HemaVision® -8;21N | HV02-821N

HemaVisionÒ-8;21N is a CE-marked in vitro diagnostic test for qualitative testing of chromosome
translocations using total RNA extracted from human blood or bone marrow. HemaVisionÒ-8;21N
detect human translocation t(8;21)(q22:q22)( RUNX1-RUNX1T1) associated with leukemia. This
translocation fuses the RUNX1 gene on chromosome 21q22 with the RUNX1T1 gene on chromosome
8q22 (Ref 1-3). HemaVisionÒ-8;21N identifies chromosomes, genes and exons at the breakpoint in
fusion genes. Furthermore, the test identifies mRNA splice variants from fusion genes.
The test uses reverse transcription of RNA to cDNA followed by multiplex nested polymerase chain
reactions, agarose gel electrophoresis, and interpretation. The kit contains primers for 25 cDNA
reactions and 25 nested PCR tests.
HemaVisionÒ-8;21N contains the same primers as the split-out reaction M4A of the kit HemaVision
Ò28N.
It is a fast one day test with very high sensitivity (>99%) and specificity (>99%) (Ref 4, 5).
Limit of detection is 10-9 mg of fusion RNA in a sample of 1 mg total RNA when the RNA quality is good.
This test brings IVD testing deeper into a detailed description of the exon organization of fusion genes
originating from chromosome translocations. This information is important for predicting development
of the disease and selection of treatment.