摘要
目的 评价BS 30 0全自动生化分析仪主要性能。方法 选定涵盖各波长的 9个项目 [丙氨酸氨基转移酶 (ALT) ,γ 谷氨酰基转移酶 (GGT) ,葡萄糖 (Glu) ,总蛋白 (TP) ,白蛋白 (Alb) ,肌酐 (Cr) ,钙 (Ca) ,氯 (Cl-) ,载脂蛋白B(ApoB) ],对深圳迈瑞BS 30 0全自动生化分析仪进行精密度、线性、交叉污染和对比试验 ,并对医学决定水平浓度进行偏倚估计。结果 BS 30 0日间、批内、批间及总CV均 <4 % ;线性稀释变异P <P0 .0 5(0 .6 84 1 ) ,线性失拟G <F0 .0 5(3.2 9) ;交叉污染率 2 .81E - 0 6 ;与AU2 70 0相关系数 (r) >0 .96 ;在医学决定水平浓度处的相对偏倚ALT、GGT、Glu、TP、Alb、Cr、Ca、Cl-(90mmol/L)、Cl-(1 2 0mmol/L)、ApoB分别为- 1 .8%、- 0 .1 %、- 3.9%、- 0 .5 %、- 2 .3%、- 7.2 %、0 .4 %、3.9%、3.2 %、- 1 .7%。结论 BS 30 0全自动生化分析仪主要性能指标达到了NCCLS标准 ,接近或达到国外同类产品要求 ,结果可靠 。
Objective To evaluate the main performance of BS 300 automatic biochemistry analyzer made in a Shenzhen Mindray Co. Methods To evaluate the precision, linearity crossing contamination and contrasting test of BS 300 automatic biochemistry analyzer by 9 items that contain all wavelength (ALT, GGT, Glu, TP, Alb, Cr, Ca, Cl -, ApoB). It was estimated its bias at medicine determined level concentration. Results The daytime run CV , within run CV , between run CV and total CV were under 4%. The diluted variance of linearity P was less than P 0.05 (0.684 1). The linear drift G was less than F 0.05 (3.29). The cross contamination rate was 2.81E 06, and correlated factor r with AU2700 was greater than 0.96. The relative biases at determined medicine level concentration with ALT,GGT,Glu,TP,Alb,Cr,Ca,Cl -(90 mmol/L), Cl -(120 mmol/L),ApoB were -1.8%,-0.1%, -3.9% ,-0.5%,-2.3%,-7.2%,0.4%,3.9%,3.2%,-1.7%. Conclusions The main performance of BS 300 automatic biochemistry analyzer accords with NCCLS, and is comparable to imported instrument. It is appropriate for small or middle sized hospital.
出处
《检验医学》
CAS
北大核心
2004年第4期330-333,共4页
Laboratory Medicine