安图A2000化学发光分析仪检测RAAS的性能验证.docVIP

安图A2000化学发光分析仪检测RAAS的性能验证 裴林 贾玫 北京大学人民医院检验科 X 关注成功！ 加关注后您将方便地在 我的关注中得到本文献的被引频次变化的通知！ 新浪微博 腾讯微博 人人网 开心网 豆瓣网 网易微博 摘????要： 目的:对安图A2000化学发光分析仪检测RAAS (肾素、血管紧张素Ⅱ和醛固酮) 的性能进行验证, 评估其能否应用于临床检验。方法:参照美国临床和实验室标准化协会 (Clinical and Laboratory Standards Institute, CLSI) EP15-A2、EP6-A2、EP7-A2和C28-A2文件对RAAS的精密度、定量检出限、分析测量范围、干扰实验和生物参考区间进行验证。结果:所有3个项目批内精密度范围为1.8%4.2%, 室内精密度范围为2.4%5.4%, 均符合给定要求及厂家声明;RAAS的检出限分别为2.7、10.0、9.5 pg/ml, 可报告范围能够满足临床需要, 无需进行样本稀释;黄疸标本对血管紧张素Ⅱ和醛固酮有明显的正向干扰, 使结果假性升高, 乳糜标本对血管紧张素Ⅱ有明显的正向干扰, 使结果假性升高, 故应避免使用黄疸和乳糜的标本;参考区间 (立位) 验证通过, 可使用厂商声明的参考区间。结论:采用安图A2000化学发光分析仪检测RAAS符合质量要求, 能够较好地满足临床需求。 关键词： 化学发光分析仪; 性能验证; 肾素; 血管紧张素Ⅱ; 醛固酮; 作者简介：裴林 (1979—) , 男, 硕士, 主治医师, 主要从事动脉粥样硬化及个体化用药方面的研究工作, E-mail:peilin@。 作者简介：贾玫, E-mail:jiamei0718@ 收稿日期：2016-12-08 Performance verification of RAAS by Auto Lumo A2000 chemiluminescence detector PEI Lin JIA Mei Department of Clinical Laboratory, Peking University People′s Hospital; Abstract： Objective To verify the performance of Auto Lumo A2000 chemiluminescence detector in the detection of renin, angiotensin and aldosterone.Methods A set of laboratory verification scheme was proposed with chemiluminescence detector with references to EP15-A2, EP6-A2, EP7-A2 and C28-A2 from Clinical and Laboratory Standards Institute (CLSI) , which detected the precision, limit of quantitation, analytical measurement range, interference testing and reference intervals.Results The coefficients of variation (CV) for repeatability precision were between 1.8% and 4.2%, and those for intermediate precision were between 2.4% and 5.4%.The limit of quantitations of renin, angiotensin and aldosterone were 2.7 pg/ml, 10.0 pg/ml, and 9.5 pg/ml, respectively.Analytical measurement ranges were accordance with the manufacturer.The results were interfered by hemolytic, jaundice or cheliform samples.The reference intervals of erect position were verified.Conclusion Auto Lumo A2000 chemiluminescence detector behaves well in the precision, limit of quantitation, analyt