血中原卟啉一级标准物质的研制及其应用

Blood reference material for erythrocyte protoporphyrin (EP)

血中原卟啉（EP）是一项评价铅接触人群健康危险度的生物监测指标，也是筛查缺铁性贫血的敏感和特异性指标。为了保证EP测定的准确度，控制分析误差，在分析中应用血EP的标准物质进行质量控制是很有必要的。根据国家计量局颁布的国家一级标准物质技术规范要求，进行了EP冻干血标准物质的研制工作。收集新鲜牛血，加入EP标准，混匀后分装，冷冻干燥，密封后辐射灭菌，低温避光保存。对样品的均匀性及稳定性进行了检验，结果符合国家一级标准物质的规定。并按照国家一级标准物质的要求，组织了9个实验室，使用灵敏、准确的方法进行定值，取得了准确的特性量值。该标准物质经过国内有关实验室试用，通过专家审查鉴定，已被国家技术监督局批准为国家一级标准物质，样品编号为GBW09136、GBW09137。

Erythrocyte protoporphyrin (EP) in human blood is a sensitive biological index used to evaluate lead exposure and anemia resulting from the shortage of Fe in blood.In order to get accurate and reliable results of Ep in blood.It is necessary to develope an apply EP reference material whose matrix is the same as that of blood sample during determination.A protocol is described for the preparation and characterization of a reference material containing low and high concentration of EP from bovine blood spiked with standard solu tion of EP.The spiked bovine blood was homogenized,distributed to vials of 3.0 ml with 1.0 ml spiked bovine blood,and then lyophilized.The intervial and intravial homogeneity,storage stability and values of low and high concentrations of EP referecne material were ascertained by determining the spiked bovine in randomly selected vials by nine laboratories using the national standard method which had been evaluated and validated for detection limit,precision and accuracy.The results showed that the characters of the EP reference material such as homogeneity,storage stability,and level of certification were satisfied with the re quiremeut of national primary reference material.