gb ONCO BCR-ABL MAJOR
one-step real-time PCR
This in vitro diagnostic kit enables detection and quantification of the major transcripts of b2a2 and b3a2 of the abberant chromosome BCR-ABL1. The examination is based on one-step RT-qPCR using fluorescently labeled probes. Quantification of both fusion and reference transcript is processed in one tube.
Clinical implications of the CE IVD kit
The BCR-ABL1 major fusion gene is found in 99% of patients with chronic myeloid leukemia. This chromosomal aberration leads to dysregulation of tyrosine kinase cascade resulting in the manifestation of leukemia. Patient response to treatment as well as minimal residual disease is monitored on a standardized basis through quantification of the BCR-ABL1 major b2a2 (e13a2) and b3a2 (e14a2) transcripts relative to the number of control gene ABL1 (GUSB) transcripts.
The results of the estimation must be converted to the International Scale (IS), which is possible thanks to the STANDARD MMR BCR-ABL MAJOR certified by the National Reference Laboratory for DNA Diagnostics (IHBT, Prague, Czech Republic).
Parameters of the real-time PCR diagnostic kit
- detection in the FAM (BCR-ABL1) channel and HEX (ABL1/GUSB) channel
- calibrating panel of standards and no template control included