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xTAG™ Cystic Fibrosis Kit

Description

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

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