Interpretation
Transcripts resulting from the two major breakpoints, BCR::ABL1 e13a2 (b2a2) and e14a2 (b3a2), and an endogenous control gene ABL1 are amplified and results are expressed as a ratio percent (BCR::ABL1/ABL x 100) according to the International Scale (IS).
The significance of BCR::ABL1 transcript level should always be considered in the context of treatment and sequential BCR::ABL1 testing. A level at or below 0.1% (IS) indicates a major molecular response.
Lower Limit of Quantitation: at least 4.52 log molecular reduction (MR) from baseline, i.e. 0.003%(IS).
Please Note: This assay will only detect the two common BCR::ABL1 p210 transcripts. If a diagnostic sample is negative for BCR-ABL1 p210 transcripts by the Xpert BCR::ABL Ultra Assay we recommend that BCR::ABL1 testing by FISH is performed to exclude rarer BCR::ABL1 transcripts associated with CML/ALL.
Test Method
Xpert BCR::ABL Ultra Assay, GeneXpert, Cepheid.