Danese Elisa, Montagnana Martina, Salvagno Gian Luca, Gelati Matteo, Peserico Denise, Pighi Laura, de Nitto Simone, Henry Brandon M, Porru Stefano, Lippi Giuseppe
University of Verona, Section of Clinical Biochemistry, Verona, Italy.
Pederzoli Hospital, Service of Laboratory Medicine, Peschiera del Garda, Italy.
J Med Biochem. 2021 Sep 3;40(4):335-340. doi: 10.5937/jomb0-31475.
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.
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.
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.
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.
由于普遍接种疫苗是减轻2019冠状病毒病（COVID-19）的最有效策略，因此对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）中和抗体进行基线评估和疫苗接种后监测对疫苗接种计划至关重要。因此，本研究旨在比较mRNA疫苗接种后五种商用抗SARS-CoV-2免疫测定的数据。
从三名医护人员身上采集静脉血，他们接受了双倍（30微克）剂量的BNT162b2 mRNA新冠疫苗（Comirnaty，辉瑞公司），在接种第一剂疫苗当天，然后在接下来的2个月内按固定间隔采集。使用罗氏总Ig抗RBD（受体结合域）、迪亚索林三聚体IgG（刺突三聚体）、贝克曼库尔特IgG抗RBD、SNIBE IgG抗RBD和Technogenetics IgG抗N/S1检测抗SARS-CoV-2中和抗体反应。
在2个月的研究期结束时共采集了45份样本。抗SARS-CoV-2抗体绝对值的斯皮尔曼相关性始终极佳（所有p<0.001），范围在0.967至0.994之间。当将五种方法的抗SARS-CoV-2抗体绝对值与平均共识值进行比较时，也观察到了令人满意的结果，相关性始终高于0.979（所有p<0.001）。抗SARS-CoV-2抗体阳性与共识中位数阳性的一致性范围在0.764至1.000之间（始终p<0.001），但在调整一种检测临界值后始终>0.900。
本研究中评估的所有免疫测定似乎都适用于监测接受mRNA COVID-19疫苗接种的受试者的抗SARS-CoV-2中和抗体反应。
