JP2015158506A - ポイントオブケア流体システムおよびその使用 - Google Patents
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- JP2015158506A JP2015158506A JP2015089977A JP2015089977A JP2015158506A JP 2015158506 A JP2015158506 A JP 2015158506A JP 2015089977 A JP2015089977 A JP 2015089977A JP 2015089977 A JP2015089977 A JP 2015089977A JP 2015158506 A JP2015158506 A JP 2015158506A
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Abstract
Description
本出願は、2005年5月9日に出願された米国仮特許出願第60/678,801号、2005年8月5日に出願された米国仮特許出願第60/705,489号、2005年9月16日に出願された米国仮特許出願第60/717,192号、および2005年9月28日に出願された米国仮特許出願第60/721,097号の利益を請求しており、それらはすべてその全体が本明細書中に参考として援用される。
本発明は医療デバイスの分野である。特に、本発明は、生体液からの検体を実時間で検出することが可能である携帯用医療デバイスを提供する。方法およびデバイスは、様々な医学的応用のためのポイントオブケア(point−of−care)検査を行うのに特に有用である。
膨大な数の疾病バイオマーカーの発見および微小マイクロ流体システムの設置は、新しい手段を開拓し、ポイントオブケア設定において疾病の予見、診断および治療のための方法およびシステムを考案してきた。ポイントオブケア検査は、結果を速やかに医療実務者に伝え、診察を早くすることができるので特に望ましい。初期診断により医療実務者は治療をより早く開始することができ、それにより付き添いの患者の状態の退歩を回避することができる。ポイントオブケア分析の実例には、グルコース検査、薬物の不正使用、血清コレステロール、妊娠、および排卵が含まれる。しかしながら、これらならびに現在使用できる他のポイントオブケア方法およびシステムは、サンプル採取、検査、分析および必要なときに医療実務者または保健提供者へ結果を伝達するための統合的解決法を提供しない。従って、オンラインの医療診察または意思決定と同様に、便利で迅速なデータ収集、伝送、分析を提供する携帯用多重パラメーター測定機器の注目に値する必要性が残る。
本発明の一側面は、患者と医療実務者との間の実時間データ伝送を提供し、歩行用の設定において高処理能力ポイントオブケア検査を容易にすることができるシステムの設計である。本明細書に提供している前記システムおよび方法は、実験室の備品または設備を使用することなく、被験体(例えば、患者)から収集されたサンプルを処理および分析する、骨の折れる、また費用のかかる手順を簡略化する。前記システムおよび方法は、診断、予後診断、治療、および治療法の開発を開始するために、体液の小さなサンプルから検体を検出するのに特に有用である。
本発明はまた、以下の項目を提供する。
(項目1)
被験体からの体液中の検体を検出するためのシステムであって、
a)流体デバイスであって、サンプル収集ユニットおよびアッセイアセンブリを備え、該サンプル収集ユニットは、体液のサンプルを、外部デバイスから伝送されるプロトコルに基づき該アッセイアセンブリ内に含有されている反応物質と反応させ、該検体の存在を示す検出可能な信号を発生する、流体デバイスと、
b)該検出可能な信号を検出するための検出アセンブリを備える読取機アセンブリと、
c)該検出信号を該外部デバイスへ伝送するための通信アセンブリと、
を備える、システム。
(項目2)
上記プロトコルは外部デバイスから無線で伝送される、項目1に記載のシステム。
(項目3)
上記流体デバイスは、上記プロトコルの上記伝送の誘因となるよう適合する該流体デバイスの同一性を与える識別子をさらに備える、項目1に記載のシステム。
(項目4)
上記プロトコルは、識別子検出器によって認識可能な上記流体デバイスの上記同一性に依存して変化する、項目1に記載のシステム。
(項目5)
上記体液のサンプルは約500μl未満である、項目1に記載のシステム。
(項目6)
被験体からの体液中の検体を検出するためのシステムであって、
a)流体デバイスであって、サンプル収集ユニットおよびアッセイアセンブリを備え、該サンプル収集ユニットは、500μl未満の体液のサンプルを該アッセイアセンブリ内に含有されている反応物質と反応させ、該体液のサンプル中の収集された該検体の存在を示す検出可能な信号を発生する、流体デバイスと、
b)該検出可能な信号を検出するための検出アセンブリを備える読取機アセンブリと、
c)該検出信号を外部デバイスへ伝送するための通信アセンブリと、
を備える、システム。
(項目7)
上記反応物質は免疫アッセイ試薬を含む、項目1または6に記載のシステム。
(項目8)
上記免疫アッセイ試薬は、細菌、ウイルス、真菌、および原虫から成る群から選択される微生物を検出する、項目7に記載のシステム。
(項目9)
上記免疫アッセイ試薬は、ポリペプチド糖タンパク質、多糖類、脂質、核酸、およびそれらの組み合わせを検出する、項目7に記載のシステム。
(項目10)
上記免疫アッセイ試薬は、薬物、薬物代謝産物、疾病を示すバイオマーカー、組織特異的マーカー、および細胞または細胞型に対して特異的なバイオマーカーから成る群から選択される要素を検出する、項目7に記載のシステム。
(項目11)
上記流体デバイスは複数の検体を検出し、かつ該流体デバイスは、該複数の検体のために免疫アッセイ試薬を備える、項目1または6に記載のシステム。
(項目12)
上記複数の検体は、3桁の範囲にわたり検出可能な明確な信号によって識別される、項目11に記載のシステム。
(項目13)
上記検出可能な信号は発光信号である、項目7に記載のシステム。
(項目14)
上記流体デバイスは、上記体液のサンプルを採取するための極微針をさらに備える、項目1または6に記載のシステム。
(項目15)
被験体の体液中の検体を検出するための方法であって、
a)項目1または6に記載のシステムを提供するステップと、
b)体液のサンプルを上記アッセイアセンブリ内に含有されている上記反応物質と反応させ、該検体の存在を示す検出可能な信号を発生するステップと、
c)該検出可能な信号を検出するステップと、
を含む、方法。
(項目16)
上記体液中に存在している上記検体の量を定量化するステップをさらに含む、項目15に記載の方法。
(項目17)
上記生体液中に存在している上記検体の上記量を上記検体の所定の量と比較するステップをさらに含む、項目16に記載の方法。
(項目18)
上記体液中に存在している上記検体の上記量が、統計的に上記所定の量と異なる場合は、医療行為を起こすステップをさらに含む、項目15に記載の方法。
(項目19)
上記医療行為は、上記被験体のための処方薬を変える必要があることを薬局に通知するステップを含む、項目18に記載の方法。
(項目20)
上記通知は電子的に伝送される、項目19に記載の方法。
(項目21)
上記通知は無線で伝送される、項目19に記載の方法。
(項目22)
上記医療行為は、被験体の治療薬の用量を変えるステップを含む、項目18に記載の方法。
(項目23)
被験体からの体液中の検体を検出する方法であって、
a)少なくとも1つのサンプル収集ユニット、免疫アッセイ試薬を含有している免疫アッセイアセンブリ、該サンプル収集ユニットおよび/または該免疫アッセイアセンブリと流体連通している複数のチャネルを備える流体デバイスを提供するステップと、
b)該流体デバイスを作動させ、該流体デバイス内の該免疫アッセイ試薬を方向づけるステップと、
c)約500μl未満の体液のサンプルを該アッセイ免疫アッセイアセンブリ内に含有されている該免疫アッセイ試薬と反応させ、該サンプル中の該検体の存在を示す検出可能な信号を発生するステップと、
d)該体液のサンプル中の収集された該検体から生成される該検出可能な信号を検出するステップと、
を含む、方法。
(項目24)
上記方向づけるステップは、毛管作用、真空吸引、引っ張り、およびそれらの組み合わせから成る群から選択される機構によって達成される、項目23に記載の方法。
(項目25)
上記流体デバイスは複数の検体を検出し、かつ該流体デバイスは該複数の検体のために免疫アッセイ試薬を備える、項目23に記載の方法。
(項目26)
上記体液のサンプルおよび上記免疫アッセイ試薬は、上記検出するステップの後も上記流体デバイスにとどまる、項目23に記載の方法。
(項目27)
上記免疫アッセイは薬物動態パラメーターを示す、項目23に記載の方法。
(項目28)
上記免疫アッセイは薬力学的パラメーターを示す、項目23に記載の方法。
(項目29)
上記流体デバイスは、上記信号に関するデータを無線伝送器経由で伝達する、項目23に記載の方法。
(項目30)
無線デバイスは、上記流体デバイスで実施される免疫アッセイプロトコルを転送する、項目23に記載の方法。
(項目31)
上記免疫アッセイプロトコルは、上記流体デバイスの同一性に依存して変化する、項目23に記載の方法。
(項目32)
上記流体デバイスは識別され、そして該流体デバイスの有効期限が登録される、項目23に記載の方法。
(項目33)
上記免疫アッセイは、疾病マーカー、薬物代謝産物および病原体についてのアッセイである、項目23に記載の方法。
(項目34)
上記検出可能な信号は化学発光信号である、項目23に記載の方法。
(項目35)
上記免疫アッセイ試薬は、アルカリホスファターゼまたは西洋ワサビペルオキシダーゼを含む、項目23に記載の方法。
(項目36)
上記検出可能な信号を上記検出するステップのためにCCDを使用する、項目23に記載の方法。
(項目37)
上記流体デバイスは、少なくとも1つのごみ処理機をさらに備える、項目23に記載の方法。
(項目38)
増幅器と接続されたピンダイオードが、上記検出可能な信号を検出するために使用される、項目23に記載の方法。
(項目39)
上記免疫アッセイアセンブリが、複数の免疫アッセイを備える、項目23に記載の方法。
(項目40)
上記流体デバイスは、上記体液のサンプルを採取するために極微針をさらに備える、項目23に記載の方法。
(項目41)
治療薬の有効性および/または毒性を評価するために有用な2つ以上の薬理学的パラメーターを測定するためのシステムであって、
a)カートリッジを備える流体デバイスであって、該カートリッジは少なくとも1つのサンプル収集ユニットおよびアセンブリを備え、該サンプル収集ユニットは、指標となる複数の検体または該2つ以上の薬理学的パラメーターを備える体液のサンプルを、該アッセイアセンブリ内に含有されている反応物質と反応させ、該反応は、該体液のサンプルから該2つ以上の薬理学的パラメーターの値を示す検出可能な信号を発生する、流体デバイスと、
b)該検出可能な信号を検出するための検出アセンブリを備える読取機アセンブリと、
c)該検出信号を外部デバイスへ伝送するための通信アセンブリと、
を備える、システム。
(項目42)
上記流体デバイスは、外部デバイスから伝送されるプロトコルに基づき上記検出可能な信号を発生する、項目41に記載のシステム。
(項目43)
上記プロトコルは無線で伝送される、項目42に記載のシステム。
(項目44)
上記流体デバイスは、上記プロトコルの上記伝送の誘因となるよう適合する該流体デバイスの同一性を与える識別子をさらに備える、項目41に記載のシステム。
(項目45)
上記プロトコルは、識別子検出器によって認識可能な上記流体デバイスの上記同一性に依存して変化する、項目41に記載のシステム。
(項目46)
上記体液のサンプルは約500μl未満である、項目41に記載のシステム。
(項目47)
上記体液のサンプルは、約50μl未満である、項目41に記載のシステム。
(項目48)
上記反応物質は免疫アッセイ試薬を含む、項目41に記載のシステム。
(項目49)
上記免疫アッセイ試薬は、ポリペプチド糖タンパク質、多糖類、脂質、核酸、およびそれらの組み合わせを検出する、項目48に記載のシステム。
(項目50)
上記免疫アッセイ試薬は、薬物、薬物代謝産物、疾病を示すバイオマーカー、組織特異的マーカー、および細胞または細胞型に対して特異的なバイオマーカーから成る群から選択される要素を検出する、項目48に記載のシステム。
(項目51)
上記複数の検体は、3桁の範囲にわたり検出可能な明確な信号によって識別される、項目41に記載のシステム。
(項目52)
上記検出可能な信号は発光信号である、項目41に記載のシステム。
(項目53)
上記検出可能な信号は化学発光信号である、項目41に記載のシステム。
(項目54)
上記流体デバイスは、上記体液のサンプルを採取するための極微針をさらに備える、項目41に記載のシステム。
(項目55)
上記薬理学的パラメーターは薬物動態パラメーターである、項目41に記載のシステム。
(項目56)
上記薬理学的パラメーターは薬力学的パラメーターである、項目41に記載のシステム。
(項目57)
上記複数の上記検体のうちの少なくとも1つは、薬力学的パラメーターを示すバイオマーカーである、項目41に記載のシステム。
(項目58)
上記複数の上記検体のうちの少なくとも1つは、薬物動態パラメーターを示す上記治療薬または該治療薬の代謝産物である、項目41に記載のシステム。
(項目59)
上記流体デバイスは、上記信号に関するデータを無線伝送器経由で伝達する、項目41に記載のシステム。
(項目60)
上記無線伝送器は携帯電話を備える、項目59に記載のシステム。
(項目61)
治療薬の有効性および/または毒性を評価するために有用な2つ以上の薬理学的パラメーターを測定するための方法であって、
a)該2つ以上の薬理学的パラメーターをプロファイリングするために、該治療薬を投与された被験体からの体液のサンプルを流体デバイスに入れるステップであって、該流体医療デバイスは、
カートリッジであって、少なくとも1つのサンプル収集ユニットと、反応試薬を含むアッセイアセンブリとを備える、ステップと、
b)該流体デバイスを作動させ、該流体デバイス内の該免疫アッセイ試薬を方向づけるステップと、
c)該体液のサンプルを免疫アッセイ試薬と反応させ、該サンプルからの該2つ以上の薬理学的パラメーターの値を示す検出可能な信号を発生するステップと、
d)該体液のサンプルから生成される該検出可能な信号を検出するステップと、
を含む、方法。
(項目62)
上記被験体に伝達される無線信号によって促進される時間間隔で(a)〜(d)の上記ステップを反復するステップをさらに含む、項目61に記載の方法。
(項目63)
上記2つ以上の薬理学的パラメーターは、上記治療薬の有効性および/または毒性を評価するのに有用な薬物動態指標および薬力学指標の両方を含む、項目61に記載の方法。
(項目64)
上記薬理学的パラメーターは薬物動態指標である、項目61に記載の方法。
(項目65)
上記薬理学的パラメーターは薬力学指標である、項目61に記載の方法。
(項目66)
上記薬理学的パラメーターは上記治療薬の濃度によって反映される、項目61に記載の方法。
(項目67)
上記薬理学的パラメーターは上記治療薬の代謝産物の濃度によって反映される、項目61に記載の方法。
(項目68)
上記薬理学的パラメーターは、上記治療薬によって直接的または間接的に作用されるバイオマーカーによって反映される、項目61に記載の方法。
(項目69)
上記薬理学的パラメーターは、上記治療薬に対する副作用を表示するバイオマーカーによって反映される、項目61に記載の方法。
(項目70)
治療薬を伴う医療的処置の患者の薬剤服用順守を自動監視するための方法であって、
a)該患者からの体液のサンプルを提供するステップと、
b)該体液のサンプルを流体デバイスでのアッセイ試薬と反応させ、該医療的処置の薬剤服用順守または薬剤服用不順守を示す検体を検出するステップと、
c)該検体の有無を検出するステップと、
d)該患者または医療実務者に該薬剤服用順守または薬剤服用不順守を通知するステップと、
を含む、方法。
(項目71)
上記流体デバイスは、
サンプル収集ユニットおよびアッセイアセンブリであって、該サンプル収集ユニットは、該体液のサンプルを外部デバイスから伝送されるプロトコルに基づき該アッセイアセンブリ内に含有されている反応物質と反応させ、上記検体の存在を示す検出可能な信号を発生する、サンプル収集ユニットおよびアッセイアセンブリと、
該検出可能な信号を検出するための検出アセンブリを備える読取機アセンブリと、
該検出信号を外部デバイスへ伝送するための通信アセンブリと
を備える、項目70に記載の方法。
(項目72)
上記信号と、上記医療的処置と関連することが知られているプロファイルとを自動的に比較する上記ステップをさらに含み、上記患者が該医療的処置を順守しているか、または順守していないかどうかを決定する、項目71に記載の方法。
(項目73)
上記通知は電子的に伝送される、項目70に記載の方法。
(項目74)
上記通知は無線で伝送される、項目70に記載の方法。
(項目75)
上記通知は携帯端末経由で伝送される、項目70の記載に方法。
(項目76)
上記体液のサンプルは約500μl未満である、項目70に記載の方法。
(項目77)
上記反応物質は免疫アッセイ試薬を含む、項目70に記載の方法。
(項目78)
上記検出可能な信号は発光信号である、項目71に記載の方法。
(項目79)
上記検出可能な信号は化学発光信号である、項目71に記載の方法。
(項目80)
流体デバイスを使用して体液のサンプルを検査するよう患者に警告する方法であって、
a)該流体デバイスで実施される、外部デバイスに位置しているプロトコルを提供するステップであって、該プロトコルは、該患者に関連付けられ、かつ該体液のサンプルを検査する時間および/または日付を含む、ステップと、
b)該サンプルがまだ検査されていなければ、該時間および/または日付で該体液を検査するよう該患者に通知するステップと、
を含む、方法。
(項目81)
上記流体デバイスは、
サンプル収集ユニットおよびアッセイアセンブリであって、該サンプル収集ユニットは、上記体液のサンプルを外部デバイスから伝送されるプロトコルに基づき該アッセイアセンブリ内に含有されている反応物質と反応させ、上記検体の存在を示す検出可能な信号を発生する、サンプル収集ユニットおよびアッセイアセンブリと、
該検出可能な信号を検出するための検出アセンブリを備える読取機アセンブリと、
該検出信号を外部デバイスへ伝送するための通信アセンブリと
を備える、項目80に記載の方法。
(項目82)
上記通知は電子的に伝送される、項目81に記載の方法。
(項目83)
上記通知は無線で伝送される、項目80に記載の方法。
(項目84)
上記通知は携帯端末経由で伝送される、項目80に記載の方法。
(項目85)
上記体液のサンプルは約500μl未満である、項目80に記載の方法。
(項目86)
上記反応物質は免疫アッセイ試薬を含む、項目80に記載の方法。
(項目87)
上記検出可能な信号は発光信号である、項目81に記載の方法。
(項目88)
個人に合わせた医療的処置を提供する際に臨床医を支援するビジネス方法であって、
a)医薬を受け取る個人から少なくとも1つの薬理学的パラメーターを収集するステップであって、体液のサンプルを流体デバイスに含有されている反応物質に与えることにより開始され、それが該個人に提供されて該少なくとも1つの薬理学的パラメーターを示す検出可能な信号を発生する、収集するステップと、
b)該個人のコンピュータ医療記録の補助と該個人の該少なくとも1つの薬理学的パラメーターを相互参照することにより、個人に合わせた医療的処置を提供する際に該臨床医を支援するステップと、
を含む、ビジネス方法。
(項目89)
上記薬理学的パラメーターは薬物動態パラメーターである、項目88に記載のビジネス方法。
(項目90)
上記薬理学的パラメーターは薬力学的パラメーターである、項目88に記載のビジネス方法。
(項目91)
上記反応物質は免疫アッセイ試薬を含む、項目88に記載のビジネス方法。
(項目92)
治療薬の臨床試験を監視するビジネス方法であって、
a)上記臨床試験において複数の時間間隔で被験体から少なくとも1つの薬理学的パラメーターを収集するステップであって、該収集するステップは、それぞれの時間間隔で、該被験体からの体液のサンプルを流体デバイスに含有されている反応物質に与えることにより開始され、該流体デバイスを該被験体に提供し、複数の時間間隔で該少なくとも1つの薬理学的パラメーターの値を示す検出可能な信号を発生する、収集するステップと、
b)該検出された値を該薬理学的パラメーターの所定の閾値と比較するステップと、
c)統計的に重大な相違が該検出された値と該閾値との間に存在する場合は、該臨床試験に関与している臨床医および/または治験依頼者に通知するステップと、
を含む、ビジネス方法。
(項目93)
上記統計的に重大な相違に基づき医療行為を起こすステップをさらに含む、項目92に記載のビジネス方法。
(項目94)
上記医療行為は上記治療薬の用量を調整するステップを伴う、項目93に記載のビジネス方法。
(項目95)
上記臨床試験を継続、修正または終了するステップを伴うビジネス決定を行うステップをさらに含む、項目92に記載のビジネス方法。
(項目96)
上記流体デバイスは、
サンプル収集ユニットおよびアッセイアセンブリであって、該サンプル収集ユニットは、上記体液のサンプルを外部デバイスから伝送されるプロトコルに基づき該アッセイアセンブリ内に含有されている反応物質と反応させ、上記検出可能な信号を発生する、サンプル収集ユニットおよびアッセイアセンブリと、
該検出可能な信号を検出するための検出アセンブリを備える読取機アセンブリと、
該検出信号を外部デバイスへ伝送するための通信アセンブリと
を備える、項目92に記載のビジネス方法。
(項目97)
上記反応物質は免疫アッセイ試薬を含む、項目92に記載のビジネス方法。
(項目98)
治療薬の有効性および/または毒性を実験動物から評価するために有用な薬理学データを獲得するための方法であって、
a)少なくとも1つのサンプル収集ユニットおよびアッセイアセンブリを備える流体デバイスと、該サンプル収集ユニットおよび/または該アッセイアセンブリと流体連通している複数のチャネルとを提供するステップと、
b)約50μl未満の生体液のサンプルを該アッセイアセンブリ内に含有されている反応物質と反応させ、薬理学的パラメーターを示す該サンプル中の最初に収集された検体から生成される検出可能な信号を発生する、ステップと、
c)該検出可能な信号を検出するステップと、
d)同じ実験動物から生体液の第2のサンプルを使用して該反応および検出するステップを反復するステップと、
を含む、方法。
(項目99)
治療薬の有効性および/または毒性を実験動物から評価するのに有用な薬理学データを採取する方法であって、
a)少なくとも1つのサンプル収集ユニット、アッセイアセンブリを備える流体デバイスと、該サンプル収集ユニットおよび/または該アッセイアセンブリと流体連通している複数のチャネルを提供するステップと、
b)生体液のサンプルを、該アッセイアセンブリ内に含有されている反応物質と反応させ、薬理学的パラメーターを示す該サンプル中の最初に収集された検体から生成される検出可能な信号を発生するステップと、
c)該検出可能な信号を検出するステップと、
d)該動物が麻酔を受けていない場合、同じ実験動物から生体液の第2のサンプルを使用して該反応および検出するステップを反復するステップと、
を含む、方法。
(項目100)
上記流体デバイスは、
サンプル収集ユニットおよびアッセイアセンブリであって、該サンプル収集ユニットは、上記体液のサンプルを外部デバイスから伝送されるプロトコルに基づき該アッセイアセンブリ内に含有されている反応物質と反応させ、上記検体の存在を示す上記検出可能な信号を発生する、サンプル収集ユニットおよびアッセイアセンブリと、
該検出可能な信号を検出するための検出アセンブリを備える読取機アセンブリと、
該検出信号を外部デバイスへ伝送するための通信アセンブリと
を備える、項目98または99に記載の方法。
(項目101)
上記流体デバイスは、外部デバイスから伝送されるプロトコルに基づき上記アッセイアセンブリ含有されている上記反応物質を充てる、項目100に記載の方法。
(項目102)
上記プロトコルは外部デバイスから無線で伝送される、項目100に記載の方法。
(項目103)
上記流体デバイスは、上記プロトコルの上記伝送の誘因となるよう適合する該流体デバイスの同一性を与える識別子をさらに備える、項目100に記載の方法。
(項目104)
上記プロトコルは、識別子検出器によって認識可能な上記流体デバイスの上記同一性に依存して変化する、項目100に記載の方法。
(項目105)
上記反応物質は免疫アッセイ試薬を含む、項目100に記載の方法。
(項目106)
上記免疫アッセイ試薬は、ポリペプチド糖タンパク質、多糖類、脂質、核酸、およびそれらの組み合わせを検出する、項目105に記載の方法。
(項目107)
上記免疫アッセイ試薬は、薬物、薬物代謝産物、疾病を示すバイオマーカー、組織特異的マーカー、および細胞または細胞型に対して特異的なバイオマーカーから成る群から選択される要素を検出する、項目105に記載の方法。
(項目108)
上記バイオマーカーは表4に示す要素である、項目105に記載の方法。
(項目109)
上記流体デバイスは複数の検体を検出し、かつ該流体デバイスは該複数の検体のための免疫アッセイ試薬を備える、項目100に記載の方法。
(項目110)
上記複数の検体は、3桁の範囲にわたり検出可能な明確な信号によって識別される、項目100に記載の方法。
(項目111)
上記検出可能な信号は発光信号である、項目100に記載の方法。
(項目112)
上記流体デバイスは、上記体液のサンプルを採取するために極微針をさらに備える、項目100に記載の方法。
(項目113)
上記生体液のサンプルは、約10マイクロリットル未満である、項目100に記載の方法。
(項目114)
上記生体液のサンプルは約5マイクロリットル未満である、項目100に記載の方法。
(項目115)
上記生体液のサンプルは約5マイクロリットルと約10マイクロリットルとの間である、項目100に記載の方法。
(項目116)
上記薬理学データは薬物動態および/または薬力学的パラメーターを含む、項目100に記載の方法。
(項目117)
流体システムを較正する精度を向上させる方法であって、
a)体液を提供するための流体デバイスを備える、被験体からの該体液中の検体を検出するためのシステムを提供するステップであって、該流体デバイスは、較正アセンブリと、該検体の存在を検出するための読取機アセンブリとを有する、ステップと、
b)該流体デバイスに関連する較正曲線の1つ以上のパラメーターを測定するステップと、
c)該1つ以上のパラメーターを該流体デバイスに関連する所定のパラメーターと比較するステップと、
d)該1つ以上のパラメーターおよび該所定のパラメーターの比率によって信号出力を調整するステップと、
を含む、方法。
(項目118)
流体システムの較正を向上させる方法であって、
a)検体の既知量を含むオリジナルのサンプルで第1の信号を測定するステップと、
b)該オリジナルのサンプル中の該検体の既知量を混ぜた後で、第2の信号を測定するステップと、
c)目標値が該検体の該既知量から予想される信号である場合、該目標値に対する該第1および第2の信号との差をプロットするステップと、
d)該目標値と計算された検体値との該差の平方和を最小限にすることによって、パラメーターの最良適合に達するステップと、
を含む、方法。
(項目119)
流体デバイスを用いて体液中の検体のためのアッセイの信頼性を評価する方法であって、a)システムを提供するステップであって、該システムは流体デバイスを備え、該流体デバイスは、被験体からの体液中の検体の存在を検出するために、サンプル収集ユニットおよびアッセイアセンブリと、上記検体の存在を検出するための読取機アセンブリとを備え、該サンプル収集ユニットは、体液のサンプルを該アッセイアセンブリ内に含有されている反応物質と反応させる、ステップと、
b)センサーにより、該システムが通常動作する動作パラメーターにおける変化を検知するステップと、
を含む、方法。
(項目120)
被験体の生体液中の検体を検出するための装置であって、
a)複数の反応部位と流体連通している生体液を導入するためのサンプル収集ユニットと、
b)該反応部位と流体連通している複数の反応物質を運ぶ複数の反応物質チェンバーであって、該複数の反応部位は該検体を検出するためにそこに結合される複数の反応物質を含んでいる、複数の反応物質チェンバーと、
c)該生体液および該複数の反応物質を、該装置に流れさせる流体チャネルのシステムであって、該複数の反応部位の間に位置している少なくとも1つのチャネルは光学バリアを備え、該検体の検出の間に該複数の該反応部位の間の光クロストークの量を軽減するシステムと、
を備える、装置。
(項目121)
被験体の生体液中の検体を検出するための装置であって、
a)複数の反応部位と流体連通している生体液を導入するためのサンプル収集ユニットであって、該複数の反応部位は、該検体を検出するための複数の結合された反応物質を含むサンプル収集ユニットと、
b)該反応部位と流体連通している複数の反応物質を運ぶ複数の反応物質チェンバーと、c)該生体液および該複数の反応物質を該装置に流れさせる流体チャネルのシステムであって、少なくとも1つの反応部位での該結合された反応物質が不規則に分配されるシステムと、
を備える、装置。
(項目122)
被験体の生体液中の検体を検出するための流体デバイスを製造する方法であって、
a)流体デバイスの複数の層を提供するステップと、
b)流体ネットワークがサンプル収集ユニットと、少なくとも1つの反応物質チェンバーと、少なくとも1つの反応部位と、少なくとも1つの廃棄チェンバーとの間に存在するように該層を合わせて超音波溶接するステップと、
を含む、方法。
本明細書に言及するすべての公開および特許出願は、それぞれ個々の公開または特許出願が、参照することによって組み込まれるよう明確に、または個別に表示するとの同じ程度まで、参照することによって本明細書に組み込まれる。
システム
本発明の一側面は、体液のサンプル中の検体を検出するためのシステムである。システムは、特異の生物過程、生理学的状態、疾患または疾患の期に関連する検体を検出および/または定量化することができる。
対象の装置およびシステムは、被験体からの体液中に存在している検体の高処理能力および実時間検出のための有効な手段を提供する。検出方法は、特異の生物過程、生理学的状態、疾患および疾患の期に関連している検体の識別および定量化を含み、多種多様な状況において使用してもよい。そのようなものとして、対象の装置およびシステムは、例えば、薬物スクリーニング、疾病診断、系統発生的分類、母体となる識別、および法医学的識別において広範囲に渡る実用性を有する。対象の装置およびシステムはまた、治療法の開発の前臨床病期および臨床病期を進めるのに、患者の薬剤服用順守を向上させるのに、処方薬に関連するADRを監視するのに、また個人に合わせた医薬を開発するのに特に有用である。
B/B0)])は、直線をもたらす対数(検体濃度)に対してプロットされる。(自然対数はまた、底10の対数の代わりに使用することができる)。このプロットの勾配および切片は、(a)検体濃度の関数としてのアッセイ信号(b)アッセイ信号の関数としての検体濃度の計算を可能にする一次方程式を導くのに使用することができる。当該の検体としてのトロンボキサンを使用してかかる分析の例を図21に示す。データに対する最良適合は、方程式1:信号=(A−D)/(l+(検体濃度./C^B)+D[方程式1]によって得られ、ここでAはゼロ検体濃度での信号、Dは無限大検体濃度での信号、CはAとDとの中間の信号レベルに達した検体濃度、Bは形状パラメーターである。検体濃度と信号との関係は、検体濃度=C*((((A−D)/(信号−D)−1)^(1/B))[方程式2]によって得られ、ここでA、B、CおよびDは、方程式1に使用したパラメーターと同一である。
(表2:1−ポイント較正のための計算されたパラメーター値)
サンプルの完全性は、多くの要因によって影響を受けることができ、いくつかは患者に内因性、またいくつは外因性である。以下に記載の、(i)間質液と血液との混合、(ii)ヘマトクリット値濃度におけるばらつき、(iii)溶血反応、および(iv)血小板およびサンプル凝固の活性化は、サンプルの完全性における誤差の原因のうちのいくつかである。
OPi=(a*IPl+b*IP2+...n*IPn)+(aa*IPl^2+bb*IP2^2+...+nn*IPn^2)+(aaa*IPl*IP2+bbb*IPl*IP3+...+nnn*IPn−l*IPn)、ここでa...n、aa...nn、aaa...nnnは任意定数である。
TI=a*IP+cc*rP3^2+nnn*IP3*IP5+...(方程式6)
図34は、TIの算出結果および治療効力を決定するためのTI概念の使用を例示する(治療指数はまた、項目の効力指数によって表示される)。図34に例示している例は、パラメーターA、BおよびCによって表される3つの生化学的検体によって表示される疾病状態(アテローム性動脈硬化)の成功している薬物療法の経時変化を示す。疾病の治療(例えば、スタチンを使用して)は、ゼロ日に開始している。
Claims (23)
- 被験体からの体液中の検体を検出するためのシステムであって、
a)複数のプロトコルを有する外部デバイスと、
b)試験デバイスであって、
(i)サンプル収集ユニット、
(ii)アッセイアセンブリ、および、
(iii)該外部デバイスから読取機アセンブリへのプロトコルの選択および伝送の誘因となるように構成された識別子
を備え、該複数のプロトコルからの該プロトコルの該選択が、識別子検出器によって認識可能な該試験デバイスの同一性に依存して変化し、該サンプル収集ユニットは、体液のサンプルを、該外部デバイスから伝送される該プロトコルに基づいて、該アッセイアセンブリ内に含有されている反応物質と反応させ、該検体の存在を示す検出可能な信号を発生する、試験デバイスと、
c)該読取機アセンブリであって、
(i)該検出可能な信号を検出するための検出アセンブリ、および、
(ii)(1)該外部デバイスからの該プロトコルを受信するように、かつ、(2)該検出された信号を該外部デバイスへ伝送するように構成された、通信アセンブリ
を備え、該プロトコルが、
(A)該検出可能な信号を生成するために、反応を該アッセイアセンブリにおいて行わせ、かつ、
(B)該検出可能な信号を検出するための検出方法の選択を行わせる、読取機アセンブリと
を備える、システム。 - 前記プロトコルは外部デバイスから無線で伝送される、請求項1に記載のシステム。
- 前記プロトコルは、前記サンプルの希釈の程度を決定し、これは前記試験デバイス上で実施される、請求項1に記載のシステム。
- 前記体液のサンプルは約500μl未満である、請求項1に記載のシステム。
- 被験体からの体液中の検体を検出するためのシステムであって、
a)複数のプロトコルを有する外部デバイスと、
b)試験デバイスであって、
(i)サンプル収集ユニット、
(ii)アッセイアセンブリ、および、
(iii)該外部デバイスから読取機アセンブリへのプロトコルの選択および伝送の誘因となるように構成された識別子
を備え、該複数のプロトコルからの該プロトコルの該選択が、識別子検出器によって認識可能な該試験デバイスの同一性に依存して変化し、該サンプル収集ユニットは、500μl未満の体液のサンプルを、該外部デバイスから伝送される該プロトコルに基づいて、該アッセイアセンブリ内に含有されている反応物質と反応させ、該体液のサンプル中の収集された該検体の存在を示す検出可能な信号を発生する、試験デバイスと、
c)読取機アセンブリであって、
(i)該検出可能な信号を検出するための検出アセンブリ、および、
(ii)該検出された信号を該外部デバイスへ伝送するための通信アセンブリ
を備え、該プロトコルが、(A)該検出可能な信号を生成するために、反応を該アッセイアセンブリにおいて行わせ、かつ、(B)該検出可能な信号を検出するための検出方法を選択させる、読取機アセンブリと
を備える、システム。 - 前記反応物質は免疫アッセイ試薬を含む、請求項1または5に記載のシステム。
- 前記免疫アッセイ試薬は、細菌、ウイルス、真菌、および原虫から成る群から選択される微生物を検出する、請求項6に記載のシステム。
- 前記免疫アッセイ試薬は、ポリペプチド糖タンパク質、多糖類、脂質、核酸、およびそれらの組み合わせを検出する、請求項6に記載のシステム。
- 前記免疫アッセイ試薬は、薬物、薬物代謝産物、疾病を示すバイオマーカー、組織特異的マーカー、および細胞または細胞型に対して特異的なバイオマーカーから成る群から選択される要素を検出する、請求項6に記載のシステム。
- 前記試験デバイスは複数の検体を検出し、かつ該試験デバイスは、該複数の検体のために免疫アッセイ試薬を備える、請求項1または5に記載のシステム。
- 前記複数の検体は、3桁の範囲にわたり検出可能な明確な信号によって識別される、請求項10に記載のシステム。
- 前記検出可能な信号は発光信号である、請求項6に記載のシステム。
- 前記試験デバイスは、前記体液のサンプルを採取するための極微針をさらに備える、請求項1または5に記載のシステム。
- 被験体の体液中の検体を検出するための方法であって、
a)請求項1または5に記載のシステムを提供するステップと、
b)体液のサンプルを前記アッセイアセンブリ内に含有されている前記反応物質と反応させ、該検体の存在を示す検出可能な信号を発生するステップと、
c)該検出可能な信号を検出するステップと、
を含む、方法。 - 前記体液中に存在している前記検体の量を定量化するステップをさらに含む、請求項14に記載の方法。
- 前記体液中に存在している前記検体の前記量を前記検体の所定の量と比較するステップをさらに含む、請求項15に記載の方法。
- 前記体液中に存在している前記検体の前記量が、統計的に前記所定の量と異なる場合は、医療行為を起こすステップをさらに含む、請求項14に記載の方法。
- 前記医療行為は、前記被験体のための処方薬を変える必要があることを薬局に通知するステップを含む、請求項17に記載の方法。
- 前記通知は電子的に伝送される、請求項18に記載の方法。
- 前記通知は無線で伝送される、請求項18に記載の方法。
- 前記医療行為は、被験体の治療薬の用量を変えるステップを含む、請求項17に記載の方法。
- 前記検体の量についての動向分析を実施するステップをさらに含む、請求項15に記載の方法。
- 前記検体が核酸である、請求項1または5に記載のシステム。
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