迈瑞BS-400全自动生化仪临床评估报告  

Clinical evaluation of BS-400 automatic chemistry analyzer

作　　者：冯志刚 李忠信 

机构地区：[1]广东省东莞康华医院,523080

出　　处：《实验与检验医学》2008年第5期493-496,502,共5页Experimental and Laboratory Medicine

摘　　要：目的评估深圳迈瑞生物医疗电子股份有限公司(以下简称迈瑞公司)BS-400全自动生化检测系统(以下简称BS-400)分析性能中的精密度、可报告范围、偏倚等三个指标。方法参照NCCLS(现已更名CLSI)的EP5-A2、EP6-A、EP9-A2文件,结合生化反应类型、检测波长等差异,选取AST、LDH、CK、TP、TG、TC、Urea、P、GLU共9个项目分别进行精密度、可报告范围、偏倚试验,其中偏倚试验是与美国德灵公司的Dimension Xpand全自动生化检测系统(以下简称Xpand)进行比对。结果9个项目的批内精密度均小于2%,总精密度均小于3.5%;AST、LDH、CK、TP、TG、TC、Urea、P、GLU的可报告范围依次为0-423(U/L)、47-961(U/L)、34-1097(U/L)、11-111(g/L)、0.16-9.22(mmol/L)、1.2-14.44(mmol/L)、0.2-33.12(mmol/L)、0.03-4.46(mmol/L)、0.06-21.45(mmol/L);与美国德灵公司的Dimension Xpand全自动生化分析仪的相关系数(r)均>0.99,两仪器测试结果总偏差符合CLIA'88要求。结论所选项目的精密度、可报告范围评价结果达到仪器与配套试剂所宣称的指标要求,符合NCCLS的相关规定。与Dimension Xpand对比测试结果符合CLIA'88要求。BS-400工作速度为每小时400个测试,配套系统完善,适合中小规模医院检验科使用。Objective To evaluate the precision, reportable range and accuracy of BS-400 automatic chemistry analyzer. Methods According to the NCCLS （renamed CLSI）guidelines of EP5-A2, EP6-A and EPg-A2 and the specificity of reaction type and monitoring wavelength, nine analyzing items including AST, LDH, CK, TP, TG, TC, Urea, P, GLU were performed to compare with the precision, reportable range and accuracy of BS-400 with Dimension Xpand. Results The within-run CV of the results for all items was less than 2% and the average CV for all items was less than 3.5%. The reportable ranges of AST, LDH, CK, TP, TG, TC, Urea, P and GLU were 0-423（U/L）, 47-961（U/L）, 34-1097（U/L）, 11-111（g/ L）, 0.16-9.22（mmol/L）, 1.2-14.44（mmol/L）, 0.2-33.12（mmol/L）, 0.03-4.46（mmol/L）and 0.06-21.45 （mmol/L）respectively. Compared to Dimension Xpand, all of the correlation coefficient （r） was greater than 0.99. The deviation of the results from BS400 and Xpand meets the requirements by CLIA＇88. Conclusions The precision and reportable ranges of nine items mentioned above meet the requirements of corresponding reagents kits. The performance of BS-400 chemistry analyzer meets the requirements of NCCLS. The BS-400 has a throughput of 400 tests/hour, and therefore applies to clinical laboratories in middle/small-scale hospitals.

关 键 词：全自动生化分析仪 性能评价 精密度 可报告范围 偏倚 

分 类 号：R446.11[医药卫生—诊断学] O231.1[医药卫生—临床医学]