Emerg Infect Dis. 2020 Jul;26(7):1478-1488. doi: 10.3201/eid2607.200841. Epub 2020 Jun 21.
A new coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has recently emerged to cause a human pandemic. Although molecular diagnostic tests were rapidly developed, serologic assays are still lacking, yet urgently needed. Validated serologic assays are needed for contact tracing, identifying the viral reservoir, and epidemiologic studies. We developed serologic assays for detection of SARS-CoV-2 neutralizing, spike protein-specific, and nucleocapsid-specific antibodies. Using serum samples from patients with PCR-confirmed SARS-CoV-2 infections, other coronaviruses, or other respiratory pathogenic infections, we validated and tested various antigens in different in-house and commercial ELISAs. We demonstrated that most PCR-confirmed SARS-CoV-2-infected persons seroconverted by 2 weeks after disease onset. We found that commercial S1 IgG or IgA ELISAs were of lower specificity, and sensitivity varied between the 2 assays; the IgA ELISA showed higher sensitivity. Overall, the validated assays described can be instrumental for detection of SARS-CoV-2-specific antibodies for diagnostic, seroepidemiologic, and vaccine evaluation studies.
一种新型冠状病毒,严重急性呼吸系统综合症冠状病毒 2(SARS-CoV-2),最近出现并引发了人类大流行。尽管已经迅速开发出分子诊断测试,但血清学检测仍然缺乏,且迫切需要这种检测。有了经过验证的血清学检测,才能进行接触者追踪、确定病毒储存库以及进行流行病学研究。我们开发了用于检测 SARS-CoV-2 中和抗体、刺突蛋白特异性抗体和核衣壳特异性抗体的血清学检测方法。我们使用经 PCR 确诊的 SARS-CoV-2 感染患者、其他冠状病毒或其他呼吸道病原体感染患者的血清样本,在不同的内部和商业 ELISA 中对各种抗原进行了验证和测试。我们证明,大多数经 PCR 确诊的 SARS-CoV-2 感染患者在发病后 2 周内出现血清转化。我们发现,商业 S1 IgG 或 IgA ELISA 的特异性较低,两种检测方法的灵敏度存在差异;IgA ELISA 的灵敏度更高。总的来说,所描述的经验证的检测方法可用于检测 SARS-CoV-2 特异性抗体,用于诊断、血清流行病学和疫苗评估研究。