JP6530109B2 - 抗腫瘍薬による表面汚染に対する直接読み取り検出キット - Google Patents
抗腫瘍薬による表面汚染に対する直接読み取り検出キット Download PDFInfo
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- JP6530109B2 JP6530109B2 JP2018108327A JP2018108327A JP6530109B2 JP 6530109 B2 JP6530109 B2 JP 6530109B2 JP 2018108327 A JP2018108327 A JP 2018108327A JP 2018108327 A JP2018108327 A JP 2018108327A JP 6530109 B2 JP6530109 B2 JP 6530109B2
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- antibody
- antineoplastic
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- FBTUMDXHSRTGRV-ALTNURHMSA-N zorubicin Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(\C)=N\NC(=O)C=1C=CC=CC=1)[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1 FBTUMDXHSRTGRV-ALTNURHMSA-N 0.000 description 1
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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
- G01N33/94—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
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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
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54366—Apparatus specially adapted for solid-phase testing
- G01N33/54386—Analytical elements
- G01N33/54387—Immunochromatographic test strips
- G01N33/54388—Immunochromatographic test strips based on lateral flow
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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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Description
この出願は、2012年7月16日に出願された米国特許仮出願第61/672,059号からの優先権を主張し、その開示内容全体は参照により本明細書に組み込まれる。
抗腫瘍薬と相溶性があり、分析されるべき表面からの薬物の放出を促進するように処方された湿潤性溶液を提供する段階と、
抗腫瘍薬の可逆的吸収のための固体マトリクスを提供する段階と、
固体マトリクスを湿潤性溶液と接触させ、分析試料マトリクスを生成する段階と、
分析試料マトリクスと表面とを接触させ、表面サンプルを生成する段階と、
表面サンプルをある量の湿潤性溶液に接触させて、流体試験サンプルを生成する段階と、
分析結果を生成するために、ラテラルフローアッセイによって流体試験サンプル中の抗腫瘍薬を分析する段階と、
分析結果を検出することにより、表面の抗腫瘍薬汚染を検出する段階とを備える。
コンジュゲートパッドは、拡散可能に結合され検出可能にラベルされた抗腫瘍薬結合剤を有し、
試験検出領域は、非拡散可能に結合された検出試薬を有し、
コントロール領域は、非拡散可能に結合されたコントロール試薬を有し、
固体または半固体の多孔質支持体は、コンジュゲートパッドおよび固体または半固体の多孔質支持体を含む流路に沿った流体試験サンプルの毛細管流動を促進するウィッキングパッドに隣接する、項目1から3のいずれかに記載の方法。
コンジュゲートパッド、コンジュゲートパッドに隣接する固体または半固体の多孔質支持体、支持体に存在する試験領域、および支持体に存在するコントロール領域を備え、
コンジュゲートパッドは、拡散可能に結合され検出可能にラベルされた抗腫瘍薬結合剤を有し、
試験検出領域は、非拡散可能に結合された検出試薬を有し、
コントロール領域は、非拡散可能に結合されたコントロール試薬を有し、
固体または半固体の多孔質支持体は、コンジュゲートパッドおよび固体または半固体の多孔質支持体を含む流路に沿った流体サンプルの毛細管流動を促進するウィッキングパッドに隣接する。
抗腫瘍薬と相溶性があり、分析されるべき表面からの薬物の放出を促進するように処方された湿潤性溶液と、
抗腫瘍薬の可逆的吸収のための固体マトリクスと、
抗腫瘍薬に対して特異的な結合剤、および、コントロール試薬を有するラテラルフロー装置と、
を備える。
結合剤は、コンジュゲートパッドに拡散可能に結合された検出可能にラベルされた抗腫瘍薬結合剤であり、
試験検出領域は、非拡散可能に結合された検出試薬を有し、
コントロール試薬は、コントロール領域に非拡散可能に結合され、
固体または半固体の多孔質支持体は、コンジュゲートパッドおよび固体または半固体の多孔質支持体を含む流路に沿った流体試験サンプルの毛細管流動を促進するウィッキングパッドに隣接する、項目24に記載のキット。
アイソクラチック 95%A、5%B 0−4.5分
グラジエント 5%A、95%Bまで 4.5−5.5分、直線型傾斜
アイソクラチック 5%A、95%B 5.5−11分
グラジエント 95%A、5%Bまで 11−12分、直線型傾斜
アイソクラチック 95%A、5%B(再平衡) 12−17分
5−フルオロウラシル(アナライト):質量対電荷(m/z)129から42まで
5−フルオロウラシル−15N2(20ng/mLレベルにおける内部標準):m/z131から43まで
Claims (25)
- セラミック、ビニール、複合物、ステンレス鋼及びガラスからなるグループから選択される硬い表面の抗腫瘍薬汚染を検出する方法であって、
前記抗腫瘍薬と相溶性があり、分析されるべき前記硬い表面からの前記抗腫瘍薬の放出を促進するように処方された0.01−10%v/vの非イオン性界面活性剤を含む湿潤性溶液を提供する段階と、
前記抗腫瘍薬の可逆的吸収のための固体マトリクスを提供する段階と、
前記固体マトリクスを前記湿潤性溶液と接触させ、分析試料マトリクスを生成する段階と、
前記分析試料マトリクスと前記表面とを接触させ、表面サンプルを生成する段階と、
前記表面サンプルを一定量の湿潤性溶液に接触させて、流体試験サンプルを生成する段階と、
分析結果を生成するために、ラテラルフローアッセイによって前記流体試験サンプル中の前記抗腫瘍薬を分析する段階と、
前記分析結果を検出することにより、前記表面の抗腫瘍薬汚染を検出する段階と、
を備え、
前記ラテラルフローアッセイは、
ラベルされた抗−抗腫瘍薬抗体と、
検出試薬と、
前記抗−抗腫瘍薬抗体に特異的に結合するコントロール試薬と、
を有する、
方法。 - 前記分析結果を基準と比較する段階をさらに備える、請求項1に記載の方法。
- 前記抗腫瘍薬は、ドキソルビシン、パクリタキセル、および5−フルオロウラシルから成る群から選択される、請求項1または請求項2に記載の方法。
- 前記ラテラルフローアッセイは、コンジュゲートパッド、前記コンジュゲートパッドに隣接する固体または半固体の多孔質支持体、前記支持体に存在する試験領域、および前記支持体に存在するコントロール領域を有するラテラルフローアッセイ装置を提供する段階を備え、
前記ラベルされた抗−抗腫瘍薬抗体は、前記コンジュゲートパッドに拡散可能に結合され、
前記検出試薬は、前記試験領域に非拡散可能に結合され、
前記コントロール試薬は、前記コントロール領域に非拡散可能に結合され、
前記固体または半固体の多孔質支持体は、前記コンジュゲートパッドおよび前記固体または半固体の多孔質支持体を含む流路に沿った前記流体試験サンプルの毛細管流動を促進するウィッキングパッドに隣接する、請求項1から請求項3のいずれか1項に記載の方法。 - 前記抗−抗腫瘍薬抗体は、抗−5−フルオロウラシル抗体、抗−パクリタキセル抗体、および抗ドキソルビシン抗体から成る群から選択される、請求項4に記載の方法。
- 前記ラテラルフローアッセイは、競合的アッセイであり、前記検出試薬は、前記抗腫瘍薬を含む、請求項4または請求項5に記載の方法。
- 前記コントロール試薬は前記抗−抗腫瘍薬抗体に特異的に結合する抗体である、請求項4から請求項6のいずれか1項に記載の方法。
- 前記ラテラルフローアッセイ装置は、前記コンジュゲートパッド、前記固体または半固体の多孔質支持体、および、前記ウィッキングパッドのうちの少なくとも1つを少なくとも部分的に包囲する筐体をさらに有する、請求項4から請求項7のいずれか1項に記載の方法。
- 前記分析結果を検出する段階は目視観測を含む、請求項1から請求項8のいずれか1項に記載の方法。
- 前記分析結果を検出する段階は電子読取器の操作を含む、請求項1から請求項8のいずれか1項に記載の方法。
- 前記湿潤性溶液は、生物学的に適合する緩衝剤、および、0.01−10%v/vの有機溶媒の少なくとも1つをさらに有する、請求項1から請求項10のいずれか1項に記載の方法。
- 前記有機溶媒は有機極性プロトン性溶媒である、請求項11に記載の方法。
- コンジュゲートパッド、前記コンジュゲートパッドに隣接する固体または半固体の多孔質支持体、前記支持体に存在する試験領域、および前記支持体に存在するコントロール領域を備え、
前記コンジュゲートパッドは、拡散可能に結合され検出可能にラベルされた抗腫瘍薬結合剤を有し、
前記試験領域は、非拡散可能に結合された検出試薬を有し、
前記コントロール領域は、非拡散可能に結合されたコントロール試薬を有し、
前記固体または半固体の多孔質支持体は、前記コンジュゲートパッドおよび前記固体または半固体の多孔質支持体を含む流路に沿った流体サンプルの毛細管流動を促進するウィッキングパッドに隣接し、
前記抗腫瘍薬結合剤は、抗−抗腫瘍薬抗体であり、
前記コントロール試薬は、前記抗−抗腫瘍薬抗体に特異的に結合し、抗腫瘍薬を含むことが疑われる、0.01−10%v/vの非イオン性界面活性剤を含む湿潤性溶液を有する流体サンプルを備え、
セラミック、ビニール、複合物、ステンレス鋼及びガラスからなるグループから選択される硬い表面上で、抗腫瘍薬を検出するためのラテラルフローアッセイ装置。 - 前記抗−抗腫瘍薬抗体は、抗−5−フルオロウラシル抗体、抗−パクリタキセル抗体、および抗ドキソルビシン抗体から成る群から選択される、請求項13に記載のラテラルフローアッセイ装置。
- 前記ラテラルフローアッセイは、競合的アッセイであり、前記検出試薬は、前記抗腫瘍薬を含む、請求項13または請求項14に記載のラテラルフローアッセイ装置。
- 前記コントロール試薬は前記抗−抗腫瘍薬抗体に特異的に結合する抗体である、請求項13から請求項15のいずれか1項に記載のラテラルフローアッセイ装置。
- 前記コンジュゲートパッド、前記固体または半固体の多孔質支持体、および、前記ウィッキングパッドのうちの少なくとも1つを少なくとも部分的に包囲する筐体をさらに備える、請求項13から請求項16のいずれか1項に記載のラテラルフローアッセイ装置。
- セラミック、ビニール、複合物、ステンレス鋼及びガラスからなるグループから選択される硬い表面の抗腫瘍薬汚染を検出するキットであって、
前記抗腫瘍薬と相溶性があり、分析されるべき前記硬い表面からの前記抗腫瘍薬の放出を促進するように処方された0.01−10%v/vの非イオン性界面活性剤を含む湿潤性溶液と、
前記抗腫瘍薬の可逆的吸収のための固体マトリクスと、
ラベルされた抗腫瘍薬結合剤、検出試薬、および、コントロール試薬を有するラテラルフローアッセイ装置と、
を備え、
前記抗腫瘍薬結合剤は抗−抗腫瘍薬抗体であり、前記コントロール試薬は前記抗−抗腫瘍薬抗体に特異的に結合する、
キット。 - 前記ラテラルフローアッセイ装置は、コンジュゲートパッド、前記コンジュゲートパッドに隣接する固体または半固体の多孔質支持体、前記支持体に存在する試験領域、および前記支持体に存在するコントロール領域を有し、
前記ラベルされた抗−抗腫瘍薬抗体は、前記コンジュゲートパッドに拡散可能に結合され、
前記検出試薬は、前記試験領域に非拡散可能に結合され、
前記コントロール試薬は、前記コントロール領域に非拡散可能に結合され、
前記固体または半固体の多孔質支持体は、前記コンジュゲートパッドおよび前記固体または半固体の多孔質支持体を含む流路に沿った流体試験サンプルの毛細管流動を促進するウィッキングパッドに隣接する、請求項18に記載のキット。 - 前記抗−抗腫瘍薬抗体は、抗−5−フルオロウラシル抗体、抗−パクリタキセル抗体、および抗ドキソルビシン抗体から成る群から選択される、請求項18または請求項19に記載のキット。
- 前記ラテラルフローアッセイは、競合的アッセイであり、前記検出試薬は、前記抗腫瘍薬を含む、請求項18から請求項20のいずれか1項に記載のキット。
- 前記コントロール試薬は、前記抗−抗腫瘍薬抗体に特異的に結合する抗体である、請求項18から請求項21のいずれか1項に記載のキット。
- 前記コンジュゲートパッド、前記固体または半固体の多孔質支持体、および、前記ウィッキングパッドのうちの少なくとも1つを少なくとも部分的に包囲する筐体をさらに備える、請求項19から請求項22のいずれか1項に記載のキット。
- 前記湿潤性溶液は、生物学的に適合する緩衝剤、および、0.01−10%v/vの有機溶媒の少なくとも1つをさらに有する、請求項18から請求項23のいずれか1項に記載のキット。
- 前記有機溶媒は有機極性プロトン性溶媒である、請求項24に記載のキット。
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