- Qualitative assay that allows determining the presence of the three possible variants (bcr1, bcr2 and bcr3) of the t(15;17)(q22;q21) rearrangement of PML-RARA in a single PCR reaction.
- It includes an endogenous GUS gene control and a positive control to confirm sample quality and integrity, ensure functionality of the PCR system, and aid interpretation in qualitative analysis.
- Allows detection of minimal residual disease (MD).
- High sensitivity and specificity: The detection limit has been set at 5 absolute copies for both the GUS reference gene and the PML-RARA rearrangement.
- It complies with the quality requirements specified by ISO 13845 and ISO 14001 in relation to the materials used in its manufacturing process.
- For in vitro diagnostic use.
Description
Detection of the PML-RARA t(15;17)(q22;q21) rearrangement associated with Acute Promyelocytic Leukemia (APL)
Format
48 x 2 rxn
Technology
Real-time PCR
Reference
IMG-130
Compatible equipment
7500 FAST Real-Time PCR System (ThermoFisher), StepOnePlus Real-Time PCR System (ThermoFisher)

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 t(15;17)(q22;q21) rearrangement and the presence of the gene GUS reference.
- Amount of cDNA required: 10 µL of cDNA resulting from the reverse transcription of 1 µg of RNA
- Sample type: Peripheral (Germinal) blood or bone marrow
- Number of reactions per sample: 2
- Number of targets: 2
- Manual working time: 45 min
- Duration of the PCR program: 1h 15 min
- Compatible cyclers: Real-time PCR cycler with the FAMTM channel
Related kits
Imegen-PML-RARA Screening
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