CD34+ Stem Cell Enumeration Programme (Accredited)

Programme objective: To assess a laboratory’s ability to calculate the absolute count (cells/µL) and percentage of CD34+ stem cells using flow cytometry.

Clinical/scientific background: In haematopoietic stem cell transplantations, the use of CD34+ Stem Cell Enumeration is an essential part of the treatment process. It allows the monitoring of donor mobilisation pre harvest and to ensure sufficient cells are collected to ensure engraftment will occur. This programme is currently the largest world-wide for CD34+ haematopoietic progenitor cell (hpc) enumeration.

Suitability: Participation in this External Quality Assessment (EQA) programme is open to laboratories employing any Flow Cytometric approach for the detection and enumeration of CD34 stems cells in a sample.

Samples are suitable for use with whole blood lysis techniques and sequential gating strategies. Laboratories are requested to report both percentage and absolute values (in cells per microlitre), although performance is only monitored using the absolute values.

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 600.

Sample type/distribution: The programme uses stabilised peripheral blood obtained from consenting patients following stem cell mobilisation. The programme issues 2 samples per trial and trials are issued a minimum of 4 and a maximum of 6 times a year.

Trial duration: Trials for this programme are live/open for a minimum of three 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, reminding them of the trial closure date.

Subcontracted areas: No activities in relation to this EQA programme are subcontracted.

Updates to the programme for current or upcoming year: 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.