For quantitative detection of PML-RARA bcr1 fusion transcripts using real-time PCR
  • Highly sensitive and accurate quantitative assay
  • EAC standardized assay for reproducible results
  • Compliance with EU IVD Directive 98/79/EC
  • Easy workflow with ready-to-use solutions
The ipsogen PML-RARA bcr1 Kit is an in vitro molecular diagnostic kit for real-time PCR on the Rotor-Gene Q and other real-time PCR instruments. The kit provides reagents optimized for reliable and sensitive detection and quantification of PML-RARA bcr1 fusion transcripts, relative to ABL control gene expression, in total RNA from bone marrow or peripheral blood samples in a subgroup of acute myeloid leukemia (AML) patients diagnosed with M3 cytomorphology and t(15;17)(q22;q21) translocation, with a breakpoint into PML intron 6. The test is intended to be used as an aid to monitor efficacy of treatment in patients undergoing therapy, and for minimal residual disease (MRD) follow-up to monitor disease relapse.
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ipsogen PML-RARA bcr1 Kit (24) CE
For 24 reactions: ABL Control Gene Standards, PML-RARA bcr1 Fusion Gene Standards, Primers and Probe Mix ABL, Primers and Probe Mix PML-RARA bcr1 Fusion Gene
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The ipsogen PML-RARA bcr1 Kit CE is intended for in vitro diagnostic use in Europe.


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PML-RARA bcr1 gene transcript.|ABL control gene transcript.|Accurate detection of PML-RARA bcr1 fusion gene plasmid standards.|Reliable detection of ABL plasmid standards.|In vitro diagnostic medical device.|CE-IVD-marked.|
||PML-RARA bcr1 fusion gene standards (F1–F5): 101, 102, 103, 105, and 106 copies/5 µl.|ABL standards (C1–C3): 103,104, and 105 copies/5 µl.|||
Performance
To ensure highest sensitivity, the ipsogen PML-RARA bcr1 kit has been optimized to detect PML-RARA bcr1 and ABL transcripts and uses prediluted plasmid standards and primers and probe mixes (see figures Accurate detection of PML-RARA bcr1 fusion gene plasmid standards and Reliable detection of ABL plasmid standards).
Principle
The ipsogen PML-RARA bcr1 Kit is a ready-to-use kit for the quantification of PML-RARA type bcr1 fusion transcripts using real-time PCR. The ipsogen PML-RARA bcr1 Kit is based on the amplification and detection of specific PML-RARA bcr1 transcripts, relative to ABL control gene expression, in total RNA extracted from bone marrow or peripheral blood samples in a subgroup of acute myeloid leukemia (AML) patients diagnosed with M3 cytomorphology and t(15;17)(q22;q21) translocation, with a breakpoint into PML intron 6 (see figures PML-RARA bcr1 gene transcript and ABL control gene transcript). The kit provides high levels of specificity, sensitivity, and reproducibility. Each ipsogen PML-RARA bcr1 Kit provides 5 standard dilutions for PML-RARA bcr1 fusion gene and 3 standard dilutions for ABL. Use of the standards enables accurate quantification of transcripts. The technology used for quantification of PML-RARA bcr1 has been standardized according to Europe Against Cancer (EAC) recommendations and the ipsogen PML-RARA bcr1 Kit uses this validated technology to calibrate results.
Procedure
The first step is reverse transcription of total RNA in a sample into cDNA. The second step is the amplification of cDNA by real-time PCR. Using the ipsogen PML-RARA bcr1 Kit allows detection and quantification of PML-RARA bcr1 and ABL transcripts. Simply start the reaction using the optimized protocols described in the kit handbook.
Applications
The ipsogen PML-RARA bcr1 Kit enable sensitive and reliable detection and quantification of PML-RARA bcr1 transcripts, relative to ABL control gene expression, for in vitro diagnostic use.

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