Lymphocyte subtype enumeration included in the WHO EDL

Berlin, 29 January 2021 - The World Health Organization (WHO) published on January 29, 2021, the third edition of the Model List of Essential In vitro Diagnostics (EDL). For the second year in a row, tests for diagnosing primary immunodeficiencies (PIDs) have been included in this Model List.


In this edition, the WHO has accepted IPOPI’s proposal to expand the list for the lymphocyte subtype enumeration and the additional evidence required for tests provisionally accepted in 2019. The tests considered as essential for PID diagnosis are:

  • Complete blood count;
  • HIV ½ antibody (anti-HIV Ab);
  • Immunoglobulin plasma levels (IgG, IgA, IgM)
  • Lymphocyte subtype enumeration (CD3, CD4, CD8, B cells CD19 and/or CD20, CD16/56 T cells and NK cells)



Epimune's lymphocyte enumeration test - i.Mune TBNK - is uniquely positioned to address the need for improved diagnosis of primary immunodeficiencies. By allowing lymphocyte enumeration from a drop of dried blood, Epimune's i.Mune TBNK test allows easy testing in individuals with unspecific symptoms of immunodeficiency as well as monitoring of diagnosed patients. 


Epimune welcomes the decision by the WHO to include lymphocyte enumeration in its list of essential diagnostic tests as well as the enduring support by IPOPI to improve PID patients' lives.