JP2009541737A - アッセイ装置と方法 - Google Patents
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- JP2009541737A JP2009541737A JP2009516452A JP2009516452A JP2009541737A JP 2009541737 A JP2009541737 A JP 2009541737A JP 2009516452 A JP2009516452 A JP 2009516452A JP 2009516452 A JP2009516452 A JP 2009516452A JP 2009541737 A JP2009541737 A JP 2009541737A
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Abstract
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 (19)
- 蓋と、ベースと、を備えているアッセイ装置であって、
上記ベースが、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、
上記複数の構成要素が、流体連通しており、且つ、サンプル追加ゾーンから吸収ゾーンへと通じる流体通路の部分を成しており、
a.サンプル追加ウェルが、蓋に一体化されており、
b.吸収ゾーンが、無孔性基板上の領域を備えており、該無孔性基板が、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、量を定めており、該量が、上記流体通路の量とともに、アッセイに供されるサンプル量を定めるものであり、
c.少なくとも1つのフィルタが、サンプル追加ウェルと、サンプル追加ゾーンと、の間にある、
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乃至3の何れか1つに記載のアッセイ装置であって、
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、を有している、
アッセイ装置。 - 請求項1乃至4の何れか1つに記載のアッセイ装置であって、
実質的に垂直な複数の突起を有している吸収ゾーンの領域が、フォイルによって覆われている、
アッセイ装置。 - 請求項5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5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。 - 請求項1乃至7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。 - 請求項1乃至7の何れか1つに記載のアッセイ装置であって、
上記フィルタが、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り、上記フィルタが、上記サンプル追加ゾーン内に実質的に垂直な複数の突起に直接接している、
アッセイ装置。 - 請求項1乃至9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。 - 請求項1乃至10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。 - 請求項1乃至11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12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12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15に記載の方法であって、
吸収ゾーンが、実質的に垂直な複数の突起を有している無孔性基板上の領域から成っている、
方法。 - 請求項16に記載の方法であって、
複数の突起が、吸収ゾーン内の上記液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、を有している、
方法。 - 請求項17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18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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- 2007-06-20 US US12/305,630 patent/US8877142B2/en active Active
- 2007-06-20 CA CA2654928A patent/CA2654928C/en active Active
- 2007-06-20 WO PCT/SE2007/050444 patent/WO2007149042A1/en active Application Filing
- 2007-06-20 BR BRPI0713028-7A patent/BRPI0713028A2/pt not_active Application Discontinuation
- 2007-06-20 JP JP2009516452A patent/JP5143832B2/ja active Active
- 2007-06-20 CN CN2007800309653A patent/CN101506656B/zh active Active
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JP2011518327A (ja) * | 2008-04-16 | 2011-06-23 | オーミック・アーベー | アッセイ方法および装置 |
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WO2013069122A1 (ja) * | 2011-11-09 | 2013-05-16 | 株式会社日立製作所 | 微粒子分離装置及び方法 |
JPWO2013069122A1 (ja) * | 2011-11-09 | 2015-04-02 | 株式会社日立製作所 | 微粒子分離装置及び方法 |
JP2013148582A (ja) * | 2012-01-20 | 2013-08-01 | Ortho-Clinical Diagnostics Inc | 制御可能なサンプル量を有するアッセイ装置 |
JP2014173937A (ja) * | 2013-03-07 | 2014-09-22 | Toshiba Corp | 半導体マイクロ分析チップ及び検体流動方法 |
US9316576B2 (en) | 2013-03-07 | 2016-04-19 | Kabushiki Kaisha Toshiba | Sample detection apparatus and detection method |
US9448153B2 (en) | 2013-03-07 | 2016-09-20 | Kabushiki Kaisha Toshiba | Semiconductor analysis microchip and method of manufacturing the same |
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Also Published As
Publication number | Publication date |
---|---|
EP2038657A1 (en) | 2009-03-25 |
AU2007261758A1 (en) | 2007-12-27 |
JP5143832B2 (ja) | 2013-02-13 |
SE0601354L (sv) | 2007-12-21 |
CN101506656B (zh) | 2013-08-21 |
WO2007149042A1 (en) | 2007-12-27 |
BRPI0713028A2 (pt) | 2012-10-16 |
EP2038657B1 (en) | 2019-01-23 |
CA2654928A1 (en) | 2007-12-27 |
SE531948C2 (sv) | 2009-09-15 |
US9606112B2 (en) | 2017-03-28 |
US8877142B2 (en) | 2014-11-04 |
US20090208920A1 (en) | 2009-08-20 |
AU2007261758B2 (en) | 2013-11-07 |
CN101506656A (zh) | 2009-08-12 |
CA2654928C (en) | 2015-07-28 |
EP2038657A4 (en) | 2010-06-02 |
US20150031586A1 (en) | 2015-01-29 |
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