JP2007514929A - 2つの異なる電位を印加して電気化学センサにおける干渉を軽減する方法に使用するための測定器 - Google Patents
2つの異なる電位を印加して電気化学センサにおける干渉を軽減する方法に使用するための測定器 Download PDFInfo
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Abstract
【解決手段】分析物の測定における干渉成分の影響を軽減する方法、具体的には、検査ストリップが2つ以上の動作電極を用いるシステムにおける干渉成分の影響を軽減する方法を利用する改善された測定器。測定器は、第1の電位(E1)を第1の動作電極(12)に印加し、この第1の電位(E1)よりも大きい同じ極性を有する第2の電位(E2)を第2の動作電極(14)に印加する。測定器は、生成された電流を測定し、所定のアルゴリズムを用いて、サンプル中の干渉成分の存在による影響を排除するために測定された電流を補正する。
【選択図】図2
Description
ライフスキャン社(LifeScan Inc.)が販売するOneTouch(登録商標)Ultra(登録商標)全血検査キットに用いられるような電気化学グルコース検査ストリップは、糖尿病患者の血液サンプル中のグルコース濃度を測定するようにデザインされている。グルコースの測定は、フラボ酵素グルコースオキシダーゼによるグルコースの特異的な酸化に基づいている。この反応の際、この酵素は還元される。この酵素は、メディエータであるフェリシアニドとの反応によって再び酸化される。フェリシアニドは、この反応中に自己還元する。これらの反応は、次のように表すことができる。
D‐グルコース+GOx(OX) → グルコン酸+GOx(RED)
GOx(RED)+2Fe(CN)6 3- → GOx(OX)+2Fe(CN)6 4-
本発明は、分析物の測定における干渉成分の影響を軽減する方法、具体的には、検査ストリップが2つ以上の動作電極を用いるシステムにおける干渉成分の影響を軽減する方法に用いるための測定器に関する。本発明の一実施形態では、測定器は、第1の電位(E1)を第1の動作電極(12)に印加し、この第1の電位(E1)よりも大きい同じ極性を有する第2の電位(E2)を第2の動作電極(14)に印加する方法で分析物を測定するように適合されている。還元電流を分析物の濃度測定に用いる実施形態でも、第2の電位を第1の電位よりも小さくすることできる。一実施形態では、第1の動作電極および第2の動作電極を、分析物特異的な酵素試薬および酸化還元メディエータで覆うことができる。第1の動作電極に印加する第1の電位は、拡散が制限されるように還元された酸化還元メディエータが酸化するのに十分となるように選択され、第2の電位は、第2の動作電極における酸化がより効率的となるように第1の電位よりも大きい電位の大きさ(すなわち、絶対値)を有するように選択する。本発明のこの実施形態では、第1の動作電極で測定器によって測定される電流は、分析物電流および干渉成分電流を含み、第2の動作電極で測定される電流は、分析物過電圧電流および干渉成分過電圧電流を含む。分析物電流および分析物過電圧電流は共に、分析物濃度に一致する電流であり、この電流が還元されたメディエータの酸化によるものであることに留意されたい。本発明の実施形態では、第1の動作電極における電流と第2の動作電極における電流との間の関係を、下記の式で表すことができる。
A1は第1の動作電極における分析物電流、
W1は第1の動作電極で測定される電流、
W2は第2の動作電極で測定される電流、
Xは分析物依存性電圧影響因子、
Yは干渉成分依存性電圧影響因子である。
本発明に従った測定器では、上記した式を用いて、干渉成分の存在によって生じる酸化電流の影響を軽減し、測定するサンプルにおける分析物の濃度をより正確に表す補正された電流値を計算することが可能である。
A1Gはグルコース電流、
W1は第1の動作電極で測定される電流、
W2は第2の動作電極で測定される電流、
XGはグルコース依存性電圧影響因子、
Yは干渉成分依存性電圧影響因子である。
本発明は、分析物を測定するためにここに記載する方法を利用する検査ストリップに用いられる測定器に関し、詳細には、ここに記載する方法に従ってプログラムされた図2に例示されている測定器に関する。
XG×A1G=A2G (式1)
但し、
XGはグルコース依存性電圧影響因子、
A1Gは第1の動作電極におけるグルコース電流、
A2Gは第2の動作電極におけるグルコース電流である。
Y×I1=I2 (式2)
但し、
Yは干渉成分依存性電圧影響因子、
I1は干渉成分電流、
I2は干渉成分過電圧電流である。
干渉成分電圧影響因子Yは、問題の1または複数の特定の干渉成分および動作電極に用いる材料を含む多数の因子に依存するため、特定のシステム、検査ストリップ、分析物、および1または複数の干渉成分についての特定の干渉成分依存性電圧影響因子の計算には、これらの基準に対する電圧影響因子を最適化するための実験が必要であろう。別法では、一定の状況下で、適切な電圧影響因子を数学的に導出または説明することができる。
η1=E1−E0、η2=E2−E0、b’は特定の電気活性干渉成分に依存する定数、
E1は第1の電位、
E2は第2の電位である。
E0の値(特定の干渉成分の標準電位)は、Δηの計算で消去されるため重要でない。式2、式2a、および式2bを組み合わせて変形し、下記の式を導出することができる。
Δη=E1−E2である。
式2cは、Δη(すなわち、第1の電位と第2の電位との差)と干渉成分依存性電圧影響因子Yとの間の関係を表す数学的関係を示している。本発明のある実施形態では、Yは、約1〜約100の範囲、より好ましくは約1〜約10の範囲とすることができる。本発明のある実施形態では、干渉成分依存性電圧影響因子Yは、特定の干渉成分または干渉成分の組合せに対して経験的に決定することができる。干渉成分の干渉成分依存性電圧影響因子Yは、通常はグルコースの電圧影響因子XGよりも大きいことに留意されたい。以降の段落で説明するように、(a)干渉成分電流I1と干渉成分過電圧電流I2と(b)グルコース電流A1Gとグルコース過電圧電流A2Gとの数学的関係により、グルコース測定における干渉成分の影響を低減するグルコースアルゴリズムを提案することが可能となる。
W1=A1G+I1 (式3)
但し、
W1は第1の動作電極における第1の電流である。
言い換えれば、第1の電流は、グルコース電流A1Gと干渉成分電流I1の合計を含む。より具体的には、干渉成分電流は、上記した直接干渉電流とすることができる。第2の動作電極において、第2の電流は、第2の電位で測定される電流、すなわち下記の式で表すことができる過電圧電流である。
W2=A2G+I2 (式4)
但し、
W2は、第2の動作電極における第2の電流、
A2Gは、第2の電位で測定されるグルコース過電圧電流、
I2は、第2の電位で測定される干渉成分過電圧電流である。
より具体的には、干渉成分過電圧電流は、上記した直接干渉成分電流とすることができる。4つの未知数(A1G、A2G、I1、およびI2)を含む上記した4つの式(式1〜式4)を用いて、干渉成分の影響のない補正されたグルコース電流の式を計算することが可能である。
W2=XGA1G+YI1 (式5)
次に、式3を、干渉成分の干渉成分依存性電圧影響因子Yで乗じて下記の式6を得ることができる。
YW1=YA1G+YI1 (式6)
式5から式6を減じて下記の式7を得ることができる。
W2−YW1=XGA1G−YA1G (式7)
ここで、式7を変形させて、下記の式8に示すように第1の電位で測定される補正されたグルコース電流A1Gを求めることができる。
でW1を平均することができる(
は、I2が低い場合式1および式4に従ったA1Gにほぼ等しいことに留意されたい)。サンプルにおける干渉成分のレベルが著しい可能性が高い一定の条件の場合にのみ式8を用いる方法により、測定されたグルコース電流を過度に補正するリスクが軽減される。W2がW1よりも著しく大きい(例えば、約100%以上)場合、これが干渉物の濃度が異常に高いことを示唆することに留意されたい。このような場合、干渉成分のレベルが極めて高いと式8の正確さが低下するため、グルコース値の代わりにエラーメッセージを出力するのが望ましいであろう。
(1)分析物の検出に用いるための改善された測定器において、
前記測定器を検査ストリップの第1の動作電極に接続するための第1のコネクタと、
前記測定器を前記検査ストリップの第2の動作電極に接続するための第2のコネクタと、
前記測定器を前記検査ストリップの基準電極に接続するための共通コネクタと、
前記第1のコネクタと前記共通コネクタとの間に接続された第1の電圧源と、
前記第2のコネクタと前記共通コネクタとの間に接続された第2の電圧源と、を含む、改善された測定器。
(2)実施態様(1)に記載の改善された測定器において、
前記検査ストリップが前記測定器内に導入され、サンプルが前記検査ストリップに導入されると、前記第1の電圧源および前記第2の電圧源がそれぞれ、前記第1のコネクタで第1の電位、前記第2のコネクタで第2の電位を生成し、前記第1の電圧および前記第2の電圧が同じ極性を有し、前記第2の電位が前記第1の電位よりも大きい、改善された測定器。
(3)実施態様(2)に記載の改善された測定器において、
前記検査ストリップが挿入され、サンプルが導入されてから一定時間が経過すると、前記測定器が、前記第1のコネクタにおける第1の電流値および前記第2のコネクタにおける第2の電流値を測定する、改善された測定器。
(4)実施態様(3)に記載の改善された測定器において、
前記測定器が、下記の式を用いて分析物電流の補正された値を計算する、改善された測定器。
A1は前記補正された分析物電流、
W1は前記所定の時間に測定される前記第1のコネクタにおける電流、
W2は前記所定の時間に前記第2のコネクタで測定される電流、
Xは分析物依存性電圧影響因子、
Yは干渉成分依存性電圧影響因子である。
Claims (4)
- 分析物の検出に用いるための改善された測定器において、
前記測定器を検査ストリップの第1の動作電極に接続するための第1のコネクタと、
前記測定器を前記検査ストリップの第2の動作電極に接続するための第2のコネクタと、
前記測定器を前記検査ストリップの基準電極に接続するための共通コネクタと、
前記第1のコネクタと前記共通コネクタとの間に接続された第1の電圧源と、
前記第2のコネクタと前記共通コネクタとの間に接続された第2の電圧源と、
を含む、改善された測定器。 - 請求項1に記載の改善された測定器において、
前記検査ストリップが前記測定器内に導入され、サンプルが前記検査ストリップに導入されると、前記第1の電圧源および前記第2の電圧源がそれぞれ、前記第1のコネクタで第1の電位、前記第2のコネクタで第2の電位を生成し、前記第1の電圧および前記第2の電圧が同じ極性を有し、前記第2の電位が前記第1の電位よりも大きい、改善された測定器。 - 請求項2に記載の改善された測定器において、
前記検査ストリップが挿入され、サンプルが導入されてから一定時間が経過すると、前記測定器が、前記第1のコネクタにおける第1の電流値および前記第2のコネクタにおける第2の電流値を測定する、改善された測定器。
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PCT/GB2004/004594 WO2005045415A1 (en) | 2003-10-31 | 2004-10-29 | A meter for use in an improved method of reducing interferences in an electrochemical sensor using two different applied potentials |
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JP2006537423A Active JP4611313B2 (ja) | 2003-10-31 | 2004-10-29 | 電気化学検査ストリップにおける直接的な干渉電流の影響を軽減する方法 |
JP2006537435A Pending JP2007514931A (ja) | 2003-10-31 | 2004-10-29 | 電気化学検査ストリップにおける直接干渉電流および間接干渉電流の影響を軽減する方法 |
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JP2006537429A Expired - Fee Related JP4694498B2 (ja) | 2003-10-31 | 2004-10-29 | 2つの異なる電位を印加して電気化学センサにおける干渉を軽減する方法 |
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