JP2012194196A - サンプル中の分析物の濃度を決定するためのシステム、デバイス、及び方法 - Google Patents
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Abstract
【課題解決手段】作用電極及び対電極を有するサンプル分析デバイスにサンプルを供給する際、電極間に電位を印加した後の初期電流を求めることにより、サンプルのデバイスへの初期充填速度を決定する。次いで、求められた初期充填速度を考慮して、分析物の濃度を計算して決定することができる。
【選択図】図2
Description
測定する電流量に基づき初期充填速度を測定するための電気化学システムの使用を、以下の実施例によって示す。以下の実施例において、システムは、サンプル分析デバイス、特に、図2の免疫センサ110、電位を印加するように構成された計器、及び初期充填速度を決定するように構成された制御ユニットを含んだ。特に、電位を、免疫センサ110の電極に印加し、ヘマトクリットのレベルを決定し、次いで、電位を逆転させた。分析物の濃度を、決定されたヘマトクリットのレベルを考慮して、その後決定した。ヘマトクリットのレベルを、計算された初期充填速度を考慮して、決定した。
測定する電流量に基づき初期充填速度を測定するための電気化学システムの使用を、別の実施例によって更に示した。本実施例に使用したサンプル分析デバイスもまた、図2の免疫センサ110、電位を印加するように構成された計器、及び初期充填速度を決定するように構成された制御ユニットであった。特に、電位を、免疫センサ110の電極に印加し、ヘマトクリットのレベルを決定し、次いで、電位を逆転させた。分析物の濃度を、決定されたヘマトクリットのレベルを考慮して、その後決定した。前述の実施例と同様に、異なるヘマトクリットレベルを有する多くのサンプルを、システムの能力を実証するために、システムと共に使用した。ヘマトクリット濃度の既知のレベルは、約33.5%、約41%、約47.5%、及び約56.5%であった。
Claims (21)
- サンプル中の分析物の濃度を決定するための方法において、
分析物を含むサンプルを、作用電極及び対電極を有するサンプル分析デバイスに提供する工程と、
前記作用電極と前記対電極との間に電位を印加する工程と、
前記サンプルの初期充填速度を決定する工程と、
前記初期充填速度を考慮して、前記分析物の濃度を計算する工程と、
を含む、方法。 - 初期充填速度を決定する工程が、
前記電位を印加した後の初期電流を測定する工程と、
前記サンプル中のヘマトクリットのレベルを決定する工程と、
前記作用電極と前記対電極との間の前記電位を逆転させる工程と、
を更に含む、請求項1に記載の方法。 - 前記分析物の前記濃度を計算する工程が、前記決定されたヘマトクリットのレベルに基づき、前記濃度を算定する工程を更に含む、請求項2に記載の方法。
- 前記電位を逆転させる工程後、一定期間にわたって、電流の変化を測定する工程を更に含み、前記分析物の濃度を計算する工程は、前記一定期間の電流における前記変化を考慮して、前記分析物の前記濃度を計算する工程を更に含む、請求項3に記載の方法。
- 前記サンプルが、全血を含み、前記方法が、前記全血の温度を測定する工程、又は前記全血の温度を推測する工程のうちの少なくとも1つを更に含む、請求項3に記載の方法。
- 初期充填速度を決定する工程が、前記初期充填速度を計算するために、光信号における変化率を決定する工程を更に含む、請求項1に記載の方法。
- 初期充填速度を決定する工程が、前記初期充填速度を決定するために、初期電流量を決定する工程を更に含む、請求項1に記載の方法。
- 初期電流量を決定する工程が、
約10ミリ秒毎に少なくとも約50ミリ秒間電流測定を実施する工程と、
前記電流測定値に基づき平均電流を計算する工程と、
を更に含む、請求項7に記載の方法。 - 初期充填速度を決定する工程が、前記サンプルが、前記サンプル分析デバイスの毛管空隙に進入した直後の初期充填速度を決定する工程を更に含む、請求項1に記載の方法。
- 初期充填速度を決定する工程が、前記サンプルが、検出信号が生成される前記サンプル分析装置の毛管空隙の領域内に横断した後の初期充填速度を決定する工程を更に含む、請求項1に記載の方法。
- 前記サンプル分析デバイスが、免疫センサを含む、請求項1に記載の方法。
- 前記電位を逆転させる工程後、一定期間にわたって、電流の変化を測定する工程を更に含み、前記分析物の濃度を計算する工程は、前記一定期間の電流における前記変化を考慮して、前記分析物の前記濃度を計算する工程を更に含む、請求項5に記載の方法。
- 下部電極及び上部電極を有する免疫センサと、
前記免疫センサの前記下部電極と前記上部電極との間に電位を印加するように構成された計器と、
前記計器に接続された制御ユニットであって、前記制御ユニットは、前記免疫センサ内に導入されたサンプルの初期充填速度を測定し、前記初期充填速度を使用して、前記サンプルが血液であるときの前記サンプルのヘマトクリット値、及び前記サンプル中の分析物の濃度のうちの少なくとも1つを計算するような、制御ユニットと、
を含む、電気化学システム。 - 前記免疫センサの少なくとも一部分を加熱するように構成された加熱要素を更に含む、請求項13に記載の電気化学システム。
- 前記免疫センサが、
緩衝液中の酵素と抱合した抗体を含む第1の液体試薬であって、前記下部電極上に縞模様に付けられ、乾燥された、第1の液体試薬と、
フェリシアン化物と、前記酵素のための基質と、希酸溶液中のメディエータとを含む第2の液体試薬であって、前記下部電極上に縞模様に付けられ、乾燥された、第2の液体試薬と、
抗原と抱合した磁気ビーズであって、前記上部電極上に縞模様に付けられ、その上で乾燥された、磁気ビーズと、
前記下部電極と上部電極との間に配設されたセパレータと、
前記セパレータ内に形成された反応チャンバーであって、前記第1の試薬、及び前記抗原と抱合した前記磁気ビーズがその中に配設された、反応チャンバーと、
前記セパレータ内に形成された検出チャンバーであって、前記第2の試薬がその中に配設された検出チャンバーと、
前記セパレータ、並びに前記下部電極及び上部電極の一方に少なくとも部分的に形成され、前記検出チャンバーからある距離だけ離間され、前記反応チャンバーの少なくとも一部分に重なり合う充填チャンバーと、
前記セパレータ、前記下部電極、及び前記上部電極の各々に少なくとも部分的に形成され、前記反応チャンバーからある距離だけ離間され、前記検出チャンバーの少なくとも一部分に重なり合う通気孔と、
前記下部電極及び上部電極のうちの一方に取り付けられ、前記通気孔の上に配設され、前記充填チャンバーの壁を形成すると共に前記通気孔を封止するように構成された、組み込まれた抗凝固剤を有する第1の封止用構成要素と、
前記下部電極及び上部電極のうちのもう一方に取り付けられ、前記通気孔の上に配設され、前記通気孔を封止するように構成された、第2の封止用構成要素と、
を更に含む、請求項13に記載の電気化学システム。 - 前記第1の封止用構成要素が、親水性接着テープを含む、請求項15に記載の電気化学システム。
- 前記制御ユニットが、前記サンプルの前記初期充填速度を測定するために、光信号における変化率を測定するように構成された光信号検出器を更に含む、請求項15に記載の電気化学システム。
- 前記制御ユニットが、前記初期充填速度を測定するために、初期電流量を測定するように構成された電流量検出器を更に含む、請求項15に記載の電気化学システム。
- 前記制御ユニットが、前記サンプルが、前記免疫センサの毛管空隙に進入した直後の前記サンプルの前記初期充填速度を測定するための構成を含む、請求項15に記載の電気化学システム。
- 前記制御ユニットが、前記サンプルが、検出信号が生成される前記免疫センサの毛管空隙の領域内に横断した後の前記サンプルの初期充填速度を測定するための構成を含む、請求項15に記載の電気化学システム。
- 前記免疫センサ、前記計器、及び前記制御ユニットのうちの少なくとも1つが、前記サンプルの温度を測定する機能、又は前記サンプルの温度を推測する機能のうちの少なくとも1つを実施するように構成される、請求項15に記載の電気化学システム。
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IL209228A0 (en) | 2011-02-28 |
CA2723353A1 (en) | 2011-06-30 |
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EP2341342A2 (en) | 2011-07-06 |
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KR101293940B1 (ko) | 2013-08-08 |
SG172562A1 (en) | 2011-07-28 |
ES2901892T3 (es) | 2022-03-24 |
AU2010257395A1 (en) | 2011-07-14 |
US9927388B2 (en) | 2018-03-27 |
US8877034B2 (en) | 2014-11-04 |
CN102116753A (zh) | 2011-07-06 |
CN102116753B (zh) | 2016-05-18 |
EP2341342A3 (en) | 2015-04-01 |
JP5788857B2 (ja) | 2015-10-07 |
JP2011137816A (ja) | 2011-07-14 |
US20110155584A1 (en) | 2011-06-30 |
CA2723353C (en) | 2017-10-17 |
JP5596752B2 (ja) | 2014-09-24 |
CA3062504A1 (en) | 2011-06-30 |
CA2977537A1 (en) | 2011-06-30 |
KR101316559B1 (ko) | 2013-10-15 |
EP2341342B1 (en) | 2021-10-20 |
JP2013050466A (ja) | 2013-03-14 |
US20150027907A1 (en) | 2015-01-29 |
TW201122471A (en) | 2011-07-01 |
BRPI1005655A2 (pt) | 2012-03-06 |
KR20120107440A (ko) | 2012-10-02 |
TWI540318B (zh) | 2016-07-01 |
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