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用于 SARS-CoV-2 高通量血清学监测的替代病毒中和试验评估。

Evaluation of a surrogate virus neutralization test for high-throughput serosurveillance of SARS-CoV-2.

机构信息

Virology Unit, Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium; Evolutionary Ecology Group, Department of Biology, University of Antwerp, Antwerp, Belgium.

Virology Unit, Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.

出版信息

J Virol Methods. 2021 Nov;297:114228. doi: 10.1016/j.jviromet.2021.114228. Epub 2021 Jul 3.

Abstract

High-throughput serological tests that can detect neutralizing antibodies against SARS-CoV-2 are desirable for serosurveillance and vaccine efficacy evaluation. Although the conventional neutralization test (cVNT) remains the gold standard to confirm the presence of neutralizing antibodies in sera, the test is too labour-intensive for massive screening programs and less reproducible as live virus and cell culture is involved. Here, we performed an independent evaluation of a commercially available surrogate virus neutralization test (sVNT, GenScript cPass™) that can be done without biosafety level 3 containment in less than 2 h. When using the cVNT and a Luminex multiplex immunoassay (MIA) as reference, the sVNT obtained a sensitivity of 94 % (CI 90-96 %) on a panel of 317 immune sera that were obtained from hospitalized and mild COVID-19 cases from Belgium and a sensitivity of 88 % (CI 81-93 %) on a panel of 184 healthcare workers from the Democratic Republic of Congo. We also found strong antibody titer correlations (r>0.8) among the different techniques used. In conclusion, our evaluation suggests that the sVNT could be a powerful tool to monitor/detect neutralising antibodies in cohort and population studies. The technique could be especially useful for vaccine evaluation studies in sub-Saharan Africa where the basic infrastructure to perform cVNTs is lacking.

摘要

高通量血清学检测方法可用于检测针对 SARS-CoV-2 的中和抗体,对于血清学监测和疫苗效果评估具有重要意义。虽然传统的中和检测(cVNT)仍然是确认血清中中和抗体存在的金标准,但由于涉及活病毒和细胞培养,该检测方法过于繁琐,不适合大规模筛查项目,并且重现性较差。在这里,我们对一种商业上可用的替代病毒中和检测(sVNT,GenScript cPass™)进行了独立评估,该检测可以在不到 2 小时的时间内在低于生物安全 3 级的条件下进行。当使用 cVNT 和 Luminex 多重免疫分析(MIA)作为参考时,sVNT 在来自比利时住院和轻症 COVID-19 病例的 317 份免疫血清样本中获得了 94%的灵敏度(90%-96%CI),在来自刚果民主共和国的 184 名医护人员的血清样本中获得了 88%的灵敏度(81%-93%CI)。我们还发现,不同技术之间的抗体滴度相关性很强(r>0.8)。总之,我们的评估表明,sVNT 可以成为监测/检测队列和人群研究中中和抗体的有力工具。该技术在缺乏进行 cVNT 的基本基础设施的撒哈拉以南非洲的疫苗评估研究中可能特别有用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b89/8253660/53d3f52ef858/gr1_lrg.jpg

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