Detection and quantification of the rearrangement M-bcr: BCR-ABL1 p210 associated with Chronic Myeloid Leukemia

48 x 2 rxn

Real-time PCR


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

  • Quantitative test that allows detecting the number of copies of the M-BCR-ABL1 rearrangement (p210), and the number of copies of the endogenous ABL1 gene, and the expression of the result according to the International System.
  • High sensitivity and specificity: The level of sensitivity that can be achieved depends on the maximum number of copies of the ABL1 reference gene. The detection limit for both ABL1 and M-BCR-ABL1 (p210) has been established at 5 total copies. The quantification limit or minimum quantifiable value has been established at 50 total copies.
  • This kit is suitable for detecting a molecular response corresponding to a 4.5 log reduction from the International Randomized study defined as:
    • Detectable disease < 0.0032% BCR-ABL1
    • Undetectable disease in cDNA with > 32,000 copies of the ABL1 reference gene.
  • It includes a standardized calibrator for the determination of the normalized copy number of M-BCR-ABL1: the pIMEGEN vector (M-BCR-ABL1:ABL1 in a 1:1 copy ratio) calibrated from the IRMM Reference Material [ERM -AD623]).
  • For in vitro diagnostic use only.

Real-time PCR analysis employing a combination of oligonucleotides and fluorescent hydrolysis probes for relative quantification of M-BCR-ABL1(p210) rearrangement copy number relative to ABL1 reference gene copy number.

  • Amount of cDNA required: 20µL of cDNA resulting from the reverse transcription of 1 µg of RNA
  • Sample type: Peripheral blood or bone marrow
  • Number of reactions per sample: 4
  • Number of targets: 2
  • Manual working time: 30 min
  • Duration of the PCR program: 1 h 15 min
  • Compatible cyclers: real-time PCR cycler with the FAMTM channel


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