Key result
Standardized AQbD-based analytical procedure improves neutralizing antibody intermediate precision over individual laboratory protocols.
Why the study?
The lack of a standardized analytical procedure for neutralizing antibodies limits comparability of results and hinders COVID-19 vaccine development and application.
Highlights the urgent need for a standardized analytical procedure for neutralizing antibodies to evaluate COVID-19 vaccines.
Provides candidate standardized Ntab assay for clinical samples; leaves open adoption for cross-trial comparability.
Vaccination is an effective strategy for controlling the COVID-19 pandemic and reducing the number of cases of hospitalization and deaths. 1 Neutralizing antibody (Ntab) is one of the key indicators for evaluating the effectiveness of COVID-19 vaccines. 2 Over 40 COVID-19 vaccines have been approved for emergency use, marketing, or marketing with conditions, and the available Ntab data from clinical trials have been published. 3 However, the lack of a standardized analytical procedure for Ntabs makes the Ntab detection results incomparable, limiting the development and application of COVID-19 vaccines. It has become an urgent issue for the World Health Organization and global vaccine regulatory agencies.
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Liu et al. (2023) conducted a letter in COVID-19 (n=272). Standardized SOP (SD-SOP) based on AQbD vs. Individual laboratory SOPs (EL-SOP) was evaluated on Intermediate precision (Geometric coefficient of variation, GCV) of Ntab titers. A standardized neutralizing antibody analytical procedure based on the AQbD concept significantly improved intermediate precision compared to individual laboratory protocols.
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