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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 Fibrosis (CFTR) v2 assays from Luminex are uniquely designed to be simple yet powerful, and 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. The test 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.

 

Over 2000 mutations have been found in the CFTR gene which is located on the long arm of chromosome 7. Many of these mutations are rare. Most of the mutations are either point mutations or small deletions of between one and 84 base pairs. The most common mutation is a three base pair deletion that results in the loss of a phenylalanine at amino acid 508 (ΔF508). This mutation accounts for 30 to 88 percent of all CF mutations, depending on the ethnic group.1 Frequencies of other mutations also vary by ethnicity.

 

xTAG Cystic Fibrosis IVD assays are designed to detect and identify the most common CFTR mutations and variants. They offer 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), as well as the flexibility to use an expanded panel of CF mutations to obtain broad ethnic coverage across populations.

 

The following products are available for targeted CF panel testing:

 

xTAG CF39v2 Kit

  • Detects 39 mutations/variants that includes ACMG 23 and 16 additional mutations commonly found in the U.S. population

 

xTAG CF60v2 Kit

  • Detects 60 mutations/variants that includes ACMG 23 mutations and 37 North American most common (16 + 21) mutations

 

xTAG CF71v2 Kit

  • Detects 71 mutations that includes ACMG 23 mutations and 48 European/North American most common (16 + 32) mutations

Flexible

Obtain the flexibility to meet your mutation coverage needs
 

Simple

Simplify workflow with faster assay turn around times
 

Reliable

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

xTAG Cystic Fibrosis Workflow

 

 

Step 1: Nucleic Acid Extraction and Purification

Many commercial DNA extraction kits are compatible with the xTAG Cystic Fibrosis Kits.

 

Step 2: Multiplex PCR Reaction with Amplicon Treatment

The nucleic acid is amplified using one polymerase chain reaction (PCR).

 

Step 3: Allele-Specific Primer Extension

The amplified DNA is mixed with short sequences (TAG primers) of DNA specific to each target. If the target is present, the primer will bind and will be lengthened through a process called allele specific primer extension. During this extension, a reporter label is incorporated.

 

Step 4: Bead Hybridization

Color-coded beads are added to identify the tagged primers. Attached to each differently colored bead is an anti-TAG sequence specific to one of the extended TAG primers. Each anti-TAG only binds to the complementary TAG sequence on the primer.

 

Step 5: Addition of Reporter Molecule

 

Step 6: Data Acquisition on Luminex Analyzer

Samples are read on a Luminex xMAP® instrument that identifies the color of the bead and the presence or absence of labeled target. For each sample, these signals are interpreted by the xTAG Data Analysis Software to determine whether the wild-type and/or mutant alleles for each of the variations have been detected.

Ordering Information

 

Luminex Direct Ordering Information
Luminex Online Order Management
Email:[email protected]
Phone:1.512.336.3550
Toll Free:1.866.401.5450
Fax:1.512.219.0544
Fax (Europe, Middle East, Asia, India):+31 (0)73 800 1998
Product NameKit SizeRegistration StatusPart Number
xTAG Cystic Fibrosis (CFTR) 39 kit v296 TestsUS-IVDI027C0231
xTAG Cystic Fibrosis (CFTR) 60 kit v296 TestsUS-IVDI024C0181
xTAG Cystic Fibrosis (CFTR) 39 kit v296 TestsCA-IVDI027C0232
xTAG Cystic Fibrosis (CFTR) 71 kit v296 TestsCA-IVDI024C0185
  1. Noone, Hamblett et al. 2001

 

For in vitro diagnostic use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

Intended Use (US-IVD):

CF39v2: The xTAG® Cystic Fibrosis (CFTR) 39 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. The panel includes mutations and 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. The xTAG Cystic Fibrosis (CFTR) 39 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.
CF60v2 (US ONLY): The xTAG® Cystic Fibrosis (CFTR) 60 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. The panel includes mutations and 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. The xTAG Cystic Fibrosis (CFTR) 60 kit v2 is a qualitative genotyping test that 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.

Intended Use (CA-IVD):

CF39v2: The xTAG® Cystic Fibrosis (CFTR) 39 kit v2 is a device used to simultaneously detects 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, “Mutations (asterisk denotes ACMG/ACOG panel) and Four Variants (variants italicized) Included in the xTAG® Cystic Fibrosis (CFTR) 39 kit v2”), plus some of the worlds most common and North American prevalent mutations. The xTAG Cystic Fibrosis (CFTR) 39 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.
CF71v2 (Canada ONLY): 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.