title: Evaluation of a new rapid immunochromatographic assay for serodiagnosis of acute hepatitis E infection.
abstract: 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.
authors.affiliation: U.S. Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand. myintk@afrims.org
authors.forename: Khin S A
authors.initials: KS
authors.lastname: Myint
authors.forename: Ming
authors.initials: M
authors.lastname: Guan
authors.forename: Hsiao Ying
authors.initials: HY
authors.lastname: Chen
authors.forename: Yang
authors.initials: Y
authors.lastname: Lu
authors.forename: David
authors.initials: D
authors.lastname: Anderson
authors.forename: Teresa
authors.initials: T
authors.lastname: Howard
authors.forename: Harald
authors.initials: H
authors.lastname: Noedl
authors.forename: Mammen P
authors.initials: MP
authors.lastname: Mammen
mesh_terms: D000208:Acute Disease; D002845:Chromatography / Q000379:methods; D006508:Hepatitis Antibodies / Q000097:blood*; D016751:Hepatitis E / Q000175:diagnosis*; D016752:Hepatitis E virus / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques; D007075:Immunoglobulin M / Q000097:blood*; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D012698:Serologic Tests; D013997:Time Factors
chemical_list: D006508:Hepatitis Antibodies; D007075:Immunoglobulin M