title: Serological detection of HBeAg and anti-HBe using automated microparticle enzyme immunoassays.
abstract: Fully automated microparticle enzyme immunoassays (EIA) were developed for the detection of HBeAg (IMx HBe) and antibodies against HBeAg (IMx anti-HBe), respectively. Specimens from blood donors, diagnostic and hospital patients and individuals with a variety of infectious and immune diseases were tested both in house and at four clinical sites. The overall agreement between IMx HBe and Abbott HBe RIA/EIA was 99.7% (2985 of 2994) and between IMx anti-HBe and anti-HBe RIA/EIA was 95.8% (2330 of 2432). Almost all anti-HBe discordant specimens (94.1%, 96 of 102) were reactive by IMx anti-HBe but negative by anti-HBe RIA/EIA. off anti-HBe discordant specimens were also reactive for anti-HBc. The IMx anti-HBe assay was 2- to 4-fold more sensitive than the current RIA as determined by serial dilution of anti-HBe reactive specimens. The ability of these IMx assays to detect HBeAg and anti-HBe in 199 HBsAg reactive specimens was also evaluated. 43.7% (87 of 199) and 66.3% (132 of 199) specimens were reactive for HBeAg and anti-HBe by IMx, respectively. Only one specimen was negative for both IMx assays compared to 14 (7.0%) non-reactive for both HBe and anti-HBe RIA. There were 24 specimens (12.1%) positive for both HBeAg and anti-HBe by IMx compared to 1 (0.5%) positive by the corresponding RIAs. This increased detectability of anti-HBe in HBsAg carriers using IMx anti-HBe may result from increased sensitivity for 'free' anti-HBe and/or increased ability to detect anti-HBe in immune complex. IMx anti-HBe also detected more reactives among volunteer blood donor specimens reactive for anti-HBc but negative for HBsAg (55.5%, 86 of 155), compared to RIA (38.7%, 60 of 155). IMx anti-HBe may be useful in confirming prior exposure to HBV in blood screened positive by Corzyme.
authors.affiliation: Hepatitis R & D, Abbott Laboratories, Abbott Park, IL 60064.
authors.forename: D
authors.initials: D
authors.lastname: Robbins
authors.forename: T
authors.initials: T
authors.lastname: Wright
authors.forename: C
authors.initials: C
authors.lastname: Coleman
authors.forename: L
authors.initials: L
authors.lastname: Umhoefer
authors.forename: B
authors.initials: B
authors.lastname: Moore
authors.forename: A
authors.initials: A
authors.lastname: Spronk
authors.forename: C
authors.initials: C
authors.lastname: Douville
authors.forename: I K
authors.initials: IK
authors.lastname: Kuramoto
authors.forename: M
authors.initials: M
authors.lastname: Rynning
authors.forename: D
authors.initials: D
authors.lastname: Gracey
mesh_terms: D005260:Female; D006509:Hepatitis B / Q000175:diagnosis* / Q000453:epidemiology; D006510:Hepatitis B Antibodies / Q000032:analysis*; D006513:Hepatitis B e Antigens / Q000032:analysis*; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D011863:Radioimmunoassay; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012698:Serologic Tests
chemical_list: D006510:Hepatitis B Antibodies; D006513:Hepatitis B e Antigens