HemaVision® -12;21 | HV03-1221

HemaVisionÒ-12;21 is a CE-marked in vitro diagnostic test for qualitative detection of the human
leukemia causing chromosomal translocation t(12;21)(p13;q22)(ETV6-RUNX1). 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 ETV6 and
RUNX1 genes. HemaVisionÒ-12;21 also detects mRNA splice variants for the t(12;21)(p13;q22)(ETV6-
RUNX1) translocation. It is a fast 4-5 hour test. The HemaVisionÒ-12;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-12;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-12;21 kit contains primers for 25 cDNA reactions, and 25 PCR tests.
The test is for professional use only.