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. 2021 Oct 7;59(12):2019-2026.
doi: 10.1515/cclm-2021-0364. Print 2021 Nov 25.

Quantitative serological evaluation as a valuable tool in the COVID-19 vaccination campaign

Davide Ferrari  1 , Alessandra Mangia  2 , Maria Sestina Spanò  3 , Lucia Zaffarano  4 , Marco Viganò  5 , Chiara Di Resta  6 , Massimo Locatelli  6 , Fabio Ciceri  6   7 , Elena De Vecchi  3
Affiliations
Free article

Quantitative serological evaluation as a valuable tool in the COVID-19 vaccination campaign

Davide Ferrari et al. Clin Chem Lab Med. .
Free article

Abstract

Objectives: After exceptional research efforts, several vaccines were developed against SARS-CoV-2 which sustains the pandemic COVID-19. The Comirnaty vaccine showed high efficacy in clinical trials and was the first to be approved for its distribution to the general population. We evaluated the immune response induced by the first vaccine dose in different sex/age groups and subjects with or without naturally present anti-SARS-CoV-2 antibodies.

Methods: As part of an Italian multicenter project (Covidiagnostix), serum samples from 4,290 health-professionals were serologically tested the day of the first vaccination dose, and 21 days later, using two different instrumentations (Siemens-Healthineers and Roche).

Results: In total, 97% of samples showed the presence of specific antibodies 21 days after the vaccination dose; the percentage of non-responders increased with age in both genders. Remarkably, naturally seropositive individuals showed antibody persistence up to 11 months and an exceptionally higher vaccination response compared to subjects never infected by SARS-CoV-2.

Conclusions: This study highlighted the importance of the serological test i) to identify naturally SARS-CoV-2 seropositive individuals and ii) to evaluate the antibody level elicited by the first vaccination dose. Both tests, highlighted differences in the immune response, when subjects were stratified by sex and age, and between naturally seropositive and seronegative subjects. The data obtained show how serological tests could play a crucial role in the triage of the population subjected to the vaccination campaign for COVID-19. The definition of suitable instrumentation-specific thresholds is needed to correctly follow eventually acquired post-vaccination immunity in the general population.

Keywords: COVID-19; Roche Anti-SARS-CoV-2-S; Siemens SARS-CoV-2 IgG; mRNA vaccine; serological test.

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