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Quantidex® QPCR BCR-ABL IS Kit

The QuantideX BCR-ABL IS Kit provides labs with a robust and reliable method for monitoring leukaemia patients, also allowing them to keep pace with the advances in TKI therapy. Reduced Complexity | Ease-of-data analysis and reporting: Direct reporting on the International Scale (IS): No sample exchange or conversion factor calculations required Data analysis software eliminates manual […]

The QuantideX BCR-ABL IS Kit provides labs with a robust and reliable method for monitoring leukaemia patients, also allowing them to keep pace with the advances in TKI therapy.

Reduced Complexity | Ease-of-data analysis and reporting:

  • Direct reporting on the International Scale (IS): No sample exchange or conversion factor calculations required
  • Data analysis software eliminates manual intervention to provide automated calculations and streamlined reporting

Optimized Workflow | Valuable operator hands-on time has been significantly reduced through:

  • Multiplexed assay design that amplifies and detects both fusion and control gene in the same reaction
  • All-inclusive reagents sourced and Quality Controlled together from a single vendor
  • Pre-mixed tubes leading to fewer pipetting steps in the mastermix preparation

Quality Performance | Detecting BCR-ABL Transcripts robustly, reliably with a highly sensitive assay:

  • Sensitivity of MR4.7 (0.002%IS): 95% positivity at this LOD as determined by testing human RNA specimens
  • Increased sensitivity without compromising specificity: Non-CML (major) transcripts not detected by the assay
  • Armoured RNA based standards providing true RNA quantification for a quantitative RNA assay
  • Robust performance as indicated by minimum variability of replicate measurements

Analytical Characteristics

  • Proven sensitivity based on rigorous testing criterion (Figure 1)
  • Minimal variability across the entire dynamic range of % IS values (figure 2)
  • Multiplexed design leads to workflow and cost efficiency (figure 3)

Proven Sensitivity Based on Rigorous Testing Criterion

Figure 1 Probit_US_IVDweb

Figure 1: LOD as determined by CLSI EP-17A2 guidelines by testing Human RNA dilutions ranging from MR4.4 to MR6: 60 replicates of each dilution for a total of 1260 data points.
Minimal Variability Across Entire Dynamic Range of %IS Values

Minimal Variability Across Entire Dynamic Range of %IS Values

Table 1 BCRABL IS Kit

Figure 2. Precision was evaluated by using 5 different levels of positive specimen, tested by 3 operators over 20 runs. Each level was tested 40 times to obtain Standard Deviations.

Multiplexed Design Leads to Workflow and Cost Efficiency

Figure 3: Comparison of a plate layout for 8 sample run on Asuragen plate (left) and an alternate non-multiplex assay (right): 19 reactions for Asuragen set up vs 60-64 reaction on a non-multiplex assay set up

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Quantidex® QPCR BCR-ABL IS Kit
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