Leukaemia Immunophenotyping (Accredited)

Programme objective: The purpose of this programme is to assess a laboratory’s ability to immunophenotype a leukaemia sample using flow cytometry and immunochemistry. This programme is designed to represent testing pathways in a clinical laboratory.

Clinical/scientific background: Immunophenotyping is an important aspect of the diagnostic pathway for patients with acute lymphoblastic and myeloid leukaemias (ALL and AML), lymphomas and chronic lymphoproliferative disorders. The use of flow cytometry and immunochemistry techniques allows the identification and characterisation of cellular populations based on the cell surface marker or intracellular antigen expression. Leukaemia immunophenotyping is also useful in the monitoring of treatment effectiveness.

Suitability: Participation in this external quality assessment (EQA) programme is open to laboratories employing any flow cytometric approach for the immunophenotyping of leukaemia samples.

To allow for a closer representation of leukaemia immunophenotyping, participants are requested to treat samples as part of their routine testing pathways. If this requires partial testing at your centre and forwarding the sample to a second centre for further testing, please do so. Participants can select the appropriate antigens/panels for analysis of samples with the aid of the clinical details, Full Blood Count (FBC) results and digital image provided on the exercise data entry page. Results should be submitted in terms of positive or negative expression of your selected antigens as related to the malignant population; this is the primary mechanism used in performance monitoring. In addition, the intensity of reaction of your chosen antigens should also be provided.

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: Blood obtained from consenting patients or diagnostic waste that is stabilised will be issued. This material can be readily analysed using whole blood lysis techniques. The samples are pre-diluted so dilution to obtain a suitable white cell count for analysis is not required.

No blood film will be provided with the sample, a digital blood image is provided. Participants should not use the stabilised sample to make peripheral blood smears as the stabilisation process is designed to preserve the cells for flow cytometric analysis, and so this may result in aberrant blood film morphology that could be misleading.

The programme issues 1 sample 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, warning 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: We're pleased to confirm that we will be returning to the full number of trial distributions in 2026-2027. We appreciate your patience during this time. Please see the website for the trial schedule.

Historically, the consensus results from Leukaemia Immunophenotyping (LI) programme were taken through to the Leukaemia Diagnostic Interpretation (LDI) programme, where they were combined with a case history, morphological information and genetics data, and participants were asked to make a diagnosis based on the World Health Organization (WHO) classification system. This approach limits the type and variety of cases we are able to issue within the programme to the common, high cell count leukaemia and lymphoma cases suitable for use in the LI programme. In 2026-2027, it will no longer be a requirement, that a patient whose sample was used in the LI programme, will be used in the LDI programme. This change will allow us to send out a broader variety of cases of greater educational value to participants. Where there is educational value we may still use a case used in the LI programme.

To register for this programme, please click here.