在对照和未知人群中进行的 SARS-CoV-2 血清学检测表明病毒中和检测的必要性。
SARS-CoV-2 Serologic Assays in Control and Unknown Populations Demonstrate the Necessity of Virus Neutralization Testing.
机构信息
Department of Immunology, Center for Innate Immunity and Immune Disease, University of Washington, Seattle, Washington, USA.
Department of Pediatric Infectious Disease, Seattle Children's Hospital/University of Washington, Seattle, Washington, USA.
出版信息
J Infect Dis. 2021 Apr 8;223(7):1120-1131. doi: 10.1093/infdis/jiaa797.
BACKGROUND
To determine how serologic antibody testing outcome links with virus neutralization of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), we evaluated individuals for SARS-CoV-2 antibody level and viral neutralization.
METHODS
We compared serum Ig levels across platforms of viral antigens and antibodies with 15 positive and 30 negative SARS-CoV-2 controls followed by viral neutralization assessment. We then applied these platforms to a clinically relevant cohort of 114 individuals with unknown histories of SARS-CoV-2 infection.
RESULTS
In controls, the best-performing virus-specific antibody detection platforms were SARS-CoV-2 receptor binding domain (RBD) IgG (sensitivity 87%, specificity 100%, positive predictive value [PPV] 100%, negative predictive value [NPV] 94%), spike IgG3 (sensitivity 93%, specificity 97%, PPV 93%, NPV 97%), and nucleocapsid protein (NP) IgG (sensitivity 93%, specificity 97%, PPV 93%, NPV 97%). Neutralization of positive and negative control sera showed 100% agreement. Twenty individuals with unknown history had detectable SARS-CoV-2 antibodies with 16 demonstrating virus neutralization. Spike IgG3 provided the highest accuracy for predicting serologically positive individuals with virus neutralization activity (misidentified 1/20 unknowns compared to 2/20 for RBD and NP IgG).
CONCLUSIONS
The coupling of virus neutralization analysis to a spike IgG3 antibody test is optimal to categorize patients for correlates of SARS-CoV-2 immune protection status.
背景
为了确定血清抗体检测结果与严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的病毒中和作用之间的关系，我们评估了个体的 SARS-CoV-2 抗体水平和病毒中和作用。
方法
我们比较了针对病毒抗原和抗体的不同平台的血清 Ig 水平，包括 15 名阳性和 30 名阴性 SARS-CoV-2 对照者，然后进行了病毒中和评估。然后，我们将这些平台应用于一个具有 114 名未知 SARS-CoV-2 感染史的临床相关队列。
结果
在对照组中，表现最佳的病毒特异性抗体检测平台是 SARS-CoV-2 受体结合域（RBD）IgG（敏感性 87%，特异性 100%，阳性预测值 [PPV] 100%，阴性预测值 [NPV] 94%）、刺突 IgG3（敏感性 93%，特异性 97%，PPV 93%，NPV 97%）和核衣壳蛋白（NP）IgG（敏感性 93%，特异性 97%，PPV 93%，NPV 97%）。阳性和阴性对照血清的中和作用显示出 100%的一致性。20 名具有未知病史的个体具有可检测到的 SARS-CoV-2 抗体，其中 16 名具有病毒中和作用。刺突 IgG3 对预测具有病毒中和活性的血清学阳性个体具有最高的准确性（与 RBD 和 NP IgG 相比，错误识别了 1/20 个未知个体，而不是 2/20 个）。
结论
将病毒中和分析与刺突 IgG3 抗体测试相结合，是分类 SARS-CoV-2 免疫保护状态相关因素的最佳方法。
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