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The xTAG™ Cystic Fibrosis Kit is the first FDA cleared IVD for cystic fibrosis genotyping. With validated performance criteria, this highly accurate and reproducible (>99.9%) assay will provide superior mutation coverage for carrier screening in adults and as an aid to diagnosis in newborns.
The xTAG™ Cystic Fibrosis Kit simultaneously screens for the 23 CFTR gene mutations and 4 variants (polymorphisms) recommended by the American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG) in 2004 †, plus 16 of the world’s most common and North American-prevalent mutations.
The validated performance characteristics of the xTAG™ Cystic Fibrosis Kit have been established in multisite studies demonstrating reproducibility by lot, site and operator.
| Measure |
xTAG™ 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 |
I006C0068 |
| CE marked in Europe. Available as an IUO elsewhere. Contact Luminex for more information. |
† For In Vitro Diagnostic Use
How to Place an Order
In the United States:
Have the following information accessible and contact Fisher Healthcare, the distributor of xTAG products to place an order.
Fisher Healthcare
Toll Free Phone: 1.800.640.0640
Fax: 1.800.290.0290
Email Request
• Customer number (or completed credit information form)
• Shipping information
• Billing information
• Purchase Order number
• Catalog number and description
• Order Quantity
• Requested Delivery date
For orders outside the United States, or for additional questions, please contact:
Luminex Molecular Diagnostics
Phone: 416.593.4323
Fax: 416.593.1066
Email: info@luminexcorp.com |
