Quality control material for plasma fibrinogen test produced from purified human fibrinogen

摘要

Plasma fibrinogen measurement is a routine laboratory procedure commonly performed on automated coagulation analysers.Its determination is quantitative,not quantitative.Yet,a lack of precision has been an issue for fibrinogen measurement.A control material derived from plasma comprises many proteins,inhibitors and fatty acids,any or all of which can interfere in the Jibrinogen assay.This study has attempted to develop a quality control material using purified human Jibrinogen and has compared measurement precision between both purified and plasma materials.Purified fibrinogen was prepared using Cohn fraction 1 and glycine-precipitation.Purified fibrinogen clottability was greater than 95%,with no main plasma proteins,lipids or fibrinogen degradation products observed.Two purified control materials were lyophilized at normal (2.30 g l~(-1)) and abnormal (1.20 g l~(-1)) levels of fibrinogen concentration.Precision was evaluated using a liquid-type reagent,Thrombocheck Fib(L),on automated coagulation analysers.Coefficient of variation for within-run,intraday and between-day precision of the purified materials was 0.7-3.5%.In comparison,the coefficient of variation for plasma materials ranged from 1.2 to 5.3%.These results suggest that materials prepared from purified fibrinogen can be useful to laboratory quality control by improving overall precision of fibrinogen measurement and are applicable to automated coagulation analysers.