- Quantitative assay to determine the number of copies of the PML-RARA t(15;17)(q22;q21) rearrangement type bcr1 and the number of copies of the endogenous GUS gene.
- Allows detection of minimal residual disease (MD). The theoretical sensitivity level that can be achieved is MR4 (0.01% of PML-RARE).
- High sensitivity and specificity: The limit of quantification (LOQ) has been set at 125 total copies for both the GUS reference gene and the PML-RARA rearrangement.
- It includes an endogenous control of the GUS gene to be able to carry out the relative quantification. In addition, it allows to confirm the quality and integrity of the sample.
- 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.
Determination of the number of copies of the rearrangement PML-RARA t(15;17)(q22;q21) type bcr1 associated with Acute Promyelocytic Leukemia (APL)
7500 FAST Real-Time PCR System (ThermoFisher), StepOnePlus Real-Time PCR System (ThermoFisher)
Real-time PCR analysis employing a combination of oligonucleotides and fluorescent hydrolysis probes for relative quantification of PML-RARA bcr1 rearrangement copy number relative to GUS 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 (Germinal)
- Number of reactions per sample: 4
- 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
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