全自动免疫分析仪ARCHITECT i2000检测HBV血清标志物性能评价  

Efficiency evaluation of detecting HBV serum markers by ARCHITECT i2000 Chemoluminescence Analyzer

作　　者：邹麟[1] 张莉萍[1] 夏吉荣[1] 田小浪[1] 李鹏[1] 

机构地区：[1]重庆医科大学附属第一医院检验科,400016

出　　处：《重庆医学》2010年第24期3353-3354,共2页Chongqing medicine

摘　　要：目的评价新检测系统全自动免疫分析仪ARCHITECT i2000的分析性能。方法分别对该系统的HBV血清标志物定量检测项目HBsAg、HBsAb的准确度、精密度、线性范围、携带污染率进行性能评价并验证其参考区间。结果 HBsAg、HBsAb批内精密度、批间精密度CV均小于10%;准确度:比对试验结果R2>0.95;线性范围:均满足厂家要求,R2>0.95;参考区间:均符合厂家要求;交叉污染率小于1%。结论全自动免疫分析仪ARCHITECTi2000分析系统的HBV血清标志物定量检测项目HBsAg、HBsAb准确度、精密度、线性范围、携带污染率均达到要求,能满足临床需要。Objective To estimate the detecting efficiency of ARCHITECT i2000 Chemoluminescence Analyzer with the requirement of ISO15189.Methods The accuracy,precision,linear range and carry over rate of this system were estimated by detecting HBV serum markers including HBsAg and HBsAb,and the reference interval was authenticated.Results both intra-assay and inter-asssy coefficient variation were less than 10%.Antitheses test of two hospitals suggested that R2 was above 0.95.Similarily,the linear range met the manufactures′ requirements with R2 above 0.95.The reference interval was in accord with the manufactures′ requirements and cross-contamination rate was less than 1%.Conclusion It is indicated that the accuracy,precision,linear range and carry over rate of ARCHITECT i2000 Chemoluminescence Analyzer are satisfied with the clinical demand for detecting HBsAg and HBsAb

关 键 词：ARCHITECT i2000 定量 HBSAG HBSAB 性能评价 

分 类 号：R446.6[医药卫生—诊断学] R512.61[医药卫生—临床医学]