摘要目的 研制氰化高铁血红蛋白(HiCN)国家一级标准物质,用作血红蛋白测定结果溯源的标准.方法 参照国际血液学标准化委员会(ICSH)的要求,制备HiCN标准物质;按照ISOGuide 35的要求,评价标准物质的均匀性和稳定性,在二者合乎要求的基础上,由多个实验室使用溯源至美国国家标准技术研究所(NIST)标准滤光片的分光光度计为HiCN标准物质定值;为验证定值结果的可靠性,使用定值仪器测定国际标准物质,将测定结果与WHO参考实验室的定值进行比较,此外,对所研制标准物质和国际标准物质的扫描图形进行了比较.结果 HiCN标准物质均匀性的不确定度为0.000 4 g/L,变异系数(CU)为0.09%;长期稳定性的不确定度为0.000 6 g/L;HiCN标准物质的定值为0.6159 g/L,不确定度为0.000 4 g/L;当扩展因子取2时,标准物质的扩展不确定度为0.001 8 g/L;定值仪器对国际标准物质的测定结果与国际标准物质定值的相对偏差为0.08%.结论 HiCN标准物质均匀性和稳定性良好,定值方法准确、可靠.

abstractsObjective To establish the national standard materials for haemiglobincyanide (HiCN) for the traceability assays of hemoglobin. Methods HiCN national standard materials were established according to the document of International Committee for Standardization in Haematology (ICSH). The standard materials were certificated according to ISO Guide 35, including homogeneity and stability. Then they were characterized by the calibrated spectrophotometer which can be traceable to National Institute of Standards and Technology (NIST). The international reference materials of HiCN were compared with the result of the WHO reference laboratory to confirm the reliability. Results The uncertainty of the HiCN standard materials was 0.000 4 g/L and the variation coefficient (CV) was 0.09%. The uncertainty of long-term stability was 0.000 6 g/L; the certificated value of the standard materials was 0.615 9 g/L with uncertainty of 0.000 4 g/L. The combined uncertainty was 0.000 9 g/L and the expanded uncertainty was 0.001 8 g/L when the cover factor was 2. The relative error was 0.08% between the result of the standard materials and the international certificated value. Conclusion The homogeneity and stability of the standard material is acceptable and the method of characterization is accurate and reliable.