1. International collaborative study to establish immunoglobulin (anti-D test) BRP batch 1.
- Author
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Thorpe SJ, Fox B, Heath A, Behr-Gross ME, Virata ML, and Yu MW
- Subjects
- Europe, Hemagglutination Tests standards, Humans, Immunoglobulins, Intravenous chemistry, Immunoglobulins, Intravenous isolation & purification, International Cooperation, Reference Standards, United States, World Health Organization, Immunoglobulins, Intravenous standards, Pharmacopoeias as Topic, Rho(D) Immune Globulin chemistry, United States Food and Drug Administration
- Abstract
An international collaborative study was organised to establish a European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) and United States (US) Food and Drug Administration (FDA) reference preparation for the test for anti-D (anti-Rho) antibodies in human normal immunoglobulin for intravenous administration (IGIV). A candidate positive control (IGIV+anti-D) and negative control IGIV were compared to corresponding World Health Organization (WHO) International Reference Reagents using a direct haemagglutination reference method. Sixteen (16) laboratories participated in the collaborative study. Further to completion of the study, the materials assayed in the study were granted the status of Ph. Eur. and US FDA reference preparations for controlling the levels of anti-D in IGIV.
- Published
- 2006