title: Laboratory Diagnosis of HEV Infection.
abstract: Serological and nucleic acid tests for detecting hepatitis E virus (HEV) have been developed for both epidemiologic and diagnostic purposes. The laboratory diagnosis of HEV infection depends on the detection of HEV antigen, HEV RNA, and serum antibodies against HEV (immunoglobulin [Ig]A, IgM, and IgG). Anti-HEV IgM antibodies can be detected during the acute phase of the illness and can last approximately 4 or 5 months, representing recent exposure, whereas anti-HEV IgG antibodies can last more than 10 years, representing remote exposure. Thus, the diagnosis of acute infection is based on the presence of anti-HEV IgM, HEV antigen, and HEV RNA, while epidemiological investigations are mainly based on anti-HEV IgG. Although significant progress has been made in developing and optimizing different formats of HEV assays, improving their sensitivity and specificity, there are many shortcomings and challenges in inter-assay concordance, validation, and standardization. This article reviews the current knowledge on the diagnosis of HEV infection, including the most common available laboratory diagnostic techniques.
authors.affiliation: Division of HIV/AIDS and Sex-transmitted Virus Vaccines, National Institutes for Food and Drug Control, No. 2 Tiantanxili, Dongcheng District, Beijing, 100050, China.
authors.forename: Chenyan
authors.initials: C
authors.lastname: Zhao
authors.affiliation: Division of HIV/AIDS and Sex-transmitted Virus Vaccines, National Institutes for Food and Drug Control, No. 2 Tiantanxili, Dongcheng District, Beijing, 100050, China. wangyc@nifdc.org.cn.
authors.forename: Youchun
authors.initials: Y
authors.lastname: Wang
mesh_terms: D019411:Clinical Laboratory Techniques / Q000379:methods*; D016751:Hepatitis E / Q000175:diagnosis* / Q000821:virology; D016752:Hepatitis E virus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D012680:Sensitivity and Specificity
keywords: Anti-HEV IgG; Anti-HEV IgM; Antigen; Assay; Diagnosis; ELISA; RNA