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Hepatitis E virus blood donor NAT screening: as much as possible or as much as needed?
Author(s) -
Vollmer T.,
Diekmann J.,
Knabbe C.,
Dreier J.
Publication year - 2019
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/trf.15058
Subject(s) - nat , hepatitis e virus , virology , nucleic acid test , blood donations , hepatitis e , medicine , biology , genotype , covid-19 , infectious disease (medical specialty) , genetics , human immunodeficiency virus (hiv) , disease , computer network , computer science , gene
BACKGROUND The cost‐benefit question of general screening of blood products for the hepatitis E virus (HEV) is currently being discussed. One central question is the need for individual nucleic acid amplification techniques (NAT) screening (ID‐NAT) versus minipool NAT screening (MP‐NAT) approaches to identify all relevant viremias in blood donors. Here, the findings of ID‐NAT versus MP‐NAT in pools of 96 samples were compared. STUDY DESIGN AND METHODS From November 2017 to January 2018, a total of 10,141 allogenic blood donations from 7650 individual German blood donors were screened for the presence of HEV RNA using MP‐NAT (96 samples) (RealStar HEV RT‐PCR Kit) compared to ID‐NAT (cobas HEV assay) on the fully automated cobas 6800 platform. RESULTS Parallel screening of MP (n = 122, 96 samples/MP) using both methods detected seven reactive pools. After pool resolution, 8 HEV RNA–positive donations were identified by the in‐house detection method, whereas 17 HEV RNA–positive donations were identified by ID‐NAT with the cobas HEV assay. This resulted in an incidence of 1:1268 donations (0.079%) for MP‐NAT screening and 1:597 donations (0.168%) for ID‐NAT screening. CONCLUSIONS The detection frequency of HEV RNA was approximately 50% higher if ID‐NAT was used compared to MP‐NAT. However, viral loads of ID‐NAT–only samples were below 25 IU/mL and will often not result in transfusion‐transmitted HEV (TT‐HEV) infection, taking into account the currently known infectious dose of 5.0E + 04 IU inevitably resulting in TT‐HEV infection. The clinical relevance and need for identification of these low‐level HEV‐positive donors still require further investigation.