Performance evaluation of Abbott ARCHITECT SARS-CoV-2 IgG immunoassay in comparison with indirect immunofluorescence and virus microneutralization test
Performance evaluation of Abbott ARCHITECT SARS-CoV-2 IgG immunoassay in comparison with indirect immunofluorescence and virus microneutralization test
复制标题
DOI：
10.1016/j.jcv.2020.104539
复制
发表时间：
2020-08-01
影响因子：
8.8
通讯作者：
Castilletti, Concetta
中科院分区：
文献类型：
--
作者：
Meschi, Silvia;Colavita, Francesca;Castilletti, Concetta
背景：抗sars - cov -2抗体的血清学检测在确定特定人群的血清阳性率、确定既往暴露情况和确定高反应性人类供体以生成治疗性恢复期血清方面正变得非常重要。目的：我们评估了雅培ARCHITECT SARS-CoV-2 IgG检测的诊断性能，这是一种全自动间接免疫检测，可检测针对重组SARS-CoV-2核衣壳抗原的抗体。研究设计：将SARS-CoV-2 IgG免疫分析法与间接免疫荧光法（IFA）在症状出现或感染其他人类冠状病毒后不同天数采集的COVID-19患者血清进行比较。并与中和试验进行了比较。结果：发病后7、14、14天，ARCHITECT阳性率为8.3%；61.9%和100%的测试样本对比58.3%；85.7%和100%是IFA。与IFA相比敏感性为72%，与实时PCR相比敏感性为66.7%，特异性为100%。在18份具有中和活性的样品中，17份样品的SARS-CoV-2 IgG检测呈阳性。结论：在我们的研究中，雅培ARCHITECT SARS-CoV-2 IgG检测方法表现出令人满意的性能，具有非常高的特异性。所有患者在症状出现两周后均可检测到IgG对sarscov - 2n抗原的反应性。此外，这种血清学反应和病毒中和反应之间的一致性表明，无论靶抗原是什么，强烈的体液反应都可能预测中和活性。这一发现支持在诊断算法和公共卫生干预中使用这种自动血清学检测，特别是在高负荷检测中。
Background: Serological tests for anti-SARS-CoV-2 antibodies are becoming of great interest to determine seroprevalence in a given population, define previous exposure and identify highly reactive human donors for the generation of convalescent serum as therapeutic.Objectives: We evaluated the diagnostic performance of the Abbott ARCHITECT SARS-CoV-2 IgG test, a fully automated indirect immunoassay that detects antibodies directed to a recombinant SARS-CoV-2 Nucleocapsid antigen.Study design: Abbott ARCHITECT SARS-CoV-2 IgG immunoassay was compared to an indirect immunofluorescence assay (IFA) on sera from patients with COVID-19 collected at different days after symptoms onset or infected by other human coronaviruses. Comparison with neutralization test was also performed.Results: After 7, 14 and > 14 days after onset ARCHITECT was positive on 8.3 %; 61.9 % and 100 % of the tested samples compared to 58.3 %; 85.7 % and 100 % by IFA. The sensitivity was 72 % vs. IFA and 66.7 % vs. a realtime PCR, the specificity was 100 %. On 18 samples with neutralizing activity, 17 were positive by Abbott ARCHITECT SARS-CoV-2 IgG.Conclusions: In our study, Abbott ARCHITECT SARS-CoV-2 IgG assay showed a satisfactory performance, with a very high specificity. IgG reactivity against SARSCoV-2 N antigen was detectable in all patients by two weeks after symptoms onset. In addition, concordance between this serological response and viral neutralization suggests that a strong humoral response may be predictive of a neutralization activity, regardless of the target antigens. This finding supports the use of this automated serological assay in diagnostic algorithm and public health intervention, especially for high loads of testing.