European flow cytometry quality assurance guidelines for the diagnosis of primary immune deficiencies and assessment of immune reconstitution following B cell depletion therapies and transplantation

Author:

Kelleher Peter12,Greathead Louise2,Whitby Liam3ORCID,Brando Bruno4, ,Barnett David3,Bloxham David5,deTute Ruth6,Dunlop Alan7,Farren Timothy89,Francis Sebastian10,Payne Daniel11,Scott Stuart3,Snowden John A.10,Sorour Youssef12,Stansfield Emma13,Virgo Paul14,Whitby Alison3

Affiliation:

1. Immunology of Infection, Department of Infectious Disease Imperial College London London UK

2. Department of Infection and Immunity Sciences North West London Pathology London UK

3. UK NEQAS for Leucocyte Immunophenotyping Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK

4. Hematology Laboratory and Transfusion Center New Hospital of Legnano: Ospedale Nuovo di Legnano Milan Italy

5. Haematopathology and Oncology Diagnostic Service Cambridge University Hospitals NHS Foundation Trust Cambridge UK

6. Haematological Malignancy Diagnostic Service St James's University Hospital Leeds UK

7. Department of Haemato‐Oncology Royal Marsden Hospital London UK

8. Division of Haemato‐Oncology St Bartholomew's Hospital, Barts Health NHS Trust London UK

9. Pathology Group Blizard Institute, Queen Mary University of London London UK

10. Department of Haematology Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK

11. Tees Valley Pathology Service James Cook University Hospital Middlesbrough UK

12. Haematology, Doncaster and Bassetlaw Teaching Hospitals NHS Trust Doncaster UK

13. Greater Manchester Immunology Service Manchester University NHS Foundation Trust Manchester UK

14. Department of Immunology and Immunogenetics North Bristol NHS Trust Bristol UK

Abstract

AbstractOver the last 15 years activity of diagnostic flow cytometry services have evolved from monitoring of CD4 T cell subsets in HIV‐1 infection to screening for primary and secondary immune deficiencies syndromes and assessment of immune constitution following B cell depleting therapy and transplantation. Changes in laboratory activity in high income countries have been driven by initiation of anti‐retroviral therapy (ART) in HIV‐1 regardless of CD4 T cell counts, increasing recognition of primary immune deficiency syndromes and the wider application of B cell depleting therapy and transplantation in clinical practice. Laboratories should use their experience in standardization and quality assurance of CD4 T cell counting in HIV‐1 infection to provide immune monitoring services to patients with primary and secondary immune deficiencies. Assessment of immune reconstitution post B cell depleting agents and transplantation can also draw on the expertise acquired by flow cytometry laboratories for detection of CD34 stem cell and assessment of MRD in hematological malignancies. This guideline provides recommendations for clinical laboratories on providing flow cytometry services in screening for immune deficiencies and its emerging role immune reconstitution after B cell targeting therapies and transplantation.

Publisher

Wiley

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