Lymphoid Gene Panels (Pilot - Not Accredited)

Programme objective To assess a laboratory’s ability to accurately determine genetic status in lymphoid malignancies, using high throughput sequencing methods.

Clinical/scientific background Lymphoid malignancies represent a heterogenous group of disorders with many overlapping biological and genetic features. Genomic data is becoming increasingly important to distinguish and classify these disorders. It is becoming deeply embedded in all aspects of patient management, providing important diagnostic and prognostic information initially and markers for measurable residual disease testing (MRD) post treatment. The increasing importance of genomic data has been acknowledged in the recent WHO5 guidelines¹.

High throughput sequencing methods have steadily evolved in recent years to allow the development of large lymphoid panels necessitating external quality assessment (EQA)/proficiency testing (PT) in this area. Initially this programme was launched as chronic lymphocytic leukaemia specific programme; however, from 2022/23 the programme was expanded to encompass a broader range of lymphoid neoplasms including for example, acute lymphoblastic leukaemia, plasma cell dyscrasia (subject to sample material availability) to reflect the application of NGS panel testing to evermore lymphoid malignancies.

Suitability Participation in this External Quality Assessment (EQA) programme is open to laboratories employing any high throughput DNA-based sequencing panel approach for the evaluation of genetic status in lymphoid neoplasms.

Please note, the programme may distribute extracted genomic DNA or patient material which was processed >48 hours following collection, which is not suitable for an RNA/transcriptome-based assay. Please contact admin@ukneqasli.co.uk if you use RNA as the primary input material for your assay.

All EQA programme communications, data entry, and reports will be conducted exclusively in the English language. Participants must ensure proficiency in English to fully engage in the programme.

The programme welcomes participation from diverse sectors including:

• Clinical Healthcare Laboratories
• Academic and Research Institutions
• In Vitro Diagnostics (IVD) Manufacturers
• Pharmaceutical companies
•  

Minimum participation level 30, maximum participation level 400.

Sample type/distribution One lyophilised cell based (cell line or patient) sample is issued twice per annum, plus additional samples e.g. DNA in tris-EDTA, where appropriate. Clinical scenarios are included with trial samples to guide panel/bioinformatic analysis. The trial schedule can be found here: https://www.ukneqasli.co.uk/eqa-pt-programmes/trial-schedules/

Trial duration Standardly trials for this programme are live/open for a minimum of 6 weeks. Please note, trials issued/closing in August or December are extended by 1 week.

Subcontracted areas Pre-issue and post-closure testing of samples for this programme are subcontracted, although the final decision about sample suitability lies with the EQA provider; no other activities in relation to this EQA programme are subcontracted.

Updates to the programme for current or upcoming year To facilitate a quicker turnaround time for trial report publication, one distribution will focus on summarising the variants detected by participants (including methodological aspects) and the other will additionally provide educational elements related to variant interpretation/classification.

References

1. Alaggio, R., Amador, C., Anagnostopoulos, I. et al. The 5th edition of the World Health Organization Classification of Haematolymphoid Tumours: Lymphoid Neoplasms. Leukemia 36, 1720–1748 (2022).

To register for this programme, please click here.