Neonatal screening programs for cystic fibrosis (CF) usually consist of an immunoreactive trypsinogen assay. The objective of this study was to validate the AutoDELFIA® Neonatal immunoreactive trypsinogen kit. We carried out a comparative study between two equipments. The following results were yielded: random error = 26.6%systematic error = 4.95% and analytical error = 31.5%. Several factors contributed to the assay variations in dried blood spot, namely chromatographic, hematocrit and total blood volume effects. These factors should be taken into account in the assessment of validation results. The studied kit can be deployed in neonatal screening routine.
neonatal screening; cystic fibrosis; validation studies; trypsinogen
