Masahiro Okuda, Yahiro Uemura, Noriyuki Tatsumi, Susumu Honda, "Proposed fibrinogen standard material with purified fibrinogen for plasma fibrinogen measurement on coagulation analyser", Journal of Analytical Methods in Chemistry, vol. 25, Article ID 843285, 5 pages, 2003. https://doi.org/10.1155/S146392460300018X
Proposed fibrinogen standard material with purified fibrinogen for plasma fibrinogen measurement on coagulation analyser
A commercially available fibrinogen standard calibrated by a World Health Organization (WHO) reference material is widely used in Japan, and most clinical laboratories use the Clauss method for plasma fibrinogen measurement. However, a current issue in fibrinogen measurement is poor laboratory-to-laboratory variability. To improve the reliability of fibrinogen values and thereby solve the poor precision and accuracy of plasma fibrinogen testing, the present paper develops a simple and large preparation procedure for a suitable fibrinogen standard and quality control material and evaluates their basic performance. With a new procedure getting high purified fibrinogen by glycine precipitation, the calibrator determined by both the Clauss and Jacobson methods produced a fibrinogen concentration of 2.20 g l−1. The total precision of the calibrator was excellent (coefficient of variation 1.4-2.1%) in comparison with current plasma fibrinogen materials from the WHO (#98/612) and with a commercial standard (CV 1.9-3.9%). The within-run precision of the calibrator on the coagulation analysers was 1.7-2.8%. Within-analyser variability among the five instruments had good consistency (mean 2.20 ± 0.022 g l−1; CV 1.0%). The degradation study of the calibrator suggested that storage at 9°C for two years was as predicted. In conclusion, the results show that the calibrator prepared herein can be useful as a candidate Japanese fibrinogen standard and is applicable to automated and semi-automated coagulation analysers. Additionally, it is expected that it will be widely used in Japan by diagnostic manufacturers and clinical laboratories as a recommended secondary standard to estimate a fibrinogen value according to the WHO primary standard.
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