胶乳免疫比浊法测定血清铁蛋白的方法学评价

摘要

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 than 5.0%, and the precision was good. FER concentration was in the range of 25~500 ng/mL, and the detection linear was good. Comparative experiments showed that the relationship of FER results determined by two manufacturers' kits were good (r2=0.9907, 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 is a convenient, rapid, cheap, accurate and reliable method for quantitating human serum FER, which can be used directly on the automatic biochemical analyzer and be suitable for clinical routine analysis.%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=0.9907,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.