QuantideX® qPCR BCR-ABL IS Kit

BCR-ABL blood cancer cells

Assessing complete molecular response requires the highest possible assay sensitivity. 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’s a qPCR-based in vitro Diagnostic test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive CML patients expressing e13a2 and/or e14a2 fusion transcripts.

Download the QuantideX qPCR BCR-ABL IS Kit Brochure

Features & Benefits

The QuantideX qPCR BCR-ABL IS Kit’s unprecedented level of sensitivity coupled to a simple-to-run, singlicate test, allows labs to reliably and reproducibly monitor much deeper molecular response.

Reduced Complexity
Ease-of-data analysis and reporting:

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

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

  • 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 vendor
  • Pre-mixed reagents leading to fewer pipetting steps in the mastermix preparation

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

  • Limit of Detection (LOD) of MR4.7 (0.002%IS): 95% detection at LOD as determined using human RNA specimens
  • Increased analytical sensitivity without compromising analytical specificity: Non-CML (major) transcripts not detected in assay
  • Armored RNA®-based standards providing true RNA quantification for a quantitative RNA assay
  • Robust performance as indicated by minimum variability of replicate measurements

Download Brochure

Analytical Characteristics

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

Proven Sensitivity Based on Rigorous Testing CriterionBCR-ABL US-IVD Table 1
Table 1:
 LOD as determined by CLSI EP17-A2 guidelines by testing Human RNA dilutions ranging from MR4.4 to MR6: 60 replicates of each dilution for a total of 1680 data points

Minimal Variability Across Entire Dynamic Range of %IS ValuesQdeX BCR-ABL US-IVD Table2
Table 2: Precision evaluated by testing 5 different MR levels, using 3 operators, 9 runs for a total of 450 data points
*The fold change column represents summarized data for clarification purpose only. To see full precision data, please refer to Table 4 of the Instruction for Use.

Multiplexed Design Leads to Workflow and Cost Efficiency
Figure 3a AsuragenPlate Layout Figure 3b CompetitorPlate2016

 

 

 

 

Figure 1: Comparison of a plate layout for 8 sample run on Asuragen plate (left) and an alternate non-multiplex assay (right): 19 reactions for Asuragen setup vs. 60-64 reactions on a non-multiplex assay setup

 

Additional Resources

Videos
View our video resources.
Posters
Publications and Articles

Browse all Publications

The test is not intended for the diagnosis of CML or for monitoring rare transcripts resulting from t(9;22).

Ordering

Product Name Number of Reactions Catalog Number
QuantideX® qPCR BCR-ABL IS Kit 60 49574

T 1-877-777-1874; 512-681-5200
F 512-681-5202
E orders@asuragen.com

QuantideX® qPCR BCR-ABL IS Kit

There’s only one way to detect complete molecular response (CMR) – with a more sensitive assay. The QuantideX® qPCR BCR-ABL IS Kit takes chronic myeloid leukemia (CML) monitoring to a new level of sensitivity – 0.002% IS (MR4.7). It’s a qPCR-based in vitro Diagnostic test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive CML patients expressing e13a2 and/or e14a2 fusion transcripts.

Download the QuantideX qPCR BCR-ABL IS Kit Brochure

Features & Benefits

ceivdThe QuantideX qPCR BCR-ABL IS Kit provides labs with a robust and reliable method for monitoring leukemia 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
  • Armored RNA based standards providing true RNA quantification for a quantitative RNA assay
  • Robust performance as indicated by minimum variability of replicate measurements


Download Brochure

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 CriterionFigure 1 Probit_US_IVDweb

Figure 1: LOD as determined by CLSI EP17-A2 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
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 3a AsuragenPlate LayoutFigure 3b CompetitorPlate2016

 

 

 

 

 

 

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 setup vs. 60-64 reactions on a non-multiplex assay setup

 

Additional Resources

Videos
View our video resources.
Posters
Publications and Articles

Browse all Publications

The test is not intended for the diagnosis of CML or for monitoring rare transcripts resulting from t(9;22).

Ordering

Product Name Number of Reactions Catalog Number
QuantideX® qPCR BCR-ABL IS Kit 60 86003

T 1-877-777-1874; 512-681-5200
F 512-681-5202
E orders@asuragen.com

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