WHO/BS/2015.2265 Proposed 1st WHO Erythropoietin antibody reference panel

Overview

A panel of 9 human monoclonal antibodies against human erythropoietin (EPO) with defined characteristics (non-neutralizing, neutralizing, various isotypes, affinities) were formulated, lyophilized, assessed for suitability in EPO antibody assays at NIBSC and evaluated in a multicentre international collaborative study involving eighteen different laboratories and different assay platforms. The latter included various binding and neutralization assays. The study clearly indicated the utility and suitability of the EPO antibody panel which represents the diverse repertoire of antibodies detectable in ESA treated patients as assay performance indicators to facilitate decision-making on assay selection for use in testing antibodies against human EPO. It is therefore proposed to the ECBS that this EPO antibody panel be established to enable selection and evaluation of the performance of appropriate EPO antibody assays for clinical use, for assay validation and for standardization of EPO antibody assays.