title: A performance evaluation of commercial fibrinogen reference preparations and assays for Clauss and PT-derived fibrinogen.
abstract: 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.
authors.affiliation: The Haematology Department, University College London, UK. i.mackie@ucl.ac.uk
authors.forename: J
authors.initials: J
authors.lastname: Mackie
authors.forename: A S
authors.initials: AS
authors.lastname: Lawrie
authors.forename: S
authors.initials: S
authors.lastname: Kitchen
authors.forename: P J
authors.initials: PJ
authors.lastname: Gaffney
authors.forename: D
authors.initials: D
authors.lastname: Howarth
authors.forename: G D O
authors.initials: GD
authors.lastname: Lowe
authors.forename: J
authors.initials: J
authors.lastname: Martin
authors.forename: G
authors.initials: G
authors.lastname: Purdy
authors.forename: P
authors.initials: P
authors.lastname: Rigsby
authors.forename: A
authors.initials: A
authors.lastname: Rumley
mesh_terms: D001780:Blood Coagulation Tests / Q000295:instrumentation / Q000379:methods / Q000592:standards; D002138:Calibration; D005340:Fibrinogen / Q000032:analysis* / Q000592:standards; D006801:Humans; D007118:Immunoassay; D007202:Indicators and Reagents / Q000592:standards; D009391:Nephelometry and Turbidimetry; D015588:Observer Variation; D011517:Prothrombin Time; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012015:Reference Standards; D015203:Reproducibility of Results
chemical_list: D007202:Indicators and Reagents; D011933:Reagent Kits, Diagnostic; D005340:Fibrinogen