Post-Stem Cell Transplant Chimerism Monitoring (Accredited)

Programme objective To assess a laboratory’s ability to accurately quantify percentage donor chimerism post haematopoietic stem cell transplantation.

Clinical/scientific background Chimerism analysis is an integral tool for the monitoring of donor engraftment following haematopoietic stem cell transplantation. It enables early detection of relapse/loss of engraftment and allows pre-emptive therapeutic intervention. Quantitative molecular analysis of donor and recipient derived cells utilises polymorphic markers, usually Short Tandem Repeats (STRs), small insertions and deletions (InDels) or Single Nucleotide Polymorphisms (SNPs), analysed via capillary electrophoresis, real-time quantitative PCR (qPCR), digital PCR (dPCR) or next generation sequencing (NGS) technologies.

Suitability Participation in this External Quality Assessment (EQA) programme is open to laboratories employing any DNA-based molecular genetic approach for the assessment of whole blood chimerism following haematopoietic stem cell transplant.

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: 200

Sample type/distribution Five trials are issued per annum, each consisting of four peripheral blood samples (1x donor, 1x recipient and 2x post SCT in each trial issue). This is to ensure adherence to the European Federation of Immunogenetics (EFI) Standards for Histocompatibility & Immunogenetics Testing, v8.1 (01.01.2024), in which standard D1.5.1.11 mandates ‘10 [EQA] tests of different donor/recipient mixtures in the range 0% - 100%, excluding the reference donor and recipient samples’ annually. Participants are asked to submit a value for % donor chimerism, together with details of the methodology used. The trial schedule can be found here: https://www.ukneqasli.co.uk/eqa-pt-programmes/trial-schedules/

Trial duration Trials for this programme are live/open for a minimum of four weeks. Please note, trials issued/closing in August or December are extended by one week. An automated email is sent two days prior to the trial closing, to any participant that has not returned results, warning them of the trial closure date.

Subcontracted areas Post-closure testing of samples for this programme is 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 N/A

To register for this programme, please click here.