Recommendations for the implementation of platelet autoantibody testing in clinical trials of immune thrombocytopenia

Abstract

The utility of platelet autoantibody testing in the management of patients with immune thrombocytopenia (ITP) remains uncertain. Because of low sensitivity reported in prospective studies [1–3], the routine use of platelet autoantibody testing has not been endorsed in recent evidence-based guidelines [4]; however, the ‘ITP syndrome’ [5], which includes primary and secondary forms, is a disorder that may comprise groups of patients with distinct clinical and serological profiles. To better understand the diagnostic, prognostic and pathogenic role of platelet autoantibodies in ITP, further systematic evaluation is required. An efficient way to study platelet autoantibodies in ITP is to incorporate testing into the design of large clinical trials. Multinational proficiency testing has shown that most laboratories can readily identify platelet alloantibodies from coded samples [6]; however, platelet autoantibodies may be more difficult to discern. In addition, large-scale implementation would require standard methods of sample collection, processing and testing. This official report of the Platelet Immunology Scientific Subcommittee of ISTH describes a standardized approach to the implementation of platelet autoantibody testing in ITP clinical trials.