深圳迈瑞BS-300全自动生化分析仪性能评价

Performance evaluation of BS-300 automatic biochemistry analyzer

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.