Quantitation of hepatitis B surface antibody by an automated microparticle enzyme immunoassay.
A fully automated microparticle enzyme immunoassay, IMx AUSAB, was developed for the detection and quantitation of antibody against hepatitis B surface antigen (anti-HBs). The IMx AUSAB assay can complete 24 tests in less than 45 minutes. Anti-HBs concentrations in specimens are calculated automatically by comparison of the specimen rate to values determined from a stored standard curve. IMx AUSAB sensitivity is 2-3 mIU/ml, equivalent in sensitivity to AUSAB RIA or EIA. Specimens from blood donors, diagnostic and hospital patients, hepatitis B vaccinees, and individuals with a variety of infectious and autoimmune diseases tested in parallel by IMx AUSAB and AUSAB RIA or IMx AUSAB and EIA gave overall qualitative agreement of 97.8% (1265/1293) and 99.1% (1281/1293), respectively. The prevalence of anti-HBs ranged from 5.9% in volunteer blood donors to 47.0% of specimens from a sexually transmitted disease clinic. Most discordant specimens (18/34) were low level reactive (less than 10 mIU/ml) by AUSAB RIA, but negative by IMx AUSAB and AUSAB EIA. These specimens were also negative for antibodies to hepatitis B core antigen (anti-HBc). Six discordants were low level reactive by IMx but negative by RIA and EIA. Three of these six specimens were also reactive for anti-HBc suggesting that the IMx AUSAB reactivity resulted from the presence of low level anti-HBs. Quantitative agreement between IMx AUSAB and RIA or IMx and EIA for 106 specimens ranging in anti-HBs concentration from 1 to 30,000 mIU/ml gave linear correlation coefficients of 0.91 and 0.96, respectively. The IMx test was useful for monitoring hepatitis B vaccine response and seroconversion levels after hepatitis B infection.
Ostrow
D H
DH
Hepatitis R & D, Abbott Laboratories, Abbott Park, IL 60064.
Edwards
B
B
Kimes
D
D
Macioszek
J
J
Irace
H
H
Nelson
L
L
Bartko
K
K
Neva
J
J
Krenc
C
C
Mimms
L
L
D001331:Automation; D006509:Hepatitis B / Q000276:immunology / Q000382:microbiology; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D007124:Immunoenzyme Techniques; D007201:Indicator Dilution Techniques; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014611:Vaccination; D014765:Viral Vaccines / Q000276:immunology
D006514:Hepatitis B Surface Antigens; D014765:Viral Vaccines