血浆纤维蛋白原不同检测系统间检测结果的一致性分析及质控品的互通性探讨

目的 比较7种不同检测系统测定血浆纤维蛋白原(Fib)结果的一致性,并观察不同厂家质控品的基质效应,评价互通性.方法 在Sysmex CS 5100,IL ACL TOP 700,STA-Compact,雷杜Rayto RAC 1830,众驰Zonci XL 1000i,赛科希德Succeeder SF 8100配套检...

Analysis of Fib Consistency among Different Detection Systems and Discussion on Commutability of Quality Control Materials

Objective To compare 7 different detection systems for plasma fibrinogen(Fib)consistency of results,matrix effect of quality control materials from different manufacturers were observed,and commutability was evaluated.Methods 40 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).Results The correlation coefficient(r²)of Fib results of patients detected by different systems were 0.674~0.944.Sysmex CS 5100 and STA-Compact were used as comparison systems,and the results between detection systems were clinically acceptable(except for some results of Succeeder SF 8100 matching detection system).The CV value of Fib test results of coagulation quality control materials from 8 manufacturers ranged from 5.49%to 14.51%.The commutability of coagulation quality control materials from different manufacturers could not be evaluated among 7 detection systems.Conclusion The correlation of Fib test results among the 7 detection systems was not good.Whether Fib test results are consistent among different detection systems needs further study,and it is unable to evaluate the commutability of coagulation quality control materials from various manufacturers.