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Evaluation of assays for antibody to hepatitis E virus by a serum panel
Author(s) -
Mast Eric E.,
Alter Miriam J.,
Holland Paul V.,
Purcell Robert H.
Publication year - 1998
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.510270331
Subject(s) - hepatitis e virus , virology , medicine , seroprevalence , antibody , concordance , hepatitis , immunology , virus , hepatitis a , hepatitis e , viral hepatitis , serology , biology , biochemistry , gene , genotype
Few data are available to evaluate the performance of existing assays for antibody to the hepatitis E virus (anti‐HEV). A panel of 164 randomized and coded sera was tested for anti‐HEV by 12 different assays. The panel included a dilution series of an early convalescent human serum, known‐positive sera (undiluted human sera obtained 2 months to 13 years after acute hepatitis E, and postinoculation chimpanzee sera), known‐negative sera (preinoculation chimpanzee sera; sera from chimpanzees with hepatitis A virus, hepatitis B virus, or hepatitis C virus infection; and normal human sera), and sera obtained from previously tested U.S. blood donors without a history of hepatitis. Six tests detected anti‐HEV in ≥90% of undiluted known‐positive sera. The sensitivity of all of the assays with known‐positive sera ranged from 17% to 100%, and the limit of detection by endpoint dilution ranged from 1:5 to 1:160. Ten tests were nonreactive for all of the 22 known‐negative sera, one test was reactive for one serum, and one test was reactive for 5 sera. In pairwise comparisons of different tests in blood donor sera, the overall concordance ranged from 49% to 94% (median, 69%) and the concordance among reactive sera ranged from 0% to 89% (median, 32%). Several of these tests performed well in detecting anti‐HEV in known positive sera. However, highly discrepant results among U.S. blood donor sera indicate that anti‐HEV seroprevalence data in non–HEV‐endemic countries may be unreliable and should be interpreted with caution.