This assay can detect three different types of BCR-ABL1 fusion transcripts associated with CML, ALL, and AML:
Lavender (EDTA), 4mL
Dk green Sodium heparin (Na hep), no gel
Ambient (preferred) - 48 hours
Total RNA is isolated from the sample and subject to a real-time, reverse transcriptase polymerase chain reaction (RT-PCR). The PCR primers and probes are specific for BCR-ABL1 e13a2, e14a2 and e1a2 fusion transcripts. The ABL1 transcript is amplified as the control for cDNA quantity and quality. Serial dilutions of a validated positive control RNA with known t(9;22) BCR-ABL1 are used as reference for quantification of BCR-ABL1 relative to ABL1. The numeric BCR-ABL1 level is reported as % BCR-ABL1/ABL1 and the detection sensitivity is 4.5 log below the standard baseline (<0.0032%).
An interpretive report will be included
The e13a2 and e14a2 transcript values are titrated to the current International Scale (IS). The standardized baseline is 100% BCR-ABL1 (IS) and major molecular response (MMR) is equivalent to 0.1% BCR-ABL1 (IS) corresponding to a 3-log reduction. Results should be correlated with appropriate clinical and laboratory information as indicated.