Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.
Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.
Diagn Microbiol Infect Dis. 2021 Oct;101(2):115441. doi: 10.1016/j.diagmicrobio.2021.115441. Epub 2021 May 28.
To meet the testing demands and overcome supply chain issues during the SARS-CoV-2 pandemic, many clinical laboratories validated multiple SARS-CoV-2 molecular testing platforms. Here, we compare three different molecular assays for SARS-CoV-2 that received emergency use authorization (EUA) from the U.S. Food and Drug Administration. In order to determine the agreement among Roche cobas® SARS-CoV-2 Test (Cobas), Abbott RealTime SARS-CoV-2 assay (ART), and Mayo Clinic Laboratory SARS-CoV-2 Molecular Detection Assay (Mayo LDT), 100 each of anterior nares (AN), nasopharyngeal (NP), oropharyngeal (OP), and NP+OP swabs were tested on each platform. The consensus result was defined as agreement by 2 or more methods. Furthermore, 30 positive NP swabs from each molecular platform (n = 90 total) were tested on the three platforms to determine the PPA among positive samples. ART platform called more specimens positive than the other two platforms. All three assays performed with greater than 90% agreement for NP specimens throughout the study.
为满足 SARS-CoV-2 大流行期间的检测需求并克服供应链问题,许多临床实验室对多种 SARS-CoV-2 分子检测平台进行了验证。在这里,我们比较了美国食品和药物管理局 (FDA) 紧急使用授权 (EUA) 的三种不同的 SARS-CoV-2 分子检测方法。为了确定罗氏 cobas® SARS-CoV-2 测试 (Cobas)、雅培实时 SARS-CoV-2 检测 (ART) 和 Mayo 临床实验室 SARS-CoV-2 分子检测 (Mayo LDT) 之间的一致性,对每个平台的 100 个前鼻拭子 (AN)、鼻咽拭子 (NP)、口咽拭子 (OP) 和 NP+OP 拭子进行了测试。共识结果定义为两种或更多方法的一致。此外,对每个分子平台的 30 个阳性 NP 拭子(共 90 个)进行了三种平台的测试,以确定阳性样本之间的 PPA。ART 平台比其他两个平台检测到更多的阳性样本。在整个研究过程中,所有三种检测方法在 NP 标本上的一致性均大于 90%。