Development and evaluation of a competitive radioimmunoassay using monoclonal antibodies against Rh D for determining anti-D potency of clinical grade immunoglobulin preparations.

A competitive radioimmunoassay using monoclonal anti-D antibodies has been developed for measuring anti-D activity in prophylactic immunoglobulin preparations. The assay is totally specific for anti-D, reproducible and gives potency estimates comparable to those determined using autoanalyzer methodology. The assay also provides a means for comparing different batches of monoclonal anti-D preparations for red-cell binding activity.