WO2023167232A1 - Étalonneur pour réactif de mesure d'autotaxine, procédé d'étalonnage pour réactif de mesure d'autotaxine, kit de mesure d'autotaxine, procédé de mesure d'autotaxine, kit d'aide au diagnostic et procédé d'aide au diagnostic - Google Patents

Étalonneur pour réactif de mesure d'autotaxine, procédé d'étalonnage pour réactif de mesure d'autotaxine, kit de mesure d'autotaxine, procédé de mesure d'autotaxine, kit d'aide au diagnostic et procédé d'aide au diagnostic Download PDF

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Publication number
WO2023167232A1
WO2023167232A1 PCT/JP2023/007548 JP2023007548W WO2023167232A1 WO 2023167232 A1 WO2023167232 A1 WO 2023167232A1 JP 2023007548 W JP2023007548 W JP 2023007548W WO 2023167232 A1 WO2023167232 A1 WO 2023167232A1
Authority
WO
WIPO (PCT)
Prior art keywords
autotaxin
calibrator
measuring
atx
reagent
Prior art date
Application number
PCT/JP2023/007548
Other languages
English (en)
Japanese (ja)
Inventor
健司 小西
信一 酒瀬川
友和 板井
喜丸 大窪
Original Assignee
旭化成ファーマ株式会社
富士フイルム株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 旭化成ファーマ株式会社, 富士フイルム株式会社 filed Critical 旭化成ファーマ株式会社
Publication of WO2023167232A1 publication Critical patent/WO2023167232A1/fr

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/16—Hydrolases (3) acting on ester bonds (3.1)
    • 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
    • C12Q1/34—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
    • C12Q1/42—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving phosphatase
    • 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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids

Definitions

  • the present invention provides a composition that can be used as a calibrator (hereinafter sometimes referred to as a “standard substance”) when measuring the activity or mass of ATX contained in human specimens, etc., and a method using the same.
  • aim to Measuring mass may include measuring concentration.
  • An autotaxin measurement kit includes a calibrator for the autotaxin measurement reagent of any one of [1] to [21] and an autotaxin measurement reagent.
  • the disease for which diagnostic aid is to be provided may be heart disease.
  • the disease for which diagnostic aid is to be provided may be a thyroid disease.
  • the hematopoietic tumor may be lymphoma.
  • the measured value may be activity or mass.
  • the heart disease may be any one selected from the group consisting of heart failure, congestive heart failure, and dilated cardiomyopathy.
  • the autotaxin measuring reagent calibrator according to the embodiment contains autotaxin (ATX), at least one of serum and plasma, and further contains a sugar alcohol. Further, the autotaxin measuring reagent calibrator according to the embodiment contains autotaxin and a sugar alcohol, and the sugar alcohol is trehalose, lactose, maltose, or saccharose.
  • the concentration of ATX in the calibrator is, for example, 5 U/L or more and 50 U/L or less, 5 U/L or more and 30 U/L or less, 5 U/L or more and 20 U/L or less, or 5 U/L or more and 16 U/L or less.
  • the ATX measurement reagent is not particularly limited as long as it can measure ATX.
  • the ATX measurement reagent may contain lysophosphatidylcholine.
  • the lysophosphatidylcholine may be myristoyl lysophosphatidylcholine.
  • the obtained ATX active fraction was concentrated with Centramate (PALL Corporation) 10K to 200 mL. 1800 mL of 10 mmol/L Tris-HCl (pH 7.5) was added. Concentration to 200 mL and addition of 1800 mL buffer were repeated twice to obtain approximately 200 mL of human-derived recombinant ATX. Human-derived recombinant ATX was subjected to SDS-PAGE. A photograph of SDS-PAGE is shown in FIG. In addition, human-derived recombinant ATX activity was measured in each purification step. Table 8 shows the measurement results.
  • sample Twenty-seven human serum specimens used as samples in this example were purchased from Busicom Japan.
  • Figure 2 shows a comparison of the ATX activity (U/L) contained in the human specimens of the 27 measured samples and the ATX mass (mg/L) contained in the human specimens.
  • the human-derived recombinant ATX prepared in Example 2 5% sugar alcohol, and human serum were mixed, 1 mL each was dispensed into vacuum vials (Nippon Electronic Glass Co., Ltd.), and the mixture was kept at -50°C. Freeze for 2 hours. Then, it was dried at ⁇ 50° C. for 0.5 hours, ⁇ 15° C. for 46 hours, and 15° C. for 20 hours, and was sealed with a frozen rubber stopper and a screw cap to obtain a freeze-dried composition. As a control, a freeze-dried composition containing human-derived recombinant ATX and human serum but containing no sugar alcohol was prepared (no addition in Table 11).

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Cell Biology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

L'invention concerne : une composition qui peut être utilisée en tant qu'étalonneur lors de la mesure de l'activité ou de la masse d'autotaxine contenue dans un échantillon humain ou similaire ; un procédé d'utilisation de la composition ; et similaire. Cet étalonneur pour un réactif de mesure d'autotaxine comprend : de l'autotaxine ; et du sérum et/ou du plasma sanguin. L'étalonneur comprend en outre un alcool de sucre. Ce procédé d'étalonnage pour un réactif de mesure d'autotaxine comprend : la mesure de l'autotaxine contenue dans l'étalonneur à l'aide du réactif de mesure d'autotaxine.
PCT/JP2023/007548 2022-03-01 2023-03-01 Étalonneur pour réactif de mesure d'autotaxine, procédé d'étalonnage pour réactif de mesure d'autotaxine, kit de mesure d'autotaxine, procédé de mesure d'autotaxine, kit d'aide au diagnostic et procédé d'aide au diagnostic WO2023167232A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2022-031036 2022-03-01
JP2022031036 2022-03-01

Publications (1)

Publication Number Publication Date
WO2023167232A1 true WO2023167232A1 (fr) 2023-09-07

Family

ID=87883812

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2023/007548 WO2023167232A1 (fr) 2022-03-01 2023-03-01 Étalonneur pour réactif de mesure d'autotaxine, procédé d'étalonnage pour réactif de mesure d'autotaxine, kit de mesure d'autotaxine, procédé de mesure d'autotaxine, kit d'aide au diagnostic et procédé d'aide au diagnostic

Country Status (1)

Country Link
WO (1) WO2023167232A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS545793A (en) * 1977-06-10 1979-01-17 Eastman Kodak Co Stailizing agent for recomposing* freezing and drying sample
JP2008203269A (ja) * 2001-07-12 2008-09-04 Kyowa Medex Co Ltd 凍結保護剤
WO2010101206A1 (fr) * 2009-03-05 2010-09-10 株式会社ビー・エム・エル Agent stabilisant pour échantillon de gestion, échantillon de gestion contenant l'agent stabilisant, et kit de mesure comprenant l'échantillon de gestion
JP2015111154A (ja) * 2006-08-03 2015-06-18 国立大学法人 東京大学 オートタキシン測定による悪性リンパ腫の検査方法および検査薬
WO2020059563A1 (fr) * 2018-09-19 2020-03-26 栄研化学株式会社 Selles artificielles et procédé de gestion de la précision d'une recherche de sang occulte dans les selles utilisant ces dernières
JP2020153832A (ja) * 2019-03-20 2020-09-24 東ソー株式会社 オートタキシン測定による神経障害性疼痛を検出する方法及び検出試薬

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS545793A (en) * 1977-06-10 1979-01-17 Eastman Kodak Co Stailizing agent for recomposing* freezing and drying sample
JP2008203269A (ja) * 2001-07-12 2008-09-04 Kyowa Medex Co Ltd 凍結保護剤
JP2015111154A (ja) * 2006-08-03 2015-06-18 国立大学法人 東京大学 オートタキシン測定による悪性リンパ腫の検査方法および検査薬
WO2010101206A1 (fr) * 2009-03-05 2010-09-10 株式会社ビー・エム・エル Agent stabilisant pour échantillon de gestion, échantillon de gestion contenant l'agent stabilisant, et kit de mesure comprenant l'échantillon de gestion
WO2020059563A1 (fr) * 2018-09-19 2020-03-26 栄研化学株式会社 Selles artificielles et procédé de gestion de la précision d'une recherche de sang occulte dans les selles utilisant ces dernières
JP2020153832A (ja) * 2019-03-20 2020-09-24 東ソー株式会社 オートタキシン測定による神経障害性疼痛を検出する方法及び検出試薬

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