Analytical and clinical performances of five immunoassays for the detection of SARS-CoV-2 antibodies in comparison with neutralization activity.
Analytical and clinical performances of five immunoassays for the detection of SARS-CoV-2 antibodies in comparison with neutralization activity.
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DOI：
10.1016/j.ebiom.2020.103101
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发表时间：
2020-12
期刊：
影响因子：
11.1
通讯作者：
Plebani M
中科院分区：
文献类型：
--
作者：
Padoan A;Bonfante F;Pagliari M;Bortolami A;Negrini D;Zuin S;Bozzato D;Cosma C;Sciacovelli L;Plebani M
为了有效遏制 COVID-19 大流行，迫切需要对 SARS-CoV-2 抗体进行可靠的高通量血清学检测，因为了解感染后免疫力的强度和持续时间，以及就激活或终止物理距离限制做出明智的决定至关重要。在来自 130 名 COVID-19 患者和 54 名 SARS-CoV-2 阴性受试者的 184 份血清样本中，四种市售化学发光测定（Abbott SARS-Cov-2 IgG、Roche Elecsys 抗 SARS-CoV-2、Ortho SARS-CoV-2 总和 IgG）和一种酶联免疫吸附测定（Diesse ENZY-WELL）的分析和临床性能 SARS-CoV-2 IgG）进行了评估，并与使用空斑减少中和试验（PRNT）实现的中和活性进行了比较。所有检测的精确度结果范围为 0.9% 至 11.8%。 Elecsys 抗 SARS-CoV-2 在截止值内的浓度下证明结果呈线性。总体而言，敏感性范围为 78.5% 至 87.7%，特异性范围为 97.6% 至 100%。将分析限制在症状出现后 12 天收集的样本后，所有检测的灵敏度均有所提高，其中使用 VITRO Anti-SARS-CoV-2 Total 和 Architect SARS-CoV-2 IgG 获得了最高值 (95.2%)。使用 ENZY-Well SARS-CoV-2 IgG 获得了最强的 PRNT50 与抗体水平的相关性 (R2adj = 0.569)。结果证实，所有免疫测定都具有出色的特异性，而不同免疫测定的灵敏度各不相同，很大程度上取决于症状出现和样本收集之间的时间间隔。应进行进一步的研究，以实现抗体测量与 PRNT50 之间更强的相关性，以便获得有用的信息，以更好地管理 COVID-19 患者、有效的被动抗体治疗以及开发针对 SARS-CoV-2 病毒的疫苗。没有任何。
Reliable high-throughput serological assays for SARS-CoV-2 antibodies are urgently needed for the effective containment of the COVID-19 pandemic, as it is of crucial importance to understand the strength and duration of immunity after infection, and to make informed decisions concerning the activation or discontinuation of physical distancing restrictions. In 184 serum samples from 130 COVID-19 patients and 54 SARS-CoV-2 negative subjects, the analytical and clinical performances of four commercially available chemiluminescent assays (Abbott SARS-Cov-2 IgG, Roche Elecsys anti-SARS-CoV-2, Ortho SARS-CoV-2 total and IgG) and one enzyme-linked immunosorbent assay (Diesse ENZY-WELL SARS-CoV-2 IgG) were evaluated and compared with the neutralization activity achieved using the plaque reduction neutralization test (PRNT). Precision results ranged from 0.9% to 11.8% for all assays. Elecsys anti-SARS-CoV-2 demonstrated linearity of results at concentrations within the cut-off value. Overall, sensitivity ranged from 78.5 to 87.7%, and specificity, from 97.6 to 100%. On limiting the analysis to samples collected 12 days after onset of symptoms, the sensitivity of all assays increased, the highest value (95.2%) being obtained with VITRO Anti-SARS-CoV-2 Total and Architect SARS-CoV-2 IgG. The strongest PRNT50 correlation with antibody levels was obtained with ENZY-Well SARS-CoV-2 IgG (R2adj = 0.569). The results confirmed that all immunoassays had an excellent specificity, whereas sensitivity varied across immunoassays, depending strongly on the time interval between symptoms onset and sample collection. Further studies should be conducted to achieve a stronger correlation between antibody measurement and PRNT50 in order to obtain useful information for providing a better management of COVID-19 patients, effective passive antibody therapy, and developing a vaccine against the SARS-CoV-2 virus. None.