罗氏全自动生化分析仪自建生化检测系统的性能验证及评价

Performance verification and evaluation of a self-developed biochemical assay system by Roche Cobas automatic biochemistry analyzer

目的 验证及评价本院罗氏Cobas c311全自动生化分析仪自建生化检测系统的免疫球蛋白G（IgG）项目的分析性能.方法 对自建IgG检测系统的精密度、正确度、分析测量范围（Analytical measurement range,AMR）、临床可报告范围（Clinical reportable range,CRR）、比对实验进行验证实验.结果 低值和高值的批内变异系数（Coefficient variation,CV）分别为3.34％和3.57％,日间CV分别为5.27％和4.74％,均少于1/4 CLIA＇88和1/3 CLIA＇88水平；相对偏倚为3.32％和-6.34％,少于1/2 CLIA＇88水平；分析测量范围为2.81～31.44 g/L,临床可报告范围为2.81～188.64 g/L;与罗氏Cobas c501全自动生化分析仪配套检测系统比较,相关系数r=0.990 1,回归方程：y=0.95x＋0.55.结论 罗氏Cobas c311全自动生化分析仪自建生化检测系统IgG项目可用于临床检测,主要分析性能符合质量目标要求.

Objective To verify and evaluate the immunoglobulin G （IgG） testing in a self-developed biochemical assay system by Roche Cobas c311 automatic biochemistry analyzer.Methods Verification experiments were taken to measure the precision,accuracy,analytical measurement range （AMR）,clinical reportable range （CRR）,contrast experiment,interference experiment of IgG testing in a self-developed biochemical assay system.Results The low and high values of coefficient variation （CV） of within-run precision were 3.34％ and 3.57％,and those of day to day precision were 5.27％ and 4.74％,which were all less than the CV provided by the 1/4 CLIA＇ 88 and 1/3 CLIA＇ 88 requirements.Relative bias was 3.32％ and-6.34％,less than 1/2 CLIA＇ 88 standard.Analytical measurement range was 2.81～31.44 g/L,and the clinical reportable range was 2.81～188.64 g/L.Comparison with Roche Cobas c501 automatic biochemistry assay system showed r=0.901,y=0.95x＋0.55.Conclusion Self-developed biochemical assay system by Roche Cobas c311 automatic biochemistry analyzer can be used for clinical testing IgG project.The main performances are according with acceptable standards.