JP4889670B2 - 溶血の影響を低減した体液成分測定用乾式分析素子 - Google Patents
溶血の影響を低減した体液成分測定用乾式分析素子 Download PDFInfo
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Classifications
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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
- G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
- G01N33/521—Single-layer analytical elements
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/26—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase
- C12Q1/28—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase involving peroxidase
Description
体液成分中の種々の成分、例えば還元性物質であるアスコルビン酸、ヘモグロビン、赤血球カタラーゼ、ビリルビン等の還元作用による負誤差の影響、また、ヘモグロビン、ビリルビン等の色素は、測定波長によっては正、負誤差の原因となり、これら色素自身の吸収が光ならびに測定試薬組成中の成分等の影響により測定中に経時的に変化し、測定結果に影響を与えることも広く知られており、このような影響を干渉という。
好ましくは、オキシダーゼ以外の試薬成分を含む高粘度液の粘度は50 mPa・s以上500mPa・s以下である。
ここで、低粘度液及び高粘度液とは、オキシダーゼを含む液の粘度の方が、オキシダーゼ以外の試薬成分を含む液の粘度より低いこと、並びにオキシダーゼ以外の試薬成分を含む液の粘度の方が、オキシダーゼを含む液の粘度より高いことをそれぞれ意味し、2種の液体の粘度の相対的な高低を意味するものである。
体液としては、血清、血漿又は尿などを用いることができる。体液試料としては、血清、血漿、尿などをそのまま使用してもよく、あるいは適宜の前処理を施したものを使用してもよい。
乾式分析素子は、水不透過性支持体の上に、少なくとも1層の試薬層(接着層とも称される場合がある)及び多孔性の展開層を有するように構成することができる。
試薬組成物は、第1の展開層に含まれてもよいが、試薬層及び展開層の両方の層に含まれてもよい。あるいは全部又は大部分の試薬組成物がいずれかの層に含まれていてもよく、あるいは試薬層と展開層以外の層に試薬組成物を添加しておいてもよい。
実施例1:本発明の乾式分析素子の作製
ゼラチン下塗りされている180μmのポリエチレンテレフタレート無色透明平滑フィルムにゼラチン水溶液(下記組成)を乾燥後の厚さが15μmになるように塗布して乾燥することによって試薬層を形成した。
ゼラチン 15.00g/m2
DAOS(同仁化学) 0.45g/m2
4-アミノアンチピリン(和光純薬) 0.30g/m2
POD 30.00kU/m2
MES Buffer(pH6.6) 9.7%(wt/wt)
コレステロールエステラーゼ(Schizophyllum commune由来) 11.0U/g
コレステロールオキシダーゼ(Pseudomonas sp.由来 6.7U/g
プルロニックF88(ADEKA) 0.76%(wt/wt)
Luviskol K17F(BASF) 2.0%(wt/wt)
MES Buffer(pH6.6) 1.1%(wt/wt)
Kollidon K90F(BASF) 7.3%(wt/wt)
エマルゲンB66(花王) 1.2%(wt/wt)
硫酸デキストラン(和光純薬) 0.4%(wt/wt)
塩化マグネシウム六水和物(和光純薬) 2.6%(wt/wt)
トリコット編み物布地を、展開層用基材として軽く圧力をかけて積層し、乾燥させる操作までは、実施例1と同様に行った。その後、下記処方の水溶液を塗布乾燥し、実施例1同様にHDL-C測定用スライドを作製した。
MES Buffer(pH6.6) 10.8%(wt/wt)
Kollidon K90F(BASF) 7.3%(wt/wt)
硫酸デキストラン(和光純薬) 0.4%(wt/wt)
塩化マグネシウム六水和物(和光純薬) 2.6%(wt/wt)
エマルゲンB66(花王) 1.2%(wt/wt)
プルロニックF88(ADEKA) 0.76%(wt/wt)
コレステロールエステラーゼ(Schizophyllum commune由来) 11.0U/g
コレステロールオキシダーゼ(Pseudomonas sp.由来 6.7U/g
健常者より抗凝固剤ヘパリンリチウム採血管を用いて、10ml採血した(HDL-C濃度が75mg/dLの検体)。1mlを−80℃にて2時間凍結後、急速に室温に戻すことで溶血させ、溶血血漿を得た。一方、残りの9mLは30分間室温にて放置後、遠心分離にて血漿を得た。溶血血漿のヘモグロビン濃度を、富士ドライケムスライドHb−Wにて測定し、ヘモグロビン濃度500mg/dLになるように血漿にて希釈した。溶血血漿を含まない、ヘモグロビン濃度0mg/dLの血漿とヘモグロビン濃度500mg/dLの血漿をそれぞれ10μLずつ実施例1にて作製したHDL-C測定用スライドに点着し、富士フィルム社製FDC7000ドライケムアナライザーにてHDL-C濃度を測定した。表1に示すとおり、ヘモグロビンによる負誤差がほとんどないスライドが得られた。
Claims (6)
- H2O2の発色試薬を含む試薬層と、該試薬層の上に設けられた展開層とを少なくとも含む体液成分測定用乾式分析素子の製造方法において、H2O2の発色試薬を含む試薬層の上に展開層用基材を設ける工程、及び該展開層用基材に対して、オキシダーゼを含む低粘度液を塗布し、次いでオキシダーゼ以外の試薬成分を含む高粘度液を塗布することによって展開層を調製する工程とを含むことを特徴とする、体液成分測定用乾式分析素子の製造方法。
- オキシダーゼを含む低粘度液の粘度が1mPa・s以上30 mPa・s以下である、請求項1に記載の方法。
- オキシダーゼ以外の試薬成分を含む高粘度液の粘度が50 mPa・s以上500mPa・s以下である、請求項1又は2に記載の方法。
- H2O2の発色試薬を含む試薬層の上に展開層用基材を設ける工程、及び該展開層用基材に対して、オキシダーゼを含む低粘度液を塗布し、次いでオキシダーゼ以外の試薬成分を含む高粘度液を塗布することによって展開層を調製する工程によって製造される、体液成分測定用乾式分析素子。
- オキシダーゼを含む低粘度液の粘度が1mPa・s以上30 mPa・s以下である、請求項4に記載の体液成分測定用乾式分析素子。
- オキシダーゼ以外の試薬成分を含む高粘度液の粘度が50 mPa・s以上500mPa・s以下である、請求項4又は5に記載の体液成分測定用乾式分析素子。
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JPS55164356A (en) | 1979-06-08 | 1980-12-22 | Fuji Photo Film Co Ltd | Multi-layer analysis sheet for liquid sample analysis |
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