The Fibrin Assay Comparison Trial (FACT) Evaluation of 23 Quantitative D-dimer Assays as Basis for the Development of D-dimer Calibrators

作者: Sybille Zips , Hanimsah Ergül , Dieter Heene , Carl-Erik Dempfle ,

DOI: 10.1055/S-0037-1615652

关键词: MedicinePlasminSerial dilutionPolyacrylamide gel electrophoresisD-dimerIn vivoFibrinogenPathologyFibrinFibrinolysisChromatography

摘要: Although D-dimer has gained widespread clinical use as a parameter for detection of in vivo fibrin formation, the issue standardization assays remains to be resolved. The FACT study was performed generate basic data development calibrators and standard preparations. A set 86 samples, including plasma samples from patients with DIC, DVT. other conditions, serial dilutions pooled containing fibrinogen- derivatives, were distributed 12 manufacturers assays. differ concerning specificity crosslinked fibrin, preference either high molecular weight complexes, or low degradation products. Terminal plasmin digests clots calibration produce aberrant results some assays, especially those derivatives. best conformity is achieved by levels antigen plasma. In vitro preparations comparable composition derivatives may also serve reference material.

参考文章(25)
M. Duet, S. Benelhadj, W. Kedra, D. Vilain, C. Ajzenberg, D. Elkharrat, L. Drouet, C. Soria, O. Mundler, A New Quantitative D-dimer Assay Appropriate in Emergency: Reliability of the Assay for Pulmonary Embolism Exclusion Diagnosis Thrombosis Research. ,vol. 91, pp. 1- 5 ,(1998) , 10.1016/S0049-3848(98)00048-6
M J Elms, I H Bunce, P G Bundesen, D B Rylatt, A J Webber, P P Masci, A N Whitaker, Measurement of crosslinked fibrin degradation products - an immunoassay using monoclonal antibodies. Thrombosis and Haemostasis. ,vol. 50, pp. 591- 594 ,(1983) , 10.1055/S-0038-1665263
Willem Nieuwenhuizen, A reference material for harmonisation of D-dimer assays Thrombosis and Haemostasis. ,vol. 77, pp. 1031- 1033 ,(1997) , 10.1055/S-0038-1656098
Henk van den Borne, Marion van der Kolk, Piet de Wild, Ger Janssen, Stan van Uum, Fedde van der Graaf, Exclusion of deep venous thrombosis with D-dimer testing--comparison of 13 D-dimer methods in 99 outpatients suspected of deep venous thrombosis using venography as reference standard. Thrombosis and Haemostasis. ,vol. 83, pp. 191- 198 ,(2000) , 10.1055/S-0037-1613784
N. Grenier, G. Freyburger, H. Trillaud, S. Labrouche, P. Gauthier, S. Javorschi, P. Bernard, D-dimer Strategy in Thrombosis Exclusion A Gold Standard Study in 100 Patients Suspected of Deep Venous Thrombosis or Pulmonary Embolism: 8 DD Methods Compared Thrombosis and Haemostasis. ,vol. 79, pp. 32- 37 ,(1998) , 10.1055/S-0037-1614214
J L Pittet, P de Moerloose, G Reber, C Durand, C Villard, N Piga, D Rolland, S Comby, G Dupuy, VIDAS D-dimer: fast quantitative ELISA for measuring D-dimer in plasma. Clinical Chemistry. ,vol. 42, pp. 410- 415 ,(1996) , 10.1093/CLINCHEM/42.3.410
C J Hillyard, A S Blake, K Wilson, D B Rylatt, S Miles, R Bunch, M J Elms, A Barnes, P G Bundesen, A latex agglutination assay for D dimer: evaluation and application to the diagnosis of thrombotic disease. Clinical Chemistry. ,vol. 33, pp. 1837- 1840 ,(1987) , 10.1093/CLINCHEM/33.10.1837
G O Gogstad, S Dale, F Brosstad, O Brandsnes, J Holtlund, E Mørk, E Gärtner, S M Borch, Assay of D-dimer based on immunofiltration and staining with gold colloids. Clinical Chemistry. ,vol. 39, pp. 2070- 2076 ,(1993) , 10.1093/CLINCHEM/39.10.2070
D.B. Rylatt, A.S. Blake, L.E. Cottis, D.A. Massingham, W.A. Fletcher, P.P. Masci, A.N. Whitaker, M. Elms, I. Bunce, A.J. Webber, D. Wyatt, P.G. Bundesen, An immunoassay for human D dimer using monoclonal antibodies Thrombosis Research. ,vol. 31, pp. 767- 778 ,(1983) , 10.1016/0049-3848(83)90108-1