HemaVision -28Q | HV01-28Q

Kit for the screening and detection of 7 chromosome translocations with more than 40 clinically relevant chromosomal breakpoints in just 4 hours. These 7 translocations are t(9,22) minor, major,and micro; t(1,19); t(12,21); inv16; t(15,17) S, V and L; t(8,21) and t(4,11). Supplied in tree types of qPCR tubes: WRP, WLP or CRP. Contain material for 12 tests.

HemaVision®-7Q is a 4 hour CE IVD marked in vitro diagnostic test for qualitative screening of 7 chromosome
translocations associated with chronic and acute leukemia.
HemaVision®-7Q is intended for testing total RNA samples from human blood or bone marrow for presence
of chromosomal translocations associated with leukemia. It is a qualitative, non-automated test. Each kit
contains 12 tests and each test is single use only. 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 (aid to diagnosis).
HemaVision®-7Q detects RNA transcripts from fusion genes using a RT-qPCR procedure. Alternative splice
variants are also detected.

PRINCIPLES OF THE TEST
HemaVision®-7Q is a RT-qPCR based assay for detection of leukemia associated fusion gene transcripts in
total RNA from whole blood or bone marrow samples. Included in the kit are ready to use cDNA and qPCR
Master Mixes. cDNA is synthesized by adding purified RNA to the HemaVision®-7Q ready to use cDNA
reaction mix. The resulting cDNA is added to 7 ready to use qPCR reaction tubes, which contain specific PCR
primers and probes for detection of fusion genes, one reference gene and an internal amplification control
(IAC). The qPCR is performed in a real-time qPCR instrument with optical filters for detection of FAM, ROX,
and CY5 fluorescence. Amplification plots and Ct (cycle at threshold) values are used for identification of the
translocation and fusion gene transcript using an easy to use interpretation table.
HemaVision®-7Q detects fusion gene transcripts using specific PCR primers and probes. The translocation
specific primers bind to exons in the fusion gene enabling amplification of the region containing the
breakpoint. The primers are designed to detect multiple clinical relevant breakpoints and splice variants
(Figure 1).
The qPCR master mix probes are dual labeled with a fluorophore and a quencher molecule at each end of
the oligoes. During the annealing step of the PCR the probe bind to the PCR products of the previous rounds.
Signals are generated in the subsequent elongation step as the 5’->3’exonuclease activity of the Taq
polymerase enzyme degrades the hybridized probe. This liberates the fluorophore from the quencher, which
thereby increases the fluorescence. The fluorescence is measured at the end of the elongation step of every
PCR cycle.

KIT COMPONENTS AND STORAGE
HemaVision®-7Q contains reagents for 12 tests.
Included in HemaVision®-7Q kit is the following components:
• 12 cDNA tubes with 28 uL reaction mix (0.65 mL tubes with yellow screw cap)
• 12 strips of 8 qPCR tubes containing 23 uL qPCR reaction mix.
• 12 extra strips of optical caps for the qPCR tubes.
• Two tubes with RNase free H2O (0.65 mL tubes with blue screw cap)
• One user manual
HemaVision®-7Q is produced in 4 formats of plastic to suit various qPCR apparatus. The qPCR mix can be
supplied in 0.1 mL white low profile (WLP), 0.2 mL white regular profile (WRP), 0.2 mL frosted regular profile
(FRP) or 0.2 mL clear regular profile (CRP) PCR tubes. Adaptor plates can be supplied with the kit if the qPCR
instrument requires a 96-tube plate format (e.g. Roche LightCycler 480 and some ABI models). For the Qiagen
Rotorgene instrument, the CRP 8-tube strip can be divided in 2x4 tubes before insertion in the instrument
rotor.