Risk of transfusion-transmitted hepatitis E virus infection from pool-tested platelets and plasma

Published:August 27, 2021DOI:


      • HEV can be transmitted in spite of pool testing of blood donors for HEV RNA.
      • APCs and FFP are associated with a higher risk of transmitting HEV than RCCs.
      • Pooled BD testing insufficiently reduces the risk of tt HEV when giving APC and FFP donations.
      • Single donor testing for HEV RNA should significantly increase the safety of blood products.

      Background and Aims

      Immunocompromised patients are at risk of chronic hepatitis E which can be acquired by blood transfusions. Currently, screening of blood donors (BDs) for HEV RNA with a limit of detection (LOD) of 2,000 IU/ml is required in Germany. However, this may result in up to 440,000 IU of HEV RNA in blood products depending on their plasma volume. We studied the residual risk of transfusion-transmitted (tt) HEV infection when an LOD of 2,000 IU/ml is applied.


      Highly sensitive individual donor testing for HEV RNA on the Grifols Procleix Panther system (LOD 7.89 IU/ml) was performed. HEV loads were quantified by real-time PCR.


      Of 16,236 donors, 31 (0.19%) were HEV RNA positive. Three BDs had viral loads between 710 and 2,000 IU/ml, which pose a significant risk of tt hepatitis E with any type of blood product. Eight BDs had viral loads of >32 to 710 IU/ml, which pose a risk of tt hepatitis E with platelet or plasma transfusions because of their higher plasma volume compared to red blood cell concentrates. Eight of these 11 potentially infectious BDs were seronegative for HEV, indicating a recent infection. Only 8 of 31 donors had viral loads >2,000 IU/ml that would also have been detected by the required screening procedure and 12 had very low HEV loads (<32 IU/ml).


      Screening of BDs with an LOD of 2,000 IU/ml reduced the risk of tt HEV infection by about 73% for red blood cell concentrates but by just 42% for platelet and fresh frozen plasma transfusions. Single donor screening (LOD <32 IU/ml) should lead to an almost 100% risk reduction.

      Lay summary

      Immunocompromised patients, such as solid organ or hematopoietic stem cell recipients, are at risk of chronic hepatitis E, which can be acquired via blood transfusions. The risk of transfusion-transmitted hepatitis E in these patients may not be sufficiently controlled by (mini-)pool hepatitis E virus RNA screening of blood donors. Single donor screening should be considered to improve the safety of blood products.

      Graphical abstract


      Linked Article

      • Identification of rabbit hepatitis E virus (HEV) and novel HEV clade in Irish blood donors
        Journal of HepatologyVol. 77Issue 3
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          We read with interest that Cordes et al.1 undertook a study wherein they performed individual donor nucleic acid testing (ID-NAT) for hepatitis E virus (HEV) in Germany using the Procleix HEV assay (Grifols, Barcelona, Spain). Using a similar approach, between January 4th, 2016 and March 17th, 2017, 172,277 blood donations were screened for HEV by the Irish Blood Transfusion Service. Screening was performed by ID-NAT using the Procleix HEV assay on the automated Procleix Panther System (Grifols).
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