Background: Since 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.
Methods: Venous 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.
Results: A 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.
Conclusions: 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.
Uvod: Pošto univerzalna vakcinacija pretstavlja najefikasniju strategiju za zaustavljanje koronavirus oboljenja 2019 (COVID-19) veoma je važno praćenje nakon vakcinacije anti-SARS-CoV-2 antitela koja su va`na za programe vakcinacije. Iz tog razloga ovo proučavanje je imalo za cilj da poredi podatke pet komercijalnih anti-SARS-CoV-2 imunodređivanja nakon davanja mRNA vakcine.
Metode: Uzeta je venska krv od tri zdravstvena radnika koja su primila duplu dozu (30 g) BNT-162b2 mRNA Covid-19 vakcine (Comirnaty, Pfizer) odmah nakon davanja prve doze vakcine a zatim u fiksiranim intervalima u roku od sledeća 2 meseca. Anti-SARS-CoV-2 neutrališuća antitela su određivana sa Roche Total Ig anti-RBD (receptor vezujući domen), DiaSorin TrimericS IgG (spike trimer), Beckman Coulter IgG anti-RBD, SNIBE IgG anti-RBD i Technogenetics IgG antiN/S1.
Rezultati: Nakon 2 meseca uzeto je 45 uzoraka. Spearma - nova korelacija apsolutnih anti-SARS-CoV-2 antitela bila je uvek odlična (svi p<0,001) sa obuhvatom između 0,967-0,994. Zadovoljavajući rezultati su dobijeni između vrednosti apsolutnih anti-SARS-CoV-2 antitela dobijenih sa svih pet metoda kad su upoređivane sa konsenzus vrednostima i korelacijom koja je bila veća od 0,979 (svi p<0,001). Slaganje pozitivnosti anti-SARS-CoV-2 antitela prema konsenzus srednjoj pozitivnosti koja se kretala između 0,764 i 1,000 (uvek p<0,001), bila je uvek >0,900 nakon podešavanja cutoff vrednosti za jedno određivanje.
Zaključak: Sva imunodređivanja koja su procenjivana u ovom izučavanju su pogodna za praćenje anti-SARS-CoV-2 netralizirajućih antitela koja nastaju kod osoba koja su bila vakcinisana sa mRNA COVID-19 vakcinom.
Keywords: BNT162b2 mRNA Covid-19 vaccine; antibodies; immune response; immunoassays comparison.
2021 Elisa Danese, Martina Montagnana, Gian Luca Salvagno, Matteo Gelati, Denise Peserico, Laura Pighi, Nitto Simone de, Brandon M. Henry, Stefano Porru, Giuseppe Lippi, published by CEON/CEES.