- Multiplexed qualitative assay: allows detection of the most frequent variants of the BCR-ABL1 rearrangement: M-BCR-ABL1(p210) and m-BCR-ABL1(p190), minimizing the number of reactions.
- High sensitivity and specificity: The detection limit for both ABL1, M-BCR-ABL1 and m-BCR-ABL1 has been established at 5 total copies, using a synthetic vector calibrated with the IRMM Reference Material [ERM -AD623].
- Includes a positive control for the BCR-ABL1 rearrangement, which guarantees the functionality of the PCR system and helps interpretation in qualitative analysis.
- Includes a target for the ABL1 gene that functions as an endogenous control to confirm sample quality and integrity.
- It complies with the quality requirements specified by ISO 13485 and ISO 14001 regarding the materials used in its manufacturing process.
- For in vitro diagnostic use only.
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