PAP assay for Cystic Fibrosis newborn screening

The Pancreatitis-associated protein (PAP) is synthesized in pancreas only during pancreatic stress. In cystic fibrosis (CF) the pancreas is already diseased in utero and PAP is synthesized before birth. Several studies have shown that PAP concentration is indeed elevated in the blood of CF newborn:

  • Iovanna et al. C R Acad Sci III. 1994; 7:561-4.
  • Sarles et al. Arch Dis Child 1999;80:F118-22.
  • Barthellemy et al. Arch. Pediatr 2001;8:275-281.
  • Sarles et al. J Pediatr 2005;147:302-305.
  • Vernooij-van Langen AM et al. Thorax. 2012;67(4):289-295
  • Cornel MC et al. J Inherit Metab Dis. 2012;35(4):635-640.
  • Sommerburg O et al J Inherit Metab Dis. 2010;33(Suppl 2):S263-271.
  • Krulisova V et al.. Eur J Pediatr. 2012;171(8):1223-1229.
  • Sommerburg O et alJ Cyst Fibros. 2013.S1569-1993.

PAP assay on Guthrie cards might therefore help screening CF newborns.

Countries using the IRT/PAP strategy

The IRT/PAP strategy is presently in routine use in:

  • the Netherlands,
  • three German Länder,
  • Argentina,
  • Austria,
  • Portugal,
  • Uruguay.

Its introduction in France is recommended by the AFDPHE and might take place in 2014. Local evaluations are programmed in Brazil and Chile.

A recent Canadian study (18) shows that among available CF screening strategies, IRT/PAP is the most cost-effective.

All PAP assay kits

PancrePAP kit

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