mSEP™ BCR::ABL1 Major dPCR Test
mSEP™ BCR::ABL1 Major dPCR Test is a RT-dPCR for quantifying BCR::ABL1 fusion and ABL1 transcript in total RNA from peripheral blood of diagnosed t(9;22) Chronic Myeloid Leukemia (CML) patient expressing p210 Major BCR::ABL1 fusion transcript type b2a2 (e13a2) and/or b3a2 (e14a2). The result is reported as a percent reduction from a baseline of 100% on the International Scale (% I.S.) and on a log Molecular Reduction (MR) scale in t(9;22) positive CML patient for Minimal Residual Disease (MRD) monitoring during treatment with Tyrosine Kinase Inhibitor (TKI).
This test serves to support the monitoring of MRD quantitation of the BCR::ABL1 major isoform by microchamber-based partition dPCR analysis using the QuantStudio™ Absolute Q™ Digital PCR System.
A set of two % I.S. Calibrator Controls [IS_10% (MR1) and IS_0.1% (MR3)] are included in mSEP™ BCR::ABL1 Major dPCR Test to function as both process and calibration controls that ensure the assay is traceable to WHO First International Genetic Reference Panel (NIBSC Code: 09/138) for the quantitation of BCR-ABL translocation.
This is a Research Use Only product.