Tricore Reference Laboratory, Albuquerque, New Mexico, USA
Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA.
J Clin Microbiol. 2020 Dec 17;59(1). doi: 10.1128/JCM.02338-20.
The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID-19 symptoms. Two studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms (≤7 days from symptom onset [DSO], ≥18 years of age) were utilized to compare Veritor with the Lyra SARS-CoV-2 PCR assay (Lyra). In the second study, nasal specimens from 361 participants with COVID-19 symptoms (≤5 DSO, ≥18 years of age) were utilized to compare performance of Veritor to that of the Sofia 2 SARS Antigen FIA test (Sofia 2). The positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) were the primary outcomes. In study 1, the PPA for Veritor, compared to Lyra, ranged from 81.8 to 87.5% across the 0 to 1 and 0 to 6 DSO ranges. In study 2, Veritor had PPA, NPA, and OPA values of 97.4, 98.1, and 98.1%, respectively, with Sofia 2. Discordant analysis showed one Lyra positive missed by Veritor and five Lyra positives missed by Sofia 2; one Veritor positive result was negative by Lyra. Veritor met FDA emergency use authorization (EUA) acceptance criteria for SARS-CoV-2 antigen testing for the 0 to 5 and 0 to 6 DSO ranges (PPA values of 83.9% and 82.4%, respectively). Veritor and Sofia 2 showed a high degree of agreement for SARS-CoV-2 detection. The Veritor test allows for more rapid COVID-19 testing utilizing easy-to-collect nasal swabs but demonstrated <100% PPA compared to PCR.
BD Veritor 系统（Veritor）用于 SARS-CoV-2 核衣壳抗原的快速检测，这是一种用于 SARS-CoV-2 即时检测的色谱免疫分析方法，其临床性能已通过有 COVID-19 症状个体的鼻标本进行了评估。完成了两项研究以确定临床性能。在第一项研究中，利用 251 名有 COVID-19 症状（症状发作后≤7 天[DSO]，≥18 岁）的参与者的鼻标本和鼻咽或口咽标本，将 Veritor 与 Lyra SARS-CoV-2 PCR 检测（Lyra）进行了比较。在第二项研究中，利用 361 名有 COVID-19 症状（DSO≤5，≥18 岁）的参与者的鼻标本，将 Veritor 与 Sofia 2 SARS 抗原 FIA 检测（Sofia 2）的性能进行了比较。主要结局为阳性、阴性和总符合率（PPA、NPA 和 OPA，分别）。在研究 1 中，与 Lyra 相比，Veritor 的 PPA 在 0 至 1 天和 0 至 6 天 DSO 范围内分别为 81.8%至 87.5%。在研究 2 中，Veritor 与 Sofia 2 的 PPA、NPA 和 OPA 值分别为 97.4%、98.1%和 98.1%。不一致性分析显示，一个 Lyra 阳性结果被 Veritor 漏检，五个 Lyra 阳性结果被 Sofia 2 漏检，一个 Veritor 阳性结果被 Lyra 检测为阴性。Veritor 满足 FDA 对 SARS-CoV-2 抗原检测的紧急使用授权（EUA）接受标准，用于 0 至 5 天和 0 至 6 天 DSO 范围（PPA 值分别为 83.9%和 82.4%）。Veritor 和 Sofia 2 对 SARS-CoV-2 的检测具有高度一致性。Veritor 检测允许使用更易于采集的鼻拭子进行更快速的 COVID-19 检测，但与 PCR 相比，PPA ＜100%。
