JP4291153B2 - 可溶性サイトケラチンフラグメントの測定による敗血症の検出方法 - Google Patents
可溶性サイトケラチンフラグメントの測定による敗血症の検出方法 Download PDFInfo
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- JP4291153B2 JP4291153B2 JP2003549926A JP2003549926A JP4291153B2 JP 4291153 B2 JP4291153 B2 JP 4291153B2 JP 2003549926 A JP2003549926 A JP 2003549926A JP 2003549926 A JP2003549926 A JP 2003549926A JP 4291153 B2 JP4291153 B2 JP 4291153B2
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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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56911—Bacteria
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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
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/26—Infectious diseases, e.g. generalised sepsis
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- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S436/00—Chemistry: analytical and immunological testing
- Y10S436/811—Test for named disease, body condition or organ function
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- Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
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Description
A.Beishuizenら, Advances in Clinical Chemistry, Vol.33, 1999, 55-131 C.Gabayら, The New England Journal of Medicine, Vol.340, No.6, 1999, 448-454 K.Reinhartら, Intensivmedizin, Georg Thieme Verlag, Stuttgart, New York, 2001, 756-760 M.Assicotら, The Lancet, Vol.341, No.8844, 1993, 515-518
1.CYFRA21−1の測定
商業的アッセイ(B.R.A.H.M.S Diagnostica GmbH社のKRYPTOR-CYFRA 21-1)を用いて、敗血症マーカープロカルシトニン(PCT)に高い値が見られた169人の敗血症患者の血清において、腫瘍マーカーCYFRA21−1の血清濃度を測定した。81%の敗血症血清において、高いCYFRA21−1濃度(1ng/mlより高い)が観察された。コントロールとして用いた50の血清中では、CYFRA21−1濃度は、僅かにたったの2例しか1ng/mlを超えなかった。
TPS測定用の商業的アッセイ(DPC-BIERMANN, Bad NauheimのTPSTM)を用いて、敗血症マーカープロカルシトニン(PCT)に高い値が見られた49人の敗血症患者の血清において、腫瘍マーカーTPSの血清濃度を測定した。90%の敗血症血清において、非常に高いTPS濃度(66U/lより高い)が観察された。一方、21人のコントロールの血清(健康な血液ドナーの血清)の全てが陰性、すなわち66U/lの基準値未満の測定値を有していた。
DE10130985.6に従って可溶性サイトケラチン−1フラグメントsCY1Fの血清濃度を、敗血症マーカープロカルシトニン(PCT)に高い値が見られた20人の敗血症患者の血清において測定した。95%の敗血症血清において、非常に高いsCY1F濃度(3ng/mlより高い)が観察された。敗血症血清中のsCY1Fの調査測定のために、この目的のために特別に開発した競争的蛍光免疫アッセイを用いた。このアッセイでは、サイトケラチン−1フラグメントの部分配列を含むペプチド(DE10130985.6の配列番号3のアミノ酸214から229のもの)に対するヒツジ抗体が用いられている。この抗体を得るために用いられ、かつ、競争剤として用いられた合成ペプチドは、ペプチドPLY17の商品名で商業的に入手可能である(Jerini BioTools GmbH)。これは、本明細書に添付する配列表に示される配列番号1のアミノ酸配列を有する。
1.上記チューブに100μgのサンプル(敗血症血清、コントロール血清、または検量溶液)をピペットで移す;
2.200μlの抗血清(PBSで1:5000に稀釈)をピペットで移す;
3.揺すりながら室温で2時間インキュベートする;
4.チューブから未結合の抗体を洗い流す(1mlのPBSを満たしデカンテーションする:4回);
5.固相に結合した抗体をマーキングするために、300mlのPBS、1%BSA中のアクリジニウムエステルでマーキングしたロバの抗ヒツジ抗体(B.R.A.H.M.S Diagnostica)を添加する;
6.室温で2時間インキュベーションした後に、未結合のマーキング抗体を4と同様に洗浄して取り除く;
7.ルミノメーター(Berthold社)により公知の方法で固相に結合したアクリジニウムエステルを測定する。
Claims (5)
- 敗血症および敗血症様全身性感染症の検出のための方法であって、敗血症を患った、または敗血症の疑いがある患者の生物学的流体における、TPSおよびCYFRA21−1から選択される一以上の可溶性サイトケラチンフラグメントの量を測定し、かつ、可溶性サイトケラチンフラグメントの測定量が、敗血症の存在、予想される経過、重篤度、および/または治療のために開始された処置の成功度を示すことを特徴とする方法。
- 可溶性サイトケラチンフラグメントの測定が、免疫検出アッセイ法によって実施されることを特徴とする、請求項1記載の方法。
- 前記少なくとも一つの可溶性サイトケラチンフラグメントに加えて、同時にさらなる敗血症パラメータのプロカルシトニンが測定されるマルチパラメータ測定法で実施され、かつ、一組の少なくとも二つの測定変数の形態の測定結果が得られ、高精度の敗血症の検出のために評価されることを特徴とする、請求項1または2記載の方法。
- マルチパラメータ測定法が、チップ技術測定装置または免疫クロマトグラフィー測定装置による同時測定として実施されることを特徴とする、請求項3記載の方法。
- 前記測定装置を用いて得られた複数の測定結果の評価がコンピュータープログラムを用いて実施されることを特徴とする、請求項4記載の方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP01128851A EP1318405B1 (de) | 2001-12-04 | 2001-12-04 | Verfahren zur Diagnose von Sepsis unter Bestimmung löslicher Cytokeratinfragmente |
PCT/EP2002/013526 WO2003048782A1 (de) | 2001-12-04 | 2002-11-29 | Verfahren zur diagnose von sepsis unter bestimmung löslicher cytokeratinfragmente |
Publications (2)
Publication Number | Publication Date |
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JP2005512060A JP2005512060A (ja) | 2005-04-28 |
JP4291153B2 true JP4291153B2 (ja) | 2009-07-08 |
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Application Number | Title | Priority Date | Filing Date |
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JP2003549926A Expired - Fee Related JP4291153B2 (ja) | 2001-12-04 | 2002-11-29 | 可溶性サイトケラチンフラグメントの測定による敗血症の検出方法 |
Country Status (6)
Country | Link |
---|---|
US (1) | US7659075B2 (ja) |
EP (1) | EP1318405B1 (ja) |
JP (1) | JP4291153B2 (ja) |
AT (1) | ATE282831T1 (ja) |
DE (1) | DE50104561D1 (ja) |
WO (1) | WO2003048782A1 (ja) |
Families Citing this family (18)
Publication number | Priority date | Publication date | Assignee | Title |
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US7758503B2 (en) * | 1997-01-27 | 2010-07-20 | Lynn Lawrence A | Microprocessor system for the analysis of physiologic and financial datasets |
US9053222B2 (en) | 2002-05-17 | 2015-06-09 | Lawrence A. Lynn | Patient safety processor |
US20070093721A1 (en) * | 2001-05-17 | 2007-04-26 | Lynn Lawrence A | Microprocessor system for the analysis of physiologic and financial datasets |
EP1318402B1 (de) * | 2001-12-04 | 2005-04-20 | B.R.A.H.M.S Aktiengesellschaft | Verfahren zur Diagnose von Sepsis unter Bestimmung von CA 125 |
ATE282831T1 (de) | 2001-12-04 | 2004-12-15 | Brahms Ag | Verfahren zur diagnose von sepsis unter bestimmung löslicher cytokeratinfragmente |
EP1355159A1 (de) * | 2002-04-19 | 2003-10-22 | B.R.A.H.M.S Aktiengesellschaft | Verwendungen von Fragmenten der Carbamoylphosphat Synthetase 1 (CPS 1) für die Diagnose von Entzündungserkrankungen und Sepsis |
EP1355158A1 (de) | 2002-04-19 | 2003-10-22 | B.R.A.H.M.S Aktiengesellschaft | Verfahren zur Diagnose von Entzündungserkrankungen und Infektionen unter Bestimmung des Phosphoproteins LASP-1 als Inflammationsmarker |
CA2505921A1 (en) * | 2002-11-12 | 2004-05-27 | Becton, Dickinson And Company | Diagnosis of sepsis or sirs using biomarker profiles |
WO2004043236A2 (en) | 2002-11-12 | 2004-05-27 | Becton, Dickinson And Company | Diagnosis of sepsis or sirs using biomarker profiles |
BRPI0609302A2 (pt) | 2005-04-15 | 2011-10-11 | Becton Dickinson Co | métodos para prever o desenvolvimento de sepse e para diagnosticar sepse em um indivìduo a ser testado, microarranjo, kit para prever o desenvolvimento de sepse em um indivìduo a ser testado, produto de programa de computador, computador, sistema de computador para determinar se um indivìduo é susceptìvel de desenvolver sepse, sinal digital embutido em uma onda portadora, e, interface gráfica de usuário para determinar se um indivìduo é susceptìvel de desenvolver sepse |
DK2185937T4 (da) | 2007-09-07 | 2014-10-20 | Univ Zuerich | Fremgangsmåde til at bestemme sepsis hos mennesker |
WO2009123737A2 (en) | 2008-04-03 | 2009-10-08 | Becton, Dickinson And Company | Advanced detection of sepsis |
US20140244304A1 (en) | 2013-02-28 | 2014-08-28 | Lawrence A. Lynn | System and Method for Generating Quaternary Images of Biologic Force Propagation and Recovery |
EP2283443A1 (en) | 2008-05-07 | 2011-02-16 | Lynn, Lawrence A. | Medical failure pattern search engine |
US10354429B2 (en) | 2012-11-14 | 2019-07-16 | Lawrence A. Lynn | Patient storm tracker and visualization processor |
US9953453B2 (en) | 2012-11-14 | 2018-04-24 | Lawrence A. Lynn | System for converting biologic particle density data into dynamic images |
US10260111B1 (en) | 2014-01-20 | 2019-04-16 | Brett Eric Etchebarne | Method of detecting sepsis-related microorganisms and detecting antibiotic-resistant sepsis-related microorganisms in a fluid sample |
WO2018088455A1 (ja) * | 2016-11-10 | 2018-05-17 | 国立大学法人千葉大学 | 敗血症診断薬 |
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US5660994A (en) | 1986-11-10 | 1997-08-26 | Progen Biotechnik Gmbh | Method of detecting tissue-specific, insoluble cytoskeletal proteins |
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 |
WO1999014372A1 (en) * | 1997-09-15 | 1999-03-25 | Abbott Laboratories | Reagents and methods useful for detecting diseases of the urinary tract |
DE19847690A1 (de) | 1998-10-15 | 2000-04-20 | Brahms Diagnostica Gmbh | Verfahren und Substanzen für die Diagnose und Therapie von Sepsis und sepsisähnlichen systemischen Infektionen |
US20020103141A1 (en) * | 1998-12-23 | 2002-08-01 | Mckearn John P. | Antiangiogenic combination therapy for the treatment of cancer |
AU2002307054A1 (en) * | 2001-03-30 | 2002-10-15 | Didier Adehl | Detection of abnormal cells |
DE10119804A1 (de) | 2001-04-23 | 2002-10-24 | Brahms Ag | Entzündungsspezifische Peptide und deren Verwendungen |
DE10130985B4 (de) * | 2001-06-27 | 2004-03-18 | B.R.A.H.M.S Ag | Verfahren zur Diagnose von Sepsis und schweren Infektionen unter Bestimmung löslicher Cytokeratin-1-Fragmente |
DE10131922A1 (de) | 2001-07-02 | 2003-01-30 | Brahms Ag | Verwendung des Calcineurin B Homologen Proteins (CHP) für die Diagnose und Therapie von Entzündungserkrankungen und Sepsis |
ATE272215T1 (de) | 2001-12-04 | 2004-08-15 | Brahms Ag | Verfahren zur diagnose von sepsis unter bestimmung von ca 19-9 |
ATE282831T1 (de) | 2001-12-04 | 2004-12-15 | Brahms Ag | Verfahren zur diagnose von sepsis unter bestimmung löslicher cytokeratinfragmente |
ATE309542T1 (de) | 2001-12-04 | 2005-11-15 | Brahms Ag | Verwendung der glycin-n-acyl-transferase (gnat) für die diagnose von entzündungserkrankungen und sepsis |
EP1318403B1 (de) | 2001-12-04 | 2004-07-28 | B.R.A.H.M.S Aktiengesellschaft | Verfahren zur Diagnose von Sepsis unter Bestimmung von S100B |
DE50103907D1 (de) * | 2001-12-07 | 2004-11-04 | Brahms Ag | Verwendungen der Aldose-1-Epimerase (Mutarotase) für die Diagnose von Entzündungserkrankungen und Sepsis |
EP1355159A1 (de) | 2002-04-19 | 2003-10-22 | B.R.A.H.M.S Aktiengesellschaft | Verwendungen von Fragmenten der Carbamoylphosphat Synthetase 1 (CPS 1) für die Diagnose von Entzündungserkrankungen und Sepsis |
EP1355158A1 (de) | 2002-04-19 | 2003-10-22 | B.R.A.H.M.S Aktiengesellschaft | Verfahren zur Diagnose von Entzündungserkrankungen und Infektionen unter Bestimmung des Phosphoproteins LASP-1 als Inflammationsmarker |
EP1369693A1 (de) | 2002-06-04 | 2003-12-10 | B.R.A.H.M.S Aktiengesellschaft | Verfahren zur Sepsisdiagnose und zur Kontrolle von Spenderblut durch Bestimmung von anti-Asialo-Gangliosid-Antikörpern |
WO2004046181A1 (de) | 2002-11-20 | 2004-06-03 | B.R.A.H.M.S Aktiengesellschaft | Sandwich-immunoassay zur bestimmung bon proanp-teilpeptiden |
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2001
- 2001-12-04 AT AT01128851T patent/ATE282831T1/de active
- 2001-12-04 DE DE50104561T patent/DE50104561D1/de not_active Expired - Lifetime
- 2001-12-04 EP EP01128851A patent/EP1318405B1/de not_active Expired - Lifetime
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2002
- 2002-11-29 US US10/496,096 patent/US7659075B2/en not_active Expired - Fee Related
- 2002-11-29 JP JP2003549926A patent/JP4291153B2/ja not_active Expired - Fee Related
- 2002-11-29 WO PCT/EP2002/013526 patent/WO2003048782A1/de active Application Filing
Also Published As
Publication number | Publication date |
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US7659075B2 (en) | 2010-02-09 |
WO2003048782A1 (de) | 2003-06-12 |
US20050106645A1 (en) | 2005-05-19 |
JP2005512060A (ja) | 2005-04-28 |
DE50104561D1 (de) | 2004-12-23 |
EP1318405A1 (de) | 2003-06-11 |
ATE282831T1 (de) | 2004-12-15 |
EP1318405B1 (de) | 2004-11-17 |
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