title: Performance of a new rapid test for detecting anti-hepatitis E virus immunoglobulin M in immunocompetent and immunocompromised patients.
abstract: BACKGROUND
  Hepatitis E virus (HEV) infections are widespread in both developing and developed countries. It is, therefore, important to assess the performance of systems for rapidly detecting anti-HEV immunoglobulin M antibodies in human sera.
  
  
  OBJECTIVE
  To evaluate the diagnostic value of a new immunochromatographic assay, the HEV IgM rapid test (Wantai).
  
  
  METHODS
  Blood samples were taken from 30 acutely infected immunocompetent and 30 acutely infected immunocompromised patients, all with HEV RNA in their blood. Specificity and cross reactivity was assessed using samples from 30HEV RNA negative immunocompetent patients who had acute Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infections and 30HEV RNA negative immunocompromised patients. The performance of the HEV IgM Rapid Test was compared to that of a conventional microplate enzyme immunoassay.
  
  
  RESULTS
  The sensitivity of the rapid test in immunocompetent patients was 90% (95% CI: 72.1-100%), similar to that of the Wantai microplate assay (sensitivity: 96.6%, 95% CI: 78.77-100%; p=0.61). The sensitivity of the rapid test in immunocompromised patients was 73.3% (95% CI: 55.4-91.2%) and that of the microplate assay was 83.3% (95% CI: 65.44-100%; p=0.53). The rapid test produced no false positive reactions with samples from HEV RNA negative patients; while the microplate assay gave two false positive results (3.3%).
  
  
  CONCLUSIONS
  The new Wantai HEV IgM rapid test is easy to use and suitable for rapidly detecting acute hepatitis E infections in both immunocompetent and immunocompromised patients. However, HEV RNA must be detected using a molecular assay for diagnosing an HEV infection in anti-HEV IgM negative patients.
authors: INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse F-31300, France; CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France.
authors: Florence
authors: F
authors: Abravanel
authors: INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse F-31300, France; CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France.
authors: Sébastien
authors: S
authors: Lhomme
authors: INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse F-31300, France; CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France.
authors: Sabine
authors: S
authors: Chapuy-Regaud
authors: CHU Toulouse, Hôpital Purpan, Département de Gastroentérologie, F-31300, France.
authors: Jean-Marie
authors: JM
authors: Peron
authors: CHU Toulouse, Hôpital Purpan, Service de Médecine Interne, F-31300, France.
authors: Laurent
authors: L
authors: Alric
authors: INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse F-31300, France; CHU Toulouse, Hôpital Rangueil, Département de Néphrologie, Dialyse et Transplantation multi-organe, F-31300, France.
authors: Lionel
authors: L
authors: Rostaing
authors: INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse F-31300, France; CHU Toulouse, Hôpital Rangueil, Département de Néphrologie, Dialyse et Transplantation multi-organe, F-31300, France.
authors: Nassim
authors: N
authors: Kamar
authors: INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse F-31300, France; CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France.
authors: Jacques
authors: J
authors: Izopet
mesh_terms: D002846:Chromatography, Affinity / Q000379:methods* / Q000592:standards*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods / Q000592:standards; D005602:France; D006508:Hepatitis Antibodies / Q000097:blood / Q000276:immunology*; D016751:Hepatitis E / Q000175:diagnosis* / Q000276:immunology* / Q000821:virology; D016752:Hepatitis E virus / Q000235:genetics / Q000276:immunology*; D006801:Humans; D016867:Immunocompromised Host; D007075:Immunoglobulin M / Q000097:blood / Q000276:immunology*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D006508:Hepatitis Antibodies; D007075:Immunoglobulin M
keywords: Hepatitis E virus; Immunochromatographis assay; Immunocompetent patients; Immunocompromised patients