HemaVision® -15;17N | HV02-1517N

HemaVisionÒ-15;17N 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 and is not
intended for stand-alone diagnosis of Leukemia (aid to diagnosis).
HemaVisionÒ-15;17N detect human translocation t(15;17)(q24:q21)( PML-RARA) associated with
leukemia. This translocation fuses the PML gene on chromosome 15q24 with the RARA gene on
chromosome 17q21 (Ref 1-3). HemaVisionÒ-15;17N 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-15;17N contains the same primers as the split-out reaction M4D and M8C in the
HemaVisionÒ-28N kit.
HemaVisionÒ-15;17N 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.