QuantideX® qPCR BCR-ABL IS Kit

bcr abl precision oncology solutions

A Scalable Workflow for BCR-ABL Monitoring in CML Patients

Confidently deliver results with the first FDA-cleared chronic myeloid leukemia (CML) monitoring assay for BCR-ABL Major breakpoints (e13a2, e14a2). Your lab is empowered to provide reliable results easily with direct reporting on the International Scale and deep clinical sensitivity of 0.002% IS (MR4.7). Scalable, high-throughput testing is enabled by QuantideX multiplex assay design and included analysis software.

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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 for your laboratory:

  • Direct reporting on the IS with four calibrators traceable to the WHO primary standards
  • All-in-one kit and software from a single vendor

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

  • Multiplex design detects BCR-ABL and ABL in the same reaction, with ability to run up to 49 samples per plate
  • Simplified reporting with included QuantideX Reporter software

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

  • Limit of Detection of MR4.7 (0.002% IS) was confirmed in clinical human blood samples, not cell lines
  • Rigorous validation with FDA-clearance, single- and multi-site reproducibility studies, and seven years in clinical market use

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Analytical Characteristics

Figure 1. Highly sensitive results

bcr abl cml monitoring kit yields highly sensitive results

LOD of 95% detection at MR4.7 was determined from 1,678 valid data points from human RNA, from 40 test runs by four operators over two kit lots, 15 days, and four instruments.†

Table 1. Highly reproducible results

bcr abl cml monitoring kit highly reproducible results

Single- and multi-site reproducibility studies† demonstrated minimal variation across the assay dynamic range, with a maximum standard deviation of 0.13 MR units.

Scalable Results

bcr abl cml monitoring kit has 8 samples including calibrators and controls

Only 19 reactions are required for eight samples tested with the QuantideX assay, compared to 64 reactions for an assay with
a simplex design and samples run in duplicate.

The QuantideX multiplex workflow allows up to 49 samples in singleton per plate, enabling efficient, high-throughput testing.

 

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

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

*US-IVD †Brown JT, et al. J Mol Diagn. 2019 Jul;21(4):718-733.

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.

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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 for your laboratory:

  • Direct reporting on the IS with four calibrators traceable to the WHO primary standards
  • All-in-one kit and software from a single vendor

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

  • Multiplex design detects BCR-ABL and ABL in the same reaction, with ability to run up to 49 samples per plate
  • Simplified reporting with included QuantideX Reporter software

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

  • Limit of Detection of MR4.7 (0.002% IS) was confirmed in clinical human blood samples, not cell lines
  • Rigorous validation with FDA-clearance, single- and multi-site reproducibility studies, and seven years in clinical market use

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

*US-IVD †Brown JT, et al. J Mol Diagn. 2019 Jul;21(4):718-733.

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