Paediatric Acute Leukaemia Translocations (Accredited)

Programme objective To assess a laboratory’s ability to accurately detect the t(12;21) (TEL::AML1 or ETV6::RUNX1), t(4;11) (KMT2A::AFF1 or MLL::AF4) and t(1;19) (E2A::PBX1 or TCF3::PBX1) rearrangement status, using molecular methods.

Clinical/scientific background The WHO classification of haematopoietic tumours uses genetic markers to aid in the classification of Precursor Lymphoid Neoplasms. The identification of the t(12;21) (TEL::AML1 or ETV6::RUNX1), t(4;11) (KMT2A::AFF1 or MLL::AF4) and t(1;19) (E2A::PBX1 or TCF3::PBX1) are useful diagnostic tools and also have prognostic significance that allow for therapeutic stratification.

Suitability Participation in this External Quality Assessment (EQA) programme is open to laboratories employing any DNA/RNA-based molecular genetic approach for the detection of the t(12;21) (TEL::AML1 or ETV6::RUNX1), t(4;11) (KMT2A::AFF1 or MLL::AF4) and t(1;19) (E2A::PBX1 or TCF3::PBX1) rearrangements. It is not mandatory to submit results for all rearrangements included in the scope of this programme; participants can submit a subset of results according to their laboratory test repertoire.

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 Two lyophilised cell line-based samples are issued three times per annum. 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 4 weeks. Please note, trials issued/closing in August or December are extended by 1 week. An automated email is sent 2 days prior to the trial closing, to any participant that has not returned results, warning them of the trial closure date.

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 No updates to report.

To register for this programme, please click here.