冰冻人血浆醛固酮标准物质的研制

The Preparation of Aldosterone Reference Material in Frozen Human Plasma

目的研制冰冻人血浆醛固酮国家二级标准物质,用于血浆醛固酮的量值溯源、室内质量控制、实验室能力验证、相关试剂和方法的评估及验证等,促进血浆醛固酮检测标准化进程,实现结果互认。方法收集无肉眼可见溶血、乳糜和黄疸的混合血浆材料,经过浓度配比、过滤、分装后,-70℃保存。参照JJG 1006-1994和JJF 1343-2012文件要求用常规测量方法评价标准物质的均匀性和稳定性。6家通过JCTLM认可和/或CNAS认可的实验室采用醛固酮ID-LC/MS/MS候选参考测量方法联合定值。分析不确定度来源并进行不确定度评定,定值结果用“认定值±不确定度”表示。参照美国国家临床实验室标准委员会EP14-A3文件要求评价互通性。结果研制了2个浓度水平标准物质,均匀性良好(P>0.05),瓶间变异均<4%。-70℃以下条件可稳定半年;冰袋运输可稳定5d;复融后室温条件下可稳定4 h,2~8℃条件下可稳定168h。2个浓度水平标准物质的定值结果分别为56.9±4.3和147±12pg/mL,k=2。标准物质在ID-LC/MS/MS法和2个常规方法间与临床血浆样本具有良好的互通性。结论研制的2个浓度水平冰冻人血浆醛固酮标准物质均匀性、稳定性、互通性良好,定值准确,已获得国家批准文号GBW(E)091171和GBW(E)091172。

Objective To develop the national secondary reference material of frozen human plasma aldosterone(ALD),which can be used for the traceability of plasma aldosterone,indoor quality control,laboratory proficiency testing,evaluation and validation of related reagents and methods,so as to promote the standardization process of plasma ALD measurement and harmonization of results.Methods The human plasma materials without visible hemolysis,chyle and jaundice were collected,mixed,concentration matched,filtrated,allotted and then stored at-70℃.According to the requirements of JJG 1006-1994 and JJF 1343-2012,the homogeneity and stability of ALD reference material were evaluated by routine methods.Samples were measured together by six laboratories passing JCTLM and/or CNAS accreditation using ALD ID-LC/MS/MS method.The potential sources of uncertainty were analyzed and the uncertainty was evaluated.Finally,the results of ALD reference material were expressed as"certified value±Uncertainty".The commutability was evaluated according to the requirements of EP14-A3 by National Committee for Clinical Laboratory Standards.Results The homogeneity of the reference materials of two concentration levels were good(P>0.05),and the variation between bottles was less than 4%.It was maintained as stable status for half a year under-70℃,for 5 days under the condition of ice bag transportation,for 4 hours at room temperature and 168 hours at 2-8℃after thawing.The certified values of reference materials were(56.9±4.3)and(147±12)pg/mL。There was a good commutability with clinical samples between ID-LC/MS/MS method and two routine methods.Conclusion The developed reference material of ALD in frozen human plasma are homogenous,stable,commutable and welled assigned.These material have obtained the national approval number GBW(E)091171 and GBW(E)091172.