睾酮冰冻人血清国家标准品的研制

Development of the national standard materials of testosterone in frozen human serum

目的研制睾酮冰冻人血清国家标准品,用于血清睾酮检测的正确度评价和标准化。方法收集含不同浓度睾酮的无脂血、黄疸和溶血的血清,经多重过滤及除菌后分装,制备成2个水平的候选品,-70℃保存。采用单因素方差分析评估候选品的均匀性。采用线性回归分析评估候选品的稳定性。采用参考方法定值,并分析不确定度。评估候选品的互通性。结果均匀性评估中,候选品Ⅰ、Ⅱ的F值分别为1.4485和1.5696,均<F0.05;候选品Ⅰ、Ⅱ在-20℃条件下,至少可稳定30 d。候选品Ⅰ、Ⅱ定值结果分别为(0.22±0.05)ng/mL(k=2)、(3.67±0.16)ng/mL(k=2)。候选品Ⅰ、Ⅱ测定值均在新鲜血清样本测定值所建立的拟合回归直线95%可信区间内,互通性良好。结论制备的候选品均匀、稳定,且互通性良好,定值准确,可作为国家标准品使用。

Objective To establish the national standard materials of testosterone in frozen human serum,to evaluate the accuracy,and to promote the standardization of testosterone assay.Methods Serum samples without lipemia,hemolysis and jaundice were collected.After multiple filtration sterilization,serum pools were packed into ampoules in 2-level candidate materials and were stored in-70℃.The homogeneity for candidate material was evaluated by single factor analysis of variance,and the stability was evaluated by linear regression analysis.The values of candidate material were assigned by reference method,and the uncertainty was calculated.The commutability was evaluated.Results The F values of homogeneity for candidate material levelⅠand levelⅡwere 1.4485 and 1.5696,respectively.All of them were<F0.05.The stabilities of levelⅠand levelⅡcan be last at least 30 d at-20℃.The assigned values of levelⅠand levelⅡwere(0.22±0.05)ng/mL(k=2)and(3.67±0.16)ng/mL(k=2),respectively.The values were all within 95%confidence interval,which showed that the commutability was good.Conclusions The homogeneity,stability and commutability of candidate material are good,and their values are assigned accurately and reliably.They can be used as national standard.