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| 献血员中新型冠状病毒SARS-CoV-2中和抗体检测分析 |
| Detection and analysis of novel coronavirus SARS-CoV-2 neutralizing antibodies in blood donors |
| 投稿时间：2020-02-28 修订日期：2020-03-16 |
| DOI： |
| 中文关键词: 新型冠状病毒SARS-CoV-2 中和抗体 静注人免疫球蛋白 血浆 筛选 |
| 英文关键词: novel coronavirus SARS-CoV-2 neutralizing antibody immunoglobulin plasma screening |
| 基金项目:十三五传染病重大专项课题资助项目（2018ZX10731101-002-006；2018ZX10731101-002-009；2018ZX10731101-001-006）；创新生物技术药评价及标准化关键技术研究（2018ZX09101001） |
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| 中文摘要: |
| 目的:静注人免疫球蛋白（IVIG）和新冠肺炎恢复者的血浆已被推荐用于重症新冠肺炎患者的治疗。因此，血浆中新型冠状病毒（SARS-CoV-2）中和抗体水平需要得以及时评价。本研究利用不需要在生物安全三级实验室操作的SARS-CoV-2假病毒中和抗体检测方法，建立了快速检测中和抗体的策略。方法：采用新型冠状病毒SARS-CoV-2假病毒，对1080份健康献血员血浆及26批次IVIG的SARS-CoV-2中和抗体进行检测。初筛采用1:30倍稀释检测；对初筛阳性（抑制率≥50%为阳性）的样本进行复试，复试采用1:30，1:90，1:270三个梯度；对于复试阳性的样本进行中和特异性分析，进一步检测针对水疱性口炎病毒(VSV)、严重急性呼吸道综合征冠状病毒(SARS-CoV)和中东呼吸综合征冠状病毒(MERS-CoV)的中和活性。结果与结论：结果发现1:30倍稀释时，26批次IVIG的SARS-CoV-2中和抗体均为阴性，1080份献血员血浆中SARS-CoV-2中和抗体阳性率为0.6%（6/1180）；对6份阳性血浆的特异性分析显示均为对VSV、SRAS-CoV或MESR-CoV假病毒的非特异中和作用。本研究表明该假病毒中和抗体检测方法和快速检测策略可以用于IVIG、健康献血员和感染者恢复期血浆中的中和抗体检测，发现IVIG针对SARS-CoV-2无特异的中和抗体活性，IVIG在临床重症治疗中发挥的是非病毒特异的辅助治疗作用。 |
| 英文摘要: |
| Objective:Human Immunoglobulin for Intravenous Injection(IVIG) and the convalescent plasma of the COVID-19 patients are recommended for the treatment of severe COVID-19 patients. The neutralizing antibody levels in plasma of novel coronavirus SARS-CoV-2 need to be examined. Methods: In this study, a rapid screening strategy for neutralizing antibodies of SARS-CoV-2 was established by using the SARS-CoV-2 pseudovirus which did not need the Biosafety Level 3 laboratory. The novel SARS-CoV-2 pseudovirus was used to detect SARS-CoV-2 neutralizing antibodies in 1080 healthy donors and 26 batches of IVIG. Results and Conclusion: In the first screening, 1:30 times dilution was used for test; in the second screening, 1:30, 1:90 and 1:270 were used for the positive samples（the inhibition rate ≥ 50%）; Further detection was carried out for positive samples in the second screening of the neutralization antibody level for the vesicular stomatitis virus (VSV), severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV). Our results showed that in 1:30 dilution, 26 batches of IVIG were all negative. The positive rate of the 1080 blood donors was 0.6% (6/1080). However, these samples also showed nonspecific neutralizing effect on VSV, SARS-CoV and MERS-CoV in the further identification assay. The rapid pseudovirus based SARS-CoV-2 neutralizing antibody assay can be used for the evaluation of neutralizing antibodies of IVIG in healthy donors and convalescent plasma in infected persons. Our results shown that IVIG has no specific neutralizing antibody activity against SARS-CoV-2. Therefore, IVIG may play a non-viral-specific supplementary role in the clinical treatment of severe patients. |
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