Cepheid xpert monitor platform for the confirmation of BCR-ABL1 IS conversion factors for the molecular monitoring of chronic myeloid leukaemia
Abstract
Molecular monitoring of BCR-ABL1 expression in chronic myeloid leukaemia (CML) is well established. As the International Scale (IS) normalised BCR-ABL1/ABL1 ratio at 3 months post-treatment is now an important milestone in patients' treatment schedule, the reliable and reproducible measurement of BCR-ABL1 levels is therefore paramount. IS conversion factors (CF) are established via sample exchange and yearly ratification with an external reference laboratory. Since any change to an established IS CF could lead to discontinuity in longitudinal results, we wished to add an internal verification step as an additional safeguard. We used the Cepheid GeneXpert qPCR and IS calibrated Xpert BCR-ABL Monitor cartridge system, parallel to our in-house pipeline on 50 CML samples, over the period of one week to verify the CF for those samples and compare it to the externally provided CF. The median non-IS in-house BCR-ABL1/ABL1 values were significantly different than that from the IS GeneXpert, but they became non-significant when adjusted to CF provided by the CXM and by the current external CF, validating it. These metrics can help decide to accept or reject an updated CF value, especially where a significant change in CF might lead to a discontinuity in ongoing patient monitoring.
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Standardized clinical assessment of mRNA expression in CML can be performed with droplet digital PCR and the Cepheid GeneXpert qPCR cartridge system.
“The technical platforms allowing a standardized clinical assessment of mRNA expression levels for CML samples include droplet digital PCR (ddPCR; ref. 46) and the Cepheid GeneXpert qPCR cartridge system (47).”
From Discovery of a Novel CIP2A Variant (NOCIVA) with Clinical Relevance in Predicting TKI Resistance in Myeloid Leukemias (2021) · cites this paper as [47]
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Mäkelä, E., Pavic, K., Varila, T., Salmenniemi, U., Löyttyniemi, E., Nagelli, S. G., Ammunét, T., Kähäri, V.-M., Clark, R. E., Elo, L. L., et al. (2021) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-20-3679 · Cited by 18 · see citing works
- Authors
- Gerrard, G., Foong, H. E., Mudge, K., Alikian, M., Apperley, J. F., & Foroni, L.
- Affiliations
- University College London (GB)
- Imperial College Healthcare NHS Trust (GB)
- Hammersmith Hospital (GB)
- Imperial College London (GB)
- Corresponding author
- Gerrard, Gareth
- Venue
- Leukemia Research
- Publisher
- Elsevier BV
- Published
- 2016-10
- Volume
- 49
- Pages
- 47-50
- ISSN
- 0145-2126 (ISSN-L)
- OpenAlex
- W2515502958
- Cited by
- 8
- References
- 10
- Citations by year
- 2026: 1 · 2024: 1 · 2023: 3 · 2021: 1 · 2020: 2
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Leukemia Research (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute for Health and Care Research (NF-SI-0611-10275)
- Imperial College London
- NIHR Imperial Biomedical Research Centre
- Topics
- Health Sciences › Medicine › Hematology › Chronic Myeloid Leukemia Treatments
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Keywords
- chronic myeloid leukemia, BCR-ABL1, molecular monitoring, qPCR assay validation
- MeSH terms
- Humans, Monitoring, Physiologic, Reference Standards, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Fusion Proteins, bcr-abl, Real-Time Polymerase Chain Reaction
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