【摘要】：目的對新引入的KHB卓越450全自動生化分析儀進(jìn)行使用前性能驗證,確保儀器滿足使用要求。方法對新儀器進(jìn)行精密度、正確度、可報告范圍評價,并與參比儀器作比對試驗,判定標(biāo)準(zhǔn)參照《血站技術(shù)操作規(guī)程(2012版)》規(guī)定的ALT方法確認(rèn)可接受標(biāo)準(zhǔn)。結(jié)果新KHB卓越450全自動生化分析儀重復(fù)測定ALT質(zhì)控血清,批內(nèi)不精密度(CV)均5%,批間CV均6.7%;驗證可報告范圍的回歸方程Y^=bx+a,相關(guān)系數(shù)R2=0.9970.99,b=1.016在0.97-1.03范圍內(nèi),a=3.271≠0,進(jìn)行截距a值與0差異的t檢驗,ta=1.54t(0.05,22),P0.05,截距a與0差異無統(tǒng)計學(xué)意義,新檢測系統(tǒng)在(26.6-325.4)U/L范圍間的結(jié)果準(zhǔn)確可靠;正確度估計通過檢測室間質(zhì)評標(biāo)本與回報結(jié)果比較,相對偏倚小于1/2 TEa;與現(xiàn)用KHB卓越450檢測系統(tǒng)比對,回歸方程Y=0.990x+0.056,R2=0.9990.95,在臨床決定水平濃度Xc在20 U/L、50 U/L和300 U/L處新檢測系統(tǒng)引入的系統(tǒng)誤差SE分別為:0.256,0.556和3.056,均1/2TEa。結(jié)論新儀器的驗證結(jié)果符合《血站技術(shù)操作規(guī)程(2012版)》規(guī)定的可接受標(biāo)準(zhǔn),可用于獻(xiàn)血者ALT的篩查;實驗室對新引入儀器進(jìn)行性能驗證是有意義的。
[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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