Analysis of COVID-19 convalescent plasma for SARS-CoV-2 IgG using two commercial immunoassays
Analysis of COVID-19 convalescent plasma for SARS-CoV-2 IgG using two commercial immunoassays
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DOI：
10.1016/j.jim.2020.112837
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发表时间：
2020-11-01
影响因子：
2.2
通讯作者：
Knight, Vijaya
中科院分区：
文献类型：
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作者：
DomBourian, Melkon G.;Annen, Kyle;Knight, Vijaya
2019冠状病毒病（COVID-19）恢复期血浆（CCP）已获FDA批准，可根据紧急研究新药（IND）方案用于COVID-19严重病例。CCP献血者的合格标准包括通过患病时的病毒RNA检测或康复后的SARS-CoV-2 IgG阳性（如果患病时未进行COVID-19诊断检测）证明COVID-19的证据。除了CCP分析外，SARS-CoV-2 IgG分析还提供了可能的既往暴露信息，并可在SARS-CoV-2 PCR为阴性且临床高度怀疑COVID-19时支持诊断。此外，对SARS-CoV-2 IgG具有高灵敏度和特异性的检测对于了解SARS-CoV-2的社区暴露率至关重要。目前，有几种检测方法可以使用多种方法检测SARS-CoV-2抗体，包括即时侧流装置、高通量免疫测定分析仪和手动方法（如ELISA）。这些检测针对许多SARS-CoV-2抗原，包括核衣壳蛋白（N）、全长刺突蛋白（S）、S1亚基或S蛋白的受体结合结构域（RBD）。鉴于SARS-CoV-2抗体检测方法和抗原靶点之间的异质性，有必要在临床使用前对这些检测方法进行仔细评估。我们比较了两种检测方法，这两种检测方法已获得监管机构批准的CE标志，并使用N抗原或S1-RBD抗原作为分析大量CCP样本的靶标。我们的数据表明，灵敏度和特异性在这些检测方法之间存在差异，可能需要一个以上的抗原靶点来提高IgG检测SARS-CoV-2的灵敏度和特异性。
Coronavirus Disease 2019 (COVID-19) convalescent plasma (CCP) was approved by the FDA for use in severe cases of COVID-19 under an emergency Investigational New Drug (IND) protocol. Eligibility criteria for CCP donors includes documentation of evidence of COVID-19 either by viral RNA detection at the time of illness or positive SARS-CoV-2 IgG after recovery if diagnostic testing for COVID-19 was not performed at the time of illness. In addition to analysis of CCP, analysis of SARS-CoV-2 IgG provides information for possible past exposure and may support diagnosis when SARS-CoV-2 PCR is negative and clinical suspicion for COVID-19 is high. Furthermore, assays with high sensitivity and specificity for SARS-CoV-2 IgG are critical for understanding community exposure rates to SARS-CoV-2. Currently, there are several assays that test for antibodies to SARS-CoV-2 using a variety of methods, including point-of-care lateral flow-based devices, high throughput immunoassay analyzers, and manual methods such as ELISA. These assays target a number of SARS-CoV-2 antigens, including the nucleocapsid protein (N), full length spike protein (S), S1 subunit, or receptor binding domain (RBD) of the S protein. Given the heterogeneity among methods for, and antigenic targets used in SARS-CoV-2 antibody assays, it is necessary for careful evaluation of these assays prior to implementation for clinical use. We compared two assays that had received the CE mark of regulatory approval and that used either the N antigen or Sl-RBD antigen as the target for analysis of a large set of CCP samples. Our data indicates that sensitivity and specificity vary between these assays and that more than one antigenic target may be required to improve the sensitivity and specificity of IgG detection to SARS-CoV-2.