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
陆茜莹 1王玲萍 1王培娟 2樊静静 2陈武炼 2刘琴1
作者信息
- 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
- 折叠
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9d;-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.
Abstract
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 ℃,and the stability of quality control materials remained good for 6 months at-20 ℃.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Key words
Neonatal screening/Dried blood spot quality control material/Tandem mass spectrometry/Uniformity/Stability引用本文复制引用
出版年
2024
NETL
NSTL
万方数据