Product Description
| Brand |
Cepheid |
| Product Type |
PCR Kit |
| Pack Size |
10T |
| CAT No |
GXBCRABL-US-10 |
| Application |
Molecular Biology |
Xpert BCR-ABL Ultra is a quantitative test for BCR-ABL major breakpoint (p210) transcripts that provides highly sensitive and on-demand molecular results. Based on the innovative GeneXpert technology, Xpert BCR-ABL Ultra automates the entire test process including RNA isolation, reverse transcription, and fully-nested real-time PCR of BCR-ABL target gene and ABL reference gene, in one fully automated cartridge.
Fast and Reliable Quantification of BCR-ABL1 TranscriptsWith a turnaround time of roughly 2 hours, the Cepheid Xpert BCR-ABL Ultra delivers both qualitative and precise quantitative results for BCR-ABL1 major fusion transcripts. The assay operates using a fully automated, cartridge-based method, minimizing manual intervention and reducing contamination risk. Its internal controls guarantee sample integrity and assay validity, supporting high diagnostic confidence for routine clinical use.
Convenient and Safe WorkflowThe single-use cartridge integrates all reagents and employs a sample-in, result-out design. Qualified laboratory staff simply add 1 mL of whole blood or bone marrow, scan the integrated barcode for tracking, and insert the cartridge into the GeneXpert platform. The closed system not only streamlines workflow but also enhances laboratory safety and minimizes exposure to biohazards.
FAQ's of Cepheid Xpert BCR-ABL Ultra:
Q: How does the Cepheid Xpert BCR-ABL Ultra cartridge work?
A: The cartridge utilizes real-time quantitative PCR (RT-qPCR) technology to detect and quantify BCR-ABL1 (p210) fusion transcripts directly from whole blood or bone marrow. After adding a 1 mL sample and inserting the cartridge into the compatible GeneXpert or Infinity system, the process is fully automated, delivering results in about 2 hours.
Q: What types of samples and how much volume are required for the assay?
A: The Xpert BCR-ABL Ultra is validated for use with whole blood and bone marrow samples. A volume of 1 mL is required for each analysis, allowing for efficient and standardized sample processing.
Q: When and where should the assay be used?
A: This test is designed for use in clinical laboratory environments by qualified laboratory personnel. It is suitable for the detection and quantification of BCR-ABL1 in patient samples at any point when molecular evaluation is indicated, such as diagnosis or monitoring of chronic myeloid leukemia (CML).
Q: What is the process for running the test?
A: To perform the assay, qualified users add the prepared sample to the pre-loaded cartridge, scan the built-in barcode for identification, load it into the GeneXpert instrument, and initiate the run. The automated workflow includes integrated sample processing and result analysis, requiring minimal hands-on time.
Q: What are the main benefits of using Cepheid Xpert BCR-ABL Ultra?
A: Key benefits include rapid, accurate results; a closed-tube, contamination-minimizing process; full automation for reduced operator error; comprehensive reagent integration; international scale reporting; and user-friendly operation-ideal for routine clinical diagnostics.
Q: Where can this assay be used?
A: The Cepheid Xpert BCR-ABL Ultra is CE-IVD certified and suitable for laboratory use in regions accepting CE-marked diagnostics, such as India and Europe. It is not FDA-cleared for use in the United States.
Q: What safety considerations and storage instructions apply?
A: The cartridge is non-toxic when used as directed. It should be stored unopened at 2-28C in dry conditions, and has a shelf life of up to 12 months under recommended storage conditions.