Comparison of five commercial anti-SARS-CoV-2 total antibodies and IgG immunoassays after vaccination with BNT162b2 mRNA.

Comparison of five commercial anti-SARS-CoV-2 total antibodies and IgG immunoassays after vaccination with BNT162b2 mRNA.
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DOI:
10.5937/jomb0-31475
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发表时间:
2021-09-03
影响因子:
2.5
通讯作者:
Lippi G
Lippi G
中科院分区:
医学4区
文献类型:
--
作者:
Danese E;Montagnana M;Salvagno GL;Gelati M;Peserico D;Pighi L;de Nitto S;Henry BM;Porru S;Lippi G

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由于全民接种疫苗是缓解2019冠状病毒病(COVID-19)的最有效策略,因此抗SARS-CoV-2中和抗体的基线评估和疫苗接种后监测对于疫苗接种计划至关重要。因此,本研究旨在比较mRNA疫苗接种后五种商业抗SARS-CoV 2免疫测定的数据。在首次接种疫苗当天以及随后2个月的固定时间间隔,从接受双倍(30 g)剂量BNT 162 b2 mRNA Covid-19疫苗(Comirnaty,Pfizer)的3名医护人员中采集静脉血。用Roche Total IG anti-RBD(受体结合域)、DiaSorin TrimericS IgG(刺突三聚体)、Beckman Coulter IgG anti-RBD、SNIBE IgG anti-RBD和Technogenetics IgG anti-N/S1测定抗SARS-CoV-2中和抗体应答。在2个月的研究期结束时,总共抽取了45个样本。绝对抗SARS-CoV-2抗体的斯皮尔曼相关性总是极好的(所有p<0.001),包括在0.967-0.994之间。当将五种方法的抗SARS-CoV-2抗体绝对值与平均一致值进行比较时,也观察到令人满意的结果,相关性始终高于0.979(所有p<0.001)。抗SARS-CoV-2抗体阳性与一致阳性中位数的一致性范围在0.764和1.000之间(始终p<0.001),但在重新调整一个测定截止值后始终>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疫苗接种的受试者中的抗SARS-CoV-2中和抗体应答。
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.