Establishment of Minimal Acceptable Standards of Potency and Specificity of Antiglobulin Reagents. Task II

摘要

The contract objective was to evaluate the usefulness of radioimmunoassay procedures for quantitative analysis of the Anti-C3d component of Anti-Human Serum. The study revealed that meaningful data could not be obtained by any technique unless the methodology was standardized to give reproducible in vitro cell preparations having similar amounts of C3d on their surface. Standardized cell preparations were achieved by methods described in the report and currently available licensed Anti-Human Sera were analyzed. A general correlation between anti-C3d antibody concentration and agglutination reactions with in vitro prepared C3d-coated red cells was observed. This correlation confirmed the usefulness of radioimmunoassay for more accurately measuring Anti-C3d activity in Anti-Human Sera products. The lack of correlation with the agglutination strength of in vivo sensitized cells, however, will require that conventional methods also be used as a part of the evaluation of Anti-Human Sera for direct antiglobulin tests.