JP4800209B2 - テストストリップ用の試薬ストライプ - Google Patents
テストストリップ用の試薬ストライプ Download PDFInfo
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- JP4800209B2 JP4800209B2 JP2006517462A JP2006517462A JP4800209B2 JP 4800209 B2 JP4800209 B2 JP 4800209B2 JP 2006517462 A JP2006517462 A JP 2006517462A JP 2006517462 A JP2006517462 A JP 2006517462A JP 4800209 B2 JP4800209 B2 JP 4800209B2
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Description
本出願は2003年6月20日に出願された米国仮出願第60/480,397号に優先権を主張する。本出願は「狭く同質の試薬ストライプを製造するための方法および試薬」と題される同一出願人による出願(以降、「同質の試薬ストライプ出願」)に関し、これによって同一の日に出願され、全体に参照してここに組込まれる。
本発明は、試料流動体中の分析物を評価するのに有用であるシステムに関する。システムは、標的分析物について試料流動体を評価するための装置および方法を含む。以降さらに十分に記述されるとおり、評価は、分析物の存在を検出することから、分析物の濃度を測定することまでにおよびうる。分析物および試料流動体は、試験システムが適切であるあらゆるものでありうる。説明の目的のみのために、分析物がグルコースであり、そして試料流動体が血液または間質液である好ましい実施態様が記述される。しかし、本発明は、明らかに範囲においてこれに限定されない。
システムの1つの要素は、試料流動体のための試料受取チャンバー、および試験分析物の存在下で電気化学的信号を生じるために適切な試薬を含む電気化学的センサーである。センサーは、好ましくは、使い捨てテストストリップ、特に試料受取チャンバーと連通する縁開口部を供する薄層状構築物を有するものからなる。試薬は、またチャンバー内に配置される作用電極に電気化学的信号を提供する位置で、試料受取チャンバー内に配置される。グルコース検出についてのような適切な環境下で、試薬は酵素、任意的にメディエーターを含みうる。
センサーは、試料流動体中の分析物の測定のためのメータと組み合わせて使用される。メータは、通常は、分析物の濃度に対応する電気化学的信号を評価するためにセンサーおよび電子回路の電極との接続を含む。メータは、試料流動体がセンサーによって受領されたこと、および試料流動体の量が、試験をするために十分であることを測定するための手段も含む。メータは、典型的には、分析結果を保存および表示するか、または代わりに、別の装置にデータを供給しうる。
システムは、分析物についての定量または定性的指標のいずれかを供しうる。一実施態様では、システムは、試料流動体中の分析物の存在のみを示す。システムは、試料流動体中の分析物の量または濃度の読取も供しうる。好ましい実施態様では、分析物濃度の非常に正確で、厳密な読取が、少量の試料流動体から早急に得られることが、本発明の特性である。
システムは、広範多様な分析物の測定のために有用である。たとえば、テストストリップは、分析物の存在を評価するために使用されうるあらゆる適切な化学物質を用いて使用するためにも十分適合される。より好ましくは、システムは、生物学的流動体中の分析物の試験のために構成および使用される。このような分析物は、たとえば、グルコース、コレステロール、HDLコレステロール、トリグリセリド、乳酸塩、乳酸脱水素酵素、アルコール、尿酸、および3−ヒドロキシ酪酸(ケトン体)を含みうる。システムに対応する改質は、当業者に明らかである。説明の目的のために、そして特に好ましい実施態様で、システムは、生物学的流動体におけるグルコースの検出に関して記述される。
試験方法論は、試料流動体中の干渉物の存在により種々に影響を及ぼされうる。たとえば、血液試料中のグルコースについての試験は、酸素、ビリルビン、ヘマトクリット、尿酸、アスコルベート、アセトアミノフェン、ガラクトース、マルトースおよび脂質のような因子によって影響を与えられうる。本システムは、試料流動体にも存在しうる干渉物の有害な影響を最小限にするか、または除去する適合性がある。これらの影響は、可能性のある干渉物により、ほとんど、またはまったく影響を受けないことが知られている化学物質の選択などによる、試験材料およびパラメーターの適切な選択により対処されうる。当業界で知られるとおり、他の工程も、干渉物が試験ゾーンに入ってくることを防止する被覆または膜の使用など、可能性のある干渉物の影響に対処するために行われうる。さらに、電極構成または呼びかけ信号法に対する改善は、干渉物の影響を最小限にするために使用されうる。
システムは、多様な試料流動体に有用であり、好ましくは、生物学的流動体中の分析物の検出のために使用される。これに関連して、用語「生物学的流動体」は、分析物が測定されうる、たとえば、間質液、真皮液、汗、涙、尿、羊膜液、脊椎液、および血液のようなあらゆる体液を含む。本発明の内容で、用語「血液」は、全血およびそれの細胞不含成分、特に血漿および血清を含む。さらに、システムは、試験用のシステムの完全な状態を確認するために従来の形態で使用される対照流動体と関連して有用である。
導入
テストストリップは、いくつかの基本的な要素を含む。ストリップは、試料流動体が、試験のために受け取られるチャンバーを画定する小型本体を包含する。この「試料受取チャンバー」に、好ましくは、毛細管作用により、適切な手段により試料流動体を充填するが、しかし任意的に、圧力または真空によっても支援される。試料受取チャンバーは、試料流動体中の分析物を示す電気化学的信号を生成することに適した電極および化学物質を含む。
特に図面に関して、本発明に従って有用なテストストリップの好ましい実施態様を示す。テストストリップ10は、基板12、スペース層14、および本体カバー18とチャンバーカバー20を含む被覆層16を包含する。スペース層14は、基板12と被覆層16のあいだで延びる試料受取チャンバー24を供するための空間部分22を包含する。
テストストリップは、コンパクトさ、および保存と使用の容易さのために寸法決めされる比較的小型の装置である。典型的な実施態様では、ストリップの長さは、長さ20から50mm程度、好ましくは約33から約38mm、そして幅5から15mm程度、好ましくは約7から約9mmである。スロットまたは排出開口部34からメータの縁までの距離は、血液が存在しない「把持領域」を供し、そしてメータ接触領域の血液混入に対して保護する大きさに作製され、したがって、5から35、好ましくは≧13mmまでの範囲でありうる。メータに挿入されるテストストリップ部分の長さ(メータ挿入末端38から)は、好ましくは、テストストリップの長軸に沿って≦6.0mmである。
テストストリップは、電極システムと他の要素を支持する絶縁材料からなる基板12を含む。典型的に、ビニル重合体、ポリイミド、ポリエステル、およびスチレンのようなプラスチックは、要求される電気的および構造的特性を提供する。さらに、テストストリップは、好ましくは材料のロールから大量生産可能であるので、材料特性は、仕上げられたストリップに有用な剛性を与えながらも、ロール加工のために十分柔軟性を有することに適合していることが望ましい。基板は、ポリエステル、特に高温ポリエステル材料;ポリエチレンナフタレート(PEN)、およびポリイミドのような柔軟性重合材料、またはこれらのうちの2つまたはそれより多くの混合物として選択されうる。ポリイミドは、たとえば、デラウエア州ウイルミントンのデュポン社(E.I.duPont de Nemours and Company)からKapton(登録商標)の商品名で市販されている。特に好ましい基板材料は、デュポン社から入手可能なMELINEX(MELINEX)(登録商標)329である。
型
本発明は、センサー内での電気化学的酸化および還元反応の手段として、分析物の存在を検出し、および/またはその濃度を測定するように構成された装置である「電気化学的センサー」に関する。これらの反応は、分析物の量または濃度に相関可能な電気的信号に変換される。したがって、テストストリップは、試料受取チャンバー内に、1組の測定電極、たとえば少なくとも作用電極と対極を含む電極システム26を含む。試料受取チャンバーは、チャンバーに入る試料流動体が、作用電極と対極の両方との電解接触されるように構成される。これは、分析物の電気的酸化または電気的還元に影響する測定電極のあいだに電流を流させる。
作用および対極、および電極システムの残りの部分は、当業界で知られるとおり、多様な材料から形成されうる。電極は、比較的低い電気抵抗を有すべきであり、そしてテストストリップの操作範囲で電気化学的に不活性であるべきである。作用電極のための適切な導体は、金、パラジウム、プラチナ、炭素、チタン、酸化ルテニウム、インジウムスズ酸化物およびイリジウム並びにその他を含む。対極は、同じまたは異なる材料、たとえば銀/塩化銀から製造されうる。好ましい実施態様では、作用および対極は、両方とも金電極である。
電極は、適切な伝導性および完全性の電極を生じるあらゆる形態の基板に適用されうる。典型的な工程は当業者に周知であり、たとえば、スパッタリング、印刷などが含まれる。好ましい実施態様では、金電極は、基板を被覆し、その後被覆の選択部分を除去して、電極システムを得ることによって供される。好ましい除去方法は、レーザー除去、さらに好ましくは、「バイオセンサーを製造する方法」と題される2003年6月20日に提出された米国特許出願第10/601,144号に開示されるとおり、広領域電界レーザー除去であり、その開示は、参照してここに組込まれる。
電極システムは、テストストリップおよびメータの操作に適した多様な構成を有する。あらゆる実施態様に関して、作用電極および対極は、好ましくはそれらを覆うために必要とされる試料流動体の体積を最小限にするように位置決めおよび寸法決めされる。電極が、比較的廉価な携帯型のメータを使用して測定可能にするために十分な大きさの電流の流れを維持するように設計されることも好ましい。
試薬組成物
テストストリップは、試験分析物と反応して、試料流動体中の分析物の存在を表す電気化学的信号を生じる試料受取チャンバー内に化学的試薬を含む。試薬層は、種々の分析物の存在および/または濃度を測定するために選択される多様な活性成分を含む。したがって、試験化学は、評価されるべき分析物に関して選択される。当業界で周知であるように、種々の分析物の各々と共に使用するのに利用可能な膨大な化学物質がある。たとえば、1つの好ましい実施態様では、本発明のテストストリップは、血液中のグルコースの存在を決定するために選択されうる1つまたはそれより多くの酵素、補酵素、およびコファクターを含みうる。したがって、適切な化学物質の選択は、十分当業界の技術の範囲内にあり、ここでのさらなる説明は、種々の分析物と共にテストストリップを作製および使用することを可能にするために要求されない。
従来の形態では、試薬化学は、試薬特性および特徴を増強する種々の添加物を含みうる。たとえば化学物質は、テストストリップへの試薬組成物の配置を促進し、ストリップの接着性を改善するか、または試料流動体により、試薬組成物の水和の速度を増大させるための材料を含む。さらに、試薬層は、得られた乾燥試薬層の物理的特性、そして分析のための液体試験試料の取込みを増強するために選択される成分を含みうる。試薬組成物と一緒に使用されるべき添加物材料の例は、増粘剤、粘度改質剤、膜形成剤、安定剤、緩衝液、洗浄剤、ゲル化剤、充填剤、膜開放剤、着色剤、およびチキソトロピー賦与剤が挙げられる。
構成
テストストリップは、基板の上にあり、そして部分的に、試料受取チャンバーを画定するスペース層14を含む。特に、スペース層14は、試料受取チャンバー24の高さおよび周囲を実質的に画定する空間部分22を含む。空間部分22は、縁開口部を有するように都合よく配置され、これにより試料流動体が縁開口部を接触し、試料受取チャンバーに入る。縁開口部は、側面縁での配置も有用であることが理解されるが、好ましくは、テストストリップの末端に配置される。
スペース層14は、テストストリップでの製造に有用なあらゆる材料から製造されうる。スペース層は、試料受取チャンバーの高さを部分的画定するため、材料は、チャンバーの所望の高さに適切な厚みで十分な強度を有すべきである。スペース層の別の機能は、基板12の上部表面に沿って延びる電極トレースを保護することである。材料は、感熱または感圧性接着剤のいずれか、またはレーザー溶着のような他の手段によって、基板およびカバー材料にもすぐに付着されるべきである。適切な材料の例は、100μmのPET、PEN箔被覆物またはアドヘッシブ リサーチインコーポレイテッド(Adhesives Research Inc.)から得られるARCare90132のような接着剤と組み合わせで含む。
構成
被覆層16は、スペース層14から受取および付着される。被覆層の1つの機能は、試料受取チャンバーの頂部表面を形成することである。別の機能は、試験試料の獲得を支援するための親水性表面の供給である。さらに、被覆層16は、好ましくは、試料流動体が試料受取チャンバーに入りそして移動するときに、空気にチャンバーの内側から逃がす排出開口部34を画定する。
本体カバーとチャンバーカバーは、テストストリップを用いた製造のために有用なあらゆる材料から作製されうる。本体カバーとチャンバーカバー用の材料は、同じであるか、または異なっていてよい。材料は、感熱または感圧性接着剤のいずれか、または加熱またはレーザー溶接のような他の手段により、スペース層にすぐに付着されるべきである。チャンバーカバーと本体カバーの両方に適切な材料の例は、およそ127μm厚のPETの箔を含む。チャンバーカバーは、好ましくは、国際公開公報第02/085185号に開示されるとおり親水性層21、アドヘッシブ リサーチインコーポレイテッド(Adhesives Research Inc.)から得られるARFlow(登録商標)90191を含む。
基板、スペース層およびチャンバーカバーにより形成される試料受取チャンバーは、本質的にその中に試料流動体が移動するいくつかの部分を基本的からなる。第一の参入部分48は、縁開口部から測定電極システムの領域まで延びる。第二の試験部分50は、電極システムの領域を通して延びる。第三の部分52は、測定電極システムから排出開口部まで延びる。試料流動体の試験は、試験部分中の電極システムの領域で起こることが理解される。しかし、試料流動体は、テストストリップを充填する過程でチャンバーの他の部分も充填する。
試料受取チャンバーの高さおよび幅は、試験されるべき流動体、および問題の分析物を含めた多様な考慮に基づいて選択される。たとえば、チャンバー寸法は、好ましくは、試験流動体のチャンバーへの毛細管の流れを促進する大きさにされる。血液と使用するための好ましいチャンバー高さは、たとえば、約50μmから約200μmまで、最も好ましくは120から180μmまでである。好ましい実施態様では、チャンバー高さは、約150μmである。チャンバーの幅は、所望の試料流動体および分析物に適合するように同様に選択されうる。たとえば、チャンバーは、所望の量の作用電極および対極を露出する十分な幅であるべきであり、過度の量の試験用の試料流動体の要求を避けるために十分に狭いべきである。試料受取チャンバーの幅と、作用電極の幅は、作用電極の領域を画定する。その領域は、それが信号増幅および設備設計に関する場合、別の設計考慮事項を表す。
試料受取チャンバーは、好ましくは、試験を行うために必要とされる試料流動体の量を減少させるために、最小の体積を有するように供される。縁開口部から排出開口部まで延びる3つの部分の全てを含めた全体の試料受取チャンバーは、縁から排出口までのチャンバーの領域、および基板からチャンバーカバー20までのチャンバーの高さの因子であると考慮されうる総体積を有する。しかし、「正味チャンバー体積」は、この空間を埋めるために必要な試料流動体の体積からなる。試料受取チャンバーの正味チャンバー体積は、電極、試薬、そして含まれる場合には、おそらく吸着剤材料のような他の物品によって占められる体積を引いた総チャンバー体積に等しい。
試料チャンバーは、別の状況では空であり、それは好ましく、あるいは、代わりに、吸着剤材料を含みうる。適切な吸着剤材料としては、ポリエステル、ナイロン、セルロース、およびニトロセルロースのようなセルロース誘導体が挙げられる。吸着剤材料は、流動体がチャンバーに移動する際に支援することによって、試料流動体の取り込みを促進するために含まれうる。吸着剤材料の使用は、試料流動体の受領のための試料受取チャンバーの空間体積をさらに減少させる役割も果たす。
試料チャンバーを充填する好ましい方法は、毛細管作用による。さらに、テストストリップの充填は、試料流動体に圧力をかけて、試料チャンバーに押出すこと、および/または試料チャンバーに真空を生成して、試料流動体をチャンバーに引き込むことのような他の手段により増大されうる。
試料受取チャンバーの毛細管充填の目的のために、種々のアプローチが、試料流動体のチャンバーへの移動を促進するために利用できる。たとえば、チャンバーを画定する表面のいずれかまたは全ては、親水性を改善するために選択または処理されうる。このような処理は、下に記述されるとおり、既知親水性材料の使用、表面への親水性材料の適用、または親水性を増大するための表面の処理からなる。さらに、試薬組成物は、容易に水和され、試料受取チャンバーの充填を勧めるために配合されうる。先に示されるとおり、吸着剤も使用されうる。
電気化学的センサーは、作用電極および対極に渡って、そして用量充足電極に渡って適切な電位または一連の電位を印加することによって操作される。メティエーターが使用される場合、作用電極および対極に渡って要求される電位の大きさは、酸化還元メディエーターによる。さらに、分析物が電解される電極での電位は、一般に、電気化学的反応を完全に、またはそれに近くまで駆動させるのに十分な大きさであるが、しかし、電位の大きさは、干渉物の重大な電気化学的反応を誘導するのに十分なほどには大きくないことが好ましい。グルコースについては、たとえば、使用される電位差は、一般に、直流計を使用した場合、約+100mVから約+550mVのあいだである。交流計を使用した場合、これらは、一般に、5から100mV RMSでありうる。
試験は、対照溶液、またさらに正しい対照溶液が投与されたことを確認するために投与後に、テストストリップに適用できる。対照溶液は、全システムが、設計仕様以内で機能していること、およびテストストリップが、不適切に保存されたか、そうでなければ誤って処理されなかったことを確認することで使用者を支援する。許容しうるストリップは、試験されるべき特定のストリップ・ロットについて特定の許容範囲内の値を回復する。問題の許容範囲は、容器ラベル上の各ストリップ・ロットについて公表される。
好ましい実施態様では、センサーは、多層の積層されたテストストリップ10からなる。先に記述されたとおり、積層体は、基板12、スペース層14、および被覆層16を含む。これらの構成要素は、種々の方法で組み立てされる。たとえば、構成要素は、接着剤、熱封止、レーザー溶着、および隣接材料を固定するために適した多様な他の適切な技術の使用により組み立てされる。テストストリップは、好ましくは、単一のシートまたはウェブ上で、多数で組立てられ、そしてその後、ストリップは、保存および使用のために分離される。
試料受取チャンバーについてこのような小さな寸法で、試薬層の特徴は、特に水和と混合特性の観点から見て、テストストリップの操作に重要な影響を示しうる。試薬層の量、位置、幅、厚み、および他の特性の制御および再現性は、チャンバー体積が減少し、そして試験時間が減少するとき、いっそう重要になる。したがって、組成物が、適用層の均一性および平坦さのような物理的特性を特に増強する材料を含むことが望ましい。さらに、適用の方法は、試薬層の物理的特性、制御および再現性に影響しうる。
試薬組成物で使用するためのメディエーターは、酵素、分析物および任意的にコファクターを含む反応スキームに関与しうるあらゆる化学種(一般に電気活性物質)、そして検出可能な電気活性反応産物を生じるその反応産物として選択されうる。典型的には、反応中のメディエーターの関与は、分析物、酵素またはコファクターのいずれか1つ、またはこれらのうちの1つの反応産物である種(たとえば、様々な酸化状態に反応するコファクター)との相互作用により、その酸化状態における変化(たとえば、還元)を含む。多様なメディエーターが、適切な電気化学的作用を示す。メディエーターは、好ましくは、その酸化形態でも安定であり、任意的に可逆性酸化還元電気化学を示し、好ましくは、水溶液中で優れた溶解性を示すことができ、そして好ましくは、迅速に反応して、電気活性反応産物を生じる。適切なメディエーターの例としては、ベンゾキノン、メルドラブルー、他の遷移金属錯体、フェリシアン酸カリウム、オスミウム誘導体(国際公開第98/35225号を参照)およびニトロソアナリン(nitrosoanaline)系メディエーター(米国特許第5,286,362号を参照)が挙げられる。好ましい実施態様では、試薬組成物は、ニトロソアニリン系化学物質を利用する。
試薬組成物の成分を、水と混合して、均一で粘性の懸濁液を提供する。添加の順序は、本発明に重要ではない。十分な量の緩衝溶液を添加して、約7のpHで試薬組成物を維持する。典型的には、選択成分を水と予め混合して、組み合わされる多様な保存溶液を供して、最終試薬組成物を得る。たとえば、リン酸塩と任意的にコハク酸ナトリウムを組み合わせることによって、緩衝溶液を製造しうる。他の保存溶液としては、増粘剤、すなわち、Keltrol Fおよびカルボキシメチルセルロース、界面活性剤、すなわち、Geropon T77およびMega 8、酵素および補酵素またはコファクター、およびメディエーターが挙げられる。
ここで、工程ライン114に関して、スペース層を作製するための工程フローチャートが示される。工程116で始めて、材料は、工程112で作製される試薬被覆ウェブの頂部に積層するためのスペース層を製造するために選択される。基板への基材膜は、多様な材料から選択されうる。基材層に類似するスペース層材料は、迅速に、そして高い効率で都合よく加工されうる細長いロールとして提供されうる。好ましい材料としては、デュポン社によりMELINEX(登録商標)の商品名で販売されるポリエステル膜を含む。本発明で使用するために適切な他の材料は、PENが挙げられうる。スペース層材料は、スペーサーを他のストリップ構成要素に積層するために使用されるあらゆる結合層の厚みと合わせるときに、テストストリップの各々に所望のチャンバー深さ(または高さ)を供するために特に選択される厚さを有する。好ましい実施態様では、スペース層は、約75μmから約150μmのあいだ、より好ましくは約100μmから約125μmまでの厚さを有するように選択される。上記されるとおり、スペース層は、両面接着剤から形成されうる。
工程128で、本体カバーのための材料は、工程に導入される。好ましい実施態様では、材料は柔軟性重合体材料であり、たとえば、デュポン社から得られるMELINEX454またはMELINEX339から選択されうる。本体カバーのための材料は、テストストリップの試料受取チャンバー中の電極トレースの少なくとも一部に重なるために十分な幅を有するような大きさに作製される。
工程140から、テストストリップの作製のための仕上工程工程を行う。工程142で、上に検討された単一のテストストリップ10に類似の単一のダイカットテストストリップを製造するかどうかの決定を行う。そうであれば、それにより、工程142から得られる多層積層体は、単一テストストリップにダイカットされるべき工程144に進行する。
次の材料を、ストリップ中で使用する:
ベース基板層12 メリネックス329 9milまたは329 10mil
導電性層26 スパッタされた金 50nm
下部接着剤層49 AR ARケア90132PSA 1〜0.5mil
スペース層14 メリネックス329または339 4〜5mil
接着層46 AR ARケア90132PSA 1〜0.5mil
ボディカバー18 メリネックス339または329または454 5mil
室カバー20 メリネックス339または329または454 4mil
親水性フォイル21 ARケア90037
ストリップは、多様な方法で包装されうる。たとえば、ストリップは、フリップ−頂部プラスチック製陽気に包装されうる(たとえば、10、25または50個)。全ての容器は、許容しうる寿命を確保するのに必要な乾燥性材料を含む。テストストリップは、好ましくは、提供されるとおりの周密に閉鎖された容器中で4〜32℃のあいだで保存される場合、18ヶ月の最小寿命を表す。
Claims (4)
- テストストリップを製造する方法であって、
(a)第一および第二ウェブ縁を有する基板材料のウェブを供給する工程、
(b)ウェブ上に複数の離間された電極組を形成する工程、
(c)前記ウェブに、前記第一ウェブ縁に平行に向けられた試薬材料の連続ストライプを設け、該ストライプによりそれぞれの電極組の少なくとも一方の電極を覆う工程、
(d)スペース層材料のウェブを提供する工程であって、当該ウェブ中に複数の空洞が形成されたウェブを提供する工程、
(e)前記工程(d)のスペース層材料のウェブを基板材料のウェブに積層し、前記複数の電極組のそれぞれ一つに整列される各空洞を有するウェブを形成し、および
(f)前記工程(e)のウェブを複数のテストストリップに切断し、それによって前記切断物が第一および第二側面を有する複数のテストストリップを画定しおよび前記基板および前記スペース層材料の間に位置決めされ、しかも前記テストストリップ第一および第二側面まで延びる試薬層を含む方法。 - スペース材料のウェブが接着剤により基板材料のウェブに積層される請求項1記載の方法。
- 前記スペース層材料のウェブを積層した後および前記ウェブを切断する前に、前記スペース層材料のウェブに被覆層材料のウェブを積層することをさらに含む請求項1または2記載の方法。
- 前記試薬ストライプが3〜20μmまでのあいだの厚さまで乾燥する請求項1〜3のいずれか1項に記載の方法。
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