Seroprevalence of hepatitis E virus (HEV) and detection of HEV RNA with a transcription-mediated amplification assay in blood donors from Catalonia (Spain).
BACKGROUND
Hepatitis E virus (HEV) is an emerging threat to the safety of blood transfusion. The aim of this study was to determine HEV immunoglobulin (Ig)G and RNA prevalence in Catalan blood donors.


METHODS
Nearly 10,000 samples were collected from anonymized, unpaid donors at the Banc de Sang i Teixits (Barcelona, Spain) from June to December 2013. For the serology study, a subset of 1082 donations was tested in parallel for HEV IgG using Wantai and Mikrogen enzyme-linked immunosorbent assay tests. Samples were tested individually (individual-donation nucleic acid test [ID-NAT]) for HEV RNA using the Procleix HEV assay (95% limit of detection 7.9 IU/mL). Procleix repeat-reactive donations were confirmed by an in-house real-time polymerase chain reaction (PCR) test.


RESULTS
The prevalences of IgG anti-HEV in Catalan blood donors were 19.96% (Wantai assay) and 10.72% (Mikrogen assay). Screening of 9998 samples with the Procleix HEV assay yielded three real-time PCR-confirmed and IgM and IgG anti-HEV-positive donations with viral loads of 250, 564, and 2755 IU/mL. The donation with highest viral load was genotype 3f. HEV RNA positivity rate was one per 3333 donations (0.03%; 95% confidence interval, 0.01%-0.09%).


CONCLUSIONS
The Procleix HEV ID-NAT screening system has provided evidence of HEV RNA presence in Catalan blood donors. Further data are needed to assess the impact of HEV infection in at-risk patients to design the best strategy to increase blood safety.
Transfusion Safety Laboratory, Banc de Sang i Teixits, Institut Català de la Salut, Barcelona, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain.
Sílvia
S
Sauleda
Hologic, Inc. (formerly Gen-Probe Incorporated), San Diego, California.
Edgar
E
Ong
Transfusion Safety Laboratory, Banc de Sang i Teixits, Institut Català de la Salut, Barcelona, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain.
Marta
M
Bes
Hologic, Inc. (formerly Gen-Probe Incorporated), San Diego, California.
Alanna
A
Janssen
Hologic, Inc. (formerly Gen-Probe Incorporated), San Diego, California.
Robin
R
Cory
Hologic, Inc. (formerly Gen-Probe Incorporated), San Diego, California.
Maria
M
Babizki
Hologic, Inc. (formerly Gen-Probe Incorporated), San Diego, California.
Tim
T
Shin
Hologic, Inc. (formerly Gen-Probe Incorporated), San Diego, California.
Andre
A
Lindquist
Hologic, Inc. (formerly Gen-Probe Incorporated), San Diego, California.
Anh
A
Hoang
Hologic, Inc. (formerly Gen-Probe Incorporated), San Diego, California.
Lee
L
Vang
Transfusion Safety Laboratory, Banc de Sang i Teixits, Institut Català de la Salut, Barcelona, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain.
Maria
M
Piron
Transfusion Safety Laboratory, Banc de Sang i Teixits, Institut Català de la Salut, Barcelona, Spain.
Natàlia
N
Casamitjana
Sanquin Diagnostics, National Screening Laboratory of Sanquin (NSS), Amsterdam, the Netherlands.
Marco
M
Koppelman
Grifols (formerly Novartis Diagnostics), Emeryville, California.
Lisa
L
Danzig
Hologic, Inc. (formerly Gen-Probe Incorporated), San Diego, California.
Jeffrey M
JM
Linnen
D000293:Adolescent; D000328:Adult; D001782:Blood Donors / Q000706:statistics & numerical data; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D016752:Hepatitis E virus / Q000235:genetics* / Q000472:pathogenicity*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008969:Molecular Sequence Data; D016133:Polymerase Chain Reaction; D012367:RNA, Viral / Q000235:genetics*; D060888:Real-Time Polymerase Chain Reaction; D016036:Seroepidemiologic Studies; D055815:Young Adult
D012367:RNA, Viral