Mei Joanne V, Zobel Sherri D, Hall Elizabeth M, De Jesús Víctor R, Adam Barbara W, Hannon W Harry
Centers for Disease Control and Prevention, 4770 Buford Highway NE, Chamblee, GA 30341, USA.
Bioanalysis. 2010 Aug;2(8):1397-403. doi: 10.4155/bio.10.73.
The Newborn Screening Quality Assurance Program at the Centers for Disease Control and Prevention assesses the adherence to established performance standards of manufactured lots of whole blood filter paper collection devices that are registered by the US FDA. We examined 26 newborn screening analytes measured from blood applied to filter papers from two FDA-cleared sources, Whatman(®) Grade 903 and Ahlstrom Grade 226. The dried blood spots contained analytes at both single levels and dose-response series.
We observed overlap at one standard deviation for each analyte, with no more than 4-5% difference between the papers.
The data demonstrated similarities of analyte recovery between the papers, indicating comparability of the devices for newborn screening and other applications.
美国疾病控制与预防中心的新生儿筛查质量保证项目评估了美国食品药品监督管理局注册的全血滤纸采集装置生产批次对既定性能标准的遵守情况。我们检测了从两种经美国食品药品监督管理局批准的滤纸来源（沃特曼（®）903级和奥斯龙226级）上采集的血液中26种新生儿筛查分析物。干血斑中含有单水平和剂量反应系列的分析物。
我们观察到每种分析物在一个标准差处有重叠，两种滤纸之间的差异不超过4 - 5%。
数据表明两种滤纸在分析物回收率方面具有相似性，这表明这些装置在新生儿筛查和其他应用方面具有可比性。
