摘要
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配套检测系统及Sysmex CS 5100仪器(太阳试剂)非配套检测系统上检测Fib不同水平患者血浆样本40份。参考美国临床实验室标准化协会(CLSI)的EP9-A2文件,对结果进行统计学分析,评价不同检测系统间Fib检测结果是否具有一致性。同时选取8个厂家凝血质控品在7种检测系统上检测Fib,参考EP14-A3文件和《基质效应与互通性评估指南》(WS/T 356-2011)的要求,评价质控品一致程度及互通性。结果不同系统检测患者样本Fib结果相关系数(r^(2))为0.674~0.944,以Sysmex CS 5100及STA-Compact作为比对系统,检测系统间结果具有临床可接受性(除赛科希德Succeeder SF 8100配套检测系统部分结果存在差异)。8个厂家凝血质控品,Fib检测结果CV值在5.49%~14.51%之间,不同厂家凝血质控品在7种检测系统间无法评估互通性。结论7种检测系统间Fib检测结果相关性不佳,Fib检测结果在不同检测系统间是否具有一致性需进一步研究,无法评估各厂家凝血质控品互通性。
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(r^(2))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.
作者
洪生静
谢小娟
周伶俐
魏力强
HONG Sheng-jing;XIE Xiao-juan;ZHOU Ling-li;WEI Li-qiang(Xi’an Medical College,Xi’an 710021,China;Shaanxi Provincial People’s Hospital,Xi’an 710021,China)
出处
《现代检验医学杂志》
CAS
2021年第2期105-110,共6页
Journal of Modern Laboratory Medicine
关键词
纤维蛋白原
凝血分析仪
质控品
fibrinogen
coagulation analyzer
quality control material
