标题：胶乳免疫比浊法测定血清铁蛋白的方法学评价

      作者：赵锐，戴雯，徐万州，梅四清，崔艳，姜树朋，李艳    (武汉大学人民医院检验医学中心，湖北 武汉 430060)

      卷次： 2017年28卷5期

      【摘要】 目的 对胶乳免疫比浊法定量测定血清铁蛋白(FER)进行方法学评价。方法 参照美国临床实验室标准化协会(CLSI)推荐的评价方法，对胶乳免疫比浊法测定血清FER的精密度、回收实验、线性范围等进行评价。结果 胶乳免疫比浊法测定血清FER的批内、日间变异系数(CV)均<5.0%，精密度良好；FER浓度在25~500 ng/mL范围内，检测线性良好；比对实验：两种厂家的试剂盒测定FER结果相关性良好(r2=0.990 7，n=40)，检测结果基本一致(P>0.05)；回收率为96.20%~102.43%；40例健康体检者样本的检测值均在待验证区间之内。结论 胶乳免疫比浊法用于定量检测人血清FER水平，测定结果准确可靠，操作简便、快速，能直接在全自动生化分析仪上使用，适用于临床样本检测。
      【关键词】 胶乳免疫比浊；铁蛋白；方法学评价
      【中图分类号】 R446.11 【文献标识码】 A 【文章编号】 1003—6350（2017）05—0763—03

Methodological evaluation of latex immunoturbidimetric assay for the detection of serum ferritin.
ZHAO Rui, DAIWen, XU Wan-zhou, MEI Si-qing, CUI Yan, JIANG Shu-peng, LI Yan. Department of Clinical Laboratory, Renmin Hospitalof Wuhan University, Wuhan 430060, Hubei, CHINA
【Abstract】 Objective To evaluate the determination of serum ferritin (FER) by latex immunoturbidimetric as-say (LIA). Methods The precision, recovery experiment and linear range of serum FER determined by LIA were as-sessed through the evaluation method recommended by American Clinical and Laboratory Standards Institute (CLSI).Results The intra-group and inter-day coefficient of variation (CV) of serum FER determined by LIA were less than5.0%, and the precision was good. FER concentration was in the range of 25~500 ng/mL, and the detection linear wasgood. Comparative experiments showed that the relationship of FER results determined by two manufacturers' kits weregood (r2=0.990 7, n=40), and the results remained in accordance (P>0.05). The recoveries were 96.20%-102.43%. The de-tection values of 40 healthy physical examination volunteers were in the range of validation interval. Conclusion LIA isa convenient, rapid, cheap, accurate and reliable method for quantitating human serum FER, which can be used directlyon the automatic biochemical analyzer and be suitable for clinical routine analysis.
      【Key words】 Latex immunoturbidimetric assay (LIA); Ferritin (FER); Methodological evaluation·论 著·doi:10.3969/j.issn.1003-6350.2017.05.026基金项目：国家863计划课题（编号：2014AA022304）