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Abstract
BackgroundSince universal vaccinations represents the most effective strategy to mitigate coronavirus disease 2019 (COVID-19), baseline assessment and post-vaccine monitoring of anti-SARS-CoV-2 neutralizing antibodies are essential to vaccination programs. Therefore, this study aimed to compare data of five commercial anti-SARS-CoV2 immunoassays after administration of an mRNA vaccine.MethodsVenous blood was collected from three healthcare workers, receiving a double (30 g) dose of BNT162b2 mRNA Covid-19 vaccine (Comirnaty, Pfizer), on the day of the first vaccine dose and then at fixed intervals for the following 2 months. Anti-SARS-CoV-2 neutralizing antibody response was assayed with Roche Total Ig anti-RBD (receptor binding domain), DiaSorin TrimericS IgG (spike trimer), Beckman Coulter IgG anti-RBD, SNIBE IgG anti-RBD and Technogenetics IgG anti-N/S1.ResultsA total number of 45 samples were drawn at the end of the 2-month study period. The Spearman's correlations of absolute anti-SARS-CoV-2 antibodies were always excellent (all p<0.001), comprised between 0.967-0.994. Satisfactory results were also observed when absolute antiSARS-CoV-2 antibodies values of the five methods were compared with the mean consensus value, with correlations always higher than 0.979 (all p<0.001). The agreement of anti-SARS-CoV-2 antibodies positivity versus the consensus median positivity ranged between 0.764 and 1.000 (always p<0.001), but become always >0.900 after readjustment of one assay cutoff.ConclusionsAll the immunoassays evaluated in this study appear suitable for monitoring anti-SARS-CoV-2 neutralizing antibodies response in subjects undergoing mRNA COVID-19 vaccination.
Highlights
Over 1 year after the severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) emerged in Wuhan and spread around the world causing the worst pandemic outbreak in several decades [1], vaccination appears the most effective strategy to limit the clinical, societal and economic burdens of coronavirus disease 2019 (COVID-19) [2]
All the immunoassays evaluated in this study appear suitable for monitoring anti-SARS-CoV-2 neutralizing antibodies response in subjects undergoing mRNA COVID-19 vaccination
Zaklju~ak: Sva imunodre|ivanja koja su procenjivana u ovom izu~avanju su pogodna za pra}enje anti-SARS-CoV-2 netraliziraju}ih antitela koja nastaju kod osoba koja su bila vakcinisana sa mRNA COVID-19 vakcinom
Summary
Over 1 year after the severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) emerged in Wuhan and spread around the world causing the worst pandemic outbreak in several decades [1], vaccination appears the most effective strategy to limit the clinical, societal and economic burdens of coronavirus disease 2019 (COVID-19) [2]. With the clear understanding that universal vaccinations will likely represent the only reliable means to mitigate the deleterious impact of COVID-19 in the forthcoming period [6], baseline assessment and post-vaccine monitoring of anti-SARS-CoV-2 neutralizing antibody (i.e., a class of immunoglobulins (Ig) targeting and thereby inactivating the spike protein and/or its receptor binding domain (RBD) are regarded as paradigms for prioritizing vaccine administration and monitoring extent and duration of the humoral immune response [7, 8] To this end, the in vitro diagnostic market is incessantly making available a vast array of anti-SARS-CoV-2 immunoassays, varying in terms of antibody class detected (i.e., total antibodies, including IgG, IgM and IgA, rather than IgG only), antigenic target (entire spike protein, subunits 1 and/or 2, RBD) and analytical techniques (ChemiLuminescent ImmunoAssays (CLIA), Enzyme Linked Fluorescent ImmunoAssays (ELFIA), manual Enzyme Linked ImmunoSorbent Assays (ELISA, etc.)). This study was aimed at comparing the short-term longitudinal results of five commercial anti-SARS-CoV-2 total antibodies and IgG immunoassays after vaccination with BNT162b2 mRNA Covid-19
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