JP5693528B2 - ヒトの体液中のターゲットを特定することにより疾病を高速に検出する方法 - Google Patents
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Description
治療に関わる問題を高速に分析することは、種々のウィルス性作用因子および他の病原性微生物学的作用因子(細菌等)を診断および治療する際にますます重要視されている。殊に、感染疾病の急性状態において、医師は、観察される症候の原因となる作用因子の直ちに検出する必要性をもっている。
第1の視点で、本発明は、次の工程:
(a)体液試料を綿棒部材で非侵襲的に捕集する工程、
(b)この試料を試料分析デバイス上の塗布帯域に移す工程、および
(c)この試料を分析する工程を有することを特徴とする、体液中の病原体および/またはアレルギーに関連する成分から選択されるターゲットを検出する方法に関する。
(a)涙液試料を綿棒部材で非侵襲的に捕集する工程、
(b)この試料を試料分析デバイス上で塗布帯域に移す工程、および
(c)この試料を分析する工程を有することを特徴とする、結膜炎を診断する方法に関する。
(a)体液試料を非侵襲的に捕集するための綿棒部材と、
(b)検出帯域を有する試料分析デバイスとを含む試験キットであって、この検出帯域が病原体および/またはアレルギーに関連する成分から選択された少なくとも1つのターゲットの存在および/または量を測定するための試薬を含有する、前記試験キットに関する。
(a)涙液試料を非侵襲的に捕集するための綿棒部材と、
(b)検出帯域を有する試料分析デバイスとを含む試験キットであって、この検出帯域が病原体および/またはアレルギーに関連する成分から選択された少なくとも1つのターゲットの存在および/または量を測定するための試薬を含有し、前記ターゲットが結膜炎の原因物質または媒介物質または複数のかかる原因物質および/または媒介物質である、前記試験キットに関する。
図1は、吸着パッド(1)を形成する複数の異なるストリップ材料と塗布帯域(2)と検出帯域(3)と廃棄帯域(4)とを有するクロマトグラフィー試験ストリップの形の試料分析デバイスを示す。ストリップ材料は、吸着性プラスチック裏地(5)上に配置されている。吸着パッド(1)は、検出帯域(3)への試料の移動を簡易化する目的で溶離媒体を添加するために備えられている。
本発明は、体液から非侵襲的な手段によって捕集された試料中のターゲット、例えば病原体および/またはアレルギーに関連した成分を検出するための感知しうる高速な方法を提供する。病原体は、ウィルス、微生物、例えば細菌類および寄生虫、例えばアメーバまたは線虫から選択される。アレルギーに関連した成分は、アレルゲンおよび抗アレルギー性成分から選択される。検出は、ターゲット、例えば病原体の直接の検出および/またはターゲット、例えば試験すべき液体試料中に存在する病原体に抗する抗体の検出を含むことができる。好ましくは、前記方法は、複数のターゲットを同時に測定することを含む。
塗布帯域。
溶離媒体で移動しうる少なくとも1つの標識化された結合成分を含有する複合帯域。この結合成分は、検体および他の特異的な試薬に検出帯域で特異的に結合しうる。
第1の検体、例えば検体のために不動態化された特異的な結合成分を有する試験系列を検出するための第1の部分と、場合によってはさらに他の検体を検出するための部分と、少なくとも1つの対照部分、例えば試験キットの機能を示す指示薬の不動態化された結合成分を有する対照系列とを含む検出帯域。
患者の眼用綿棒からのアデノウィルスを検出するための試験キット。試験ストリップの構造は、図1に示されている。
Claims (18)
- 体液中の病原体およびアレルギーに関連する成分から選択されるターゲットを検出する方法において、次の工程:
(a)体液試料を綿棒部材で非侵襲的に捕集する工程、
(b)前記綿棒部材を側方流クロマトグラフィー試験ストリップ上の試料塗布帯域に直接接触させる工程であって、前記試料が、前記綿棒部材と前記側方流クロマトグラフィー試験ストリップ上の試料塗布帯域とに接触する前には希釈されることがなく、かつ、前記綿棒部材の前記試料塗布帯域への接触に起因して前記体液試料の少なくとも一部が前記試料塗布帯域に直接的に放出される、工程であって、ここで、前記側方流クロマトグラフィー試験ストリップは、前記試料塗布帯域内において少なくとも部分的に位置している複合帯域をさらに備えているとともに、前記ターゲットのための結合成分を少なくとも1種含んでいる、工程、
(c)前記側方流クロマトグラフィー試験ストリップ上の試料塗布帯域の側方上流に位置する吸収パッドに溶離媒体を適用して前記試料を前記側方流クロマトグラフィー試験ストリップ上の検出帯域に移動させる工程、ならびに
(d)前記試料を分析する工程
を有することを特徴とする、
方法。 - 前記病原体が、ウィルス、細菌類、微生物および寄生虫から選択され、かつ、前記アレルギーに関連する成分が、アレルゲンおよび抗アレルゲンから選択される、請求項1記載の方法。
- 前記ターゲットが、結膜炎の原因物質または複数のかかる原因物質である病原体であり、かつ/または、前記ターゲットが、結膜炎の原因物質または媒介物質または複数のかかる原因物質および/または媒介物質であるアレルギーに関連する成分である、請求項1記載の方法。
- 前記ターゲットは、少なくとも1つの病原体およびアレルギーに関連する少なくとも1種の成分を有する、請求項1記載の方法。
- 前記試料は、0.1μl〜100μlである、請求項1記載の方法。
- 前記工程(a)は、試験すべき体液を含む身体部分の表面上で、前記綿棒部材でぬぐい操作するかまたは軽くたたく操作を行う副工程を含む、請求項1記載の方法。
- 請求項1に記載の方法であって、
前記複合帯域中の結合成分は、前記溶離媒体で拡散可能な標識化された結合成分を少なくとも1種含み、かつ、
前記複合帯域は、前記吸収パッドと前記試料塗布帯域の間に位置している、
方法。 - 前記工程(d)は、免疫学的検出または酵素検出を有する、請求項1記載の方法。
- 結膜炎の存在を検出する方法において、次の工程:
(a)涙液試料を無菌の綿棒部材で非侵襲的に捕集する工程、
(b)前記綿棒部材を側方流クロマトグラフィー試験ストリップ上の試料塗布帯域に直接接触させる工程であって、前記涙液試料が、前記綿棒部材と前記側方流クロマトグラフィー試験ストリップ上の試料塗布帯域とに接触する前には希釈されることがなく、かつ、前記綿棒部材の前記試料塗布帯域への接触に起因して前記涙液試料の少なくとも一部が前記試料塗布帯域に直接的に放出される、工程であって、ここで、前記側方流クロマトグラフィー試験ストリップは、前記試料塗布帯域内において少なくとも部分的に位置している複合帯域をさらに備えているとともに、前記ターゲットのための結合成分を少なくとも1種含んでいる、工程、
(c)前記側方流クロマトグラフィー試験ストリップ上の試料塗布帯域の側方上流に位置する吸収パッドに溶離媒体を適用して前記涙液試料を前記側方流クロマトグラフィー試験ストリップ上の検出帯域に移動させる工程、ならびに
(d)前記試料を分析する工程
を有することを特徴とする、方法。 - 前記涙液試料は、結膜炎の原因物質または複数のかかる原因物質である病原体の存在について分析され、かつ/または、前記涙液試料は、結膜炎の原因物質または媒介物質または複数のかかる原因物質および/または媒介物質であるアレルギーに関連する成分の存在について分析される、請求項9記載の方法。
- 請求項9記載の方法であって、
前記複合帯域中の結合成分は、前記溶離媒体で拡散可能な標識化された結合成分を少なくとも1種含み、かつ、
前記複合帯域は、前記吸収パッドと前記試料塗布帯域の間に位置している、
方法。 - 体液から分析対象を検出するための検査キットであって、
(a)側方流クロマトグラフィー試験ストリップであって、
(i)試料塗布帯域;
(ii)前記試料塗布帯域の側方下流に位置する検出帯域;
(iii)当該側方流クロマトグラフィー試験ストリップ上にある吸収パッドであって、体液試料を前記検出帯域に移動させるための溶離媒体を適用するための吸収パッドであるとともに、前記試料塗布帯域と前記検出帯域からは側方上流に位置している吸収パッド;及び
(iv)前記試料塗布帯域内において少なくとも部分的に位置する複合帯域であって、前記溶離媒体で拡散可能な、分析対象のための標識化された結合成分を少なくとも1種含む複合帯域
を含む側方流クロマトグラフィー試験ストリップと、
(b)無菌の綿棒部材であって、前記体液試料に接触する位置にあるときに当該体液試料を非侵襲的に捕集するとともに、前記試料塗布帯域に接触したときに前記体液試料の少なくとも一部を当該体液試料の希釈を行うことなく前記試料塗布帯域に直接的に放出する綿棒部材と
を含み、
前記分析対象が、病原体および/またはアレルギーに関連する成分から選択されたターゲットであり、ここで、前記病原体が結膜炎の原因物質または複数のかかる原因物質であり、かつ、前記アレルギーに関連する成分が結膜炎の原因物質または媒介物質または複数のかかる原因物質および/または媒介物質である、
検査キット。 - 前記複合帯域が前記吸収パッドおよび前記試料塗布帯域の間に位置する、
請求項12に記載の検査キット。 - 体液から分析対象を検出するためのデバイスであって、
(i)側方流クロマトグラフィー試験ストリップ上の試料塗布帯域;
(ii)前記側方流クロマトグラフィー試験ストリップ上の試料塗布帯域の側方下流に位置する検出帯域;
(iii)吸収パッドであって、前記体液試料を前記検出帯域に移動させるための溶離媒体を適用するための吸収パッドであり、かつ前記側方流クロマトグラフィー試験ストリップ上の試料塗布帯域と前記検出帯域からは側方上流に位置している吸収パッド;
(iv)無菌の綿棒部材であって、前記体液試料に接触する位置にあるときに当該体液試料を非侵襲的に捕集するとともに、前記試料塗布帯域に接触したときに前記体液試料の少なくとも一部を当該体液試料の希釈を行うことなく前記試料塗布帯域に直接的に放出する綿棒部材;及び
(v)前記試料塗布帯域内において少なくとも部分的に位置する複合帯域であって、前記溶離媒体で拡散可能な、分析対象のための結合成分を少なくとも1種含む複合帯域
を含み、
前記分析対象が、病原体および/またはアレルギーに関連する成分から選択されたターゲットである、
デバイス。 - 前記病原体が結膜炎の原因物質または複数のかかる原因物質であり、かつ、前記アレルギーに関連する成分が結膜炎の原因物質または媒介物質または複数のかかる原因物質および/または媒介物質である、
請求項14記載のデバイス。 - 前記複合帯域が前記吸収パッドおよび前記試料塗布帯域の間に位置する、
請求項14記載のデバイス。 - 請求項1に記載の方法であって、
前記工程(b)が前記綿棒部材を前記試料塗布帯域と液接触させるように位置決めする副工程を含む、
方法。 - 請求項9に記載の方法であって、
前記工程(b)が前記綿棒部材を前記試料塗布帯域と液接触させるように位置決めする副工程を含む、
方法。
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JP5630936B2 (ja) | 2014-11-26 |
US10001482B2 (en) | 2018-06-19 |
ATE442590T1 (de) | 2009-09-15 |
CA2554904C (en) | 2013-01-22 |
US20050175992A1 (en) | 2005-08-11 |
ES2332523T3 (es) | 2010-02-08 |
JP2007534935A (ja) | 2007-11-29 |
AU2005210742A1 (en) | 2005-08-18 |
WO2005075982A3 (en) | 2006-02-09 |
DE602005016527D1 (de) | 2009-10-22 |
US8647890B2 (en) | 2014-02-11 |
US20100143891A1 (en) | 2010-06-10 |
US20070141564A1 (en) | 2007-06-21 |
JP2012181211A (ja) | 2012-09-20 |
AU2005210742B2 (en) | 2011-06-09 |
US20140080204A1 (en) | 2014-03-20 |
EP1718973B1 (en) | 2009-09-09 |
WO2005075982A2 (en) | 2005-08-18 |
US7723124B2 (en) | 2010-05-25 |
CA2554904A1 (en) | 2005-08-18 |
EP1718973A2 (en) | 2006-11-08 |
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