摘要
目的对强生Vitros350生化分析仪验收及性能进行综合评价。方法依据ISO/15189对实验室质量和能力的要求对强生Vitros350生化分析仪进行验收。参照临床实验室标准化协会的EP6-A、EP9-A2文件和强生公司提供的性能评价方案,对21项生化指标的准确度、精密度、临床参考区间和线性范围进行验证,与BeckmanLX-20生化分析仪进行相关性比较,并用Westgard标准决定图描述实验系统误差。结果 21项生化指标的准确度、精密度、线性范围和正常参考区间均符合厂商说明;K和Na在Level1水平的Westgard标准决定图中处于良好操作点,其余各项和Level2所有项目均在优秀操作点;与BeckmanLX-20生化分析仪进行相关性比较,除CK-MB(Y=0.8317X-2.8822,r=0.850)和Bc(Y=0.7619X-4.1093,r=0.913)不呈线性相关外,K、Na、Cl、Glu、Urea、Cre、Uric、ALT、TP、Alb、TBil、AST、CK、TC和TG均呈线性相关(r>0.975)。以Statland医学决定水平(Xc)判断临床可接受性,ALT和Urea在Xc1处不可接受,但无临床意义;TP在Xc1处不可接受,可经过强生Vitros350的斜率和截距进行调整;TBil差异较大,考虑到方法学的因素,暂时以强生Vitros350为基准。结论强生Vitros350生化分析仪已通过系统的验收和验证。
Objective To evaluate the acceptance of the John＆John Vitros 350 assay system. Methods Based on laboratory quality and competence requirements of the ISO/15189 to evaluate the Vitros 350 biochemistry analyzer. According to CLSI＇s EP6- A,EP9-A2,and John＆John corporation demonstration project to demonstrate for potassmm（K） and other 21 items of the accura ey, reliability, linear range and clinical reference,and compared with Beckman LX-20 analyzer, and use Westgard method evaluation decision chart to describe the systematic errors. Results 21 items of the accuracy, reliability, linear range and clinical reference ac- corded all with the declaration of the corporation; K and sodium（Na） in the Level 1 decision diagram Westgard standards in good operating point,all items remaining and Le：cel 2 are in excellent operating point. Compared with,the Beckman LX-20 analyzer, except CK MB（Y=0. 831 7X=2. 882 2,r=0. 850） and Bc（Y：0. 761 9X=4. 109 3,r=0. 913） is not linearly related to external,K,Na, C1,Glu,Urea,Cre,Urie,ALT, TP, Alb, TBil, AST,CK,TC and TG of the values are 〉0. 975. To judge the clinical acceptability with the level of Statland Medicine（Xc）, ALT and Urea in the Xcl unacceptable, but no clinical significance. TP in the Xcl unac ceptable and through adjust the slope and intercept acception. TBil difference Significantly,think methodology over, use Vitros 350 as the benchmark. Conclusion The function of Vitros 350 is accorded to the requirements of acceptance and demonstration for quality assurance for laboratories.
出处
《国际检验医学杂志》
CAS
2011年第1期3-5,8,共4页
International Journal of Laboratory Medicine
关键词
评价研究
验收
性能验证
acceptance
performance demonstration
evaluation
