The clinical utility of fibrinogen measurement has been limited by large in
traindividual variability. Several approaches that have been shown to impro
ve the repeatability of fibrinogen include acquisition of samples at the sa
me time of day, standardized sample procurement techniques, and multiple re
plicate sampling. This study employed established pre-analytical and analyt
ical techniques known to reduce fibrinogen variability, including the acqui
sition of three replicate samples, each analyzed in duplicate, to evaluate
the impact of intraindividual variability in fibrinogen measurement at base
line and 3 months on cardiovascular risk in 60 healthy subjects. Classifica
tion accuracy was evaluated by the ability to categorize subjects into tert
iles of fibrinogen. Only 55% (33/60) of the subjects were correctly assigne
d to the appropriate fibrinogen tertile. Fibrinogen measurements varied by
more than 10% in 45% of subjects and by 5% in 80% of subjects. Intraindivid
ual variability in fibrinogen measurement with a functional assay limits ca
rdiovascular risk assessment even when three replicates are averaged. (C) 2
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