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Clin. Vaccine Immunol. doi:10.1128/CVI.00231-06
Copyright (c) 2007, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Experience with diagnostic investigations of genotype 1 and genotype 3 hepatitis E patients in a low-endemic setting

National Institute for Public Health and the Environment (RIVM). Diagnostic Laboratory for infectious diseases and perinatal screening

^* To whom correspondence should be addressed. Email: Tineke.Herremans{at}rivm.nl.

	Abstract

Because of the occurrence of genotype 3 HEV in the low-endemic regions, it is important to validate the currently used serological assays for diagnosing infections with viruses belonging to this lineage since these assays only use antigens derived from genotype 1 and 2 viruses. We evaluated the Genelabs ELISA and the RecomBlot from Mikrogen for the detection of HEV-specific IgM and IgG under low-endemic conditions. We compared test result of 16 locally acquired genotype 3 HEV patients, 8 genotype 1 patients, 167 healthy controls from the general population and 101 cases with hepatitis due to other viral causes. The measured specificity of the ELISA (98%) and the RecomBlot (97%) were comparable to those given by the manufacturer for IgM but was significantly lower for IgG (93% ELISA and 66% immunoblot, reported 98% ELISA, 95% blot). Antibody levels detected following infections with genotype 3 were lower than those following genotype 1 infections except for those measured in the IgM ELISA. Reactivity to the four antigens used in the immunoblot were analysed and showed differences in the IgM immunoblot reactions between genotype 1 patients, and genotype 3 patients. The ORF3 antigen was the most specific antigen. The specificity could be improved by a combined testing regime with confirmation by immunoblot of all positive ELISA results and by raising the cut-off of the IgG immunoblot without loss of sensitivity. We conclude that a combination of ELISA and immunoblot is needed for acceptable specificity and sensitivity of HEV assays under low-endemic conditions.

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