Study on commutability evaluation of reference materials for fibrinogen

To discuss the commutability evaluation method of reference materials for fibrinogen measurement and evaluate the commutability of the Third WHO International Standard Fibrinogen Plasma (WHO 09/264), SSC/ISTH Secondary Coagulation Standard (SSC LOT4) and homemade reference materials (RM01, RM02) in order to provide suggestions on how to determine the suitable method of commutability evaluation and reliable traceability standard. The comparability of fibrinogen among different measurement systems were evaluated and WHO 09/264 was used to calibrate each system to improve the comparability if the comparability among different systems couldn't be accepted. Forty clinical samples and the reference materials randomly interspersed among the clinical samples were measured on Stago STA-R Evolution, Sysmex CS 5100, IL ACL TOP 700 simultaneously. Measurement results were pairwise analyzed by Deming regression and difference in bias approach according to the Clinical and Laboratory Standards Institute (CLSI) EP14-A3 prot