![]() highlighted the utility of antibody assays as a highly cost-effective tool for a vaccination strategy to promote public health. Regarding vaccine application, Gudbjartsson et al. Nowadays, antibody testing may provide valuable data on: 1) surveillance and epidemiological assessment to evaluate the immunization status of the population, 2) diagnosis of suspected cases with negative viral RNA test to increased diagnostic sensitivity for COVID‐19 patients, , 3) selection of hyperimmune plasma for convalescent plasma therapy, 4) therapeutic antibody development and evaluation, 5) assessment of COVID-19 vaccines immune responses and durability. Simultaneously, in September 2020 the WHO issued the target product profiles for COVID-19 diagnostics, indicating 95–97% and 98–99% as acceptable criteria for sensitivity and specificity, respectively. Īs of 12 April 2021, there are at least 655 immunoassays for antibodies that are either commercially available or in development, according to the Foundation for Innovative New Diagnostics (FIND) ( ), a World Health Organization (WHO) collaborating center for Laboratory Strengthening and Diagnostic Technology Evaluation. Since the beginning, the US Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUA) for hundreds of serological assays to support COVID-19 diagnosis. ![]() SARS-CoV-2 antibody assays have been and continue to be essential in managing the COVID-19 pandemic,. ![]()
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