Detection of Low-Level Transcripts

Cepheid's Xpert^® BCR-ABL Ultra Test demonstrates a limit of detection down to MR4.5 (BCR-ABL1 IS 0.0032%) giving  confidence in measuring a deep molecular response (DMR).

A 4mL blood sample from a CML patient ensures reproducible detection of low-level BCR-ABL1 transcripts while adhering to recommended guidelines for monitoring response to TKI therapy.¹³

Figure 1.0 illustrates the levels of molecular response in CML as standardized by the International Scale (IS).²⁰

Normalized Results Reported on Accepted Standards

Treatment decisions are directly influenced by CML monitoring results. This makes the sensitivity of a BCR-ABL1 test crucial for patient management, particularly for patients who achieve a deep molecular response.¹⁶

The quantitative results for Cepheid's Xpert^® BCR-ABL Ultra Test are normalized against the reference gene ABL and converted to the International Scale (IS) via secondary standards derived from the World Health Organization standards. All this is performed for each lot of the test and by Cepheid such that no end user calculations are required to gain results on the %IS.

How long would you wait for your CML monitoring results?

3 hours? 15 days? 3 weeks?

The Xpert^® BCR-ABL Ultra Test provides CML monitoring results in less than 2.5 hours supporting informed clinical decisions.

The reduction in wait time for CML monitoring results is a consequence of a shortened testing process that streamlines the
laboratory workflow.

Figure 1.1 shows a comparison of time between a manual in-house assay and the Xpert^® BCR-ABL Ultra Test.^18,19

Easy Same-Day Process

The Xpert^® BCR-ABL Ultra Test runs on a fully integrated GeneXpert^® System that is automated for on-demand monitoring. Cepheid’s integrated platform and test reduce the long wait time to batch extract samples so that processing a patient’s blood upon arrival becomes a possibility. Perform your CML monitoring tests when it best fits your schedule.

Figure 1.2 highlights the steps required to load the assay and run the test on Cepheid’s GeneXpert System. The 2.5 hours test time does not include time needed for hands-on sample preparation.

GeneXpert^® Quality Controls for Xpert^® BCR-ABL Ultra

All tests, including the Xpert BCR-ABL Ultra Test, contain
internal quality controls, meaning every patient sample is
controlled independently.¹⁷

Internal Controls:

Sample Processing Control - controls the sample processing steps (e.g. lysis and extraction) and preserves the integrity of the nucleic acid and reagent bead rehydration

Amplification Control - detects enzyme integrity and possible PCR inhibition

Reagent Controls - checks the integrity of the probes and proper reconstitution of reagents

Instrument System Control - validates optics, temperature of the module and mechanical integrity¹⁷
 

Download the GeneXpert Quality Controls Brochure

Look Inside the Cartridge

Watch the video below to learn about the inner workings of the Cepheid's Xpert^® Test

29 Tests. 1 Platform.*

The Xpert^® BCR-ABL Ultra Test is one of many tests that run on the GeneXpert family of systems. Each individual test cartridge automates sample extraction, amplification, and detection within the GeneXpert System, which is available in different sizes to suit differing laboratory requirements and situations.

Discover the Scalability of GeneXpert Systems

*Not all tests run on the GeneXpert Systems are available in all countries.