title: Evaluation of an immunochromatographic assay for the detection of anti-hepatitis A virus IgM.
abstract: BACKGROUND
  Hepatitis A virus (HAV) is a causative agent of acute hepatitis, which is transmitted by person-to-person contact and via the faecal-oral route. Acute HAV infection is usually confirmed by anti-HAV IgM detection. In order to detect anti-HAV IgM in the serum of patients infected with HAV, we developed a rapid assay based on immunochromatography (ICA) and evaluated the sensitivity of this assay by comparing it with a commercial microparticle enzyme immunoassay (MEIA) that is widely used for serological diagnosis.
  
  
  RESULTS
  The newly developed ICA showed 100% sensitivity and specificity when used to test 150 anti-HAV IgM-positive sera collected from infected patients and 75 negative sera from healthy subjects. Also, the sensitivity of ICA is about 10 times higher than MEIA used in this study by determining end point to detect independent on infected genotype of HAV. In addition, the ICA was able to detect 1 positive sample from among 50 sera from acute hepatitis patients that had tested negative for anti-HAV IgM using the MEIA.
  
  
  CONCLUSIONS
  Conclusively, ICA for the detection of anti-HAV IgM will be very effective for rapid assay to apply clinical diagnosis and epidemiological investigation on epidemics due to the simplicity, rapidity and specificity.
authors.affiliation: Division of Enteric and Hepatitis Viruses, Center for Infectious Diseases, National Institute of Health, Korea Centers for Disease Control and Prevention, Seoul, South Korea. cheonds@hanmail.net
authors.forename: Hyeok-Jin
authors.initials: HJ
authors.lastname: Lee
authors.forename: Hye Sook
authors.initials: HS
authors.lastname: Jeong
authors.forename: Byung-Ki
authors.initials: BK
authors.lastname: Cho
authors.forename: Mi-Jeong
authors.initials: MJ
authors.lastname: Ji
authors.forename: Ji-Ha
authors.initials: JH
authors.lastname: Kim
authors.forename: An-Na
authors.initials: AN
authors.lastname: Lee
authors.forename: Kyoung-Ryul
authors.initials: KR
authors.lastname: Lee
authors.forename: Doo-Sung
authors.initials: DS
authors.lastname: Cheon
mesh_terms: D006506:Hepatitis A / Q000097:blood* / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D035922:Hepatitis A Antibodies / Q000097:blood* / Q000276:immunology; D030041:Hepatitis A virus / Q000276:immunology* / Q000302:isolation & purification; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007075:Immunoglobulin M / Q000097:blood* / Q000276:immunology; D012680:Sensitivity and Specificity
chemical_list: D035922:Hepatitis A Antibodies; D007075:Immunoglobulin M