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Updated: Sep 28, 2026
Viability Assays for Cells in Culture
Published on: January 20, 2014
A stable lyophilized reagent for use in a potential reference assay for quantitation of anti-D in immunoglobulin
Susan J Thorpe1, Bernard Fox, Dawn Sands
1Division of Haematology, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK. sthorpe@nibsc.ac.uk
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.
