Method performance verification of the detection of interleukin-6 by using IMMUNITE1000 chemiluminescence detection system
10.3969/j.issn.1673-4130.2015.13.024
- VernacularTitle:IMMUNITE1000化学发光分析系统检测白细胞介素-6的性能验证
- Author:
Fei SUN
;
Tianpen CUI
;
Lan ZHAO
;
Jiayi CHEN
;
Yanyan WANG
- Publication Type:Journal Article
- Keywords:
interleukin-6;
chemiluminescence;
performance verification
- From:
International Journal of Laboratory Medicine
2015;(13):1858-1860
- CountryChina
- Language:Chinese
-
Abstract:
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.
