WHO manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection: calibration to WHO International Standards, Annex 6, TRS No 1004

Overview

Through its Expert Committee on Biological Standardization, WHO developed its Guidelines for the preparation and establishment of reference materials and reference reagents for biological substances in 1978 (1). This document was
last revised in 2004 (2). In the revised WHO Recommendations document, secondary standards are defined as reference preparations established by regional or national authorities, or by other laboratories, that are calibrated against and traceable to WHO reference materials. Part B of the 2004 Recommendations deals with general considerations for the preparation, characterization and calibration of regional or national biological reference standards.