Combining Immunoreactive Trypsinogen and Pancreatitis-Associated Protein Assays, a Method of Newborn Screening for Cystic Fibrosis that Avoids DNA Analysis - 21/08/11
, Patrice Berthézène, MSc, Christian Le Louarn, BSc, Claude Somma, MD, Jean-Marc Perini, MD, Michael Catheline, MD, Sophie Mirallié, MD, Karine Luzet, BSc, Michael Roussey, MD, Jean-Pierre Farriaux, MD, Jacques Berthelot, MD, Jean-Charles Dagorn, PhD
Reprint requests: Jacques Sarles, Service de Pédiatrie Multidisciplinaire, Hôpital d'Enfants de la Timone, F-13385 Marseille Cedex 05, France.See related articles, p 295, p 306, p 312, p 316, p 321, p 327, p 382, and p 402.
Abstract |
Objectives |
To evaluate the performance of a strategy in which, after immunoreactive trypsinogen (IRT) determination, genetic analysis is replaced by a biological test, the pancreatitis-associated protein (PAP) enzyme-linked immunosorbent assay (ELISA).
Study design |
The French newborn screening program includes cystic fibrosis (CF) screening by the IRT/CFTR mutation strategy. PAP was assayed on screening cards, in parallel with IRT, in all newborns from 5 French regions (n=204,749). Analysis of PAP values in CF and non-CF newborns with elevated IRT allowed direct comparison between the current strategy and the proposed IRT/PAP strategy.
Results |
A protocol in which newborns with IRT >50 ng/mL and PAP >1.8 ng/mL and those with IRT >100 ng/mL and PAP >1.0 ng/mL are directly recalled for sweat testing would have the same performance as the IRT/CFTR mutation strategy.
Conclusions |
The IRT/PAP strategy is an alternative for CF newborn screening, which avoids the drawbacks of genetic analysis and is cheaper and easier to implement than the current IRT/CFTR mutation strategy.
Le texte complet de cet article est disponible en PDF.Mots-clés : CF, ELISA, IRT, PAP
Plan
| Supported by a grant from the Caisse Nationale d'Assurance Maladie des Travailleurs Salariés. J.C. Dagorn is a consultant for DYNABIO S.A., which produces the MucoPAP ELISA kits used in this study. None of the other authors has any personal or financial relationships to report that could cause a conflict of interest with this study. |
Vol 147 - N° 3
P. 302-305 - septembre 2005 Retour au numéro
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- Improving Subspecialty Healthcare: Lessons from Cystic Fibrosis
- Michael S. Schechter, Peter Margolis
- Newborn Screening for Cystic Fibrosis is Associated with Reduced Treatment Intensity
- Erika J. Sims, Jonathan McCormick, Gita Mehta, Anil Mehta
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