BCR-ABL mutation test kit RQ-105 series

oncologyfluorescencefor RT-PCR

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. Peculiarity 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 Kit content Ready-to-use reagents for Real time amplification Positive control (DNA containing part of the sequence BCR-ABL p210 and ABL)