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Clinical and Diagnostic Laboratory Immunology, July 2003, p. 579-586, Vol. 10, No. 4
1071-412X/03/$08.00+0     DOI: 10.1128/CDLI.10.4.579-586.2003

Detection of Immunoglobulin M Antibodies to Hepatitis E Virus by Class Capture Enzyme Immunoassay

C. Yu,^1* R. E. Engle,¹ J. P. Bryan,² S. U. Emerson,¹ and R. H. Purcell¹

Hepatitis Viruses and Molecular Hepatitis Sections, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health,¹ Department of Prevention Medicine and Biometrics, Uniformed Services University of the Health Sciences, Bethesda, Maryland²

Received 27 November 2002/ Returned for modification 21 March 2003/ Accepted 3 April 2003

The measurement of antibodies to hepatitis E virus (anti-HEV) has been essential for understanding the epidemiology of hepatitis E. Studies to determine the prevalence of HEV infections require a reliable serologic assay that is sensitive and specific. It is also important to distinguish the acute from the convalescent phase of an infection; this usually requires the detection of the immunoglobulin M (IgM) class of antibody. Few enzyme immunoassays (EIAs) that measure IgM anti-HEV have been described, and most have utilized the sandwich method. The present study describes an EIA that detects IgM anti-HEV by antibody class capture methodology. The assay was validated by using serum and/or plasma panels from experimentally infected nonhuman primates. It was used to demonstrate an anamnestic response and the reappearance of IgM anti-HEV in a chimpanzee experimentally challenged with HEV at two different times 45 months apart. The class capture method was more sensitive than the sandwich EIA when used to test clinical samples from two hepatitis E epidemics in Pakistan; it also had the advantage of distinguishing IgM anti-HEV in the presence of high titers of IgG anti-HEV.

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* Corresponding author. Mailing address: Hepatitis Viruses Section, Laboratory of Infectious Diseases, National Institutes of Health, Twinbrook I, Room 1502, 5640 Fishers Lane, Rockville, MD 20852. Phone: (301) 594-4050. Fax: (301) 480-1280. E-mail: clyu{at}niaid.nih.gov.

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Clinical and Diagnostic Laboratory Immunology, July 2003, p. 579-586, Vol. 10, No. 4
1071-412X/03/$08.00+0     DOI: 10.1128/CDLI.10.4.579-586.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

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