title: Specifications for anti-A and anti-B in intravenous immunoglobulin: history and rationale.
abstract: Intravenous immunoglobulin (IVIG) products are generally safe and efficacious, although treatment-related adverse reactions can occur in recipients. Adverse reactions include hemolysis in non-blood group O recipients linked to the passive transfer of anti-A and/or anti-B present in the fractionated immunoglobulin product. In light of the recent increase in reported cases of severe hemolysis associated with anti-A and/or anti-B, this article traces the development of pharmacopoeial specifications, tests, and reference reagents to control their titers in IVIG products.
authors.affiliation: Biotherapeutics Group, National Institute for Biological Standards and Control, Medicines and Healthcare Products Regulatory Agency, Herts, UK.
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Thorpe
mesh_terms: D000017:ABO Blood-Group System / Q000276:immunology*; D006461:Hemolysis / Q000187:drug effects / Q000276:immunology; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects* / Q000276:immunology* / Q000627:therapeutic use; D007518:Isoantibodies / Q000009:adverse effects* / Q000276:immunology*
chemical_list: D000017:ABO Blood-Group System; D016756:Immunoglobulins, Intravenous; D007518:Isoantibodies