Studies on the development of enzyme linked immunosorbent assay (ELISA) for hepatitis B surface antigen(HBsAg) by monoclonal antibodies of different affinity constants

1987 ◽  
Vol 10 (1) ◽  
pp. 18-24 ◽  
Author(s):  
Gye Won Kim ◽  
Sung Youl Hong ◽  
Soon Cheon Shin ◽  
Sung Hee Lee ◽  
Won Bae Kim
Keyword(s):  
Monoclonal Antibodies ◽  
Hepatitis B ◽  
Immunosorbent Assay ◽  
Surface Antigen ◽  
Hepatitis B Surface Antigen ◽  
Enzyme Linked Immunosorbent Assay ◽  
Affinity Constants

scholarly journals An enzyme-linked immunosorbent assay for subtypic determinants of hepatitis B surface antigen with monoclonal antibodies.

1990 ◽  
Vol 13 (1) ◽  
pp. 65-71
Author(s):  
Hiroshi Ikeda ◽  
Kazuharu Matsuura ◽  
Yoshiaki Iwasaki ◽  
Kazuhiro Nouso ◽  
Kouichi Takaguchi ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Hepatitis B ◽  
Immunosorbent Assay ◽  
Surface Antigen ◽  
Hepatitis B Surface Antigen ◽  
Enzyme Linked Immunosorbent Assay

scholarly journals Development and Technical and Clinical Validation of a Quantitative Enzyme-Linked Immunosorbent Assay for the Detection of Human Antibodies to Hepatitis B Surface Antigen in Recipients of Recombinant Hepatitis B Virus Vaccine

2009 ◽  
Vol 16 (8) ◽  
pp. 1236-1246 ◽  
Author(s):  
Pierre Cambron ◽  
Jeanne-Marie Jacquet ◽  
Bernard Hoet ◽  
Marc Lievens
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Immunosorbent Assay ◽  
Surface Antigen ◽  
Hepatitis B Surface Antigen ◽  
Geometric Mean ◽  
Enzyme Linked Immunosorbent Assay ◽  
Analytical Sensitivity ◽  
Limit Of Quantitation ◽  
B Virus

ABSTRACT Pending removal from the market of a commercial assay (the AUSAB [Abbott Laboratories] enzyme immunoassay [EIA]) for the determination of antibodies to hepatitis B surface antigen (HBsAg), a new in-house quantitative enzyme-linked immunosorbent assay (ELISA) to measure antibodies against HBsAg (anti-HBs) was developed (anti-HBs in-house). Specific anti-HBs antibodies were sandwiched between the precoated HBsAg ad and ay subtypes purified from plasma from hepatitis B virus (HBV) human carriers and the recombinant HBsAg adw2 subtype tagged with horseradish peroxidase. The assay was calibrated against the 1st International Reference Preparation for anti-hepatitis B immunoglobulin (lot 1977-W1042). Analytical sensitivity and the limit of quantitation were estimated at 0.43 mIU/ml and 2.0 mIU/ml, respectively. Overall reproducibility was 11.86%, and accuracy was estimated to be 94.89%. More than 4,000 samples from seven clinical trials were tested with the anti-HBs in-house assay and compared to results generated with AUSAB EIA and AUSAB radioimmunoassay (RIA). During the technical validation, the anti-HBs in-house assay was compared to the AUSAB RIA as a reference (n = 919). Overall assessment of concordance and Deming's regression analysis were performed. The coefficient of correlation between the AUSAB RIA and anti-HBs in-house assay was 0.9815 with a slope of 0.9187. The overall agreement between anti-HBs in-house and AUSAB RIA was 97.61%, considering the clinical cutoffs at 3.3 mIU/ml and 1.0 mIU/ml for the respective assays. From a clinical perspective, seroprotection rates and anti-HBs geometric mean antibody concentrations for individual studies calculated with either the in-house assay or the reference assays were similar. Conclusions of individual studies were confirmed. The performance characteristics of the in-house assay are acceptable. There is no evidence that use of the new assay would lead to different clinical conclusions from the reference method.

Enzyme-Linked Immunosorbent Assay for Hepatitis B Surface Antigen

1977 ◽  
Vol 136 (Supplement 2) ◽  
pp. S311-S317 ◽  
Author(s):  
G. Wolters ◽  
L. P. C. Kuijpers ◽  
J. Kacaki ◽  
A. H. W. M. Schuurs
Keyword(s):  
Hepatitis B ◽  
Immunosorbent Assay ◽  
Surface Antigen ◽  
Hepatitis B Surface Antigen ◽  
Enzyme Linked Immunosorbent Assay

Sensitivities of Radioimmunoassay and Enzyme-Linked Immunosorbent Assay for Detection of Hepatitis B Surface Antigen

Vox Sanguinis ◽  
1979 ◽  
Vol 36 (3) ◽  
pp. 137-141
Author(s):  
C.A. Hyland ◽  
E.C. Mason ◽  
P.A. Harden ◽  
A.E. Shaw ◽  
D. Maurer ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Immunosorbent Assay ◽  
Surface Antigen ◽  
Hepatitis B Surface Antigen ◽  
Enzyme Linked Immunosorbent Assay
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