多系统量值传递制备人血清甲胎蛋白标准物质

The preparation of human serum based reference materials for alpha-fetoprotein assay through quantity value transmission from multiple analysis systems

目的：通过多系统量值传递制备3个水平冰冻混合人血清AFP标准物质。方法方法学建立。按照国家标准物质制备要求，对研制的人血清AFP标准物质进行均匀性、稳定性检验；并对研制的人血清AFP标准物质和不同稀释度的WHO标准物质72／225，进行互通性评估。采用4个化学发光免疫分析系统同批测定人血清AFP标准物质与WHO标准物质72／225，将结果进行比较，对人血清AFP标准物质准确赋值，并进行全面不确定度评定。结果人血清AFP标准物质经检验均匀性良好；－80℃保存14个月稳定性良好。不同稀释度的WHO AFP标物72／225及人血清AFP标准物质在4种检测系统间互通性良好。通过多系统量值传递及总不确定度评定，人血清AFP标准物质定值（单位：IU／ml）为：23．0±3．0，93．2±7．2，（26．1±2．4）×10^2。结论3个水平冰冻混合人血清AFP标准物质均匀性和稳定性均符合标准物质制备要求，在4个检测系统间互通性良好，定值可靠，已获批为人血清AFP国家二级标准物质。可望用于临床实验室常规检测方法的校准／校准验证、室间质量评价计划。

Objective To prepare the frozen human serum pools for AFP reference materials through quantity value transmission from several analysis systems . Methods Method establishment. According to the requirement of preparation for the national standard materials , the studies of homogeneity and stability of frozen human serum pools for AFP reference materials were carried out .The commutability of prepared AFP reference materials and WHO AFP 72/225 reference material were assessed .By use of four automated chemiluminescence analysis systems , the prepared reference materials and different dilutions of WHO reference material 72/225 were tested in the same run.The values of prepared AFP reference materials were assigned by comparing these results and the uncertainty was evaluated .Results The three levels of AFP reference materials were tested to be homogeneous .The long term stability had been observed at -80℃for 14 months.The different dilutions of WHO AFP 72/225 reference material and three levels of prepared reference materials were commutable with patient serum samples among the four analysis systems .Through multiple system quantity value transmission and total uncertainty evaluation , the assigned values （ IU/ml） of three levels of AFP reference materials were 23.0 ±3.0, 93.2 ±7.2, （ 26.1 ±2.4 ） ×102 respectively.Conclusions The three levels of AFP reference materials were homogeneous and stable in accordance with requirement of preparation for national standard materials .The assigned values were reliable.The materials showed accepted commutability across 4 analytical systems.These materials had been approved as the national certified reference materials .These reference materials could be applied for the calibration or calibration verification of clinical analytical systems and the external quality assessment schemes for clinical laboratories.