血清铁测量参考方法的建立及方法学评价  

Development and Validation of Reference Methods for Determination of Serum iron

作　　者：黄妍[1] 马怀安[2] 徐静[1] 张建平[1] 王清涛[1] 

机构地区：[1]首都医科大学附属北京朝阳医院检验科,北京100020 [2]首都医科大学燕京医学院

出　　处：《中国实验诊断学》2011年第3期453-457,共5页Chinese Journal of Laboratory Diagnosis

基　　金："十一五"国家科技支撑计划资金资助(2007BAI05B09);国家高技术研究发展计划(863计划)资金资助(2006AA020909)

摘　　要：目的建立血清铁测定亚铁嗪分光光度比色法的参考方法,对此方法进行性能验证,评价其是否可以作为参考方法用于临床实验室。方法按照美国临床和实验室标准协会(CLSI)的推荐方法,建立参考方法,通过测定标准参考物质(SRM)以及回收实验,来验证参考方法的准确性。测定3个不同浓度的混合血清样本,观察该方法的精密度。结果用亚铁嗪分光光度比色法测定SRM3126a,偏倚为0.04%-0.74%,回收率为101.33%-101.47%。3个不同浓度的混合血清样本批内变异系数(CV)为0.20%-0.28%,批间CV为0.26%-0.70%,总CV为0.33%-0.75%。基质中已知的其它成分对血清铁的测定结果无干扰。结论亚铁嗪分光光度比色法测定血清铁精密度高、准确度好,建议其作为测定血清铁的候选参考方法。Objective To establish the spectrophotometric reference method with ferrozine and to validate the method for an reference method.Methods The CLSI spectrophotometric reference method with ferrozine was established and the preformance was validated through testing a standard reference material（SRM） and the recovery.For three levels pool serum were analyzed to evaluate the precision.Results When SRM3126a was determined,the bias is 0.04%-0.74%,the recovery is 101.33%-101.47%.The method showed within-run,between-run and total CVs of 0.20%-0.28%,0.26%-0.70%,0.33%-0.75%.,respectively.No significant interferences were detected.Conclusion The spectrophotometric reference method for the serum iron has been established.The method is simple and accurate and my be used as a candidate reference method for the serum iron.

关 键 词：血清铁 分光光度法 亚铁嗪 

分 类 号：R446.1[医药卫生—诊断学]