About Inplex® CF
Brought to you by the makers of the ThinPrep® Pap Test and the new Cervista® HPV test, InPlex® CF is a DNA-based test for the presence of genetic mutations associated with cystic fibrosis. Your testing laboratory may offer InPlex® CF as its choice for CF carrier screening. If your chosen lab does not offer CF carrier screening, tell them that InPlex® CF is the easiest to use and most economical CF test available.
The InPlex® CF Molecular Test is an in vitro diagnostic (IVD) that simultaneously tests for twenty-three separate mutations in the Cystic Fibrosis Transmembrane Receptor (CFTR) gene. In addition, the IVS8-5T/7T/9T markers are automatically reflexed as part of the test. All mutations contained in the assay are recommended for testing by the American College of Obstetricians and Gynecologists (ACOG) and the American College of Medical Genetics (ACMG). For a full description of intended usage for the InPlex® CF Molecular test, please read the Intended Use section below.
Intended Use1
InPlex® CF Molecular Test is an in vitro diagnostic device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA samples isolated from human peripheral whole blood specimens. The panel includes mutations and variants recommended by the 2004 American College of Medical Genetics (ACMG). The InPlex® CF Molecular Test is a qualitative genotyping test that provides information intended to be used for cystic fibrosis carrier screening as recommended by ACMG and the 2005 American College of Obstetricians and Gynecologists (ACOG) for adults of reproductive age, as an aid in newborn screening for cystic fibrosis, and in confirmatory diagnostic testing for cystic fibrosis in newborns and children.
The test is not indicated for use in fetal diagnostic or pre-implantation testing. This test is also not indicated for stand-alone diagnostic purposes and results should be used in conjunction with other available laboratory and clinical information.
1InPlex® CF Molecular Test Package Insert, #15-3122, 2008.