JP5964835B2 - エラー検出を有するグルコースの電気化学的測定法 - Google Patents
エラー検出を有するグルコースの電気化学的測定法 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
- G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
-
- 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
- C12Q1/54—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving glucose or galactose
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
- G01N27/3274—Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration
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- Life Sciences & Earth Sciences (AREA)
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- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
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- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Electrochemistry (AREA)
- Organic Chemistry (AREA)
- Cell Biology (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Diabetes (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Emergency Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
Description
GO(red)+2Fe(CN)63−→GO(ox)+2Fe(CN)64−(B)
Gはヘマトクリット値補正されたグルコース濃度であり、
I1は第1の検査電流であり、
I2は第2の検査電流であり、
I3は第3の検査電流であり、
I4は第2の検査電流であり、
I5は第3の検査電流であり、
a及びbは、実験により導き出されるチューニングパラメータであり、
切片は、
勾配は、
IWE1@tn=第2(second)の作用電極で時間tnにサンプリングした電流、
tn〜1.1秒、好ましくは1.12秒、及び
K〜本明細書の特定の実施形態では1〜2、好ましくは1.4である。
Claims (14)
- テストストリップと、マイクロプロセッサを含む検査回路を有する計測器とを有するシステムを用いてグルコース濃度を測定する方法であって、
前記テストストリップの参照電極と試薬層でコーティングされた第2の作用電極との間、及び前記参照電極と試薬層でコーティングされた第1の作用電極との間の化学反応を開始させる工程と、
前記第1及び前記第2の作用電極の一方の一次検査電流及び二次検査電流を測定する工程と、
前記一次検査電流と前記二次検査電流との差がゼロ未満かどうかを判定する工程と、
真と判定された場合には、前記の複数の検査電流に基づいてグルコース濃度を導出し、真でない場合にはエラーを戻す工程と、
前記第2及び前記第1の作用電極のそれぞれからサンプリングしたそれぞれの三次検査電流から電流比を決定する工程と、
前記第2の作用電極と前記第1の作用電極との前記電流比が、前記第1の作用電極と前記第2の作用電極における正常な電流トランジェントKより大きい場合には、導出ステップを飛び越えて進む工程と、を含み、
前記複数の測定された又はサンプリングされた検査電流が、第1、第2、第3、第4、及び第5の検査電流を有し、Kが1.0〜1.4の値を有する、方法。 - 前記一次検査電流が、サンプリングステップの開始時にサンプリングされた電流を含む、請求項1に記載の方法。
- 前記二次検査電流が、サンプリングステップの開始後0.8秒でサンプリングされた電流を含む、請求項1に記載の方法。
- Kが1.4の定数を有する、請求項1に記載の方法。
- テストストリップと、マイクロプロセッサを含む検査回路を有する計測器とを有するシステムを用いてグルコース濃度を測定する方法であって、
前記テストストリップの参照電極と試薬層でコーティングされた第2の作用電極との間、及び前記参照電極と試薬層でコーティングされた第1の作用電極との間の化学反応を開始させる工程と、
血液試料を前記テストストリップに適用した後に、複数の検査電流をサンプリングする工程と、
前記第2及び前記第1の作用電極のそれぞれからサンプリングしたそれぞれの三次検査電流から電流比を決定する工程と、
前記第2の作用電極と前記第1の作用電極との電流比が、前記第1の作用電極と前記第2の作用電極における正常な電流トランジェントK未満であるかどうか質問し、真である場合、前記複数の検査電流に基づいてグルコース濃度を導出し、真でない場合には、エラーを戻す工程と、を含み、
前記複数の測定された又はサンプリングされた検査電流が、第1、第2、第3、第4、及び第5の検査電流を有し、Kが1.0〜1.4の値を有する、方法。 - 前記第1及び前記第2の作用電極の一方の一次検査電流及び二次検査電流を測定する工程と、
前記一次検査電流と前記二次検査電流との差がゼロ未満かどうかを判定する工程と、
真と判定された場合には、導出ステップを終了させる工程と、を更に含む、請求項5に記載の方法。 - テストストリップと、マイクロプロセッサを含む検査回路を有する計測器とを有するシステムを用いてグルコース濃度を測定する方法であって、
前記テストストリップの参照電極と試薬層でコーティングされた第2の作用電極との間、及び前記参照電極と試薬層でコーティングされた第1の作用電極との間の化学反応を開始させる工程と、
前記第1及び前記第2の作用電極の一方の一次検査電流及び二次検査電流を測定する工程と、
前記一次検査電流と前記二次検査電流との差がゼロ未満かどうかを判定する工程と、
前記第2及び前記第1の作用電極のそれぞれからサンプリングしたそれぞれの三次検査電流から電流比を決定する工程と、
前記第2及び前記第1の作用電極のそれぞれからサンプリングしたそれぞれの三次検査電流から得た電流比が、前記第1の作用電極と前記第2の作用電極における正常な電流トランジェントKより大きいかどうか評価する工程と、
前記判定する工程又は前記評価する工程の一方又は両方が真である場合にはエラーを戻し、真でない場合には、前記複数の検査電流に基づいてグルコース濃度を導出する工程と、を含み、
前記複数の測定された又はサンプリングされた検査電流が、第1、第2、第3、第4、及び第5の検査電流を有し、Kが1.0〜1.4の値を有する、方法。 - 前記第1の検査電流が、前記測定の開始後0.98〜1.00秒で測定された検査電流を有する、請求項1,5,7のいずれか一項に記載の方法。
- 前記第2の検査電流が、前記測定の開始後1.98〜2.00秒で測定された検査電流を有する、請求項1,5,7のいずれか一項に記載の方法。
- 前記第3の検査電流が、前記測定の開始後2.43〜2.45秒で測定された検査電流を含む、請求項1,5,7のいずれか一項に記載の方法。
- 前記第4の検査電流が、前記測定の開始後2.61〜2.63秒で測定された検査電流を含む、請求項1,5,7のいずれか一項に記載の方法。
- 前記第5の検査電流が、前記測定の開始後2.70〜2.72秒で測定された検査電流を含む、請求項1,5,7のいずれか一項に記載の方法。
- 前記導出する工程が、次の形の式を用いてグルコース濃度を表す値を算出する工程を含む:
Gはグルコース濃度を意味し、
I1は前記第1の検査電流を意味し、
I2は前記第2の検査電流を意味し、
I3は前記第3の検査電流を意味し、
I4は前記第4の検査電流を意味し、
I5は前記第5の検査電流を意味し、
aは第1のチューニングパラメータを意味し、bは第2のチューニングパラメータを意味し、
切片は、
勾配は、
- 第1のチューニングパラメータが9.9〜10.2の値を有し、第2のチューニングパラメータが10.8〜11.2の値を有する、請求項13に記載の方法。
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PCT/GB2011/001412 WO2012042211A2 (en) | 2010-09-28 | 2011-09-28 | Analyte measurement method and system with error trapping |
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KR101596901B1 (ko) * | 2014-07-09 | 2016-02-24 | 주식회사 아이센스 | 휴대용 혈당 측정기 |
GB201419799D0 (en) * | 2014-11-06 | 2014-12-24 | Inside Biometrics Ltd | A test device and method of using a test device |
AU2019272518B2 (en) * | 2018-05-22 | 2024-06-13 | Katherine Konstantin SIZOV | Ethylene receptor biosensor |
KR102179203B1 (ko) * | 2018-07-09 | 2020-11-16 | 주식회사 필로시스 | 혈당 센싱 데이터 판별 방법 및 장치 |
KR102226295B1 (ko) * | 2019-10-15 | 2021-03-10 | 주식회사 비바이오 | 생체물질 센싱용 스트립 및 그 제조 방법 |
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EP2770063B1 (en) | 2017-04-19 |
ES2552454T3 (es) | 2015-11-30 |
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EP2622092A2 (en) | 2013-08-07 |
HK1201566A1 (en) | 2015-09-04 |
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CN105181776A (zh) | 2015-12-23 |
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CN103237897B (zh) | 2015-11-25 |
AU2011309958A1 (en) | 2013-05-02 |
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HK1188256A1 (zh) | 2014-04-25 |
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