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These devices are 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. All panels include 23 mutations and 4 variants currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG), plus some of the world's most common and North American-prevalent mutations. These assays are qualitative genotyping tests 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.
Key attributes of the xTAG® Cystic Fibrosis Assays from Luminex:
Comprehensive
The xTAG® Cystic Fibrosis assays offer the most comprehensive mutation coverage in IVD CFTR assays. The result is a wider range of mutation coverage amongst CFTR mutations prevalent in populations of differing or mixed-ethnic backgrounds, including Hispanic American, African American, Ashkenazi Jews and Asian American.
Flexible
Ability to choose your assay and choose your CFTR mutation coverage level from 39 to 60/71** CFTR mutations, yet always maintaining the ability to screen for only the ACMG/ACOG recommended 23 mutations.
Easy-To-Use
The version 2 assays have been designed to offer a more streamlined workflow and much less hands on time (HOT) resulting in faster turn around times (TAT) for test results. Moreover, all the required ancillary enzymes reagents are now included in the kit, so you are ready to run your assays once you receive your kit.
Reliable
Built upon Luminex’s proprietary xMAP technology, these next generation, IVD assays offer 100% overall accuracy and >99% precision.
Cost Effective
Multiplexed genotyping. No reflex testing necessary for 5T/7T/9T and F508C; I507V and I506V.
**xTAG® Cystic Fibrosis (CFTR) 71 kit v2 is available only outside of the U.S.
**Products listed are region specific and intended for residents of a particular country/region; this site contains information on devices that may not be approved in some countries/regions, therefore please contact Luminex to obtain the appropriate product info for your country of residence.
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