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Updated: Jun 15, 2026
Real-Time Polymerase Chain Reaction-Based Detection and Quantification of Hepatitis B Virus DNA
Published on: December 15, 2023
Calibration of the second International Standard for hepatitis B immunoglobulin in an international collaborative
1Division of Virology, National Institute for Biological Standards and Control, South Mimms, Herts, UK.
Background And Objectives:
The International Standard for hepatitis B immunoglobulin is used in the standardization of the anti-HBs content of immunoglobulins for prophylactic and therapeutic use and also in the standardization and calibration of quantitative diagnostic anti-HBs assay kits. A collaborative study was undertaken to assess the suitability of a candidate Second International Standard (2nd IS), and to calibrate it in International Units (IU).
Materials And Methods:
The candidate 2nd IS was prepared from a bulk of 5% hepatitis B immunoglobulin (NIBSC code 07/164). Twenty-two participants from 12 countries assayed the first IS, the candidate 2nd IS, a freeze-dried pool of plasma containing anti-HBs and a plasma from a blood donor. These samples were assayed with 19 different assay kits.
Results:
Data from 102 assays were received. The mean potencies of two coded samples of the candidate 2nd IS were 100.7 and 101.4 IU/ml (combined potency 101.0 IU/ml). The geometric coefficients of variation for these samples were both 13%. The predicted long-term stability of 07/164 was assessed by assaying samples stored at elevated temperatures for a period of 6 months. 07/164 was predicted to be stable at -20 degrees C with the estimated % loss per year of below 0.2%.
Conclusion:
07/164 was established as the 2nd IS for hepatitis B immunoglobulin with an assigned potency of 100 IU/ampoule by the WHO Expert Committee on Biological Standardisation. The United States Food and Drug Administration has adopted the same standard as the new Reference for Hepatitis B Immunoglobulin, Lot 3.
