Flow Cytometry Programmes
All of these programmes use stabilised blood products. The samples you will receive are stabilised using a patented procedure and will remain stable up to 1 year at between +2 and +8 degrees C. Please store any samples at this temperature until testing but allow the samples to reach ambient temperature before staining.
Because the material is stabilised some minor adjustments may be required to the Forward Scatter (FSc) and Side Scatter (SSc) Photo Multiplier Tube (PMT) voltages. This is normal and does not affect the staining characteristics. Owing to the stabilisation process, the cells are not viable. UK NEQAS LI therefore recommends that viability dyes are either not used or, if used, all cells are included in the viable cells gate. In addition, the stabilisation process allows for haemoglobin to leach out of the red blood cells. As a result of this the samples may have a haemolysed appearance. This is normal and the samples can be tested.
Do not be concerned if the haematology profile on these samples does not give a valid differential. This is due to the stabilisation process. These samples have been developed to give the optimum performance using “flow cytometric” assays and have been used in these EQA programmes for over fifteen years.
***NEW FOR 2026-2027***
Pilot CD19 CAR-T Cell Monitoring by Flow Cytometry Programme
Following two successful pre-pilot studies, the CD19 CAR-T Cell Monitoring by Flow Cytometry External Quality Assessment programme will be available for registration in 2026-2027. The programme will assess participants’ ability to detect CART19 positive cells in a peripheral blood background. There will be a limited number of registrations in the new programme for the initial launch year. See the website for details of how to register your interest.
Changes to the Leukaemia lmmunophenotyping and Leukaemia Diagnostic Interpretation Programmes
In 2026-2027, we plan to separate the Leukaemia lmmunophenotyping (LI) and Leukaemia Diagnostic Interpretation (LDI) programmes, so that the same case that has been used in LI does not need to be used in LDI. This will allow us to provide a wider variety of clinical scenarios to better reflect the range of cases laboratories are seeing. Please note, for a minority of cases where there is specific educational value, we may still send out the same case for both programmes. We will also be asking for participants to provide an approximate diagnosis (e.g. chronic/acute, myeloid/lymphoid) and information around further testing that they would recommend following testing in the LI programme, for educational purposes.
Webinar Plans
To promote the changes to the LI and LDI programmes we will be hosting a webinar in March 2026. This will focus on how leukaemia diagnosis is changing in the light of greater scientific understanding and technological advances. We will discuss how the UK NEQAS LI programmes are evolving to support this.
Development of the Immune Monitoring Programme
As part of our commitment to developing the EQA programmes provided by this centre we are in the process of developing the Immune Monitoring Programme to incorporate a wider selection of tests. Any further updates will be communicated to participants.
Trial Schedule
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.
* denotes changes to the programme in 2026/2027
Please see programme specific pages on our website for further details.
CD19 CAR-T Cell Monitoring by Flow Cytometry Programme (Pilot – Not Accredited)
Programme objective:
To assess a laboratory’s ability to detect CD19 CAR-T cells using flow cytometry.
Clinical/scientific background:
Chimeric Antigen Receptor (CAR) T-cell therapy is a form of immunotherapy used to treat various forms of haematological malignancies. A patient’s T cells are removed by leukapheresis and engineered in order to express a CAR. The CAR-T cells are manufactured so that they specifically target and destroy cells expressing the antigen they were manufactured for. The CAR-T cells are then cultured before they are infused back into the patient. Currently, there are licensed CAR-T cells available to treat haematological malignancies with CD19 and B Cell Maturation Antigen (BCMA) as the targets. Monitoring CAR T-cell populations in routine use is helpful to evaluate the success of the therapy and the status of the applied CAR-T cells. Such patient monitoring helps to estimate the systemic immune response and indicate the risk of immediate adverse effects or long-term complications1.
Suitability:
Participation in this External Quality Assessment (EQA) programme is open to laboratories employing any Flow Cytometric approach for the detection and enumeration of CAR-T cells in a sample.
Samples are suitable for use with whole blood lysis techniques and sequential gating strategies. Laboratories are requested to report the percentage of CAR-T cells in the sample.
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
Participation level is currently limited to 30 participants; however, this may be expanded as time goes on.
Sample type/distribution:
The programme uses stabilised peripheral blood containing CAR-T cells obtained from either consenting patients following CAR-T cell therapy or off-the-shelf CAR-T cells. The programme issues one sample per trial with one trial scheduled for issue per year although this may be increased.
Trial duration:
Trials for this programme are live/open for a week. Due to the nature of the sample, participants will be required to test the sample within a week of receipt. Sample delivery will be by courier only.
Subcontracted areas:
No activities in relation to this EQA programme are subcontracted. CAR-T cells used in manufacturing the samples may be obtained from a commercial company.
Updates to the programme for current or upcoming year:
N/A
To register for this programme, please click here
References:
- Blache U, Weiss R, Boldt A, Kapinsky M, Blaudszun AR, Quaiser A, Pohl A, Miloud T, Burgaud M, Vucinic V, Platzbecker U, Sack U, Fricke S and Koehl U (2021) Advanced Flow Cytometry Assays for Immune Monitoring of CAR-T Cell Applications. Front. Immunol. 12:658314. doi: 10.3389/fimmu.2021.658314
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:
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.
To register for this programme, please click here
Related Documents
Cerebrospinal Fluid (CSF) Immunophenotyping (Pilot – Not Accredited)
Programme objective:
This programme is designed to assess a laboratory’s ability to immunophenotype leukaemic cells in CSF by flow Cytometry.
Clinical/scientific background:
The infiltration of leukaemic cells into cerebrospinal fluids (CSF) is often associated with a poor prognosis.
Suitability:
Participation in this External Quality Assessment (EQA) programme is open to laboratories employing any Flow Cytometric approach for the detection of leukaemic cells in a CSF sample.
Participants are required to analyse the sample using their routine testing procedure to ascertain if there is CSF involvement of the disease type given. Results for CSF cell count, cell morphology and immunophenotyping via flow cytometry are requested in this programme. No cytospin film will be provided with the sample. Participants should not use the stabilised sample to make a cytospin 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.
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:
One sample is issued per trial and this programme issues samples a minimum of 2 times per annum and a maximum of 3. A sample of stabilised white cells suspended in artificial CSF will be provided together with a digital cytospin image for preliminary morphological analysis prior to undertaking flow cytometric assessment.
Trial duration:
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.
To register for this programme, please click here
Related Documents
Haematological Malignancy Bone Marrow Aspirate Assessment (Pilot – Not Accredited)
Programme objective:
This programme is designed to assess the ability of participants to identify cell types in a bone marrow aspirate.
Clinical/scientific background:
Bone marrow aspirate morphology is usually carried out to investigate evidence of haematological malignancy. It allows laboratories to look at cells present in the bone marrow and identify any morphological abnormalities or abnormal infiltration. Findings from bone marrow aspirate morphology can be combined with, immunophenotyping, histopathology and genetic results to reach a final confirmatory diagnosis.
Suitability:
Participation in this External Quality Assessment (EQA) programme is open to laboratories or individuals with the ability to analyse and report a bone marrow slide.
HMBMAA Individual: This option is for individuals wishing to take part in the programme for their own personal CPD purposes and who are paying for the registration themselves. It is not possible to register for this option in combination with any other programme. The invoicing address should be a personal address, and no purchase order number is required.
HMBMAA Institute Individual: This option is for individuals wishing to take part in the programme for their own personal CPD purposes, but their institute is funding their participation. It is not possible to register for this option in combination with any other programme. The invoicing address should be that of the institute finance department and a purchase order number is required.
HMBMAA 1-5 user license
HMBMAA 6-10 user license
HMBMAA 11-20 user license
These options are available for institutes who wish to enrol multiple people from their laboratory in the HMBMAA programme. The main laboratory can be included as one of the ‘users’ but this is not mandatory. Each person for whom a license is purchased will be allocated their own participant number with which to participate, but the institute will be invoiced centrally. NB if the main laboratory is included as a user in the HMBMAA programme it will be added to their general laboratory registration, a new participant number will not be issued in this instance. A ‘supervisor’ contact will also be added to the institute lab which will receive separate participant hub log in details. This will allow them to access functionality that will allow them to maintain the users within the license themselves (Add/Remove users from the license). If required, and on request only, we can also use this functionality to provide details of lab participation to the ‘supervisor’ including trial issues and confirming if results have been returned for each participant number associated with the license – please enquire about this service.
The invoicing address should be that of the ‘supervisors’ institute finance department and a purchase order number is required. These options can be used in combination with other programmes offered by UK NEQAS LI. Additional license requests over 20 users per laboratory should contact UK NEQAS LI for further assistance.
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- no limit.
Sample type/distribution:
This programme is totally web based and as such no samples are issued. Each trial consists of a digital image and participants will be required to provide assessment of the aspirate, perform a differential and report the blast cell population (total blast cells counted, total nucleated cells counted and blast cell populations size as a percentage), identify pre labelled blood cells and provide details of any further testing required following assessment of the bone marrow aspirate
This programme issues samples a minimum of 2 times per annum and a maximum of three
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 email is sent to supervisors a week before trial closure.
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.
To register for this programme, please click here
Related Documents
Immune Monitoring (Accredited)
Programme objective:
To assess a laboratory’s ability to calculate the absolute count (cells/µL) and percentage of lymphocyte subsets using flow cytometry.
Clinical/scientific background:
The enumeration of lymphocyte subsets is important in a variety of conditions such as primary immunodeficiency (e.g. Severe Combined Immunodeficiency / SCID) or the monitoring of drug therapies such as rituximab in autoimmune disorders. However, the most common use is in the monitoring of Human Immunodeficiency Virus / HIV, a secondary immunodeficiency disorder.
Suitability:
Participation in this External Quality Assessment (EQA) programme is open to laboratories employing any Flow Cytometric approach for the identification and enumeration of lymphocyte subsets 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), and performance is monitored using this data, unless a centre chooses to eschew either parameter in which case they would not be performance monitored for the relevant parameters. Non-flow cytometric systems and those that include electronic volume measurement to identify cells will be scored as separate cohorts to allow for the performance monitoring of these systems.
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 1200.
Sample type/distribution:
To ensure that the programme meets the requirements of all users the programme issues stabilised whole blood with laboratories required to determine the lymphocyte subsets (CD3+, CD3+/CD4+, CD3+/CD8+, CD19+ and CD16+/56+). 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, 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:
As part of our commitment to develop the External Quality Assessment (EQA) programmes provided by this centre we are in the process of developing the Immune Monitoring Programme to incorporate a wider selection of tests. Any further updates will be communicated to participants.
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.
To register for this programme, please click here
Related Documents
Leukaemia Diagnostic Interpretation (Accredited)
Programme objective:
The purpose of the programme is to assess an institute or an individual’s ability to diagnose leukaemia using a full spectrum of laboratory results and case information. This programme is designed to provide for a more realistic leukaemia diagnosis process.
The programme issues and examines a wide variety of cases. Each trial will consist of:
- Immunophenotype results
- A detailed case history
- Digital blood/marrow smears for morphological analysis using, where possible, a variety of stains
- Cytogenetics and Molecular Genetics data
Participants are expected to use this information, and, in the diagnosis, section provide a suitable diagnosis based on the 5th edition of the World Health Organization Classification of Haematolymphoid Tumours: Myeloid and Histiocytic/Dendritic Neoplasm and the International Consensus Classification of Myeloid Neoplasms and Acute Leukaemia.
Clinical/scientific background:
A diagnosis of leukaemia involves a combination of laboratory results and clinical information. It is important that laboratories can accurately interpret and diagnose the specific type and subtype of Leukaemia to guide treatment options, assess the prognosis and monitor a patient’s response to treatment.
Suitability:
Participation in this External Quality Assessment (EQA) programme is open to laboratories or individuals with the ability to diagnose leukaemia using a full spectrum of laboratory results and case information.
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- no limit.
Sample type/distribution:
No samples are issued for this programme; it is totally web-based. Each trial will consist of: Immunophenotype results, a detailed case history, digitally scanned blood film for morphological analysis, cytogenetics and molecular genetics data.
The programme is 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:
Following a reduction in the trial schedule in 2025-2026 we will be returning to the full trial schedule in 2026-2027. We apologise for any inconvenience caused.
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, genetics and histology data (where available), 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.
Participants will be able to register as an ‘Individual’ or an ‘Institute’ for this programme.
Institute – A laboratory or multidisciplinary team that diagnoses and classifies haemato-oncological disorders in clinical practice. Institutional participation enables formal external quality assessment of diagnostic performance.
Individual – A healthcare professional involved in the diagnosis of haemato-oncological disorders (e.g. haematologist, biomedical scientist, clinical scientist, histopathologist) who has registered for educational and continuing professional development purposes. Individual participation does not constitute formal external quality assessment.
Whereas historically ‘Individuals’ have been able to register free of charge for the LDI programme, due to concerns from the UK NEQAS LI steering committee around low return rates, there will now be a nominal charge for participation. There are significant administrative costs to participation, even if participants do not return results.
To register for this programme, please click here
Related Documents
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, genetics and histology 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 LDI 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
Low Level Leucocyte Enumeration (Accredited)
Programme objective:
The purpose of this programme is to assess a laboratory’s ability to calculate the absolute count (cells/μL) of leucocytes in leucodepleted blood products.
Clinical/scientific background:
The use of leucocyte depleted blood products became standard practice in blood transfusion in response to the possible risk of variant Creutzfeldt-Jakob disease (v-CJD) transmission. However, leucodepletion also has many other benefits such as a reduction in febrile transfusion reactions and a reduction in the risk of cytomegalovirus (CMV) transmission. As such most countries now routinely perform leucodepletion on all donated blood products to ensure a minimal number of residual leucocytes remain.
Suitability:
Participation in this External Quality Assessment (EQA) programme is open to laboratories employing any Flow Cytometric approach for the enumeration of low level leucocytes in a sample.
Laboratories are requested to report the absolute numbers of leucocytes in each sample expressed in cells per microlitre.
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:
Three stabilised red blood cell samples and three stabilised platelet samples are issued per trial. This programme issues samples 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.
To register for this programme, please click here
Related Documents
Measurable Residual Disease for ALL by Flow Cytometry (Accredited)
Programme objective:
This programme issues stabilised whole blood which has been spiked with 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.
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.
To register for this programme, please click here
Related Documents
Measurable Residual Disease for AML by Flow Cytometry (Pilot -Not Accredited)
Programme objective:
This programme issues stabilised whole blood into which has been spiked stabilised Acute Myeloid Leukaemia (AML) 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 two and a maximum of three 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 AML case and are designed to represent different stages post treatment to assess the ability of a centre to detect AML 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:
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 and a move towards accredited status. Please note that the Flow Cytometer Specific Statistics and MRD Group Specific Statistics tables will now only display robust data for groups of 20 or more. The number of returns for each method will still be shown.
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.
To register for this programme, please click here
Related Documents
Measurable Residual Disease for CLL by Flow Cytometry (Pilot – Not Accredited)
Programme objective:
This programme issues stabilised whole blood which has been spiked with stabilised Chronic Lymphocytic Leukaemia (CLL) 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 2 samples, a minimum of three and maximum of four times per annum, subject to sample availability. The 2 samples are manufactured from the same CLL case and are designed to represent different stages post treatment to assess the ability of a centre to detect CLL 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:
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 and a move towards accredited status. Please note that the Flow Cytometer Specific Statistics and MRD Group Specific Statistics tables will now only display robust data for groups of 20 or more. The number of returns for each method will still be shown
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.
To register for this programme, please click here
Related Documents
Measurable Residual Disease for Plasma Cell Myeloma by Flow Cytometry (Pilot -Not Accredited)
Programme objective:
This programme issues stabilised whole blood into which has been spiked stabilised Plasma Cell Myeloma (PCM) 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 two samples, a minimum of two times per annum and a maximum of three, subject to sample availability. The 2 samples are manufactured from the same PCM case and are designed to represent different stages post treatment to assess the ability of a centre to detect PCM 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. Where possible we may also issue a presentation sample although this is dependent upon the material characteristics. One electronic exercise will also be issued based on electronic data file analysis where participants will be asked to analyse the files and submit answers to a JotForm questionnaire.
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:
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.
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.
To register for this programme, please click here
Paroxysmal Nocturnal Haemoglobinuria (Accredited)
Programme objective:
Laboratories are requested to report the percentage of PNH erythrocytes (total, type II and type III) and the total clone size as a percentage for both PNH neutrophils and PNH monocytes in each sample. Additionally, they are asked to record whether a clone is present or absent. If a cell population is not routinely tested, then this option must be selected. Participants are also requested to provide information relating to gating and GPI linked antibodies and should also state their level of sensitivity for the assay for each cell population analysed.
Clinical/scientific background:
PNH is an acquired stem cell disorder affecting all blood cell lines that has severe implications to both the life expectancy and quality of life affected individuals. In addition, treatment of the disorder is expensive. For these reasons PNH testing by flow cytometry is classed as a critical clinical diagnostic test.
Suitability:
Participation in this External Quality Assessment (EQA) programme is open to laboratories employing any Flow Cytometric approach for the detection of PNH clone in a sample.
These samples are suitable for flow cytometric analysis only, and they are not suitable for those who use other detection methods such as gel cards.
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 two samples per trial, these are of stabilised whole blood into which stabilised PNH material may be spiked to create PNH Clone Present samples, PNH Clone Absent samples are also issued. This programme issues samples a minimum of 4 times per annum and a maximum of 6, subject to sample availability. 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 testing of samples for this programme is subcontracted to an approved accredited laboratory.
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.
To register for this programme, please click here