TRUPCR® PML-RARA kwantitatief

• CE-IVD • First commercial assay to accurately detect, differentiate and quantify bcr1, bcr2 & bcr3 fusion transcripts. • Detection and differentiation of both 5’ and 3’ forms of bcr2 (variant) form. • Higher sensitivity and specificity with easy workflow and quick analysis. • All the reagents required for the test included in the kit. • Compatible with various real time PCR instruments.

TRUPCR®PML-RARA is anin vitronucleic acid amplification assay for the qualitative and quantitative detection of PML/RAR-alpha fusion transcripts in human clinical samples. In this multi-tube assay, extracted RNA is subjected to a separate Real-time reverse transcription-polymerase chain reaction (RT-PCR) procedures to detect and quantitate long (L or bcr1), variant (V or bcr2) and short (S or bcr3) isoforms simultaneously. An additional amplification for the ABL gene is performed as a control for sample RNA quality and as a reference for relative quantification. Detection of the PML/RARA t (15;17) translocation is diagnostic for acute promyelocytic leukaemia (APL), although the diagnosis can also be based on morphology. Investigations suggest that 99% of APL patients harbour a translocation between chromosomes 15 and 17, which fuses the retinoic acid receptor alpha (RARA) gene on chromosome 17 with the PML gene on chromosome 15. Detection of the PML/RARA t (15;17) translocation is therefore used within clinical research as an identifier for APL. Depending on the location of breakpoints within the PML site, intron 6, exon 6 and intron 3, the respective PML-RARA transcript subtypes referred to as long (L or bcr1), variant (V or bcr2) and short (S or bcr3), may be formed. They represent 50-55%, 5-10% and 30-40% of the cases respectively. The presence of this translocation is necessary for response to all-trans-retinoic acid and arsenic trioxide. Thus, the PML/RARA t (15;17) assay is useful for diagnosis and predicting treatment response. It is also helpful for monitoring therapeutic response and MRD and for detecting early relapse.