辉瑞/生物新技术公司（BioNTech/Pfizer）的 Comirnaty（BNT162b2）接种一剂或两剂后针对 SARS-CoV-2 的中和抗体：动力学和与化学发光检测的比较。
SARS-CoV-2 neutralizing antibodies after one or two doses of Comirnaty (BNT162b2, BioNTech/Pfizer): Kinetics and comparison with chemiluminescent assays.
机构信息
Department of Medicine-DIMED, University of Padua, Italy; Department of Laboratory Medicine, University-Hospital of Padua, Italy.
Department of Laboratory Medicine, University-Hospital of Padua, Italy.
出版信息
Clin Chim Acta. 2021 Dec;523:446-453. doi: 10.1016/j.cca.2021.10.028. Epub 2021 Oct 28.
BACKGROUND
Studies evaluating neutralizing antibody (NAb) after BNT162b2 vaccine are scarce. We therefore compared NAb using the plaque reduction neutralization test (PRNT) in vaccinated subjects, with those from five chemiluminescent (CLIA) assays, two targeting ACE and S-RBD interaction.
METHODS
Sera from 174 completely Comirnaty/BNT162b2 vaccinated healthcare workers (HCW) were evaluated at t and t. NAb titers at low (PRNT) or high (PRNT) stringency were compared with: Liaison SARS-CoV-2 Trimeric-S IgG, Elecsys S-RBD Ab, Maglumi SARS-CoV-2 S-RBD IgG and SARS-CoV-2 Nab; iFlash 2019-nCoV NAb.
RESULTS
Neither PRNT nor PRNT correlated with age (range, 24-65 years); no significant differences were found for gender. PRNT and PRNT seropositive titers (≥1:20) were 43 (24.7%) and 15 (8.6%) at t and 167 (95.9%) and 149 (85.6%) at t. CLIA results at t were uncorrelated with age, apart from Elecsys S-RBD Ab (r = -0.164, p = 0.046). Gender differences were found for Maglumi SARS-CoV-2 S-RBD IgG (p = 0.037) and Maglumi NAb (p = 0.046). Considering PRNT at thresholds of 1:20 (or 1:40) and 1:160 (or 1:320), corresponding to different immune protective levels, CLIA cut-offs have been identified.
CONCLUSIONS
Comirnaty/BNT162b2 elicits strong NAb production, especially 28 days after first inoculum. Differences in correlation between Nab titers and circulating antibodies measured by 5 immunoassays have been found, being stronger the correlation for Maglumi Nab.
背景
目前评估 BNT162b2 疫苗接种后中和抗体（NAb）的研究较少。因此，我们比较了 174 名完全接种 Comirnaty/BNT162b2 的医护人员（HCW）在接种前后的血清中使用蚀斑减少中和试验（PRNT）检测的 NAb，以及使用五种化学发光（CLIA）检测试剂盒检测的 NAb，其中两种试剂盒针对 ACE 和 S-RBD 相互作用。
方法
在 t 和 t 时，评估了 174 名完全接种 Comirnaty/BNT162b2 的医护人员的血清。将低（PRNT）或高（PRNT）严格性的 NAb 滴度与以下各项进行比较：Liaison SARS-CoV-2 三聚体-S IgG、Elecsys S-RBD Ab、Maglumi SARS-CoV-2 S-RBD IgG 和 SARS-CoV-2 Nab；iFlash 2019-nCoV NAb。
结果
PRNT 和 PRNT 均与年龄（24-65 岁）无关；性别之间无显著差异。在 t 时，PRNT 和 PRNT 阳性滴度（≥1:20）分别为 43（24.7%）和 15（8.6%），在 t 时，分别为 167（95.9%）和 149（85.6%）。CLIA 结果在 t 时与年龄无关，但 Elecsys S-RBD Ab 除外（r= -0.164，p= 0.046）。Maglumi SARS-CoV-2 S-RBD IgG（p= 0.037）和 Maglumi Nab（p= 0.046）的性别差异。考虑到 PRNT 的阈值为 1:20（或 1:40）和 1:160（或 1:320），分别对应于不同的免疫保护水平，确定了 CLIA 的临界值。
结论
Comirnaty/BNT162b2 可诱导强烈的 NAb 产生，尤其是在第一次接种后 28 天。在 5 种免疫测定中，Nab 滴度与循环抗体之间的相关性存在差异，Maglumi Nab 的相关性更强。
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