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xTAG^® Cystic Fibrosis (CFTR)

Help clinicians detect and identify the most common CFTR mutations

xTAG^® CFTR is a highly scalable genetic test with clinically relevant mutations.

Disease state

Cystic fibrosis affects the cells that produce mucus, sweat, and digestive juices. It causes these fluids to become thick and sticky. They then plug up tubes, ducts, and airways in the body.

Symptoms vary and can include cough, repeated lung infections, inability to gain weight, and fatty stools. Treatments may ease symptoms and reduce complications. Newborn screening helps with early diagnosis.

Cystic fibrosis mutations are inherited and can lead to a cascade of problems

The value of xTAG^® Cystic Fibrosis (CFTR)

Empower clinicians to have the ability to test for the 23 CFTR mutations recommended by ACMG/ACOG.

Flexible

Obtain the flexibility to meet your mutation coverage needs.

Simple

Simplify workflow with faster assay turnaround times.

Reliable

Utilize IVD-cleared assay with 100% overall accuracy and >91% precision (after allowable re-runs).

How the xTAG^® Cystic Fibrosis (CFTR) test works

xTAG^® Cystic Fibrosis (CFTR) is a multiplexed nucleic acid test intended for the detection of clinically relevant mutations by ACMG/ACOG.

High complexity workflow

Nucleic acid extraction and purification, multiplex amplification, bead hybridization and detection, and data acquisition and analysis by Luminex^® 200™ with xPONENT^® software.

Time to results

Within 8 hours, a laboratory can detect and determine the relevant genotypes for their clients.

Indications for xTAG^® Cystic Fibrosis (CFTR) test use

System

The xTAG^® Cystic Fibrosis kits are used to simultaneously detect and identify a panel of mutations and variants in human blood specimens