WHO/BS/2022.2432: Report on the WHO collaborative study to establish Universal Reagents for the D-Antigen potency testing of Inactivated Polio Vaccines

Overview

The D-Antigen potency of inactivated polio vaccine (IPV) is measured in vitro using a validated ELISA test with suitable reference preparations. There are currently two WHO International Standards (IS) for both conventional IPV (cIPV) and Sabin IPV (sIPV) products. The current cIPV IS, 12/104, is a vaccine produced from a wild-type poliovirus strain. In a previous study, it was found not suitable for measuring the D-Antigen content of sIPV products, therefore, 17/160, a reference made from a Sabin live-attenuated strain, was established as the IS for use in measuring the Sabin D-Antigen Units (SDU) of sIPV products. To allow harmonisation with different vaccine products it may be advantageous to produce a set of antibodies ‘universal reagents' that could be used by manufacturers and national control laboratories (NCL). To this end, a new collaborative study has been conducted with the aim to establish universal reagents that could be used to test all IPV products for potency