JP5932897B2 - 尿中のバクテリアの同定を行うためのシステム - Google Patents
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Description
本出願は、ここにそれら全体を参考文献として合体させる、全て2007年10月10日出願の、米国仮特許出願第60/978,810号、第60/978,820号、第60/978,856号及び第60/978,862号の優先権を主張するものである。
本発明は、尿サンプル中の微生物、例えばバクテリア、の同定及び定量を行うためのシステムに関する。詳しくは、本発明は、尿サンプル中のバクテリアを同定するためのシステムであって、(1)遠心分離管と、互いに異なる容量を有する2つのピペットチップと、光学カップ又はキュベットと、を含む使い捨てコンポーネントを保持するための使い捨てカートリッジ又はホルダと、(2)前記尿サンプルを処理又は調製するためのサンプル処理装置と、(3)処理済み尿サンプルを分析する光学分析装置と、を有するシステムに関する。4つのコンポーネントを有する前記使い捨てカートリッジは、サンプル処理装置に使用され、特に、前記光学カップ又はキュベットが、前記光学分析装置に使用される。
一般に、尿サンプル中の微生物、例えばバクテリア、を同定する現在の慣行は、微生物学研究所において微生物を同定するという、複雑で時間がかかり、かつ高コストのプロセスを伴うものである。この現在の慣行では、サンプルが研究所に受け入れられる。次に、これらの標本(被検査試料)は、仕分けされ、ラベリングされて、その後、滅菌ループを用いて血液寒天培地に植菌される。次に、これらの標本は、専用のインキュベータに24時間入れられる。1日後、研究所の技術者によって、標本の陽性培養と陰性培養とについてのスクリーニングが行われる。一般に、大半の培養物は陰性であり、それらは手作業によって報告される。陽性の培養物は単離されて生化学的流体中に懸濁される。これは、懸濁、希釈、ボルテックス、及び濁度測定を伴うものであるが、それらによって生化学的廃棄物が生じる。次に、前記培養物は、種同定と、標本を複数の試薬に晒す抗生物質感受性テストにかけられる。更にその6〜24時間の培養期間後、その知見が研究者の技術者によって解釈されて報告される。この全プロセスは、通常、標本結果を得るのに11の工程と50時間かかり、そのプロセスには多大な労働力を要する。
本発明のシステムは、標本結果を得るためのこの現在のシステムを合理化するものである。当該システムは、環境に優しく、迅速な診断を可能にするものであり、その結果には一貫性があり、何ら試薬を必要とせず、しかも多重機能診断が提供される。尿サンプルは、4つの使い捨てコンポーネント、すなわち、遠心分離管、互いに容量の異なる2つのピペットチップ、及び光学キュベット、を保持する使い捨てカートリッジに入れられる。これらのカートリッジにはバーコードが付され、患者のIDと関連付けられている。これらのカートリッジはマガジンに挿入され、その後、このマガジンが、標本を処理するサンプル処理装置に挿入される。調製された標本は、光学キュベットに移され、その後、前記マガジンは標本を分析する光学分析装置に挿入される。前記光学分析装置は、分析を行って、バクテリアの最終処理を可能にする完全な結果を提供する。このシステムは熟練したオペレータを必要とせず、迅速に結果を提供する。このシステムは、効率を向上させ、作業負荷を改善し、時間と費用を節約し、しかも操作が容易である。サンプルの調製を、標本分析と並行して行うことができ、1〜50の標本を同時に分析することができる。
Claims (13)
- 流体サンプル中の微生物の同定及び定量に使用される使い捨てカートリッジであって、
カートリッジ本体と、
前記カートリッジ本体によって受けられる複数の使い捨てコンポーネントと、を備え、
前記複数の使い捨てコンポーネントが、
未処理流体サンプルのための取り外し可能な管と、
光学分析における使用のために、処理済み流体サンプルを収容する光学カップ又はキュベットと、を含み、
前記光学カップ又はキュベットが、
前記処理済み流体サンプルの前記光学分析のために光が入る開口部と、
前記光学分析を増強させるための反射面と、を有し、
前記光学カップ又はキュベットは、円錐台の端部までその長さに沿って連続的にテーパー状に形成された側面を有し、
光学分析の際に前記光が下方へと前記開口部を通して前記流体サンプルに入り、前記側面は前記光学分析を補助するように構成され、
前記光学カップ又はキュベットの前記反射面が、光学分析のため前記流体サンプルからの蛍光発光を光収集ユニットへ向けて上方へ戻すように反射させ、
前記カートリッジ本体が前記サンプルの処理のためにサンプル処理装置内に受け入れられ、その後、前記処理済み流体サンプルを分析するために光学分析装置内に受け入れられるように構成されているカートリッジ。 - 前記流体サンプルは尿である請求項1に記載のカートリッジ。
- 前記光は紫外(UV)光線を含み、前記カートリッジ本体にはバーコードが付されている請求項1に記載のカートリッジ。
- 流体サンプル中の微生物の同定及び定量に使用される流体サンプルを調製するためのサンプル処理装置であって、
回転テーブルと、
未処理の流体サンプルのための取り外し可能な管と、光学カップ又はキュベットと、を含む複数の使い捨てコンポーネントを保持するための複数のカートリッジを保持するように構成され、
前記回転テーブルによって支持されるマガジンと、を備え、
前記光学カップ又はキュベットは、前記流体サンプルの光学分析のために光が入る開口部と、前記光学分析を増強させるための反射面と、を有し、
前記光学カップ又はキュベットは、円錐台の端部までその長さに沿って連続的にテーパー状に形成された側面を有し、
光学分析の際に光が下方へと前記開口部を通して前記流体サンプルに入り、前記側面は前記光学分析を補助するように構成され、
前記光学カップ又はキュベットの前記反射面が、光学分析のために前記流体サンプルから蛍光発光を光収集ユニットへ向けて上方へ戻すように反射させるサンプル処理装置。 - 前記流体サンプル中の溶解物を希釈するとともに、希釈された流体サンプルを各カートリッジの前記光学カップ又はキュベットへと移す可動流体移送アームを更に備える請求項4に記載のサンプル処理装置。
- 前記流体サンプル中の溶解物の希釈のために、クリーンな流体を前記流体サンプルに移すシリンジポンプディスペンサ流体システムを更に備える請求項4に記載のサンプル処理装置。
- 前記流体サンプルは尿である請求項4に記載のサンプル処理装置。
- 流体サンプル中の微生物の同定及び定量を行うためのシステムであって、
未処理流体サンプルのための取り外し可能な管と、光学カップ又はキュベットと、を含む複数の使い捨てコンポーネントを保持する複数の使い捨てカートリッジを備え、
前記光学カップ又はキュベットは、円錐台の端部までその長さに沿って連続的にテーパー状に形成された側面と反射面とを有し、
さらに、前記複数の使い捨てカートリッジを受け取るとともに、前記流体サンプルを調製し、これらの流体サンプルを、各前記使い捨てカートリッジの各光学サンプルカップ又はキュベットに移すように構成されたサンプル処理装置と、
前記複数の使い捨てカートリッジを受け取るとともに、前記流体サンプル中に含まれる微生物のタイプと量とを分析する光学分析装置と、を備え、
前記光学分析装置は、前記光学カップ又はキュベットの上方に位置する励起ユニットと、光収集ユニットを有し、
光学分析の際に光が下方へ向かい前記光学カップ又はキュベットの開口部を通して前記流体サンプルに入り、前記側面は前記光学分析を補助するように構成され、
前記光学カップ又はキュベットの前記反射面が、前記流体サンプルから蛍光発光を光学分析のために前記光収集ユニットへ向けて上方へ戻すように反射させるシステム。 - 前記流体サンプルは尿である請求項8に記載のシステム。
- 前記使い捨てカートリッジはカートリッジ本体を更に有し、前記カートリッジ本体にはバーコードが付されている請求項8に記載のシステム。
- 前記光は、紫外(UV)光を含む請求項8に記載のシステム。
- 前記容器は、プラスチック、ガラス及びアルミニウムから成るグループから選択される材料から形成され、前記反射面は、材料コーティング及び材料層から成るグループから選択される請求項8に記載のシステム。
- 前記反射面は前記容器の内側反射面であり、前記容器が使い捨て材料から形成されている請求項8に記載のシステム。
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CN101918581B (zh) | 2015-04-15 |
EP2209904A2 (en) | 2010-07-28 |
IL254555A0 (en) | 2017-11-30 |
US8808649B2 (en) | 2014-08-19 |
US10656140B2 (en) | 2020-05-19 |
US20200240977A1 (en) | 2020-07-30 |
US9606105B2 (en) | 2017-03-28 |
EP2209904A4 (en) | 2013-05-29 |
EP3192876A1 (en) | 2017-07-19 |
JP2016145841A (ja) | 2016-08-12 |
EP2209904B1 (en) | 2017-03-01 |
US20150010993A1 (en) | 2015-01-08 |
JP2011501132A (ja) | 2011-01-06 |
US20110008825A1 (en) | 2011-01-13 |
JP6673970B2 (ja) | 2020-04-01 |
JP2017156355A (ja) | 2017-09-07 |
WO2009049171A3 (en) | 2009-07-16 |
IL204975A (en) | 2017-12-31 |
US20170146515A1 (en) | 2017-05-25 |
WO2009049171A2 (en) | 2009-04-16 |
JP6151822B2 (ja) | 2017-06-21 |
IL254555B (en) | 2021-01-31 |
CN101918581A (zh) | 2010-12-15 |
JP6334783B2 (ja) | 2018-05-30 |
CN104777291A (zh) | 2015-07-15 |
JP2014197025A (ja) | 2014-10-16 |
CN104777291B (zh) | 2017-09-12 |
JP2018151392A (ja) | 2018-09-27 |
IL204975A0 (en) | 2010-11-30 |
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