JP2004279433A - 凹みを有する改良型電気化学バイオセンサ検査ストリップ - Google Patents
凹みを有する改良型電気化学バイオセンサ検査ストリップ Download PDFInfo
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Abstract
【解決手段】 毛細管状検査室、サンプル供給口、および前記サンプル供給口(20)を容易に識別できるように検査ストリップの一つの縁端部に沿って形成された凹み、を含んでなる電気化学バイオセンサ検査ストリップ。
【選択図】 図2
Description
(1) サンプル供給口を触覚により識別するための縁部に沿った凹みを備えた検査ストリップであって、
第1および第2面と、縁部に沿った凹みと、空気孔を備えた第1絶縁基板;
第1絶縁基板の第1面に固定された少なくとも2つの導電性軌道;
第1および第2面と、縁部に沿った凹みと、第1および第2開口部を備えた第2絶縁基板であって、第2面は、導電性軌道と第1絶縁基板の第1面に固定され、第1開口部は、導電性軌道の一部を、電気特性の測定が可能な測定機器に電気的に接続するために露出させ、第2開口部は、縁部に沿って配置され且つ導電性軌道の異なる部分と空気孔を露出させるものである第2絶縁基板;
第2開口部により露出された導電性軌道の少なくとも1部分を被う検査試薬;ならびに
第1および第2面と、縁部に沿った凹みを備えた蓋部であって、蓋部の第2面は、第2絶縁基板の第1面に固定され、蓋部の第2面と第1絶縁基板の面が、第2絶縁基板の縁部にサンプル供給口を有する毛細管状充填室の対向する壁部を形成するように配置されている蓋部を含み、第2絶縁基板の第2開口部ならびに第1絶縁基板、第2絶縁基板および蓋部の凹みが位置合わせされていることによりサンプル供給口を触覚により識別することができる、上記検査ストリップ。
(2) 第1および第2面と、縁部に沿った切欠きと、空気孔を備えた第1絶縁基板;
第1絶縁基板の第1面に固定された少なくとも2つの導電性軌道;
第1および第2面と第1および第2開口部を備えた第2絶縁基板であって、第2面は、導電性軌道と第1絶縁基板の第1面に固定され、第1開口部は、導電性軌道の一部を、電気特性の測定が可能な測定機器に電気的に接続するために露出させ、第2開口部は、第2絶縁基板の縁部に沿って配置され且つ導電性軌道の異なる部分、第1絶縁基板の切欠き、および空気孔を露出させるものである第2絶縁基板;
第2開口部により露出された導電性軌道の少なくとも1部分を被う検査試薬;ならびに
第1および第2面と、縁部に沿った切欠きを備えた蓋部であって、蓋部の第2面は、第2絶縁基板の第1面に固定され、1)蓋部の第2面と第1絶縁基板の第1面が、第2絶縁基板の縁部にサンプル供給口を有する毛細管状充填室の対向する壁部を形成し且つ2)蓋部の切欠きが第1絶縁基板の切欠きに重なるように配置されている蓋部を含み、
蓋部の切欠きと第1絶縁基板の切欠きにより、液体水性サンプルがサンプル供給口に接触した場合に毛細管状室に有意に逡巡することなく流入する、検査ストリップ。
(3) 第1および第2面と空気孔を備えた第1絶縁基板;
第1絶縁基板の第1面に固定された少なくとも2つの導電性軌道;
第1および第2面と第1および第2開口部を備えた第2絶縁基板であって、第2面は、導電性軌道と第1絶縁軌道の第1面に固定され、第1開口部は、導電性軌道の一部を、電気特性の測定が可能な測定機器に電気的に接続するために露出させ、第2開口部は、第2絶縁基板の縁部に沿って配置され且つ導電性軌道の異なる部分と空気孔を露出させるものである第2絶縁基板;
第2開口部により露出された導電性軌道の少なくとも1部分を被う検査試薬;ならびに
第1および第2面と固体の透明または半透明窓部を備えた蓋部であって、蓋部の第2面は、第2絶縁基板の第1面に固定され、第2絶縁基板の第2開口部と重なり且つ蓋部の第2面と第1絶縁基板の第1面が第2絶縁基板の縁部にサンプル供給口を有する毛細管状充填室の対向する壁部を形成するように配置されており、透明または半透明窓部は、窓部の全体の長さと幅が毛細管状検査室の長さと幅より短く、窓部がサンプル供給口からはみ出し且つ導電性軌道の1つの幅全体と他の導電性軌道の幅の少なくとも約10%に重なるように寸法取りされ、配置されている蓋部含む検査ストリップ。
(4) 検査を実行するのに適した反応成分と、約100キロダルトン〜約900キロダルトンの平均分子量をもつ酸化ポリエチレンを約0.2重量%〜約2重量%含む溶解可能または懸濁可能な薄膜形成混合物を含み、
試薬は、湿潤状態で検査ストリップに加えら得るものであり、その後乾燥され得るものであり、次いで水性検査サンプルがその乾燥試薬に加えられると再溶解又は再懸濁され得る検査ストリップ用の試薬。
(5) 第1絶縁基板の凹みに沿った第1切欠きと、蓋部の凹みに沿った切欠きを含み、第1および第2切欠きは互いに重なるように配置されている(1)の検査ストリップ。
(6) 蓋部に固体の透明または半透明窓部が備えられ、窓部は、該窓部が第1絶縁基板の凹みに最も近い導電性軌道の幅全体と他の導電性軌道の幅の少なくとも約10%に重なるように寸法取りされ、配置されている(1)の検査ストリップ。
検査試薬は、湿潤状態で検査ストリップに加えられ得るものであり、その後乾燥され得るものであり、次いで水性検査サンプルがその乾燥試薬に加えられると再溶解または再懸濁され得る、(1)の検査ストリップ。
検査試薬は、湿潤状態で検査ストリップに加えられ得るものであり、その後乾燥され得るものであり、次いで水性検査サンプルがその乾燥試薬に加えられると再溶解または再懸濁され得る、(5)の検査ストリップ。
検査試薬は、湿潤状態で検査ストリップに加えられ得るものであり、その後乾燥され得るものであり、次いで水性検査サンプルがその乾燥試薬に加えられると再溶解または再懸濁され得る、(6)の検査ストリップ。
検査試薬は、湿潤状態で検査ストリップに加えられ得るものであり、その後乾燥され得るものであり、次いで水性検査サンプルがその乾燥試薬に加えられると再溶解または再懸濁され得る、(7)の検査ストリップ。
試薬は、水性検査サンプルを加えると、再溶解または再懸濁する、検査ストリップ用の試薬。
試薬は、水性検査サンプルを加えると、再溶解または再懸濁する、(1)の検査ストリップ。
試薬は、水性検査サンプルを加えると、再溶解または再懸濁する、(5)の検査ストリップ。
試薬は、水性検査サンプルを加えると、再溶解または再懸濁する、(6)の検査ストリップ。
試薬は、水性検査サンプルを加えると、再溶解または再懸濁する、(7)の検査ストリップ。
毎秒1センチメートル当り約20〜約90ワットのワット密度でコロナアークを表面に印加する工程と、
コロナ処理の作用を取り消すのが望ましい領域に水の薄膜を選択的に付加する工程と、
乾燥により水を取り除く工程を含む方法。
第1および第2面と、縁部に沿った凹みを備えた第1絶縁基板;
第1絶縁基板の第1面に固定された少なくとも2つの導電性軌道;
第1および第2面と、縁部に沿った凹みと、開口部を備えた第2絶縁基板であって、第2面は、導電性軌道と第1絶縁基板の第1面に固定され、第2絶縁基板は、導電性軌道の一部を、電気特性の測定が可能な測定機器に電気的に接続するために露出させるように配置され、開口部は、縁部に沿って配置され且つ導電性軌道の異なる部分を露出させるものである第2絶縁基板;
開口部により露出された導電性軌道の少なくとも1部分を被う検査試薬;
第1および第2面と、縁部に沿った凹みを備えた蓋部であって、蓋部の第2面は、第2絶縁基板の第1面に固定され、開口部と重なり且つ蓋部の第2面と第1絶縁基板の第1面が、第2絶縁基板の縁部にサンプル供給口を有する毛細管状充填室の対向する壁部を形成するように配置されている蓋部;ならびに
毛細管状充填室と通じている空気孔を含み、
第2絶縁基板の開口部ならびに第1絶縁基板、第2絶縁基板および蓋部の凹みが位置合わせされていることによりサンプル供給口を触覚により認識することができる、上記検査ストリップ。
第1絶縁基板の第1面に固定された少なくとも2つの導電性軌道;
第1および第2面と開口部を備えた第2絶縁基板であって、第2面は、導電性軌道と第1絶縁基板の第1面に固定され、第2絶縁基板は、導電性軌道の一部を、電気特性の測定が可能な測定機器に電気的に接続するために露出させるように配置され、開口部は、第2絶縁基板の縁部に沿って配置され且つ導電性軌道の異なる部分を露出させ且つ第1絶縁基板における切欠きと重なるものである第2絶縁基板;
開口部により露出された導電性軌道の少なくとも1部分を被う検査試薬;
第1および第2面と、縁部に沿った切欠きを備えた蓋部であって、蓋部の第2面は、第2絶縁基板の第1面に固定され、1)蓋部の第2面と第1絶縁基板の第1面が、第2絶縁基板の縁部にサンプル供給口を有する毛細管状充填室の対向する壁部を形成し且つ2)蓋部の切欠きが第1絶縁基板の切欠きに重なるように配置されている蓋部;ならびに
毛細管状充填室と通じている空気孔を含み、
蓋部の切欠きと第1絶縁基板の切欠きにより、液体水性サンプルがサンプル供給口に接触した場合に毛細管状室に有意に逡巡することなく流入する、検査ストリップ。
第1絶縁基板の第1面に固定された少なくとも2つの導電性軌道;
第1および第2面と開口部を備えた第2絶縁基板であって、第2面は、導電性軌道と第1絶縁基板の第1面に固定され、第2絶縁基板は、導電性軌道の一部を、電気特性の測定が可能な測定機器に電気的に接続するために露出させるように配置され、開口部は第2絶縁基板の縁部に沿って配置され且つ導電性軌道の異なる部分を露出させるものである第2絶縁基板;
開口部により露出された導電性軌道の少なくとも1部分を被う検査試薬;
第1および第2面と固体の透明または半透明窓部を備えた蓋部であって、蓋部の第2面は、第2絶縁基板の第1面に固定され、蓋部の第2面が第2絶縁基板の開口部と重なり且つ蓋部の第2面と第1絶縁基板の第1面が第2絶縁基板の縁部にサンプル供給口を有する毛細管状充填室の対向する壁部を形成するように配置されており、透明または半透明窓部は、窓部の全体の長さと幅が毛細管状検査室の長さと幅より短く、窓部がサンプル供給口からはみ出し且つ導電性軌道の1つの幅全体と他の導電性軌道の幅の少なくとも約10%に重なるように寸法取りされ、配置されている蓋部;ならびに
毛細管状充填室に通じている空気孔
を含む、検査ストリップ。
工程1:NATROSOLの脱イオン水溶液を調製する。これは、確実に30分以上の間1分当り250回転以上の速度で掻き混ぜながら、NATROSOL-250M(微晶性ヒドロキシエチルセルロース、Aqualonから市販)0.45グラム(g)を脱イオン水414gに加えることにより行われる。この混合は、3または4本の刃をもつタービン型プロペラを用いてオーバーヘッド回転インぺラにより最も適切に実施される。プロペラサイズと配置の選択は主に使用される混合容器の半径に基づく。選択されたプロペラの半径は典型的には混合容器の半径の75%以上である。
工程6:工程5で得た溶液に、キノタンパク質グルコースデヒドロゲナーゼのアポ酵素121万単位を、泡がたつのを防ぐために低速度で(磁気撹拌板で400rpm未満)撹拌しながら徐々に加える。その結果生成された溶液を、2時間以上の間混合して、酵素およびコエンザイムの会合を安定化し、それによってキノタンパク質グルコースデヒドロゲナーゼの溶液を得る。
3.3mg のNATROSOL 250M
41.5mgのAVICEL RC-591F
89.4mg のリン酸二水素二カリウム
157.9mg のリン酸水素二カリウム
437.3mg のフェリシアン化カリウム
46.0mg のコハク酸ナトリウム
148.0mg のトレハロース
2.6mg のTRITON X-100界面活性剤
重要なことは、上記で参照された湿潤試薬において平均分子量が約100キロダルトン〜約900キロダルトンの酸化ポリエチレンを約0.2重量%〜約2重量%、好ましくは、300キロダルトンの平均分子量の酸化ポリエチレンを約0.71重量%含んでいれば、乾燥した場合に、機械的穴開けなどのストリップ加工プロセスに耐えられるほど頑強であり、検査ストリップユーザによる機械的操作に耐えられるほど頑強であり、人の血液などの水性サンプルを加えたときに再溶解または再懸濁する検査試薬が形成される。乾燥後、酸化ポリエチレンのパーセンテージは約1.75%(重量対重量)から17.5%(重量対重量)の範囲である。好適な乾燥試薬では、酸化ポリエチレンのパーセンテージは約6.2%(重量対重量)である。
(ただし[分析物]はサンプル中の分析物の濃度を表し(図6を参照)、i7.5は、電極間に電位差を加えた7.5秒後に測定された電流(マイクロアンペア)であり、Cは直線30の勾配であり(図6)、dは軸切片である(図6)。)
既知濃度の分析物で測定を行うことにより、較正曲線30(図6)が構成可能である。この較正値は測定機器の読出し専用メモリ(ROM)キーに記憶され、検査ストリップの特定のロットに適用可能になる。図6の直線31と32は、検査ストリップの2つのその他の異なるロット用の他の仮説上の較正曲線を表す。これらのバイオセンサのロットについての較正は、上記のアルゴリズムにおけるCとdに対してわずかに異なる値を生ずる。
(ただし、i1は第1の測定時間(300ミリボルトの電位差の印加の3秒後)に測定された電流であり、i2は第2の測定時間(300ミリボルトの電位差の印加の3.5秒後)に測定された電流であり、i3は第3の測定時間(300ミリボルトの電位差の印加の4秒後)に測定された電流で、inは第n番目の測定時間(本例では、第13測定時間、または300ミリボルトの電位差の印加の9秒後)に測定された電流であり、C1,、C2,、C3およびCnは、主成分分析(Principle Components Analysis)や部分最小二乗法などの多変量回帰解析技術から誘導される係数であり、dは回帰切片(グルコース濃度単位)である。)
一方、測定されるサンプルにおけるグルコースの濃度は、ある時間間隔(たとえば、300ミリボルト電位差の印加後3秒から9秒)にわたって電流i対測定時間をプロットすることで作成された曲線を積分することにより判定可能であり、それによって測定時間中に移動した総電荷が得られる。移動した総電荷は測定されるサンプル中のグルコースの濃度に正比例している。
(ただし、Tはサンプル測定時の環境温度(℃)であり、Kは以下の回帰方程式: Y = K(T-23)
(ただし、
Kの値を計算するために、多数の多種多様なグルコース濃度それぞれが、様々な温度Tおよび23℃(基準ケース)で測定機器により測定される。次に、T-23上のYの線形回帰が実行される。Kの値はこの回帰の勾配である。
Claims (16)
- 毛細管状検査室、サンプル供給口、および前記サンプル供給口(20)を容易に識別できるように検査ストリップの一つの縁端部に沿って形成された凹み、を含んでなる電気化学バイオセンサ検査ストリップ。
- サンプルを、サンプル供給口を通って毛細管状検査室に導入する、請求項1記載のバイオセンサ検査ストリップ。
- 前記毛細管状検査室に露出する少なくとも2つの導電性軌道(5, 6)をさらに含んでなる、請求項1記載のバイオセンサ検査ストリップ。
- 前記少なくとも2つの導電性軌道が前記毛細管状検査室を横切って延びている、請求項3記載のバイオセンサ検査ストリップ。
- 前記導電性軌道の少なくとも一部分を被う検査試薬(12)を含む、請求項3記載のバイオセンサ検査ストリップ。
- 可撓性を有する絶縁基板(1)を含んでなる、請求項1または2記載のバイオセンサ検査ストリップ。
- 半透明窓部(18)を有しており、これを通してその下にある毛細管状流路の幅のかなりの部分が見える、請求項1記載のバイオセンサ検査ストリップ。
- 窓部(18)の直交方向の寸法が作用電極(5)の幅全体を露出させる、請求項7記載のバイオセンサ検査ストリップ。
- 窓部の長さと幅が毛細管状検査室の長さと幅よりも短い、請求項7記載のバイオセンサ検査ストリップ。
- 窓部が蓋部(13)に備えられている、請求項7記載のバイオセンサ検査ストリップ。
- 窓部によって、検査サンプルがストリップに十分に添加されたことが視覚的にフィードバックされる、請求項7記載のバイオセンサ検査ストリップ。
- サンプル供給口に配置された1つの切欠きを含んでなる、請求項1記載のバイオセンサ検査ストリップ。
- 切欠きが第1絶縁基板とストリップの蓋部の両方に形成されている、請求項12記載のバイオセンサ検査ストリップ。
- 切欠きが、検査ストリップで互いに重なりあうように寸法取りされ、配置されている、請求項13記載のバイオセンサ検査ストリップ。
- 前記蓋部と絶縁基板とが毛細管状検査室の対向する壁部を形成している、請求項13記載のバイオセンサ検査ストリップ。
- 親水性コーティングを含む蓋部を含んでなる、請求項12または13記載のバイオセンサ検査ストリップ。
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2010071846A (ja) * | 2008-09-19 | 2010-04-02 | Seiko Epson Corp | バイオセンサおよびバイオセンサの製造方法 |
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