JP2016509236A - 転換領域を持つ複数面の側方流動アッセイ - Google Patents
転換領域を持つ複数面の側方流動アッセイ Download PDFInfo
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Abstract
Description
本出願は、以下の係属中の特許出願からの優先権を主張するものである:
2013年3月7日出願の米国特許出願第13/788,616号、表題「MULTIPLANAR LATERAL FLOW ASSAY WITH DIVERTING ZONE」;
2013年3月8日出願の米国特許出願第13/790,125号、表題「METHOD AND DEVICE FOR COMBINED DETECTION OF VIRAL AND BACTERIAL INFECTIONS」;
2013年3月8日出願の米国特許出願第13/790,160号、表題「METHOD AND DEVICE FOR COMBINED DETECTION OF VIRAL AND BACTERIAL INFECTIONS」。
本発明はポイント・オブ・ケア検査の分野に関する。より具体的には、本発明は側方流動アッセイに関する。
側方流動アッセイは、1つのアッセイストリップで様々な試薬と製造工程を組み合わせて、それにより標的分子の検出のための高感度且つ迅速な手段を提供する、アッセイの一部(subset)である。抗体に基づいた側方流動イムノアッセイは、多様な標的分析物に利用可能であり、サンドイッチ試験又は競合試験の原理のために設計され得る。一般的に、複数のエピトープを含む高分子量の分析物は、サンドイッチ形式で分析されるが、1つのエピトープのみを表す小分子は、競合アッセイによって検出される。最初の試験は、ヒト絨毛性ゴナドトロピン(hCG)のために行なわれた。今日では、排卵をモニタリングするための、感染症の病原体を検出するための、薬物の乱用を分析するための、及び、人間生理学にとって重要な他の分析物を測定するための、商業上利用可能な試験が存在する。獣医試験、環境試験、および、製品のモニタリングのための商品も導入されている。
領域の境界は、好ましくは、横方向に垂直な平面である。用語「領域」は用語「線」を包含し、「線」は幅よりもかなり小さな横方向の長さを有する領域を指す。
その後、試験領域(45)中の固定化されたタグ(511)はタグ(519)と結合する。標識化された接合体(505)が標識(509)を含んでいるので、形成される複合物は検知可能であり、陽性の結果を示す。試験の適切な操作は、好ましくは、対照領域(46)の対照領域結合パートナーとその固定化されたパートナーとの間の相互作用によって、対照領域(46)で検知可能な陽性結果をもたらす。
分離すると、MxAもCRPのみも、ウイルス感染と細菌感染の両方の同定では敏感でなく且つ特異的ではない。CRPの低いカットオフ値は、細菌感染を検出するための高感度と低特異性を示す。CRPの高いカットオフ値は、細菌感染を検出するための低感度と高特異性を示す。MxAはウイルス感染の同定に特異的であるが、それは細菌感染に敏感ではない。低CRP、高CRP、及びMxAのカットオフレベルを反映した医療決定点を含む結果の多重化したパターンは、ウイルス感染及び/又は細菌感染に対する免疫反応を同定するための、敏感且つ特異的な方法を提供する。
Claims (21)
- サンプル中の分析物を検知するための側方流動デバイスであって、該デバイスは:
サンプル圧縮機と;
試験領域と試験領域の上流にある転換領域とを含む試験ストリップであって、転換領域は、試験ストリップ上の側方流動を妨げる、試験ストリップと;
分析物及び標識のための第1の結合パートナーを含む接合体と;
分析物のための第2の結合パートナーと;
サンプルが側方流動デバイスに塗布されるサンプル塗布領域であって、サンプル塗布領域は、i)検出領域の上流にある試験ストリップの上;ii)サンプル圧縮機の上;及びiii)サンプルの採取のためのサンプル採取部を含むサンプル採取装置の上から成る群から選択された場所に位置する、サンプル塗布領域と
を含み;
接合体、第2の結合パートナー、及び接合体と第2の結合パートナーの両方から成る群から選択される構成要素は、側方流動デバイスの使用前に試験ストリップ上に置かれず;及び
サンプル圧縮機は、サンプル圧縮機の上に流れを転換し、且つ、転換領域の端部にて試験ストリップへ流れを戻すために、転換領域の上にブリッジを作成する
ことを特徴とする側方流動デバイス。 - サンプル塗布領域がサンプル採取装置上にある場合、サンプル採取装置は、サンプル圧縮機と、垂直な堆積物中の試験ストリップとの間に置かれる、ことを特徴とする請求項1に記載の側方流動デバイス。
- 転換領域は、試験ストリップ上の横方向の流動を止める又は遅延する、物理的障壁を含む、ことを特徴とする請求項1に記載の側方流動デバイス。
- 物理的障壁はカプセル化した構成要素を含み、物理的障壁は溶出媒体の塗布後に溶解する、ことを特徴とする請求項3に記載の側方流動デバイス。
- 転換領域は、試験ストリップ上の横方向の流動を止める又は遅延する、化学的障壁を含む、ことを特徴とする請求項1に記載の側方流動デバイス。
- 転換領域は、試験ストリップ上の横方向の流動を止める間隙を含む、ことを特徴とする請求項1に記載の側方流動デバイス。
- サンプル圧縮機はパッドを含み、接合体又は第2の結合パートナーは側方流動デバイスの使用前にパッド上に置かれる、ことを特徴とする請求項1に記載の側方流動デバイス。
- サンプル圧縮機は、パッド上に置かれた第1の対照結合パートナーと、試験ストリップの対照領域において固定される第2の対照結合パートナーとを備える、パッドを含み、第1の対照結合パートナーは、第2の対照結合パートナーのための結合パートナーである、ことを特徴とする請求項1に記載の側方流動デバイス。
- 側方流動デバイスは、陽性の結果が、分析物、第1の結合パートナー、及び第2の結合パートナーの間の複合物の形成を介して、試験領域における分析物の捕捉によってのみ達成されるように、形成される、ことを特徴とする請求項1に記載の側方流動デバイス。
- 試験領域は、特異的に分析物に結合する分子を含まない、ことを特徴とする請求項1に記載の側方流動デバイス。
- 第2の結合パートナーはタグを含み、試験領域はタグのための固定された結合パートナーを含む、ことを特徴とする請求項1に記載の側方流動デバイス。
- 試験ストリップとサンプル圧縮機とを含む側方流動デバイス上でサンプルのアッセイを実行する方法であって、該方法は:
a)側方流動デバイスの上にサンプルを置く工程;
b)試験ストリップ上に転換領域を含むことにより試験ストリップ上の側方流動を妨げる工程;
c)サンプル圧縮機を使用してデバイスに圧力を加えることにより、妨げられた流動をサンプル圧縮機へと転換する工程;及び
d)転換領域の端部で試験ストリップに流動を戻す工程
を含む方法。 - 工程a)において、サンプルは、i)検出領域の上流にある試験ストリップの上;ii)サンプル圧縮機の上;及び、iii)サンプルの採取のためのサンプル採取部を含むサンプル採取装置の上から成る群から選択される場所に置かれるサンプル塗布領域上に配される、ことを特徴とする請求項12に記載の方法。
- サンプルがサンプル採取装置上に配される場合、サンプル採取装置は、サンプル圧縮機と、垂直な堆積物中の試験ストリップとの間に置かれる、ことを特徴とする請求項13に記載の方法。
- 工程a)は、垂直な堆積物上の分析物のための結合パートナーによりパッドを配する工程を更に含み、工程d)において、結合パートナーの少なくとも一部は試験ストリップに移される、ことを特徴とする請求項14に記載の方法。
- 転換領域は、試験ストリップ上の横方向の流動を止める又は遅延する、物理的障壁を含む、ことを特徴とする請求項12に記載の方法。
- 物的的障壁が少なくとも1つのカプセル化した構成要素を含み、カプセル化した構成要素を放出するため物理的障壁を溶解する工程を更に含む、請求項16に記載の方法。
- 転換領域は、試験ストリップ上の横方向の流動を止める間隙を含む、ことを特徴とする請求項12に記載の方法。
- サンプル圧縮機は、第1の結合パートナー、第2の結合パートナー、及び第1の結合パートナーと第2の結合パートナーの両方から成る群から選択された構成要素を含む、ことを特徴とする請求項12に記載の方法。
- サンプル中の分析物を検知するための側方流動デバイスであって、該デバイスは:
サンプル圧縮機と;
サンプルの採取のためのサンプル採取部を含むサンプル採取装置と;
サンプル塗布領域、試験領域、及び転換領域を含む試験ストリップであって、転換領域は、試験ストリップ上の側方流動を妨げる、試験ストリップと;
分析物及び標識のための第1の結合パートナーを含む接合体と;
分析物のための第2の結合パートナーと
を含み;
接合体、第2の結合パートナー、及び接合体と第2の結合パートナーの両方から成る群から選択される構成要素は、側方流動デバイスの使用前に試験ストリップ上に置かれず;
サンプル圧縮機、サンプル採取装置、及び試験ストリップは、圧縮によって試験ストリップにサンプルを塗布するために垂直な堆積物を形成し;
サンプル圧縮機は、転換領域の上にブリッジを作成すること、サンプル圧縮機の上に流動を転換すること、及び転換領域の端部にて流動を試験ストリップへと戻すことにより、流動を再開し;及び
サンプル採取装置は、サンプル圧縮機と、垂直な堆積物中の試験ストリップとの間に置かれる
ことを特徴とする側方流動デバイス。 - 試験ストリップを含む側方流動デバイス上でサンプルのアッセイを実行する方法であって、該方法は:
a)サンプル圧縮機と試験ストリップのサンプル塗布領域との間に、垂直な堆積物中にサンプルを備えるサンプル採取部を含むサンプル採取装置を配する工程;
b)試験ストリップ上に転換領域を含むことにより試験ストリップ上の側方流動を妨げる工程;
c)サンプル圧縮機を使用して垂直な堆積物に圧力を加えることにより、妨げられた流動をサンプル圧縮機へと転換する工程;及び
d)転換領域の端部で試験ストリップに流動を戻す工程
を含む方法。
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