Scientific Publications by FDA Staff

J Virol Methods 2020 Feb;276:113785

Universal ELISA for quantification of D-antigen in inactivated poliovirus vaccines.

Kouiavskaia D, Devudu Puligedda R, Dessain SK, Chumakov K

To address the biosafety and biosecurity concerns related to the manufacture of inactivated polio vaccine (IPV), several manufacturers started producing it from attenuated Sabin strains. Slight immunological differences between wild and attenuated strains create a challenge for testing IPV potency, which is defined as the content of protective D-antigen determined in an ELISA test. Some ELISA reagents selected for testing conventional IPV made from wild strains (cIPV) may not be suitable for testing Sabin IPV (sIPV). This paper describes an ELISA procedure using human monoclonal antibodies selected to capture equally well both wild and attenuated strains of poliovirus. A unique monoclonal antibody neutralizing all three serotypes of poliovirus was used as the detection antibody. The method was shown to detect only D-antigen of both conventional and Sabin IPV and to be strictly serotype-specific. The method is highly sensitive and robust and produces linear results in a wide range of concentrations. We have also found that reference standards used for measuring potency of cIPV and sIPV must be made from respective vaccines. This makes it impossible to cross-calibrate potency reagents made from heterologous vaccine and requires the establishment of a new unit to measure potency of sIPV that is different from conventional D-antigen unit.