Clinical and Analytical Performance of an Automated Serological Test That Identifies S1/S2-Neutralizing IgG in COVID-19 Patients Semiquantitatively
Clinical and Analytical Performance of an Automated Serological Test That Identifies S1/S2-Neutralizing IgG in COVID-19 Patients Semiquantitatively
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DOI：
10.1128/jcm.01224-20
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发表时间：
2020-09-01
影响因子：
9.4
通讯作者：
Baldanti, Fausto
中科院分区：
文献类型：
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作者：
Bonelli, Fabrizio;Sarasini, Antonella;Baldanti, Fausto
在2019年冠状病毒病（COVID-19）大流行中，高度选择性的血清学检测对于确定是否暴露于严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）至关重要。已经开发了许多测试，但对第一次结果的速度不同，并且质量未知，特别是在考虑预测中和能力时。LIAISON SARS-CoV-2 S1/S2 IgG检测方法设计用于在标准化自动化化学发光试验中检测针对SARS-CoV-2天然S1/S2蛋白的抗体。在一项观察性研究中，该测试的临床和分析性能得到了验证，该研究使用了COVID-19诊断阳性或阴性的剩余样本（bbb1500）。经证实，LIAISON SARS-CoV-2 S1/S2 IgG检测具有高度选择性和特异性，并提供具有中和活性的血清或血浆抗S1/S2 IgG水平的半定量测量。在诊断后5天或15天，该方法的诊断敏感性分别为91.3%和95.7%，与中和试验相比，该方法的诊断敏感性为100%。该检测的特异性在97%到98.5%之间。测定的平均不精密度为a
In the coronavirus (CoV) disease 2019 (COVID-19) pandemic, highly selective serological testing is essential to define exposure to severe acute respiratory syndrome CoV 2 (SARS-CoV-2). Many tests have been developed, yet with variable speeds to first results, and are of unknown quality, particularly when considering the prediction of neutralizing capacity. The LIAISON SARS-CoV-2 S1/S2 IgG assay was designed to measure antibodies against the SARS-CoV-2 native S1/S2 proteins in a standardized automated chemiluminescence assay. The clinical and analytical performances of the test were validated in an observational study using residual samples (>1,500) with a positive or negative COVID-19 diagnosis. The LIAISON SARS-CoV-2 S1/S2 IgG assay proved to be highly selective and specific and offered semiquantitative measures of serum or plasma levels of anti-S1/S2 IgG with neutralizing activity. The assay's diagnostic sensitivities were 91.3% and 95.7% at >5 or >= 15 days from diagnosis, respectively, and 100% when assessed against a neutralizing assay. The assay's specificity ranged between 97% and 98.5%. The average imprecision of the assay was a