E25Bio, Inc., Cambridge, MA 01239, USA.
Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.
Viruses. 2022 Feb 25;14(3):468. doi: 10.3390/v14030468.
Human transmission of SARS-CoV-2 and emergent variants of concern continue to occur globally, despite mass vaccination campaigns. Public health strategies to reduce virus spread should therefore rely, in part, on frequent screening with rapid, inexpensive, and sensitive tests. We evaluated two digitally integrated rapid tests and assessed their performance using stored nasal swab specimens collected from individuals with or without COVID-19. An isothermal amplification assay combined with a lateral flow test had a limit of detection of 10 RNA copies per reaction, and a positive percent agreement (PPA)/negative percent agreement (NPA) during the asymptomatic and symptomatic phases of 100%/100% and 95.83/100%, respectively. Comparatively, an antigen-based lateral flow test had a limit of detection of 30,000 copies and a PPA/NPA during the asymptomatic and symptomatic phases of 82.86%/98.68% and 91.67/100%, respectively. Both the isothermal amplification and antigen-based lateral flow tests had optimized detection of SARS-CoV-2 during the peak period of transmission; however, the antigen-based test had reduced sensitivity in clinical samples with qPCR Ct values greater than 29.8. Low-cost, high-throughput screening enabled by isothermal amplification or antigen-based techniques have value for outbreak control.
尽管进行了大规模疫苗接种活动，但SARS-CoV-2 的人际传播和新出现的关注变种仍在全球范围内持续发生。因此，减少病毒传播的公共卫生策略部分应依赖于使用快速、廉价和敏感的测试进行频繁筛查。我们评估了两种数字化集成的快速检测方法，并使用从有或没有 COVID-19 的个体采集的储存鼻拭子标本评估了它们的性能。一种等温扩增检测与侧向流检测相结合的检测方法的检测限为每个反应 10 个 RNA 拷贝，在无症状和有症状阶段的阳性百分比一致（PPA）/阴性百分比一致（NPA）分别为 100%/100%和 95.83%/100%。相比之下，基于抗原的侧向流检测的检测限为 30,000 拷贝，在无症状和有症状阶段的 PPA/NPA 分别为 82.86%/98.68%和 91.67%/100%。等温扩增和基于抗原的侧向流检测在传播高峰期都能优化检测 SARS-CoV-2；然而，在 qPCR Ct 值大于 29.8 的临床样本中，基于抗原的检测灵敏度降低。基于等温扩增或抗原的技术的低成本、高通量筛选对于控制疫情具有重要价值。
