冰冻人血清α-淀粉酶催化活性浓度候选二级标准物质的研制

Production of candidate secondary reference material for catalytic activity concentration of alpha-amylase in frozen human serum

目的研制冰冻人血清α-淀粉酶催化活性浓度候选二级标准物质,作为量值传递的标准。方法参照JJF 1343—2012《标准物质定值的通用原则及统计学原理》和JJF 1644—2017《临床酶学标准物质的研制》要求进行均匀性、稳定性、互换性评价;联合6家通过中国合格评定国家认可委员会(CNAS)认可的校准实验室对标准物质进行定值,评定其均匀性、稳定性和定值引入的不确定度,计算扩展不确定度。结果标准物质均匀性和稳定性均良好,互通性评价结果显示,4个常规检测系统的测量值均位于95%可信区间内。定值结果:水平1为(106.3±4.3)U/L(k=2),水平2为(268.1±7.9)U/L(k=2)。结论研制的冰冻人血清α-淀粉酶催化活性浓度候选二级标准物质标示值可靠,均匀性、稳定性较好,具有互换性。

Objective To develop a candidate secondary reference material for the catalytic activity of alphaamylase in frozen human serum as a standard for value transmission.Methods According to JJF 1343-2012 General and Statistical Principles for Characterization of Reference Materials and JJF 1644-2017 Production of Reference Materials for Clinical Enzymology,the homogeneity,stability and commutability were evaluated.The value of the reference material was determined by 6 China National Accreditation Service(CNAS)accredited reference laboratories.The uncertainties of the certified values were calculated.Results The results of homogeneity and stability were both good.The measured values were in the 95%confidence interval in the 4 conventional detection systems for commutability.The values were(106.3±4.3)U/L(k=2)on level 1 and(268.1±7.9)U/L(k=2)on level 2.Conclusions The candidate secondary reference material of alpha-amylase has promising homogeneity,stability and commutability,and its labeled values are reliable.