Goal: Monitoring the genetic diversity and emerging mutations of SARS-CoV-2 is crucial for understanding the evolution of the virus and assuring the performance of diagnostic tests, vaccines, and therapies against COVID-19. SARS-CoV-2 is still adapting to humans and, as illustrated by B.1.1.7 (Alpha) and B.1.617.2 (Delta), lineage dynamics are fluid, and strain prevalence may change radically in a matter of months. The National Institutes of Health's Rapid Acceleration of Diagnostics (RADx ^SM ) initiative created a Variant Task Force to assess the impact of emerging SARS-CoV-2 variants on in vitro diagnostic testing. Working in tandem with clinical laboratories, the FDA, and the CDC, the Variant Task Force uses both in silico modeling and in vitro testing to determine the effect of SARS-CoV-2 mutations on diagnostic molecular and antigen tests. Here, we offer an overview of the approach and activities of the RADx Variant Task Force to ensure test performance against emerging SARS-CoV-2 lineages.

中文翻译：

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RADx 变体工作组计划，用于评估变体对 SARS-CoV-2 分子和抗原测试的影响


目标：监测 SARS-CoV-2 的遗传多样性和新出现的突变对于了解病毒的进化并确保针对 COVID-19 的诊断测试、疫苗和疗法的性能至关重要。 SARS-CoV-2 仍在适应人类，并且如 B.1.1.7（Alpha）和 B.1.617.2（Delta）所示，谱系动态是不稳定的，菌株流行率可能在几个月内发生根本性变化。美国国立卫生研究院的快速诊断加速 (RADx ^SM ) 计划创建了一个变体工作组，以评估新出现的 SARS-CoV-2 变体对体外诊断测试的影响。变体工作组与临床实验室、FDA 和 CDC 合作，利用计算机建模和体外测试来确定 SARS-CoV-2 突变对诊断分子和抗原测试的影响。在此，我们概述了 RADx 变体工作组的方法和活动，以确保针对新兴 SARS-CoV-2 谱系的测试性能。