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InPlex® CF Molecular Test

With recent advances in molecular diagnostics, patients and clinicians have never had more information and options to consider. And, the demand for easier and faster lab processes has never been greater. The InPlex® CF Molecular Test combines class-leading speed with outstanding repeat rate and reproducibility.

The InPlex® CF format is an easy multiplex format with:

  • Few steps and few repeats
  • No reflex testing necessary
  • Very little hands-on time

The InPlex® CF format is more economical for your lab:

  • Lowest start-up costs
  • Lowest hands-on time
  • Fastest time to results1

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).

ACOG/ACMG 23

A455EG551DR553X711+1G>T3120+1G>A

deltaF508N1303KR560T1717-1G>A3659delC

deltaI507R117HR1162X1898+1G>A3849+10kbC>T

G85ER334WW1282X2184delA

G542XR347P621+1G>T2789+5G>A

Automatic Reflex Markers

IVS8-5TIVS8-7TIVS8-9T

Other Mutations

F508C*2183AA>G*

*Used for analytical interpretation only

Intended Use2

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.

1Johnson et al., “A Comparative Study of Five Technologically Diverse CFTR Testing Platforms”,
Journal of Molecular Diagnostics, July 2007 Vol. 9, No. 3.

2InPlex® CF Molecular Test Package Insert, #15-3122, 2008.