JP2018534541A - サンプルの収集、安定化、および保存のためのシステム、方法およびデバイス - Google Patents
サンプルの収集、安定化、および保存のためのシステム、方法およびデバイス Download PDFInfo
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Abstract
【選択図】図1A
Description
[0001] 本出願は、2015年9月9日出願の米国仮特許出願第62/216,312号の優先権を主張するものとし、2015年11月25日出願の米国仮特許出願第62/260,172号の優先権を主張するものとし、2016年7月26日出願の米国仮特許出願第62/367,056号の優先権を主張するものとし、2016年7月29日出願の米国仮特許出願第62/368,817号の優先権を主張するものとし、その全体の開示は参照により本明細書に組み込まれる。
参照による援用
核酸の溶出
タンパク質の溶出
Claims (60)
- (a)タグ付きのサンプル獲得および安定化システムを対象に配置するステップであって、前記システムが、(i)前記対象からの構成要素を含む血液サンプルを収集するために構成された血液収集ユニットと、(ii)前記収集された血液サンプルから前記構成要素を安定化させるために構成された安定化マトリックスと、を含み、前記タグがアッセイに関連するラベルを含む、ステップと、
(b)前記配置されたタグ付きサンプル獲得および安定化システムを収集するステップと、
(c)前記タグに基づいて前記安定化された構成要素についてアッセイを実施するステップと、
(d)前記実施されたアッセイに関するレポートを提供するステップと、を含む、方法。 - ステップ(c)の前に前記安定化マトリックスを前記システムから分離するステップをさらに含む、請求項1に記載の方法。
- 前記タグが、前記安定化マトリックス上にある、請求項1に記載の方法。
- 前記サンプル獲得および安定化システムが、前記収集された血液サンプルから前記構成要素を分離するための分離モジュールをさらに含む、請求項1に記載の方法。
- 前記タグが、前記分離モジュール上にある、請求項4に記載の方法。
- 前記安定化マトリックスが、複数のアッセイを実施するように構成されている、請求項1に記載の方法。
- 前記配置されたサンプル獲得および安定化システムに存在する前記タグに基づいて前記血液サンプル内の安定化された生物学的構成要素を同定すること、ならびに前記同定から、実施すべき安定化構成要素特異的アッセイを決定することをさらに含む、請求項1に記載の方法。
- 前記サンプル獲得および安定化システムが、RFIDトランスミッタ、カラーラベル、バーコード、または前記サンプルタグとは異なる第2のラベルでラベル付けされる、請求項1に記載の方法。
- 対象の生物学的サンプル由来の1つ以上の生物学的構成要素の分析を実施するための方法であって、
(a)(i)サンプル獲得構成要素、ならびに(ii)RNA、DNA、およびタンパク質からなる群から選択される少なくとも1つの生物学的構成要素を選択的に安定化させるように構成された1種以上の安定化試薬を含む安定化マトリックスを含む、サンプリングデバイスを得るステップと、
(b)ステップ(a)から離れた場所で、前記サンプリングデバイス内または前記サンプリングデバイス上の前記少なくとも1つの安定化された生物学的構成要素についてアッセイを実施するステップと、を含む、方法。 - 前記1種以上の安定化試薬が、固体マトリックス上に配置されるか、または固体マトリックスと一体化され、実質的に乾燥状態にある、請求項9に記載の方法。
- 前記固体マトリックスが、37℃で少なくとも11日間RNAを実質的に安定化するように構成されている、請求項9に記載の方法。
- 前記デバイス内または前記デバイス上で実施される前記アッセイが、ポリメラーゼ連鎖反応(PCR)、DNAシーケンシング、RNA発現分析、または逆転写RT−PCRのうちの1つ以上を含む、請求項10に記載の方法。
- 対象の生物学的サンプル由来の1つ以上の生物学的構成要素の分析を実施するための方法であって、
(a)(i)サンプル獲得構成要素、ならびに(ii)RNA、DNA、およびタンパク質からなる群から選択される1つ以上の生物学的構成要素を選択的に安定化させるように構成された1種以上の安定化試薬を含む安定化マトリックスを含む、サンプリングデバイスを得るステップと、
(b)前記1つ以上の生物学的構成要素を有する前記安定化マトリックスを前記サンプリングデバイスから取り出すステップと、
(c)前記安定化マトリックスについて1つ以上のアッセイを実施するステップと、を含む、方法。 - 前記安定化マトリックスが、ステップ(a)から離れた位置で前記サンプリングデバイスから取り出される、請求項13に記載の方法。
- (a)DNA、RNAおよびタンパク質からなる群から選択される1つ以上の生物学的構成要素を選択的に安定化させる1種以上の安定化試薬を含む、実質的に乾燥した固体マトリックスを周囲条件下で受け取ることと、
(b)前記1つ以上の選択的に安定化された生物学的構成要素を分析するために、前記乾燥固体マトリックスから直接的に1つ以上のアッセイを実施することと、を含む、方法。 - 前記安定化試薬が、2%未満の含水量を有する実質的に乾燥状態のメレジトースを含有する固体基板を含む、請求項15に記載の方法。
- 前記安定化試薬が、前記生物学的サンプルから核酸を抽出および保存するための固体マトリックスを含むサンプル獲得構成要素に結合し、前記固体マトリックスから得られたRNAは、少なくとも4のRNA Integrity number(RIN)を有する、請求項15に記載の方法。
- 生物学的サンプルを収集し、安定化させるためのデバイスであって、
(a)本体およびプランジャを含むサンプル獲得構成要素であって、前記本体ga、近位端と、遠位端と、前記近位端と前記遠位端との間に延在する外側本体表面と、少なくとも1つの孔を含み、前記遠位端に取り付けられている基部と、前記本体h表面内で画定された内腔と、を含み、前記プランジャが前記内腔内に配置され、前記プランジャが、近位端、遠位端、およびいずれかの端部に接続された少なくとも1つのニードルを備え、前記少なくとも1つのニードルが、前記プランジャが作動されたときに前記基部内の前記少なくとも1つの孔を貫通するように構成されている、サンプル獲得構成要素と、
試薬および基板を含むサンプル安定化構成要素であって、生物学的サンプルの構成要素が収集点から前記マトリックスを通って移動するときに、前記生物学的サンプルの構成要素が抽出され、安定化させるように構成され、前記サンプル安定化構成要素が、前記本体の前記内腔内に配置され、前記プランジャを作動させることにより、前記生物学的サンプルが、前記マトリックスの中に入り、前記生物学的サンプルの分離がさらに容易となるサンプル安定化構成要素と、を含む、デバイス。 - サンプルを収集し、安定化させるためのシステムであって、
(a)皮膚に貫入して血液を露出させるために構成された1つ以上の穿刺要素を有するサンプル獲得構成要素と、
(b)実質的に乾燥状態のメレジトースを含有する固体基板を含む、サンプル安定化構成要素と、を含む、システム。 - 前記固体基板が、溶解試薬または生体分子安定化試薬をさらに含む、請求項19に記載のシステム。
- 前記固体基板が、メレジトースを含有する液体溶液に浸漬され、メレジトースを含有する前記液体溶液が、10〜30%の範囲の濃度で存在する、請求項19に記載のシステム。
- 前記固体基板が、酵素活性を保存するために構成されている、請求項19に記載のシステム。
- 前記キットが、血漿分離構成要素をさらに含む、請求項19に記載のシステム。
- 生物学的サンプルを収集し、安定化させるためのシステムであって、
(a)皮膚に貫入して血液を露出させるために構成された1つ以上の穿刺要素を有するサンプル獲得構成要素と、
(b)RNA、DNAまたはタンパク質を選択的に安定化させるための固体マトリックスを含むサンプル安定化構成要素と、を含む、システム。 - 前記固体マトリックスが、RNAを選択的に安定化し、前記固体マトリックスから得られたRNAが、4より大きいRIN値を有する、請求項24に記載のシステム。
- 血漿分離構成要素をさらに含む、請求項24に記載のシステム。
- 前記固体マトリックスから得られたRNAが、少なくとも5のRINを有する、請求項24に記載のシステム。
- 前記固体マトリックスから得られたRNAが、少なくとも6のRINを有する、請求項24に記載のシステム。
- 前記固体マトリックスから得られたRNAが、少なくとも7のRINを有する、請求項24に記載のシステム。
- 前記固体マトリックスから得られたRNAが、7を超えるRINを有する、請求項24に記載のシステム。
- 前記固体マトリックスが、乾燥状態で前記固体マトリックス中に存在する少なくとも1種のタンパク質変性剤をさらに含む、請求項24に記載のシステム。
- 前記固体マトリックスは、乾燥状態で前記固体マトリックス中に少なくとも1種の還元剤をさらに含む、請求項24に記載のシステム。
- 前記固体マトリックスは、乾燥状態で前記固体マトリックス中に少なくとも1種のUV保護剤をさらに含む、請求項24に記載のシステム。
- 前記固体マトリックスは、乾燥状態で前記固体マトリックス中に存在する少なくとも1種の緩衝液をさらに含む、請求項24に記載のシステム。
- 前記緩衝液が、約3〜約6の範囲のpHを生じる酸滴定緩衝液試薬である、請求項34に記載のシステム。
- 前記固体マトリックスが、セルロース、酢酸セルロース、ガラス繊維、またはそれらの組み合わせを含む多孔質マトリックスである、請求項24に記載のシステム。
- 前記固体マトリックスが、不溶性乾燥固体材料である、請求項24に記載のシステム。
- 前記固体マトリックスが、水和時に酸性pHをもたらすように構成される、請求項24に記載のシステム。
- 前記固体マトリックスが、サンプルから核酸を抽出し、周囲温度で実質的に乾燥した状態で前記核酸を保存するように構成されている、請求項24に記載のシステム。
- 前記サンプル獲得構成要素が、前記サンプル安定化構成要素に接続されている、請求項24に記載のシステム。
- サンプルを収集し、安定化させるためのシステムであって、
(a)皮膚に貫入して血液を露出させるために構成された1つ以上の穿刺要素を有するサンプル獲得構成要素と、
(b)2%未満の含水量を有する実質的に乾燥した状態のメレジトースを含有する固体基板を含む、前記サンプル獲得構成要素に結合されたサンプル安定化構成要素と、を含む、システム。 - 前記固体基板が、溶解試薬、1つ以上の生体分子安定化試薬、またはそれらの組み合わせを含む、請求項41に記載のシステム。
- 前記固体基板が、メレジトースを含有する液体溶液に浸漬され、メレジトースが、約10%〜約30%の範囲の濃度で前記液体溶液中に存在する、請求項41に記載のシステム。
- 前記固体基板が、酵素活性を保存するために構成されている、請求項41に記載のシステム。
- 生物学的サンプルを収集し、安定化させるためのシステムであって、
(a)皮膚に貫入して血液を露出させるために構成された1つ以上の穿刺要素を有するサンプル獲得構成要素と、
(b)前記固体マトリックスから得られたRNAが、少なくとも4のRINを有する、前記生物学的サンプルから核酸を抽出および保存するための固体マトリックスを含む、サンプル獲得構成要素に結合したサンプル安定化構成要素と、を含む、システム。 - 前記固体マトリックスから得られたRNAが、少なくとも5のRINを有する、請求項45に記載のシステム。
- 前記固体マトリックスから得られたRNAが、少なくとも6のRINを有する、請求項45に記載のシステム。
- 前記固体マトリックスから得られたRNAが、少なくとも7のRINを有する、請求項45に記載のシステム。
- 前記固体マトリックスから得られたRNAが、7を超えるRINを有する、請求項45に記載のシステム。
- 前記固体マトリックスが、乾燥状態で前記固体マトリックス中に存在する少なくとも1種のタンパク質変性剤をさらに含む、請求項45に記載のシステム。
- 前記固体マトリックスが、乾燥状態で前記固体マトリックス中に少なくとも1種の還元剤をさらに含む、請求項45に記載のシステム。
- 前記固体マトリックスが、乾燥状態で前記固体マトリックス中に少なくとも1種のUV保護剤をさらに含む、請求項45に記載のシステム。
- 前記固体マトリックスが、前記固体マトリックス上に配置されるか、または前記固体マトリックス内に含浸される少なくとも1種の緩衝液をさらに含み、前記固体マトリックスが、実質的に乾燥しており、含水量が2%未満である、請求項45に記載のシステム。
- 前記少なくとも1種の緩衝液が、約3〜約6の範囲のpHを生じる酸滴定緩衝液試薬である、請求項53に記載のシステム。
- 前記固体マトリックスが、セルロース、酢酸セルロース、ガラス繊維、またはそれらの組み合わせを含む多孔質マトリックスである、請求項45に記載のシステム。
- 前記固体マトリックスが、不溶性乾燥固体材料である、請求項45に記載のシステム。
- 前記固体マトリックスが、水和時に酸性pHをもたらすように構成される、請求項45に記載のシステム。
- 前記固体マトリックスが、サンプルから核酸を抽出し、周囲温度で実質的に乾燥状態で前記核酸を保存するように構成されている、請求項45に記載のシステム。
- 前記サンプル獲得構成要素が、前記サンプル安定化構成要素に接続されている、請求項45に記載のシステム。
- 生物学的サンプルを収集し、安定化させるためのシステムであって、
(a)皮膚に貫入して血液を露出させるために構成された1つ以上の穿刺要素を有するサンプル獲得構成要素と、
(b)前記膜が、前記生物学的サンプルの1つの構成要素が第1の膜上に収集され、前記サンプルの前記残部が第2の膜上に収集されるように構成されている、2つ以上の部分的に重なる膜を含む前記サンプル獲得構成要素に結合されたサンプル分離構成要素と、を含む、システム。
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