Abstract
BackgroundHepatitis 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.ResultsThe 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.ConclusionConclusively, 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.
Highlights
Hepatitis A virus (HAV) is a causative agent of acute hepatitis, which is transmitted by person-toperson contact and via the faecal-oral route
We developed an immunochromatographic assay for the detection of anti-HAV immunoglobulin M (IgM) and applied this to clinical specimens in order to determine the sensitivity and usefulness of this assay compared with a chemiluminescent-linked immunoassay that is widely used for the routine diagnosis of HAV infection
Sensitivity and specificity of the ICA compared with the microparticle enzyme immunoassay (MEIA) By using the ICA devised in this investigation, we were able detect anti-HAV IgM in 150 sera from patients with acute viral hepatitis, who were infected by 1 of 3 different HAV genotypes
Summary
Hepatitis A virus (HAV) is a causative agent of acute hepatitis, which is transmitted by person-toperson 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. Hepatitis A virus (HAV) is one of the common causative agents of acute hepatitis worldwide [1]. The clinical manifestation of HAV infection in humans can vary greatly, ranging from asymptomatic infection to fulminant hepatitis [2,3]. The standard diagnosis of acute hepatitis A is based on the detection of the immunoglobulin M (IgM) antibody to HAV (HAV-IgM) in patients who present with clinical features of hepatitis. Since many cases of hepatitis A are asymptomatic, HAVIgM can be found in individuals who do not have clinical
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