Rao Anuradha, Westbrook Adrianna, Bassit Leda, Parsons Richard, Fitts Eric, Greenleaf Morgan, McLendon Kaleb, Sullivan Julie A, O'Sick William, Baugh Tyler, Bowers Heather B, Frank Filipp, Wang Ethan, Le Mimi, Frediani Jennifer, Roychoudhury Pavitra, Greninger Alexander L, Jerris Robert, Pollock Nira R, Ortlund Eric A, Roback John D, Lam Wilbur A, Piantadosi Anne
The Atlanta Center for Microsystems-Engineered Point-of-Care Technologies, Atlanta, GA, United States of America.
Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.
medRxiv. 2023 Feb 10:2023.02.09.23285583. doi: 10.1101/2023.02.09.23285583.
Rapid Antigen Tests (RAT) have become an invaluable tool for combating the COVID-19 pandemic. However, concerns have been raised regarding the ability of existing RATs to effectively detect emerging SARS-CoV-2 variants. We compared the performance of eight commercially available, emergency use authorized RATs against the Delta and Omicron SARS-CoV-2 variants using individual patient and serially diluted pooled clinical samples. The RATs exhibited lower sensitivity for Omicron samples when using PCR Cycle threshold (C ) value (a proxy for RNA concentration) as the comparator. Interestingly, however, they exhibited similar sensitivity for Omicron and Delta samples when using quantitative antigen concentration as the comparator. We further found that the Omicron samples had lower ratios of antigen to RNA, which offers a potential explanation for the apparent lower sensitivity of RATs for that variant when using C value as a reference. Our findings underscore the complexity in assessing RAT performance against emerging variants and highlight the need for ongoing evaluation in the face of changing population immunity and virus evolution.
快速抗原检测(RAT)已成为抗击新冠疫情的一项宝贵工具。然而,人们对现有快速抗原检测有效检测新出现的严重急性呼吸综合征冠状病毒2(SARS-CoV-2)变体的能力提出了担忧。我们使用个体患者样本和系列稀释的混合临床样本,比较了八种获得紧急使用授权的市售快速抗原检测针对德尔塔和奥密克戎SARS-CoV-2变体的性能。当使用聚合酶链反应循环阈值(C )值(作为RNA浓度的替代指标)作为比较标准时,快速抗原检测对奥密克戎样本的敏感性较低。然而,有趣的是,当使用定量抗原浓度作为比较标准时,它们对奥密克戎和德尔塔样本表现出相似的敏感性。我们进一步发现,奥密克戎样本的抗原与RNA比值较低,这为快速抗原检测在以C 值作为参考时对该变体明显较低的敏感性提供了一个潜在解释。我们的研究结果强调了评估快速抗原检测针对新出现变体的性能的复杂性,并突出了面对不断变化的人群免疫力和病毒进化进行持续评估的必要性。