Xpert^® BCR-ABL Ultra p190

The Need

The ongoing presence of the Ph chromosome in ALL patients after consolidation therapy is a significant predictor of relapse, and monitoring is recommended. Established international organizations recommend definitive timepoints for monitoring BCR-ABL p190 in ALL and CML patients.^7-10 Unlike the BCR-ABL World Health Organization international standard (WHO IS) for the p210 transcript, currently, there are no international standards that can be used to standardize the p190 fusion transcript, posing a challenge for a quantitative assay monitoring p190 transcript level.

Current testing options for BCR-ABL p190 monitoring for both CML and ALL patients are not only cumbersome, but can be expensive and time consuming for the lab to implement because:

• Available testing methods can be complex and create inefficient laboratory workflows.
• No international scale has been established for p190 monitoring, so laboratories are dependent on ratios and must run laborious standard curves.

The Solution

Xpert BCR-ABL Ultra p190 is an automated test for quantifying the amount of BCR-ABL p190 transcript as a ratio of BCR-ABL p190/ABL with high sensitivity.

Based on the innovative GeneXpert^® technology, Xpert BCR-ABL Ultra p190 automates the testing procedure, including RNA isolation, reverse transcription, and fully nested real-time PCR of BCR-ABL target gene and ABL reference gene in one automated cartridge.

Leveraging Cepheid’s lab in a cartridge™ technology, the Xpert BCR-ABL p190 test decreases workflow complexity and hands-on time by automating the entire testing process, delivering faster results.

Xpert BCR-ABL Ultra p190 is a quantitative test for the BCR-ABL minor breakpoint (p190) transcripts that provide high test sensitivity, standardization, and on-demand molecular results in ≤2.5 hours. With minimal hands-on time and a streamlined workflow, Xpert BCR-ABL Ultra p190 eliminates the need for time-consuming hands-on processes and enables the laboratory to run p190 testing in-house.

Performance:

Simple & Easy to Use

• ≤2.5 hours total testing process
• Simply add treated blood sample and an off-board reagent to the Xpert cartridge

Sensitive & Robust Design

• Includes two internal controls
• 4 mL input volume of EDTA whole blood supports high test sensitivity for detection of low-level transcripts
• High sensitivity and low inter-laboratory variation¹¹
• Clinically demonstrated limit of detection of 0.0065%¹¹