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BCR/ABL1 QUANT™ TEST

The BCR/ABL1 Quant™ Test is a quantitative in vitro diagnostic device to monitor the BCR-ABL1 to ABL1 ratio by RT-qPCR on whole blood of diagnosed Ph+ Chronic myeloid leukemia (CML) patients expressing e13a2, e14a2 or e1a2 fusion transcripts as an aid in the assessment of complete cytogenetic response, major molecular response, minimal residual disease and relapse.

The Test starts with total RNA in a reverse transcription (RT), followed by multiplex real-time quantitative PCR (qPCR) amplification and quantification of BCR-ABL1 (e13a2, e14a2 and e1a2) fusion transcripts and the ABL1 transcript on a laboratory validated Real-Time PCR instrument.

  • Multiplexed assay design leads to operational and cost efficiencies; All inclusive BCR/ABL1 kit: No additional reagents required
  • Robust and reliable assay based on Armored RNA® technology for standard curve: RNA based calibrators for quantifying RNA
  • Analytical sensitivity of at least 1:105 and linear dynamic range across 6 logs
  • Assay aligned with the IS through the WHO primary standard

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