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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=1.540.05,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 the pre-use performance verification of the newly introduced KHB Excellence 450 automatic biochemical analyzer to ensure that the instrument meets the requirements for use. Methods The precision, accuracy and reportable range of the new instrument were evaluated and compared with the reference instrument. The standard of determination was confirmed by the ALT method according to the Blood Bank Technical Operating Procedures (Version 2012). Results The new KHB 450 automatic biochemical analyzer was used to determine ALT quality control serum repeatedly. The intra-assay inaccuracy (CV) were all less than 5%, and the CV between batches was <6.7%. The regression equation of verifiable reportable range was Y ^ = bx + a, t = 1.54 0.99, b = 1.016 in the range of 0.97-1.03, a = 3.271 ≠ 0. P > 0.05, the intercept a and 0 were not statistically significant, the new detection system in the (26.6-325.4) U / L range of results accurate and reliable; the accuracy of the assessment by testing the inter room quality evaluation of the specimens compared with the return, the relative The bias was less than 1/2 TEa. Compared with the current KHB Excellence 450 detection system, the regression equation was Y = 0.990x + 0.056, R2 = 0.999> 0.95. When the clinical level of Xc was 20 U / L, 50 U / L and The systematic errors SE introduced by the new detection system at 300 U / L were respectively 0.256, 0.556 and 3.056, all <1/2 TEa. Conclusion The validation results of the new instrument meet the acceptable standards as set forth in the Blood Station Technical Code of Practice (2012 Edition) and can be used to screen for ALT in blood donors. It is significant for laboratories to verify the performance of newly introduced instruments.