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在生物安全 2 级实验室中进行 COVID-19 血清学检测的单次感染荧光 SARS-CoV-2 中和试验。

A Single-Round Infection Fluorescent SARS-CoV-2 Neutralization Test for COVID-19 Serological Testing at a Biosafety Level-2 Laboratory.

机构信息

Department of Biochemistry & Molecular Biology, University of Texas Medical Branch, Galveston, TX 77555, USA.

Institute for Human Infection and Immunity, University of Texas Medical Branch, Galveston, TX 77555, USA.

出版信息

Viruses. 2022 Jun 2;14(6):1211. doi: 10.3390/v14061211.

DOI:10.3390/v14061211
PMID:35746682
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9230609/
Abstract

A robust serological test to measure neutralizing antibodies against SARS-CoV-2 in biosafety level-2 (BSL-2) laboratories is useful for monitoring antibody response after vaccination or natural infection. The gold standard assay is the conventional plaque reduction neutralization test (PRNT) which requires extensive labor, live viruses, and BSL-3 facilities. Recently, we developed a novel single-round infection fluorescent SARS-CoV-2 virus (SFV) that can be safely used at BSL-2 laboratories for high-throughput neutralization and antiviral testing. In this study, we evaluated the performance of the neutralization test using this SFV with 80 PRNT-positive and 92 PRNT-negative clinical serum or plasma specimens. The SFV neutralization test (SFVNT) has 100% sensitivity and specificity compared to the PRNT. Furthermore, the neutralizing titers generated by the SFVNT and PRNT are highly correlated, with R2 = 0.903 (p < 0.0001). Due to high sensitivity, specificity, accuracy, and reproducibility, the SFVNT can be deployed for the large-scale testing of COVID-19 patients or vaccinated people in general lab settings.

摘要

一种在生物安全二级(BSL-2)实验室中测量针对 SARS-CoV-2 的中和抗体的可靠血清学检测方法,对于监测接种疫苗或自然感染后的抗体反应很有用。金标准检测方法是传统的蚀斑减少中和试验(PRNT),它需要大量的劳动力、活病毒和 BSL-3 设施。最近,我们开发了一种新型的单轮感染荧光 SARS-CoV-2 病毒(SFV),可在 BSL-2 实验室中安全用于高通量中和和抗病毒测试。在这项研究中,我们使用 80 份 PRNT 阳性和 92 份 PRNT 阴性的临床血清或血浆标本评估了该 SFV 的中和检测性能。与 PRNT 相比,SFV 中和检测(SFVNT)具有 100%的灵敏度和特异性。此外,SFVNT 和 PRNT 产生的中和滴度高度相关,R2=0.903(p<0.0001)。由于具有高灵敏度、特异性、准确性和重现性,SFVNT 可用于在一般实验室环境中对 COVID-19 患者或接种疫苗人群进行大规模检测。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4861/9230609/9fb3d277968c/viruses-14-01211-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4861/9230609/00abf14e93e5/viruses-14-01211-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4861/9230609/45df32e67f8d/viruses-14-01211-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4861/9230609/236da5db347b/viruses-14-01211-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4861/9230609/ed8b4008b4e7/viruses-14-01211-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4861/9230609/9fb3d277968c/viruses-14-01211-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4861/9230609/00abf14e93e5/viruses-14-01211-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4861/9230609/45df32e67f8d/viruses-14-01211-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4861/9230609/236da5db347b/viruses-14-01211-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4861/9230609/ed8b4008b4e7/viruses-14-01211-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4861/9230609/9fb3d277968c/viruses-14-01211-g005.jpg

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