JP5143832B2 - アッセイ装置と方法 - Google Patents
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- JP5143832B2 JP5143832B2 JP2009516452A JP2009516452A JP5143832B2 JP 5143832 B2 JP5143832 B2 JP 5143832B2 JP 2009516452 A JP2009516452 A JP 2009516452A JP 2009516452 A JP2009516452 A JP 2009516452A JP 5143832 B2 JP5143832 B2 JP 5143832B2
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Description
・優位性あるアッセイ、即ち、限られた量の抗体を用いるアッセイと、
・過剰な量の抗体を用いるもので、免疫メトリックアッセイとも呼ばれる、固相サンドイッチアッセイと、
に分けることができる。
材料と方法:
WO03/103835に記載されているようなマイクロピラー構造は、スェーデン、Uppsalaにある、Åmic AB社によって生産されており、且つ、サンプル追加ゾーンと、反応ゾーンと、吸収ゾーンと、を形成するのに用いられている。多重テスト構造は、厚さ1mmの熱可塑性ディスク上に製造されている。上記ディスクは、複数のストリップへと切り分けられる。各ストリップは、垂直な複数の突起又はマイクロピラーから成る、流体通路又はオープン流路を有している。ディスクを製造するために用いられている材料は、登録商標Zeonor(ゼオン株式会社、日本)の、優れた光学特性を有している環状オレフィンポリマーである。
25mgの乾燥Sephadex G25(medium、Amersham Biosciences、Uppsala、Sweden)は、垂直な複数の突起の周りに分散されている、流路の遠位端に置かれた。流れは、上述したような緩衝剤添加によって計測された。結果を表1に示す。
長さ25mm、幅5mmのCF6(Whatman、Maidstone、England)吸収フィルタは、垂直な複数の突起によって決まる、流路の遠位端に置かれた。流れは、上述したような緩衝剤添加によって計測された。結果を表2に示す。
ポリウレタンフォームは、装置上の原位置、流路の遠位端、垂直な複数の突起から成る領域において、硬化された。フォームは、残りの流路との間で良好な流体の流れを提供している、複数の突起同士の間の空間を充填した。100μlがフォームによって吸収される時間が、異なるサンプルについて3回測定された。結果(表3)は、フォームが吸収ゾーンとしての役を果たすことができ、関連する流れが得られる、ということを示している。多孔、硬化、他の特性についてフォームの最小化が、すこしでも、より良い流量を結果として生じる、ことが予期されている。
テストストリップは、以下の寸法、即ち、高さ69μm、直径46μm、互いの間隔が略29μm、であるマイクロピラーの領域から成り、又は、該領域へと導いている、流体通路を有するように生産されたものである。流路は、約25mmの長さと、4mmの幅と、を有している。遠位端は、サンプル追加に関連し、接着フォイルによって覆われている。親水性の粘着剤と、疎水性の粘着剤と、を有している異なる複数のフォイル(サンプルは、例えば、米国のAdhesives Research Inc.によって提供されたものである)が、テストされた。
Claims (14)
- 蓋(7)とベース(1)とを含むアッセイ装置であって、
前記ベース(1)は、サンプル追加ゾーン(3)と反応ゾーンと吸収ゾーン(5)とを含み、前記複数の構成要素は、流体連通し、且つ、サンプル追加ゾーン(3)から吸収ゾーン(5)へと通じる流体通路(2)の部分を成し、
a.サンプル追加ウェル(9)は、蓋(7)に一体化され、
b.吸収ゾーン(5)は、無孔性基板上の領域を含み、該無孔性基板が、実質的に垂直な複数の突起を有し、前記複数の突起が、量を定め、該量が、上記流体通路の量と共に、アッセイに供給されるサンプル量を定め、
c.サンプル追加ゾーン(3)は、前記ベース(1)に対して実質的に垂直な複数の突起を含み、
d.少なくとも1つのフィルタ(10)は、サンプル追加ウェル(9)とサンプル追加ゾーン(3)との間にあり、血漿から赤血球を分離する能力を持つ親水性ポリマー膜であり、サンプル追加ゾーン上の実質的に垂直な複数の突起に接触し、
e.前記複数の突起は、吸収ゾーン(5)内の前記流体の側方毛細管流動が達成されるように高さ(H)、直径(D)、及び、突起間の距離(t1, t2)を有し、
f.実質的に垂直な複数の突起を有する吸収ゾーン(5)の領域は、フォイル(6)によって覆われている、アッセイ装置。 - 請求項1に記載のアッセイ装置であって、
流体通路が、ベースのうちの、一体化されている部分である、アッセイ装置。 - 請求項1、2の何れか1つに記載のアッセイ装置であって、
アッセイ装置が更に、底を備えている、アッセイ装置。 - 請求項1に記載のアッセイ装置であって、
フォイルが、親水性を有している、アッセイ装置。 - 請求項1に記載のアッセイ装置であって、
フォイルが、親水性物質を用いて、垂直な複数の突起に、取り付けられている、アッセイ装置。 - 前記請求項の何れか1つに記載のアッセイ装置であって、
少なくとも1つのフィルタが、血漿から赤血球を分離する能力を持つ親水性ポリマー膜である、アッセイ装置。 - 前記請求項の何れか1つに記載のアッセイ装置であって、
ベースが、透明であり、上記ベースを通って結果を読み取ることができる、アッセイ装置。 - 前記請求項の何れか1つに記載のアッセイ装置であって、
サンプル追加ゾーンの、中又はその付近に、予め投薬されている検出共役物を備えている、アッセイ装置。 - 前記請求項の何れか1つに記載のアッセイ装置であって、
サンプル追加ウェルが、ピペットがフィルタを通って挿入されることを妨げる装置を備えている、アッセイ装置。 - 流体サンプルを取り扱うための方法であって、
請求項1乃至9の何れか1つに記載の装置が、用いられる、方法。 - 診断アッセイを実行するための方法であって、
請求項1乃至9の何れか1つに記載の装置が、用いられる、方法 - 全血サンプルを取り扱うための方法であって、
全血サンプルが、サンプル追加ウェル内に置かれ、且つ、フィルタを用いて、赤血球の分離を受けるものであり、
血漿が、流体通路に接しながら運ばれ、
上記流体通路が、サンプル追加ゾーンと、反応ゾーンと、吸収ゾーンと、を備えており、
吸収ゾーンが、無孔性基板上の領域を備えており、上記無孔性基板が、実質的に垂直な複数の突起を有しており、上記複数の突起が、吸収ゾーン内の上記流体の側方毛細管流動が達成されるような、高さと直径と突起同士の間隔とを備えており、
上記フィルタが、サンプル追加ゾーン上にある複数の突起に接しており、
吸収ゾーンと流体通路との量が、反応ゾーンを通って、引き込まれた血漿の量を定める、方法。 - 請求項12に記載の方法であって、
複数の突起が、フォイルによって覆われている、方法。 - 請求項13に記載の方法であって、
流量が、フォイルの親水性の選択によって制御される、方法。
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SE0601354A SE531948C2 (sv) | 2006-06-20 | 2006-06-20 | Analysanordning för vätskeprover innefattande filter i direkt kontakt med projektioner |
SE0601354-4 | 2006-06-20 | ||
PCT/SE2007/050444 WO2007149042A1 (en) | 2006-06-20 | 2007-06-20 | Assay device and method |
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JP2009541737A JP2009541737A (ja) | 2009-11-26 |
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US (2) | US8877142B2 (ja) |
EP (1) | EP2038657B1 (ja) |
JP (1) | JP5143832B2 (ja) |
CN (1) | CN101506656B (ja) |
AU (1) | AU2007261758B2 (ja) |
BR (1) | BRPI0713028A2 (ja) |
CA (1) | CA2654928C (ja) |
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- 2007-06-20 AU AU2007261758A patent/AU2007261758B2/en active Active
- 2007-06-20 US US12/305,630 patent/US8877142B2/en active Active
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPWO2014051033A1 (ja) * | 2012-09-28 | 2016-08-22 | 国立研究開発法人産業技術総合研究所 | 多孔質媒体を利用したアッセイ装置 |
JP2015172492A (ja) * | 2014-03-11 | 2015-10-01 | 国立研究開発法人産業技術総合研究所 | 多孔質媒体を利用したアッセイ装置 |
Also Published As
Publication number | Publication date |
---|---|
US20150031586A1 (en) | 2015-01-29 |
SE531948C2 (sv) | 2009-09-15 |
JP2009541737A (ja) | 2009-11-26 |
CN101506656B (zh) | 2013-08-21 |
EP2038657A4 (en) | 2010-06-02 |
AU2007261758A1 (en) | 2007-12-27 |
BRPI0713028A2 (pt) | 2012-10-16 |
CA2654928C (en) | 2015-07-28 |
US9606112B2 (en) | 2017-03-28 |
US8877142B2 (en) | 2014-11-04 |
US20090208920A1 (en) | 2009-08-20 |
CA2654928A1 (en) | 2007-12-27 |
AU2007261758B2 (en) | 2013-11-07 |
WO2007149042A1 (en) | 2007-12-27 |
CN101506656A (zh) | 2009-08-12 |
SE0601354L (sv) | 2007-12-21 |
EP2038657A1 (en) | 2009-03-25 |
EP2038657B1 (en) | 2019-01-23 |
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