JP2020046434A - ユニ−及びノー−コード試験ストリップの製造方法 - Google Patents
ユニ−及びノー−コード試験ストリップの製造方法 Download PDFInfo
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Abstract
Description
(a)分析物を含むと思われる体液と、本発明の診断試験エレメントとを、検出層に含まれる検出試薬により分析物の検出を可能にするために適切な条件下で、接触する工程;
(b)診断試薬エレメント上の湿潤された層におけるインジケーター試薬の少なくとも1つの光学特性の変化を測定し、それにより、体液試料中の分析物の存在又は量を決定する工程。
実施例1:診断試験エレメントの製造
血液グルコースを、Accu−Chek−Active MICアッセイにおいて標準(MIC)及びノーコードコーティングシステム上でのいくつかのパラメーターに対する影響を決定するために、異なったコーティングを有する診断試験エレメントを用いて、異なった濃度(すなわち、O、10、60、120、300及び600mg/dlの血液)で測定した。次の組合せを測定した:
−フェリシアン化カリウム(K3)を伴ってのMIC;
−K3を伴ってのノーコード;
−K3なしでのノーコード;
−K3なしでの分散されたノーコード。
−OAF及びK3を伴ってMIC。
リンモリブデン酸は、後の測定との干渉を回避するために、できるだけ短期、コーティング組成物に留まることがさらに見出された。さらに、コーティング組成物のpH調節を行うために使用されるNaOHは、加水分解を回避するために、リンモリブデン酸の添加の前、添加されることが見出された。コーティング組成物の製造は、それに応じて修正された。しかしながら、この場合でされ、校正コード曲線は、高グルコース濃度と低グルコース濃度との間の差別を困難にするS字型であったことが見出された。さらに、測定時間もまた、高められることが見出された。
Claims (15)
- 体液試料に含まれる分析物を決定するための診断試験エレメントであって、前記試験エレメントが少なくとも1つの検出層及び少なくとも1つの分離層を有する少なくとも1つの試験フィールドを含み、前記少なくとも1つの分離層が分散−飽和固形成分及び約1.0〜1.6g/m2の量でSiO2を含む、診断試験エレメント。
- 前記少なくとも1つの分離層がさらに、TiO2を含む、請求項1に記載の診断試験エレメント。
- 前記TiO2が、約5.5〜9.0g/cm2の量で存在する、請求項2に記載の診断試験エレメント。
- 前記TiO2が約0.11:0.29のSiO2:TiO2比を形成する量で存在する、請求項1又は2に記載の診断試験エレメント。
- 前記検出層及び分離層が鉄含有酸化剤を本質的に含まない、請求項1〜4のいずれか1項に記載の診断試験エレメント。
- 前記鉄含有酸化剤がフェリシアン化カリウム(III )である、請求項5に記載の診断試験エレメント。
- 前記分散−飽和固形成分が、前記固形成分を、分離層を形成するコーティング組成物に、前記分散された固形成分の量のさらなる増加が観察され得ないよう最大値に達するまで(プラトー段階)、分散することにより得られた、請求項1〜6のいずれか1項に記載の診断試験エレメント。
- 請求項1〜7のいずれか1項に記載の診断試験エレメント上に分離層を形成することができるコーティング組成物。
- 前記組成物が、コーティング組成物100g当たり約2.0g〜3.5gの量でケイ酸を含む、請求項8に記載のコーティング組成物。
- 前記組成物が、コーティング組成物100g当たり約11.0g〜18.0gの量でTiO2を含む、請求項8又は9に記載のコーティング組成物。
- 請求項1〜7のいずれか1項に記載の診断試験エレメントの製造方法であって、コーティング組成物において、分離層のための固形成分を、分散された固形成分のさらなる増加が生じないよう最大値に達するまで(プラトー段階)、分散し、前記コーティング組成物がコーティング組成物100g当たり約2.0g〜3.5gの量でケイ酸を含む、方法。
- 前記コーティング組成物に、指標としてリンモリブデン酸を添加することをさらに含む、請求項11に記載の方法。
- 前記リンモリブデン酸が、前記診断試験エレメントの試験フィールドに、前記コーティング組成物を添加する前、2日未満で、1日未満で、6時間未満で、3時間未満で、2時間未満で又は1時間未満で添加される、請求項12に記載の方法。
- 前記リンモリブデン酸が、前記コーティング組成物のpH調節の後、添加される、請求項12又は13に記載の方法。
- 対象の試料における分析物、好ましくはグルコースの量を決定するための請求項1〜7のいずれか1項に記載の診断試験エレメントの使用。
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US20090145775A1 (en) * | 2007-12-10 | 2009-06-11 | Bayer Healthcare Llc | Reagents and methods for detecting analytes |
JP2012508372A (ja) * | 2008-11-07 | 2012-04-05 | エフ.ホフマン−ラ ロシュ アーゲー | 光度反応フィルム用微粒子充填物質 |
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DE3714387A1 (de) * | 1987-04-30 | 1988-11-10 | Degussa | Verfahren und vorrichtung zum kontinuierlichen dosieren von pulverfoermigen stoffen mittels pressgas |
DE19629657A1 (de) | 1996-07-23 | 1998-01-29 | Boehringer Mannheim Gmbh | Volumenunabhängiger diagnostischer Testträger und Verfahren zur Bestimmung von Analyt mit dessen Hilfe |
DE19753851A1 (de) | 1997-12-04 | 1999-06-10 | Roche Diagnostics Gmbh | Vorrichtung zum kapillaren Flüssigkeitstransport |
DE19753850A1 (de) | 1997-12-04 | 1999-06-10 | Roche Diagnostics Gmbh | Probennahmevorrichtung |
DE19849008A1 (de) * | 1998-10-23 | 2000-04-27 | Roche Diagnostics Gmbh | Spreitschichten, Netzmittel zu ihrer Herstellung und deren Verwendung in Teststreifen |
US6824974B2 (en) | 2001-06-11 | 2004-11-30 | Genorx, Inc. | Electronic detection of biological molecules using thin layers |
DE102004007983A1 (de) * | 2004-02-18 | 2005-09-08 | Roche Diagnostics Gmbh | Testelement mit Einschicht-Reaktionsfilm |
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US9399716B2 (en) * | 2013-07-02 | 2016-07-26 | Chromatic Technologies Inc. | Yellow thermochromic dyes, inks composition and level indicators |
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Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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US5652148A (en) * | 1993-04-20 | 1997-07-29 | Actimed Laboratories, Inc. | Method and apparatus for red blood cell separation |
JPH1078430A (ja) * | 1996-07-23 | 1998-03-24 | Boehringer Mannheim Gmbh | 多層試験領域を有する診断試験担体および被検体測定の ためのその使用方法 |
US20090145775A1 (en) * | 2007-12-10 | 2009-06-11 | Bayer Healthcare Llc | Reagents and methods for detecting analytes |
JP2012508372A (ja) * | 2008-11-07 | 2012-04-05 | エフ.ホフマン−ラ ロシュ アーゲー | 光度反応フィルム用微粒子充填物質 |
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WO2015110500A1 (en) | 2015-07-30 |
JP7025398B2 (ja) | 2022-02-24 |
BR112016015156B1 (pt) | 2021-01-26 |
RU2680140C2 (ru) | 2019-02-18 |
RU2016134420A3 (ja) | 2018-03-01 |
ZA201604112B (en) | 2019-12-18 |
AU2015208214A1 (en) | 2016-08-11 |
CN105917216A (zh) | 2016-08-31 |
MX2016009382A (es) | 2016-09-16 |
IL246278B2 (en) | 2023-04-01 |
US10371697B2 (en) | 2019-08-06 |
NZ720942A (en) | 2018-02-23 |
IL246278B (en) | 2022-12-01 |
RU2019103900A3 (ja) | 2019-09-19 |
JP2017504020A (ja) | 2017-02-02 |
KR20160102291A (ko) | 2016-08-29 |
RU2016134420A (ru) | 2018-03-01 |
RU2019103900A (ru) | 2019-03-25 |
CA2936337C (en) | 2018-08-28 |
IL246278A0 (en) | 2016-07-31 |
SG11201605911RA (en) | 2016-08-30 |
RU2723537C2 (ru) | 2020-06-15 |
CN105917216B (zh) | 2020-03-17 |
AU2015208214B2 (en) | 2018-04-12 |
EP3097406A1 (en) | 2016-11-30 |
KR101847758B1 (ko) | 2018-04-10 |
US20160327547A1 (en) | 2016-11-10 |
AU2015208214C1 (en) | 2018-10-04 |
CA2936337A1 (en) | 2015-07-30 |
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