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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 |
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* 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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