中国医学装备2025，Vol.22Issue(7)：35-39,5.DOI:10.3969/j.issn.1672-8270.2025.07.007
全自动干式生化免疫分析仪开放试剂仓检测血清胱抑素C的性能验证
Performance validation of opened reagent compartment of full automatic dry biochemical immunoassay analyzer in detecting serum cystatin C
摘要
Abstract
Objective:To validate and evaluate the performance of opened reagent warehouse of VITROS 5600 full automatic dry biochemical immunoassay analyzer,which carried domestic serum cystatin C(Cys C)kit of Lidman.Methods:The precision,correctness,linear range,the maximum dilution and biological reference interval of Cystatin C were validated according to evaluation criteria of the National Committee for Clinical Laboratory Standardization(NCCLS)for instrument,which also referred to<Analytical performance standard for routine analytes in clinical chemistry>,<Guidelines for the verification of analytical performance of quantitative examination procedures>and others.Results:①Precision measurement results:the Sintra-assay of cystatin C were respectively 0.046 and 0.147,and the Sindoor were respectively 0.046 and 0.130,which were less than those of the Sintra-assay of the manufacturer's statement(0.083,0.178),and the requirement of industry standard for Sindoor(0.100,0.213)of imprecision.②Correctness:The absolute value|b|of bias of detecting standard substances of five concentration levels were respectively 0.032,0.014,0.062,0.013,and 0.200,all of which were less than the prescribed bias in the industry standards(0.04,0.08,0.16,0.32,0.64).③Linear range:The linear regression equation was y=1.011 2x+0.111,R2=0.997 4,showing a linear relationship.④The cystatin C:the measurement range was 0.51-7.66 mg/L,and the maximum acceptable dilution was 2-fold,and the clinically reportable range was 0.51～15.32 mg/L;⑤Biological reference interval validation:All the detection values of cystatin C of the health population(the age of 40 cases≤50 years old,and that of 20 cases>50 years old)were within the claimed reference intervals of manufactory.Conclusion:The precision,correctness,linear range and biological reference interval of the opened reagent warehouse of VITROS 5600 full automatic dry biochemical immunoassay analyzer,which carried Liedemann serum cystatin C kit,can meet the experimental requirements in clinical application,and can be used in detecting clinical routine specimen.关键词
干化学/胱抑素C(Cys C)/性能验证/精密度/正确度/线性范围/开放试剂仓Key words
Dry chemistry/Cystatin C/Performance validation/Precision/Accuracy/Linearity range/Opened reagent warehouse分类
医药卫生引用本文复制引用
庞欢,尹倩雯,阮竞雄,王晓琴..全自动干式生化免疫分析仪开放试剂仓检测血清胱抑素C的性能验证[J].中国医学装备,2025,22(7):35-39,5.基金项目
西安市重点产业链技术攻关集群项目(24LLRHZDZX0028)The Key industrial chain technology Breakthrough Cluster Project of Xi'an City(24LLRHZDZX0028) （24LLRHZDZX0028）
