中文摘要：

目的 研制红细胞比容国家一级标准物质,作为红细胞比容检测结果溯源的标准.方法 新鲜血经稳定化处理、调整浓度后分装成待评价的标准物质;参照ISO Guide 35（2006版）和《一级标准物质技术规范》的要求进行均匀性和稳定性评价,使用直接溯源至参考方法的标准仪器对标准物质进行定值;对标准物质的均匀性、稳定性和定值过程引入的不确定度进行评定,计算合成标准不确定度和扩展不确定度;将一级标准物质与二级标准物质的不确定度进行比较.结果 标准物质的均匀性评价方差分析结果显示P＞0.05,表明标准物质是均匀的;瓶间均匀性的标准不确定度ubb为0.22％.12周内稳定性评价趋势分析结果显示P＞0.05,表明该期限内标准物质是稳定的;长期稳定性的标准不确定度ults为0.27％.定值结果的标准不确定度uchar为0.59％;合成并扩展不确定度后,定值结果的表达式为（38.7±1.4）％.一级标准物质的相对不确定度（3.6％）小于国家二级标准物质（4.8％）.结论 标准物质的均匀性和稳定性良好,定值方法可靠.

英文摘要：

Objective To study and prepare hematocrit primary reference material for traceability.Methods Hematocrit primary reference material was prepared by stabilizing the blood cells,adjusting the concentration,and subpackaging the blood.The candidates were evaluated according to ISO Guide 35 and ＂Technical Norm of Primary Reference Material＂,including homogeneity and stability studies,and characterization by the standard analyzer which is traceable to reference method directly.The uncertainty from homogeneity,stability,and characterization was evaluated.The combined uncertainty and extended uncertainty were calculated.The uncertainty between prepared reference material and the secondary reference material were compared.Results The results of one-way analysis of variance of hematocrit showed that the reference material was homogeneous （P〉0.05）.The bottle to bottle homogeneity uncertainty （ubb） was 0.22%.The reference material was stable in 12 weeks by trend analysis （P〉0.05）.The stability uncertainty （ults） was 0.27%.The characterization uncertainty （uchar） was 0.59%.The assigned value was found to be （38.7± 1.4）% through calculation of the combined uncertainty and extended uncertainty.The uncertainty of the primary reference material（3.6%） is smaller than that of the secondary reference material（4.8%）.Conclusion The candidate reference material had promising homogeneity and stability,and the method of characterization of the candidates was accurate and reliable.