The CEPI centralised laboratory network: supporting COVID-19 vaccine development

Evaluation of Three Quantitative Anti-SARS-CoV-2 Antibody Immunoassays

“…The NIBSC international standard was also essential for comparing the antibody titers obtained with the commercial immunoassays ( 15 ). The lower detection limits determined with this standard for each assay agreed with the better diagnostic sensitivity observed with the Wantaï assay in the “late” infection group.…”

“…This study evaluated the clinical performances and antibody quantifying capacity of three commercially available assays. We used the first NIBSC standard as a reference for anti-S antibodies ( 14 , 15 ). The Wantaï SARS-CoV-2 antibody (Ab) enzyme-linked immunosorbent assay (ELISA) measures total anti-SARS-CoV-2 antibodies.…”

Antibody titers and protection against a SARS-CoV-2 infection

“…In contrast only 0.6% [95 % CI: 0% -1.5%] of those with NAb titers of 64 to 128 became infected together with none of those with NAb titers of 256 and above ( Figure1 , p<0.01, Chi 2 test). The correlation between the ELISA total antibody values expressed in binding antibody units (BAU) per ml using the WHO international standard (NIBSC code 20/136) [6] and the neutralizing antibody titers from July 2020 to April 2021 was 0.8 for unvaccinated HCWs and 0.79 for vaccinated HCWs. Analysis of ELISA total antibody concentrations indicated that 12.1% [95 % CI: 11.5% -12.8%] of HCWs with a negative ELISA or an ELISA concentration below 13 BAU/ml became infected between July 2020 and April 2021, as did 10.6% [95 % CI: 6.5% -16.1%] of HCWs that had an ELISA concentration between 13 and 141 BAU/ml.…”

Covid-19 vaccines production and societal immunization under the serendipity-mindsponge-3D knowledge management theory and conceptual framework

“…The first Covid-19vaccine that completed phase 3 in the world, Pfizer/BioNTech BNT162b2, is the product of Project Lightspeed [66] Additionally, in a global crisis, the issue of expertise was also considered on international levels. On October 2, 2020, CEPI announced establishing a global network of laboratories to compare immunological responses of Covid-19 vaccines [71,72]. All Covid-19 vaccine developers in the world can utilize the network to quickly and accurately assess candidates.…”