JP2010243498A - アッセイカートリッジ及び同アッセイカートリッジを用いた方法 - Google Patents
アッセイカートリッジ及び同アッセイカートリッジを用いた方法 Download PDFInfo
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- Y10T436/25—Chemistry: analytical and immunological testing including sample preparation
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Abstract
【解決手段】本モジュールは、電極誘起化学発光測定を実行するのに使用されてよい集積化した電極を備えた検出チャンバを含むことが好ましい。電極及び他の表面上に制御された様式でアッセイ試薬を固定化する方法を記載する。好適には集積化した電極を有する検出チャンバ及び標本チャンバ、廃棄物チャンバ、導管、ベント、気泡トラップ、試薬チャンバ、乾燥試薬錠剤ゾーン等を含んでよい他の流体コンポーネントを備えた、アッセイモジュール及びカートリッジも記載する。好適な実施例では、このようなモジュールはアプリケータスティック上に採取された標本を受け取り、且つ分析するように適合される。
【選択図】なし
Description
Claims (53)
- シャフト及び標本採取ヘッドを備えたアプリケータスティックを用いて採取された標本を分析するアッセイカートリッジであって、
第1の細長形領域及び第2の細長形領域を有する細長形の空洞を含んだ標本チャンバであり、前記領域は相互に対してある角度で配向された標本チャンバを備えており、
前記角度は、前記アプリケータスティックが前記標本導管内に挿入されると同時に折れ曲がって、前記シャフトの破壊を促進するように選択されたアッセイカートリッジ。 - 前記角度は30〜70である請求項1に記載のアッセイカートリッジ。
- 前記空洞の断面積は前記アプリケータスティックヘッドの幅の2倍未満である請求項1又は2に記載のアッセイカートリッジ。
- 前記カートリッジは前記標本コンパートメントを密閉する密閉可能なクロージャをさらに含む請求項1〜3のいずれか1項に記載のアッセイカートリッジ。
- アッセイカートリッジであって、
抽出試薬を保持する抽出試薬チャンバと、
アプリケータスティックを受け取るように適合された標本チャンバであり、抽出試薬導管を介して前記抽出試薬チャンバに接続され、密閉可能なクロージャを備えた標本導入口を有する標本チャンバと、
第1の標本導管を介して前記標本チャンバに接続された第1の検出チャンバとを備えたアッセイカートリッジ。 - 前記標本チャンバと前記標本導管との間にフィルタをさらに含んだ請求項5に記載のアッセイカートリッジ。
- 前記標本チャンバは前記カートリッジ内の細長形空洞であり、前記標本導管導入口は前記細長形空洞の一端に設置された請求項5又は6に記載のアッセイカートリッジ。
- 前記標本導管及び前記抽出試薬導管は前記空洞の長さに沿って接続且つ配置された請求項5〜7のいずれか1項に記載のアッセイカートリッジ。
- 前記細長形空洞は第1の細長形領域及び第2の細長形領域を有し、該領域は相互に対してある角度で配向されており、且つ前記角度は前記アプリケータスティックが標本導管に挿入されると同時に前記シャフトを折り曲げ、且つ前記シャフトの破壊を促進するように選択される請求項7又は8に記載のアッセイカートリッジ。
- 前記破壊によって前記アプリケータスティックの標本採取ヘッドを含んだアプリケータスティックの断片を短くし、前記断片の長さは前記キャビティの長さ未満である請求項1又は5に記載のアッセイカートリッジ。
- 洗浄試薬を保持する洗浄試薬チャンバであり、洗浄試薬導管を介して前記検出チャンバに接続された洗浄試薬チャンバと、廃棄物導管を介して前記標本導管に接続された廃棄物チャンバとを含んだ請求項1〜10のいずれか1項に記載のアッセイカートリッジ。
- 廃棄物導管を介して前記検出チャンバに接続された廃棄物チャンバと、洗浄試薬を保持する洗浄試薬チャンバであり、洗浄導管を介して前記標本導管に接続された洗浄試薬チャンバとをさらに含んだ請求項1〜11のいずれか1項に記載のアッセイカートリッジ。
- 前記抽出試薬チャンバは亜硝酸又は硝酸塩を含む請求項5〜12のいずれか1項に記載のアッセイカートリッジ。
- 前記標本導管に連結された気泡トラップをさらに含む請求項5〜13のいずれか1項に記載のアッセイカートリッジ。
- 分析用の標本を調整する方法であって、
標本チャンバを含んだカートリッジ内に標本を採取するアプリケータスティックを挿入する工程であり、前記アプリケータスティックはシャフト及び標本採取ヘッドを備えた工程と、
前記アプリケータスティックのシャフトを破壊してシャフト部分とヘッド部分とに分割する工程と、
前記標本チャンバ内で前記ヘッドを密閉する工程とを含んだ方法。 - 前記挿入工程及び前記破壊工程は同時に行われる請求項15に記載の方法。
- 前記挿入工程は前記破壊工程の前に行われる請求項15に記載の方法。
- 前記破壊工程は前記シャフトに対して垂直に力を印加する工程を含む請求項15〜17のいずれか1項に記載の方法。
- 前記標本チャンバは力集束要素をさらに含む請求項15に記載の方法。
- 前記標本チャンバは第1の細長形領域及び第2の細長形領域を有する細長形の空洞含んだ標本チャンバであり前記領域は相互に対してある角度で配向された標本チャンバを備えており、
前記挿入工程は、前記シャフトを折り曲げてそれを破壊するように、前記第1の領域を通して前記第2の領域内に前記標本採取ヘッドを押し込む抵抗を含む請求項16に記載の方法。 - 前記アプリケータスティックはスワブである請求項20に記載の方法。
- 前記アプリケータスティックは前記シャフト上に位置する所定の弱点において折れる請求項20に記載の方法。
- 前記アプリケータスティックは完全に挿入され、前記弱点は前記第1の領域と前記第2の領域との間に位置する請求項22に記載の方法。
- 前記カートリッジは、
抽出試薬を含んだ抽出試薬チャンバであり、抽出試薬チャンバ導管を介して前記標本チャンバに接続された抽出試薬チャンバと、
標本導管を介して前記標本チャンバに接続された検出チャンバとをさらに備え、
前記方法は、
標本液体を形成するように前記標本チャンバに前記抽出試薬を通過させる工程と、
前記標本液を前記検出チャンバ内に導入する工程とをさらに含む請求項16に記載の方法。 - 前記標本導管はフィルタを含む請求項16に記載の方法。
- 前記カートリッジは、
前記標本チャンバに接続された気泡トラップチャンバをさらに含み、
前記方法は、
前記検出チャンバ内に前記標本液を導入する前に、前記標本液を前記気泡トラップに導入して、前記標本液から気泡を除去する工程をさらに含む請求項24に記載の方法。 - 前記気泡トラップチャンバは前記標本導管に接続された気泡トラップ導管を介して前記標本チャンバに接続され、前記気泡トラップは前記気泡トラップチャンバの底部において又はその近傍で前記気泡トラップチャンバに接続されており、
前記気泡を除去する工程は、前記標本液中の気泡を前記標本液の上部まで上昇させるように、前記標本液を前記気泡トラップ内で十分な時間維持し、且つ前記気泡トラップチャンバ導管を介して前記気泡トラップチャンバから前記標本液の低減された気泡部分を除去する工程を含む請求項26に記載の方法。 - 前記気泡トラップは前記標本導管と前記検出チャンバとの間に挿置され、且つ前記標本導管に接続された入口及び前記検出チャンバに接続された出口を有し、前記出口は前記気泡トラップチャンバにおいて又はその近傍に配置されており、
気泡を除去する前記工程は、
前記標本液中の気泡を前記標本液の上部まで上昇させるように、前記標本液を前記気泡トラップ内で十分な時間維持し、且つ前記気泡トラップチャンバ導管を介して前記気泡トラップチャンバから前記標本液の低減された気泡部分を除去する工程を含む請求項26に記載の方法。 - 請求項1〜14のいずれか1項に記載のカートリッジ及び前記カートリッジを用いてアッセイを実行するように適合されたカートリッジリーダーを含むアッセイシステム。
- 請求項1〜14のいずれか1項に記載のカートリッジ及びアプリケータスティックを含んだキット。
- 前記カートリッジは標本チャンバを含み、前記アプリケータスティックは前記標本チャンバ内で密閉するには長過ぎるものであり、前記アプリケータスティックは前記標本内で密閉され得るヘッド部分を形成するように前記アプリケータスティックを弱点で分割できるように構成された弱点を有する請求項30に記載のキット。
- 複数の生化学アッセイを実行する装置であって、
少なくとも1つの専用の作用電極、少なくとも1つの二役電極、及び少なくとも1つの対向電極を含んだ複数の電極であり、前記専用の作用電極及び二役電極の上にはアッセイ試薬が付着された複数の電極を備え、
前記二役電極は最初は作用電極として働き、次に対向電極として働くように構成された装置。 - 前記アッセイ試薬は対象とする被検体に固有の結合試薬である請求項32に記載の装置。
- 前記結合試薬は前記専用の作用電極及び二役電極の各々について異なっている請求項33に記載の装置。
- 前記複数の電極はフローセル内に配置され、該フローセルはフローセル経路を有する請求項32〜34のいずれか1項に記載の装置。
- 前記複数の電極は前記フローセル経路に沿って配置されている請求項35に記載の装置。
- 前記専用の対向電極は前記二役電極に隣接しており、且つ前記二役電極は前記専用の作用電極に隣接している請求項32〜36のいずれか1項に記載の装置。
- 前記複数の電極は単一の検出チャンバ内に配置されている請求項32〜37のいずれか1項に記載の装置。
- 前記複数の電極は印刷されたカーボンインクである請求項32〜38のいずれか1項に記載の装置。
- 前記アッセイ試薬は前記専用の作用電極及び二役電極上の誘電体層によって定められたアッセイ領域内に存在する請求項33に記載の装置。
- 前記複数の電極に電気エネルギーを供給する専用の作用電極リード線、二役電極リード線、及び専用の対向電極リード線であり、少なくとも2つの隣接しない電気リード線はその上に露出表面を有しているリード線と、
前記フローセルと流体的に連通し、且つ前記リード線の前記露出表面によって少なくとも部分的に定められた入口導管とをさらに備え、
前記入口導管内の流体は、前記露出表面と電気接触しており、
前記露出表面は、前記露出表面間に入口導管検査電位を印加して、前記入口導管内の流体の存在又は組成を判断するように構成された請求項35に記載の装置。 - 前記露出表面は前記印加した検査電位が前記対応する電極において電気化学発光を誘起するのに不十分であるようにさらに構成された請求項41に記載の装置。
- 複数のアッセイを実行するカートリッジであって、
入口、出口、及び検出チャンバを有するフローセルであり、該入口、検出チャンバ及び出口は該フローセルを通る流路を形成するフローセルを備えており、前記検出チャンバは、
少なくとも第1の電極の上には第1のアッセイ試薬が固定化された複数の電極であり、前記流路に沿って1次元アレイで配置された複数の電極と、
前記複数の電極に電気エネルギーを供給する複数の電気リード線とを含んでいるカートリッジ。 - 第2のアッセイ試薬がその上に固定化された第2の電極をさらに備え、前記第2の電極は前記第1の電極に隣接して配置された請求項43に記載のカートリッジ。
- 前記複数の電極はカーボンインクを含む請求項43又は44に記載のカートリッジ。
- 前記検出チャンバは少なくとも1つの検出チャンバ表面をさらに含み、前記検出チャンバ表面の少なくとも一部分は透明である請求項43〜45のいずれか1項29に記載のカートリッジ。
- 複数のアッセイを実行するカートリッジであって、
入口、出口、及び検出チャンバを有するフローセルであり、前記入口、検出チャンバ、及び出口が前記フローセルを通る流路を形成するフローセルを備えており、前記検出チャンバは、
前記流路に沿って1次元アレイで配置された、アッセイ試薬が上に固定化された複数の作用電極と、
共通の対向電極とを含んだカートリッジ。 - アッセイカートリッジであって、
第1の側を有するカートリッジボディと、
前記カートリッジボディ及び前記第1の側がその間に1つ又は複数の第1の側の流体ネットワークを定める層を覆うように、前記第1の側に結合された1つ又は複数の第1の側のカバー層とを備え、前記アッセイカートリッジが、
密閉可能なクロージャを有する標本導入口を有する標本チャンバと、
前記標本チャンバに接続された標本チャンバベントポートと、
第1の廃棄物チャンバと、
前記第1の廃棄物チャンバに接続された第1の廃棄物チャンバベントポートと、
第1の標本導管を介して前記標本チャンバに接続され、且つ第1の廃棄物導管を介して前記第1の廃棄物チャンバに接続された第1の検出チャンバとを含んだアッセイカートリッジ。 - 前記カートリッジボディは第2の側及び該第2の側に結合された1つ又は複数の第2の側のカバー層をさらに含み、前記カートリッジボディ及び前記第2側のカバー層は1つ又は複数の第2の側の流体ネットワークをその間に定め、
前記カートリッジボディは前記第1及び第2の側の流体ネットワークの間に流体的連通を形成する少なくとも1つの貫通孔を有する請求項48に記載のアッセイカートリッジ。 - 前記流体ネットワークの少なくとも1つは、少なくとも部分的には、前記カートリッジボディ及び/又は前記カバー層の凹部によって形成された請求項47又は48に記載のアッセイカートリッジ。
- 1つ又は複数の開口部を有するガスケットをさらに含み、該ガスケットは前記カートリッジボディと前記カバー層の少なくとも1つとの間に配設されており、前記流体ネットワークの少なくとも1つは、少なくとも部分的には、前記開口部によって形成された請求項47〜50のいずれか1項に記載のアッセイカートリッジ。
- カートリッジベースのアッセイを実行する方法であって、
標本チャンバベントポートを有する標本チャンバであり、第1の乾燥試薬を含んだ第1の標本導管分岐を有する標本導管に接続された標本チャンバと、
廃棄物チャンバと、
前記廃棄物チャンバに接続された第1の廃棄物チャンバベントポートと、
前記第1の標本導管分岐を介して前記標本チャンバに接続され、且つ第1の廃棄物導管を介して前記第1の廃棄物チャンバに接続された第1の検出チャンバと、
ある量の第1の液体試薬を含んだ第1の試薬チャンバであり、第1の試薬導管を介して前記標本導管に接続された第1の試薬チャンバと、
前記第1の試薬チャンバに接続された第1の試薬チャンバベントポートと、
前記標本導管又は前記第1の標本導管分岐に接続された空気ベントポートとを備えており、
前記方法は、
前記標本チャンバから前記第1の標本導管分岐内に前記標本を移動する工程と、
前記標本内で前記第1の乾燥試薬を戻す工程と、
所定の量を有する前記標本のスラグを、前記第1の検出チャンバ内に移動する工程と、
前記第1の検出チャンバ内の前記標本を前記第1の廃棄物チャンバ内に移動する工程と、
前記第1の液体試薬を前記第1の検出チャンバ内に移動する工程と、
前記第1の検出チャンバからの信号を測定する方法とを含んだ方法。 - カートリッジベースのアッセイを実行する方法であって、
前記カートリッジは、
標本チャンバベントポートを有する標本チャンバであり、第1の乾燥試薬を含んだ標本導管に接続された標本チャンバと、
第1の廃棄物チャンバ導管を介して前記標本導管に接続された第1の廃棄物チャンバと、
前記廃棄物チャンバに接続された第1の廃棄物チャンバベントポートと、
ある量の第1の液体試薬を含んだ第1の試薬チャンバと、
前記第1の試薬チャンバに接続された第1の試薬チャンバベントポートと、
前記標本導管を介して前記標本チャンバに接続され、且つ第1の試薬チャンバ導管を介して前記第1の試薬チャンバに接続された第1の検出チャンバと、
前記標本導管又は前記第1の試薬導管に接続された空気ベントポートとを備え、
前記方法は、
前記標本チャンバから前記第1の標本導管に前記標本を移動する工程と、
前記標本内で前記第1の試薬を戻す工程と、
所定の量を有する前記標本の第1のスラグを前記第1の検出チャンバ内に移動する工程と、
前記第1の検出チャンバ内の前記標本を前記廃棄物チャンバ内に移動する工程と、
前記第1の液体試薬を前記第1の検出チャンバ内に移動する工程と、
前記第1の検出チャンバからの信号を測定する工程とを含む方法。
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