Cystic fibrosis (CF) is an inherited chronic respiratory disease that affects children and adults. Guidelines for population-wide screening for CF mutations in pre-pregnancy were published by the American College of Medical Genetics (ACMG) in 2001 and 2004.
The Cystic Fibrosis Genotyping Assay is a qualitative in vitro diagnostic device used to a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) in isolated from human whole blood specimens. Cleared by the US Food and Drug Administration (FDA) in 2007, Celera’s CF assay is also CE Marked and available world-wide.
The panel includes mutations and variants recommended by the American College of Medical Genetics (ACMG, 2004) and the American College of Obstetricians and Gynecologists (ACOG, 2005), plus additional multiethnic mutations and variants.
The Cystic Fibrosis Genotyping Assay provides information intended to be used for carrier screening in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children.
Core CFTR Mutation Panel (32)
For more product information, contact your local Abbott Molecular representative http://www.abbottmolecular.com/