HemaVision® -9;22N | HV02-922N

HemaVisionÒ-9;22N is a CE-marked in vitro diagnostic test for qualitative testing of chromosome
translocations using total RNA extracted from human blood or bone marrow. Tests should be
performed and results should be analysed by professionals only. The test is intended for use as an
adjunct to evaluation of Leukemia in conjunction with other clinicopathological factors for stand-alone
diagnosis of Leukemia (aid to diagnosis).
HemaVisionÒ-9;22N detects human translocation t(9;22)(q34:q11)( BCR-ABL1) associated with
leukemia. This translocation fuses the BCR gene on chromosome 22q11 with the ABL1 gene on
chromosome 9q34 (Ref 1-3). HemaVisionÒ-9;22N 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-9;22N contains the same primers as the split-out reaction M6B and M8F in the
HemaVisionÒ-28N kit.
HemaVisionÒ-9;22N 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 provides a more detailed description of the exon organization of fusion genes originating from
chromosome translocations.
The test is for professional use only.