Volume 73, Issue 5
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645


A rapid and reliable diagnostic assay for acute hepatitis E virus (HEV) infection is needed. We evaluated a rapid, immunochromatographic assay for IgM antibodies to HEV (ASSURE™ HEV IgM Rapid Test) using acute-phase HEV samples (n = 200) from Indonesia and Nepal and convalescent-phase HEV samples (n = 70) from Nepal. Blood donors in Thailand (n = 100), individuals with hepatitis A (n = 80), hepatitis B (n = 45), and hepatitis C (n = 50) in Thailand and Nepal, acute-phase sera of individuals with Epstein-Barr virus infection (n = 20), and rheumatoid factor–positive blood (n = 26) served as negative controls. The assay had a sensitivity of 93% (95% confidence interval [CI] = 88.5–96.1%) and a specificity of 99.7% (95% CI = 98.3–100%). The positive and negative predictive values were 99.5% (95% CI = 97.1–100%) and 95.8% (95% CI = 93.1–97.7%), respectively. These results suggest that this assay is a sensitive and specific tool for the rapid diagnosis of acute HEV infection.


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  • Received : 27 Jan 2005
  • Accepted : 19 May 2005

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