罗氏Modular全自动生化分析仪酶学指标检测性能验证  

Performance verification of enzymological items measurement by Roche Modular automatic biochemical analyzer

作　　者：徐建华[1] 黄宪章[1] 庄俊华[1] 张秀明[2] 徐宁[1] 陈曲波[1] 林莲英[1] 谢湘媚[3] 

机构地区：[1]广东省中医院检验科,广东广州510120 [2]中山大学附属中山医院,广东中山528403 [3]广州医学院检验系,广东广州510182

出　　处：《检验医学》2010年第2期81-85,共5页Laboratory Medicine

基　　金：国家科技支撑计划项目(药品临床研究实验室关键技术研究与应用)(2006BAI14B00);广东省中医院青年后备人才科研项目(E206001)

摘　　要：目的验证罗氏Modular全自动生化分析仪酶学指标丙氨酸氨基转移酶(ALT)和天门冬氨酸氨基转移酶(AST)分析性能。方法根据美国临床实验室标准化研究所(CLSI)系列文件(EP5-A2、EP15-A2、EP6-A2、EP7-A2、C28-A2)和其他相关文献的实验方案,对罗氏Modular全自动生化分析仪检测ALT、AST的精密度、准确度、线性、临床可报告范围、干扰和生物参考区间6大性能进行验证,并与厂商声明的性能或公认的质量标准进行比较。结果精密度均符合罗氏性能标准;对卫生部5份室间质控品检测结果与靶值的相对偏倚(SE%)在-3.94%^-9.09%之间,变异指数得分(VIS)均<50,室内质控(IQC)结果与罗氏全球质控系统(QCS)结果相对SE%在-3.70%~5.85%之间;ALT、AST检测均呈一次线性(r=0.999,P<0.05),线性范围分别为4~1 332 U/L、4~1 031 U/L;ALT、AST的临床可报告范围分别为0~133 200 U/L和0~206 200 U/L;血红蛋白(Hb)对AST检测有正干扰,Hb≤6.025 g/L的干扰效应剂量曲线呈一次线性(P<0.05);ALT、AST生物参考区间验证结果均在本实验室给出的参考区间内。结论罗氏Modular生化分析仪ALT、AST检测的主要分析性能符合质量目标要求,CLSI实验评价方案具有可操作性和实用性。Objective To validate the analytic characteristic of alanine aminotransferase （ALT） and aspartate aminotransferase（ AST ）measurement by Roche Modular automatic biochemical analyzer. Methods The precision, accuracy, linearity, clinical reportable range , interference and biotic reference interval of ALT and AST were validated according to Clinical and Laboratory Standards Institute （CLSI） documents （ EPS-A2, EP15-A2, EP6-A2, EP7-A2 and C28-A2） and other experimental procedures. The results were compared with manufacturer＇s claims and acceptable quality standards. Results The precisions were in line with the Roche performance standard. The system error （SE%） of five external quality assessment control samples was -3.94%- -9.09% and the variance index scores （VIS） were 〈 50. The SE% of internal quality control（IQC）and quality control service （QCS） was -3.70% - 5.85%. ALT and AST showed good linearity （r =0.999,P 〈0.05） and linearity range （4-1 332 U/L and 4-1 031 U/L）, and the clinical reportable ranges were 0-133 200 U/L and 0-206 200 U/L respectively. As for AST, hemoglobin（Hb） showed positive interference. As Hb ≤ 6.025 g / L, the interference dose-response series showed linear relationship （ P 〈 0.05 ）. The validation results of biotic reference interval of ALT and AST were in line with our laboratory reference interval. Conclusions The main analytic characteristic of ALT and AST measurement by Roche biochemical autoanalyzers is consistent with acceptable quality standards, and the experimental evaluation project of CLSI shows maneuverability and practicability.

关 键 词：丙氨酸氨基转移酶 天门冬氨酸氨基转移酶 分析性能 验证 

分 类 号：Q555[生物学—生物化学]