Imegen-BCR-ABL Screening

Detection of BCR-ABL1 t(9;22)(q34;q11) rearrangement associated with Chronic Myeloid Leukemia.

48 × 2 rxn

real-time PCR

IMG-108

7500 FAST Real-Time PCR System (ThermoFisher), StepOnePlus Real-Time PCR System (ThermoFisher)

  • 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.

Qualitative real-time PCR assay employing a combination of oligonucleotides and fluorescent hydrolysis probes in a validated assay to simultaneously detect the presence of the most common variants of the BCR-ABL1 rearrangement (M-BCR-ABL1(p210) and m-BCR -ABL1(p190)), and the presence of the ABL1 reference gene.

  • Amount of cDNA required: 10 µL of cDNA resulting from the reverse transcription of 1 µg of RNA.
  • Sample type: Peripheral blood or bone marrow
  • Number of reactions per sample: 2
  • Number of targets: 2
  • Manual work time: 30 min
  • Duration of the PCR program: 1h 05 min
  • Compatible cyclers: real-time PCR cycler with the FAMTM channel

Imegen-BCR-ABL Screening

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