Document Detail


The Fibrin Assay Comparison Trial (FACT): evaluation of 23 quantitative D-dimer assays as basis for the development of D-dimer calibrators. FACT study group.
MedLine Citation:
PMID:  11341504     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Although D-dimer has gained widespread clinical use as a parameter for detection of in vivo fibrin formation, the issue of standardization of D-dimer assays remains to be resolved. The FACT study was performed to generate basic data for development of calibrators and standard preparations. A set of 86 samples, including plasma samples from patients with DIC, DVT. and other clinical conditions, serial dilutions of pooled plasma samples, and plasma samples containing fibrinogen- and fibrin derivatives, were distributed to 12 manufacturers of D-dimer assays. D-dimer assays differ concerning specificity for crosslinked fibrin, and preference for either high molecular weight fibrin complexes, or low molecular weight fibrin degradation products. Terminal plasmin digests of fibrin clots for calibration produce aberrant results in some assays, especially those with preference for high molecular weight crosslinked fibrin derivatives. The best conformity is achieved by the use of pooled plasma samples from patients with high levels of D-dimer antigen in plasma. In vitro preparations containing a comparable composition of fibrin derivatives to clinical plasma samples may also serve as reference material.
Authors:
C E Dempfle; S Zips; H Ergül; D L Heene;
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Publication Detail:
Type:  Comparative Study; Evaluation Studies; Journal Article    
Journal Detail:
Title:  Thrombosis and haemostasis     Volume:  85     ISSN:  0340-6245     ISO Abbreviation:  Thromb. Haemost.     Publication Date:  2001 Apr 
Date Detail:
Created Date:  2001-05-08     Completed Date:  2001-12-04     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7608063     Medline TA:  Thromb Haemost     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  671-8     Citation Subset:  IM    
Affiliation:
University of Heidelberg, Mannheim University Hospital, I Department of Medicine, Germany. dempfle@verw.ma.uni.uni-heidelberg.de
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MeSH Terms
Descriptor/Qualifier:
Adult
Blood Protein Electrophoresis
Calibration
Electrophoresis, Polyacrylamide Gel
Enzyme-Linked Immunosorbent Assay
Fibrin Fibrinogen Degradation Products / analysis*
Humans
Immunoassay / standards*
Molecular Weight
Plasma
Reference Standards
Chemical
Reg. No./Substance:
0/Fibrin Fibrinogen Degradation Products; 0/fibrin fragment D

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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