Evaluation of the complete molecular response requires the highest possible sensitivity of the assay. The FDA-cleared QuantideX qPCR BCR-ABL IS Kit takes chronic myeloid leukemia (CML) monitoring to a new level of sensitivity: 0.002% IS (MR4.7).

It is a qPCR-based in vitro diagnostic test for the quantification of BCR-ABL1 and ABL1 transcripts in whole blood total RNA from patients diagnosed with positive t (9; 22) CML expressing e13a2 and/or fusion transcripts. e14a2.

Features & Benefits

The unprecedented level of sensitivity of the QuantideX qPCR BCR-ABL IS Kit, coupled with a simple to run the individual test, enables laboratories to reliably and reproducibly monitor a much deeper molecular response.

Reduced complexity

Ease of data analysis and reporting:

  • Direct reporting on the international scale (IS) – no conversion factor calculations or sample swapping required
  • Data analysis software eliminates manual intervention to provide automated calculations and streamlined reports

Optimized workflow

Valuable operator intervention time has been significantly reduced thanks to:

  • Multiplexed design amplifies and detects both fusion and control gene in the same reaction All-inclusive reagents sourced and quality-controlled together from a single source Premixed reagents leading to fewer pipetting steps in master mix preparation

Quality performance

Robust and Reliable Detection of BCR-ABL Transcripts with a High Sensitivity Assay:

  • MR4.7 Limit of Detection (LOD) (0.002% IS): 95% detection in LOD as determined using human RNA samples Increased analytical sensitivity without compromising analytical specificity: no CML-related (major) transcripts are detected in the assay Armored RNA┬«-based standards that provide true RNA quantification for a quantitative RNA assay Robust performance as indicated by minimal variability from repeated measurements

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