Antigenic and physicochemical characterization of the 2nd International Standard for hepatitis B virus surface antigen (HBsAg) |
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| Authors: | Christian G. Schüttler Ulrike C. Wend Fabian M. Faupel P. Nico Lelie Wolfram H. Gerlich |
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| Affiliation: | 1. Institute for Medical Virology, Justus Liebig University, Frankfurter Str. 107, 35392 Giessen, Germany;2. Central Laboratory of the Red Cross Blood Transfusion Service (CLB), Sanquin, Amsterdam, Netherlands;1. “L. Spallanzani” National Institute for Infectious Diseases, Rome, Italy;2. Research & Development, Bristol-Myers Squibb, Wallingford, CT, United States;3. Research & Development, Bristol-Myers Squibb, Princeton, NJ, United States;1. Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC;2. Feinstein Institute for Medical Research, North Shore–Long Island Jewish Health System, Manhasset, NY;3. Department of Molecular Genetics and Microbiology, Duke University Medical Center, Durham, NC;1. Laboratory of Disease Genomics and Individualized Medicine, Beijing Institute of Genomics, Chinese Academy of Sciences, Beijing 100101, China;2. University of Chinese Academy of Sciences, Beijing 100049, China;3. College of Life Sciences Inner Mongolia University, Hohhot 010021, China;4. Science and Technology Department, People’s Government of Inner Mongolia Autonomous Region, Hohhot 010010, China;1. Inserm U1110, University of Strasbourg and Center for Liver and Digestive Diseases, Strasbourg University Hospitals, 3 Rue Koeberlé, F-67000 Strasbourg, France;2. Centre for Human Virology, NIHR Centre for Liver Disease, University of Birmingham, Vincent Drive, Birmingham B15 2TT, UK;3. Department of Infectious Diseases, Molecular Virology, University Hospital Heidelberg, ImNeuenheimer Feld 345, D-69120 Heidelberg, Germany;1. Central Laboratories of the Ministry of Health, Cairo, Egypt;2. Department of Clinical and Chemical Pathology, Kasr Alainy School of Medicine, Cairo University, Cairo, Egypt;3. Department of Biochemistry & Molecular Biology, Theodor Bilharz Research Institute, Giza, Egypt;1. Islamic Azad University, Shahrekord Branch, Shahrekord, Iran;2. Department of Microbiology, Faculty of Basic Sciences, Islamic Azad University, Shahrekord Branch, Shahrekord, Iran;3. Department of Microbiology, Faculty of Veterinary Medicine, Islamic Azad University, Shahrekord Branch, Shahrekord, Iran |
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| Abstract: | BackgroundStandard preparations for HBsAg are required for quality control of test kits and clinical studies on HBsAg quantitation. WHO provides purified heat inactivated HBsAg diluted in negative defribinated plasma as 2nd International Standard (IS) for quality control of tests.ObjectiveStudy of possible alterations of antigenicity, protein composition, size and density of the heat inactivated source material (SM) for the 2nd IS.Study designNative HBsAg and SM were examined by quantitative immune electrophoresis (QIE), SDS-PAGE, ultracentrifugation and gel chromatography. HBV DNA was sequenced and the HBsAg geno/subtype derived.ResultsThe SM contained 97,600 International Units HBsAg/ml in QIE which agreed very well with the previous evaluations by WHO using 10 different assays. In SDS-PAGE, SM showed on a strong background the small HBs proteins but no preS proteins. SM had a more heterogeneous density than native HBsAg and contained particle aggregates. The HBsAg geno/subtype of SM was A2/adw2.ConclusionsThe IS has very good HBs antigenicity, but it lacks the preS domains, has modified HBs proteins and is partially aggregated. While it has been proven very useful for quality control of tests, certain inconsistencies due to the altered structure of its HBsAg cannot be excluded. |
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