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xTAG® CYSTIC FIBROSIS

Cystic Fibrosis Genetic Testing

Cystic Fibrosis disease may be variable. Our test results are definitive.

xTAG® Cystic Fibrosis

The xTAG® Cystic Fibrosis1 (CF) family of assays offer the utmost flexibility with the ability to test for the 23 CFTR mutations recommended by the American College of Medical Genetics/American College of Obstetricians and Gynecologists (ACMG/ACOG) and an expanded panel of CF mutations providing broad ethnic coverage across populations.

Product Details

Product Details

Workflow

Workflow

Ordering

Ordering

Resources

Resources

Support

Support

  1. For in vitro diagnostic use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at support@luminexcorp.com to obtain the appropriate product information for your country of residence.
  2. Intended Use (EU-IVD/SFDA Approved):

    The xTAG® Cystic Fibrosis 71 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens and blood spots. The panel includes mutations and variants currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG) (Table 1), plus some of the world’s most common and North American prevalent mutations (Table 2). The xTAG Cystic Fibrosis 71 Kit v2 is a qualitative genotyping test which provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children. The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes.