Xpert BCR-ABL IS Panel C130

Xpert BCR-ABL IS Panel C130

The Xpert BCR-ABL IS Panel C130 is intended for use as an assayed external quality control to monitor the performance of the in vitro quantitative detection of BCR-ABL1 translocation mRNA e14a2/b3a2 transcripts and the ABL1 endogenous control mRNA transcript when analyzed using the Xpert® BCR-ABL Ultra assay on Cepheid GeneXpert® Instrument Systems.

The Philadelphia chromosome, a translocation between the ABL1 gene on chromosome 9 and the BCR gene on chromosome 22, designated as t(9;22), generates the fusion gene BCR-ABL1 which is present in most chronic myelogenous leukemia patients. Quantitative monitoring of BCR-ABL1 transcripts in patient blood is an important tool for measuring response to therapy. In 2009, the World Health Organization (WHO) developed a panel of four BCR-ABL1 primary standards to establish an international scale (IS), a standardized method for reporting assay results as a ratio of fusion transcripts to control gene transcripts (%IS), useful to the harmonization of patient care across laboratories worldwide.1,2 The %IS can also be expressed as molecular response (MR), the log reduction from a standardized baseline of 100% on the IS. The Xpert BCR-ABL IS Panel C130 is traceable to the WHO International Genetic Reference Panel for Quantitation of BCR-ABL Translocation (WHO Reference Panel), NIBSC code 09/138, and designed for use with the Xpert BCR-ABL Ultra assay which reports on the international scale.


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For in vitro diagnostic use

ORDERING INFORMATION:

Xpert BCR-ABL IS Panel C130
Part Number: C130
Kit Contains:
12 bottles x 4 mL
2 of each %IS levels 1-6