REALQUALITY RQ-BCR-ABL p210 One-Step
REALQUALITY RQ-BCR-ABL p210 One-Step is a CE-IVD kit for the identification and quantification of the t(9;22) (q34;q11) translocation, in the variant p210 (M-bcr b3a2 and b2a2 transcripts) , which involves the ABL proto-oncogene on chromosome 9 and part of the BCR gene on chromosome 22, by one-step Real-time RT-PCR of the BCR-ABL fusion gene.
- The device was developed in accordance with the Europe Against Cancer (EAC) guidelines and validated using the "Raccomandazioni e Indicazioni Laboratoristiche" of the LabNet network.
- The device is validated on RNA extracted from leukocyte pellet
- 5 µL of extracted RNA/reaction are sufficient for the assay to be performed
- It is equipped with a dUTP/UNG system for the prevention of carry-over contamination and a fluorescence normalizer
- With the use of quantified standards calibrated with reference material IRMM ERM-AD623 BCR-ABL1 (REALQUALITY RQ-BCR-ABL p210 STANDARD), the assay is quantitative and usable for monitoring the Minimum Residual Disease (MRD)
- With the use of known concentration reference RNA (BCR-ABL p210 REFERENCE) allows to calculate the Conversion Factor (FC) of the lab, it is necessary to convert the final results of the analysis into Internationale Scale (IS) value
- Real time reverse transcription and amplification take place in a single step (Real-Time RT-PCR)
- The assay shares the same thermal profile as the REALQUALITY RQ-BCR-ABL p190 One-Step kit
- It is validated on the most common Applied Biosystems Real-Time PCR thermocyclers
- Ready-to-use reagents for Real time amplification
- Positive control (DNA containing part of the sequence BCR-ABL p210 and ABL)
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