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Thromb Haemost 2002; 87(06): 997-1005
DOI: 10.1055/s-0037-1613124
Review Article
Schattauer GmbH

A Performance Evaluation of Commercial Fibrinogen Reference Preparations and Assays for Clauss and PT-derived Fibrinogen

I. J. Mackie
1   The Haematology Department, University College London, London
,
A. S. Lawrie
1   The Haematology Department, University College London, London
,
S. Kitchen
2   Sheffield Haemophilia and Thrombosis Centre, Royal Hallamshire Hospital, Sheffield
,
P. J. Gaffney
3   National Institute for Biological Standards and Control, Potters Bar
,
D. Howarth
4   MRC Epidemiology & Medical Care Unit, Wolfson Institute of Preventative Medicine, London
,
G. D. O. Lowe
5   Department of Medicine, University of Glasgow, UK
,
J. Martin
4   MRC Epidemiology & Medical Care Unit, Wolfson Institute of Preventative Medicine, London
,
G. Purdy
1   The Haematology Department, University College London, London
,
P. Rigsby
3   National Institute for Biological Standards and Control, Potters Bar
,
A. Rumley
5   Department of Medicine, University of Glasgow, UK
› Author Affiliations
Further Information

Publication History

Received 30 June 2001

Accepted after resubmission 28 February 2002

Publication Date:
08 December 2017 (online)

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Summary

The wide availability of fibrinogen estimations based on the prothrombin time (PT-Fg) has caused concern about the variability and clinical utility of fibrinogen assays. In a multi-centre study, we investigated fibrinogen assays using various reagents and analysers. Clauss assays generally gave good agreement, although one reagent gave 15–30% higher values in DIC and thrombolysis. Two commercial reference preparations had much lower potencies than the manufacturers declared, and plasma turbidity influenced parallelism in some Clauss assays. PT-Fg assays gave higher values than Clauss and showed calibrant dependent effects, the degree of disparity correlating with calibrant and test sample turbidity. Analyser and thromboplastin dependent differences were noted. The relationship between Clauss and PT-Fg assays was sigmoid, and the plateau of maximal PT-Fg differed by about 2 g/l between reagents. ELISA and immunonephelometric assays correlated well, but with a high degree of scatter. Antigen levels were higher than Clauss, but slightly lower than PT-Fg assays, which appeared to be influenced by degraded fibrinogen. Clauss assays are generally reproducible between centres, analysers and reagents, but PT-Fg assays are not reliable in clinical settings.

Keywords

Fibrinogen assays - coagulation analysers - Clauss reagents - thromboplastin reagent - reference plasmas
 

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