Original article

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Seven years (2015-2021) of blood donor screening for HEV-RNA in France: lessons and perspectives

Authors

Key words: hepatitis E virus, blood donations, nucleic acid testing, pooling, transfusiontransmitted infection
Publication Date: 2022-07-25

Abstract

Background - The French health authorities are considering expanding the current selective HEV-RNA testing procedure to include all donations in order to further reduce transfusion-transmitted HEV infection. Data obtained from blood donors (BDs) tested for HEV-RNA between 2015 and 2021 were used to assess the most efficient nucleic acid testing (NAT) strategy.
Materials and methods - Viral loads (VLs) and the plasma volume of blood components, as well as an HEV-RNA dose of 3.85 log IU as the infectious threshold and an assay with a 95% limit of detection (LOD) at 17 IU/mL, were used to assess the proportion of: (i) HEV-RNA-positive BDs that would remain undetected; and (ii) blood components associated with these undetected BDs with an HEV-RNA dose >3.85 log IU, considering 4 NAT options (Individual testing [ID], MP-6, MP-12, and MP-24).
Results - Of the 510,118 BDs collected during the study period, 510 (0.10%) were HEV-RNA-positive. Based on measurable VLs available in 388 cases, 1%, 15.2%, 21.8%, and 32.6% of BDs would theoretically pass undetected due to a VL below the LOD of ID, MP-6, MP-12, and MP-24 testing, respectively. All BDs associated with a potentially infectious blood component would be detected with ID-NAT while 13% of them would be undetected with MP-6, 19.6% with MP-12, and 30.4% with MP-24 depending on the plasma volume. No red blood cell (RBC) components with an HEV-RNA dose >3.85 log IU would enter the blood supply, regardless of the NAT strategy used.
Discussion - A highly sensitive ID-NAT would ensure maximum safety. However, an MP-based strategy can be considered given that: (i) the risk of transmission is closely related to the plasma volume of blood components; (ii) RBC are the most commonly transfused components and have a low plasma content; and (iii) HEV-RNA doses transmitting infection exceed 4 log IU. To minimise the potential risk associated with apheresis platelet components and fresh frozen plasma, less than 12 donations should be pooled using an NAT assay with a LOD of approximately 20 IU/mL.

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Authors

Syria Laperche - Etablissement Français du Sang, La Plaine St-Denis, France; Unité des Virus Émergents (UVE) Aix-Marseille-IRD 190-Inserm 1207 -Marseille, France

Claude Maugard - Etablissement Français du Sang Occitanie, Montpellier, France

Sébastien Lhomme - Infinity, Université Toulouse III, CNRS, INSERM, Toulouse, France; Laboratoire de Virologie, Hôpital Purpan, CHU, Toulouse, France

Sophie Lecam - Etablissement Français du Sang, La Plaine St-Denis, France; Etablissement Français du Sang, Centre Pays de la Loire, Angers, France

Céline Ricard - Etablissement Français du Sang Hauts de France Normandie, Loos, France

Isabelle Dupont - Etablissement Français du Sang Bretagne, Brest, France

Pascale Richard - Etablissement Français du Sang, La Plaine St-Denis, France

Pierre Tiberghien - Etablissement Français du Sang, La Plaine St-Denis, France; UMR 1098 RIGHT INSERM Université de Franche-Comté Etablissement Français du Sang, Besançon, France

Florence Abravanel - Infinity, Université Toulouse III, CNRS, INSERM, Toulouse, France; Laboratoire de Virologie, Hôpital Purpan, CHU, Toulouse, France

Pascal Morel - Etablissement Français du Sang, La Plaine St-Denis, France; UMR 1098 RIGHT INSERM Université de Franche-Comté Etablissement Français du Sang, Besançon, France

Jacques Izopet - Infinity, Université Toulouse III, CNRS, INSERM, Toulouse, France; Laboratoire de Virologie, Hôpital Purpan, CHU, Toulouse, France;

Pierre Gallian - Etablissement Français du Sang, La Plaine St-Denis, France; Unité des Virus Émergents (UVE) Aix-Marseille-IRD 190-Inserm 1207 -Marseille, France

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