Comparison of different IRT-PAP protocols to screen newborns for cystic fibrosis in three central European populations
Abstrakt
Background: In recent years different IRT/PAP protocols have been evaluated, but the individual performance remains unclear. To optimize the IRT/PAP strategy we compared protocols from three regional CF newborn screening centers (Heidelberg, Dresden, and Prague).
Methods: We evaluated the effect of elevating the IRT-cut-off from 50 to 65 mu g/l (similar to 97.5th to similar to 99.0th percentile), the need of a failsafe protocol (FS, lRT }= 99.9th percentile) and the relative performance using either two lRT-dependent PAP-cut-offs or one PAP-cut-off. Findings: Elevation of the IRT cut-off to 65 mu g/l (similar to 99.0th percentile) increased the PPV significantly (Dresden: 0.065 vs. 0.080, p <0.0001, Prague: 0.052 vs. 0.074, p <0.0001) without reducing sensitivity.
All three IRT/PAP protocols showed a trend towards a higher sensitivity with FS than without and when using one PAP-cut-off instead of two IRT-dependent PAP-cut-offs. Conclusions: For best performance we suggest an IRT/PAP protocol with an lRT-cut-off close to the 99.0th percentile, FS, and a single PAP-cut-off. (C) 2013 European Cystic Fibrosis Society.
Published by Elsevier B.V. All rights reserved.