NEW INTERNATIONAL REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM (RPPHS)

Quality-control surveys in recent years, in various parts of the world , have shown poor between-laboratory agreement for measurements of pla sma proteins. Despite the existence of international reference materia ls distributed by the World Health Organization, standards produced by diagnostics manufacturers and professional organizations differ signi ficantly in their ascribed values. The reasons for this are complex bu t include poor availability of the primary materials, confusion about their use, and the fact that their turbidity on reconstitution preclud es their use in modern optical immunoassays. This unfortunate situatio n led to an important initiative to produce sufficient quantities of a widely available optically clear secondary reference material for pla sma proteins that could be used worldwide by manufacturers, profession al organizations, and laboratories. Here we present an overview on how the laboratory community, including manufacturers, clinical laborator ies, professional societies, and regulators, has reached what we consi der is a successful conclusion to a difficult problem.