- Certificate: CE-IVD
- Description: t(9;22)(q34;q11) chromosomal translocation is the creation of an oncogenic fusion gene between ABL proto-oncogene and BCR on chromosomes 9 and 22, respectively. The breakpoint on chromosome 22 occurs between exons 12 and 16 of the BCR gene (Major breakpoint cluster region; Mbcr), while the breakpoint on chromosome 9 mostly occurs between exons 1 and 2 of the ABL gene. The two most common fusion variants are b2a2 and b3a2, which encode for a constitutively active chimeric tyrosine kinase of 210kDa (P210).
- Results aligned with IS – control standard included with the P210 kit is aligned with WHO BCR-ABL primary standards
- Sample material: total RNA isolated from bone marrow or peripheral blood
- BCR-ABL fusion transcript is detected on FAM channel and ABL as Internal control on HEX/VIC channel.
- Validated on: ABI (7500, 7900HT, StepOne, StepOne Plus); Rotor-Gene (Q, 3000, 6000); LightCycler 480; Cobas® 4800, Cobas® z480