全自动生化分析仪在献血者ALT检测前性能验证分析

发布时间：2019-03-04 16:04

【摘要】：目的对新引入的KHB卓越450全自动生化分析仪进行使用前性能验证,确保仪器满足使用要求。方法对新仪器进行精密度、正确度、可报告范围评价,并与参比仪器作比对试验,判定标准参照《血站技术操作规程(2012版)》规定的ALT方法确认可接受标准。结果新KHB卓越450全自动生化分析仪重复测定ALT质控血清,批内不精密度(CV)均5%,批间CV均6.7%;验证可报告范围的回归方程Y^=bx+a,相关系数R2=0.9970.99,b=1.016在0.97-1.03范围内,a=3.271≠0,进行截距a值与0差异的t检验,ta=1.54t(0.05,22),P0.05,截距a与0差异无统计学意义,新检测系统在(26.6-325.4)U/L范围间的结果准确可靠;正确度估计通过检测室间质评标本与回报结果比较,相对偏倚小于1/2 TEa;与现用KHB卓越450检测系统比对,回归方程Y=0.990x+0.056,R2=0.9990.95,在临床决定水平浓度Xc在20 U/L、50 U/L和300 U/L处新检测系统引入的系统误差SE分别为:0.256,0.556和3.056,均1/2TEa。结论新仪器的验证结果符合《血站技术操作规程(2012版)》规定的可接受标准,可用于献血者ALT的筛查;实验室对新引入仪器进行性能验证是有意义的。
[Abstract]:Aim to verify the pre-service performance of the newly introduced KHB Zhuoyu 450 automatic biochemical analyzer to ensure that the instrument meets the requirements of application. Methods the precision, accuracy, reporting range of the new instrument were evaluated, and compared with the reference instrument, the acceptable standard was confirmed by reference to the ALT method stipulated in the Technical practice of Blood Station (2012 Edition). Results the ALT quality control serum was repeatedly determined by the new KHB Zhuoyu 450 automatic biochemical analyzer. The intra-assay imprecision (CV) and inter-assay CV were 5% and 6.7% respectively. The regression equation Y ^ = bx a was verified, the correlation coefficient was R 2 = 0.99799, the correlation coefficient was R 2 = 0.970.16 in the range of 0.97 渭 1.03, a = 3.271 鈮，

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