Purpose/Principle

This test detects the Major BCR::ABL1 fusion transcript (p210) using a reverse transcriptase PCR-based real-time fluorescent signal detection is utilized. Results are reported based on the International Scale (IS), with an established upper limit of linearity of 55% IS and a lower limit of linearity of 0.003% IS, corresponding to 4.52 log reduction. Transcripts detected above the upper limit of linearity will be reported as greater than 55% IS. Transcripts detected at a level below the linear range of the assay will be reported as such, without a quantitative % IS. This assay detects the e13-a2 and e14-a2 fusion types and does not detect other BCR::ABL1 transcripts.