Research ArticleHEV-positive blood donations represent a relevant infection risk for immunosuppressed recipients
Graphical abstract
Introduction
HEV infections are present worldwide.1 Consumption of pork meat has been considered to be the major source of HEV Genotype (GT) 3 infections in Europe. In addition to zoonotic transmission, blood products were shown to be a potential source of acute and chronic HEV infection in industrialised countries.[2], [3] The anti-HEV seroprevalence rate in Europe, depicting the number of people previously exposed to HEV, varies largely depending on the region and the assay used.4 A high seroprevalence rate of 30% was found in healthy German individuals using the sensitive Wantai anti-HEV IgG assay.5 In addition to serological studies, blood donors were tested for HEV viraemia by PCR in various European studies, and rates of HEV positivity from 1:726 to 1:3,333 have been determined.[6], [7], [8], [9], [10], [11] The largest of these studies was conducted in the UK. In this study, 225,000 blood donations were tested in pools of 24 samples by an in-house assay, and 79 specimens tested positive for HEV PCR (1 out of 2,850). The likelihood of developing clinically relevant hepatitis E after transfusion of an HEV-contaminated blood product was 42%,10 while in a Japanese study, 50% of recipients of HEV-contaminated blood products developed HEV infection.12 Since it became apparent how frequently HEV was found in blood products, routine testing of blood products has been discussed controversially in many European countries. In the vast majority of these countries, HEV screening has not been implemented, while authorities in the UK, Ireland, and the Netherlands decided to test all blood products for HEV.13 The aim of the present study was to determine the prevalence of blood-borne HEV infections at our academic tertiary care centre in Northern Germany and to evaluate whether routine HEV testing of blood products should be performed.
Section snippets
Routine screening
Routine screening of all blood donations for HEV RNA was implemented at our centre, the University Medical Center Hamburg-Eppendorf, in October 2016. Here, we present data from a three-day preliminary testing phase in September 2016 in addition to 8-month routine screening data following the implementation of screening (October 2016 to May 2017). Identical protocols were applied in preliminary and routine screening phases. The study was in line with the recommendations of the local ethics
Identification of HEV RNA-positive blood donors through prospective screening
From October 2016 to May 2017, 18,737 blood donations were prospectively tested for HEV viraemia at the blood transfusion service of the University Medical Center Hamburg-Eppendorf. HEV viraemia was detected in 23 asymptomatic blood donors (D1–D23), resulting in an HEV RNA prevalence of 0.12% (1:815) in this cohort (Table 1; Fig. 1). At the time of blood donation, only 3 out of 23 HEV RNA-positive blood donors presented with detectable anti-HEV IgG and IgM; one donor tested positive for
Discussion
Here, we report the first study describing the experience with prospective routine HEV screening of blood donations at a German academic tertiary care centre. The authors of individual case reports and small retrospective case series have studied the severity of transfusion-associated HEV infections.[2], [3], [12] Furthermore, a number of prospective studies have evaluated the frequency of HEV RNA-positive blood donations in numerous European countries,[6], [7], [8], [9], [10] and a
Financial support
The authors received no financial support to produce this manuscript.
Conflict of interest
ML reports personal fees from lectures and advising for Roche Diagnostics, and grants from validation of laboratory-developed-test assays on the cobas 6800 (Roche), outside the submitted work. SP reports personal fees from Roche Diagnostics and MSD, outside the submitted work.
Please refer to the accompanying ICMJE disclosure forms for further details.
Authors’ contributions
DW, ML, and SP developed the concept of the study and wrote the manuscript. DW and SP coordinated the follow-up of HEV viraemic blood donors. ML, SG, and NF were responsible for the sequencing. ML, SP, UD, JB and JH coordinated the collection, pooling, and testing of blood samples. JH, DW, FA, MR, TH, and SP supervised the data collection and reviewed the drafts. MMA, AWL, JSW and BG revised the manuscript for important intellectual content. All authors reviewed the final manuscript.
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These authors contributed equally and are both first authors.
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These authors contributed equally and share senior authorship.