xTAG^® Cystic Fibrosis Assays

xTAG Cystic Fibrosis Overview

Cystic Fibrosis (CF) is a multisystem disease that can affect the respiratory tract, pancreas, sweat glands, intestine, male genital tract, and liver. Pulmonary disease is one of the most notable characteristics of CF and is the leading cause of death in CF patients. The symptoms of pulmonary disease in CF include persistent cough, wheezing, and frequent pneumonia. For patients with pancreatic disease, digestive enzymes are retained in the pancreas and cannot reach the intestine, and food is poorly digested and absorbed. Ten to twenty percent of adult patients develop insulin-dependent diabetes mellitus. Many men with CF are infertile. Over 1300 mutations have been found in the CFTR gene which is located on the long arm of chromosome 7; however, many of these mutations have only been found once or in a small number of cases. 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. Frequencies of other mutations also vary by ethnicity. 

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 provide 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.

xTAG Cystic Fibrosis 39 kit v2* xTAG Cystic Fibrosis 60 kit v2* xTAG Cystic Fibrosis 71 kit v2* IVD Cleared*

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.

xTAG Cystic Fibrosis Product Description

The next generation, IVD xTAG Cystic Fibrosis (CFTR) v2 assays from Luminex Molecular Diagnostics are uniquely designed to be simple, yet powerful assays that offer physicians the ability to test for the most prevalent CFTR gene mutations in a variety of populations. Offering the utmost in flexibility, the xTAG Cystic Fibrosis family of assays offer the ability to test a patient for only the 23 CFTR mutations recommended by the ACMG/ACOG or to also test for an additional 16 (with the xTAG Cystic Fibrosis (CFTR) 39 kit v2) or an additional 37 (with the xTAG Cystic Fibrosis (CFTR) 60 kit v2) of the world's most common and North American-prevalent mutations.

Key Features and Attributes

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 (after allowable re-runs).

Cost Effective

Multiplexed genotyping. No reflex testing necessary for 5T/7T/9T and F508C; I507V and I506V.

Registration Status

• US-IVD
• CE-IVD; Health Canada

xTAG Cystic Fibrosis US-IVD

xTAG Cystic Fibrosis (US) mutation coverage

Comparison of CFTR mutation detection rate with the different xTAG Cystic Fibrosis assays

See the complete list of CFTR mutations by kit here.
See the CF60 panel B alleles literature summary table here.

xTAG Cystic Fibrosis CE-IVD; Health Canada

xTAG Cystic Fibrosis mutation coverage

Comparison of CFTR mutation detection rate with the different xTAG Cystic Fibrosis assays

See the complete list of CFTR mutations by kit here.

xTAG Cystic Fibrosis Assay Performance

xTAG Cystic Fibrosis Kits

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.

xTAG Cystic Fibrosis Assay Technology

How the xTAG Cystic Fibrosis 39 Kit v2* and the xTAG Cystic Fibrosis 60*/71 Kit v2* works:

	Nucleic Acid Extraction and Purification Many commercial DNA extraction kits are available which will provide high quality genomic DNA (UV 260/280 ratios: >1.5-1.7) compatible with the xTAG Cystic Fibrosis 39 kit v2 from human blood specimens. A optimal input quantity of 50ng (range of 10 ng to 1.5 ug) per sample is required to perform the assay. Step time will vary depending the choice of extraction method.
	Step 1 - Multiplex PCR Reaction The nucleic acid is amplified using one polymerase chain reaction (PCR), a molecular biology technique for rapidly creating multiple copies of DNA. In this case, the technique will make multiple copies of multiple DNA targets within the CFTR gene. For 48 Samples       xTAG CF 39 Kit v2 xTAG CF 60/71 kit v2 Turn Around Time 81 min 81 min Hands On Time 18 min 18 min
	Step 2 - Amplicon Treatment Enzymatic treatment of amplified PCR products cleaves unused reagents (primers and dNTPs) left over after PCR. For 48 Samples       xTAG CF 39 Kit v2 xTAG CF 60/71 kit v2 Turn Around Time 57 min 57 min Hands On Time 20 min 20 min
	Step 3 - Allele-specific primer extension (for CF) 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 extension. During this extension, a reporter label is incorporated. For 48 Samples       xTAG CF 39 Kit v2 xTAG CF 60/71 kit v2 Turn Around Time 81 min 91 min Hands On Time 20 min 30 min
	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. For 48 Samples       xTAG CF 39 Kit v2 xTAG CF 60/71 kit v2 Turn Around Time 38 min 42 min Hands On Time 5 min 9 min
	Step 5 - Addition of Reporter Molecule The reporter solution is the Streptavidin, R-Phycoerythrin conjugate and will be used to detect the target. For 48 Samples       xTAG CF 39 Kit v2 xTAG CF 60/71 kit v2 Turn Around Time 17.5 min 21 min Hands On Time 2.5 min 6 min
	Step 6 - Data Acquisition on Luminex Analyser Samples are then placed in a Luminex xMAP® instrument where beads are read and analyzed by lasers. The lasers identify the color of the bead and the presence or absence of the 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. For 48 Samples       xTAG CF 39 Kit v2 xTAG CF 60/71 kit v2 Turn Around Time 30 min 55 min Hands On Time 5 min 5 min

Turn Around Time And Hands On Time For 48 Samples

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.

Downloads

Document	Language	Type	Download
MSDS
MSDS (click to search database)
Data Sheets and Brochures
xTAG Cystic Fibrosis Assays U.S. Fact Sheet	English	pdf
xTAG Cystic Fibrosis Assays (EU and Canada) Fact Sheet	English	pdf
xTAG Cystic Fibrosis Assays Mutations By Kit	English	pdf
xTAG Cystic Fibrosis Assays 60 Panel B Alleles Literature Summary	English	pdf

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.

xTAG Cystic Fibrosis v2 Training Courses

At Luminex Learning, we offer online, live online, and classroom training options. To view a list of our course offerings, or to enroll in a course, please visit our training page.

Support Information

Luminex offers comprehensive technical support enabling companies and laboratories to perform clinical diagnosis quickly, accurately, and cost effectively while optimizing the customer experience with Luminex assays and systems.

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.

Ordering Information

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.