Scientific Publications by FDA Staff

Expert Rev Vaccines 2005 Apr;4(2):167-72

ELISA as a possible alternative to the neutralization test for evaluating the immune response to poliovirus vaccines.

Ivanov AP, Dragunsky EM

Ivanov AP, US FDA, Ctr Biol Evaluat & Res, 1401 Rockville Pike, Rockville, MD 20852 USA US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA

This review describes several enzyme-linked immunosorbent assay (ELISA) techniques proposed to replace the neutralization test for detecting neutralization-relevant antibodies to polioviruses in recipients of inactivated poliovirus vaccine and oral poliovirus vaccine, and for seroepidemiologic studies. Comparisons of results from ELISA and the neutralization test suggest that ELISA variants, based on the principle of blocking or binding inhibition that emulate the neutralization test, might offer an alternative to the neutralization test. However, to replace the neutralization test with ELISA would first require extensive studies with very large numbers of serum samples, including sera having low titers of neutralizing antibodies, in order to obtain reliable and statistically sound validation.