VITROS 5600型全自动生化免疫分析仪检测性能验证

Verification of the test performance of VITROS 5600 fully automatic biochemical immune analyzer

目的:对VITROS 5600型全自动生化免疫分析仪检测系统、检测程序和方法进行性能验证。方法:使用VITROS 5600型全自动生化免疫分析仪从精密度、正确度、线性范围、最大稀释度及生物参考区间等性能方面,对常规检测指标肌酸激酶(CK)、天门冬氨酸氨基转移酶(AST)、丙氨酸氨基转移酶(ALT)、碱性磷酸酶(ALP)、γ-谷氨酰基转移酶(GGT)、总蛋白(TP)、白蛋白(ALB)、肌酐(CRE)、尿酸(UA)、尿素氮(BUN)、葡萄糖(GLU)、钠(Na)、钾(K)、氯(Cl)、钙(Ca)、磷(P)16个检测项目进行性能验证。结果:16个项目检测水平的低值和高值两个不同浓度水平校准品结果批内变异系数(CV)均≤1/4允许总误差(TEa),批间CV均≤1/3 TEa,精密度验证通过;该设备最近3次参加国家卫健委临床检验中心16个项目的室间质评的检测结果与靶值之间的平均偏倚均≤1/2 TEa,正确度验证通过;线性范围验证中,16个项目线性方程中的斜率(b)均在0.97~1.03范围内,相关系数的平方(R^(2))值均>0.95,与厂家给出的参数相符。除ALB、Na、K、CL、Ca、P等6个项目在常规检测中无需稀释外,其他10个项目的最大稀释倍数在1~32倍间不等;16个项目生物参考区间验证,各个项目对健康人群的检测值在参考范围的比例(R)值均≥95%,表明厂家提供的16个检测项目的生物参考区间均可接受。结论:VITROS 5600型全自动生化免疫分析仪对16个检测项目从精密度、正确度、线性范围、最大稀释度及生物参考区间等性能验证,各项验证结果均与厂家声明的各项指标要求相符,检测结果准确、可靠,能够满足对上述项目用于临床标本的检测要求。

Objective:To perform performance verification for the detection system,detection program and detection method of the VITROS 5600 fully automatic biochemical immune analyzer.Methods:Using the VITROS 5600 fully automatic biochemical immune analyzer,the performances of 16 conventionally detective indicators included creatine kinase(CK),aspartate aminotransferase(AST),alanine aminotransferase(ALT),alkaline phosphatase(ALP),γ-glutamate(GGT),total protein(TP),albumin(ALB),creatinine(CRE),uric acid(UA),urea nitrogen(BUN),glucose(GLU),sodium(NA),potassium(K),chlorine(CL),calcium(CA)and phosphorus(P)were tested according to a series of performances included precision,accuracy,linear range,maximum dilution and biological reference interval.Results:The coefficient of variation(CV)of intra batch of the two standards with different concentrations(detective level 1:low value,detective level 2:high value)of 16 items with different concentration levels of high and low values were≤1/4 of the allowable total error(TEa),and the inter batch CVs both of them were≤1/3 of TEa,and the precision verification passed.The average bias of 16 indicators was≤1/2 TEa between the inter laboratory quality assessment of the National Center for Clinical Laboratories of the National Health Commission in the last 3 times and target values,and the accuracy verification passed.In the validation of linear range,the slopes(b)in the linear equations of 16 items was within the range from 0.97 to 1.03,and the square values(R^(2))of the correlation coefficients of them were greater than 0.95,which was consistent with the parameters provided by the manufacturer.The maximum dilution ratio was within the range from 1:1 to 1:32 in 10 items except 6 items(ALB,Na,K,Cl,Ca,P)did not need be diluted in the conventional detection.In the validation of biological reference interval of 16 items,the ratio(R)value that detective value of each item for health population was within the reference range was≥95%,which indicated that the biological reference intervals provided by the manufacturer for the 16 detective items were acceptable.Conclusion:The VITROS 5600 fully automatic biochemical immune analyzer verified the performance of 16 detective items in terms of precision,accuracy,linear range,the maximum dilution and biological reference interval.The verified result of each item is consistent with the requirement of the declaration of manufacturer for each item,and the detective result is accurate and reliable,which can meet the detective requirement of above items are used in clinical specimens.