白介素6量值溯源体系的建立与评价  

The Development and Evaluation of IL-6 Traceability System

作　　者：罗继全 彭琳 李宗祥 滕玉斌 李凤叶 LUO Jiquan;PENG Lin;LI Zongxiang;TENG Yubin;LI Fengye(Sinocare Inc.,Changsha 410000,China;Hunan Drug Insprction Center,Changsha 410000,China)

机构地区：[1]三诺生物传感股份有限公司,湖南长沙410000 [2]湖南省药品审核查验中心,湖南长沙410000

出　　处：《标记免疫分析与临床》2023年第4期690-694,共5页Labeled Immunoassays and Clinical Medicine

基　　金：湖南省自然科学基金全科药联合基金(编号:2021JJ80016);湖南省高新技术产业科技创新引领计划(编号:20022GK4021)。

摘　　要：目的 通过对白介素6(IL-6)的量值溯源方法进行研究,期望建立IL-6检测项目的量值溯源体系,确保IL-6检测结果准确可靠,促进IL-6项目检测结果的临床互认。方法 根据国际标准ISO17511-2020的要求,建立IL-6的量值溯源体系;通过对校准品进行互换性和不确定度评估,确保量值溯源建立的过程有效;通过正确性评估、室间质量评价(EQA)、方法学比对这3种方法,评价常规检测系统的准确性。结果 三诺IL-6项目溯源至国际约定校准品(NIBSC code:89/245):校准品互换性评估结果均在规定的临床样本测试95%置信区间内,互换性满足要求;两水平校准品标准相对不确定度分别为1.35%、1.27%,在50%的目标不确定度范围内。回收率实验的比例系统误差为3.85%;通过了IL-6项目的上海市临床检验中心室间质评;同罗氏检测系统进行方法学比对,回归曲线Y=0.998X+0.225,决定系数R2=0.992,斜率为0.9981,两系统检测结果具有一致性。结论 建立了IL-6的量值溯源体系,溯源至国际约定校准物,量值溯源结果准确可靠。Objective To conduct a research on the traceability of interleukin-6(IL-6).so as to establish a traceability system of IL-6 to improve the accuracy of IL-6 testing results,and to promote clinical mutual recognition of IL-6.Methods According to the requirements of the international standard ISO17511-2020,the quantitative traceability system of IL-6 was established.We evaluated the interchangeability and uncertainty of the calibrators to ensure the process of establishing the quantitative traceability was effective.The accuracy of the conventional detection system was evaluated by three methods:the correctness assessment,the external quality assessment(EQA),and the methodological comparison.Results IL-6 project of sinocare was traced to the international standard calibration product(NIBSC code:89/245)and showed as following:the interchangeability evaluation results of the calibrators were within the prescribed 95%confidence interval of clinical sample testing,and the interchangeability met the requirements.The relative uncertainties of the two levels of calibrators were 1.35%and 1.27%,respectively,which were within the target uncertainty range of 50%.The proportional systematic error of the recovery test was 3.85%.The IL-6 project passed the EQA of Shanghai Clinical Laboratory Center.Compared with Roche detection system,the regression curve was Y=0.998054 X+0.224845 with correlation coefficient R^(2),and the slope was 0.9981.The detection results of the two systems were consistent.Conclusion The quantification traceability system of IL-6 is established,which is traced to the international standard calibration product,and the quantification traceability results are accurate and reliable.

关 键 词：白介素6 量值溯源 互换性 不确定度 

分 类 号：R-331[医药卫生]