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1. WO2020067120 - METHOD FOR EVALUATING QUALITY OF DEPHOSPHORYLATION REAGENT AND METHOD FOR DETECTING TARGET NUCLEIC ACID

Publication Number WO/2020/067120
Publication Date 02.04.2020
International Application No. PCT/JP2019/037518
International Filing Date 25.09.2019
IPC
C12Q 1/42 2006.01
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
QMEASURING 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
1Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
34involving hydrolase
42involving phosphatase
C12N 15/55 2006.01
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09Recombinant DNA-technology
11DNA or RNA fragments; Modified forms thereof
52Genes encoding for enzymes or proenzymes
55Hydrolases (3)
C12Q 1/6823 2018.01
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
QMEASURING 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
1Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
68involving nucleic acids
6813Hybridisation assays
6816characterised by the detection means
6823Release of bound markers
G01N 33/50 2006.01
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33Investigating or analysing materials by specific methods not covered by groups G01N1/-G01N31/131
48Biological material, e.g. blood, urine; Haemocytometers
50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
G01N 33/53 2006.01
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33Investigating or analysing materials by specific methods not covered by groups G01N1/-G01N31/131
48Biological material, e.g. blood, urine; Haemocytometers
50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
53Immunoassay; Biospecific binding assay; Materials therefor
C12N 9/16 2006.01
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12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
9Enzymes, e.g. ligases (6.); Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating, or purifying enzymes
14Hydrolases (3.)
16acting on ester bonds (3.1)
CPC
C12N 9/16
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12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
9Enzymes; Proenzymes; Compositions thereof
14Hydrolases (3)
16acting on ester bonds (3.1)
C12Q 1/42
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS
1Measuring or testing processes involving enzymes, nucleic acids or microorganisms
34involving hydrolase
42involving phosphatase
C12Q 1/6823
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS
1Measuring or testing processes involving enzymes, nucleic acids or microorganisms
68involving nucleic acids
6813Hybridisation assays
6816characterised by the detection means
6823Release of bound markers
G01N 33/50
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
48Biological material, e.g. blood, urine
50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
G01N 33/53
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
48Biological material, e.g. blood, urine
50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
53Immunoassay; Biospecific binding assay; Materials therefor
Applicants
  • 東レ株式会社 TORAY INDUSTRIES, INC. [JP]/[JP]
Inventors
  • 伊藤 正照 ITO Masateru
  • 上田 洋二 UEDA Yoji
  • 瀧井 有樹 TAKII Yuki
  • 八木 麻衣 YAGI Mai
Agents
  • 永井 浩之 NAGAI Hiroshi
  • 中村 行孝 NAKAMURA Yukitaka
  • 朝倉 悟 ASAKURA Satoru
  • 浅野 真理 ASANO Makoto
  • 反町 洋 SORIMACHI Hiroshi
  • 鈴木 啓靖 SUZUKI Hiroyasu
Priority Data
2018-17952925.09.2018JP
Publication Language Japanese (JA)
Filing Language Japanese (JA)
Designated States
Title
(EN) METHOD FOR EVALUATING QUALITY OF DEPHOSPHORYLATION REAGENT AND METHOD FOR DETECTING TARGET NUCLEIC ACID
(FR) PROCÉDÉ D'ÉVALUATION DE LA QUALITÉ D'UN RÉACTIF DE DÉPHOSPHORYLATION ET PROCÉDÉ DE DÉTECTION D'ACIDE NUCLÉIQUE CIBLE
(JA) 脱リン酸化試薬の品質を評価する方法及び標的核酸を検出する方法
Abstract
(EN)
The purpose of the present invention is to provide a method for evaluating the quality of a dephosphorylation reagent that contains alkaline phosphatase, and a method for detecting a target nucleic acid with the use of a dephosphorylation reagent that is evaluated as having a high quality by the aforesaid evaluation method. To achieve this purpose, provided is a method for evaluating the quality of a dephosphorylation reagent, said method comprising: step (1-1) for preparing a dephosphorylation reagent that contains alkaline phosphatase and a peptide fragment derived from the alkaline phosphatase; and step (1-2) for, when the ratio of the content of the peptide fragment to the content of the alkaline phosphatase is not more than a preset reference value, then evaluating the dephosphorylation reagent as having a high quality.
(FR)
L'objectif de la présente invention est de fournir un procédé d'évaluation de la qualité d'un réactif de déphosphorylation qui contient une phosphatase alcaline et un procédé de détection d'un acide nucléique cible au moyen d'un réactif de déphosphorylation qui est évalué comme ayant une qualité élevée par le procédé d'évaluation susmentionné. À cet effet, l'invention concerne un procédé d'évaluation de la qualité d'un réactif de déphosphorylation, ledit procédé comprenant : une étape (1-1) de préparation d'un réactif de déphosphorylation qui contient une phosphatase alcaline et un fragment peptidique dérivé de la phosphatase alcaline ; ainsi qu'une étape (1-2) d'évaluation du réactif de déphosphorylation comme ayant une qualité élevée, dès lors que le rapport de la teneur du fragment peptidique au contenu de la phosphatase alcaline n'est pas supérieur à une valeur de référence prédéfinie.
(JA)
本発明は、アルカリホスファターゼを含有する脱リン酸化試薬の品質を評価する方法、及び、該評価方法により品質が高いと評価された脱リン酸化試薬を使用して標的核酸を検出する方法を提供することを目的とし、かかる目的を達成するために、本発明は、脱リン酸化試薬の品質を評価する方法であって、以下の工程: (1-1)アルカリホスファターゼと、前記アルカリホスファターゼに由来するペプチド断片とを含有する脱リン酸化試薬を準備する工程;及び (1-2)前記アルカリホスファターゼの含有量に対する前記ペプチド断片の含有量の比率が所定の基準値以下である場合に、前記脱リン酸化試薬の品質が高いと評価する工程 を含む、前記方法を提供する。
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