Journal
LEUKEMIA
Volume 33, Issue 9, Pages 2254-2265Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/s41375-019-0499-4
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Funding
- Ministry of Health of the Czech Republic [16-34272A]
- CESNET under the programme Projects of Large Research, Development, and Innovations Infrastructures [LM2015042]
- CERIT Scientific Cloud under the programme Projects of Large Research, Development, and Innovations Infrastructures [LM2015085]
- Ministry of Health, Czech Republic [00064203]
- Italian Association for Cancer Research (AIRC)
- Comitato Maria Letizia Verga
- [PRIMUS/17/MED/11]
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Assessment of clonality, marker identification and measurement of minimal residual disease (MRD) of immunoglobulin (IG) and T cell receptor (TR) gene rearrangements in lymphoid neoplasms using next-generation sequencing (NGS) is currently under intensive development for use in clinical diagnostics. So far, however, there is a lack of suitable quality control (QC) options with regard to standardisation and quality metrics to ensure robust clinical application of such approaches. The EuroClonality-NGS Working Group has therefore established two types of QCs to accompany the NGS-based IG/TR assays. First, a central polytarget QC (cPT-QC) is used to monitor the primer performance of each of the EuroClonality multiplex NGS assays; second, a standardised human cell line-based DNA control is spiked into each patient DNA sample to work as a central in-tube QC and calibrator for MRD quantification (cIT-QC). Having integrated those two reference standards in the ARResT/Interrogate bioinformatic platform, EuroClonality-NGS provides a complete protocol for standardised IG/TR gene rearrangement analysis by NGS with high reproducibility, accuracy and precision for valid marker identification and quantification in diagnostics of lymphoid malignancies.
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