- 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.
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