JP2007524816A - 細い均一な試薬ストリップの製造方法およびその試薬 - Google Patents
細い均一な試薬ストリップの製造方法およびその試薬 Download PDFInfo
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
- Y10T156/10—Methods of surface bonding and/or assembly therefor
- Y10T156/1052—Methods of surface bonding and/or assembly therefor with cutting, punching, tearing or severing
- Y10T156/1059—Splitting sheet lamina in plane intermediate of faces
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
- Y10T156/10—Methods of surface bonding and/or assembly therefor
- Y10T156/1052—Methods of surface bonding and/or assembly therefor with cutting, punching, tearing or severing
- Y10T156/1084—Methods of surface bonding and/or assembly therefor with cutting, punching, tearing or severing of continuous or running length bonded web
Abstract
Description
本出願は、2003年6月20日にファイルされた米国仮特許出願連続番号60/480397に対して、優先権を請求するものである。本出願は、「試験ストリップ用試薬の縞」(以下「試薬の縞出願」とする)という名称で、かつ同日付でファイルされまた完全を期するために参照としてここに併合した、同一出願人による出願に関するものである。
[技術分野]
本発明は、一般的には、バイオセンサーあるいは試験ストリップに使用される試薬に関するものであり、またさらに詳しくは、試験ストリップの平坦な表面上への、細い均一な縞の製造に関するものである。
a)塗布および乾燥プロセス後に膜材料が、傷ついてロールに巻き取られた場合に、フォイル/担体の未塗布面上に、乾燥フィルムの逆移送を防止する、および
b)スムーズな塗膜層に比較して、乾燥された塗膜層の比表面積を拡大する。
2はスパッターされた金属膜を示し、
3は電極対1の作用電極を示し、
3’は電極対2の作用電極を示し、
4は電極対1の参照電極/対向電極を示し、
4’は電極対2の参照電極/対向電極を示し、
5は試薬の縞1を示し、
5’は試薬の縞2を示し、
6はスペーサーを示し、
7はトップフォイルを示し、
8はトップフォイル中の通気開口を示す。
次の成分の水性混合物を調製した。
次の成分の水性混合物を調製した。
次の成分の水性混合物を調製した。
次の成分の水性混合物を調製した。
スロット・ダイ・ヘッドおよびバックアップローラを含んでいる塗布領域中に、ポリマー膜(メリネックス(登録商標)329、デュポン社を移動させる。スロット・ダイ・ヘッド(TSE,スイス)を、膜表面に対してゼロに設定し、スロットを、74μmの膜ギャップに調節する。塗膜を膜上に堆積させるために、膜速度を0から38m/分までの傾斜を付ける。試薬マトリックスは、ギヤポンプ、ピストン、注射器、気泡システムを含めた種々の手段を用いて、スロット・ダイ・ヘッドに、搬送できる。試薬配送システムは、塗布ヘッドを経由して、塗膜重量を53g/m2で送るために、水流速を13.58ml/分に調節される。得られた塗膜の縞の幅は、7.0±0.3mmである。塗膜は、加熱された乾燥ゾーン(38m/分の速度で、長さ15m、温度110℃)で乾燥されて、巻き戻し台にある糸巻き上に巻き戻される。
実施例1の試薬組成物中、CMC,ケルトロール(登録商標)、プロピオファン(登録商標)およびPVPの成分の含有量を、次の表にしたがって変化させた。
Claims (20)
- スロット・ダイ塗布法に有用な、70程度から130mPa程度のあいだの粘度と、30〜50mN/mのあいだの表面張力をもつせん断欠乏性のやや揺変性あるいは揺変性の試薬組成物。
- 95〜115mPaの範囲の粘度をもっていることを特徴とする請求項1記載の試薬。
- 40±2mN/m程度の表面張力をもっていることを特徴とする請求項1または2記載の試薬。
- シリカを含むことを特徴とする請求項1、2または3記載の試薬。
- 緩衝液類あるいは酵素類あるいは媒介物類あるいは安定剤類あるいはたんぱく質類あるいは指示薬類あるいは色素類あるいは膜形成剤類あるいは界面活性剤あるいは補助要因類あるいは前述の成分の組み合わせを、さらに含むことを特徴とする請求項1、2、3または4記載の試薬。
- キサンタンガムを含むことを特徴とする請求項1、2、3、4または5記載の試薬。
- カルボキシメチルセルロースを含むことを特徴とする請求項1、2、3、4、5または6記載の試薬。
- さらにキサンタンガムおよびカルボキシメチルセルロースを含むことを特徴とする請求項1、2、3、4、5、6または7記載の試薬。
- 固体支持材料としてポリマー膜上に試薬層を製造するプロセスであって、次の工程すなわち固体支持材料を提供する工程と、
固体支持材料かあるいはスロット・ダイ塗布ヘッドを移動することにより、スロット・ダイ塗布ヘッドに対して、固体支持材料を移動させ、それにより、固体支持材料の表面とスロット・ダイ塗布ヘッドのあいだの所定の距離を維持する工程と、
スロット・ダイ塗布ヘッドを経由して、請求項1から8のいずれかに記載の試薬を堆積させ、固体支持材料上に試薬の連続縞を作る工程と、膜上の塗布された試薬の縞を乾燥する工程とからなることを特徴とするプロセス。 - 試薬の縞の幅が、1cm未満であることを特徴とする請求項9記載のプロセス。
- 試薬の縞が、乾燥した膜厚で10μm未満の高さであることを特徴とする請求項9記載のプロセス。
- スロット・ダイ塗布ヘッドに対して、固体支持材料を移動させる速度が、20から80m/分のあいだであることを特徴とする請求項9記載のプロセス。
- スロット・ダイ塗布ヘッドに対して、支持材料を移動させる速度が、30から40m/分のあいだであることを特徴とする請求項9記載のプロセス。
- 5.5から30g/分の塗布フラックスで、試薬を支持材料に送ることを特徴とする請求項9または12記載のプロセス。
- 13から15g/分の塗布フラックスで、試薬を支持材料に送ることを特徴とする請求項9または12記載のプロセス。
- スロット・ダイ塗布ヘッドおよび支持材料のあいだの距離が、30から90μmのあいだであることを特徴とする請求項9記載のプロセス。
- 第1固体支持材料としてのポリマー膜と、第1固体支持材料に塗布される試薬の縞からなる分析試験エレメントであって、試薬縞の試薬が、請求項1、2、3、4、5、6、7または8記載の試薬であることを特徴とする分析試験エレメント。
- 第1固体支持材料としてのポリマー膜と、第1固体支持材料に塗布される試薬の縞からなる分析試験エレメントであって、試薬が、請求項9、10、11、12、13、14、15または16記載のプロセスにより、第1固体支持材料上に塗布されることを特徴とする分析試験エレメント。
- 毛細管ギャップを定めるためのスペ−サー層として作用しかつ試薬の縞の1部を覆う両面接着テープと、スペ−サー層に付着されかつ第1固体支持材料、試薬の縞およびスペ−サー層と協力して、両面接着テープで覆われていない試薬の縞の部分上に、毛細管スペースを作る第2固体支持材料をさらに含むことを特徴とする請求項17または18記載の分析試験エレメント。
- 第1固体支持材料上の2つの電極をさらに含み、この電極が、部分的に試薬の縞で覆われていることを特徴とする請求項17、18または19記載の分析試験エレメント。
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US48039703P | 2003-06-20 | 2003-06-20 | |
US60/480,397 | 2003-06-20 | ||
PCT/US2004/019591 WO2004113917A2 (en) | 2003-06-20 | 2004-06-18 | Method and reagent for producing narrow, homogenous reagent strips |
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JP2011000051A Division JP5064576B2 (ja) | 2003-06-20 | 2011-01-04 | 細い均一な試薬ストリップの製造方法およびその試薬 |
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JP2007524816A5 JP2007524816A5 (ja) | 2009-11-05 |
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JP2006517460A Active JP4447009B2 (ja) | 2003-06-20 | 2004-06-18 | スロットベント開口を有するテストストリップ |
JP2006517430A Pending JP2007524816A (ja) | 2003-06-20 | 2004-06-18 | 細い均一な試薬ストリップの製造方法およびその試薬 |
JP2006517462A Active JP4800209B2 (ja) | 2003-06-20 | 2004-06-18 | テストストリップ用の試薬ストライプ |
JP2006517459A Active JP4619359B2 (ja) | 2003-06-20 | 2004-06-18 | フレア状に形成された試料受入チャンバーを持つ試験片 |
JP2010177438A Active JP4912489B2 (ja) | 2003-06-20 | 2010-08-06 | フレア状に形成された試料受入チャンバーを持つ試験片を作製する方法 |
JP2011000051A Active JP5064576B2 (ja) | 2003-06-20 | 2011-01-04 | 細い均一な試薬ストリップの製造方法およびその試薬 |
JP2011127587A Active JP5159920B2 (ja) | 2003-06-20 | 2011-06-07 | テストストリップ用の試薬ストライプ |
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JP2006517459A Active JP4619359B2 (ja) | 2003-06-20 | 2004-06-18 | フレア状に形成された試料受入チャンバーを持つ試験片 |
JP2010177438A Active JP4912489B2 (ja) | 2003-06-20 | 2010-08-06 | フレア状に形成された試料受入チャンバーを持つ試験片を作製する方法 |
JP2011000051A Active JP5064576B2 (ja) | 2003-06-20 | 2011-01-04 | 細い均一な試薬ストリップの製造方法およびその試薬 |
JP2011127587A Active JP5159920B2 (ja) | 2003-06-20 | 2011-06-07 | テストストリップ用の試薬ストライプ |
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US (8) | US7829023B2 (ja) |
EP (4) | EP1639353B8 (ja) |
JP (7) | JP4447009B2 (ja) |
KR (1) | KR100785670B1 (ja) |
CN (2) | CN100504369C (ja) |
CA (4) | CA2530297C (ja) |
ES (4) | ES2682450T3 (ja) |
HK (1) | HK1094599A1 (ja) |
HU (1) | HUE039852T2 (ja) |
MX (1) | MXPA05013635A (ja) |
PL (4) | PL1642117T3 (ja) |
PT (1) | PT1639352T (ja) |
TR (1) | TR201810169T4 (ja) |
WO (4) | WO2004113917A2 (ja) |
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