gb ONCO CLL
reverse transcription + real-time PCR
This in vitro diagnostic kit is intended for prognosis assessment in CLL patients by analysis of cDNA (reverse transcribed RNA) samples of human B lymphocytes obtained from peripheral blood. The kit is based on reverse transcription together with quantitative real-time polymerase chain reaction (qRT-PCR) using fluorescently labelled probes.
Clinical implications of the CE IVD kit
Chronic lymphocytic leukemia (CLL) occurs mostly in elderly people (median age 65 years) and is the most common leukemia in Europe and North America where CLL comprises of about 30 % of leukemic diseases of adults. The frequency of CLL is approximately two-times higher in men than in women. IGHV mutational status analysis helps to better predict disease progression and patient survival.
Somatic hypermutation of IGHV is the physiological process that leads to an increase in antibody diversity. In patients with mutated IGHV, better prognosis with a slower progression of disease and a longer patient´s survival can be observed. In those with unmutated IGHV a worse clinical course and prognosis can be expected.The kit contains all components necessary for analysis of gene expression. Two of six genes are housekeeping genes (B2M, HPRT1) and three of them are target genes (LPL, ZAP70 and COBLL1). The remaining gene CD3D serves as contamination marker (sample contamination by T lymphocytes).
Parameters of the real-time PCR diagnostic kit
- ready-to-use assays
- RNA input 500–1000 ng
- reverse transcription reagents included
- negative and positive controls included
- FAM channel detection
ABI 7300 (ABI)
ABI 7900HT (ABI)
AriaMx (Agilent Technologies)
iCycler iQ5 (Bio-Rad)
RG 3000 (Corbett Research)
RG 6000/Q (Corbett Research/Qiagen)