Imegen-PML-RARA Screening

Detection of the PML-RARA t(15;17)(q22;q21) rearrangement associated with Acute Promyelocytic Leukemia (APL)

48 x 2 rxn

Real-time PCR

IMG-130

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

  • 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 13485 and ISO 14001 in relation to the materials used in its manufacturing process.
  • For in vitro diagnostic use.

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

  • 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

Imegen-PML-RARA Screening

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