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.

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
  • 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 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

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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

 

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

Resources

1. Establishment of the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL mRNA. White et. al. Blood. 2010;116(22):e111-7. doi: 10.1182/blood-2010-06-291641. Epub 2010 Aug 18

2. Establishment of a standardized multiplex assay with the analytical performance required for quantitative measurement of BCR-ABL1 on the international reporting scale. Brown et. al. Blood Cancer J. 2011;1(3):e13. doi: 10.1038/bcj.2011.10. Epub 2011 Mar 25

3. Establishment and validation of analytical reference panels for the standardization of BCR-ABL1 quantitative measurements on the international scale. White et. al. Clin Chem. 2013 Mar 7. [Epub ahead of print]

Browse all Publications

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

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.

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

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

 

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

Resources

1. Establishment of the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL mRNA. White et. al. Blood. 2010;116(22):e111-7. doi: 10.1182/blood-2010-06-291641. Epub 2010 Aug 18

2. Establishment of a standardized multiplex assay with the analytical performance required for quantitative measurement of BCR-ABL1 on the international reporting scale. Brown et. al. Blood Cancer J. 2011;1(3):e13. doi: 10.1038/bcj.2011.10. Epub 2011 Mar 25

3. Establishment and validation of analytical reference panels for the standardization of BCR-ABL1 quantitative measurements on the international scale. White et. al. Clin Chem. 2013 Mar 7. [Epub ahead of print]

Browse all Publications

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