WHO manual for the preparation of reference materials for use as secondary standards in antibody testing

Overview

The development, establishment and promotion of international reference standards for biological materials is a core function of WHO and plays an important role in ensuring the quality and consistent dosing of biological medicinal products used worldwide. These standards are widely used in the development, evaluation, standardization and control of such products by industry and regulatory authorities, as well as supporting biological research in other scientific organizations.

WHO International Standards (IS) are established by the Expert Committee on Biological Standardization with an assigned International Unit (IU). Metrologically, IS serve as the primary standard for the calibration of national and other secondary standards, and are considered to be of the highest order. Consequently, it is important to conserve the typically limited stocks of an IS, and to this end national authorities frequently consider establishing their own secondary reference materials (see Appendices 1–4). Similarly, manufacturers or research centres conducting numerous assays as part of their product development programme usually establish a secondary standard for routine use. The biological activities of such secondary materials should be calibrated in IU by direct comparison with the respective IS.