DE69029785T2 - Kinetische Bestimmungsmethode für Endotoxin unter Verwendung von Limulus-Amoebocyten-Lysat und chromogenem Substrat - Google Patents
Kinetische Bestimmungsmethode für Endotoxin unter Verwendung von Limulus-Amoebocyten-Lysat und chromogenem SubstratInfo
- Publication number
- DE69029785T2 DE69029785T2 DE69029785T DE69029785T DE69029785T2 DE 69029785 T2 DE69029785 T2 DE 69029785T2 DE 69029785 T DE69029785 T DE 69029785T DE 69029785 T DE69029785 T DE 69029785T DE 69029785 T2 DE69029785 T2 DE 69029785T2
- Authority
- DE
- Germany
- Prior art keywords
- endotoxin
- substrate
- determination
- chromogenic
- sample
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Lifetime
Links
- 239000002158 endotoxin Substances 0.000 title claims abstract description 125
- 238000000034 method Methods 0.000 title claims abstract description 53
- 239000003593 chromogenic compound Substances 0.000 title claims abstract description 37
- 241000239218 Limulus Species 0.000 title claims description 19
- 108010072542 endotoxin binding proteins Proteins 0.000 title claims description 15
- 239000000758 substrate Substances 0.000 claims abstract description 52
- 239000000203 mixture Substances 0.000 claims abstract description 34
- 239000003153 chemical reaction reagent Substances 0.000 claims abstract description 18
- 238000012360 testing method Methods 0.000 claims description 42
- 238000002360 preparation method Methods 0.000 claims description 33
- 108090000790 Enzymes Proteins 0.000 claims description 23
- 102000004190 Enzymes Human genes 0.000 claims description 23
- 238000011088 calibration curve Methods 0.000 claims description 17
- 230000008859 change Effects 0.000 claims description 15
- 239000012530 fluid Substances 0.000 claims description 13
- 150000001875 compounds Chemical class 0.000 claims description 12
- 238000002835 absorbance Methods 0.000 claims description 11
- 238000010521 absorption reaction Methods 0.000 claims description 11
- 239000006166 lysate Substances 0.000 claims description 11
- 125000005647 linker group Chemical group 0.000 claims description 8
- 230000003287 optical effect Effects 0.000 claims description 8
- 239000012482 calibration solution Substances 0.000 claims description 7
- 239000004094 surface-active agent Substances 0.000 claims description 7
- 239000003112 inhibitor Substances 0.000 claims description 6
- 239000004475 Arginine Substances 0.000 claims description 5
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 5
- 239000003550 marker Substances 0.000 claims description 5
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- 206010011732 Cyst Diseases 0.000 claims description 4
- 150000008574 D-amino acids Chemical class 0.000 claims description 4
- 125000002252 acyl group Chemical group 0.000 claims description 4
- 150000004945 aromatic hydrocarbons Chemical class 0.000 claims description 4
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- 208000031513 cyst Diseases 0.000 claims description 4
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- 229910052739 hydrogen Inorganic materials 0.000 claims description 4
- 239000001257 hydrogen Substances 0.000 claims description 4
- 125000004435 hydrogen atom Chemical group [H]* 0.000 claims description 4
- 238000002798 spectrophotometry method Methods 0.000 claims description 4
- 108010055222 clotting enzyme Proteins 0.000 claims description 3
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- 230000035945 sensitivity Effects 0.000 abstract description 10
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- 238000003367 kinetic assay Methods 0.000 abstract description 3
- 239000000523 sample Substances 0.000 description 36
- 239000000243 solution Substances 0.000 description 30
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 24
- 229940088598 enzyme Drugs 0.000 description 21
- 238000010790 dilution Methods 0.000 description 20
- 239000012895 dilution Substances 0.000 description 20
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 14
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- 230000005764 inhibitory process Effects 0.000 description 10
- 239000000872 buffer Substances 0.000 description 7
- 238000012454 limulus amebocyte lysate test Methods 0.000 description 7
- 239000000463 material Substances 0.000 description 7
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 description 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
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- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 3
- TYMLOMAKGOJONV-UHFFFAOYSA-N 4-nitroaniline Chemical compound NC1=CC=C([N+]([O-])=O)C=C1 TYMLOMAKGOJONV-UHFFFAOYSA-N 0.000 description 2
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- 208000007536 Thrombosis Diseases 0.000 description 2
- BHATUINFZWUDIX-UHFFFAOYSA-N Zwittergent 3-14 Chemical group CCCCCCCCCCCCCC[N+](C)(C)CCCS([O-])(=O)=O BHATUINFZWUDIX-UHFFFAOYSA-N 0.000 description 2
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- BPKIGYQJPYCAOW-FFJTTWKXSA-I calcium;potassium;disodium;(2s)-2-hydroxypropanoate;dichloride;dihydroxide;hydrate Chemical compound O.[OH-].[OH-].[Na+].[Na+].[Cl-].[Cl-].[K+].[Ca+2].C[C@H](O)C([O-])=O BPKIGYQJPYCAOW-FFJTTWKXSA-I 0.000 description 2
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- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 description 2
- 230000007246 mechanism Effects 0.000 description 2
- 235000016709 nutrition Nutrition 0.000 description 2
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- PGOHTUIFYSHAQG-LJSDBVFPSA-N (2S)-6-amino-2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-4-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[(2S)-1-[(2S,3R)-2-[[(2S)-2-[[(2S)-2-[[(2R)-2-[[(2S)-2-[[(2S)-2-[[2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-1-[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-amino-4-methylsulfanylbutanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-5-carbamimidamidopentanoyl]amino]propanoyl]pyrrolidine-2-carbonyl]amino]-3-methylbutanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]acetyl]amino]-3-hydroxypropanoyl]amino]-4-methylpentanoyl]amino]-3-sulfanylpropanoyl]amino]-4-methylsulfanylbutanoyl]amino]-5-carbamimidamidopentanoyl]amino]-3-hydroxybutanoyl]pyrrolidine-2-carbonyl]amino]-5-oxopentanoyl]amino]-3-hydroxypropanoyl]amino]-3-hydroxypropanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-4-methylpentanoyl]amino]-3-hydroxybutanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-5-carbamimidamidopentanoyl]amino]-5-oxopentanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-hydroxypropanoyl]amino]-5-oxopentanoyl]amino]-5-oxopentanoyl]amino]-3-phenylpropanoyl]amino]-5-carbamimidamidopentanoyl]amino]-3-methylbutanoyl]amino]-4-methylpentanoyl]amino]-4-oxobutanoyl]amino]-5-carbamimidamidopentanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-4-carboxybutanoyl]amino]-5-oxopentanoyl]amino]hexanoic acid Chemical compound CSCC[C@H](N)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](Cc1ccccc1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCCCN)C(O)=O PGOHTUIFYSHAQG-LJSDBVFPSA-N 0.000 description 1
- 102000010911 Enzyme Precursors Human genes 0.000 description 1
- 108010062466 Enzyme Precursors Proteins 0.000 description 1
- 108010088842 Fibrinolysin Proteins 0.000 description 1
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- 102400001063 Fibrinopeptide B Human genes 0.000 description 1
- 239000004471 Glycine Substances 0.000 description 1
- 150000008575 L-amino acids Chemical class 0.000 description 1
- 241000239220 Limulus polyphemus Species 0.000 description 1
- 102000004895 Lipoproteins Human genes 0.000 description 1
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- 102000003990 Urokinase-type plasminogen activator Human genes 0.000 description 1
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- 238000009825 accumulation Methods 0.000 description 1
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- WGYFACNYUJGZQO-UHFFFAOYSA-N aminomethanetriol Chemical compound NC(O)(O)O WGYFACNYUJGZQO-UHFFFAOYSA-N 0.000 description 1
- 125000000637 arginyl group Chemical group N[C@@H](CCCNC(N)=N)C(=O)* 0.000 description 1
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Classifications
-
- 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
- G01N33/579—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving limulus lysate
-
- 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
-
- 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
- C12Q2337/00—N-linked chromogens for determinations of peptidases and proteinases
- C12Q2337/10—Anilides
- C12Q2337/12—Para-Nitroanilides p-NA
-
- 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
- G01N2333/90—Enzymes; Proenzymes
- G01N2333/914—Hydrolases (3)
- G01N2333/948—Hydrolases (3) acting on peptide bonds (3.4)
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Zoology (AREA)
- General Health & Medical Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Microbiology (AREA)
- Urology & Nephrology (AREA)
- Analytical Chemistry (AREA)
- Wood Science & Technology (AREA)
- Physics & Mathematics (AREA)
- Biochemistry (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- Genetics & Genomics (AREA)
- General Engineering & Computer Science (AREA)
- Cell Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US42830089A | 1989-10-30 | 1989-10-30 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| DE69029785D1 DE69029785D1 (de) | 1997-03-06 |
| DE69029785T2 true DE69029785T2 (de) | 1997-05-28 |
Family
ID=23698313
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE69029785T Expired - Lifetime DE69029785T2 (de) | 1989-10-30 | 1990-10-26 | Kinetische Bestimmungsmethode für Endotoxin unter Verwendung von Limulus-Amoebocyten-Lysat und chromogenem Substrat |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US5310657A (enExample) |
| EP (1) | EP0426395B1 (enExample) |
| JP (1) | JP2955345B2 (enExample) |
| AT (1) | ATE148230T1 (enExample) |
| AU (1) | AU644109B2 (enExample) |
| CA (1) | CA2028789C (enExample) |
| DE (1) | DE69029785T2 (enExample) |
| DK (1) | DK0426395T3 (enExample) |
| ES (1) | ES2098256T3 (enExample) |
| GR (1) | GR3023298T3 (enExample) |
Families Citing this family (35)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0549102B1 (en) * | 1991-12-25 | 1996-07-03 | Maruha Corporation | Beta-glucans detection reagents and methods of detecting beta-glucans |
| JP3242733B2 (ja) * | 1993-02-26 | 2001-12-25 | 生化学工業株式会社 | エンドトキシン特異的測定剤 |
| US6270982B1 (en) | 1997-10-09 | 2001-08-07 | Charles River Laboratories | Methods and compositions for the detection of bacterial endotoxins |
| JP4235279B2 (ja) * | 1998-04-10 | 2009-03-11 | 生化学工業株式会社 | 新規酵素反応測定法 |
| US20050244299A1 (en) * | 2002-04-30 | 2005-11-03 | Biowittaker Technologies Inc | Automated sequential injection analysis systems for the determination of trace endotoxin levels |
| US20040138577A1 (en) * | 2002-12-20 | 2004-07-15 | Kline Jeffrey A. | Disposable hand-held device for collection of exhaled breath condensate |
| US7828741B2 (en) * | 2002-12-20 | 2010-11-09 | The Charlotte-Mecklenburg Hospital Authority | Utilizing lipopolysaccharide in exhaled breath condensate to diagnose gram negative pneumonia |
| WO2004073497A2 (en) * | 2003-02-14 | 2004-09-02 | The Charlotte-Mecklenburg Hospital Authority | Device and method for collection of exhaled alveolar breath condensate |
| US7329538B2 (en) | 2003-03-17 | 2008-02-12 | Charles River Laboratories, Inc. | Methods and compositions for the detection of microbial contaminants |
| US20050026239A1 (en) * | 2003-04-18 | 2005-02-03 | Associates Of Cape Cod, Inc. | Kit for detecting endotoxin in aqueous solutions |
| US20050048655A1 (en) * | 2003-04-18 | 2005-03-03 | Novitsky Thomas J. | Kit for detecting endotoxin |
| CA2517890A1 (en) * | 2003-11-07 | 2005-05-26 | Cambrex Bio Science Walkersville, Inc. | On-line apparatus and method for determining endotoxin levels |
| US7968280B2 (en) * | 2004-12-02 | 2011-06-28 | Charles River Laboratories, Inc. | Methods for the detection and/or quantification of gram positive bacterial contaminants |
| DE602006004553D1 (de) | 2005-01-13 | 2009-02-12 | Charles River Lab Inc | Verfahren zur klassifizierung von mikroben in einer biologischen probe |
| CN101454448A (zh) * | 2006-07-07 | 2009-06-10 | 生化学工业株式会社 | 凝固酶原以及使用所述酶检测内毒素或(1→3)-β-D-葡聚糖的方法 |
| US20080124248A1 (en) * | 2006-11-29 | 2008-05-29 | Edward Andrew Sobek | Endotoxins and glucans quantification in indoor air |
| WO2009137244A1 (en) * | 2008-04-15 | 2009-11-12 | Charles River Laboratories, Inc. | Cartridge and method for sample analysis |
| CA2755276A1 (en) | 2009-03-13 | 2010-09-16 | Kowa Company, Ltd. | Method for measuring physiologically active substance of biological origin, program for implementing the same, and apparatus for measuring physiologically active substance of biological origin |
| JP5489680B2 (ja) * | 2009-12-02 | 2014-05-14 | 興和株式会社 | 生物由来の生理活性物質の測定方法、それを実行するためのプログラム及び、生物由来の生理活性物質の測定装置 |
| EP2446018B1 (en) | 2009-06-26 | 2017-01-18 | Charles River Laboratories, Inc. | Heat-treated limulus amebocyte lysates |
| GB2477752A (en) * | 2010-02-11 | 2011-08-17 | Arab Biotechnology Company | Detection of bacteria |
| CU24073B1 (es) | 2011-12-27 | 2015-01-29 | Ct De Investigación Y Desarrollo De Medicamentos Cidem | COMPOSICIÓN A PARTIR DE EXTRACTO DE HEMOCITOS DE LANGOSTA PARA LA DETECCIÓN DE LIPOPOLISACÁRIDOS, PEPTIDOGLICANOS Y 1,3-ß-D-GLUCANOS |
| US20130078665A1 (en) * | 2012-07-18 | 2013-03-28 | Deepika Bodapati | Test strip, a test kit and a method for detection of endotoxin in food |
| EP3425401B1 (en) | 2012-10-08 | 2023-09-27 | BL Technologies, Inc. | Preloaded test substrates for testing lal-reactive substances, methods of use, and methods of making |
| US10309947B2 (en) | 2013-02-27 | 2019-06-04 | Trace-Ability, Inc. | System and method for radiosynthesis, quality control and dose dispensing |
| US10895563B2 (en) | 2014-02-26 | 2021-01-19 | Trace-Ability, Inc. | Palette-based systems for analyte characterization |
| US11002717B2 (en) | 2014-02-26 | 2021-05-11 | Trace-Ability, Inc. | Systems and methods for characterizing radioactive analytes |
| IL264464B2 (en) * | 2016-08-03 | 2024-02-01 | Lonza Walkersville Inc | A method for detecting endotoxin using Limulus extract of amoeba, which is mainly free of coagulogen |
| WO2018132562A1 (en) | 2017-01-11 | 2018-07-19 | Lonza Walkersville, Inc. | Coagulogen-free clarified limulus amebocyte lysate |
| EP3622297A1 (en) | 2017-06-28 | 2020-03-18 | Lonza Walkersville, Inc. | Cartridge for endotoxin detection |
| US11892397B2 (en) * | 2017-10-17 | 2024-02-06 | Board Of Regents, The University Of Texas System | Endotoxin testing assay and method of same |
| CN109387637A (zh) * | 2018-10-12 | 2019-02-26 | 四川升和药业股份有限公司 | 丹参注射液细菌内毒素检测方法 |
| CN111077307B (zh) * | 2018-10-21 | 2022-08-23 | 厦门鲎试剂生物科技股份有限公司 | 一种用革兰氏阴性细菌感染快速检测脓毒病的新方法 |
| US12158471B2 (en) | 2022-02-11 | 2024-12-03 | Charles River Laboratories, Inc. | Recombinant amebocyte lysate and uses thereof |
| CN121443750A (zh) | 2023-06-05 | 2026-01-30 | 查尔斯河实验室公司 | 重组变形细胞凝血因子及其用途 |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5415797A (en) * | 1977-06-14 | 1979-02-05 | Seikagaku Kogyo Co Ltd | Detection and measurement of toxin in cells |
| US4322217A (en) * | 1980-06-27 | 1982-03-30 | Mallinckrodt, Inc. | Process for preparing Limulus lysate |
| US4406832A (en) * | 1981-09-03 | 1983-09-27 | Mallinckrodt, Inc. | Peptide-type substrates useful in the quantitative determination of endotoxin |
| US4510241A (en) * | 1981-09-03 | 1985-04-09 | Mallinckrodt, Inc. | Peptide-type substrates useful in the quantitative determination of endotoxin |
| DE3439761A1 (de) * | 1984-10-31 | 1986-05-07 | Klaus-Peter 6800 Mannheim Becker | Verfahren zur bestimmung von endotoxinkonzentrationen |
-
1990
- 1990-10-26 DK DK90311771.1T patent/DK0426395T3/da active
- 1990-10-26 AT AT90311771T patent/ATE148230T1/de not_active IP Right Cessation
- 1990-10-26 ES ES90311771T patent/ES2098256T3/es not_active Expired - Lifetime
- 1990-10-26 EP EP90311771A patent/EP0426395B1/en not_active Expired - Lifetime
- 1990-10-26 DE DE69029785T patent/DE69029785T2/de not_active Expired - Lifetime
- 1990-10-29 CA CA002028789A patent/CA2028789C/en not_active Expired - Lifetime
- 1990-10-29 AU AU65556/90A patent/AU644109B2/en not_active Expired
- 1990-10-30 JP JP2295164A patent/JP2955345B2/ja not_active Expired - Lifetime
-
1992
- 1992-07-13 US US07/911,375 patent/US5310657A/en not_active Expired - Lifetime
-
1997
- 1997-04-08 GR GR970400118T patent/GR3023298T3/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CA2028789C (en) | 2001-02-06 |
| EP0426395B1 (en) | 1997-01-22 |
| CA2028789A1 (en) | 1991-05-01 |
| ATE148230T1 (de) | 1997-02-15 |
| DE69029785D1 (de) | 1997-03-06 |
| US5310657A (en) | 1994-05-10 |
| DK0426395T3 (enExample) | 1997-03-03 |
| AU644109B2 (en) | 1993-12-02 |
| JP2955345B2 (ja) | 1999-10-04 |
| AU6555690A (en) | 1991-05-02 |
| ES2098256T3 (es) | 1997-05-01 |
| EP0426395A1 (en) | 1991-05-08 |
| JPH03220456A (ja) | 1991-09-27 |
| GR3023298T3 (en) | 1997-07-30 |
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