Performance properties of filter paper devices for whole blood collection

Abstract

Background: 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. Results: We observed overlap at one standard deviation for each analyte, with no more than 4–5% difference between the papers. Conclusion: The data demonstrated similarities of analyte recovery between the papers, indicating comparability of the devices for newborn screening and other applications.