DK2425259T3 - Immunoassay til detektering af procalcitonin - Google Patents
Immunoassay til detektering af procalcitonin Download PDFInfo
- Publication number
- DK2425259T3 DK2425259T3 DK10715266.2T DK10715266T DK2425259T3 DK 2425259 T3 DK2425259 T3 DK 2425259T3 DK 10715266 T DK10715266 T DK 10715266T DK 2425259 T3 DK2425259 T3 DK 2425259T3
- Authority
- DK
- Denmark
- Prior art keywords
- procalcitonin
- antibody
- pct
- fragment
- sequence spanning
- Prior art date
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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
- G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/26—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/575—Hormones
- G01N2333/5753—Calcitonin gene related peptide
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/575—Hormones
- G01N2333/585—Calcitonins
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Biomedical Technology (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Endocrinology (AREA)
- Medicinal Chemistry (AREA)
- Genetics & Genomics (AREA)
- Biotechnology (AREA)
- Cell Biology (AREA)
- Microbiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Biophysics (AREA)
- Food Science & Technology (AREA)
- Analytical Chemistry (AREA)
- Physics & Mathematics (AREA)
- Peptides Or Proteins (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- General Engineering & Computer Science (AREA)
Claims (8)
1. In v/fro-fremgangsmåde til detektering af procalcitonin som defineret i SEQ ID NO: 1 eller et fragment deraf omfattende aminosyreresterne 3-116 af SEQ ID NO: 1 i en biologisk prøve, der stammer fra en kropsvæske opnået fra et individ, omfattende trinnene: a. at bringe prøven i kontakt med mindst to antistoffer eller funktionelle fragmenter deraf rettet mod forskellige epitoper i procalcitonin og b. kvalitativt eller kvantitativt at detektere binding af mindst to antistoffer til procalcitonin eller fragmentet deraf, hvor binding indikerer tilstedeværelse eller koncentration af procalcitonin eller fragmentet i prøven, hvor mindst et antistof eller funktionelt fragment deraf er rettet mod en epitop indeholdt i sekvensen, der strækker sig over aminosyreresterne 25 til 37 af procalcitonin, hvor antistoffet er produceret af en hybridomcellelinje, der er deponeret ved DSMZ under accessionsnummer DSM ACC2993, og hvor et andet antistof eller funktionelt fragment deraf er rettet mod en epitop indeholdt i sekvensen, der strækker sig over aminosyreresterne 96 til 116 af procalcitonin, eller en epitop indeholdt i sekvensen, der strækker sig over aminosyreresterne 60 til 91 af procalcitonin, og hvor det andet antistof eller det funktionelle fragment deraf er et monoklonalt antistof.
2. Antistof eller et funktionelt fragment deraf imod en epitop indeholdt i sekvensen, der strækker sig over aminosyreresterne 25 til 37 af procalcitonin, hvor antistoffet er produceret af en hybridomcellelinje, der er deponeret ved DSMZ under accessionsnummer DSM ACC2993.
3. Kit omfattende mindst a. et første antistof eller et funktionelt fragment deraf rettet imod en epitop indeholdt i sekvensen, der strækker sig over aminosyreresterne 25 til 37 af procalcitonin, hvor antistoffet er produceret af en hybridomcellelinje, der er deponeret ved DSMZ under accessionsnummer DSM DSM ACC2993, og b. et andet antistof eller et funktionelt fragmenter deraf, der er rettet mod en epitop indeholdt i sekvensen, der strækker sig over aminosyreresterne 96 til 116 af procalcitonin, eller en epitop indeholdt i sekvensen, der strækker sig over aminosyreresterne 60 til 91 af procalcitonin.
4. Anvendelse af et kit ifølge krav 3 i en sandwich-immunoassay til in vitro-detektering og/eller kvantificering af procalcitonin som defineret i SEQ ID No. 1 eller et fragment deraf omfattende aminosyreresterne 3-116 af SEQ ID NO: 1 i en biologisk prøve fra en kropsvæske.
5. Anvendelse af fremgangsmåden ifølge krav 1, antistoffet ifølge krav 2 eller kittet ifølge krav 3 til in vitro-bestemmelse af tilstedeværelse eller fravær af procalcitonin eller et fragment deraf eller til kvantificering af procalcitonin eller et fragment deraf i en biologisk prøve fra en kropsvæske.
6. Anvendelse ifølge krav 5 til in vitro-diagnose, prognose, risikostratificering, behandlingsmonitorering, behandlingsvejledning eller stratificering til anvendelse af terapeutiske foranstaltninger ved en sygdom eller tilstand, der er forbundet med forhøjede niveauer af procalcitonin.
7. Anvendelse ifølge krav 6, hvor sygdommen eller tilstanden er udvalgt fra gruppen af lokale bakterieinfektioner, sepsis, svær sepsis, septisk shock, ikke-infektiøs sygdom, herunder kardiovaskulære sygdomme (akut koronart syndrom, hjertesvigt, koronar ateriesygdom, aterosklerose, slagtilfælde), cancer, diabetes, kroniske gastrointestinale sygdomme, kroniske nyresygdomme, hypertension, ortopædiske sygdomme, herunder osteoporose, og neurodegenerative sygdomme, herunder Alzheimers sygdom.
8. Hybridomcellelinje, der er deponeret ved DSMZ under accessionsnummer DSM ACC2993.
Applications Claiming Priority (3)
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| EP09165227 | 2009-07-10 | ||
| PCT/EP2010/055648 WO2010125076A1 (en) | 2009-04-28 | 2010-04-27 | Immunoassay for the detection of procalcitonin |
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| EP (1) | EP2425259B1 (da) |
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| CN (1) | CN102395887B (da) |
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| ES (1) | ES2666332T3 (da) |
| TR (1) | TR201806292T4 (da) |
| WO (1) | WO2010125076A1 (da) |
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| US20130046085A1 (en) * | 2011-06-22 | 2013-02-21 | Universidad De Sevilla | Antibodies against n-procalcitonin |
| CN102759631B (zh) * | 2012-08-02 | 2016-05-11 | 南京诺尔曼生物技术有限公司 | 一种定量检测降钙素原pct的胶乳增强免疫比浊试剂盒 |
| CN102928606B (zh) * | 2012-11-16 | 2015-10-07 | 武汉明德生物科技股份有限公司 | 多抗体标记的降钙素原快速检测试剂盒 |
| WO2014083232A1 (es) * | 2012-11-30 | 2014-06-05 | Servicio Andaluz De Salud | Uso de péptidos o anticuerpos anti n-procalcitonina para el tratamiento de lesiones pulmonares |
| WO2015104443A1 (es) * | 2014-01-08 | 2015-07-16 | Servicio Andaluz De Salud | Agentes moduladores de n-procalcitonina para la prevención y el tratamiento de enfermedades neurodegenerativas |
| CN104792997B (zh) * | 2014-01-22 | 2017-07-11 | 天津汇滨生物科技有限公司 | 一种人降钙素原免疫检测试剂盒及其制备方法与应用 |
| DE102014106854A1 (de) | 2014-05-15 | 2016-01-28 | Odos Imaging Ltd. | Bildgebendes System und Verfahren zum Überwachen eines Sichtfeldes |
| CN104090109A (zh) * | 2014-07-25 | 2014-10-08 | 胡晓武 | 快速检测人血降钙素原胶体金免疫层析试纸及其检测方法 |
| CN104745534B (zh) * | 2015-03-02 | 2018-06-22 | 南方医科大学 | 一种降钙素原单克隆抗体杂交瘤2h4及单克隆抗体 |
| CN111793133A (zh) * | 2015-07-09 | 2020-10-20 | 南京诺尔曼生物技术有限公司 | 人源降钙素原的单克隆抗体其制备方法和用途 |
| CN106841606B (zh) * | 2017-03-28 | 2019-03-05 | 广州瑞博奥生物科技有限公司 | 检测pct的胶体金免疫层析试纸条、试剂盒及其制备方法 |
| JP7051096B2 (ja) * | 2018-05-30 | 2022-04-11 | 国立大学法人山口大学 | ウシプロカルシトニンを特異的に認識する抗体、その抗原結合断片、および、その使用 |
| CN108998421A (zh) * | 2018-07-31 | 2018-12-14 | 广东立诊得生物科技有限公司 | 杂交瘤细胞株a4-1b1及其产生的降钙素原单克隆抗体和应用 |
| CN109055318A (zh) * | 2018-07-31 | 2018-12-21 | 广东立诊得生物科技有限公司 | 杂交瘤细胞株a4-6a2及其产生的降钙素原单克隆抗体和应用 |
| CN109652382A (zh) * | 2018-12-12 | 2019-04-19 | 杭州华葵金配生物科技有限公司 | 一种降钙素原单克隆抗体杂交瘤细胞株及其单克隆抗体的应用 |
| JP7205691B2 (ja) * | 2019-01-23 | 2023-01-17 | ウシオ電機株式会社 | 抗イヌプロカルシトニン抗体及びこれを用いた検査用キット |
| CN119959558A (zh) * | 2019-12-17 | 2025-05-09 | 上海奥普生物医药股份有限公司 | 一种降钙素原检测试剂盒、制备方法及用途 |
| CN116178543B (zh) * | 2022-10-27 | 2025-05-13 | 广州锐达生物科技有限公司 | 一种抗降钙素原的Fab抗体及其制备方法与应用 |
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| US4208479A (en) * | 1977-07-14 | 1980-06-17 | Syva Company | Label modified immunoassays |
| DE4227454C1 (de) | 1992-08-19 | 1994-02-03 | Henning Berlin Gmbh | Verfahren zur Früherkennung, zur Erkennung des Schweregrads sowie zur therapiebegleitenden Verlaufsbeurteilung einer Sepsis sowie Mittel zur Durchführung des Verfahrens |
| WO2005026342A1 (en) * | 2003-09-18 | 2005-03-24 | Garvan Institute Of Medical Research | Methods of modulating bone growth, bone remodeling and adiposity |
| DE102005034174A1 (de) * | 2005-07-21 | 2007-02-08 | B.R.A.H.M.S Ag | Liquordiagnostisches in vitro Verfahren zur Diagnose von Demenz-Erkrankungen und neuroinflammatorischen Erkrankungen |
| CN1800384A (zh) * | 2005-11-08 | 2006-07-12 | 浙江大学 | 降钙素原的制备方法 |
| CN101029897A (zh) * | 2007-02-09 | 2007-09-05 | 深圳市新产业生物医学工程有限公司 | 一种降钙素原测试试剂盒及其测试方法 |
| DE102007009751A1 (de) * | 2007-02-28 | 2008-09-04 | B.R.A.H.M.S Aktiengesellschaft | Verfahren zur selektiven Bestimmung von Procalcitonin 1-116 für diagnostische Zwecke sowie Antikörper und Kits zur Durchführung eines solchen Verfahrens |
| RU2342666C1 (ru) * | 2007-07-02 | 2008-12-27 | Государственное образовательное учреждение высшего профессионального образования "Пермская государственная медицинская академия имени академика Е.А. Вагнера Федерального агентства по здравоохранению и социальному развитию" | Способ определения степени тяжести гестоза |
| EP2020603A1 (en) * | 2007-08-03 | 2009-02-04 | BRAHMS Aktiengesellschaft | Method for risk stratification in stable coronary artery disease |
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2010
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- 2010-04-27 WO PCT/EP2010/055648 patent/WO2010125076A1/en not_active Ceased
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- 2010-04-27 US US13/266,594 patent/US20120122114A1/en not_active Abandoned
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- 2010-04-27 EP EP10715266.2A patent/EP2425259B1/en active Active
- 2010-04-27 TR TR2018/06292T patent/TR201806292T4/tr unknown
- 2010-04-27 CN CN201080016842.6A patent/CN102395887B/zh not_active Ceased
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2015
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2017
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2018
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| WO2010125076A1 (en) | 2010-11-04 |
| TR201806292T4 (tr) | 2018-06-21 |
| US10048280B2 (en) | 2018-08-14 |
| JP6100822B2 (ja) | 2017-03-22 |
| CN102395887B (zh) | 2015-04-08 |
| US20190041408A1 (en) | 2019-02-07 |
| CN102395887A (zh) | 2012-03-28 |
| JP2015163877A (ja) | 2015-09-10 |
| JP6009938B2 (ja) | 2016-10-19 |
| ES2666332T3 (es) | 2018-05-04 |
| EP2425259A1 (en) | 2012-03-07 |
| JP2012525568A (ja) | 2012-10-22 |
| EP2425259B1 (en) | 2018-02-28 |
| US20120122114A1 (en) | 2012-05-17 |
| HK1167180A1 (en) | 2012-11-23 |
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