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=0.997>0.99,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=1.54<t(0.05,22),P>0.05,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=0.999>0.95,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。
Objective To perform verification of the new KHB ZhuoYue 450 automatic biochemical analyzer before its usage to ensure that the instrument met the requirement. Methods The new instrument was evaluated in terms of precision, accuracy, reportable range and was compared with the reference instrument. The criterion referred to the acceptance criteria for confirmation of the methods for detecting alanine aminotransferase （ALT）, according to the 2012 edition of ＂Technical Operating Procedures in Blood Station. ＂ Results The ALT quality control serum were repeatedly tested in the new KHP ZhuoYue 450 automatic biochemical analyzer. The coettlcients of variation （CV） of intra-assay were less than 5 %, and the CV of inter-assay were less than 6. 7%. The regression equation that was used to verify reportable range was Y^ = bx ＋ a. The correlation coefficient R2 =0. 997 〉0. 99, b = 1,016 was in the range from 0. 97 to 1.03, a =3.271 ~0. T test was per- formed to verify the differences between the intercept value a and 0, t. = 1.54 〈 t〈0 o5.22） , P 〉0. 05. The difference was not statistically significant between a and （）. The results were accurate and reliable in the new test system between 26. 6 to 325.4 （U/L）. The estimation of accuracy was performed by testing samples from external quality assessment and compared with prior results. The relative bias was less than 1/2 of the allowable total error （TEa）. Compared with KHB ZhuoYue 450 in use, the regression equation was Y = 0. 990x ＋ O. 056, R2 = 0. 999 〉 O. 95. At the concentration Xc, 20U/L, 50U/L and 300U/L, the systematic errors （SE） introduced ]0y new test system were 0.256, 0.556 and 3. 056, respectively. All were less than 1/2 TEa. Conclusion The verification results from the new instrument met the acceptance criteria according to the 2012 edition of ＂Technical Operating Procedures in Blood Station. ＂ The new instrument could be used for screening blood donors＇ ALT： Performance verification for new instruments in lab
出处
《中国输血杂志》
CAS
北大核心
2016年第2期147-150,共4页
Chinese Journal of Blood Transfusion
关键词
性能验证
全自动生化分析仪
ALT
比对试验
performance verification
automatic biochemical analyzer
ALT
comparison test
