5水平冰冻混合人血清葡萄糖候选标准物质的制备研究

目的研制5水平冰冻混合人血清葡萄糖标准物质,为葡萄糖常规方法的准确度验证,提供稳定和互通性良好的真实值控制品。方法收集足量正常体检人群无肉眼溶血、脂血和黄疸的血清标本,依次采用Sartorius公司的0.8、0.45、0.2μm过滤微膜过滤除菌后分装于冻存管中。按《标准物质/标准样品生产者能力认可准则》1]的要求,对冰冻混合人血清进行均匀性研究,短期稳定性(室温、4℃、-20℃)和长期稳定性(-80℃)研究,定值结果用"靶值±不确定度"表示,2家候选葡萄糖参考实验室测定结果均值作为靶值,不确定度包括测定变异和测定系统偏差、瓶间差及稳定性所带来的不确定度。并对冰冻混合人血清在6种进口配套检测系统中的互通性进行观察。结果共制备5水平冰冻混合人血清(C1、C2、C3、C4、C5)。C4水平血清瓶间标准偏差为0.018 mmol/L,其余4水平瓶间偏差为零,经单因素方差分析后P值全部大于0.05。稳定性研究经线性回归方差分析P值全部大于0.05。2家候选葡萄糖参考实验室测定结果的均值为3.08、5.92、13.60、9.311、8.71 mmol/L,不确定度相应为0.09、0.17、0.36、0.230、.55 mmol/L。5水平冰冻混合人血清的坐标点全部位于40份人血清标本的直线回归95%可信区间范围内,该5水平冰冻混合人血清与血清的反应性相同。结论 5水平冰冻混合人血清均匀性、稳定性、互通性良好,定值准确。

The study of 5 levels serum glucose standard reference materials

Objective To prepare 5 levels serum glucose standard reference materials,in order to provide material to evaluate glucose routine analyzed systems.Methods Fresh sera without hemolysis,lipemia and choloplania were collected.Serum pools were filtered with 0.8,0.45 and 0.2 μm filtration membrane of Sartorius company and were sub-packed in frozen tubes.According to《Accreditation Criteria for the Competence of Reference Material Producers》,the uniformity of the pools were examined,Stability study includes short-term（room temperture、4℃、-20℃）and long-term（-80℃） stability.Results were expressed as ＂target value ± uncertainty＂,mean value of 2 glucose reference laboratories was used as target value,the uncertainty includes determination of vatiation and uncertainty brought by measurement system bias,Sbb,long-term stability.We observed commutability of serum on 6 routine analyzed systems.Results The 5 levels serum have been obtained（C1,C2,C3,C4 and C5）.Sbb of level C4 is 0.018 mmol/L and others are zero,P value of all levels are greater than 0.05.P value of linear regression analysis of variance are greater than 0.05.Mean value of 2 glucose reference laboratories are 3.08,5.92,13.60,9.31 and 18.71 mmol/L.Uncertainty are 0.09,0.17,0.36,0.23 and 0.55 mmol/L respectively.Coordinate dots of 5 levels serum are all within 95% confidence interval range of 40 serums regression line.They have the same speciality as serum.Conclusion The uniformity,stability and commutability of 5 levels serum all meet the requirements,the target values are assigned accurately.