title: Comparison of a new immunochromatographic test to enzyme-linked immunosorbent assay for rapid detection of immunoglobulin m antibodies to hepatitis e virus in human sera.
abstract: An immunochromatographic test for rapid detection of IgM antibodies in patients with acute hepatitis E infection was developed utilizing the well-characterized recombinant protein EP2.1 and monoclonal antibody 4B2. The new rapid test based on a novel reverse-flow technology was able to generate a positive result within 2 to 3 min. Our study showed that this test was able to detect anti-HEV IgM antibodies in 96.7% of the patient samples tested (n = 151) while maintaining an excellent specificity of 98.6% with samples from various patient or healthy control groups (total n = 208). Furthermore, this rapid test gave a good specificity of 90.9% when tested with rheumatoid factor (RF)-positive sera (RF value of < or =850 IU/ml; n = 11) although a higher concentration of RF in samples might cause cross-reactivity. The new test has a good agreement of 97.2% with a kappa value of 0.943 when compared with a reference enzyme-linked immunosorbent assay. The positive predictive value and the negative predictive value for the rapid test thus reached 98.0 and 97.6%, respectively. This is the first rapid, point-of-care test for hepatitis E and will be especially useful for the diagnosis of acute hepatitis E virus infection in field and emergency settings and in resource-poor countries.
authors.affiliation: Genelabs Diagnostics Pte. Ltd., Product Development, 85 Science Park Drive 04-01, Singapore Science Park, Singapore 118259, Republic of Singapore.
authors.forename: Hsiao Ying
authors.initials: HY
authors.lastname: Chen
authors.forename: Yang
authors.initials: Y
authors.lastname: Lu
authors.forename: Teresa
authors.initials: T
authors.lastname: Howard
authors.forename: David
authors.initials: D
authors.lastname: Anderson
authors.forename: Priscilla Yiquan
authors.initials: PY
authors.lastname: Fong
authors.forename: Wei-Ping
authors.initials: WP
authors.lastname: Hu
authors.forename: Chee Poh
authors.initials: CP
authors.lastname: Chia
authors.forename: Ming
authors.initials: M
authors.lastname: Guan
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D002846:Chromatography, Affinity; D003429:Cross Reactions / Q000276:immunology; D004797:Enzyme-Linked Immunosorbent Assay; D016751:Hepatitis E / Q000175:diagnosis*; D016752:Hepatitis E virus / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007118:Immunoassay; D007075:Immunoglobulin M / Q000097:blood*; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D012698:Serologic Tests
chemical_list: D000914:Antibodies, Viral; D007075:Immunoglobulin M