Measurable Residual Disease for ALL by Flow Cytometry (Accredited)

Programme objective: This programme issues stabilised whole blood into which has been spiked stabilised B cell acute lymphoblastic leukaemia (B-ALL) material. Laboratories are required to determine the level of measurable residual disease by flow cytometry, please note this programme is not suitable for the measurement of MRD by molecular methods.

Clinical/scientific background: The assessment of measurable Residual Disease (MRD) populations is often performed following treatment for leukaemic disorders. The levels of MRD are used as a predictive factor for relapse and as an indicator for patients entering remission. As such the measurement of MRD can have a direct effect on the treatment regimen of a patient.

Suitability: Participation in this External Quality Assessment (EQA) programme is open to laboratories employing any Flow Cytometric approach for the detection of measurable residual disease in a sample.

These samples are suitable for flow cytometric analysis only, they are not suitable for molecular methods. For molecular MRD EQA programmes, please follow this link https://www.ukneqasli.co.uk/eqa-pt-programmes/molecular-haemato-oncology-programmes/

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 300.

Sample type/distribution: The programme issues a presentation sample together with 2 follow up samples a minimum of three and a maximum of four times per annum, subject to sample availability. Please note that the presentation sample will not contain the expected level of disease seen in a typical clinical scenario. The 2 follow up samples are manufactured from the same B-ALL case and are designed to represent different stages post treatment to assess the ability of a centre to detect B-ALL leukaemic cells at measurable residual disease levels within a background of stabilised normal whole blood. Laboratories are requested to report the percentage of residual leukaemic cells in the 2 follow up samples as a percentage of the total leucocytes. A trial schedule may be found here https://www.ukneqasli.co.uk/eqa-pt-programmes/trial-schedules/

Trial duration: Trials for this programme are live/open for 3 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 not subcontracted.

Updates to the programme for current or upcoming year: Samples issued will typically be within the range 0.01% to 0.10% to reflect current thresholds for risk stratification, (0.01% and 0.1% MRD at day 29 identifying good risk and poor risk respectively). Occasionally samples <0.01% to 0.001% will be issued to reflect higher sensitivity MRD assays in development. In such instances, the sample will not be scored thus no performance classifications will be applied.

For all MRD programmes, where a sample containing an MRD population has been issued, participants that submit a result of zero will automatically receive a critical classification.

Further electronic exercises may be issued. Each year we quote a minimum and a maximum number of possible trial distributions that will be issued on our website, subject to sample availability. Historically, we have consistently achieved the maximum number of distributions. In 2025-2026 due to staffing shortage, we are unlikely to hit the maximum number of distributions, as we have in previous years and trials may not be equally distributed throughout the year i.e; bimonthly. We will return to the full trial distribution schedule in 2026-2027. Please accept our apologies for this short-term decrease in our services.

To register for this programme, please click here.