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xTAG® Cystic Fibrosis Kit

Description

The xTAG® Cystic Fibrosis Kit 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 23 mutations and
4 variants currently recommended by the American College of Medical Genetics and
American College of Obstetricians and Gynecologists (ACMG/ACOG), plus 16 of the
worlds most common and North American-prevalent mutations. The xTAG Cystic
Fibrosis Kit 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.

The validated performance characteristics of the xTAG Cystic Fibrosis Kit have been established in multisite studies demonstrating reproducibility by lot, site and operator.

For In Vitro Diagnostic Use.

Measure xTAG CF Assay Performance
Accuracy 100%
Precision >99.9%
Reproducibility: Site to site >99.9%
Lot to lot >99.9%
Operator to operator >99.9%


 Mutations Detected

ΔDF508*

1717-1G>A* W1282X* 2307insA
ΔI507* R560T* N1303K* Y1092X
G542X* R553X* 394delTT M1101K
G85E* G551D*  Y122X S1255X
R117H* 1898+1G>A* R347H 3876delA
621+1G>T* 2184delA* V520F 3905insT
711+1G>T* 2789+5G>A* A559T 5/7/9T
1078delT 3120+1G>A* S549N F508C
R334W* R1162X* S549R I507V
R347P* 3659delC* 1898+5G>T I506V
A455E* 3849+10kbC>T* 2183AA>G

* ACMG recommended, variants in italics.
1. Genet Med. 2004 Sep-Oct;6(5):387-91.

Product Description Reagent Size (Tests) Catalog Number
xTAG Cystic Fibrosis Kit 96 I006C0071 (Canada)**
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 information for your country of residence.

How to Place an Order

For orders in Canada, or for additional questions, please contact:
Luminex Molecular Diagnostics
Phone:  416.593.4323
Fax:  416.593.1066
Email:  info@luminexcorp.com

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