2015-10-24-世界卫生组织-WHO_BS_2015.2265_Proposed_1st_WHO_Erythropoietin_antibody_reference_panel_47页_1mb

This document summarizes a WHO Expert Committee on Biological Standardization report on a proposed EPO antibody reference panel. The study involved developing a panel of 9 human monoclonal antibodies against erythropoietin (EPO) with defined characteristics, including neutralizing and non-neutralizing antibodies, and various affinities and isotypes. These antibodies were lyophilized and evaluated in a multi-center international collaborative study involving 18 laboratories and multiple assay platforms to assess their suitability for use as performance indicators in EPO antibody assays.

Key findings from the study showed variability in assay sensitivity and performance across different platforms, but the antibody panel proved useful for standardizing assays. The panel can aid in selecting and validating appropriate EPO antibody assays, monitoring their performance, and supporting pharmacovigilance efforts. The document recommends establishing this EPO antibody reference panel to enhance the safety and efficacy monitoring of erythropoiesis-stimulating agents (ESAs), addressing the risk of antibody-mediated pure red cell aplasia (PRCA) in treated patients. No universally accepted reference materials for EPO antibody testing were available prior to this work.

In conclusion, the report proposes the establishment of the EPO antibody panel to enable standardization, validation, and improved detection of EPO antibodies across different settings.