JP6722699B2 - 生体サンプルの収集および分析デバイスならびにその使用方法 - Google Patents
生体サンプルの収集および分析デバイスならびにその使用方法 Download PDFInfo
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- JP6722699B2 JP6722699B2 JP2017561047A JP2017561047A JP6722699B2 JP 6722699 B2 JP6722699 B2 JP 6722699B2 JP 2017561047 A JP2017561047 A JP 2017561047A JP 2017561047 A JP2017561047 A JP 2017561047A JP 6722699 B2 JP6722699 B2 JP 6722699B2
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Description
Claims (13)
- デバイスであって、
亜硝酸塩を含む抽出試薬で満たされた抽出チャンバーと、
ステムに取り付けられ、該ステムのサンプル収集帯において生体サンプルを得るように構成される吸収要素を有して成るスワブと、
前記生体サンプルからの被分析物の抽出後に抽出溶液との流体連通をもたらすように構成される検査ストリップとを有して成り、
前記吸収要素が不揮発性試薬を含んで成り、
前記不揮発性試薬が前記抽出溶液を形成するように前記抽出試薬と反応するように構成され、
前記抽出溶液が前記生体サンプルから被分析物を抽出するように構成され、
前記不揮発性試薬が前記生体サンプルと反応しないように構成され、
前記不揮発性試薬が酸性であり、
前記抽出溶液を形成するために、前記抽出試薬と流体連通する前記スワブの吸収要素を位置付けるように、該スワブが前記抽出チャンバー内に受け入れられるように構成され、
前記検査ストリップが、
サンプルを受け入れるように構成されるサンプル受け部と、
被分析物特異的標識試薬が組み込まれている前記検査ストリップ上の部位と、
アッセイ完了時に陽性または陰性の結果の表示をもたらすように、前記生体サンプルおよび前記被分析物特異的標識試薬から、前記被分析物を受け取るように構成される捕捉部分と、ならびに、
前記検査ストリップの遠位端に取り付けられ、過剰な抽出試薬に結合するように構成され、それにより該検査ストリップを横切る流れを可能とする吸着パッドとを有して成り、
前記サンプルが液体サンプルであり、ならびに、
前記サンプル受け部が、キャピラリー作用により前記検査ストリップを通るような前記液体サンプル中の前記被分析物の移動を可能とするように構成され、
前記被分析物特異的標識試薬が、前記生体サンプルからの前記被分析物を結合するように構成され、ならびに、
前記被分析物特異的標識試薬が、特異的に、また高い親和力で前記被分析物を結合する分子を含んで成り、および該被分析物特異的標識試薬が、前記被分析物の検出を可能にする標識で標識される、デバイス。 - 前記被分析物が、A群連鎖球菌の炭水化物抗原である、請求項1に記載のデバイス。
- 前記スワブおよび前記検査ストリップが、該スワブの吸収要素から該検査ストリップのサンプル受け部までキャピラリー・フローをもたらすように流体連通するように構成される、請求項1または2に記載のデバイス。
- 前記ステムが、固体、ポーラス状もしくはそれらの組合せであり、ならびに/または前記ステムが、前記スワブの吸収要素のための機械的なサポートおよび該ステムのポーラス状コアを通るようなキャピラリー・フローを供するように構成される、請求項1〜3のいずれかに記載のデバイス。
- 前記スワブの吸収要素が、ファイバー、ポリマー材の発泡体、吸収性物質、またはそれらのいずれかの組合せから成る、請求項1〜4のいずれかに記載のデバイス。
- 前記酸性の不揮発性試薬が、前記スワブの吸収要素に、酸性の不揮発性試薬を含む溶剤をスプレーイング、ディッピング、もしくはディスパージングすること、および該溶剤を気化させることによって、該スワブの吸収要素に堆積され、ならびに/または前記酸性の不揮発性試薬の量が、2〜800マイクロモルである、請求項1〜5のいずれかに記載のデバイス。
- 前記酸性の不揮発性試薬が、前記抽出試薬に可溶である、請求項1〜6のいずれかに記載のデバイス。
- 前記酸性の不揮発性試薬が、前記抽出試薬に不溶である、請求項1〜6のいずれかに記載のデバイス。
- 前記酸性の不揮発性試薬が、前記抽出試薬とプロトンを交換するようになっており、ならびに/または
前記不溶性の酸性の不揮発性試薬が、前記吸収要素に付くように構成される領域内で前記スワブに堆積され、および前記不溶性の酸性の不揮発性試薬が、酸と対象物との間の直接的な接触を避けることをもたらすように、前記吸収要素の適用前に、ポリマー材の、メンブレンもしくはフィルムでコーティングされることによって、前記スワブに堆積される、請求項8に記載のデバイス。 - 前記酸性の不揮発性試薬が、有機物または無機物である、請求項1〜9のいずれかに記載のデバイス。
- 前記デバイスが、
前記スワブのステムによって、該スワブの吸収要素を取り付けるように構成される第1構造要素、
前記検査ストリップを収納するように構成される第2構造要素を有して成り、
前記吸収要素および前記検査ストリップのサンプル受け部が、第1構造要素と第2構造要素とを連結すると流体連通する、請求項1〜10のいずれかに記載のデバイス。 - (i)生体サンプルと反応しないように構成される第1不揮発性試薬を含んで成るスワブの収集範囲において該スワブを用いることによって、対象の生体サンプルを集めること、
(ii)前記不揮発性試薬が抽出試薬と反応することを可能とし、また抽出溶液を生成することをもたらすように、前記不揮発性試薬と反応するように構成される該抽出試薬を含むチャンバーに前記スワブを移動させること、
(iii)前記抽出溶液によって、前記対象の生体サンプルから被分析物を抽出すること、
(iv)前記抽出した被分析物を含む抽出溶液と、標識被分析物特異的試薬を含んで成る側方流動イムノクロマトグラフィー・アッセイ・デバイスとを接触させること、ならびに、
(v)前記対象の生体サンプル中で抽出した被分析物の陽性または陰性を判定することを含んで成り、
捕捉試薬への前記被分析物の結合によって、標識被分析物指標複合体を、側方流動イムノクロマトグラフィー・アッセイ・デバイスに、特異的に固定化することをもたらしており、また該捕捉試薬が該被分析物に特異的に結合するように構成される、方法。 - (i)スワブの吸収要素によって、対象の生体サンプルを集めること、
(ii)前記スワブの吸収要素を、不揮発性試薬と反応するように構成される抽出試薬を含むチャンバーに移動させること、
(iii)前記生体サンプルから被分析物を抽出すること、
(iv)捕捉試薬への標識被分析物指標複合体の結合によって生じる信号を測定することによって、前記対象の生体サンプル中で抽出した被分析物の陽性または陰性を判定することを含んで成り、
前記スワブの吸収要素が、標識被分析物特異的試薬を含んで成る、側方流動イムノクロマトグラフィー・アッセイの検査ストリップのサンプル受け部と物理的に接触するように構成され、および
前記スワブの吸収要素が、それに組み込まれる前記不揮発性試薬を含み、該不揮発性試薬が前記生体サンプルと反応しないように構成され、
抽出溶液が、前記抽出試薬と前記スワブの吸収要素に組み込まれている付加的な不揮発性試薬との反応によって、インシチュで形成され、および、
前記抽出溶液が、前記対象の生体サンプルを抽出するように構成され、
前記捕捉試薬が、前記側方流動イムノクロマトグラフィー・アッセイ・デバイスに固定化され、および、
前記捕捉試薬が、前記被分析物を特異的に結合するように構成される、方法。
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|
R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |