JP6306557B2 - サンプル中の検体濃度を測定するためのシステム及び方法 - Google Patents
サンプル中の検体濃度を測定するためのシステム及び方法 Download PDFInfo
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- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
- G01N27/3274—Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration
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Description
CS/血液識別試験1806には、第1の参照値及び第2の参照値を用いることができる。第1の参照値は、第1の時間区分t1の間の電流値に基づくものであり、第2の参照値は、第2の時間区分t2と第3の時間区分t3の両区分の間の電流値に基づくものである。一実施形態では、図6の試験電圧波形を用いる場合、第1の参照値は第1の過渡電流時間に得られた電流値の総和を取ることにより得ることができる。非制限例では、第1の参照値isumは、数式1により表される。
サンプルが血液であると同定されれば、試験電流値に対してステップ1810の血液グルコースアルゴリズムが実行される。数式4に示されるグルコースアルゴリズムを用いて、第1のグルコース濃度G1が算出される。
サンプルがCSと識別されれば、ステップ1824のCSグルコースアルゴリズムは、試験電流値を用いて実行することができる。CSに対するa、p及びzの値は、血液に対する値とは異なるが、CSに対する第1のグルコース濃度G1は上記数式7を用いて算出することができる。
内因性の干渉物に加えて、ある環境下での異常ヘマトクリットレベルは、グルコース測定の精度に影響を与える。それゆえに、サンプルが異常ヘマトクリットレベル(例えば約20%又は約60%)を有する場合でも正確である第2のグルコース濃度G2を与えるようにG1を修正して、ヘマトクリット補正1812を行なうことができる。
図8へ戻り、温度の低減効果でグルコース濃度の正確さの改善を図るために、血液温度補正1814を試験電流値に適用することができる。温度補正されたグルコース濃度を算出するための方法は、温度の値の測定と第2の補正値Corr2の算出とを含む。この第2の補正値Corr2は、温度の値と第1のグルコース濃度G1又は第2のグルコース濃度G2の何れかに基づくものであるが、G1及びG2は前述したように温度補正を含まない。従って、第2の補正値Corr2は、グルコース濃度G1又はG2を温度補正するために用いられる。
図15は、CS温度補正を適用する方法1826の一実施形態を描写するフローダイアグラムである。このCS温度補正は、Corr2を算出するための温度関数が異なる点を除き、血液温度補正に類似している。
試験を実行する場合のユーザーエラー、試験用計器エラー、及び試験片不良を含む多様なシステムエラーを同定するための様々な実施形態もまた提供される。システムは、部分充填又は二重充填されたサンプルチャンバを用いた試験を識別できるように構成される。また、このシステムは、試験の完全性を危うくするサンプルチャンバからの漏洩状態、及び/又はシステムのある部分(例えば、試験片)の損傷状態を同定可能に構成される。
十分量チェックを行なうための実施形態の一つとして、容量測定が用いられる。容量測定は、原理的に電極―溶液界面にイオン層が形成された結果生じるイオン二重層容量を測定するものである。この容量の大きさは、サンプルで覆われた電極の面積に比例する。一旦、容量の大きさが測定されると、その値が閾値よりも大きければ、その試験片は、正確な測定を行なうために十分な溶液容積を有するものであり、グルコース濃度が出力される。しかし、その値が閾値以下であれば、その試験片は、正確な測定を行なうために十分な溶液容積を有するものではなく、エラーメッセージが出力される。
二重投与は、ユーザーが不十分な血液量をサンプル反応チャンバに注ぎ、続いて、更にこのサンプル反応チャンバを満たすために血液を追加投与する場合に起こる。ユーザーの指先または不安定な指から搾り出された血液量は、二重投与事故を起こすことがある。今までに開示されたシステム及び方法は、このような二重投与事故を識別するように構成することができる。例えば、図22は、試験過渡電流を表し、この過渡期間には、第2の検査時間区分t2の間にユーザーが二重投与を行いスパイクが観測される(実線を参照)。二重投与事故が無い場合には、試験過渡電流はピークを持たない(図22の破線を参照)。
図12のステップ1012a、1012bおよび1012cに述べられているように、最大電流チェックは、試験用計器エラーあるいは試験片欠陥を特定するために用いることができる。試験用計器エラーの例は、血液が、投与されてから遅い時点で検出される場合に見られる。欠陥試験片の例は、第1と第2の電極とがショートした場合に見られる。図23は、試験過渡電流を表し、試験用計器は試験片中への血液投与の直後を検出していない(実線参照)。このようなシナリオにおいて、遅延開始は、第2の試験電圧V2が印加される前に相当量のフェロシアニドを生成し相対的に大きな試験電流が観測される。対照的に、血液が注がれたときに試験用計器が試験電圧波形を適切に開始させると、図23に破線で示されているように、第2の時間区分に対する試験電流値はより少なくなる。
図18のステップ1014bおよび1014cで述べられているように、最小電流チェックは、グルコース試験の誤スタート、試験用計器による不適切な時間シフトおよび早期試験片除去を特定するために用いることができる。誤スタートは、試験片にサンプルが未注入の状態で試験用計器がグルコース試験を開始する場合に起きる。試験用計器に何らかの事情で検査を開始させる状況の例は、静電気放電(ESD)または第1と第2の電極間の一時的なショートである。このような状況では、試験片に液体サンプルが注がれていなくても試験を開始させる相対的に大きな電流が、少なくともショートの瞬間に合わせて観測される。
図18のステップ1022cに記述されているように、不正確なグルコース測定値を齎す高抵抗トラックが試験片上に検出されることがある。高抵抗トラックは、絶縁性スクラッチを持つ試験片上または汚染された電極面に現れる。スパッタ金膜またはスパッタパラジウム膜で電極層が作成された場所では、スクラッチは、試験片の取り扱い中および製造中に容易に生じうる。例えば、第1の電極層66上の一方の外側縁56から他の外側縁58にわたるスクラッチは、第1のコンタクトパッド67と第1の電極166との間の抵抗を増大させる。スパッタ金属膜は、普通非常に薄く(例えば10から50nm)、試験片の取り扱い中および製造中に傷つきやすい。更に、スパッタ金属膜は、例えば炭化水素のような揮発性化合物に晒されて汚染される。この露出により、電極面上に抵抗を増大させる絶縁物膜が形成される。高抵抗トラックを形成する他の考えうる状況は、スパッタ金属膜が薄すぎる場合(例えば<<10nm)である。高抵抗トラックを生じさせるさらに別の状況は、試験用計器のコネクターが試験片コンタクトパッドと十分な導電性接続を形成しない場合である。例えば、試験用計器のコネクター上に存在する乾燥血液は、試験片接続パッドへの十分な導電性接続を妨げる。
図18のステップ1024cに既に述べられているように、スペーサ60が第1の電極層66と十分な強度の液体不浸透性シールを形成することができない場合、試験片上に漏洩が検出される。漏洩は、液体がスペーサ60と第1の電極166との間、および/または第2の電極164との間に漏れた場合に現れる。図4Bは、スペーサ60の壁に直接に隣接している試薬層72を表していることに注意されたい。しかしながら、漏洩がさらに生じやすい他の実施形態(示されていない)においては、試薬層72は、試薬層72の一部をスペーサ60と第1の電極層66との間に生じさせるカットアウト層68よりも大きな面積を有する。ある環境下では、試薬層72の一部をスペーサ60と第1の電極層66との間に配置することは、液体不浸透性シールの形成を阻害する。その結果、第1の電極166上の何れかに実質的にさらに大きな面積を作る漏洩が生じ、順次、これが不正確なグルコースの測定結果を引き起こす。第1の電極166と第2の電極164の間の面積の非対称性は、図26に図解するように試験過渡電流を歪め、そこでは第3の時間区分t3の間に余分な盛り上がりが現れる。
Claims (9)
- 試験片がサンプルで十分に満たされているか否かを判定する方法であって、
前記試験片の第1の電極と第2の電極との間に第1の試験電圧を印加するステップと、
前記試験片の第1の電極と第2の電極との間に第2の試験電圧を印加するステップであって、前記第2の試験電圧は、一定のDC電圧成分及び重畳されたAC電圧成分を有し、前記AC電圧成分は、前記第2の試験電圧が印加された後の所定時間に印加され、前記DC電圧成分は、前記第2の試験電圧の印加の開始時に印加され、前記第2の電極は、試薬層を有さない、ステップと、
前記AC電圧成分による試験電流に基づいて、前記第1の電極と第2の電極との間の電気容量値を算出するステップと、を含み、
前記電気容量値を算出するステップは、前記AC電圧成分がゼロとなるゼロ電圧交差点前の約四分の一波長から前記ゼロ電圧交差点後の約四分の一波長まで前記試験電流を加算するステップを含み、
前記電気容量値を算出するステップは、前記第1の試験電圧の印加開始から1.3秒から1.4秒の間の前記試験電流を用いて行われる、方法。 - 前記第2の試験電圧の大きさは、前記第2の電極で還元された媒介物質を酸化させるために十分である請求項1に記載の方法。
- 前記DC電圧成分は、前記第2の電極に対して約−0.3Vである請求項1に記載の方法。
- 前記AC電圧成分は、周波数が約109Hz、振幅が約+/−50mVの正弦波である請求項1に記載の方法。
- 前記試薬層は、前記第1の電極上である請求項1に記載の方法。
- 前記試薬層は、媒介物質と酵素とを含み、前記試薬層は、検体の存在下で、前記酵素の反応により、還元された媒介物質を生成するように構成される請求項1に記載の方法。
- 前記酵素は、サンプルが前記試験片に導入されたときに、実質的に前記第1の電極から前記第2の電極に拡散しない物質で構成される請求項6に記載の方法。
- 前記第1の電極と前記第2の電極とは、対向面構成である請求項1に記載の方法。
- 前記電気容量値が予め定められた閾値を超える場合には、前記試験片が前記サンプルで十分に充填されていると判定し、前記電気容量値が予め定められた閾値未満の場合には、前記試験片が前記サンプルで十分に充填されていないと判定するステップを更に含む請求項1に記載の方法。
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ES2647238T3 (es) | 2017-12-20 |
HK1172692A1 (en) | 2013-04-26 |
EP2138841A2 (en) | 2009-12-30 |
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AU2011201224B2 (en) | 2012-04-12 |
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AU2011201224A1 (en) | 2011-04-07 |
JP2014142363A (ja) | 2014-08-07 |
US20090301899A1 (en) | 2009-12-10 |
AU2009202200B2 (en) | 2011-01-06 |
JP2013040972A (ja) | 2013-02-28 |
JP5237201B2 (ja) | 2013-07-17 |
US8551320B2 (en) | 2013-10-08 |
JP5806195B2 (ja) | 2015-11-10 |
CA2668237C (en) | 2017-02-28 |
AU2009202200A1 (en) | 2009-12-24 |
EP2138841B8 (en) | 2017-12-13 |
EP2482069A1 (en) | 2012-08-01 |
JP5934284B2 (ja) | 2016-06-15 |
EP2138841A3 (en) | 2011-10-12 |
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EP2138841B1 (en) | 2017-10-18 |
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