IMMUNITE1000化学发光分析系统检测白细胞介素-6的性能验证

Method performance verification of the detection of interleukin-6by using IMMUNITE1000chemiluminescence detection system

目的验证IMMUNITE1000化学发光仪分析系统定量检测白细胞介素-6（IL-6）的性能。方法按国际标准化组织（ISO）15189实验室认可的要求,收集血清标本进行IL-6检测,验证IMMUNITE1000化学发光仪分析系统定量检测IL-6的精密度、准确度、线性范围、临床可报告范围及正常参考区间,评估其检验效能。结果高值与低值标本的日间变异系数（CV）分别为6.42%、1.97%,批内CV分别为3.40%、3.82%;标准品检测值相对偏倚（bias%）为0.91%;回归方程：Y=0.986 X-7.1（r2=0.999,P〈0.05）;稀释至27倍,回收率在97%~100%之间,临床可报告范围为2~27 000pg/mL;95%参考区间为0~5.3pg/mL。结论该系统检测性能符合厂家声明,满足临床实验室质量要求。

Objective To verify the performance of quantitative detection of interleukin-6 by using IMMUNITE1000 chemilumi-nescence analyzer.Methods According to the requirements of International Organization for Standardization（ISO）1 5 189,serum specimen were collected and levels of IL-6 were detected.The precision,accuracy,analytical measurement range,reportable range amd normal reference range of quantitative detection of interleukin-6 by using IMMUNITE1000 chemiluminescence analyzer were verified,and its performance was evaluated.Results The coefficient variation（CV）of between-day precision of high and low value was 6.42% and 1.97% respectively,and that of within-run precision was 3.40% and 3.82% respectively.Compared the test re-sults with the target values,the bias % was 0.91%.The regression equation：Y =0.986X - 7.1 （r 2 = 0.999,P 〈 0.05 ）.With 27 times diluted,the recovery rate was from 97% to 100%,and the clinical reportable range was 2 to 27 000 pg/mL.The 95% refer-ence interval ranged from 0 to 5.3 pg/mL.Conclusion The performance of this system meets the manufacturer′s declaration,and could satisfy the quality requirements of clinical laboratory.