JP6773304B2 - 診断方法及びその実行装置 - Google Patents
診断方法及びその実行装置 Download PDFInfo
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Description
[技術的課題]
本開示の一態様は、試料を便利でより正確に診断する装置によって試験キットを制御する診断方法及びそれを実行する診断装置を提供することである。
本開示の一態様によれば、試料が塗抹される試料領域を有する試料プレート及び試料に接触して試料を染色する接触型パッチを格納するように構成されたパッチプレートを備えた試験キットを用いる診断装置であって、試験キットが配置される載荷領域を有する本体と、試験キットのパッチプレート及び試料プレートを互いに相対移動させることにより、試験キットに配置された試料が試料領域において塗抹されるように構成された移動ユニットと、接触型パッチが塗抹された試料に接触することにより、塗抹された試料が染色されるように、試験キットの構造体を移動させるように構成された接触ユニットと、を備えた、診断装置が提供される。
本開示によれば、サンプル(試料)を診断する診断方法が便利でより正確となり得るように、試験キットが装置により制御される。
1.1 ゲル相接触型染色パッチ
以下、本開示の一実施形態に係る、接触型染色パッチ100について説明する。
図1は、本開示の一実施形態に係る、接触型染色パッチ100の断面図である。
染色試薬140は、必要に応じて、溶媒に溶ける形態でゲル受容体120の細孔122に収容されていてもよい。ここでは、染色試薬140と染色対象の物質との間で反応が起こる場合の反応条件を生成する緩衝液Bが溶媒として用いられるようになっていてもよい。
接触型染色パッチ100は、様々な付加的構成をさらに含んでいてもよい。染色試薬140と同様に、これら付加的な構成についても、接触型染色パッチ100に含まれるゲル受容体120の細孔122に収容されていてもよい。
図2は、従来の血液塗抹検査プロセスを示した図であり、図3は、従来の血液塗抹検査プロセスの染色プロセスに関する図である。
以下、本開示の一実施形態に係る、上述の接触型染色パッチ100の製造方法について説明する。
以下、本開示の一実施形態に係る、上述の接触型染色パッチ100の実験例について説明する。
上記を考慮して、接触型染色パッチ100を利用する代表例は、以下の通りである。
血液学で用いられる従来の染色技術においては、液相の染色溶液が血液細胞又は組織に噴霧される。ただし、この方法では、残留物が試料T上に残り、残留物の除去に必須の洗浄及び乾燥プロセスを一定に制御するのが困難である。また、使用する染色試薬の製造方法、製造期間、緩衝剤のpH濃度の変化等に係る変化の影響を結果が受けやすいため、安定した染色結果を得るのが困難である。さらに、従来の標準的なプロセスには、様々な種類の機器が必要であり、当該機器を使用する手順が相当複雑であることから、非熟練者がこの手順を実行するのは極めて困難である。
免疫組織化学又は酵素結合免疫吸着検査法(ELISA)の実行において、抗体パッチは、抗体を運搬可能なパッチである。或いは、従来の液体状態の代わりとなるヒドロゲル状態において、蛍光物質等のレポータが結合された抗体を運搬可能なパッチである。
FISH試験等の実行において、DNAパッチは、蛍光物質レポータが結合されたDNAプローブを運搬するパッチであり、従来の液体状態の代わりとなるヒドロゲル状態において運搬されるパッチである。
反応対象の物質である試料Tと反応する染色試薬140を含む接触型染色パッチ100を説明した。以下では、例えば試料Tの固定又は緩衝、脱色、媒染、洗浄等、染色プロセスの全体を通して行われる他のプロセスを実行する、本開示の一実施形態に係る接触型染色補助パッチ100’について説明する。
基本的に、接触型染色補助パッチ100’の構成は、接触型染色パッチ100の構成と実質的に同じである。具体的には、接触型染色パッチ100と同様に、接触型染色補助パッチ100’は、ゲル受容体120を具備しており、染色試薬140の代わりに染色促進剤160を含んでいてもよい。
例えば、試料Tの固定に用いられる場合、染色促進剤160は、試料TをスライドS等に固定するアルコール(エタノール、メタノール、又はその他)等の試料固定剤であってもよい。
別の例において、脱色又は媒染に染色促進剤160が用いられる場合は、脱色剤又は媒染剤が染色促進剤160として用いられるようになっていてもよい。グラム染色技術においては、主染色剤としてクリスタルバイオレットを用いることによりグラム陽性細菌及びグラム陰性細菌の両者が染色された後、媒染剤としてヨウ素を用いることにより主染色剤がグラム陽性細菌に固定され、アルコール(エタノール、メタノール、又はその他)等の脱色剤を用いることにより、グラム陰性細菌に固定されていない主染色剤がグラム陰性細菌から剥がされ、コントラスト染色剤としてサフラニンを用いることにより、脱色されたグラム陰性細菌が染色されるため、グラム陽性細菌が主染色剤により染色され、グラム陰性細菌がコントラスト染色剤により染色されて、結果的に両者が互いに異なる色を示す。このプロセスにおいて、実際の染色が主染色剤及びコントラスト染色剤のみで構成されている場合、媒染剤及び脱色剤は、染色自体は行わないものの、染色を補助する役割を果たす。グラム染色技術においては、本開示の一実施形態に係る接触型染色パッチ100として、クリスタルバイオレット(主染色剤)を染色試薬140として使用する主染色パッチ及びサフラニン0(コントラスト染色剤)を染色試薬140として使用するコントラスト染色パッチが準備されるとともに、本開示の一実施形態に係る接触型染色補助パッチ100’として、ヨウ素(媒染剤)を染色促進剤160として含む媒染パッチ及びアルコール(脱色剤)を染色促進剤160として含む脱色パッチが準備されるため、主染色パッチ、媒染パッチ、脱色パッチ、及びコントラスト染色パッチをこの順序で試料Tと接触させることによって、グラム染色技術を実行することができる。
さらに別の例においては、染色促進剤160として緩衝液Bを使用する緩衝パッチが考えられる。緩衝パッチは、試料Tの染色前、染色後、又はその両者に試料Tと接触することで試料Tにおける染色の反応条件(環境条件)を生成するパッチであってもよい。ギムザ染色の場合、緩衝パッチは、ギムザ染色に適したpHの緩衝液Bが染色促進剤160としてゲル受容体120に収容された形態で設けられていてもよい。
さらに別の例においては、洗浄パッチが存在していてもよい。洗浄パッチは、染色プロセス中に洗浄を実行するパッチであり、上述の接触型染色補助パッチ100’とはいくらか異なっていて、別個の染色促進剤160を含んでいなくてもよいし、染色促進剤160として少量の水、アルコール等を使用していてもよい。
以上、接触型染色補助パッチ100’の各機能を説明したが、染色補助パッチは場合により、2つ以上の機能を同時に有していてもよい。
以下、本開示の一実施形態に係る、上述の接触型染色補助パッチ100’の製造方法について説明する。
以下、本開示の一実施形態に係る、上述の接触型染色補助パッチ100’の実験例について説明する。
以下、本開示の一実施形態に係る、試験キットについて説明する。
試験キットは、2つのプレートを具備していてもよい。ここで、2つのプレートのうちの一方は、接触型染色パッチ100を含むプレート(以下、「パッチプレート」と称する)であってもよく、2つのプレートのうちの他方は、試料Tが塗抹されるプレート(以下、「試料プレート」と称する)であってもよい。
まず、回転型試験キット1000について説明する。
図17は、本開示の一実施形態に係る、回転型試験キット1000のパッチプレート1200の一例の斜視図である。
図21は、本開示の一実施形態に係る、回転型試験キット1000の試料プレート1400の一例の斜視図である。図21を参照して、上述の通り、試料プレート1400は、内側面1404、外側面、及び側面を有するディスク状本体1402を有していてもよい。内側面1404は、パッチプレート1200に対向する表面であり、本実施形態においては、円形状に設けられていてもよい。
試験キット1000は、試料領域1420に滴下された試料Tを塗抹するように構成された塗抹ユニット1240をさらに具備していてもよい。以下、試料を塗抹する塗抹ユニット1240について説明する。
以上では、パッチプレート1200を試料プレート1400に対して回転させつつ、試料プレート1400に適用された試料Tに接触型パッチを接触させることによって、試料Tを染色するプロセスを実行可能であることを述べた。
以下、摺動型試験キット2000について説明する。
図31は、本開示の一実施形態に係る、摺動型試験キット2000のパッチプレート2200の一例の斜視図である。
図32は、図30に係る、摺動型試験キット2000の試料プレート2400の一例に関連する図である。
以上では、試料プレート2400に対して摺動させつつ、試料プレート2400上の塗抹された試料Tに接触型パッチを接触させることによって、パッチプレート2200により試料Tの染色プロセスが実行可能であることを述べた。
摺動型試験キット2000の上記説明においては、パッチプレート2200に配設されるものとして載荷ユニット2250を説明したが、その代替として、載荷ユニット2250は、試料プレート2400上に配設されていてもよい。
以上では、摺動型試験キット2000の構造を説明した。ただし、摺動型試験キット2000の構造は、種々改良可能である。特に、載荷ユニット2250、収容部2220、及び塗抹ユニット2240の配置順の種々改良によって、摺動動作の方向又は数を適正に調整するようにしてもよい。
以上では、試験キットを用いた塗抹手段において、試料が滴下される方向(正方向)に塗抹フィルムが移動することでスライドSの長手方向に試料が広がった後、塗抹フィルムが別の方向(逆方向)に移動することでスライドSの試料領域1420及び2420において試料が塗抹されることを説明した。
塗抹フィルムが正方向に試料Tまで移動し、試料Tと接触することによって塗抹フィルムの幅方向(すなわち、スライドSの幅方向)に試料が広がった後、逆方向に移動することにより試料領域において試料Tが塗抹される代わりに、試料Tに向かって正方向に移動する場合、塗抹フィルムは、(逆転位置まで)所定距離だけ試料Tを通過して移動した後、逆方向に移動するようになっていてもよい。
以上では、主に試料に適した塗抹フィルムに基づいて説明を行ってきたが、塗抹フィルムは、その表面の特性により、試料に適したフィルムと試料に適さないフィルムとに分類可能である。
塗抹フィルムを用いた塗抹においては、塗抹速度及び塗抹フィルムとスライドとの間の角度が重要と考えられる。
以上では、試料Tの挿入に際して試料Tを染色する試験キットについて説明した。以下では、上述の試験キットを使用して、試料Tの診断を自動的に実行する本開示の一実施形態に係る診断システム4300について説明する。
本開示の一実施形態に係る診断装置4310は、試験キット中に配置された試料Tを塗抹し、塗抹された試料Tを染色し、染色された試料Tの画像を取得するように構成された装置であってもよい。
本開示の一実施形態に係る移動ユニット4311は、試験キットの構造を移動させて、試験キット中に配置された試料Tの塗抹及び/又は染色の動作を行うようにしてもよい。例えば、移動ユニットは、上述の試験キットの構造を構成するパッチプレート、試料プレート、塗抹ユニット、載荷領域4610等を移動させるようにしてもよい。以下、説明を容易にするため、移動ユニット4311が試験キットの構造体を移動させる動作は、移動動作と称する。
本開示の一実施形態に係る接触ユニット4313は、試験キットの構造体を移動させて、塗抹された試料Tを染色するようにしてもよい。試験キットの構造体の移動により、接触ユニット4313は、パッチプレートに含まれる接触型パッチを試料Tと接触させるようにしてもよい。
本開示の一実施形態に係る画像取得ユニット4317は、染色された試料Tの画像を生成するようにしてもよい。
本開示の一実施形態に係る診断結果生成装置4319は、診断システム4300の診断動作により生成されたデータを解析して、試料Tの状態を診断するようにしてもよい。本実施形態において、診断結果生成装置4319は、染色された試料Tから得られた画像を解析して、試料Tの状態を診断するようにしてもよい。
図47は、本開示の一実施形態に係る、診断装置の他の要素に関連するブロック図である。
本開示の一実施形態に係る診断システム4300は、試料Tの状態が診断される診断動作を実行するようにしてもよい。
本開示の一実施形態に係る診断装置4310は、診断動作が実行可能となるように試験キットが準備される載荷動作を実行するようにしてもよい。
本開示の一実施形態に係る診断システム4300は、試験キット中に配置された試料Tが塗抹される塗抹動作を実行するようにしてもよい。
本開示の一実施形態に係る診断システム4300は、移動ユニット4311の相対移動動作によって、試験キットの塗抹ユニットを試料Tと接触させる第1の塗抹動作を実行するようにしてもよい。
本開示の一実施形態に係る診断システム4300は、移動ユニット4311の相対移動動作によって、試験キットの塗抹ユニットに試料領域の試料Tを塗抹させる第2の塗抹動作を実行するようにしてもよい。例えば、第1の塗抹動作の後、試料Tを塗抹するため、移動ユニットは、試験キットの構造体の相対移動によって、第1の動作の逆方向に試料プレートの試料領域を掃引しつつ塗抹ユニットが移動する第2の塗抹動作を実行するようにしてもよい。
本開示の一実施形態に係る診断システム4300は、試験キット中の塗抹された試料Tが染色される染色動作を実行するようにしてもよい。上述の通り、接触型パッチが試料領域の塗抹された試料と接触するように接触ユニットが接触動作を実行することによって、染色動作が実行されるようになっていてもよい。
本開示の一実施形態に係る診断システム4300は、試験キット中のパッチプレートの位置及び/又は試料プレートの位置が染色動作用に調整される動作を実行するようにしてもよい。
本開示の一実施形態に係る診断システム4300は、試料Tが染色される染色動作を実行するようにしてもよい。
以下、上述の塗抹動作及び/又は染色動作により染色された試料Tの状態を診断するために実行される診断システム4300の画像取得動作について説明する。
本開示の一実施形態に係る診断システム4300は、試験キット中に配置された染色された試料の画像を取得する場合、試験キットの構造体を移動させて画像を取得するようにしてもよい。
本開示の一実施形態に係る診断システム4300は、試験キットの構造体及び/又は試験キットが移動する上記動作の後、染色された試料Tの画像が取得される画像取得動作を実行するようにしてもよい。
診断システム4300は、染色された試料の画像が解析されて診断結果が生成される動作を実行するようにしてもよい。
本開示の一実施形態に係る試験キットのユーザは、試験キットのパッチプレートに形成された試料注入部を通じて、試料プレートの試料領域に試料を注入するようにしてもよい。試験キットの試料プレート上に配置された試料の状態を診断するため、ユーザは、本開示の診断システム4300を使用してもよい。
以下、上述の診断システム4300に関連する一連のプロセス及び/又は診断システム4300が実行する診断動作について説明する。
Claims (13)
- 試料が塗抹される試料領域を有する試料プレート及び前記試料に接触して前記試料を染色する接触型パッチを格納するように構成されたパッチプレートを備えた試験キットを用いる診断装置であって、
前記試験キットが配置される載荷領域を有する本体と、
前記試験キットの前記パッチプレート及び前記試料プレートを互いに相対移動させることにより、前記試験キットに配置された前記試料が前記試料領域上で塗抹されるように構成された移動ユニットと、
前記接触型パッチが塗抹された前記試料に接触することにより、塗抹された前記試料が染色されるように、前記試験キットの構造体を移動させるように構成された接触ユニットと、
を備えた、診断装置。 - 前記移動ユニット及び前記接触ユニットから選択される少なくとも一つが、動力を発生させるように構成された動力発生装置及び前記動力を前記試験キットの前記構造体に伝達するように構成された動力伝達部材を具備した、請求項1に記載の診断装置。
- 前記動力発生装置及び前記動力伝達部材が、互いに係合しており、
前記移動ユニット又は前記接触ユニットが、前記動力伝達部材を通じて、前記試料プレート及び前記パッチプレートに前記動力を伝達する、請求項2に記載の診断装置。 - 前記移動ユニットが、
前記接触型パッチが前記試料領域と接触している場合に、前記試験キットの前記相対移動を許可せず、
前記接触型パッチが前記試料領域と接触していない場合に、前記試験キットの前記相対移動を許可する、請求項1〜3のいずれか一項に記載の診断装置。 - 当該診断装置の前記相対移動が、前記パッチプレートが一方向に移動し、前記試料プレートが固定又は移動する形態を有しており、
前記試料プレートが前記一方向に移動する場合、前記パッチプレートの移動速度が前記試料プレートの移動速度よりも大きい、請求項1〜4のいずれか一項に記載の診断装置。 - 前記載荷領域が、前記本体の内側に形成されており、
当該診断装置が、前記載荷領域を移動させるように構成された載荷領域移動ユニットをさらに備えており、
前記載荷領域移動ユニットが、前記載荷領域の移動により、ユーザが前記試験キットを前記載荷領域に配置できるようにする、請求項1〜5のいずれか一項に記載の診断装置。 - 染色された前記試料の画像を取得するように構成された画像取得モジュールをさらに備えた、請求項1〜6のいずれか一項に記載の診断装置。
- 染色された前記試料の前記画像が、染色された前記試料が配置された前記試験キット及び前記試験キットの前記構造体から選択される少なくとも一つが移動した後に生成される、請求項7に記載の診断装置。
- 染色された前記試料の前記画像が、染色された前記試料の複数のフレーム画像の組み合わせにより生成される、請求項7又は8に記載の診断装置。
- 染色された前記試料の取得された前記画像に基づいて前記試料の状態を診断するように構成された診断モジュールをさらに備えた、請求項7〜9のいずれか一項に記載の診断装置。
- 複数の接触型パッチが存在する場合に、前記接触ユニットが、前記複数の接触型パッチが前記試料領域に順次接触するように、前記試験キットの前記構造体に動力を伝達する、請求項1〜10のいずれか一項に記載の診断装置。
- 前記接触ユニットが、前記試験キットの前記構造体において前記パッチプレートに格納された前記複数の接触型パッチに動力を伝達する、請求項11に記載の診断装置。
- 前記接触ユニットが、所定の時間にわたって、前記試験キットの前記構造体に動力を伝達することにより、前記所定の時間にわたって、前記接触型パッチが前記試料領域に接触するようにする、請求項1〜12のいずれか一項に記載の診断装置。
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