西门子Atellica CH930全自动生化分析仪常规生化检测项目性能验证

Performance evaluation of SIEMENS Atellica CH930 automatic biochemical analyzer for detecting routine biochemical testing items

目的:对西门子Atellica CH930全自动生化分析仪常规生化检测项目:总蛋白(TP)、白蛋白(ALB)、天门冬氨酸氨基转移酶(AST)、谷氨酸氨基转移酶(ALT)、碱性磷酸酶(AKP)、尿素(UN)、肌酐(CREA)、尿酸(UA)、血糖(GLU)、胆固醇(Cho)、甘油三酯(TG)的分析性能进行验证。方法:参考《临床实验室对商品定量试剂盒分析性能的验证》、《临床化学定量检验程序性能验证指南》并结合检验工作实际情况,对Atellica CH930全自动生化分析仪测定血清总蛋白等13项常规生化项目的精密度、正确度、临床分析测量范围以及生物参考区间进行验证和评价。结果:总蛋白等11项常规生化检测项目在2个不同浓度水平测定的期间标准差都小于厂家规定的不精密度要求;采用室间质评样本作为参考物质,11项常规生化检测项目的参考物质偏移值小于参考物质赋值的不确定度,验证厂家声称可靠;验证的分析测量范围分别为:TP 21.35~108.9 g/L,ALB 13.5~57.4 g/L,AST 9.5~862 U/L,ALT 11~776 U/L,AKP 11~931 U/L,UN 2.04~48.77 mmoml/L,CREA 14.85~2400.65 Umol/L,UA 39.5~1095 mmol/L,GLU 0.75~38.27 mmol/L,Cho 0.87~7.59 mmol/L,TG 0.14~5.82 mmol/L;经验证仪器自动稀释功能稀释检测后,临床可报告范围分别为:TP21.35~217.8 g/L,ALB 13.5~114.8 g/L,AST 9.5~5172 U/L,ALT 11~2329 U/L,AKP 11~2793 U/L,UN 2.04~97.54 mmoml/L,CREA 14.85~12003.25 Umol/L,UA 39.5~5475 mmol/L,GLU 0.75~84.81 mmol/L,Cho 0.87~15.18 mmol/L,TG 0.14~11.64 mmol/L;生物参考区间验证结果均在设定的范围之内。结论:西门子Atellica CH930全自动生化分析仪测定总蛋白等11项常规生化项目的分析性能满足厂商声明的质量和性能要求,符合临床的要求,可应用于临床。

Objective:To evaluate the performace verification of serum routine biochemical testing items(TP、ALB、ALT、AST、AKP、UN、CREA、UA、GLU、CHO、TG) detected by SIEMENS Atellica CH930 automatic biochemical analyzer.Methods:According to clinical and practial requirements,the accuracy and precision of these items were detected by Atellica CH930,and their linear range,biological reference and maximum dilution multiple were evaluated referring to the evaluation method of “Verification of the analytical performance of commercial quantitative kits by clinical laboratories” and Guidelines for performance verification of clinical chemistry quantitative testing procedures.Results:The standard deviation of 11 routine biochemical test items such as total protein during the measurement at 2 different concentration levels meets the imprecision requirements specified by the manufacturer.Using PT samples as reference substances,the reference substance offset value of 11 items is less than the uncertainty of the reference substance assignment,which verifies that the manufacturer claims to be reliable.The analytical measurement ranges verified were:TP 21.35~108.9 g/L,ALB 13.5~57.4 g/L,AST 9.5~862 U/L,ALT 11~776 U/L,AKP 11~931 U/L,UN 2.04~48.77 mmoml/L,CREA 14.85-2400.65 Umol/L,UA 39.5-1095 mmol/L,GLU 0.75-38.27 mmol/L,Chol 0.87~7.59 mmol/L,TG 0.14~5.82 mmol/L.After the dilution test of the automatic dilution function of the verified instrument,the clinical reportable ranges were:TP 21.35~217.8 g/L,ALB 13.5~114.8 g/L,AST 9.5~5172 U/L,ALT 11~2329 U/L,AKP 11~2793 U/L,UN 2.04~97.54 mmoml/L,CREA 14.85~12003.25 Umol/L,UA 39.5~5475 mmol/L,GLU 0.75~84.81 mmol/L,Chol 0.87~15.18 mmol/L,TG 0.14~11.64 mmol/L.Biological reference interval verification results are within the set range.Conclusion:The main analysis performance of SIEMENS Atellica CH930 automatic biochemical analyzer meets the manufacturer’s declared quality and performance requirements,meets the clinical requirements,and can be used in clinical applications.