WHO Consultation on Global Measurement Standards and their use in the in vitro Biological Diagnostic Field

Overview

The WHO Consultation on Global Measurement Standards and their use in the in vitro Biological Diagnostic Field was held to discuss how the concepts of metrological traceability and measurement uncertainty could be applied to biological reference materials with assigned values for biological activity. Data from the WHO collaborative study on the 2nd HBsAg IS as well as from WHO collaborative studies on selected blood coagulation and hormone protein standards were considered as models for the discussions.

This meeting was also deemed appropriate in light of new European regulations concerning in vitro diagnostic devices. These regulations involve new requirements to show consistency of laboratory results based on metrological parameters. It is essential for competent regulatory authorities and manufacturers to have standards in the “higher order” category under the above regulations, and the WHO International Standards would meet this need.