JP2021509709A - 病状をモニターするためにペプチド濃度を測定する生体医療用測定装置、システム、及び方法 - Google Patents
病状をモニターするためにペプチド濃度を測定する生体医療用測定装置、システム、及び方法 Download PDFInfo
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Abstract
Description
実施態様は、主にうっ血性心不全等の、使用者の病状をモニタリングするためのイムノアッセイに関し、より具体的には、試験片及びモバイル装置と接続された、携帯可能な光電子読み取り装置を使用して、血液サンプル中のN末端プロB型ナトリウム利尿ペプチドのレベルを測定する方法並びにシステムに関する。
イムノアッセイは、抗原又は抗体としてのそれらの特性を利用して、特定のタンパク質やその他の物質を検出又は測定するための手順である。近年のイムノアッセイの開発には、臨床現場検査(point-of-care test)が含まれ、それは光電子装置又はその付属品を使用し、限定するものではないが、例えば蛍光イムノクロマトグラフィーアッセイ等のイムノアッセイが、スマートフォン、ラップトップ、タブレット、ブレスレット、スマートウォッチ、若しくはその他の携帯可能な装置等のモバイル機器と組み合わせて実施され、光電子装置から収集されたデータは処理されて、使用者の病状がモニターされる。
本発明の実施態様は、病状をモニターするために、血液、血漿、血清、唾液、汗、尿等の担体、若しくは他の適切な担体中の、タンパク質又はペプチド(オリゴ若しくはポリ)又はその他のマーカー、又は被検物質の、濃度を検出するシステム並びに方法に関し、当該システムは、例えば、(i)光電子読み取りのために該マーカーを単離するように特別に構成された試験片、(ii)光電子読み取り装置、(iii)信号を分析する方法、及び任意で(iv)試験片ホルダ、を含む。効率を上げるため、本明細書に記載される実施態様は、心不全等の心臓の病状をモニタリングするために血液、血清又は血漿中のNT-proBNPの濃度を検出するためのシステム及び方法に特化している。しかし、当業者であれば、当該システム及び方法は、心不全以外の病状をモニタリングするために、別のタンパク質、又は疾患マーカーの濃度を検出する構成とすることを認識するだろう。
下記様々な実施態様の詳細な説明を付属図面と組み合わせて考慮することにより、本明細書の主題は更に完全に理解できるものとなる。
下記実施態様は、網羅的であることを意図しておらず、本発明を下記詳細な説明に開示される厳密な形態に限定することを意図するものではない。むしろ、これら実施態様は、当業者が開示全体を認識して真価を認めるために、選択されて記載されている。
ニトロセルロースの鋭敏化方法の一つは、下記ステップを含む。モノクローナル抗体を、裏打ちされた又は裏打ちされないニトロセルロース膜上に、ドットや線を付する装置を使用して配置する。一の実施態様では、ニトロセルロース膜は、毛細管吸い上げ速度が110〜165s/40mmの裏打ちされない材料である。印刷用15F11濃度は、0.5mg/mL〜3mg/mLの間である。抗体の合計量は、0.2μg抗体/cmニトロセルロース〜5μg抗体/cmニトロセルロースの間である。一の実施態様では、印刷のためのバッファは、20mMトリス(Tris)pH8.0であるが、他のpH範囲(例えば、pH6〜pH9)を有する他のバッファも使用できる。
Claims (15)
- 血液、血清又は血漿サンプル中のNT-proBNP濃度を測定する方法であって:
固相へ結合したモノクローナル抗体15F11 (アミノ酸残基13〜24)、及び、蛍光マイクロ粒子へコンジュゲートされたモノクローナル抗体24E11 (アミノ酸残基67〜76)若しくは16E6 (アミノ酸残基34〜39)を有する、ラテラルフローイムノアッセイ試験片を用意する工程;並びに、
モバイル装置へ動作可能に接続している光電子読み取り装置を使用する工程であって:
サンプルへ曝露した後の試験片から一の蛍光信号の測定値を取得し;
経時的に複数の測定値を組み合わせて、血液、血清若しくは血漿中のNT-proBNP濃度の推定値を提供する、前記工程、を含む前記方法。 - 前記ラテラルフローイムノアッセイ試験片を用意する工程は;
前記蛍光マイクロ粒子がユウロピウムキレートを有するポリスチレンビーズである該試験片を用意することを含み、
好ましくは該ポリスチレンビーズは該モノクローナル抗体24E1へ共有的に結合しており、
該試験片を用意する工程には、該試験片上にユウロピウムキレートの基準線を印刷することが含まれ;かつ、
前記測定値を取得することは、検査信号を発生させることを含み、それはサンプルが添加される前にNT-proBNPの濃度の推定値を提供するために使用される基準線アッセイを行うことも含む、請求項1記載の方法。 - 請求項1記載の方法であって、
前記試験片を用意する工程では、蛍光信号のために、異なる励起波長若しくは発光波長を有する2種の蛍光標識、又は異なる吸収波長を有する2種の着色ビーズが使用され、
検査領域及びコントロール線は、それぞれが展開するに従って同時に読み取られ、複数の時点で測定された検査信号を使用して、前記推定値が動的に区別され、
異なる時点を利用して、サンプル中の異なる濃度レベルの推定値が提供され、好ましくは初期時点で検査読み取り値が生成し、かつ初期時点後の検査信号発生時間中に複数の所定間隔でも生成し、好ましくは、該検査信号の動的挙動は、フック効果のために、他の方法では終点測定値のみによる見分けが困難なサンプル間の差異を区別するために使用できる、前記方法。 - 試験片ホルダが、前記基準線と前記光電子読み取り装置との位置合わせに使用され、かつ前記試験片へサンプルを導入可能にする、請求項2記載の方法。
- 前記光電子読み取り装置は、350〜400nmの発光ピークを有する発光ダイオードを使用して前記試験片を照射して、検査信号が取得される、請求項1記載の方法。
- 前記試験片は、検査信号が測定される試験片の面とは反対側の試験片の面に、前記サンプルが添加されるように構成される、請求項1記載の方法。
- 前記試験片用の裏打ち材は、350〜400nmでの透過率が80%を超える黒色不透明プラスチック又は透明プラスチック材料の一種である、請求項1記載の方法。
- 前記光電子読み取り装置は、オーディオジャック又は無線接続の一種を介してモバイル装置へ接続される、請求項1記載の方法。
- 前記サンプルが前記試験片へ添加され、次に洗浄用バッファが該試験片へ添加されてバックグラウンド信号が減少する、好ましくは該サンプルは希釈剤へ添加され、混合され、次に該試験片へ添加される、請求項1記載の方法。
- 光電子読み取り装置付属品をモバイル装置と共に使用して試験片を分析する、全血、血清又は血漿中の被検物質NT-proBNPを検査するためのシステムであって、該モバイル装置は中央処理ユニットを含み、該システムは:
試験片であって、
血液細胞を保持する一方、流体は該試験片上の受動的吸収部を通過するように構成されたサンプルパッド、
該試験片上に吸収された流体と接触すると蛍光標識された抗体を放出するように構成されたコンジュゲートパッド、及び
NT-proBNPを選択的に捕獲するように構成され、検査線で鋭敏化されている膜であって、該試験片上の該コンジュゲートパッドと流体接触している膜、を含む、前記試験片;並びに、
該モバイル装置と接続するように構成された光電子読み取り装置付属品であって、
光が画定された視軸で該光電子読み取り装置へ入光して通過し出光することを可能とするように構成された開口部が画定されている構造、
該試験片を動作可能に挿入するためにスロットを画定する構造であって、該スロットは、該画定された視軸と交差するように該試験片を方向付けるように構成されている、前記構造、
光電子読み取り装置内の回路上の電子部品を制御し、該モバイル装置の中央処理ユニットと動作可能に通信するように構成されたマイクロコントローラ、
300〜400nmの波長で光を放射するように構成された少なくとも1つの光源、
少なくとも一の光源からの光が該試験片の検査領域の表面へ導かれるように構成された反射面、
検査時間中に試験片からの複数の光信号を検出するように構成された光学システム、及び、
該光電子読み取り装置内に設置され、該マイクロコントローラ、少なくとも一の光源、及び該光学システムと動作可能に接続されている電源、を含む、前記付属品を含み、
該付属品が該光学システムからの光信号を表す信号を該モバイル装置の該中央処理ユニットへ通信し、該信号が分析されて、検査時間中に得られた光信号を表す信号に基づき、血液、血清又は血漿中のNT-proBNPの濃度の推定値が提供されるように構成されている、
前記システム。 - 基準蛍光材料が前記試験片の検査線上に共配置され、好ましくは該基準蛍光材料はユウロピウムキレートを含む、請求項10記載のシステム。
- 前記試験片は、前記光電子読み取り装置付属品に適合するカセット内に収容される、請求項10記載のシステム。
- 更に、検査範囲外の状態を検出するように構成された、前記光電子読み取り装置内の回路を含み、好ましくは該回路は低バッテリ検出回路及び温度範囲外回路の内の一つである、請求項10記載のシステム。
- 前記試験片は、更に、該試験片全体に吸収流れを提供するように構成されたエンドパッドを含み、該エンドパッドは、該試験片上の前記膜と流体接続している、請求項10記載のシステム。
- 流体中の被検物質濃度の測定法であり:
蛍光的又は視覚的に標識化されたマーカーを放出するように構成されたラテラルフローイムノアッセイ試験片を提供する工程;
該試験片から得られた信号を分析するために、モバイル装置と接続可能な、光電子読み取り装置を提供する工程;
該ラテラルフローイムノアッセイ試験片と、該光電子読み取り装置及び該モバイル装置とを組み合わせて使用するための指示書を提供する工程であって、該指示書は:
流体のサンプルを、該試験片上へ置くステップ、
該サンプルへの曝露後の試験片からの蛍光信号の測定値を得る分析のために、該試験片を該光電子読み取り装置内へ挿入するステップ、
及び、
該試験片の経時的な測定に基づいて、該サンプル中の被検物質濃度の推定値を得るために、該モバイル装置を使用するステップを含む、前記工程、を含む、前記方法。
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US20190187154A1 (en) | 2019-06-20 |
WO2019118971A1 (en) | 2019-06-20 |
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