Analysis Of Fibrinogen Consistency Among Different Detection Systems And Discussion On Commutability Of Quality Control Materials

ObjectiveTo compare the correlation and consistency of plasma fibrinogen(FIB)measured by 7 different detection systems using clinical plasma samples,and to observe the matrix effect of coagulation quality control materials from 8 manufacturers,and to evaluate whether they are commutability.To analyze the difference of results among different testing systems,promote the mutual recognition of FIB test results among different laboratories,select appropriate EQA samples,and objectively and fairly evaluate the testing ability of laboratories;At the same time,it can provide reference for manufacturers to improve the preparation technology and clinical laboratories to select the appropriate FIB quality control materials.Methods40 plasma samples of patients with different FIB levels were detected by Sysmex CS 5100,IL ACL TOP 700,STA-compact,Rayto RAC 1830,Zonci XL 1000i,Succeeder SF 8100 and Sysmex CS 5100(solar reagent)non matching detection system.According to the EP9-A2 document of Clinical and Laboratory Standards Institute(CLSI),the results were statistically analyzed to evaluate the consistency of FIB test results among different detection systems.At the same time,8 coagulation quality control materials from 8 manufacturers were selected to test FIB on seven detection systems,and the consistency and commutability of quality control materials were evaluated according to EP14-A3 document and Guideline for evaluation of matrix effects and commutability(WS/T 356-2011).Results1.When Sysmex CS 5100 matching detection system was used as the comparison system,the correlation between different detection systems was r~2=0.944～0.733.When IL ACL TOP 700 matching detection system was used as the comparison system,r~2=0.809～0.674.When STA-compact was used as the comparison system,r~2=0.809-0.677.2.Using partial bias method to analyze and compare the consistency of FIB results among different detection systems,FIB results are different among different detection systems,especially when FIB concentration is less than 2g/L.3.The CV value of FIB test results of coagulation quality control materials from8 manufacturers ranged from 5.49%to 14.51%.The commutability of coagulation quality control materials from different manufacturers could not be evaluated among7 detection systems.ConclusionThe correlation between the seven detection systems is poor,especially between the domestic detection system and the imported detection system;There are differences in FIB results among different detection systems,and whether there is consistency needs further study.The FIB test results of coagulation quality control materials from 8 manufacturers were different in 7 kinds of test systems,so the commutability could not be evaluated,especially for coagulation quality control materials with abnormal levels.The development of FIB quality assessment samples suitable for different detection systems is the key factor to promote the consistency of results among laboratories.