JP2015530601A - マイクロ流体素子を用いるlal反応性物質試験方法及び装置 - Google Patents
マイクロ流体素子を用いるlal反応性物質試験方法及び装置 Download PDFInfo
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Abstract
Description
12 上部プレート
14 下部プレート
16 試験モジュール
18 入口ポート
20 リザーバー
22 第1の流体マニフォールド
24 移送チャネル
26 試験チャネル
28 出口チャネル
30 出口ポート
32 第1の弁
34 第2の弁
36 計測部分
38 分析部分
40 混合部分
42 第3の弁
44 第1の圧力ポート
46 第2の流体マニフォールド
48 光学チャンバ
50 第4の弁
52 第2の圧力ポート
54 第3の流体マニフォールド
56 ディスク
58 ハブ
60 試験区域
62 外縁部
64 流体素子回路網
Claims (22)
- 2以上の試験モジュールを含む、流体試料を試験するためのマイクロ流体カートリッジであって、
試験モジュールは各々、流体試料のうちの1つを受けるための1以上の入口ポート及び入口ポートと流体連通する4以上の試験チャネルを含み、
試験チャネルは各々、流体試料のアリコートを計測する計測部分、分析部分及び混合部分を含み、弁が計測部分と分析部分の間に配置されて、選択的流体的に計測部分と分析部分を隔てており、
試験モジュールは各々、1種以上の試薬が内部に単離される1以上の試験チャネルを有し、試薬はLAL反応性物質を含んでいる、
マイクロ流体カートリッジ。 - 1以上の試験モジュールが8以上の試験チャネルを含む較正モジュールであって、
試験チャネルの2以上は内部にLAL反応性物質を有しておらず、
試験チャネルの2以上は内部に第1の量のLAL反応性物質が単離され、
試験チャネルの2以上は内部に第2の量のLAL反応性物質が単離され、
試験チャネルの2以上は内部に第3の量のLAL反応性物質が単離されている、
請求項1記載のマイクロ流体カートリッジ。 - 1以上の試験モジュールが4以上の試験チャネルを含む試料測定モジュールであり、
試験チャネルの2以上は内部にLAL反応性物質を有しておらず、
試験チャネルの2以上は内部に第4の量のLAL反応性物質を有するスパイクが単離されている、
請求項1記載のマイクロ流体カートリッジ。 - 試験チャネルすべての内部に1種以上の追加の試薬が単離され、追加の試薬は検出試薬を含んでいる、請求項1記載のマイクロ流体カートリッジ。
- 入口ポートと流体連通して余剰の流体試料を回収する出口ポートをさらに含む、請求項1記載のマイクロ流体カートリッジ。
- 弁は、真空、遠心力又は空気圧がアリコートを駆動して、弁を通過して計測部分から分析部分に流れるのを許可するように構成されている、請求項1記載のマイクロ流体カートリッジ。
- 分析部分の端部に隣接して計測部分内に配置されて、試験チャネル内に圧力差を発生させる第1の圧力ポートをさらに含んでいる、請求項1記載のマイクロ流体カートリッジ。
- 混合部分内に配置されて、試験チャネル内に圧力差を発生させる第2の圧力弁をさらに含んでいる、請求項1記載のマイクロ流体カートリッジ。
- 分析部分は、アリコートの少なくとも一部を受けて流体試料の光学的測定を行う光学チャンバ(48)を含んでいる、請求項1記載のマイクロ流体カートリッジ。
- 混合部分は、アリコートが混合部分内で試薬と混合できるように構成されている、請求項1記載のマイクロ流体カートリッジ。
- 試薬は混合部分内に固定化されている、請求項1記載のマイクロ流体カートリッジ。
- 1種以上の流体試料のLAL反応性物質を検査するための方法であって、
マイクロ流体カートリッジを使用するステップであって、マイクロ流体カートリッジは2以上の試験モジュールを含み、
試験モジュールは各々、流体試料のうちの1つを受けるための1以上の入口ポート及び入口ポートと流体連通する4以上の試験チャネルを含み、
試験チャネルは各々、流体試料のアリコートを計測する計測部分、分析部分及び混合部分を含み、弁が計測部分と分析部分の間に配置されて、選択的流体的に計測部分と分析部分を隔てている、ステップ、
1種以上の流体試料を入口ポートのうちの少なくとも1つに導入するステップ、
マイクロ流体カートリッジ内の1種以上の流体試料の各々について試験プロセスを実施するステップ及び
試験プロセスの測定データを記録するステップ
を含む方法。 - アリコート各々の流れを計測部分から分析部分に駆動して、各試験チャネルの分析部分で光学測定を行うステップをさらに含む、請求項12記載の方法。
- 真空、遠心力又は空気圧が、アリコートの流れを駆動して弁を通過させ計測部分から分析部分に流れさせる、請求項13記載の方法。
- 試験モジュールは各々、真空又は空気圧がかけられて試験モジュール内に圧力差を発生させてアリコートの流れを駆動する1以上の圧力ポートを含んでいる、請求項14記載の方法。
- 1種以上の流体試料を入口ポートのうちの少なくとも1つに導入するステップは、1種以上の流体試料を手動で導入するか又は1種以上の流体試料を自動式に導入することを含んでいる、請求項12記載の方法。
- 1種以上の流体試料を入口ポートのうちの1つに導入するステップの前に、マイクロ流体カートリッジを光学リーダーに導入するステップをさらに含んでいる、請求項12記載の方法。
- 流体試料は、試験プロセスの間に試薬と混合される、請求項12記載の方法。
- 試薬は混合部分内に固定化されている、請求項12記載の方法。
- 測定データは、アリコートの体積、反応動態、流体運動、透過、吸光、光密度、色、明度、色相、スペクトル、濁度、散乱光、化学発光、蛍光及び磁気共鳴を含んでいる、請求項12記載の方法。
- 試験プロセス及び測定データは、従前の測定データ及び/又は既知の反応動態データを用いてバリデートされる、請求項20記載の方法。
- トレーサーが混合部分及び/又は分析部分の内部に固定化されて、流体の運動及び/又はアリコートの体積を測定しバリデートするのを補助する、請求項21記載の方法。
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