两种血清铁生化诊断试剂的临床比对分析  

Comparison analysis on two kinds of serum iron biochemical diagnostic reagent

作　　者：王惠萱[1] 滕毅[1] 秦忠燕[1] 王珂[1] 陈峻功[1] 毕再华[1] 

机构地区：[1]中国人民解放军成都军区昆明总医院检验科,云南昆明650032

出　　处：《国际检验医学杂志》2012年第20期2455-2457,共3页International Journal of Laboratory Medicine

基　　金：国家高技术研究发展计划"863计划"资助项目(2011AA02A111)

摘　　要：目的进行自主研发的国产铁(Fe)生化诊断试剂与进口优质Fe诊断试剂对Fe实验诊断检测的可比性及偏倚评估,确认研发试剂是否符合临床要求。方法按照美国CLSI EP9-A文件,每天选择高、中、低值临床血清标本10份,分别用北京九强生物科技公司试剂和ROCHE试剂在日本OLYMPUS AU5421自动生化分析仪上测定Fe,以进口ROCHE试剂为对照组,北京九强生物科技公司生化试剂为实验组。每份标本正序、倒序各测定1次,连测10d每天10份,共计100份标本。记录测定结果,做统计学分析。结果进口ROCHE和国产中生两种Fe检验试剂对临床标本Fe的检测结果显示,方法内重复性检查DX′i≤4DX′、DY′i≤4DY′,离群点检查Eij≤4E、Eij′≤4E′,线性回归r=0.999、系统误差的估计值及其置信区间│BClow,BChigh│小于允许误差,系统误差符合临床要求。结论自主研发的Fe生化诊断试剂与公认的优质进口ROCHE诊断试剂两者间具有良好的可比性和相关性。自主研发Fe生化诊断试剂符合临床应用要求,用于检测血清铁,其结果准确可靠。Objective To ewduate the comparability and the bias of serum Fe results determined by domestic Fe（Iron）diagnostic reagent and imported diagnostic reagent. Methods According to the CLSI EP9-A document,eight serum samples with high-,mid- dle and low Fe values were selected and the Fe concentrations determination were carried out by OI.YMPUS AU5421 automatic bi- ochemical analyzer with Beijing Jiuqiang Fe Reagent and ROCHE Fe Reagent respectively. The control group is ROCHE reagent, the experimental group is Beijing Jiuqiang reagent. The working group recommends that 40 patient samples were analyzed 5 operat- ing days. The results were recorded and statistical analysis was performed. Results Two types of Fe diagnostic reagent,ROCHE and Jiuqiang on delection of clinical specimens Fe showed that, methods with in the repetitive inspection DX＇i≤4DX＇, Dy＇i≤ 44 DY＇.Outlier chePs Eij ≤4E, Eij＇≤ 4 E＇, linear regression r = 0. 999, systematic errors estimates and confidence interval 丨Bclow, Bchigh丨 〈permissible error,systematic errors in line with the clinical requirements. Conclusion Determination of the results of Fe determined by Domestic BIOSIN0 BIO Technology Co. Fe Diagnostic Reagent and ROCHE Corporation Fe Diagnostic Reagent, there was a good comparability and positive correlation between the results resulted from two kinds of reagents.

关 键 词：铁 试剂盒 诊断 比对 

分 类 号：R446.1[医药卫生—诊断学]