Implementation of amotosalen plus ultraviolet A‐mediated pathogen reduction for all platelet concentrates in France: Impact on the risk of transfusion‐transmitted infections

Author:

Richard Pascale1ORCID,Pouchol Elodie1,Sandid Imad2,Aoustin Laurent1,Lefort Caroline3,Chartois Anne‐Gaële3,Baima Alexis1,Malard Lucile1,Bacquet Caroline1,Ferrera‐Tourenc Virginie1,Gallian Pierre1ORCID,Laperche Syria1ORCID,Bliem Cathy1,Morel Pascal14,Tiberghien Pierre14ORCID

Affiliation:

1. Etablissement Français du Sang La Plaine St‐Denis France

2. Agence Nationale de Sécurité du Médicament (ANSM) St‐Denis France

3. Etablissement Français du Sang Nantes France

4. UMR RIGHT 1098, Inserm, Etablissement Français du Sang, Université de Franche‐Comté Besançon France

Abstract

AbstractBackground and ObjectivesPathogen reduction (PR) technology may reduce the risk of transfusion‐transmitted infections (TTIs), notably transfusion‐transmitted bacterial infection (TTBI) associated with platelet concentrates (PCs). PR (amotosalen/UVA treatment) was implemented for all PCs transfused in France in November 2017. No bacterial detection was in place beforehand. The study aimed to assess the impact of PR PC on TTI and TTBI near‐miss occurrences.Materials and MethodsTTI and TTBI near‐miss occurrences were compared before and after 100% PR implementation. The study period ran from 2013 to 2022. Over 300,000 PCs were transfused yearly.ResultsNo PC‐related transmission of human immunodeficiency virus, hepatitis C virus, hepatitis B virus and human T‐cell lymphotropic virus was reported throughout the study period. PC‐mediated hepatitis E virus and hepatitis A virus infections occurred irrespective of PR implementation. Mean PC‐mediated TTBI occurrence before PR‐PC implementation was 3/year (SD: 1; n = 15; 1/92,687 PC between 2013 and 2016) with a fatal outcome in two patients. Since PR implementation, one TTBI has been reported (day 4 PC, Bacillus cereus) (1/1,645,295 PC between 2018 and 2022; p < 0.001). Two PR PC quarantined because of a negative swirling test harboured bacteria: a day 6 PC in 2021 (B. cereus and Staphylococcus epidermidis) and a day 7 PC in 2022 (Staphylococcus aureus). Five similar occurrences with untreated PC were reported between 2013 and 2020.ConclusionTransfusion of 100% PR PC resulted in a steep reduction in TTBI occurrence. TTBI may, however, still occur. Pathogen‐reduced PC‐related TTI involving non‐enveloped viruses occurs as well.

Publisher

Wiley

Subject

Hematology,General Medicine

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