HemaVision® -8;21 | HV03-821

HemaVisionÒ-8;21 is a CE-marked in vitro diagnostic test for qualitative detection of the human leukemia
causing chromosomal translocation t(8;21)(q22;q22)(RUNX1-RUNX1T1). 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).
The test screens RNA from blood or bone marrow for breakpoints resulting in the exon fusions RUNX1 and
RUNX1T1 genes. HemaVisionÒ-8;21 also detects mRNA splice variants for the t(8;21)(q22;q22)(RUNX1-
RUNX1T1) translocation. It is a fast 4-5 hour test. The HemaVisionÒ-8;21 test has sensitivity (>99%) and
specificity (>96%). Limit of detection is 10-8 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.
HemaVisionÒ-8;21 is a qualitative test using total RNA extracted from human whole blood or bone marrow
cells as starting material in the test. The test uses reverse transcription of RNA to cDNA followed by
multiplex PCR (Polymerase Chain Reaction), agarose gel electrophoresis, and interpretation.
The HemaVisionÒ-8;21 kit contains primers for 25 cDNA reactions, and 25 PCR tests.
The test is for professional use only.