Second generation assays for the detection of antibody to HBsAg using recombinant DNA-derived HBsAg.
A second generation radioimmunoassay (RIA) and enzyme-linked immunoassay (EIA) for the detection and quantitation of the antibody to hepatitis B surface antigen (anti-HBs) was developed which utilizes recombinant DNA-derived HBsAg (rHBsAg) in place of human plasma derived HBsAg. In these sandwich assays, rHBsAg immobilized on a solid phase was used to capture anti-HBs from the specimen and rHBsAg conjugated to horseradish peroxidase or radiolabeled with 125I was used as a detecting reagent. These rHBsAg-based assays were compared to a commercial radioimmunoassay for anti-HBs detection (AUSAB RIA). For a population of 1711 sera and plasma specimens, 99.2% overall agreement was demonstrated between the recombinant RIA and EIA and 98.6% agreement was observed between the recombinant assays and AUSAB-RIA. The recombinant assays demonstrated equivalent sensitivity and detectability to AUSAB RIA. Most discrepant samples were low-level reactive by AUSAB-RIA, generally less than 10 mIU/ml, and likely represent nonspecific reactivity since no other marker for hepatitis B infection was detected in these samples.
Mimms
L
L
Hepatitis/AIDS Research, Abbott Laboratories, Abbott Park, IL 60064.
Goetze
A
A
Swanson
S
S
Floreani
M
M
Edwards
B
B
Macioszek
J
J
Okasinski
G
G
Kiang
W
W
D001327:Autoimmune Diseases / Q000276:immunology; D001782:Blood Donors; D015153:Blotting, Western; D004274:DNA, Recombinant; D004591:Electrophoresis, Polyacrylamide Gel; D004797:Enzyme-Linked Immunosorbent Assay; D000939:Epitopes / Q000032:analysis; D006509:Hepatitis B / Q000276:immunology*; D006510:Hepatitis B Antibodies / Q000032:analysis*; D006514:Hepatitis B Surface Antigens / Q000276:immunology*; D006801:Humans; D007106:Immune Sera; D008854:Microscopy, Electron; D011863:Radioimmunoassay; D011994:Recombinant Proteins / Q000276:immunology
D004274:DNA, Recombinant; D000939:Epitopes; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D007106:Immune Sera; D011994:Recombinant Proteins