title: A stable lyophilized reagent for use in a potential reference assay for quantitation of anti-D in immunoglobulin products.
abstract: Quality control of anti-D immunoglobulins intended for in vivo clinical use requires in vitro assay of potency. A lyophilized biotinylated monoclonal anti-D (biotinylated Brad-5; 99/698) has been evaluated for its suitability to serve as a working reagent in a competitive enzyme-linked immunoassay (EIA) for anti-D quantitation. The reagent demonstrated acceptable stability in accelerated degradation tests and following reconstitution. Twelve international laboratories obtained comparable potencies for each of nine anti-D samples using 99/698 in a standardized assay procedure using erythrocytes fixed to microtitre plates. We also describe the use of trehalose for stabilization of dried erythrocyte-coated microtitre plates.
authors.affiliation: Division of Haematology, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK. sthorpe@nibsc.ac.uk
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Thorpe
authors.forename: Bernard
authors.initials: B
authors.lastname: Fox
authors.forename: Dawn
authors.initials: D
authors.lastname: Sands
mesh_terms: D000911:Antibodies, Monoclonal; D001710:Biotin; D004355:Drug Stability; D004912:Erythrocytes; D005612:Freeze Drying; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods* / Q000592:standards; D007202:Indicators and Reagents; D007753:Laboratories; D011786:Quality Control; D018029:Rho(D) Immune Globulin / Q000032:analysis*
chemical_list: D000911:Antibodies, Monoclonal; D007202:Indicators and Reagents; D018029:Rho(D) Immune Globulin; D001710:Biotin