JP6400012B2 - 診断装置および方法 - Google Patents
診断装置および方法 Download PDFInfo
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Description
本発明は、人間または動物の体における妊娠などの状態を特定するための装置および方法に関する。
特定のための1つまたは複数の検査部と、
第1の対象状態のマーカーを提供する、体からの生体サンプル中の第1の分析物と、
前記生体サンプル中の、第1の分析物とは異なる第2の分析物と、を含み、
第1および第2の分析物の両方の特定に基づいて、体における第1の対象状態を特定するように構成された装置を提供する。
第1の対象状態のマーカーを提供する、体からの生体サンプル中の第1の分析物を特定する段階と、
生体サンプル中の、第1の分析物とは異なる第2の分析物を特定する段階と、
第1および第2の分析物の両方の特定に基づいて、体における第1の対象状態を特定する段階と、
を含む方法を提供する。
複数の第1および第2の標識結合抗体を含む標識保持部であって、第1の標識結合抗体の各々が第1の蛍光構造体を含み、かつ生体サンプル中の第1の分析物の分子と結合して標識された第1の分析物複合体を形成するように構成され、第2の標識結合抗体の各々が第2の蛍光構造体を含み、かつ生体サンプル中の第2の分析物の分子と結合して標識された第2の分析物複合体を形成するように構成された、標識保持部と、
前記標識された第1の分析物複合体および標識された第2の分析物複合体の両方を固定化するように構成された検査部と、を備え、
光による励起によって、第1の蛍光構造体が第1の波長で蛍光発光するように構成され、第2の蛍光構造体が第1の波長とは異なる第2の波長で蛍光発光するように構成された、ラテラルフロー試験片が提供される。
少なくとも部分的にラテラルフロー試験片を収納し、1つまたは複数の光源および1つまたは複数の光検出器に隣接して試験片の検査部を配置するように構成されたハウジングと、
1つまたは複数の光検出器に接続されたプロセッサと、を備え、
試験片の検査部を1つまたは複数の光源によって照射することによって、プロセッサが、(i)検査部で複数の第1の蛍光構造体から放出される第1の波長の光の強度、および(ii)検査部で複数の第2の蛍光構造体から放出される、第1の波長とは異なる第2の波長の光の強度、を示す信号を1つまたは複数の光検出器から受信するように構成された、読取機が提供される。
サンプル中のMUC5Aタンパク質のレベルにかかわらず、サンプル中のインフルエンザ抗原が抗原閾値レベル(TFlu)以上であるとの判断に基づいて、インフルエンザを有さないと特定することができ、
サンプル中のインフルエンザ抗原が抗原閾値レベル(TFlu)未満であり、かつサンプル中のMUC5Aタンパク質のレベルが閾値(TMUC5A)以上であるとの判断に基づいて、インフルエンザを有さないと特定することができ、かつ/または
サンプル中のインフルエンザ抗原が抗原閾値レベル(TFlu)未満であり、かつサンプル中のMUC5Aタンパク質のレベルがMUC5A閾値レベル(TMUC5A)未満であるとの判断に基づいて、装置がインフルエンザの特定が不可能であるかまたは不明であることを示すことができるように構成され得る。
ここで、添付の図面を参照した特定の実施例によって本発明の実施形態を説明する。
Claims (22)
- 人間または動物の体における少なくとも妊娠を特定する検査装置であって、前記検査装置が、
第1の分析物および第2の分析物を含む前記体からの生体サンプルを収容するための1つまたは複数の検査部と、
前記1つまたは複数の検査部を分析し、
前記体からの前記生体サンプル中の前記第1の分析物のレベルと、
前記生体サンプル中の前記第2の分析物のレベルと、を特定する読取機と、を備え、
前記第1の分析物がヒト絨毛性ゴナドトロピン(hCG)であり、前記第2の分析物が黄体形成ホルモン(LH)であり、
前記検査装置が、特定されたhCGのレベルがhCG閾値を超えている場合に前記体における妊娠を特定するように構成され、前記検査装置が前記サンプル中の特定されたLHのレベルに応じて前記hCG閾値を変更する、検査装置。 - 前記hCG閾値が、前記サンプル中の特定されたLHのレベルに依存する連続変数である、請求項1に記載の検査装置。
- 前記hCG閾値が、前記サンプル中の特定されたLHのレベルに依存する離散変数である、請求項1に記載の検査装置。
- 前記検査装置が、前記サンプル中の特定されたLHのレベルがLH閾値未満である場合には、妊娠を特定するために前記hCG閾値を第1hCG閾値に設定し、前記サンプル中の特定されたLHのレベルがLH閾値を超える場合には、妊娠を特定するために前記hCG閾値を第2hCG閾値に設定し、前記第1hCG閾値が前記第2hCG閾値より低い、請求項1に記載の検査装置。
- 前記第1hCG閾値と前記第2hCG閾値との差が少なくとも5IU/Lである、請求項4に記載の検査装置。
- 前記第1hCG閾値と前記第2hCG閾値との差が少なくとも15IU/Lである、請求項4に記載の検査装置。
- 妊娠を特定するための前記hCG閾値が、前記サンプル中の特定されたLHのレベルに応じて3またはそれより多くの異なるhCG閾値の1つに設定される、請求項1に記載の検査装置。
- 前記検査装置が、前記体における妊娠を特定し、かつ前記体における月経周期における排卵期を特定するためのものであり、
前記体において妊娠が特定されない場合、前記サンプル中の特定されたLHのレベルがLH閾値を超えている場合には前記体における月経周期における排卵期を特定するように前記検査装置が構成されている、請求項1に記載の検査装置。 - ディスプレイを備え、該ディスプレイを介して妊娠の特定に関する情報をユーザーに表示するように構成された、請求項1から8のいずれか一項に記載の検査装置。
- 前記検査装置が携帯型検査装置である、請求項1から9のいずれか一項に記載の検査装置。
- 1つまたは複数のラテラルフロー試験片を備え、1つまたは複数の検査部が1つまたは複数のラテラルフロー試験片内に設けられている、請求項1から10のいずれか一項に記載の検査装置。
- 前記ラテラルフロー試験片の1つが前記第1の分析物および前記第2の分析物の両方を特定するために使用される、請求項11に記載の検査装置。
- 前記ラテラルフロー試験片の1つが、それぞれ第1および第2の分析物を標識するように構成された第1および第2の蛍光構造体を少なくとも含み、前記第1および第2の蛍光構造体が異なる波長で蛍光を発するように構成された、請求項12に記載の検査装置。
- 前記読取機が、1つまたは複数の検査部での光反射または光出力を観察することができる1つまたは複数の光検出器を含む、請求項1から13のいずれか一項に記載の検査装置。
- 人間または動物の体における少なくとも妊娠を特定するための方法であって、
前記体からの生体サンプル中の第1の分析物を特定する段階であって、前記第1の分析物がhCGである、段階と、
前記生体サンプル中の第2の分析物を特定する段階であって、前記第2の分析物がLHである、段階と、
前記サンプル中の特定されたLHのレベルに基づいて、妊娠を特定するためのhCG閾値を変更する段階と、
前記サンプル中の特定されたhCGのレベルが変更後のhCG閾値を超えている場合には、前記体における妊娠の指標を提供する段階と、を含む方法。 - 前記hCG閾値が、前記サンプル中の特定されたLHのレベルに依存する連続変数である、請求項15に記載の方法。
- 前記hCG閾値が、前記サンプル中の特定されたLHのレベルに依存する離散変数である、請求項15に記載の方法。
- 前記サンプル中の特定されたhCGのレベルが第1hCG閾値を超えており、前記サンプル中の特定されたLHのレベルがLH閾値未満である場合には、前記体における妊娠の指標を提供する段階と、
前記サンプル中の特定されたhCGのレベルが第2hCG閾値を超えており、前記サンプル中の特定されたLHのレベルがLH閾値を超えている場合には、前記体における妊娠の指標を提供する段階と、を含み、
前記第1hCG閾値が前記第2hCG閾値より低い、請求項15に記載の方法。 - 前記第1hCG閾値と前記第2hCG閾値との差が少なくとも5IU/Lである、請求項18に記載の方法。
- 前記第1hCG閾値と前記第2hCG閾値との差が少なくとも15IU/Lである、請求項18に記載の方法。
- 妊娠を特定するための前記hCG閾値が、前記サンプル中の特定されたLHのレベルに応じて3またはそれより多くの異なるhCG閾値の1つに設定される、請求項15に記載の方法。
- 前記方法が、前記体における妊娠を特定し、かつ前記体における月経周期における排卵期を特定するためのものであり、
前記体における妊娠の指標が提供されない場合、特定されたLHのレベルがLH閾値を超えている場合には前記体における月経周期における排卵期の指標を提供する段階をさらに含む、請求項15に記載の方法。
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