含35种诊断标志物的新生儿筛查干血片质控物的研制  

Development of dried blood spot quality control materials containing 35 diagnostic markers for neonatal screening

作　　者：陆茜莹 王玲萍 王培娟 樊静静 陈武炼 刘琴 LU Qian-ying;WANG Ling-ping;WANG Pei-juan;FAN Jing-jing;CHEN Wu-lian;LIU Qin(Caohu People′s Hospital of Xiangcheng District,Suzhou Jiangsu 215000,China;不详)

机构地区：[1]苏州市相城区漕湖人民医院,江苏苏州215000 [2]上海安谱实验科技股份有限公司

出　　处：《江苏预防医学》2024年第2期230-233,共4页Jiangsu Journal of Preventive Medicine

基　　金：上海市分析实验基础耗材及标准品专业技术服务平台项目(21DZ2292900);上海市松江区“卡脖子”工程项目。

摘　　要：目的研制基于我国人群血液基质的含35种诊断标志物的新生儿筛查干血片质控物。方法通过外源添加方式,将包含13种氨基酸、19种肉碱及琥珀酰丙酮、乳清酸、溶血膦酯酰胆碱-26等35种诊断标志物添加到中国人群血液基质中,混合后再滴定滤纸上风干,得到高、低浓度新生儿筛查干血片质控物。采用非衍生化流动注射串联质谱法对干血片质控物进行均匀性、稳定性测试。结果干血片质控物均匀性良好,35个诊断标志物的检测浓度值在靶值3个标准偏差(±3SD)范围内,相对标准偏差(RSD)在1.01%~16.67%;45℃存储条件下,该质控物可保存至少9 d;-20℃存储条件下,6个月稳定性良好。结论研制的干血片质控物,可用于新生儿筛查实验室的室内质控。Objective To develop dried blood spot quality control materials containing 35 diagnostic markers based on Chinese populations′blood matrix.Methods Chinese populations′blood matrix was transferred with exogenous addition of 13 amino acids,19 carnitine,succinylacetone,orotic acid and lysophosphatidylcholine 26,mixed evenly,transferred to filter papers and air-dried to yield high-and low-concentration dried blood spot quality control materials for neonatal screening.The uniformity and stability of dried blood spot quality control materials were determined using non-derivatized flow injection analysis-tandem mass spectrometry.Results The dried blood spot quality control materials had high uniformity.The concentrations of 35 diagnostic markers were within the target±3 standard deviations(SD),with a relative standard deviation of 1.01%to 16.67%.The quality control materials were stored for at least 9 days at 45°C,and the stability of quality control materials remained good for 6 months at-20°C.Conclusions The developed dried blood spot quality control materials may be used for intra-laboratory quality control in neonatal screening laboratories.

关 键 词：新生儿筛查 干血片质控物 串联质谱 均匀性 稳定性 

分 类 号：R392[医药卫生—免疫学]