title: Evaluation of rapid tests for diagnosis of acute hepatitis E.
abstract: BACKGROUND
  Hepatitis E virus diagnosis still presents difficulties due to discordant results among diagnostic tests.
  
  
  OBJECTIVE
  The aim of this study was to evaluate the performance of two rapid tests for detection of anti-HEV IgM antibodies.
  
  
  METHODS
  The rapid tests were compared with three commercial anti-HEV ELISA assays and one Real-Time PCR assay on 59 sera from patients with acute viral non-AC hepatitis.
  
  
  RESULTS
  The presence of anti-HEV IgM antibodies was evaluated by two rapid tests (Wantai and Assure) on 25 HEV RNA positive samples. Anti-HEV IgM antibodies were detected in 24/25 and 23/25 samples respectively. The sensitivity and specificity of Wantai and Assure Rapid tests were evaluated using the 25 HEV RNA positive samples and 50 HEV RNA negative samples (including sera from acute-phase HAV and HBV infections and blood donors). Overall, the sensitivity of Wantai Rapid and Assure Rapid tests was 96.1% and 92.6% respectively; the specificity of the 2 tests was 100%.
  
  
  CONCLUSIONS
  Our data suggest the potential use of anti-HEV IgM rapid assays as a first line test in primary health care settings, particularly useful for patients with chronic liver disease or pregnant women who urgently need an antiviral treatment.
authors.affiliation: Department of Infectious, Parasitic and Immune-Mediated Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Chionne
authors.affiliation: Department of Infectious, Parasitic and Immune-Mediated Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Madonna
authors.affiliation: Center for Immunobiologicals Research and Evaluation, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Giulio
authors.initials: G
authors.lastname: Pisani
authors.affiliation: Department of Infectious, Parasitic and Immune-Mediated Diseases, Istituto Superiore di Sanità, Rome, Italy. Electronic address: stefania.taffon@iss.it.
authors.forename: Stefania
authors.initials: S
authors.lastname: Taffon
authors.affiliation: Department of Environment and Primary Prevention, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Giuseppina
authors.initials: G
authors.lastname: La Rosa
authors.affiliation: Department of Infectious, Parasitic and Immune-Mediated Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Candido
authors.affiliation: Department of Infectious, Parasitic and Immune-Mediated Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Dettori
authors.affiliation: Department of Infectious, Parasitic and Immune-Mediated Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Tritarelli
authors.affiliation: Department of Cell Biology and Neurosciences, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Equestre
authors.affiliation: Department of Infectious, Parasitic and Immune-Mediated Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Bruni
authors.affiliation: Department of Infectious, Parasitic and Immune-Mediated Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Anna Rita
authors.initials: AR
authors.lastname: Ciccaglione
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D002846:Chromatography, Affinity / Q000379:methods*; D016751:Hepatitis E / Q000175:diagnosis*; D016752:Hepatitis E virus / Q000276:immunology*; D006801:Humans; D007075:Immunoglobulin M / Q000097:blood*; D012680:Sensitivity and Specificity
chemical_list: D000914:Antibodies, Viral; D007075:Immunoglobulin M
keywords: ELISA assays; Hepatitis E; Rapid tests; Real-Time PCR