物的初始浓度。

在本发明方法中使用的变量γ定义为描述电化学电池与理想状态的偏差。作为基础知识,应该指出在第一次脉冲结束之前,试剂已达平衡且葡萄糖反应完全的理想条件下,γ值应接近于1。任何的反应不完全条件将导致比率偏离非“一”的值。γ值(分数)的分子定义为在给电池施加第二电势后观察到的稳态电流值,即在t=∝时第二时间-电流瞬变值的预测值。分母定义为在接近第一时间段结束时即接近于施加第一次电势或第一次脉冲结束时一个短时间内的平均电流值。测定平均电流的该短时间范围典型为约0.2-2秒,通常为约0.2-1.5秒,更通常为约0.2-1.25秒,许多具体实施方案中短时间段约0.3秒。在接近第一时间段结束时测定平均电流,典型地为约0.1-1秒时间段内。在某些具体实施方案中,变量γ由下式描述:γ=iss/ipp其中:iss是第二施加电势的稳态电流;ipp是接近第一时间段结束时的短时间内的平均电流,即接近给电池施加第一电势期间结束时。如第一时间是10秒长,平均电流可以是在这10秒长时间内从8.5到9.5秒期间的平均电流,这个时间段是1.0秒,距第一时间段结束前0.5秒。如上提到,第一和第二时间-电流瞬变值也可用于求算被化验样品的初始分析物浓度值。许多具体实施方案中,初始分析物浓度用下列公式计算:i(t)=iss{1+4exp(-4π2Dt/L2)}iss=2FADC0/L其中,iss是施加第二电势后的稳态电流;i是测量的电流值,其为时间函数。D是电池的扩散系数,该系数可由Fick′s第一定律确定,即J(x,t)=-DdC(x,t)/dxL是间隔厚度;t是施加第二电势的时间,其中t=0表示脉冲开始C0是分析物初始浓度;F是法拉弟常数,即9.6485×104C/mol;及A是工作电极面积。

按上述的公式和步骤,所观测的第一和第二时间-电流瞬变值被用于测定本发明方法中电化学电池的变量γ值,及受试生理样品中的所述分析物的初始浓度值。

从所测得的变量γ值和初始分析物浓度值,可测出血球比率校正因子,该血球比率校正因子用于由上述初始分析物浓度值,得到血球比率校正的分析物浓度值。用血球比率校正因子乘以初始分析物浓度(通常扣除本底值),以获得血球比率校正的分析物浓度值,即已去除血球比率成分的浓度值。血球比率校正因子是初始分析物浓度值和电化学电池变量γ值的函数。

任何可以乘以初始浓度值(通常扣除本底值,以下将详述)的血球比率校正因子可用于本发明方法。用于本发明方法的一类血球比率校正因子可以从C0、γ和α(C0,γ)的三维图表中得出,C0、γ和α(C0,γ)数据是从用宽范围分析物和血球比率值进行实验所得数据中得到的。血球比率校正因子α(C0,γ)由下式计算:α(C0,γ)=实际浓度/(C0-本底值)(例如,当分析物是葡萄糖时,许多具体实施方案中α(C0,γ)是用Yellow Springs Instrument的23A型葡萄糖分析仪测定的葡萄糖浓度(见美国专利5,968,760公开内容,在此引入作为参考)除以C0扣除本底的值,该本底值例如22mg/dL)。此类血球比率校正因子通常是可拟合光滑曲面函数的公式,所述函数可将预计值与实际值间的误差减到最小。见例如以下实验部分。一个用于本发明方法的有代表性的血球比率校正因子是:1/((0.6637)+((4.9466*ln(C0))/C0)+(-0.4012*1n(γ)))根据本发明测定血球比率校正的分析物浓度时,将如上所测的初始分析物浓度(C0)扣除本底信号值,再与血球比率校正因子相乘。从初始浓度值中扣除的本底值根据被测定的分析物而改变。对于葡萄糖,该值一般为约0-40mg/dL,通常为约8-25mg/dL,许多具体实施方案中,本底值约为22mg/dL或22mg/dL。

一般来说,根据本发明下列公式用于测定血球比率校正的分析物浓度:血球比率校正的浓度=血球比率校正因子×[C0-β]其中β是本底值;C0是初始分析物浓度。

上述方法得出了血球比率校正的分析物浓度值,即去除血球比率成份的浓度值。由此,上述方法提供了分析物在被测样品中实际浓度值。

本发明方法的上述计算步骤可以用人工方式完成,也可用自动化的计算手段完成。其中许多具体实施方案优选采用自动化的计算手段,如下面描述的与本发明装置有关方法。装置本发明还提供了用于实施本发明的测量仪器。本测量仪器通常是测量电流的仪器,用于测定生理样品中血球比率校正的分析物浓度。本发明测量仪器通常包括:(a)给已引入样品的电化学电池施加第一电势的装置,该装置还能测定作为时间函数的电池电流以获得第一时间-电流瞬变值;(b)给电化学电池施加第二电势的装置,该装置还能测定作为时间函数的电池电流以获得第二时间-电流瞬变值;(c)测定由所述第一和第二时间-电流得到初始分析物浓度值及变量γ值的装置;及(d)在所述样品中从初始浓度值中除去血球比率成分,得出血球比率校正的分析物浓度的装置。装置(a)和(b)可以是任何合适的装置,其中有代表性的装置见WO 97/18465和美国专利5,942,102;其公开内容中的描述在此引入作为参考。装置(c)和(d)通常是仪器中的计算装置,可利用已测定的第一和第二时间-电流瞬变值最终获得血球比率校正的分析物浓度。由此,装置(c)通常能用前述公式从第一和第二时间-电流瞬变值测定所述分析物初始浓度和变量γ值。同样,装置(d)通常能用前述公式测定血球比率校正的分析物浓度,其中这种装置包括血球比率校正因子。

提供下列实施例是为了说明本发明,而非进行限制。

用下列公式得出C0:

i(t)=iss{1+4exp(-4π2Dt/L2)}iss=2FADC0/L其中,iss是施加第二电势后的稳态电流;i是测量的电流,其为时间函数。D是电池的扩散系数,该系数可用Fick′s第一定律确定,即J(x,t)=-D/dC(x,t)/dxL是间隔厚度;t是施加第二电势时间,其中t=0是脉冲开始时间C0是分析物初始浓度;F是法拉弟常数,即9.6485×104C/mol;及A是电极表面面积。变量γ值由下式得出:γ=iss/ipp其中:iss是施加第二电势或第二脉冲的稳态电流;ipp是施加第一脉冲10秒期间内从8.5秒到9.5秒的平均电流。

用下式确定α(C0,γ):α(C0,γ)=YSI浓度/(C0-22mg/dL)其中YSI是用Yellow Springs Instrument的23A型葡萄糖分析仪测得的葡萄糖浓度(见美国专利5,968,760,其公开内容在此引入作为参考)。

对于宽范围的葡萄糖和血球比率值,绘制了其已确定的C0、γ和α(Co,γ)的三维曲线图,并示于表1中。然后对曲线进行简单的方程拟合,以确定曲面。监视拟合数值的残差以确保模型方程的精度。发现如下经验式:血球比率校正因子=1/((0.6637)+((4.9466*1n(C0))/C0)+(-0.4012*1n(γ)))发现上述校正因子在γ>0.7及C0>40mg/dL时有效。IV.血球比率校正值与YSI测定值的比较用宽范围的葡萄糖和血球比率水平,通过测定几个葡萄糖试片得到了一套预测数据。使用拟合C0、γ和α(C0,γ)项的模型,从这套数据可得出血球比率校正公式。发现对于预测的数据,用血球比率校正公式导致大多数数据点落在+/-15%的范围内。还发现葡萄糖偏差的42%源于血球比率,表明将血球比率对该套数据的影响最小化。为确定此运算规则,用来自不同供血者的测定了另一批葡萄糖敏感元件,发现此运算规则仍然正确,所观察到的血球比率的影响与上述结论一致。

上述结果和讨论表明,本发明提供了一种简便和有力的工具,以得到分析物浓度值,其中由血球比率派生的误差如果没有被完全消除,也基本上被消除了。本发明方法仅需测定时间-电流瞬变值,可用相对简单的电化学装置便可操作。而且,仅需少量样品,化验时间相对较短。由此,本发明对本领域的技术作出了重大的贡献。

本说明书中引用的所有出版物和专利在此引入作为参考,正如每一出版物或专利在此都是专门且单独地引入作为参考,所引用的任何文献是由于其公开日早于本发明申请日,而不应解释为承认本发明没有在时间上居先是由于借助于在先发明。

为清楚地理解本发明,尽管采用说明和实施例对前述的发明进行了一定程度的详述,对于本领域普通技术人员根据本发明的教导对发明所进行的某些改变或变化,很显然不脱离本发明所附权利要求的精神和范围。

Claims (20)

1.一种检测生理样品中血球比率校正的分析物浓度的方法,该方法包括:(a)将所述生理样品引入电化学电池中,所述电池包括:(i)空间分隔的工作和参比电极;及(ii)包括酶和介质的氧化还原剂系统;(b)给所述反应电池施加第一电势,并测定作为时间函数的电池电流,以获得第一时间-电流瞬变值;(c)给所述电池施加第二电势,并测定作为时间函数的电池电流,以获得第二时间-电流瞬变值;及(d)从所述第一和第二时间-电流瞬变值得出初始分析物浓度;及(e)将所述初始分析物浓度扣除本底值后与血球比率校正因子相乘得出所述样品中血球比率校正的分析物浓度;由此可测出所述样品中血球比率校正的所述分析物浓度。
2.根据权利要求1的方法,其中所述血球比率校正因子调整初始分析物浓度值,以除去来自所述初始分析物浓度值中的血球比率衍生的成份。
3.根据权利要求1的方法,其中所述血球比率校正因子是所述初始分析物浓度和所述电化学电池γ值的函数。
4.根据权利要求1的方法,其中所述生理样品是全血或其衍生物。
5.根据权利要求1的方法,其中所述分析物是葡萄糖。
6.一种检测全血样中血球比率校正的分析物浓度的方法,该方法包括:(a)将所述全血样引入电化学电池中,所述电池包括:(i)空间分隔的工作和参比电极;及(ii)包括酶和介质的氧化还原剂系统;(b)给所述反应电池施加第一电势,并测定作为时间函数的电池电流,以获得第一时间-电流瞬变值;(c)给所述电池施加第二电势,并测定作为时间函数的电池电流,以获得第二时间-电流瞬变值;及(d)从所述第一和第二时间-电流瞬变值得出初始分析物浓度;及(e)将所述初始分析物浓度扣除本底值后,与从所述初始浓度值中除去血球比率成分的血球比率校正因子相乘,得出所述样品血球比率校正的分析物浓度;由此可测出所述样品中血球比率校正的所述分析物浓度。
7.根据权利要求6的方法,其中所述血球比率校正因子是所述初始分析物浓度和所述电化学电池变量γ值的函数。
8.根据权利要求6的方法,其中所述分析物是葡萄糖。
9.根据权利要求6的方法,其中所述酶是氧化酶。
10.根据权利要求9的方法,其中所述氧化酶是葡萄糖氧化酶。
11.一种检测全血样中血球比率校正的葡萄糖浓度的方法,该方法包括:(a)将所述全血样引入电化学电池中,所述电池包括:(i)空间分隔的工作和参比电极;及(ii)包括葡萄糖氧化酶和介质的氧化还原剂系统;(b)给所述反应电池施加第一电势,并测定作为时间函数的电池电流,以获得第一时间-电流瞬变值;(c)给所述反应电池施加第二电势,并测定作为时间函数的电池电流,以获得第二时间-电流瞬变值;及(d)从所述第一和第二时间-电流瞬变值得出初始葡萄糖浓度;及(e)将所述初始葡萄糖浓度扣除本底值后,与从初始浓度值中除去血球比率成分的血球比率校正因子相乘,得出所述样品中血球比率校正的葡萄糖浓度;由此可测出所述样品中血球比率校正的葡萄糖浓度。
12.根据权利要求11的方法,其中所述血球比率校正因子是所述初始分析物浓度和所述电化学电池变量γ值的函数。
13.根据权利要求12的方法,其中所述血球比率校正因子等于:1/((0.6637)+((4.9466*1n(C0))/C0)+(-0.4012*1n(γ)))其中:C0是所述初始浓度;及γ是所述所述电化学电池可变的电流比率。
14.根据权利要求13的方法,其中所述样品的所述初始葡萄糖浓度大于40mg/dL。
15.根据权利要求13的方法,其中所述电化学电池的所述变量γ值大于0.7。
16.一种采用测定电流而测定生理样品中分析物浓度的测量仪器,所述测量仪器包括:(a)给包括所述样品的电化学电池施加第一电势的装置,该装置并能并测定作为时间函数的电池电流以获得第一时间-电流瞬变值;(b)给所述电化学电池施加第二电势的装置,该装置并能测定作为时间函数的电池电流以获得第二时间-电流瞬变值;(c)测定从所述第一和第二时间-电流得到的初始分析物浓度值及变量γ值的装置;及(d)从所述初始浓度值中除去血球比率成分,以得出所述分析物在所述样品中浓度的装置。
17.根据权利要求16的测量仪器,其中所述除去血球比率成分的装置是将所述初始分析物浓度值扣除本底值后并与血球比率校正因子相乘的装置。
18.根据权利要求16的测量仪器,其中所述血球比率校正因子是所述初始分析物浓度和所述电化学电池的所述变量γ值的函数。
19.根据权利要求18的测量仪器,其中所述血球比率校正因子等于:1/((0.6637)+((4.9466*1n(C0))/C0)+(-0.4012*1n(γ)))其中:C0是所述初始浓度;γ是所述电化学电池所述的可变电流比率。
20.根据权利要求16的测量仪器,其中所述分析物是葡萄糖。
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