# Imegen-m-BCR-ABL1

: Detection and quantification of the m-bcr rearrangement: BCR-ABL1 p190 associated with Chronic Myeloid Leukemia

48 × 2 rxn

real-time PCR

IMG-122

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

• Quantitative real-time PCR assay to determine the number of copies of the m-BCR-ABL1 (p190) rearrangement, and the number of copies of the endogenous ABL1 gene.
• 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 (p190) 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 log reduction from the International Randomized study defined as:
• Detectable disease < 0.01% BCR-ABL1
• Undetectable disease on cDNA with > 10,000 copies of the ABL1 reference gene.
• Includes a standard calibrated with the IRMM Reference Material [ERM-AD623] for the relative quantification of the number of copies of the m-BCR-ABL1 rearrangement (p190) with respect to the number of copies of the ABL1 gene.
• 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.

Real-time PCR analysis using a combination of oligonucleotides and fluorescent hydrolysis probes for relative quantification of the number of copies of the m-BCR-ABL1(p190) rearrangement relative to the number of copies of the ABL1 reference gene.

• 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 work time: 30 min
• Duration of the PCR program: 1 h 15 min
• Compatible cyclers: real-time PCR cycler with the FAMTM channel

## Imegen-m-BCR-ABL1

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